APO-RIVASTIGMINE CAPSULE

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Доступно од:

APOTEX INC

АТЦ код:

N06DA03

INN (Међународно име):

RIVASTIGMINE

Дозирање:

1.5MG

Фармацеутски облик:

CAPSULE

Састав:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0140521001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2009-11-04

Карактеристике производа

Page 1 of 53
PRODUCT MONOGRAPH
PR APO-RIVASTIGMINE
1.5 MG, 3 MG, 4.5 MG AND 6 MG RIVASTIGMINE
(AS RIVASTIGMINE HYDROGEN TARTRATE)
CAPSULES USP
CHOLINESTERASE INHIBITOR
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
TORONTO, ONTARIO MAY 12, 2015
M9L 1T9
CONTROL NO. 184244
Page 2 of 53
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................
3
CONTRAINDICATIONS
......................................................................................................................
3
WARNINGS AND PRECAUTIONS
.....................................................................................................
4
ADVERSE REACTIONS
....................................................................................................................
10
DRUG INTERACTIONS
.....................................................................................................................
25
DOSAGE AND ADMINISTRATION
.................................................................................................
26
OVERDOSAGE
...................................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
29
STORAGE AND STABILITY
.............................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 32
PART II: SCIENTIFIC INFORMATION
...........................................................................................
33
PHARMACEUTICAL INFORMATION
...................................................