ONSIOR 20MG/ML INJ 20ML

Target species Cats and dogs. Indications for use, specifying the target species For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs. For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in cats. Contraindications Do not use in animals suffering from gastrointestinal ulceration. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant and lactating animals (see section Use during pregnancy). Special warnings for each target species None. Special precautions for use Special precautions for use in animals The safety of the veterinary medicinal product has not been established in cats less than 4 months of age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight. Use in animals with impaired cardiac, renal or hepatic function or those are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these animals require careful monitoring and fluid therapy. Use this veterinary medicinal product under strict veterinary monitoring in cases at risk of gastrointestinal ulceration, or if the animal previously displayed intolerance to other NSAIDs. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands and exposed skin immediately after use of the product. In case of accidental ingestion or self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. For pregnant women, particularly near term pregnant women, accidental injection and prolonged dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus. Adverse reactions (frequency and seriousness) Cats: Gastrointestinal adverse events (vomiting, soft faeces or diarrhoea) were commonly reported, but most cases were mild and recovered without treatment. Diarrhoea or vomiting with blood was uncommon. Pain at injection site was commonly reported. Dogs: Gastrointestinal adverse events (diarrhoea and vomiting) were commonly reported but most cases were mild and recovered without treatment. Soft and dark faeces or reduced appetite were uncommon. Slight pain at injection site was commonly reported. Moderate or severe pain at injection site was uncommon. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). Use during pregnancy, lactation or lay Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding. Interaction with other medicinal products and other forms of interaction Onsior must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously. Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensin-converting enzyme (ACE) inhibitors, should be subject to clinical monitoring. In healthy cats or dogs treated with or without the diuretic furosemide, concomitant administration of Onsior with the ACE inhibitor benazepril for 7 days was not associated with any negative effects on plasma (cats) or urine (dogs) aldosterone concentrations, plasma renin activity or glomerular filtration rate. No safety data in the target population and no efficacy data in general exist for the combined treatment of robenacoxib and benazepril. As anaesthetics may affect renal perfusion, the use of parenteral fluid therapy during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively. Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity. Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.