Amix Vet CTC 1000 mg/g oral powder

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Amix Vet CTC 1000 mg/g oral powder

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances:

Chlortetracycline hydrochloride 100% w/w

3. PHARMACEUTICAL FORM

Oral powder

4. CLINICAL PARTICULARS

4.1 Target species

Pigs

4.2 Indications for use, specifying the target species

For oral administration via the feed for treatment and control of respiratory and systemic infections associated with organisms sensitive to chlortetracycline in pigs

4.3 Contraindications

Not applicable.

4.4 Special warnings, for each target species

Nil

4.5 Special precautions for use

(i) Special precautions for use in animals

Nil

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

Do not handle this product if you know you are sensitised or if you have been told not to work with such preparations. It should use protective gloves and glasses

Handle this product with great care to avoid exposure taking all recommended precautions.

If you developed symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning.

Swelling of the face or eyes or difficulty in breathing is more serious symptoms and requires urgent medical attention.

Wash hands after use and before meals.

4.6 Adverse reactions (frequency and seriousness)

Tetracyclines can be an irritant to skin; in this case, discontinue use immediately

4.7 Use during pregnancy, lactation or lay

No particular restrictions use of this product.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

For oral adminsteration incorporation into animal feeding stuffs for individual animals. No for direct feeding to livestock

Dosage

Treatment

Dose: 20 mg/kg bodyweight daily

The inclusion level is 450/tonne of finished feed (equivalent to 450 ppm) for 5-7 days
Preventive:

Dose: 10 – 15 mg/kg bodyweight daily

The inclusion level is 225-300 g /tonne of finished feed (equivalent 225-300 ppm) for 5-7 days.

Dose/kg of feed:

mg Amix CTC 1000 mg/g / kg feed =

required dose (mg/kg) x 2 x body weight (kg)/daily feed intake (kg)

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

Chlortetracycline of low toxicity as presented in the formulation and there is a wide safety margin at recommended dosage.

4.11 Withdrawal period(s)

Meat: 10 days

5. PHARMACOLOGICAL PROPERTIES

pharmacotherapeutic group: Veterinary pharmaceutical, Veterinary 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 hydrochloride against some indicative organisms:

Pathogen	MIC
Pasteurella multocida	0.1-0.5 mcg/ml
Streptococcus suis	0.025-0.1 mcg/ml
Streptococcus suis	0,45 mcg/ml
Actinobacillus pleuropneumoniae	0.39-0.45 mcg/ml *)

*) = MIC ₉₀

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

PHARMACEUTICAL PARTICULARS

6.1 Incompatibilities

Not applicable.

6.2 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.

6.3 Special precautions for storage

Store in a dry place

Store in tightly closed original container

Do not store above 25^oC.

6.4 Nature and composition of immediate packaging

Multi-walled paper sacks in 5 kg ,

0,5 kg in aluminum sachet

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.

7. MARKETING AUTHORISATION HOLDER

Cymedica s.r.o.

Hořovice

Czech Republic

8. MARKETING AUTHORISATION NUMBER(S)

Czech Republic

96/469/96-C

Slovak Republic

96/0086/97-S