Duphatrim IS Injectable Solution
Duphatrim IS (Injectable Solution) is a sterile, clear yellow, aqueous solution of trimethoprim and sulfadiazine for parenteral administration. Each ml contains the following active ingredients:
Chlorocresol (as antimicrobial preservative)
Sodium Formaldehyde Sulphoxylate (as antioxidant)
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
Cattle and pigs:
The recommended dose rate is 15mg of active ingredients per kilogram bodyweight (1ml per 16kg bodyweight) once by intramuscular or slow intravenous injection, 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 trimethoprim and Sulfadiazine are required.
The recommended dose rate is 15mg of active ingredients per kilogram bodyweight (1ml per 16 kg bodyweight), by slow intravenous injection.
Dogs and Cats:
The recommended dose rate is 30mg of active ingredients per kilogram bodyweight (1ml per 8kg bodyweight), by subcutaneous injection only.
The recommended site in dogs is the loose skin at the top of the neck.
A single injection may be sufficient in uncomplicated conditions, but in severe infections it may be repeated daily for up to 5 days or until 2 days after the symptoms have resolved.
The suggested dosage rates are:
Contra-indications, warnings, etc
Injections should not be given by routes other than those recommended. Not to be administered
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).
Anaphylactic shock has been observed on rare occasions following administration of potentiated sulphonamide preparations, mostly after intravenous injection. 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.
The possibility of anaphylaxis should be considered and the intravenous route in the horse should only be used if therapeutically justified.
Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cattle 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.
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.
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.
Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Keep out of the reach and sight of children.
For animal treatment only.
Multidose vials of 100 ml.
Duphatrim IS can be safely administered to pregnant and lactating animals.
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