FrancophonIA/ELRC3.0 huggingface dataset:
English: Cross allergenicity with sulphonylureas, sulphonamides or related substances is possible.
Croatian: Moguća je i križna alergija sa sulfonilurejama, sulfonamidima i sličnim tvarima.
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 opažena 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 se mora savjetovati da se strogo pridržavaju dijete s kontroliranim unosom kalorija.
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 sniženja bila opažena uz metformin i gliklazid.
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Croatian: Stope edema u skupinama liječenima komparatorom (sulfonilureja, metformin) iznosile su 2-5%.
English: No animal studies have been conducted with the combined products of Tandemact.
Croatian: Nisu provedena ispitivanja kombiniranog lijeka Tandemact na životinjama.
English: In particular when treating hypoglycaemia due to accidental intake of Tandemact in infants and young children, the dose of glucose given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia.
Croatian: Kod liječenja hipoglikemije u dojenčadi i male djece zbog nehotičnog gutanja lijeka Tandemact, doza primijenjene glukoze mora se osobito pažljivo kontrolirati kako bi se izbjegao mogući razvoj opasne hiperglikemije.
English: There are no adequate data from the use of glimepiride in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni glimepirida u trudnica.
English: This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
Croatian: To se pretežno događa putem citokroma P450 2C8, iako mogu biti uključeni i drugi izoenzimi, ali u manjem stupnju.
English: Liver enzymes should be checked prior to the initiation of therapy with Tandemact in all patients.
Croatian: Jetrene enzime se mora provjeriti u svih bolesnika prije početka terapije lijekom Tandemact.
English: Glimepiride may either potentiate or weaken the effects of coumarin derivatives.
Croatian: Glimepirid može pojačati ili oslabiti učinke derivata kumarina.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Tandemact.
Croatian: Sljedeće tvrdnje odnose se na farmakokinetička svojstva pojedine djelatne tvari u lijeku Tandemact.
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 komparatorom.
English: Some patients experienced the following side effects whilst taking pioglitazone and sulphonylureas, including glimepiride:
Croatian: Neki su bolesnici razvili sljedeće nuspojave za vrijeme uzimanja pioglitazona i sulfonilureja, uključujući glimepirid:
English: In patients with low creatinine clearance, there was a tendency for glimepiride clearance to increase and for average serum concentrations to decrease, most probably resulting from a more rapid elimination because of lower protein binding.
Croatian: U bolesnika s niskim klirensom kreatinina, klirens glimepirida naginjao je povećanju, a prosječne koncentracije u serumu smanjenju, što je najvjerojatnije rezultat brže eliminacije zbog nižeg vezanja za proteine.
English: Tandemact should not be used in patients with severe renal function disorders (creatinine clearance < 30 ml/min, see section 4.3).
Croatian: Tandemact se ne smije primjenjivati u bolesnika s teškim poremećajem funkcije bubrega (klirens kreatinina < 30 ml/min, vidjeti dio 4.3).
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 s oprezom razmotriti kombiniranu primjenu s inzulinom zbog povišenog rizika od ozbiljnog zatajenja srca.
English: Clinical trials have been conducted with co-administered pioglitazone and glimepiride (see section 5.1).
Croatian: Provedena su klinička ispitivanja sa istovremeno primijenjenim pioglitazonom i glimepiridom (vidjeti dio 5.1).
English: Tandemact is contraindicated during pregnancy (see section 4.3).
Croatian: Tandemact je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
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 razvoj HbA1c  8,0% nakon prvih šest mjeseci terapije).
English: Mean dominant serum half-life, which is of relevance for the serum concentrations under multiple-dose conditions, is about 5 to 8 hours.
Croatian: Prosječni poluvijek u serumu, koji je važan za koncentracije u serumu kod primjene višestrukih doza, pretežno iznosi oko 5 do 8 sati.
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 ili indeks plodnosti.
English: How to take Tandemact
Croatian: Kako uzimati Tandemact
English: This is a serious reaction which may occur uncommonly (≥ 1/1,000 to < 1/100) (see section 4.4).
Croatian: Hipoglikemija je ozbiljna reakcija koja može nastati manje često (≥ 1/1000 i < 1/100) (vidjeti dio 4.4).
English: Hypoglycaemic reactions mostly occur immediately due to the sulphonylurea component of Tandemact.
Croatian: Hipoglikemijske reakcije uglavnom nastaju odmah, zbog toga što Tandemact sadrži sulfonilureju.
