Equine Product Range Second Edition Contents Antibiotics Pages 3 - 12 DevomycinPage 4 Metabolites Pages 27 - 28 Glutalyte Page 28 ® Devomycin DPage 5 Norocillin LAPage 6 Anthelmintics OpticloxPage 7 Noromectin® Page 30 Pen & Strep®Page 8 Cefenil®Page 9 Sulphonamides Pages 13 - 18 Norodine 24Page 14 ® Norodine PastePage 16 Pages 29 - 30 Vitamins Pages 31 - 34 Intravit 12 Page 32 CombivitPage 33 MultivitaminPage 34 ® Norodine® GranulesPage 17 Anti-inflammatories Pages 19 - 26 Pages 35 - 40 Lignocaine and Adrenaline Page 36 Multi Derm Range Page 37 ColvasonePage 20 Norofulvin® PastePage 38 EquinixinPage 21 Norofulvin® Granules Page 39 FlunixinPage 22 Water for Injections Page 40 NorocarpPage 24 Loxicom® Injection Page 25 Loxicom® Equine Oral Paste 2 Miscellaneous Page 26 ContactsPage 41 Products Overview Page 42 - 43 Antibiotics 3 Devomycin 250mg/ml Solution for Injection Presentation Operator Warnings A clear, pale yellow sterile aqueous solution containing: Streptomycin Sulphate 250mg/ml Do not handle this product if you are sensitised (allergic) to aminoglycoside antibiotics. Chlorocresol 1.0mg/ml In case of accidental contact with skin or eyes, wash the affected area with plenty of water immediately. Sodium Metabisulphate 1.0mg/ml Wash hands after use. Uses Devomycin is active against a wide range of Gram-negative organisms and some Gram-positive pathogens. It is indicated in the treatment of organisms sensitive to streptomycin. In particular E. coli, Klebsiella spp, Mycobacterium tuberculosis and some species of Proteus, Pasteurella and Salmonella. Use of the product should be based on susceptibility testing of bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Dosage and Administration For intramuscular injection only. The injection site should be massaged after administration. Horses, cattle and sheep: 1ml/25kg for up to 3 days (10mg streptomycin/kg bw). For cattle, the maximum dose volume to be administered at a single site is 10ml and for sheep is 5ml. Dogs and cats: 1ml/10kg (25mg streptomycin/kg bw). Care should be taken in computing the dose to avoid overdosage. Withdrawal Period Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 16 days from the last treatment. Milk for human consumption may only be taken from cattle after 48 hours from the last treatment. Sheep may be slaughtered for human consumption only after 18 days from the last treatment. Not to be used in ewes producing milk for human consumption. Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. Contraindications, Warnings, etc Contraindicated in cases of known hypersensitivity to the active ingredients. Excessive and prolonged administration can lead to interference with balance and hearing. In extreme cases damage can be permanent. Cats are the most susceptible animals. 4 Contraindicated in cases of known hypersensitivity to the active ingredients. Take particular care when treating animals suffering from renal damage. Pharmaceutical Precautions Do not store above 25ºC. Protect from light. Following withdrawal of the first dose, use the product within 28 days. When the container is broached for the first time, using the in-use shelf-life which is specified on the package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Legal Category POM-V To be supplied only on Veterinary Prescription. Package Quantities Multidose vials of 50ml and 100ml. VM No: 02000/4018 For Animal Treatment Only Keep out of reach and sight of Children Devomycin D Solution for Injection Presentation Operator Warnings A clear pale yellow sterile aqueous solution containing: Streptomycin Sulphate 150mg/ml Do not handle this product if you are sensitised (allergic) to aminoglycoside antibiotics. Dihydrostreptomycin Sulphate 150mg/ml Care should be taken to avoid accidental self-injection. In case of accidental injection seek medical advice. Chlorocresol 1.0mg/ml Sodium Metabisulphate 1.0mg/ml In case of accidental contact with skin or eyes, wash the affected area with plenty of water immediately. Uses Wash hands after use. For treatment of Horses, Cattle, Sheep, Dogs and Cats. Devomycin D Injection is active against a wide range of Gram-negative organisms and some Gram-positive pathogens. It is indicated in the treatment of organisms sensitive to Streptomycin. Among the more sensitive to streptomycin in vitro are Actinobacillus equuli, A. Lignieresii, Actinomyces bovis, Brucella spp, E. coli, Haemophilus spp, Klebsiella spp, Leptospira canicola and L. ictero-haemorrhagiae, Pseudomonas aeruginosa and some species of Proteus, Pasteurella and Salmonella. Pharmaceutical Precautions Do not store above 25ºC. Protect from light. Following withdrawal of the first dose, use the product within 28 days. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority Use of the product should be based on susceptibility testing of bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Legal Category Dosage and Administration Multidose vials of 100ml. For intramuscular injection only. VM No: 02000/4034 Horses, cattle and sheep: 10mg active ingredients/kg bodyweight daily (1ml/30kg bodyweight) for a maximum of 3 days. Dogs and cats: 25mg active ingredients/kg bodyweight daily (1ml/12kg bodyweight) for a maximum of 3 days. For Animal Treatment Only POM-V To be supplied only on Veterinary Prescription. Package Quantities Keep out of reach and sight of Children Care should be taken in computing the dose to avoid overdosage. Withdrawal Period Cattle Meat and Offal: 14 days Cattle Milk: 48 hours Do not inject more than 10ml of this product into any one injection site. Failure to heed this warning may lead to residues above the legal limit in food for human consumption. Sheep Meat and Offal: 14 days Not to be used in sheep producing milk for human consumption. Horses: Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. Contraindications, Warnings, etc Excessive and prolonged administration can lead to interference with balance and hearing. In extreme cases damage can be permanent. Cats are the most susceptible animals. Contraindicated in cases of known hypersensitivity to the active ingredients. Take particular care when treating animals suffering from renal damage. 5 Norocillin® LA Suspension for Injection Presentation Norocillin LA is a sterile white aqueous suspension. Each ml contains: Benzathine Penicillin 112.5mg Procaine Penicillin. 150.0mg Methyl Hydroxybenzoate 0.200% w/v Propyl Hydroxybenzoate 0.020% w/v as antimicrobial preservatives. Uses Norocillin LA is indicated in the treatment of systemic infections caused by or associated with organisms sensitive to penicillin in Horses, Dogs and Cats. Procaine Penicillin when administered by intramuscular injection will provide effective therapeutic blood levels for approximately 24 hours, whilst benzathine penicillin is absorbed slowly in the tissue fluid and maintains blood levels for three to four days. Hypersensitivity to penicillin may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. 1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. 2. Handle this type of product with great care to avoid exposure, taking all recommended precautions. 3. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use. Norocillin LA is of particular value in reducing the number of injections in a course of penicillin therapy. Pharmaceutical Precautions Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information. Protect from light. Dosage and Administration By deep intramuscular injection only. This product is recommended for a single administration only. Horses: 6mg/kg bodyweight procaine penicillin with 4.5mg/kg bodyweight benzathine penicillin equivalent to 1ml per 25kg bodyweight. Dogs and Cats: 15mg/kg procaine penicillin with 11.25mg/kg benzathine penicillin equivalent to 1ml per 10kg bodyweight e.g. Store below 25ºC. Following withdrawal of the first dose, use the product within 28 days. Discard unused material. When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this package leaflet, the date on which any product remaining in the container should be worked out. This discard date should be written in the space provided on the label. Keep the container in outer carton. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Species Weight Dose Volume Legal Category Horses Dogs Cats 500kg 10kg 5kg 20ml 1ml 0.5ml POM-V To be supplied only on Veterinary Prescription. Shake the container before use. An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small dose volumes. This product is recommended for single administration only. Withdrawal Periods Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. Contraindications, Warnings, etc Contraindicated in known cases of hypersensitivity to penicillins. Do not inject intravenously. Care should be taken not to overdose. Not to be used on very small herbivores such as guinea pigs, gerbils and hamsters. 6 Not effective against beta-lactamase producing organisms. Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Package Quantities 50ml/100ml VM No: 02000/4057 For Animal Treatment Only Keep out of reach and sight of Children Opticlox Eye Ointment 16.7% w/w Presentation Pharmaceutical Precautions A smooth sterile cream for ophthalmic use. Do not store above 25ºC. Each 5g syringe contains: 16.7% w/w Cloxacillin (as cloxacillin benzathine 21.3% w/w) In a long- acting base. Each syringe should be used on one occasion only. Cloxacillin Benzathine is a semi-synthetic penicillin derived from 6 amino-penicillanic acid. Uses For the treatment of eye infections caused by Staphylococcus spp, and Bacillus spp, in cattle, sheep, horses, dogs and cats. Dosage and Administration For topical administration only. Evert the lower eyelid and instil a steady flow of ointment into the lower conjunctival sac. Dosage Guide Unused ointment should be discarded after treatment. For external use only. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Legal Category POM-V To be supplied only on Veterinary Prescription. Package Quantities Opticlox Eye Ointment is supplied in cartons of 4 x 5g syringes. VM No: 02000/4075 For Animal Treatment Only Keep out of reach and sight of Children Cattle and Horses: Approximately 5-10 cm of ointment per eye. Sheep: Approximately 5 cm of ointment per eye. Dogs and Cats: Approximately 2 cm of ointment per eye. Normally a single application only is required; but treatment may be repeated after 48 to 72 hours if necessary. For animals with only a single infected eye it is recommended to prevent cross infection, that both eyes be treated; treating the uninfected eye first to avoid transferring the infection. Each syringe should be used on one occasion only. Withdrawal Period Withdrawal period: Meat/milk - Nil. Contraindications, Warnings, etc Operator Warning Penicillin/Cephalosporin Sensitivity: Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. 1. Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations. 2. Handle this product with great care to avoid exposure, taking all recommended precautions. 3. