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

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

IRINOTECAN HYDROCHLORIDE, TRIHYDRATE

Pieejams no:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATĶ kods:

L01XX19

SNN (starptautisko nepatentēto nosaukumu):

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg/ml

Zāļu forma:

CONCENTRATE FOR SOLUTION FOR INFUSION

Kompozīcija:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg/ml

Receptes veids:

POM

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Autorizācija statuss:

Withdrawn

Autorizācija datums:

2019-06-12

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN MYLAN 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,nurse or
pharmacist.
_-_
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 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 Mylan is and what it is used for
2.
What you need to know before you use Irinotecan Mylan
3.
How to use Irinotecan Mylan
4.
Possible side effects
5.
How to store Irinotecan Mylan
6.
Contents of the pack and other information
1.
WHAT IRINOTECAN MYLAN IS AND WHAT IT IS USED FOR
Your medicine is called Irinotecan Mylan. Irinotecan Mylan belongs to
a group of medicines
called
CYTOSTATICS (ANTI-CANCER MEDICINES).
Irinotecan Mylan may be used alone or in combination with a number of
other medicines used to
treat cancer. These combinations may be used to treat
CANCER OF THE LARGE INTESTINE (COLON OR
RECUM)
where the disease is at an
ADVANCED STAGE.
Your doctor may use a combination of Irinotecan Mylan with
5-FLUROURACIL/FOLINIC ACID
(5FU/FA)
and
BEVACIZUMAB
to treat your
CANCER OF THE LARGE INTESTINE (COLON OR RECUM).
Your doctor may use a combination of Irinotecan Mylan with
CAPECITABINE
with or without
BEVACIZUMAB
to treat your
CANCER OF THE COLON OR RECUM.
Your doctor may use a combination of
Irinotecan Mylan with
CETUXIMAB
to trate a particular type of
CANCER OF THE LARGE INTESTINE
(KRAS WILD-TYPE)
which expresses a protein called
EGFR.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IRINOTECAN MYLAN
_ _
DO NOT USE IRINOTECAN MYLAN
_-_
if you are allergic to
IRINOTECAN HYDROCHLORIDE
or any of the other

Produkta apraksts

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irinotecan Mylan 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 2ml contains 40 mg of irinotecan hydrochloride
trihydrate.
Each vial of 5ml contains 100 mg of irinotecan hydrochloride
trihydrate.
Each vial of 15ml contains 300 mg of irinotecan hydrochloride
trihydrate.
Each vial of 25ml contains 500 mg of irinotecan hydrochloride
trihydrate.
Excipients with known effect: Also includes sorbitol (45 mg/ml) and
sodium (less than 1 mmol
sodium (23 mg) per dose, i.e. essentially ‘sodium- free’).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Pale yellow color clear aqueous solution, free from visible particles.
pH 3.0 to 3.8.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irinotecan 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, KRAS wild-type metastatic
colorectal cancer, who had not
received prior treatment for metastatic disease or after failure of
irinotecan-including cytotoxic therapy
(please see 5.1).
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.
Irinotecan in combination with capecitabine with or without
bevacizumab is indicated for first-line
treatment of patients with metastatic colorectal carcinoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For adults only. Irinotecan solution for infus