LINCOMED 100- lincomycin injection 
Bimeda Inc., Division of Cross Vetpharm Group

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ANADA 200-368, Approved by FDA

LincoMed® 100

lincomycin injection, USP

For Intramuscular Use in Swine Only         

LincoMed® 100 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:

LincoMed® 100 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, use of LincoMed® 100 is contraindicated in animals previously found to be hypersensitive to the drug.

Residue Warning: Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment.

Human Warnings: Not for use in human. Keep out of reach of children.

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 effects 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. One mL per 20 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.

Each mL contains:

Lincomycin hydrochloride equivalent to lincomycin 100 mg; also benzyl alcohol 9.45 mg added as a preservative.

HOW SUPPLIED:

LincoMed® is available in two concentrations: 100 mg/mL and 300 mg/mL.

100mg/mL: Supplied in 100 mL multiple dose vial.

300 mg/mL: For use in swine weighing 300 pounds or more. Supplied in 100 mL multiple dose vial.

STORE AT 20⁰C - 25⁰C (68⁰F - 77⁰F).

KEEP FROM FREEZING

image description

LINCOMED 100 
lincomycin injection
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-6000
Route of Administration INTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN 100 mg  in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61133-6000-1 100 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., Division of Cross Vetpharm Group (060492923)
Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
Establishment
Name Address ID/FEI Business Operations
Bimeda-MTC Animal Health, Division of Cross Vetpharm Group 256232216 manufacture
Establishment
Name Address ID/FEI Business Operations
Xinyu Pharmaceutical Co., Ltd. 654258862 api manufacture
Establishment
Name Address ID/FEI Business Operations
JIANGXI GUOYAO PHARMACEUTICAL, LLC., CO. 420560294 api manufacture

Revised: 10/2016
Document Id: f2be10ab-ac0c-4739-9c63-0d6ac34d32c7
Set id: 4c35730f-62b9-422f-8eb9-6cc4bbbeaaa7
Version: 7
Effective Time: 20161018
 
Bimeda Inc., Division of Cross Vetpharm Group