Deferiprone DOC 500 mg Filmdragerad tablett

Country: Շվեդիա

language: շվեդերեն

source: Läkemedelsverket (Medical Products Agency)

active_ingredient:

deferipron

MAH:

DOC Generici Srl

ATC_code:

V03AC02

INN:

deferiprone

dosage:

500 mg

pharmaceutical_form:

Filmdragerad tablett

composition:

deferipron 500 mg Aktiv substans

prescription_type:

Receptbelagt

leaflet_short:

Förpacknings: Blister, 100 tabletter

authorization_status:

Godkänd

authorization_date:

2018-02-05

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Deferiprone DOC 500 mg film-coated tablets.
Deferiprone DOC 1000 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Deferiprone DOC 500 mg film-coated tablets
Each tablet contains 500 mg deferiprone.
Deferiprone DOC 1000 mg film-coated tablets
Each tablet contains 1000 mg deferiprone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Deferiprone DOC 500 mg film-coated tablets
White to off-white film coated tablets, debossed with ‘DL 500’
with a score line on one side and plain on the
other and with dimensions of 14.2 mm x 8.2 mm. The tablet can be
divided into equal halves.
Deferiprone DOC 1000 mg film-coated tablets
White to off-white film coated tablets, debossed with ‘DH 1000’
with a score line on one side and plain on
the other and with dimensions of 19.2 mm x 9.2 mm. The tablet can be
divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deferiprone DOC monotherapy is indicated for the treatment of iron
overload in patients with thalassaemia
major when current chelation therapy is contraindicated or inadequate.
Deferiprone DOC in combination with another chelator (see section 4.4)
is indicated in patients with
thalassaemia major when monotherapy with any iron chelator is
ineffective, or when prevention or treatment
of life-threatening consequences of iron overload (mainly cardiac
overload) justifies rapid or intensive
correction (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Deferiprone therapy should be initiated and maintained by a physician
experienced in the treatment of
patients with thalassaemia.
Posology
Deferiprone is usually given as 25 mg/kg body weight, orally, three
times a day for a total daily dose of 75
mg/kg body weight. Dose per kilogram body weight should be calculated
to the nearest half tablet. See tables
below for recommended doses for body weights at 10 kg increments.
To obtain a dose of about 75 mg/kg/day, use