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention. Wash hands after use. 7 Pen & Strep® Suspension for Injection Presentation Contraindications, Warnings, etc A white to off-white aqueous suspension for parenteral administration. Each ml contains: Procaine Penicillin 200mg Contraindicated in known cases of hypersensitivity to penicillins. Occasionally in sucking and fattening pigs administration of this product may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. Additionally in pregnant sows and gilts, a vulval discharge which could be associated with abortion, has been reported. Care should be taken not to exceed the recommended dosage. Dihydrostreptomycin Sulphate 250mg Hydroxybenzoate Esters (as Nipasept sodium) as antimicrobial preservative 1.5mg Sodium Formaldehyde Sulphoxylate Dihydrate as antioxidant 1.25mg Uses Pen & Strep Injection is indicated for use in cattle, horses, pigs and sheep for the treatment of infections caused by, or associated with, organisms sensitive to Penicillin and/or Streptomycin including: Arcanobacterium pyogenes, Erysipelothrix rhusiopathiae, Klebsiella pneumonia, Listeria spp, Mannheimia haemolytica, Pasteurella multocida, Staphylococcus spp, Streptococcus spp and Salmonella spp. Pen & Strep will therefore be effective in the treatment of infections caused by susceptible organisms including: Erysipelas; navel/joint ill; respiratory tract infections including pneumonia and atrophic rhinitis; listeriosis; meningitis; septicaemia; toxaemia associated with mastitis; urogenital tract infections; enteritis associated with Salmonella spp, salmonellosis; and the control of secondary bacterial invaders in diseases of primary viral origin. The combination of penicillin and dihydrostreptomycin is especially useful in the treatment of mixed infections involving both Gram-positive and Gram-negative organisms. Penicillin/Cephalosporin Sensitivity: Care should be taken to avoid accidental self-injection. In the case of accidental self-injection, seek medical advice immediately. Penicillins and cephalosporins may cause sensitisation following injection, inhalation, ingestion or skin contact. Sensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances are occasionally serious. 1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. 2. Handle this product with great care to avoid exposure taking all recommended precautions. 3. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention. 4. Wash hands after use. Pharmaceutical Precautions Dosage and Administration Shake the container before use. The recommended daily dose for cattle, horses, pigs and sheep is 8mg procaine penicillin and 10mg dihydrostreptomycin sulphate per kg bodyweight achieved by administering 1ml Pen & Strep per 25kg bodyweight. The dose should be given once daily by deep intramuscular injection for up to three consecutive days. The maximum dose volume administered at one site should not exceed 15ml for horses, 6ml for cattle, 3ml for sheep and 1.5ml for pigs. Do not store above 25ºC. Protect from light. Withdrawal Period Following withdrawal of the first dose, use the product within 28 days. Discard unused material. Keep container in outer carton. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Legal Category POM-V To be supplied only on Veterinary Prescription. Animals must not be slaughtered for human consumption during treatment. Sheep, Milk: Not to be used in sheep producing milk for human consumption. Package Quantities Sheep, Meat: 31 days. VM No: 02000/4100 Cattle, Milk: 60 hours. Milk for human consumption must not be taken during treatment. For Animal Treatment Only Cattle, Meat: 23 days. Pigs, Meat: 18 days. Horses: Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. 8 Operator Warnings 50ml and 100ml vials. Keep out of reach and sight of Children Cefenil® 50mg/ml Powder and Solvent for Solution for Injection for Cattle, Pigs and Horses Presentation Vials containing a powder for solution for injection. Vials contain either 1g or 4g ceftiofur as the sterile, freeze-dried sodium salt. Ceftiofur sodium is an off-white to brown coloured powder requiring reconstitution with water for injection. Each ml reconstituted solution contains ceftiofur sodium equivalent to 50mg ceftiofur. In pigs, an appropriately-graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting piglets weighing less than 16kg. Do not administer more than 10ml per injection site. Do not exceed 20 broachings per vial. If more than 20 broachings are required, the use of a draw-off needle is recommended. Uses Contraindications, Warnings etc. Cattle: Treatment of cattle with acute bacterial respiratory disease in which Mannheimia haemolytica, Pasteurella multocida or Histophilus somni sensitive to ceftiofur are involved. Treatment of cattle with acute interdigital necrobacillosis (foul in the foot) in which Fusobacterium necrophorum and Bacteroides melaninogenicus are involved. Do not use in animals previously found to be hypersensitive to ceftiofur and other b-lactam antibiotics. Pigs: Treatment of pigs with bacterial respiratory disease in which Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida and/or Streptococcus suis sensitive to ceftiofur are involved. Horses: Treatment of horses with bacterial respiratory disease in which Streptococcus spp including Streptococcus zooepidermicus and Streptococcus equi, Staphylococcus spp and/or Pasteurella spp are involved. Dosage and Administration This product is for intramuscular use only. See section 4.5(i). Normal aseptic injection technique should be practiced. Reconstitution 1 g vial: reconstitute by adding 20ml of water for injection. 4 g vial: reconstitute by adding 80ml of water for injection. Directions for Reconstitution 1. Remove stopper overseal from diluent and sterile powder vials. 2. Remove exactly 20ml (80ml) Water for Injections using a sterile 18G needle and syringe. 3. Inject the exact volume of diluent into sterile powder vial. 4. Shake solution until complete reconstitution of powder occurs. Rapid addition of diluent maintained at room temperature will give best results. Normally accepted aseptic technique should be followed during reconstitution to avoid microbial contamination. The resulting solution contains 50mg of ceftiofur per ml. Dosage in Cattle, Pigs and Horses Target species Dosage Dosage of reconstituted product Indication Frequency of administration Respiratory disease Once daily at 24 hour intervals for 3-5 days in total Do not use in case of known resistance to the active substance. Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans. Special Warnings for Each Target Species The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhoea, which could be fatal. If acute diarrhoea is observed, discontinue use of this antimicrobial and initiate appropriate therapy. Special Precautions for Use Cefenil 50mg/ml Powder and Solvent for Solution for Injection selects for resistant strains such as bacteria carrying extended spectrum betalactamases (ESBL) and may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, Cefenil 50mg/ml Powder and Solvent for Solution for Injection should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly (refers to very acute cases when treatment must be initiated without bacteriological diagnosis) to first line treatment. Official, national and regional antimicrobial policies should be taken into account when the product is used. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of such resistance. Whenever possible, Cefenil 50mg/ml Powder and Solvent for Solution for Injection should only be used based on susceptibility testing. Cefenil 50mg/ml Powder and Solvent for Solution for Injection is intended for treatment of individual animals. Do not use for disease prevention or as a part of herd health programmes. Treatment of groups of animals should be strictly restricted to ongoing disease outbreaks according to the approved conditions of use. Foul in the foot Once daily at 24 hour intervals for 3 days in total If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria and may decrease the effectiveness of treatment with other cephalosporins, due to the potential for cross resistance. 1ml/16kg Respiratory disease Once daily at 24 hour intervals for 3 days in total In the pig, particular care must be taken to avoid injection into the fat tissue. 2ml/50kg Respiratory disease Once daily at 24 hour intervals for up to 10 days in total (or 48 hours after clinical signs have disappeared) Avoid repeated injection at the same site. Cattle 1mg/kg 1ml/50kg Pigs 3mg/kg Horses 2mg/kg 9 Cefenil® 50mg/ml Powder and Solvent for Solution for Injection for Cattle, Pigs and Horses Continued Special precautions to be taken by the person administering the veterinary medicinal product to animals. Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Pharmaceutical Precautions Do not handle this product if you are sensitised or if you have been advised not to work with such preparations. Shelf-life of diluent: 2 years. Handle this product with great care to avoid exposure, taking all recommended precautions. Keep the container in the outer carton in order to protect from light. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Any reconstituted product remaining after the stated periods should be discarded. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Diluent: Store in the refrigerator (2°C to 8°C). Wash hands after use. Adverse Reactions (Frequency and Seriousness) Use of this product may cause transient local discomfort at the site of the injection. Hypersensitivity reactions can occasionally occur. In the case of an allergic reaction, treatment should be stopped. In pigs, local irritation at the injection site may occur and can persist for 5 days or more. Use During Pregnancy, Lactation or Lay Laboratory studies in the rat have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been assessed during pregnancy and lactation in cattle, pigs or horses. Use only according to the benefit/risk assessment by the responsible veterinarian. Interaction with Other Medicinal Products and Other Forms of Interaction None known. Overdose (Symptoms, Emergency Procedures, Antidotes), if Necessary In cattle, no evidence of systemic toxicity was observed following administration of an overdose. In pigs, no evidence of systemic toxicity was observed following the administration of doses of up to 8 times the recommended dose, administered daily by intramuscular injection for 15 days. Withdrawal Periods Cattle Meat and offal 1 day Milk zero hours Pigs Meat and offal 2 days Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. 10 In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. Shelf life of the veterinary medicinal product as packaged for sale: 18 months. Shelf-life of the veterinary medicinal product after reconstitution: 24 hours. Store unreconstituted product in the refrigerator (2°C to 8°C). After reconstitution, store in a refrigerator (2°C to 8°C). Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Package Quantities Powder: Type II clear glass vials sealed by bromobutyl stoppers and an aluminium seal with a cool green (1g) or yellow (4g) flip-off plastic disc. Diluent: Type I clear glass vials sealed with bromobutyl stoppers and aluminium caps. One vial with 1 g Cefenil Sterile Powder with one vial with 20ml Water for Injections per carton in packs of 1, 6 and 12 presentations. One vial with 4 g Cefenil Sterile Powder with one vial with 80ml Water for Injections per carton in packs of 1, 6 and 12 presentations. Not all pack sizes may be marketed. Pharmacodynamic Properties The active ingredient, ceftiofur sodium, is a third-generation cephalosporin (beta-lactam antibiotic) which acts against both gram-positive and gram-negative bacteria, including betalactam-producing bacteria. Also its main metabolite, desfuroylceftiofur, shows some antibacterial activity. Ceftiofur is a bactericidal antibiotic in vitro which acts by interfering with bacterial cell-wall synthesis. In cattle, ceftiofur is active against the following microorganisms found in respiratory-tract infections: Mannheimia haemolytica, Pasteurella multocida, Histophilus somni as well as the following bacteria responsible for acute interdigital necrobacillosis: Fusobacterium necrophorum and Bacteroides melaninogenicus. In pigs, ceftiofur is active against the following microorganisms: Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida and/or Streptococcus suis. In horses, ceftiofur is active against the following microorganisms, found in respiratory-tract infections: Streptococcus spp (including Streptococcus zooepidermicus and Streptococcus equi), Staphylococcus spp, Pasteurella spp. Cell wall synthesis is dependent on enzymes that are called penicillin-binding proteins (PBP’s). Bacteria develop resistance to cephalosporins by four basic mechanisms: 1) altering or acquiring penicillin binding proteins insensitive to an otherwise effective b-lactam; 2) altering the permeability of the cell to Cefenil® 50mg/ml Powder and Solvent for Solution for Injection for Cattle, Pigs and Horses Continued b-lactams; 3) producing b-lactamases that cleave the b-lactam ring of the molecule, or 4) active efflux. The following ceftiofur breakpoints are used: 2 μg/mL (Susceptible), 4 μg/mL (Intermediate) and 8 μg/mL (Resistant). The following Minimum Inhibitory Concentrations (MIC) have been determined for ceftiofur in European isolates (France, United Kingdom, Netherlands, Denmark, Germany, Belgium, Italy, Czech Republic, Ireland, Poland and Spain) collected from diseased animals between 2000 to 2007: MIC of ceftiofur (μg/mL) Bacteria species Origin Year No. of strains Range MIC50 MIC90 Pasteurella multocida Cattle 2004 to 2006 82 0.0019 – 0.0625 0.003 0.005 Pigs 2004 to 2006 66 0.0019 – 0.0156 0.003 0.006 Mannheimia haemolytica Cattle 2004 to 2006 72 0.0019 – 0.0156 0.005 0.008 Haemophilus somnus Cattle 2005 to 2007 62 0.0019 – 0.125 0.004 0.02 Actinobacillus pleuropneumoniae Pigs 2003 / 2004 58 0.0039 – 0.0312 0.006 0.02 Streptococcus suis Pigs 2004 to 2006 44 0.0312 – 0.5 0.2 0.3 Fusobacterium necrophorum Cattle 2000 to 2006 27 0.015 – 16 0 0.1 0.2 Rhodoccus equi Horses 2002 to 2003 64 0.5 - 2 0.5 2.0 Streptococcus spp Horses 2002 to 2003 47 0.5 0.5 0.5 Staphylococcus spp Horses 2002 to 2003 18 0.5 - 4 0.5 4.0 Pasteurella spp Horses 2002 to 2003 11 0.5 0.5 0.5 The following ceftiofur breakpoints are used: 2 μg/mL (Susceptible), 4 μg/mL (Intermediate) and 8 μg/mL (Resistant). Pharmacokinetic Particulars After intramuscular administration ceftiofur is quickly metabolised to desfuroylceftiofur which reaches maximum plasma concentration within 1 hour. The plasma half-life for desfuroylceftiofur is on average over 9 hours in cattle and 13 hours in pigs. No accumulation has been shown after several administrations. Legal Category POM-V To be supplied only on Veterinary Prescription. Marketing Authorisation Number VM No: 02000/4306 For Animal Treatment Only. Keep out of reach and sight of Children. 11 “ When you are on a great horse, you “ have the best seat you will ever have. Sir Winston Churchill 12 Sulphonamides 13 Norodine® 24 Solution for Injection Presentation Withdrawal Period A clear yellow aqueous solution for parenteral administration containing as active ingredients per ml: Sulfadiazine 200mg Milk for human consumption must not be taken from a cow during treatment. Trimethoprim 40mg Animals must not be slaughtered for human consumption during treatment. Preservative: Chlorocresol 1mg/ml Not to be used in horses intended for human consumption. Antioxidant: Sodium Formaldehyde Sulphoxylate Dihydrate 1mg/ml Treated horses may never be slaughtered for human consumption. Uses Norodine 24 is indicated in the treatment of acute, subacute and chronic conditions of bacterial origin in horses, cattle, pigs, dogs and cats. The therapeutic spectrum includes both Gram-negative and Gram-positive bacteria including Streptococci, Staphylococci, Actinobacilli, Actinomycae, Salmonella, Pasteurella, Pneumococci, Proteus, E. coli, Corynebacteria, Vibrio, Bordetella, Brucella, Klebsiellae and Haemophilae. It is also indicated in species where there may be an existing antibiotic drug resistance. Norodine 24 may be administered in respiratory infections of bacterial origin including rhinitis, pneumonia, bronchitis and in bacterial infections secondary to viral disease such as viral pneumonia or mycoplasma infections. It is also indicated in urogenital tract infections (cystitis, vaginitis, urethritis, nephritis and metritis) and alimentary tract infections (including neonatal diarrhoea and salmonellosis). Other infections include foul-in-the-foot, severe mastitis, bacterial agalactia of sows, and infections of eye, ear and mouth. Dosage and Administration For cattle and pigs the dose is 1ml per 16kg bodyweight daily by intramuscular or slow intravenous injection. Norodine 24 may be administered by intravenous injection when rapid blood levels of sulfadiazine and trimethoprim are required. For horses the dose is 1ml per 16kg bodyweight by slow intravenous injection. For dogs and cats the dose is 1ml per 8kg bodyweight, by subcutaneous injection only. The recommended site in dogs is the loose skin at the top of the neck. A single injection may be sufficient in uncomplicated conditions, but in severe infections they may be repeated daily until two days after the symptoms resolve, up to a maximum of 5 days. An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes. Advice on Correct Administration Injections should not be given by routes other than those recommended. Not to be administered intraperitoneally. 14 The horse must have been declared as not intended for human consumption under national horse passport legislation. Cattle: Meat 12 days Milk 48 hours Pigs: Meat 20 days Contraindications, Warnings, etc Norodine 24 is contraindicated in animals with known sulfonamide sensitivity, severe liver parenchymal damage, or blood dyscrasias. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. Pharmaceutical Precautions Do not store above 25ºC. Protect from freezing. Crystallization of the product at low temperatures can be reversed by gentle warming. Protect from light. Following withdrawal of the first dose, use the product within 28 days. Discard unused material. Adequate drinking water should be available during the therapeutic effect of the product. Do not administer to horses exhibiting drug-induced cardiac arrhythmias. Such arrhythmias may be associated with the administration of certain anaesthetic and sedative agents. Anaphylactic shock, potentially fatal, has been observed on rare occasions following administration of potentiated sulfonamide preparations, particularly by the intravenous route. Veterinary surgeons should be mindful of this possibility during the injection process. For intravenous administration the product should be warmed to body temperature and injected slowly over as long a period as is reasonably practical. At the first sign of intolerance the injection should be interrupted and shock treatment initiated. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Norodine® 24 Solution for Injection Continued User Warnings Legal Category Care should be taken to avoid accidental self-injection and contact with the skin. POM-V To be supplied only on Veterinary Prescription. Wash hands after use. Package Quantities Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics. Multidose vials of 50ml and 100ml. Allergic reactions to these substances may occasionally be serious. For Animal Treatment Only 1. Do not handle this product if you know you are sensitive to sulphonamides. Keep out of reach and sight of Children Not all pack sizes may be marketed. VM No: 02000/4061 2. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Further Information When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label. 15 Norodine® Equine Oral Paste Presentation Contraindications, Warnings, etc Each syringe contains 45g of oral paste containing: Trimethoprim 5.80% w/w Sulfadiazine 28.83% w/w Do not use in cases of known hypersensitivity, severe hepatic dysfunction or cardiac arrhythmias. Do not use the same syringe to treat more than one animal unless horses are running together or in direct contact with each other on the same premises. The product can be safely administered during pregnancy and lactation. Uses Indicated in the treatment of bacterial infections in horses caused by sensitive microorganisms including: Escherichia coli, Rhodococcus (Corynebacterium) equi, Staphylococcus spp and Streptococcus spp. Norodine Equine Paste may be effective in treating the following conditions. Alimentary tract infections including diarrhoea. Respiratory infections including pneumonia, pleurisy, strangles. Wounds, septicaemia and general infections. Use of the following product should be based on susceptibility testing and take into account official and local antimicrobial policies. Take care to avoid skin and eye contact. Gloves and suitable eye protection should be worn whilst handling this product. Wash hands and exposed skin after use. Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics. Allergic reactions to these substances may occasionally be serious. Dosage and Administration 1. Do not handle this product if you know you are sensitive to sulphonamides. Dosages: The daily dose is 30mg combined active ingredients per kg bodyweight. 2. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Each syringe provides one daily dose for a 500kg horse. Each division on the dial-a-dose plunger provides sufficient product to treat 50kg of bodyweight. Treatment should be continued for up to five days or until two days after symptoms have resolved. Drug absorption may be greater if food is withheld for a few hours prior to dosing. Administration: Adjust screw gauge on dial-a-dose plunger to the bodyweight of the horse. Remove cap from nozzle. Place nozzle in corner of mouth. Depress plunger depositing paste on upper surface of tongue. Replace cap after use. Pharmaceutical Precautions Do not store above 25°C. Do not freeze. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Legal Category POM-V To be supplied only on Veterinary Prescription. Package Quantities 3 x 45g dial-a-dose Syringe. Withdrawal Period VM No: 02000/4098 Not to be used in horses intended for human consumption. For Animal Treatment Only Treated horses may never be slaughtered for human consumption. Keep out of reach and sight of Children The horse must have been declared as not intended for human consumption under national horse passport legislation. 16 Norodine® Granules Presentation Withdrawal Period White to off-white granules with broad-spectrum antibacterial activity. Presented in aluminium foil sachets. Norodine Granules are for oral administration to horses after mixing with feed. Not to be used in horses intended for human consumption. Each sachet contains 37.5 g of product containing: Trimethoprim 2.5g Sulfadiazine 12.5g Uses For the treatment of bacterial infections in horses. Norodine is a broad-spectrum antibacterial, active against a wide range of Gram-positive and Gram-negative organisms. Together the active ingredients produce a double blockade of folinic acid synthesis in bacteria resulting in a level of activity much greater than that obtained from either drug alone. In vitro Norodine is effective against Escherichia coli, Rhodococcus equi, Staphylococcus spp and Streptococcus spp. When susceptible organisms are present Norodine Granules may be effective in treating the following conditions: Alimentary tract infections including diarrhoea. Respiratory tract infections including pneumonia, pleurisy and strangles. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. Contraindications, Warnings, etc Do not use in horses with known sulphonamide sensitivity, with hepatic damage or with blood dyscrasias. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. Operator Warnings Avoid inhalation and take care to avoid skin and eye contact. Gloves and suitable eye protection should be worn whilst handling this product. Wash hands and exposed skin after use. Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics. Allergic reactions to these substances may occasionally be serious. Wounds, septicaemia and general infections. 1. Do not handle this product if you know you are sensitive to sulphonamides. Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. 2. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Dosage and Administration Pharmaceutical Precautions Dosage: The daily dose is 30mg combined active ingredients per kg bodyweight (25mg sulfadiazine and 5mg trimethoprim per kg bodyweight). Each sachet contains one daily dose for a 500kg horse. Any unused drug in open sachets remaining after the course of treatment should be discarded. Daily Dosage Guide: Bodyweight 100kg 200kg 300kg 400kg 500kg Weight of Norodine Granules 7.5g 15g 22.5g 30g 37.5g Number of Scoops ½ 1 1½ 2 Whole Sachet Treatment should be continued for up to 5 days or until 2 days after symptoms have resolved. The scoop provided dispenses 15g of granules. Administration Do not store above 25ºC. Dispose of any unused product, unused medicated feed and empty containers in accordance with guidance from your local waste regulation authority. Legal Category POM-V To be supplied only on Veterinary Prescription. Package Quantities Cartons of 10 sachets, each sachet containing 37.5g of Norodine Granules. VM No: 02000/4114 For Animal Treatment Only Keep out of reach and sight of Children After careful estimation of the weight of the horse, the required dose of Norodine Granules should be mixed well with the horse’s feed prior to administration. Add to feed immediately before administration. Discard any remaining medicated feed. 17 “ “ A horse! A horse! My kingdom for a horse! William Shakespeare (Richard III) 18 Anti-inflammatories 19 Colvasone 0.2% w/v Solution for Injection Presentation A sterile solution for injection containing: Dexamethasone Sodium Phosphate 2mg/ml Benzyl Alcohol as preservative 20mg/ml Uses Dexamethasone is a synthetic corticosteroid with a potent anti-inflammatory action: Colvasone can be used for: 1. Intravenous therapy in cases where emergency treatment is indicated, particularly shock and circulatory collapse, fog fever, acute mastitis and burns. 2. Acetonaemia (Ketosis) in cattle: Colvasone has a marked glucogenic action. 3. Inflammatory conditions in all species: Colvasone will suppress inflammation and is indicated in the treatment of arthritis, laminitis (excluding horses), dermititis, etc. Dosage and Administration By intravenous or intramuscular injection. Normal aseptic precautions should be observed. Horses and cattle: 1ml per 25kg bodyweight Dogs and cats: 1ml per 10kg bodyweight Animal Weight kg Dose Horses Cattle Dogs Cats 500kg 400kg 10kg 5kg 20ml 16ml 1ml 0.5ml To ensure accuracy of dosing, a suitably graduated syringe should be used when treating small animals. Withdrawal Period Cattle must not be slaughted for human consumption during treatment. Cattle may be slaughtered for human consumption only after 21 days from the last treatment. Milk must not be taken for human consumption during treatment. Milk for human consumption may be taken from cows only from 84 hours after the last treatment. Do not use in horses intended for human consumption. Contraindications, Warnings, etc Care should be taken to avoid accidental self-injection. Consideration should therefore be given to means of minimising problems of adrenal insufficiency following the withdrawal of treatment, e.g. a gradual reduction of dosage (for further discussion see standard texts). Systemically acting corticosteroids may cause polyuria, polydipsia and polyphagia, particularly during the early stages of therapy. Some corticosteroids may cause sodium and water retention and hypokalaemia in long term use. Systemic corticosteroids have caused deposition of calcium in the skin (calcinosis cutis). Corticosteroids are not recommended for use in pregnant animals. Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals. Administration in late pregnancy may cause early parturition or abortion. Corticosteroids may delay wound healing and the immunosuppressant actions may weaken resistance to or exacerbate existing infections. In the presence of bacterial infection, anti-bacterial drug cover is usually required when steroids are used. In the presence of viral infections, steroids may worsen or hasten the progress of the disease. Gastrointestinal ulceration has been reported in animals treated with corticosteroids and gastrointestinal ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in corticosteroid-treated animals with spinal cord trauma. Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes. Use of the product in horses could induce laminitis and therefore careful observations during treatment should be made. During a course of treatment the situation should be reviewed frequently by close veterinary supervision. Pharmaceutical Precautions Do not store above 25°C. Once a vial has been broached, the contents should be used within 28 days. Discard any unused material. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Systemic corticosteroid therapy is generally contraindicated in patients with renal disease and diabetes mellitus. Wash hands after use. Anti-inflammatory corticosteroids, such as dexamethasone, are known to exert a wide range of side effects. Whilst single high doses are generally well tolerated, they may induce severe side-effects in long term use and when esters possessing a long duration of action are administered. Legal Category Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms. Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral 20 metabolism, e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result. During therapy effective doses suppress the Hypothalamo-PituitrealAdrenal axis. Following cessation of treatment, symptoms of adrenal insufficiency extending to adrenocorticol atrophy can arise and this may render the animal unable to deal adequately with stressful situations. POM-V To be supplied only on Veterinary Prescription. Package Quantities Multidose vials of 50ml. VM No: 02000/4009 For Animal Treatment Only Keep out of reach and sight of Children Equinixin 2.5% w/w Granules for Horses Presentation White to cream coloured granules containing: 250mg Flunixin, as Flunixin Meglumine per 10 gram sachet. Uses Flunixin meglumine is a relatively potent non-narcotic, non-steroidal analgesic with anti-inflammatory and anti-pyretic properties for use in treating horses. Horses intended for racing and competition should be prevented from racing or competing when in need of treatment and horses which have been recently treated should be dealt with according to local requirements. Appropriate precautions must be taken to ensure compliance with competition regulations. If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. In the horse, Equinixin Granules are indicated for the alleviation of inflammation and pain associated with musculoskeletal disorders. Overdosage is associated with gastrointestinal toxicity. Dosage and Administration Avoid inhalation, contact with eyes and direct contact with skin. In case of spillage onto skin wash immediately with water. In the case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice. Equinixin Granules is indicated for oral administration to horses. Easily administered by sprinkling on a small amount of food. Add to feed immediately before administration. Discard any remaining medicated feed. The recommended dosage is the contents of one sachet (10 grams) Equinixin Granules per 227kg (500 lbs) bodyweight (equivalent to 1.1mg flunixin per kg) once daily for up to 5 consecutive days according to clinical response. Withdrawal Period Horses may be slaughtered for human consumption only after 15 days from the last treatment. Operator Warnings To avoid possible sensitisation reactions, avoid contact with the skin. Gloves should be worn during application. Wash hands after use. The product may cause reactions in sensitive individuals. If you have known hypersensitivity for non-steroidal anti-inflammatory products do not handle the product. Reactions may be serious. Do not use in mares producing milk for human consumption. Pharmaceutical Precautions Contraindications, Warnings, etc Do not store above 25°C. Do not administer the product to pregnant mares. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Keep the sachet in the outer carton. Gastrointestinal tract ulceration may be exacerbated by corticosteroids in patients given NSAIDs. POM-V To be supplied only on Veterinary Prescription. Concurrent administration of potentially nephrotoxic drugs should be avoided. Package Quantities It is preferable that NSAID’s which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered. Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastrointestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Legal Category 10 gram laminated foil sachets containing white to cream coloured granules. Cartons of 10 sachets, each sachet contains 250mg of Flunixin. VM No: 02000/4241 For Animal Treatment Only Keep out of reach and sight of Children Do not exceed the recommended dose or the duration of treatment. Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity. 21 Flunixin 50mg/ml Solution for Injection for Cattle, Horses and Pigs Presentation Withdrawal Period Flunixin Injection is a clear colourless solution for injection containing, per ml: Flunixin, as Flunixin Meglumine 50mg Cattle: Meat: 7 Days Milk: 36 Hours Phenol, as preservative 5mg Horses: Meat: 7 Days Sodium Formaldehyde Sulphoxylate Dihydrate 2.5mg Pigs: Meat: 22 Days Uses Do not use in mares producing milk for human consumption. Flunixin meglumine is a relatively potent non-narcotic, non-steroidal analgesic with anti-inflammatory, anti-endotoxic and anti-pyretic properties. In horses, indicated for the alleviation of inflammation and pain associated with musculoskeletal disorders and for the alleviation of visceral pain associated with colic, also indicated for the treatment of endotoxaemia or septic shock associated with gastric torsion and for other conditions in which the circulation of the blood to the gastrointestinal tract is compromised. Contraindications, Warnings, etc In cattle, indicated for the control of acute inflammation associated with respiratory disease. It may also be used as adjunctive therapy in the treatment of acute mastitis. In Pigs, Flunixin Injection is indicated as an adjunctive therapy in the treatment of swine respiratory diseases. Dosage and Administration Flunixin Injection is indicated for intravenous administration to cattle and horses and intramuscular injection to pigs. Horses: For use in equine colic, the recommended dose rate is 1.1mg flunixin/kg bodyweight equivalent to 1ml per 45kg bodyweight. Treatment may be repeated once or twice if colic recurs. For use in musculoskeletal disorders, the recommended dose rate is 1.1mg flunixin/kg bodyweight equivalent to 1ml per 45kg bodyweight, once daily for up to 5 days according to clinical response. For the treatment of endotoxaemia or septic shock associated with gastric torsion and with other conditions in which the circulation of blood to the gastrointestinal tract is compromised: 0.25mg/kg (1ml per 200kg) every 6-8 hours. Cattle: The recommended dose rate is 2.2mg flunixin/kg bodyweight equivalent to 2ml per 45kg bodyweight. Repeat as necessary at 24 hour intervals for up to 5 consecutive days. Pigs: For use in pigs, the recommended dose rate is 2ml per 45kg bodyweight (equivalent to 2.2mg flunixin/kg) once by intramuscular injection, in the neck, in conjunction with appropriate antimicrobial therapy. The injection volume should be limited to a maximum of 5ml per injection site. The stopper should not be punctured more than 50 times. A draw off needle should be used to avoid excessive puncturing of the stopper. Do not exceed the recommended dose or duration of treatment. An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes. Cattle should be treated with flunixin in conjunction with disease-specific therapy and an improvement in housing conditions. The use of flunixin in conjunction with disease-specific antibiotic therapy may mask antibiotic resistance of the bacteria, due to alleviation of inflammation symptoms. 