Irinotecan 500mg/25ml concentrate for solution for infusion vials

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Irinotecan hydrochloride trihydrate

Dostupné z:

Accord-UK Ltd

ATC kód:

L01CE02

INN (Medzinárodný Name):

Irinotecan hydrochloride trihydrate

Dávkovanie:

20mg/1ml

Forma lieku:

Solution for infusion

Spôsob podávania:

Intravenous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 08010500; GTIN: 5055565729786

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
IRINOTECAN HYDROCHLORIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
irinotecan hydrochloride trihydrate
The name of your medicine is ‘Irinotecan Hydrochloride 20 mg/ml
Concentrate for Solution for
Infusion’ but in the rest of the leaflet it will be called
“Irinotecan Injection”.
Read all of this leaflet carefully before you start using this
medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1.
What Irinotecan Injection
is and what it is used for
2.
What you need to know before you are given Irinotecan Injection
3.
How you will be given Irinotecan Injection
4.
Possible side effects
5.
How to store Irinotecan Injection
6.
Contents of the pack and other information
1. WHAT IRINOTECAN INJECTION IS AND WHAT IT IS USED FOR
Irinotecan belongs to a group of medicines called cytostatics
(anti-cancer medicines). Irinotecan is
used for the treatment of advanced cancer of the colon and rectum in
adults, either in a combination
with other medicines or alone.
Your doctor may use a combination of Irinotecan with
5-FLUOROURACIL/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 with
CAPECITABINE
with or without
BEVACIZUMAB
to
treat your
CANCER OF THE COLON AND RECTUM.
Your doctor may use a combination of Irinotecan 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 ARE GIVEN IRINOTECAN INJECTION
YOU SHOULD NOT BE GIVEN IRINOTECAN INJECTION IF YOU

are allergic to Irinotecan Injection or any of the other ingredie

Súhrn charakteristických

OBJECT 1
IRINOTECAN HYDROCHLORIDE ACCORD 20 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 07-Apr-2018 | Accord
Healthcare Limited
1. Name of the medicinal product
Irinotecan Hydrochloride 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 2 ml contains 40 mg of irinotecan hydrochloride
trihydrate (40 mg/2 ml)
Each vial of 5 ml contains 100 mg of irinotecan hydrochloride
trihydrate (100 mg/5 ml)
Each vial of 15 ml contains 300 mg of irinotecan hydrochloride
trihydrate (300 mg/15 ml)
Each vial of 25 ml contains 500 mg of irinotecan hydrochloride
trihydrate (500 mg/25 ml)
Excipient with known effect
Each ml contains 45 mg sorbitol.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
A pale yellow clear solution practically free from particles. pH in
the range of approximately 3.0 to 3.8
and osmolality in the range of approximately 270 to 330 mOsmol/kg.
4. Clinical particulars
4.1 Therapeutic indications
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for
Infusion 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 20 mg/ml Concentrate for Solution for
Infusion 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. (see
section 5.1)
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for
Infusion in combination with 5-
fluorouracil, foli