Label: GENTAMED- gentamicin sulfate powder

  • NDC Code(s): 61133-5135-1
  • Packager: Bimeda, Inc., Division of Cross Vetpharm Group
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

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  • DESCRIPTION

    GentaMedSoluble Powder 

    (gentamicin sulfate)                                                                                                                                                                 

    ANTIBACTERIAL                                                                                                                                                                                     

    FOR SWINE DRINKING WATER ONLY                                                                                                                                                                       

    DESCRIPTION:

    Each gram of GentaMed™ Soluble Powder contains gentamicin sulfate equivalent to 333.33 mg gentamicin base.

    RESIDUE WARNING:

    For use in swine drinking water only. Swine treated with the recommended dose of GentaMed™ Soluble Powder must not be slaughtered for food for at least (10) days following the last treatment.

    INDICATIONS:

    GentaMed™ Soluble Powder is recommended for the control and treatment of colibacillosis in weanling swine caused by strains of E. coli sensitive to gentamicin and for the control and treatment of swine dysentery associated with Treponema hyodysenteriae.

    DOSAGE AND ADMINISTRATION:

    GentaMed™ Soluble Powder is available in a 360 gram jar. The 360 gram jar contains a scoop that provides approximately 18 grams of product when level full.

    For Control and treatment of Colibacillosis-Administer GentaMed™ Soluble Powder in drinking water at the recommended level of 25 mg per gallon (1 scoop/240 gallons) for three consecutive days.

    For Control and treatment of Swine Dysentery-Administer GentaMed™ Soluble Powder in drinking water at the recommended level of 50 mg per gallon (1 scoop/120 gallons) for three consecutive days.

    The concentration of the medication should be adjusted in extremely hot or cold weather to ensure a gentamicin dosage of approximately 0.5 mg/lb/day for 3 days for colibacillosis or 1.0 mg/lb/day for 3 days for swine dysentery. A 50-lb pig will, under average conditions, consume 0.9 gallons of water per day.

    For swine dysentery, if the condition recurs, the medication may be repeated. Because of the tendency for the disease to recur on a premise with a history of swine dysentery, a control program should be used following treatment.

    DIRECTION FOR USE:

    To prepare medicated water, mix GentaMed™ Soluble Powder and drinking water according to the following tables:

    Proportioner Use:

    For Control and Treatment of Colibacillosis

    Add 18 g (1 scoop) GentaMed™ Soluble Powder to 2 gallons of water to make stock solution and dispense at the rate of one ounce per gallon of drinking water. This will result in drinking water that contains 25 mg/gallon.

    For Control and Treatment of Swine Dysentery

    Add 18 g (1 scoop) GentaMed™ Soluble Powder to 1 gallon of water to make stock solution and dispense at the rate of one ounce per gallon of drinking water. This will result in drinking water that contains 50 mg/gallon.


    Bulk Preparation:

    For Control and Treatment of Colibacillosis

    Add 18 g (1 scoop) GentaMed™ Soluble Powder to 240 gallons of water.

    For Control and Treatment of Swine Dysentery

    Add 18 g (1 scoop) GentaMed™ Soluble powder to 120 gallons of water.

    Medicated drinking water should not be stored or offered in rusty containers since the drug is quickly destroyed in such containers.

    Medicated water should be prepared daily and be the sole source of drinking water for 3 consecutive days.

    The daily water consumption figures shown below are approximations for mild temperatures and are presented as a guide only. Actual water consumption varies with environmental temperature, humidity, and diet.

    Approximate Daily Water Consumption

     Weight of Pig(lb)  Gallon for 5 Pigs  Gallons for 10 Pigs
     25  3.0  6.0
     50  4.5  9.0
     75  6.0  12.0
     100  7.5  15.0

    SIDE EFFECTS: There have been no reported side effect following the recommended use of GentaMed™ Soluble Powder in swine.

    CONTRAINDICATIONS:

    There are no known contraindications to this drug when used as directed.

    PRECAUTIONS:

    Store at controlled room temperature 20 degrees C - 25 degrees C (68 degrees F - 77 degrees F), with excursions permitted to 15 degrees C - 30 degrees C (59 degrees F - 86 degrees F).

    HOW SUPPLIED:

    GentaMed™ Soluble Powder is available in a 360 gram jar with 2 jars per shipper.

    For Animal Use Only

    Keep Out of Reach of Children

    Restricted Drug (California) - Use Only as Directed

    Do not store or offer medicated water in rusty metal containers.

    Read accompanying directions carefully.                                                                                                                                                      

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  • INGREDIENTS AND APPEARANCE
    GENTAMED 
    gentamicin sulfate powder
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61133-5135
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    gentamicin sulfate (GENTAMICIN) GENTAMICIN 120 g  in 360 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61133-5135-1 360 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200494 12/14/2011
    Labeler - Bimeda, Inc., Division of Cross Vetpharm Group (060492923)
    Registrant - Bimeda, Inc., Division of Cross Vetpharm Group (060492923)
    Establishment
    Name Address ID/FEI Business Operations
    Bimeda, Inc., Division of Cross Vetpharm Group 060492923 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Xian Lijun Pharmaceutical Co., Ltd. 545360711 api manufacture
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