FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve.
Croatian: Bolesnici trebaju biti pod nadzorom zbog znakova i simptoma zatajenja srca, povećanja tjelesne težine ili pojave edema, osobito oni sa smanjenom srčanom rezervom.
English: Since there is a potential for an increase in doserelated adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Croatian: Budući da postoji mogućnost povećanja nuspojava povezanih s dozom, možda bude potrebno sniziti dozu pioglitazona kod istodobne primjene gemfibrozila.
English: After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Croatian: Bolesnicima treba napraviti pretrage 3 do 6 mjeseci nakon početka terapije pioglitazonom, kako bi se procijenilo imaju li primjereni odgovor na liječenje (npr. smanjenje HbA1c).
English: Package leaflet: Information for the user Pioglitazone Teva 15 mg tablets
Croatian: Uputa o lijeku: Informacija za korisnika Pioglitazon Teva 15 mg tablete
English: Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
Croatian: Svaku makroskopsku hematuriju treba provjeriti prije početka terapije pioglitazonom.
English: A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Croatian: Ispitivanje kardiovaskularnog ishoda kod primjene pioglitazona provedeno je u bolesnika mlađih od 75 godina sa šećernom bolešću tipa 2 i postojećom teškom makrovaskularnom bolešću.
English: In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar.
Croatian: U bolesnika s oštećenjem funkcije bubrega, koncentracije pioglitazona i njegovih metabolita u plazmi niže su od onih opaženih u ispitanika s normalnom funkcijom bubrega, ali oralni klirens prekursora je sličan.
English: This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
Croatian: To se moglo pripisati djelovanju pioglitazona na smanjenje hiperinzulinemije u majke i povećanje inzulinske rezistencije koje nastaje tijekom trudnoće i tako smanjuje raspoloživost metaboličkih supstrata za fetalni rast.
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Croatian: Stope edema u skupinama koje su primale usporedni lijek (sulfonilureju, metformin) iznosile su 2-5%.
English: Pioglitazone Teva should be used every day to work properly.
Croatian: Da bi Pioglitazon Teva ispravno djelovao, treba ga uzimati svaki dan.
English: A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Croatian: Kliničko ispitivanje pioglitazona u usporedbi s monoterapijom gliklazidom bilo je produljeno na dvije godine kako bi se procijenilo vrijeme do prestanka odgovora na terapiju (definirano kao nastanak HbA1c ≥ 8,0% nakon prvih šest mjeseci terapije).
English: In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥65 years compared with those less than 65 years (9.7% compared to 4.0%).
Croatian: U ovom ispitivanju, u bolesnika koji su primali pioglitazon i inzulin zabilježen je veći postotak bolesnika sa zatajenjem srca u skupini bolesnika u dobi od ≥65 godina u odnosu na one mlađe od 65 godina (9,7% u odnosu na 4,0%).
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin
Croatian: Kombinacija s metforminom sa sulfonilurejom s metforminom i sulfonilurejom s inzulinom
English: Investigations weight increased6 common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
Croatian: Povišena kreatin fosfokinaza u krvi povišena laktična dehidrogenaza manje često povišena alanin aminotransferaza7
English: Patients should be advised to promptly seek the attention of their physician if macroscopic haematuria or other symptoms such as dysuria or urinary urgency develop during treatment.
Croatian: Bolesnicima treba savjetovati da odmah potraže liječničku pomoć ako tijekom liječenja razviju makroskopsku hematuriju ili druge simptome, kao što su dizurija ili neodgodiva potreba za mokrenjem.
English: Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Croatian: Bolesnici koji su primali pioglitazon imali su prosječno smanjenje HbA1c za 0,45% u usporedbi s onima koji su nastavili primati samo inzulin, a u skupini koja je liječena pioglitazonom smanjena je doza inzulina.
English: You may also experience a reduction in blood count (anaemia).
Croatian: Može Vam se pogoršati i krvna slika (anemija).
English: Your blood sugar will be checked, and your dose of Pioglitazone Teva may need to be changed.
Croatian: Provjerit će Vam šećer u krvi i nakon toga će možda biti potrebno promijeniti dozu lijeka Pioglitazon Teva Pioglitazon Teva s hranom i pićem
English: Environmental Risk Assessment (ERA): No environmental impact is anticipated from the clinical use of pioglitazone.
