TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Предлага се от:

TEVA CANADA LIMITED

АТС код:

J05AR06

INN (Международно Name):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

дозиране:

600MG; 200MG; 300MG

Лекарствена форма:

TABLET

Композиция:

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

Начин на приложение:

ORAL

Броя в опаковка:

30

Вид предписание :

Prescription

Терапевтична област:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2017-07-26

Данни за продукта

PRODUCT MONOGRAPH
PR
TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR
Efavirenz, Emtricitabine and Tenofovir Tablets
Teva Standard
600 mg/200 mg/300 mg
(efavirenz/emtricitabine/tenofovir disoproxil fumarate)
Antiretroviral Agent
Teva Canada Limited
Date of Revision:
30 Novopharm Court
June 1, 2020
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control No.: 238915
_TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR Product Monograph _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................................3
INDICATIONS AND CLINICAL USE
.......................................................................................3
CONTRAINDICATIONS
............................................................................................................3
WARNINGS AND PRECAUTIONS
...........................................................................................4
ADVERSE REACTIONS
...........................................................................................................15
DRUG INTERACTIONS
...........................................................................................................23
DOSAGE AND ADMINISTRATION
.......................................................................................39
OVERDOSAGE
.........................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................40
STORAGE AND STABILITY
...................................................................................................44
SPECIAL HANDLING INSTRUCTIONS
................................................................................44
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................44
PART II: SCIENTIFIC INFORMATION
..................................