Zalmoxis

Country: European Union

Language: Slovenian

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:

Alogenskih T celice, gensko spremenjene z retrovirusni vektor kodiranje za skrajšani obliki ljudi nizko afiniteto živca rastni faktor receptor (ΔLNGFR) in herpes simplex virus timidin-kinazo (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:

Zalmoxis je indiciran kot dodatno zdravljenje pri haploidentični hematopoetski presaditvi matičnih celic (HSCT) pri odraslih bolnikih z visokim tveganjem hematoloških malignomov.

Product summary:

Revision: 1

Authorization status:

Umaknjeno

Authorization date:

2016-08-18

Patient Information leaflet

                                17
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP:
Rok uporabnosti po odtajanju: 2 uri pri sobni temperaturi (15 °C do
30 °C)
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v hlapih tekočega dušika.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO
POTREBNI
To zdravilo vsebuje gensko spremenjene celice. Za neuporabljeno
zdravilo ali odpadni material
morate upoštevati lokalna navodila za biološko varnost, ki veljajo
za ta zdravila.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
MolMed S.p.A.
Via Olgettina 58
20132 Milano
Italija
12.
ŠTEVILKA DOVOLJENJA ZA PROMET
EU/1/16/1121/001
13.
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
_ _
Številka serije:
Koda bolnika:
Koda darovalca:
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Navedba smiselno ni potrebna.
18
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
Navedba smiselno ni potrebna
19
PODATKI NA PRIMARNI OVOJNINI
PLASTIČNA VREČA
1.
IME ZDRAVILA
Zalmoxis 5-20 x 10
6
celic/ml, disperzija za infundiranje
Alogenske celice T, gensko spremenjene z retrovirusnim vektorjem,
kodirane za skrajšano obliko
človeškega receptorja živčnega rastnega faktorja z nizko afiniteto
_(ΔLNGFR-low affinity nerve _
_growth factor receptor)_
in timidin-kinazo virusa herpesa simpleksa I (HSV-TK Mut2).
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Zdravilo Zalmoxis vsebuje 10 do 100 ml zamrznjene disperzije v
koncentraciji 5 do 20 x 10
6
celic/ml.
3.
SEZNAM POMOŽNIH SNOVI
humani serumski albumin, dimetil sulfoksid, natrijev klorid
Za nadaljne informacije glejte navodilo za uporabo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
disperzija za infundiranje
Volumen vreče:___________ml
Odmerek: 1 x 10
7
celic/kg
Koncentracija: _____x 10
x
celic/ml
Skupno število celic: _____x 10
X
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
intravenska uporaba
Pred uporabo preberite prilo
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
Za to zdravilo se izvaja dodatno spremljanje varnosti. Tako bodo
hitreje na voljo nove informacije
o njegovi varnosti. Zdravstvene delavce naprošamo, da poročajo o
katerem koli domnevnem
neželenem učinku zdravila. Glejte poglavje 4.8, kako poročati o
neželenih učinkih.
1.
IME ZDRAVILA
Zalmoxis 5-20 x 10
6
celic/ml disperzija za infundiranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
2.1
SPLOŠEN OPIS
Alogenske celice T, gensko spremenjene z retrovirusnim vektorjem,
kodirane za skrajšano obliko
humanega receptorja živčnega rastnega faktorja z nizko afiniteto
(ΔLNGFR-low affinity nerve growth
factor receptor) in timidin-kinazo virusa herpesa simpleksa I (HSV-TK
Mut2).
2.2
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena vreča zdravila Zalmoxis vsebuje 10 do 100 ml zamrznjene
disperzije v koncentraciji 5 do 20 x
10
6
celic/ml. Celice so humanega izvora in so gensko spremenjene z
replikacijsko okvarjenim γ-
retrovirusnim vektorjem, ki kodira gene HSV-TK in ΔLNGFR, tako da se
ta zaporedja vgradijo v
genom gostiteljskih celic.
Celična zgradba in končno število celic se med bolniki razlikujejo
glede na telesno maso. Poleg
celic T so lahko prisotne tudi celice NK in rezidualne ravni monocitov
in B-celic.
Pomožna snov z znanim učinkom:
_ _
Ena vreča vsebuje približno 13,3 mmol (305,63 mg) natrija na
odmerek.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
disperzija za infundiranje
Neprosojna, belkasta zamrznjena disperzija
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Zalmoxis je indicirano kot dodatno zdravljenje pri
haploidentični presaditvi krvotvornih
matičnih celic (HSCT-haematopoietic stem cell transplantation)
odraslih bolnikov z velikim
tveganjem za hematološke malignosti (glejte poglavje 5.1).
_ _
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravilo Zalmoxis je treba dajati pod nadzorom zdravnika z izkušnjami
v HSCT pri hematoloških
malignostih.
3
Odmerjanje
Priporočeni odmerek in režim dajanja je 1 ± 0,2 x 10
7
celic/
                                
                                Read the complete document

Similar products

Active ingredient Alogenskih T celice, gensko spremenjene z retrovirusni vektor kodiranje za skrajšani obliki ljudi nizko afiniteto živca rastni faktor receptor (ΔLNGFR) in herpes simplex virus timidin-kinazo (HSV-TK Mut2)

Alogenskih T celice, gensko spremenjene z retrovirusni vektor kodiranje za skrajšani obliki ljudi nizko afiniteto živca rastni faktor receptor (ΔLNGFR) in herpes simplex virus timidin-kinazo (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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Zalmoxis Alogenskih celice, gensko spremenjene allogeneic cells genetically modified

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Zalmoxis