Label: LINCOMYCIN 300- lincomycin injection
- NDC Code(s): 13985-577-10
- Packager: MWI Veterinary Supply, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated August 30, 2023
If you are a consumer or patient please visit this version.
brand of Lincomycin hydrochloride injectable
STERILE LINCOMYCIN HYDROCHLORIDE INJECTION
Not for Use in Humans
Caution:Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Approved by FDA under ANADA # 200-315
For Intramuscular Use in Swine Over 300 lbs.
Lincomycin Injectable 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 FOR SWINE
Indicated for the treatment of arthritis caused by susceptible organisms and for mycoplasma pneumonia.
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.
- WARNINGS AND PRECAUTIONS
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 AND ADMINISTRATION
Usual daily dose for arthritis or mycoplasma pneumonia - 5 mg per pound of body weight (1 mL per each 60 pounds of body weight) intramuscularly for three to seven days.
See package insert for complete product information:
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/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 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 added as preservative. Supplied in 100 mL vials.
- STORAGE AND HANDLING
To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data sheet (SDS), contact Sparhawk Laboratories Inc at 1-800-255-6388 or 1-913-888-7500. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:13985-577 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:13985-577-10 100 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200315 04/07/2014 Labeler - MWI Veterinary Supply, Inc. (019926120) Registrant - Sparhawk Laboratories, Inc. (147979082) Establishment Name Address ID/FEI Business Operations Sparhawk Laboratories, Inc. 147979082 manufacture, analysis Establishment Name Address ID/FEI Business Operations HEC Pharm Co., Ltd. 554546110 api manufacture