SUMMARY OF PRODUCT CHARACTERISTICS

Tetsol 800

80% w/w Powder for Oral Solution.

Tetracycline hydrochloride 80.0% on an acidified carrier to 100.0%.

For a full list of excipients, see section 6.1.

Powder for oral solution.

Yellow powder.

4.1 Target species

Pigs and chickens

4.2 Indications for use, specifying the target species

For use against diseases caused by Clostridium perfringens in chickens and those caused by Actinobacillus (Haemophilus) pleuropneumoniaein pigs.

4.3 Contraindications

None.

4.4 Special warnings for each target species

None known.

4.5 Special precautions for use

i) Special precautions for use in animals

None known.

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

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.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

No specific restrictions.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

For administration in the 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 that 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.

No of level scoops daily = no of pigs x av wt (kg) ÷ 1000.

For example 50 pigs with an average weight of 20 kg: No of level scoops daily = 50 x 20 ÷ 1000 = 1 scoop per day which should be added to 120 litres of water.

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

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

None known.

4.11 Withdrawal period(s)

Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption after the following periods from the last treatment: Chickens: 3 days. Pigs: 6 days.

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

Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines

ATCvet code QJ01AA07

5.1 Pharmacodynamic properties

The tetracyclines are bacteriostatic antibiotics that inhibit protein synthesis in susceptible microorganisms. After they diffuse through the outer cell membrane, an active carrier mediated process transports the drug through the inner cytoplasmic membrane. Once inside the cell, they bind irreversibly to receptors on the 30S subunit of the bacterial ribosome where they interfere with the binding of the aminoacyl-transfer RNA to the acceptor site on the messenger RNA ribosome complex. This effectively prevents the addition of amino acids to the elongating peptide chain, inhibiting protein synthesis.

5.2 Pharmacokinetic particulars

The tetracycline group members vary in lipid solubility: it is this property which seems largely to determine their distribution and rate of excretion. They enter most tissues and body fluids with the exception of cerebrospinal fluid. As a result of chelation with calcium, tetracyclines become bound at active sites of ossification and in developing teeth. They cross the placenta to reach the foetus and are secreted in milk where they reach concentrations approximately those of serum. Most tetracyclines are excreted unchanged in urine and to a lesser extent, in bile. Tetracyclines undergo enterohepatic circulation, with much of the compound excreted in bile being reabsorbed from the intestine. This process contributes to the half-life of 6 - 10 hours, longer than might be anticipated with substances that are eliminated mainly by renal excretion.

6.1 List of excipients

Citric acid anhydrous

6.2 Incompatibilities

None known.

6.3 Shelf life

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

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

6.4 Special precautions for storage

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

Close container after use.

6.5 Nature and composition of immediate packaging

Pack size: 125 g

Container: Polyethylene coated aluminium foil sachet

Closure: Heat seal

Pack size: 2 kg

Container: White opaque polypropylene tub, containing polythene bag

Closure: Red brown polypropylene push fit lid

Dosing device: Polypropylene scoop (75 ml giving a 50 g dose)

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 waster material arising from such veterinary medicinal products should be disposed of in accordance with local requirements.

Novartis Animal Health UK Limited
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
United Kingdom

Vm 12501/4128

Date of first authorisation: 5 December 1995

Date of last renewal: 05 December 2005

March 2008