Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Sodium hyaluronate
Dechra Regulatory B.V.
QM09AX01
Sodium hyaluronate
17 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
hyaluronic acid
Authorised
2016-01-22
_[Version 8.1,01/2017] _ ANNEX I 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. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Pregnancy and lactation: 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 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE For intra-articular and intravenous administration. Intravenous injection: 3 ml intravenously repeated at weekly intervals for a total of three treatments. For single intra-articular injection: 3 ml (51 mg) intra-articularly into medium sized and large joints. Smaller joints such as intertarsal, Preberite celoten dokument