Trinacol Injection Solution for Injection

Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

A sterile clear yellow aqueous solution for parenteral administration.

Each ml contains Sulfadiazine 200 mg, Trimethoprim 40 mg and Chlorocresol 1 mg as preservative.

Uses

Trinacol is indicated in the treatment of acute, subacute and chronic conditions of bacterial origin in cattle, pigs and dogs.

The therapeutic spectrum includes both Gram-negative and Gram-positive bacteria including Streptococci, Staphylococci, Actinobacilli, Actinomycae, Salmonella, Pasteurella, Pneumococci, Proteus, E. coli, Corynebacteria, Vibrio, Bordetella, Brucella, Klebsiellae and Haemophilae.

Dosage and administration

Cattle and Pigs

1 ml per 16 kg body weight (15mg/kg) daily by intramuscular or slow intravenous injection.

Dogs

1 ml per 8 kg body weight (30mg/kg) daily by subcutaneous injection only. The recommended site in dogs is the loose skin at the top of the neck.

Maximum recommended volume to be administered at a single intramuscular site : 15ml of product. A single injection may be sufficient in uncomplicated conditions, but in severe infections treatment may be repeated up to a maximum of 5 days, or until 2 days after the symptoms resolve.

Contra-indications, warnings, etc

Anaphylactic shock has been observed on rare occasions following administration of potentiated sulphonamide preparations particularly by the intravenous route. For intravenous administration the product should be warmed to body temperature and injected slowly over as long a period as is reasonably practical. At the first sign of intolerance the injection should be interrupted and shock treatment initiated. Intravenous administration should be used with extreme caution and only if therapeutically justified. Local reaction characterised by swelling and/or hardness may be observed at the injection site following treatment.

Injections should not be given by routes other than those recommended. Not to be administered intraperitoneally.

Do not administer to animals with known sulphonamide sensitivity, severe liver parenchymal damage, or blood dyscrasias.

Withdrawal Periods Milk for human consumption may be taken only from cattle after 48 hours from the last treatment. Cattle intended for human consumption should not be slaughtered until 12 days after the last treatment. Pigs intended for human consumption should not be slaughtered until 20 days after the last treatment.

Adequate drinking water should be available during the therapeutic effect of the product.

Care should be taken to avoid accidental self-injection. Following withdrawal of the first dose, use the product within 28 days. Unused product and containers should be disposed of in accordance with national requirements.

For animal treatment only

Pharmaceutical precautions

Store at room temperature, not exceeding 25°C. Do not freeze. Crystallisation of the product at low temperatures can be reversed by gentle warming. Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur, the product should be discarded. Protect from light. Keep out of the reach and sight of children.

Legal category

POM-V

Packaging Quantities

100 ml.

Further information

Nil.

Marketing authorisation number

Vm 00015/4024.