MYLAN-NEVIRAPINE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

NEVIRAPINE

Доступно од:

MYLAN PHARMACEUTICALS ULC

АТЦ код:

J05AG01

INN (Међународно име):

NEVIRAPINE

Дозирање:

200MG

Фармацеутски облик:

TABLET

Састав:

NEVIRAPINE 200MG

Пут администрације:

ORAL

Јединице у пакету:

60/100

Тип рецептора:

Prescription

Терапеутска област:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2012-06-20

Карактеристике производа

_MYLAN-NEVIRAPINE Product Monograph _
_Page 1 of 62 _
PRODUCT MONOGRAPH
PR
MYLAN-NEVIRAPINE
NEVIRAPINE TABLETS USP
200 MG
ANTIRETROVIRAL AGENT
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
WITH ACTIVITY AGAINST
HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)
Mylan Pharmaceuticals ULC
85 Advance Road
Toronto, ON
M8Z 2S6
Submission Control No.: 171881
Date of Preparation:
February 13, 2014
_MYLAN-NEVIRAPINE 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
..............................................................................................
16
DRUG INTERACTIONS
...............................................................................................
22
DOSAGE AND ADMINISTRATION
...........................................................................
37
OVERDOSAGE
.............................................................................................................
38
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 39
STORAGE AND STABILITY
......................................................................................
42
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 42
PART II: SCIENTIFIC INFORMATION
.............................................................. 43
PHARMACEUTICAL INFORMATION
......................................................................
43
CLINICAL TRIALS
.......................................................................................................
44