FrancophonIA/ELRC3.0 huggingface dataset:
English: Eye disorders visual disturbance4
Croatian: Poremećaji oka poremećaj vida 4
English: This finding is based on conventional safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, and reproduction toxicity studies.
Croatian: Ovaj se nalaz temelji na konvencionalnim ispitivanjima sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti i reproduktivne toksičnosti.
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, 28065 Cerano (NO), Italy Takeda GmbH, Production Site Oranienburg, Lehnitzstrasse 70 - 98, 16515 Oranienburg, Germany
Croatian: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Irska Delpharm Novara S.r.l., Via Crosa, 86, 28065 Cerano (NO), Italija Takeda GmbH, Production Site Oranienburg, Lehnitzstrasse 70 - 98, 16515 Oranienburg, Njemačka
English: The safety and efficacy of Tandemact in children and adolescents under 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Tandemact u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
English: If you stop taking Tandemact
Croatian: Ako prestanete uzimati Tandemact
English: Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Croatian: Također, ako ste već imali zamagljen vid i simptom se pogoršava, obratite se čim prije svom liječniku.
English: In some cases weight increase may be a symptom of cardiac failure therefore weight should be closely monitored.
Croatian: U nekim slučajevima povećanje tjelesne težine može biti simptom zatajenja srca te je stoga potrebno pažljivo pratiti tjelesnu težinu.
English: Pharmacokinetics in five non-diabetic patients after bile duct surgery were similar to those in healthy persons.
Croatian: Farmakokinetika u pet bolesnika bez šećerne bolesti nakon operacije žučnih vodova bila je slična onoj u zdravih osoba.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Croatian: Bolesnicima treba savjetovati da primijene mjere opreza kako bi izbjegli hipoglikemiju za vrijeme upravljanja vozilima.
English: Tell your doctor or pharmacist if you are taking any of these.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate neke od ovih lijekova.
English: Patients who experience visual disturbance should be cautious when driving or using machines.
Croatian: Bolesnici koji razviju poremećaj vida trebaju biti oprezni za vrijeme upravljanja vozilima i rada sa strojevima.
English: Studies of pioglitazone in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja pioglitazona u životinja pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: It is important to know what symptoms to expect when hypoglycaemia (low blood sugar) occurs.
Croatian: Preporučuje se da znate koje simptome možete očekivati kad nastupi hipoglikemija (sniženi šećer u krvi).
English: Treatment with Tandemact therefore requires regular haematological monitoring (especially leucocytes and platelets).
Croatian: Liječenje lijekom Tandemact stoga zahtijeva redovito hematološko praćenje (osobito leukocita i trombocita).
English: In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Croatian: U životinjskom modelu obiteljske adenomatozne polipoze (FAP), liječenje s druga dva tiazolidindiona povećalo je brojnost tumora u debelom crijevu.
English: This is particularly important in those who have reduced or absent awareness of the warnings of hypoglycaemia or have frequent episodes of hypoglycaemia.
Croatian: To je osobito važno u onih koji ne prepoznaju ili slabije prepoznaju znakove upozorenja hipoglikemije ili imaju česte epizode hipoglikemije.
English: In patients who fail to show an adequate response, pioglitazone should be discontinued.
Croatian: U bolesnika koji nemaju prikladni odgovor primjenu pioglitazona je nužno prekinuti.
English: Tandemact may either increase or weaken the effects of the following medicines: - coumarin derivatives such as warfarin (to slow down or stop blood clotting)
Croatian: Tandemact može ili pojačati ili oslabiti učinke sljedećih lijekova: - derivati kumarina kao što je varfarin (da bi se usporilo ili zaustavilo zgrušavanje krvi)
English: Risk related to glimepiride
Croatian: Rizik povezan s glimepiridom
English: Blood glucose should be closely monitored.
Croatian: Glukozu u krvi nužno je pažljivo pratiti.
