Onsior (10 - 20 kg)

4 x 7 pc

Tablet

Active substance

Robenacoxib : 20 mg

ATC code

QM01AH91 Robenacoxib

QM01AH Coxibs

QM01A Antiinflammatory and antirheumatic products, non-steroids (NSAIDs)

QM01 Antiinflammatory and antirheumatic products

QM Musculo-skeletal system

Species

Dogs

Indications

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.

Dose to be administered and administration route

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.

Number of Tablets by Strength and Body Weight for Osteoarthritis

Body Weight (kg)	Number of Tablets by Strength
Body Weight (kg)	5 mg	10 mg	20 mg	40 mg
2.5 to < 5	1 tablet
5 to < 10		1 tablet
10 to < 20			1 tablet
20 to < 40				1 tablet
40 to 80				2 tablets

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.

Number of Tablets by Strength and Body Weight for Soft Tissue Surgery

Body Weight (kg)	Number of Tablets by Strength
Body Weight (kg)	5 mg	10 mg	20 mg	40 mg
2.5	1 tablet
> 2.5 to < 5		1 tablet
5 to < 10			1 tablet
10 to < 20				1 tablet
20 to < 40				2 tablets
40 to < 60				3 tablets
60 to 80				4 tablets

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.

Adverse reactions

Dogs:

Very common

(>1 animal / 10 animals treated):

Digestive tract disorder^{^[1]}, Diarrhoea, Vomiting

Common

(1 to 10 animals / 100 animals treated):

Elevated liver enzymes^{^[2]}

Decreased appetite

Uncommon

(1 to 10 animals / 1,000 animals treated):

Blood in the faeces

Very rare

(< 1 animal / 10,000 animals treated, including isolated reports):

Lethargy

¹Most cases were mild and recovered after treatment.

² In 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