MONTELUKAST TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MONTELUKAST (MONTELUKAST SODIUM)

Sẵn có từ:

RANBAXY PHARMACEUTICALS CANADA INC.

Mã ATC:

R03DC03

INN (Tên quốc tế):

MONTELUKAST

Liều dùng:

10MG

Dạng dược phẩm:

TABLET

Thành phần:

MONTELUKAST (MONTELUKAST SODIUM) 10MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

LEUKOTRIENE MODIFIERS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0133823002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2013-08-16

Đặc tính sản phẩm

_ _
_MONTELUKAST (montelukast sodium) Product Monograph _
_Page 1 of 26_
PRODUCT MONOGRAPH
PR
MONTELUKAST
montelukast (as montelukast sodium)
10 mg tablets
Professed Standard
Leukotriene Receptor Antagonist
Ranbaxy Pharmaceuticals Canada Inc.
Date of Preparation: August 9, 2013
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario
L4W 0A5
SUBMISSION CONTROL NO.: 166985
_ _
_ _
_MONTELUKAST (montelukast sodium) Product Monograph _
_Page 2 of 26_
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
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II : SCIENTIFIC INFORMATION
..............................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
...................................