MYLAN-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Disponible des:

MYLAN PHARMACEUTICALS ULC

Codi ATC:

N06DA04

Designació comuna internacional (DCI):

GALANTAMINE

Dosis:

8MG

formulario farmacéutico:

CAPSULE (EXTENDED RELEASE)

Composición:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG

Vía de administración:

ORAL

Unidades en paquete:

30/100

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:

2011-11-12

Fitxa tècnica

Page 1 of 55
PRODUCT MONOGRAPH
Pr
MYLAN-GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: April 13, 2017
Submission Control No: 204535
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
...............................................................................................................
18
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
...............................................