Glybera

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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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:

alipogen tiparvovec

Available from:

uniQure biopharma B.V. 

ATC code:

C10AX10

INN (International Name):

alipogene tiparvovec

Therapeutic group:

Sredstva za spreminjanje lipidov

Therapeutic area:

Hiperlipoproteinemija tipa I

Therapeutic indications:

Zdravilo Glybera je indicirano za odrasle bolnike z diagnozo familialne lipoproteinske lipaze (LPLD) in hude ali večkratne napade pankreatitisa, čeprav omejitve maščobnih maščob. Diagnozo LPLD je treba potrditi z genetskim testiranjem. Indikacija je omejena na bolnike z zaznavnimi nivoji beljakovin LPL.

Product summary:

Revision: 8

Authorization status:

Umaknjeno

Authorization date:

2012-10-25

Patient Information leaflet

                                22
Uporabno do
Rok uporabnosti po prvem odpiranju v brizgah: 8 ur (če prostor to
dovoljuje)
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Vialo shranjujte in prevažajte zamrznjeno pri temperaturi –25 °C
do –15 °C.
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred
svetlobo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
To zdravilo vsebuje gensko spremenjene organizme.
Neuporabljeno zdravilo je treba odstraniti skladno z lokalnimi
predpisi za gensko spremenjene
organizme.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
uniQure biopharma B.V.
Meibergdreef 61, 1105 BA Amsterdam, Nizozemska.
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/12/791/001
13.
ŠTEVILKA SERIJE
Serija
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Zdravilo nima več dovoljenja za promet
23
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC:
SN:
NN:
Zdravilo nima več dovoljenja za promet
24
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PROZOREN, ZATESNJEN PLASTIČEN OVOJ (PAKIRANJE Z 2 VIALAMA)
1.
IME ZDRAVILA
Glybera 3 × 10
12
genomskih kopij/ml raztopina za injiciranje
alipogentiparvovek
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
uniQure biopharma B.V.
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do
4.
ŠTEVILKA SERIJE
Serija
5.
DRUGI PODATKI
intramuskularna uporaba
Pred uporabo preberite priloženo navodilo.
Shranjujte zamrznjeno pri temperaturi –25 °C do –15 °C.
To zdravilo vsebuje gensko spremenjene organizme.
Velikost pakiranja po 2 viali
Zdravilo nima več dovoljenja za promet
25
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PROZOREN, ZATESNJEN PLASTIČEN OVOJ (PAKIRANJE S 3 VIALAMI)
1.
IME ZDR
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima več dovoljenja za promet
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
Glybera 3 × 10
12
genomskih kopij/ml raztopina za injiciranje
2. KAKOVOSTNA IN KOLIČINSKA SESTAVA
2.1 SPLOŠEN OPIS
Alipogentiparvovek vsebuje humano različico gena lipoproteinske
lipaze LPL
S447X
v vektorju. Vektor
je sestavljen iz proteinske kapsule, pridobljene iz adenoasociiranega
virusnega serotipa 1 (AAV1),
promotorja citomegalovirusa (CMV), elementa za posttranskripcijsko
regulacijo virusa hepatitisa
svizca in invertiranih terminalnih zaporedij, pridobljenih iz serotipa
AAV2. Alipogentiparvovek je
izdelan z uporabo celic žuželk in rekombinantne bakulovirusne
tehnologije.
2.2 KAKOVOSTNA IN KOLIČINSKA SESTAVA
Vsaka viala alipogentiparvoveka vsebuje 1 ml raztopine, ki ga je
mogoče ekstrahirati in vsebuje
3 x
10
12
genomskih kopij (gk).
Vsako za bolnika specifično pakiranje vsebuje zadostno količino vial
za odmerjanje 1 x 10
12
LPL
S447X
gk/kg telesne mase bolnika.
Pomožne snovi z znanim učinkom:
To zdravilo vsebuje 47,5 mg natrija na vsako uporabo na 27 mestih
injiciranja do 105,6 mg natrija na
uporabo na 60 mestih injiciranja.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3. FARMACEVTSKA OBLIKA
raztopina za injiciranje
Bistra do rahlo opalescentna brezbarvna raztopina
4. KLINIČNI PODATKI
4.1 TERAPEVTSKE INDIKACIJE
Zdravilo Glybera je indicirano za odrasle bolnike z diagnozo
družinskega pomanjkanja lipoproteinske
lipaze (LPLD) in multiplimi napadi pankreatitisa kljub omejevanju
vnosa maščobe s hrano. Diagnozo
LPLD je treba potrditi z genskimi preiskavami. Indikacija je omejena
na bolnike z določljivimi ravnmi
proteina LPL (glejte poglavje 4.4).
4.2 ODMERJANJE IN NAČIN UPORABE
Zdravilo Glybera se sme upora
                                
                                Read the complete document

Similar products

Active ingredient alipogen tiparvovec

alipogen tiparvovec

ATC code C10AX10

C10AX10

Marketed by uniQure biopharma B.V. 

uniQure biopharma B.V. 

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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Glybera