TRUVADA TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

متاح من:

GILEAD SCIENCES CANADA INC

ATC رمز:

J05AR03

INN (الاسم الدولي):

TENOFOVIR DISOPROXIL AND EMTRICITABINE

جرعة:

300MG; 200MG

الشكل الصيدلاني:

TABLET

تركيب:

TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0251568001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2006-01-06

خصائص المنتج

_ _
PRODUCT MONOGRAPH
PR
TRUVADA
®
(EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE) TABLETS
(200 MG/300 MG)
ANTIRETROVIRAL AGENT
Gilead Sciences, Inc.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga L5N 2W3
Canada
www.gilead.ca
Submission Control No.: 215258
Date of Revision: July 5, 2018
TRUVADA (emtricitabine/tenofovir disoproxil fumarate) tablets
Product Monograph
FINAL
Page 2
TABLE OF CONTENTS
PART I.
HEALTH PROFESSIONAL INFORMATION
...............................................................................
3
SUMMARY PRODUCT INFORMATION
..................................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................................
3
CONTRAINDICATIONS
.............................................................................................................................
5
WARNINGS AND PRECAUTIONS
............................................................................................................
6
ADVERSE REACTIONS
............................................................................................................................
15
DRUG INTERACTIONS
............................................................................................................................
24
DOSAGE AND ADMINISTRATION
........................................................................................................
36
OVERDOSAGE
..........................................................................................................................................
38
ACTION AND CLINICAL PHARMACOLOGY
......................................................................................
39
STORAGE AND STABILITY
....................................................................................................................
41
SPECIAL HANDLING INSTRUCTIONS
.......................................................................................