FrancophonIA/ELRC3.0 huggingface dataset:
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic impairment.
Croatian: Intoksikacija alkoholom povezana je s povećanim rizikom od laktacidoze, osobito u slučajevima gladovanja, pothranjenosti ili oštećenja funkcije jetre.
English: On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za glimepirid/pioglitazonklorid, metformin/pioglitazon, pioglitazon, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) glimepirid/pioglitazonklorid, metformin/pioglitazon, pioglitazon nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
Croatian: Simptomi uključuju bol u trbuhu, ubrzano i duboko disanje, pospanost ili Vam dah ima neobičan voćni miris. - ako imate ili ste imali karcinom mokraćnog mjehura.
English: If this happens you must stop taking Glubrava and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Croatian: Ako Vam se to dogodi, morate prestati uzimati lijek Glubrava i odmah se obratiti liječniku ili otići u najbližu bolnicu, jer laktacidoza može dovesti do kome.
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, p=0.029).
Croatian: U metaanalizi kontroliranih kliničkih ispitivanja, slučajevi karcinoma mokraćnog mjehura češće su zabilježeni 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, p = 0,029).
English: Very rare - decrease in amount of vitamin B12 in the blood - redness of the skin - itchy skin - raised and itchy rash (hives)
Croatian: Vrlo rijetko - sniženje količine vitamina B12 u krvi - crvenilo kože - svrbež kože - uzdignuti osip uz svrbež (koprivnjača)
English: The following statements reflect the information available on the individual active substances (pioglitazone and metformin).
Croatian: Sljedeće tvrdnje donose informacije dostupne za pojedine djelatne tvari (pioglitazon i metformin).
English: These reactions include anaphylaxis, angioedema, and urticaria.
Croatian: Ove reakcije uključuju anafilaksiju, angioedem i urtikariju.
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 učestalost hiperplazije (mužjaci i ženke) i tumora (mužjaci) epitela mokraćnog mjehura opažena je u štakora liječenih pioglitazonom u razdoblju do 2 godine.
English: Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared with placebo, whilst reductions where observed with metformin and gliclazide.
Croatian: Pioglitazon nije uzrokovao statistički značajna povišenja razine LDL-kolesterola u usporedbi s placebom, dok su sniženja bila opažena uz metformin i gliklazid.
English: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
Croatian: Rizik od razvoja laktacidoze također je povećan uz nekontroliranu šećernu bolest, ozbiljne infekcije, dugotrajno gladovanje ili uzimanje alkohola, dehidraciju (dodatne informacije vidjeti niže), tegobe s jetrom i sva zdravstvena stanja u kojima dio tijela ima smanjenu opskrbu kisikom (kao što je akutna teška srčana bolest).
English: The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
Croatian: Izračunata incidencija prijeloma iznosila je 1,9 prijeloma na 100 bolesnik-godina u žena liječenih pioglitazonom i 1,1 prijeloma na 100 bolesnik-godina u žena liječenih usporednim lijekom.
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: Bolesnici pogodni za uključenje u ispitivanje trebali su imati jedan od sljedećih kriterija: infarkt miokarda, moždani udar, perkutanu srčanu intervenciju ili premosnicu koronarne arterije, akutni koronarni sindrom, bolest koronarnih arterija ili opstruktivnu bolest perifernih arterija.
English: What Glubrava contains The active substances are pioglitazone and metformin hydrochloride.
Croatian: Što Glubrava sadrži - Djelatne tvari su pioglitazon i metforminklorid.
English: If necessary, the dose of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Croatian: Ako je potrebno, dozu antihiperglikemijskog lijeka treba prilagoditi tijekom terapije i nakon prestanka terapije tim drugim lijekom.
English: Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Croatian: Drugi čimbenici rizika za laktacidozu su prekomjerni unos alkohola, insuficijencija jetre, neodgovarajuće kontrolirana šećerna bolest, ketoza, dugotrajno gladovanje i svako stanje povezano s hipoksijom, kao i istodobna primjena lijekova koji mogu uzrokovati laktacidozu (vidjeti dijelove 4.3 i 4.5).
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 ishodišnog spoja je sličan.
English: If you forget to take Glubrava
Croatian: Ako ste zaboravili uzeti lijek Glubrava
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 srednju vrijednost sniženja vrijednosti HbA1c za 0,45% u usporedbi s onima koji su nastavili uzimati samo inzulin i doza inzulina bila je snižena u skupini liječenoj pioglitazonom.
