FrancophonIA/ELRC3.0 huggingface dataset:
English: Animal studies show that empagliflozin crosses the placenta during late gestation to a very limited extent but do not indicate direct or indirect harmful effects with respect to early embryonic development.
Croatian: Ispitivanja na životinjama pokazuju da empagliflozin prolazi placentu tijekom kasne trudnoće u vrlo ograničenoj količini, ali ne ukazuju na izravne ili neizravne štetne učinke na rani embrionalni razvoj.
English: The majority of drug-related radioactivity recovered in faeces was unchanged parent drug and approximately half of drug related radioactivity excreted in urine was unchanged parent drug.
Croatian: Većina radioaktivnosti povezane s lijekom, koja je pronađena u fecesu, bio je nepromijenjeni roditeljski lijek, a približno polovica radioaktivnosti povezane s lijekom, koja se izlučila mokraćom, bila je nepromijenjeni roditeljski lijek.
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Croatian: Kada dijeta i tjelovježba same ne pružaju odgovarajuću kontrolu glikemije kod bolesnika u kojih se primjena metformina ne smatra prikladnom zbog nepodnošenja.
English: This medicine is subject to additional monitoring.
Croatian: Ovaj lijek je pod dodatnim praćenjem.
English: No such effect was seen at systemic exposure equal to the maximal clinical exposure to empagliflozin.
Croatian: Takav učinak nije opažen pri sistemskoj izloženosti koja je bila jednaka maksimalnoj kliničkoj izloženosti empagliflozinu.
English: In patients where DKA is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately.
Croatian: U bolesnika u kojih se sumnja na DKA ili je ista dijagnosticirana, liječenje empagliflozinom treba odmah prekinuti.
English: This results in high levels of glucose in your blood which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs.
Croatian: To rezultira visokim razinama glukoze u krvi što može dovesti do medicinskih problema poput bolesti srca, bolesti bubrega, sljepoće i slabe cirkulacije u udovima.
English: A total of 13,076 patients with type 2 diabetes were included in clinical studies to evaluate the safety of empagliflozin.
Croatian: Ukupno je 13 076 bolesnika sa šećernom bolešću tipa 2 bilo uključeno u klinička ispitivanja za ocjenu sigurnosti primjene empagliflozina.
English: Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia).
Croatian: Vaš liječnik će možda htjeti sniziti dozu ovih drugih lijekova kako bi se spriječio nastanak pretjerano niske razine šećera u krvi (hipoglikemija).
English: • Swallow the tablet whole with water
Croatian: • Progutajte cijelu tabletu s vodom.
English: Your doctor has prescribed this medicine to help lower your blood sugar.
Croatian: Liječnik Vam je propisao ovaj lijek kako bi Vam se snizila razina šećera u krvi.
English: The mode of action for these tumours is dependent on the natural predisposition of the male mouse to renal pathology and a metabolic pathway not reflective of humans.
Croatian: Način djelovanja za ove tumore ovisan je o prirodnoj predispoziciji mužjaka miša za bubrežnu patologiju i metaboličkom putu koji se ne odnosi na ljude.
English: It is responsible, as the predominant transporter, for the reabsorption of glucose from the glomerular filtrate back into the circulation.
Croatian: Kao glavni prijenosnik odgovoran je za reapsorpciju glukoze iz glomerularnog filtrata natrag u cirkulaciju.
English: Systemic exposure of empagliflozin increased in a dose-proportional manner.
Croatian: Sistemska izloženost empagliflozinu povećala se proporcionalno dozi.
English: Hypoglycaemia (when used with sulphonylurea or insulin)a
Croatian: Hipoglikemija (kada je primjena bila sa sulfonilurejom ili inzulinom)a
English: • if you have a serious infection of the kidney or the urinary tract with fever.
Croatian: • ako imate ozbiljnu infekciju bubrega ili mokraćnog sustava s vrućicom.
English: What Jardiance contains - The active substance is empagliflozin.
Croatian: Što Jardiance sadrži - Djelatna tvar je empagliflozin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters (perforated)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri (perforirani)
English: Type 2 diabetes is a disease that comes from both your genes and your lifestyle.
Croatian: Šećerna bolest tipa 2 je bolest za koju su odgovorni kako geni tako i način života.
English: Empagliflozin is not genotoxic.
Croatian: Empagliflozin nije genotoksičan.
English: Insulin and insulin secretagogues, such as sulphonylureas, may increase the risk of hypoglycaemia.
Croatian: Inzulin i inzulinski sekretagozi, poput sulfonilureja, mogu povećati rizik od hipoglikemije.
