FrancophonIA/ELRC3.0 huggingface dataset:
English: Epidemiological studies have also suggested a small increased risk of bladder cancer in diabetic patients treated with pioglitazone, although not all studies identified a statistically significant increased risk.
Croatian: Epidemiološka ispitivanja također su ukazala na malo povećan rizik od karcinoma mokraćnog mjehura u bolesnika sa šećernom bolešću liječenih pioglitazonom, iako statistički značajno povećan rizik nije zabilježeno u svim ispitivanjima.
English: Glubrava may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Croatian: Glubrava može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Croatian: Iako studija nije uspjela u pogledu njenog primarnog ishoda, koji je bio sastavljen od smrtnosti svih uzroka, ne-fatalnog infarkta miokarda, moždanog udara, akutnog koronarnog sindroma, veće amputacije noge, koronarne revaskularizacije i revaskularizacije noge, rezultati pokazuju da nema dugoročnih kardiovaskularnih opasnosti prilikom primjene pioglitazona.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Croatian: Vršna vrijednost u krvi niža je od vršne vrijednosti u plazmi i nastaje u približno isto vrijeme.
English: Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Croatian: Kaplan-Meierova analiza pokazala je kraće vrijeme do neuspjeha liječenja u bolesnika liječenih gliklazidom u usporedbi s onima liječenima pioglitazonom.
English: if you have heart failure or have had heart failure in the past.
Croatian: - ako imate ili ste ranije imali zatajenje srca.
English: 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 netko drugi ili dijete uzme
English: Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Croatian: Pioglitazon može dovesti do zadržavanja tekućine, što može pogoršati ili uzrokovati zatajenje srca.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g every 3-6 months.
Croatian: U bolesnika s povećanim rizikom od daljnje progresije oštećenja funkcije bubrega i u starijih osoba, funkciju bubrega treba procjenjivati češće, npr. svakih 3-6 mjeseci.
English: As Glubrava contains metformin hydrochloride, it must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Croatian: Budući da lijek Glubrava sadrži metforminklorid, njegovu primjenu mora se prekinuti u vrijeme kirurških zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: These effects were independent of pioglitazone's effects on glycaemia and were statistically significantly different to glibenclamide.
Croatian: Ovi učinci nisu ovisili o učincima pioglitazona na glikemiju i bili su statistički značajno različiti u odnosu na glibenklamid.
English: Therapy with Glubrava should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Croatian: Terapija lijekom Glubrava ne smije se započeti u bolesnika s povišenim razinama jetrenih enzima (ALT povišena > 2,5 x iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
English: If you stop taking Glubrava
Croatian: Ako prestanete uzimati lijek Glubrava
English: At two years, glycaemic control (defined as HbA1c <8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of patients on gliclazide.
Croatian: Nakon dvije godine, kontrola glikemije (definirane kao HbA1c 8,0%) bila je održana u 69% bolesnika liječenih pioglitazonom u usporedbi s 50% bolesnika liječenih gliklazidom.
English: Fluid retention and cardiac failure
Croatian: Zadržavanje tekućine i zatajenje srca
English: Angiotensin-converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
Croatian: Inhibitori angiotenzin-konvertirajućeg enzima (ACE inhibitori) mogu sniziti razinu glukoze u krvi.
English: Dose titration with pioglitazone (added to the optimal dose of metformin) should be considered before the patient is switched to Glubrava.
Croatian: Titraciju doze pioglitazona (pridodanog optimalnoj dozi metformina) treba razmotriti prije nego što se bolesnika prebaci na lijek Glubrava.
English: Stop taking Glubrava for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Croatian: Prestanite nakratko uzimati Glubrava ako imate stanje koje može biti povezano s dehidracijom (značajan gubitak tjelesnih tekućina) kao što je jako povraćanje, proljev, vrućica, izloženost vrućini ili ako pijete manje tekućine nego obično.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates).
Croatian: Gotovo su svi ispitanici (95%) uzimali kardiovaskularne lijekove (beta blokatore, ACE inhibitore, antagoniste angiotenzina II, blokatore kalcijevih kanala, nitrate, diuretike, acetilsalicilatnu kiselinu, statine, fibrate).
English: Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate.
Croatian: Znakovi i simptomi uključuju krv u mokraći, bol pri mokrenju ili iznenadnu potrebu za mokrenjem.
English: Metformin partitions into erythrocytes.
