Cyclosol 200 LA (Canada)

Oxytetracycline (as dihydrate) Injectable Solution

A long-acting broad-spectrum antibiotic

VETERINARY USE ONLY

Sterile

DIN 02248742

Description

CYCLOSOL 200 LA oxytetracycline injection is a unique, patented formulation containing 200 mg oxytetracycline (as oxytetracycline dihydrate BP) per mL. N-methyl-2-pyrrolidone is used as co-solvent. 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. CYCLOSOL 200 LA injection is a sterile, clear, stable, ready-to-use solution.

Sustained Antibiotic Action:

Oxytetracycline has long been recognized as the proven drug of choice for the treatment of a wide variety of diseases caused by susceptible Gram-positive and Gram-negative bacteria. The use of parenterally-administered oxytetracycline in the management of diseases is based on an accurate diagnosis and an adequate course of treatment that normally consists of repeated injections over a three-day period.

There are many instances where a prolonged course of parenteral antibiotic therapy is desirable, but impractical due to inaccessibility of the animal and extra labour costs associated with daily retreatment practices. CYCLOSOL 200 LA injection is ideally suited for use in these instances.

The sustained action of CYCLOSOL 200 LA injection is believed to be in large part due to a controlled precipitation of oxytetracycline at the injection site. In effect, a depot of oxytetracycline is formed and the drug is absorbed and distributed throughout the body more slowly. Several factors are believed to play a role including: (1) the high concentration of CYCLOSOL 200 LA injection results in a proportionately smaller area for drug adsorption from the site of injection than that of less concentrated formulations; (2) the inherent and unique composition of the formulation allows “limited” and controlled precipitation of the drug to occur. If precipitation was not controlled and too much of the drug precipitated at the injection site, blood levels would be markedly lower, accompanied by severe and long-lasting tissue damage at the injection site.

CYCLOSOL 200 LA injection provides broad-spectrum effectiveness and sustained antibiotic blood level action from a single intramuscular injection in cattle and swine.

Cyclosol 200 LA 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 CYCLOSOL 200 LA injection to body temperature before administering.

CYCLOSOL 200 LA injection is designed for intramuscular administration in cattle and swine 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, preferably in the lateral neck region.

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 50 kg body weight, the dose may be injected into one site, but for pigs over 50 kg body weight the dose should be divided to minimize pain and local tissue irritation and administered into separate injection sites. No more than 5 mL should be injected into any one site.

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

Note:

Intramuscular injection in cattle can cause a local tissue reaction that may result in trim loss of edible tissue at slaughter. In severe disease cases, treatment with CYCLOSOL 200 LA injection only, may be insufficient.

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.

Warnings

Treated animals must not be slaughtered for use in food for at least 28 days after the latest treatment with this drug. This product must not be used in lactating dairy cattle. Keep out of reach of children.

Storage

Do not store above 25°C, do not freeze, protect from light.

In use shelf-life:

4 weeks when stored between 8°C and 40°C

Presentation:

Available in multi-dose 500 mL ready-to-use vials.

Manufactured By: Eurovet Animal Health BV, The Netherlands

Imported and Distributed by: Dominion Veterinary Laboratories Ltd., 1199 Sanford Street, Winnipeg, Manitoba R3E 3A1

616775

CPN: 1181094.2