KIDROLASE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ASPARAGINASE

Available from:

JAZZ PHARMACEUTICALS FRANCE SAS

ATC code:

L01XX02

INN (International Name):

ASPARAGINASE

Dosage:

10000UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

ASPARAGINASE 10000UNIT

Administration route:

INTRAMUSCULAR

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-07-07

Summary of Product characteristics

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