Croatian: Dio metformina ulazi u eritrocite.
English: Glubrava is not recommended in women of childbearing potential not using contraception.
Croatian: Glubrava se ne preporučuje u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Post-marketing, bone fractures have been reported in both male and female patients (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet, prijavljeni su prijelomi kostiju i kod muških i kod ženskih bolesnika (vidjeti dio 4.4).
English: Pioglitazone was associated with significant weight gain.
Croatian: Pioglitazon je bio povezan sa značajnim povećanjem tjelesne težine.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda (logo)
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda (logo)
English: A large overdose of metformin (or coexisting risks of lactic acidosis) may lead to lactic acidosis which is a medical emergency and must be treated in hospital.
Croatian: Teško predoziranje metforminom (ili istovremeno prisutni rizici od laktacidoze) može dovesti do laktacidoze, koja je hitno medicinsko stanje i mora se liječiti u bolnici.
English: Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Croatian: Ne očekuju se interakcije s tvarima koje ti enzimi metaboliziraju npr. oralnim kontraceptivima, ciklosporinom, blokatorima kalcijevih kanala i inhibitorima reduktaze HMGCoA.
English: Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
Croatian: Svaku makrohematuriju treba obraditi prije početka liječenja pioglitazonom.
English: Monitoring of liver function
Croatian: Praćenje funkcije jetre
English: Pioglitazone
Croatian: Pioglitazon
English: Lactic acidosis is a serious reaction which may occur very rarely (< 1/10,000) (see section 4.4) and other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Croatian: Laktacidoza je ozbiljna nuspojava, koja nastaje vrlo rijetko (< 1/10 000) (vidjeti dio 4.4), dok se druge nuspojave, kao što su prijelom kosti, povećanje tjelesne težine i edemi pojavljuju često (≥ 1/100 i < 1/10) (vidjeti dio 4.4).
English: Skin and subcutaneous tissue disorders erythema very rare very rare pruritis very rare very rare urticaria very rare very rare
Croatian: Poremećaji kože i potkožnog tkiva eritem vrlo rijetko vrlo rijetko pruritis vrlo rijetko vrlo rijetko urtikarija vrlo rijetko vrlo rijetko
English: Food decreases the extent and slightly delays the absorption of metformin.
Croatian: Hrana smanjuje opseg i blago usporava apsorpciju metformina.
English: Absorption is not influenced by food intake.
Croatian: Uzimanje hrane ne utječe na apsorpciju.
English: However, the incidence of oedema, weight gain and heart failure were increased.
Croatian: Ipak, incidencija edema, porasta tjelesne težine i srčanog zatajenja je bila povećana.
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: As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Croatian: Zbog posljedičnog pojačanja djelovanja inzulina, liječenje pioglitazonom u bolesnica sa sindromom policističnih jajnika može rezultirati ponovnom uspostavom ovulacije.
English: After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Croatian: Nakon isključenja bolesnika koji su u vrijeme dijagnosticiranja karcinoma mokraćnog mjehura bili izloženi ispitivanom lijeku kraće od godinu dana, u skupinama koje su primale pioglitazon bilo je 7 slučajeva (0,06%), a u kontrolnim skupinama 2 slučaja (0,02%).
English: Intrinsic clearance is therefore reduced, coupled with a higher unbound fraction of pioglitazone.
Croatian: Intrinzički klirens stoga je smanjen, a povezan je s većim udjelom nevezanog pioglitazona.
English: Given the accumulation of data since the implementation of the additional risk minimisation measures, the PRAC agreed with the MAH's proposal to remove the additional risk minimisation measures.
Croatian: Uzimajući u obzir akumuljrane podatake od implementacije dodatnih mjera minimizacije rizika, PRAC se slaže s uklanjanjem dodatnih mjera minimizacije rizika, predloženim od strane nositelja odobrenja.
English: Studies of pioglitazone in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja pioglitazona na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
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 (see section 4.8).
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 (vidjeti dio 4.8).
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Croatian: Bubrežni klirens metformina je 400 ml/min, što pokazuje da se metformin eliminira glomerularnom filtracijom i tubularnom sekrecijom.
English: Glubrava is contraindicated in patients with:
Croatian: Glubrava je kontraindicirana u bolesnika s:
English: Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Croatian: Nakon peroralne primjene, pioglitazon se brzo apsorbira, a vršne koncentracije neizmijenjenog pioglitazona u plazmi obično se postižu 2 sata nakon primjene.
