Adequan IM
Name: Adequan IM
Dosage and administration
The recommended dose of Adequan® i.m. Multi-Dose in horses is 500 mg every 4 days for 28 days intramuscularly. The injection site must be thoroughly cleansed prior to injection. Do not mix Adequan® i.m. Multi-Dose with other drugs or solvents.
Warnings
Do not use in horses intended for human consumption. Not for use in humans. Keep this and all medications out of the reach of children.
Precautions
The safe use of Adequan® i.m. Multi-Dose in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated.
Animal safety
Animal Safety studies utilizing Adequan® i.m. Multi-Dose were not performed. Safety studies were conducted in horses using the single dose formulation. Doses as high as 2,500 mg were administered intramuscularly to 6 horses twice a week for 12 weeks. This dosage is 5 times the recommended dosage and 3 times the recommended therapeutic regimen. Clinical observations revealed no soreness or swelling at the injection site or in the affected joint. No animal had any clinical or laboratory evidence of toxicity.
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML LABEL
NDC 10797-959-01
Adequan®i.m. Multi-Dose
(POLYSULFATED GLYCOSAMINOGLYCAN)
100 mg/mL
50 mL Preserved Multiple Dose Vial
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
For Intramuscular Use in Horses Only. Not for Intra-Articular Use.
Each mL contains PSGAG 100 mg, Benzyl Alcohol 0.9% v/v as a preservative, and Water for Injection q.s.
WARNING: Do not use in horses intended for human consumption.
Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).
See package insert for full directions.
Luitpold Pharmaceuticals, Inc., Animal Health Division
Shirley, NY 11967
NADA 140-901, Approved by FDA
Rev. 2/08
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML CARTON
NDC 10797-959-01
Adequan® i.m.
(POLYSULFATED GLYCOSAMINOGLYCAN)
MULTI-DOSE
100 mg/mL
(5000 mg/50 mL)
PSGAG injection for intramuscular use in horses only. Not for intra-articular use.
Contains one 50 mL Preserved Multiple Dose Vial
Luitpold Pharmaceuticals, Inc.
Animal Health Division
Shirley, NY 11967
(800) 458-0163
NADA 140-901, Approved by FDA
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| Labeler - Luitpold Pharmaceuticals, Inc. (002033710) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Luitpold Pharmaceuticals, Inc. | 002033710 | MANUFACTURE, ANALYSIS, LABEL, PACK, STERILIZE | |