Label: GENTAMED- gentamicin sulfate powder

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

Drug Label Information

Updated May 19, 2017

If you are a consumer or patient please visit this version.

  • DESCRIPTION

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

    Close
  • RESIDUE WARNING

    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 ten (10) days following the last treatment.

    Close
  • INDICATIONS & USAGE

    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 Brachyspira hyodysenteriae.

    Close
  • DOSAGE & ADMINISTRATION

    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.

    DIRECTIONS 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

    Close
  • ADVERSE REACTIONS

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

    Close
  • CONTRAINDICATIONS

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

    Close
  • PRECAUTIONS

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

    Close
  • HOW SUPPLIED

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

    Close
  • DESCRIPTION

    GentaMed™ Soluble Powder

    (Gentamicin Sulfate)

    Contains 120 grams of Gentamicin per jar

    Antibacterial

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

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

    Restricted Drug (California)-Use Only as Directed

    ANADA 200-494, Approved by FDA

    Net weight: 360 g (12.7 oz)

    Close
  • INGREDIENTS AND APPEARANCE
    GENTAMED 
    gentamicin sulfate powder
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61133-5135
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    gentamicin sulfate (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) 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
    Fujian Fukang Pharmaceutical Co., Ltd. 528180884 api manufacture
    Close