MAR-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
15-01-2018
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Aktivní složka:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Dostupné s:
MARCAN PHARMACEUTICALS INC
ATC kód:
N06DA04
INN (Mezinárodní Name):
GALANTAMINE
Dávkování:
16MG
Léková forma:
CAPSULE (EXTENDED RELEASE)
Složení:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG
Podání:
ORAL
Jednotky v balení:
30
Druh předpisu:
Prescription
Terapeutické oblasti:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0144660004; AHFS:
Stav Autorizace:
CANCELLED POST MARKET
Datum autorizace:
2021-05-10
Charakteristika produktu
1
PRODUCT MONOGRAPH
PR
MAR-GALANTAMINE ER
galantamine hydrobromide extended release capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
Marcan Pharmaceuticals Inc.
Date of Revision:
77 Auriga Drive, Unit# 4
January 15, 2018
Ottawa, ON, CANADA
K2E 7Z7
Control No.: 212078
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...............................................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................................
3
CONTRAINDICATIONS
............................................................................................................................
3
WARNINGS AND PRECAUTIONS
..........................................................................................................
3
ADVERSE REACTIONS
............................................................................................................................
7
DRUG INTERACTIONS
...........................................................................................................................
12
DOSAGE AND ADMINISTRATION
......................................................................................................
14
OVERDOSAGE
.........................................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................................
16
STORAGE AND STABILITY
..................................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
20
PART II: SCIENTIFIC INFORMATION
..............................................................................................
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