DASATINIB SANDOZ 140 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

DASATINIB

Commercializzato da:

NOVARTIS ISRAEL LTD

Codice ATC:

L01XE06

Forma farmaceutica:

FILM COATED TABLETS

Composizione:

DASATINIB 140 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

LEK PHARMACEUTICALS D.D., SLOVENIA

Area terapeutica:

DASATINIB

Indicazioni terapeutiche:

Treatment of adult patients with : Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. Chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

Data dell'autorizzazione:

2023-05-10

Foglio illustrativo

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( - 1986
This medicine is dispensed with a doctor’s prescription only
Dasatinib Sandoz
®
20 mg
Film-coated tablets
Dasatinib Sandoz
®
50 mg
Film-coated tablets
Dasatinib Sandoz
®
70 mg
Film-coated tablets
COMPOSITION:
Each tablet contains:
dasatinib 20 mg
COMPOSITION:
Each tablet contains:
dasatinib 50 mg
COMPOSITION:
Each tablet contains:
dasatinib 70 mg
Dasatinib Sandoz
®
100 mg
Film-coated tablets
Dasatinib Sandoz
®
140 mg
Film-coated tablets
COMPOSITION:
Each tablet contains:
dasatinib 100 mg
COMPOSITION:
Each tablet contains:
dasatinib 140 mg
Inactive ingredients and allergens: see section 2 under ‘Important
information about some
of this medicine’s ingredients’, and section 6 ‘Additional
information’.
Read the entire leaflet carefully before you start using this
medicine.
This
leaflet
contains
concise
information
about
this
medicine.
If
you
have
any
further
questions,
consult
your
doctor
or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
Dasatinib Sandoz is not intended for use in children and adolescents
under the age of 18.
There is limited experience with the use of dasatinib in this age
group.
1. What is this medicine intended for?
Dasatinib Sandoz is a medicine intended for treatment of adult
patients with:
Newly diagnosed Philadelphia chromosome positive chronic myelogenous
leukaemia
)CML( in the chronic phase.
Chronic, accelerated or blast phase CML with resistance or intolerance
to prior therapy
including imatinib mesilate.
Philadelphia chromosome positive acute lymphoblastic leukaemia )ALL(
and lymphoid
blast CML with resistance or intolerance to prior therapy.
THERAPEUTIC GROUP: Protein kinase inhibitors.
2. Before using this medicine
Do not use this medicine if:
you are sensitive )allergic( to the active ingredient )dasatinib( or
to any of the other
ingredients in this med