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AMIX Vet A 500 mg/g powder for oral solution

Pack:
1 kg
Pharmaceutical form:
Powder for oral solution
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

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Amix Vet A 500 mg/g powder for oral solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Amoxicillin trihydrate 50% w/w (equivalent to Amoxicillin 45.7% w/w)

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Powder for oral solution. A white powder

4. CLINICAL PARTICULARS

    1. Target species

Pigs.

4.2 Indications for use, specifying the target species

Pigs: For the treatment of diseases caused by isolates sensitive to amoxicillin.

4.3 Contra-indications

Do not use in animals with known hypersensitivity to the active substance.

4.4 Special warnings for each target species

None

4.5 Special precautions for use

(i) Special precautions for use in animals

Take into account official and local antimicrobial policies.

(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Avoid inhalation of dust.

Wash hands after use.

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.

    1. Adverse reactions (frequency and seriousness)

None known.

    1. Use during pregnancy, lactation or lay

Laboratory studies in rats have not produced any evidence of a teratogenic effect due to the administration of amoxicillin.

Use only according to the benefit/risk assessment of the responsible veterinarian.

    1. Interaction with other medicinal products and other forms of interaction

None known.

    1. Amounts to be administered and administration route

Product is administered in drinking water

Prepare the solution with fresh tap water.

Any medicated water which is not consumed within 12 hours should be discarded.

In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst on treatment.

Pigs

Administer in the drinking water to give 20mg/kg bodyweight daily. The dose should be divided and administered at approximately 12 hourly intervals for up to 5 days

    1. Overdose (symptoms, emergency procedures, antidotes), if necessary

No problems with overdosage have been reported. Treatment should be symptomatic and no specific antidote is available.

    1. Withdrawal period(s)

Meat:

Pigs: 7 days

  1. PHARMACOLOGICAL PROPERTIES

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. 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. Amoxicillin is well distributed in body fluids.

Studies in birds have indicated that amoxicillin is distributed and eliminated more rapidly than in mammals. Biotransformation appeared a more important route of elimination in birds than in mammals.

  1. PHARMACEUTICAL PARTICULARS

    1. List of excipients

Citric Acid Anhydrous

    1. Incompatibilities

None known.

    1. Shelf life

Shelf life of the veterinary medicinal product as packaged for sale 24 months. Shelf life after dilution or reconstitution according to directions 24 hours.

    1. Special precautions for storage

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

    1. Nature and composition of immediate packaging

1 kg in foil/polyethylene sachets

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 s.r.o.

Hořovice

Czech Republic

8. MARKETING AUTHORISATION NUMBER(S)

In Czech Republic

96/032/06-C

In Slovak Republic

96/061/07-S

AMIX Vet A 500 mg/g powder for oral solution