莫帕滋長效注射劑

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)
06-03-2022
公众评估报告 公众评估报告 (PAR)
06-03-2022

有效成分:

Cabotegravir

可用日期:

荷商葛蘭素史克藥廠股份有限公司台灣分公司 台北市中正區忠孝西路一段66號23-24樓 (86927438)

ATC代码:

J05AJ04

药物剂型:

注射用懸液劑

组成:

Cabotegravir (0818007100) MG

每包单位数:

玻璃小瓶裝;;玻璃小瓶裝;;盒裝

类:

製 劑

处方类型:

限由醫師使用

厂商:

VIIV HEALTHCARE B.V. VAN ASCH VAN WIJCKSTRAAT 55H, 3811 LP AMERSFOORT, NETHERLANDS NL

治疗领域:

cabotegravir

疗效迹象:

與rilpivirine注射劑併用,治療已達病毒學抑制效果(HIV-1 RNA <50 copies/mL)且對cabotegravir及rilpivirine不具已知或疑似抗藥性之成人的HIV-1感染症。

產品總結:

有效日期: 2026/12/24; 英文品名: Vocabria prolonged-release suspension for injection

授权日期:

2021-12-24

资料单张

                                VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION
L60000000127610_v01
028218
1.
Vocabria prolonged-release suspension for injection
2.
400
400cabotegravir (2
)
600
600cabotegravir (3
)
6.1
3.
Cabotegravir
(3S,11aR)-N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-
dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide.
C
19
H
17
F
2
N
3
O
5
405.35 g/mol
4.
4.1
rilpivirine(HIV-1 RNA <50 copies/mL)
cabotegravir
rilpivirine
HIV-1
4.2
HIVVocabria
VocabriarilpivirineHIV-1
rilpivirine
BVOCABRIA (4.4)
VOCABRIA
VOCABRIA
RILPIVIRINEVOCABRIA1
2
VOCABRIA2
(4.4)
Vocabriacabotegravirrilpivirine
1
(
28
)cabotegravir
rilpivirine(
4.4
)
cabotegravir 30rilpivirine 25rilpivirine
cabotegravir
(cabotegravir
)
(600 3)
Vocabria
600Vocabria
rilpivirine
(4002)
Vocabria400
Vocabriarilpivirine
4007
1
1(28)2
3
Vocabria
30
600
400
Rilpivirine
25
900
600
2
–1(600)
Vocabria
600(2)
(2)Vocabria 600
7600
Vocabriarilpivirine
–2(600)
Vocabria2
600
(
5)
Vocabriarilpivirine
26007
2 2
(1)
(2)
1(28)235
Vocabria
30
600
600
Rilpivirine
25
900
900
2
2
4001
600cabotegravir
2600
2
2
6002
400cabotegravir
400
3
7
(
30
cabotegravir25rilpivirine)
2
2
Vocabria
rilpivirine
1(+/- 7
)
3
3 VOCABRIA
≤2
400
>2
600400
2
Vocabria
7
(
30cabotegravir25rilpivirine)
1
2
2
cabotegravir
rilpivirine
2(+/- 7
)
4
4 2
(3)
2
(3)
≤2
600
2
>2
600
600
2
3
(5)
≤3
600
2
>3
600
600
2
65
(
)cabotegravir
(5.2)
(CrCl<30/
)
(
5.2
)
cabotegravircabotegravir99%
cabotegravir
cabotegravir
(Child-PughA
B
)
(Child-PughC
)cabotegravir(
5.2
)
Vocabria18
Vocabria
Vo c a b r i a r i l p i v i r i n e
rilpivirine
Vocabria
(BMI)
10
(ventrogluteal) (
)(dorsogluteal)
4.3
6.1
RIFAMPICIN
R I F A P E N T I N E
CARBAMAZEPINE
OXCARBAZEPINE
PHENYTOIN
PHENOBARBITAL(4.5)
4.4
VOCABRIA1
2
VOCABRIA2
VOCABRIA
CABOTEGRAVIR(
12)
VOCABRIA
(
4.5
4.64.74.9)
2
RILPIVIRINE
HIV-1
A6/A1BMI
30 KG/M
2
BMI30 KG/M
2
HIV-1 A6/A1(5.1)
VOCABRIA
(
)
VOCABRIA (
4.2
VOCABRIA)
VOCABRIA
(4.8)
VOCABRIA(
VOCABRIA)
HBV/HCV
VOCABRIAB
B
VOCABRIA
B
HIV
C
C
VOCABRIA(4.5)
VOCABRIARIFABUTIN(4.5)
HI
                                
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