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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Amix Vet CTC 150 mg/g oral powder
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Chlortetracycline hydrochloride 15% 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
Wash hands thoroughly after use.
Avoid breathing dust.
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
The inclusion level is 3- 4kg/tonne of finished feed (equivalent to 450 – 600g CTC/tone that means 450 – 600ppm). This dose is 20-30mg/kg body weight.
Preventive:
The inclusion level is 1,5 – 2kg/tonne of finished feed (equivalent to 225 – 300g CTC/tone that means 225 – 300ppm). This dose is 10-15mg/kg body weight
The correct incorporation rate should always be calculated based on the feed consumption rates of the animals to be treated.
Treatment should be continued for a period of five to seven days for respiratory or systemic infections. To ensure thorough dispersion of the product, it should first be mixed with a suitable quantity of feed ingredients before incorporation into the final mix.
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
Chlortetracycline is a broad spectrum antibiotic of the tetracycline group active against a wide range of Gram-positive and Gram-negative bacteria. The mode of action is bacteriostatic by binding irreversibly to the 30S ribosomal unit and blocking protein synthesis. When dosed orally it is absorbed into the blood stream, and is excreted in urine and faeces.
6. 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 25oC.
6.4 Nature and composition of immediate packaging
Multi-walled paper sacks
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
96/1352/97-C
Slovak Republic
96/064/02-S
