APO-GALANTAMINE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

から入手可能:

APOTEX INC

ATCコード:

N06DA04

INN（国際名）:

GALANTAMINE

投薬量:

4MG

医薬品形態:

TABLET

構図:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 4MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

製品概要:

Active ingredient group (AIG) number: 0144660001; AHFS:

認証ステータス:

APPROVED

承認日:

2009-12-21

製品の特徴

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