Adequan 100 mg/ml Solution for Injection

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Polysulphated Glycosaminoglycan

Disponibil de la:

Daiichi Sankyo Altkirch SARL

Codul ATC:

QM01AX12

INN (nume internaţional):

Polysulphated Glycosaminoglycan

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Horses

Zonă Terapeutică:

Anti Inflammatory

Statutul autorizaţiei:

Authorized

Data de autorizare:

1996-01-05

Caracteristicilor produsului

Revised: July 2022
AN: 00022/2022
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Adequan 100 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
Polysulphated Glycosaminoglycan (PSGAG) 100 mg/ml
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of lameness in horses due to traumatic or degenerative
aseptic
joint disease and acute superficial digital flexor tendonitis.
4.3
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
For intramuscular administration only.
If signs or symptoms of hypersensitivity occur, the treatment must be
discontinued.
Revised: July 2022
AN: 00022/2022
Page 2 of 4
ii.
Special precautions to be taken by the person administering the
medicinal product to animals
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.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Adequan should not be used in pregnant animals.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Adequan may potentiate the action of anticoagulant preparations.
4.9
AMOUNT TO BE ADMINISTERED AND ADMINISTRATION ROUTE
The contents of a 5 ml vial are injected by deep intra-muscular
injection every
four days for a total of seven injections.
This product does not contain an antimicrobial preservative. Any
solution
remaining in the vial after withdrawal