natgillin/translations-raw huggingface dataset:
In reviewing the results of the thorough QTc study, out of 94 patients exposed to Iloperidone at different doses without metabolic inhibition in the Secondary QTc population 43 and 2 patients respectively developed a prolongation of the QTcF of more than 30 and 60 msec.
Pri pregledu rezultatov temeljite študije intervala QTc se je od 94 bolnikov, ki so bili izpostavljeni iloperidonu v različnih odmerkih brez zaviranja presnove v sekundarni populaciji QTc, pri 43 oziroma pri 2 bolnikih razvilo podaljšanje intervala QTcF, ki je znašalo več kot 30 in 60 ms.
Although comparative efficacy was not the primary objective of those studies, the magnitude of effect of Fanaptum appeared similar to Ziprasidone but compared negatively with
Čeprav primarni cilj teh študij ni bila primerjalna učinkovitost, se je obseg učinka zdravila Fanaptum zdel podoben obsegu učinka zdravila ziprasidon, v primerjavi z zdraviloma haloperidol in risperidon pa je bil negativen.
In conclusion, Iloperidone has a modest efficacy.
Zaključek je, da je iloperidon zmerno učinkovit.
Iloperidone has a high affinity to the hERG channels and causes QTc exposure-dependent prolongation.
Iloperidon ima visoko afiniteto do kanala hERG in povzroča podaljšanje intervala QTc, ki je odvisno od izpostavljenosti.
As mentioned for the one related to Efficacy, the indirect comparison for Akathisia proposed by the Applicant does not fulfil the methodological standards of systematic reviews (for instance, comprehensive search strategy, transparent and replicable inclusion criteria), and this limits the reliability of the conclusions that can be drawn from it.
Kot je bilo že navedeno za primerjavo, povezano z učinkovitostjo, posredna primerjava akatizije, ki jo je predlagal predlagatelj, ne izpolnjuje metodoloških standardov sistematičnih pregledov (na primer strategije izčrpnega iskanja, preglednih in ponovljivih meril vključitve), zato je zanesljivost sklepov, ki jih je mogoče iz nje izpeljati, omejena.
However, the metabolism of Iloperidone is still of concern in relation to its exposure-dependent risks.
Vendar je presnova iloperidona v povezavi z njegovimi tveganji, odvisnimi od izpostavljenosti, še vedno vprašljiva.
In the thorough QTc study (Study CILO522A2328), the mean change in QTcF from baseline to steady state at Tmax was approximately 9 msec in the 8 mg and 12 mg BID groups and was 15.4 msec in the group receiving Iloperidone 24 mg q.d.
V temeljiti študiji intervala QTc (študiji CILO522A2328) je srednja vrednost spremembe intervala QTcF od izhodišča do stanja dinamičnega ravnovesja pri Tmax znašala približno 9 ms v skupinah BID z odmerkoma 8 mg in 12 mg ter 15,4 ms v skupini, ki je prejemala 24-miligramski odmerek iloperidona enkrat na dan v primerjavi z 1,3 ms v skupini, ki je prejemala kvetiapin (negativno kontrolo).
Action potential prolongation was observed in ventricular dog Purkinje fibres, confirming the pro-arrhythmogenic potential of Iloperidone.
Pri ventrikularnih Purkynějevih vlaknih pri psih so opazili podaljšanje akcijskega potenciala, kar potrjuje proaritmogeni potencial iloperidona.
It is currently unknown if Iloperidone can be safely administered with weak and/or moderate inhibitors of CYP2D6 and/or CYP3A4 given the likely variability of the efficiency of minor metabolic pathways.
Trenutno ni znano, ali je zaradi verjetne spremenljivosti učinkovitosti manjših presnovnih poti mogoče iloperidon varno dajati s šibkimi in/ali zmernimi zaviralci CYP2D6 in/ali CYP3A4.
At least one fatal case could possibly have been preceded by ventricular arrhythmia and Torsades de Pointes.
Pri vsaj enem smrtnem primeru sta se predhodno morda pojavila ventrikularna aritmija in pojav torsades de pointes (vrsta polimorfne ventrikularne tahikardije).
There were 6 cases of sudden deaths or deaths due to cardiac AE in the clinical trials.
Pri kliničnih preskušanjih je bilo 6 primerov nenadne smrti ali smrti zaradi kardioloških neželenih učinkov.
In conclusion, there was no robust support for statements concerning dose-response relationship below 24 mg/day (the dose used in study 3101).
