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Date: Saturday, December 5, 2020 0:00

Release 2.52
Aurofac Granular 100 mg/g Premix for Medicated Feeding Stuff
 
Species: Pigs, Chickens, Ducks, Turkeys
Therapeutic indication: Medicinal feed additives: Antimicrobials and antimicrobials combination
Active ingredient: Chlortetracycline Hydrochloride
Product:Aurofac® Granular 100 mg/g Premix
Product index: Aurofac Granular 100 mg/g Premix
Pig - meat: 10 days
Poultry - meat: 2 days
Withdrawal notes: Ducks (meat): 4 days. Eggs: chickens, turkeys and ducks: eggs of treated animals should not be used for human consumption.
Presentation
The product is a premix consisting of yellow free flowing granules and contains 100 g chlortetracycline hydrochloride per kg.
Uses
For treatment and control of respiratory and systemic infections associated with organisms sensitive to chlortetracycline.
Dosage and administration
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 Aurofac 100 Granular 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.
Contra-indications, warnings, etc
Do not use in ruminants.
No known problems if used during pregnancy or lactation.
Chlortetracycline is of low toxicity and there is a wide safety margin at the recommended dosage. On rare occasions overdosage may cause diarrhoea and overgrowth of yeast and fungi. Under such conditions, withdraw medication and apply appropriate treatment.
The product is of low toxicity and side effects are rarely encountered. If suspected adverse reactions occur, treatment should be discontinued immediately.
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.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Withdrawal periods
Meat and offal:
Pigs: 10 days
Chickens: 2 days
Turkeys: 2 days
Ducks: 4 days
Eggs:
Chickens, turkeys and ducks - Eggs of treated animals should not be used for human consumption.
User warnings
If you know you are hypersensitive (allergic) to chloretracycline, 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.
Pharmaceutical precautions
Store apart from animal feeding stuffs. Do not store above 30°C.
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.
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.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed in accordance with local requirements.
Keep out of reach and sight of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
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.
Further information
Nil.
Marketing Authorisation Number
Vm 42058/4007
Significant changes
GTIN
GTIN description:8 x 3 kg:
GTIN:05425008730523
GTIN description:1 x 25 kg:
GTIN:05414736045924