LINCOMYCIN   - lincomycin hydrochloride injection 
Sparhawk Laboratories, Inc.

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LINCOMYCIN 300 INJECTION

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

Lincomycin Injectable contains lincomycin hydrochloride, an antibiotic produced byStreptomyces 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 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.

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
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

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 does. 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.

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

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

LINCOMYCIN 300 INJECTION
300 mg/mL
STERILE LINCOMYCIN HYDROCHLORIDE INJECTION

SWINE ANTIBIOTIC

For intramuslcular Use in Swine Over 300 lbs.
Restricted Drug - Use Only As Directed
(California). For Use in Animals Only.

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.

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

ANADA #: 200-315, Approved by F.D.A.

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

TAKE TIME OBSERVE LABEL DIRECTIONS

LINCOMYCIN   lincomycin   injection

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 58005-636 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LINCOMYCIN HYDROCHLORIDE (LINCOMYCIN) LINCOMYCIN HYDROCHLORIDE 300 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58005-636-04 100 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200-315	01/21/2004

Labeler - Sparhawk Laboratories, Inc. (958829558)

Revised: 05/2010Sparhawk Laboratories, Inc.