LINCOMYCIN 300- lincomycin injection 
MWI Veterinary Supply, Inc.

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Linco-Bac 300

(lincomycin)

brand of Lincomycin hydrochloride injectable

300 mg/mL

SWINE ANTIBIOTIC

STERILE LINCOMYCIN HYDROCHLORIDE INJECTION

Not for Use in Humans

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

Approved by FDA under ANADA # 200-315

For Intramuscular Use in Swine Over 300 lbs.

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

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.

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/mLFor 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.

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

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.

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

MWI LincoBac 300MWI LincoBac 300 - Onsert

LINCOMYCIN  300
lincomycin injection
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-577
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN300 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13985-577-10100 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20031504/07/2014
Labeler - MWI Veterinary Supply, Inc. (019926120)
Registrant - Sparhawk Laboratories, Inc. (147979082)
Establishment
NameAddressID/FEIBusiness Operations
Sparhawk Laboratories, Inc.147979082manufacture, analysis
Establishment
NameAddressID/FEIBusiness Operations
HEC Pharm Co., Ltd.554546110api manufacture

Revised: 5/2024
Document Id: 1474f7fa-f4c2-4a7a-8717-9f8391d4328e
Set id: 4a7c5e34-6b57-4019-9b76-5dfa06cacce0
Version: 9
Effective Time: 20240530
 
MWI Veterinary Supply, Inc.