NAVELBINE 50MG/5ML CONCENTRATE FOR SOLUTION FOR INFUSION

Država: Cipar

Jezik: grčki

Izvor: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Aktivni sastojci:

VINORELBINE TARTRATE

Dostupno od:

PIERRE FABRE MEDICAMENT (0000003610) 45 PLACE ABEL GANCE, BOULOGNE, 92100

ATC koda:

L01CA04

INN (International ime):

VINORELBINE

Doziranje:

50MG/5ML

Farmaceutski oblik:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sastav:

VINORELBINE TARTRATE (8000002466) 69.250000000000MG

Administracija rute:

INTRAVENOUS USE

Tip recepta:

Εθνική Διαδικασία

Područje terapije:

VINORELBINE

Proizvod sažetak:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 10 VIALS X 5ML (980000901) 10.00 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
NAVELBINE, CONCENTRATE FOR SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Navelbine
10mg/ml, concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Navelbine
is a clear colourless to pale yellow solution with a pH range from 3.3
to 3.8.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Non-small cell lung cancer.
Advanced breast cancer.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Strictly intravenous administration after appropriate dilution.
Intra-thecal administration of NAVELBINE
®
may be fatal.
Instructions for use and handling: see section 6.6.
It is recommended to infuse NAVELBINE
®
over 6-10 minutes after dilution in 20-50 ml of sodium
chloride 9 mg/ml (0.9%) solution for injection or in glucose solution
for injection 5%.
Administration should always be followed with at least 250 ml of an
isotonic solution infusion to flush
the vein.
Posology
_cy_9800009_spc.doc_
ACTIVE
INGREDIENT
FORMULATION
10 mg/1ml
50 mg/5 ml
vinorelbine tartrate
(mg)
13.85
69.25
equivalent to
vinorelbine (INN) base
(mg)
10.00
50.00
1
- NON-SMALL CELL LUNG CANCER AND ADVANCED BREAST CANCER
In monotherapy the usual dose given is 25-30 mg/m² once weekly.
In combination chemotherapy the usual dose (25-30 mg/m²) is usually
maintained, while the
frequency of administration is reduced e.g. day 1 and 5 every 3 weeks
or day 1 and 8 every 3 weeks
according to treatment protocol.
Special populations
- ADMINISTRATION IN THE ELDERLY
Clinical experience has not identified relevant differences among
elderly patients with regard to the
response rate, although greater sensitivity in some of these patients
cannot be excluded. Age does not
modify the pharmacokinetics of vinorelbine (see section 5.2).
- ADMINISTRATION IN PATIENTS WITH LIVER INSUFFICIENCY
The pharmacokinetics of NAVELBINE
®
is not modified in patients presenting moderate or seve