CYTOSAR POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CYTARABINE

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

L01BC01

INN (Tên quốc tế):

CYTARABINE

Liều dùng:

100MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

CYTARABINE 100MG

Tuyến hành chính:

INTRATHECAL

Các đơn vị trong gói:

250ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0108854005; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

1997-08-05

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
CYTOSAR
CYTARABINE FOR INJECTION, USP
LYOPHILIZED POWDER FOR INJECTION
(100 MG, 500 MG, 1 G AND 2 G)
CYTARABINE SOLUTION FOR INJECTION
HOUSE STANDARD
SOLUTION FOR INJECTION
(20 MG/ML AND 100 MG/ML)
ANTILEUKEMIC AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4 DATE OF REVISION:
May 17, 2017
www.pharmascience.com
Control No.: 204769
_CYTOSAR (cytarabine) Product Monograph _
_Page 2 of 51_
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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 27
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
......................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL INFORMATION
.............................