APO-RIVASTIGMINE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Disponible depuis:

APOTEX INC

Code ATC:

N06DA03

DCI (Dénomination commune internationale):

RIVASTIGMINE

Dosage:

4.5MG

forme pharmaceutique:

CAPSULE

Composition:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 4.5MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0140521003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2009-11-04

Résumé des caractéristiques du produit

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
...................................................