Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
HYALURONATE SODIUM
Dechra Limited
QM09AX01
HYALURONATE SODIUM
17 Mg/Ml
Solution for Injection
POM
Equine
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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 22/01/2016_ _CRN 7017092_ _page number: 1_ 4.7 USE DURING PREGNANCY, LACTATION OR LAY The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Use only according to the benefit/risk assessment by the responsible veterinarian. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No data available. 4.9 Lugege kogu dokumenti