Topotecan Hospira

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

topotecan

Dostupné z:

Pfizer Europe MA EEIG

ATC kód:

L01CE01

INN (Medzinárodný Name):

topotecan

Terapeutické skupiny:

Other antineoplastic agents

Terapeutické oblasti:

Uterine Cervical Neoplasms; Small Cell Lung Carcinoma

Terapeutické indikácie:

Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.,

Prehľad produktov:

Revision: 19

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2010-06-09

Príbalový leták

23
B. PACKAGE LEAFLET
24
Package leaflet: Information for the user
Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion
topotecan
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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet:
1.
What Topotecan Hospira is and what it is used for
2.
What you need to know before you are given Topotecan Hospira
3.
How Topotecan Hospira is used
4.
Possible side effects
5.
How to store Topotecan Hospira
6.
Contents of the pack and other information
1.
What Topotecan Hospira is and what it is used for
Topotecan Hospira helps to destroy tumours. A doctor or a nurse will
give you the medicine as an
infusion into a vein in hospital.
Topotecan Hospira is used to treat:

ovarian cancer or small cell lung cancer that has come back after
chemotherapy.

advanced cervical cancer if surgery or radiotherapy treatment is not
possible. When treating
cervical cancer, Topotecan Hospira is combined with another medicine
called cisplatin.
Your doctor will decide with you whether Topotecan Hospira therapy is
better than further treatment
with your initial chemotherapy.
2.
What you need to know before you are given Topotecan Hospira
You should not receive Topotecan Hospira:

if you are allergic to topotecan or any of the other ingredients of
this medicine (listed in
section 6)

if you are breast-feeding

if your blood cell counts are too low. Your doctor will tell you
whether this is the case, based on
the results of your last blood test.
Tell your doctor if any of these applies to you.
Warnings and precautions
Before you are given this medicine your doctor needs to know:

if you have any kidney or liver problems. Your dose of Topotecan
Hospira may need to be
adjusted.

if you are pre

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg topotecan
(as hydrochloride).
Each 4 ml vial of concentrate contains 4 mg topotecan (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
A clear yellow to yellow-green solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Topotecan monotherapy is indicated for the treatment of:

patients with metastatic carcinoma of the ovary after failure of
first-line or subsequent therapy.

patients with relapsed small cell lung cancer (SCLC) for whom
re-treatment with the first-line
regimen is not considered appropriate (see section 5.1).
Topotecan in combination with cisplatin is indicated for patients with
carcinoma of the cervix
recurrent after radiotherapy and for patients with Stage IVB disease.
Patients with prior exposure to
cisplatin require a sustained treatment-free interval to justify
treatment with the combination (see
section 5.1).
4.2
Posology and method of administration
The use of topotecan should be confined to units specialised in the
administration of cytotoxic
chemotherapy. Topotecan should only be administered under the
supervision of a physician
experienced in the use of chemotherapy (see section 6.6).
Posology
When topotecan is used in combination with cisplatin, the full
prescribing information for cisplatin
should be consulted.
Prior to administration of the first course of topotecan, patients
must have a baseline neutrophil count
of ≥1.5 x 10
9
/l, a platelet count of ≥100 x 10
9
/l and a haemoglobin level of ≥9 g/dl (after transfusion if
necessary).
Ovarian and small cell lung carcinoma
Initial dose
The recommended dose of topotecan is 1.5 mg/m
2
body surface area per day administered by
intravenous infusion over 30 minutes daily for f