APO-GALANTAMINE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
24-02-2023
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Aktiv ingrediens:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Tilgjengelig fra:
APOTEX INC
ATC-kode:
N06DA04
INN (International Name):
GALANTAMINE
Dosering :
8MG
Legemiddelform:
TABLET
Sammensetning:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0144660002; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2009-12-21
Preparatomtale
APO-GALANTAMINE (galantamine hydrobromide tablets)
Page 1 of 57
PRODUCT MONOGRAPH
Pr
APO-GALANTAMINE
galantamine hydrobromide tablets
tablets, 4 mg, 8 mg, 12 mg galantamine base
Cholinesterase Inhibitor
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Date of Preparation:
December 17, 2009
Date of Revision:
February 24, 2023
Submission Control No.: 267800
APO-GALANTAMINE (galantamine hydrobromide tablets)
Page 2 of 57
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
.........................................................................................................
7
DRUG INTERACTIONS
.......................................................................................................
13
DOSAGE AND ADMINISTRATION
...................................................................................
15
OVERDOSAGE
......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 17
STORAGE AND STABILITY
...............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
...............................................................................
23
CLIN
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