POLYMYXIN B FOR INJECTION USP POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

POLYMYXIN B (POLYMYXIN B SULFATE)

Sẵn có từ:

STERIMAX INC

Mã ATC:

J01XB02

INN (Tên quốc tế):

POLYMYXIN B

Liều dùng:

50MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

POLYMYXIN B (POLYMYXIN B SULFATE) 50MG

Tuyến hành chính:

INTRAMUSCULAR

Các đơn vị trong gói:

SINGLE VIAL

Loại thuốc theo toa:

Prescription

Khu trị liệu:

POLYMYXINS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0153043001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2011-11-16

Đặc tính sản phẩm

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_Polymyxin B for Injection USP _
_Page 1 of 26_
PRODUCT MONOGRAPH
PR
POLYMYXIN B FOR INJECTION USP
Powder for Solution
Polymyxin B, 50 mg/vial (500,000 units)
(as polymyxin B sulphate)
Antibiotic
SteriMax Inc.
1-2735 Matheson Blvd. East
Mississauga ON
L4W 4M8
Date of Preparation:
November 9, 2011
Submission Control No: 143565
_ _
_Polymyxin B for Injection _
_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....................................................................................................9
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND
ADMINISTRATION..............................................................................11
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND
STABILITY..........................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL
INFORMATION..........................................................................18
CLINICAL
TRIALS..........................................................................................................19
DETAIL