Krystexxa

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
22-07-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
22-07-2016

Active ingredient:

pegloticase

Available from:

Crealta Pharmaceuticals Ireland Limited

ATC code:

M04AX02

INN (International Name):

pegloticase

Therapeutic group:

Antigadni pripravci

Therapeutic area:

Giht

Therapeutic indications:

Krystexxa je indiciran za liječenje teškog oslabiti kronične tophaceous gihta u odraslih bolesnika koji može imati erozivni zajednički angažman i koji nisu uspjeli normalizirati serumske mokraćne kiseline s ksantin oksidaza inhibitori maksimalno medicinski odgovarajuće doze ili kojima ovi lijekovi su kontraindicirani.

Product summary:

Revision: 3

Authorization status:

povučen

Authorization date:

2013-01-08

Patient Information leaflet

                                21
B. UPUTA O LIJEKU
Lijek koji više nije odobren
22
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
KRYSTEXXA 8 MG KONCENTRAT ZA OTOPINU ZA INFUZIJU
peglotikaza
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(joj) liječniku,
ljekarniku ili medicinskoj sestri.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika, ljekarnika ili medicinsku
sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je KRYSTEXXA i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati lijek KRYSTEXXA
3.
Kako primjenjivati lijek KRYSTEXXA
4.
Moguće nuspojave
5.
Kako čuvati lijek KRYSTEXXA
6.
Sadržaj pakovanja i druge informacije
1.
ŠTO JE KRYSTEXXA I ZA ŠTO SE KORISTI
KRYSTEXXA sadrži djelatnu tvar peglotikazu. Peglotikaza pripada
skupini lijekova protiv gihta.
Peglotikaza se koristi za liječenje teškog, dugotrajnog gihta u
odraslih bolesnika, koji imaju jedan ili
više bolnih depozita kristala urične kiseline pod kožom koji
uzrokuju poteškoće u svakodnevnim
aktivnostima, i koji ne reagiraju na ili ne mogu primati lijekove
protiv gihta.
KAKO KRYSTEXXA DJELUJE
Osobe s gihtom imaju višak mokraćne kiseline u svom tijelu.
Mokraćna kiselina taloži se u
zglobovima, bubrezima i drugim organima što može uzrokovati izrazitu
bol, crvenilo i oticanje
(upalu).
KRYSTEXXA sadrži enzim zvan urikaza koji pretvara mokraćnu kiselinu
u tvar zvanu alantoin koja
se može jednostavno izlučiti mokraćom.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMJENJIVATI LIJEK KRYSTEXXA
NEMOJTE PRIMJENJIVATI LIJEK KRYSTEXXA
•
Ako ste alergični na peglotikazu ili druge urikaze ili neki drugi
sastojak ovog lijeka (naveden u
dijelu 6.).
•
Ako imate rijetki poremećaj zvan nedostatak 6-fosfat dehidrogenaze
(G6PD) ili favizam. Vaš
liječnik može Vas testirati na G6PD prije poč
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV GOTOVOG LIJEKA
KRYSTEXXA 8 mg koncentrat za otopinu za infuziju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna bočica sadrži 8 mg peglotikaze (koncentrat 8 mg/ml). Jačina
ukazuje na količinu urikaze u
peglotikazi bez uzimanja u obzir PEGilacije.
Djelatna tvar peglotikaza je kovalentni konjugat urikaze dobivene
genetski modificiranim sojem
bakterije _Escherichia coli_ i monometoksipolija (etilen glikola).
Jačina ovog lijeka ne smije se uspoređivati s drugim pegiliranim ili
nepegiliranim proteinom iste
terapijske klase.
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1
3.
FARMACEUTSKI OBLIK
Koncentrat za otopinu za infuziju.
Bistra do blago zamućena, bezbojna otopina s pH od 7,3±0,3.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
KRYSTEXXA je indicirana za liječenje teškog, onesposobljavajućeg
kroničnog gihta s tofima u
odraslih bolesnika koji također mogu imati erozivne promjene na
zglobovima i koji nisu uspjeli
normalizirati serumske razine mokraćne kiseline inhibitorima ksantin
oksidaze pri maksimalnoj
odgovarajućoj dozi ili u bolesnika kod kojih su ovi lijekovi
kontraindicirani (vidjetio dio 4.4).
Odluku o liječenju lijekom KRYSTEXXA treba temeljiti na tekućim
procjenama dobrobiti i rizika za
pojedinog bolesnika (vidjeti dio 4.4).
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje treba započeti i nadzirati liječnik specijalist iskusan u
dijagnosticiranju i liječenju teškog,
refraktornog, kroničnog gihta.
Lijek trebaju primjenjivati zdravstveni djelatnici pripravni na
liječenje anafilaktičkih i infuzijskih
reakcija u odgovarajuće opremljenim zdravstvenim ustanovama. Potreban
je pažljivi nadzor tijekom
infuzije i još najmanje 2 sata nakon završetka infuzije. Potrebno je
osigurati dostupnost opreme za
oživljavanje. Zabilježene su i reakcije preosjetljivosti kasnog
tipa.
Doziranje
Preporučena doza je 8 mg peglotikaze u obliku intravenske infuzije
svaka dva tjedna.
Prije infuzije bolesnici trebaju primiti prem
                                
                                Read the complete document

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Active ingredient pegloticase

pegloticase

ATC code M04AX02

M04AX02

Marketed by Crealta Pharmaceuticals Ireland Limited

Crealta Pharmaceuticals Ireland Limited

INN (International Name) pegloticase

pegloticase

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