MYLAN-EMTRICITABINE/TENOFOVIR DISOPROXIL TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Beszerezhető a:

MYLAN PHARMACEUTICALS ULC

ATC-kód:

J05AR03

INN (nemzetközi neve):

TENOFOVIR DISOPROXIL AND EMTRICITABINE

Adagolás:

300MG; 200MG

Gyógyszerészeti forma:

TABLET

Összetétel:

TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG

Az alkalmazás módja:

ORAL

db csomag:

30

Recept típusa:

Prescription

Terápiás terület:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2017-07-26

Termékjellemzők

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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