FrancophonIA/ELRC3.0 huggingface dataset:
English: No data in humans are available on excretion of empagliflozin into milk.
Croatian: Dojenje Nisu dostupni podaci u ljudi o izlučivanju empagliflozina u majčino mlijeko.
English: In a juvenile toxicity study in the rat, when empagliflozin was administered from postnatal day 21 until postnatal day 90, non-adverse, minimal to mild renal tubular and pelvic dilation in juvenile rats was seen only at 100 mg/kg/day, which approximates 11-times the maximum clinical dose of 25 mg.
Croatian: U ispitivanju toksičnosti na mladunčadi štakora, kada se empagliflozin primijenio od 21. postnatalnog dana do 90. postnatalnog dana, opažena je neštetna, minimalna do blaga dilatacija bubrežnih tubula i pelvisa u mladunčadi štakora tek pri 100 mg/kg/dan, što je približno 11 puta veća doza od maksimalne kliničke doze od 25 mg.
English: Oval, pale yellow, biconvex film-coated tablet debossed with “S25” on one side and the Boehringer Ingelheim logo on the other (tablet length: 11.1 mm, tablet width: 5.6 mm).
Croatian: Ovalna, blijedožuta, bikonveksna, filmom obložena tableta s oznakom "S25" utisnutom na jednoj te logom Boehringer Ingelheim na drugoj strani (duljina tablete: 11,1 mm, širina tablete: 5,6 mm).
English: Add-on to metformin and a sulphonylurea therapy Placebo
Croatian: Dodatak uz terapiju metforminom i sulfonilurejom Placebo
English: Body Mass Index
Croatian: Indeks tjelesne mase (BMI)
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Croatian: Bolesnici (%) s postignutim HbA1c <7% s početnom vrijednošću HbA1c ≥7%2
English: They have “S25” on one side and the Boehringer Ingelheim logo on the other side.
Croatian: Na jednoj strani imaju oznaku „S25“, a na drugoj strani logo tvrtke Boehringer Ingelheim.
English: INFORMATION IN BRAILLE Jardiance 25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Jardiance 25 mg
English: Skin and subcutaneous disorders
Croatian: Poremećaji kože i potkožnog tkiva
English: Table 5: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add on to multiple daily doses of insulin with or without metformin
Croatian: Tablica 5: Rezultati djelotvornosti u 18. i 52. tjednu u placebom kontroliranom ispitivanju empagliflozina kao dodatka uz višekratne dnevne doze inzulina sa ili bez metformina
English: Empagliflozin improves glycaemic control in patients with type 2 diabetes by reducing renal glucose reabsorption.
Croatian: Empagliflozin poboljšava kontrolu glikemije u bolesnika sa šećernom bolešću tipa 2 na način da smanjuje reapsorpciju glukoze u bubregu.
English: Peak plasma levels of empagliflozin were similar in subjects with moderate renal impairment and kidney failure/ESRD compared to patients with normal renal function.
Croatian: Vršne razine empagliflozina u plazmi bile su slične u ispitanika s umjerenim oštećenjem bubrežne funkcije i zatajenjem bubrega/ESRD u usporedbi s bolesnicima s normalnom bubrežnom funkcijom.
English: Empagliflozin increased urine glucose excretion leading to an increase in urine volume.
Croatian: Empagliflozin je povećao izlučivanje glukoze mokraćom dovodeći do povećanja volumena mokraće.
English: Difference from placebo1 (95% CI)
Croatian: Razlika od placeba2 (95% CI)
English: Pack sizes of 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1, and 100 x 1 film-coated tablets.
Croatian: Veličine pakiranja od 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1 i 100 x 1 filmom obloženih tableta.
English: Treatment with empagliflozin led to a statistically significant reduction of HbA1c (Table 7) and clinically meaningful improvement in FPG compared to placebo at Week 24.