Croatian: Procjena rizika za okoliš: ne očekuje se utjecaj na okoliš tijekom kliničke primjene pioglitazona.
English: • The risk of bladder cancer risk and relevant risk minimisation advice.
Croatian: • Rizik od karcinoma mokraćnog mjehura i odgovarajuće savjete o smanjivanju rizika.
English: Broken bones have been reported commonly (may affect 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 (mogu se javiti do 1 od 10 osoba) 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: Following initiation of therapy with pioglitazone, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Croatian: Nakon početka terapije pioglitazonom preporučuje se povremeno određivati jetrene enzime na temelju kliničke procjene.
English: Blood and lymphatic system disorders anaemia common
Croatian: Poremećaji krvi i limfnog sustava anemija
English: In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
Croatian: U kliničkim ispitivanjima u trajanju od jedne godine, pioglitazon je dosljedno pokazivao statistički značajno sniženje omjera albumina i kreatinina u usporedbi s početnim omjerom.
English: In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Croatian: S obzirom na moguće rizike produljene terapije, liječnici koji propisuju lijek trebaju i dalje rutinski procjenjivati nastavak koristi od liječenja pioglitazonom (vidjeti dio 4.4).
English: Reproductive system and breast disorders erectile dysfunction common
Croatian: Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija
English: In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included insulin.
Croatian: ispitivanju ishoda u bolesnika s postojećom teškom makrovaskularnom bolešću, incidencija ozbiljnog zatajenja srca bila je 1,6% viša uz pioglitazon nego uz placebo kad se pioglitazon dodao terapiji koja je uključivala inzulin.
English: The usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily.
Croatian: Uobičajena početna doza je jedna tableta od 15 mg ili od 30 mg pioglitazona jedanput na dan.
English: The formation and presence of urinary calculi with subsequent irritation and hyperplasia was postulated as the mechanistic basis for the observed tumourigenic response in the male rat.
Croatian: Stvaranje i prisutnost kamenaca u mokraćnom sustavu s posljedičnom nadraženošću i hiperplazijom postavila se kao temeljni mehanizam opaženog tumorogenog odgovora u mužjaka štakora.
English: If ALT levels are increased to 3 X upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Croatian: Ako se tijekom terapije pioglitazonom razine ALT povise na vrijednosti koje su 3 puta iznad gornje granice normale, razine jetrenih enzima treba čim prije ponovno provjeriti.
English: Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Croatian: Farmakokinetika stanja dinamičke ravnoteže u bolesnika u dobi od 65 ili više godina slična je onoj u mlađih osoba.
English: In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
Croatian: U jednom ispitivanju u trajanju od 20 tjedana, osim što je smanjio trigliceride natašte, pioglitazon je smanjio postprandijalnu hipertrigliceridemiju tako što je utjecao kako na apsorbirane trigliceride, tako i na one sintetizirane u jetri.
English: In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg.
Croatian: Dodavanje pioglitazona metforminu u kombiniranim ispitivanjima rezultiralo je prosječnim povećanjem tjelesne težine tijekom jedne godine za 1,5 kg, a dodavanje pioglitazona sulfonilureji za 2,8 kg.
English: - metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Croatian: - metforminom i sulfonilurejom, u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) s nedostatnom kontrolom glikemije usprkos dvojnoj peroralnoj terapiji.
English: - if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss,
Croatian: - ako imate dijabetičku ketoacidozu (komplikacija šećerne bolesti koja uzrokuje nagli gubitak na tjelesnoj težini, mučninu i povraćanje).
English: Skin and subcutaneous tissue disorders sweating uncommon
Croatian: Poremećaji kože i potkožnog tkiva znojenje manje često
English: In clinical trials of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL cholesterol levels, compared with placebo, metformin or gliclazide.
Croatian: U kliničkim ispitivanjima u trajanju do dvije godine, pioglitazon je snizio ukupne trigliceride u plazmi i slobodne masne kiseline te povisio razine HDL-kolesterola u usporedbi s placebom, metforminom i gliklazidom.
English: In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
Croatian: Kliničkim ispitivanjima pioglitazona pokazalo se da je povećanje tjelesne težine povezano s dozom, što može biti posljedica nakupljanja masnog tkiva, a u nekim je slučajevima povezano sa zadržavanjem tekućine.
English: Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Croatian: Slične promjene u raspodjeli masnog tkiva u tijelu uz pioglitazon praćene su poboljšanom inzulinskom osjetljivošću.