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with empagliflozin in NYHA class III-IV.
Croatian: Iskustvo s bolesnicima klase I-II prema klasifikaciji NYHA (New York Heart Association) je ograničeno, a ne postoje iskustva iz kliničkih ispitivanja primjene empagliflozina u bolesnika klase
English: It is not known if Jardiance passes into human breast milk.
Croatian: Nije poznato prelazi li Jardiance u majčino mlijeko.
English: Increased urinary glucose excretion was maintained at the end of the 4-week treatment period, averaging approximately 78 g/day.
Croatian: Povećano izlučivanje glukoze u mokraći održalo se pri kraju 4-tjednog perioda liječenja iznoseći u prosjeku približno 78 g/dan.
English: The amount of glucose removed by the kidney through this glucuretic mechanism is dependent on blood glucose concentration and GFR.
Croatian: Količina glukoze koju bubreg eliminira pomoću tog glukuretskog mehanizma ovisna je o koncentraciji glukoze u krvi i GFR-u.
English: Jardiance 10 mg film-coated tablets EU/1/14/930/010
Croatian: Jardiance 10 mg filmom obložene tablete EU/1/14/930/010
English: Jardiance 25 mg film-coated tablets EU/1/14/930/001
Croatian: Jardiance 25 mg filmom obložene tablete EU/1/14/930/001
English: Following administration of an oral [14C]-empagliflozin solution to healthy volunteers, approximately 96% of the drug-related radioactivity was eliminated in faeces (41%) or urine (54%).
Croatian: Nakon primjene oralne otopine [14C] empagliflozina u zdravih dobrovoljaca, oko 96% radioaktivnosti povezane s lijekom bilo je izlučeno putem fecesa (41%) ili urina (54%).
English: Temporary interruption of treatment with empagliflozin should be considered until the fluid loss is corrected.
Croatian: Potrebno je razmotriti privremeni prekid liječenja empagliflozinom dok se gubitak tekućine ne korigira.
English: Jardiance has minor influence on the ability to drive and use machines.
Croatian: Jardiance zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The glucosuria observed with empagliflozin is accompanied by mild diuresis which may contribute to sustained and moderate reduction of blood pressure.
Croatian: Glukozurija, koja je opažena s empagliflozinom, bila je praćena blagom diurezom, koja može doprinijeti trajnom i umjerenom snižavanju krvnog tlaka.
English: Dysuria a see subsections below for additional information b derived from postmarketing experience * see section 4.4
Croatian: Dizurija a za dodatne informacije vidjeti niže navedene odjeljke b podatak iz iskustva nakon stavljanja lijeka u promet * vidjeti dio 4.4
English: Placebo Empagliflozin 25 mg eGFR ≥60 to <90 ml/min/1.73 m²
Croatian: Placebo Empagliflozin 25 mg eGFR ≥60 do <90 ml/min./1,73 m²
English: Your doctor may prescribe Jardiance together with another diabetes medicine.
Croatian: Liječnik Vam može propisati Jardiance u kombinaciji s drugim lijekom za liječenje šećerne bolesti.
English: Based on the population pharmacokinetic analysis, the apparent terminal elimination half-life of empagliflozin was estimated to be 12.4 hours and apparent oral clearance was 10.6 l/hour.
Croatian: Na temelju farmakokinetičke analize populacije procijenjeno je da prividni terminalni poluvijek eliminacije empagliflozina iznosi 12,4 sati, a prividni oralni klirens je iznosio 10,6 l/sat.
English: In the event of an overdose, treatment should be initiated as appropriate to the patient‘s clinical status.
Croatian: U slučaju predoziranja potrebno je započeti liječenje ovisno o bolesnikovom kliničkom statusu.
English: In 5 placebo-controlled trials of 18 to 24 weeks duration, 2,971 patients were included of which 995 were treated with placebo and 1,976 with empagliflozin.
Croatian: U 5 placebom kontroliranih ispitivanja, u trajanju od 18 do 24 tjedna, bilo je uključeno 2971 bolesnika od kojih je 995 bilo liječeno placebom, a 1976 empagliflozinom.
English: Jardiance contains lactose
Croatian: Jardiance sadrži laktozu
English: After oral administration, empagliflozin was rapidly absorbed with peak plasma concentrations occurring at a median tmax of 1.5 hours post-dose.
Croatian: Nakon oralne primjene, empagliflozin se brzo apsorbirao, s pojavom vršnih koncentracija u plazmi pri medijanu tmax od 1,5 sati nakon primijenjene doze.
