APO-NEVIRAPINE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

NEVIRAPINE

Tilgjengelig fra:

APOTEX INC

ATC-kode:

J05AG01

INN (International Name):

NEVIRAPINE

Dosering :

200MG

Legemiddelform:

TABLET

Sammensetning:

NEVIRAPINE 200MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0134602001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2012-11-07

Preparatomtale

_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
...........................................................................