Země: Tchaj-wan
Jazyk: čínština
Zdroj: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
IMATINIB MESYLATE
台灣諾華股份有限公司 台北市中山區民生東路三段2號8樓 (01516589)
L01EA01
膠囊劑
IMATINIB MESYLATE (1013000710) MG
盒裝
製 劑
須由醫師處方使用
NOVARTIS PHARMA AG CH-4056 BASEL SWITZERLAND CH
imatinib
治療正值急性轉化期(BLAST CRISIS)、加速期或經ALPHA-干擾素治療無效之慢性期的慢性骨髓性白血病(CML)患者,治療成年人無法手術切除或轉移的惡性胃腸道基質瘤。用於治療初診斷為慢性骨髓性白血病(CML)的病人。治療初診斷為費城染色體陽性急性淋巴性白血病(Ph+ ALL)且併用化療之成年及兒童患者。做為治療成人復發性或難治性費城染色體陽性急性淋巴性白血病(Ph+ ALL)之單一療法。治療患有與血小板衍生生長因子受體(PDGFR)基因重組相關之骨髓發育不全症候群(MDS)/骨髓增生性疾病(MPD)之成人患者。治療患有系統性肥大細胞增生症(SM),限具FIP1L1-PDGFR基因變異且不具有c-Kit基因D816V突變之成人患者。治療嗜伊紅性白血球增加症候群(HES)與或慢性嗜伊紅性白血病(CEL)且有血小板衍生生長因子受體(PDGFR)基因重組之成人患者。作為成人KIT(CD 117)陽性胃腸道基質瘤完全切除(complete gross resection)後之術後輔助治療。治療患有無法手術切除、復發性或轉移性且有血小板衍生生長因子受體(PDGFR)基因重組之隆突性皮膚纖維肉瘤(DFSP)之成人患者。
註銷日期: 2021/05/07; 註銷理由: 自請註銷; 有效日期: 2021/10/03; 英文品名: GLIVEC CAPSULES 100MG
已註銷
2001-10-03
GLIVEC 100 MG HARD CAPSULES DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) 100 MG CAPSULES White to yellow powder in an orange to greyish-orange opaque capsule, marked “NVR SI”. ACTIVE SUBSTANCE(S) HARD CAPSULES Each capsule contains 50 or 100 mg imatinib (as mesylate beta crystals). EXCIPIENTS 100 MG CAPSULES Capsule content: Cellulose microcrystalline; Crospovidone; Magnesium stearate; Silica colloidal, anhydrous. Capsule shell: Gelatin; Iron oxide, red (E 172); Iron oxide, yellow (E 172); Titanium dioxide (E 171). Printing ink: Shellac E904 、 Red iron oxide E172 、 Propylene Glycol 、 Strong Ammonia Solution 、 Potassium hydroxide 、 Isopropyl alcohol 、 Dehydrated alcohol 、 Butyl alcohol 、 Purified water. Information might differ in some countries. INDICATIONS Glivec ® is indicated for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) (for pediatric use see section 4 Dosage and administration), treatment of adult and pediatric patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for pediatric use see section 4 Dosage and administration), treatment of adult and pediatric 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 myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, treatment of adult patients with systemic mastocytosis (SM) without the D816V c-Kit mutation or with c-Kit mutational status unknown, treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL), treatment of adult patients with Kit+ (CD117) unresectable and/or metastatic malignant gastrointestinal stromal tumors Přečtěte si celý dokument