Tredaptive

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-05-2012
Summary of Product characteristics Summary of Product characteristics (SPC)
31-05-2012
Public Assessment Report Public Assessment Report (PAR)
11-07-2008

Active ingredient:

laropiprant, nicotinic kisline

Available from:

Merck Sharp Dohme Ltd.

ATC code:

C10AD52

INN (International Name):

laropiprant, nicotinic acid

Therapeutic group:

Sredstva za spreminjanje lipidov

Therapeutic area:

Dislipidemije

Therapeutic indications:

Tredaptive je indiciran za zdravljenje dyslipidaemia, zlasti pri bolnikih s kombinirano mešani dyslipidaemia (značilno povišane ravni nizko-gostoto-nizke gostote (LDL) holesterola in trigliceridov in nizko visoko-gostoto-lipoprotein (HDL ) holesterol) in pri bolnikih s primarno hiperholesterolemijo (heterozigotno družinsko in družinsko). Tredaptive je treba uporabljati pri bolnikih, ki v kombinaciji z 3-hidroksi-3-metil-glutaryl-co-encim-A (HMG-CoA)-reductase inhibitorji (statins), ko je raven holesterola,-znižuje učinek HMG-CoA-reductase zaviralec monotherapy je neustrezna. Lahko se uporablja kot monotherapy le pri bolnikih, pri katerih HMG-CoA-reductase inhibitorji so se štejejo za neprimerne ali ne prenaša. Prehrana in druge ne-farmakološko zdravljenje (e. vadba, zmanjšanje telesne mase), bi bilo treba še naprej med terapijo z Tredaptive.

Product summary:

Revision: 11

Authorization status:

Umaknjeno

Authorization date:

2008-07-03

Patient Information leaflet

                                24
Ne shranjujte pri temperaturi nad 30 °C.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred
svetlobo in 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
Merck Sharp & Dohme Ltd.
Hertford Road, Hoddesdon
Hertfordshire EN11 9BU
Velika Britanija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/08/459/009 14 tablet s prirejenim sproščanjem
EU/1/08/459/010 28 tablet s prirejenim sproščanjem
EU/1/08/459/011 56 tablet s prirejenim sproščanjem
EU/1/08/459/013 168 tablet s prirejenim sproščanjem
EU/1/08/459/014 32 x 1 tableta s prirejenim sproščanjem
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
Tredaptive
Zdravilo nima veā dovoljenja za promet
25
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA (S PVC/ACLAR PRETISNIMI OMOTI)
1.
IME ZDRAVILA
Tredaptive 1.000 mg/20 mg tablete s prirejenim sproščanjem
nikotinska kislina/laropiprant
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena tableta s prirejenim sproščanjem vsebuje 1.000 mg nikotinske
kisline in 20 mg laropipranta.
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje laktozo monohidrat. Za dodatne informacije glejte navodilo za
uporabo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
14 tablet s prirejenim sproščanjem
28 tablet s prirejenim sproščanjem
56 tablet s prirejenim sproščanjem
84 tablet s prirejenim sproščanjem
98 tablet s prirejenim sproščanjem
168 tablet s prirejenim sproščanjem
196 tablet s prirejenim sproščanjem
Multi pakiranje po 196 (2 pakiranji po 98) tablet s prirejenim
sproščanjem
49 x 1 tableta s prirejenim sproščanjem
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.
DATU
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Tredaptive 1.000 mg/20 mg tablete s prirejenim sproščanjem
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena tableta s prirejenim sproščanjem vsebuje 1.000 mg nikotinske
kisline in 20 mg laropipranta.
Pomožne snovi z znanim učinkom:
Ena tableta s prirejenim sproščanjem vsebuje 128,4 mg laktoze
monohidrata.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
tableta s prirejenim sproščanjem
tablete v obliki kapsule in bele do kremaste barve z vtisnjeno oznako
"552" na eni strani
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Tredaptive je indicirano za zdravljenje dislipidemije, zlasti
pri odraslih bolnikih s
kombinirano mešano dislipidemijo (za katero so značilni zvišani LDL
holesterol in trigliceridi in
nizek HDL holesterol), in pri odraslih bolnikih s primarno
hiperholesterolemijo (heterozigotno
družinsko in nedružinsko).
Zdravilo Tredaptive je treba uporabljati v kombinaciji z zaviralci
reduktaze HMG-CoA (statini), če
monoterapija z zaviralcem reduktaze HMG-CoA holesterola ne zniža v
zadostni meri. Kot
monoterapija se lahko uporabi samo pri bolnikih, za katere zaviralci
reduktaze HMG-CoA niso
primerni ali jih ne prenašajo. Med zdravljenjem z zdravilom
Tredaptive mora bolnik še naprej
upoštevati dieto in druge nefarmakološke ukrepe zdravljenja (npr.
telesno dejavnost, zmanjšanje
telesne mase).
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Začetni odmerek je ena tableta s prirejenim sproščanjem (1.000 mg
nikotinske kisline/20 mg
laropipranta) enkrat na dan. Po štirih tednih je bolnike
priporočljivo prevesti na vzdrževalni odmerek
2.000 mg/40 mg v obliki dveh tablet s prirejenim sproščanjem (vsaka
1.000 mg/20 mg) enkrat na dan.
Dnevni odmerki, večji od 2.000 mg/40 mg, niso raziskani in zato niso
priporočljivi.
Če bolnik zdravila Tredaptive ne vzame manj kot 7 dni zapored, ga
lahko znova začne jemati v
nazadnje uporabljanem odmerku. Če pa zdravila 
                                
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Similar products

Active ingredient laropiprant, nicotinic kisline

laropiprant, nicotinic kisline

ATC code C10AD52

C10AD52

Marketed by Merck Sharp Dohme Ltd.

