País: Canadà
Idioma: anglès
Font: Health Canada
CYTARABINE
SANDOZ CANADA INCORPORATED
L01BC01
CYTARABINE
100MG
SOLUTION
CYTARABINE 100MG
INTRATHECAL
1/5/10/20ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0108854005; AHFS:
CANCELLED PRE MARKET
2019-08-01
_ _ _Cytarabine Injection BP _ _Page 1 of 41_ PRODUCT MONOGRAPH PR CYTARABINE INJECTION BP 100 mg / mL (100 mg / 1 mL, 500 mg / 5 mL, 1 g / 10 mL, 2 g / 20 mL) Antileukemic Agent Sandoz Canada Inc. 145, Jules-Léger Boucherville, Quebec J4B 7K8 Date of Revision: December 06, 2017 Submission Control No: 199911 _ _ _Cytarabine Injection BP _ _Page 2 of 41_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ................................................................................................... 9 DRUG INTERACTIONS ................................................................................................. 13 DOSAGE AND ADMINISTRATION ............................................................................. 14 OVERDOSAGE ............................................................................................................... 21 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 21 STORAGE AND STABILITY ......................................................................................... 23 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 24 PART II: SCIENTIFIC INFORMATION ............................................................................... 25 PHARMACEUTICAL INFORMATION ......................................................................... 25 DETAILED PHARMACOLOGY .................. Llegiu el document complet