ELMIRON CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PENTOSAN POLYSULFATE SODIUM

Sẵn có từ:

JANSSEN INC

Mã ATC:

C05BA04

INN (Tên quốc tế):

PENTOSTAN POLYSULFATE SODIUM

Liều dùng:

100MG

Dạng dược phẩm:

CAPSULE

Thành phần:

PENTOSAN POLYSULFATE SODIUM 100MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS THERAPEUTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0124416001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2002-05-01

Đặc tính sản phẩm

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_Page 1 of 21 _
PRODUCT MONOGRAPH
PR
ELMIRON
®*
pentosan polysulfate sodium
Capsules 100 mg
Glycosaminoglycan Substitute
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Preparation:
September 28, 1998
Date of Revision:
October 1, 2020
Submission Control No: 239842
*Registered trademark of IVAX Research, LLC. Used under license.
©2020 JANSSEN Inc.
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_Page 2 of 21 _
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
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................12
PHARMACEUTICAL INFORMATION
..........................................................................12
CLINICAL TRIALS
...........................................................