Croatian: Liječenje empagliflozinom je dovelo do statistički značajnog sniženja vrijednosti HbA1c (Tablica 7) i klinički značajnog sniženja vrijednosti FPG u usporedbi s placebom u 24. tjednu.
English: At week 18, empagliflozin provided statistically significant improvement in HbA1c (Table 6).
Croatian: U 18. tjednu empagliflozin je postigao statistički značajno poboljšanje vrijednosti HbA1c (Tablica 6).
English: Round, pale yellow, biconvex, bevel-edged film-coated tablet debossed with “S10” on one side and the Boehringer Ingelheim logo on the other (tablet diameter: 9.1 mm).
Croatian: Okrugla, blijedožuta, bikonveksna, filmom obložena tableta ukošenih rubova s oznakom "S10" utisnutom na jednoj te logom Boehringer Ingelheim na drugoj strani (promjer tablete: 9,1 mm).
English: In a prespecified analysis of patients (N=201) with a baseline HbA1c ≥8.5%, treatment resulted in a reduction in HbA1c from baseline of -1.44% for empagliflozin 10 mg, -1.43% for empagliflozin 25 mg, -1.04% for sitagliptin, and an increase of 0.01% for placebo.
Croatian: U prethodno određenoj analizi bolesnika (N=201) s početnom vrijednošću HbA1c ≥8,5% liječenje je rezultiralo sniženjem vrijednosti HbA1c u odnosu na početnu vrijednost u iznosu od -1,44% za empagliflozin od 10 mg, -1,43% za empagliflozin od 25 mg, -1,04% za sitagliptin te povećanjem od 0,01% za placebo.
English: Urine laboratory assessments
Croatian: Laboratorijska ispitivanja mokraće
English: INFORMATION IN BRAILLE Jardiance 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Jardiance 10 mg
English: This type usually starts when you are young and your body does not produce any insulin.
Croatian: Ovaj tip bolesti obilježen je početkom u mlađoj životnoj dobi i potpunim odsustvom stvaranja inzulina u Vašem tijelu.
English: The pharmacokinetics of empagliflozin have been extensively characterised in healthy volunteers and patients with type 2 diabetes.
Croatian: Farmakokinetika empagliflozina opsežno je ispitana u zdravih dobrovoljaca i bolesnika sa šećernom bolešću tipa
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Croatian: Srednja plazmatska AUC vrijednost i Cmax u stanju dinamičke ravnoteže iznosile su 1870 nmol.h i 259 nmol/l s empagliflozinom od 10 mg te 4740 nmol.h i 687 nmol/l s empagliflozinom 25 mg primijenjenim jedanput dnevno.
English: Effects of other medicinal products on empagliflozin In vitro data suggest that the primary route of metabolism of empagliflozin in humans is glucuronidation by uridine 5'-diphosphoglucuronosyltransferases UGT1A3, UGT1A8, UGT1A9, and UGT2B7.
Croatian: Podaci in vitro sugeriraju da je primarni put metabolizma empagliflozina u ljudi glukuronidacija pomoću uridin 5'-difosfoglukuronoziltransferaza UGT1A3, UGT1A8, UGT1A9 i UGT2B7.
English: Treatment with empagliflozin as monotherapy and in combination with metformin, pioglitazone, a sulphonylurea, DPP-4 inhibitors, and insulin lead to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, and systolic and diastolic blood pressure.
Croatian: Liječenje empagliflozinom u obliku monoterapije i u kombinaciji s metforminom, pioglitazonom, sulfonilurejom, inhibitorima enzima DPP-4 i inzulinom dovelo je do klinički značajnog sniženja vrijednosti HbA1c i glukoze u plazmi natašte (FPG), smanjenja tjelesne težine, te sistoličkog i dijastoličkog krvnog tlaka.
English: The pack sizes are 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1, and 100 x 1 film-coated tablets.
Croatian: Veličine pakiranja su 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1 i 100 x 1 filmom obložene tablete.
