JAMP EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
19-08-2021
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유효 성분:
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
제공처:
JAMP PHARMA CORPORATION
ATC 코드:
J05AR06
INN (국제 이름):
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:
15G/50G
처방전 유형:
Prescription
치료 영역:
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0352327001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2021-08-23
제품 특성 요약
JAMP Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Product
Monograph
Page 1
PRODUCT MONOGRAPH
Pr
JAMP EFAVIRENZ / EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE
Efavirenz / Emtricitabine /
Tenofovir Disoproxil Fumarate Tablets
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
House Standard
Antiretroviral Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville,
Québec,
J4B 5H3, Canada
Submission Control No.: 220334
Date of Preparation:
August 19, 2021
JAMP Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Product
Monograph
Page 2
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
...................................................................................................................................
25
DOSAGE AND ADMINISTRATION
..............................................................................................................
44
OVERDOSAGE
..................................................................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
............................................................................................46
STORAGE AND
STABI
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