GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
23-06-2017
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Aktiv bestanddel:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Tilgængelig fra:
SANIS HEALTH INC
ATC-kode:
N06DA04
INN (International Name):
GALANTAMINE
Dosering:
16MG
Lægemiddelform:
CAPSULE (EXTENDED RELEASE)
Sammensætning:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0144660004; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2016-01-07
Produktets egenskaber
Page 1 of 55
PRODUCT MONOGRAPH
PR
GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision: June 22, 2017
Submission Control No: 206599
Page 2 of 55
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
..............................................
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