Irinotecan Kabi 20mg/ml Concentrate for Soln for Inf (2ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IRINOTECAN HYDROCHLORIDE, TRIHYDRATE

Available from:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC code:

L01XX19

INN (International Name):

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2012-03-07

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN KABI 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 Kabi is and what it is used for
2.
What you need to know before you use Irinotecan Kabi
3.
How to use Irinotecan Kabi
4.
Possible side effects
5.
How to store Irinotecan Kabi
6.
Contents of the pack and other information
1.
WHAT IRINOTECAN KABI IS AND WHAT IT IS USED FOR
Irinotecan Kabi 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 KABI
DO NOT USE IRINOTECAN KABI
•
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
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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irinotecan Kabi 20 mg/ml, concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The concentrate contains 20 mg/ml irinotecan hydrochloride trihydrate
(equivalent to 17.33 mg/ml
_ _
irinotecan).
One vial of 2 ml contains 40 mg of irinotecan hydrochloride
trihydrate.
One vial of 5ml contains 100 mg of irinotecan hydrochloride
trihydrate.
One vial of 15 ml contains 300 mg of irinotecan hydrochloride
trihydrate.
One vial of 25 ml contains 500 mg of irinotecan hydrochloride
trihydrate.
Excipient(s) with known effect:
Each ml contains 45 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The concentrate is a light yellow coloured solution, free from visible
particles.
pH: 3.0 to 3.8
Osmolarity: 250 to 400 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irinotecan Kabi 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 (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.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For adults only. Irinotecan Kabi solution for