RATIO-GALANTAMINE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Disponible depuis:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

Code ATC:

N06DA04

DCI (Dénomination commune internationale):

GALANTAMINE

Dosage:

8MG

forme pharmaceutique:

TABLET

Composition:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0144660002; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2015-10-16

Résumé des caractéristiques du produit

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
.....................................................................................