MYLAN-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
21-04-2017
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Aktiva substanser:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Tillgänglig från:
MYLAN PHARMACEUTICALS ULC
ATC-kod:
N06DA04
INN (International namn):
GALANTAMINE
Dos:
24MG
Läkemedelsform:
CAPSULE (EXTENDED RELEASE)
Sammansättning:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 24MG
Administreringssätt:
ORAL
Enheter i paketet:
30/100
Receptbelagda typ:
Prescription
Terapiområde:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0144660005; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2011-11-12
Produktens egenskaper
Page 1 of 55
PRODUCT MONOGRAPH
Pr
MYLAN-GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: April 13, 2017
Submission Control No: 204535
Page 2 of 55
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
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
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
...............................................
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