English: The observed effect of food on empagliflozin pharmacokinetics was not considered clinically relevant and empagliflozin may be administered with or without food.
Croatian: Opaženi učinak hrane na farmakokinetiku empagliflozina nije se smatrao klinički značajnim te se empagliflozin može primijenjivati sa ili bez hrane.
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excl. insulins, ATC code: A10BX12
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti, drugi lijekovi za snižavanje glukoze u krvi, isključujući inzuline, ATK oznaka: A10BX12
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with empagliflozin (see sections 4.2 and 4.8).
Croatian: Stoga, može biti potrebna niža doza inzulina ili inzulinskog sekretagoga kako bi se smanjio rizik od hipoglikemije kada se primjenjuju u kombinaciji s empagliflozinom (vidjeti dijelove 4.2 i 4.8).
English: Most toxicity was consistent with secondary pharmacology related to urinary glucose loss and electrolyte imbalances including decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism and gluconeogenesis, urinary changes such as polyuria and glucosuria, and microscopic changes including mineralisation in kidney and some soft and vascular tissues.
Croatian: Većina toksičnosti je bila konzistentna sa sekundarnom farmakologijom povezanom s gubitkom glukoze putem mokraće i neravnotežom elektrolita uključujući smanjenu tjelesnu težinu i tjelesnu masnoću, povećanu konzumaciju hrane, dijareju, dehidraciju, sniženu vrijednost glukoze u serumu i povećanje drugih serumskih parametara koji odražavaju povećani metabolizam proteina i glukoneogenezu, promjene u mokraći poput poliurije i glukozurije, te mikroskopske promjene uključujući mineralizaciju u bubregu i nekim mekim i vaskularnim tkivima.
English: The male mouse renal tumours are considered not relevant to humans.
Croatian: Tumori bubrega u mužjaka miša ne smatraju se relevantnim za ljude.
English: The effect of empagliflozin on urinary glucose excretion is associated with osmotic diuresis, which could affect the hydration status.
Croatian: Učinak empagliflozina na izlučivanje glukoze mokraćom povezan je s osmotskom diurezom, koja može utjecati na hidracijski status.
English: Jardiance tablets are available in PVC/aluminium perforated unit dose blisters.
Croatian: Tablete Jardiance su dostupne u perforiranim PVC/aluminij perforiranim blisterima djeljivim na jedinične doze.
English: Therapeutic experience in patients with severe hepatic impairment is limited and therefore not recommended for use in this population (see section
Croatian: Terapijsko iskustvo u bolesnika s teškim oštećenjem jetre je ograničeno i stoga se ne preporučuje za uporabu u ovoj populaciji (vidjeti dio 5.2).
English: Drug-drug interactions involving the major CYP450 and UGT isoforms with empagliflozin and concomitantly administered substrates of these enzymes are therefore considered unlikely.
Croatian: Stoga se interakcije među lijekovima koje uključuju glavne izoforme enzima CYP450 i UGT s empagliflozinom i istodobno primijenjenim supstratima tih enzima, ne smatraju vjerojatnima.
English: During the initial 18 weeks the insulin dose was kept stable, but was adjusted to achieve a FPG <110 mg/dl in the following 60 weeks.
Croatian: Tijekom početnih 18 tjedana doza inzulina je bila stabilna, ali se prilagođavala u cilju postizanja razine glukoze natašte (FPG) <110 mg/dl u narednih 60 tjedana.
English: In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32 times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin (equivalent to 4 times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity.
Croatian: U kontroliranim kliničkim ispitivanjima, jednokratne doze do 800 mg empagliflozina (što odgovara dozi 32 puta višoj od najviše preporučene dnevne doze) u zdravih dobrovoljaca i višekratne dnevne doze do 100 mg empagliflozina (što odgovara dozi 4 puta višoj od najviše preporučene dnevne doze) u bolesnika sa šećernom bolešću tipa 2 nisu pokazale toksičnost.
English: Based on the mode of action of SGLT-2 inhibitors, osmotic diuresis accompanying therapeutic glucosuria may lead to a modest decrease in blood pressure (see section 5.1).
Croatian: Na temelju načina djelovanja inhibitora SGLT-2, osmotska diureza, koja prati terapijsku glukozuriju, može dovesti do blagog sniženja krvnog tlaka (vidjeti dio 5.1).
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza „EXP“, odnosno „Rok valjanosti“.
English: Empagliflozin administered during the period of organogenesis was not teratogenic.
Croatian: Empagliflozin, koji se primijenio tijekom razdoblja organogeneze, nije imao teratogeni učinak.