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 primijete makrohematuriju ili druge simptome kao što su dizurija ili urgencija.
English: If you are following a special diet for diabetes, you should continue with this while you are taking Glubrava.
Croatian: Ako se pridržavate posebne dijete kod šećerne bolesti, nastavite s takvom prehranom dok uzimate lijek Glubrava.
English: Glubrava contains pioglitazone and metformin which are anti-diabetic medicines, used to control blood sugar level.
Croatian: Glubrava sadrži pioglitazon i metformin, antidijabetičke lijekove koji se primjenjuju za kontrolu šećera u krvi.
English: Stop taking Glubrava and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Croatian: Prestanite uzimati Glubrava i odmah se obratite liječniku ili otiđite u najbližu bolnicu ako osjetite neke od simptoma laktacidoze, jer to stanje može dovesti do kome.
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Croatian: Obavijestite svog liječnika čim prije ako osjetite znakove zatajenja srca kao što su neuobičajen nedostatak zraka ili brzo povećanje tjelesne težine ili lokalizirani otok (edem).
English: 7 In active comparator controlled trials oedema was reported in 6.3% of patients treated with metformin and pioglitazone, whereas the addition of sulphonylurea to metformin treatment resulted in oedema in 2.2% of patients.
Croatian: 7 U ispitivanjima kontroliranima aktivnim komparatorom, edemi su zabilježeni u 6,3% bolesnika liječenih metforminom i pioglitazonom, dok je dodavanje sulfonilureje terapiji metforminom rezultiralo edemima u 2,2% bolesnika.
English: Food had no effect on the AUC and Cmax of pioglitazone when Glubrava was administered to healthy volunteers.
Croatian: Hrana nije utjecala na AUC i Cmax pioglitazona kad se lijek Glubrava primijenio u zdravih dobrovoljaca.
English: If you need to have major surgery you must stop taking Glubrava during and for some time after the procedure.
Croatian: Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Glubrava tijekom i još neko vrijeme nakon zahvata.
English: 180 tablets
Croatian: 180 tableta
English: Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Croatian: Nakon peroralne primjene radioaktivno označenog pioglitazona u čovjeka, označeni lijek većim se dijelom otkrio u stolici (55%) i u manjoj mjeri u mokraći (45%).
English: Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
Croatian: Pioglitazon nije pokazao genotoksični potencijal u sveobuhvatnoj bateriji in vivo i in vitro testova genotoksičnosti.
English: Combination use with insulin should be considered with caution in the elderly because of increased risk of serious heart failure.
Croatian: U starijih bolesnika treba oprezno razmotriti kombiniranu primjenu s inzulinom, zbog povišenog rizika od ozbiljnog zatajenja srca.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting treatment with a NSAID.
Croatian: Potreban je poseban oprez u situacijama u kojim funkcija bubrega može biti narušena, na primjer, kad se započinje antihipertenzivna ili diuretska terapija i na početku liječenja nesteroidnim protuupalnim lijekovima.
English: Cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Croatian: Kationski lijekovi koji se eliminiraju tubularnom sekrecijom u bubrezima (npr. cimetidin) mogu stupiti u interakciju s metforminom zbog kompeticije za zajedničke sustave tubularnog transporta u bubrezima.
English: Visceral fat was significantly decreased, while there was an increase in extra-abdominal fat mass.
Croatian: Visceralno masno tkivo bilo je značajno smanjeno, dok se ekstraabdominalno masno tkivo povećalo.
English: In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg.
Croatian: U kombiniranim ispitivanjima dodavanje pioglitazona metforminu rezultiralo je srednjom vrijednošću povećanja tjelesne težine tijekom jedne godine za 1,5 kg.
English: Glubrava may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Croatian: Glubrava može uzrokovati vrlo rijetku (može se javiti u manje od 1 korisnika na 10 000), ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza (vidjeti dio “Upozorenja i mjere opreza”).
English: When starting or using such products in combination with Glubrava, close monitoring of renal function is necessary.
Croatian: Kad se takvi lijekovi uvode ili primjenjuju u kombinaciji s lijekom Glubrava, potrebno je pažljivo praćenje funkcije bubrega.
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: Pretpostavilo se da je stvaranje i prisutnost mokraćnih kamenaca s posljedičnom iritacijom i hiperplazijom mehanička osnova za opaženi tumorogeni odgovor u mužjaka štakora.
