Label: LINCOMED 100- lincomycin hydrochloride injection

  • NDC Code(s): 61133-6000-1
  • 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 08/13

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  • DESCRIPTION

    LincoMed® 100

    lincomycin injection, USP

    Swine Antibiotic

    Restricted Drug (California) - Use only as Directed.     

    For Use in Animals Only                

    ANADA 200-368, Approved  by FDA

    Net Content: 100ml (3.3 fl oz)           

    For use in swine weighing 300 pounds or more.

    For Intramuscular Use in Swine Only

    DESCRIPTION:

    LincoMed® 100 contains lincomycin hydrochloride, an antibiotic produced by Streptomyces lincolnensis var. lincolnensis which is chemically distinct from all other clinically available antibiotics and is isolated as a white crystalline solid.

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  • INDICATIONS & USAGE

    INDICATIONS FOR SWINE:

    LincoMed® 100 is indicated for the treatment of infectious forms of arthritis caused by organisms sensitive to its activity. This includes most of the organisms responsible for the various infectious arthritides in swine, such as staphylococci, streptococci, Erysipelothrix and Mycoplasma spp.

    It is also indicated for the treatment of mycoplasma pneumonia.

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  • CONTRAINDICATIONS

    CONTRAINDICATIONS:

    As with all drugs, use of LincoMed® 100 is contraindicated in animals previously found to be hypersensitive to the drug.

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  • RESIDUE WARNING

    Residue Warning: Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment.

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  • GENERAL PRECAUTIONS

    Human Warnings: Not for use in human. Keep out of reach of children.

    CAUTION:

    If no improvement is noted within 48 hours, consult a veterinarian.

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  • ADVERSE REACTIONS

    ADVERSE REACTIONS:

    The intramuscular administration to swine may cause a transient diarrhea or loose stools. Although this effect has rarely been reported, one must be alert to the possibility that it may occur.

    Should this occur, it is important that the necessary steps be taken to prevent the effects of dehydration.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:

    For arthritis or mycoplasma pneumonia - 5 mg per pound of body weight intramuscularly once daily for three to seven days as needed. One mL per 60 lb body weight will provide 5 mg/lb.

    For optimal results, initiate treatment as soon as possible. As with any multi-dose vial, practice aseptic techniques in withdrawing each dose. Adequately clean and disinfect the vial closure prior to entry with a sterile needle and syringe. No vial closure should be entered more that 20 times.

    Each mL contains:

    Lincomycin hydrochloride equivalent to lincomycin 100mg; also benzyl alcohol 9.45 mg added as a preservative.

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  • HOW SUPPLIED

    HOW SUPPLIED:

    100 mL mutiple dose vials.

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  • STORAGE AND HANDLING

    STORAGE: Store at  20⁰C - 25⁰C (68⁰F - 77⁰F).

    KEEP FROM FREEZING

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  • INGREDIENTS AND APPEARANCE
    LINCOMED 100 
    lincomycin injection
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61133-6000
    Route of Administration INTRAMUSCULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LINCOMYCIN HYDROCHLORIDE (LINCOMYCIN) LINCOMYCIN 100 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61133-6000-1 100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200368 08/02/2006
    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-MTC Animal Health, Division of Cross Vetpharm Group 256232216 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Anhui Wanbei Pharmaceutical Co., Ltd. 654258862 api manufacture
    Establishment
    Name Address ID/FEI Business Operations
    JIANGXI GUOYAO PHARMACEUTICAL, LLC., CO. 420560294 api manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Suzhou no. 4 Pharmaceutical Factory 654159557 api manufacture
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