MYLAN-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Država: Kanada
Jezik: engleski
Izvor: Health Canada
Svojstava lijeka
(SPC)
21-04-2017
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Pošalji zahtjev.
Pošalji zahtjev.
Aktivni sastojci:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Dostupno od:
MYLAN PHARMACEUTICALS ULC
ATC koda:
N06DA04
INN (International ime):
GALANTAMINE
Doziranje:
24MG
Farmaceutski oblik:
CAPSULE (EXTENDED RELEASE)
Sastav:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 24MG
Administracija rute:
ORAL
Jedinice u paketu:
30/100
Tip recepta:
Prescription
Područje terapije:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Proizvod sažetak:
Active ingredient group (AIG) number: 0144660005; AHFS:
Status autorizacije:
APPROVED
Datum autorizacije:
2011-11-12
Svojstava lijeka
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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