ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
Name of the veterinary medicine
Gyramox, soluble powder for oral use for pigs, broilers and turkeys.
2.
Qualitative and quantitative composition
100 g contain:
Active principles
Amoxicillin trihydrate
25.82 g
(equal to amoxicillin 22.50 g)
Flumequine
15.00 g
Excipients
For the complete list of the excipients see paragraph 6.1.
3.
Pharmaceutical form
Soluble powder for oral use to be dissolved exclusively in drinking water or
liquid feed.
4. Clinical information
4.1. Target species
Pigs, Broilers and Turkeys.
4.2. Indications for use specifying the target species
The combination of amoxicillin and Flumequine is indicated for the three
destination species in the treatment of bacterial diseases sustained by
microorganisms that are sensitive to the two active principles, namely:
Pigs:

infections of the respiratory tract (bronchitis, bronchopneumonia,
pneumonia, pleurisy, pulmonary disorders of viral infections);

infections of the gastroenteric tract (enteritis, cholangiohepatitis);

urinary infections (nephrite, cystitis);

infections of skin and soft tissues (pedal infections and abscesses
included);

articular infections (polyarthritis);

streptococcal infections;

colibacillosis, salmonellosis and pasteurellosis.
Broilers and turkeys.

Salmonellosis;

Colibacillosis;

Staphylococcosis;

Pasteurellosis;

