APO-NEVIRAPINE XR TABLET (EXTENDED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

NEVIRAPINE

Disponible des:

APOTEX INC

Codi ATC:

J05AG01

Designació comuna internacional (DCI):

NEVIRAPINE

Dosis:

400MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

NEVIRAPINE 400MG

Vía de administración:

ORAL

Unidades en paquete:

10/30/60/100

tipo de receta:

Prescription

Área terapéutica:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0134602002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2014-08-06

Fitxa tècnica

_APO-NEVIRAPINE and APO-NEVIRAPINEXR Product Monograph_
Page 1 of 65
PRODUCT MONOGRAPH
Pr
APO-NEVIRAPINE
NEVIRAPINE TABLETS USP
200 MG
PR
APO-NEVIRAPINE XR
NEVIRAPINE EXTENDED-RELEASE TABLETS
400 MG ANTIRETROVIRAL AGENT
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
WITH ACTIVITY AGAINST
HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
SEPTEMBER 11, 2014
TORONTO, ONTARIO
M9L 1T9
CONTROL NO. 177473
_APO-NEVIRAPINE and APO-NEVIRAPINEXR Product Monograph_
Page 2 of 65
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
.................................................................................
3
INDICATIONS AND CLINICAL USE
.......................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.......................................................................................................
14
DRUG INTERACTIONS
........................................................................................................
21
DOSAGE AND ADMINISTRATION
.......................................................................................
36
OVERDOSAGE
.....................................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
38
STORAGE AND STABILITY
.................................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 41
PART II: SCIENTIFIC INFORMATION
...........................................................................