CYTARABINE INJECTION BP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CYTARABINE

Tilgjengelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

L01BC01

INN (International Name):

CYTARABINE

Dosering :

100MG

Legemiddelform:

SOLUTION

Sammensetning:

CYTARABINE 100MG

Administreringsrute:

INTRATHECAL

Enheter i pakken:

1/5/10/20ML

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2019-08-01

Preparatomtale

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_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
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_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
..................