FrancophonIA/ELRC3.0 huggingface dataset:
English: Doses as low as 4-8 mg/day appeared effective in one study (3004), and in some studies doses of 12 mg/day (3000), 10-16 mg/day (3004) or 12-16 mg/day (3005) likewise showed superiority to placebo.
Croatian: U jednom ispitivanju (3004) niske doze (4-8 mg/dan) pokazale su se učinkovitima, a u nekim ispitivanjima doze od 12 mg/dan (3000), 1016 mg/dan (3004) ili 12-16 mg/dan (3005) također su se pokazale superiornijima u odnosu na placebo.
English: In consideration of the complex causal chain linking the exposure to Iloperidone to events such as Torsade de Pointes, including unknown and stochastic elements and elements subject to an unpredictable variability, it is considered that the risk minimization measures proposed would not adequately address in clinical practice the risk identified.
Croatian: U skladu sa složenim uzročno-posljedičnim lancem koji povezuje izloženost Iloperidonu s događajima poput Torsade de Pointesa, uključujući i nepoznate i stohastične elemente i elemente podložne nepredvidivoj varijabilnosti, smatra se da predložene mjere svođenja rizika na najmanju moguću mjeru ne bi prikladno riješile rizike utvrđene u kliničkim ispitivanjima.
English: Hence, the safety of Iloperidone has not been sufficiently demonstrated.
Croatian: Dakle, sigurnost Iloperidona nije dostatno dokazana.
English: In the clinical trial programme, 4.5% of the patients treated with iloperidone regardless of dose (4-24 mg/day) had an increase more than 60 msec at some time point.
Croatian: U programu kliničkog ispitivanja, u 4,5 % bolesnika liječenih Iloperidonom neovisno o dozi (424 mg/dan) u nekom je trenutku utvrđeno povećanje od više od 60 ms.
English: In addition, it has shown a delayed onset of action, which is a significant concern in the treatment of acute exacerbation of schizophrenia.
Croatian: Osim toga, dokazano je da lijek ima kasniji početak djelovanja, što je razlog za znatnu zabrinutost u liječenju akutne egzacerbacije shizofrenije.
English: This indicates that Iloperidone could cause QT prolongation.
Croatian: To pokazuje da lijek Iloperidon može uzrokovati produljenje QT intervala.
English: In conclusion, Iloperidone has a substantial arrhythmogenic potential, which becomes obvious if all available non-clinical and clinical data (including the thorough QTc study, the overall clinical program and also the cases of cardiac-related/sudden unexplained death in clinical trials and post-marketing) are taken into account.
Croatian: Zaključno, Iloperidon ima znatan aritmogeni potencijal, što postaje očito ako se uzmu u obzir svi dostupni klinički i neklinički podatci (uključujući temeljita ispitivanja QTc intervala, ukupan klinički program i slučajeve smrti uzrokovane problemima sa srcem ili slučajeve iznenadne ili neobjašnjene smrti u kliničkim ispitivanjima i razdoblju nakon stavljanja lijeka u promet).
English: However, the exposure in the dog studies appears to be lower than in the clinical setting, and therefore the absence of any QT prolongation in the in vivo dog studies is not considered to alleviate the concerns raised based on the in vitro studies.
Croatian: Međutim, čini se da je izloženost u ispitivanjima na psima bila znatno niža nego u kliničkom okruženju i stoga se ne smatra da izostanak produljenja QT intervala u in vivo ispitivanjima na psima umanjuje zabrinutost na osnovi in vitro ispitivanja.
English: However, as the randomised withdrawal study by design has to include the responders only i.e., the population is enriched, the magnitude of the effect can only be derived from the short term studies.
Croatian: Međutim, budući da ispitivanje randomiziranog povlačenja mora uključivati isključivo bolesnike koji su odgovorili na liječenje, tj. obogaćenu populaciju, razmjer učinka može se odrediti samo na temelju kratkoročnih ispitivanja.
English: For instance, in Study 3101 where full effect vs placebo would correspond to a reduction of 5 PANSS-T points, it is remarkable that the difference at Week 1 was already 2.4 for ziprasidone, whereas it was 0.1 for Fanaptum.
