IRINOTECAN HYDROCHLORIDE 20 MG/ML CONCENTRATE FOR

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

Disponível em:

Fresenius Kabi Oncology Plc

Código ATC:

L01XX19

DCI (Denominação Comum Internacional):

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

Dosagem:

20 Micromol

Forma farmacêutica:

Solution for Infusion

Tipo de prescrição:

Product subject to prescription which may not be renewed (A)

Área terapêutica:

irinotecan

Status de autorização:

Marketed

Data de autorização:

2008-11-03

Folheto informativo - Bula

IRINOTECAN-PACK INSERT-(ACCORD)-UK+IE-BORDON-592X300 (RFI)-
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Date: 01 August 2017 Version: 01
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Form No.: SOP/PDD/014-02 Rev. 00
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN HYDROCHLORIDE 20 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
Irinotecan Hydrochloride Trihydrate
Read all of this leaflet carefully before you start using this
medicine.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1. What Irinotecan Hydrochloride is and what it is used for
2. Before you use Irinotecan Hydrochloride
3. How to use Irinotecan Hydrochloride
4. Possible side effects
5. How to store Irinotecan Hydrochloride
6. Further information
1. WHAT IRINOTECAN HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Irinotecan Hydrochloride belongs to a group of medicines called
cytostatics (anti-cancer medicines). Irinotecan Hydrochloride is used
for the treatment of advanced cancer of the colon and rectum in
adults,
either in a combination with other medicines or alone.
2. BEFORE YOU USE IRINOTECAN HYDROCHLORIDE
DO NOT USE IRINOTECAN HYDROCHLORIDE IF YOU
•
are allergic (hypersensitive) to Irinotecan Hydrochloride Trihydrate
or any of the other ingredients of Irinotecan
•
have
or
had
chronic
inflammatory
bowel
disease
or
bowel
obstruction
•
are pregnant or breast fe

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 20 mg Irinotecan hydrochloride
trihydrate equivalent to 17.33 mg irinotecan.
Each 2 ml or 5 ml or 15ml or 25 ml vial of Irinotecan concentrate for
solution for infusion contains 40 mg or 100 mg or
300mg or 500 mg of Irinotecan hydrochloride trihydrate respectively.
Excipient:
Sorbitol E420
Sodium
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A pale yellow clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irinotecan concentrate for solution for infusion is indicated for the
treatment of patients with advanced colorectal
cancer:
•
In combination with 5-fluorouracil and folinic acid in patients
without prior chemotherapy for advanced disease,
•
As a single agent in patients who have failed an established
5-fluorouracil containing treatment regimen.
Irinotecan in combination with cetuximab is indicated for the
treatment of patients with epidermal growth factor
receptor (EGFR)-expressing metastatic colorectal cancer after failure
of irinotecan-including cytotoxic therapy.
Irinotecan in combination with 5-fluorouracil, folinic acid and
bevacizumab is indicated for first-line treatment of
patients with metastatic carcinoma of the colon or rectum.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For adults only. After dilution Irinotecan concentrate for solution
for infusion should be infused into a peripheral or
central vein.
RECOMMENDED DOSAGE:
In monotherapy (for previously treated patient):
The recommended dosage of Irinotecan Hydrochloride Trihydrate is 350
mg/m² administered as an intravenous
infusion over a 30 to 90 minute period every three weeks (see below
“Method of Administration” and section 4.4 and
6.6).
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