English: H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of the blood glucose lowering effect.
Croatian: H2 antagonisti, beta blokatori, klonidin i rezerpin mogu dovesti ili do pojačanja ili do slabljenja učinka snižavanja glukoze u krvi.
English: As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Croatian: Budući pojačava djelovanje inzulina, primjena pioglitazona u bolesnica sa sindromom policističnih jajnika može rezultirati ponovnom uspostavom ovulacije.
English: The tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption.
Croatian: Ove tablete sadrže laktozu hidrat i stoga se ne smiju primjenjivati u bolesnika s rijetkim nasljednim poremećajima nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze.
English: Tandemact 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 glimepiride, a member of the sulphonylurea class.
Croatian: Tandemact 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 glimepiridom, iz klase sulfonilureja.
English: Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Croatian: Bolesnici su uzimali pioglitazon ili placebo uz postojeću antidijabetičku i kardiovaskularnu terapiju u trajanju do 3,5 godine.
English: Hepatobiliary disorders6 hepatitis very rare very rare impairment of liver function (with cholestasis and jaundice)
Croatian: Poremećaji jetre i žuči6 hepatitis vrlo rijetko vrlo rijetko oštećenje funkcije jetre (s kolestazom i žuticom)
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 sniženje 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: Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Croatian: Čini se da istovremena primjena pioglitazona sa sulfonilurejama ne utječe na farmakokinetiku sulfonilureja.
English: Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Tandemact and have also been reported in male patients (frequency cannot be estimated from the available data) taking Tandemact.
Croatian: Prijelomi kostiju su često prijavljivani (mogu se pojaviti u do 1 na 10 osoba) u žena koje su uzimale Tandemact, a također su prijavljivani i u muškaraca (učestalost se ne može procijeniti iz dostupnih podataka) koji su uzimali Tandemact.
English: Glimepiride binds with a high exchange rate to a beta cell membrane protein which is associated with the ATP-sensitive potassium channel but which is different from the usual sulphonylurea binding site.
Croatian: Glimepirid se, uz visoku stopu razmjene, veže za protein na membrani beta stanica koji je povezan s ATP-osjetljivim kalijevim kanalima, ali koji se razlikuje od uobičajenog mjesta vezanja sulfonilureja.
English: In combination trials pioglitazone added to a sulphonylurea resulted in a mean weight increase over one year of 2.8 kg.
Croatian: U kombiniranim ispitivanjima dodavanje pioglitazona sulfonilureji rezultiralo je prosječnim povećanjem tjelesne težine tijekom jedne godine za 2,8 kg.
English: Insulin release
Croatian: Oslobađanje inzulina
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: Ask your doctor or pharmacist for more information if you are not sure how to recognise this.
Croatian: Obratite se liječniku ili ljekarniku za dodatne informacije ako niste sigurni kako prepoznati to stanje.
English: common common common increased lactic dehydrogenase uncommon decrease in sodium serum concentrations very rare very rare alanine aminotransferase increase10
Croatian: često često često povišena laktat dehidrogenaza manje često sniženje koncentracije natrija u serumu vrlo rijetko vrlo rijetko povišenje alanin aminotransferaze10
English: Glimepiride inhibits the glucose production in the liver by increasing the intracellular concentration of fructose-2,6-bisphosphate, which in turn inhibits the gluconeogenesis.
Croatian: Glimepirid inhibira proizvodnju glukoze u jetri tako što povećava unutarstaničnu koncentraciju fruktoza-2,6-bisfosfata, koji pak inhibira glukoneogenezu.
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: Your doctor will ask you to have blood tests periodically during treatment with Tandemact.
Croatian: Liječnik će Vam reći da povremeno za vrijeme liječenja lijekom Tandemact radite krvne pretrage.
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 u osoba s normalnom funkcijom bubrega, ali oralni klirens prekursora je sličan.
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 in 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 se pioglitazon dodao terapiji koja je uključivala inzulin.
English: Closing the potassium channel induces depolarisation of the beta cell and results - by opening of calcium channels - in an increased influx of calcium into the cell.
Croatian: Zatvaranje kalijevih kanala izaziva depolarizaciju beta stanica i rezultira otvaranjem kalcijevih kanala te povećanim utokom kalcija u stanice.
English: Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema.
Croatian: Budući su i inzulin i pioglitazon povezani sa zadržavanjem tekućine, istovremena primjena može povećati rizik od edema.
