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.

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).

None.

i) 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.

ii) 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.

Not applicable.

iii). Other precautions

Not applicable.

Cats:

1 Moderate or severe pain at injection site was uncommon

2 Most cases were mild and recovered without treatment.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

The safety of the veterinary medicinal product has not been established in cats and dogs for breeding.

This veterinary medicinal product 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 this veterinary medicinal product. 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 this veterinary medicinal product 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.

Subcutaneous use.

Administer subcutaneously to cats or dogs approximately 30 minutes before the start of surgery, for example around the time of induction of general anaesthesia, at a dose of 1 ml per 10 kg of body weight (2 mg/kg). After surgery in cats, once daily treatment may be continued at the same dosage and at the same time every day for up to 2 days. After soft tissue surgery in dogs, once daily treatment may be continued at the same dosage and at the same time every day for up to 2 days.

The interchangeable use of Onsior tablets and Onsior solution for injection has been tested in target animal safety studies and was shown to be well tolerated by cats and dogs.

Onsior solution for injection or tablets may be used interchangeably in accordance with the indications and directions of use approved for each pharmaceutical form. Treatment should not exceed one dose (either tablet or injection) per day. Please note that the recommended doses for the two formulations may be different.

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 gastrointestinal, kidney or liver toxicity and had 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 robenacoxib 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 signs of gastrointestinal, kidney or liver toxicity and had no effect on bleeding time. Reversible, minimal injection site reactions were noted in both dose groups.

The interchangeable use of Onsior tablets and Onsior solution for injection in 4-month old cats at overdoses of up to 3 times the maximum recommended dose (2.4 mg, 4.8 mg, 7.2 mg robenacoxib/kg orally and 2.0 mg, 4.0 mg and 6.0 mg robenacoxib/kg subcutaneously) resulted in a dose-dependent increase of sporadic oedema at the injection site and minimal to mild subacute/chronic inflammation of the subcutaneous tissue. A dose-dependent increase in the QT interval, a decreased heart rate and corresponding increased respiratory rate were observed in laboratory studies. No relevant effects on body weight, bleeding time or evidence of any gastrointestinal, kidney or liver toxicity were observed.

In overdose studies conducted in cats, there was a dose-dependent increase in the QT interval. The biological relevance of increased QT intervals outside of normal variations observed following overdose of robenacoxib is unknown. No changes in the QT interval were observed after single intravenous administration of 2 or 4 mg /kg robenacoxib to anaesthetised healthy cats.

The interchangeable use of Onsior tablets and Onsior solution for injection in mongrel dogs at overdoses of up to 3 times the maximum recommended dose (2.0, 4.0 and 6.0 plus 4.0, 8.0 and 12.0 mg robenacoxib/kg orally and 2.0 mg, 4.0 mg and 6.0 mg robenacoxib/kg subcutaneously) resulted in dose-related oedema, erythema, thickening of the skin and skin ulceration at the subcutaneous injection site and inflammation, congestion, or haemorrhage in the duodenum, jejunum, and caecum. No relevant effects on body weight, bleeding time or evidence of any kidney or liver toxicity were observed.

No changes to blood pressure or the electrocardiogram were observed after single administration to healthy dogs of 2 mg/kg robenacoxib subcutaneously or 2 or 4 mg/kg intravenously. Vomiting occurred 6 or 8 hours post-dosing in 2 of 8 dogs administered the solution for injection at a dosage of 4 mg/kg intravenously.

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.

Not applicable.