AURO-DARUNAVIR TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE)

Tillgänglig från:

AURO PHARMA INC

ATC-kod:

J05AE10

INN (International namn):

DARUNAVIR

Dos:

400MG

Läkemedelsform:

TABLET

Sammansättning:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE) 400MG

Administreringssätt:

ORAL

Enheter i paketet:

100

Receptbelagda typ:

Prescription

Terapiområde:

HIV PROTEASE INHIBITORS

Produktsammanfattning:

Active ingredient group (AIG) number: 0151656002; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2020-01-02

Produktens egenskaper

_Auro-Darunavir Product Monograph _Page 1 of 88
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DARUNAVIR
Darunavir Tablets
Tablets, 400 mg, 600 mg and 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:
January 4, 2023
Submission Control Number: 270155
_Auro-Darunavir Product Monograph _Page 2 of 88
RECENT MAJOR LABEL CHANGES
N/A
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 OVE