FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Pioglitazone Teva Contents of the pack and other information
Croatian: Kako čuvati Pioglitazon Teva Sadržaj pakiranja i druge informacije
English: Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
Croatian: Pioglitazon je indiciran kao druga ili treća linija liječenja šećerne bolesti tipa 2 na sljedeći način:
English: Eye disorders visual disturbance2
Croatian: Poremećaji oka poremećaj vida2
English: If jaundice is observed, the medicinal product should be discontinued.
Croatian: Ako se primijeti žutica, primjenu lijeka treba prekinuti.
English: Your doctor may increase the dose to a maximum of 45 mg once a day.
Croatian: Vaš liječnik može povećati dozu do maksimalno 45 mg jedanput na dan.
English: 2 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: 2 Poremećaj vida zabilježen je uglavnom rano tijekom liječenja i povezan je s promjenama glukoze u krvi zbog privremene promjene u turgoru i indeksu loma leće kakav se vidi i kod drugih hipoglikemijskih terapija.
English: - if you have blood in your urine that your doctor has not checked.
Croatian: - ako imate krv u mokraći, a niste proveli odgovarajuće pretrage.
English: 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets
Croatian: 14 tableta 28 tableta 30 tableta 50 tableta 56 tableta 84 tableta 90 tableta 98 tableta 112 tableta 196 tableta
English: Pioglitazone Teva has no or negligible influence on the ability to drive and use machines.
Croatian: Pioglitazon Teva ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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: Liječnici trebaju započeti liječenje najnižom dostupnom dozom i postupno je povećavati, osobito kad se pioglitazon primjenjuje u kombinaciji s inzulinom (vidjeti dio 4.4 Zadržavanje tekućine i zatajenje srca).
English: When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose and increase the dose gradually.
Croatian: Kod liječenja bolesnika s najmanje jednim čimbenikom rizika od razvoja kongestivnog zatajenja srca (npr. prethodni infarkt miokarda, simptomatska koronarna bolest ili starija dob), liječnici trebaju započeti s najnižom dostupnom dozom i postupno je povećavati.
English: Pioglitazone should be discontinued if any deterioration in cardiac status occurs.
Croatian: Liječenje pioglitazonom treba prekinuti ako nastupi pogoršanje srčanog statusa.
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: These effects were independent of pioglitazone's effects on glycaemia and were statistically significantly different to glibenclamide.
Croatian: Ti su učinci bili neovisni o učincima pioglitazona na glikemiju i statistički značajno različiti u odnosu na glibenklamid.
English: Brampton Road, Hampden Park, Eastbourne, East Sussex - BN22 9AG United Kingdom
Croatian: Brampton Road, Hampden Park, Eastbourne, East Sussex - BN22 9AG Ujedinjeno Kraljevstvo
English: Your blood sugar could fall below the normal level and can be increased by taking sugar.
Croatian: Može doći do sniženja šećera u krvi ispod normalne razine, no razina šećera u krvi može se povisiti uzimanjem šećera.
English: As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.
Croatian: Kao posljedica povećane inzulinske osjetljivosti, bolesnici koji uzimaju pioglitazon u sklopu dvojne ili trojne peroralne terapije sa sulfonilurejom ili u sklopu dvojne terapije s inzulinom mogu imati rizik od hipoglikemije povezane s dozom pa možda bude potrebno smanjiti dozu sulfonilureje ili inzulina.
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 zabilježen u svim ispitivanjima.
English: If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Croatian: 65 godina, odmah potražite liječnički savjet.
English: Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Croatian: Ukupna koncentracija pioglitazona u plazmi nije izmijenjena, ali je volumen raspodjele povećan.
English: Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all patients.
Croatian: Jetrene enzime treba provjeriti prije početka terapije pioglitazonom u svih bolesnika.
