Zalmoxis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
05-09-2016
Charakterystyka produktu
(SPC)
05-09-2016
Sprawozdanie z oceny publicznego
(PAR)
05-09-2016
Składnik aktywny:
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Dostępny od:
MolMed SpA
Kod ATC:
L01
INN (International Nazwa):
allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
Wskazania:
Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies.
Podsumowanie produktu:
Revision: 1
Status autoryzacji:
Withdrawn
Data autoryzacji:
2016-08-18
Ulotka dla pacjenta
B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZALMOXIS
5-20 X 10
6 CELLS/ML DISPERSION FOR INFUSION
Allogeneic T cells genetically modified with a retroviral vector
encoding for a truncated form of the
human low affinity nerve growth factor receptor (ΔLNGFR) and the
herpes simplex I virus thymidine
kinase (HSV-TK Mut2)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, or a physician
experienced in the medical
treatment of blood cancer.
-
If you get any side effects, talk to your doctor, or a physician
experienced in the medical
treatment of blood cancer. This includes any possible side effects not
listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Zalmoxis is and what it is used for
2.
What you need to know before you are given Zalmoxis
3.
How Zalmoxis is given to you
4.
Possible side effects
5.
How to store Zalmoxis
6.
Contents of the pack and other information
1.
WHAT ZALMOXIS
IS AND WHAT IT IS USED FOR
Zalmoxis consists of white blood cells called T cells that are
obtained from the donor. These cells will
be genetically modified by introducing a “suicide” gene (HSV-TK
Mut2) in their genetic code which
can be activated later on in case of graft-versus-host disease. This
will ensure that the cells can be
eliminated before they can cause damage to the patient’s cells.
Zalmoxis is intended for use in adults with certain tumours of the
blood known as high-risk
haemotological malignancies. It is given after haploidentical bone
marrow transplantation
(haematopoietic cell transplantation). Haploidentical means that the
cells have been obtained from a
donor whose tissues part
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Zalmoxis 5-20 x 10
6
cells/mL dispersion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Allogeneic T cells genetically modified with a retroviral vector
encoding for a truncated form of the
human low affinity nerve growth factor receptor (ΔLNGFR) and the
herpes simplex I virus thymidine
kinase (HSV-TK Mut2).
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag of Zalmoxis contains a volume of 10-100 mL of frozen
dispersion at the concentration of
5-20 x 10
6
cells/mL. The cells are of human origin and genetically modified with
a replication-
defective γ-retroviral vector coding for the HSV-TK and ΔLNGFR genes
so that these sequences are
integrated in the genome of the host cells.
The cellular composition and the final cell number will vary according
to the weight of the patient. In
addition to T cells, NK cells and residual levels of monocytes and of
B cells may be present.
Excipient with known effect
_ _
Each bag contains approximately 13.3 mmol (305.63 mg) of sodium per
dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersion for infusion.
Opaque, off-white frozen dispersion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zalmoxis is indicated as adjunctive treatment in haploidentical
haematopoietic stem cell
transplantation (HSCT) of adult patients with high-risk haematological
malignancies (see section 5.1).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zalmoxis must be administered under the supervision of a physician
experienced in HSCT for
haematological malignancies.
Posology
The recommended dose and schedule is 1 ± 0.2 x 10
7
cells/kg given as an intravenous infusion at a
time interval of 21-49 days from
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