HETERO IMATINIB FILM COATED TABLETS 100 MG

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

Imatinib Mesylate (Form-α) eqv Imatinib

Verfügbar ab:

HETERO SINGAPORE PTE. LTD.

ATC-Code:

L01EA01

Darreichungsform:

TABLET, FILM COATED

Zusammensetzung:

Imatinib Mesylate (Form-α) eqv Imatinib 100.00mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

Hetero Labs Limited, Unit-VI

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2021-07-22

Fachinformation

IMATINIB TABLETS
100 mg and 400 mg Film-Coated Tablets
FORMULATION
Imatinib Tablets 100 mg:
Each Film-Coated tablet contains 119.50 mg of Imatinib Mesilate
equivalent to 100 mg of Imatinib.
Imatinib Tablets 400 mg:
Each Film-Coated tablet contains 478.00 mg of Imatinib Mesilate
equivalent to 400 mg of Imatinib.
DESCRIPTION
Imatinib is a small molecule kinase inhibitor. Imatinib mesilate
film-coated tablets contain imatinib mesilate equivalent to
100 mg or 400 mg of imatinib free base. Imatinib mesilate is
designated chemically as 4-[(4-Methyl1-piperazinyl)methyl]-
N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl] amino]-phenyl]benzamide
methanesulfonate.
The structural formula is as follows:
Imatinib mesilate is a white to off-white to brownish or yellowish
tinged crystalline powder. Its molecular formula is
C H N O CH SO and its molecular weight is 589.7. Imatinib mesilate is
soluble in aqueous buffers ≤ pH 5.5 but is very
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7
4
3
slightly soluble to insoluble in neutral/alkaline aqueous buffers. In
non-aqueous solvents, the drug substance is freely
soluble to very slightly soluble in dimethyl sulfoxide, methanol and
ethanol, but is insoluble in n-octanol, acetone and
acetonitrile.
THERAPEUTIC INDICATIONS
Imatinib is indicated for the
·
treatment of adult and paediatric patients with newly diagnosed
Philadelphia chromosome positive chronic myeloid
leukaemia (Ph+ CML) (for paediatric use see section DOSAGE REGIMEN AND
ADMINISTRATION).
·
treatment of adult and paediatric patients with Ph+ CML in blast
crisis, accelerated phase, or in chronic phase after
failure of interferon-alpha therapy (for paediatric use see section
DOSAGE REGIMEN AND ADMINISTRATION).
·
treatment of paediatric 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 Kit+ (CD117) unresectable and/or
metastatic malignant gastrointestinal stromal
tum