ChondroCelect

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
12-01-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
12-01-2017
Public Assessment Report Public Assessment Report (PAR)
12-01-2017

Active ingredient:

Ċelloli tal-qarquċa awtoloġiċi vijabbli kkaratterizzati estiżi ex vivo li jesprimu proteini indikaturi speċifiċi

Available from:

TiGenix N.V.

ATC code:

M09AX02

INN (International Name):

characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

Therapeutic group:

Mediċini oħra għal disturbi fis-sistema muskoloskeletali

Therapeutic area:

Mard tal-qarquċa

Therapeutic indications:

Tiswija ta 'difetti sintomiċi tal-qarquċa singulari tal-kundil femorali ta' l-irkoppa (Seklu Internazzjonali tat-Tiswija tal-Qarquċaġjar [ICRS] grad III jew IV) f'adulti. Fl-istess ħin asintomatiċi ' feriti fil-qarquċa (ICRS grad I jew II) jistgħu jkunu preżenti. - Turija ta'l-effikaċja hija ibbażata fuq prova randomised u kkontrollata l-evalwazzjoni tal-effikaċja tal-Chondrocelect f'pazjenti b'leżjonijiet bejn 1 u 5 cm2.

Product summary:

Revision: 6

Authorization status:

Irtirat

Authorization date:

2009-10-05

Patient Information leaflet

                                23
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
24
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
CHONDROCELECT 10,000 ĊELLOLA/MIKROLITRU TA’ SUSPENSJONI GĦAL
IMPJANT
Ċelloli awtologi vijabbli karatterizzati tal-qarquċa mwessgħin
_ex vivo_
li jesprimu proteini markers
speċifiċi
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-kirurgu jew
lit-terapista fiżiku tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib lill-kirurgu jew
lit-terapista fiżiku tiegħek.
Dan jinkludi xi effett sekondarju possibbli li m’huwiex elenkat
f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu ChondroCelect u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża ChondroCelect
3.
Kif għandek tuża ChondroCelect
4.
Effetti sekondarji possibbli
5.
Kif taħżen ChondroCelect
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU CHONDROCELECT U GЋALXIEX JINTUŻA
ChondroCelect jikkonsisti minn ċelloli awtologi kulturati
tal-qarquċa. Dan il-prodott
huwa magħmul minn kampjun żgħir ta’ ċelloli tal-qarquċa
(bijopsija) meħudin minn
irkopptok.
•
AWTOLOGI
tfisser li jintużaw iċ-ċelloli tieg
ħ
ek stess biex isir ChondroCelect.
•
Il-
QARQUĊA
hija tessut li huwa preżenti f’kull ġog. Hija tipproteġi t-truf
tal-g
ħ
adam tag
ħ
na u
tippermetti l-ġogi tag
ħ
na li ja
ħ
dmu ming
ħ
ajr problemi.
ChondroCelect jintuża biex isewwi difett singolu sintomatiku
tal-qarquċa fil-kondil
femorali tal-irkoppa fl-adulti. Id-difett jista’ jkun ikkawżat minn
trawma akuta, bħal
waqgħa. Jista’ jkun ikkawżat ukoll minn trawma ripetittiva, bħala
riżultat ta’ piż eċċessiv
jew minħabba tqandil inkorrett ta’ piż fuq l-irkoppa
b’konsegwenza ta’ deformità tal-
irkoppa.
•
Il-
KONDIL FEMORALI
huwa t-tarf tal-għadma tal-koxxa, li jifforma parti minn irkopptok.
2
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
ChondroCelect 10,000 ċellola/mikrolitru ta’ suspensjoni għal
impjant
_ _
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
_ _
2.1
DESKRIZZJONI
ġ
ENERALI
Ċelluli ta’ qarquċa awtologi vijabbli mkabbra
_ex vivo_
li jesprimu proteini b’markers speċifiċi
2.2
GĦAMLA KWALITATTIVA U KWANTITATTIVA
_ _
Kull kunjett tal-prodott fih 4 miljun ċellola awtologa ta’ qarquċa
umana f’0.4 ml ta’ suspensjoni
ta’ ċelloli, li jikkorrispondi għal konċentrazzjoni ta’ 10,000
ċellola/mikrolitru.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Suspensjoni għal impjant
Qabel suspensjoni mill-ġdid, iċ-ċelloli jkunu fil-qiegħ
tal-kontenitur b’forma ta’ saff offwajt u s-
sustanza mhux attiva hija likwidu ċar mingħajr lewn.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Tiswija ta’ difetti singoli sintomatiċi fil-qarquċa tal-kondil
femorali tal-irkoppa (Soċjetà
Internazzjonali għat-Tiswija tal-Qarquċa [ICRS] grad III jew IV)
minn 2 cm² ’il quddiem fl-adulti.
Jista’ jkun hemm leżjonijiet konkomitanti mingħajr sintomi
fil-qarquċa (ICRS grad I jew II). It-
turija tal-effikaċja hija bbażata fuq studju kkontrollat każwali li
jeżamina l-effikaċja ta’
ChondroCelect f’pazjenti b’leżjonijiet li jvarjaw bejn 1 u 5 cm
2.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
ChondroCelect irid jingħata minn kirurgu kkwalifikat kif suppost u
huwa ristrett għall-użu fl-
isptar biss. ChondroCelect huwa intenzjonat biss għal użu awtologu u
għandu jingħata flimkien
mat-tneħħija ta’ materja barranija u tessut mejjet (tħejjija
tal-bażi tad-difett), siġill fiżiku tal-
leżjoni (tqegħid ta’ membrana bijoloġika, preferibbilment
membrana tal-collagen) u
riabilitazzjoni.
Pożoloġija
L-ammont ta’ ċelloli li għandu jingħata jiddependi fuq id-daqs
(superfiċje f’cm²) tad-difett fil-
qarquċa. Kull prodott fih doż
                                
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Active ingredient Ċelloli tal-qarquċa awtoloġiċi vijabbli kkaratterizzati estiżi ex vivo li jesprimu proteini indikaturi speċifiċi

Ċelloli tal-qarquċa awtoloġiċi vijabbli kkaratterizzati estiżi ex vivo li jesprimu proteini indikaturi speċifiċi

ATC code M09AX02

M09AX02

Marketed by TiGenix N.V.

TiGenix N.V.

INN (International Name) characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

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ChondroCelect Ċelloli tal-qarquċa awtoloġiċi vijabbli characterised viable autologous cartilage

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ChondroCelect