Your browser does not support JavaScript! LINCOMED 100 (LINCOMYCIN) INJECTION [BIMEDA INC., DIVISION OF CROSS VETPHARM GROUP]

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LINCOMED 100 (lincomycin) injection
[Bimeda Inc., Division of Cross Vetpharm Group]


Category DEA Schedule Marketing Status
OTC ANIMAL DRUG LABEL Abbreviated New Animal Drug Application
Drug Label Sections

LincoMed® 100

lincomycin injection, USP

Swine Antibiotic

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

DESCRIPTION:

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.

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.

CONTRAINDICATIONS:

As with all drugs, use of LincoMed® 100 is contraindicated in animals previously found to be hypersensitive to the drug.

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

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

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. 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.

HOW SUPPLIED:

100 mL mutiple dose vials.

STORAGE: Store at  20⁰C - 25⁰C (68⁰F - 77⁰F).

KEEP FROM FREEZING

label.jpg

LINCOMED 100 
lincomycin injection
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:61133-6000
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LINCOMYCIN HYDROCHLORIDE (LINCOMYCIN) LINCOMYCIN100 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61133-6000-1100 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20036808/02/2006
Labeler - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
Establishment
NameAddressID/FEIBusiness Operations
Bimeda-MTC Animal Health, Division of Cross Vetpharm Group256232216manufacture
Establishment
NameAddressID/FEIBusiness Operations
Anhui Wanbei Pharmaceutical Co., Ltd.654258862api manufacture
Establishment
NameAddressID/FEIBusiness Operations
JIANGXI GUOYAO PHARMACEUTICAL, LLC., CO.420560294api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Suzhou no. 4 Pharmaceutical Factory654159557api manufacture

Revised: 8/2013
 
Bimeda Inc., Division of Cross Vetpharm Group

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