Onsior Dog , Robenacoxib , 30 tablets

Name:
Onsior

Manufacturer:
Elanco

Description:
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.

Ingredients:
Robenacoxib
Excipients list: Yeast powder, Microcrystalline cellulose, Povidone (K-30), Crospovidone, Colloidal anhydrous silica, Magnesium stearate, Powdered cellulose, Artificial beef flavour.

Key benefits:
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class.
Robenacoxib tablets reduced pain and inflammation associated with acute musculoskeletal disorders and reduced the need for emergency treatment when administered as premedication prior to orthopaedic procedures in combination with opioids.
In clinical trials in dogs, robenacoxib reduced lameness and inflammation associated with chronic osteoarthritis and pain, inflammation and the need for emergency treatment in dogs undergoing soft tissue surgery.

Intended use:
Dogs.

Method of administration:
Oral administration.

Do not administer with food.

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

Onsior for osteoarthritis – Recommended doses by weight
Clinical response occurs within one week.
Treatment should be discontinued after 10 days if no visible improvement is observed.
For long-term treatment, once a clinical effect has been achieved, the dose of Onsior may be adjusted to the lowest individual effective dose, reflecting the fact that the degree of pain and inflammation associated with chronic osteoarthritis may vary over time.

Soft tissue surgery: The recommended dose of robenacoxib is 2 mg/kg body weight, with a range of 2-4 mg/kg.
A single oral dose is administered prior to soft tissue surgery.
The tablet(s) should be taken without food at least 30 minutes prior to surgery.
Following surgery, treatment should be continued once daily for 2 additional days.

The interchangeable use of Onsior tablets and Onsior solution for injection has been tested in an animal safety study and has been shown to be well tolerated by dogs.
Treatment should not exceed one dose (either tablet or solution for injection) per day.
Please note that the recommended dose may differ for the 2 formulations.

Possible side effects:
Gastrointestinal adverse reactions have been reported very commonly, but most cases were mild and resolved without treatment.
Vomiting and soft faeces were very commonly reported, decreased appetite and diarrhoea were common, and cases of bloody faeces were uncommon.
No increases in liver enzyme levels were observed in dogs treated for up to 2 weeks. However, with long-term treatment, increases in liver enzyme levels were commonly observed. In most cases, there were no clinical symptoms and liver enzyme activity either stabilised or decreased with continued treatment.
Cases of increased liver enzyme levels associated with clinical symptoms of anorexia, apathy or vomiting were uncommon.
In very rare cases, lethargy may be observed.
If you notice any serious reactions or other effects not mentioned in the package leaflet, please inform your veterinarian.

Precautions:
Do not use in dogs suffering from gastrointestinal ulcers or liver 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 or lactating animals.
In clinical trials in dogs with osteoarthritis, an inadequate response to treatment was observed in 10-15% of dogs.
The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or less than 3 months of age.
In the case of long-term treatment, liver enzymes should be monitored at the beginning of treatment, e.g. after 2, 4 and 8 weeks. Thereafter, regular monitoring is recommended, e.g. every 3-6 months. Treatment should be discontinued if liver enzyme activity increases markedly or if the dog shows clinical signs such as anorexia, apathy or vomiting in combination with elevated liver enzymes.
The use of the product in dogs with impaired cardiac, renal or hepatic function or which are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these dogs require close monitoring.
Use this veterinary medicinal product under strict veterinary supervision in dogs at risk of gastrointestinal ulceration or in dogs with a history of intolerance to other NSAIDs.
Onsior should not be administered concomitantly with other NSAIDs or glucocorticosteroids.
Previous treatment with other anti-inflammatory drugs may result in additional or increased adverse effects and, therefore, there should be a period of at least 24 hours without treatment with such substances before starting treatment with Onsior.
Simultaneous administration of potentially nephrotoxic substances should be avoided as this may lead to an increased risk of renal toxicity.

Storage:
Store in a dry place away from moisture and direct sunlight, at temperatures up to 25°C.

In case of overdose:
In healthy young dogs aged 5 to 6 months, robenacoxib administered orally at high doses (4.6 or 10 mg/kg/day for 6 months) did not cause signs of toxicity, including signs of gastrointestinal, renal or hepatic toxicity, and had no effect on clotting time.
Robenacoxib also had no harmful effects on cartilage and joints.
As with any NSAID, overdose may cause gastrointestinal, renal or hepatic toxicity in dogs predisposed to such conditions or with a history of such conditions.
There is no specific antidote. Symptomatic, supportive treatment is recommended, which should include administration of gastrointestinal protective agents and infusion of saline.
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 mg plus 4.0, 8.0 and 12.0 mg robenacoxib/kg body weight orally and 2.0 mg, 4.0 mg and 6.0 mg robenacoxib/kg body weight subcutaneously) resulted in dose-dependent increases in edema, erythema, skin thickening and skin ulceration at the subcutaneous injection site and inflammation, congestion and hemorrhage in the duodenum, jejunum and cecum. No relevant effects on body weight, bleeding time or signs of renal or hepatic toxicity were observed.
In case of overdose, please contact your veterinarian immediately.