Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Irinotecan hydrochloride trihydrate

Διαθέσιμο από:

Fresenius Kabi Deutschland GmbH

Φαρμακολογική κατηγορία (ATC):

L01XX; L01XX19

INN (Διεθνής Όνομα):

Irinotecan hydrochloride trihydrate

Δοσολογία:

20 micromole(s)

Φαρμακοτεχνική μορφή:

Solution for infusion

Θεραπευτική περιοχή:

Other antineoplastic agents; irinotecan

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2008-11-03

Φύλλο οδηγιών χρήσης

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
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.
WHAT IS IN THIS LEAFLET
1.
What Irinotecan is and what it is used for
2.
What you need to know before you use Irinotecan
3.
How to use Irinotecan
4.
Possible side effects
5.
How to store Irinotecan
6.
Contents of the pack and other information
1. WHAT IRINOTECAN IS AND WHAT IT IS USED FOR
Irinotecan belongs to a group of medicines called cytostatics (anti-
cancer medicines).
This medicine is used for the treatment of advanced cancer of colon
and rectum in adults and where the disease is at an advanced stage
in the large intestine, either in combination with other medicines
(combination therapy) or alone (monotherapy).
Your doctor may use a combination of irinotecan with 5-fluorouracil/
folinic acid (5FU/FA) and bevacizumab to treat your cancer of the
colon and rectum.
Your doctor may use a combination of irinotecan with capecitabine
with or without bevacizumab to treat your cancer of the colon and
rectum.
•
if you are using natural remedy St John’s Wort (_hypericum _
_perforatum_)
WARNINGS AND PRECAUTIONS:
Special care is also needed in elderly patients due to their greater
frequency of decreased biological functions.
As irinotecan is an anti-cancer medicine it will be administered to
you
in a special unit and under the supervision of a doctor qualified in
the
use of anti cancer medicines. The unit’s personnel will explain to
you
what you need to take special care of during and after the treatment.
This leaflet helps you to remember that.
If
you
receive
ir

Αρχείο Π.Χ.Π.

HealthProductsRegulatoryAuthority
18April2019
CRN008RX6
Page1of19
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