ADEQUAN 250 MG/ML SOLUTION FOR INJECTION

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

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SPC SPC (SPC)
16-05-2015

active_ingredient:

POLYSULPHATED GLYCOSAMINOGLYCAN

MAH:

Daiichi Sankyo Altkirch SARL

ATC_code:

QM01AX12

INN:

POLYSULPHATED GLYCOSAMINOGLYCAN

dosage:

250 Mg/Ml

pharmaceutical_form:

Solution for Injection

prescription_type:

POM

therapeutic_group:

Equine - Food

therapeutic_area:

Glucosaminoglycan polysulfate

therapeutic_indication:

N.S.A.I.D

authorization_status:

Authorised

authorization_date:

2015-05-01

SPC

                                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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 01/05/2015_
_CRN 7020829_
_page number: 1_
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 
                                
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