MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
27-07-2020
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유효 성분:
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
제공처:
MYLAN PHARMACEUTICALS ULC
ATC 코드:
J05AR06
INN (International Name):
EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ
복용량:
600MG; 200MG; 300MG
약제 형태:
TABLET
구성:
EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG
관리 경로:
ORAL
패키지 단위:
30
처방전 유형:
Prescription
치료 영역:
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0352327001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2017-07-26
제품 특성 요약
PAGE 1 OF 75
PRODUCT MONOGRAPH
PR MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLETS
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
MYLAN STD.
ANTIRETROVIRAL AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: July 27, 2020
Submission Control No: 241548
PAGE 2 OF 75
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................................
3
SUMMARY
PRODUCT
INFORMATION
..............................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
....................................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................................
3
WARNINGS
AND
PRECAUTIONS
.......................................................................................................................
5
ADVERSE
REACTIONS
.......................................................................................................................................
15
DRUG
INTERACTIONS
.......................................................................................................................................
24
DOSAGE
AND
ADMINISTRATION....................................................................................................................
40
OVERDOSAGE
.....................................................................................................................................................
41
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
42
STORAGE
AND
STABILITY
.......................................................................................................................
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