Beromun

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
11-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
11-01-2022

Active ingredient:

tasonermin

Available from:

Belpharma s.a.

ATC code:

L03AX11

INN (International Name):

tasonermin

Therapeutic group:

Иммуностимуляторы,

Therapeutic area:

Sarkom

Therapeutic indications:

Beromun prikazan u odraslih kao dodatak operacije za naknadno uklanjanje tumora, kako bi se spriječiti ili odgoditi ампутацию, ili palijativnu situacije, za нерезектабельных sarkom mekih tkiva ekstremiteta, koriste u kombinaciji s мелфаланом kroz blagi гипертермической izolirani udova perfuzije (ИЛП).

Product summary:

Revision: 15

Authorization status:

odobren

Authorization date:

1999-04-12

Patient Information leaflet

                                20
B. UPUTA O LIJEKU
21
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
BEROMUN 1 MG PRAŠAK ZA OTOPINU ZA INFUZIJU
tasonermin
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE PRIMJENJIVATI
OVAJ LIJEK JER SADRŽI VAMA
VAŽNE PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika. To uključuje i svaku
moguću nuspojavu koja nije navedena u ovoj uputi.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Beromun i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati Beromun
3.
Kako primjenjivati Beromun
4.
Moguće nuspojave
5.
Kako čuvati Beromun
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE BEROMUN I ZA ŠTO SE KORISTI
Beromun sadrži djelatnu tvar tasonermin (čimbenik nekroze tumora
α-1a), koji se proizvodi
rekombinantnom DNA tehnologijom. Pripada skupini lijekova poznatih kao
imunostimulansi koji
pomažu Vašem imunološkom sustavu u borbi protiv stanica raka.
Beromun se primjenjuje zajedno s lijekom koji sadrži melfalan za
liječenje sarkoma mekog tkiva ruku
i nogu. Svrha liječenja je smanjenjem veličine tumora olakšati
uklanjanje tumora kirurškim zahvatom
ili spriječiti teško oštećenje okolnog zdravog tkiva, čime se
odgađa ili sprječava potreba za
amputacijom ruke ili noge.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMJENJIVATI BEROMUN
NEMOJTE PRIMJENJIVATI BEROMUN
-
ako ste alergični na tasonermin ili neki drugi sastojak ovog lijeka
(naveden u dijelu 6.)
-
ako imate značajne probleme sa srcem
-
ako imate tešku bolest pluća
-
ako imate ili ste nedavno imali čir na želucu
-
ako imate pretjerano nizak broj krvnih stanica ili poremećaje
zgrušavanja krvi
-
ako imate umjerenu do tešku bolest jetre ili bubrega
-
ako ne možete uzimati vazopresorne lijekove (primjenjuju se za
povišenje niskog krvnog tlaka),
antikoagulanse (primjenjuju se za sprječavanje zgrušavanja krvi) ili
radioaktivno označene tvari
-
ako primjenjujete drug
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Beromun 1 mg prašak za otopinu za infuziju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka bočica sadrži 1 mg tasonermina*, što odgovara 3,0-6,0 x 10
7
IU (internacionalnih jedinica).
*Čimbenik nekroze tumora alfa-1a (TNFα-1a) koji se proizvodi
tehnologijom rekombinantne DNA u
_E. coli_
.
Pomoćna(e) tvar(i) s poznatim učinkom:
_ _
Svaka bočica sadrži 20,12 mg (0,87 mmol) natrija. Nakon
rekonstitucije u 0,9%-tnoj fiziološkoj
otopini natrijevog klorida, količina natrija je 37,82 mg (1,64 mmol).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Prašak za otopinu za infuziju (prašak za infuziju).
Bijeli do bjelkasti prašak.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Beromun je indiciran u odraslih osoba kao dodatno liječenje prije
kirurškog uklanjanja tumora, a u
svrhu sprječavanja ili odgode amputacije, ili kao palijativna
terapija, kod neresektabilnog sarkoma
mekog tkiva udova. Primjenjuje se u kombinaciji s melfalanom putem
blage hipertermičke izolirane
perfuzije uda.
4.2
DOZIRANJE I NAČIN PRIMJENE
Ovo liječenje trebaju provoditi kirurški timovi s iskustvom u
liječenju sarkoma udova i provođenju
postupka izolirane perfuzije uda u specijaliziranim ustanovama, s
pripravnom jedinicom intenzivnog
liječenja i opremom za kontinuirani nadzor zbog mogućeg propuštanja
lijeka u sistemsku cirkulaciju.
Doziranje
_Beromun: _
Gornji udovi: 3 mg ukupna doza izoliranom perfuzijom uda
Donji udovi: 4 mg ukupna doza izoliranom perfuzijom uda
_Melfalan: _
Dozu melfalana potrebno je izračunati prema Wieberdinkovoj metodi
litra-volumen (Wieberdink J,
Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA. Dosimetry in
isolation perfusion of the
limbs by assessments of perfused tissue volume and grading of toxic
tissue reactions.
_Eur J Cancer _
_Clin Oncol_
1982; 18: 905-910.), a maksimalna doza iznosi 150 mg.
13 mg/l perfundiranog volumena gornjeg uda
10 mg/l perfundiranog volumena donjeg uda
_Pedijatrijska populacija_
Sigur
                                
                                Read the complete document

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Active ingredient tasonermin

tasonermin

ATC code L03AX11

L03AX11

Marketed by Belpharma s.a.

Belpharma s.a.

INN (International Name) tasonermin

tasonermin

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