Adequan 250 mg/ml Solution for Injection

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Glycosaminoglycan polysulfate

Fáanlegur frá:

Daiichi Sankyo Altkirch SARL

ATC númer:

QM01AX12

INN (Alþjóðlegt nafn):

Glycosaminoglycan polysulfate

Skammtar:

250 milligram(s)/millilitre

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Horses

Lækningarsvæði:

glucosaminoglycan polysulfate

Ábendingar:

N.S.A.I.D.

Leyfisstaða:

Authorised

Leyfisdagur:

2010-07-02

Vara einkenni

Health Products Regulatory Authority
17 June 2019
CRN0094HT
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Adequan 250 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Polysulphated glycosaminoglycan (PSGAG) 250 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, 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.
4.3 CONTRAINDICATIONS
Do not use in animals with infected or actively inflamed joints or
with severe degradation of joint cartilage.
Do not use in animals with known sensitivity 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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In the presence of an active joint inflammation, therapy with a
suitable anti-inflammatory agent should be given prior to
intra-articular treatment with Adequan. The anti-inflammatory
treatment should be discontinued as soon as possible since
steroidal and non-steroidal agents may contribute to the degeneration
of cartilage.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY 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.
Health Products Regulatory Authority
17 June 2019
CRN0094HT
Page 2 of 3
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
After intra-articular injection, reactions in the joint, including
joint oedema, may occur after the first injection and occasionally
after further injections.
Should an acute inflammation occur, postpone further injecti