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Croatian: Ispitivanja na ljudima sugeriraju da nema indukcije glavnih inducibilnih citokroma P450, 1A, 2C8/9 i 3A4.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD05.
Croatian: Farmakoterapijska skupina: Lijekovi za primjenu kod šećerne bolesti, kombinirani peroralni lijekovi za snižavanje glukoze u krvi, ATK oznaka: A10BD05
English: Taking into account the PRAC Assessment Report on the PSUR(s) for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za glimepirid/pioglitazonklorid, metformin/pioglitazon, pioglitazon, znanstveni zaključci CHMP-a su sljedeći:
English: Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).
Croatian: Liječenje treba započeti najnižom dostupnom dozom uz postupno povećavanje doze osobito kad se pioglitazon primjenjuje u kombinaciji s inzulinom (vidjeti dio 4.4 Zadržavanje tekućine i zatajenje srca).
English: a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021)
Croatian: - značajno sniženje apsolutnog rizika za sve komplikacije šećerne bolesti u skupini koja je primala metformin (29,8 događaja na 1000 bolesnik-godina) u odnosu na skupinu liječenu samo dijetom (43,3 događaja na 1000 bolesnik-godina), p = 0,0023, i kombinirane skupine na sulfonilureji i inzulinskoj monoterapiji (40,1 događaja na 1000 bolesnik-godina), p = 0,0034 - značajno sniženje apsolutnog rizika svih uzroka smrtnosti povezanih sa šećernom bolešću: metformin sa 7,5 događaja na 1000 bolesnik-godina, samo dijeta s 12,7 događaja na 1000 bolesnik-godina, p = 0,017 - značajno sniženje apsolutnog rizika ukupne smrtnosti: metformin s 13,5 događaja na 1000 bolesnik-godina u odnosu na samo dijetu s 20,6 događaja na 1000 bolesnik-godina (p = 0,011), i kombinirane skupine na sulfonilureji i inzulinskoj monoterapiji s 18,9 događaja na 1000 bolesnik-godina (p = 0,021) - značajno sniženje apsolutnog rizika od infarkta miokarda: metformin s 11 događaja na 1000 bolesnik-godina, samo dijeta s 18 događaja na 1000 bolesnik-godina, (p = 0,01).
English: After 24 weeks of treatment, the primary endpoint of mean change from baseline in HbA1c was -1.83% in the combination group versus -0.96% in the pioglitazone group (p< 0.0001) and -0.99% in the metformin group (p< 0.0001).
Croatian: Nakon 24 tjedna liječenja, primarni ishod bila je srednja vrijednost promjene u odnosu na početnu vrijednost HbA1c i iznosila je -1,83% u skupini koja je primala kombinaciju naspram -0,96% u skupini koja je primala pioglitazon (p< 0,0001) i -0,99% u skupini koja je primala metformin (p< 0,0001).
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 gliklazidom u obliku monoterapije bilo je produženo na dvije godine kako bi se procijenilo vrijeme do neuspjeha liječenja (definirano kao vrijednosti HbA1c 8,0% nakon prvih šest mjeseci terapije).
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 pripisalo djelovanju pioglitazona na smanjenje hiperinzulinemije u majke i povećanje inzulinske rezistencije koja nastaje tijekom trudnoće te tako smanjuje dostupnost metaboličkih supstrata potrebnih za rast fetusa.
English: This is because some medicines can weaken or strenghten the effect of Glubrava on the level of sugar in your blood.
Croatian: Razlog tome je taj što neki lijekovi mogu oslabiti ili pojačati učinak lijeka Glubrava na razinu šećera u krvi.
English: Close monitoring of glycaemic control should be considered (see section 4.4).
Croatian: Potrebne su pažljive kontrole glikemije (vidjeti dio 4.4).
English: In light of age- related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly.
Croatian: Kod procjene rizika povezanih sa životnom dobi (osobito karcinoma mokraćnog mjehura, prijeloma kostiju i zatajenja srca), potrebno je pažljivo razmotriti ravnotežu između koristi i rizika kako prije, tako i tijekom liječenja starijih bolesnika.
English: In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Glubrava should be temporarily discontinued and contact with a health care professional is recommended.
Croatian: U slučaju dehidracije (teški proljev ili povraćanje, vrućica, izloženost vrućini ili smanjen unos tekućine), potrebno je privremeno prekinuti primjenu Glubrava i preporučuje se obratiti se zdravstvenom radniku.