FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate diet and exercise help your body use its blood sugar better.
Croatian: Odgovarajuća dijeta i tjelovježba pomažu Vašem tijelu da ono što bolje iskoristi šećer u krvi.
English: • if you have serious kidney or liver problems - your doctor may ask you to take a different medicine.
Croatian: • ako imate ozbiljnu bolest bubrega ili jetre - Vaš liječnik može zatražiti da uzimate drugi lijek.
English: • if you are taking medicines that increase urine production (diuretics).
Croatian: • ako uzimate lijekove koji povećavaju stvaranje mokraće (diuretici).
English: Severe allergic reaction, seen with unknown frequency (frequency cannot be estimated from the available data )
Croatian: Teška alergijska reakcija, zabilježena s nepoznatom učestalošću (učestalost se ne može procijeniti iz dostupnih podataka)
English: Thereby Jardiance lowers the amount of sugar in your blood.
Croatian: Jardiance snizuje količinu šećera u krvi.
English: Necrotising fasciitis of the perineum (Fournier´s gangrene)*
Croatian: Nekrotizirajući fasciitis perineuma (Fournierova gangrena)
English: • blood tests may show a decrease in kidney function (creatinine or urea)
Croatian: • krvne pretrage mogu pokazati smanjenje povezano s funkcijom bubrega (kreatinin ili urea)
English: • swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)
Croatian: • oticanje lica, usana, usta, jezika ili grla što može dovesti do otežanog disanja ili gutanja
English: Co-treatment with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Croatian: Potrebno je izbjegavati istodobno liječenje poznatim induktorima enzima UGT zbog potencijalnog rizika smanjene djelotvornosti.
English: - Prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
Croatian: • Prije započinjanja istodobne terapije bilo kojim lijekom koji može imati negativan učinak na funkciju bubrega.
English: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2, ‘Warnings and precautions'):
Croatian: Dijabetička ketoacidoza, rijetko zabilježena (može se javiti u do 1 na 1000 osoba) Ovo su znakovi dijabetičke ketoacidoze (također vidjeti dio 2, „Upozorenja i mjere opreza“):
English: • might be at risk of dehydration, for example: o if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink o if you are taking medicines that increase urine production [diuretics] or lower blood pressure o if you are over 75 years old.
Croatian: • imate rizik od dehidracije, na primjer: o ako povraćate, imate proljev ili vrućicu ili ako ne možete jesti ili piti o ako uzimate lijekove koji povećavaju stvaranje mokraće [diuretici] ili snizuju krvni tlak o ako imate više od 75 godina.
English: Other side effects while taking Jardiance:
Croatian: Druge nuspojave tijekom uzimanja lijeka Jardiance:
English: Like for all diabetic patients it is important to counsel patients on routine preventative foot-care.
Croatian: Kao i kod svih bolesnika s dijabetesom važno je savjetovati bolesnike o rutinskoj, preventivnoj njezi stopala.
English: Jardiance works by blocking the SGLT2 protein in your kidneys.
Croatian: Jardiance djeluje blokiranjem proteina SGLT2 u bubrezima.
English: Difference from placebo
Croatian: Razlika od placeba
English: If Fournier´s gangrene is suspected, Jardiance should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Croatian: Ako se sumnja na Fournierovu gangrenu, potrebno je prekinuti uzimanje lijeka Jardiance te hitno započeti s liječenjem (uključujući antibiotike i kirurški debridman).
English: Jardiance tablets are available in PVC/aluminium perforated unit dose blisters.
Croatian: Tablete Jardiance su dostupne u PVC/aluminij perforiranim blisterima s jediničnim dozama.
English: • blood tests may show an increase in blood fat (cholesterol) levels in your blood
Croatian: • krvne pretrage mogu pokazati povećanje u razinama masnoća (kolesterol) u Vašoj krvi
English: Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) If you take Jardiance with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher.
