NAVELBINE 50MG/5ML CONCENTRATE FOR SOLUTION FOR INFUSION

Riik: Küpros

keel: kreeka

Allikas: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Toimeaine:

VINORELBINE TARTRATE

Saadav alates:

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

ATC kood:

L01CA04

INN (Rahvusvaheline Nimetus):

VINORELBINE

Annus:

50MG/5ML

Ravimvorm:

CONCENTRATE FOR SOLUTION FOR INFUSION

Koostis:

VINORELBINE TARTRATE (8000002466) 69.250000000000MG

Manustamisviis:

INTRAVENOUS USE

Retsepti tüüp:

Εθνική Διαδικασία

Terapeutiline ala:

VINORELBINE

Toote kokkuvõte:

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

Toote omadused

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