Label: LINCOMED 300- lincomycin injection

  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated March 27, 2024

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  • DESCRIPTION

    LincoMed® 300
    (lincomycin injection)

    For use in swine weighing 300 pounds or more.
    For Intramuscular Use in Swine Only

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

    LincoMed 300 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.

  • INDICATIONS & USAGE

    INDICATIONS FOR SWINE:

    LincoMed 300 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.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS:

    As with all drugs, the use of LincoMed 300 is contraindicated in animals previously found to be hypersensitive to the drug.

  • RESIDUE WARNING

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

  • WARNINGS

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

  • PRECAUTIONS

    CAUTION:

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

  • 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.

    The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:

    For arthritis or mycoplasma pneumonia - 5 mg/lb 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 300mg; also benzyl alcohol 9.45 mg added as a preservative.

  • HOW SUPPLIED

    HOW SUPPLIED:

    LincoMed is available in two concentrations: 100 mg/mL and 300 mg/mL.

    300 mg/mL: For use in swine weighing 300 pounds or more. Supplied in 100 mL multiple dose vial.

    100mg/mL: Supplied in 100 mL multiple dose vial.

  • STORAGE AND HANDLING

    Store at 20⁰C - 25⁰C (68⁰F - 77⁰F). Keep from freezing.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    LINCOMED 300 
    lincomycin injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61133-6001
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lincomycin (UNII: BOD072YW0F) (Lincomycin - UNII:BOD072YW0F) Lincomycin300 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-6001-1100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20036808/02/2006
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda-MTC256232216manufacture