KIDROLASE POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ASPARAGINASE

Tilgjengelig fra:

JAZZ PHARMACEUTICALS FRANCE SAS

ATC-kode:

L01XX02

INN (International Name):

ASPARAGINASE

Dosering :

10000UNIT

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

ASPARAGINASE 10000UNIT

Administreringsrute:

INTRAMUSCULAR

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0109328001; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2021-07-07

Preparatomtale

1
PRODUCT MONOGRAPH
PR
KIDROLASE
®
(L-asparaginase)
10,000 IU/Vial
Powder for Solution for Intramuscular injection or Intravenous
infusion
OTHER ANTINEOPLASTIC AGENTS
L01XX02
Jazz Pharmaceuticals France SAS
69006 Lyon
France
Control No. : 227233
Date of Initial Approval:
December 31, 1974
Date of Revision:
August 12, 2019
2
RECENT MAJOR LABEL CHANGES
Part I: Health Professional Information
2. Contraindications
Aug, 2019
3. Serious Warnings and Precautions Box
Aug, 2019
7. Warnings and Precautions, General
Aug, 2019
7. Warnings and Precautions, Endocrine and Metabolism
Aug, 2019
7. Warnings and Precautions, Immune
Aug, 2019
7. Warnings and Precautions, Special Populations
Aug, 2019
8. Adverse Drug Reactions
Aug, 2019
3
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
1
INDICATIONS .....................................................................................................................
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
.......................................................................................................
5
4.4
Reconstitution
.......................................................................................................
6
4.5
Missed Dose
.........................................................................................................
6
5
OVERDOSAGE ...................................................................................................................
6