Tribrissen 48% (Canada)

Trimethoprim and Sulfadiazine Sterile Injection

Antibacterial

DIN 02146045

For Veterinary Use Only

Chemistry

The active ingredients of TRIBRISSEN are a combination of trimethoprim and sulfadiazine which has been established in a ratio of 1:5.

Action

TRIBRISSEN 48% contains trimethoprim, a synthetic antibacterial, and sulfadiazine, a sulfonamide.

The two components of TRIBRISSEN produce a sequential double blockade of bacterial metabolism, giving a level of activity many times greater than that obtained from either drug alone.

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

Tribrissen 48% Indications And Clinical Uses

TRIBRISSEN has shown activity in vitro against the following organisms:

Very sensitive organisms:

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

Sensitive organisms:

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

Moderately sensitive organisms:

Enterobacter aerogenes, Nocardia spp.

Non-sensitive organisms:

Pseudomonas aeruginosa , Leptospira spp., Mycobacterium tuberculosis, Erysipelothrix rhusiopathiae

usually non-sensitive

TRIBRISSEN 48% is indicated in horses for the treatment of the following infections when caused by susceptible organisms:

- Acute strangles

- Other respiratory tract infections

- Wounds and postoperative infections

Contraindications

TRIBRISSEN 48% should not be used in horses showing marked liver parenchymal damage or blood dyscrasias, nor in those with a history of sulfonamide sensitivity.

Adverse Reactions

No significant adverse reactions have been reported.

Tribrissen 48% Cautions

Following subcutaneous or accidental perivascular infiltration, tissue damage accompanied by swelling and pain has been reported. Injection site reactions have been reported occasionally as a sequel to intramuscular injection. These are usually slight, however, and do not normally require treatment.

TRIBRISSEN 48% should not be administered to pregnant mares as the effects of this product, when used as recommended, on the unborn foal have not been determined.

With parenteral sulfonamide therapy, hypersensitivity reactions can occur and should be appropriately treated with corticosteroids or epinephrine.

Warnings

Not for use in horses intended for food.

Tribrissen 48% Dosage And Administration

Shake the vial well before use.

TRIBRISSEN 48% should be administered to horses either intravenously or intramuscularly at the rate of 1 mL per 20 kg bodyweight (24 mg/kg) daily.

A convenient dosage guide is:

TRIBRISSEN 48%

100 kg - 5 mL

200 kg - 10 mL

300 kg - 15 mL

400 kg - 20 mL

500 kg - 25 mL

600 kg - 30 mL

Treatment should continue until 2-3 days after the symptoms have subsided. The usual course of treatment is for not longer than 7 consecutive days.

Dosage Form

TRIBRISSEN 48% is an aqueous suspension of trimethoprim in a solution of the sodium salt of sulfadiazine.

Each mL contains 80 mg trimethoprim and 400 mg sulfadiazine.

Storage

Store between 15 and 30°C. Protect from light.

Contents should be used within 28 days after the first dose is

removed.

How Supplied

100 mL vial

^® Registered trademark of Intervet Inc. Used under license.

Intervet Canada Corp., subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, Kirkland, QC H9H 4M7

1 866 683-7838

Version April 26, 2013

13-0061INS

146660 R1

CPN: 1208087.5