PMS-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

มีจำหน่ายจาก:

PHARMASCIENCE INC

รหัส ATC:

N06DA04

INN (ชื่อสากล):

GALANTAMINE

ปริมาณ:

16MG

แบบฟอร์มเภสัชกรรม:

CAPSULE (EXTENDED RELEASE)

องค์ประกอบ:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

30/100

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

สรุปสินค้า:

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

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2012-12-14

สรุปลักษณะสินค้า

_pms-GALANTAMINE ER _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-GALANTAMINE ER
galantamine hydrobromide extended release capsules
Extended release capsules, 8 mg, 16 mg, 24 mg galantamine base, oral
House Standard
Cholinesterase Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite #100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
DEC 14, 2012
Date of Revision:
JAN 28, 2022
Submission Control Number: 256025
_pms-GALANTAMINE ER _
_Page 2 of 64_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
01/2022
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
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................................
4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics................................................................................................................
4
2
CONTRAINDICATIONS........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment.......................................................... 5
4.4
Administration......................................................................................................