MAR-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
15-01-2018
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Aktivna sestavina:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Dostopno od:
MARCAN PHARMACEUTICALS INC
Koda artikla:
N06DA04
INN (mednarodno ime):
GALANTAMINE
Odmerek:
24MG
Farmacevtska oblika:
CAPSULE (EXTENDED RELEASE)
Sestava:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 24MG
Pot uporabe:
ORAL
Enote v paketu:
30
Tip zastaranja:
Prescription
Terapevtsko območje:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0144660005; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2021-05-10
Lastnosti izdelka
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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