ADEQUAN 100 MG/ML SOLUTION FOR INJECTION

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

POLYSULPHATED GLYCOSAMINOGLYCAN

MAH:

Daiichi Sankyo Altkirch SARL

ATC_code:

QM01AX12

INN:

POLYSULPHATED GLYCOSAMINOGLYCAN

dosage:

100 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 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 01/05/2015_
_CRN 7020829_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For intramuscular administration only
If signs or symptoms of hypersensitivity occur, the treatment must be discontinued
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.
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 acti