Irinotecan Koanaa 20 mg/ml concentrate for solution for infusion

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Irinotecan hydrochloride trihydrate

Saadav alates:

Koanaa Healthcare Limited

ATC kood:

L01XX; L01XX19

INN (Rahvusvaheline Nimetus):

Irinotecan hydrochloride trihydrate

Annus:

20 milligram(s)/millilitre

Ravimvorm:

Concentrate for solution for infusion

Retsepti tüüp:

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

Terapeutiline ala:

Other antineoplastic agents; irinotecan

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2017-07-07

Infovoldik

V03 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN KOANAA 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 Koanaa is and what it is used for
2.
What you need to know before you use Irinotecan Koanaa
3.
How to use Irinotecan Koanaa
4.
Possible side effects
5.
How to store Irinotecan Koanaa
6.
Contents of the pack and other information
1.
WHAT IRINOTECAN KOANAA IS AND WHAT IT IS USED FOR
Your medicine is called Irinotecan Koanaa. Irinotecan Koanaa belongs
to a group of
medicines called
CYTOSTATICS (ANTI-CANCER MEDICINES).
Irinotecan Koanaa 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 RECTUM)
where the disease is at an
ADVANCED STAGE.
Your doctor may use a combination of Irinotecan Koanaa with
5-FLUROURACIL/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 Koanaa with
CAPECITABINE
with or without
BEVACIZUMAB
to treat your
CANCER OF THE COLON OR RECTUM.
Your doctor may use a
combination of Irinotecan Koanaa with
CETUXIMAB
to treat 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 KOANAA
DO NOT USE IRINOTECAN KOANAA
-
if you are allergic to
IRINOTECAN HYDROCHLORIDE
or a

Toote omadused

Health Products Regulatory Authority
16 March 2020
CRN009DY8
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irinotecan Koanaa 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.
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 infusion should b