APO-DARUNAVIR TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

DARUNAVIR

Предлага се от:

APOTEX INC

АТС код:

J05AE10

INN (Международно Name):

DARUNAVIR

дозиране:

600MG

Лекарствена форма:

TABLET

Композиция:

DARUNAVIR 600MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Терапевтична област:

HIV PROTEASE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0151656003; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2020-01-02

Данни за продукта

_APO-DARUNAVIR (Darunavir Tablets) _
_Page 1 of 106_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DARUNAVIR
Darunavir Tablets
Tablets, 600 mg and 800 mg, Oral
Human Immunodeficiency Virus (HIV) Protease Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada, M9L 1T9
Date of Initial Authorization:
JAN 02, 2020
Date of Revision:
JUN 15, 2023
Submission Control Number: 271086
_APO-DARUNAVIR (Darunavir Tablets) _
_Page 2 of 106_
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
......................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................. 5
4.5
Missed Dose
..................................................................................................................
8
5
OVERDOSAGE
..............