LINCOMED 300- lincomycin injection

LincoMed 300 by

Drug Labeling and Warnings

LincoMed 300 by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., Bimeda-MTC, Jiangxi GuoYao Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

LincoMed® 300

lincomycin injection, USP
SWINE ANTIBIOTIC

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.

CONTRAINDICATIONS

CONTRAINDICATIONS:

As with all drugs, the use of LincoMed® 300 is contraindicated in animals previously found to be hypersensitive to the drug.

RESIDUE WARNING

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

WARNINGS

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

PRECAUTIONS

CAUTION:

If no improvement is noted within 48 hours, consult a veterinarian.

ADVERSE REACTIONS

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 & 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

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.

STORAGE AND HANDLING

STORAGE: Store at 20⁰C - 25⁰C (68⁰F - 77⁰F).

KEEP FROM FREEZING

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LINCOMED 300 
lincomycin injection

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi GuoYao Pharmaceutical		420560294	api manufacture