22 Do not exceed the recommended dose or the duration of treatment. Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product. Do not use in dehydrated animals suffering from ileus associated colic. The cause of the underlying inflammatory condition or colic should be determined and treated with appropriate concomitant therapy. Non-steroidal anti-inflammatory drugs are not permitted under the Rules of Racing and under rules covering other competitive events. Horses intended for racing and competition should be prevented from racing or competing when in need of treatment and horses which have been Flunixin Injection recently treated should be dealt with according to local requirements. Appropriate precautions must be taken to ensure compliance with competition regulations. Due to the excipient propylene glycol, life-threatening shock reactions may occur in rare cases. The solution for injection should therefore be injected slowly and be of approximate body temperature. Avoid intra-arterial injection. Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management. Do not use in piglets weighing less than 6kg. Avoid use in any dehydrated, hypovolaemic or hypotensive animal except in the case of endotoxaemia or septic shock. It is preferable that NSAIDs, which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered. Flunixin meglumine is a non-steroidal anti-inflammatory drug (NSAID). Untoward effects include gastrointestinal irritation, ulceration and, in dehydrated or hypovolaemic animals, potential for renal damage. In pigs, transient irritation may occur at the injection site, this resolves spontaneously within 14 days. Rare cases of anaphylactic reaction have been reported. May be used in pregnant and lactating cattle. Do not administer to pregnant mares. Do not administer to pregnant sows, gilts at mating and in breeding boars. Safety studies in pregnant mares or sows have not been conducted. The product should not be used in lactating sows. Monitor drug compatibility closely where adjunctive therapy is required. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. Flunixin 50mg/ml Solution for Injection for Cattle, Horses and Pigs Continued Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Concurrent administration of potentially nephrotoxic drugs should be avoided. Overdose studies in the target species have shown the product to be well tolerated. Overdosage is associated with gastrointestinal toxicity. In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products. Operator Warnings Avoid eye contact and direct contact with skin. In the case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice. Avoid accidental self-injection. To avoid possible sensitisation reactions, avoid contact with the skin. Gloves should be worn during application. The product may cause reactions in sensitive individuals. If you have known hypersensitivity for non-steroidal anti-inflammatory products do not handle the product. Reactions may be serious. Wash hands after use. Pharmaceutical Precautions Do not store above 25°C. Keep the vial in the outer carton to protect from light. Avoid introduction of contamination. Following withdrawal of the first dose, use the product within 28 days. Discard unused product. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Legal Category POM-V To be supplied only on Veterinary Prescription. Package Quantities Multi-dose vials of 50ml, 100ml and 250ml. VM No: 02000/4170 For Animal Treatment Only Keep out of reach and sight of Children 23 Norocarp 50mg/ml Solution for Injection for Cattle and Horses Presentation Norocarp 50mg/ml Solution for Injection for Cattle and Horses is a clear colourless to pale yellow solution for injection, containing: Carprofen 50mg/ml Ethanol (as preservative) 100μl/ml Sodium Formaldehyde Sulphoxylate (as antioxidant) 2mg/ml Uses Carprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-pyretic properties. In young cattle (under 12 months old) the product is indicated as adjunctive therapy for the control of acute inflammation associated with respiratory disease. The cause of the condition should be determined and treated with an appropriate antimicrobial. In horses and ponies, it is indicated for analgesic and anti-inflammatory action in musculoskeletal disorders and after surgery. Dosage and Administration Do not use in animals suffering from cardiac, hepatic, or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia or hypersensitivity to the product. Adverse Reactions If adverse reactions occur, use of the product should be stopped and the advice of a veterinarian should be sought. Typical undesirable effects associated with NSAID administration such as faecal occult blood, loss of appetite and lethargy have been reported. These adverse reactions occur generally within the first week and in most cases are transient and disappear following termination of treatment, but in rare cases may be serious or fatal. Transient injection site reactions may be observed in young cattle after subcutaneous administration, these resolve within 24 hours. In young cattle, the recommended dosage is 1.4mg carprofen per kilogram (1ml/35kg) bodyweight once, administered by subcutaneous or intravenous injection. In horses and ponies, the recommended dosage is 0.7mg/kg (1ml/70kg) bodyweight by intravenous injection as a single dose. This can be repeated after 24 hours, or followed by therapy with an oral formulation of carprofen, according to the duration of clinical signs. After this, further use should follow another clinical evaluation. Special Precautions for Use Do not exceed stated dose or duration of treatment. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is potential risk of increased renal toxicity. Withdrawal Period Cattle: Do not use in cows producing milk for human consumption. Cattle must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 21 days from last treatment. Horses: Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under the national horse passport legislation. Contraindications, Warnings, etc For intravenous use only in the horse. For specific information about the time which must elapse between the treatment and competition, veterinary surgeons are advised to consult the authority responsible for the competition in question (e.g the Jockey club in the case of racing in the UK). Do not administer other NSAIDs or glucocorticoids concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects. Use in any animal less than 6 weeks of age, or aged animals, may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management. In the absence of any specific studies the use in pregnant or lactating animals is not recommended. Carprofen is well tolerated at doses up to 3 times the recommended dose for cattle and 2 times the recommended dose for horses. There is no specific antidote for carprofen overdosage but general supportive therapy as applied to clinical overdosage with NSAIDs should be applied. Avoid skin contact with the product. Wash off any splashes immediately. Take care to avoid accidental self injection. Wash hands after use. Pharmaceutical Precautions Do not store above 25°C. Protect from light. Following withdrawal of the first dose, use the remainder of the product within 28 days. When the container is broached for the first time, using the in use shelf life which is specified on the package insert, the date on which any product remaining in the container should be discarded should be worked out. The discard date should be written in the space provided on the label. Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Gastrointestinal tract ulceration may be exacerbated by corticosteroids in patients given NSAIDs. Legal Category No significant drug interactions have been reported for Carprofen. POM-V To be supplied only on Veterinary Prescription. During clinical studies in cattle four different antibiotic classes were used, macrolides, tetracyclines, cephalosporins and potentiated penicillins without known interactions. The acute toxicity of Carprofen in animals was not significantly affected in tests with 15 concomitantly administered drugs. These were acetylsalicylic acid, amphetamine, atropine, chloropromazine, diazepam, diphenhydramine, ethyl alcohol, 24 hydrochlorothiazide, imipramine, meperidine, proxyphene, phenobarbital, sulfisoxazole, tetracycline and tolbutamide. Package Quantities 50ml multidose amber glass vials VM No: 02000/4277 For Animal Treatment Only Keep out of reach and sight of Children Loxicom® 20mg/ml Solution for Injection for Cattle, Pigs and Horses Presentation One ml contains: Meloxicam 20mg Ethanol 150mg Uses Cattle: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. Pigs: For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy. Horses: For use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders. For the relief of pain associated with equine colic. Dosage and Administration Cattle: Single subcutaneous or intravenous injection at a dosage of 0.5mg meloxicam/kg body weight (i.e., 2.5ml/100kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate. The recommended maximum volume to be administered at a single injection site is 10ml. Pigs: Single intramuscular injection at a dosage of 0.4mg meloxicam/kg body weight (i.e., 2.0ml/100kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours. The recommended maximum volume to be administered at a single injection site is 2ml. Horses: Single intravenous injection at a dosage of 0.6mg meloxicam/kg body weight (i.e., 3.0ml/100kg body weight). For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders. A suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment. Avoid introduction of contamination during use. If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity. In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention. Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician. Use During Pregnancy and Lactation Cattle and pigs: Can be used during pregnancy and lactation. Horses: See section “Contraindications”. Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents. In the case of overdose, symptomatic treatment should be initiated. Waste materials should be disposed of in accordance with local requirements. Pharmaceuticals Precautions Keep out of the reach and sight of children. This veterinary medicinal product does not require any special storage conditions. Do not use after the expiry date (EXP) stated on the carton and vial. Shelf life after first broaching the glass vial: 28 days. Legal Category UK: POM-V To be supplied only on Veterinary Prescription. ROI: POM To be supplied only on veterinary prescription. Packaging Quantities 50ml, 100ml and 250ml vials Withdrawal Periods Contraindications and Warnings Cattle: Meat and offal: Milk: Pigs: Meat and offal: Horses: Meat and offal: Do not use in horses less than 6 weeks of age. Not authorised for use in horses producing milk for human consumption. Do not use in pregnant or lactating mares. Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. Authorised Veterinary Medicinal Product Do not use in case of hypersensitivity to the active substance or to any of the excipients. EU/2/08/090/005 Do not exceed 50 broachings per vial. If more than 50 broachings are required, the use of a draw-off needle is recommended. 