English: Start the administration of glucose as soon as possible, if necessary by a bolus intravenous injection of 50 ml of a 50% solution, followed by an infusion of a 10% solution with strict monitoring of blood glucose.
Croatian: Započnite s primjenom glukoze čim prije i, ako je potrebno, intravenski primijenite bolus injekciju od 50 ml 50%-tne otopine glukoze, a nakon toga infuziju 10%-tne otopine uz strogi nadzor glukoze u krvi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 January 2007
Croatian: Datum prvog odobrenja: 08. siječnja 2007.
English: In the latter (covering embryotoxicity, teratogenicity and developmental toxicity), undesirable effects observed were considered to be secondary to the hypoglycaemic effects induced by the compound in dams and in offspring.
Croatian: U ovim zadnjim (uključuju embriotoksičnost, teratogenost i razvoju toksičnost), primijećene nuspojave smatrale su se sekundarnima hipoglikemijskom učinku koji je spoj izazvao u ženki i njihovom potomstvu.
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 neobičan nedostatak zraka ili naglo povećanje tjelesne težine ili lokalizirano oticanje (edemi).
English: Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable fashion.
Croatian: Uzimanje alkohola može pojačati ili oslabiti hipoglikemijsko djelovanje glimepirida na nepredvidljiv način.
English: These findings were observed across species at plasma concentrations  4 times the clinical exposure.
Croatian: Ovi su nalazi opaženi u svih životinjskih vrsta kod koncentracije u plazmi koja je  4 puta veća od izloženosti kod kliničke primjene.
English: 6 Elevation of liver enzymes may occur.
Croatian: 6 Mogu se povisiti vrijednosti jetrenih enzima.
English: The effect of glimepiride is dose-dependent and reproducible.
Croatian: Učinak glimepirida ovisi o dozi i ponovljiv je.
English: As with other sulphonylureas this effect is based on an increase of responsiveness of the pancreatic beta cells to the physiological glucose stimulus.
Croatian: Kao i s drugim sulfonilurejama, ovaj se učinak temelji na povećanoj sposobnosti beta stanica gušterače da odgovore na fiziološki poticaj glukozom.
English: However, the incidence of oedema, weight gain and heart failure were increased.
Croatian: Međutim, incidencija edema, povećanja tjelesne težine i zatajenja srca bila je povećana.
English: The transport of glucose in these tissues is the rate limiting step in the use of glucose.
Croatian: Transport glukoze u tim tkivima korak je koji ograničava brzinu iskorištavanja glukoze.
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: S obzirom na rizike povezane sa životnom dobi (osobito karcinom mokraćnog mjehura, prijelom kostiju i zatajenje srca), u starijih je bolesnika potrebno pažljivo razmotriti ravnotežu između koristi i rizika kako prije tako i tijekom liječenja.
English: The tablets are supplied in aluminium/aluminium blister packs containing either 14, 28, 30, 50, 90 or 98 tablets.
Croatian: Tablete se isporučuju u aluminij/aluminij blister pakiranjima koja sadrže 14, 28, 30, 50, 90 ili 98 tableta.
English: Decrease in blood platelets (which increases risk of bleeding or bruising), red blood cells (which makes the skin pale and cause weakness or breathlessness) and white blood cells(which makes infections more likely) have been reported in patients taking Tandemact rarely (may affect up to 1 in 1,000 people).
Croatian: Sniženje broja krvnih pločica (što povećava rizik od krvarenja ili nastanka modrica), crvenih krvnih stanica (što dovodi do blijede kože i slabosti ili osjećaja nedostatka zraka) i bijelih krvnih stanica (što povećava vjerojatnost infekcije) rijetko je zabilježeno u bolesnika koji su uzimali Tandemact (može se javiti u do 1 na 1000 osoba).
English: The recommended dose is one tablet taken once daily shortly before or with the first main meal.
