APO-GALANTAMINE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
24-02-2023
Nogle dokumenter til dette produkt er ikke tilgængelige i øjeblikket, du kan sende en anmodning til vores kundeservice, og vi vil underrette dig, så snart vi er i stand til at få dem.
Send anmodning.
Send anmodning.
Aktiv bestanddel:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Tilgængelig fra:
APOTEX INC
ATC-kode:
N06DA04
INN (International Name):
GALANTAMINE
Dosering:
4MG
Lægemiddelform:
TABLET
Sammensætning:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 4MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0144660001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2009-12-21
Produktets egenskaber
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
Læs hele dokumentet
