ADEQUAN I.M.- polysulfated glycosaminoglycan injection, solution

Drug Labeling and Warnings

Drug Details [pdf]

Adequan polysulphated glycosaminoglycan

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing Authorisation Holder

Aniserve GmbH

Geyerspergerstr. 27

80689 Muenchen

Germany

Manufacturing Authorisation Holder Responsible for Batch Release

Klifovet GmbH

Geyerspergerstr. 27

80689 München

Germany

NAME OF THE VETERINARY MEDICINAL PRODUCT

Adequan 100 mg/ml Solution for Injection

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Active Substance:

Polysulphated Glycosaminoglycan (PSGAG) 100 mg/ml

Clear, colourless to pale yellow aqueous solution.

INDICATIONS

For treatment of lameness in horses due to traumatic or degenerative aseptic joint disease and acute superficial digital flexor tendonitis.

CONTRAINDICATIONS

Do not use in animals with known hypersensitivity to the active ingredient.

Do not use in cases of advanced renal or hepatic disease.

Do not use in pregnant animals.

Any solution remaining in the vial after withdrawal of the required dose should be discarded.

If you notice any serious effect or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

ADVERSE REACTIONS

None known.

TARGET SPECIES

Horse

For animal treatment only

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

The contents of a 5 ml vial are injected by deep intra-muscular injection every four days for a total of seven injections.

ADVICE ON CORRECT ADMINISTRATION

 

This product does not contain an antimicrobial preservative. Any solution remaining in the vial after withdrawal of the required dose should be discarded.

For single use only.

 

WITHDRAWAL PERIOD

Meat and offal - Zero days

SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children. 

Do not store above 25 ºC.

Protect from light.

Keep the vial in the carton.

Do not use after the expiry date which is stated on the label and carton.

The expiry date refers to the last date of that month.

 

SPECIAL WARNINGS

Special precautions for use in animals

For intramuscular administration only.

If signs or symptoms of hypersensitivity occur, the treatment must be discontinued.

User Warnings

Care should be taken to avoid accidental self-injection.

In the case of accidental eye or skin contact, wash the affected area thoroughly with copious amounts of water. If irritation persists, seek medical attention.

Interaction with other medicinal products and other forms of interaction

Adequan may potentiate the action of anticoagulant preparations.

Overdose (symptoms, emergency procedures, antidotes)

In the case of overdosage, blood coagulation time, as measured by activated partial thromboplastin time, may be prolonged for a few hours after the injection.

For Animal Treatment Only

 

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS

 

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

OTHER INFORMATION

The active ingredient is a semisynthetic substance, similar to the physiological mucopolysaccharides which are the basic component of cartilage.  In healthy joints, the synthesis and degradation of cartilage is in equilibrium.  In traumatic and degenerative joint disease, the natural equilibrium between synthesis and degradation of the cartilage is disturbed.  This results in an increased degradation which further results in a loss of glycosaminoglycans.

Adequan inhibits cartilage degrading enzymes (various glycanohydrolases and glycosidases), stimulates the proteoglycan synthesis and hyaluronic acid synthesis and thus increases the viscosity of the synovia.

Various in-vitro studies and animal models have been employed to investigate the anti-osteoarthritis activities of PSGAG.

The finding, that the development and progression of degenerative joint diseases were inhibited in all species and models tested, indicates that PSGAG will also therapeutically influence degenerative or traumatic joint diseases in horses.

• MA Number:

  Legal Category

• Vm 48469/4001:

  POM-V To be supplied only on veterinary prescription

Veterinary Medicinal product authorised for use in the UK.

ADEQUAN and the related logos are trademarks of American Regent, Inc.

RQ1121-B

Rev. 03/2025

PRINCIPAL DISPLAY PANEL

Adequan 

polysulphated glycosaminoglycan

Adequan 100 mg/ml

Solution for Injection

For intramuscular injection.

For treatment of lameness in horses due to traumatic or degenerative aspetic joint disease and acute superficial digital flexor tendonitis.

7x 5 ml

INGREDIENTS AND APPEARANCE

ADEQUAN I.M. 
polysulfated glycosaminoglycan injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 10797-995
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) (POLYSULFATED GLYCOSAMINOGLYCAN - UNII:268AW7000T)	POLYSULFATED GLYCOSAMINOGLYCAN	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10797-995-94	7 in 1 CARTON
1		5 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		10/07/2025

Labeler - American Regent, Inc. (002033710)

Registrant - American Regent, Inc. (002033710)