Siklos

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
31-07-2023
Public Assessment Report Public Assessment Report (PAR)
27-05-2014

Active ingredient:

hidroksikarbamid

Available from:

Theravia

ATC code:

L01XX05

INN (International Name):

hydroxycarbamide

Therapeutic group:

Antineoplastična sredstva

Therapeutic area:

Anemija, Srčna celica

Therapeutic indications:

Siklos je indicirano za preprečevanje ponavljajočih se boleče vaso-okluzivni krize, vključno z akutno prsih sindrom iz pediatrije in odraslih bolnikih, ki trpijo za simptomatsko anemija srpastih celic sindrom.

Product summary:

Revision: 24

Authorization status:

Pooblaščeni

Authorization date:

2007-06-29

Patient Information leaflet

                                19
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
THERAVIA, 16 Rue Montrosier, 92200 Neuilly-sur-Seine, Francija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/07/397/002 60 tablet
EU/1/07/397/003 90 tablet
EU/1/07/397/004 120 tablet
13.
ŠTEVILKA SERIJE
Lot:
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
siklos 100 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC:
SN:
NN:
20
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PLASTENKA
1.
IME ZDRAVILA IN POT(I) UPORABE
Siklos 100 mg tableta
hidroksikarbamid
Peroralna uporaba
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP:
4.
ŠTEVILKA SERIJE
Lot:
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
60 tablet
90 tablet
120 tablet
6.
DRUGI PODATKI
CITOTOKSIČNO
21
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Siklos 1 000 mg filmsko obložena tableta
HIDROKSIKARBAMID
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena tableta vsebuje 1 000 mg hidroksikarbamida.
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
30 filmsko obloženih tablet
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
PERORALNA UPORABA.
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
CITOTOKSIČNO
: s tabletami ravnajte previdno.
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP:
Rok uporabe prelomljenih tablet: 3 mesece.
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 30 °C.
22
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
THERAVIA, 16 Rue Montrosier, 
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Siklos 100 mg filmsko obložena tableta
Siklos 1 000 mg filmsko obložena tableta
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Siklos 100 mg filmsko obložena tableta
Ena filmsko obložena tableta vsebuje 100 mg hidroksikarbamida.
Siklos 1 000 mg filmsko obložena tableta
Ena filmsko obložena tableta vsebuje 1 000 mg hidroksikarbamida.
Za popoln seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta (tableta)
Siklos 100 mg filmsko obložena tableta
Sivobela, podolgovata, filmsko obložena tableta z zarezo na polovici
na obeh straneh.
Tableto se lahko razdeli na dva enaka dela. Vsaka polovica tablete ima
na eni strani izbočeno črko
"H".
Siklos 1 000 mg filmsko obložena tableta
Sivobela, filmsko obložena tableta v obliki kapsule s tremi zarezami
na obeh straneh.
Tableta se lahko deli na štiri enake dele. Vsaka četrtina tablete
ima na eni strani izbočeno črko "T".
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Siklos je indicirano za preprečevanje ponavljajočih se
bolečih vazookluzivnih kriz, vključno
z akutnim sindromom bolečine v prsih pri odraslih bolnikih in
otrocih, starih več kot 2 leti, ki imajo
simptomatični srpastocelični sindrom. (glejte poglavje 5.1).
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravljenje z zdravilom Siklos mora začeti zdravnik, izkušen v
obravnavanju srpastoceličnega
sindroma.
Odmerjanje
_Pri odraslih, mladostnikih in otrocih, starejših od 2 let _
Odmerjanje je treba določiti na podlagi bolnikove telesne mase (TM).
Začetni odmerek hidroksikarbamida je 15 mg/kg TM, običajni odmerek
znaša med 15 in
30 mg/kg TM/dan.
Dokler se bolnik na terapijo bodisi klinično bodisi hematološko
(npr. zvišanje koncentracije fetalnega
hemoglobina F (HbF), povprečnega volumna eritrocitov (PVE), števila
nevtrofilcev) odziva, je treba
odmerek zdravila Siklos vzdrževati.
V primeru neodzivnosti (ponovni pojav kriz ali nezmanjšano število
kriz) se dnevni odmerek lahko
zveča v korakih
                                
