Lincomix: Product Information

LINCOMIX- lincomycin hydrochloride injection
Zoetis Inc.

brand of lincomycin injection

For Intramuscular Use in Swine Only

LINCOMIX 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

LINCOMIX 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 the staphylococci, streptococci, Erysipelothrix and Mycoplasma spp.
It is also indicated for the treatment of mycoplasma pneumonia.

CONTRAINDICATIONS

As with all drugs, the use of LINCOMIX 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

For arthritis or mycoplasma pneumonia—5 mg per pound of body weight intramuscularly once daily for three to seven days as needed. When using LINCOMIX Injectable containing 100 mg/mL, 1 mL/20 lb body weight will provide 5 mg/lb. When using LINCOMIX 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

LINCOMIX Injectable is available in two concentrations: 300 mg/mL and 100 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.

Store at controlled room temperature 20°-25°C (68°- 77°F), with excursions between 15°- 40°C (59°- 104°F).

Use contents within 28 days of first vial broach.

Approved by FDA under NADA # 034-025
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
Revised: May 2019
40027759

PRINCIPAL DISPLAY PANEL — 100 mg Vial Label

100 mg Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 300 mg vial label

300 mg Vial Label
(click image for full-size original)
LINCOMIX
lincomycin injection
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-0617
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LINCOMYCIN HYDROCHLORIDE (LINCOMYCIN) LINCOMYCIN 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9.45 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-0617-1 100 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA034025 06/06/1967
LINCOMIX
lincomycin injection
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-3256
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LINCOMYCIN HYDROCHLORIDE (LINCOMYCIN) LINCOMYCIN 300 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9.45 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-3256-1 100 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA034025 06/06/1967
Labeler — Zoetis Inc. (828851555)

Revised: 05/2020 Zoetis Inc.

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