Croatian: Na primjer, u ispitivanju 3101, u kojemu bi puni učinak lijeka u odnosu na placebo odgovarao smanjenju od 5 bodova na ljestvici PANSS-T, uočljivo je da je razlika za Ziprasidon već u prvom tjednu iznosila 2,4, a za Fanaptum 0,1.
English: • Considering all available non-clinical and clinical data (including the thorough QTc study, the overall clinical program and the cases of cardiac-related/sudden unexplained death in clinical trials and post-marketing), Iloperidone has a substantial and exposure-dependent arrhythmogenic potential.
Croatian: • Uzimajući u obzir sve dostupne nekliničke i kliničke podatke (uključujući temeljita ispitivanja QTc intervala, ukupan klinički program i slučajeve smrti uzrokovane problemima sa srcem ili slučajeve iznenadne ili neobjašnjene smrti u kliničkim ispitivanjima i razdoblju nakon stavljanja lijeka u promet), Iloperidon ima značajan aritmogeni potencijal ovisan o izloženosti.
English: The arrhythmogenicity of Iloperidone is mechanistically related to its selective inhibition of cardiac potassium channels leading to delayed repolarization which is seen in the characteristic action potential prolongations in ventricular dog Purkinje fibres.
Croatian: Aritmogenost Iloperidona mehanistički je povezana s njegovom selektivnom inhibicijom kalijeva kanala u srcu, koja dovodi do odgođene repolarizacije, što se očituje u produljenju akcijskog potencijala u Purkinjeovih vlakana u ventrikulima kod pasa.
English: Of those, three - B202, 3000, and 3005 - failed to show superiority over placebo according to their pre-specified primary endpoints and analysis plans, and two3004 and 3101 - met their pre-specified criteria for superiority over placebo.
Croatian: Od tih pet ispitivanja, u trima(B202, 3000 i 3005) nije utvrđena superiornost u odnosu na placebo prema prethodno specificiranim primarnim ishodima i planovima analize, a u dvama (3004 i 3101) utvrđeno je da ispunjavaju prethodno specificirane kriterije za superiornost u odnosu na placebo.
English: Furthermore, as the metabolism of iloperidone relies heavily on CYP3A4 and CYP2D6, this creates the potential of increased exposure to the drug as a consequence of drug-drug interactions and genetic polymorphisms.
Croatian: Nadalje, metabolizam Iloperidona snažno se oslanja na genotipe CYP3A4 i CYP2D6, zbog čega nastaje mogućnost povećane izloženosti lijeku kao posljedica interakcije između dvaju lijekova i genskog polimorfizma.
English: Acknowledging the relationship between QTc prolongation (and the connected risks) and exposure, the Applicant proposed for this re-examination a contraindication in CYP2D6 poor metabolisers or in those patients with unknown CYP2D6 metaboliser status, and for concomitant use with drugs that are known strong CYP2D6 or CYP3A4 inhibitors.
Croatian: Utvrđivanjem odnosa između produljenja QTc intervala (i povezanih rizika) i izloženosti, podnositelj zahtjeva za preispitivanje predložio je kontraindikaciju u slabom metabolizatoru gena CYP2D6 ili u bolesnika s nepoznatim statusom metabolizatora gena CYP2D6 te za kombiniranu primjenu s lijekovima koji su poznati kao jaki inhibitori CYP2D6 ili CYP3A4.
English: The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the SmPC.
Croatian: Kvaliteta lijeka smatra se prihvatljivom kada se on primjenjuje u skladu s uvjetima utvrđenima u sažetku opisa svojstava lijeka.
English: The indirect comparison for efficacy 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.
Croatian: Neizravna usporedba djelotvornosti koju predlaže podnositelj zahtjeva ne ispunjava metodološke standarde sustavnih ocjenjivanja (na primjer, sveobuhvatna strategija pretraživanja, transparentni kriteriji uključivanja koji se mogu ponoviti), čime je pouzdanost zaključaka koji se mogu izvesti iz nje ograničena.
