APO-GALANTAMINE TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

มีจำหน่ายจาก:

APOTEX INC

รหัส ATC:

N06DA04

INN (ชื่อสากล):

GALANTAMINE

ปริมาณ:

12MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 12MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

100

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

สรุปสินค้า:

Active ingredient group (AIG) number: 0144660003; AHFS:

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2009-12-21

สรุปลักษณะสินค้า

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