IPG-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-11-2017
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Active ingredient:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Available from:
MARCAN PHARMACEUTICALS INC
ATC code:
N06DA04
INN (International Name):
GALANTAMINE
Dosage:
16MG
Pharmaceutical form:
CAPSULE (EXTENDED RELEASE)
Composition:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG
Administration route:
ORAL
Units in package:
10
Prescription type:
Prescription
Therapeutic area:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product summary:
Active ingredient group (AIG) number: 0144660004; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-09-07
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
IPG-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
November 27, 2017
Ottawa, ON, CANADA
K2E 7Z7
Control No.: 210932
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
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3
SUMMARY PRODUCT INFORMATION
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3
INDICATIONS AND CLINICAL USE
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3
CONTRAINDICATIONS
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3
WARNINGS AND PRECAUTIONS
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3
ADVERSE REACTIONS
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7
DRUG INTERACTIONS
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12
DOSAGE AND ADMINISTRATION
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14
OVERDOSAGE
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15
ACTION AND CLINICAL PHARMACOLOGY
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16
STORAGE AND STABILITY
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20
DOSAGE FORMS, COMPOSITION AND PACKAGING
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20
PART II: SCIENTIFIC INFORMATION
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