Zaključek je, da za odmerke, manjše od 24 mg/dan (kar je odmerek, uporabljen v študiji 3101), ni zanesljive podpore za izjave v zvezi z razmerjem odmerek-odziv.
Continued, long-term efficacy after stabilisation with Fanaptum has been studied and demonstrated in Study 2301, in which patients continuing on Fanaptum had a significantly lower rate of relapses or impending relapses compared to patients switched to placebo.
V študiji 2301, v kateri je bilo število relapsov ali število neizbežnih relapsov pri bolnikih, ki so nadaljevali zdravljenje z zdravilom Fanaptum, v primerjavi z bolniki, ki so prešli na placebo, znatno nižje, so preučili in dokazali neprekinjeno, dolgotrajno učinkovitost po stabilizaciji z zdravilom Fanaptum.
Iloperidone lacks any significant affinity for cardiac sodium and/or calcium channels at therapeutic plasma concentrations.
Iloperidon v terapevtskih plazemskih koncentracijah nima nobene pomembne afinitete do natrijevih in/ali kalcijevih kanalčkov v srcu.
In particular, Akathisia was reported at lower rates in patients treated with Iloperidone than in patients treated with the active comparators in the active-controlled trials submitted, where the comparators were antipsychotics with an acknowledged degree of propensity to cause Akathisia at the doses studied.
Zlasti je bilo v primerjavi z bolniki, zdravljenimi z aktivnimi primerjalnimi zdravili v predloženih aktivno nadzorovanih preskušanjih, pri katerih so bila primerjalna zdravila antipsihotiki s potrjeno stopnjo nagnjenosti k povzročanju akatizije pri proučevanih odmerkih, manj poročil o akatiziji pri bolnikih, zdravljenih z iloperidonom.
No QT prolongation was observed in the in vivo dog studies.
V študijah pri psih in vivo niso opazili podaljšanja intervala QT.
Children and adolescents Use in children under 18 years is not recommended.
Otroci in mladostniki Uporaba pri otrocih, mlajših od 18 let, ni priporočljiva.
Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Your doctor will advise you to discontinue this medicine.
Zdravnik vam bo svetoval, da prenehate uporabljati to zdravilo.
Pioglitazone Actavis has no or negligible effect on the ability to drive and use machines.
Pioglitazon Actavis Group nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
If you have the impression that the effect of Pioglitazone Actavis is too weak, talk to your doctor.
Če menite, da je učinek zdravila Pioglitazon Actavis prešibak, se posvetujte z zdravnikom.
If you take more Pioglitazone Actavis than you should If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila Pioglitazon Actavis, kot bi smeli Če pomotoma vzamete preveč tablet, ali če vaše zdravilo vzame kdo drug ali otrok, se nemudoma posvetujte z zdravnikom ali farmacevtom.
When Pioglitazone Actavis is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Če uporabljate zdravilo Pioglitazon Actavis v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni (npr. z insulinom, klorpropamidom, glibenklamidom, gliklazidom, tolbutamidom), vam bo zdravnik povedal, ali morate uporabiti manjši odmerek zdravil.
Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
O edemih so poročali pri 6 do 9 % bolnikov, ki so v kontroliranih kliničnih preskušanjih prejemali pioglitazon več kot eno leto.
Do not take Pioglitazone Actavis - if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of
Ne jemljite zdravila Pioglitazon Actavis - če ste preobčutljivi za (alergični na) pioglitazon ali katero koli sestavino zdravila Pioglitazon
If you stop using Pioglitazone Actavis, your blood sugar may go up.
Če prenehate jemati zdravilo Pioglitazon Actavis, se vam lahko krvni sladkor zviša.
Pioglitazone Actavis contains lactose monohydrate If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Actavis.
Zdravilo Pioglitazon Actavis vsebuje lakotozo monohidrat Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se z njim posvetujte, preden vzamete to zdravilo Pioglitazon Actavis.
Your blood sugar will be checked, and your dose of Pioglitazone Actavis may need to be changed.
Kontroliral vam bo krvni sladkor in morda bo treba prilagoditi odmerek zdravila Pioglitazon Actavis.
Do not use Pioglitazone Actavis after the expiry date which is stated on the carton and the blister pack after the word “EXP”.
