GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
23-06-2017
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Disponibbli minn:
SANIS HEALTH INC
Kodiċi ATC:
N06DA04
INN (Isem Internazzjonali):
GALANTAMINE
Dożaġġ:
16MG
Għamla farmaċewtika:
CAPSULE (EXTENDED RELEASE)
Kompożizzjoni:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
100
Tip ta 'preskrizzjoni:
Prescription
Żona terapewtika:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0144660004; AHFS:
L-istatus ta 'awtorizzazzjoni:
APPROVED
Data ta 'l-awtorizzazzjoni:
2016-01-07
Karatteristiċi tal-prodott
Page 1 of 55
PRODUCT MONOGRAPH
PR
GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision: June 22, 2017
Submission Control No: 206599
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
...............................................................................................................
17
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
..............................................
Aqra d-dokument sħiħ
