Glivec 400mg Tab 400 mg

Country: Jordan

Bahasa: Inggeris

Sumber: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Bahan aktif:

Imatinib 400 mg

Boleh didapati daripada:

شركة مستودع الأدوية الأردني - The Jordan Drugstore Co

Kod ATC:

L01XE01

INN (Nama Antarabangsa):

Imatinib 400 mg

Dos:

400 mg

Unit dalam pakej:

30

Dikeluarkan oleh:

NOVARTIS PHARMA STEIN AG /SWI (سويسرا)

Risalah maklumat

GLIVEC
®
1. NAME OF THE MEDICINAL PRODUCT
Glivec 100 mg film-coated tablets
Glivec 400 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Glivec 100 mg film-coated tablets
Each film-coated tablet contains 100 mg imatinib (as mesilate).
Glivec 400 mg film-coated tablets
Each film-coated tablet contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Glivec 100 mg film-coated tablets
Very dark yellow to brownish-orange film-coated tablet, round,
biconvex with bevelled edges, with “NVR” on one side and “SA”
and
score on the other side.
Glivec 400 mg film-coated tablets
Very dark yellow to brownish-orange, ovaloid, biconvex film-coated
tablet with bevelled edges, debossed with “NVR” on one side and
“SL” on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glivec is indicated for the treatment of
•
adult and paediatric patients with newly diagnosed Philadelphia
chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML)
for whom bone marrow transplantation is not considered as the first
line of treatment.
•
adult and paediatric patients with Ph+ CML in chronic phase after
failure of interferon-alpha therapy, or in accelerated phase or blast
crisis.
•
adult and paediatric patients with newly diagnosed Philadelphia
chromosome positive acute lymphoblastic leukaemia (Ph+ ALL)
integrated with chemotherapy.
•
adult patients with relapsed or refractory Ph+ ALL as monotherapy.
•
adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD) associated with platelet-derived growth factor receptor
(PDGFR) gene re-arrangements.
•
adult patients with advanced hypereosinophilic syndrome (HES) and/or
chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR
a
rearrangement.
The effect of Glivec on the outcome of bone marrow transplantation has
not been determined.
Glivec is indicated for
•
the treatment of adult patients with Kit (CD 117) positive
unresectable and/or metastatic