Topotecan Eagle
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
14-11-2014
Produktets egenskaber
(SPC)
14-11-2014
Offentlige vurderingsrapport
(PAR)
14-11-2014
Aktiv bestanddel:
topotecan (as hydrochloride)
Tilgængelig fra:
Eagle Laboratories Ltd.
ATC-kode:
L01CE01
INN (International Name):
topotecan
Terapeutisk gruppe:
Antineoplastic and immunomodulating agents
Terapeutisk område:
Carcinoma; Small Cell Lung Carcinoma
Terapeutiske indikationer:
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.
Produkt oversigt:
Revision: 2
Autorisation status:
Withdrawn
Autorisation dato:
2011-12-22
Indlægsseddel
43
B. PACKAGE LEAFLET
_ _
Medicinal Product no longer authorised
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPOTECAN EAGLE 3 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION
topotecan
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 or nurse.
-
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 or nurse.
IN THIS LEAFLET:
1.
WHAT TOPOTECAN EAGLE IS AND WHAT IT IS USED FOR
2.
BEFORE YOU ARE GIVEN TOPOTECAN EAGLE
3.
HOW TO USE TOPOTECAN EAGLE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TOPOTECAN EAGLE
6.
FURTHER INFORMATION
1.
WHAT TOPOTECAN EAGLE IS AND WHAT IT IS USED FOR
The name of your medicine is Topotecan Eagle 3 mg/1 ml concentrate for
solution for infusion (called
Topotecan Eagle in this leaflet).
Topotecan Eagle helps to kill tumour cells. It is a type of
chemotherapy.
Topotecan Eagle is used to treat:
-
small cell lung cancer that has come back after chemotherapy
-
advanced cervical cancer when surgery or radiotherapy are not
possible. In this case, it is used
with another medicine called cisplatin.
2.
BEFORE YOU ARE GIVEN TOPOTECAN EAGLE
YOU SHOULD NOT RECEIVE TOPOTECAN EAGLE:
-
if you are allergic (hypersensitive) to topotecan or to any of the
other ingredients of this
medicine listed in Section 6
-
if you are breast-feeding. You should stop breast-feeding before
starting treatment with
Topotecan Eagle
-
if your blood cell count is too low. Your doctor will check this.
Do not use Topotecan Eagle if any of the above apply to you. If you
are not sure, talk to your doctor
or nurse before using this medicine.
TAKE SPECIAL CARE WITH TOPOTECAN EAGLE
Check with your doctor or nurse before using your medicine:
-
if you have any kidney problems. Your dose of Topotecan Eagle may
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate for solution for infusion contains 3 mg
topotecan (as hydrochloride).
Each 1 ml single dose vial contains 3 mg of topotecan.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear light yellow to orange solution, pH ≤ 1.2.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 (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
Posology
When 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).
_Small Cell Lung Carcinoma _
_Initial dose _
The recommended dose of topotecan is 1.5 mg/m
2
body surface area/day administered by intravenous
infusion over 30 minutes daily for five consecutive days with a three
week interval between the start
of each course. If well tolerated, treatment may continue until
disease progression (see sections 4.8
and 5.1).
_Subsequent doses _
Topotecan should not be re-administered unless the neutrophil count is
≥ 1 x 10
9
/l, the platelet count
is ≥ 100 x 10
9
/l, and the haemoglobin level is ≥ 9 g
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