Croatian: Niska razina šećera u krvi (hipoglikemija), vrlo često (može se javiti kod više od 1 na 10 osoba) Ako uzimate Jardiance s drugim lijekom koji može izazvati nisku razinu šećera u krvi, poput sulfonilureje ili inzulina, rizik od nastanka niske razine šećera u krvi je viši.
English: Insulin and insulin secretagogues, such as sulphonylureas, may increase the risk of hypoglycaemia.
Croatian: Inzulin i inzulinski sekretagogi, poput sulfonilureja, mogu povećati rizik od hipoglikemije.
English: PVC/aluminium perforated unit dose blisters.
Croatian: PVC/aluminij perforirani blisteri s jediničnim dozama.
English: • rash or red skin - this may be itchy and include raised bumps, oozing fluid or blisters
Croatian: • osip ili crvenilo kože - koji može svrbjeti i uključivati uzdignuta područja na koži, vlaženje ili mjehuriće
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excl. insulins, ATC code: A10BK03
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti, drugi lijekovi za snižavanje glukoze u krvi, isključujući inzuline, ATK oznaka: A10BK03
English: These symptoms could be a sign of “diabetic ketoacidosis” - a rare, but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Croatian: Ovi simptomi mogu biti znak „dijabetičke ketoacidoze“rijetkog, ali ozbiljnog i ponekad po život opasnog problema koji se može javiti uz šećernu bolest zbog povišenih razina „ketonskih tijela“ u mokraći ili krvi, što je vidljivo u nalazima pretraga.
English: Insulin and insulin secretagogues
Croatian: Inzulin i inzulinski sekretagogi
English: How Jardiance works
Croatian: Kako Jardiance djeluje
English: - The other ingredients are: tablet core: lactose monohydrate (see end of section 2 under ‘Jardiance contains lactose'), microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium (see end of section 2 under ‘Jardiance contains sodium'), colloidal anhydrous silica, magnesium stearate film-coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
Croatian: • Drugi sastojci su: - jezgra tablete: laktoza hidrat (vidjeti kraj dijela 2 pod ‘Jardiance sadrži laktozu'), mikrokristalična celuloza, hidroksipropilceluloza, umrežena karmelozanatrij (vidjeti kraj dijela 2 pod ‘Jardiance sadrži natrij'), bezvodni koloidni silicijev dioksid, magnezijev stearat - film ovojnica: hipromeloza, titanijev dioksid (E171), talk, makrogol (400), žuti željezov oksid (E172)
English: This causes blood sugar (glucose) to be removed in your urine.
Croatian: To dovodi do uklanjanja šećera (glukoze) iz krvi putem mokraće.
English: Each tablet contains lactose monohydrate equivalent to 154.3 mg lactose anhydrous.
Croatian: Jedna tableta sadrži laktozu hidrat što odgovara 154,3 mg bezvodne laktoze.
English: Therefore assessment of renal function is recommended as follows: - Prior to empagliflozin initiation and periodically during treatment, i.e. at least yearly (see sections 4.2, 5.1 and 5.2).
Croatian: • Prije započinjanja terapije empagliflozinom i periodično tijekom liječenja, tj. barem jedanput godišnje (vidjeti dijelove 4.2, 5.1 i 5.2)
English: Adverse reactions classified by system organ class and MedDRA preferred terms reported in patients who received empagliflozin in placebo-controlled studies are presented in the table below (Table 1).
Croatian: Nuspojave, klasificirane prema klasifikaciji organskih sustava i MedDRA preporučenim pojmovima, prijavljene u bolesnika koji su primali empagliflozin u placebom kontroliranim ispitivanjima prikazane su u donjoj tablici (Tablica 1).
English: Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with active substances that are P-gp substrates.
Croatian: Na temelju in vitro ispitivanja ne smatra se da empagliflozin izaziva interakcije s djelatnim tvarima koji su P-gp supstrati.
English: Each tablet contains 10 mg or 25 mg empagliflozin.
Croatian: - Jedna tableta sadrži 10 mg ili 25 mg empagliflozina.