English: There were no clinically relevant differences in empagliflozin pharmacokinetics between healthy volunteers and patients with type 2 diabetes.
Croatian: Nije bilo klinički značajnih razlika u farmakokinetici empagliflozina između zdravih dobrovoljaca i bolesnika sa šećernom bolešću tipa 2.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infectiona Urinary tract infectiona
Croatian: Vaginalna monilijaza, vulvovaginitis, balanitis i druge genitalne infekcijea
English: Jardiance should not be used during breast-feeding.
Croatian: Jardiance se ne smije primjenjivati tijekom dojenja.
English: Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Croatian: Uzimanje ovog lijeka u kombinaciji s lijekovima koji se nazivaju sulfonilureje ili s inzulinom može dovesti do pretjerano niskih razina šećera u krvi (hipoglikemija), što može izazvati simptome poput drhtavice, znojenja i promjene vida, te može utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Croatian: Viša početna vrijednost HbA1c bila je povezana s većim sniženjem vrijednosti HbA1c.
English: 4.9 Overdose
Croatian: 4.9 Predoziranje Simptomi
English: Empagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is 5000 times more selective for SGLT2 versus SGLT1, the major transporter responsible for glucose absorption in the gut.
Croatian: Empagliflozin ne inhibira druge prijenosnike glukoze važne za prijenos glukoze u periferna tkiva te je 5000 puta selektivniji za SGLT2 naspram SGLT1, glavnog prijenosnika odgovornog za apsorpciju glukoze u crijevu.
English: Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2).
Croatian: Empagliflozin je reverzibilni, visoko potentni (IC50 iznosi 1,3 nmol) i selektivni kompetitivni inhibitor suprijenosnika natrija i glukoze 2 (engl. sodium-glucose co-transporter 2, SGLT2).
English: Do not take Jardiance: - if you are allergic to empagliflozin or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na empagliflozin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: PVC/aluminium perforated unit dose blisters.
Croatian: PVC/aluminij perforirani blisteri djeljivi na jedinične doze.
English: By blocking this protein, the medicine causes glucose (blood sugar), to be removed via the urine and blood glucose levels, which are too high because of your type 2 diabetes, are thereby reduced.
Croatian: Blokiranjem tog proteina ovaj lijek uzrokuje izlučivanje glukoze (šećer u krvi) putem mokraće, a razine glukoze u krvi, koje su zbog šećerne bolesti tipa 2 previsoke, time se snižavaju.
English: Jardiance should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Croatian: Općenito Jardiance se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 ili u liječenju dijabetičke ketoacidoze.
English: Empagliflozin is a substrate of the human uptake transporters OAT3, OATP1B1, and OATP1B3, but not OAT1 and OCT2.
Croatian: Empagliflozin je supstrat humanih prijenosnika za unos OAT3, OATP1B1 i OATP1B3, ali ne OAT1 i OCT2.
English: In addition it resulted in a clinically meaningful reduction in FPG, systolic and diastolic blood pressure compared to placebo.
Croatian: Uz to, došlo je do klinički značajnog sniženja vrijednosti FPG, sistoličkog i dijastoličkog krvnog tlaka u usporedbi s placebom.
English: Due to the mechanism of action, the efficacy of empagliflozin is dependent on renal function.
Croatian: Zbog mehanizma djelovanja, djelotvornost empagliflozina je ovisna o funkciji bubrega.
English: In patients with type 2 diabetes, urinary glucose excretion increased immediately following the first dose of empagliflozin and is continuous over the 24 hour dosing interval.
Croatian: U bolesnika sa šećernom bolešću tipa 2 izlučivanje glukoze mokraćom povećalo se neposredno nakon prve doze empagliflozina i stabilno je tijekom 24-satnog intervala doziranja.
English: • lightheadedness or dizziness upon standing
Croatian: • ošamućenost ili omaglicu prilikom ustajanja
English: SGLT2 prevents glucose from being excreted in urine by absorbing glucose into the bloodstream as blood is being filtered in the kidneys.
Croatian: SGLT2 sprječava izlučivanje glukoze mokraćom tako što apsorbira glukozu u krvotok dok se krv filtrira u bubrezima.
English: Your doctor may ask you to stop taking Jardiance until you have recovered.
Croatian: Vaš liječnik može zatražiti da prestanete uzimati Jardiance sve dok se ne oporavite.
English: No dose adjustment is recommended based on age.
Croatian: Nije preporučeno prilagođavanje doze prema dobi.
