Aurofac Granular 250 Mg/G Premix For Medicated Feeding Stuff
Revised: September 2014
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Aurofac Granular 250 mg/g Premix for Medicated Feeding Stuff
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Chlortetracycline hydrochloride 250mg/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
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
Special precautions for use
i) Special precautions for use in animals
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 the 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 the product. If contact with the 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 1.2 kg of Aurofac 250 Granular 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.
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 250 Granular 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.
A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products must be responsible for mixing when incorporation is less than 2kg per tonne for final feed.
For incorporation into dry feed at the registeredmill.
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 periods
Meat and offal:
Pigs: 10 days
Chickens: 2 days
Turkeys: 2 days
Ducks: 4 days
Not authorized for use in laying birds producing eggs for human consumption.
Do not use within 14 days of the onset of laying.
5. PHARMACOLOGICAL PROPERTIES
Chlortetracycline is a natural broad spectrum antibiotic of the tetracycline group.
ATC Vet Code:QJ01AA03
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.
5.2 Pharmacokinetic particulars
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.
5.3 Environmental properties
Studies have demonstrated that under correct conditions of use no negative impact on the environment can be expected.
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 meal or pelleted feed: 3 months
6.4 Special precautions for storage
Store apart from animal feeding stuffs.
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
Polyethylene bags containing 2 kg, 3 kg, 4.8 kg, 6.4 kg, 8 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
9. DATE OF FIRST AUTHORISATION
Date:28 September 2007
10. DATE OF REVISION OF THE TEXT
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