ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
Name of the veterinary medicine
ZEMAMIX
Premix for medicated feedingstuff for pigs.
2.
Qualitative and quantitative composition
100 g of ZEMAMIX contain:
Active principles
Microencapsulated amoxicillin trihydrate
equal to amoxicillin
Granulated colistin sulphate
Excipients
Butyl hydroxitoluene (E321)
For the complete list of excipients see paragraph 6.1
3.
4.
11.48 g
10.00 g
4.00 g
0.25 g
Pharmaceutical form
Premix for medicated feedingstuff in insoluble powder, to be administered orally
properly mixed in solid feed.
Clinical information
4.1 Target species
Pigs
4.2. Instructions for use, specifying target species
Pigs: bacterial diseases sustained by amoxicillin- and colistin-sensitive
microorganisms, and particularly respiratory and pneumo-enteric syndromes.
4.3. Contraindications
Do not administer the medicine to animals that are hypersensitive to penicillins,
to cephalosporins, to polypeptidic antibiotics, or to one of excipients.
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4.4. Special warnings for each target species
Owing to possible variations (with the time, or geographic) of the sensitiveness,
of amoxicillin ad colistin microbial target species one recommend to carry out
the bacteriological examination and the sensitivity test. The improper use of the
product could increase the preponderance of resistant bacteria to amoxicillin or
colistin and lower the treatment efficacy with other beta-lactam or polypeptidic
antibiotics.
4.5. Special precaution for use
Special precaution for use in the animals
Don’t mix in drinking water or in liquid feed. The consumption of medicated
premix can be altered owing to disease. In the case of medicated feed
inadequate consumption, the animals should be treated for parenteral route.
Special precautions to be taken by the person administering the product to the
animals
The person with known oversensitivity towards amoxicillin or colistin must avoid
the contact with the product. The oversensitivity towards penicillins can be
associated to cross-reactivity towards cephalosporins and vice versa. During
medicated feed manufacture, assure a homogeneous mixing of the feed and
follow suitable cleaning procedures. During product handling don’t eat, drink or
smoke. In order to avoid powder inhalation, skin and eyes contact utilise
protective glasses, mask and gloves. In case of casual contact wash the skin
and eyes with plenty of water. Wash your hands after use.
4.6. Adverse reactions (frequency and seriousness)
Cross allergy with all other penicillins may occur. Oversensitive subjects can
show allergic phenomena with variable clinical symptoms from temporary
cutaneous reactions to anaphylactic shock. Incidental allergic phenomena can
be fought with timely inoculation of antihistaminics and analeptics. In the
mammalians the extended use of amoxicillin or Colistin can rise to intestinal
microbism disorder with the appearance of symptoms like diarrhoea, gastralgia
and gas store.
4.7. Use during pregnancy and lactation
Utilise only in accordance to the evaluation of the risk/benefit ratio of the
responsible veterinarian.
4.8. Interactions with other drugs 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. Cross-resistance with penicillins develops
rapidly, especially with ampicillin and cephalosporins. The simultaneous use
with probenecid and sulfinpyrazone determine the reduction of penicillin
excretion.
Colistin sulphate exhibits cross-resistance with polimixin B. The action of
Colistin is inhibited by divalent cations like Ba2+, Ca2+, and Mg2+, saturated fatty
acids and quaternary ammonium compounds.
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4.9. Dosage and way of administration
Pigs: g 180 - 900 of medicated premix per 100 kg of fodder (equal to 9 - 18 mg
of amoxicillin base and 3.6 - 7.2 mg of colistin sulphate per kg of live weight per
day) per 100 kg of fodder, according to the following dosing method:
pigs fed at the rate of 5% of live weight = 180 -360 g of premix;
pigs fed at the rate of 3% of live weight = 300 - 600 g of premix;
pigs fed at the rate of 2% of live weight = 450 - 900 g of premix.
The premix should be properly mixed with solid fodder.
