LINCOMYCIN 300- lincomycin injection

LINCOMYCIN by

Drug Labeling and Warnings

LINCOMYCIN by is a Animal medication manufactured, distributed, or labeled by MWI Veterinary Supply, Inc., Sparhawk Laboratories, Inc., HEC Pharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

(lincomycin)

brand of Lincomycin hydrochloride injectable

300 mg/mL

SWINE ANTIBIOTIC

STERILE LINCOMYCIN HYDROCHLORIDE INJECTION

Restricted Drug - Use Only as Directed (California).

For Use in Animals Only.

ANADA 200-315, Approved by FDA

For Intramuscular Use in Swine Over 300 lbs.

Lincomycin Injectable 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

Indicated for the treatment of arthritis caused by susceptible organisms and for mycoplasma pneumonia.

Lincomycin Injectable 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

As with all drugs, the use of Lincomycin Injectable is contraindicated in animals previously found to be hypersensitive to the drug.

WARNINGS AND PRECAUTIONS

WARNING

Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment. Not for human use.

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

Dosage:

Usual daily dose for arthritis or mycoplasma pneumonia - 5 mg per pound of body weight (1 mL per each 60 pounds of body weight) intramuscularly for three to seven days.

See package insert for complete product information:

For arthritis or mycoplasma pneumonia-5 mg per pound of body weight intramuscularly once daily for three to seven days as needed. When using Lincomycin Injectable containing 25 mg/mL, 1 mL/5 lb. body weight will provide 5 mg/lb. When using Lincomycin Injectable containing 100 mg/mL, 1 mL/20 lb body weight will provide 5 mg/lb.  When using Lincomycin Injectable containing 300 mg/mL, 1 mL/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

Lincomycin Injectable is available in three concentrations: 300 mg/mL, 100 mg/mL and 25 mg/mL.

300 mg/mL:  For use in swine weighing 300 pounds or more. Each mL contains lincomycin hydrochloride equivalent to lincomycin, 300 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

100 mg/mL: Each mL contains lincomycin hydrochloride equivalent to lincomycin, 100 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

25 mg/mL: Special baby pig concentration. Each mL contains lincomycin hydrochloride equivalent to lincomycin, 25 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

COMPONENTS

Contains per mL: Lincomycin Hydrochloride equivalent to Lincomycin 300 mg; also Benzyl Alcohol, 9.45 mg added as preservative.

STORAGE AND HANDLING

Store at controlled room temperature: 20° to 25°C (68° to 77°F) [see USP]

TAKE TIME OBSERVE LABEL DIRECTIONS

Warning

Not for human use. Keep out of reach of children. Swine intended for human consumption should not be slaughtered within 48 hours in latest treatment.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LINCOMYCIN  300
lincomycin injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-577
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: 13985-577-10	100 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200315	04/07/2014

Labeler - MWI Veterinary Supply, Inc. (019926120)

Registrant - Sparhawk Laboratories, Inc. (147979082)

Establishment
Name	Address	ID/FEI	Business Operations
Sparhawk Laboratories, Inc.		147979082	manufacture, analysis

Establishment
Name	Address	ID/FEI	Business Operations
JIANGXI GUOYAO LIMITED LIABILITY COMPANY		420560294	api manufacture