Country: Canada
Language: English
Source: Health Canada
CYTARABINE
PHARMASCIENCE INC
L01BC01
CYTARABINE
100MG
SOLUTION
CYTARABINE 100MG
INTRATHECAL
10ML/20ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0108854005; AHFS:
APPROVED
2017-05-17
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 ............................. Read the complete document