LINCOMIX- lincomycin injection

Lincomix by

Drug Labeling and Warnings

Lincomix by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

NADA #34-025, Approved by FDA

Zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
Revised: June 2017

Made in Spain

PRINCIPAL DISPLAY PANEL - 100 mg Vial Label

Lincomix 100

Injectable

lincomycin injection, USP

Swine Antibiotic

Indicated for the treatment of arthritis caused

by susceptible organisms and for

mycoplasma pneumonia.

Contains per mL:

lincomycin hydrochloride equivalent to

lincomycin, 100 mg; also benzyl alcohol,

9.45 mg added as preservative.

NADA #34-025, approved by FDA

100 mL (3.3 Fl Oz)

Lincomix Injectable 100 label

PRINCIPAL DISPLAY PANEL - 300 mg vial label

Lincomix 300

Injectable

lincomycin injection, USP

Swine Antibiotic

Indicated for the treatment of arthritis caused

by susceptible organisms and for

mycoplasma pneumonia.

Contains per mL:

lincomycin hydrochloride equivalent to

lincomycin, 300 mg; also benzyl alcohol,

9.45 mg added as preservative.

NADA #34-025, approved by FDA

100 mL (3.3 Fl Oz)

Lincomix Injectable 300 label

INGREDIENTS AND APPEARANCE

LINCOMIX 
lincomycin injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 54771-0617
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)	LINCOMYCIN	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	9.45 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-0617-1	100 mL in 1 VIAL

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)	LINCOMYCIN	300 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	9.45 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-3256-1	100 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA034025	06/06/1967

Labeler - Zoetis Inc. (828851555)