ATRIPLA TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Доступна з:

GILEAD SCIENCES, LLC

Код атс:

J05AR06

ІПН (Міжнародна Ім'я):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Дозування:

600MG; 200MG; 300MG

Фармацевтична форма:

TABLET

Склад:

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

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30

Тип рецепту:

Prescription

Терапевтична области:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2021-12-22

Характеристики продукта

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........