Irinotecan 20 mg/ml Concentrate for solution for infusion

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Irinotecan

Inapatikana kutoka:

Fresenius Kabi Deutschland GmbH

ATC kanuni:

L01XX; L01XX09

INN (Jina la Kimataifa):

Irinotecan

Kipimo:

20 milligram(s)/millilitre

Dawa fomu:

Concentrate for solution for infusion

Eneo la matibabu:

Other antineoplastic agents; miltefosine

Idhini hali ya:

Marketed

Idhini ya tarehe:

2008-05-02

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN 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 have chronic inflammatory bowel disease and/or bowel
obstruction

if you are allergic to irinotecan hydrochloride trihydrate or any of
the other ingredients of this
medicine (listed in section 6 “What Irinotecan contains”)

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 (an herbal
extract containing Hypericum

Tabia za bidhaa

Health Products Regulatory Authority
10 March 2022
CRN00CQWT
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Irinotecan 20 mg/ml Concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20 mg Irinotecan hydrochloride trihydrate, equivalent
to 17.33 mg Irinotecan.
Each vial with 2 ml contains 40 mg Irinotecan hydrochloride
trihydrate.
Each vial with 5 ml contains 100 mg Irinotecan hydrochloride
trihydrate.
Each vial with 15 ml contains 300 mg Irinotecan hydrochloride
trihydrate.
Each vial with 25 ml contains 500 mg Irinotecan hydrochloride
trihydrate.
Excipient(s) with known effect:
Each ml contains 45 mg sorbitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Light yellow coloured solution.
pH: 3.0 – 3.7
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 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 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
POSOLOGY
For adults only. Irinotecan solution for infusion should be infused
into a peripheral or central vein.
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