MERIDIA CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE

Sẵn có từ:

ABBOTT LABORATORIES, LIMITED

Mã ATC:

A08AA10

INN (Tên quốc tế):

SIBUTRAMINE

Liều dùng:

15MG

Dạng dược phẩm:

CAPSULE

Thành phần:

SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE 15MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANOREXIGENIC AGENTS & RESPIRATORY AND CEREBRAL STIMULANTS, MISCELLANEOUS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0142562002; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2010-10-12

Đặc tính sản phẩm

_MERIDIA_
_®_
_ Product Monograph _
_Page 1 of 46 _
_ _
PRODUCT MONOGRAPH
PR
MERIDIA
®
sibutramine hydrochloride monohydrate
10 mg and 15 mg capsules
Anorexiant / Antiobesity Agent
Abbott Laboratories, Limited
Date of Revision:
8401 Trans-Canada Highway
November 26, 2009
St-Laurent, Qc H4S 1Z1
Submission Control No: 130400
_MERIDIA_
_®_
_ Product Monograph _
_Page 2 of 46 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................6
WARNINGS AND
PRECAUTIONS..................................................................................7
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND
ADMINISTRATION..............................................................................20
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND
STABILITY..........................................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
................................................................................27
PHARMACEUTICAL
INFORMATION..........................................................................27
CLINICAL
TRIALS..........................................................................................................27
D