Croatian: Preporučena doza je jedna tableta koja se uzima jedanput na dan, kroz usta, neposredno prije ili tijekom prvog glavnog obroka.
English: The rate of deterioration of HbA1c during the second year was less with pioglitazone than with gliclazide.
Croatian: Stopa pogoršanja vrijednosti HbA1c tijekom druge godine bila je manja uz pioglitazon nego uz gliklazid.
English: When you take Tandemact, your blood sugar could fall below the normal level (hypoglycaemia).
Croatian: Kad uzmete Tandemact, razina šećera u krvi može Vam se spustiti ispod normalne razine (hipoglikemija).
English: If patients report hypoglycaemia, the dose of Tandemact should be reduced or free combination therapy should be considered.
Croatian: Ako bolesnici prijave hipoglikemiju, doza lijeka Tandemact se mora sniziti ili se mora razmotriti terapija slobodnom kombinacijom lijekova.
English: Animal studies have shown reproductive toxicity which was most likely related to the pharmacological action (hypoglycaemia) of glimepiride.
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, koja je najvjerojatnije povezana s farmakološkim djelovanjem (hipoglikemija) glimepirida.
English: After a single dose of radiolabelled glimepiride, 58% of the radioactivity was recovered in the urine, and 35% in the faeces.
Croatian: Nakon primjene jednokratne doze radiološki označenog glimepirida, 58% radioaktivnosti otkrilo se u mokraći, a 35% u stolici.
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: Mehanističko ispitivanje u trajanju od 24 mjeseca u mužjaka štakora pokazalo je da je primjena pioglitazona rezultirala povećanom incidencijom hiperplastičnih promjena u mokraćnom mjehuru.
English: Linearity/non-linearity Single dose studies demonstrate linearity of pharmacokinetics in the therapeutic dose range.
Croatian: Linearnost/nelinearnost Ispitivanja jednokratne doze pokazuju linearnost farmakokinetike u terapijskom rasponu doza.
English: Take care if you experience abnormal vision.
Croatian: Budite oprezni ako imate poremećaj vida.
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: Food intake has no relevant influence on absorption, only absorption rate is slightly diminished.
Croatian: Uzimanje hrane nema važnog utjecaja na apsorpciju, samo je brzina apsorpcije blago smanjena.
English: Therapy with Tandemact 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 Tandemact se ne smije započeti u bolesnika s povišenim razinama jetrenih enzima (ALT povišena više od 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
English: Risk related to pioglitazone
Croatian: Rizik povezan s pioglitazonom
English: If you forget to take Tandemact
Croatian: Ako ste zaboravili uzeti Tandemact
English: Blood and lymphatic system disorders changes in haematology1
Croatian: Poremećaji krvi i limfnog sustava hematološke promjene1
English: The physiological response to acute physical exercise, reduction of insulin secretion, is still present under glimepiride.
Croatian: Fiziološki odgovor na akutno fizičko opterećenje, smanjenje lučenja inzulina, još je prisutno pod utjecajem glimepirida.
English: Treatment of overdose of Tandemact primarily consists of preventing absorption of glimepiride by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium-sulphate (laxative).
Croatian: Liječenje predoziranja lijekom Tandemact prvenstveno se sastoji od sprječavanja apsorpcije glimepirida izazivanjem povraćanja a potom ispijanja vode ili limunade s aktivnim ugljenom (adsorbens) i natrijevim sulfatom (laksativ).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tandemact.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije nego što uzmete Tandemact.
English: Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Croatian: Pioglitazon može dovesti do zadržavanja tekućine, koje može pogoršati ili izazvati zatajenje srca.
English: 4 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 medicinal products.
Croatian: 4 Poremećaji vida zabilježeni su relativno rano u početku liječenja i povezani su s promjenama glukoze u krvi zbog privremeno promijenjenog turgora i indeksa refrakcije leće, kakvi se vide i uz druge hipoglikemijske lijekove.
