PMS-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
28-01-2022
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Aktiv bestanddel:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Tilgængelig fra:
PHARMASCIENCE INC
ATC-kode:
N06DA04
INN (International Name):
GALANTAMINE
Dosering:
8MG
Lægemiddelform:
CAPSULE (EXTENDED RELEASE)
Sammensætning:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/100
Recept type:
Prescription
Terapeutisk område:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0144660002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2012-12-14
Produktets egenskaber
_pms-GALANTAMINE ER _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-GALANTAMINE ER
galantamine hydrobromide extended release capsules
Extended release capsules, 8 mg, 16 mg, 24 mg galantamine base, oral
House Standard
Cholinesterase Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite #100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
DEC 14, 2012
Date of Revision:
JAN 28, 2022
Submission Control Number: 256025
_pms-GALANTAMINE ER _
_Page 2 of 64_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
01/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................................
4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics................................................................................................................
4
2
CONTRAINDICATIONS........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment.......................................................... 5
4.4
Administration......................................................................................................
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