English: Inhibition of SGLT2 in patients with type 2 diabetes and hyperglycaemia leads to excess glucose excretion in the urine.
Croatian: SGLT2 u bolesnika sa šećernom bolešću tipa 2 i hiperglikemijom dovodi do izlučivanja viška glukoze u mokraću.
English: In a pre-specified pooled analysis of 4 placebo controlled studies, treatment with empagliflozin resulted in body weight reduction (-0.24 kg for placebo, -2.04 kg for empagliflozin 10 mg and -2.26 kg for empagliflozin 25 mg) at week 24 that was maintained up to week 52 (-0.16 kg for placebo, -1.96 kg for empagliflozin 10 mg and -2.25 kg for empagliflozin 25 mg).
Croatian: U prethodno specificiranim združenim analizama 4 placebom kontroliranih studija, liječenje empagliflozinom rezultiralo je smanjenjem tjelesne težine (-0,24 kg za placebo, -2,04 kg za empagliflozin 10 mg i -2,26 kg za empagliflozin 25 mg) u 24. tjednu koje se održalo do 52. tjedna (-0,16 kg za placebo, -1,96 kg za empagliflozin 10 mg i -2,25 kg za empagliflozin 25 mg).
English: With once-daily dosing, steady-state plasma concentrations of empagliflozin were reached by the fifth dose.
Croatian: Doziranjem jedanput na dan plazmatske koncentracije empagliflozina u stanju dinamičke ravnoteže postignute su petom dozom.
English: Increased urination (including the predefined terms pollakiuria, polyuria, and nocturia) was observed at higher frequencies in patients treated with empagliflozin (empagliflozin 10 mg: 3.4%, empagliflozin 25 mg: 3.2%) compared to placebo (1.0%).
Croatian: Pojačano mokrenje (uključujući prethodno definirane pojmove polakizuriju, poliuriju i nokturiju) bile su opažene češće u bolesnika liječenih empagliflozinom (empagliflozin 10 mg: 3,4%, empagliflozin 25 mg: 3,2%) u usporedbi s placebom (1,0%).
English: Increased urination was mostly mild or moderate in intensity.
Croatian: Pojačano mokrenje je uglavnom bilo blago do umjereno po intenzitetu.
English: The efficacy and safety of empagliflozin as add on to basal insulin with or without metformin and/or a sulphonylurea was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration.
Croatian: Djelotvornost i sigurnost empagliflozina kao dodatka bazalnom inzulinu sa ili bez metformina i/ili sulfonilureje ocijenjena je u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od
English: In a 2 year carcinogenicity study, empagliflozin did not increase the incidence of tumours in female rats up to the highest dose of 700 mg/kg/day, which corresponds to approximately 72-times the maximal clinical AUC exposure to empagliflozin.
Croatian: U 2-godišnjem ispitivanju kancerogenosti, empagliflozin nije povećao incidenciju tumora u ženki štakora do najviše doze od 700 mg/kg/dan, što približno odgovara 72-strukom iznosu maksimalne kliničke AUC izloženosti empagliflozinu.
English: Each tablet contains 10 mg or 25 mg empagliflozin.
Croatian: - Svaka tableta sadrži 10 mg ili 25 mg empagliflozina.
English: Empagliflozin 24 months data, as add on to metformin in comparison to glimepiride In a study comparing the efficacy and safety of empagliflozin 25 mg versus glimepiride (up to 4 mg per day) in patients with inadequate glycaemic control on metformin alone, treatment with empagliflozin daily resulted in superior reduction in HbA1c (Table 4), and a clinically meaningful reduction in FPG, compared to glimepiride.
Croatian: U ispitivanju u kojem su se usporedili djelotvornost i sigurnost empagliflozina od 25 mg naspram glimepirida (do 4 mg na dan) u bolesnika s nezadovoljavajućom regulacijom glikemije na monoterapiji metforminom svakodnevno liječenje empagliflozinom rezultiralo je superiornim sniženjem vrijednosti HbA1c (Tablica 4) te klinički značajnim sniženjem vrijednosti FPG u usporedbi s glimepiridom.
