TEVA-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

MAH:

TEVA CANADA LIMITED

ATC_code:

N06DA04

INN:

GALANTAMINE

dosage:

16MG

pharmaceutical_form:

CAPSULE (EXTENDED RELEASE)

composition:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG

administration_route:

ORAL

units_in_package:

30/100

prescription_type:

Prescription

therapeutic_area:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0144660004; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2018-06-22

SPC

_TEVA-GALANTAMINE _
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PRODUCT MONOGRAPH
PR
TEVA-GALANTAMINE ER
galantamine hydrobromide extended release capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
Teva Canada Limited
Date of Revision:
30 Novopharm Court
September 3, 2014
Toronto, Ontario
M1B 2K9
Submission Control No: 177342
_TEVA-GALANTAMINE _
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_Page 2 of 55 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
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
....................................................................................
35
TOXICOLOGY
...........