Yondelis

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

trabectedin

Διαθέσιμο από:

Pharma Mar S.A.

Φαρμακολογική κατηγορία (ATC):

L01CX01

INN (Διεθνής Όνομα):

trabectedin

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Ovarian Neoplasms; Sarcoma

Θεραπευτικές ενδείξεις:

Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.

Περίληψη προϊόντος:

Revision: 27

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2007-09-17

Φύλλο οδηγιών χρήσης

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
YONDELIS 0.25 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
YONDELIS 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
trabectedin
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 Yondelis is and what it is used for
2.
What you need to know before you are given Yondelis
3.
How to use Yondelis
4.
Possible side effects
5.
How to store Yondelis
6.
Contents of the pack and other information
1.
WHAT YONDELIS IS AND WHAT IT IS USED FOR
Yondelis contains the active substance trabectedin. Yondelis is an
anti-cancer medicine that works
by preventing the tumour cells from multiplying.
Yondelis is used for the treatment of patients with advanced soft
tissue sarcoma, when previous
medicines have been unsuccessful or the patients are unsuited to
receive them. Soft tissue sarcoma
is a malignant disease that starts somewhere in the soft tissues, such
as the muscles, fat or other
tissues (for example cartilages or vessels).
Yondelis in combination with pegylated liposomal doxorubicin (PLD:
another anti-cancer medicine)
is used for the treatment of patients with ovarian cancer that has
come back after at least 1 previous
therapy and are not resistant to anti-cancer medicines containing
platinum compounds.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN YONDELIS
DO NOT USE YONDELIS
-
if you are allergic to trabectedin or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have any serious infections.
-
if you are breast-feeding.
-
if you will receive yellow fever vaccine.
36
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Yondelis
Yondelis or its combination with PLD must not be

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Yondelis 0.25 mg powder for concentrate for solution for infusion.
Yondelis 1 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
YONDELIS 0.25 MG
Each vial of powder contains 0.25 mg of trabectedin.
One ml of reconstituted solution contains 0.05 mg of trabectedin.
Excipients with known effect:
Each vial of powder contains 2 mg of potassium and 0.1 g of sucrose.
For the full list of excipients, see section 6.1.
YONDELIS 1 MG
Each vial of powder contains 1 mg of trabectedin.
One ml of reconstituted solution contains 0.05 mg of trabectedin.
Excipients with known effect:
Each vial of powder contains 8 mg of potassium and 0.4 g of sucrose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Yondelis is indicated for the treatment of adult patients with
advanced soft tissue sarcoma, after
failure of anthracyclines and ifosfamide, or who are unsuited to
receive these agents. Efficacy data
are based mainly on liposarcoma and leiomyosarcoma patients.
Yondelis in combination with pegylated liposomal doxorubicin (PLD) is
indicated for the treatment
of patients with relapsed platinum-sensitive ovarian cancer.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Yondelis must be administered under the supervision of a physician
experienced in the use of
chemotherapy. Its use should be confined to qualified oncologists or
other health professionals
specialised in the administration of cytotoxic agents.
Posology
For the treatment of soft tissue sarcoma, the recommended dose is 1.5
mg/m
2
body surface area,
administered as an intravenous infusion over 24 hours with a
three-week interval between cycles.
For the treatment of ovarian cancer Yondelis is administered every
three weeks as a 3-hour infusion
at a dose of 1.1 mg/m
2
, immediately after PLD 30 mg/m
2
. To minim