捷伏滋膠囊250毫克

国家: 台湾

语言: 中文

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

资料单张 资料单张 (PIL)
06-06-2023
公众评估报告 公众评估报告 (PAR)
11-04-2020

有效成分:

TIPRANAVIR

可用日期:

台灣百靈佳殷格翰股份有限公司 台北市中山區民生東路三段2號12樓 (12469866)

ATC代码:

J05AE09

药物剂型:

軟膠囊劑

组成:

TIPRANAVIR (0818003200) MG

每包单位数:

塑膠瓶裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

WEST-WARD COLUMBUS INC. 1809, Wilson Road, Columbus, OH 43228, USA US

治疗领域:

tipranavir

疗效迹象:

Aptivus與低劑量ritonavir合用,適用於曾經接受三種主要類別的抗病毒藥物充分治療(highly treatment-experienced)失敗,或對多種蛋白酶抑制劑產生抗藥性之愛滋病毒感染的成人。

產品總結:

註銷日期: 2020/11/06; 註銷理由: 自請註銷; 有效日期: 2021/10/30; 英文品名: Aptivus Capsules 250mg

授权状态:

已註銷

授权日期:

2006-10-30

资料单张

                                Excipients
polyoxyl castor oil, ethanol 100% (w/w), mono/diglycerides
of caprylic/capric acid, propylene glycol, purified water,
trometamol, propyl gallate
Capsule shell: gelatin, ferric oxide red, propylene glycol,
purified water, sorbitol special glycerine blend A810, and
titanium dioxide
Black printing ink: SDA 35 alcohol, propylene glycol, ferric
oxide black, polyvinyl acetate phthalate, purified water,
isopropyl alcohol, macrogol/PEG 400 and ammonia
hydroxide 28%
Autoimmune disorders (such as Graves' disease,
polymyositis, and Guillain-Barré syndrome) have also
been reported to occur in the setting of immune
reconstitution; however, the time to onset is more variable,
and can occur many months after initiation of treatment.
20100906+HA request dated on 20120727
賦形劑:polyoxyl castor oil, ethanol 100% (w/w),
mono/diglycerides of caprylic/capric acid, propylene
glycol, purified water, trometamol, propyl gallate
膠囊殼: gelatin, ferric oxide red, propylene glycol,
purified water, sorbitol special glycerine blend A810,
and titanium dioxide
Black printing ink: SDA 35 alcohol, propylene glycol,
ferric oxide black, polyvinyl acetate phthalate, purified
water, isopropyl alcohol, macrogol/PEG 400 and
ammonia hydroxide 28%
曾有報告顯示,使用該藥品可能發生自體免疫異常之
狀況(例如Grave's disease, polymyositis, Guillain-Barre
syndrome) ,其發生時間不確定,可能於開始治療數個
月後。
20100906 + HA request dated on 20120727
PDE-5抑制劑:
Tadalafil:APTIVUS與低劑量ritonavir合用,同時又投與
狀態,若有臨床需要則可增加tadalafil的劑量。
tadalafil ,於APTIVUS/ritonavir的首次劑量時會導致
tadalafil濃度增加2.3倍,但在APTIVUS/ritonavir穩定濃
度狀態時則無變化。如果tadalafil在APTIVUS/ritonavir
療法的第一天就併用,則應投與最低劑量。然而經過7-
10天的給藥後,tipranavir與ritonavir皆達到穩定濃度
                                
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