Introduction

Company name: Alpharma Belgium bvba

Address: Garden Square,

Laarstraat 16

2610 Antwerp - Belgium

Telephone: +44 1728621556 (Mobile: +44 7740 483818)

Fax: +44 1728621556

Email: patrick.garland@alpharma.com

Telephone: +44 140 025 0911 (Mobile: +44 771 734 5108)

Email: philip.keogh@alpharma.com

Website: www.alpharmaah.com

Presentation

The product is a premix consisting of yellow free flowing granules and contains 250 g of 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: 10-20mg/kg bodyweight daily

broilers: 20-30mg/kg bodyweight daily

layers: 20-25mg/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 1.2kg of Aurofac® 250mg/g Granular Premix per tonne of complete feed to give a concentration of 300 ppm chlortetracycline hydrochloride. However the correct incorporation rate should 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® 250mg/g Granular Premix can be incorporated in pelletes 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.

Contra-indications, warnings, etc

Do not use in ruminants. No special warnings. No problems known when used during pregnancy, lactation or hay. 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.

Withdrawal periods

Pigs(meat) : 10 days

Chickens (meat) :2 days

Chickens (eggs) : 4 days

Turkeys (meat) : 2 days

Ducks(meat) : 4 days

Not to be used in ducks producing eggs for human consumption.

Pharmaceutical precautions

Store apart from animal feeding stuff. 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.

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

Shelf-life after first opening the immediate packaging: 14 days

Shelf-life after incorporation into feed: as mash: 3 months, as pellets: 3 months

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

General precautions:

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.

Do not handle this product if you know you are sensitised or if you have been told not to work with such preparations. 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 are more serious symptoms and require urgent medical attention.

Wash hands after use and before meals.