Robexera
Active substance
ATC code
Species
Dogs.
Indications
For the treatment of pain and inflammation associated with chronic osteoarthritis.
For the treatment of pain and inflammation associated with soft tissue surgery.
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. 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 |
|||
|
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 robenacoxib 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 |
|||
|
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 |
|||
Adverse reactions
Dogs:
|
Very common (>1 animal / 10 animals treated): |
Gastrointestinal adverse events.1 Vomiting, loose stool.1 |
|
Common (1 to 10 animals / 100 animals treated): |
Decreased appetite.1 Diarrhoea.1 Elevated liver enzymes.2 |
|
Uncommon (1 to 10 animals / 1,000 animals treated): |
Blood in faeces1, vomiting3. Anorexia, apathy.3 |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Lethargy. |
1 Most cases were mild and recovered without treatment.
2 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 there were no clinical signs and the liver enzyme activities either stabilised or decreased with continued treatment.
3 Clinical signs associated with increases in liver enzyme activities.
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 “Contact details” of the package leaflet for contact details.
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