Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Duphatrim IS (Injectable Solution) is a clear yellow aqueous solution of trimethoprim and sulfadiazine for parenteral administration. Each ml contains the following active ingredients:

Trimethoprim PhEur	40 mg
Sulfadiazine PhEur	200 mg
Chlorocresol (as preservative) Sodium Formaldehyde Sulphoxylate	1 mg 1 mg

Uses

Duphatrim IS is a broad-spectrum antibacterial indicated in the treatment of a wide range of Gram-positive and Gram-negative organisms.

The two active ingredients, trimethoprim and sulfadiazine, sequentially block bacterial and protozoal synthesis of folinic acid, thus greatly potentiating the activity obtained when either ingredient is used alone.

In vitro antibacterial activity of Duphatrim IS is extensive, including Actinobacillus spp, Actinomyces spp, Bordetella spp, Brucella spp, Corynebacterium spp, E. coli, Haemophilus spp, Klebsiella spp, Pasteurella spp, Pneumococcus spp, Proteus spp, Salmonella spp, Staphylococcus spp (including penicillin-sensitive and penicillin-resistant), Streptococcus spp.

Duphatrim IS is indicated for use in horses, cattle, pigs, dogs and cats, for the treatment of acute, subacute and chronic bacterial infections sensitive to trimethoprim/sulfadiazine therapy such as:

Bacterial infections of the respiratory tract, including rhinitis, pneumonia, bronchitis and in bacterial infections secondary to viral disease such as viral pneumonia or mycoplasma infections.

Urogenital tract infections, including cystitis, vaginitis, urethritis, nephritis and metritis.

Alimentary tract infections, including neonatal diarrhoea and salmonellosis.

Other infections, such as foul-in-the-foot, severe mastitis, bacterial agalactia of sows, infections of the eye, ear or mouth.

Dosage and administration

For cattle and pigs the dose is 1 ml per 16 kg (35 lb) bodyweight by intramuscular or slow intravenous injection (equivalent to 15 mg of combined active ingredients per kg bodyweight) once, but in severe infections it may be repeated daily until 2 days after symptoms resolve up to a maximum of 5 days.

Duphatrim IS may be administered by intravenous injection when rapid blood levels of sulfadiazine and trimethoprim are required.

For horses the dose is 1 ml per 16 kg bodyweight daily, by slow intravenous injection only.

For dogs and cats the dose is 1 ml per 8 kg bodyweight daily, by subcutaneous injection only (equivalent to 30 mg of combined active ingredients per kg bodyweight). The recommended site in dogs is the loose skin at the base of the neck.

A single injection may be sufficient in uncomplicated conditions, but in severe infections the dose may be repeated for up to a maximum of 5 consecutive days, or until 2 days after the symptoms resolve.

The suggested dosage rates are:
Horse	480 kg	30 ml
Cattle	400 kg	25 ml
Pig	80 kg	5 ml
Dog	16 kg	2 ml
Cat	4 kg	0.5 ml

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

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

intraperitoneally.

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

Do not administer to animals with known sulphonamide sensitivity, severe liver parenchymal damage, or blood dyscrasias. As with all Trimethoprim/Sulphonamide formulations the possibility of potential damage to the kidney or liver or haemapoeitic system should be considered.

Do not administer to horses exhibiting drug-induced cardiac arrhythmias. Such arrhythmias may be associated with the administration of certain anaesthetic and sedative agents. The intravenous route is contraindicated in the case of concurrent or previous administration of central nervous system depressants (e.g. anaesthetics, neuroleptics).

Intravenous injections should be at body temperature and administered slowly over as long a period as is reasonably practical in order to avoid possible anaphylactic shock. If intolerance develops, immediately interrupt the injection and initiate shock treatment.

The possibility of anaphylaxis should be considered and the intravenous route in the horse should only be used if therapeutically justified.

Withdrawal periods

Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cows only after 48 hours from the last treatment.

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 12 days from the last treatment. Pigs may be slaughtered for human consumption only after 20 days from the last treatment.

Not to be used in horses intended for human consumption.

The horse must have been declared as not intended for human consumption in accordance with the UK's Horse Passport Legislation.

Operator Warnings

Care must be taken to avoid accidental self-injection.

Avoid direct contact with skin and eyes. In the event of accidental spillage, wash affected area with copious amounts of water, seek medical advice if irritation persists.

Wash hands after use.

Pharmaceutical precautions

Do not store above 25°C. Do not freeze. Crystallisation of the product at low temperatures can be reversed by gentle warming. Protect from light. Keep out of the reach and sight of children.

Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Legal category

POM-V

Packaging Quantities

Multidose vials of 100 ml.

Further information

Disposal

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Marketing authorisation number

Vm 01596/4140.