Zdravila Pioglitazon Actavis ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
What Pioglitazone Actavis is and what it is used for What you need to know before you take Pioglitazone Actavis How to take Pioglitazone Actavis Possible side effects
Kaj je zdravilo Pioglitazon Actavis in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Pioglitazon Actavis Kako jemati zdravilo Pioglitazon Actavis Možni neželeni učinki
For the 14, 28, 56, 84 and 98 tablets pack sizes, you can check the day on which you last took a tablet of Pioglitazone Actavis by referring to the calendar printed on the blister.
Pri pakiranih s 14, 28, 56, 84 in 98 tabletami lahko dan, ko ste vzeli zadnjo tableto zdravila Pioglitazon Actavis, preverite na koledarčku, ki je natisnjen na pretisnem omotu.
What Pioglitazone Actavis is and what it is used for
Kaj je zdravilo pioglitazon actavis in za kaj ga uporabljamo
If you take Pioglitazone Actavis with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Če jemljete zdravilo Pioglitazon Actavis skupaj z drugimi zdravili za sladkorno bolezen, obstaja večja možnost za znižanje krvnega sladkorja pod normalno raven (hipoglikemija).
Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.
O motnjah vida so poročali predvsem zgodaj med zdravljenjem, povezane pa so s spremembami vrednosti glukoze v krvi, in sicer zaradi začasnih sprememb nabreklosti (turgidnosti) in refrakcijskega indeksa leče, kakršne se pojavljajo tudi pri drugih zdravilih za znižanje glikemije.
Before you start taking Pioglitazone Actavis you will have a blood sample taken to check your liver function.
Pred začetkom jemanja zdravila Pioglitazon Actavis boste morali opraviti preiskavo krvi za kontrolo delovanja jeter.
What you need to know before you take Pioglitazone Actavis
Kaj morate vedeti, preden boste vzeli zdravilo pioglitazon actavis
Pioglitazone Actavis can be taken with or without food.
Zdravilo Pioglitazon Actavis lahko vzamete s hrano ali brez nje.
Pioglitazone Actavis (see section 6 for a list of ingredients).
Actavis (za seznam sestavin glejte poglavje 6).
Postmarketing, bone fractures have been reported in both male and female patients (see section 4.4).
V obdobju trženja zdravila so poročali o zlomih kosti tako pri bolnikih kot bolnicah (glejte poglavje 4.4).
If you are following a diabetic diet, you should continue with this while you are taking Pioglitazone Actavis.
Če se držite diabetične diete, dieto nadaljujte tudi med jemanjem zdravila Pioglitazon Actavis.
Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Actavis.
Zdravnik vam bo naročil, da med zdravljenjem z zdravilom Pioglitazon Actavis redno opravljate preiskave krvi.
You can usually continue to take other medicines whilst you are being treated with Pioglitazone Actavis.
Po navadi lahko med jemanjem zdravila Pioglitazon Actavis še naprej jemljete tudi druga zdravila.
Immune System Disorders Hypersensitivity and allergic reactions not known not known not known not known not known
Preobčutljivost in alergijske reakcije ni znano ni znano ni znano ni znano ni znano
Pioglitazone Actavis helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Zdravilo Pioglitazon Actavis pri sladkorni bolezni tipa 2 pomaga obvladati koncentracijo krvnega sladkorja, ker telesu pomaga bolje izrabiti insulin.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Drugiha zdravila in zdravilo Pioglitazon Actavis Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
Your doctor will check whether Pioglitazone Actavis is working 3 to 6 months after you start taking it.
Vaš zdravnik bo od 3 do 6 mesecev potem, ko boste začeli jemati zdravilo Pioglitazon Actavis, preveril, ali zdravilo pri vas deluje.
Pioglitazone Actavis with food and drink You may take your tablets with or without food.
Zdravilo Pioglitazon Actavis skupaj s hrano in pijačo Tablete lahko vzamete s hrano ali brez nje.
Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
V poročilih po pridobitvi dovoljenja za promet so poročali o preobčutljivostnih reakcijah pri bolnikih zdravljenih s pioglitazonom.
Pioglitazone Actavis tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Tablete Pioglitazon Actavis vsebujejo laktoza monohidrat, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze, ne smejo jemati tega zdravila.
In comparator groups, addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
primerjalnih skupinah je dodatek sulfonilsečnine metforminu povzročil povprečno povečanje telesne mase za 1,3 kg in dodatek metformina sulfonilsečnini povprečno zmanjšanje telesne mase za 1,0 kg.
In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
V kontroliranih kliničnih preskušanjih je bila incidenca srčnega popuščanja med zdravljenjem s pioglitazonom enaka kot med prejemniki placeba, metformina in sulfonilsečnine, večja pa je bila med uporabo v kombiniranem zdravljenju z insulinom.