English: A higher number of these patients treated with empagliflozin had adverse reactions related to volume depletion as compared to placebo (see section 4.8).
Croatian: Veći broj takvih bolesnika koji su liječeni empagliflozinom, imali su nuspojave povezane s deplecijom volumena u usporedbi sa skupinom koja je primala placebo (vidjeti dio 4.8).
English: Empagliflozin does not inhibit human uptake transporters such as OAT3, OATP1B1, and OATP1B3 in vitro at clinically relevant plasma concentrations and, as such, drug-drug interactions with substrates of these uptake transporters are considered unlikely.
Croatian: Empagliflozin ne inhibira humane prijenosnike za unos poput OAT3, OATP1B1 i OATP1B3 in vitro pri klinički značajnim koncentracijama u plazmi, te se kao takve, interakcije među lijekovima sa supstratima tih prijenosnika za unos ne smatraju vjerojatnima.
English: The improvement in HbA1c, body weight, and blood pressure was sustained up to 52 weeks.
Croatian: Poboljšanje vrijednosti HbA1c, tjelesne težine i krvnog tlaka je bilo održano do 52 tjedna.
English: No studies on the effect on human fertility have been conducted for Jardiance.
Croatian: Plodnost Nisu provedena ispitivanja učinka lijeka Jardiance na ljudsku plodnost.
English: The mechanism of action of empagliflozin is independent of beta cell function and insulin pathway and this contributes to a low risk of hypoglycaemia.
Croatian: Mehanizam djelovanja empagliflozinaneovisan je o funkciji beta-stanica i inzulinskom putu, a to doprinosi niskom riziku od hipoglikemije.
English: There are no data from the use of empagliflozin in pregnant women.
Croatian: Nema podataka o primjeni empagliflozina u trudnica.
English: Add-on to pioglitazone +/- metformin therapy Placebo
Croatian: Dodatak uzterapiju ioglitazonom +/- metformin Placebo
English: The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin.
Croatian: Preporučena početna doza je 10 mg empagliflozina jedanput dnevno za monoterapiju i za dodatak kombiniranoj terapiji s drugim lijekovima koji snižavaju glukozu u krvi uključujući inzulin.
English: Cases of hepatic injury have been reported with empagliflozin in clinical trials.
Croatian: Prijavljeni su slučajevi oštećenja jetre tijekom primjene empagliflozina u kliničkim ispitivanjima.
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and Cmax by approximately 37% compared to fasted condition.
Croatian: Primjena empagliflozina od 25 mg nakon unosa obroka s visokim sadržajem masti i kalorija rezultirala je neznatno nižom izloženošću; AUC se smanjio za približno 16%, a Cmax za približno 37% u usporedbi sa stanjem natašte.
English: 2856 patients received empagliflozin 10 mg and 3,738 patients received empagliflozin 25 mg for at least 24 weeks and 601 or 881 patients for at least 76 weeks, either alone or in combination with metformin, a sulphonylurea, pioglitazone, DPP-4 inhibitors, or insulin.
Croatian: 2856 bolesnika je primalo empagliflozin od 10 mg i 3738 bolesnika je primalo empagliflozin od 25 mg tijekom najmanje 24 tjedna, a 601ili 881 bolesnik tijekom najmanje 76 tjedana, bilo u obliku monoterapije ili u kombinaciji s metforminom, sulfonilurejom, pioglitazonom, inhibitorima enzima DPP-4 ili inzulinom.
English: In addition, urinary glucose excretion triggers calorie loss, associated with body fat loss and body weight reduction.
Croatian: Uz to, izlučivanje glukoze mokraćom pokreće gubitak kalorija koji je povezan s gubitkom tjelesne masti i smanjenjem tjelesne težine.
English: Table 1: Adverse reactions reported in placebo-controlled studies System organ class
Croatian: Tablica 1: nuspojave prijavljene u placebom kontroliranim ispitivanjima Klasifikacija organskih sustava
English: Patients with high baseline HbA1c >10%
Croatian: Bolesnici s visokom početnom vrijednošću HbA1c >10%
English: The population pharmacokinetic analysis showed that the apparent oral clearance of empagliflozin decreased with a decrease in eGFR leading to an increase in drug exposure.
Croatian: Farmakokinetička analiza populacije pokazala je da se prividni oralni klirens empagliflozina smanjio sa smanjenjem vrijednosti eGFR dovodeći do povećanja izloženosti lijeku.
English: Available toxicological data in animals have shown excretion of empagliflozin in milk.
Croatian: Dostupni toksikološki podaci u životinja pokazali su da se empagliflozin izlučuje u mlijeko.