Label: LINCOMYCIN- lincomycin injection
- NDC Code(s): 46066-246-04
- Packager: Aspen Veterinary Resources, Ltd.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated March 20, 2024
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- Official Label (Printer Friendly)
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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 childrenApproved 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.
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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
- WARNING
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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.
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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
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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
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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
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LINCOMYCIN
lincomycin injectionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-246 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN 300 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-246-04 100 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200315 02/21/2006 Labeler - Aspen Veterinary Resources, Ltd. (627265361)