Febuxostat multichem

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Febuxostat 120mg (as febuxostat hemihydrate)

Beszerezhető a:

Multichem NZ Limited

Adagolás:

120 mg

Gyógyszerészeti forma:

Film coated tablet

Összetétel:

Active: Febuxostat 120mg (as febuxostat hemihydrate) Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 85F32004 Poloxamer 407 Purified water  

Recept típusa:

Prescription

Terápiás javallatok:

Treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis).

Termék összefoglaló:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/aluminium or PVC/PCTFE/aluminium - 28 tablets - 36 months from date of manufacture stored at or below 25°C

Engedély dátuma:

2019-09-02

Termékjellemzők

NEW ZEALAND DATA SHEET
FEBUXOSTAT MULTICHEM
Page 1 of 23
1.
NAME OF THE MEDICINAL PRODUCT
Febuxostat multichem, 80 mg, film-coated tablets.
Febuxostat multichem, 120 mg, film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 80 mg tablet contains 80 mg of febuxostat (as hemihydrate).
Each 120 mg tablet contains 120 mg of febuxostat (as hemihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Febuxostat multichem are immediate release, film-coated tablets.
Febuxostat multichem, 80 mg:
Yellow, oblong biconvex film-
coated tablets, marked on one side with “80”.
Febuxostat multichem, 120 mg:
Yellow, oblong biconvex film-
coated tablets, marked on one side with “120”.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Febuxostat multichem, 80 mg:
Febuxostat multichem is indicated for the treatment of chronic
hyperuricaemia in patients with
gout (including a history, or presence of, tophus and/or gouty
arthritis).
Febuxostat multichem is indicated in adults.
Febuxostat multichem, 120 mg:
Febuxostat multichem is indicated for the treatment of chronic
hyperuricaemia in patients with
gout (including a history, or presence of, tophus and/or gouty
arthritis).
Febuxostat multichem 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 multichem is indicated in adults.
4.2
Dose and method of administration
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.
NEW ZEALAND DATA SHEET
FEBUXOSTAT MULTICHEM
Page 2 of 23
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 (357μmol/L).
Gout flare prophylaxis of at least 6 months is recommended (see
section 4.4).
T