Irinotecan Hydrochloride 20 mg/mL concentrate for solution for infusion

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Irinotecan hydrochloride trihydrate

Prieinama:

Teva B.V.

ATC kodas:

L01XX; L01XX19

INN (Tarptautinis Pavadinimas):

Irinotecan hydrochloride trihydrate

Dozė:

20 milligram(s)/millilitre

Vaisto forma:

Concentrate for solution for infusion

Recepto tipas:

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

Gydymo sritis:

Other antineoplastic agents; irinotecan

Autorizacija statusas:

Marketed

Leidimo data:

2008-05-16

Pakuotės lapelis

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 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.
Irinotecan is indicated in combination with other medicines for the
treatment of patients with
advanced or metastatic cancer of the colon or rectum.
Irinotecan may be used alone in patients with metastatic cancer of the
colon or rectum whose
disease has recurred or progressed following initial
fluorouracil-based therapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IRINOTECAN
DO NOT USE IRINOTECAN
-
if you are allergic to irinotecan hydrochloride trihydrate or any of
the other ingredients
of this medicine (listed in section 6)
-
if you have chronic inflammatory bowel disease and/or bowel
obstruction
-
if you are a breast-feeding woman (see section 2)
-
if your bilirubin level is higher than 3 times the upper limit of the
normal range
-
if you have severe bone marrow failure
-
if you are in poor general condition (WHO performance status higher
than 2)
-
if you are taking or have recently taken St John’s Wort (a herbal
extract containing
Hypericum)
-
if you are to take or have rec

Prekės savybės

Health Products Regulatory Authority
21 November 2022
CRN00CKHG
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
Each mL of concentrate for solution for infusion contains 20 mg
irinotecan hydrochloride trihydrate, equivalent to 17.33 mg
irinotecan.
Each 2 mL vial contains 34.66 mg of irinotecan as 40 mg of irinotecan
hydrochloride trihydrate (40 mg/2 mL).
Each 5 mL vial contains 86.65 mg of irinotecan as 100 mg of irinotecan
hydrochloride trihydrate (100 mg/5 mL).
Each 15 mL vial contains 259.95 mg of irinotecan as 300 mg of
irinotecan hydrochloride trihydrate (300 mg/15 mL).
Each 25 mL vial contains 433.25 mg of irinotecan as 500 mg of
irinotecan hydrochloride trihydrate (500 mg/25 mL).
Excipient with known effect:
Each mL of concentrate for solution for infusion contains 45 mg
sorbitol (E420).
Each 2 mL vial contains 90 mg sorbitol (E420).
Each 5 mL vial contains 225 mg sorbitol (E420).
Each 15 mL vial contains 675 mg sorbitol (E420).
Each 25 mL vial contains 1.125 mg of sorbitol (E420).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irinotecan Hydrochloride 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 in combination with cetuximab is indicated
for the treatment of patients with epidermal growth factor
receptor (EGFR)-expressing RAS 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 Hydrochlori