AURO-DARUNAVIR TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE)

Dostupné z:

AURO PHARMA INC

ATC kód:

J05AE10

INN (Medzinárodný Name):

DARUNAVIR

Dávkovanie:

800MG

Forma lieku:

TABLET

Zloženie:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE) 800MG

Spôsob podávania:

ORAL

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

HIV PROTEASE INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0151656006; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2020-01-02

Súhrn charakteristických

Auro-Darunavir Product Monograph
Page 1 of 96
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DARUNAVIR
Darunavir Tablets
Tablets, 400 mg, 600 mg, 800 mg darunavir (as darunavir propylene
glycolate), Oral
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
January 2, 2020
Date of Revision:
December 7, 2023
Submission Control Number: 276175
Auro-Darunavir Product Monograph
Page 2 of 96
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
............................................