English: Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
Croatian: Poboljšava se kontrola glikemije natašte i nakon obroka u bolesnika sa šećernom bolešću tipa 2.
English: Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.
Croatian: Pokazalo se da liječenje pioglitazonom smanjuje proizvodnju glukoze u jetri i povećava periferno uklanjanje glukoze u slučaju inzulinske rezistencije.
English: Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.
Croatian: Prijelomi su opaženi u 2,6% žena koje su uzimale pioglitazon u odnosu na 1,7% žena liječenih usporednim lijekom.
English: The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations.
Croatian: Poboljšana kontrola glikemije povezana je sa smanjenjem koncentracije inzulina u plazmi kako natašte, tako i nakon obroka.
English: Teva Norway AS Tlf: +47 66 77 55 90
Croatian: Tlf: +47 66 77 55 90
English: 3 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: 3 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 a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Croatian: U ispitivanju kombinirane terapije u trajanju od dvije godine u kojem se pioglitazon uspoređivao s gliklazidom kad se dodavao metforminu, kontrola glikemije mjerena kao prosječna promjena u odnosu na početnu vrijednost HbA1c bila je slična u obje terapijske skupine nakon jedne godine.
English: The dose may be increased in increments up to 45 mg once daily.
Croatian: Doza se može postupno povećavati do 45 mg jedanput na dan.
English: Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
Croatian: Pioglitazon nije pokazao genotoksično djelovanje u sveobuhvatnom nizu testova genotoksičnosti in vivo i in vitro.
English: The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Croatian: Učinak pioglitazona (monoterapija dozom od 45 mg u odnosu na placebo) ispitivao se u malom ispitivanju u trajanju od 18 tjedana u bolesnika sa šećernom bolešću tipa
English: - if you have cysts on your ovaries (polycystic ovary syndrome).
Croatian: - ako imate ciste na jajnicima (sindrom policističnih jajnika).
English: 7 In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Croatian: 7 U kliničkim ispitivanjima pioglitazona, incidencija povišenja ALT-a za više od tri puta iznad gornje granice normale bila je jednaka onoj uz placebo, ali manja od one opažene u skupinama koje su kao usporedni lijek primale metformin ili sulfonilureju.
English: If you experience this symptom for the first time, talk to your doctor as soon as possible.
Croatian: Ako prvi put osjetite ovaj simptom, čim prije razgovarajte Vašim liječnikom.
English: Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Croatian: KaplanMeierovom analizom pokazalo se da je vrijeme do prestanka odgovora na terapiju u bolesnika liječenih gliklazidom kraće nego kod liječenja pioglitazonom.
English: In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months.
Croatian: U placebo kontroliranom ispitivanju, bolesnici s neodgovarajućom kontrolom glikemije usprkos tromjesečnog razdoblja optimizacije inzulina bili su randomizacijom raspodijeljeni u skupinu koja je primala pioglitazon odnosno skupinu koja je primala placebo tijekom 12 mjeseci.
English: 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.
Croatian: U skupinama koje su primale usporedni lijek, dodavanje sulfonilureje metforminu rezultiralo je prosječnim povećanjem tjelesne težine za 1,3 kg, a dodavanje metformina sulfonilureji smanjenjem tjelesne težine za 1,0 kg.
English: The decision whether to continue the patient on therapy with pioglitazone should be guided by clinical judgement pending laboratory evaluations.
Croatian: Odluku o nastavku liječenja pioglitazonom treba donijeti na temelju kliničke procjene ovisno o laboratorijskim nalazima.
English: If you stop taking Pioglitazone Teva
Croatian: Ako prestanete uzimati Pioglitazon Teva
English: Part of the treatment of diabetes is dietary control.
Croatian: Dijeta s kontroliranim unosom kalorija dio je liječenja šećerne bolesti.
English: In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and preexisting major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Croatian: U PROactive ispitivanju kardiovaskularnih ishoda, 5238 bolesnika sa šećernom bolešću tipa 2 i postojećom teškom makrovaskularnom bolešću bilo je randomizacijom raspodijeljeno u skupinu koja je primala pioglitazon i onu koja je primala placebo uz postojeću antidijabetičku i kardiovaskularnu terapiju u trajanju do 3,5 godine.
