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

ADEQUAN I.M. 
polysulfated glycosaminoglycan injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:10797-959
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
polysulfated glycosaminoglycan (polysulfated glycosaminoglycan) polysulfated glycosaminoglycan 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol  
water  
Packaging
# Item Code Package Description
1 NDC:10797-959-01 1 VIAL, MULTI-DOSE (1 VIAL) in 1 CARTON
1 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140901 12/20/2009
Labeler - Luitpold Pharmaceuticals, Inc. (002033710)
Establishment
Name Address ID/FEI Operations
Luitpold Pharmaceuticals, Inc. 002033710 MANUFACTURE, ANALYSIS, LABEL, PACK, STERILIZE
Revised: 01/2011   Luitpold Pharmaceuticals, Inc.
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