Animal NDC 46066-502-02 Lincomycin

Animal Product Information

Field Name Field Value
Animal NDC Code 46066-502-02
Proprietary Name Lincomycin 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 Aspen Veterinary Resources
Product Type Prescription Animal Drug
Usage Information
    INDICATIONS FOR SWINE:Lincomycin 300 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.
Active Ingredient(s)
  • Lincomycin Hydrochloride
Marketing Category ANADA - ABBREVIATED 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 ANADA200368 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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Lincomycin 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



Description



Lincomycin 300
(lincomycin injection)

For use in swine weighing 300 pounds or more.
For Intramuscular Use in Swine Only

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

Lincomycin 300 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 & Usage



INDICATIONS FOR SWINE:
Lincomycin 300 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



CONTRAINDICATIONS:
As with all drugs, the use of Lincomycin 300 is contraindicated in animals previously found to be hypersensitive to the drug.


Residue Warning



Residue Warning: Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment.


User Safety Warnings



Human Warnings: Not for human use. Keep out of reach of children.


General Precautions



CAUTION:
If no improvement is noted within 48 hours, consult a veterinarian.


Adverse Reactions



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.

The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Aspen Veterinary Resources at [email protected]. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.


Dosage & Administration



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. One mL per 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.

Each mL contains:
Lincomycin hydrochloride equivalent to lincomycin 300mg; also benzyl alcohol 9.45 mg added as a preservative.


How Supplied



HOW SUPPLIED:
Lincomycin 300, 300 mg/mL: For use in swine weighing 300 pounds or more. Supplied in 100 mL multiple dose vial.


Storage And Handling



Store at 20°C - 25°C (68°F - 77°F). Keep from freezing.

Approved by FDA under ANADA # 200-368


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