English: At least one fatal case could possibly have been preceded by ventricular arrhythmia and Torsades de Pointes.
Croatian: Najmanje jednom smrtnom slučaju mogla je prethoditi ventrikularna aritmija i Torsades de Pointes.
English: In conclusion, Iloperidone has a modest efficacy.
Croatian: Zaključno, Iloperidon ima ograničenu djelotvornost.
English: Iloperidone has a high affinity to the hERG channels and causes QTc exposure-dependent prolongation.
Croatian: Iloperidon ima visok stupanj vezivanja na hERG kanale i uzrokuje produljenje QTc intervala ovisno o izloženosti.
English: 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.
Croatian: Konkretno, akatizija je rjeđe zabilježena u bolesnika liječenih Iloperidonom nego u onih liječenih aktivnim usporednim lijekovima u prijavljenim ispitivanjima aktivne kontrole u kojima su usporedni lijekovi bili antipsihotici s prihvaćenom razinom sklonosti uzrokovanju akatizije u ispitanim dozama.
English: Furthermore, risperidone was still associated with a numerically superior effect estimate - even for patients treated for >2 weeks.
Croatian: Nadalje, Risperidon je još uvijek bio povezan s brojčano superiornom procjenom učinka, čak i u bolesnika podvrgnutih liječenju koje je trajalo kraće od dva tjedna.
English: Action potential prolongation was observed in ventricular dog Purkinje fibres, confirming the pro-arrhythmogenic potential of Iloperidone.
Croatian: Produljenje akcijskog potencijala uočeno je u Purkinjeovim vlaknima u ventrikulima kod pasa, čime je potvrđen proaritmogeni potencijal Iloperidona.
English: Iloperidone lacks any significant affinity for cardiac sodium and/or calcium channels at therapeutic plasma concentrations.
Croatian: Iloperidon nema značajan stupanj vezivanja na natrijeve i/ili kalcijeve kanale u srcu u pogledu koncentracija terapijske plazme.
English: PK-PD analyses presented were fundamentally flawed in that placebo patients were included with an assigned value of zero - impacting the results of the analysis.
Croatian: Predstavljene farmakokinetičke i farmakodinamičke analize manjkave su jer su bolesnici koji su dobivali placebo uključeni s dodijeljenom vrijednošću od nule, što je utjecalo na rezultate analize.
English: 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.
Croatian: Provjerom rezultata temeljitog ispitivanja QTc intervala, od 94 bolesnika izložena Iloperidonu u različitim dozama bez inhibicije metabolizma u populaciji sa sekundarnim QTc intervalom, u 43 bolesnika razvilo se produljenje QTcF intervala od više od 30 ms, a u dvoje bolesnika od više od 60 ms.
English: 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.
Croatian: Kao što je navedeno u poglavlju o djelotvornosti, neizravna usporedba za akatiziju koju predlaže podnositelj zahtjeva ne ispunjava metodološke standarde sustavnih ocjenjivanja (na primjer, sveobuhvatna strategija pretraživanja, transparentni kriteriji uključivanja koji se mogu ponoviti), čime je pouzdanost zaključaka koji se mogu izvesti iz nje ograničena.
English: 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.
Croatian: U temeljitom ispitivanju ispravljenog QTc intervala (ispitivanje CILO522A2328), prosječna promjena QTcF intervala od početka liječenja do stabilnog stanja za Tmax iznosila je oko 9 ms u skupinama koje su uzimale doze od 8 mg i 12 mg dva puta dnevno, a u skupinama koje su primale Iloperidon u dozi od 24 mg jedanput dnevno iznosila je 15,4 ms u usporedbi s 1,3 ms u skupini koja je primala kvetiapin (negativna kontrola).
English: There were 6 cases of sudden deaths or deaths due to cardiac AE in the clinical trials.
Croatian: Zabilježeno je 6 slučajeva iznenadne smrti uzrokovane štetnim događajem povezanim sa srcem.
English: No QT prolongation was observed in the in vivo dog studies.
Croatian: Tijekom in vivo ispitivanja na psima produljenje QT intervala nije zamijećeno.
