国: シンガポール
言語: 英語
ソース: HSA (Health Sciences Authority)
Imatinib mesylate 119.470mg eqv Imatinib
APEX PHARMA MARKETING PTE. LTD.
L01EA01
CAPSULE
Imatinib mesylate 119.470mg eqv Imatinib 100 mg
ORAL
Prescription Only
Adamed Pharma S.A.
ACTIVE
2016-10-25
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 完全なドキュメントを読む