English: When Pioglitazone Teva 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 Teva 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: What Pioglitazone Teva looks like and contents of the pack
Croatian: Kako Pioglitazon Teva izgleda i sadržaj pakiranja
English: What Pioglitazone Teva is and what it is used for What you need to know before you take Pioglitazone Teva How to take Pioglitazone Teva Possible side effects
Croatian: Što je Pioglitazon Teva i za što se koristi Što morate znati prije nego počnete uzimati Pioglitazon Teva Kako uzimati Pioglitazon Teva
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03.
Croatian: Farmakoterapijska skupina: Pripravci za liječenje šećerne bolesti, lijekovi za snižavanje glukoze u krvi, osim inzulina; ATK oznaka: A10BG03.
English: Close monitoring of glycaemic control should be considered (see section 4.4).
Croatian: Preporučuje se pozorno praćenje kontrole glikemije (vidjeti dio 4.4).
English: If you are following a special diet for diabetes, you should continue with this while you are taking Pioglitazone Teva.
Croatian: Ako se pridržavate posebne dijete za šećernu bolest, trebate nastaviti s dijetom dok uzimate Pioglitazon Teva.
English: - The other ingredients are mannitol, carmellose calcium, hydroxypropylcellulose and magnesium stearate.
Croatian: - Ostali sastojci su manitol, karmelozakalcij hidroksipropilceluloza i magnezijev stearat.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Croatian: primali kardiovaskularne lijekove (beta blokatore, ACE inhibitore, antagoniste angiotenzina II, blokatore kalcijevih kanala, nitrate, diuretike, aspirin, statine, fibrate).
English: Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
Croatian: Neka epidemiološka ispitivanja ukazuju na jednako povećani rizik od lomova i kod muškaraca i kod žena
English: Therapy with pioglitazone 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 pioglitazonom ne smije se započeti u bolesnika s povišenim početnim razinama jetrenih enzima (ALT više od 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
English: Pioglitazone has been shown to be present in the milk of lactating rats.
Croatian: Pokazalo se da je pioglitazon prisutan u mlijeku štakorica tijekom laktacije.
English: Pioglitazone Teva 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 Teva 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 su metformin, sulfonilureja ili insulin) koji nisu uspjeli osigurati dostatnu kontrolu šećera u krvi.
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: U svjetlu rizika povezanih sa životnom dobi (osobito karcinoma mokraćnog mjehura, prijeloma i zatajenja srca), potrebno je pažljivo razmotriti ravnotežu između koristi i rizika kako prije, tako i tijekom liječenja starijih bolesnika.
English: Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Croatian: Pioglitazon vjerojatno djeluje putem aktivacije posebnih receptora u jezgri (receptor gama aktiviran peroksizomskim proliferatorom), što u životinja dovodi do povećane osjetljivosti jetre, masnog tkiva i skeletnih mišića na inzulin.
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure)
Croatian: • Oprez kod primjene u starijih s obzirom na rizike povezane s dobi (osobito karcinom mokraćnog mjehura, prijelome i zatajenje srca).
English: Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Croatian: U svakoj klasi organskih sustava nuspojave su prikazane slijedom prema sve manjoj incidenciji te sve manjoj ozbiljnosti.
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 i iznenadnu potreba za mokrenjem.
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets
Croatian: Aluminij/aluminij blisteri, pakiranja sa 14, 28, 30, 50, 56, 84, 90, 98, 112 i 196 tableta.
English: - The tablets are supplied in blisters in packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets.
Croatian: - Tablete se isporučuju u blisterima u pakiranjima sa 14, 28, 30, 50, 56, 84, 90, 98, 112 ili 196 tableta.
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
English: However, the incidences of oedema, weight gain and heart failure were increased.
Croatian: Međutim, incidencija edema, povećanja tjelesne težine i zatajenja srca bila je povišena.
English: Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Croatian: Istodobna primjena pioglitazona sa sulfonilurejama čini se da ne utječe na farmakokinetiku sulfonilureje.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza “Rok valjanosti”.
English: In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Croatian: Na životinjskom modelu obiteljske adenomatozne polipoze, liječenje s dva druga tiazolidindiona povećala je brojnost tumora u debelom crijevu.