15 days 5 days 5 days 5 days. EU/2/08/090/003 EU/2/08/090/004 For Animal Treatment Only For the treatment of diarrhoea in cattle. Do not use in animals of less than one week of age. 25 Loxicom® 50mg/g Oral Paste for Horses Presentation Pharmaceutical Precautions A pale yellow homogenous oral paste. Store below 30 ºC One gram contains: Active substance: Meloxicam - 50 mg Special Warnings Excipient: Benzyl Alcohol - 10 mg Special precautions for use in animals: Uses Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of renal toxicity. Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses. Do not exceed the recommended dose or duration of treatment due to the possibility of severe adverse reactions. Dosage And Administration Special precautions to be taken by the person administering the veterinary medicinal product to animals: Administer 0.6 mg/kg body weight, once daily for up to 14 days. To be administered directly into the mouth over the back of the tongue keeping the animal’s head raised until swallowed. One syringe division of paste should be administered per 50 kg bodyweight. The syringe has an integrated adapter and has a kg/ bodyweight graduation. Each syringe delivers 420 mg meloxicam, sufficient to treat 700 kg of bodyweight. Withdrawal Period Meat and offal: 3 days. Not authorised for use in animals producing milk for human consumption. Contraindications, Warnings, Etc Do not use in pregnant or lactating mares. Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. Avoid skin and eye contact with the product. If skin and/or eye contact occurs, wash the affected parts immediately with water. Should irritation occur and persist, seek medical advice. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Shelf life of the veterinary medicinal product as packaged for sales: 18 months. Shelf life after first opening the immediate packaging: 28 days. Disposal Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Legal Category Do not use in case of hypersensitivity to the active substance or to any of the excipients. UK POM-V To be supplied only on veterinary prescription. Do not use in horses less than 6 weeks of age. Package Quantities Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore the use in this species is not recommended during pregnancy and lactation. Low-density polyethylene pre-filled syringes containing 8.4 g of product in cartons of 1, 7, or 14 syringes. Each syringe has an integrated adapter and with a “kg/body weight” graduation, in divisions of paste per 50 kg bodyweight. Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents. Not all pack sizes may be marketed. Adverse Reactions: Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible. Commonly, a reduction in blood albumin concentration will occur during the period of treatment (up to 14 days). “ Marketing Authorisation Numbers EU/2/08/090/029 (1 syringe) EU/2/08/090/030 (1 x 7 syringes) EU/2/08/090/031 (1 x 14 syringes) I can make a General in five minutes but a good horse is hard to replace. Advice On Correct Administration Avoid introduction of contamination during use. 26 “ In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported. In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically. If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. For Animal Treatment Only Keep Out Of Reach And Sight Of Children Abraham Lincoln Metabolites 27 Glutalyte® Equine Presentation Administration A powder which is a dietetic feed source of predominately electrolytes and easily absorbable carbohydrates. Administer for up to 3 days as required. If necessary administration may be continued for a further 4 days (up to seven days in total). More specifically it includes: % w/w Dextrose Glutamine Sodium Citrate Glutamine Sodium Chloride Potassium Chloride Magnesium Acetate Calcium Chloride Sodium Propionate Sodium Acetate 75.689 5.446 4.879 3.379 2.490 1.434 1.108 1.067 0.731 Contents 180g Energy values: Each sachet provides: 13.469 kj/g 2,424.42 kj Uses A readily available nutritional source of highly digestible ingredients to help stabilise water and electrolyte balance in horses and ponies to compensate for electrolyte loss following heavy sweating or during periods of convalescence and when nutritional restoration is required. Dosage and Administration Dosage: Glutalyte is intended for oral administration only. Dissolve the contents of one sachet in 2 litres (3.5 pints) of warm water. Offer the solution in place of drinking water. Water should be made available to animals that will not take Glutalyte for horses and ponies. Make a fresh solution every 24 hours. 28 Precautions It is recommended that a Veterinary Surgeon’s advice is sought before use. Store in a dry place below 25ºC. Package Quantities Cartons of 8 x 180g sachets. Net weight not less than 180g. One sachet made up in 2 litres of warm water. Further Information A fine deposit of insoluble carrier may remain after dissolving the contents of the sachet, this does not affect the efficacy of the product. This is not an authorised veterinary medicine. For Animal Treatment Only Keep out of reach and sight of Children Anthelmintics 29 Noromectin® 1.87% Oral Paste for Horses Presentation Withdrawal Period Ivermectin 1.87% w/w Animals must not be slaughtered for human consumption during treatment. Horses must not be treated within 34 days of slaughter for human consumption. Do not use in mares producing milk for human consumption. Uses Noromectin 1.87% Oral Paste for Horses kills the adult and some larval stages of the important internal parasites of horses. Noromectin 1.87% Oral Paste for Horses at the recommended dose rate of 200 μg ivermectin per kg bodyweight is indicated for the treatment of the following internal parasites of horses: Large strongyles (redworms): adults and 4th larval (arterial) stages of Strongylus vulgaris, adults and tissue larval stages of S. edentatus and adults of S. equinus. Adult small strongyles (redworms) including benzimidazole resistant strains: Cyathostomum catinatum, Cyathostomum pateratum, Cylicocyclus ashworthi, Cylicocyclus elongatus, Cylicocyclus insigne, Cylicocyclus leptostomum, Cylicocyclus nassatus, Cylicocyclus radiatus, Cylicostephanus asymetricus, Cylicostephanus bidentatus, Cylicostephanus calicatus, Cylicostephanus goldi, Cylicostephanus longibursatus, Cylicostephanus minutus, Cylicodontophorus bicornatus and Gyalocephalus capitatus. Adult and immature lungworms: Dictyocaulus arnfieldi. Pinworms: Adult and immature Oxyuris equi. Ascarids: Adult and 3rd and 4th stage Parascaris equorum. Hairworms: Adult Trichostrongylus axei. Intestinal threadworms: Adult Strongyloides westeri. Neck threadworms: Microfilariae of Onchocerca spp. Oral and gastric larval stages of stomach bots: Gasterophilus spp. Ivermectin is not effective against encysted larval stages of the small strongyles. Dosage and Administration Noromectin 1.87% Oral Paste for Horses is administered orally at a single dose rate of 200 μg/kg of bodyweight. One syringe division of paste should be administered per 100kg bodyweight (based on the recommended dosage of 200 μg/kg). Each syringe delivers 140mg ivermectin, sufficient to treat 700kg of bodyweight. The tip of the syringe barrel should be inserted at the interdental space (the gap between the front and back teeth). The horse’s head should be raised for a few seconds after dosing. Horses’ weight should be accurately determined for the correct use of the paste. The animal’s mouth should be free of food to ensure swallowing. For best results all horses in a yard or grazing together should be included in a regular parasite control programme and treated at the same time. All horses should be included in a regular parasite control programme, with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6-8 weeks of age and routine treatment repeated as appropriate. Retreatment should be carried out according to the epidemiological situation, but not less than at a 30 day interval. Do not use the same syringe to treat more than one animal unless horses are running together or in direct contact with each other on the same premises. As with all anthelmintics, a veterinary surgeon should establish appropriate dosing programmes and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance developing. Contraindications, Warnings, etc Noromectin 1.87% Oral Paste for Horses has been formulated for use in horses only. Dogs and cats may be adversely affected by the concentration of ivermectin in the veterinary medicinal product if they are allowed to ingest spilled paste or have access to used syringes. Avermectins may not be well tolerated in all non-target species (cases of intolerance with fatal outcome are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises). Do not use in dogs or cats as severe adverse reactions may occur. This is a unidose product which should be disposed of after use. Frequent and repeated use may lead to the development of resistance. Some horses have experienced reactions involving cutaneous swelling and itching shortly after treatment. In most of these cases, the horses have been diagnosed as carrying heavy infections of Onchocerca microfilariae, and it is assumed the reactions are a result of the microfilariae dying in large numbers. Although the signs will resolve spontaneously in a few days, symptomatic treatment may be advisable. Consult your veterinary surgeon should these signs persist. Horses of all ages, including young foals, pregnant mares and breeding stallions have been treated with no adverse effects on their health and fertility. Ivermectin passes readily into milk. When administering to lactating females, residues of ivermectin could be present in the maternal milk. No studies have been reported on the effect of ingestion of milk on the development of newborn foals, therefore it would be prudent not to feed very young animals with milk obtained from the mother. Mild transitory signs (slowed pupillary light response and depression) have been seen at a higher dose of 1.8mg/kg (9 times the recommended dose level). Other signs seen at higher doses include mydriasis, ataxia, tremors, stupor, coma and death. The less severe signs have been transitory. Although no antidote has been identified, symptomatic therapy may be beneficial. Pharmaceutical Precautions Do not smoke or eat while handling the product. Wash hands after use. Avoid eye contact. Do not store above 25ºC. Keep the container in the outer carton in order to protect from light. EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface water or ditches with product or used containers. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Legal Category POM-VPS Package Quantities Syringes containing 7.49g of product in cartons of: 1,2, and 10 syringes. VM No: 02000/4208 For Animal Treatment Only Keep out of reach and sight of Children 30 Vitamins 31 Intravit 12 Solution for Injection 0.05% w/v Presentation Pharmaceutical Precautions An aqueous solution for injection, containing: Cyanocobalamin 0.05% w/v Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Phenol as a preservative 0.5% w/v Uses POM-VPS Cyanocobalamin (Vitamin B12) is essential for the synthesis of nucleic acids. Consequently it plays an essential role in cell metabolism and the maintenance of metabolic functions including haemopoiesis. Package Quantities Dosage and Administration Further Information By intramuscular or subcutaneous injection, once or twice a week. Normal aseptic precautions should be observed. When administering the product to a large number of animals a multiple dose injector must be used. Ensure that suitable equipment is used when administering small dose volumes. When the container is broached for the first time, using the in-use shelf-life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. Cattle, Horses: 2–5ml Calves, Foals: 1–3ml Sheep and Pigs: 0.5–1.5ml Withdrawal Period Withdrawal period for meat/milk: Nil. Contraindications, Warnings, etc No known contraindications. Care should be taken to avoid accidental self-injection or ingestion. In case of accidental self-injection, seek medical advice as a precautionary measure. Following skin/eye contamination, wash/irrigate area thoroughly with cold water. Seek medical attention if irritation persists. Following withdrawal of the first dose, use the product within 28 days. Wash hands after use. 32 Legal Category Multidose vials of 100ml. This discard date should be written in the space provided on the label. VM No: 02000/4116 For Animal Treatment Only Keep out of reach and sight of Children Combivit Solution for Injection Presentation Contraindications, Warnings, etc Combivit is a pale yellow to brown sterile solution for injection containing four members of the B-complex vitamins together with vitamin C. Anaphylactoid reactions, particularly in the horse may occur following intravenous administration. When this route is used Combivit should be given slowly and may be diluted with sterile saline or sterile dextrose saline solution. This may be achieved by drawing sterile diluting solution into a syringe, followed by the required volume of Combivit. Each ml contains: Thiamine Hydrochloride (Vitamin B1) 35mg Riboflavine Sodium Phosphate (Vitamin B2) 0.5mg Pyridoxine Hydrochloride (Vitamin B6) 7mg Nicotinamide 23mg Ascorbic Acid (Vitamin C) 70mg Chlorocresol (preservative) 1mg The diluted product must be administered immediately after preparation and must not be stored. Aseptic precautions should be observed. There may be slight irritation at the site of injection when the product is given by the subcutaneous or intramuscular routes. Pharmaceutical Precautions Uses Do not store above 25ºC. Combivit may be used in the following cases: 1. Wherever deficiency of vitamin B group is suspected in horses, cattle and sheep. Protect from light. 2. In treatment of cerebrocortical necrosis in cattle and sheep. 3. In treatment of bracken poisoning in horses. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Dosage and Administration Legal Category Administer by subcutaneous, deep intramuscular or slow intravenous injection. The dose should be repeated daily as required. Normal aseptic precautions should be observed. POM-VPS Following withdrawal of the first dose, use the product within 28 days. Discard unused material. Package Quantities Multidose vials of 50ml and 100ml. Species Dosage Horses, Cattle: 20–30ml Further Information Calves, Foals: 5–10ml Sheep: 5–10ml When the container is broached (opened) for the first time, using the in-use shelf life which is specified on this carton, the date on which any product remaining in the container should be discarded should be worked out. Withdrawal Period Withdrawal period for meat and milk: Zero days. This discard date should be written in the space provided on the label. VM No: 02000/4118 For Animal Treatment Only Keep out of reach and sight of Children 33 Multivitamin Injection Presentation Withdrawal Period A golden brown sterile aqueous solution, containing per ml: Not to be used in animals intended for human consumption. Retinol Palmitate (Vitamin A) 15,000iu Cholecalciferol (Vitamin D3) 25mcg Alpha tocopheryl Acetate (Vitamin E) 20mg Thiamine Hydrochloride (Vitamin B1) 10mg Riboflavin Sodium Phosphate (Vitamin B2) 5mg Pyridoxine Hydrochloride (Vitamin B6) 3mg Nicotinamide35mg Dexpanthenol25mg Cyanocobalamin (Vitamin B12) 25mg Treated horses may never be slaughtered for human consumption. Excipient(s): Discard unused material. Chlorocresol (as preservative) 1mg Butylhydroxyanisole (E320)0.1mg Butylhydroxhtoluene (E321)0.1mg Disodium Edetate0.5mg Pharmaceutical Precautions Store below 25°C. Protect from light. Following withdrawal of the first dose, use the product within 14 days. Legal Category POM-VPS Package Quantities Uses Multidose vials of 100ml. Multivitamin Injection is indicated for the prevention and treatment of vitamin deficiencies in horses, particularly during periods of illness, convalescence and general unthriftiness. VM No: 02000/4131 Dosage and Administration Administer by intramuscular or subcutaneous injection. Horses: 20 - 30ml The injection may be repeated at intervals of 10 – 14 days. Normal aseptic precautions should be observed. 34 The horse must have been declared as not intended for human consumption under the national Horse Passport Legislation. For Animal Treatment Only Keep out of reach and sight of Children Miscellaneous 35 Lignocaine and Adrenaline Solution for Injection Presentation Pharmaceutical Precautions A bright almost colourless solution containing: Lignocaine Hydrochloride 2.0% w/v Protect from light. Adrenaline (as Acid Tartrate) 0.00227% w/v Following withdrawal of the first dose, use the product within 28 days. Antimicrobial preservative: Chlorocresol 0.1% w/v Discard any unused material. Uses When the container is broached (opened) for the first time, the date on which any product remaining in the container should be discarded should be calculated. A statement of the in-use shelf life of the product is given on the package insert. Local anaesthetic for parenteral administration to horses. It may be used for infiltration anaesthesia (local or field block) and regional anaesthesia including paravertebral nerve blocks. Dosage and Administration This discard date should be written in the space provided on the label. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. • For intramuscular and subcutaneous injection only. • Local infiltration and field block anaesthesia: Legal Category • The recommended dose is: Horses: up to 100 - 200ml per surgical site POM-VPS • In cases of repeated administration, the total volume administered should not exceed 0.5ml/kg bodyweight. Package Quantities • Paravertebral anaesthesia: Approx 7ml per site VM No: 02000/4135 Withdrawal Period Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. Contraindications, Warnings, etc Avoid accidental intravascular injection. In mild cases of overdose, animals become anxious and restless. The symptoms are transient and will pass off with little or no treatment being necessary. In severe cases of overdose convulsions may occur, and respiratory and circulatory failure may follow. Overdosage may be treated by administering respiratory stimulants and keeping animals warm. In case of accidental self-injection seek medical advice immediately. In case of eye contamination or excessive skin contact, irrigate/wash immediately with plenty of clean water. Seek medical attention if irritation persists. Wash hands after use. Care should be taken in the administration of repeat doses in cases where the desired degree of anaesthesia has not been attained. 36 Do not store above 25ºC. Multidose vials of 100ml. For Animal Treatment Only Keep out of reach and sight of Children Multi Derm Aerosol, Powder and Ointment Presentation Package Quantities: Multi Derm Aerosol, Powder and Ointment contains: Crude Fish Oil Multi Derm Aerosol 140g Multi Derm Powder 125g Multi Derm Ointment 125g Raw Linseed Oil Spirits of Turpentine Balsam of Fir Contraindications, Warnings, etc Withdrawal period for meat/milk: Nil. Uses Avoid contact with the eyes. • Conditions and softens hard or chapped skin tissues. Wash and dry the teats prior to milking to remove residual product. • Aids in the management of cuts and sores on cattle and horses. For external use only. • Provides a protective and flexible barrier for wounds. • Promotes natural healing and tissue regeneration. In case of deep puncture wounds or serious burns consult a veterinary surgeon. Directions If redness, irritation or swelling persists or increases, discontinue use and consult a veterinary surgeon. Clean area before application. This is not an authorised veterinary medicine. Small cut: Apply once daily. For Animal Treatment Only Larger wounds: Apply once/twice daily, washing wound on alternate days and re-apply. Keep out of reach and sight of Children Multi Derm acts as a breathable bandage: Do not wrap the wound, apply thoroughly. 37 Norofulvin® 33.3% Equine Oral Paste Presentation A white viscous paste containing: 33.3% w/w Griseofulvin in a 70g dial-a-dose syringe. Long-term administration of high doses of griseofulvin with foods has been reported to induce hepatomas in mice and thyroid tumours in rats, but not hamsters. The clinical significance of those findings for man is not known. Uses Norofulvin Equine Paste is an oral antifungal antibiotic effective in the treatment of ringworm in horses caused by Trichophyton and Microsporum spp. After absorption from the gastrointestinal tract the antifungal antibiotic is concentrated in the newly formed keratin enabling the cells of the skin and hair to resist fungal attack. Pharmaceutical Precautions Do not store above 25ºC. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Legal Category POM-V To be supplied only on Veterinary Prescription. Dosage and Administration There are 15 x 150kg doses marked on the syringe. For oral administration using a dial-a-dose syringe, 10mg Griseofulvin/kg bodyweight daily for 7 consecutive days. The following is the dosing regimen recommended for each of the 7 days dosing period. Horse Liveweight Dose (Expressed as number of Dial turns) 150kg 300kg 450kg 600kg 1 2 3 4 Where the animals weight is other than above weight, ¼, ½, or ¾ turns of the dial may be given where appropriate. Prophylactic administration of Norofulvin Equine Paste is advisable for in contact animals only. Withdrawal Period Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. Contraindications, Warnings, etc Concurrent administration of substances such as Phenylbutazone and sedatives which induce drug metabolizing enzymes may result in impaired efficacy of Norofulvin. Norofulvin is not recommended for use in pregnant mares. Other systemic fungal infections including Candida albicans and Aspergillis spp do not respond to Griseofulvin therapy. Norofulvin Equine Paste must not be handled by women of child bearing potential. Protective gloves should be worn when using this product. Take care to avoid skin contact. In the case of skin contact wash affected area thoroughly. If irritation occurs/persists seek medical advice. Take care to avoid accidental eye contact. In case of accidental eye contact flush thoroughly with clean water and seek medical advice. Ingestion: If accidentally swallowed, seek medical attention and show product label and/or pack insert to the doctor. Wash hands thoroughly after using this product. 38 Package Quantities 70g dial-a-dose syringe. Further Information The normal seven day course is recommended. Stables occupied by infected horses should be thoroughly disinfected and cleaned; all equipment used during the treatment should also be cleaned and disinfected. These measures will minimize the risk of cross infection. VM No: 02000/4055 For Animal Treatment Only Keep out of reach and sight of Children Norofulvin® 7.5% w/w Granules for Top Dressing Use Presentation Contraindications, Warnings, etc White to off-white granules containing: Griseofulvin 7.5% w/w Norofulvin Granules must not be used for the treatment of pregnant mares. Uses Other systemic fungal infections including those caused by Candida albicans and Aspergillus spp do not respond to griseofulvin therapy. Griseofulvin is an antifungal antibiotic, for the treatment of ringworm in horses caused by Trichophyton spp and Microsporum spp. After absorption from the gastrointestinal tract, griseofulvin is concentrated in the newly formed keratin enabling the cells of the skin and hair to resist fungal attack. Dosage and Administration Norofulvin Granules should be administered orally, by addition to the feed ration. Operator Warnings Impervious gloves must be worn when handling this product or feed containing the product. The product or feed containing the product must not be handled by women with child bearing potential. General Precautions The recommended dose rate is 10mg griseofulvin per kg bodyweight daily for seven consecutive days. Long-term administration of high doses of griseofulvin with food has been reported to be hepatotoxic in cats and to induce hepatomas in mice and thyroid tumours in rats but not hamsters. This is achieved by administering 10g Norofulvin Granules per 75kg bodyweight daily. The clinical significance of these findings for man or the target species is not known. Dosage Guide: Do not use in horses with severe hepatic impairment. Bodyweight 150kg 225kg 300kg 375kg 450kg 525kg Over 525kg Daily Dose 20g 30g 40g 50g 60g 70g 70g + 10g for each additional 75kg bodyweight. Pharmaceutical Precautions Do not store above 25ºC. Protect from light. Store separately from animal feeds. Disposal of any unused product and empty container in accordance with guidance from your local waste regulation authority. In severe cases treatment may be continued for an additional seven days at the same dose rate. Legal Category Norofulvin Granules should be mixed thoroughly with the total feed ration so that the required dose is contained in the amount each animal will consume at one feed. Package Quantities Add to feed immediately prior to administration. POM-V To be supplied only on Veterinary Prescription. 