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Similar products

Active ingredient hidroksikarbamid

hidroksikarbamid

ATC code L01XX05

L01XX05

Marketed by Theravia

Theravia

INN (International Name) hydroxycarbamide

hydroxycarbamide

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Patient Information leaflet Patient Information leaflet Bulgarian 31-07-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 31-07-2023
Public Assessment Report Public Assessment Report Bulgarian 27-05-2014
Patient Information leaflet Patient Information leaflet Spanish 31-07-2023
Summary of Product characteristics Summary of Product characteristics Spanish 31-07-2023
Public Assessment Report Public Assessment Report Spanish 27-05-2014
Patient Information leaflet Patient Information leaflet Czech 31-07-2023
Summary of Product characteristics Summary of Product characteristics Czech 31-07-2023
Public Assessment Report Public Assessment Report Czech 27-05-2014
Patient Information leaflet Patient Information leaflet Danish 31-07-2023
Summary of Product characteristics Summary of Product characteristics Danish 31-07-2023
Public Assessment Report Public Assessment Report Danish 27-05-2014
Patient Information leaflet Patient Information leaflet German 31-07-2023
Summary of Product characteristics Summary of Product characteristics German 31-07-2023
Public Assessment Report Public Assessment Report German 27-05-2014
Patient Information leaflet Patient Information leaflet Estonian 31-07-2023
Summary of Product characteristics Summary of Product characteristics Estonian 31-07-2023
Public Assessment Report Public Assessment Report Estonian 27-05-2014
Patient Information leaflet Patient Information leaflet Greek 31-07-2023
Summary of Product characteristics Summary of Product characteristics Greek 31-07-2023
Public Assessment Report Public Assessment Report Greek 27-05-2014
Patient Information leaflet Patient Information leaflet English 31-07-2023
Summary of Product characteristics Summary of Product characteristics English 31-07-2023
Public Assessment Report Public Assessment Report English 27-05-2014
Patient Information leaflet Patient Information leaflet French 31-07-2023
Summary of Product characteristics Summary of Product characteristics French 31-07-2023
Public Assessment Report Public Assessment Report French 27-05-2014
Patient Information leaflet Patient Information leaflet Italian 31-07-2023
Summary of Product characteristics Summary of Product characteristics Italian 31-07-2023
Public Assessment Report Public Assessment Report Italian 27-05-2014
Patient Information leaflet Patient Information leaflet Latvian 31-07-2023
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Public Assessment Report Public Assessment Report Latvian 27-05-2014
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Public Assessment Report Public Assessment Report Lithuanian 27-05-2014
Patient Information leaflet Patient Information leaflet Hungarian 31-07-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 31-07-2023
Public Assessment Report Public Assessment Report Hungarian 27-05-2014
Patient Information leaflet Patient Information leaflet Maltese 31-07-2023
Summary of Product characteristics Summary of Product characteristics Maltese 31-07-2023
Public Assessment Report Public Assessment Report Maltese 27-05-2014
Patient Information leaflet Patient Information leaflet Dutch 31-07-2023
Summary of Product characteristics Summary of Product characteristics Dutch 31-07-2023
Public Assessment Report Public Assessment Report Dutch 27-05-2014
Patient Information leaflet Patient Information leaflet Polish 31-07-2023
Summary of Product characteristics Summary of Product characteristics Polish 31-07-2023
Public Assessment Report Public Assessment Report Polish 27-05-2014
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Summary of Product characteristics Summary of Product characteristics Portuguese 31-07-2023
Public Assessment Report Public Assessment Report Portuguese 27-05-2014
Patient Information leaflet Patient Information leaflet Romanian 31-07-2023
Summary of Product characteristics Summary of Product characteristics Romanian 31-07-2023
Public Assessment Report Public Assessment Report Romanian 27-05-2014
Patient Information leaflet Patient Information leaflet Slovak 31-07-2023
Summary of Product characteristics Summary of Product characteristics Slovak 31-07-2023
Public Assessment Report Public Assessment Report Slovak 27-05-2014
Patient Information leaflet Patient Information leaflet Finnish 31-07-2023
Summary of Product characteristics Summary of Product characteristics Finnish 31-07-2023
Public Assessment Report Public Assessment Report Finnish 27-05-2014
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Summary of Product characteristics Summary of Product characteristics Swedish 31-07-2023
Public Assessment Report Public Assessment Report Swedish 27-05-2014
Patient Information leaflet Patient Information leaflet Norwegian 31-07-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 31-07-2023
Patient Information leaflet Patient Information leaflet Icelandic 31-07-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 31-07-2023
Patient Information leaflet Patient Information leaflet Croatian 31-07-2023
Summary of Product characteristics Summary of Product characteristics Croatian 31-07-2023
Public Assessment Report Public Assessment Report Croatian 27-05-2014

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Siklos