Label: LINCOMED 100- lincomycin hydrochloride injection
- NDC Code(s): 61133-6000-1
- Packager: Bimeda Inc., Division of Cross Vetpharm Group
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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lincomycin injection, USP
Restricted Drug (California) - Use only as Directed.
For Use in Animals Only
ANADA 200-368, Approved by FDA
Net Content: 100ml (3.3 fl oz)
For use in swine weighing 300 pounds or more.
For Intramuscular Use in Swine Only
LincoMed® 100 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.Close
- INDICATIONS & USAGE
INDICATIONS FOR SWINE:
LincoMed® 100 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.Close
As with all drugs, use of LincoMed® 100 is contraindicated in animals previously found to be hypersensitive to the drug.Close
- RESIDUE WARNING
Residue Warning: Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment.Close
- GENERAL PRECAUTIONS
Human Warnings: Not for use in human. Keep out of reach of children.
If no improvement is noted within 48 hours, consult a veterinarian.Close
- 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.Close
- 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 that 20 times.
Each mL contains:
Lincomycin hydrochloride equivalent to lincomycin 100mg; also benzyl alcohol 9.45 mg added as a preservative.Close
- HOW SUPPLIED
100 mL mutiple dose vials.Close
- STORAGE AND HANDLING
STORAGE: Store at 20⁰C - 25⁰C (68⁰F - 77⁰F).
KEEP FROM FREEZINGClose
- INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-6000 Route of Administration INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN 100 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-6000-1 100 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200368 08/02/2006 Labeler - Bimeda Inc., Division of Cross Vetpharm Group (060492923) Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492923) Establishment Name Address ID/FEI Business Operations Bimeda-MTC Animal Health, Division of Cross Vetpharm Group 256232216 manufacture Establishment Name Address ID/FEI Business Operations Anhui Wanbei Pharmaceutical Co., Ltd. 654258862 api manufacture Establishment Name Address ID/FEI Business Operations JIANGXI GUOYAO PHARMACEUTICAL, LLC., CO. 420560294 api manufacture Establishment Name Address ID/FEI Business Operations Suzhou no. 4 Pharmaceutical Factory 654159557 api manufacture