"康普萊"膜衣錠

国: 台湾

言語: 中国語

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

有効成分:

EMTRICITABINE;;RILPIVIRINE HYDROCHLORIDE;;TENOFOVIR DISOPROXIL FUMARATE

から入手可能:

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コード:

J05AR19

医薬品形態:

膜衣錠

構図:

主成分 () ; TENOFOVIR DISOPROXIL FUMARATE (0818003510) eq to 245mg tenofovir disoproxilMG; EMTRICITABINE (0818003700) MG; RILPIVIRINE HYDROCHLORIDE (0818004310) eq to 25mg rilpivirineMG

パッケージ内のユニット:

塑膠瓶裝(HDPE)

クラス:

製　劑

処方タイプ:

須由醫師處方使用

製:

JANSSEN-CILAG SPA VIA C. JANSSEN, B.GO SAN MICHELE, 04100 LATINA, ITALY IT

治療領域:

emtricitabine, tenofovir alafenamide and rilpivirine

適応症:

COMPLERA®（emtricitabine/rilpivirine/tenofovir disoproxil fumarate）是由兩種核苷類似物反轉錄酶抑制劑（NRTIs）（emtricitabine/tenofovir DF）及一種非核苷反轉錄酶抑制劑（NNRTI） （rilpivirine）組成之複方療法，適用於先前未曾使用過抗病毒藥物治療之愛滋病毒（HIV-1）感染之完整治療，且在治療開始時其病毒量HIV-1 RNA≤100,000 copies/mL之12歲（含）以上且體重至少35公斤的患者；適用於特定正穩定接受抗反轉錄病毒療法，且治療開始時已達病毒學抑制狀態（HIV-1 RNA <50 copies/mL）的患者，取代其現有的抗反轉錄病毒療法。對COMPLERA®三個成分（emtricitabine/rilpivirine/tenofovir disoproxil fumarate)的任一成分，患者過去或現在應無抗藥性病史才適用。

製品概要:

有效日期: 2025/10/20; 英文品名: Complera Film-coated Tablets

承認日:

2015-10-20

情報リーフレット

®
COMPLERA
®
Film-coated Tablets
emtricitabine/rilpivirine/tenofovir
disoproxil fumarate
026602
1
B
HBV
HIV-1EMTRICITABINE (FTC)
/
TENOFOVIR DISOPROXIL FUMARATE (TDF) [COMPLERA
®
]
B(HBV)
HBV
HIV-1COMPLERA
®
B
[(5.1)]
1
COMPLERA
®
(emtricitabine/rilpivirine/tenofovir disoproxil fumarate)
(NRTIs) (emtricitabine/tenofovir DF)
2
(NNRTI) (rilpivirine)
(HIV-1)
HIV-1 RNA≤100,000 copies/mL
12
(
)35
(HIV-1 RNA<50
copies/mL)(
)
COMPLERA
®
(emtricitabine/rilpivirine/tenofovir disoproxil
fumarate)
●
HIV-1 RNA>100,000 copies/mLrilpivirine
(HIV-1 RNA≥50 copies/mL)
HIV-1
RNA≤100,000 copies/mL
(14)
3
2
2.1 COMPLERA
®
COMPLERA
®
B
(5.1)
COMPLERA
®
COMPLERA
®
(5.5)
2.2
COMPLERA
®
200
emtricitabine (FTC)
25
rilpivirine (RPV)
300
tenofovir
disoproxil fumarate (TDF)12()35
4
COMPLERA
®
(8.4)(12.3)
2.3
COMPLERA
®
(HIV-1 RNA
< 50 copies/mL)COMPLERA
®
rilpivirine (COMPLERA
®
)
(8.1)
(12.3)
2.4
COMPLERA
®
(
50/
)
(5.5)
(8.6)
5
2.5 RIFABUTIN
COMPLERA
®
rifabutinrifabutin
25rilpivirine (EDURANT
®
)
COMPLERA
®
(7.6)(12.3)
3
COMPLERA
®
200emtricitabine (FTC)
27.5
rilpivirine hydrochloride (25rilpivirine [RPV])
300
tenofovir disoproxil fumarate (TDF245tenofovir
disoproxil)
GSI
6
4
COMPLERA
®
COMPLERA
®
NNRTIs
(5.7)(7)
(12.3)
• carbamazepine
oxcarbazepine
phenobarbital
phenytoin
• rifampinrifapentine
• ()dexamethasone ()
• (
Hypericum perforatum
)
• dexlansoprazole
esomeprazole
lansoprazole
omeprazolepantoprazolerabeprazole
7
5
5.1 HIV-1HBVB
HIV-1
B
(2.1)
HBV
HIV-1FTC
/
TDF (COMPLERA
®
)
B
(
)
HBV
HIV-1COMPLERA
®
B
8
5.2
RPV
(Drug Reaction with Eosinophilia and Systemic Symptoms,
DRESS)
1%RPV+FTC/TDF
2
(Grade 2)
1
2
(Grade1 or 2)
(6.16.2)
COMPLERA
®