RATIO-GALANTAMINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-12-2009
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Active ingredient:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Available from:
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
ATC code:
N06DA04
INN (International Name):
GALANTAMINE
Dosage:
8MG
Pharmaceutical form:
TABLET
Composition:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product summary:
Active ingredient group (AIG) number: 0144660002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2015-10-16
Summary of Product characteristics
ratio-GALANTAMINE
Page 1 of 53
PRODUCT MONOGRAPH
Pr
RATIO-GALANTAMINE
galantamine hydrobromide tablets
4 mg, 8 mg and 12 mg galantamine base
Cholinesterase Inhibitor
ratiopharm inc.
17 800 Rue Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Control #096316
Date of Preparation:
December 1, 2009
ratio-GALANTAMINE
Page 2 of 53
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................3
SUMMARY PRODUCT INFORMATION
...............................................................3
INDICATIONS AND CLINICAL USE
.....................................................................3
CONTRAINDICATIONS
..........................................................................................4
WARNINGS AND PRECAUTIONS
........................................................................4
ADVERSE REACTIONS
..........................................................................................8
DRUG INTERACTIONS
.........................................................................................14
DOSAGE AND ADMINISTRATION
.....................................................................16
OVERDOSAGE
.......................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
...................................................19
STORAGE AND STABILITY
................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................24
PART II SCIENTIFIC INFORMATION
........................................................................25
PHARMACEUTICAL INFORMATION
................................................................25
CLINICAL TRIALS
.................................................................................................26
DETAILED PHARMACOLOGY
............................................................................34
TOXICOLOGY
.....................................................................................
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