Avandia

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-06-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
08-06-2016
Public Assessment Report Public Assessment Report (PAR)
08-06-2016

Active ingredient:

rosiglitazon

Available from:

SmithKline Beecham Plc

ATC code:

A10BG02

INN (International Name):

rosiglitazone

Therapeutic group:

Zdravila, ki se uporabljajo pri diabetesu

Therapeutic area:

Diabetes Mellitus, tip 2

Therapeutic indications:

Rosiglitazone je navedeno v zdravljenju diabetesa tipa 2 bolezni:kot monotherapy-pri bolnikih, ki (še posebej prekomerno telesno težo bolnikov) neustrezno nadzorovane z dieto in telesno vadbo, za katere metformin ni primeren, ker kontraindikacije ali intoleranceas dvojno oralna terapija v kombinaciji z metforminom, v bolniki (zlasti prekomerno telesno težo bolnikov) z nezadostno glycaemic nadzor kljub maksimalne dopustne odmerek monotherapy z metforminom-sulfonil sečnine, le pri bolnikih, ki kažejo, nestrpnost do metforminom ali za katere metformin je kontraindiciran, z nezadostno glycaemic nadzor kljub monotherapy z sulphonylureaas trojno oralna terapija v kombinaciji z metforminom in sulfonil sečnine, v bolniki (zlasti prekomerno telesno težo bolnikov) z nezadostno glycaemic nadzor kljub dvojno oralna terapija (glej poglavje 4.

Product summary:

Revision: 23

Authorization status:

Umaknjeno

Authorization date:

2000-07-11

Patient Information leaflet

                                9.
POSEBNA NAVODILA ZA SHRANJEVANJE
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
SmithKline Beecham Ltd,
980 Great West Road
Brentford, Middlesex, TW8 9GS
Velika Britanija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/00/137/002 56 tablet
EU/1/00/137/003 112 tablet
EU/1/00/137/013 168 tablet
EU/1/00/137/016 180 tablet
EU/1/00/137/004 56 tablet, pakiranje po enoti odmerka
13.
ŠTEVILKA SERIJE
LOT
14.
NAČIN IZDAJANJA ZDRAVILA
Izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
avandia 2 mg
47
Zdravilo nima več dovoljenja za promet
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
PRETISNI OMOTI
1.
IME ZDRAVILA
AVANDIA 2 mg tablete
rosiglitazon
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
SmithKline Beecham Ltd
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
LOT
5.
DRUGI PODATKI
48
Zdravilo nima več dovoljenja za promet
PODATKI NA ZUNANJI OVOJNINI
ZUNANJA OVOJNINA
1.
IME ZDRAVILA
AVANDIA 4 mg filmsko obložene tablete
rosiglitazon
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Vsaka tableta vsebuje rosiglitazonijev maleat, ki ustreza 4 mg
rosiglitazona.
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje laktozo. Za dodatne informacije glejte navodilo za uporabo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
7 filmsko obloženih tablet
28 filmsko obloženih tablet
56 filmsko obloženih tablet
84 filmsko obloženih tablet
90 filmsko obloženih tablet
112 filmsko obloženih tablet
56 filmsko obloženih tablet, pakiranje po enoti odmerka
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Peroralna uporaba.
Pred uporabo preberite priloženo navodilo.
Pri uporabi zdravila natančno upoštevajte zdravnikova navodila.
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
49
Zdravil
                                
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Summary of Product characteristics

                                DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
1
Zdravilo nima več dovoljenja za promet
1.
IME ZDRAVILA
AVANDIA 2 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Vsaka tableta vsebuje rosiglitazonijev maleat, ki ustreza 2 mg
rosiglitazona.
Pomožna snov
Vsebuje laktozo (približno 108 mg)
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Filmsko obložena tableta
Rožnate filmsko obložene tablete, označene z “GSK” na eni in
“2” na drugi strani.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Rosiglitazon je indiciran za zdravljenje sladkorne bolezni tipa 2:
kot
SAMOSTOJNO ZDRAVILO
–
pri bolnikih (še posebej bolnikih s prekomerno telesno maso), ki z
dieto in telesno vadbo niso
zadostno nadzorovani in pri katerih uporaba metformina zaradi
kontraindikacij ali intolerance ni
primerna.
kot del
PERORALNEGA ZDRAVLJENJA Z DVEMA ZDRAVILOMA
v kombinaciji
–
z metforminom, pri bolnikih (še posebej bolnikih s prekomerno telesno
maso) z nezadostno
urejenostjo glikemije kljub zdravljenju z največjim dovoljenim
odmerkom metformina samega.
–
s sulfonilsečnino, vendar le pri bolnikih z intoleranco za metformin
ali bolnikih pri katerih je
metformin kontraindiciran in pri katerih je urejenost glikemije
nezadostna kljub zdravljenju s
sulfonilsečnino samo.
kot del
PERORALNEGA ZDRAVLJENJA S TREMI ZDRAVILI
v kombinaciji
–
z metforminom in s sulfonilsečnino, pri bolnikih (še posebej
bolnikih s prekomerno telesno
maso) z nezadostno urejenostjo glikemije kljub peroralnemu zdravljenju
z dvema zdraviloma
(glejte poglavje 4.4).
4.2
ODMERJANJE IN NAČIN UPORABE
Začetni odmerek rosiglitazona je običajno 4 mg/dan. Če je potrebna
boljša urejenost glikemije, se ta
odmerek lahko po osmih tednih poveča na 8 mg/dan. Pri bolnikih, ki
rosiglitazon jemljejo v
kombinaciji s sulfonilsečnino je pri povečanju odmerka rosiglitazona
na 8 mg/dan potrebna
previdnost. Pred tem je treba opraviti ustrezen klinični pregled in
oceniti bolnikovo ogroženost za
pojav neželenih učinkov,
                                
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Active ingredient rosiglitazon

rosiglitazon

ATC code A10BG02

A10BG02

Marketed by SmithKline Beecham Plc

SmithKline Beecham Plc

INN (International Name) rosiglitazone

rosiglitazone

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Avandia