Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: VMD (Veterinary Medicines Directorate)
Sodium Hyaluronate
Dechra Limited
QM09AX01
Sodium Hyaluronate
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Horses
Anti Inflammatory
Authorized
1998-06-12
Revised: March 2016 AN: 01470/2015 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HY-50 Vet 17 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Sodium Hyaluronate 17 mg/ml EXCIPIENTS: For a 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 Horse. 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 i. 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. Revised: March 2016 AN: 01470/2015 Page 2 of 5 ii. 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 Safety in pregnant and lactating mares has not been documented. 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 Intravenous use: 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, tarsometatarsal and interphalangeal joints can be treated with a 1.5 ml dose (25.5 Lesen Sie das vollständige Dokument