GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
23-06-2017
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ingredients actius:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Disponible des:
SANIS HEALTH INC
Codi ATC:
N06DA04
Designació comuna internacional (DCI):
GALANTAMINE
Dosis:
24MG
formulario farmacéutico:
CAPSULE (EXTENDED RELEASE)
Composición:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 24MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0144660005; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2016-01-07
Fitxa tècnica
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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