平特羅25凍晶注射劑

Country: Թայվան

language: չինարեն

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

active_ingredient:

Bendamustine Hydrochloride Monohydrate

MAH:

凱沛爾藥品有限公司 臺北市信義區光復南路495號6樓 (82967660)

pharmaceutical_form:

凍晶注射劑

composition:

Bendamustine Hydrochloride Monohydrate (1004002500) (Equivalent. to Bendamustine hydrochloride...25mg) (corresponding to Bendamustine..22.7mg)MG

units_in_package:

玻璃小瓶裝;;盒裝

class:

製　劑

prescription_type:

限由醫師使用

manufactured_by:

HETERO LABS LIMITED SURVEY NO.410 & 411, TSIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL,MAHABOOB NAGAR DISTRICT, TELANGANA, INDIA IN

therapeutic_indication:

1.Binet分類stage B及C之慢性淋巴球白血病(chronic lymphocytic leukemia, CLL)。2.曾接受至少一種化療之和緩性非何杰金氏淋巴瘤，六個月內曾以rituximab治療失敗之單一治療。3.Bendamustine合併Rituximab適用於先前未曾接受治療的CD20陽性、第III/IV期和緩性非何杰金氏淋巴癌(non-hodgkin lymphoma, NHL)。Bendamustine合併Rituximab適用於先前未曾接受治療且不適合自體幹細胞移植的第III/IV期被套細胞淋巴癌(mantle cell lymphoma, MCL)。

leaflet_short:

有效日期: 2028/04/19; 英文品名: BENTERO 25 (Bendamustine Hydrochloride 25mg)

authorization_date:

2023-04-19