APO-NEVIRAPINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

NEVIRAPINE

Tersedia dari:

APOTEX INC

Kode ATC:

J05AG01

INN (Nama Internasional):

NEVIRAPINE

Dosis:

200MG

Bentuk farmasi:

TABLET

Komposisi:

NEVIRAPINE 200MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2012-11-07

Karakteristik produk

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