Tetsol 800 80% w/w Powder for Oral Solution

Introduction

Company name: Novartis Animal Health UK Ltd

Address: Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

Telephone: 01276 694402

Fax: 01276 694403

Presentation

Tetsol 800 (80% w/w) Powder for Oral solution.

A yellow water-soluble powder containing 800 g tetracycline hydrochloride per kg.

Uses

Tetsol 800 is indicated for the treatment of diseases caused by Clostridium perfringens in chickens and those caused by Actinobacillus (Haemophilus) pleuropneumoniae in pigs.

Dosage and administration

For administration in drinking water for up to 5 days. Allow birds and animals access to medicated water only during treatment. Medicated water should be prepared daily, and any medicated water which is not consumed within 24 hours should be discarded.

Chickens

Use 1 sachet (125 g) Tetsol 800 to medicate 180 litres of water, providing 100 g of active ingredient per 180 litres. This is approximately equivalent to 60 mg tetracycline hydrochloride/kg bodyweight daily.

This dosage may be achieved by using the scoop supplied which when levelled, delivers 50 g product. Use one scoop to medicate 72 litres of water, providing 1 g of active ingredient per 1.8 litres.

To obtain the number of scoops needed to medicate a flock of chickens, take the total bodyweight in kg, multiply by 75/1000 to obtain the amount of product in grams and then divide by 50 for the number of scoops needed.

For example 10,000 kg x 75/1000 = 750, then ÷ 50 = 15 scoops.

Pigs

Use 1 sachet (125 g) Tetsol 800 to medicate 300 litres of water, providing 100 g of active ingredient per 300 litres. This is approximately equivalent to 40 mg tetracycline hydrochloride/kg bodyweight daily.

This dosage may be achieved by using the scoop supplied which, when levelled, delivers 50 g of product. Use one scoop to medicate 120 litres of water, providing 1 g of active ingredient per 3 litres.

Number of level scoops daily=

No. of pigs×Average Wt. (Kg)

     1,000

For example, 50 pigs with an average weight of 20 kg:

Number of level scoops daily=

50×20

1,000

 =

1 scoop per day, which should be added to 120 litres of water

The daily dose may be given in concentrations of up to 125 g Tetsol 800 per 100 litres water.

Contra-indications, warnings, etc

Withdrawal Periods

Chickens

3 days

Pigs

6 days

Do not use in laying birds producing eggs for human consumption.

Allow chickens and pigs access only to medicated water during treatment. Access to unmedicated water should be allowed after each day's dose has been consumed.

Keep out of the reach and sight of children.

For animal treatment only.

Safety precautions

Wear suitable protective clothing, eye/face protection and impervious gloves before using the product.

Wash hands and exposed skin after handling the product.

Do not handle this product if you are allergic to tetracyclines.

In case of eye contact, rinse abundantly with water.

If you develop symptoms following exposure, such as skin rash, skin or eye irritation, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Pharmaceutical precautions

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

Shelf life after dilution or reconstitution according to directions: 24 hours.

Do not store above 25°C. Store in a dry place. Protect from light.

Close container after use.

Disposal

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

Legal category

POM-V

Packaging Quantities

125 g polyethylene-coated aluminium sachet, 2 kg white polypropylene tub.

Further information

To allow ready dissolution of Tetsol 800, dissolve the required amount of product in a few litres of water, before addition to the header tank.

In areas where water is very hard, it is advisable to add Tetsol 800 at a rate of 2.5 scoops or 1 sachet (125 g) to 100 litres of header tank water to ensure complete dissolution.

Marketing authorisation number

Vm 12501/4128.