CYCLOPHOSPHAMIDE FOR INJECTION POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CYCLOPHOSPHAMIDE

Sẵn có từ:

ACCORD HEALTHCARE INC

Mã ATC:

L01AA01

INN (Tên quốc tế):

CYCLOPHOSPHAMIDE

Liều dùng:

1000MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

CYCLOPHOSPHAMIDE 1000MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0107630007; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2022-09-16

Đặc tính sản phẩm

_ Cyclophosphamide for Injection (Cyclophosphamide)_
_Page 1 of 63_
PRODUCT MONOGRAPH
PR
CYCLOPHOSPHAMIDE FOR INJECTION
USP
500 mg, 1000 mg and 2000 mg per vial
Lyophilized Powder for Injection
ANTINEOPLASTIC AGENT
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC H9H 5B9,
Canada
Date of Initial Approval:
September 14, 2022
Submission Control No: 249010
_ Cyclophosphamide for Injection (Cyclophosphamide)_
_Page 2 of 63_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
5
WARNINGS AND PRECAUTIONS
..................................................................................
5
ADVERSE REACTIONS
..................................................................................................
13
DRUG INTERACTIONS
..................................................................................................
16
DOSAGE AND ADMINISTRATION
..............................................................................
26
OVERDOSAGE
................................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 44
STORAGE AND STABILITY
..........................................................................................
46
SPECIAL HANDLING INSTRUCTIONS
........................................................................
47
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 48
PART II: SCIENTIFIC INFORMATION
...............................................................................
49
PHARMACEUTICAL INFORMATION
................