Target species
•Horses
•Cattle
•Pigs
•Dogs
•Cats
Indications for use, specifying the target species
Norodine 24 Injectable Solution is indicated in the treatment of systemic infections caused by or associated with organisms sensitive to the Trimethoprim:Sulfadiazine combination. The spectrum of activity includes both Gram-positive and Gram-negative organisms including:
•Actinobacilli
•Actinomycae
•Bordetella spp
•Brucella
•Corynebacteria
•Escherichia coli
•Haemophilus spp
•Klebsiella spp
•Pasteurella spp
•Pneumococci
•Proteus
•Salmonella spp
•Staphylococci
•Streptococci
•Vibrio
Contraindications
Norodine 24 Injectable Solution should not be given by routes other than those recommended. Not to be administered intraperitoneally, intra-arterially or intrathecally.
Do not administer to animals with known sulphonamide sensitivity, severe liver parenchymal damage or blood dyscrasias.
Special Warnings for each target species
None known
Special precautions for use
Special precautions for use in animals
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.
Adequate drinking water should be available during the therapeutic effect of the product.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental injection and contact with the skin. Wash hands after use.
Sulphonamides may cause hypertensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypesensitivity to sulphonamides may lead to cross reactions with other antibiotics. Allergic reactions to these substances may occasionally be serious.
•Do not handle this product if you know you are sensitive to sulphonamides.
•If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.
•Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental selfinjection.
Adverse reactions (frequency and seriousness)
Anaphylactic shock, potentially fatal, has been observed on rare occasions following administration of potentiated sulphonamide preparations, particularly by the intravenous route. Veterinary surgeons should be mindful of this possibility during the injection process
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in Horses, Cattle, Pigs, Dogs, Cats during pregnancy, lactation, lay or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient Nmethyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Do not administer to horses exhibiting drug-induced cardiac arrhythmias. Such arrhythmias may be associated with the administration of certain anaesthetic and sedative agents.
Amounts to be administered and administration route
Cattle and Pigs:
The recommended dose rate is 15 mg of active ingredients per kilogram bodyweight (1 ml per 16 kg bodyweight) by intramuscular or slow intravenous injection.
Norodine 24 Injectable Solution may be administered by intravenous injection when rapid blood levels of trimethoprim and Sulfadiazine are required.
Horses:
The recommended dose rate is 15 mg of active ingredients per kilogram bodyweight (1 ml per 16 kg bodyweight), by slow intravenous injection.
Dogs and Cats:
The recommended dose rate is 30 mg of active ingredients per kilogram bodyweight (1 ml per 8 kg 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 until 2 days after symptoms resolve, up to a maximum of 5 days.
An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No treatment specified.
Withdrawal period
Not to be used for horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.
Cattle:
•Meat – 12 days
•Milk – 48 hours
Pigs:
•Meat – 20 days