Merck Sharp Dohme Ltd.

INN (International Name) laropiprant, nicotinic acid

laropiprant, nicotinic acid

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 31-05-2012
Summary of Product characteristics Summary of Product characteristics Bulgarian 31-05-2012
Public Assessment Report Public Assessment Report Bulgarian 11-07-2008
Patient Information leaflet Patient Information leaflet Spanish 31-05-2012
Summary of Product characteristics Summary of Product characteristics Spanish 31-05-2012
Public Assessment Report Public Assessment Report Spanish 11-07-2008
Patient Information leaflet Patient Information leaflet Czech 31-05-2012
Summary of Product characteristics Summary of Product characteristics Czech 31-05-2012
Public Assessment Report Public Assessment Report Czech 11-07-2008
Patient Information leaflet Patient Information leaflet Danish 31-05-2012
Summary of Product characteristics Summary of Product characteristics Danish 31-05-2012
Public Assessment Report Public Assessment Report Danish 11-07-2008
Patient Information leaflet Patient Information leaflet German 31-05-2012
Summary of Product characteristics Summary of Product characteristics German 31-05-2012
Public Assessment Report Public Assessment Report German 11-07-2008
Patient Information leaflet Patient Information leaflet Estonian 31-05-2012
Summary of Product characteristics Summary of Product characteristics Estonian 31-05-2012
Public Assessment Report Public Assessment Report Estonian 11-07-2008
Patient Information leaflet Patient Information leaflet Greek 31-05-2012
Summary of Product characteristics Summary of Product characteristics Greek 31-05-2012
Public Assessment Report Public Assessment Report Greek 11-07-2008
Patient Information leaflet Patient Information leaflet English 31-05-2012
Summary of Product characteristics Summary of Product characteristics English 31-05-2012
Public Assessment Report Public Assessment Report English 11-07-2008
Patient Information leaflet Patient Information leaflet French 31-05-2012
Summary of Product characteristics Summary of Product characteristics French 31-05-2012
Public Assessment Report Public Assessment Report French 11-07-2008
Patient Information leaflet Patient Information leaflet Italian 31-05-2012
Summary of Product characteristics Summary of Product characteristics Italian 31-05-2012
Public Assessment Report Public Assessment Report Italian 11-07-2008
Patient Information leaflet Patient Information leaflet Latvian 31-05-2012
Summary of Product characteristics Summary of Product characteristics Latvian 31-05-2012
Public Assessment Report Public Assessment Report Latvian 11-07-2008
Patient Information leaflet Patient Information leaflet Lithuanian 31-05-2012
Summary of Product characteristics Summary of Product characteristics Lithuanian 31-05-2012
Public Assessment Report Public Assessment Report Lithuanian 11-07-2008
Patient Information leaflet Patient Information leaflet Hungarian 31-05-2012
Summary of Product characteristics Summary of Product characteristics Hungarian 31-05-2012
Public Assessment Report Public Assessment Report Hungarian 11-07-2008
Patient Information leaflet Patient Information leaflet Maltese 31-05-2012
Summary of Product characteristics Summary of Product characteristics Maltese 31-05-2012
Public Assessment Report Public Assessment Report Maltese 11-07-2008
Patient Information leaflet Patient Information leaflet Dutch 31-05-2012
Summary of Product characteristics Summary of Product characteristics Dutch 31-05-2012
Public Assessment Report Public Assessment Report Dutch 11-07-2008
Patient Information leaflet Patient Information leaflet Polish 31-05-2012
Summary of Product characteristics Summary of Product characteristics Polish 31-05-2012
Public Assessment Report Public Assessment Report Polish 11-07-2008
Patient Information leaflet Patient Information leaflet Portuguese 31-05-2012
Summary of Product characteristics Summary of Product characteristics Portuguese 31-05-2012
Public Assessment Report Public Assessment Report Portuguese 11-07-2008
Patient Information leaflet Patient Information leaflet Romanian 31-05-2012
Summary of Product characteristics Summary of Product characteristics Romanian 31-05-2012
Public Assessment Report Public Assessment Report Romanian 11-07-2008
Patient Information leaflet Patient Information leaflet Slovak 31-05-2012
Summary of Product characteristics Summary of Product characteristics Slovak 31-05-2012
Public Assessment Report Public Assessment Report Slovak 11-07-2008
Patient Information leaflet Patient Information leaflet Finnish 31-05-2012
Summary of Product characteristics Summary of Product characteristics Finnish 31-05-2012
Public Assessment Report Public Assessment Report Finnish 11-07-2008
Patient Information leaflet Patient Information leaflet Swedish 31-05-2012
Summary of Product characteristics Summary of Product characteristics Swedish 31-05-2012
Public Assessment Report Public Assessment Report Swedish 11-07-2008
Patient Information leaflet Patient Information leaflet Norwegian 31-05-2012
Summary of Product characteristics Summary of Product characteristics Norwegian 31-05-2012
Patient Information leaflet Patient Information leaflet Icelandic 31-05-2012
Summary of Product characteristics Summary of Product characteristics Icelandic 31-05-2012

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Tredaptive