VIRAMUNE XR TABLET (EXTENDED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

NEVIRAPINE

Tersedia dari:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Kode ATC:

J05AG01

INN (Nama Internasional):

NEVIRAPINE

Dosis:

400MG

Bentuk farmasi:

TABLET (EXTENDED-RELEASE)

Komposisi:

NEVIRAPINE 400MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2019-08-20

Karakteristik produk

_ _
_VIRAMUNE Product Monograph_
_ _
_Page 1 of 62_
PRODUCT MONOGRAPH
Pr
VIRAMUNE®
(NEVIRAPINE)
IMMEDIATE-RELEASE TABLETS
200 MG
Pr
VIRAMUNE® XR
(NEVIRAPINE)
EXTENDED-RELEASE TABLETS
400 MG
ANTIRETROVIRAL AGENT
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
WITH ACTIVITY AGAINST
HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)
BOEHRINGER INGELHEIM (CANADA) LTD.
5180 SOUTH SERVICE ROAD
BURLINGTON, ONTARIO
L7L 5H4
DATE OF REVISION:
NOVEMBER 18, 2013
CONTROL NUMBER: 167894
For BICL use only: Tracking CCDS # 0199-17
_ _
_VIRAMUNE Product Monograph_
_ _
_Page 2 of 62_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................21
DOSAGE AND ADMINISTRATION
..............................................................................34
OVERDOSAGE
................................................................................................................36
ACTION AND CLINICAL PHARMACOLOGY
............................................................36
STORAGE AND STABILITY
..........................................................................................39
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................39
PART II: SCIENTIFIC INFORMATION
...............................................................................41
PHARMACEUTICAL INFORMATION
..............