莫帕滋膜衣錠30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)
06-03-2022
公众评估报告 公众评估报告 (PAR)
06-03-2022

有效成分:

Cabotegravir sodium

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:

膜衣錠

组成:

Cabotegravir sodium (0818007200) Cabotegravir sodium, micronized (equivalent to 30.00 mg of Cabotegravir)MG

每包单位数:

塑膠瓶裝(HDPE)

类:

製 劑

处方类型:

須由醫師處方使用

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錠劑併用,短期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人類免疫不全病毒(HIV)-1感染症,治療的目的為:1.在投予長效型(LA) cabotegravir注射劑之前先進行口服導入治療,藉以評估對cabotegravir的耐受性。2.為錯過計劃注射cabotegravir注射劑時間的成人進行口服治療。

產品總結:

有效日期: 2026/12/24; 英文品名: Vocabria 30 mg film-coated tablets

授权日期:

2021-12-24

资料单张

                                30
VOCABRIA 30 MG FI LM-COATED TABLETS
L60000000127610_v01
028219
1.
30
Vocabria 30 mg fi lm-coated tablets
2.
(cabotegravir sodium)
30cabotegravir
155()
6.1
3.
()
(8.0 14.3)SV CTV
Cabotegravir sodiumsodium
(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
16
F
2
N
3
NaO
5
427.33 g/mol
4.
4.1
rilpivirine(
)
(HIV-1 RNA
<50 copies/mL)cabotegravir
rilpivirine
(HIV)-1
• (LA) cabotegravir cabotegravir
• cabotegravir
4.2
HIVVocabria
VocabriarilpivirineHIVrilpivirine
BVOCABRIA (4.4)
VOCABRIA
(4.4)
cabotegravirVocabriarilpivirine1
(
28
)cabotegravir
rilpivirine(
4.4
)
Vocabria 30rilpivirine 25rilpivirinecabotegravir
1
1
Vocabria
30
Rilpivirine
25
cabotegravir
7
(
Vocabria
30rilpivirine 25)2
12
2
cabotegravir
rilpivirine
1(+/-
7
)2
cabotegravir
rilpivirine
2(+/- 7
)
Vocabria12
12
Vocabria4
Vocabria
Vocabria4
Vocabria
65
(
)cabotegravir
(5.2)
(CrCl<30/
)
(5.2
)cabotegravir
cabotegravir99%
cabotegravircabotegravir
(Child-PughA
B
)
(Child-PughC
)cabotegravir(
5.2
)
Vocabria18
rilpivirine
Vocabria
4.3
6.1
RIFAMPICIN
RIFAPENTINE
CARBAMAZEPINE
OXCARBAZEPINE
PHENYTOIN
PHENOBARBITAL
(4.5)
4.4
2
RILPIVIRINEHIV-1A6/
A1BMI
30 KG/M
2
BMI30 KG/M
2
HIV-1 A6/A1(5.1)
VOCABRIA
(
)
VOCABRIA (4.2)
VOCABRIA
(4.8)
VOCABRIA(
VOCABRIA
)
HBV/HCV
VOCABRIAB
B
VOCABRIAB
HIV
C
C
VOCABRIA(4.5)
VOCABRIA2
4
(
4.5)
HIV
HIV(CART)
CART
/
(
GRAVES)
VOCABRIAHIV
HIV
HIV
-
1 (23)
4.5
VOCABRIARILPIVIRINE
HIV-1RILPIVIRINE
CABOTEGRAVIR
CABOTEGRAVIR(UGT) 1A1
UGT1A9UGT1A1
UGT1A9
CABOTEGRAVIR(
4.35)UGT1A1
(
UGT1A1)
CABOTEGRAVIR
AUC C
MAX
C
TAU
1.5UGT1A1CABOTEGRAVIR
UGT1A1
(ATAZANAVIRERLOTINIB
SORAFENIB)VOCABRIA
CABOTEGRAVIR
P(P-GP)(BCRP)
P-GPBCRP
CABOTEGRAVIR
CABOTEGRAVIRMIDAZOLAM (P450 (CYP) 3A4
)
CABOTEGRAVIRCYP1A2
CYP2B6
CYP3A4
CABOTEGRAVIR
(OAT) 1 (IC
50
=0.81 ΜM)OAT3
(IC
50
=0.41 ΜM)OAT1/3(
METHOTREXATE)
CABOTEGRAVIR
IBALIZUMAB
2CABOTEGRAVIR(
↑
↓
↔
AUCC
MAX
C
Τ
)
2
(%)
HIV-1
ETRAVIRINE
CABOTEGRAVIR ↔
AUC ↑ 1%
C
MAX ↑ 4%
CΤ ↔ 0%
E
                                
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