維提歐膜衣錠100毫克

Страна: Тайвань

мова: китайська

Джерело: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Активний інгредієнт:

IMATINIB MESYLATE

Доступна з:

瑞士商愛爾康大藥廠股份有限公司台灣分公司 台北市中正區仁愛路二段99號11樓 (20916488)

Код атс:

L01EA01

Фармацевтична форма:

膜衣錠

Склад:

IMATINIB MESYLATE (1013000710) (eq. to Imatinib 100mg)MG

Одиниць в упаковці:

鋁箔盒裝

Клас:

製　劑

Тип рецепту:

須由醫師處方使用

Виробник:

NOVARTIS PHARMA PRODUKTIONS GMBH OEFLINGERSTRASSE 44, 79664 WEHR, GERMANY DE

Терапевтична области:

imatinib

Терапевтичні свідчення:

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FIPILI-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後（complete gross resection）之術後輔助治療。‧治療無法手術切除、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。

Огляд продуктів:

註銷日期: 2021/02/19; 註銷理由: 自請註銷; 有效日期: 2024/08/25; 英文品名: Vativio film-coated tablets 100mg

Статус Авторизація:

已註銷

Дата Авторизація:

2014-08-25

інформаційний буклет

VATIVIO
 100 MG FILM-COATED TABLETS
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Film-coated tablets
100 MG TABLETS, DIVISIBLE
Very dark yellow to brownish orange film-coated tablets, round with
imprint “NVR” on one side and “SA” and score on the other
side.
ACTIVE SUBSTANCE(S)
FILM-COATED TABLETS
Each tablet contains 100 mg imatinib (as mesylate beta crystals).
EXCIPIENTS
100 MG (DIVISIBLE) FILM-COATED TABLETS
Tablet content: Cellulose microcrystalline, Crospovidone,
Hypromellose,
Magnesium
stearate, Silica colloidal anhydrous.
Coating content: Hypromellose, Macrogol, Talc, Iron oxide, red (E
172),
Iron oxide, yellow (E 172).
INDICATIONS
Imatinib
®
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 (GIST).

adjuvant treatment of adult patients following resection of Kit+
GIST,

treatment of adult patients with unresectable