Opgenra

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
14-07-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
14-07-2016

Active ingredient:

eptotermin alfa

Available from:

Olympus Biotech International Limited

ATC code:

M05BC02

INN (International Name):

eptotermin alfa

Therapeutic group:

Lijekovi za liječenje bolesti kostiju

Therapeutic area:

spondilolisteze

Therapeutic indications:

Opgenra je indicirana za posterolateralnu lumbalnu spinalnu fuzije u odraslih bolesnika s spondilolistezijom u kojima autograft nije uspio ili je kontraindiciran.

Product summary:

Revision: 9

Authorization status:

povučen

Authorization date:

2009-02-19

Patient Information leaflet

                                B. UPUTA O LIJEKU
23
Lijek koji više nije odobren
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
OPGENRA 3,3 MG PRAŠAK ZA SUSPENZIJU IMPLANTATA
eptotermin alfa
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 PRIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se svom liječniku.
-
Ako dobijete bilo koju nuspojavu obratite se svom liječniku. To
uključuje i svaku moguću
nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Opgenra i zašto se koristi.
2.
Što morate znati prije nego primite lijek Opgenra.
3.
Kako se koristi Opgenra.
4.
Moguće nuspojave.
5.
Kako čuvati lijek Opgenra.
6.
Sadržaj pakiranja i druge informacije.
1.
ŠTO JE OPGENRA I ZA ŠTO SE KORISTI
Opgenra sadrži djelatnu tvar eptotermin alfa.
Opgenra je vrsta lijeka poznata kao koštani morfogenetski protein
(BMP). Ta skupina lijekova
uzrokuje rast nove kosti na mjestu na kojem kirurg postavi
(implantira) lijek.
Opgenra se implantira odraslim bolesnicima s listezom kralježnice
(spondilolisteza) u slučajevima
gdje liječenje putem autolognog koštanog presatka (kost
transplantirana iz kuka) nije uspjelo ili se ne
smije koristiti.
2.
ŠTO MORATE ZNATI PRIJE NEGO PRIMITE LIJEK OPGENRA
NEMOJTE PRIMATI LIJEK OPGENRA
-
ako ste alergični na eptotermin alfa ili na bilo koji drugi sastojak
ovog lijeka (vidjeti dio 6).
-
ako bolujete od autoimune bolesti (bolest koja se razvija iz vlastitog
tkiva ili je usmjerena protiv
vlastitog tkiva), uključujući Crohnovu bolest, reumatoidni artritis,
sistemski eritematozni lupus,
sklerodermiju, Sjögrenov sindrom i dermatomiozitis/polimiozitis.
-
ako imate aktivnu infekciju na kralježnici ili Vam je rečeno da
imate aktivnu internu (sistemsku
                                
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Summary of Product characteristics

                                DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
1
Lijek koji više nije odobren
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih djelatnika se traži da prijave svaku
sumnju na nuspojavu za ovaj lijek.
Za postupak prijavljivanja nuspojava vidjeti dio 4.8.
1.
NAZIV LIJEKA
Opgenra 3,3 mg prašak za suspenziju implantata
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna bočica sadrži 1 g praška s 3,3 mg eptotermina alfa*.
Nakon rekonstitucije, Opgenra sadrži 1 mg/ml eptotermina alfa.
*Eptotermin alfa je ljudski rekombinantni osteogeni protein 1 (OP-1)
proizveden na staničnoj liniji
jajnika kineskog hrčka (CHO).
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Prašak za suspenziju implantata.
Prašak koji sadrži djelatnu tvar je zrnate strukture i bijele do
gotovo bijele boje.
Prašak koji sadrži pomoćnu tvar karmelozu (karboksimetilcelulozu)
je žućkasto bijele boje.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Opgenra je indicirana za posterolateralnu lumbalnu spinalnu fuziju u
odraslih bolesnika sa
spondilolistezom u slučaju kada fuzija autolognim presadakom nije
uspjela ili je kontraindicirana.
4.2
DOZIRANJE I NAČIN PRIMJENE
Ovaj lijek treba primijeniti odgovarajuće osposobljen kirurg.
Doziranje
Opgenra je namijenjena samo za jednokratnu uporabu na jednom
bolesniku. Liječenje zahtijeva jedan
kirurški zahvat. Za fuziju na jednoj razini lumbalne kralježnice
koristi se jedna jedinica lijeka na
svakoj strani kralježnice. Maksimalna doza za ljude ne smije
premašiti 2 jedinice s obzirom da
djelotvornost i neškodljivost lijeka kod postupaka spinalne fuzije
koji zahtijevaju veće doze još nisu
utvrđene.
_Pedijatrijska populacija _
Opgenra je kontraindicirana u djece (u dobi <12 godina), adolescenata
(u dobi 12-18 godina) i osoba s
nerazvijenim kosturom (vidjeti dio 4.3).
_Oštećenje bubrega/jetre _
Treba biti oprezan s uporabom lijeka Opgenra u bolesnika s
oštećenjem bubrega ili jetre (vidjeti
dio 4.4).
2
Lije
                                
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Similar products

Active ingredient eptotermin alfa

eptotermin alfa

ATC code M05BC02

M05BC02

Marketed by Olympus Biotech International Limited

Olympus Biotech International Limited

INN (International Name) eptotermin alfa

eptotermin alfa

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Opgenra