PMS-GALANTAMINE TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
12-10-2016
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ingredients actius:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Disponible des:
PHARMASCIENCE INC
Codi ATC:
N06DA04
Designació comuna internacional (DCI):
GALANTAMINE
Dosis:
8MG
formulario farmacéutico:
TABLET
Composición:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG
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: 0144660002; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2010-01-26
Fitxa tècnica
Page 1 of 53
PRODUCT MONOGRAPH
Pr
PMS-GALANTAMINE
galantamine hydrobromide tablets
4 mg, 8 mg and 12 mg galantamine base
Cholinesterase Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave, Suite #100
Montreal, Quebec
H4P 2T4
Control #
106278
Date of Preparation:
January 22, 2010
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
..........................................................................................8
DRUG INTERACTIONS
.........................................................................................14
DOSAGE AND ADMINISTRATION
.....................................................................16
OVERDOSAGE
.......................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
...................................................19
STORAGE AND STABILITY
................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................24
PART II SCIENTIFIC INFORMATION
........................................................................25
PHARMACEUTICAL INFORMATION
................................................................25
CLINICAL TRIALS
.................................................................................................26
DETAILED PHARMACOLOGY
............................................................................34
TOXICOLOGY
........................................................................................................35
REFEREN
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