TOPOTECAN VENUS 4MG/VIAL ΚΟΝΙΣ ΓΙΑ ΕΝΑΙΩΡΗΜΑ ΠΡΟΣ ΕΓΧΥΣΗ

Nazione: Cipro

Lingua: greco

Fonte: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Principio attivo:

TOPOTECAN HYDROCHLORIDE

Commercializzato da:

VENUS PHARMA GMBH (0000008606) AM BAHNHOF 1-3, WERNE, 59368

Codice ATC:

L01CE01

INN (Nome Internazionale):

TOPOTECAN

Dosaggio:

4MG/VIAL

Forma farmaceutica:

ΚΟΝΙΣ ΓΙΑ ΕΝΑΙΩΡΗΜΑ ΠΡΟΣ ΕΓΧΥΣΗ

Composizione:

TOPOTECAN HYDROCHLORIDE (8000001521) 4,34MG

Via di somministrazione:

INTRAVENOUS USE

Tipo di ricetta:

Εθνική Διαδικασία

Area terapeutica:

TOPOTECAN

Dettagli prodotto:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 5 VIALS X 4MG (310033601) 5 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Scheda tecnica

Page 2 of 15
1
.
NAME OF THE MEDICINAL PRODUCT
Topotecan Venus 4mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 4 mg topotecan (as hydrochloride).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Light yellow to greenish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topotecan Venus monotherapy is indicated for the treatment of:

patients with metastatic carcinoma of the ovary after failure of
first-line or subsequent
t
h
e
r
a
py.

patients with relapsed small cell lung cancer [SCLC] for whom
re-treatment with the f
i
rs
t
-
line
regimen is not considered appropriate (see section 5.1).
Topotecan Venus 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).
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).
Page 3 of 15
Topotecan Venus must be reconstituted and further diluted before use
(see section 6.6).
_Ovarian and 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 5 consecutive days with a 3 week
interval between the start of ea