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Croatian: usporednim kontroliranim ispitivanjima pioglitazona opažene su slične promjene u bolesnika liječenih metforminom (relativno smanjenje hemoglobina za 3-4% i hematokrita za 3,6-4,1%) i u manjoj mjeri u bolesnika liječenih sulfonilurejom i inzulinom (relativno smanjenje hemoglobina za 1-2% i hematokrita za 1-3,2%).
English: In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator.
Croatian: U PROactive ispitivanju u trajanju od 3,5 godine, 44/870 (5,1%) bolesnica liječenih pioglitazonom doživjelo je prijelom u usporedbi s 23/905 (2,5%; %) bolesnica liječenih usporednim lijekom.
English: Frequency of adverse reactions of pioglitazone by treatment regimen
Croatian: Učestalost nuspojava pioglitazona prema režimu liječenja
English: An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
Croatian: Povećana incidencija prijeloma kostiju u žena opažena je u analizi objedinjenih podataka o prijelomima kostiju kao nuspojava u randomiziranim, kontroliranim, dvostruko slijepim kliničkim ispitivanjima na više od 8100 bolesnika liječenih pioglitazonom i 7400 bolesnika liječenih usporednim lijekom u trajanju do najviše 3,5 godine.
English: 1 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Croatian: Opis odabranih nuspojava 1Nakon stavljanja lijeka u promet postoje izvještaji o reakcijama preosjetljivosti kod bolesnika liječenih pioglitazonom.
English: If you stop using Pioglitazone Teva, your blood sugar may go up.
Croatian: Pioglitazon Teva, šećer u krvi Vam se može povisiti.
English: 6 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Croatian: 6 U ispitivanjima kontroliranima aktivnim usporednim lijekom, prosječno povećanje tjelesne težine tijekom monoterapije pioglitazonom iznosilo je 2-3 kg tijekom jedne godine.
English: 4 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.
Croatian: 4 Provedena je analiza objedinjenih podataka o prijelomima kostiju kao nuspojavama u randomiziranim, usporednim lijekom kontroliranim, dvostruko slijepim kliničkim ispitivanjima u više od 8100 bolesnika u skupinama liječenima pioglitazonom i 7400 bolesnika u skupinama liječenima usporednim lijekom u trajanju do 3,5 godine.
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Croatian: U razdoblju nakon stavljanja lijeka u promet zabilježeni su slučajevi novonastalog ili pogoršanja već postojećeg dijabetičkog makularnog edema sa smanjivanjem oštrine vida uz tiazolidindione, uključujući pioglitazon.
English: Pioglitazone Teva contains pioglitazone.
Croatian: Pioglitazon Teva sadrži pioglitazon.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Teva and insulin experienced the development of heart failure.
Croatian: U nekih bolesnika koji su dugo imali šećernu bolest tipa 2 i srčanu bolest ili su preboljeli moždani udar, a liječili su se lijekom Pioglitazon Teva i inzulinom došlo je do zatajenja srca.
English: - The active substance is pioglitazone.
Croatian: - Djelatna tvar je pioglitazon.
English: In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Croatian: U PROactive ispitivanju kardiovaskularnog rizika u trajanju od 3,5 godine, 44/870 (5,1%; 1,0 prijelom na 100 bolesnik-godina) bolesnica liječenih pioglitazonom doživjelo je prijelom u usporedbi s 23/905 (2,5%; 0,5 prijeloma na 100 bolesnik-godina) bolesnica liječenih usporednim lijekom.
English: If you forget to take Pioglitazone Teva
Croatian: Ako ste zaboravili uzeti Pioglitazon Teva
English: Musculoskeletal and connective tissue disorders fracture bone4
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva prijelom kosti4
English: What you need to know before you take Pioglitazone Teva Do not take Pioglitazone Teva
Croatian: Što morate znati prije nego počnete uzimati Pioglitazon Teva
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Croatian: Nakon stavljanja lijeka u promet zabilježeni su rijetki slučajevi poremećaja hepatocelularne funkcije (vidjeti dio 4.8).
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness - increased appetite
Croatian: često (mogu se javiti do 1 od 10 osoba) - glavobolja - omaglica - bol u zglobovima - impotencija - križobolja - nedostatak zraka - manje sniženje broja crvenih krvnih stanica - nadutost manje često (mogu se javiti do 1 od 100 osoba)
English: There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Croatian: (relativno smanjenje za 4%) i hematokrita (relativno smanjenje za 4,1%), sukladno hemodiluciji.