ATRIPLA TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Доступна с:

GILEAD SCIENCES, LLC

код АТС:

J05AR06

ИНН (Международная Имя):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

дозировка:

600MG; 200MG; 300MG

Фармацевтическая форма:

TABLET

состав:

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

Администрация маршрут:

ORAL

Штук в упаковке:

30

Тип рецепта:

Prescription

Терапевтические области:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Обзор продуктов:

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

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

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........