Kepivance

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-04-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
08-04-2016
Public Assessment Report Public Assessment Report (PAR)
08-04-2016

Active ingredient:

palifermin

Available from:

Swedish Orphan Biovitrum AB (publ)

ATC code:

V03AF08

INN (International Name):

palifermin

Therapeutic group:

Svi ostali terapeutski proizvodi

Therapeutic area:

mukozitis

Therapeutic indications:

Kepivance je indiciran smanjiti učestalost, trajanje i ozbiljnost oralni mukozitis u odraslih bolesnika s hematološkim malignim bolestima koji primaju mijeloablativnu radiochemotherapy povezane s visokom učestalosti teških mukozitis i zahtijeva autolognih krvotvornih-Kljun-stanica za.

Product summary:

Revision: 19

Authorization status:

povučen

Authorization date:

2005-10-25

Patient Information leaflet

                                19
B. UPUTA O LIJEKU
Lijek koji više nije odobren
20
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
_ _
KEPIVANCE 6,25 MG PRAŠAK ZA OTOPINU ZA INJEKCIJU
palifermin
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 ili
ljekarniku.
-
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 Kepivance i za što se koristi
2.
Što morate znati prije nego počnete primati Kepivance
3.
Kako primjenjivati Kepivance
4.
Moguće nuspojave
5.
Kako čuvati Kepivance
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE KEPIVANCE I ZA ŠTO SE KORISTI
Kepivance sadrži djelatnu tvar palifermin, protein proizveden
biotehnologijom u bakteriji
_Escherichia coli_
. Palifermin potiče rast posebnih stanica koje se nazivaju epitelne
stanice, a oblikuju
tkivo kojim su obložena Vaša usta i probavna cijev, kao i druga
tkiva poput kože. Palifermin djeluje
na isti način kao i čimbenik rasta keratinocita koji Vaše tijelo
prirodno stvara u malim količinama.
Kepivance se koristi za liječenje oralnog mukozitisa (bol, suhoća i
upala usta) koji nastaje kao
nuspojava u liječenju raka krvi.
Za liječenje raka krvi možete primati kemoterapiju, zračenje ili
presađivanje vlastitih krvotvornih
matičnih stanica (stanice iz Vašeg tijela koje proizvode druge krvne
stanice). Jedna od nuspojava tih
liječenja je oralni mukozitis. Kepivance se koristi za smanjenje
učestalosti, trajanja i težine simptoma
oralnog mukozitisa.
Kepivance smiju uzimati samo odrasle osobe starije od 18 godina.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMATI KEPIVANCE
_ _
NEMOJTE PRIMJENJIVATI KEPIVANCE:
-
ako ste alergični na palifermin, proteine dobivene iz
_Escherichie coli_
ili druge sastojke ovog
lijeka (navedene u dijelu
                                
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Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA_ _
Lijek koji više nije odobren
2
1.
NAZIV LIJEKA
Kepivance 6,25 mg prašak za otopinu za injekciju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka bočica sadrži 6,25 mg palifermina.
Palifermin je humani čimbenik rasta keratinocita (od engl.
_Keratinocyte growth factor_
- KGF) koji se
proizvodi tehnologijom rekombinantne DNK u stanicama
_Escherichia coli_
.
Nakon pripreme za primjenu Kepivance sadrži 5 mg/ml palifermina.
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Prašak za otopinu za injekciju (prašak za injekciju).
Bijeli liofilizirani prašak.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Kepivance je indiciran za smanjenje incidencije, trajanja i težine
oralnog mukozitisa u odraslih
bolesnika s hematološkim malignim bolestima koji primaju
mijeloablativnu radiokemoterapiju
povezanu s visokom stopom incidencije teškog mukozitisa i kojima je
potrebna terapija autolognim
krvotvornim matičnim stanicama
_. _
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje Kepivanceom treba nadzirati liječnik s iskustvom u
primjeni onkološkog liječenja.
Doziranje
_Odrasli _
Preporučena doza Kepivancea iznosi 60 mikrograma/kg/dan, primijenjena
u obliku intravenske bolus
injekcije kroz 3 uzastopna dana prije i 3 uzastopna dana nakon
mijeloablativne radiokemoterapije,
ukupno 6 doza. Razmak između posljednje doze Kepivancea prije
mijeloablativne radiokemoterapije i
prve doze Kepivancea nakon mijeloablativne radiokemoterapije treba
iznositi najmanje sedam dana.
_Prije_
_mijeloablativne radiokemoterapije:_
Prve 3 doze treba primijeniti prije mijeloablativnog
_ _
liječenja, tako da se 3. doza primijeni 24 do 48
sati prije mijeloablativne radiokemoterapije.
_Nakon_
_mijeloablativne radiokemoterapije: _
Posljednje 3 doze treba primijeniti nakon mijeloablativne
radiokemoterapije. Prvu od posljednje 3
doze treba primijeniti nakon liječenja, ali isti dan kao i infuziju
krvotvornih matičnih stanica i
najmanje sedam dana nakon zadnje primjenjene doze Kepivancea 
                                
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Active ingredient palifermin

palifermin

ATC code V03AF08

V03AF08

Marketed by Swedish Orphan Biovitrum AB (publ)

Swedish Orphan Biovitrum AB (publ)

INN (International Name) palifermin

palifermin

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