Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Febuxostat hemihydrate 120mg
Douglas Pharmaceuticals Limited
120 mg
Film coated tablet
Active: Febuxostat hemihydrate 120mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 85F42129 Purified water
Prescription
Treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). DP-Febuxostat is indicated in adults. 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).
Package - Contents - Shelf Life: Blister pack, PVC/ACLAR/aluminium in outer carton - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/aluminium in outer carton - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/aluminium in outer carton - 84 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/aluminium in outer carton - 90 tablets - 24 months from date of manufacture stored at or below 25°C
2021-01-11
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME DP-Febuxostat, film coated tablet, 80 mg DP-Febuxostat, film coated tablet, 120 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 80 mg of febuxostat (as hemihydrate). Each film coated tablet contains 120 mg of febuxostat (as hemihydrate). EXCIPIENT(S) WITH KNOWN EFFECT DP-Febuxostat contains lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DP-Febuxostat 80 mg tablets are pale yellow to yellow coloured, capsule shaped biconvex, film coated tablets, debossed with ‘80’ on one side and plain on other side. The size is 17 mm x 6 mm. DP-Febuxostat 120 mg tablets are pale yellow to yellow coloured, capsule shaped biconvex, film coated tablets, debossed with ‘120’ on one side and plain on other side. The size is 19 mm x 8 mm. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS DP-FEBUXOSTAT 80 MG DP-Febuxostat is indicated for the treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). DP-Febuxostat is indicated in adults. DP-FEBUXOSTAT 120 MG DP-Febuxostat is indicated for the treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). DP-Febuxostat is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor 2 | P a g e Lysis Syndrome (TLS). DP-Febuxostat is indicated in adults. 4.2. DOSE AND METHOD OF ADMINISTRATION DOSE _GOUT _ The recommended oral dose of DP-Febuxostat is 80 mg once daily with or without food. If serum uric acid is > 6 mg/dl (357 micromole/L) after 2-4 weeks, DP-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 (357micromole/L). Gout flare prophylaxis of at l Lees het volledige document