Label: LINCOMYCIN 300- lincomycin injection
- NDC Code(s): 13985-577-10
- Packager: MWI Veterinary Supply, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated November 1, 2022
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DESCRIPTION
(lincomycin)
brand of Lincomycin hydrochloride injectable
300 mg/mL
SWINE ANTIBIOTIC
STERILE LINCOMYCIN HYDROCHLORIDE INJECTION
Restricted Drug - Use Only as Directed (California).
For Use in Animals Only.
ANADA 200-315, Approved by FDA
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.
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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.
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
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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.
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DOSAGE AND ADMINISTRATION
Dosage:
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.
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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 added as preservative. Supplied in 100 mL vials.
- COMPONENTS
- STORAGE AND HANDLING
- Warning
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LINCOMYCIN 300
lincomycin injectionProduct Information Product Type OTC 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