Label: LINCOMYCIN injection

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)

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:

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

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.

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. 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:

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

Store at 20°C - 25°C (68°F - 77°F).

KEEP FROM FREEZING.