Enviage

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
19-05-2011
Download Summary of Product characteristics (SPC)
19-05-2011
Download Public Assessment Report (PAR)
19-05-2011

Active ingredient:

aliskiren

Available from:

Novartis Europharm Ltd.

ATC code:

C09XA02

INN (International Name):

aliskiren

Therapeutic group:

Sredstva, ki delujejo na sistem renin-angiotenzin

Therapeutic area:

Hipertenzija

Therapeutic indications:

Zdravljenje esencialne hipertenzije.

Product summary:

Revision: 4

Authorization status:

Umaknjeno

Authorization date:

2007-08-22

Patient Information leaflet

                                9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 30 °C.
Shranjujte v originalni ovojnini za zagotovitev zašč
ite pred vlago.
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
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
Velika Britanija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/07/406/001
7 filmsko obloženih tablet
EU/1/07/406/002
14 filmsko obloženih tablet
EU/1/07/406/003
28 filmsko obloženih tablet
EU/1/07/406/004
30 filmsko obloženih tablet
EU/1/07/406/005
50 filmsko obloženih tablet
EU/1/07/406/006
56 filmsko obloženih tablet
EU/1/07/406/008
90 filmsko obloženih tablet
13.
ŠTEVILKA SERIJE
Serija
14.
NAČIN IZ
DAJANJA ZDRAVILA
Izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Enviage 150 mg
27
Zdravilo nima veā dovoljenja za promet
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOT
PRETISNI OMOT (KOLEDARSKO PAKIRANJE)
1.
IME ZDRAVILA
Enviage 150 mg filmsko obložene tablete
aliskiren
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Novartis Europharm Limited
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
DRUGI PODATKI
ponedeljek
torek
sreda
četrtek
petek
sobota
nedelja
28
Zdravilo nima veā dovoljenja za promet
PODATKI NA ZUNANJI OVOJNINI
VMESNA ŠKATLA V SKUPNEM PAKIRANJU (BREZ PODATKOV ZA “BLUE BOX”)
1.
IME ZDRAVILA
Enviage 150 mg filmsko obložene tablete
aliskiren
2.
NAVEDBA ENE ALI VEČ Z
DRAVILNIH UČINKOVIN
Vsaka filmsko obložena tableta vsebuje 150 mg aliskirena (v obliki
hem
ifumarata).
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
14 filmsko obloženih tablet
del skupnega pakiranja z 20 škatlam
i po 14 tablet
28 filmsko obloženih tablet
del skupnega pakiranja s 3 škatlami po 28 tablet.
49 filmsko obloženih tablet
del skupnega pakiranja z 2 škatlama po 49 tablet
5.
POSTO
                                
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Summary of Product characteristics

                                DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI Z
DRAVILA
1
Zdravilo nima veā dovoljenja za promet
1.
IME ZDRAVILA
Enviage 150 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Vsaka filmsko obložena tableta vsebuje 150 mg aliskirena (v obliki
hem
ifumarata).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Bikonveksna okrogla tableta svetlo roza barve, z vtisnjeno oznako
‘IL’ na eni strani in ‘NVR’ na
drugi.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje esencialne hipertenzije.
4.2
ODMERJANJE IN NAČ
IN UPORABE
Priporoč
eni odmerek zdravila Enviage je 150 mg enkrat dnevno. Pri bolnikih,
katerih krvni tlak ni
urejen v zadostni meri, je mogoče odmerek zvišati na 300 mg enkrat
dnevno.
Antihipertenzivni uč
inek se v precejšnji meri izrazi v dveh tednih (85 - 90 %) po
začetku zdravljenja z
odmerkom 150 mg enkrat dnevno.
Enviage se lahko jemlje samostojno ali v kombinaciji z drugimi uč
inkovinami za zniževanje krvnega
tlaka (glejte poglavji 4.4 in 5.1).
Zdravilo Enviage je treba jemati z lahkim obrokom enkrat na dan,
najbolje vsak dan ob istem č
asu.
Zdravila Enviage se ne sme jemati skupaj z grenivkinim sokom.
Okvara ledvic
Bolnikom z blago do hudo okvaro ledvic ni potrebno prilagajati zač
etnega odmerka (glejte poglavji
4.4 in 5.2).
Okvara jeter
Bolnikom z blago do hudo okvaro jeter ni potrebno prilagajati zač
etnega odmerka (glejte poglavje
5.2).
Starejši bolniki (starejši od 65 let)
Starejšim bolnikom ni potrebno prilagajati zač
etnega odmerka.
Pediatrični bolniki (mlajši od 18 let)
Zaradi pomanjkanja podatkov o varnosti in uč
inkovitosti uporaba zdravila Enviage pri otrocih in
mladostnikih pod 18 let ni priporočljiva (glejte poglavje 5.2).
2
Zdravilo nima veā dovoljenja za promet
4.3
KONTRAINDIKACIJE
Preobč
utljivost za zdravilno učinkovino ali katerokoli pomožno snov.
Anamneza angioedema zaradi aliskirena.
Drugo in tretje trimeseč
je nosečnosti (glejte poglavje 4.6).
Sočasna uporaba aliskirena in cikl
                                
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Patient Information leaflet Patient Information leaflet Bulgarian 19-05-2011
Summary of Product characteristics Summary of Product characteristics Bulgarian 19-05-2011
Public Assessment Report Public Assessment Report Bulgarian 19-05-2011
Patient Information leaflet Patient Information leaflet Spanish 19-05-2011
Summary of Product characteristics Summary of Product characteristics Spanish 19-05-2011
Public Assessment Report Public Assessment Report Spanish 19-05-2011
Patient Information leaflet Patient Information leaflet Czech 19-05-2011
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Public Assessment Report Public Assessment Report Czech 19-05-2011
Patient Information leaflet Patient Information leaflet Danish 19-05-2011
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Public Assessment Report Public Assessment Report Danish 19-05-2011
Patient Information leaflet Patient Information leaflet German 19-05-2011
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Public Assessment Report Public Assessment Report German 19-05-2011
Patient Information leaflet Patient Information leaflet Estonian 19-05-2011
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Public Assessment Report Public Assessment Report Estonian 19-05-2011
Patient Information leaflet Patient Information leaflet Greek 19-05-2011
Summary of Product characteristics Summary of Product characteristics Greek 19-05-2011
Public Assessment Report Public Assessment Report Greek 19-05-2011
Patient Information leaflet Patient Information leaflet English 19-05-2011
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Public Assessment Report Public Assessment Report English 19-05-2011
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