Adequan 100 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glycosaminoglycan polysulfate

Available from:

Daiichi Sankyo Altkirch SARL

ATC code:

QM01AX12

INN (International Name):

Glycosaminoglycan polysulfate

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Horses

Therapeutic area:

glucosaminoglycan polysulfate

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

2010-07-02

Summary of Product characteristics

Revised: January 2015
AN: 01275/2014
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Adequan IM 500 mg/5 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Polysulphated glycosaminoglycan (PSGAG) 500 mg per 5
ml vial
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slightly brownish-yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In horses:
For treatment of lameness due to degenerative aseptic joint disease.
4.3
CONTRAINDICATIONS
Do not administer when a pre-existent tendency to haemorrhage or
increased
coagulation time is known.
Do not administer within 24 hours after surgery.
Do not use for the treatment of septic arthritis; in this case
appropriate treatment
such as surgery and / or antimicrobial therapy should be instigated.
Treatment should not be given in cases of advanced renal or hepatic
disease or
in cases where there is a history of hypersensitivity to PSGAG.
Reference is also made to section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
This product does not contain an antimicrobial preservative. Any
solution
remaining in the vial following withdrawal of the required dose should
be
discarded.
Revised: January 2015
AN: 01275/2014
This product must be used with caution in horses suffering with
hepatic
dysfunction.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
In view of possible sensitization, contact dermatitis and skin
irritation any
skin contact with the product should be avoided. Wear protective
gloves.
Avoid self-injection. Self-injection may cause delayed blood
coagulation for
a few hours. In case of accidental self-injection seek medical advice
immediately and show the package leaflet or the label to the doctor.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
On rare occasi