PHL-RIVASTIGMINE CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Verfügbar ab:

PHARMEL INC

ATC-Code:

N06DA03

INN (Internationale Bezeichnung):

RIVASTIGMINE

Dosierung:

1.5MG

Darreichungsform:

CAPSULE

Zusammensetzung:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100/500

Verschreibungstyp:

Prescription

Therapiebereich:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED PRE MARKET

Berechtigungsdatum:

2017-09-13

Fachinformation

PRODUCT MONOGRAPH
PR
PHL-RIVASTIGMINE
Rivastigmine Hydrogen Tartrate Capsules, House Standard
1.5 mg, 3 mg, 4.5 mg and 6 mg of Rivastigmine
(as Rivastigmine Hydrogen Tartrate)
Cholinestesterase Inhibitor
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision :
April 25, 2016
SUBMISSION CONTROL NO: 193498
_ _
_phl-RIVASTIGMINE Product Monograph _
_Page 2 of 53_
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
................................................................................................11
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
..........................................................................30
CLINICAL TRIALS
.............................................................................................