Animal NDC 58005-636-04 Lincomycin
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 58005-636-04 |
| 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 | Sparhawk Laboratories, Inc. |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| 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
Indications & Usage
300 mg/mL
STERILE LINCOMYCIN INJECTION
Caution:Federal law restricts this drug to use by or on the order of a licenced veterinarian.
SWINE ANTIBIOTIC
Indicated for the treatment of arthritis caused by susceptible ortanisims and for mycoplasma pneumonia.
Lincomycin Injectable contains lincomycin hydrochloride, an antibiotic produced bySteptomyces lincolnensis var. lincolnensis, which is chemically distinct from all other clinically avaialbel antibiotics and is isolated as a white crystalline solid
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
INDICATIONS FOR SWINE
Lincomycin 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 staphylococci, streptococci,Erysipelothrix and Mycoplasma spp.
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 had 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
Dosage And Administration
For arthritis or mycoplasma pneumonia-5mg per pound of body weight intramuscularly once daily for three to seven days as needed. When using lincomycin injection containing 25 mg/mL, 1 mL/5 lb. body weight will provide 5 mg/lb.
When using lincomycin injection containing 100 mg/mL, 1mL/20lb body weight will provide 5mg/lb. When using lincomycin injection 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
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 Benyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.
Storage And Handling
Store at controlled room temperature: 20o to 25oC (68o to 77oF) [see USP]
Lincomycin 300
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.