English: In the EMPA-REG Outcome study, haematocrit values returned towards baseline values after a follow-up period of 30 days after treatment stop.
Croatian: U ispitivanju EMPA-REG Outcome vrijednosti hematokrita vratile su se prema početnim vrijednostima nakon razdoblja praćenja od 30 dana nakon prekida liječenja. vidjeti dio 4.4
English: Jardiance is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors.
Croatian: Jardiance pripada skupini lijekova koji se nazivaju suprijenosnici natrija i glukoze 2 (engl. sodiumglucose co-transporter 2, SGLT2).
English: Each tablet contains lactose monohydrate equivalent to 107.4 mg lactose anhydrous.
Croatian: Jedna tableta sadrži laktozu hidrat što odgovara 107,4 mg bezvodne laktoze.
English: Co administration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6% increase in AUC and14% increase in Cmax of digoxin.
Croatian: Istodobna primjena digoksina, supstrata P-gp-a, s empagliflozinom rezultirala je 6%-tnim povećanjem vrijednosti AUC i 14%-tnim povećanjem vrijednosti Cmax za digoksin.
English: EU/1/14/930/010 7 tablets EU/1/14/930/011 10 tablets EU/1/14/930/012 14 tablets EU/1/14/930/013 28 tablets EU/1/14/930/014 30 tablets EU/1/14/930/015 60 tablets EU/1/14/930/016 70 tablets EU/1/14/930/017 90 tablets EU/1/14/930/018 100 tablets
Croatian: EU/1/14/930/010 7 tableta EU/1/14/930/011 10 tableta EU/1/14/930/012 14 tableta EU/1/14/930/013 28 tableta EU/1/14/930/014 30 tableta EU/1/14/930/015 60 tableta EU/1/14/930/016 70 tableta EU/1/14/930/017 90 tableta EU/1/14/930/018 100 tableta
English: Table 1: Tabulated list of adverse reactions (MedDRA) from reported placebo-controlled studies and from post-marketing experience System organ class
Croatian: Tablica 1: Tablični popis nuspojava (MedDRA) prijavljenih u placebom kontroliranim ispitivanjima i iz razdoblja nakon stavljanja lijeka u promet
English: What Jardiance is Jardiance contains the active substance empagliflozin.
Croatian: Što je Jardiance Jardiance sadrži djelatnu tvar empagliflozin.
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: Table 11:Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressure
Croatian: Tablica 11: Rezultati djelotvornosti u 12. tjednu u placebom kontroliranom ispitivanju empagliflozina u bolesnika sa šećernom bolešću tipa 2 i nereguliranim krvnim tlakom
English: Jardiance 10 mg film-coated tablets EU/1/14/930/010
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Jardiance 10 mg filmom obložene tablete EU/1/14/930/010
English: The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.6%, empagliflozin 25 mg: 0.4%) and placebo (0.3%).
Croatian: Sveukupna učestalost deplecije volumena (uključujući prethodno definirane pojmove sniženi krvni tlak (izmjeren ambulantno), sniženi sistolički krvni tlak, dehidraciju, hipotenziju, hipovolemiju, ortostatsku hipotenziju i sinkopu) bila je slična u bolesnika liječenih empagliflozinom (empagliflozin 10 mg: 0,6%, empagliflozin 25 mg: 0,4%) i placebom (0,3%).
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: Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased a see subsections below for additional information Mean percent increases from baseline for empagliflozin 10 mg and 25 mg versus placebo, respectively, were total cholesterol 4.9% and 5.7% versus 3.5%; HDL-cholesterol 3.3% and 3.6% versus 0.4 %; LDL-cholesterol 9.5% and 10.0% versus 7.5%; triglycerides 9.2% and 9.9% versus 10.5%.
