SynVet-50 50mg/2.5 ml Solution for Intra-Articular Injection for horses

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 case 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. 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 reactions (frequency and seriousness) The most commonly reported adverse reaction are transient mild swelling and/or heat occurring in approximately 2.7% of the treated joints. These self-limiting local signs typically resolve spontaneously within 48 hours. However, since the early signs of septic arthritis may be similar, it is advised that a thorough clinical examination and monitoring are carried out if these clinical signs occur. Consideration should be given to appropriate further investigations. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 4.7 Use during pregnancy, lactation or lay The safety of the product has not been established in pregnant and lactating mares. 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 regarding the interaction with other medicinal products. It is described that hyaluronic acid competes with other high molecular weight polysaccharides such as chondroitin sulphate for receptor binding and thus for uptake in the articular cartilage tissue.
Vat Rate: 20%