Zalmoxis

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
05-09-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
05-09-2016
Public Assessment Report Public Assessment Report (PAR)
05-09-2016

Active ingredient:

Alogenih T stanica genetski modificirani sa retrovirusni vektor kodiranje za skraćeni oblik ljudske nizak afinitet receptora faktora rasta živaca (ΔLNGFR) i herpes simplex virus timidin kinaze (HSV-TK Mut2)

Available from:

MolMed SpA

ATC code:

L01

INN (International Name):

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)

Therapeutic group:

Antineoplastična sredstva

Therapeutic area:

Hematopoietic Stem Cell Transplantation; Graft vs Host Disease

Therapeutic indications:

Zalmoksis je indiciran kao dodatna terapija u haploidentical hematopoetskih matičnih stanica (HSCT) odraslih bolesnika s visokog rizika hematoloških malignih bolesti.

Product summary:

Revision: 1

Authorization status:

povučen

Authorization date:

2016-08-18

Patient Information leaflet

                                23
B. UPUTA O LIJEKU
24
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
ZALMOXIS 5-20 X 10
6 STANICA/ML DISPERZIJA ZA INFUZIJU
Alogene T-stanice genetski modificirane retrovirusnim vektorom koji
kodira skraćeni oblik ljudskog
receptora za faktor rasta živaca niskog afiniteta (ΔLNGFR) i timidin
kinazu virusa
_herpes simplex_
tip
1 (HSV-TK Mut2)
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Prijavom svih sumnji na nuspojavu i Vi možete pomoći.
Za postupak prijavljivanja
nuspojava, pogledajte dio 4.
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE PRIMJENJIVATI
OVAJ LIJEK JER SADRŽI VAMA
VAŽNE PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku ili liječniku s
iskustvom u liječenju raka krvi.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili liječnika s iskustvom u
liječenju raka krvi. To uključuje i svaku moguću nuspojavu koja
nije navedena u ovoj uputi.
Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Zalmoxis i za što se koristi
2.
Što morate znati prije nego Vam se da Zalmoxis
3.
Kako se daje Zalmoxis
4.
Moguće nuspojave
5.
Kako čuvati Zalmoxis
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE ZALMOXIS I ZA ŠTO SE KORISTI
Zalmoxis se sastoji od bijelih krvnih stanica zvanih T-stanice, koje
se dobivaju od donora. Te stanice
će biti genetski modificirane uvođenjem gena „samoubojice“
(HSV-TK Mut2) u njihov genetski kod
koji se kasnije može aktivirati u slučaju reakcije presatka protiv
primatelja. To će osigurati da stanice
budu eliminirane prije nego uzrokuju štetu stanicama bolesnika.
Zalmoxis je namijenjen odraslima s određenim vrstama raka krvi
poznatima kao hematološke
zloćudne bolesti visokog rizika. Primjenjuje se nakon haploidentične
transplantacije koštane srži
(transplantacija hematopoetskih stanica). „Haploidentične“ znači
da su stanice dobivene od donora čije
se tkivo djelomično podudara s 
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih radnika se traži da prijave svaku sumnju
na nuspojavu za ovaj lijek. Za
postupak prijavljivanja nuspojava vidjeti dio 4.8.
1.
NAZIV LIJEKA
Zalmoxis 5-20 x 10
6
stanica/ml disperzija za infuziju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
2.1
OPĆI OPIS
Alogene T-stanice genetski modificirane retrovirusnim vektorom koji
kodira skraćeni oblik ljudskog
receptora za faktor rasta živaca niskog afiniteta (ΔLNGFR) i timidin
kinazu virusa
_herpes simplex_
tip
1 (HSV-TK Mut2).
2.2
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka vrećica Zalmoxisa sadrži volumen od 10-100 ml smrznute
disperzije pri koncentraciji od 5-20 x
10
6
stanica/ml. Stanice su ljudskog podrijetla te su genetski modificirane
γ-retrovirusnim vektorom
bez svojstva replikacije koji kodira gene za HSV-TK i ΔLNGFR tako da
se te sekvence ugrade u
genom stanica domaćina.
Stanični sastav i konačan broj stanica varirat će ovisno o težini
bolesnika. Uz T-stanice mogu biti
prisutne i NK stanice te ostatne količine monocita i B-stanica.
Pomoćne tvari s poznatim učinkom
_ _
Svaka vrećica sadrži približno 13,3 mmol (305,63 mg) natrija po
dozi.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Disperzija za infuziju.
Neprozirna, bjelkasta, smrznuta disperzija.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Zalmoxis je indiciran kao pomoćno liječenje kod haploidentične
transplantacije hematopoetskih
matičnih stanica (HSCT, engl.
_haematopoietic stem cell transplantation_
) u odraslih bolesnika s
hematološkim zloćudnim bolestima visokog rizika (vidjeti dio 5.1).
_ _
4.2
DOZIRANJE I NAČIN PRIMJENE
Zalmoxis se mora primjenjivati pod nadzorom liječnika s iskustvom u
transplantaciji hematopoetskih
matičnih stanica zbog hematoloških zloćudnih bolesti.
3
Doziranje
Preporučena doza i raspored primjene je 1 ± 0,2 x 10
7
stanica/kg dano u obliku intravenske infuzije,
izm
                                
                                Read the complete document

Similar products

Active ingredient Alogenih T stanica genetski modificirani sa retrovirusni vektor kodiranje za skraćeni oblik ljudske nizak afinitet receptora faktora rasta živaca (ΔLNGFR) i herpes simplex virus timidin kinaze (HSV-TK Mut2)

Alogenih T stanica genetski modificirani sa retrovirusni vektor kodiranje za skraćeni oblik ljudske nizak afinitet receptora faktora rasta živaca (ΔLNGFR) i herpes simplex virus timidin kinaze (HSV-TK Mut2)

ATC code L01

L01

Marketed by MolMed SpA

MolMed SpA

INN (International Name) 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)

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)

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Alerts Zalmoxis Alogenih stanica genetski modificirani allogeneic cells genetically modified

Zalmoxis Alogenih stanica genetski modificirani allogeneic cells genetically modified

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Zalmoxis