English: Talk to your doctor before you start to take this medicine: - if you retain water (fluid retention) or have heart failure problems and in particular if you are over 75 years old.
Croatian: Obratite se svom liječniku prije nego uzmete ovaj lijekPioglitazon Actavis: - ako zadržavate vodu (nakupljanje tekućine) ili imate tegobe sa zatajivanjem srca, osobito ako ste stariji od 75 godina.
English: Children and adolescents Use in children under 18 years is not recommended.
Croatian: Ne preporučuje se primjena u djece mlađe od 18 godina.
English: If you have the impression that the effect of Pioglitazone Actavis is too weak, talk to your doctor.
Croatian: Ako imate dojam da je učinak lijeka Pioglitazon Actavis preslab, razgovarajte o tome sa svojim liječnikom.
English: Your doctor will check whether Pioglitazone Actavis is working 3 to 6 months after you start taking it.
Croatian: Liječnik će provjeriti djelovanje lijeka Pioglitazon Actavis 3 do 6 mjeseci nakon što ga počnete uzimati.
English: 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.
Croatian: Pioglitazon Actavis pridonosi kontroli razine šećera u krvi kad imate šećernu bolest tipa 2, tako što pomaže Vašem tijelu da bolje iskoristi inzulin koji proizvodi.
English: What Pioglitazone Actavis is and what it is used for
Croatian: Što je Pioglitazon Actavis i za što se koristi
English: Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Croatian: Edem je bio zabilježen u 6-9% bolesnika liječenih pioglitazonom tijekom jedne godine u kontroliranim kliničkim ispitivanjima.
English: Before you start taking Pioglitazone Actavis you will have a blood sample taken to check your liver function.
Croatian: Prije nego što počnete uzimati Pioglitazon Actavis uzet će Vam uzorak krvi da bi se provjerilo kako radi
English: 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).
Croatian: Ako uzimate Pioglitazon Actavis s drugim lijekovima za šećernu bolest, veća je vjerojatnost da Vam šećer u krvi padne ispod normalne razine (hipoglikemija).
English: If you stop using Pioglitazone Actavis, your blood sugar may go up.
Croatian: Ako prestanete uzimati Pioglitazon Actavis, šećer u krvi Vam se može povisiti.
English: How to store Pioglitazone Actavis Contents of the pack and other information
Croatian: Kako čuvati Pioglitazon Actavis Sadržaj pakiranja i druge informacije
English: 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
Croatian: Što je Pioglitazon Actavis i za što se koristi Što morate znati prije nego počnete uzimati Pioglitazon Actavis Kako uzimati Pioglitazon Actavis Moguće nuspojave
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA 15. ožujka 2012.
English: Pioglitazone Actavis has no or negligible effect on the ability to drive and use machines.
Croatian: Pioglitazon Actavis ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: 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.
Croatian: Poremećaj vida zabilježen je uglavnom rano tijekom liječenja i povezan s promjenama glukoze u krvi zbog privremene promjene u turgoru i indeksu loma leće kakav se vidi i kod druge hipoglikemijske terapije.
English: Pioglitazone Actavis can be taken with or without food.
Croatian: Pioglitazon Actavis se može uzimati s hranom ili bez nje.
English: 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).
Croatian: Učestalost je navedena kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000);
English: Do not take Pioglitazone Actavis - if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of
Croatian: Nemojte uzimati Pioglitazon Actavis - ako ste preosjetljivi (alergični) na pioglitazon ili neki drugi sastojak lijeka Pioglitazon Actavis
English: 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.
Croatian: Prijelomi kostiju su često prijavljivani (u do 1 na 10 ljudi) su zabilježeni u žena koje su uzimale pioglitazon, a također su prijavljivani i u muškaraca (učestalost se ne može procijeniti iz dostupnih podataka) koji su uzimali pioglitazon.
English: Take Pioglitazone Actavis daily as prescribed.
Croatian: Uzimajte Pioglitazon Actavis svaki dan, onako kako je propisano.
English: 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.
