Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Glycosaminoglycan polysulfate
Daiichi Sankyo Altkirch SARL
QM01AX12
Glycosaminoglycan polysulfate
250 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Horses
glucosaminoglycan polysulfate
N.S.A.I.D.
Authorised
2010-07-02
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 Perskaitykite visą dokumentą