Topotecan Teva

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

topotecan

Tilgængelig fra:

Teva B.V.

ATC-kode:

L01CE01

INN (International Name):

topotecan

Terapeutisk gruppe:

Antineoplastic agents

Terapeutisk område:

Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma

Terapeutiske indikationer:

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. , 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.,

Produkt oversigt:

Revision: 8

Autorisation status:

Withdrawn

Autorisation dato:

2009-09-21

Indlægsseddel

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPOTECAN TEVA 1 MG/1 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 or nurse.
-
If you get any side effects talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Topotecan Teva is and what it is used for
2.
What you need to know before you use Toptecan Teva
3.
How to use Topotecan Teva
4.
Possible side effects
5.
How to store Topotecan Teva
6.
Contents of the pack and other information
1.
WHAT TOPOTECAN TEVA IS AND WHAT IT IS USED FOR
Topotecan Teva helps to kill tumour cells.
Topotecan Teva 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 Teva is combined with another medicine
called cisplatin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TOPOTECAN TEVA
DO NOT USE TOPOTECAN TEVA:
-
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 cells count is 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 you think any of these could apply to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Topotecan Teva:
-
if you have any kidney problems. Your dose of Topotecan Teva may need
to be adjusted. The
use of Topotecan Teva is not recommended in patients with severe renal
impairment;
-
if you have liver problems. Your dose of Topotecan Teva may need to be
adjusted. The use of
Topotecan Teva is not recommended in patients with severe liver
impairment;
-
if you currently have lung p

Produktets egenskaber

1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Topotecan Teva 1 mg/1 ml concentrate for solution for infusion
Topotecan Teva 4 mg/4 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Topotecan Teva 1 mg/1 ml concentrate for solution for infusion
1 ml of concentrate for solution for infusion contains 1 mg topotecan
(as hydrochloride).
Topotecan Teva 4 mg/4 ml concentrate for solution for infusion
1 ml of concentrate for solution for infusion contains 1 mg topotecan
(as hydrochloride).
One vial of 4 ml of concentrate for solution for infusion contains 4
mg topotecan (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear pale yellow liquid. pH = 2.0-2.6.
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 and 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 cou