BO-SE 1mg/ml Injection

PHARMACOLOGY: It has been demonstrated that selenium and tocopherol exert physiological effects and that these effects are intertwined with sulfur metabolism. Additionally, tocopherol appears to have a significant role in the oxidation process, thus suggesting an interrelationship between selenium and tocopherol in overcoming sulfur-induced depletion and restoring normal metabolism. Although oral ingestion of adequate amounts of selenium and tocopherol would seemingly restore normal metabolism, it is apparent that the presence of sulfur and perhaps other factors interfere during the digestive process with the proper utilization of selenium and tocopherol. When selenium and tocopherol are injected, they bypass the digestive process and exert their full metabolic effects promptly on cell metabolism. Anti-inflammatory action has been demonstrated by selenium-tocopherol in the Selye Pouch Technique and experimentally induced polyarthritis study in rats.

INDICATIONS: BO-SE (selenium, vitamin E) is recommended for the prevention and treatment of white muscle disease (Selenium-Tocopherol Deficiency) syndrome in calves, lambs, and ewes. Clinical signs are: Stiffness and lameness, diarrhea and unthriftiness, pulmonary distress and/or cardiac arrest. In sows and weanling pigs, as an aid in the prevention and treatment of diseases associated with Selenium-Tocopherol Deficiency such as hepatic necrosis, mulberryheart disease, and white muscle disease. Where known deficiencies of selenium and/or vitamin E exist, it is advisable, from the prevention and control standpoint, to inject the sow during the last week of pregnancy.

CONTRAINDICATIONS: DO NOT USE IN PREGNANT EWES. Deaths and abortions have been reported in pregnant ewes injected with this product.

WARNINGS: Anaphylactoid reactions, some of which have been fatal, have been reported in animals administered BO-SE Injection. Signs include excitement, sweating, trembling, ataxia, respiratory distress and cardiac dysfunction.

Discontinue use 30 days before the treated calves are slaughtered for human consumption. Discontinue use 14 days before the treated lambs, ewes, sows and pigs are slaughtered for human consumption. Selenium-Vitamin E preparations can be toxic when improperly administered.

PRECAUTIONS: Selenium-Tocopherol Deficiency (STD) syndrome produces a variety and complexity of symptoms often interfering with a proper diagnosis. Even in selenium deficient areas there are other disease conditions which produce similar clinical signs. It is imperative that all these conditions be carefully considered prior to the treatment of STD syndrome. Serum selenium levels, elevated SGOT, and creatine serum levels may serve as aids in arriving at a diagnosis of STD, when associated with other indices. Selenium is toxic if administered in excess. A fixed dose schedule is therefore important (read the package insert for each selenium-tocopherol product carefully before using).

Important: Use only the selenium-tocopherol product recommended for each species. Each formulation is designed for the species indicated to produce the maximum efficacy and safety.

DOSAGE AND ADMINISTRATION: Inject subcutaneously or intramuscularly.

Calves:2.5-3.75 mL per 100 pounds of bodyweight depending on the severity of the condition and the geographical area. Lambs 2 weeks of age and older: 1 mL per 40 pounds of body weight(minimum, 1 mL). Ewes: 2.5 mL per 100 pounds of body weight.

Sows: 1 mL per 40 pounds of body weight. Weanling pigs: 1 mL per 40 pounds of body weight (minimum 1 mL). Not for use in newborn pigs.

STORAGE: Store between 2° and 30°C (36° and 86°F). Protect from freezing.

HOW SUPPLIED: 100 mL sterile, multiple dose vial, NDC 0061-0807-05.

NADA #12-635, Approved by FDA.

October 1998

Copyright © 1985, 1996, 1998, Schering-Plough Animal Health Corp., Union, NJ 07083.

Made in Germany.

USA006541INV

US 3493

F-22232401

B-22232401

Nac No.