RATIO-GALANTAMINE TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
09-12-2009
Alguns documents d’aquest producte actualment no estan disponibles, podeu enviar una sol·licitud al nostre servei d’atenció al client i us ho notificarem tan bon punt puguem obtenir-los.
Enviar sol.licitud.
Enviar sol.licitud.
ingredients actius:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Disponible des:
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
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:
CANCELLED PRE MARKET
Data d'autorització:
2015-10-16
Fitxa tècnica
ratio-GALANTAMINE
Page 1 of 53
PRODUCT MONOGRAPH
Pr
RATIO-GALANTAMINE
galantamine hydrobromide tablets
4 mg, 8 mg and 12 mg galantamine base
Cholinesterase Inhibitor
ratiopharm inc.
17 800 Rue Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Control #096316
Date of Preparation:
December 1, 2009
ratio-GALANTAMINE
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
.....................................................................................
Llegiu el document complet
