DASATINIB SANDOZ 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DASATINIB

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L01XE06

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DASATINIB 50 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

LEK PHARMACEUTICALS D.D., SLOVENIA

Therapeutic area:

DASATINIB

Therapeutic indications:

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.

Authorization date:

2023-05-10

Patient Information leaflet

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