JAMP EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Доступна з:

JAMP PHARMA CORPORATION

Код атс:

J05AR03

ІПН (Міжнародна Ім'я):

TENOFOVIR DISOPROXIL AND EMTRICITABINE

Дозування:

300MG; 200MG

Фармацевтична форма:

TABLET

Склад:

TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Терапевтична области:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Огляд продуктів:

Active ingredient group (AIG) number: 0251568001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2019-05-21

Характеристики продукта

JAMP Emtricitabine / Tenofovir Disoproxil Fumarate (Emtricitabine and
Tenofovir Tablets) Page 1 of 67
PRODUCT MONOGRAPH
Pr
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Tablets
200 mg / 300 mg
(Emtricitabine / Tenofovir disoproxil fumarate)
House Standard
Antiretroviral Agent
JAMP Pharma Corporation
1310 rue Nobel,
Boucherville,
Québec
J4B 5H3, Canada
Submission Control No.: 248455
Date of Revision: May 19, 2021
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate (Emtricitabine and
Tenofovir Tablets) Page 2 of 67
TABLE OF CONTENTS
PART I.
HEALTH PROFESSIONAL INFORMATION
.............................................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................................
3
CONTRAINDICATIONS
.......................................................................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................................................................
5
ADVERSE
REACTIONS......................................................................................................................................
14
DRUG INTERACTIONS
......................................................................................................................................
22
DOSAGE AND ADMINISTRATION
.................................................................................................................
34
OVERDOSAGE
.....................................................................................................................................................
36
ACTION AND CLINICAL
PHARMACOLOGY................................................................................................
37
STORAGE