Croatian: Srednje vrijednosti postotnih povećanja od početne vrijednosti za empagliflozin 10 mg odnosno 25 mg naspram placeba bila su: ukupni kolesterol 4,9% i 5,7% naspram 3,5%; HDL-kolesterol 3,3% i 3,6% naspram 0,4%; LDL-kolesterol 9,5% i 10,0% naspram 7,5%; trigliceridi 9,2% i 9,9% naspram 10,5%.
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: What Jardiance is used for
Croatian: Za što se Jardiance koristi
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h/l and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h/l 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/l i 259 nmol/l s empagliflozinom od 10 mg te 4740 nmol.h/l i 687 nmol/l s empagliflozinom 25 mg primijenjenim jedanput dnevno.
English: Each tablet contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free'.
Croatian: Jedna tableta sadrži manje od 1 mmol (23 mg) natrija, tj. zanemarive količine natrija.
English: Body Weight (kg) at week 52 Baseline (mean) Change from baseline Difference from placebo (97.5% CI) Mean adjusted for baseline value 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: Promjena od početne vrijednosti Razlika od placeba (97,5% CI) Srednja vrijednost prilagođena za početnu vrijednost 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: Jardiance contains sodium
Croatian: Jardiance sadrži natrij
English: Jardiance 25 mg film-coated tablets Each tablet contains 25 mg empagliflozin.
Croatian: Jardiance 25 mg filmom obložene tablete Jedna tableta sadrži 25 mg empagliflozina.
English: In a pre-specified pooled analysis of three phase 3 studies, treatment with open-label empagliflozin 25 mg in patients with severe hyperglycaemia (N=184, mean baseline HbA1c 11.15%) resulted in a clinically meaningful reduction in HbA1c from baseline of 3.27% at week 24; no placebo or empagliflozin 10 mg arms were included in these studies.
Croatian: Bolesnici s visokom početnom vrijednošću HbA1c >10% U prethodno specificiranoj združenoj analizi triju otvorenih ispitivanja faze 3, liječenje empagliflozinom od 25 mg u bolesnika s teškom hiperglikemijom (N=184, srednja početna vrijednost HbA1c 11,15%) rezultiralo je klinički značajnim smanjenjem HbA1c od početne vrijednosti za 3,27% u 24. tjednu; skupine koje su primale placebo ili empagliflozin od 10 mg nisu bile uključene u ova ispitivanja.
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Up to 4 mg glimepiride Mean adjusted for baseline value LOCF, values after antihypertensive rescue censored * p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Croatian: Last observation carried forward, LOCF) prije primjene pomoćne terapije za postizanje zadovoljavajuće glikemije (engl. glycaemic rescue) Do 4 mg glimepirida Srednja vrijednost prilagođena za početnu vrijednost LOCF, cenzurirane vrijednosti nakon dodavanja terapije za postizanje zadovoljavajućeg krvnog tlaka (engl. antihypertensive rescue) * p-vrijednost<0,0001 za neinferiornost i p-vrijednost = 0,0153 za superiornost ** p-vrijednost <0,0001
English: An increase in cases of lower limb amputation (primarily of the toe) has been observed in long-term clinical studies with another SGLT2 inhibitor.
Croatian: U dugoročnim kliničkim ispitivanjima s drugim SGLT2 inhibitorom, opaženo je povećanje broja slučajeva amputacije donjih ekstremiteta (prvenstveno nožnog prsta).
English: Post-marketing cases of complicated urinary tract infections including pyelonephritis and urosepsis have been reported in patients treated with empagliflozin.
Croatian: Nakon stavljanja lijeka u promet, u bolesnika liječenih empagliflozinom zabilježeni su slučajevi kompliciranih infekcija mokraćnog sustava uključujući pijelonefritis i urosepsu.