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 ispitivanje nije uspjelo u pogledu kompozitnog primarnog ishoda, koji je obuhvaćao smrtnost svih uzroka, infarkt miokarda bez smrtnog ishoda, moždani udar, akutni koronarni sindrom, veća amputacija noge, koronarna revaskularizacija i revaskularizacija noge, rezultati pokazuju da primjena pioglitazona nije nosila dugoročne kardiovaskularne rizike.
English: The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Croatian: Dozu pioglitazona možda će trebati povisiti kad se istodobno primjenjuje rifampicin.
English: • This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Croatian: • Svrha ovog edukacijskog paketa jest povisiti svijest o važnosti utvrđenih rizika od karcinoma mokraćnog mjehura i zatajenja srca te opće preporuke namijenjene optimizaciji raspona koristi u odnosu na rizik na razini bolesnika.
English: If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked.
Croatian: Ako neki bolesnik razvije simptome koji ukazuju na poremećaj funkcije jetre, koji mogu uključivati neobjašnjenu mučninu, povraćanje, bol u abdomenu, umor, anoreksiju i/ili tamnu boju mokraće, potrebno je provjeriti jetrene enzime.
English: This medicinal product does not require any special storage conditions.
Croatian: Ovaj lijek ne zahtjeva posebne uvjete čuvanja.
English: It is an anti-diabetic medicine used to treat type 2 (noninsulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately.
Croatian: To je antidijabetički lijek koji se primjenjuje za liječenje šećerne bolesti tipa 2 (neovisne o inzulinu) kod odraslih, kada metformin nije pogodan ili nije imao odgovarajuće djelovanje.
English: Intrinsic clearance is therefore reduced, coupled with a higher unbound fraction of pioglitazone.
Croatian: Intrinzički klirens stoga je smanjen, povezan s većim udjelom nevezanog pioglitazona.
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 dijagnoze 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: Foetal growth restriction was apparent in animal studies with pioglitazone.
Croatian: Ograničenje fetalnog rasta bilo je očigledno u ispitivanjima pioglitazona na životinjama.
English: Pioglitazone should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Croatian: Pioglitazon se ne smije primjenjivati u bolesnika s oštećenjem jetre (vidjeti dio 4.3 i 4.4).
English: Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Croatian: Ako ste već prije imali zamagljen vid i taj se simptom pogoršava, čim prije razgovarajte sa svojim liječnikom.
English: If patients report hypoglycaemia, the dose of insulin should be decreased.
Croatian: Ako bolesnici prijave hipoglikemiju, doza inzulina mora se sniziti.
English: This check may be repeated at intervals.
Croatian: Ta će se pretraga ponavljati u redovitim razmacima.
English: A 24-month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
Croatian: Ispitivanjem u trajanju od 24 mjeseca u mužjaka štakora pokazalo se da primjena pioglitazona rezultira povećanom incidencijom hiperplastičkih promjena u mokraćnom mjehuru.
English: Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema.
Croatian: Budući da su i inzulin i pioglitazon povezani sa zadržavanjem tekućine, njihova istovremena primjena može povećati rizik od edema.
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
Croatian: U meta-analizi kontroliranih kliničkih ispitivanja češće su zabilježeni slučajevi karcinoma mokraćnog mjehura u skupinama koje su primale pioglitazon (19 slučajeva na 12 506 bolesnika, 0,15%) nego u kontrolnim skupinama (7 slučajeva na 10 212 bolesnika, 0,07%) HR=2,64 (95% CI 1,11-6,31,
English: Pioglitazone did not cause statistically significant increases in LDL cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
Croatian: Pioglitazon nije uzrokovao statistički značajna povišenja razine LDL-kolesterola u usporedbi s placebom, dok su smanjenja opažena uz metformin i gliklazid.
English: In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy.
Croatian: Kod kombinacije s inzulinom, može se nastaviti s postojećom dozom inzulina nakon što se započne terapija pioglitazonom.
