FLUDARABINE PHOSPHATE INJECTION SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

FLUDARABINE PHOSPHATE

Sẵn có từ:

FRESENIUS KABI CANADA LTD

Mã ATC:

L01BB05

INN (Tên quốc tế):

FLUDARABINE

Liều dùng:

25MG

Dạng dược phẩm:

SOLUTION

Thành phần:

FLUDARABINE PHOSPHATE 25MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

2ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0123842003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2015-06-04

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
FLUDARABINE PHOSPHATE INJECTION
25 mg/mL
USP
PR
FLUDARABINE PHOSPHATE FOR INJECTION
50 mg/vial
USP
Antineoplastic
FRESENIUS KABI CANADA LTD.
Date of Revision:
45 Vogell Rd, Suite 200
January 9, 2017
Richmond Hill, ON, L4B 3P6
Control No. 201501
_ _
Fludarabine Liq-PM-ENG-v2.0-Proposed PM_ _
_Page 2 of 57 _
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
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
..........................................................................................................19
DETAILED PHARMACOLOGY
...........................