CASPOFUNGIN POWDER FOR INJECTION POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CASPOFUNGIN (CASPOFUNGIN ACETATE)

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

J02AX04

INN (Tên quốc tế):

CASPOFUNGIN

Liều dùng:

70MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 70MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

10ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ECHINOCANDINS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0144763002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2017-04-18

Đặc tính sản phẩm

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_Caspofungin Powder for Injection _
_Page 1 of 54_
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PRODUCT MONOGRAPH
PR
CASPOFUNGIN POWDER FOR INJECTION
caspofungin for injection, Professed Standard
50 mg or 70 mg caspofungin (as caspofungin acetate) per vial
Antifungal
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Date of Revision:
July 21, 2017
SUBMISSION CONTROL NO: 207358
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_Caspofungin Powder for Injection _
_Page 2 of 54_
_ _
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
...............................................................................................................
8
DRUG INTERACTIONS
.............................................................................................................
23
DOSAGE AND ADMINISTRATION
.........................................................................................
24
OVERDOSAGE
...........................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
31
STORAGE AND STABILITY
.....................................................................................................
33
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................... 33
PART II: SCIENTIFIC
INFORMATION ............................................................................................
34
PHARM