Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Firocoxib
LIVISTO Int'l, S.L.
QM01AH90
Firocoxib
227 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
firocoxib
Authorised
2021-06-18
Health Products Regulatory Authority 18 June 2021 CRN009JDP Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ficoxil 227 mg chewable tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Firocoxib 227 mg EXCIPIENTS: Red iron oxide (E172) 0.525 mg Yellow iron oxide(E172) 0.225 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablets. Biconvex rosaceous round tablets with a double groove on one side without inscriptions. Tablets can be divided into 2 or 4 equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the relief of pain and inflammation associated with osteoarthritis in dogs. For the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs. 4.3 CONTRAINDICATIONS Do not use in pregnant or lactating bitches. Do not use in animals less than 10 weeks of age or less than 3 kg body weight. Do not use in animals suffering from gastrointestinal bleeding, blood dyscrasia or haemorrhagic disorders. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in known cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals As the tablets are flavoured, they should be stored in a safe place out of the reach of animals. The recommended dose, as indicated in the dosing table, should not be exceeded. Use in very young animals, or animals with suspected or confirmed impairment of renal, cardiac or hepatic function may involve additional risk. If such use cannot be avoided, those dogs require careful veterinary monitoring. Health Products Regulatory Authority 18 June 2021 CRN009JDP Page 2 of 5 Avoid use in any dehydrated, Citiți documentul complet