Glybera

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
10-07-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
10-07-2017
Public Assessment Report Public Assessment Report (PAR)
15-06-2016

Active ingredient:

alipogene tiparvovec

Available from:

uniQure biopharma B.V. 

ATC code:

C10AX10

INN (International Name):

alipogene tiparvovec

Therapeutic group:

Aġenti li jimmodifikaw il-lipidi

Therapeutic area:

Iperlipoproteinemija Tip I

Therapeutic indications:

Glybera huwa indikat għal pazjenti adulti dijanjostikati b'defiċjenza ta 'lipoproteina lipase familjali (LPLD) u li jbatu minn attakki severi jew multipli ta' pankreatite minkejja r-restrizzjonijiet tad-dieta tax-xaħam. Id-dijanjożi ta 'LPLD trid tiġi kkonfermata b'testjar ġenetiku. L-indikazzjoni hija ristretta għal pazjenti b'livelli li jistgħu jiġu osservati ta 'proteina LPL.

Product summary:

Revision: 8

Authorization status:

Irtirat

Authorization date:

2012-10-25

Patient Information leaflet

                                28
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
29
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL UTENT
GLYBERA 3 X 10
12
KOPJI TAL-GENOMA /ML SOLUZZJONI GĦAL INJEZZJONI
Alipogene tiparvovec
▼ Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin billi tirrapporta
kwalunkwe effett sekondarju li jista’ jkollok. Ara t-tmiem ta’
sezzjoni 4 biex tara kif għandek
tirrapporta effetti sekondarji.
AQRA SEW DAN IL-FULJETT KOLLU QABEL TINGĦATA 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 tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib tiegħek. Dan
jinkludi xi effett sekondarju
possibbli li mhuwiex elenkat f’dan il-fuljett.
-
Ingħatajt kartuna għall-pazjent mit-tabib tiegħek. Aqraha sew u
segwi l-istuzzjonijiet relatati.
-
Għandek tippreżenta din il-kartuna lill-professjonisti tal-kura
tas-saħħa (tabib, infermier)
tiegħek waqt konsultazzjoni jew kura fl-isptar. Ara sezzjoni 4.
F’DAN IL-FULJETT
:
1.
X’inhu Glybera u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Glybera
3.
Kif għandu jingħatalek Glybera
4.
Effetti sekondarji possibbli
5.
Kif taħżen Glybera
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU GLYBERA U GЋALXIEX JINTUŻA
Glybera fih alipogene tiparvovec, prodott ta’ terapija tal-ġeni li
jaħdem billi jwassal ġene fil-ġisem
biex jikkoreġi defiċjenza ġenetika. Jagħmel parti minn grupp ta’
mediċini msejħa sustanzi li
jimmodifikaw il-lipidi.
ondizzjoni speċifika li tintiret magħrufa bħala “defiċjenza
tal-lipoproteina lipase (LPLD -
_lipoprotein _
_lipase deficiency_
)”.
Lipoproteina lipase (LPL -
_lipoprotein lipase_
) hija sustanza li tinstab b’mod naturali fil-ġisem
(magħrufa bħala enzima) li tikkontrolla l-livell ta’ ċerti
xaħ
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
▼ Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Il-professjonisti dwar il-kura tas-
saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa
suspettata. Ara sezzjoni 4.8 dwar kif
għandhom jiġu rappurtati reazzjonijiet avversi.
1.
ISEM IL-PRODOTT MEDIĊINALI
Glybera 3 × 10
12
kopji tal-genoma/ml soluzzjoni għal injezzjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
2.1
DESKRIZZJONI ĠENERALI
Alipogene tiparvovec fih il-varjant LPL
S447X
tal-ġene tal-lipoproteina lipase tal-bniedem (LPL
_- _
_lipoprotein lipase_
) f’vettur. Il-vettur fih qoxra magħmula minn proteina li ġejja
minn virus adeno-
assoċjat ta’ serotip 1 (AAV1 -
_adeno-associated virus serotype 1_
), il-promutur ta’ Cytomegalovirus
(CMV), element post traskrizzjonali regolatorju tal-virus woodchuck
tal-epatite u
_inverted terminal _
_repeats _
ġejjin minn AAV2. Alipogene tiparvovec jiġi prodott permezz ta’
ċelluli tal-insetti u
teknoloġija rikombinanti tal-baculovirus.
2.2
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull kunjett ta’ alipogene tiparvovec fih 1 ml ta’ soluzzjoni li
tista’ tiġi estratta, li fiha 3 x 10
12
kopji
tal-genoma (gc -
_genome copies_
).
Kull pakkett speċifiku għall-pazjent fih ammont suffiċjenti ta’
kunjetti biex jagħti doża ta’ 1 x 10
12
LPL
S447X
gc/kg tal-piż tal-ġisem lil kull pazjent.
Eċċipjent b’effett magħuf:
Dan il-prodott mediċinali fih 47.5 mg ta’ sodium f’kull għotja
f’27 sit tal-injezzjoni sa 105.6 mg ta’
sodium f’kull għotja f’60 sit tal-injezzjoni.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għal injezzjoni.
Soluzzjoni ċara, għal ftit opalexxenti, mingħajr kulur.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Glybera huwa indikat għal pazjenti adulti dijanjostikati
b’defiċjenza f
                                
                                Read the complete document

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Active ingredient alipogene tiparvovec

alipogene tiparvovec

ATC code C10AX10

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Marketed by uniQure biopharma B.V. 

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INN (International Name) alipogene tiparvovec

alipogene tiparvovec

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Patient Information leaflet Patient Information leaflet Bulgarian 10-07-2017
Summary of Product characteristics Summary of Product characteristics Bulgarian 10-07-2017
Public Assessment Report Public Assessment Report Bulgarian 15-06-2016
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Summary of Product characteristics Summary of Product characteristics Spanish 10-07-2017
Public Assessment Report Public Assessment Report Spanish 15-06-2016
Patient Information leaflet Patient Information leaflet Czech 10-07-2017
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Public Assessment Report Public Assessment Report Czech 15-06-2016
Patient Information leaflet Patient Information leaflet Danish 10-07-2017
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Public Assessment Report Public Assessment Report Danish 15-06-2016
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Public Assessment Report Public Assessment Report German 15-06-2016
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Patient Information leaflet Patient Information leaflet English 10-07-2017
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Glybera