Irinotecan Kabi Concentrate for Soln for Inf 500mg/25ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IRINOTECAN

Available from:

Fresenius Kabi Oncology PLC

ATC code:

L01XX19

INN (International Name):

IRINOTECAN

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

IRINOTECAN 20 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Patient Information leaflet

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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes side
effects not listed in this leaflet.
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 belongs to a group of medicines called cytostatics
(anti-cancer
medicines).
This medicine is used for the treatment of advanced cancer of the
colon and rectum in
adults, either in a combination with other medicines (i.e.
5-fluorouracil/folinic acid,
bevacizumab, cetuximab, capecitabine) or alone.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE IRINOTECAN KABI
DO NOT USE IRINOTECAN KABI
-
if you are allergic to irinotecan hydrochloride trihydrate or any of
the other
ingredients of this medicine (listed in section 6).
-
if you have any other bowel disease or a history of bowel obstruction
-
if you are breast-feeding
-
if you have increased levels of bilirubin in the blood (more than 3
times the upper
limit of normal)
-
if you do not have enough blood cells(severe bone marrow failure)
-
if you are in a poor general health (evaluated by an international
standard)
-
if you are using the natural remedy St Johns’ Wort (_Hypericum
perforatum_).
Please
consult
the
package
leaflet
of
cetuximab,
bevacizumab
or
capecitabine
for
additional informati

Summary of Product characteristics

Page 1 of 24
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:
45 mg sorbitol (E420) per ml.
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, 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 capecitabine with or without
bevacizumab is indicated
for first-line treatment of patients with metastatic colorectal
carcinoma.
Irinotecan in combination with 5-fluorouracil, folinic acid and
bevacizumab is
Page 2 of 24
indicated for first-line treatment of patients with metastatic
carcinoma of the colon
or rectum.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For adults only. After dilution Irinotecan Kabi, solution for infu