KIDROLASE POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ASPARAGINASE

Διαθέσιμο από:

JAZZ PHARMACEUTICALS FRANCE SAS

Φαρμακολογική κατηγορία (ATC):

L01XX02

INN (Διεθνής Όνομα):

ASPARAGINASE

Δοσολογία:

10000UNIT

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

ASPARAGINASE 10000UNIT

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2021-07-07

Αρχείο Π.Χ.Π.

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