Label: LINCOMED 300- lincomycin injection
- NDC Code(s): 61133-6001-1
- Packager: Bimeda, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated May 17, 2022
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lincomycin injection, USP
Restricted Drug (California) - Use only as Directed.
For Use in Animals Only
ANADA 200-368, Approved by FDA
Net Content: 100 mL (3.3 fl oz)
For use in swine weighing 300 pounds or more.
For Intramuscular Use in Swine Only
LincoMed® 300 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® 300 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 Mycoplasmaspp.
It is also indicated for the treatment of mycoplasma pneumonia.
- RESIDUE WARNING
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/lb body weight intramuscularly once daily for three to seven days as needed. One mL per 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 that 20 times.
Each mL contains:
Lincomycin hydrochloride equivalent to lincomycin 300mg; also benzyl alcohol 9.45 mg added as a preservative.
- HOW SUPPLIED
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-6001 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lincomycin (UNII: BOD072YW0F) (Lincomycin - UNII:BOD072YW0F) Lincomycin 300 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-6001-1 100 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200368 08/02/2006 Labeler - Bimeda, Inc. (060492923) Registrant - Bimeda, Inc. (060492923) Establishment Name Address ID/FEI Business Operations Bimeda-MTC 256232216 manufacture