GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Sẵn có từ:

SANIS HEALTH INC

Mã ATC:

N06DA04

INN (Tên quốc tế):

GALANTAMINE

Liều dùng:

8MG

Dạng dược phẩm:

CAPSULE (EXTENDED RELEASE)

Thành phần:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0144660002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2016-01-07

Đặc tính sản phẩm

Page 1 of 55
PRODUCT MONOGRAPH
PR
GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision: June 22, 2017
Submission Control No: 206599
Page 2 of 55
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
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
..............................................