English: Pioglitazone effects may be mediated by a reduction of insulin resistance.
Croatian: Učinci pioglitazona mogu biti posredovani smanjenjem inzulinske rezistencije.
English: It is unknown whether pioglitazone and metformin are excreted in human milk.
Croatian: Nije poznato izlučuju li se pioglitazon i metformin u majčino mlijeko.
English: In animal fertility studies with pioglitazone, there was no effect on copulation, impregnation or fertility index.
Croatian: U ispitivanjima utjecaja pioglitazona na plodnost u životinja nije bilo učinka na kopulaciju, oplodnju i indeks plodnosti.
English: Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment (risks include age, smoking history, exposure to some occupational or chemotherapy agents e.g. cyclophosphamide or prior radiation treatment in the pelvic region).
Croatian: Prije početka liječenja pioglitazonom treba procijeniti čimbenike rizika za karcinom mokraćnog mjehura (rizici uključuju dob, pušenje, profesionalnu izloženost nekim tvarima ili kemoterapeuticima, npr. ciklofosfamidu ili prethodnu radioterapiju u području zdjelice).
English: Following initiation of therapy with Glubrava, it is recommended that liver enzymes be monitored periodically according to clinical judgement.
Croatian: Nakon početka terapije lijekom Glubrava preporučuje se povremeno određivati jetrene enzime na temelju kliničke procjene.
English: Glubrava is indicated as second line treatment of type 2 diabetes mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Croatian: Glubrava je indicirana kao druga linija liječenja šećerne bolesti tipa 2 u odraslih bolesnika, osobito onih s prekomjernom tjelesnom težinom, koji ne mogu postići zadovoljavajuću kontrolu glikemije samo peroralnim metforminom u najvišim podnošljivim dozama.
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 izazivao statistički značajno sniženje omjera albumin/kreatinin u usporedbi s početnim vrijednostima.
English: Reproductive system and breast disorders erectile dysfunction common
Croatian: Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija često
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 promjenu terapije šećerne bolesti (vidjeti dio 4.5).
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Croatian: U toksikološkim su ispitivanjima dosljedno opažene ekspanzija volumena plazme sa hemodilucijom, anemija i reverzibilna ekscentrična hipertrofija srca nakon ponovljenog doziranja u miševa, štakora, pasa i majmuna.
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: Čini se da pioglitazon djeluje putem aktivacije posebnih jezgrinih receptora (receptora za aktivator proliferacije peroksisoma-gama) što u životinja dovodi do pojačane osjetljivosti jetre, masnog tkiva i stanica skeletnih mišića na inzulin.
English: Available toxicological data in animals have shown excretion of pioglitazone and metformin in the milk of lactating rats (see section 5.3).
Croatian: Dostupni toksikološki podaci u životinja pokazuju da se pioglitazon i metformin izlučuju u mlijeko ženki štakora tijekom laktacije (vidjeti dio 5.3).
English: Special populations Elderly
Croatian: Posebne populacije
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin together experienced the development of heart failure.
Croatian: Neki bolesnici s dugotrajnom šećernom bolešću tipa 2 i srčanom bolešću ili prethodnim moždanim udarom koji su bili liječeni pioglitazonom zajedno s inzulinom razvili su zatajenje srca.
English: Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Croatian: Pioglitazon se opsežno metabolizira u jetri hidroksilacijom alifatskih metilenskih skupina.
English: Patients receiving pioglitazone in dual oral therapy with a sulphonylurea may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea may be necessary.
Croatian: U bolesnika koji u sklopu dvojne peroralne terapije primaju pioglitazon sa sulfonilurejom može postojati rizik od hipoglikemije povezane s dozom pa može biti potrebno sniziti dozu sulfonilureje.
English: The tablets are white to off-white, oblong, film-coated, embossed ‘15 / 850' on one face and ‘4833M' on the other.
Croatian: Tablete su bijele do gotovo bijele boje, ovalne, filmom obložene s utisnutim „15 / 850“ na jednoj strani i „4833M“ na drugoj.
English: if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section “Risk of lactic acidosis”) or ketoacidosis.
