1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Amix Vet CTC 150 mg/g premix

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance

Chlortetracycline hydrochloride 150 mg/g

3. PHARMACEUTICAL FORM

Premix for medicated feed

4. PHARMACOLOGICAL PROPERTIES AND PHARMACOKINETIC PARTICULARS

4.1. Pharmacodynamic properties

Farmacotherapeutic group: Veterinarny farmaceutic, Veterinarny antibiotic

ATC Vet Code: Q07AH

The product is a veterinary medicinal product containing the antibiotic chlortetracycline hydrochloride. It is broad-spectrum antibiotic with a wide range of activity against both Gram-Positive and Gram-negative bacteria particularly against Clostridia, Actinomyces pyogenes, Staphylococcus spp., Streptococcus spp., Spirochaeta, Mycoplasma spp., E. coli, Actinobacillus spp., Haemophilus spp., Klebsiella spp., Pasteurella spp., Campylobacter spp., Moraxella spp.,.

Its activity is bacteriostatic by interfering with the protein synthesis at the S70 ribosome sub-unit.

Minimal inhibitory concentration (MIC) of Chlortetracycline hydrochloridum against some indicative organisms:

*) = MIC ₉₀

Resistance to chlortetracycline: Resistance is plasmid-mediated and cross-resistance to other tetracyclines is common

4.2. Pharmacokinetic properties

Chlortetracycline chelates calcium in teeth and bone. It becomes incorporated into these structures, inhibits calcification. It is also nephrotoxic and may led to tubular nephrosis. When dosed orally it is quickly absorbed into the blood stream. Bacteriostatic activity starts in pigs during few hours after application.

The half-life in serum is about three hours and virtually disappears within 18-24 hours. Its bioavalability is about 2%. To sustain its level in the blood, it is necessary to administrate daily for 5-7 days.

5. CLINICAL PARTICULARS

5.1. Target species

Pigs

5.2. Indications for use

For treatment and control of respiratory and systemic infections associated with organisms sensitive to chlortetracycline.

5.3. Contra-indications

Do not administer to animals with intolerance to tetracyclines.

5.4. Undesirable effects, frequency and seriousness

In rare cases, temporary erythema might occur, which disappears after treatment cease.

5.5. Special precautions for use

None known

5.6. Use during pregnancy and lactation

No problems known

5.7. Interaction with other medicaments and other forms of interaction

None known

5.8. Posology and method of administration

The product is presented in feed medicated premix for incorporation in finished animal feed

Therapeutic dosag:

These dose rates can usually be achieved by mixing 3,0-4,0 kg equivalent to (450g – 600g CTC) per tone of complete feed to give a concentration of (450-600 ppm). Chlortetracycline hydrochloride. The dose is 20 mg – 30 mg per kg bodyweight daily administered for 5 to 7 days

Preventive dosage:

These dose rates can usually be achieved by mixing 1,5 – 2,0 kg equivalent to (225 – 300 g CTC) per tone of complete feed to give a concentration of (225-300 ppm). Chlortetracycline hydrochloride. The dose is 10 mg – 15 mg mg per kg bodyweight daily administered for 5 to 7 days

5.9. Overdose (symptoms, emergency procedures, antidotes)

The product is well tolerant.

5.10. Special warnings for each target species,

None

5.11. Withdrawal periods:

Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after the following number of days from the end of treatment:

Pigs: 10 days

5.12. 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

6. PHARMACEUTICAL PARTICULARS

6.1. Major incompatibilities

None known

6.2. Shelf life

2 years

In final feed: 3 months

Opened bags of premix: 30 days

6.3. Storage precautions

Do not store above 25ºC.

Protect from light. Store in a dry place. Keep out of children.

6.4. Nature and content of containers

Polyethylene bags containing 7,5 kg and 25 kg

6.5. Special precautions for the disposal of unused medicinal product or waste materials, if any.

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

7. NAME or corporate name AND address or registered place of business of the marketing authorisation holder

Authorisation holder

Cymedica spol. s r.o.,

Hořovice

Czech Republic

Manufacturer of medicinal product

Cymedica spol. s r.o.,

Hořovice,

Czech Republic

8. Marketing authorisation number

Czech Republic

98/147/04-C

Slovak Republic

98/042/06-S