PHL-RIVASTIGMINE CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
26-04-2016
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Aktiva substanser:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
Tillgänglig från:
PHARMEL INC
ATC-kod:
N06DA03
INN (International namn):
RIVASTIGMINE
Dos:
1.5MG
Läkemedelsform:
CAPSULE
Sammansättning:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 1.5MG
Administreringssätt:
ORAL
Enheter i paketet:
100/500
Receptbelagda typ:
Prescription
Terapiområde:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0140521001; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2017-09-13
Produktens egenskaper
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
.............................................................................................
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