Esmya

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
03-02-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
03-02-2021
Public Assessment Report Public Assessment Report (PAR)
03-02-2021

Active ingredient:

ulipristal acetat

Available from:

Gedeon Richter Ltd 

ATC code:

G03XB02

INN (International Name):

ulipristal

Therapeutic group:

Spolni hormoni in zdravila genitalni sistem,

Therapeutic area:

Leiomyoma

Therapeutic indications:

Ulipristalacetat je indiciran za predoperativno zdravljenje zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v reproduktivni dobi. Ulipristal acetata je primerna za občasno zdravljenje zmerne do hude simptome maternice fibroids v odrasle ženske v rodni dobi.

Product summary:

Revision: 16

Authorization status:

Pooblaščeni

Authorization date:

2012-02-22

Patient Information leaflet

                                22
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
_ _
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Madžarska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/12/750/001 28 tablet
EU/1/12/750/002 84 tablet
EU/1/12/750/003 30 tablet
EU/1/12/750/004 28 tablet
EU/1/12/750/005 84 tablet
13.
ŠTEVILKA SERIJE
_ _
Serija
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
_ _
16.
PODATKI V BRAILLOVI PISAVI_ _
Esmya
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
PC:
SN:
NN:
23
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOT
1.
IME ZDRAVILA
_ _
Esmya 5 mg tablete
ulipristalacetat
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Gedeon Richter
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
_ _
EXP
4.
ŠTEVILKA SERIJE
_ _
Serija
5.
DRUGI PODATKI
_ _
24
ESMYA 5 MG TABLETE
OPOZORILNA KARTICA ZA BOLNICO
KAJ MORATE VEDETI PRED UPORABO?
Zdravilo Esmya lahko povzroči neželene učinke, ki pa se ne pojavijo
pri vseh bolnicah. Eden izmed
možnih neželenih učinkov je resna okvara jeter. Poročali so o
primerih odpovedi jeter pri ženskah, ki
so jemale zdravilo Esmya; v majhnem številu teh primerov je bila
potrebna presaditev jeter.
Ta kartica vsebuje informacije o krvnih preiskavah, ki jih boste
opravili tekom zdravljenja, in o tem,
kaj morate storiti, če se pojavijo neželeni učinki povezani z
delovanjem jeter.
Ne jemljite zdravila Esmya, če imate težave z jetri. Povejte svojemu
zdravniku, če veste, da imate
težave z jetri ali če imate kakšne pomisleke glede stanja jeter.
KAJ STORITI PRED, MED IN PO ZDRAVLJENJU?
REDNO OPRAVLJANJE KRVNIH PREISKAV
Pred vsakim začetkom cikla zdravljenja boste opravili krvne
preiskave, da se ugotovi, kako delujejo
vaša jetra. Glede na rezultate teh preiskav se bo zdravnik odločil,
ali je zdravljenje z zdravilom Esmya
za vas primerno.
Med zdravljenjem z zdr
                                
                                Read the complete document

Summary of Product characteristics

                                1
_ _
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
_ _
Esmya 5 mg tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena tableta vsebuje 5 mg ulipristalacetata.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
tableta
Bela do umazano bela okrogla bikonveksna tableta s premerom 7 mm, z
vtisnjenim napisom »ES5« na
eni strani.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Ulipristalacetat je indiciran za intermitentno zdravljenje zmernih do
hudih simptomov materničnih
leiomiomov pri odraslih ženskah, ki še niso v menopavzi, kadar
embolizacija materničnih fibroidov
in/ali kirurško zdravljenje nista primerna ali pa nista uspela.
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravljenje z zdravilom Esmya morajo uvesti in nadzorovati zdravniki,
z izkušnjami pri
diagnosticiranju in zdravljenju materničnih leiomiomov.
Odmerjanje
Bolnica jemlje eno 5-miligramsko tableto enkrat dnevno v ciklih
zdravljenja, ki trajajo do 3 mesece.
Tablete se lahko jemljejo s hrano ali brez nje.
Cikli se smejo začeti samo ob nastopu menstruacije:
-
prvi cikel zdravljenja se mora začeti v prvem tednu menstruacije.
-
ponovna zdravljenja se lahko začnejo šele v prvem tednu druge
menstruacije po zaključenem
prejšnjem ciklu zdravljenja.
Lečeči zdravnik mora bolnici pojasniti, zakaj potrebuje obdobja brez
zdravljenja.
Pri ponavljajočem se intermitentnem zdravljenju so preučili do 4
intermitentne cikle zdravljenja.
Če bolnica pozabi vzeti odmerek, mora vzeti ulipristalacetat čim
prej. Če je odmerek zamudila za več
kot 12 ur, ne sme vzeti izpuščenega odmerka, ampak mora preprosto
nadaljevati običajni razpored
odmerjanja.
_Posebne populacije _
_Ledvična okvara _
Pri bolnicah z blago ali zmerno ledvično okvaro prilagoditev odmerka
ni potrebna. Specifičnih študij
niso opravili, zato uporaba ulipristalacetata pri bolnicah s hudo
ledvično okvaro ni priporočljiva, razen
če bolnico pozorno spremljate (glejte poglavji 4.4 in 5.2).
_Pediatrična populacija _
Ulipristalacetat ni primeren za upo
                                
                                Read the complete document

Similar products

Active ingredient ulipristal acetat

ulipristal acetat

ATC code G03XB02

G03XB02

Marketed by Gedeon Richter Ltd 

Gedeon Richter Ltd 

INN (International Name) ulipristal

ulipristal

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