Febuxostat Tiefenbacher 120 mg Filmdragerad tablett

Држава: Шведска

Језик: Шведски

Извор: Läkemedelsverket (Medical Products Agency)

Активни састојак:

febuxostat (vattenfritt)

Доступно од:

Alfred E Tiefenbacher (GmbH & Co. KG)

АТЦ код:

M04AA03

INN (Међународно име):

Febuxostat (anhydrous)

Дозирање:

120 mg

Фармацеутски облик:

Filmdragerad tablett

Састав:

mannitol Hjälpämne; febuxostat (vattenfritt) 120 mg Aktiv substans; natriumlaurilsulfat Hjälpämne

Тип рецептора:

Receptbelagt

Резиме производа:

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)

Статус ауторизације:

Avregistrerad

Датум одобрења:

2017-07-07

Карактеристике производа

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