MYLAN-EMTRICITABINE/TENOFOVIR DISOPROXIL TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

متاح من:

MYLAN PHARMACEUTICALS ULC

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:

2017-07-26

خصائص المنتج

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_Page 1 of 73_
PRODUCT MONOGRAPH
PR MYLAN-EMTRICITABINE/TENOFOVIR DISOPROXIL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS
200 MG EMTRICITABINE AND 300 MG TENOFOVIR DISOPROXIL FUMARATE PER
TABLET
ANTIRETROVIRAL AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
October 24, 2018
Submission Control No: 220516
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_Page 2 of 73_
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
.............................................................................
36
OVERDOSAGE
...............................................................................................................
38
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 38
STORAGE AND STABILITY
.........................................................................................
41
SPECIAL HANDLING INSTRUCTIONS
......................................................................
42
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 42
PART II: SCIENTIFIC INFORMATION
...............................................................................
43
PHARMACEUTICAL INFORMATION
.........................................................................
43
CLINICAL TRI