English: To be eligible patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Croatian: Da bi bili pogodni za ispitivanje, bolesnici su morali imati jedno ili više od sljedećeg: infarkt miokarda, moždani udar, perkutanu srčanu intervenciju ili premosnicu koronarne arterije, akutni koronarni sindrom, bolest koronarnih arterija ili opstruktivnu bolest perifernih arterija.
English: Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Croatian: Treba razmotriti prilagodbu doze pioglitazona unutar preporučenog doziranja ili promjene u liječenju šećerne bolesti (vidjeti dio 4.5).
English: Hypoglycaemia may occur in combination with sulphonylureas or insulin.
Croatian: Hipoglikemija može nastati u kombinaciji sa sulfonilurejom ili inzulinom.
English: Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking pioglitazone.
Croatian: Zabilježene su alergijske reakcije (učestalost se ne može procijeniti iz dostupnih podataka) kod bolesnika koji uzimaju pioglitazone.
English: If you take more Pioglitazone Teva than you should
Croatian: Ako uzmete više Pioglitazon Teva tableta nego što ste trebali
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Croatian: Ispitivanja u čovjeka sugeriraju da nema indukcije glavnih inducibilnih citokroma P450, 1A, 2C8/9 i 3A4.
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 neka druga osoba ili dijete uzmu
English: These reactions include anaphylaxis, angioedema, and urticaria.
Croatian: Takva reakcija uključuje anafilaksiju, angioedem i urtikariju.
English: This is similar to that seen in a sulphonylurea active comparator group.
Croatian: To je slično onome opaženom u skupini koja je primala sulfonilureju kao aktivni usporedni lijek.
English: No information is available from dialysed patients therefore pioglitazone should not be used in such patients.
Croatian: Nema dostupnih informacija o bolesnicima na dijalizi pa se pioglitazon ne smije primjenjivati u tih bolesnika.
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 (definirana kao HbA1c < 8,0%) bila je održana u 69% bolesnika liječenih pioglitazonom u odnosu na
English: Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily.
Croatian: Liječenje pioglitazonom može se započeti dozom od 15 mg ili 30 mg jedanput na dan.
English: As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Croatian: Zbog pojačanog djelovanja inzulina, liječenje pioglitazonom u bolesnica sa sindromom policističnih jajnika može rezultirati povratkom ovulacije.
English: common common uncommon macular oedema not known not known not known not known not known
Croatian: manje često makularni edem nepoznato nepoznato nepoznato nepoznato nepoznato
English: In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥65 years compared to 4.0% in patients less than 65 years.
Croatian: U bolesnika na inzulinu bez pioglitazona, incidencija srčanog zatajenja bila je 8,2% kod osoba u dobi ≥65 godina, u odnosu na 4,0% u bolesnika mlađih od 65 godina.
English: Mean levels of liver enzymes decreased with treatment with pioglitazone.
Croatian: Prosječne razine jetrenih enzima smanjivale su se s liječenjem pioglitazonom.
English: • The risk of heart failure and relevant risk minimisation advice.
Croatian: • Rizik od zatajenja srca i odgovarajuće savjete o smanjivanju rizika.
English: An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
Croatian: Povećana incidencija hiperplazije (mužjaci i ženke) i tumora (mužjaci) epitela mokraćnog mjehura primijećena je u štakora liječenih pioglitazonom u razdoblju do 2 godine.
English: Patients should be advised to adhere strictly to a calorie-controlled diet.
Croatian: Bolesnicima treba savjetovati da se strogo pridržavaju dijete s ograničenim unosom kalorija.
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 masa izvanabdominalnog masnog tkiva povećala.
English: Your doctor will take this into account when treating your diabetes.
Croatian: Liječnik koji Vas liječi zbog šećerne bolesti će to uzeti u obzir.
English: - Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Croatian: - Pioglitazon je također indiciran u kombinaciji s inzulinom u odraslih bolesnika sa šećernom bolešću tipa 2 i nedostatnom kontrolom glikemije pomoću inzulina u kojih je metformin neprikladan zbog kontraindikacija ili nepodnošljivosti (vidjeti dio 4.4).