The medicated premix should be administered for 3 - 5 days.
4.10. Excessive doses (symptoms, emergency procedures, and antidotes)
Not available data. Do not exceed the recommended doses.
4.11. Withdrawal time
Meat and viscera: 5 days
5.
Pharmacological properties
Pharmacotherapeutic group: antibacterial for systemic use – penicillins in
combination with other antibiotics.
ATC vet code:
Amoxicillin + Colistin: QJ01RA01
5.1 Pharmacodynamics properties
Amoxicillin is semi-synthetic penicillin with bactericidal activity on numerous
bacteria; colistin sulphate is a polypeptidic antibiotic belonging to the group of
polimixins with bactericidal and bacteriostatic activity.
The synergic association of amoxicillin and colistin sulphate has a wide range
of antimicrobial activity, thus it may face complex infections sustained by Grampositive and Gram-negative bacteria.
After oral administration, thanks to their different pharmacokinetics, colistin acts
almost only within the intestine, as its absorption is very low; by contrast
amoxicillin performs a prevailing systemic activity and is distributed evenly in all
the tissues of the organism.
Colistin modifies the structure of the bacterial cells' phospholipids, whereas
amoxicillin acts on their wall during cellular multiplication, with subsequent
lysis.
Colistin is featured by bactericidal and bacteriostatic activity on Gram-negative
microorganisms; it is considered as a first-choice drug in the treatment of
neonatal colibacillosis in piglets and performs a specific antitoxic activity within
the gastrointestinal tract on the colibacillary endotoxins. Amoxicillin is effective
in the treatment of infections caused by B. anthracis, Streptococcus D,
Staphilococcus, Clostridia, Erysipelothrix, Streptococcus, Corynebacterium,
Pasteurella, Brucella, Sphaerophorus, Haemophilus, Fusiformis, Proteus
mirabilis, Salmonella, Treponema and Moraxella.
Effectiveness tests carried out in two spontaneously diseased swine farms, in
which a respiratory and a pneumo-enteric syndrome were present,
demonstrated that, already after the first days of treatment with Zemamix, a
regression of the symptoms connected with the pathology (such as cough,
diarrhoea and hyperthermia) was noticed in animals, as well as an easier
recovery of productivity and an increase in vivacity and mobility, with no signs
of undesired effects.
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5.2 Pharmacokinetics information.
After oral administration, thanks to their different pharmacokinetics, Colistin acts
almost exclusively at intestinal level as its absorption is extremely reduced,
while amoxicillin has a main systemic activity and distributes homogenously in
all organism tissues.
Both active principles, when administered orally, exhibit an excellent tolerability.
Amoxicillin is excreted in its active form mainly through the urinary tract; colistin
is mostly disposed of unchanged with the faeces.
6.
Pharmaceutical information
6.1. List of excipients
Glycerinpolyethylenglicol ricinoleate (E-484)
Corn gluten meal
Stearic acid
Butylhydroxitoluene (E -321)
6.2. Incompatibility
Don’t mix with other medicines.
6.3. Validity period
Validity period of the veterinary medicine packaged for selling: 24 months.
Validity period after the first opening of the primary package: 6 months.
Validity period after mixing in the dry feed: 3 months.
6.4. Special precaution for the storage
The product must be stored in a dry place, at a temperature not exceeding 25
°C.
6.5. Nature and composition of the primary package
The product is packaged in a 25 kg food grade polythene bag, sealed with
plastic string and kept inside a cardboard box, onto which the label is applied.
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.
7.
Holder of marketing authorisation
Vétoquinol Italia S.r.l., Via Piana 265 – 47032 Bertinoro (FC) Italy
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8.
Marketing authorisation number
CY00053V
9.
Date of first marketing authorisation or authorisation renewal
Date of first authorisation: 30/4/2004
Date of renewal:22/11/2012
9.
Date of text renewal
22/11/2012
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