Norovet TMPS (Canada)

(Sulfadoxine - Trimethoprim)

INJECTABLE SOLUTION

For Veterinary Use Only

DIN 01923838

Sterile

Description

A clear, yellow aqueous solution for parenteral administration. The active ingredients of NOROVET TMPS are a combination of Trimethoprim and Sulfadoxine which has been established in a ratio of 1:5.

Dosage Form: NOROVET TMPS is a solution containing 4% w/v Trimethoprim and 20% w/v Sulfadoxine in an organic solvent.

Each ml contains 40 mg of Trimethoprim and 200 mg of Sulfadoxine.

Chlorocresol is used as a preservative at a concentration of 1 mg/ml.

Pharmacology

Action: NOROVET TMPS contains trimethoprim, a synthetic antibacterial and sulfadoxine, a sulphonamide. The two components of NOROVET TMPS produce a sequential double blockade of bacterial metabolism, giving a level of activity many times greater than that obtained by either drug alone.

NOROVET TMPS provides effective antibacterial activity against a wide range of infections caused by Gram-positive and Gram-negative bacteria.

NOROVET TMPS has shown activity in vitro against the following organisms:

Very sensitive organisms:

Escherichia coli, Bacillus anthracis, Clostridium spp, Pasteurella spp, Shigella spp, Haemophilus influenzae, Salmonella spp, Streptococcus zooepidemicus, Proteus mirabilis, Vibrio spp.

Sensitive organisms:

Streptococcus viridans, Klebsiella spp, Brucella spp, Proteus spp, Enterococci spp, Actinomyces, Staphylococcus aureus (including penicillinase-producing organisms), Corynebacterium spp, Bordetella spp, Neisseria spp.

Moderately sensitive organisms:

Enterobacter aereogenes, Nocardia spp.

Non-sensitive organisms:

Pseudonomas aeruginosa*, Leptospira spp, Mycobacterium tuberculosis, Erysipelothrix rhusiopathiae.

*usually non-sensitive.

Norovet TMPS Indications

NOROVET TMPS may be used in cattle and swine where potent systemic antibacterial action against a wide range of sensitive organisms is required.

NOROVET TMPS is indicated in cattle for the treatment of:

Respiratory tract infections: Bacterial pneumonias including bovine pneumonic pasteurellosis (shipping fever).

Alimentary tract infections: Primarily enteric and septicaemic colibacillosis and salmonellosis.

Other infections: Infectious pododermatitis (foot rot, foul in the foot) and septicaemias.

NOROVET TMPS is indicated in swine for the treatment of:

Respiratory tract infections: Bacterial pneumonias.

Alimentary tract infections: Colibacillosis and post-weaning scours.

Other infections: Mastitis-metritis-agalactia syndrome of sows (MMA) and bacterial arthritis.

Dosage and Administration

NOROVET TMPS should be administered at a dose rate of 1 mL per 15 kg bodyweight daily. In piglets weighing less than 4.5 kg do not exceed a dose of 0.5 mL. Intramuscular injection is recommended for cattle and swine, but if a particularly rapid response is required in acute infections, NOROVET TMPS can be administered by slow intravenous injection.

Treatment should continue for 2-3 days after symptoms have subsided. The usual course of treatment is for not longer than 5 consecutive days.

Contraindications

NOROVET TMPS should not be used in cattle or swine showing marked liver parenchymal damage or blood dyscrasias, nor in those with history of sulphonamide sensitivity.

Cautions:

With intravenous therapy generally, and sulphonamides in particular, hypersensitivity reactions can occur and should be appropriately treated with corticosteroids or epinephrine. Temporary local, irritating swellings are encountered occasionally after intramuscular injection of NOROVET TMPS.

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

Warnings

Milk taken from treated animals during treatment and within 96 hours after the latest treatment must not be used in food.

Treated animals must not be slaughtered for use in food for at least 10 days after the latest treatment with this drug.

Side Effects

Adverse Reactions: No significant adverse reactions have been reported.

Storage

Store at room temperature, not exceeding 25°C.

Do not freeze. Protect from light.

Presentation:

Available in 100 mL, 250 mL and 500 mL vials.

Manufactured by: Norbrook Laboratories Limited, Station Works, Newry, Co. Down, BT35 6JP, Northern Ireland

Distributed by: Kane Veterinary Supplies Ltd., 11204 - 186 Street, Edmonton, AB T5S 2W2

028154I02

CPN: 12540100