Animal NDC 54771-3256-1 Lincomix
Lincomycin

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-3256-1
Proprietary Name Lincomix What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Lincomycin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Prescription Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Lincomycin Hydrochloride
Inactive Ingredient(s)
  • BENZYL ALCOHOL (LKG8494WBH)
  • BENZYL ALCOHOL (LKG8494WBH)
  • BENZYL ALCOHOL (LKG8494WBH)
  • BENZYL ALCOHOL (LKG8494WBH)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA034025 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

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Lincomix Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Principal Display Panel - 100 Mg Vial Label





Principal Display Panel - 300 Mg Vial Label





* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.