ATRIPLA TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Saadav alates:

GILEAD SCIENCES, LLC

ATC kood:

J05AR06

INN (Rahvusvaheline Nimetus):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Annus:

600MG; 200MG; 300MG

Ravimvorm:

TABLET

Koostis:

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

Manustamisviis:

ORAL

Ühikuid pakis:

30

Retsepti tüüp:

Prescription

Terapeutiline ala:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2021-12-22

Toote omadused

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........