RAN-MONTELUKAST TABLET (CHEWABLE)

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:

5MG

Dạng dược phẩm:

TABLET (CHEWABLE)

Thành phần:

MONTELUKAST (MONTELUKAST SODIUM) 5MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

LEUKOTRIENE MODIFIERS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0133823001; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2022-07-28

Đặc tính sản phẩm

1
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PRODUCT MONOGRAPH
PR
RAN™-MONTELUKAST
Montelukast Chewable Tablets
montelukast (as montelukast sodium)
4mg and 5mg
Leukotriene Receptor Antagonist
Ranbaxy Pharmaceuticals Canada Inc.
DATE OF REVISION:
126 East Drive
March 21, 2016
Brampton, ON
L6T 1C1
Control #: 192448
RAN Trademark owned by Sun Pharmaceutical Industries Ltd.
2
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
.....................................................................................................................
7
DRUG INTERACTIONS
....................................................................................................................
10
DOSAGE AND ADMINISTRATION
................................................................................................
12
OVERDOSAGE
..................................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................
13
STORAGE AND STABILITY
............................................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................................... 17
PART II: SCIENTIFIC INFORMATION
...........................................................................................
18
CLINICAL TRIALS
....................