English: It is important to stay on the diet and exercise program recommended by your doctor while taking Jardiance.
Croatian: Važno je da nastavite s dijetom i tjelovježbom prema preporukama koje ste dobili od Vašeg liječnika,
English: The removal of empagliflozin by haemodialysis has not been studied.
Croatian: Eliminacija empagliflozina hemodijalizom nije ispitivana.
English: Hypoglycaemia The frequency of hypoglycaemia depended on the background therapy in the respective studies.
Croatian: Učestalost hipoglikemije ovisila je o osnovnoj terapiji u odgovarajućim ispitivanjima.
English: This effect was observed after
Croatian: Last observation carried forward.
English: - The other ingredients are: tablet core: lactose monohydrate (see end of section 2 under ‘Jardiance contains lactose'), cellulose microcrystalline, hydroxypropylcellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate film-coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
Croatian: bezvodni koloidni silicijev dioksid, magnezijev stearat - film ovojnica: hipromeloza, titanijev dioksid (E171), talk, makrogol (400), žuti željezov oksid (E172)
English: Each tablet contains 10 mg empagliflozin.
Croatian: Svaka tableta sadrži 10 mg empagliflozina.
English: Uncommon • straining or pain when emptying the bladder
Croatian: • naprezanje ili bol kod pražnjenja mjehura Prijavljivanje nuspojava
English: In the double-blind placebo-controlled extension of these studies, reduction of HbA1c, body weight and blood pressure were sustained up to Week 52.
Croatian: U dvostruko slijepom i placebom kontroliranom produžetku ovih ispitivanja, sniženje vrijednosti HbA1c, tjelesne težine i krvnog tlaka bilo je održano do 52. tjedna.
English: Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Croatian: Jezgra tablete laktoza hidrat celuloza mikrokristalična hidroksipropilceluloza karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: At Week 18, empagliflozin provided statistically significant improvement in HbA1c compared with placebo (Table 5).
Croatian: U 18. tjednu empagliflozin je pružio statistički značajno poboljšanje vrijednosti HbA1c u usporedbi s placebom (Tablica 5).
English: An increased frequency was noted when given as add-on to insulin with or without metformin and with or without a sulfonylurea (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo: 0% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo 0% over the 78-week trial).
Croatian: Povećana učestalost je zabilježena kada je lijek primjenjivan kao dodatak uz inzulin sa ili bez metformina te sa ili bez sulfonilureje (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1,3%, placebo: 0% tijekom početnih 18 tjedana liječenja kada se inzulin nije mogao prilagođavati; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1,3%, placebo 0% tijekom 78-tjednog ispitivanja).
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Croatian: Dob nije imala klinički značajan učinak na farmakokinetiku empagliflozina na osnovi farmakokinetičke analize populacije.
English: 2 Week 19-40: treat-to-target regimen for insulin dose adjustment to achieve pre-defined glucose target levels (pre-prandial <100 mg/dl (5.5 mmol/l), post-prandial <140 mg/dl (7.8 mmol/l) * p-value <0.0001 ** p-value = 0.0003 *** p-value = 0.0005 # p-value = 0.0040
Croatian: 1 Srednja vrijednost prilagođena za početnu vrijednost 2 19.-40. tjedan: režim liječenja usmjerenog ka cilju (engl. treat-to-target) za prilagođavanje doze inzulina kako bi se postigle prethodno definirane ciljne razine glukoze u krvi ( <100 mg/dl (5,5 mmol/l) preprandijalno, <140 mg/dl (7,8 mmol/l) postprandijalno) * p-vrijednost<0,0001 ** p-vrijednost = 0,0003 *** p-vrijednost = 0,0005 # p-vrijednost = 0,0040
English: 2 Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 3 LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored 4 Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products
Croatian: 2 Srednja vrijednost prilagođena za početnu vrijednost HbA1c, početnu vrijednost eGFR, zemljopisno područje i broj antihipertenzivnih lijekova 3 LOCF, cenzurirane vrijednosti nakon uzimanja pomoćne antidijabetičke terapije (engl. antidiabetic rescue therapy) ili promjene pomoćne antihipertenzivne terapije (engl. antihypertensive rescue therapy)
English: The overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo and higher in patients treated with empagliflozin 10 mg (see section 4.8).
