IMATINIB TARO 100 MG

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

IMATINIB AS MESYLATE

Tillgänglig från:

TARO INTERNATIONAL LTD, ISRAEL

ATC-kod:

L01XE01

Läkemedelsform:

FILM COATED TABLETS

Sammansättning:

IMATINIB AS MESYLATE 100 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

SUN PHARMACEUTICAL INDUSTRIES LTD., INDIA

Terapiområde:

IMATINIB

Terapeutiska indikationer:

Imatinib Taro is indicated for the• Treatment of adult patients and children 3 years of age and above with Ph+ chronic myeloid leukaemia (Ph+ -CML) in chronic phase, accelerated phase or blast crisis.• Treatment of adult patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). • Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.• Treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy. • Treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. • Treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.• Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements. • Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1- PDGFRα fusion kinase negative. • Treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-kit mutation.

Tillstånd datum:

2021-01-24

Bipacksedel

Page 1 of 10
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
IMATINIB TARO
100 MG
IMATINIB TARO
400 MG
Film-coated tablets
Film-coated tablets
COMPOSITION:
Each film-coated tablet contains:
Each film-coated tablet contains:
imatinib (as mesylate) 100 mg
imatinib (as mesylate) 400 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. Keep this
leaflet. This leaflet contains concise information about this
medicine. If you have any
further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Imatinib Taro is indicated for the treatment of adults and children 3
years of age and
above with Philadelphia chromosome-positive chronic myeloid leukemia
(CML) in the
chronic phase, accelerated phase or blast crisis phase.
Imatinib Taro is indicated for the treatment of adults with
Kit-positive (CD117)
metastatic malignant and/or unresectable gastrointestinal stromal
tumors (GIST).
Imatinib Taro is indicated as an adjuvant therapy in adults after
complete tumor
resection of Kit-positive (CD117) gastrointestinal stromal tumor
(GIST).
Imatinib Taro is indicated for the treatment of adults with newly
diagnosed
Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL),
in
combination with chemotherapy.
Imatinib Taro is indicated for the treatment of adults with relapsed
or refractory
Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) as
monotherapy.
Imatinib Taro is indicated for the treatment of adults with
unresectable
dermatofibrosarcoma protuberans (DFSP) and adults with recurrent
and/or
metastatic DFSP who are not eligi