Quốc gia: Thụy Điển
Ngôn ngữ: Tiếng Thụy Điển
Nguồn: Läkemedelsverket (Medical Products Agency)
febuxostat (vattenfritt)
Alfred E Tiefenbacher (GmbH & Co. KG)
M04AA03
Febuxostat (anhydrous)
120 mg
Filmdragerad tablett
mannitol Hjälpämne; febuxostat (vattenfritt) 120 mg Aktiv substans; natriumlaurilsulfat Hjälpämne
Receptbelagt
Förpacknings: Blister, 14 tabletter (Al); Blister, 28 tabletter (Al); Blister, 42 tabletter (Al); Blister, 56 tabletter (Al); Blister, 84 tabletter (Al); Blister, 98 tabletter (Al); Blister, 14 tabletter (plast/Al); Blister, 28 tabletter (plast/Al); Blister, 42 tabletter (plast/Al); Blister, 56 tabletter (plast/Al); Blister, 84 tabletter (plast/Al); Blister, 98 tabletter (plast/Al)
Avregistrerad
2017-07-07
V01 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Febuxostat Tiefenbacher 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 120 mg of febuxostat. 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 of 19.0 x 7.6 mm, plain on both sides and engraved with “F120” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Febuxostat Tiefenbacher 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 Tiefenbacher 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 Tiefenbacher is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Gout:_ The recommended oral dose of febuxostat 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 120 mg once daily may be considered. Febuxostat 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 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 chemotherapy duration as per clinical judgment. _Elderly_ No dose adjustment is required in the elderly (see section 5.2). V01 2 _Renal _ impairment The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine Đọc toàn bộ tài liệu