ATRIPLA TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

متاح من:

GILEAD SCIENCES, LLC

ATC رمز:

J05AR06

INN (الاسم الدولي):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

جرعة:

600MG; 200MG; 300MG

الشكل الصيدلاني:

TABLET

تركيب:

EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0352327001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2021-12-22

خصائص المنتج

PRODUCT MONOGRAPH
PR
ATRIPLA
®
(EFAVIRENZ/EMTRICITABINE/
TENOFOVIR DISOPROXIL FUMARATE) TABLETS
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
ANTIRETROVIRAL AGENT
Gilead Sciences, LLC.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
www.gilead.ca
Submission Control No.: 235076_ _
Date of Revision:
February 12, 2020
ATRIPLA
®
(efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets
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 STABILITY
....................................................................................................................
50
SPECIAL HANDLING
INSTRUCTIONS........