Label: LINCOMED 100- lincomycin injection

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated November 29, 2018

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  • DESCRIPTION

    LincoMed® 100

    lincomycin injection, USP

    Swine Antibiotic

    Restricted Drug (California) - Use only as Directed.

    ANADA 200-368, Approved by FDA

    Net Contents: 100 mL (3.3 fl oz)

    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.

  • 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.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS:

    As with all drugs, use of LincoMed® 100 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 use in human. Keep out of reach of children.

    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.

  • 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 20 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 than 20 times.

    Each mL contains:

    Lincomycin hydrochloride equivalent to lincomycin 100 mg; 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.

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

    300 mg/mL: For use in swine weighing 300 pounds or more. 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 100 
    lincomycin injection
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:61133-6000
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN100 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-6000-1100 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-MTC Animal Health256232216manufacture