Croatian: Sveukupna učestalost infekcija mokraćnog sustava prijavljenih kao štetni događaj bila je slična u bolesnika koji su liječeni empagliflozinom od 25 mg i placebom, te viša u bolesnika liječenih empagliflozinom od 10 mg (vidjeti dio 4.8).
English: (95% CI) 24 hour DBP at week 123
Croatian: CI) 24-satni DKT u 12. tjednu3
English: Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Croatian: Spol nije imao klinički značajan učinak na farmakokinetiku empagliflozina na osnovi farmakokinetičke analize populacije.
English: In subjects with mild, moderate, and severe hepatic impairment according to the Child-Pugh classification, AUC of empagliflozin increased approximately by 23%, 47%, and 75% and Cmax by approximately 4%, 23%, and 48%, respectively, compared to subjects with normal hepatic function.
Croatian: U ispitanika s blagim, umjerenim i teškim oštećenjem jetre, prema klasifikaciji Child-Pugh, AUC empagliflozina se povećao za približno 23%, 47% odnosno 75%, a Cmax za približno 4%, 23%
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Croatian: Bolesnici koji mogu biti pod većim rizikom od DKA uključuju bolesnike s niskom rezervom funkcije beta-stanica (npr. bolesnici sa šećernom bolešću tipa 2 koji imaju nisku razinu C-peptida ili bolesnici s latentnom autoimunom šećernom bolešću u odraslih (engl. latent autoimmune diabetes in adults,
English: Urinary tract infection, seen commonly (may affect up to 1 in 10 people) The signs of urinary tract infection are:
Croatian: Infekcija mokraćnog sustava, često (može se javiti u do 1 na 10 osoba)
English: Table 2: Efficacy results of a 24 week placebo-controlled study of empagliflozin as monotherapya
Croatian: Tablica 2: Rezultati djelotvornosti placebom kontroliranog ispitivanja empagliflozina kao monoterapije u trajanju 24 tjednaa
English: Inhibition of OATP1B1/1B3 transporters by co-administration with rifampicin resulted in a 75% increase in Cmax and a 35% increase in AUC of empagliflozin.
Croatian: Inhibicija prijenosnika OATP1B1/1B3 putem istodobne primjene s rifampicinom rezultirala je 75%
English: (95% CI) a Full analysis set (FAS)
Croatian: (95% CI) aPotpuni skup za analizu (Full analysis set, FAS) s prenošenjem posljednjih opažanja dalje (engl.
English: The overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo (7.6%) and higher in empagliflozin 10 mg (9.3%).
Croatian: Sveukupna učestalost infekcija mokraćnog sustava prijavljenih kao štetni događaj bila je slična u bolesnika koji su liječeni empagliflozinom od 25 mg i placebom (7,6%) te veća u bolesnika liječenih empagliflozinom od 10 mg (9,3%).
English: Minor hypoglycaemia
Croatian: Blaga hipoglikemija
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim International GmbH
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Boehringer Ingelheim International GmbH
English: In the double-blind placebo-controlled extension of this study, reductions of HbA1c, body weight and blood pressure were sustained up to Week 52.
Croatian: U dvostruko slijepom i placebom kontroliranom produžetku ovog ispitivanja, snižene vrijednosti HbA1c, tjelesne težine i krvnog tlaka bila su održane do 52. tjedna.
English: What Jardiance is and what it is used for 2.
