Irinotecan Hydrochloride 20mg/ml Concentrate for Solution for Infusion (25ml vial)

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

IRINOTECAN HYDROCHLORIDE, TRIHYDRATE

Disponible depuis:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Code ATC:

L01XX19

DCI (Dénomination commune internationale):

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg/ml

forme pharmaceutique:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg/ml

Type d'ordonnance:

POM

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2016-05-25

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN HYDROCHLORIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
irinotecan hydrochloride trihydrate
The name of your medicine is ‘Irinotecan Hydrochloride 20 mg/ml
Concentrate for Solution for
Infusion’ but in the rest of the leaflet it will be called
“Irinotecan Injection”.
Read all of this leaflet carefully before you start using this
medicine because it contains important
information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Irinotecan Injection
is and what it is used for
2.
What you need to know before you are given Irinotecan Injection
3.
How you will be given Irinotecan Injection
4.
Possible side effects
5.
How to store Irinotecan Injection
6.
Contents of the pack and other information
1. WHAT IRINOTECAN INJECTION IS AND WHAT IT IS USED FOR
Irinotecan belongs to a group of medicines called cytostatics
(anti-cancer medicines). Irinotecan is
used for the treatment of advanced cancer of the colon and rectum in
adults, either in a combination
with other medicines or alone. Irinotecan Injection is an anticancer
medicine containing the active
substance irinotecan hydrochloride, trihydrate. Irinotecan
hydrochloride trihydrate interferes with the
growth and spread of cancer cells in the body.
Your doctor may use a combination of Irinotecan with
5-FLUOROURACIL/FOLINIC ACID (5FU/FA)
and
BEVACIZUMAB
to treat your
CANCER OF THE LARGE INTESTINE (COLON OR RECTUM).
Your doctor may use a combination of Irinotecan with
CAPECITABINE
with or without
BEVACIZUMAB
to
treat your
CANCER OF THE COLON AND RECTUM.
Your doctor may use a combination of Irinotecan with
CETUXIMAB
to treat a particular type of
CANCER
OF THE LARGE INTESTINE (KRAS WILD-TYPE)
which expresses a protein called
EGFR

Résumé des caractéristiques du produit

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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 vial of 2 ml contains 40 mg of irinotecan hydrochloride
trihydrate (40 mg/2 ml)
Each vial of 5 ml contains 100 mg of irinotecan hydrochloride
trihydrate (100 mg/5 ml)
Each vial of 15 ml contains 300 mg of irinotecan hydrochloride
trihydrate (300 mg/15 ml)
Each vial of 25 ml contains 500 mg of irinotecan hydrochloride
trihydrate (500 mg/25 ml)
Each vial of 50 ml contains 1000 mg of Irinotecan hydrochloride
trihydrate (1000 mg/50 ml)
Excipient with known effect
Each ml contains 45 mg sorbitol.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A pale yellow clear solution practically free from particles. pH in
the range of approximately 3.0 to 3.8
and osmolality in the range of approximately 270 to 330 mOsmol/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irinotecan Hydrochloride 20 mg/ml 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 Hydrochloride 20 mg/ml Concentrate for
Solution
for Infusion
in combination
with
cetuximab is indicated for the treatment of patients with epidermal
growth factor receptor (EGFR)-
expressing, KRAS wild- type metastatic colorectal cancer, who had not
received prior treatment for
metastatic disease or after failure of irinotecan-including cytotoxic
therapy. (see section 5.1)
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for
Infusion in combination with 5-
fluorouracil, folinic acid and bevacizumab is indicated for first-line
treatment of pati