JAVLOR

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

VINFLUNINE DITARTRATE

Tillgänglig från:

PERRIGO ISRAEL AGENCIES LTD

ATC-kod:

L01CA05

Läkemedelsform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sammansättning:

VINFLUNINE DITARTRATE 25 MG/ML

Administreringssätt:

I.V

Receptbelagda typ:

Required

Tillverkad av:

PIERRE FABRE MEDICAMENT PRODUCTION, FRANCE

Terapeutisk grupp:

VINFLUNINE

Terapiområde:

VINFLUNINE

Terapeutiska indikationer:

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 platinium-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with Performance Status ≥2.

Tillstånd datum:

2017-08-31

Bipacksedel

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
12/12/2013
םש
רישכת
תילגנאב
רפסמו :םושירה
JAVLOR -
148 69 33536 00
םש
לעב
םושירה
ןיילידמ
מ"עב
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE &
ADMINISTRATION
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS FOR USE
INTERACTION WITH OTHER
MEDICAMENTS AND OTHER
FORMS OF INTERACTION
FERTILITY, PREGNANCY AND
LACTATION
ADVERSE EVENTS
NA
Vascular disorders: Phlebitis
ב"צמ
ובש ,ןולעה
נמוסמ
תו
תורמחהה
שקובמה
תו
לע
עקר
בוהצ
.
םייוניש
םניאש
רדגב
תורמחה
ונמוס
)ןולעב(
עבצב
שי .הנוש
ןמסל
קר
ןכות
יתוהמ
אלו
םייוניש
םוקימב
.טסקטה

Produktens egenskaper

1
טמרופ
ע עבקנ הז ןולע
"
ב רשואו קדבנ ונכותו תואירבה דרשמ י
רבמטפס
2014
SUMMARY OF PRODUCT CHARACTERISTICS
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.
_U_
Posology
The recommended dose is 320 mg/m² vinflunine as a 20 minute
intravenous infusion every 3 weeks.
2
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-m