KIDROLASE POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ASPARAGINASE

Commercializzato da:

JAZZ PHARMACEUTICALS FRANCE SAS

Codice ATC:

L01XX02

INN (Nome Internazionale):

ASPARAGINASE

Dosaggio:

10000UNIT

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

ASPARAGINASE 10000UNIT

Via di somministrazione:

INTRAMUSCULAR

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2021-07-07

Scheda tecnica

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