Bio-Mycin 200 (Canada)

Company: Boehringer

DIN 02182890

Oxytetracycline (as oxytetracycline dihydrate) 200 mg/mL Injectable Solution

A long-acting broad-spectrum antibiotic

Veterinary Use Only

Sterile

Description

BIO-MYCIN 200 is a new, unique Boehringer Ingelheim patented formulation containing 200 mg oxytetracycline (as oxytetracycline dihydrate) base per mL. It provides sustained antibiotic blood level action over a 3 to 5 day period in cattle and over a 3 to 4 day period in swine following a single treatment. BIO-MYCIN 200 is a sterile, clear, stable, ready-to-use solution. Non-medicinal ingredients (in alphabetical order): magnesium oxide, monoethanolamine, polyethylene glycol 400, sodium formaldehyde sulfoxylate dihydrate, and water for injection.

Indications: Cattle: For the treatment of bacterial pneumonia, pasteurellosis (associated with the shipping fever complex) and footrot caused or complicated by bacteria susceptible to oxytetracycline, and for the treatment of pinkeye (infectious bovine keratoconjunctivitis) caused by Moraxella bovis.

Swine: For the treatment of bacterial pneumonia caused or complicated by bacteria susceptible to oxytetracycline.

Dosage and Administration

Warm BIO-MYCIN 200 to body temperature before administering. BIO-MYCIN 200 is designed for intramuscular or subcutaneous administration in cattle and intramuscular administration in pigs at the single dose rate of 1 mL per 10 kg body weight, thus providing 20 mg oxytetracycline per kg body weight. Intramuscular injections should be made deep into the fleshy part of the muscle. Subcutaneous injections in cattle should be administered in the neck region, just in front of the shoulder.

To minimize pain and local tissue irritation at the injection site in cattle, it is recommended that the dose be divided and administered into separate injection sites; no more than 10 mL should be injected into any one site.

For young pigs less than 10 kg body weight, it is recommended that they receive a dose of 1 mL per animal. For pigs up to 100 kg body weight, the dose may be injected into one site, but for pigs over 100 kg body weight, the dose should be divided, to minimize pain and local tissue irritation, and administered into two injection sites.

If clinical improvement is not observed within 48 to 72 hours following injection, the diagnosis should be re-evaluated.

Note: In severe disease cases, treatment with BIO-MYCIN 200 only, may be insufficient.

Warnings: Intramuscular Injection: Treated animals must not be slaughtered for use in food for at least 28 days after the latest treatment with this drug.

Subcutaneous Injection: Treated cattle must not be slaughtered for use in food for at least 48 days after the latest subcutaneous treatment with this drug.

This product must not be used in lactating dairy cattle. Keep out of reach of children.

Cautions: Occasional sensitivity reactions (anaphylaxis) to oxytetracycline have been known to occur. In such cases, administer epinephrine immediately.

Due to the high concentration and long-acting effect, temporary localized swelling at the injection site may be observed for up to five days following injection.

Storage

Store at controlled room temperature 15-25°C. Protect from freezing. Exposure to colder temperatures may cause cloudiness. Gently warm the product to restore clarity. Handle aseptically.

Presentation: BIO-MYCIN 200 is available in multidose 100 mL, 250 mL and 500 mL vials. The product is ready to use and requires no further preparation.

BIO-MYCIN^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

Boehringer Ingelheim (Canada) Ltd., 5180 South Service Road, Burlington, Ontario L7L 5H4

CPN: 1230005.6