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Norodine 24 Solution for Injection 100 ml

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Norodine 24 Solution for Injection

 

 

Presentation


A clear yellow aqueous solution for parenteral administration containing as active ingredients per ml:

Sulfadiazine 200mg
Trimethoprim 40mg

Preservative: Chlorocresol 1mg/ml
Antioxidant:
Sodium Formaldehyde Sulphoxylate Dihydrate 1mg/ml

 

Uses


Norodine 24 is indicated in the treatment of acute, subacute and chronic conditions of bacterial origin in horses, cattle, pigs, dogs and cats.

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.

It is also indicated in species where there may be an existing antibiotic drug resistance. Norodine 24 may be administered in respiratory infections of bacterial origin including rhinitis, pneumonia, bronchitis and in bacterial infections secondary to viral disease such as viral pneumonia or mycoplasma infections. It is also indicated in urogenital tract infections (cystitis, vaginitis, urethritis, nephritis and metritis) and alimentary tract infections (including neonatal diarrhoea and
salmonellosis). Other infections include foul-in-the-foot, severe mastitis, bacterial agalactia of sows, and infections of eye, ear and mouth.

 

Dosage & Administration


For cattle and pigs the dose is 1ml per 16kg bodyweight daily by intramuscular or slow intravenous injection.

Norodine 24 may be administered by intravenous injection when rapid blood levels of sulfadiazine and trimethoprim are required.

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

For dogs and cats the dose is 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 they may be repeated daily until two days after the 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. 

Advice On Correct Administration: Injections should not be given by routes other than those recommended. Not to be administered intraperitoneally.

 

Withdrawal Period


Milk for human consumption must not be taken from a cow during treatment.

Animals must not be slaughtered for human consumption during treatment.

Not to be used in 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

 

Contraindictions, Warnings etc


Norodine 24 is contraindicated in animals with known sulfonamide sensitivity, severe liver parenchymal damage, or blood dyscrasias.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

 

Pharmaceutical Precautions


Do not store above 25ºC. Protect from freezing. Crystallization 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.

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

Do not administer to horses exhibiting drug-induced cardiac arrhythmias. Such arrhythmias may be associated with the administration of certain anaesthetic and sedative agents.

Anaphylactic shock, potentially fatal, has been observed on rare occasions following administration of potentiated sulfonamide preparations, particularly by the intravenous route. Veterinary surgeons should be mindful of this possibility during the injection process. 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.

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

User Warnings:
Care should be taken to avoid accidental self-injection and contact with the skin. Wash hands after use.

Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics. Allergic reactions to these substances may occasionally be serious.

1. Do not handle this product if you know you are sensitive to sulphonamides.
2. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.

 

Further Information


When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.

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