Product Type

ONSIOR is a coxib NSAID (non-steroidal anti-inflammatory drug) for the relief of pain and inflammation in cats and dogs.

Description and Composition

Onsior is available as flavored tablets:

• Onsior Cat 6 mg, a tablet containing 6 mg of robenacoxib.
• Onsior Dog 5 mg, a tablet containing 5 mg of robenacoxib.
• Onsior Dog 10 mg, a tablet containing 10 mg of robenacoxib.
• Onsior Dog 20 mg, a tablet containing 20 mg of robenacoxib.
• Onsior Dog 40 mg, a tablet containing 40 mg of robenacoxib.

Onsior is also avialable as injectable solution:

• Onsior 20 mg/ml injection, a solution containing 20 mg of robenacoxib per milliliter.

Properties

Onsior contains the active ingredient robenacoxib. Robenacoxib is a COX-2 selective NSAID (non-steroidal anti-inflammatory drug). It targets the pain-causing COX-2 enzymes while sparing the protective actions of COX-1 enzymes at labeled dosages.
Onsior is tissue selective. Idenitifying and targeting inflamed and painful sites, Onsior travels rapidly through the bloodstream and exits it very quickly - persisting longer at the point of inflammation.

Indications

Onsior is formulated to fit in with an effective pain management protocol. Onsior tablets for cats are small and flavored to be accepted easily by the majority of cats suffering from pain and inflammation due to musculo-skeletal disorders.
Onsior tablets for dogs are beef-flavored and indicated to relieve pain and inflammation associated with chronic osteoarthritis.
For surgery, Onsior injectable in cats (one single injection for soft tissue surgery) and in dogs (one single injection for orthopedic or soft tissue surgery) can be used.

Dosage and Administration

Tablets

For cats the recommended dose of robenacoxib is 1 mg/kg body weight with a range 1-2.4 mg/kg. Administer once daily at the same time every day, for up to 6 days according to the table below.

For dogs 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.

Injectable Solution

Administer the solution 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).

Contradictions

• Do not use in cats suffering from ulceration in the digestive tract.
• Do not use in dogs suffering from stomach ulcer or with liver disease.
• Do not use together with non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, medicines commonly used in the treatment of pain, inflammation and allergies.
• Do not use in case of hypersensitivity to robenacoxib or to any of the constituents and ingredients of the tablets and the solution.
• Do not use in pregnant or lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding.

Special Precautions and Warnings

• Use in animals with impaired function of the heart, kidneys or liver or in animals that are dehydrated, have low volume of circulating blood or have low blood pressure 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 animals at risk of ulceration of the digestive tract, or if the animal previously displayed intolerance to other NSAIDs.
• Onsior must not be administered in conjunction with other NSAIDs. 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.
• 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.

Special Warnings for Onsoir 20 mg/ml injection:

• The safety of this 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.
• 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.
• In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Special Warnings for Onsoir tablets:

• The safety of this veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age.
• The safety of this veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 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 symptoms such as anorexia, apathy or vomiting in combination with elevated liver enzymes.

Adverse Reactions* of Onsior 20 mg/ml injection:

Cats:

• Adverse reactions of the digestive tract (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.

Dogs:

• Adverse reactions of the digestive tract (such as vomiting) were commonly reported but most cases were mild and recovered without treatment. Diarrhoea, soft and dark faeces or reduced appetite were uncommon.
• Slight pain at injection was commonly reported. Moderate or severe pain at injection was uncommon.

Adverse Reactions* of Onsior tablets:

• Adverse reactions of the digestive tract were reported very commonly, but most cases were mild and recovered without treatment. Vomiting and soft faeces were very common, decreased appetite and diarrhoea were common, and blood in the faeces was uncommon.
• In dogs treated up to 2 weeks no increases in liver enzyme activities were observed. However, with long-term treatment increases in liver enzyme activities were common. In most cases the liver enzyme activities either stabilised or decreased with continued treatment. Increases in liver enzyme activities associated with symptoms of anorexia, apathy or vomiting were uncommon.

The frequency of possible adverse effects is defined using the following convention:
very common (affects more than 1 animal in 10)
common (affects 1 to 10 animals in 100)
uncommon (affects 1 to 10 animals in 1,000)
rare (affects 1 to 10 animals in 10,000)
very rare (affects less than 1 animals in 10,000)
not known (frequency cannot be estimated from the available data).

For the person administering the veterinary medicinal product to animals:

• Wash hands and exposed skin immediately after use of the veterinary medicinal 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 might increase the risk to the foetus.