LINCOBAC 300- lincomycin injection

LincoBac 300 by

Drug Labeling and Warnings

LincoBac 300 by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Bimeda, Inc., Bimeda-MTC Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

LincoBac™ 300

(lincomycin injection, USP)

Injection

Swine Antibiotic

For use in swine weighing 300 pounds or more.

For Intramuscular Use in Swine Only

LincoBac™ 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.

ANADA 200-368, Approved by FDA

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.

HOW SUPPLIED

HOW SUPPLIED: 100 mL multiple dose vial.

INDICATIONS & USAGE

INDICATIONS FOR SWINE:

LincoBac™ 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.

STORAGE AND HANDLING

STORAGE: Store at 20°-25°C (68°-77°F). Protect from freezing.

CONTRAINDICATIONS

CONTRAINDICATIONS: As with all drugs, the use of LincoBac™ 300 is contraindicated in animals previously found to be hypersensitive to the drug.

WARNINGS

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LINCOBAC 300 
lincomycin injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-576
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

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	9.45 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-576-10	100 mL in 1 VIAL, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200368	08/02/2006

Labeler - MWI/VetOne (019926120)

Registrant - Bimeda, Inc. (060492923)

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