Lincomycin by Aspen Veterinary Resources / Bimeda, Inc. / Bimeda-MTC LINCOMYCIN injection

Lincomycin by

Drug Labeling and Warnings

Lincomycin by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resources, Bimeda, Inc., Bimeda-MTC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

ANADA 200-368, Approved by FDA

Lincomycin 300

Lincomycin Injection USP

300 mg

Swine Antibiotic

Restricted Drug (California)-Use Only as Directed.

For Use in Animals Only

Net Contents: 100 mL (3.3 fl oz)

INDICATIONS & USAGE

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 indicated for the treatment of mycoplasma pneumonia.

CONTRAINDICATIONS

CONTRAINDICATIONS:

As with all drugs, the use of Lincomycin 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

USER SAFETY WARNINGS

Human Warnings:

Not for use in humans. Keep out of reach of children.

GENERAL 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 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

HOW SUPPLIED:

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

STORAGE AND HANDLING

Store at 20°C - 25°C (68°F - 77°F).

KEEP FROM FREEZING.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LINCOMYCIN 
lincomycin injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-502
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)	LINCOMYCIN	300 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-502-02	100 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200368	06/30/2008

Labeler - Aspen Veterinary Resources (627265361)

Registrant - Bimeda, Inc. (060492923)

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