RATIO-GALANTAMINE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
09-12-2009
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Aktívna zložka:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Dostupné z:
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
ATC kód:
N06DA04
INN (Medzinárodný Name):
GALANTAMINE
Dávkovanie:
8MG
Forma lieku:
TABLET
Zloženie:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0144660002; AHFS:
Stav Autorizácia:
CANCELLED PRE MARKET
Dátum Autorizácia:
2015-10-16
Súhrn charakteristických
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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