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LINCOMYCIN

Sparhawk Laboratories, Inc.

LINCOMYCIN 300 INJECTION


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Lincomycin Injectable brand of Lincomycin hydrochloride injectable
For Intramuscular Use in Swine Only

Streptomyces lincolnensis var. lincolnensis

INDICATIONS FOR SWINE

Lincomycin injectable is indicated for the treatment of infectious forms of arthritis caused by organisms sensitive to its activity. This included 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.

LINCOMYCIN CONTRAINDICATIONS

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

WARNING

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

CAUTION

LINCOMYCIN 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.

LINCOMYCIN 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. 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.

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

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

Warning

DOSAGE

For Intramuscular Use in Swine Over 300 lbs.

Restricted Drug - Use Only As Directed

(California) For Use In Animals Only.

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 ocmplete product information.

Contains per mL

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

Store at controlled room temperature: 20o to 25oC (68o to 77oF) [See USP]

LINCOMYCIN 300 INJECTION
300 mg/mL

Sterile Lincomycin Hydrochloride Injection

SWINE ANTIBIOTIC

LINCOMYCIN

LINCOMYCIN

LINCOMYCIN

LINCOMYCIN INJECTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:58005-636
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LINCOMYCIN HYDROCHLORIDE lincomycin 300 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58005-636-04 100 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200315 2004-01-21


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