1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Amix Vet A 500 mg/g premix
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin 50% w/w (equivalent to Amoxicillin trihydrate 573 mg/g)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Premix for medicated feed
4. CLINICAL PARTICULARS
4.1. Target species
4.2. Indications for use
For treatment and control of respiratory and enteric infections associated with organisms sensitive to amoxicillin.
Does not use in animals with know hypersensitivity to penicillins
4.4. Special precautions for use
4.5. Special precautions for use
(i) Special precautions for use in animals
It is medicated premix for medicated feeding stuff for pigs.
(ii) Special precautions to be taken by the person administering the medicinal product to animals
When mixing the veterinary medicinal product and handling the medicated feed, direct contact with eyes, skin and mucous membranes should be avoided. Personal protective equipment should be worn when mixing the veterinary medicinal product or handling the medicated feed. Wash hands after product handling
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy and lactation
Laboratory studies in rats have not produced any evidence of a teratogenic effect due to the administration of amoxicillin. As amoxicillin crosses to milk, so it should not use during lactation
4.8 Interaction with other medicinal products and other forms of interaction
It should not be used with bacteriostatic antibiotics
4.9 Amounts to be administered and administration route
The product is presented in feed medicated premix for incorporation in finished animal feed
20mg amoxicillin/kg body weight, This dose rate can usually be achieved by mixing 800 g per tone of complete feed to daily for 5 days
mg Aureomix A 500 mg/g premix/kg feed = Dosage required (mg/kg) x 2 x bodyweight (kg)/Daily feed intake (kg).
Maximal temperature for the pelleting process 70ºC
4.10 Overdose (symptoms, emergency procedures, antidotes)
The product is well tolerant in pig.
5.10 Special warnings for each target species,
4.11 Withdrawal periods:
Pigs: 7 days
5. PHARMACEUTICAL PARTICULARS
ATC vet code: QJ01CA04
Pharmacotherapeutic Group: antibacterials for systemic use.
5.1 Pharmacodynamic properties: Amoxicillin is a bacterial semisynthetic penicillin with a broad spectrum of activity against Gram positive and Gram negative bacteria including Streptococcus, Actinomyces, Clostridium) a gram-negativním baktériím jako Pasteurella spp., Escherichia coli, Salmonella spp., Brachyspira hyodysenteriae, Bordetella bronchiseptica, Actinobacillus pleuropneumonie, Proteus. IT owes its activity to the inhibition of the development of the peptidoglycan network structure in the bacterial cell wall.
5.2 Pharmacokinetic properties: Amoxicillin is well absorbed following oral administration and it is stable in the presence of gastric acids. Excretion of amoxicillin is mainly in the unchanged form via the kidneys to give high concentration in renal tissue and urine after 12 hours post-administration. Amoxicillin is well distributed in body fluids.
List of excipients
Shelf life of the veterinary medicinal product as packaged for sale 24 months.
Shelf-life when incorporated into meal feed: 2 months
Shelf-life when incorporated into pelleted feed: 1 month
Shelf-life after first opening the immediate packaging: 28 days
Special precautions for storage
Do not store above 25°C. Store in a dry place.
Nature and composition of immediate packaging
The product is packed in polythene-lined multi-walled paper bag
Pack size: 10 kg, 25 kg
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Cymedica spol. s r.o.,
8. MARKETING AUTHORISATION NUMBER(S)