ATRIPLA TABLET

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Disponibbli minn:

GILEAD SCIENCES, LLC

Kodiċi ATC:

J05AR06

INN (Isem Internazzjonali):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Dożaġġ:

600MG; 200MG; 300MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

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

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2021-12-22

Karatteristiċi tal-prodott

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........