LINCOMED 100- lincomycin injection

LincoMed 100 by

Drug Labeling and Warnings

LincoMed 100 by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., Bimeda-MTC Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

LincoMed® 100

lincomycin injection, USP

Swine Antibiotic

Restricted Drug (California) - Use only as Directed.

ANADA 200-368, Approved by FDA

Net Contents: 100 mL (3.3 fl oz)

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 & USAGE

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

CONTRAINDICATIONS:

As with all drugs, use of LincoMed® 100 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 use in human. Keep out of reach of children.

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 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

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

STORE AT 20⁰C - 25⁰C (68⁰F - 77⁰F).

KEEP FROM FREEZING

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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. (060492923)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda-MTC Animal Health		256232216	manufacture