VINORELBINE ACTAVIS 10 MGML

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

VINORELBINE AS TARTRATE

Beschikbaar vanaf:

DEVRIES & CO. LTD

ATC-code:

L01CA04

farmaceutische vorm:

CONCENTRATE FOR SOLUTION FOR INFUSION

Samenstelling:

VINORELBINE AS TARTRATE 10 MG/ML

Toedieningsweg:

I.V

Prescription-type:

Required

Geproduceerd door:

ACTAVIS ITALY S.P.A

Therapeutisch gebied:

VINORELBINE

therapeutische indicaties:

For the treatment of non small cell lung cancer. For the treatment of advanced breast cancer. Hormone- refractory prostate cancer, especially in combination with low dose oral corticoid therapy or Estramustin.

Autorisatie datum:

2015-01-28

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vinorelbine Actavis 10mg/ml concentrate for solution for
infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 10mg vinorelbine
base equivalent
to 13.85mg vinorelbine tartrate.
Each 1 ml vial contains 10 mg vinorelbine (as tartrate).
Each 5 ml vial contains 50 mg vinorelbine (as tartrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to slightly yellow solution with a pH of 3.3 to 3.8
and an osmolarity
of about 330mOsm/l.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vinorelbine
Actavis
is
indicated
in
adults
in
the
treatment of:
-
Non-small cell lung cancer
Advanced breast cancer
-
Hormone- refractory prostate cancer, especially in combination with
low dose oral
corticoid therapy or Estramustin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Strictly for intravenous administration after appropriate dilution ._
Intra-thecal administration is contra-indicated and may be fatal.
For instructions on dilution of the product before administration and
other handling,
see section 6.6.
Vinorelbine Actavis 10mg/ml concentrate for solution for infusion
should be given
in cooperation with a physician with extensive experience in therapy
with
cytostatics.
Posology
_Non-small cell lung cancer_ As a single agent the normal dose is
25-30mg/m²,
administered once weekly. In polychemotherapy the schedule regimen is
a function of
the protocol. The normal dose could be used (25-30mg/m²), but the
frequency of the
administration be reduced to for example day 1 and 5 every third week
or day 1 and 8
every third week according to the regimen.
_Advanced or metastatic breast cancer_
The normal dose is 25-30mg/m², administered once weekly.
The maximum tolerated dose per administration: 35.4 mg/m
2
body surface area.
Special populations
_OLDER PEOPLE_
Clinical experience has not identified relevant differences among
elderly patients with
reg