CYTOSAR POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CYTARABINE

Available from:

PHARMASCIENCE INC

ATC code:

L01BC01

INN (International Name):

CYTARABINE

Dosage:

500MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CYTARABINE 500MG

Administration route:

INTRATHECAL

Units in package:

250ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0108854004; AHFS:

Authorization status:

APPROVED

Authorization date:

1997-08-05

Summary of Product characteristics

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
.............................