500g, 1kg and 3.5kg bulk packs. Discard any remaining medicated feed. Further Information Norofulvin Granules may be used for the treatment of groups of animals or for individuals. For group dosing animals should be approximately equal in bodyweight. Adequate trough space should be available and shy feeders should be fed individually to ensure adequate dosage. Prophylactic therapy is advised for in-contact animals only. Withdrawal Period These measures will minimise risk of infection. Not to be used in horses intended for human consumption. VM No: 02000/4084 Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. For Animal Treatment Only The normal 7 day course is recommended. Buildings occupied by infected animals should be thoroughly cleaned and disinfected; all equipment used during the treatment should also be cleaned and disinfected. Keep out of reach and sight of Children 39 Water for Injections 100% v/v Solvent for Parenteral Use Presentation Legal Category Sterile Water contains no preservative. Sterile Water 100% v/v POM-V To be supplied only on Veterinary Prescription. Package Quantities Uses Water for Injections is available in 20ml, 50ml and 100ml vials. Water for Injections is intended for use as a sterile solvent for the preparation of medicines intended for parenteral administration. Where water is a component of the preparation and for reconstituting or diluting medicines for parenteral administration immediately before use. VM No: 02000/4122 Dosage and Administration As required. Pharmaceutical Precautions Do not store above 25°C. Take adequate precautions to maintain sterility. After initial use discard remainder of product. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. 40 For Animal Treatment Only Keep out of reach and sight of Children for horses powder & paste power high performance horse A naturally superior and highly palatable nutritional supplement to help maintain healthy cartilage and joint fluid in horses (paste only) For more information about the entire equine product range contact your Norbrook® territory manager: Laura Tattersfield Northern England & Scottish Borders 07798 607081 Jane Hutcheon Scotland (North) 07798 607093 Barbara Harrison Scotland (South) 07825 883315 Joanne Beardsworth North 07788 436035 Gary Sheils North West 07798 607087 Shane Brewer East Anglia 07798 607082 Jayne Painter South East 07909 538565 Lyn Hanson London 07786 338305 Domenico Traversari South 07798 607088 Stephen Bull South West 07795 563290 Karen Harrison Wales (South) 07887 827232 Gerald Hegarty Wales (North) 07833 256416 Paul Uglow Midlands 07769 897016 or visit www.norbrook.com 41 Products Overview Category Antibiotics Product Devomycin Injection Active Streptomycin Sulphate Species Horses Cattle Withdrawal * Milk: 48 hrs Sheep Meat: 16 days Meat: 18 days Dogs, Cats Horses ** Nil * Sheep Meat: 14 days Cattle ** Milk: 48 hrs Dogs and Cats Meat: 14 days Nil Benzathine Penicillin, Horses * Procaine Penicillin Dogs and Cats Cattle Nil Milk/meat: Nil Devomycin D Injection Streptomycin Sulphate, Dihydrostreptomycin Sulphate Norocillin LA Suspension for Injection Opticlox Eye Ointment Cloxacillin Benzathine 16.7% w/w Pen and Strep Cefenil Powder and Solvent 1g and 4g Sulphonamides Norodine 24% Solution for Injection Procaine Penicillin, Dihydrostreptomycin Sulphate Ceftiofur Sodium Sulfadiazine, Trimethoprim Specific indications Indicated for the treatment of organisms sensitive to Streptomycin. In particular E.coli, Klebsiella spp, Mycobacterium tuberculosis and some species of Proteus, Pasturella and Salmonella. Packaging quantities and sizes 50ml and 100ml vial Indicated for the treatment of organisms sensitive to 100ml vial Streptomycin. Among the more sensitive to streptomycin in vitro are Actinobacillus equuli, A. Lignieresii, Actinomyces bovis, Brucella spp, E.coli, Haemophilus spp, Klebsiella spp, Leptospira canicola and L.ictero-haemorrhagiae, Pseudomonas aeruginosa and some species of Proteus, Pasturella and Salmonella. Norocillin LA is quick acting, long lasting treatment of systemic 50ml and 100ml vial infections caused by or associated with organisms sensitive to penicillin in horses, dogs and cats. Eye infections caused by Staphylococcus spp. and Bacillus spp. 4 x5g syringes Horses Sheep Horses * Cattle Milk: 60 hrs Sheep Meat: 23 days Milk: ** Pigs Horses Meat: 31 days Meat: 18 days * Cattle Milk: 0 hrs Pigs Horses Cattle Meat: 1 day Meat: 2 days Meat: 28 days Milk: 48 hrs Pigs Dogs Effective in the treatment of the following: Erysipelas; Navel/ 50ml and 100ml vials joint ill; respiratory tract infections including pneumonia and atrophic rhinitis; listeriosis; meningitis; septicaemia; toxaemia associated with mastitis; urogenital tract infections; enteritis associated with Salmonella spp, salmonellosis; and the control of secondary bacterial invaders in disease of primary viral origin. Bacterial respiratory disease. 1g and 4g vial Treatment of acute bacterial respiratory disease and acute interdigital necrobacillosis (foul in the foot). Bacterial respiratory disease. Respiratory infections, urogenital tract infections and alimentary tract infections. 50ml and 100ml vial Alimentary tract infections; 3 x 45 g dial-a-dose syringe Meat : 12 days Meat: 20 days Cats Norodine Equine Oral Paste Sulfadiazine, Norodine granules Sulfadiazine, Anti-inflammatories Colvasone 2mg/ml Solution for Injection Horses Meat: 28 days Trimethoprim Trimethoprim Dexamethasone Sodium Phosphate Respiratory tract infections; Horses Horses Cattle Meat 28 days Wounds, septicaemia and general infections. Respiratory tract infections; Meat:21 days Meat 21 days Wounds, septicaemia and general infections. Intravenous therapy; Acetonaemia in cattle; inflammatory conditions (all indicated species). 10 sachets of 37.5g 50ml vial Milk: 72 hrs Equinixin 25 mg/g Granules for Horses Flunixin Meglumine Flunixin 50mg/ml Injection Flunixin Meglumine Norocarp 50mg/ml Solution for Injection Carprofen Loxicom 20mg/ml Solution for Injection Meloxicam Loxicom 5% Oral Paste for Horses Meloxicam Dogs Cats Horses Meat: 15 days Horses Cattle Meat: 7 days Meat: 7 days Pigs Milk: 36 hrs Meat 24 days Horses * Cattle Milk: ** Horses Meat: 21 days Meat: 5 days Cattle Meat: 15 days Pigs Horses Milk: 5 days Meat: 5 days Meat: 3 days Peppermint flavoured granules indicated for the alleviation 10 x 10g sachets containing 250mg of inflammation and pain associated with musculoskeletal Flunixin disorders. Potent non-narcotic, non-steroidal analgesic with 50ml, 100ml and 250ml anti-inflammatory, anti-endotoxic and anti-pyretic properties. Species dependent inflammatory conditions. NSAID with analgesic, anti-pyretic and anti-inflammatory properties. Used for adjunctive therapy in cattle, for control of acute inflammation associated with respiratory disease. 50ml glass vials Species dependent (alleviation of inflammation and relief from pain - both chronic and acute; in combination with antibiotic therapy or oral rehydration.) 50ml and 100ml Anti-inflammatory, analgesic, anti-exudative, anti-pyretic and anti-endotoxic properties for alleviation of musculo-skeletal disorders in horses. 1 syringe, 7 pack, 14 pack Apple flavours, dial-a-dose syringe. 42 Category Metabolites Product Glutalyte Equine Active Glutamine, Sodium Citrate, Sodium Chloride, Potassium Chloride, Magnesium Acetate, etc. Ivermectin Anthelmintics Noromectin Miscellaneous Intravit 12 0.05% w/v Cyanocobalamin Solution for Injection (B12) Species Horses Withdrawal Nil Specific indications Oral rehydration following heavy sweating or during periods of convalescence when nutrition restoration is required. Packaging quantities and sizes 8 x 180g sachets Horses Meat: 34 days 1,2, 10 syringes Horses Nil Nematodes and insect (Bots) - see data sheet for in depth nematodes. (not indicated for tapeworm or small encysted redworm). Administer in cases of un-thriftiness, debility and convalescence in known cases of B12 deficiency. Nil Indicated for deficiencies (vit B), cerebrocortical necrosis in cattle and sheep and also the treatment of bracken poisoning in horses. 50ml and 100ml 100ml vial 100ml vial Cattle Sheep Pigs Goats Combivit Solution for Injection Thiamine Hydrochloride, Riboflavine Sodium Phosphate, Pyridoxine Hydrochloride, Nicotinamide, Ascorbic Acid, Chlorocresol Dogs/cats Horses Cattle Sheep Multivitamin Injection Vitamin A, D3, E, B1, B2,B6, B12, Nicotinamide and Dexpanthenol Horses * Indicated for the treatment and prevention of vitamin deficiencies in horses particularly during periods of illness, convalescence and general unthriftiness. Norocaine Lidocaine Hydrochloride, Adrenaline Crude Fish Oil, Raw Linseed Oil, Spirits of Turpentine, Balsam of Fir, Sulphuric Acid Horses * Local anaesthetic for horses (local or field block and Regional). 100ml Vial Horses Nil Conditions and softens hard or chapped skin; Norfulvin 33.3 % Equine paste Griseofulvin Horses * Oral antifungal antibiotic effective in the treatment of ringworm. 70g dial-a-dose syringe Norfulvin 7.5%w/w Granules Griseofulvin Horses * Oral antifungal antibiotic effective in the treatment of ringworm. 500g, 1kg, 3.5kg. Noroquin Joint Supplement Glucosamine, Chrondroitin Sulphate, N-Acetyl-D-Glucosamine, Ascorbic Acid, Zinc Sulphate Horses Nil A naturally superior and highly palatable nutritional supplement to help maintain health cartilage and joint fluid in horses. 10g powder sachets, 1kg powder, 17g paste, 102g paste Muti Derm Range Cattle Management in cuts and sores; controls proud flesh; management of sweet itch. Multiderm Aerosol 140g Powder: 125g Ointment: 125g *Not to be used in animals slaughtered for human consumption **Not to be used in animals producing milk for human consumption 43 Championing Animal Healthcare Since its foundation in 1968, Norbrook® has grown to be one of the world’s leading pharmaceutical companies with manufacturing facilities on four continents and sales and marketing offices in over 30 countries. The Company exports to more than 120 countries worldwide and was awarded the Queen’s Award for Enterprise in International Trade in 2011. Get our FREE Veterinary Excellence iPhone App or visit norbrook.com to download the Compendium! www.norbrook.com Manufactured and distributed in NI by: Norbrook Laboratories Ltd, Station Works, Newry, Co. Down, BT35 6JP. Distributed in GB by: Norbrook Laboratories (GB) Ltd, 1 Saxon Way East, Oakley Hay Industrial Estate, Corby, NN18 9EX. 1649-EQ-v2-UK-15/07/13