LincoBac 300

(lincomycin)

Injection

300 mg/mL

SWINE ANTIBIOTIC

STERILE LINCOMYCIN HYDROCHLORIDE INJECTION

Approved by FDA under ANADA # 200-315

For Intramuscular Use in Over 300 lbs.

Restricted Drug - Use Only As Directed (California). For Use in Animals Only.

brand of lincomycin hydrochloride injectable

For Intramuscular Use in Swine Only

Lincomycin Injection 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.

LincoBac 300 Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Not for Use in Humans

Keep out of reach of children

LincoBac 300 Indications For Swine

Lincomycin Injection 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 Injection 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.

LincoBac 300 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.

CONTACT INFORMATION: To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data sheet (SDS), contact Sparhawk Laboratories Inc at 1-800-255-6388 or 1-913-888-7500. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

LincoBac 300 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 Injection 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 one concentration: 300 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.

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

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

Approved by FDA under ANADA # 200-315

Distributed by: MWI, Boise, ID 83705

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CPN: 1315192.1