Label: GENTAMICIN PIGLET - gentamicin sulfate injection 

  • Label RSS
  • NDC Code(s): 57561-638-05
  • Packager: Agri Laboratories, Ltd.
  • 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 02/13

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

  • DESCRIPTION


    Piglet Injection Veterinary
    Antibacterial
    For Piglets Up to 3 days of age

    Gentamicin Piglet Injection is a sterile preparation for intramuscular administration in piglets up to 3 days of age.  Each milliliter contains gentamicin sulfate, USP equivalent to 5 mg gentamicin base, 2 mg sodium bisulfite, 0.1 mg edetate disodium, 7.46 mg sodium acetate, 3 mg glacial acetic acid; 1.3 mg methylparaben and 0.2 mg propylparaben as preservatives, water for injection q.s.
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  • WARNING


    Piglets injected with Gentamicin Piglet Injection must not be slaughtered for food at least 40 days following treatment.

    Restricted Drug (California)--use only as directed.

    Read accompanying directions carefully.

    Store between 2o and 30oC (36o and 86oF)

    Protect from freezing.

    For intramuscular use only.

    ANADA #: 200-394  Approved by F.D.A.

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  • INDICATIONS

    Gentamicin Piglet Injection is recommended for the treatment of porcine colibacillosis caused by strains of E.coli sensitive to gentamicin.

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  • DOSAGE AND ADMINISTRATION

    The recommended dose is 1 mL (5 mg) administered intramuscularly. Gentamicin Piglet Injection is not to be used more than once in each piglet.
    If piglets do not respond to treatment with Gentamicin Piglet Injection, diagnosis should be reevaluated. Clean and sterilize needles and syringes
    by boiling in water for 15 minutes prior to use.

    Prior to injection, disinfect the injection site and top of the vial with a suitable disinfectant, such as 70% alcohol.

    Use all precautions to prevent contamination of vial contents.

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  • CONTRAINDICATIONS

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

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  • PRECAUTIONS


    Store between 2 o and 30 oC (36 o and 86 oF)
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  • CHEMISTRY

    Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin sulfate, USP
    is a mixture of sulfate salts of the antibiotics produced in this fermentation. The salts are weakly acidic and freely soluble in water.
    Gentamicin sulfate, USP is stable in solution for the period of time indicated on the labels by the expiration date.

    Gentamicin sulfate, USP contains not less than 500 micrograms of gentamicin base per milligram.

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  • HOW SUPPLIED

    Gentamicin Piglet Injection, 5 mg/mL is available in 100 mL, 250 mL and 500 mL multiple dose vials.

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  • PRINCIPAL DISPLAY PANEL

    Antibacterial
    100 Doses

    Rev. 09-10

    Manufactured for:
    Agri Laboratories, Ltd.
    St. Joseph, MO  64503


    AL-Gentamicin Piglet label

    AL-Gentamicin Piglet Onsert





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  • INGREDIENTS AND APPEARANCE
    GENTAMICIN PIGLET 
    gentamicin sulfate injection
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:57561-638
    Route of Administration INTRAMUSCULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN 5 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57561-638-05 250 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200394 01/18/2008
    Labeler - Agri Laboratories, Ltd. (155594450)
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