APO-DARUNAVIR TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

DARUNAVIR

Beschikbaar vanaf:

APOTEX INC

ATC-code:

J05AE10

INN (Algemene Internationale Benaming):

DARUNAVIR

Dosering:

600MG

farmaceutische vorm:

TABLET

Samenstelling:

DARUNAVIR 600MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

HIV PROTEASE INHIBITORS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2020-01-02

Productkenmerken

_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
..............