Onsior imjection for pain & inflammation of soft tissue-Hyperdrug

Presentation Each millilitre of clear, colourless to slightly coloured (pink) solution for injection contains 20 mg of robenacoxib as active substance. Uses Robenacoxib is part of the coxib class of non-steroidal anti-inflammatory drugs (NSAIDs). Onsior solution for injection is recommended for the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs and for the treatment of pain and inflammation associated with soft tissue surgery in cats. Robenacoxib is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions , e.g in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme and is responsible for the production of mediators including prostaglandin E2 (PGE2) which induce pain, inflammation or fever. In cats using an in vitro whole blood assay, robenacoxib was approximately 500 fold selective for COX-2 as compared to COX-1. In vivo, robenacoxib solution for injection produced marked inhibition of COX-2 activity and had no effect on COX-1 activity. At the recommended dosage (2 mg/kg), analgesic, anti-inflammatory and anti-pyretic effects were demonstrated in an inflammation model, and in clinical trials, robenacoxib reduced pain and inflammation in cats undergoing soft tissue surgery. In dogs, robencoxib was in vitro approximately 140 fold selective for COX-2 as compared to COX-1. In vivo, robenacoxib solution for injection produced marked inhibition of COX-2 activity and had no effect on COX-1 activity. At dosages ranging from 0.25 to 4 mg/kg, robenacoxib had analgesic, anti-inflammatory and anti-pyretic effects in an inflammation model with a rapid onset of action (1hour). In clinical trials at the recommended dose (2 mg/kg), robenacoxib reduced pain and inflammation in dogs undergoing orthopaedic or soft tissue surgery. Peak blood concentrations of robenacoxib are attained rapidly after subcutaneous injection in cats and dogs. After a dosage of 2 mg/kg a Tmax of 1 hour (cats and dogs). Robenacoxib is highly bound to plasma proteins (>99%) and is extensively metabolised by the liver in cats and dogs. After subcutaneous administration, the terminal half-life from blood was 1.1 hour in cats and 1.2 hour in dogs. Robenacoxib persists longer and in higher concentrations at sites of inflammation than in blood. Robenacoxib is excreted predominately via the biliary route in cats (~70%) and dogs (~65%) and the remainder via the kidneys. Repeated subcutaneous administration at dosages of 2 -20 mg/kg produced no change in the blood profile, with neither bioaccumulation of robenacoxib nor enzyme induction.

Contra-indications, warnings, etc 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 exipients. Because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding, it is not recommended for use in pregnant and lactating animals. The safety of the veterinary medicinal product has not been established in cats less than 4 months of age and in dogs les than 2 months of age, or in cats or dogs less than 2.5 kg bodyweight. Use in animals with impaired cardiac, renal or hepatic function or that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these animals require careful monitoring and fluid therapy. In cats, gastrointestinal adverse events (such as vomiting) were very commonly reported, but most cases were mild and recovered without treatment. Diarrhoea or vomiting with blood were uncommon. Slight pain at injection was very commonly reported. Moderate or severe pain at injection was commonly reported. In dogs, gastrointestinal adverse events (such as vomiting) were commonly reported but most cases were mild and recovered without treatment. Diarrhoea, soft and dark faeces or reduced appetitie were uncommon. Slight pain at injection was commonly reported. Moderate or severe pain at injection was uncommon. 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. As anaesthetics may effect 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. Pharmaceutical precautions Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first broaching of the vial: 28 days. Store in a refrigerator (2°C - 8°C). Avoid introduction of contamination. Keep the vial in the outer carton. In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. 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. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category POM-V Packaging Quantities Multi-dose amber glass vial containing 20 ml solution for injection, closed with a rubber stopper and sealed with an aluminium cap. One vial packed in a cardboard box. Further information In healthy young dogs aged 6 months, once daily subcutaneous administration of robenacoxib at doses of 2 (recommended therapeutic dose; RTD) 6 (3 times RTD), and 20 mg/kg (10 times RTD) for 9 administrations over a 5 week period (3 cycles of 3 consecutive once daily injections) did not produce any signs of toxicity, including no gastrointestinal, kidney or liver toxicity and no effect on bleeding time. Reversible inflammation at the injection site was noted in all groups (including controls) and was more severe in the 6 and 20 mg/kg dose groups. In healthy young cats aged 10 months, once daily subcutaneous administration of roenacoxib at doses of 4 mg/kg (twice RTD) for 2 consecutive days and 10 mg/kg (5 times RTD) for 3 consecutive days did not produce any signs of toxicity, including no signs of gastrointestinal, kidney or liver toxicity and no effect on bleeding time. Reversible, minimal injection site reactions were noted in both dose groups. As with any NSAID, overdose may cause gastrointestinal, kidney or liver toxicity in sensitive or compromised animals. There is no specific antidote. Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.

Onsior 20mg/ml Injection 20ml