Robexera Chewable Tablets for Dogs, POM-V

Product Description

Robexera Chewable Tablets For Dogs

Dosage and administration

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.

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

Adverse events

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Pregnancy and lactation: Do not use during pregnancy and lactation. Fertility: Do not use in breeding animals

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