English: Time to first event of CV death, non-fatal MI, or non-fatal stroke N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority CV Death N (%) Hazard ratio vs. placebo (95% CI) p-value Non-fatal MI N (%) Hazard ratio vs. placebo (95% CI) p−value Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI) CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Croatian: Omjer hazarda naspram placeba (95% CI) p−vrijednost Moždani udar bez smrtnog ishoda N (%) Omjer hazarda naspram placeba (95% CI) p−vrijednost Mortalitet svih uzroka N (%) Omjer hazarda naspram placeba (95% CI) p-vrijednost Nekardiovaskularni mortalitet N (%) Omjer hazarda naspram placeba (95% CI) Liječena skupina, tj. bolesnici koji su primili najmanje jednu dozu ispitivanog lijeka.
English: 1 (97.5% CI) Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% Body Weight (kg) Baseline (mean) Change from baseline Difference from glimepiride
Croatian: 1 (97,5% CI) Bolesnici (%) s postignutim HbA1c <7% s početnom vrijednošću HbA1c ≥7% Tjelesna težina (kg) Početna vrijednost (srednja vrijednost)
English: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), add-on to basal insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 28.4%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg and 25 mg: 36.1%, placebo 35.3% over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 39.8%, empagliflozin 25 mg: 41.3%, placebo: 37.2% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 51.1%, empagliflozin 25 mg: 57.7%, placebo: 58% over the 52-week trial).
Croatian: Povećana učestalost je zabilježena kada je lijek primjenjivan kao dodatak uz metformin i sulfonilureju (empagliflozin 10 mg: 16,1%, empagliflozin 25 mg: 11,5%, placebo: 8,4%), kao dodatak uz bazalni inzulin sa ili bez metformina te sa ili bez sulfonilureje (empagliflozin 10 mg: 19,5%, empagliflozin 25 mg: 28,4%, placebo: 20,6% tijekom početnih 18 tjedana liječenja kada se doza inzulina nije mogla prilagođavati; empagliflozin 10 mg i 25 mg: 36,1%, placebo 35,3% tijekom 78-tjednog ispitivanja) te kao dodatak uz višekratnu dnevnu primjenu inzulina sa ili bez metformina (empagliflozin 10 mg: 39,8%, empagliflozin 25 mg: 41,3% placebo: 37,2% tijekom početnih 18 tjedana liječenja kada se inzulin nije mogao prilagoditi; empagliflozin 10 mg: 51,1%, empagliflozin 25 mg: 57,7%, placebo: 58% tijekom 52-tjednog ispitivanja).
English: An increased frequency was noted when given as add-on to basal 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), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.5%, placebo: 0.5% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 1.6%, empagliflozin 25 mg: 0.5%, placebo: 1.6% over the 52-week trial).
Croatian: Povećana učestalost je zabilježena kada je lijek primjenjivan kao dodatak uz bazalni 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), kao dodatak uz višekratnu dnevnu primjenu inzulina sa ili bez metformina (empagliflozin 10 mg: 0,5%, empagliflozin 25 mg: 0,5%, placebo: 0,5% tijekom početnog 18-tjednog liječenja kada se inzulin nije mogao prilagoditi; empagliflozin 10 mg: 1,6%, empagliflozin 25 mg: 0,5%, placebo: 1,6% tijekom 52-tjednog ispitivanja).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of empagliflozin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 10 mg empagliflozina.
English: Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets empagliflozin
Croatian: Jardiance 10 mg filmom obložene tablete Jardiance 25 mg filmom obložene tablete empagliflozin
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg tablets empagliflozin
Croatian: NAZIV LIJEKA Jardiance 10 mg tablete empagliflozin
English: NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg tablets empagliflozin
Croatian: NAZIV LIJEKA Jardiance 25 mg tablete empagliflozin
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Mean adjusted for baseline value Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure * p<0.0001
Croatian: Last observation carried forward, LOCF) prije primjene pomoćne terapije za postizanje zadovoljavajuće glikemije (engl. glycaemic rescue) Srednja vrijednost prilagođena za početnu vrijednost Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde * p<0,0001
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg of empagliflozin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 25 mg empagliflozina.
English: Temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections.
Croatian: U bolesnika s kompliciranim infekcijama mokraćnog sustava potrebno je razmotriti privremeni prekid terapije empagliflozinom.