SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Amix Vet D 500 mg/g Oral Powder

2. Qualitative and quantitative composition:

Active substance:

Doxycycline 50% w/w

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Powder for oral solution

4. Clinical particulars

4.1 Target species

Pigs

4.2 Indications for use

For use in the treatment of infections due to susceptible bacteria pigs

Pigs: it is used in the treatment and control of diseases caused by sensitive microorganism to doxycycline. It is active against Mycoplasma hyopneumoniae, Pasteurella multocida and to Bordetella.

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4.3 Contra-indications

None Known

4.4 Special warnings for each target species

None Known

4.5 Special precautions for use

i. Special precautions for use in animals

Pigs should have access only to medicated water during treatment

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

Avoid inhalation of dust by wearing a protective mask. Wear disposable half-mask.

In case of accidental spillage on to the skin or eyes, wash the affected area with clean running water immediately. Seek medical attention if irritation occurs/persists. Wash hands thoroughly after using this product.

4.6 Adverse reactions (frequency and seriousness)

Not applicable

4.7 Use during pregnancy, lactation or lay

Studies conducted on laboratory animals during pregnancy or lactation did not show any side effects

4.8 Interaction with other medicaments and other forms of interaction

Absorption of doxycycline from the alimentary tract is reduced by calcium, iron, magnesium and zinc salts.

4.9 Amounts to be administered and administration route

It is recommended for oral administration in drinking water.

10-12,5 mg/body weight corresponds to 1-1,25 g of the product for 50 kg body weight. 200-250 g of the product per 1000l of water and administered daily for up to 5-8 days

Allowance for wastage of medicated water and reduced water intake should be made and the necessary adjustment made to the amount of product used.

Medicated water should be prepared daily and any unused water should be discarded safely. Pigs should have access only to medicated water during treatment.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No specific antidote is available.

4.11 Withdrawal period(s)

Pigs 8 days

5. Pharmacological properties

ATC Vet Code: QJ01AA02 Antibacterials for systemic use (doxycycline)

Pharmacodynamic properties

doxycycline hydrochloride is a bacteriostatic antibiotic belonging to the tetracycline group, which acts by inhibition of protein synthesis.

Pharmacokinetic properties

Doxycycline hydrochloride is readily absorbed and distributed in the tissues in pigs. Blood concentrations may be enhanced by administration with citric acid.

6. Pharmaceutical particulars

6.1 List of excipients

Anhydrous citric acid

6.2 Incompatibilities

Absorption of doxycycline from the alimentary tract is reduced by calcium, iron, magnesium and zinc salts.

6.3 Shelf-life

Powder: The shelf-life of the unopened sachet is 24 months.

On dilution: Any medicated water that is not consumed within 12 hours should be discarded safely.

6.4 Special precautions for storage

Store in a dry place

Do not store above 25°C.

6.5 Nature and composition of immediate packaging

The product is available in a laminated foil sachet containing 1kg of the product .

6.6 Special precautions for the disposal of unused veterinary medicinal product of waste materials derived from the use of such products if appropriate

Any unused product or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Cymedica spol. s r.o.,
Hořovice

Czech Republic

8. MARKETING AUTHORISATION NUMBERS

In Czech Republic

96/036/06-C

In Slovak Republic

96/061/07-S