Croatian: Kad se Pioglitazon Actavis uzima zajedno s drugim lijekovima za liječenje šećerne bolesti (kao što su inzulin, klorpropamid, glibenklamid, gliklazid, tolbutamid) liječnik će Vam reći trebate li te lijekove uzimati u manjim dozama.
English: 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.
Croatian: Pioglitazon Actavis se može primjenjivati sam u bolesnika koji ne mogu uzimati metformin, a kod kojih se liječenjem dijetom i tjelovježbom nije uspjela postići kontrola šećera u krvi ili se može dodati drugim lijekovima (kao što je metformin, sulfonilureja ili inzulin) koji nisu uspjeli osigurati dostatnu kontrolu šećera u krvi.
English: If you are following a diabetic diet, you should continue with this while you are taking Pioglitazone Actavis.
Croatian: Ako se pridržavate dijabetičke dijete, trebate nastaviti s dijetom dok uzimate Pioglitazon Actavis.
English: 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.
Croatian: Za pakiranja koja sadrže 14, 28, 56, 84 i 98 tableta, možete provjeriti dan kad ste uzeli zadnju Pioglitazon Actavis tabletu na kalendaru tiskanom na blisteru.
English: What you need to know before you take Pioglitazone Actavis
Croatian: Što morate znati prije nego počnete uzimati Pioglitazon Actavis
English: Your blood sugar will be checked, and your dose of Pioglitazone Actavis may need to be changed.
Croatian: Provjerit će Vam šećer u krvi i nakon toga možda promijeniti dozu lijeka Pioglitazon Actavis.
English: Other medicines and Pioglitazone Actavis
Croatian: Drugi lijekovi i Pioglitazon Actavis
English: Pioglitazone Actavis should be used every day to work properly.
Croatian: Da bi Pioglitazon Actavis ispravno djelovao, treba ga uzimati svaki dan.
English: 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.
Croatian: Pioglitazon Actavis tablete sadrže laktozu hidrat te se stoga ne smiju primjenjivati u bolesnika s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcijom glukoze-galaktoze.
English: Pioglitazone Actavis with food and drink You may take your tablets with or without food.
Croatian: Pioglitazon Actavis s hranom i pićem Tablete možete uzimati s hranom ili bez nje.
English: 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.
Croatian: Ako slučajno uzmete previše tableta ili ako neka druga osoba ili dijete uzmu
English: What Pioglitazone Actavis contains - The active substance is pioglitazone.
Croatian: Što Pioglitazon Actavis sadrži - Djelatna tvar je pioglitazon.
English: Immune System Disorders Hypersensitivity and allergic reactions not known not known not known not known not known
Croatian: Preosjetljivost i alergijske reakcije nepoznato nepoznato nepoznato nepoznato nepoznato
English: Pioglitazone Actavis contains pioglitazone.
Croatian: Pioglitazon Actavis sadrži pioglitazon.
English: Do not use Pioglitazone Actavis after the expiry date which is stated on the carton and the blister pack after the word “EXP”.
Croatian: Pioglitazon Actavis se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok valjanosti“.
English: 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
Croatian: Poremećaji oka poremećaj vida često često manje često makularni edem nepoznato nepoznato nepoznato nepoznato nepoznato Poremećaji uha i labirinta vrtoglavica manje često
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG} Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: 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.
Croatian: U kontroliranim kliničkim ispitivanjima, incidencija prijavljenih zatajenja srca uz liječenje pioglitazonom bila je podjednaka onoj u skupinama koje su primale placebo, metformin ili sulfonilureju, ali povišena kad se pioglitazon primjenjivao u kombiniranoj terapiji s inzulinom.
English: In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Croatian: U većini kliničkih ispitivanja primijećeno je sniženje ukupnih triglicerida i slobodnih masnih kiselina u plazmi te povišenje razine HDL-kolesterola u usporedbi s placebom, uz mala ali ne i klinički značajna povišenja razine LDLkolesterola.
English: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.
Croatian: kao monoterapija - u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) u kojih se kontrola ne postiže dijetom i tjelovježbom i u kojih metformin nije prikladan zbog kontraindikacija ili nepodnošenja.