Croatian: - ako imate nekontroliranu šećernu bolest uz, primjerice, tešku hiperglikemiju (visoka razina glukoze u krvi), mučninu, povraćanje, proljev, brz gubitak tjelesne težine, laktacidozu (vidjeti dio “Rizik od laktacidoze”) ili ketoacidozu.
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Glubrava should have their renal function monitored regularly (see sections 4.3 and 4.4).
Croatian: Budući da se metformin izlučuje putem bubrega, a funkcija bubrega u starijih bolesnika može biti smanjena, potrebno je redovito provjeravati funkciju bubrega u starijih bolesnika koji uzimaju lijek Glubrava (vidjeti dijelove 4.3 i 4.4).
English: Take Glubrava daily as prescribed.
Croatian: Uzimajte lijek Glubrava svakodnevno, kako je propisano.
English: If you have any further questions, ask your doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: Clinical trials have been conducted with Glubrava tablets and co-administered pioglitazone and metformin (see section 5.1).
Croatian: Klinička ispitivanja provedena su s tabletama Glubrava i istodobno primijenjenima pioglitazonom i metforminom (vidjeti dio 5.1).
English: Adverse reactions reported in double-blind studies and post-marketing experience are listed below as MedDRA preferred term by system organ class and absolute frequency.
Croatian: Nuspojave zabilježene u dvostruko slijepim ispitivanjima i iskustvu nakon stavljanja lijeka u promet navedene su niže prema MedDRA klasifikaciji organskih sustava i apsolutnoj učestalosti.
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: U ispitivanju ishoda u bolesnika s postojećom teškom makrovaskularnom bolešću, incidencija ozbiljnog zatajenja srca bila je 1,6% viša uz pioglitazon nego uz placebo kad je pioglitazon pridodan terapiji koja je uključivala inzulin.
English: The RMP has been updated in accordance.
Croatian: RMP je ažuriran sukladno tome.
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 utjecaja pioglitazona na kardiovaskularni ishod provedeno je u bolesnika mlađih od 75 godina sa šećernom bolešću tipa 2 i postojećom teškom makrovaskularnom bolešću.
English: Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Croatian: Ispitivanja interakcija pokazala su da pioglitazon nema važnih učinaka niti na farmakokinetiku niti na farmakodinamiku digoksina, varfarina, fenprokumona i metformina.
English: If 3 to 6 months after starting Glubrava your sugar control is not improved, the medicine should be discontinued.
Croatian: Ako Vam se kontrola šećera u krvi ne poboljša nakon 3 do 6 mjeseci uzimanja lijeka Glubrava, primjenu lijeka treba prekinuti.
English: Other:
Croatian: Drugo:
English: De uts chland Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
Croatian: Deutschland Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
English: Bioequivalence studies in healthy volunteers have shown Glubrava to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets.
Croatian: Ispitivanja bioekvivalencije u zdravih dobrovoljaca pokazala su da je lijek Glubrava bioekvivalentan primjeni pioglitazona i metformina kad se daju kao zasebne tablete.
English: There are limited amount of data from the use of metformin in pregnant women.
Croatian: Podaci o primjeni metformina u trudnica su ograničeni.
English: Glubrava combines two antihyperglycaemic active substances with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: pioglitazone, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Croatian: Glubrava je kombinacija dvije antihiperglikemijske djelatne tvari s komplementarnim mehanizmom djelovanja koje poboljšavaju kontrolu glikemije u bolesnika sa šećernom bolešću tipa 2: pioglitazonom iz klase tiazolidindiona i metforminkloridom iz klase bigvanida.
English: Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
Croatian: Obavijestite svog liječnika čim prije ako razvijete simptome koji ukazuju na tegobe s jetrom (poput neobjašnjive mučnine, povraćanja, bolova u trbuhu, umora, gubitka apetita i/ili tamne mokraće), jer tada treba provjeriti funkciju jetre.
English: There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man.
Croatian: Nema indukcije glavnih inducibilnih izoenzima P450 1A, 2C8/9 i 3A4 u čovjeka.
English: Ne de rland Takeda Nederland bv Tel: +31 23 56 68 777
Croatian: Nederland Takeda Nederland bv Tel: +31 23 56 68 777
English: Metformin is excreted unchanged in the urine.
Croatian: Biotransformacija Metformin se izlučuje neizmijenjen u mokraći.
