PMS-RIVASTIGMINE CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
08-11-2016
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Werkstoffen:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
Beschikbaar vanaf:
PHARMASCIENCE INC
ATC-code:
N06DA03
INN (Algemene Internationale Benaming):
RIVASTIGMINE
Dosering:
3.0MG
farmaceutische vorm:
CAPSULE
Samenstelling:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 3.0MG
Toedieningsweg:
ORAL
Eenheden in pakket:
60/100
Prescription-type:
Prescription
Therapeutisch gebied:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0140521002; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2009-07-20
Productkenmerken
PRODUCT MONOGRAPH
PR
PMS-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
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision :
November 1, 2016
www.pharmascience.com
SUBMISSION CONTROL NO: 199174
_ _
_pms-RIVASTIGMINE Product Monograph _
_Page 2 of 52_
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
..............................................................................................
23
DOSAGE AND ADMINISTRATION
..........................................................................
24
OVERDOSAGE
...........................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 27
STORAGE AND STABILITY
......................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 29
PART II: SCIENTIFIC INFORMATION
...........................................................................
31
PHARMACEUTICAL INFORMATION
......................................................................
31
CLINICAL TRIALS
....................................................................................................
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