English: Two metabolites - most probably resulting from hepatic metabolism (major enzyme is CYP2C9) - were identified both in urine and faeces: the hydroxy derivative and the carboxy derivative.
Croatian: Dva metabolitanajvjerojatnije rezultat metabolizma u jetri (glavni enzim je CYP2C9) - pronađeni su i u mokraći i u stolici: hidroksi-derivat i karboksi-derivat.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Tandemact.
Croatian: Postoji povećana mogućnost trudnoće, zato što Vam se za vrijeme uzimanja lijeka Tandemact može vratiti ovulacija.
English: In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Croatian: S obzirom na moguće rizike dugotrajnije terapije, liječnici koji propisuju lijek moraju naknadnim rutinskim procjenama potvrđivati da je korist od liječenja pioglitazonom održana (vidjeti dio 4.4).
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 of pioglitazone and increase the dose gradually.
Croatian: Kod liječenja bolesnika s najmanje jednim čimbenikom rizika za razvoj kongestivnog zatajenja srca (npr. prethodni infarkt miokarda, simptomatska bolest koronarnih arterija ili starija dob), liječnici moraju započeti liječenje s najnižom dostupnom dozom pioglitazona i postupno je povećavati.
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 meta-analizi 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: Tandemact contains pioglitazone and glimepiride which are anti-diabetic medicines, used to control blood sugar level.
Croatian: Tandemact sadrži pioglitazon i glimepirid, koji su antidijabetički lijekovi i primjenjuju se za kontrolu razine šećera u krvi.
English: There is a linear relationship between dose and both Cmax and AUC (area under the time/concentration curve).
Croatian: Linearnost/nelinearnost Postoji linearni odnos između doze i Cmax i AUC (površina ispod krivulje vrijeme-koncentracija).
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 treba očekivati interakcije s tvarima koje ovi enzimi metaboliziraju, npr. oralnim kontraceptivima, ciklosporinom, blokatorima kalcijevih kanala i inhibitorima reduktaze HMGCoA.
English: Sulphonylurea-derivatives like glimepiride pass into the breast milk.
Croatian: Derivati sulfonilureje poput glimepirida prelaze u majčino mlijeko.
English: Maximum serum concentrations (Cmax) are reached approximately 2.5 hours after oral intake (mean 0.3 µg/mL during multiple dosing of 4 mg daily).
Croatian: Najviše koncentracije u serumu (Cmax) postižu se približno 2,5 sata nakon peroralnog unosa (prosječno 0,3 µg/ml tijekom višekratne primjene doze od 4 mg na dan).
English: Close monitoring of glycaemic control should be considered (see section 4.4).
Croatian: Potrebno je razmotriti pažljivo praćenje kontrole glikemije (vidjeti dio 4.4).
English: It is used in adults when metformin is not suitable to treat type 2 (non-insulin dependent) diabetes mellitus.
Croatian: Tandemact se primjenjuje u odraslih kad metformin nije prikladan za liječenje šećerne bolesti tipa 2 (neovisne o inzulinu).
English: If glimepiride is taken simultaneously with certain other medicinal products, both undesired increases and decreases in the hypoglycaemic action of glimepiride can occur.
Croatian: Ako se glimepirid uzme istovremeno s određenim lijekovima, mogu nastati i neželjena pojačanja i neželjena smanjenja hipoglikemijskog učinka glimepirida.
English: After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Croatian: Bolesnike se mora pregledati 3 do 6 mjeseci nakon početka terapije pioglitazonom kako bi se procijenila prikladnost odgovora na liječenje (npr. sniženje HbA1c).
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, zabilježeno je 7 slučajeva (0,06%) u skupinama koje su primale pioglitazon i 2 slučaja (0,02%) u kontrolnim skupinama.
English: If you experience symptoms of hypoglycaemia such as cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea, you should take some sugar to increase your blood sugar level again.
