Label: MU-SE- sodium selenite and .alpha.-tocopherol acetate, d- injection, solution

  • NDC Code(s): 0061-0950-04
  • Packager: Merck Sharp & Dohme Corp.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated December 3, 2019

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  • SPL UNCLASSIFIED SECTION

    NADA #30-314, Approved by FDA.

    PRODUCT INFORMATION

    FOR VETERINARY USE ONLY

    CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • DESCRIPTION

    DESCRIPTION MU-SE (selenium, vitamin E) is an emulsion of selenium-tocopherol for the prevention and treatment of Selenium-Tocopherol Deficiency (STD) syndrome in weanling calves and breeding beef cattle. Each mL contains: 10.95 mg sodium selenite (equivalent to 5 mg selenium), 50 mg (68 USP units) vitamin E (as d-alpha tocopheryl acetate), 250 mg polysorbate 80, 2% benzyl alcohol (preservative), water for injection q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

  • MECHANISM OF ACTION

    ACTIONS 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 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.

  • VETERINARY INDICATIONS

    INDICATIONS MU-SE (selenium, vitamin E) is recommended for the prevention and treatment of STD syndrome in weanling calves and breeding beef cattle. Clinical signs are: stiffness and lameness; chronic, persistent diarrhea; unthriftiness; abortions and/or weak premature calves.

  • CONTRAINDICATIONS

    CONTRAINDICATION Do not use in adult dairy cattle. Premature births and abortions have been reported in dairy cattle injected with this product during the third trimester of pregnancy.

  • WARNINGS

    WARNINGS Anaphylactoid reactions, some of which have been fatal, have been reported in cattle administered the MU-SE product. Signs include excitement, sweating, trembling, ataxia, respiratory distress, and cardiac dysfunction.

    Use only as directed in weanling calves and breeding beef cows. Discontinue use 30 days before the treated cattle are slaughtered for human consumption.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION Inject subcutaneously or intramuscularly. Weanling calves: 1 mL per 200 pounds of body weight. Breeding beef cows: 1 mL per 200 pounds of body weight during the middle third of pregnancy, and 30 days before calving.

  • SPL UNCLASSIFIED SECTION

    CAUTION Selenium is toxic if administered in excess. A fixed dose schedule is therefore important (read package insert for each selenium-tocopherol product carefully before using).

  • PRECAUTIONS

    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 treatment of STD syndrome. Serum selenium levels, elevated SGOT, and creatine levels may serve as aids in arriving at a diagnosis of STD, when associated with other indices.

  • SPL UNCLASSIFIED SECTION

    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.

  • HOW SUPPLIED

    HOW SUPPLIED 100 mL sterile, multiple dose vial.

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    Copyright © 1985, 1996, 1998, 2015,
    Intervet Inc., a subsidiary of Merck & Co., Inc.
    Madison, NJ 07940. All rights reserved.
    Made in Germany.
    Rev. 03/15

    MERCK
    Animal Health

    138188 R1

  • PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton

    100 mL Sterile
    5 mg/mL

    SELENIUM

    NDC 0061-0950-04

    MU-SE®
    (SELENIUM, VITAMIN E)

    Injection
    Veterinary

    Caution: Federal law restricts
    this drug to use by or on the
    order of a licensed veterinarian.

    NADA #30-314,
    Approved by FDA.

    MERCK
    Animal Health

    PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    MU-SE 
    sodium selenite and .alpha.-tocopherol acetate, d- injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0061-0950
    Route of AdministrationSUBCUTANEOUS, INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM SELENITE (UNII: HIW548RQ3W) (SELENITE ION - UNII:KXO0259XJ1) SELENIUM5 mg  in 1 mL
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-68 [USP'U]  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0061-0950-041 in 1 CARTON
    1100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03031407/09/1964
    Labeler - Merck Sharp & Dohme Corp. (001317601)