Secondary bacterial infections of viral infections such as C.R.D.
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4.3. Contraindications
Do not administer to animals that are hypersensitive to penicillins, to rabbits,
small rodents, polygastric animals with functioning rumen, and to laying hens.
Do not associate to treatments with systemic sulphonamides and Trimethoprim.
4.4. Special warnings for each target species
Don’t administer to layers producing eggs for human consumption.
4.5. Special precautions
Special precautions for the use in the animals
Do not mix with solid feed.
While using this veterinary medicine, always comply with the official and local
regulations on the use of antimicrobial drugs.
If possible, the quinolones should be used only based on the results of the
antibiotic assay.
A use of such products not compliant with the instructions supplied in the SPC
may lead to an increase in the prevalence of bacteria being resistant to the
quinolones and also reduce at the same time the efficacy of the treatment with
other (fluoro)quinolones because of cross-resistance.
Special precautions to be taken by the person administering the product to the
animals
During handling contact with the product must be avoided. For this aim it is a
good practice wear suitable protective clothes. Avoid wasting the environment
with the product. For handling product utilise suitable protective gloves. In case
of accidental contamination, wash accurately with water and soap. Persons
with known oversensitivity towards the product must avoid the contact with it.
4.6. Adverse reactions (frequency and seriousness)
Gastrointestinal troubles and oversensitivity reactions that vary from light
urticaria to lethal anaphylactic shock. Can occurs cross allergy with all other
penicillins. Should any serious adverse reactions or other not mentioned in this
label reaction occur, please inform the responsible veterinarian.
.
4.7. Use during pregnancy, lactation or laying
Utilise only in accordance to the evaluation of the risk/benefit ratio of the
responsible veterinarian.
4.8. Interactions with other medicines and further forms of interaction
The simultaneous administration of amoxicillin with bacteriostatic antibiotics,
such as tetracyclines and macrolides, should be avoided as the antibacterial
activity of amoxicillin is reduced.
Synergism of action occurs when amoxicillin is administered along with
cloxacillin, polimixins (such as colistin) and aminoglycosides (such as
streptomycin, neomycin, gentamycin and kanamycin).
Cross-resistance with penicillins develops rapidly, especially with ampicillin.
The combination with clavulanic acid causes enhanced action.
The administration of flumequine is not compatible with that of systemic
sulphonamides and trimethroprim.
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4.9. Dosage and way of administration
Pigs, broilers and turkeys: 8 g of «Gyramox »
every 100 kg of body weight (equal to 18 mg of amoxicillin and 12 mg of
flumequine per kg of body weight) for 5 days.
The product should be administered in drinking water or liquid feed according to
the instructions of the prescribing Veterinarian, taking care not to exceed the
daily dose of active principle allowed (expressed in mg/kg of body weight).
The concentration in drinking water should be calculated according to the body
weight of the animals to be treated and the water consumption. It is
recommended to give no water to animals in the hours immediately prior to the
treatment.
4.10. Excessive doses (symptoms, emergency procedures, and antidotes)
Not available data. Do not exceed the recommended doses.
4.11. Withdrawal time
Pigs:
Broilers:
Turkeys
5.
5 days
3 days
3 days
Pharmacological properties
ATC vet code:
QJ01CA04 amoxicillin
QJ01MB07 flumequine
Pharmacotherapeutic group: anti-infective for systemic use.
5.1 Pharmacodynamics properties
Amoxicillin is a semisynthetic penicillin with bactericidal activity against many
Gram-positive and Gram-negative bacteria.
Particularly sensitive microorganisms: Streptococci and Staphylococci not
producing penicillinase, Pasteurella spp., Haemophilus spp., Bacillus anthracis,
Bacillus subtilis, Brucella spp., Clostridium spp., Corynebacterium spp.,
Erysipelothrix rhusiopathiae, Fusiformis spp., Listeria monocytogenes and
Spherophorus necrophorus.
Moderately sensitive microorganisms: Salmonella spp., Streptococcus
faecalis, Treponema hyodysenteriae, Moraxella spp., Escherichia coli, Proteus
mirabilis and Vibrio cholerae.
Amoxicillin acts by inhibiting the synthesis of peptidoglycan, which forms the
wall of the bacterial cell. Amoxicillin performs a stronger bactericidal activity
than ampicillin, which means a better therapeutic effect.
Flumequine is a quinolone of synthesis which is mainly active against Gramnegative bacteria. The following bacteria are sensitive to its action in general:
Aeromonas, E. coli, Klebsiella, Enterobacter, Yersinia, Salmonella, Pasteurella,
Proteus, Vibrio anguillarum. It performs its bactericidal activity by inhibiting the
replication of bacterial DNA. It is active when exudates, organic liquids, plasma
proteins and serum are present.
Amoxicillin and flumequine, by performing their bactericidal activity at various
levels, prevent the onset of cross-resistance phenomena and the selection of
resistant bacterial strains. The synergic action of the two active principles
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assures a better activity mainly against those Gram-negative microorganisms
that are less sensitive to amoxicillin.
5.2 Pharmacodynamics information
Oral amoxicillin is absorbed more rapidly and better than ampicillin, due to its
high resistance to the gastric secretions' acidity. Compared to the dose given
orally, the share of amoxicillin actually absorbed by the gastrointestinal tract is
around 70%, thus reaching high levels in blood. The absorption is not
influenced in any way by the simultaneous administration of foods. Thanks to its
high fat solubility, amoxicillin spreads evenly in all the body's tissues. If no
inflammatory events involving the meninges are present, amoxicillin passes
through the blood-brain barrier scarcely. The antibiotic is eliminated in its active
form mainly through the urinary tract, just a small part of it is metabolized by
liver into penicilloic acid. 80% of the medicine which is eliminated through the
urinary tract is excreted through tubular secretions, the remaining 20% by
glomerular filtration. Amoxicillin is an extremely safe antibiotic, as it is well
tolerated by the animals.
The flumequine is a quinolone of synthesis, active mainly against Gramnegative bacteria. To its action in general are susceptible bacteria: Aeromonas,
E. coli, Klebsiella, Enterobacter, Yersinia, Salmonella, Pasteurella, Proteus,
Vibrio anguillarum. Exerts its bactericidal action by inhibiting bacterial DNA
replication. It is active in the presence of exudates, body fluids, plasma and
serum proteins.
6.
6.1.
6.2.
Pharmaceutical information
List of excipients
Sodium carbonate
Anhydrous glucose
Incompatibilities
See contraindications and interactions. Lacking compatibility studies don’t mix
with other veterinary medicines.
6.3.
Shelf life
Shelf life of the veterinary medicine packaged for selling: 24 months.
Shelf life after the first opening of the primary package: 6 months.
Shelf life after dilution or reconstitution in accordance with instructions: 12 hours
6.4.
Special storage precautions
The product must be stored in a dry place, at a temperature lower than +25 °C.
Keep out of children’s reach.
6.5.
Nature and contents of containers
The product is packaged in 100 g packet, 1 and 5 kg bags of polyethylene aluminium – polyester (PET/AL/PE).
6.6.
Special precautions to be taken for the disposal of unused veterinary
medicines and/or waste materials
All the unused veterinary medicines or the waste derived from these medicines
must be disposed in compliance with local laws.
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7.
Holder of marketing authorisation
Vétoquinol Italia S.r.l., Via Piana 265 – 47032 Bertinoro (FC)
8.
Marketing authorisation numbers
CY 00054V
9.
Date of first marketing authorisation or authorisation renewal
Date of first authorisation: 30/4/2004
Date of renewal: 2/11/2012
9.
Date of text renewal: 15/01/2014
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