GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Country: Կանադա
language: անգլերեն
source: Health Canada
SPC
(SPC)
23-06-2017
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documentation_request_send
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active_ingredient:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
MAH:
SANIS HEALTH INC
ATC_code:
N06DA04
INN:
GALANTAMINE
dosage:
8MG
pharmaceutical_form:
CAPSULE (EXTENDED RELEASE)
composition:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG
administration_route:
ORAL
units_in_package:
100
prescription_type:
Prescription
therapeutic_area:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
leaflet_short:
Active ingredient group (AIG) number: 0144660002; AHFS:
authorization_status:
APPROVED
authorization_date:
2016-01-07
SPC
Page 1 of 55
PRODUCT MONOGRAPH
PR
GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision: June 22, 2017
Submission Control No: 206599
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
...............................................................................................................
17
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
..............................................
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