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Animal NDC 46066-246-04 Lincomycin

Animal Product Information

Field Name Field Value
Animal NDC Code 46066-246-04
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, Ltd.
Product Type Otc Animal Drug
Usage Information
    Lincomycin Injectable is indcated fot he treatmen 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 ssp.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 ANADA200315 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.

Lincomycin Images

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



Sterile Lincomycin Hydrochloride Injection

Swine Antibiotic

300 mg/mL

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

Not for Use in Humans
Keep out of reach of children

Approved by FDA under ANADA # 200-315

NET CONTENTS:

3.38 fl oz (100 mL)

For Intramuscular Use in Swine
Over 300 lbs. Restricted Drug - Use
Only As Directed (California).
For Use in Animals Only.

Lincomycin Injectable brand of Lincomycin hydrochloride injectable 

For Intramuscular Use in Swine 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



Lincomycin Injectable is indcated fot he treatmen 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 ssp.

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.


Contact Information



To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet, 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


How Supplied



Lincomycin Injectable is available in three concentrations: 300 mg/mL, 100 mg/mL and 25 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.

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.


Warnings



Indicated for the treatment of arthritis caused by susceptible organisms and for mycoplasma pneumonia.

Warning: Not for human use. Keep out of reach of children. Swine intended for human consumption shold not be slaughtered within 48 hours of latest treatment.


Dosage



For Intramuscular Use in Swine Over 300 lbs.

For Use in Animals Only.

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 ocmplete product information.

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 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, 1mL/20lb body weight will provide 5mg/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.


Contains Per Ml



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


Storage And Handling



Store at controlled room temperature: 20o to 25oC (68o to 77oF) [See USP]


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