IRINOTECAN HYDROCHLORIDE INJECTION USP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IRINOTECAN HYDROCHLORIDE

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

L01CE02

INN (nume internaţional):

IRINOTECAN

Dozare:

20MG

Forma farmaceutică:

SOLUTION

Compoziție:

IRINOTECAN HYDROCHLORIDE 20MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

2/5/25ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0132910001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2007-06-07

Caracteristicilor produsului

_Product Monograph _
_ _
_Irinotecan Hydrochloride Injection USP _
_Page 1 of 71_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
IRINOTECAN HYDROCHLORIDE INJECTION USP
(Irinotecan Hydrochloride Injection)
Solution, 20 mg / mL, Intravenous
USP
Antineoplastic Agent
ATC: L01XX19
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
APR 20, 2005
Date of Revision:
SEP 14, 2022
Submission Control Number: 262849
_ _
_Product Monograph _
_ _
_Irinotecan Hydrochloride Injection USP _
_Page 2 of 71_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
07/2021
7 Warnings and Precautions, 7.1.2 Breast-feeding
07/2021
7 Warnings and Precautions, General, Patients with reduced
UGT1A1 activity
09/2022
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
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
...............................................