Label: LINCOMYCIN injection

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

Drug Label Information

Updated May 18, 2017

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  • INDICATIONS & USAGE

    ANADA #200-315, APPROVED BY F.D.A.

    Lincomycin Injectable brand of Lincomycin hydrochloride injectable

    For intramuscular Use in Swine over 300 lbs. Only

    Swine Antibiotic

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

    Indicated for the treatment of arthrits caused by susceptible organisms and for mycoplasma pneumonia.


    INDICATIONS FOR SWINE

    Lincomycin Injectable 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

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

  • WARNING

    Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment. Not for human use.

  • CAUTION

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

  • 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 effect of dehydration.

  • 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.  When using Lincomycin Injectable containing 25 mg/mL, 1 ml/5 lb body weight will provide 5 mg/lb.  When using Lincomycin Injectable containing 100 mg/mL, 1 mL/20 lb. body weight will provide 5 mg/lb.  When using Lincomycin Injectable containing 300 mg/mL, 1 mL/50 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.

  • HOW SUPPLIED

    Lincomycin Injectable is available in three concentrations:  300 mg/mL, 100 mg/mL and 25 mg/mL.

    300 mg/mL: For use in swine weighing 300 pounds or more. Each mL contains lincomycin hydrochloride equivalent to lincomycin, 300 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

    100 mg/mL: Each mL contains lincomycin hydrochloride equivalent to lincomycin 100 mg/ also Benzyl Alcohol, 9.45 mg added as preservative.  Supplied in 100 mL vials.

    25 mg/mL:  Special baby pig concentration. Each mL contains lincomycin hydrochloride equivalent to lincomycin, 25 mg; also Benzyl Alcohol, 9.45 mg ad3d as preservative.  Supplied in 100 mL vials.

  • COMPONENTS

    Contains per mL: Lincomycin Hydrochloride equivalent to Lincomycin, 300 mg; also Benzyl Alcohol, 0.45 mg added as preservative.

  • STORAGE AND HANDLING

    Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]

    TAKE TIME OBSERVE LABEL DIRECTIONS.

  • PRINCIPAL DISPLAY PANEL


    DV Linco 300

    DV Linco 300 Onsert

  • INGREDIENTS AND APPEARANCE
    LINCOMYCIN  
    lincomycin injection
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:30798-336
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN300 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30798-336-10100 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20031506/03/2003
    Labeler - Durvet, Inc. (056387798)