斯耐瑞錠20毫克

Land: Taiwan

Taal: Chinees

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

Werkstoffen:

Bedaquiline Fumarate

Beschikbaar vanaf:

嬌生股份有限公司 台北市中山區民生東路三段2號10樓及11樓 (30814854)

ATC-code:

J04AK05

farmaceutische vorm:

錠劑

Samenstelling:

主成分 () ; Bedaquiline Fumarate (0816002310) (equivalent to Bedaquiline……...20 MG )MG

Eenheden in pakket:

塑膠瓶裝(HDPE)

klasse:

製　劑

Prescription-type:

須由醫師處方使用

Geproduceerd door:

Recipharm Pharmaservices Pvt. Ltd. 34th KM, T-Begur, Nelamangala, Tumkur Road, Bangalore Rural-562123, Karnataka, India IN

Therapeutisch gebied:

bedaquiline

therapeutische indicaties:

diarylquinoline類的抗分枝桿菌藥物，適用於作為肺部多重抗藥性結核病(MDR-TB)成人與兒童病人(5歲(含)以上，且體重至少15公斤)之複合式治療的一部分。本品a應保留至無法提供其他有效治療方案時才使用。

Product samenvatting:

有效日期: 2026/12/20; 英文品名: SIRTURO 20mg Tablets

Autorisatie datum:

2021-12-20

Bijsluiter

8
24SIRTURO
MDR-TB
(SIRTURO) (n=23)MDR-TB(
) (n=24)
21
SIRTURO23MDR-TB
8SIRTURO
8
24
38.9% (95% CI[12.3%, 63.1%]p0.004)15.7% (95% CI[-11.9%, 41.9%]p
0.32)
3
(Phase 2b)233(
)
MDR-TBSIRTUROMDR-TB
24
SIRTURO
24SIRTURO
(NTP)
120120
1
13.2 (518)
(
4
NCT02354014)5
18MDR-TBSIRTURO
(1218)
15
14
18
16
80%
53%
33%
13%
12
14
SIRTURO2
40022200
100
MDR-TB24bedaquiline
75.0% (6/8)
(512)
15
5
127
60%
60%33%7%1012
14361
14SIRTURO
22002210020
MDR-TB24bedaquiline
100.0% (3/3)
14
1. Martin A, Portaels F, Palomino JC. Colorimetric redox-indicator
methods for the rapid
detection of multidrug resistance in
Mycobacterium tuberculosis
: a systematic review and
meta-analysis. J Antimicrob Chemother. 2007; 59 (2): 175-83.
15 /
15.1
SIRTURO 20
20
SIRTURO 100100 mg
T207100
SIRTURO(HDPE)
(PP)
• 20 – 60
• 100 – 188
15.2
SIRTURO 20
30
°
C15
°
C30
°
C
SIRTURO 100
3
30
°
C
16
FDA(Medication Guide)
SIRTURO/
/
SIRTURO
(1)
(2)SIRTURO
2
3
3
7
SIRTURO
(24)
SIRTURO
SIRTURO 20
•
()
(
)
•
•
[(2.6)]
SIRTURO
bedaquilinebedaquiline
(
)
[(6)
(8.2)]
(MEDICATION GUIDE)
® SIRTURO
® TABLETS (BEDAQUILINE)
SIRTURO
SIRTURO
SIRTURO
•
(
)
SIRTURO
• QT
SIRTURO
SIRTURO
(
)
SIRTURO
Diarylquinoline5
(
)
(MDR-TB)
SIRTURO
• (TB)TB(TB)
•
•
•
• (HIV)MDR-TB
• 515(33)
Bedaquiline Agar MIC Distribution Against Baseline
Clinical Isolates from Study 1, Study 2 and Study 3
mlTT Subjects (MDR
H&R
-TB, N=203)
Bedaquiline MIC (µg/mL)
% Total
≤0.008 0.015 0.03 0.06 0.12 0.25 0.5 ≥1
45.0
40.0
35.0
30.0
25.0
20.0
15.0
10.0
5.0
0.0
Bedaquiline REMA MIC Distribution Against Baseline
Clinical Isolates from Study 1, Study 2 and Study 3
mlTT Subjects (MDR
H&R
-TB, N=200)
Bedaquiline MIC (µg/mL)
% Total
≤0.008 0.015 0.03 0.06 0.12 0.25 ≥0.5
45.0
40.0
35.0
30.0
25.0
20.0
15.0
10.0
5.0
0.0
1123mITTMDR
H&R
-TBbedaquiline
MIC()(REMA)()
1
3MICs24
6
bedaquiline MIC
613MITT24(24
)BEDAQUILINE MIC
BEDAQUILINE
MIC
(MCG/ML)
SIRTURO (BEDAQUILINE)
24
N/N (%)
7H11
7H9 BROTH(REMA)
≤0.008
2/2 (100)
21/25 (84.0)
0.015
13/15 (86.7)
33/39 (84.6)
0.03
36/46 (78.3)