MINT-RIVASTIGMINE CAPSULE
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
22-12-2016
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Aktiv bestanddel:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
Tilgængelig fra:
MINT PHARMACEUTICALS INC
ATC-kode:
N06DA03
INN (International Name):
RIVASTIGMINE
Dosering:
6MG
Lægemiddelform:
CAPSULE
Sammensætning:
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 6MG
Indgivelsesvej:
ORAL
Enheder i pakken:
56/100
Recept type:
Prescription
Terapeutisk område:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0140521004; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2017-06-19
Produktets egenskaber
PRODUCT MONOGRAPH
PR
MINT-RIVASTIGMINE
1.5 mg, 3 mg, 4.5 mg, 6 mg Rivastigmine
(supplied as Rivastigmine Hydrogen Tartrate)
Capsules
Mint Standard
Cholinesterase Inhibitor
Mint Pharmaceuticals Inc. Date of Revision: December 22, 2016
1093 Meyerside Drive, Unit 1
Mississauga, Ontario
L5T 1J6
Submission Control No: 200803
2
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
............................................................................................
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
........................................................................
33
CLINICAL TRIALS
.....................................................................................................
34
DETAILED PHARMACOLOGY
..........................................................................
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