Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Febuxostat
Accord Healthcare Ireland Ltd.
M04AA03
Febuxostat
120 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
febuxostat
Marketed
2019-02-08
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Febuxostat Accord 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 120 mg of febuxostat (as magnesium salts). _Excipient with known effect: _ Each tablet contains 114.70 mg lactose monohydrate. Each tablet contains 0.25 mmol (5.86 mg) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “120” on one side, 19.2 ± 0.2 mm in length, 8.2 ± 0.2 mm in width, 6.1 ± 0.2 mm in thickness. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Febuxostat Accord is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Accord is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Febuxostat Accord is indicated in adults. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Gout: The recommended oral dose of Febuxostat Accord is 80 mg once daily without regard to food. If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat Accord 120 mg once daily may be considered. Febuxostat Accord works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L). Gout flare prophylaxis of at least 6 months is recommended (see section 4.4). _ _ Tumor Lysis Syndrome: The recommended oral dose of Febuxostat Accord is 120 mg once daily without regard to food. 2 Febuxostat Accord should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however, treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment. _El Prečítajte si celý dokument
Health Products Regulatory Authority 26 January 2023 CRN00CZRX Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Febuxostat Accord 120mg Film Coated Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 120 mg of febuxostat (as magnesium salts). _Excipient with known effect:_ Each tablet contains 114.70 mg lactose monohydrate. Each tablet contains 0.25 mmol (5.86 mg) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “120” on one side, 19.2 ± 0.2 mm in length, 8.2 ± 0.2 mm in width, 6.1 ± 0.2 mm in thickness. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Febuxostat Accord is indicated for thetreatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Accord is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Febuxostat Accord is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Gout: The recommended oral dose of Febuxostat Accord is 80 mg once daily without regard to food. If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat Accord 120 mg once daily may be considered. Febuxostat Accord works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L). Gout flare prophylaxis of at least 6 months is recommended (see section 4.4). Tumour Lysis Syndrome: The recommended oral dose of febuxostat is 120 mg once daily without regard to food. Febuxostat should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however, treatment may be prolonged up to 9 days according to chemothe Prečítajte si celý dokument