Croatian: Ako iskusite simptome hipoglikemije poput hladnog znoja, umora, glavobolje, ubrzanih otkucaja srca, boli od gladi, razdražljivosti, nervoze ili mučnine, trebate uzeti malo šećera kako biste ponovno povećali svoju razinu šećera u krvi.
English: Treatment with Tandemact requires regular monitoring of glycaemic control.
Croatian: Liječenje lijekom Tandemact zahtijeva redovito praćenje kontrole glikemije.
English: The hypoglycaemia may in general be accompanied by neurological symptoms like restlessness, tremor, visual disturbances, coordination problems, sleepiness, coma and convulsions.
Croatian: Hipoglikemija može općenito biti praćena neurološkim simptomima poput nemira, tremora, poremećaja vida, otežane koordinacije, pospanosti, kome i konvulzija.
English: There are no adequate data from the use of pioglitazone in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni pioglitazona u trudnica.
English: This may affect your ability to drive or use machines.
Croatian: To može utjecati na Vašu sposobnost upravljanja vozilima i rada na strojevima.
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 iznenadna potreba za mokrenjem.
English: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia from glimepiride or, for example, as a result of visual impairment.
Croatian: Sposobnost bolesnika da se usredotoči i reagira može biti narušena zbog hipoglikemije ili hiperglikemije prouzročene glimepiridom ili, na primjer, zbog poremećaja vida.
English: In general observation in hospital is recommended.
Croatian: Općenito se preporučuje hospitalizirati bolesnika zbog promatranja.
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 netko drugi ili dijete uzme
English: MAO-inhibitors quinolone antibiotics probenecid miconazole pentoxyfylline (high dose parenteral) tritoqualine fluconazole
Croatian: MAO inhibitori kinolonski antibiotici probenecid mikonazol pentoksifilin (visoke parenteralne doze) tritokvalin flukonazol
English: The uptake of glucose from blood into peripheral muscle and fat tissues occurs via a special transport proteins, located in the cells membrane.
Croatian: Unos glukoze iz krvi u periferne mišiće i masno tkivo odvija se putem posebnih transportnih proteina smještenih u staničnim membranama.
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Croatian: Ispitivanja u čovjeka ne sugeriraju da postoji indukcija glavnog inducibilnog citokroma P450, 1A, 2C8/9 i 3A4.
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 primarnog ishoda, tj. kompozitne mjere sastavljene od mortaliteta svih uzroka, infarkta miokarda bez smrtnog ishoda, moždanog udara, akutnog koronarnog sindroma, velike amputacije noge, koronarne revaskularizacije i revaskularizacije noge, rezultati pokazuju da nije bilo dugotrajnih kardiovaskularnih rizika kod primjene pioglitazona.
English: Glycaemic control should be monitored closely.
Croatian: Kontrolu glikemije je nužno pozorno pratiti.
English: Avoid alcohol while taking Tandemact since alcohol may increase or decrease the blood sugar lowering action of Tandemact in an unpredictable way.
Croatian: Izbjegavajte piti alkohol dok uzimate Tandemact, jer alkohol može pojačati ili oslabiti učinak lijeka Tandemact na sniženje šećera u krvi na nepredvidljiv način.
English: Pioglitazone has been shown to be present in the milk of lactating rats.
Croatian: Pokazalo se da je pioglitazon prisutan u mlijeku štakorica u vrijeme laktacije.
English: If you are following a special diet for diabetes, you should continue with this while you are taking Tandemact.
Croatian: Ako ste na posebnoj dijeti zbog šećerne bolesti, za vrijeme uzimanja lijeka Tandemact morate nastaviti s dijetom.
English: You must tell your doctor if you are, you think you may be pregnant or are planning to have a baby.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
English: Following initiation of therapy with Tandemact, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Croatian: Nakon početka terapije lijekom Tandemact preporučuje se povremeno određivati jetrene enzime na temelju kliničke procjene.