GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

제공처:

PRO DOC LIMITEE

ATC 코드:

N06DA04

INN (International Name):

GALANTAMINE

복용량:

16MG

약제 형태:

CAPSULE (EXTENDED RELEASE)

구성:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

제품 요약:

Active ingredient group (AIG) number: 0144660004; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2023-07-10

제품 특성 요약

_GALANTAMINE ER _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GALANTAMINE ER
galantamine hydrobromide extended release capsules
Extended release capsules, 8 mg, 16 mg, 24 mg galantamine base, oral
House Standard
Cholinesterase Inhibitor
PRO DOC LTÉE
2925 Boul. Industriel
Laval, Québec
H7L 3W9
Date of Initial Authorization:
DEC 03, 2013
Date of Revision:
FEB 25, 2022
Submission Control Number: 261429
_GALANTAMINE ER _
_Page 2 of 64_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
..................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
............................................................. 5
4.4
Administration
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6
4.5
Missed Dose
.........