国家: 英国
语言: 英文
来源: VMD (Veterinary Medicines Directorate)
Sodium Hyaluronate
Zoetis UK Limited
QM09AX01
Sodium Hyaluronate
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Horses
Anti Inflammatory
Expired
1994-07-19
Revised: April 2014 AN: 01715/2013 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HYLARTIL VET 10 mg/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2ml syringe contains: ACTIVE SUBSTANCE: Sodium Hyaluronate (MrM, mean relative molecular mass ≥ 3.0 x106) 20.00 mg (10mg/ml) For full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Horses. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Hylartil Vet (10mg/ml) is indicated for use in horses as follows: i) For the local treatment of non-infectious inflammatory joint disease in horses. ii) For the local treatment of tendinitis in horses. 4.3. CONTRAINDICATIONS None. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. 4.5. SPECIAL PRECAUTIONS FOR USE Please note the syringe is sealed with a membrane which must be ruptured prior to use (see directions in carton). i) Special precautions for use in animals None known. Revised: April 2014 AN: 01715/2013 Page 2 of 4 ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Directly after use of this product, hands and exposed skin should be washed thoroughly. 4.6. ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Transient swelling may occur at the injection site. 4.7. USE DURING PREGNANCY, LACTATION OR LAY Hylartil Vet can, as far is known, be used during pregnancy and lactation. 4.8. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.9. AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE For intra-articular use and direct injection into tendons. Two ml (20 mg) of Hylartil Vet is given intra-articularly in small and medium size joints and can also be injected directly into tendons. In the treatment of larger joints/tendons the dosage may be increased to 4 ml (40 mg). The injection should be given under strict aseptic conditions. The treatment may be repeated at weekly intervals f 阅读完整的文件