Læknablaðið - 01.10.2017, Qupperneq 20

420 LÆKNAblaðið 2017/103
R A N N S Ó K N
Heimildir
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Pakkningar:
Lyfjaform og styrkur, pakkningastærð
Forðatöflur 4 mg 28 stk
Forðatöflur 4 mg 84 stk
Forðatöflur 8 mg 28 stk
Forðatöflur 8 mg 84 stk

fesoterodin fumarat
Með Toviaz® 4 mg og Toviaz® 8 mg borið saman við lyfleysu í viku 12 ** Með Toviaz® 8 mg borið saman við lyfleysu og tolterodin ER 4 mg í viku 12 *** Færri salernisferðir með Toviaz® 8 mg en með lyfleysu **** Meðferð með Toviaz® 8 mg
dró marktækt úr fjölda tilvika bráðaþvagleka í viku 12 borið saman við tolterodin ER 4mg (p= 0,017) og lyfleysu (p<0,001) 1. Toviaz SmPC 3. ágúst 2016 2. Chapple C. et al. BJU Int. 2014;114:418-26. 3. Kaplan S.A. et al. BJU Int. 2010;107:
1432-1440. 4. Chapple C. et al. Eur Urol. 2007;52(4):1204-12. 5. Herschorn S. et al. BJU Int. 2010;105(1):58-66.
Þegar manni er mál, þá er manni mál!
Fleiri sjúklingar
haldast „þurrir“ 5****
2
af hverjum
3
Minnkuð tíðni
bráðaþvagleka2*
-80%
Minnkuð
tíðni bráðrar
þvaglátaþarfar3**
-45.5%
-18.6%
Toviaz ® (fesoterodine) Meðferð við einkennum
[aukinni tíðni þvagláta og/eða bráðri þvaglátaþörf
og/eða bráðaþvagleka] sem geta komið fram hjá
fullorðnum sjúklingum með ofvirka þvagblöðru.
P
P
1
7
0
5
0
1
Minnkuð
tíðni þvagláta4***
Skyndileg bráð þvaglátaþörf og bráðaþvagleki eru algengustu einkenni ofvirkrar þvagblöðru.
Með Toviaz® 4 og 8mg er hægt að draga marktækt úr einkennum, borið saman við lyfleysu.2,3
Verð er hægt að sjá á www.lgn.is
Greiðsluþátttaka: Já.
Stjörnumerktur texti (*) er umskrifaður og/eða styttur úr upplýsingum um lyfið, sem samþykktar voru af EMA 3. ágúst 2016. Upplýsingar um lyfið er að finna á www.serlyfjaskra.is, auk þess sem hægt er að fá hann hjá
umboðsaðila Pfizer, Icepharma hf
Icepharma . Lyngháls 13 . 110 Reykjavík . S: 540-8000 . www.icepharma.is
Stytt samantekt á eiginleikum lyfs fyrir Toviaz® (fesoterodine)
TOVIAZ 4 mg og 8 mg forðatöflur. Innihaldslýsing: Hver forðatafla inniheldur fesóteródín fumarat 4 mg, sem samsvarar 3,1 mg af fesóteródíni, eða fesóteródín fumarat
8 mg, sem samsvarar 6,2 mg af fesóteródíni. Ábendingar: TOVIAZ er ætlað til meðferðar hjá fullorðnum á einkennum (aukin tíðni þvagláta og/eða bráð þörf fyrir þvaglát
og/eða bráðaþvagleki) sem fram geta komið hjá sjúklingum með ofvirka þvagblöðru (overactive bladder syndrome). Frábendingar: Ofnæmi fyrir virka efninu eða fyrir
jarðhnetum eða soja eða einhverju hjálparefnanna. Þvagteppa. Magateppa. Ómeðhöndluð (uncontrolled) þrönghornsgláka. Vöðvaslensfár. Alvarlega skert lifrarstarfsemi
(Child Pugh flokkur C). Samhliðanotkun öflugra CYP3A4 hemla hjá sjúklingum með meðal til alvarlega skerðingu á nýrna- eða lifrarstarfsemi. Alvarleg sáraristilbólga.
Eitrunarrisaristill (toxic megacolon). Upplýsingar um aukaverkanir, milliverkanir, varnaðarorð og önnur mikilvæg atriði má nálgast í sérlyfjaskrá - www.serlyfjaskra.is.
Dags. síðustu samþykktar SmPC sem þessi stytti texti byggir á: 3. ágúst 2016. Markaðsleyfishafi: Pfizer Limited. Fyrir frekari upplýsingar um lyfið má hafa samband
við Icepharma hf. Lynghálsi 13, s. 540 8000.
Dregur úr einkennum ofvirkrar þvagblöðru
1
1