English: Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Croatian: Potrebno je razmotriti prilagodbu doze pioglitazona unutar preporučenog doziranja ili promjenu terapije šećerne bolesti (vidjeti dio 4.5).
English: In addition, glimepiride seems to have pronounced extrapancreatic effects also postulated for other sulphonylureas.
Croatian: Osim toga, čini se da glimepirid ima izražene učinke i izvan gušterače kakve imaju i druge sulfonilureje.
English: In the 3.5 year 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 ispitivanju PROactive u trajanju od 3,5 godine, 44 od 870 (5,1%; 1,0 prijeloma na 100 bolesnik-godina) žena liječenih pioglitazonom imalo je prijelom u usporedbi s 23 od 905 (2,5%; 0,5 prijeloma na 100 bolesnik-godina) žena liječenih komparatorom.
English: During therapy with pioglitazone there was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction), consistent with haemodilution.
Croatian: Za vrijeme terapije pioglitazonom bilo je prisutno malo sniženje prosječne vrijednosti hemoglobina (relativno sniženje za 4%) i hematokrita (relativno sniženje za 4,1%), sukladno hemodiluciji.
English: If ALT levels are increased to 3 x upper limit of normal during Tandemact therapy, liver enzyme levels should be reassessed as soon as possible.
Croatian: Ako se tijekom terapije lijekom Tandemact razine ALT-a povise na vrijednosti koje su 3 puta više od gornje granice normale, razinu jetrenih enzima treba čim prije ponovno provjeriti.
English: Under the influence of sympatholytic active substances such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
Croatian: Pod utjecajem simpatolitičkih djelatnih tvari kao što su beta blokatori, klonidin, gvanetidin i rezerpin može doći do slabljenja ili izostanka znakova adrenergičke proturegulacije hipoglikemije.
English: Other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Croatian: Često se mogu javiti druge reakcije kao što su prijelom kosti, povećanje tjelesne težine i edemi (≥ 1/100 i < 1/10) (vidjeti dio 4.4).
English: The following statements reflect the information available on the individual active substances (pioglitazone and glimepiride).
Croatian: Sljedeće tvrdnje odnose se na dostupne podatke za pojedinu djelatnu tvari (pioglitazon i glimepirid).
English: Tandemact is indicated as second line treatment of adult patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Croatian: Tandemact je indiciran kao druga linija liječenja u odraslih bolesnika sa šećernom bolešću tipa 2 koji ne podnose metformin ili u kojih je metformin kontraindiciran i koji se već liječe kombinacijom pioglitazona i glimepirida.
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 seriji in vivo i in vitro testova genotoksičnosti.
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, što može uključivati neobjašnjivu mučninu, povraćanje, bol u abdomenu, umor, anoreksiju i/ili tamnu boju mokraće, potrebno je provjeriti jetrene enzime.
English: Not known (frequency can not be estimated from the available data) - increase in liver enzymes - itchy skin - raised and itchy rash (hives)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) - povišeni jetreni enzimi - svrbež kože - uzdignuti osip uz svrbež (koprivnjača)
English: Preclinical effects observed occurred at exposures sufficiently in excess of the maximum human exposure as to indicate little relevance to clinical use, or were due to the pharmacodynamic action (hypoglycaemia) of the compound.
Croatian: Opaženi neklinički učinci nastali su kod izloženosti koja je bila dovoljno veća od najveće izloženosti ljudi, što pokazuje da imaju malu važnost za kliničku primjenu ili da su nastali zbog farmakodinamičkog djelovanja (hipoglikemija) spoja.
English: Glimepiride increases the activity of the glycosyl-phosphatidylinositol-specific phospholipase C which may be correlated with the induced lipogenesis and glycogenesis in isolated fat and muscle cells.
Croatian: Glimepirid pojačava djelovanje glikozil-fosfatidillinozitol-specifične fosfolipaze C, koje se može korelirati s induciranom lipogenezom i glikogenezom u izoliranim masnim i mišićnim stanicama.
English: Sulphonylureas regulate insulin secretion by closing the ATP-sensitive potassium channel in the beta cell membrane.
Croatian: Sulfonilureje reguliraju izlučivanje inzulina zatvaranjem ATP-osjetljivih kalijevih kanala u membrani beta stanica.
English: Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia.
Croatian: Liječenje sulfonilurejom u bolesnika s nedostatkom G6PD može dovesti do hemolitičke anemije.
