Rienso

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-07-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2015
Public Assessment Report Public Assessment Report (PAR)
13-07-2015

Active ingredient:

Ферумокситол

Available from:

Takeda Pharma A/S

ATC code:

B03

INN (International Name):

ferumoxytol

Therapeutic group:

Ostali lijekovi противоанемические

Therapeutic area:

Anemia; Kidney Failure, Chronic

Therapeutic indications:

Rienso je indiciran za intravensku terapiju željeza-anemija u odraslih bolesnika s kroničnim bubrežnim zatajenjem (CKD). Dijagnoze nedostatka željeza mora se temeljiti na odgovarajućim laboratorijskim testovima (vidi odjeljak 4.

Product summary:

Revision: 7

Authorization status:

povučen

Authorization date:

2012-06-15

Patient Information leaflet

                                23
B. UPUTA O LIJEKU
_ _
Lijek više nije odobren
24
UPUTA O LIJEKU: INFORMACIJA ZA BOLESNIKA
_ _
RIENSO 30 MG/ML OTOPINA ZA INFUZIJU
željezo u obliku ferumoksitola
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 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, 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. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Rienso i za što se koristi
2.
Što morate znati prije nego počnete primati Rienso
3.
Kako se Rienso primjenjuje
4.
Moguće nuspojave
5.
Kako čuvati Rienso
6.
Sadržaj pakiranja i dodatne informacije
1.
ŠTO JE RIENSO I ZA ŠTO SE KORISTI
Rienso je pripravak željeza koji sadrži djelatnu tvar ferumoksitol i
daje se infuzijom u venu.
Primjenjuje se za liječenje anemije zbog manjka željeza koja nastaje
zbog nedostatka zaliha željeza u
tijelu kod odraslih bolesnika sa smanjenom funkcijom bubrega.
Željezo je esencijalni element potreban za stvaranje hemoglobina,
molekule u crvenim krvnim
stanicama koja omogućuje prijenos kisika po tijelu. Kad u tijelu nema
dovoljno željeza, ne može se
stvoriti hemoglobin, zbog čega nastaje anemija (niske razine
hemoglobina).
Cilj terapije lijekom Rienso jest obnova zaliha željeza u tijelu.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMATI RIENSO
Prije nego što Vam je propisao Rienso, liječnik Vam je napravio
krvne pretrage da bi provjerio je li
stvarno prisutna anemija zbog manjka željeza.
NE SMIJETE PRIMITI RIENSO:
-
ako ste alergični (preosjetljivi) na lijek ili bilo koji drugi
sastojak ovog l
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
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_ _
_ _
_ _
Lijek više nije odobren
2
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih djelatnika traži se da prijave svaku
sumnju na nuspojavu za ovaj lijek.
Za postupak prijavljivanja nuspojava vidjeti dio 4.8.
1.
NAZIV LIJEKA
Rienso 30 mg/ml otopina za infuziju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
1 ml otopine sadrži 30 mg željeza u obliku ferumoksitola.
Jedna bočica sa 17 ml otopine sadrži 510 mg željeza u obliku
ferumoksitola.
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Otopina za infuziju.
Crna do crvenkasto-smeđa otopina
Osmolalnost: 270-330 mosm/kg
pH: 6,5 do 8,0
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Rienso je indiciran za intravensko liječenje anemije zbog nedostatka
željeza kod odraslih bolesnika s
kroničnom bolešću bubrega (KBB).
Dijagnoza nedostatka željeza mora se temeljiti na odgovarajućim
laboratorijskim pretragama (vidjeti
dio 4.2).
4.2
DOZIRANJE I NAČIN PRIMJENE
Rienso se smije primjenjivati samo kada je osoblje izučeno za
procjenu i zbrinjavanje anafilaktičkih
reakcija odmah na raspolaganju, u okruženju u kojem je dostupna puna
oprema za reanimaciju.
Bolesnike treba pažljivo nadzirati zbog znakova i simptoma reakcija
preosjetljivosti, uključujući
praćenje krvnog tlaka i pulsa, tijekom i najmanje 30 minuta nakon
svake infuzije lijeka Rienso. Osim
toga, bolesnike treba postaviti u ležeći ili poluležeći položaj
tijekom infuzije i najmanje 30 minuta
nakon infuzije (vidjeti dio 4.4).
Doziranje
_Tijek liječenja _
Preporučeni tijek liječenja lijekom Rienso temelji se na vrijednosti
hemoglobina prije liječenja i
tjelesnoj težini bolesnika, kako je prikazano u tablici 1.
Lijek više nije odobren
3
Svaka doza od 510 mg primjenjuje se kao intravenska infuzija tijekom
najmanje 15 minuta. Kod
bolesnika koji primaju dvije doze, drugu infuziju doze od 510 mg treba
primijeniti 2 do 8 dana 
                                
                                Read the complete document

Similar products

Active ingredient Ферумокситол

Ферумокситол

ATC code B03

B03

Marketed by Takeda Pharma A/S

Takeda Pharma A/S

INN (International Name) ferumoxytol

ferumoxytol

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