Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Sodium hyaluronate
Equi Pharma Ltd
QM09AX01
Sodium hyaluronate
50 mg/syringe
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
hyaluronic acid
Authorised
2014-07-18
Health Products Regulatory Authority 15 October 2021 CRN009M05 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT SynVet-50; 50 mg solution for injection for horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each 2.5 ml syringe contains: Sodium Hyaluronate 50 mg (equivalent to hyaluronic acid) 47 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 Horse 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For adjunctive intra-articular treatment of joint disease associated with non-infectious synovitis in horses. 4.3 CONTRAINDICATIONS Do not use in cases of joint infections. Do not use in cases of known hypersensitivity to exogenous sodium hyaluronate or to any of the excipients of the product. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The treated horse should be box-rested for 2 days before gradually resuming a normal exercise pattern. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Excess synovial fluid should be removed whenever possible prior to injection. The injection should be administered under strict aseptic conditions through healthy undamaged skin. Appropriate investigations should be carried out in cases of acute, severe lameness to ensure that the joints are free from fractures, OCD fragments and infections. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In case of accidental contact with skin, wash with soap and water. In case of accidental contact with eyes, blurred vision may occur because of the viscous nature of the product. Rinse immediately with plenty of clean water. Health Products Regulatory Authority 15 October 2021 CRN009M05 Page 2 of 4 In the event of accidental self-injection, seek medical advice immediately and show the package leaflet of the label to the physician. Wash hands after use. 4.6 ADVERSE REACTION Đọc toàn bộ tài liệu