SANDOZ DARUNAVIR TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DARUNAVIR

Disponible desde:

SANDOZ CANADA INCORPORATED

Código ATC:

J05AE10

Designación común internacional (DCI):

DARUNAVIR

Dosis:

800MG

formulario farmacéutico:

TABLET

Composición:

DARUNAVIR 800MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

HIV PROTEASE INHIBITORS

Resumen del producto:

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

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2022-07-25

Ficha técnica

_Sandoz Darunavir _
_Page 1 of 91_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SANDOZ
® DARUNAVIR
Darunavir tablets
600 mg, 800 mg darunavir
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Sandoz Canada Inc.
110, de Lauzon Street
Boucherville, QC, Canada
J4B 1E6
Date of Preparation:
August 27, 2021
Submission Control No: 234310
_Sandoz Darunavir _
_Page 2 of 91_
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
3
1 INDICATIONS AND CLINICAL USE
.................................................................... 3
1.1 Pediatrics
..................................................................................................
3
1.2 Geriatrics
..................................................................................................
3
2
CONTRAINDICATIONS.......................................................................................
3
4 DOSAGE AND ADMINISTRATION
......................................................................
4
4.1 Dosing Considerations
..............................................................................
4
4.2 Recommended Dose and Dosage Adjustment
........................................... 4
4.5 Missed Dose
.............................................................................................
6
5 OVERDOSAGE
...................................................................................................
6
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................
7
7 WARNINGS AND PRECAUTIONS
......................................................................
7
7.1 Special Populations
.................................................................................
11
7.1.1 Pregnant Women
....................