SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Amix Vet D 500 mg/g premix

2. Qualitative and quantitative composition:

Active substance:

Doxycycline 50% w/w

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Premix

4. Clinical particulars

4.1 Target species

Pigs

4.2 Indications for use

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

Pigs: it is used in the treatment and control Mycoplasma hyopneumoniae, Pasteurella multocida., Bordetella bronchiseptica and Brachyspira hyodysenteriae.

.

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 feed 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 either 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 chlortetracycline from the alimentary tract is reduced by calcium, iron, magnesium and zinc salts.

4.9 Amounts to be administered and administration route

Pigs: In order to achieve the recommended dosage rate of 10-12,5 mg doxycycline HCl/kg, 500g of product should be mixed with tonne of feed for 5-8 days.

Dosage/kg feed= required dose /mg/kg)x2x body weight x daily feed intake

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. Its half life is 14-18 hour.

6. Pharmaceutical particulars

6.1 List of excipients

Farina

Saccharine

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. After first opening 28 days. 2 month in medicated feed meal and 1 month in pellets.

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 two pack sizes: multi-walled paper bag 10 and 25 kg

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.,
Pod Nádražím 853, CZ – 268 01 Hořovice

8. MARKETING AUTHORISATION NUMBERS

In Czech Republic

98/035/06-C

In Slovak Republic

98/062/07-S