English: Polycystic ovarian syndrome
Croatian: Sindrom policističnih jajnika
English: 4 Gastrointestinal disorders occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Croatian: Poremećaji probavnog sustava češće nastaju u početku liječenja i u većine se slučajeva spontano povlače.
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Croatian: Slične promjene opažene su u bolesnika liječenih metforminom (relativno smanjenje hemoglobina za 3-4% i hematokrita za 3,6-4,1%) u usporednim kontroliranim ispitivanjima s pioglitazonom.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Croatian: Metformin je bigvanid s antihiperglikemijskim učincima koji snizuje kako bazalnu, tako i postprandijalnu razinu glukoze u plazmi.
English: Glubrava should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Croatian: Glubrava se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.3 i 4.4).
English: This can lead to a risk of hyperglycaemia (high blood sugar level): - rifampicin (to treat tuberculosis and other infections) - glucocorticoids (to treat allergies and inflammation) - beta-2-agonists (to treat asthma) - medicines which increase urine production (diuretics, to treat high blood pressure)
Croatian: To može dovesti do rizika od hiperglikemije (povišenog šećera u krvi): - rifampicin (za liječenje tuberkuloze i drugih infekcija) - glukokortikoidi (za liječenje alergija i upale) - beta-2-agonisti (za liječenje astme) - lijekove koji povećavaju stvaranje mokraće (diuretici, za liječenje visokog krvnog tlaka)
English: 5 Isolated reports: liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Croatian: Izolirani slučajevi: poremećaji testova jetrene funkcije ili hepatitis koji se povlači nakon prestanka primjene metformina.
English: 6 A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Croatian: Provedena je analiza objedinjenih podataka o prijelomima kostiju prijavljenih kao štetan događaj u randomiziranim, dvostruko slijepim kliničkim ispitivanjima kontroliranima komparatorom u više od 8100 bolesnika liječenih pioglitazonom i 7400 bolesnika liječenih komparatorima u trajanju do najviše 3,5 godine.
English: by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation by delaying intestinal glucose absorption.
Croatian: - smanjenjem sinteze glukoze u jetri inhibicijom glukoneogeneze i glikogenolize - u mišićima, umjerenim povećavanjem osjetljivosti na inzulin, poboljšava periferni unos i iskorištenje glukoze - usporavanjem intestinalne apsorpcije glukoze.
English: Blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has also been reported in patients taking Glubrava (frequency cannot be estimated from the available data).
Croatian: Zabilježen je i zamagljen vid zbog oticanja (ili nakupljanja tekućine) u stražnjem segmentu oka (makularni edem) u bolesnika koji uzimaju lijek Glubrava (učestalost se ne može procijeniti iz dostupnih podataka).
English: The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Croatian: Dozu pioglitazona možda će trebati povisiti kod istodobne primjene rifampicina.
English: Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate
Croatian: Jezgra tablete mikrokristalična celuloza povidon (K30) umrežena karmelozanatrij magnezijev stearat
English: You may also experience a reduction in blood count (anaemia).
Croatian: Može Vam se smanjiti i broj krvnih stanica (anemija).
English: Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Croatian: U svakoj skupini nuspojave su prikazane u padajućem nizu prema sve manjoj incidenciji i ozbiljnosti.
English: Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Croatian: Budući da postoji povećana mogućnost nuspojava povezanih s dozom, možda će trebati sniziti dozu pioglitazona kod istodobne primjene gemfibrozila.
English: Mean levels of liver enzymes decreased with treatment with pioglitazone.
Croatian: Srednje vrijednosti razine jetrenih enzima opadale su s trajanjem liječenja pioglitazonom.
English: The risk of fractures should be considered in the long term care of patients treated with pioglitazone (see section 4.8).
Croatian: Rizik od prijeloma treba uzeti u obzir kod dugotrajnog liječenja bolesnika pioglitazonom (vidjeti dio 4.8).
English: Unite d Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900
Croatian: United Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900
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 bolesnik razvije simptome koji ukazuju na poremećaj funkcije jetre, što može uključivati neobjašnjenu mučninu, povraćanje, bol u abdomenu, umor, anoreksiju i/ili tamnu boju mokraće, potrebno je provjeriti jetrene enzime.
English: Metabolism and nutrition disorders Vitamin B12 absorption decreased2
Croatian: Poremećaji metabolizma i prehrane snižena apsorpcija vitamina B12
English: Risk of lactic acidosis
Croatian: Rizik od laktacidoze