Zevalin
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
09-03-2020
Karatteristiċi tal-prodott
(SPC)
09-03-2020
Rapport ta 'Valutazzjoni Pubblika
(PAR)
27-09-2011
Ingredjent attiv:
ibritumomab tiuxetan
Disponibbli minn:
Ceft Biopharma s.r.o.
Kodiċi ATC:
V10XX02
INN (Isem Internazzjonali):
ibritumomab tiuxetan
Grupp terapewtiku:
Therapeutic radiopharmaceuticals
Żona terapewtika:
Lymphoma, Follicular
Indikazzjonijiet terapewtiċi:
Zevalin is indicated in adults.[90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.[90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsedorrefractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
Sommarju tal-prodott:
Revision: 23
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2004-01-16
Fuljett ta 'informazzjoni
32
B. PACKAGE LEAFLET
_ _
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZEVALIN 1.6 MG/ML KIT FOR RADIOPHARMACEUTICAL PREPARATIONS FOR
INFUSION
IBRITUMOMAB TIUXETAN [
90
Y]
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zevalin is and what it is used for
2.
What you need to know before you are given Zevalin
3.
How to use Zevalin
4.
Possible side effects
5.
How to store Zevalin
6.
Contents of the pack and other information
1.
WHAT ZEVALIN IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for therapy only.
Zevalin is a kit for the preparation of the active substance
ibritumomab tiuxetan [
90
Y], a monoclonal
antibody labelled with the radioactive substance yttrium-90 (
90
Y). Zevalin attaches to a protein
(CD20) on the surface of certain white blood cells (B-cells) and kills
them by irradiation.
Zevalin is used to treat patients suffering from specific subgroups of
B-cell non-Hodgkin’s lymphoma
(CD20+ indolent or transformed B-cell NHL) if an earlier rituximab,
another monoclonal antibody,
treatment has not worked, or has stopped working (refractory or
relapsed disease).
Zevalin is also used in previously untreated patients with follicular
lymphoma. It is used as a
CONSOLIDATION
therapy to improve the reduction in the number of lymphoma cells
(remission)
achieved with the initial chemotherapy regimen.
The use of Zevalin does involve exposure to small amounts of
radioactivity. Your doctor and the
nuclear medicine doctor have considered that the clinical benefit that
you will obtain from the
procedure with the radiopharmaceutical outweighs the risk due to
radiation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEVALIN
YOU
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Zevalin is supplied as a kit for the preparation of yttrium-90
radiolabelled ibritumomab tiuxetan.
The kit contains one ibritumomab tiuxetan vial, one sodium acetate
vial, one formulation buffer vial,
and one empty reaction vial. The radionuclide is not part of the kit.
One ibritumomab tiuxetan vial contains 3.2 mg ibritumomab tiuxetan* in
2 ml solution (1.6 mg per
ml).
*murine IgG
1
monoclonal antibody produced by recombinant DNA technology in a
Chinese hamster
ovary (CHO) cell line and conjugated to the chelating agent MX-DTPA.
The final formulation after radiolabelling contains 2.08 mg
ibritumomab tiuxetan [
90
Y] in a total
volume of 10 ml.
_Excipients _
_ _
This medicinal product can contain up to 28 mg sodium per dose,
depending on the radioactivity
concentration. To be taken into consideration by patients on a
controlled sodium diet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparations for infusion.
Ibritumomab tiuxetan vial: Clear colourless solution.
Sodium acetate vial: Clear colourless solution.
Formulation buffer vial: Clear yellow to amber coloured solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zevalin is indicated in adults.
[
90
Y]-radiolabelled Zevalin is indicated as consolidation therapy after
remission induction in
previously untreated patients with follicular lymphoma. The benefit of
Zevalin following rituximab in
combination with chemotherapy has not been established.
[
90
Y]-radiolabelled Zevalin is indicated for the treatment of adult
patients with rituximab relapsed or
refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
[
90
Y]-radiolabelled Zevalin must only be received, handled and
administered by qualified personnel
and must be prepared in accordance with both
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