Land: Kanada
Språk: engelska
Källa: Health Canada
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
APOTEX INC
N06DA04
GALANTAMINE
8MG
TABLET
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG
ORAL
100
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0144660002; AHFS:
APPROVED
2009-12-21
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 Läs hela dokumentet