PREZCOBIX TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DARUNAVIR (DARUNAVIR ETHANOLATE); COBICISTAT

זמין מ:

JANSSEN INC

קוד ATC:

J05AR14

INN (שם בינלאומי):

DARUNAVIR AND COBICISTAT

כמות:

800MG; 150MG

טופס פרצבטיות:

TABLET

הרכב:

DARUNAVIR (DARUNAVIR ETHANOLATE) 800MG; COBICISTAT 150MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30

סוג מרשם:

Prescription

איזור תרפויטי:

HIV PROTEASE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0255810001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2014-06-19

מאפייני מוצר

Non Ann PM PRCB SNDS 268359 02222023.docx
EDMS-ERI-840430 V8.0_ _
_Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PREZCOBIX
®
darunavir (as darunavir ethanolate)/cobicistat
film-coated tablets (800 mg/150 mg)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
June 18, 2014
Date of Revision:
March 3, 2023
Submission Control Number: 268359
© 2023 Janssen Inc.
All trademarks used under license.
Non Ann PM PRCB SNDS 268359 02222023.docx
EDMS-ERI-840430 V8.0_ _
_Page 2 of 65_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2022
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
4.4
Administration
......................................................................................................
7
4.5
Missed