Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Glycosaminoglycan polysulfate
Daiichi Sankyo Altkirch SARL
QM01AX12
Glycosaminoglycan polysulfate
100 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
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 Прочитајте комплетан документ