CYSTADANE POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

BETAINE

Sẵn có từ:

RECORDATI RARE DISEASES CANADA INC

Mã ATC:

A16AA06

INN (Tên quốc tế):

BETAINE

Liều dùng:

1G

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

BETAINE 1G

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

180G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0134220001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2010-04-07

Đặc tính sản phẩm

PRODUCT MONOGRAPH
Pr
Cystadane
®
betaine anhydrous powder for oral solution
1 gram/1.7 cc scoop
Professed Standard
Anti-Homocysteine Agent
Recordati Rare Diseases Canada Inc.
3080 Yonge Street, Suite 6060
Toronto, ON
M4N 3N1
Distributed by:
Recordati Rare Diseases Canada Inc.
Oakville, ON
L6M 2W2
Date of Revision:
April 10, 2018
Submission Control No: 213241
_Cystadane_
_®_
_ Product Monograph _
_Page 2 of 19_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STABILITY
..........................................................................................10
SPECIAL HANDLING INSTRUCTIONS
.......................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................12
PHARMACEUTICAL INFORMATION
........................................................