CASPOFUNGIN ACETATE 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:

SANDOZ CANADA INCORPORATED

Mã ATC:

J02AX04

INN (Tên quốc tế):

CASPOFUNGIN

Liều dùng:

50MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 50MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ECHINOCANDINS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0144763001; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2018-08-01

Đặc tính sản phẩm

_ _
_Caspofungin Acetate for Injection _
_Page 1 of 53_
PRODUCT MONOGRAPH
PR
CASPOFUNGIN ACETATE FOR INJECTION
50 mg/vial and 70 mg/vial caspofungin (as caspofungin acetate)
Antifungal
Sandoz Canada Inc.
145 Jules-Léger
Boucherville (QC)
J4B 7K8
Date of Revision:
July 17, 2017
Submission Control No: 207225
_ _
_Caspofungin Acetate for Injection _
_Page 2 of 53_
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
..............................................................................25
OVERDOSAGE
................................................................................................................32
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................35
PHARMACEUTICAL INFORMATION
..........................................................................35
CLINICAL TRIALS
..........................................................................................................36
DETAILED PHAR