国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Sodium hyaluronate
Dechra Ltd
QM09AX01
Sodium hyaluronate
17 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Horses
hyaluronic acid
Miscellaneous
Authorised
2016-01-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT HY-50 Vet. 17 mg/ml solution for injection for horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active substance: Sodium hyaluronate 17 mg Excipients: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless, viscous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For intra-articular and intravenous treatment of lameness caused by joint dysfunction associated with non-infectious synovitis. 4.3 CONTRAINDICATIONS Do not use in cases of joint infection. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Radiographic evaluation should be carried out in cases of acute, severe lameness to ensure that the joints are free from serious fractures. Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Transient mild swelling and/or heat has been reported in treated joints (2.7%). These self-limiting local signs resolve spontaneously within 48 hours, and do not negate a successful therapeutic outcome. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _2_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _7_ _0_ _9_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.7 USE DU 阅读完整的文件