Dog

For the treatment of pain and inflammation associated with chronic osteoarthritis in dogs.

For the treatment of pain and inflammation associated with soft tissue surgery in dogs.

Do not use in dogs suffering from gastrointestinal ulceration or with hepatic disease.

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 below).

In clinical studies in dogs with osteoarthritis, inadequate response to treatment was seen in 10–15% of the dogs.

i) Special precautions for use in animals

The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age.

For long term therapy, liver enzymes should be monitored at the start of therapy, e.g. after 2, 4 and 8 weeks. Thereafter it is recommended to continue regular monitoring, e.g. every 3–6 months. Therapy should be discontinued if liver enzyme activities increase markedly or the dog shows clinical signs such as anorexia, apathy or vomiting in combination with elevated liver enzymes.

Use in dogs with impaired cardiac or renal function or dogs that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these dogs require careful monitoring.

Use this product under strict veterinary monitoring in dogs with a risk of gastrointestinal ulcers, or if the dog previously displayed intolerance to other NSAIDs.

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after use of the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In small children, accidental ingestion increases the risk for NSAID adverse effects.

For pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk of premature closure of the ductus arteriosus in the foetus.

iii). Other precautions

Not applicable.

Dogs:

1Most cases were mild and recovered after treatment.

2In dogs treated up to 2 weeks, there were no increases in liver enzyme activities observed. However, with long-term treatment, increases in liver enzyme activities were reported. In most cases there were no clinical signs and the liver enzyme activities either stabilised or decreased with continued treatment. Increases in liver enzyme activities associated with clinical signs of anorexia, apathy or vomiting were uncommon.

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 dogs used for breeding.

This veterinary medicinal product must not be administered in conjunction with other NSAIDs or glucocorticoids. 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 dogs treated with and 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 urine 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.

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.

For oral use.

Do not administer with food since clinical trials demonstrated better efficacy of robenacoxib for osteoarthritis when administered without food or at least 30 minutes before or after a meal.

Tablets are flavoured and are taken voluntarily by most dogs. The tablets should not be divided or broken.

Osteoarthritis: The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2 mg/kg. Administer once daily at the same time every day according to the table below.

A clinical response is normally seen within a week. Treatment should be discontinued after 10 days if no clinical improvement is apparent.

For long-term treatment, once a clinical response has been observed, the dose of this veterinary medicinal product can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic osteoarthritis may vary over time. Regular monitoring should be undertaken by the veterinarian.

Soft tissue surgery: The recommended dose of robenacoxib is 2 mg/kg body weight with a range of 2-4 mg/kg. Give as a single oral treatment prior to soft tissue surgery.

The tablet(s) should be administered without food at least 30 minutes prior to surgery.

After surgery, once daily treatment may be continued for up to two further days.

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

For 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 5–6 months, oral robenacoxib administered at high overdoses (4, 6 or 10 mg/kg/day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time. Robenacoxib also had no detrimental effects on cartilages or joints.

As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs. There is no specific antidote. Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.

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.

Withdrawal period
Not applicable.