Thelin

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
02-03-2011
Summary of Product characteristics Summary of Product characteristics (SPC)
02-03-2011
Public Assessment Report Public Assessment Report (PAR)
02-03-2011

Active ingredient:

sitaksentan natrij

Available from:

Pfizer Ltd.

ATC code:

C02KX03

INN (International Name):

sitaxentan sodium

Therapeutic group:

Antihipertenzivi,

Therapeutic area:

Hipertenzija, pljučnica

Therapeutic indications:

Zdravljenje bolnikov s pljučno arterijsko hipertenzijo (PAH), razvrščenimi kot funkcijski razred III SZO, za izboljšanje telesne zmogljivosti. Učinkovitosti dokazano v primarno pljučno hipertenzijo in v pljučno hipertenzijo, povezane z boleznijo vezivnega tkiva.

Product summary:

Revision: 13

Authorization status:

Umaknjeno

Authorization date:

2006-08-10

Patient Information leaflet

                                21
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
Pfizer Limited
Sandwich
Kent CT13 9NJ
Velika Britanija
12.
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/06/353/001 (14 filmsko obloženih tablet v pretisnih omotih)
EU/1/06/353/002 (28 filmsko obloženih tablet v pretisnih omotih)
EU/1/06/353/003 (56 filmsko obloženih tablet v pretisnih omotih)
EU/1/06/353/004 (84 filmsko obloženih tablet v pretisnih omotih)
13.
ŠTEVILKA SERIJE
Lot: {številka}
14.
NAČIN IZDAJANJA ZDRAVILA
Izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
sitaksentanat
Se izpiše v Braillovi pisavi ob izdelavi.
Zdravilo nima veā dovoljenja za promet
22
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOTI IZ ALUMINIJA IN S PODLAGO IZ PVC/ACLAR/PAPIRJA
1.
IME ZDRAVILA
Thelin 100 mg filmsko obložene tablete
natrijev sitaksentanat
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Pfizer Limited
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP: {MM/LLLL}
4.
ŠTEVILKA SERIJE
Lot: {številka}
5.
DRUGI PODATKI
Zdravilo nima veā dovoljenja za promet
23
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
NALEPKA NA PLASTENKI (FIX-A FORM)
1.
IME ZDRAVILA
Thelin 100 mg filmsko obložene tablete
natrijev sitaksentanat
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena tableta vsebuje 100 mg natrijevega sitaksentanata.
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje laktoza monohidrat
4.
FARMACEVTSKA OBLIKA IN VSEBINA
28 filmsko obloženih tablet
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Peroralna uporaba.
Pred uporabo preberite priloženo navodilo.
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 25 °C.
10.
POSEBNI VARNOSTNI UKRE
                                
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Summary of Product characteristics

                                1
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Thelin 100 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena filmsko obložena tableta vsebuje 100 mg natrijevega
sitaksentanata.
Pomožne snovi:
Vsebuje tudi 166,3 mg laktoze monohidrata.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Rumene do oranžne filmsko obložene tablete v obliki kapsule z
vrezanim napisom T-100 na eni strani.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje bolnikov s pljučno arterijsko hipertenzijo (PAH), ki so
uvrščeni v funkcionalni razred III
po WHO, za izboljšanje vadbene zmogljivosti. Učinkovitost je bila
pokazana za primarno pljučno
hipertenzijo in pljučno hipertenzijo, povezano z boleznimi vezivnega
tkiva.
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravljenje lahko uvede in spremlja le zdravnik, ki ima izkušnje z
zdravljenjem PAH.
Thelin se jemlje peroralno v odmerku 100 mg enkrat na dan. Lahko se
jemlje s hrano ali brez. Ura
jemanja ni pomembna.
V primeru kliničnega poslabšanja kljub zdravljenju z zdravilom
Thelin najmanj 12 tednov, morate
preučiti možnosti alternativnih načinov zdravljenja. Vendar je bil
pri številnih bolnikih, ki se niso
odzvali na zdravljenje z zdravilom Thelin do 12. tedna, odziv do 24.
tedna ugoden. Zato lahko
upoštevate možnost zdravljenja še dodatnih 12 tednov.
Višji odmerki niso povečali koristnih učinkov v primerjavi s
povečanim tveganjem neželenih učinkov,
zlasti okvar jeter (glejte poglavje 4.4).
Prekinitev zdravljenja
Izkušenj z nenadno prekinitvijo zdravljenja z natrijevim
sitaksentanatom je malo. Ni opaženih
dokazov o akutnem poslabšanju na prvotno stanje bolezni.
Bolniki z jetrno okvaro:
Raziskave na bolnikih z obstoječo jetrno okvaro niso bile opravljene.
Zdravilo Thelin je
kontraindicirano za zdravljenje bolnikov, ki imajo pred začetkom
zdravljenja zvišane vrednosti jetrnih
aminotransferaz (> 3 × zgornja meja normalne vrednosti (Z
                                
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Active ingredient sitaksentan natrij

sitaksentan natrij

ATC code C02KX03

C02KX03

Marketed by Pfizer Ltd.

Pfizer Ltd.

INN (International Name) sitaxentan sodium

sitaxentan sodium

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Thelin