IMATINIB-AFT CAPSULES 400MG

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

Imatinib mesylate 477.88mg eqv Imatinib

Prieinama:

APEX PHARMA MARKETING PTE. LTD.

ATC kodas:

L01EA01

Vaisto forma:

CAPSULE

Sudėtis:

Imatinib mesylate 477.88mg eqv Imatinib 400 mg

Vartojimo būdas:

ORAL

Recepto tipas:

Prescription Only

Pagaminta:

Adamed Pharma S.A.

Autorizacija statusas:

ACTIVE

Leidimo data:

2016-10-25

Prekės savybės

1
IMATINIB - AFT
AFT PHARMACEUTICALS LTD.
1
DESCRIPTION AND COMPOSITION
1.1
PHARMACEUTICAL FORMS
Capsule, hard:
100 mg: Orange body and cap, capsule of size “3”
400 mg: Caramel body and capsule of size “00”
1.2
ACTIVE SUBSTANCE
Each capsule contains 100 mg or 400 mg of imatinib (as mesylate)
1.3
EXCIPIENTS
Capsule filling: crospovidone (Type A), lactose monohydrate, magnesium
stearate
Capsule shell (100 mg): gelatin, yellow iron oxide (E172), titanium
dioxide (E171), red
iron oxide (E172)
Capsule shell (400 mg): gelatin, yellow iron oxide (E172), titanium
dioxide (E171), red
iron oxide (E172), black iron oxide (E172)
Each 100 mg capsule contains 12.518 mg of lactose monohydrate.
Each 400 mg capsule contains 50.072 mg of lactose monohydrate.
2
INDICATIONS
Imatinib – AFT is indicated for:
•
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 tumours (GIST).
•
adjuvant treatment of adult patients following complete gross
resection of Kit+
GIST
The effectiveness of Imatinib – AFT is based on overall
haematological and cytogenetic
response rates and progression-free survival in CML, on haematological
and cytogenetic
response rates in relapsed or refractory adult Ph+ ALL, on objective
response rates in
unresectable and/or metastatic GIST and on recurrence free survival in
adjuvant G