ATRIANCE SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

NELARABINE

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

L01BB07

INN (Kansainvälinen yleisnimi):

NELARABINE

Annos:

5MG

Lääkemuoto:

SOLUTION

Koostumus:

NELARABINE 5MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

6X50ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0152299001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2007-09-22

Valmisteyhteenveto

_ATRIANCE_
_ ®_
_ (nelarabine Injection)_
_Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATRIANCE
®
Nelarabine Injection
Solution for intravenous infusion 5 mg/mL
Antineoplastic Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Authorization:
Nov 30, 2022
Submission Control Number: 269418
_ATRIANCE is a registered trademark._
_ _
_ATRIANCE_
_ ®_
_ (nelarabine Injection)_
_Product Monograph _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
11 STORAGE, STABILITY AND DISPOSAL
[01/2021]
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.3
Administration
........................................