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Contra-indications, warnings, etc
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 cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in pregnant and lactating animals (see section Dosage and Administration).
Special warnings for each target species
In clinical studies in dogs with osteoarthritis, inadequate response to treatment was seen in 10-15% of the dogs.
Special precautions for use
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. Tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals For pregnant women, particularly near-term pregnant women, prolonged dermal exposure increases the risk of premature closure of the ductus arteriosus in the foetus. Pregnant women should take special care to avoid accidental exposure. Accidental ingestion increases the risk for NSAID adverse effects, particularly in small children. Care should be taken to avoid accidental ingestion by children. In order to prevent children from accessing the product, do not remove tablets from the blister until ready to administer to the animal. Tablets should be administered and stored (in the original packaging) out of sight and reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use of the veterinary medicinal product. Special precautions for the protection of the environment: Not applicable.
iii)Other precautions Not applicable.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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 use of robenacoxib tablets 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) resulted in 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.