Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Robenacoxib
Krka, d.d., Novo mesto
QM01AH91
Robenacoxib
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
robenacoxib
2023-08-21
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Robexera 20 mg chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCE: Robenacoxib 20 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _ Cellulose, microcrystalline _ _ Povidone _ _ Crospovidone _ _ Yeast powder _ _ Meat flavour Silica, colloidal anhydrous Magnesium stearate Light brown, round, biconvex tablets with lighter and darker dots and marked with T3 on one side of the tablet. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the treatment of pain and inflammation associated with chronic osteoarthritis. For the treatment of pain and inflammation associated with soft tissue surgery. 3.3 CONTRAINDICATIONS Do not use in dogs suffering from gastrointestinal ulceration or with hepatic disease. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant and lactating animals (see section 3.7). 3.4 SPECIAL WARNINGS In clinical studies in dogs with osteoarthritis, inadequate response to treatment was seen in 10-15% of the dogs. 2 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 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 clinical signs such as anorexia, apathy or vomiting in combination with elevated liver enzymes. Use in dogs with impaired cardiac or renal function or dogs that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot Прочетете целия документ