Aurofac Granular 100 Mg/G Premix For Medicated Feeding Stuff
Revised: June 2013
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Aurofac Granular 100 mg/g Premix for Medicated Feeding Stuff
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Chlortetracycline hydrochloride 100 mg/g
Carrier: Calcium sulphate dihydrate
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Premix for medicated feeding stuff
The product is a premix consisting of yellow free flowing granules
4. CLINICAL PARTICULARS
4.1 Target species
Pigs, chickens, turkeys, ducks
4.2 Indications for use, specifying the target species
For treatment and control of respiratory and systemic infections associated with organisms sensitive to chlortetracycline.
Do not use in ruminants
4.4 Special warnings
4.5 Special precautions for use
i. Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
If you know you are hypersensitive (allergic) to chlortetracycline, do not handle the product.
When handling this product, inhalation of the dust must be avoided by wearing a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143.
Avoid contact with skin and eyes. Gloves should be worn whilst handling this product. If contact with skin or eyes occurs, wash area immediately with clean fresh water. If irritation persists seek medical attention.
Do not eat, drink or smoke whilst handling the product. Hands and exposed skin should be washed thoroughly after use.
4.6 Adverse reactions (frequency and seriousness)
The product is of low toxicity and side effects are rarely encountered. If suspected adverse reactions occur, treatment should be discontinued immediately.
4.7 Use during pregnancy, lactation or lay
No problems known
4.8 Interaction with other medicinal products and other forms of interaction
Chlortetracycline is sometimes used in association with other antimicrobials, notably sulphadimidine, penicillin and neomycin. There are no known adverse reactions with these or any other substances.
4.9 Amounts to be administered and administration route
The recommended dose rates are as follows:
Pigs: 10–20 mg/kg bodyweight daily
Chickens: 20-30 mg/kg bodyweight daily
Turkeys: 10-30 mg/kg bodyweight daily
Ducks: 10-30 mg/kg bodyweight daily
These dose rates can usually be achieved by mixing 3.0 kg of Aurofac Granular 100 mg/g Premix for Medicated Feeding Stuff per tonne of complete feed to give a concentration of 300 ppm chlortetracycline hydrochloride. However, the correct incorporation rate should always be calculated based on the feed consumption rates of the animals to be treated.
The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of chlortetracycline has to be adjusted accordingly.
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.
Aurofac Granular 100 mg/g Premix for Medicated Feeding Stuff can be incorporated in pelleted feed preconditioned at temperatures up to 70°C.
The medicated feed should be supplied to the affected pen(s) or group(s) of pigs, chickens, turkeys or ducks. Treatment should be continued for a period of five to seven days for respiratory or systemic infections. During the treatment period, only feed medicated with the product should be supplied.
For incorporation into dry feed at the registered mill. A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or pre-mixtures containing such products must be responsible for mixing when incorporation is less than 2 kg per tonne for final feed.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Chlortetracycline is of low toxicity and there is a wide safety margin at the recommended dosage. On rare occasions overdosage may cause diarrhoea and over growth of yeast and fungi. Under such conditions, withdraw medication and apply appropriate treatment.
4.11 Withdrawal period(s)
Meat:Animals must not be slaughtered for human consumption during treatment.
Pigs 10 days
Chickens 2 days
Turkeys 2 days
Ducks 4 days
Eggs: Chicken’s, Turkeys and Ducks - Eggs of treated animals should not be used for human consumption
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antibacterials for systemic use, etracyclines
ATCVet Code: QJ01AA03
5.1 Pharmacodynamic properties
Chlortetracycline is a natural broad spectrum antibiotic of the tetracycline group. Its activity is bacteriostatic by interfering with the protein synthesis at the S30 ribosome sub-unit.
At recommended dosages it has no pharmacological effects on cardiovascular, nervous or other body systems.
When dosed orally it is quickly absorbed into the blood stream. In-feed dosing provides steady to near steady state plasma levels. This provides effective concentrations in various tissues, including lungs and other respiratory tissues.
The major metabolite is 4-epi-chlortetracycline.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Calcium sulphate dihydrate
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale 3 years.
Shelf life after first opening the immediate packaging 14 days.
Shelf life after incorporation into mashed feed 2 months.
Shelf life after incorporation into pelleted feed 3 weeks.
6.4 Special precautions for storage
Store apart from animal feedingstuffs.
Do not store above 30ºC.
After first opening the bag of premix, any remaining contents should be stored in a dry place and the bag should be closed and secured with a suitable bag tie.
6.5 Nature and composition of immediate packaging
Heat sealed polyethylene bags containing 2 kg, 3 kg, 9 kg, 12 kg, 16 kg, 20 kg and 25 kg.
Cardboard cartons containing 8 x 3 kg polyethylene bags, 12 x 2 kg polyethylene bags
Not all pack sizes may be marketed.
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
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION
Date:27 May 2005
10. DATE OF REVISION OF THE TEXT
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