NORVIR SEC CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

RITONAVIR

Disponible desde:

ABBVIE CORPORATION

Código ATC:

J05AE03

Designación común internacional (DCI):

RITONAVIR

Dosis:

100MG

formulario farmacéutico:

CAPSULE

Composición:

RITONAVIR 100MG

Vía de administración:

ORAL

Unidades en paquete:

120

tipo de receta:

Prescription

Área terapéutica:

HIV PROTEASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0128780001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2014-11-25

Ficha técnica

_ _
_NORVIR_
_®_
_, NORVIR_
_®_
_ SEC Product Monograph _
_Page 1 of 78 _
_Date of Revision: June 13, 2014 and Control No. 173634 _
PRODUCT MONOGRAPH
PR
NORVIR
®
Ritonavir
film-coated tablets (100 mg)
PR
NORVIR
®
Ritonavir
oral solution (80 mg/mL)
PR
NORVIR
®
SEC
Ritonavir
soft elastic capsules (100 mg)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
AbbVie Corporation
Date of Revision:
8401 Trans-Canada Highway
July 21, 2014
St-Laurent, Qc H4S 1Z1
Submission Control No: 173634
_ _
_NORVIR_
_®_
_, NORVIR_
_®_
_ SEC Product Monograph _
_Page 2 of 78 _
_Date of Revision: June 13, 2014 and Control No. 173634 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................34
OVERDOSAGE
................................................................................................................37
ACTION AND CLINICAL PHARMACOLOGY
............................................................37
STORAGE AND STABILITY
..........................................................................................42
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................43
PART II: SCIENTIFIC INFORMATION
.............................................................