JAMP EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
19-05-2021
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유효 성분:
TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE
제공처:
JAMP PHARMA CORPORATION
ATC 코드:
J05AR03
INN (International Name):
TENOFOVIR DISOPROXIL AND EMTRICITABINE
복용량:
300MG; 200MG
약제 형태:
TABLET
구성:
TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG
관리 경로:
ORAL
패키지 단위:
15G/50G
처방전 유형:
Prescription
치료 영역:
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0251568001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2019-05-21
제품 특성 요약
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate (Emtricitabine and
Tenofovir Tablets) Page 1 of 67
PRODUCT MONOGRAPH
Pr
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Tablets
200 mg / 300 mg
(Emtricitabine / Tenofovir disoproxil fumarate)
House Standard
Antiretroviral Agent
JAMP Pharma Corporation
1310 rue Nobel,
Boucherville,
Québec
J4B 5H3, Canada
Submission Control No.: 248455
Date of Revision: May 19, 2021
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate (Emtricitabine and
Tenofovir Tablets) Page 2 of 67
TABLE OF CONTENTS
PART I.
HEALTH PROFESSIONAL INFORMATION
.............................................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................................
3
CONTRAINDICATIONS
.......................................................................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................................................................
5
ADVERSE
REACTIONS......................................................................................................................................
14
DRUG INTERACTIONS
......................................................................................................................................
22
DOSAGE AND ADMINISTRATION
.................................................................................................................
34
OVERDOSAGE
.....................................................................................................................................................
36
ACTION AND CLINICAL
PHARMACOLOGY................................................................................................
37
STORAGE
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