Toviaz

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-12-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
08-12-2023
Public Assessment Report Public Assessment Report (PAR)
14-09-2012

Active ingredient:

fesoterodin fumarat

Available from:

Pfizer Europe MA EEIG

ATC code:

G04BD11

INN (International Name):

fesoterodine

Therapeutic group:

Urološki

Therapeutic area:

Sečnega mehurja, čezmerno

Therapeutic indications:

Zdravljenje simptomov (povečana pogostnost urina in / ali nujnost in / ali nujna inkontinenca), ki se lahko pojavijo pri bolnikih s sindromom preobčutljivega mehurja.

Product summary:

Revision: 27

Authorization status:

Pooblaščeni

Authorization date:

2007-04-20

Patient Information leaflet

                                20
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do:
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 25 °C.
Shranjujte v originalni ovojnini za zagotovitev zaščite 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
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/07/386/001 7 tablet s podaljšanim sproščanjem
EU/1/07/386/002 14 tablet s podaljšanim sproščanjem
EU/1/07/386/003 28 tablet s podaljšanim sproščanjem
EU/1/07/386/019 30 tablet s podaljšanim sproščanjem
EU/1/07/386/004 56 tablet s podaljšanim sproščanjem
EU/1/07/386/005 98 tablet s podaljšanim sproščanjem
EU/1/07/386/011 84 tablet s podaljšanim sproščanjem
EU/1/07/386/017 100 tablet s podaljšanim sproščanjem
13.
ŠTEVILKA SERIJE
Številka serije:
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
TOVIAZ 4 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
21
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC
SN
NN
22
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJNEM TRAKU
OZNAKA NA PRETISNEM OMOTU 4 MG
1.
IME ZDRAVILA
TOVIAZ 4 mg tablete s podaljšanim sproščanjem
fesoterodinijev fumarat
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Pfizer Europe MA EEIG (kot logotip imetnika DzP)
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP:
4.
ŠTEVILKA SERIJE
Lot:
5.
DRUGI PODATKI
Ponedeljek
Torek
Sreda
Četrtek
Petek
Sobota
Nedelja
23
PODATKI NA PRIMARNI OVOJNINI
PRIMARNA OVOJNINA PLASTENKA IZ HDPE – 4 MG
1.
IME ZDRAVILA
TOVIAZ 4 mg tablete s podaljšanim sproščanjem
fesoterodinijev fumarat
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena tableta vsebuje 4 mg fesoterodinijevega fumarata.
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje laktozo in sojin lecitin: za dodatne informacije glejte
navodilo 
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
TOVIAZ 4 mg tablete s podaljšanim sproščanjem
TOVIAZ 8 mg tablete s podaljšanim sproščanjem
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
TOVIAZ 4 mg tablete
Ena tableta s podaljšanim sproščanjem vsebuje 4 mg
fesoterodinijevega fumarata, kar ustreza 3,1 mg
fesoterodina.
TOVIAZ 8 mg tablete
Ena tableta s podaljšanim sproščanjem vsebuje 8 mg
fesoterodinijevega fumarata, kar ustreza 6,2 mg
fesoterodina.
Pomožne snovi z znanim učinkom:
_TOVIAZ 4 mg tablete_
Ena 4 mg tableta s podaljšanim sproščanjem vsebuje 0,525 mg
sojinega lecitina in 91,125 mg laktoze.
_TOVIAZ 8 mg tablete_
Ena 8 mg tableta s podaljšanim sproščanjem vsebuje 0,525 mg
sojinega lecitina in 58,125 mg laktoze.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
tableta s podaljšanim sproščanjem
TOVIAZ 4 mg tablete
4 mg tablete so svetlo modre, ovalne, bikonveksne, filmsko obložene
in imajo na eni strani vtisnjeno
oznako “FS”.
TOVIAZ 8 mg tablete
8 mg tablete so modre, ovalne, bikonveksne, filmsko obložene in imajo
na eni strani vtisnjeno oznako
“FT”.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo TOVIAZ je indicirano pri odraslih za zdravljenje simptomov
(povečana pogostnost uriniranja
in/ali urgentna mikcija in/ali urgentna inkontinenca), ki se lahko
pojavijo pri sindromu čezmerno
aktivnega sečnega mehurja.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
_Odrasli (vključno s starejšimi bolniki)_
Priporočeni začetni odmerek je 4 mg enkrat na dan. Glede na odziv
posameznika se odmerek lahko
poveča na 8 mg enkrat na dan. Največji dnevni odmerek je 8 mg.
3
Poln učinek zdravljenja so opazili med 2 in 8 tedni. Po 8 tednih
zdravljenja je torej priporočljivo
ponovno oceniti učinkovitost za posameznega bolnika.
Pri bolnikih z normalnim delovanjem ledvic in jeter, ki sočasno
prejemajo močne zaviralce CYP3A4,
je največji dnevni odmerek zdravila TOVIAZ 4 mg enkrat na dan (glejte
poglavje 4.5).
Posebne skupine bolnikov
_Okvara
                                
                                Read the complete document

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Active ingredient fesoterodin fumarat

fesoterodin fumarat

ATC code G04BD11

G04BD11

Marketed by Pfizer Europe MA EEIG

Pfizer Europe MA EEIG

INN (International Name) fesoterodine

fesoterodine

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Patient Information leaflet Patient Information leaflet Bulgarian 08-12-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 08-12-2023
Public Assessment Report Public Assessment Report Bulgarian 14-09-2012
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Summary of Product characteristics Summary of Product characteristics Spanish 08-12-2023
Public Assessment Report Public Assessment Report Spanish 14-09-2012
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Toviaz