Croatian: Što se nalazi u ovoj uputi: 1. Što je Jardiance i za što se koristi
English: Empagliflozin should not be used in patients with end stage renal disease (ESRD) or in patients on dialysis as it is not expected to be effective in these patients (see sections 4.4 and 5.2).
Croatian: Empagliflozin se ne smije koristiti u bolesnika u završnom stadiju bolesti bubrega ili u bolesnika na dijalizi, budući da se ne očekuje da empagliflozin bude učinkovit u tih bolesnika (vidjeti dijelove 4.4 i
English: At 78 weeks, empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared to placebo.
Croatian: U 78. tjednu empagliflozin je postigao statistički značajno sniženje vrijednosti HbA1c i uštedu inzulina u usporedbi s placebom.
English: The efficacy and safety of empagliflozin as monotherapy was evaluated in a double-blind, placebo- and active-controlled study of 24 weeks duration in treatment-naïve patients.
Croatian: Djelotvornost i sigurnost monoterapije empagliflozinom ocijenjena je u dvostruko slijepom, placebom i aktivno kontroliranom ispitivanju u trajanju od 24 tjedna u prethodno neliječenih bolesnika.
English: The frequency of patients with minor hypoglycaemia was similar for empagliflozin and placebo as monotherapy, add-on to metformin, and add-on to pioglitazone with or without metformin.
Croatian: Učestalost blage hipoglikemije kod bolesnika bila je slična u skupinama koje su primale empagliflozin i placebo u obliku monoterapije, te kao dodatak metforminu odnosno pioglitazonu sa ili bez metformina.
English: Dehydration, seen uncommonly (may affect up to 1 in 100 people) The signs of dehydration are not specific, but may include:
Croatian: Znakovi dehidracije nisu specifični, ali mogu uključivati:
English: Interaction studies conducted in healthy volunteers suggest that the pharmacokinetics of empagliflozin were not influenced by co-administration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Croatian: Ispitivanja interakcija provedenih u zdravih dobrovoljaca sugeriraju da istodobna primjena s metforminom, glimepiridom, pioglitazonom, sitagliptinom, linagliptinom, varfarinom, verapamilom, ramiprilom, simvastatinom, torasemidom i hidroklorotiazidom nije utjecala na farmakokinetiku empagliflozina.
English: No dose adjustment is required for patients with an eGFR ≥60 ml/min/1.73 m2 or CrCl ≥60 ml/min.
Croatian: Nije potrebno prilagođavanje doze u bolesnika s eGFR ≥60 ml/min/1,73 m2 ili klirensom kreatinina ≥60 ml/min.
English: Jardiance 25 mg film-coated tablets are oval, pale yellow and biconvex.
Croatian: Jardiance 25 mg filmom obložene tablete su ovalne, blijedožute i bikonveksne.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Boehringer Ingelheim
English: Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min.
Croatian: Terapija empagliflozinom mora se prekinuti kada je eGFR perzistentno ispod 45 ml/min/1,73 m2 ili klirens kreatinina perzistentno ispod 45 ml/min.
English: Empagliflozin did not increase the incidence of tumours in female mice at doses up to 1000 mg/kg/day, which corresponds to approximately 62-times the maximal clinical exposure to empagliflozin.
Croatian: Empagliflozin nije povećao incidenciju tumora u ženki miša u dozama do 1000 mg/kg/dan, što približno odgovara 62-strukom iznosu maksimalne kliničke izloženosti empagliflozinu.
English: The most frequently reported adverse reaction was hypoglycaemia when used with sulphonylurea or insulin (see description of selected adverse reactions).
Croatian: Kada se empagliflozin primjenjivao sa sulfonilurejom ili inzulinom, najčešće prijavljena nuspojava je bila hipoglikemija (vidjeti opis odabranih nuspojava).
English: Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment-β (HOMA-β) was noted.
Croatian: Homeostasis Model Assessment-β).
English: • burning sensation when passing urine
Croatian: • osjećaj pečenja pri mokrenju