ONSIOR FOR PAIN AND INFLAMMATION

NAME OF ONSIOR VETERINARY MEDICINAL PRODUCT - robenacoxib

What is Onsior used for?

In cats, Onsior tablets are used to treat acute pain and inflammation associated with musculoskeletal disorders (muscle and bone problems).

In dogs, Onsior tablets are used to treat pain and inflammation associated with chronic osteoarthritis (a long-term disease that causes joint pain).

The tablets are administered once a day, at the same time, in a dose of 1 mg per kilogram of body weight, with a dose range of 1-2 mg/kg.

Treatment for cats is limited to six days. Dogs must be treated as long as necessary.

How does Onsior work?

The active substance in Onsior, robenacoxib, belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking an enzyme called cyclo-oxygenase 2 (COX-2). This enzyme is involved in the synthesis of substances called prostaglandins, which are involved in pain and inflammation. By blocking prostaglandin synthesis, robenacoxib reduces pain and inflammation caused by musculoskeletal disorders, surgery or osteoarthritis.

How was Onsior studied?

Onsior has been studied in laboratory animals as well as in "clinical studies" with cats and dogs treated in veterinary offices and clinics in Europe. In clinical studies, Onsior was compared with other veterinary medicines containing NSAIDs (ketoprofen, meloxicam or carprofen ).The studies involved cats and dogs of different ages, sexes and breeds.

The tablets have been studied for five or six days in cats with acute musculoskeletal disorders and for up to a year in dogs with osteoarthritis.

The tablets were administered to the animals once or twice a day. The effectiveness was determined based on the examinations performed by a veterinarian and the evaluations made by the owner of the animal.

What benefits did Onsior present during the studies?

Onsior tablets administered once a day reduced pain and improved mobility in both cats and dogs. Onsior was as effective as the comparator NSAID.

What are the risks associated with Onsior?

The side effects of Onsior are similar to those seen with other NSAIDs. The most common side effects of the administration of the tablets and the injectable solution are mild and transient effects on the stomach and intestine, manifested in the form of vomiting, soft feces and diarrhea. In 1% to 10% of dogs, there was an increase in liver enzyme levels following long-term tablet treatment. The injectable solution can also cause pain at the injection site. For the full list of all reported side effects associated with Onsior, see the package leaflet.

Onsior tablets should not be administered to dogs or cats with existing diseases of the stomach and intestine, such as gastric ulcers or bleeding, or to dogs with liver diseases. It should not be administered to pregnant animals, which are nursing puppies or cats or are used for mating or which are hypersensitive (allergic) to robenacoxib or any other ingredient of this medicine.

They must be administered with care to cats and dogs known to have heart or kidney problems and to cats with liver problems.

Onsior should not be administered together with other NSAIDs or glucocorticoids.

What are the precautionary measures for the person who administers the medicine or who comes into contact with the animal?

Wash your hands after administering the medicine to a dog or cat.

In case of accidental ingestion of tablets, especially in small children, seek medical help immediately and show the doctor the leaflet or the label.

In the case of pregnant women, especially those in an advanced stage of pregnancy, accidental ingestion of Onsior can be dangerous for the unborn child.

Why was Onsior approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Onsior outweighed the risks in the treatment of dogs and cats according to the approved indications and recommended granting marketing authorization for Onsior.