MYLAN-RIVASTIGMINE CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
03-06-2015
Sommige documenten voor dit product zijn momenteel niet beschikbaar, u kunt een verzoek sturen naar onze klantenservice en we zullen u hiervan op de hoogte stellen zodra we ze kunnen verkrijgen.
Verzend verzoek.
Verzend verzoek.
Werkstoffen:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
Beschikbaar vanaf:
MYLAN PHARMACEUTICALS ULC
ATC-code:
N06DA03
INN (Algemene Internationale Benaming):
RIVASTIGMINE
Dosering:
3MG
farmaceutische vorm:
CAPSULE
Samenstelling:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 3MG
Toedieningsweg:
ORAL
Eenheden in pakket:
14/100
Prescription-type:
Prescription
Therapeutisch gebied:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0140521002; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2016-11-02
Productkenmerken
_Page 1 of 56 _
PRODUCT MONOGRAPH
PR
MYLAN-RIVASTIGMINE
Rivastigmine Hydrogen Tartrate Capsules
1.5 mg, 3 mg, 4.5 mg and 6 mg Rivastigmine
Cholinesterase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: May 7, 2015
Submission Control Number: 184285
_Page 2 of 56 _
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
.................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 31
PART II: SCIENTIFIC INFORMATION
..............................................................................
33
PHARMACEUTICAL INFORMATION
.........................................................................
33
CLINICAL TRIALS
.........................................................................................................
34
DETAILED PHARMACOLOGY
................................................
Lees het volledige document
