CYTARABINE INJECTION BP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CYTARABINE

Commercializzato da:

SANDOZ CANADA INCORPORATED

Codice ATC:

L01BC01

INN (Nome Internazionale):

CYTARABINE

Dosaggio:

100MG

Forma farmaceutica:

SOLUTION

Composizione:

CYTARABINE 100MG

Via di somministrazione:

INTRATHECAL

Confezione:

1/5/10/20ML

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2019-08-01

Scheda tecnica

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