Ferriprox

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-12-2022
Public Assessment Report Public Assessment Report (PAR)
28-10-2019

Active ingredient:

Deferiprone

Available from:

Chiesi Farmaceutici S.p.A.

ATC code:

V03AC02

INN (International Name):

deferiprone

Therapeutic group:

Vsi drugi terapevtski izdelki

Therapeutic area:

beta-Thalassemia; Iron Overload

Therapeutic indications:

Monoterapija Ferriprox je indicirana za zdravljenje preobremenjenosti železa pri bolnikih s talasemijo, ko je sedanja kelacijska terapija kontraindicirana ali nezadostna. Ferriprox v kombinaciji z drugo chelator je indicirana pri bolnikih z talasemija major, ko monotherapy z vsemi železa chelator je neučinkovita, ali ko je preprečevanje ali zdravljenje življenjsko nevarne posledice železa preobremenitve (predvsem srčno preobremenitve) utemeljuje hitro ali intenzivno popravek.

Product summary:

Revision: 32

Authorization status:

Pooblaščeni

Authorization date:

1999-08-25

Patient Information leaflet

                                32
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italija
12.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/99/108/001
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Ferriprox 500 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
PC
SN
NN
33
PODATKI NA PRIMARNI OVOJNINI
500 MG FILMSKO OBLOŽENE TABLETE
PLASTENKA S 100 TABLETAMI
NALEPKA
1.
IME ZDRAVILA
Ferriprox 500 mg filmsko obložene tablete
deferipron
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena tableta vsebuje 500 mg deferiprona.
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
filmsko obložena tableta
100 filmsko obloženih tablet
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
za peroralno uporabo
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 30

C.
34
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Chiesi (logotip)
12.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/99/108/001
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
35
PODATKI NA ZUNANJI OVOJNINI
PLASTENKA Z 250 ML ALI S 500 ML PERORALNE RAZTOPINE
ŠKATLA
1.
IME ZDRAVILA
Ferriprox 100 mg/ml peroralna raztopina
deferipron
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
En ml p
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Ferriprox 500 mg filmsko obložene tablete
Ferriprox 1000 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ferriprox 500 mg filmsko obložene tablete
Ena tableta vsebuje 500 mg deferiprona.
Ferriprox 1000 mg filmsko obložene tablete
Ena tableta vsebuje 1000 mg deferiprona.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Ferriprox 500 mg filmsko obložene tablete
Bela do sivobela, filmsko obložena tableta v obliki kapsule; na eni
strani je odtisnjeno »APO« zareza
»500«, druga stran je gladka. Tableta je velika 7,1 mm × 17,5 mm ×
6,8 mm in ima razdelilno zarezo.
Tableta se lahko deli na enaki polovici.
Ferriprox 1000 mg filmsko obložene tablete
Bela do sivobela, filmsko obložena tableta v obliki kapsule; na eni
strani je odtisnjeno »APO« zareza
»1000«, druga stran je gladka. Tableta je velika 7,9 mm × 19,1 mm
× 7 mm in ima razdelilno zarezo.
Tableta se lahko deli na enaki polovici.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Monoterapija z zdravilom Ferriprox je indicirana za zdravljenje
preobremenjenosti z železom pri
bolnikih s talasemijo major, če je trenutna kelacijska terapija
kontraindicirana ali nezadostna.
Zdravilo Ferriprox je v kombinaciji z drugim kelatorjem (glejte
poglavje 4.4) indicirano pri bolnikih s
talasemijo major, če je monoterapija s katerim koli kelatorjem
železa neučinkovita, ali kadar
preprečevanje ali zdravljenje življenjsko nevarnih posledic
preobremenitve z železom (predvsem srčne
preobremenitve) opravičuje hiter ali intenziven popravek (glejte
poglavje 4.2).
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravljenje z deferipronom naj uvede in nadzira zdravnik, ki ima
izkušnje z zdravljenjem bolnikov s
talasemijo.
3
Odmerjanje
Deferipron se najpogosteje predpisuje v odmerku 25 mg/kg telesne mase,
peroralno, trikrat na dan,
največji skupni dnevni odmerek je 75 mg/kg telesne mase. Odmerek na
kilogram telesne mase naj se
izračuna do
                                
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Similar products

Active ingredient Deferiprone

Deferiprone

ATC code V03AC02

V03AC02

Marketed by Chiesi Farmaceutici S.p.A.

Chiesi Farmaceutici S.p.A.

INN (International Name) deferiprone

deferiprone

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Summary of Product characteristics Summary of Product characteristics Bulgarian 13-12-2022
Public Assessment Report Public Assessment Report Bulgarian 28-10-2019
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