ATryn

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
02-07-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
02-07-2019
Public Assessment Report Public Assessment Report (PAR)
02-07-2019

Active ingredient:

Антитромбин Alfa

Available from:

Laboratoire Francais du Fractionnement et des Biotechnologies

ATC code:

B01AB02

INN (International Name):

antithrombin alfa

Therapeutic group:

Antitrombotska sredstva

Therapeutic area:

Nedostatak antitrombina III

Therapeutic indications:

ATryn je indiciran za profilaksu venske tromboembolije u kirurgiji bolesnika s kongenitalnim nedostatkom antitrombina. ATryn se normalno daje u kombinaciji s heparinom ili heparinom male molekulske mase.

Product summary:

Revision: 16

Authorization status:

povučen

Authorization date:

2006-07-28

Patient Information leaflet

                                18
B. UPUTA O LIJEKU
Lijek koji više nije odobren
19
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
ATRYN 1750 IU PRAŠAK ZA OTOPINU ZA INFUZIJU
antitrombin alfa (rDNK)
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 PRIMJENJIVATI
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 primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika. To uključuje i svaku
moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je ATryn i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati ATryn
3.
Kako primjenjivati ATryn
4.
Moguće nuspojave
5.
Kako čuvati ATryn
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE ATRYN I ZA ŠTO SE KORISTI
ATryn sadrži antitrombin alfa koji je sličan prirodnom ljudskom
antitrombinu. Antitrombin u tijelu
blokira trombin, tvar koja igra središnju ulogu u procesu
zgrušavanja krvi.
Ako imate urođeni nedostatak antitrombina, razina antitrombina u
vašoj krvi je niža od normale. To
može rezultirati većom s
klonošću za stvaranje ugrušaka u krvnim žilama. To može biti u
žilama nogu
(tromboza dubokih vena) ili u drugim žilama tijela (tromboembolija).
Ta se sklonost zgrušavanju
dodatno povećava kod većih kirurških zahvata. Zato je bitno da se
razina antitrombina u krvi u tim
situacijama održava na dostatnoj razini.
Ovaj lijek se koristi kod bolesnika koji imaju „urođeni nedostatak
antitrombina” (naslijeđene niske
razine proteina antitrombina). Koristi se kad bolesnici imaju
operaciju kako bi se spriječili problemi
uzrokovani stvaranjem krvnih ugrušaka u žilama. Obično se daje
zajedno s heparinom ili heparinom
niske molekulske težine (drugim lijekom
                                
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Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih radnika se traži da prijave svaku sumnju
na nuspojavu za ovaj lijek. Za
postupak prijavljivanja nuspojava vidjeti dio 4.8.
1.
NAZIV LIJEKA
ATryn 1750 IU prašak za otopinu za infuziju.
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna bočica nominalno sadrži 1750 IU* antitrombina alfa**.
Nakon rekonstitucije, 1 ml otopine sadrži 175 IU antitrombina alfa.
Specifična aktivnost lijeka ATryn je približno 7 IU/mg proteina.
* jačina (IU) određena pomoću kromogenog testa Europske
farmakopeje.
** rekombinantni ljudski antitrombin proizveden u mlijeku transgenskih
koza tehnologijom
rekombinantne DNK (rDNK).
Pomoćna tvar s poznatim učinkom
Ovaj lijek sadrži 38 mg (1,65 mmol) natrija u bočici od 10 ml.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Prašak za otopinu za infuziju
Prašak je bijel do bjelkast.
4.
KLINIČKI
PODACI
4.1
TERAPIJSKE INDIKACIJE
ATryn je indiciran za profilaksu venske tromboembolije u kirurgiji
odraslih bolesnika s urođenim
nedostatkom antitrombina. Obično se daje zajedno s heparinom ili
heparinom niske molekulske težine._ _
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje treba početi pod nadzorom liječnika koji ima iskustva u
liječenju bolesnika s urođenim
nedostatkom antitrombina.
Doziranje
Zbog razlika u farmakokinetici antitrombina alfa i antitrombina
dobivenog iz plazme, liječenje treba
pratiti specifične preporuke za doziranje navedene u nastavku. U
liječenju urođenog nedostatka
antitrombina, dozu i trajanje liječenja treba individualizirati za
svakog bolesnika uzimajući u obzir
obiteljsku anamnezu s obzirom na tromboembolijske događaje, stvarne
čimbenike kliničkog rizika i
laboratorijsku procjenu.
Broj jedinica danog antitrombina alfa izražava se u međunarodnim
jedinicama (IU), što se odnosi na
važeće standarde WHO za koncentrat antitrombina. Aktivn
                                
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Active ingredient Антитромбин Alfa

Антитромбин Alfa

ATC code B01AB02

B01AB02

Marketed by Laboratoire Francais du Fractionnement et des Biotechnologies

Laboratoire Francais du Fractionnement et des Biotechnologies

INN (International Name) antithrombin alfa

antithrombin alfa

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ATryn