How to store Pioglitazone Actavis Contents of the pack and other information
Shranjevanje zdravila Pioglitazon Actavis Vsebina pakiranja in dodatne informacije
The packs with 14, 28, 56, 84 and 98 tablets contain blisters with abbreviations for days of the week printed on the blister (Mon, Tue, Wed, Thu, Fri, Sat, Sun).
Pakiranja s 14, 28, 56, 84 in 98 tabletami vsebujejo pretisne omote, na katerih so natisnjene okrajšave za dneve v tednu (PON, TOR, SRE, ČET, PET, SOB, NED).
The usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily.
Običajni začetni odmerek je ena 15-miligramska ali 30-miligramska tableta pioglitazona enkrat na dan.
Pioglitazone Actavis contains pioglitazone.
Zdravilo Pioglitazon Actavis vsebuje pioglitazon.
as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
- pri odraslih bolnikih (zlasti bolnikih s čezmerno telesno maso), ki imajo bolezen nezadostno urejeno z dieto in telesno dejavnostjo in za katere metformin ni primeren zaradi kontraindikacij ali neprenašanja.
A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Opravljena je bila kumulativna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom kontroliranih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikih, zdravljenih s pioglitazonom, in 7400 bolnikih, ki so prejemali primerjalna zdravila, v obdobju do 3,5 leta.
Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon
Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi) rak sečnega mehurja občasno občasno občasno občasno občasno
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Actavis.
Obstaja lahko večja možnost, da zanosite, ker se lahko ob uporabi zdravila Pioglitazon Actavis znova pojavi ovulacija (sprostitev jajčeca).
In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
V preskušanjih, kontroliranih s primerjalnim zdravilom, je bilo povprečno povečanje telesne mase s pioglitazonom v monoterapiji od 2 do 3 kg v enem letu.
How to take Pioglitazone Actavis
Kako jemati zdravilo pioglitazon actavis
Monotherapy
Kot monoterapija
Pioglitazone Actavis 15 mg, 30 mg and 45 mg tablets Pioglitazone Actavis 15 mg tablets
Pioglitazon Actavis 15 mg, 30 mg in 45 mg tablete Pioglitazon Actavis 15 mg tablete
What Pioglitazone Actavis contains - The active substance is pioglitazone.
Kaj vsebuje zdravilo Pioglitazon Actavis - Zdravilna učinkovina je pioglitazon.
Broken bones have been reported commonly (up to 1 in 10 people) in female patients taking pioglitazone and have also been reported in male patients (frequency cannot be estimated from the available data) taking pioglitazone.
O zlomih so poročali tudi pri bolnikih, ki so se zdravili s pioglitazonom (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Musculoskeletal and connective tissue disorders fracture bone common common common common common arthralgia common common common back pain common
Bolezni mišičnoskeletnega sistema in vezivnega tkiva zlom kosti pogosto pogosto pogosto pogosto pogosto artralgija pogosto pogosto pogosto bolečine v hrbtu pogosto
General disorders and administration site conditions oedema very common fatigue uncommon
Splošne težave in spremembe na mestu aplikacije edemi zelo pogosto utrujenost občasno
If you experience this side effect, talk to your doctor as soon as possible.
Če se vam pojavi ta neželeni učinek, se čim prej posvetujte z zdravnikom.
What Pioglitazone Actavis looks like and contents of the pack Pioglitazone Actavis 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with ‘TZ15' on one side.
Izgled zdravila Pioglitazon Actavis in vsebina pakiranja Tablete Pioglitazon Actavis 15 mg so bele, okrogle, ploščate, na obeh straneh izbočene tablete s premerom 5,5 mm, ki imajo na eni strani vtisnjeno oznako 'TZ15'.
Cardiac disorders heart failure common
Srčne bolezni srčno popuščanje pogosto
Investigations weight increased common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon
Preiskave povečanje telesne mase pogosto pogosto pogosto pogosto pogosto zvišanje kreatin-fosfokinaze pogosto zvišanje laktat-dehidrogenaz e občasno
Pioglitazone Actavis may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Zdravilo Pioglitazon Actavis lahko uporabljamo samo pri bolnikih, ki ne morejo jemati metformina, in ko zdravljenje z dieto in telesno vadbo ni uspešno pri nadzoru krvnega sladkorja.
Pioglitazone Actavis should be used every day to work properly.
