Rixubis

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
26-09-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
26-09-2022
Public Assessment Report Public Assessment Report (PAR)
10-02-2015

Active ingredient:

Nonacog gamma

Available from:

Baxalta Innovations GmbH

ATC code:

B02BD04

INN (International Name):

nonacog gamma

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Hemofilija B

Therapeutic indications:

Liječenje i profilaksu krvarenja u bolesnika s hemofilijom B (nedostatak prirođenog faktora IX).

Product summary:

Revision: 11

Authorization status:

odobren

Authorization date:

2014-12-19

Patient Information leaflet

                                40
B. UPUTA O LIJEKU
41
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
RIXUBIS 250 IU PRAŠAK I OTAPALO ZA OTOPINU ZA INJEKCIJU
RIXUBIS 500 IU PRAŠAK I OTAPALO ZA OTOPINU ZA INJEKCIJU
RIXUBIS 1000 IU PRAŠAK I OTAPALO ZA OTOPINU ZA INJEKCIJU
RIXUBIS 2000 IU PRAŠAK I OTAPALO ZA OTOPINU ZA INJEKCIJU
RIXUBIS 3000 IU PRAŠAK I OTAPALO ZA OTOPINU ZA INJEKCIJU
nonakog gama (rekombinantni ljudski faktor zgrušavanja IX)
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 ili ljekarniku.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika.
To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj
uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je RIXUBIS i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati RIXUBIS
3.
Kako primjenjivati RIXUBIS
4.
Moguće nuspojave
5.
Kako čuvati RIXUBIS
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE RIXUBIS I ZA ŠTO SE KORISTI
RIXUBIS sadrži djelatnu tvar nonakog gama i lijek je s faktorom
zgrušavanja (koagulacije) IX. Faktor
IX normalni je sastojak ljudske krvi nužan za učinkovito
zgrušavanje krvi. RIXUBIS se koristi kod
bolesnika s hemofilijom B (Christmasovom bolesti, nasljednim
poremećajem krvarenja uzrokovanim
manjkom faktora IX). Djeluje tako da zamjenjuje faktor IX koji
nedostaje kako bi omogućio
zgrušavanje krvi bolesnika.
RIXUBIS se koristi za liječenje i prevenciju krvarenja kod bolesnika
s hemofilijom B u svim dobnim
skupinama.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMJENJIVATI RIXUBIS
NEMOJTE PRIMJENJIVATI RIXUBIS
-
ako ste alergični na nonakog gamu ili neki drugi sastojak ovog lijeka
(naveden u dijelu 6.)
-
ako ste alergični na bjelančevine hrčka
UPOZORENJA 
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
RIXUBIS 250 IU prašak i otapalo za otopinu za injekciju
RIXUBIS 500 IU prašak i otapalo za otopinu za injekciju
RIXUBIS 1000 IU prašak i otapalo za otopinu za injekciju
RIXUBIS 2000 IU prašak i otapalo za otopinu za injekciju
RIXUBIS 3000 IU prašak i otapalo za otopinu za injekciju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
RIXUBIS 250 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 250 IU nonakoga gama, rekombinantnog
koagulacijskog faktora IX,
ljudskog (rDNA), što odgovara koncentraciji od 50 IU/ml nakon
rekonstitucije s 5 ml otapala.
RIXUBIS 500 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 500 IU nonakoga gama, rekombinantnog
koagulacijskog faktora IX,
ljudskog (rDNA), što odgovara koncentraciji od 100 IU/ml nakon
rekonstitucije s 5 ml otapala.
RIXUBIS 1000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 1000 IU nonakoga gama, rekombinantnog
koagulacijskog faktora IX,
ljudskog (rDNA), što odgovara koncentraciji od 200 IU/ml nakon
rekonstitucije s 5 ml otapala.
RIXUBIS 2000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 2000 IU nonakoga gama, rekombinantnog
koagulacijskog faktora IX,
ljudskog (rDNA), što odgovara koncentraciji od 400 IU/ml nakon
rekonstitucije s 5 ml otapala.
RIXUBIS 3000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 3000 IU nonakoga gama, rekombinantnog
koagulacijskog faktora IX,
ljudskog (rDNA), što odgovara koncentraciji od 600 IU/ml nakon
rekonstitucije s 5 ml otapala.
Jačina (IU) je određena pomoću jednofaznog testa zgrušavanja krvi
prema Europskoj farmakopeji.
Specifična aktivnost lijeka RIXUBIS je otprilike 200-390 IU/mg
proteina.
Nonakog gama (rekombinantni faktor zgrušavanja IX) je jednolančani
prošišćeni glikoprotein koji se
sastoji od 415 aminokiselina. Proizvodi se rekombinantnom DNA
tehnologijom u staničnoj liniji
jajnika kineskog hrčka (CHO).
Pomoćna(e)
                                
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Active ingredient Nonacog gamma

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ATC code B02BD04

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INN (International Name) nonacog gamma

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Patient Information leaflet Patient Information leaflet Bulgarian 26-09-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 26-09-2022
Public Assessment Report Public Assessment Report Bulgarian 10-02-2015
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Public Assessment Report Public Assessment Report Spanish 10-02-2015
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