English: 7 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: 7 Provedena je analiza objedinjenih podataka o prijelomima kostiju kao štetnim događajima u randomiziranim, dvostruko slijepim kontroliranim kliničkim ispitivanjima u kojima je više od 8100 bolesnika bilo liječeno pioglitazonom i 7400 bolesnika bilo liječeno komparatorima u trajanju do najviše 3,5 godine.
English: Investigations weight increased9
Croatian: Pretrage povećanje tjelesne težine9
English: phenylbutazone, azapropazone and oxyfenbutazone insulin and oral antidiabetic products metformin salicylates and p-amino-salicylic acid anabolic steroids and male sex hormones chloramphenicol clarithromycin coumarin anticoagulants disopyramide fenfluramine fibrates angiotensin-converting enzyme (ACE) inhibitors fluoxetine allopurinol sympatholytics cyclo-, tro- and iphosphamides sulphinpyrazone certain long-acting sulphonamides tetracyclines
Croatian: fenilbutazon, azapropazon i oksifenbutazon inzulin i oralni antidijabetički lijekovi metformin salicilati i p-amino-salicilna kiselina anabolički steroidi i muški spolni hormoni kloramfenikol klaritromicin kumarinski antikoagulansi disopiramid fenfluramin fibrati inhibitori angiotenzin-konvertirajućeg enzima (ACE) fluoksetin alopurinol simpatolitici ciklofosfamid, trofosfamid i ifosfamid sulfinpirazon određeni sulfonamidi dugotrajnog djelovanja tetraciklini
English: If jaundice is observed, the medicinal product should be discontinued.
Croatian: Ako se opazi žutica, primjenu lijeka treba prekinuti.
English: Since glimepiride belongs to the chemical class of sulfonylurea medicinal products, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.
Croatian: Budući glimepirid kemijski pripada klasi sulfonilureja, potreban je oprez kad se primjenjuje u bolesnika s nedostatkom G6PD te je potrebno razmotriti primjenu alternativnog lijeka koji ne pripada skupini sulfonilureja.
English: Via Crosa 86, 28065 Cerano (NO) Italy
Croatian: Delpharm Novara S.r.l. Via Crosa 86, 28065 Cerano (NO) Italija
English: The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Croatian: Moguća je potreba za povećanjem doze pioglitazona kad se primjenjuje istovremeno uz rifampicin.
English: Do not take Tandemact: - if you are allergic to pioglitazone, glimepiride, other sulphonylureas or sulphonamides, or any of the other ingredients of this medicine (listed in section 6) - if you have heart failure or have had heart failure in the past - if you have liver disease - if you have diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea or vomiting) - if you have severe problems with your kidneys - if you have or have ever had bladder cancer - if you have blood in your urine that your doctor has not checked - if you have insulin dependent diabetes (type 1) - if you are in a diabetic coma - if you are pregnant - if you are breast-feeding
Croatian: Nemojte uzimati Tandemact - ako ste alergični na pioglitazon, glimepirid, druge sulfonilureje ili sulfonamide ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako imate ili ste prije imali zatajenje srca - ako imate bolest jetre - ako imate dijabetičku ketoacidozu (komplikacija šećerne bolesti s brzim gubitkom na tjelesnoj težini, mučninom i povraćanjem) - ako imate tešku bolest bubrega - ako imate ili ste imali rak mokraćnog mjehura - ako imate krv u mokraći, što Vaš liječnik nije provjerio - ako imate šećernu bolest ovisnu o inzulinu (tip 1) - ako ste u dijabetičkoj komi - ako ste trudni - ako dojite.
English: There is no clinical trial experience of other oral anti-hyperglycaemic medicinal products added to treatment with Tandemact or concomitantly administered glimepiride and pioglitazone.
Croatian: Nema kliničkog iskustva s drugim oralnim antihiperglikemičkim lijekovima uz terapiju lijekom Tandemact ili uz istovremenu primjenu glimepirida i pioglitazona.
English: In clinical trials with pioglitazone and sulphonylurea monotherapy or in combination there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
Croatian: U kliničkim ispitivanjima monoterapije pioglitazonom ili sulfonilurejom ili njihove kombinacije pokazalo se da je povećanje tjelesne težine povezano s dozom, koje može biti posljedica nakupljanja masti, a u nekim je slučajevima povezano sa zadržavanjem tekućine.