Če ste prenehali jemati zdravilo Pioglitazon Actavis Zdravilo Pioglitazon Actavis morate vzeti vsak dan, da bo delovalo pravilno.
Take Pioglitazone Actavis daily as prescribed.
Če ste pozabili vzeti zdravilo Pioglitazon Actavis Zdravilo Pioglitazon Actavis vzemite vsak dan, kot je predpisano.
Allergic reactions have been reported (frequency not known) in patients taking Pioglitazone Actavis.
Pri bolnikih, ki jemljejo zdravilo Pioglitazon Actavis, so poročali o alergijskih reakcijah (pogostnost ni znana).
as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.
kot dvojno peroralno zdravljenje v kombinaciji: - z metforminom pri odraslih bolnikih (predvsem bolnikih s prekomerno telesno maso) z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku metformina v monoterapiji - s sulfonilsečnino, le pri odraslih bolnikih, ki ne prenašajo metformina ali je metformin pri njih kontraindiciran, z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku sulfonilsečnine v monoterapiji.
NAME OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Actavis Group PTC ehf.
Other medicines and Pioglitazone Actavis
Shranjevanje zdravila pioglitazon actavis
Pioglitazone Actavis 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with ‘TZ45' on one side.
Tablete Pioglitazon Actavis 45 mg so bele, okrogle, ploščate, na obeh straneh izbočene tablete s premerom 8 mm, ki imajo na eni strani vtisnjeno oznako 'TZ45'.
EU/1/12/755/001 [14 tablets] EU/1/12/755/002 [28 tablets] EU/1/12/755/003 [30 tablets] EU/1/12/755/004 [50 tablets] EU/1/12/755/005 [56 tablets] EU/1/12/755/006 [84 tablets] EU/1/12/755/007 [90 tablets] EU/1/12/755/008 [98 tablets] EU/1/12/755/009 [100 tablets]
EU/1/12/755/001 [14 tablet] EU/1/12/755/002 [28 tablet] EU/1/12/755/003 [30 tablet] EU/1/12/755/004 [50 tablet] EU/1/12/755/005 [56 tablet] EU/1/12/755/006 [84 tablet] EU/1/12/755/007 [90 tablet] EU/1/12/755/008 [98 tablet] EU/1/12/755/009 [100 tablet]
Pioglitazone Actavis 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with ‘TZ30' on one side.
Tablete Pioglitazon Actavis 30 mg so bele, okrogle, ploščate, na obeh straneh izbočene tablete s premerom 7 mm, ki imajo na eni strani vtisnjeno oznako 'TZ30'.
EU/1/12/755/019 [14 tablets] EU/1/12/755/020 [28 tablets] EU/1/12/755/021 [30 tablets] EU/1/12/755/022 [50 tablets] EU/1/12/755/023 [56 tablets] EU/1/12/755/024 [84 tablets] EU/1/12/755/025 [90 tablets] EU/1/12/755/026 [98 tablets] EU/1/12/755/027 [100 tablets]
EU/1/12/755/019 [14 tablet] EU/1/12/755/020 [28 tablet] EU/1/12/755/021 [30 tablet] EU/1/12/755/022 [50 tablet] EU/1/12/755/023 [56 tablet] EU/1/12/755/024 [84 tablet] EU/1/12/755/025 [90 tablet] EU/1/12/755/026 [98 tablet] EU/1/12/755/027 [100 tablet]
EU/1/12/755/010 [14 tablets] EU/1/12/755/011 [28 tablets] EU/1/12/755/012 [30 tablets] EU/1/12/755/013 [50 tablets] EU/1/12/755/014 [56 tablets] EU/1/12/755/015 [84 tablets] EU/1/12/755/016 [90 tablets] EU/1/12/755/017 [98 tablets] EU/1/12/755/018 [100 tablets]
EU/1/12/755/010 [14 tablet] EU/1/12/755/011 [28 tablet] EU/1/12/755/012 [30 tablet] EU/1/12/755/013 [50 tablet] EU/1/12/755/014 [56 tablet] EU/1/12/755/015 [84 tablet] EU/1/12/755/016 [90 tablet] EU/1/12/755/017 [98 tablet] EU/1/12/755/018 [100 tablet]
Eye disorders visual disturbance common common uncommon macular oedema not known not known not known not known not known Ear and labyrinth disorders vertigo uncommon
Očesne bolezni motnje vida pogosto pogosto občasno edem makule ni znano ni znano ni znano ni znano ni znano