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Lincomycin

Generic name: Lincomycin hydrochloride injection
Dosage form: FOR ANIMAL USE ONLY

Lincomycin 300

Lincomycin Injetion, USP

For use in swine weighing 300 pounds or more. For Intramuscular Use in Swine Only.

Lincomycin 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 FOR SWINE:

Lincomycin 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 Mycoplasma spp. It is also indicted for the treatment of mycoplasma pneumonia.

CONTRAINDICATIONS: As with all drugs, the use of Lincomycin 300 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 humans. 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 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.


Each mL contains:

Lincomycin hydrochloride equivalent to Lincomycin 300 mg; also benzyl alcohol 9.45 mg added as a preservative.

HOW SUPPLIED:

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

STORE AT 20° C - 25° C (68° F - 77° F).

PROTECT FROM FREEZING.

Lincomycin
Lincomycin injection
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:30798-843
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lincomycin (Lincomycin) Lincomycin 300 mg in 1 mL
Packaging
# Item Code Package Description
1 NDC:30798-843-10 100 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 - Durvet (056387798)
Registrant - Bimeda, Inc. Division of Cross Vetphar Group (060492923)
Establishment
Name Address ID/FEI Operations
Bimeda-MTC Animal Health, Division of Cross Vetpharm Group 256232216 manufacture
Establishment
Name Address ID/FEI Operations
Jiangxi Guoyao Pharmaceutical LLC, Co. 420560294 api manufacture
Establishment
Name Address ID/FEI Operations
Anhui Wanbei Pharmaceutical Co., Ltd. 654258862 api manufacture
Durvet