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AMIX Vet A 500 mg/g premix

Pack:
10, 25 kg
Pharmaceutical form:
Premix
Active substance:
Amoxicillinum 500,0 mg (eq. 573 mg Amoxicillinum trihydricum)
Detail:
Amoxicillinum 500,0 mg (eq. 573 mg Amoxicillinum trihydricum)
Description:
Group:
Veterinary product
Animal:
Pig

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Amix Vet A 500 mg/g premix

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance

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

Pigs

4.2. Indications for use

For treatment and control of respiratory and enteric infections associated with organisms sensitive to amoxicillin.

4.3. Contra-indications

Does not use in animals with know hypersensitivity to penicillins

4.4. Special precautions for use

None known

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)

None known

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

Dose calculation

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,

None

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.

  1. PHARMACEUTICAL PARTICULARS

    1. List of excipients

Sodium Sacharin

Farina tritici

    1. Incompatibilities

None known

    1. Shelf life

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

    1. Special precautions for storage

Do not store above 25°C. Store in a dry place.

    1. 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.

  1. MARKETING AUTHORISATION HOLDER

Cymedica spol. s r.o.,

Hořovice

Czech Republic

8. MARKETING AUTHORISATION NUMBER(S)

Czech Republic

98/034/06-C

Slovak Republic

98/060/07-S

AMIX Vet A 500 mg/g premix