Javlor

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

vinflunine

Saatavilla:

Pierre Fabre Medicament

ATC-koodi:

L01CA05

INN (Kansainvälinen yleisnimi):

vinflunine

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Carcinoma, Transitional Cell; Urologic Neoplasms

Käyttöaiheet:

Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.

Tuoteyhteenveto:

Revision: 10

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-09-21

Pakkausseloste

7
B. PACKAGE LEAFLET
8
PACKAGE LEAFLET: INFORMATION FOR THE USER
JAVLOR 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
vinflunine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Javlor is and what it is used for
2.
What you need to know before you use Javlor
3.
How to use Javlor
4.
Possible side effects
5.
How to store Javlor
6.
Content of the pack and other information
1.
WHAT JAVLOR IS AND WHAT IT IS USED FOR
Javlor contains the active substance vinflunine, which belongs to a
group of anticancer medicines
called vinca alkaloids. These medicines affect cancer cell growth by
stopping cell division, leading to
cell death (cytotoxicity).
Javlor is used to treat advanced or metastatic cancer of the bladder
and urinary tract when a previous
therapy with platinum-containing medicines has failed.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE JAVLOR
DO NOT USE JAVLOR
-
if you are allergic to the active substance (vinflunine) or to other
vinca alkaloids (vinblastine,
vincristine, vindesine, vinorelbine),
-
if you have had (in the last 2 weeks) or currently have a severe
infection,
-
if you are breast-feeding,
-
if your levels of white blood cells and/or platelets are too low
WARNINGS AND PRECAUTIONS
Tell your doctor:
-
if you have liver, kidney or heart problems,
-
if you experience any neurological symptoms such as headaches, changed
mental state which may
lead to confusion and coma, convulsions, blurred vision and high blood
pressure as you may need
to stop taking this medicine,
-
if you are taking other medicines mentioned in “Using other
medicines” below,
-
if you have constipation, or if you are treated with medicines against
pain (opioids), or if you have
an abdominal cancer,

Valmisteyhteenveto

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Javlor 25 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of concentrate contains 25 mg of vinflunine (as ditartrate).
One 2 mL vial contains 50 mg of vinflunine (as ditartrate).
One 4 mL vial contains 100 mg of vinflunine (as ditartrate).
One 10 mL vial contains 250 mg of vinflunine (as ditartrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Javlor is indicated in monotherapy for the treatment of adult patients
with advanced or metastatic
transitional cell carcinoma of the urothelial tract after failure of a
prior platinum-containing regimen
Efficacy and safety of vinflunine have not been studied in patients
with performance status
≥
2.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vinflunine treatment should be initiated under the responsibility of a
physician qualified in the use of
anticancer chemotherapy and is confined to units specialised in the
administration of cytotoxic
chemotherapy.
Before each cycle, adequate monitoring of complete blood counts should
be conducted to verify the
absolute neutrophil count (ANC), platelets and haemoglobin as
neutropenia, thrombocytopenia and
anaemia are frequent adverse reactions of vinflunine.
Posology
The recommended dose is 320 mg/m² vinflunine as a 20 minute
intravenous infusion every 3 weeks.
In case of WHO/ECOG performance status (PS) of 1 or PS of 0 and prior
pelvic irradiation, the
treatment should be started at the dose of 280 mg/m². In the absence
of any haematological toxicity
during the first cycle causing treatment delay or dose reduction, the
dose will be increased to
320 mg/m² every 3 weeks for the subsequent cycles.
_Recommended co-medication _
In order to prevent constipation, laxatives and dietary measures
including oral hydration are
recomm