Label: LINCOMYCIN- lincomycin injection
- NDC Code(s): 30798-336-10
- Packager: Durvet, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated November 14, 2022
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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
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.
- ADVERSE REACTIONS
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.
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.
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- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:30798-336 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN 300 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30798-336-10 100 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200315 06/03/2003 Labeler - Durvet, Inc. (056387798)