Campto 100mg/5ml 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:

Pfizer 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: 5013457010619

Príbalový leták

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAMPTO 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 CAMPTO is and what it is used for
2.
What you need to know before you use CAMPTO
3.
How to use CAMPTO
4.
Possible side effects
5.
How to store CAMPTO
6.
Contents of the pack and other information
1.
WHAT CAMPTO IS AND WHAT IT IS USED FOR
CAMPTO 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.
CAMPTO is indicated in combination with other medicines for the
treatment of patients with
advanced or metastatic cancer of the colon or rectum.
CAMPTO 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 CAMPTO
DO NOT USE CAMPTO

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 CAMPTO
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 (a herbal
extract containing
Hypericum)

if you are to take or have recent

Súhrn charakteristických

OBJECT 1
CAMPTO 20 MG/ML, CONCENTRATE FOR SOLUTION FOR
INFUSION (100MG & 300MG PRESENTATION)
Summary of Product Characteristics Updated 05-Jun-2018 | Pfizer
Limited
1. Name of the medicinal product
CAMPTO 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 34.66 mg of irinotecan as 40 mg of
irinotecan hydrochloride, trihydrate (40
mg/2 ml).
One vial of 5 ml contains 86.65 mg of irinotecan as 100 mg of
irinotecan hydrochloride, trihydrate (100
mg/5 ml).
One vial of 15 ml contains 259.95 mg of irinotecan as 300 mg of
irinotecan hydrochloride, trihydrate (300
mg/15 ml).
Excipient(s) with known effect
Sorbitol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
4. Clinical particulars
4.1 Therapeutic indications
CAMPTO 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.
CAMPTO 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).
CAMPTO 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.
CAMPTO 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. CAMPTO solution for infusion should be infused into a
peripheral or ce