FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: V 2-letni študiji karcinogenosti empagliflozin ni povečal incidence tumorjev pri podganjih samicah do največjega odmerka 700 mg/kg/dan, kar ustreza približno 72-kratni največji klinični izpostavljenosti empagliflozinu na podlagi vrednosti AUC.
English: Empagliflozin improves both fasting and post-prandial plasma glucose levels.
Slovenian: Empagliflozin izboljša ravni glukoze v plazmi na tešče in po jedi.
English: FPG of -20.5 mg/dl [-1.14 mmol/l] for empagliflozin 10 mg and -23.2 mg/dl [-1.29 mmol/l] for empagliflozin 25 mg compared to placebo (7.4 mg/dl [0.41 mmol/l]).
Slovenian: za vrednost FPG -20,5 mg/dl [-1,14 mmol/l] za empagliflozin 10 mg in -23,2 mg/dl [-1,29 mmol/l] za empagliflozin 25 mg.
English: At 78 weeks, empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared to placebo.
Slovenian: V 78. tednu je empagliflozin povzročil statistično značilno zmanjšanje vrednosti HbA1c in varčevanje z insulinom glede na placebo.
English: Increased urinary glucose excretion resulted in an immediate reduction in plasma glucose levels in patients with type 2 diabetes.
Slovenian: Večje izločanje glukoze v urinu je pri bolnikih s sladkorno boleznijo tipa 2 povzročilo takojšnje zmanjšanje ravni glukoze v plazmi.
English: In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥60 ml/min/1.73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily.
Slovenian: Pri bolnikih, ki prenašajo empagliflozin 10 mg enkrat na dan, z eGFR ≥ 60 ml/min/1,73 m2 in pri katerih je potrebna boljša urejenost glikemije, lahko odmerek povečamo na 25 mg enkrat na dan.
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.
Slovenian: V študiji, v kateri so primerjali učinkovitost in varnost empagliflozina 25 mg z glimepiridom (do 4 mg na dan) pri bolnikih z neustrezno urejeno glikemijo, ki so dobivali samo metformin, je dnevno zdravljenje z empagliflozinom povzročilo večje zmanjšanje vrednosti HbA1c (preglednica 4), in klinično pomembno zmanjšanje vrednosti FPG, v primerjavi z gimepiridom.
English: • thrush or genital yeast infection
Slovenian: • ustni oprh ali glivična okužba spolovil
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).
Slovenian: V primerjavi s placebom je imelo večje število teh bolnikov, zdravljenih z empagliflozinom, neželene učinke, povezane z zmanjšanjem volumna (glejte poglavje 4.8).
English: Table 1: Adverse reactions reported in placebo-controlled studies System organ class
Slovenian: Neželeni učinki, o katerih so poročali v s placebom nadzorovanih študijah
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.
Slovenian: V dvojno slepih, s placebom nadzorovanih podaljških teh študij, so se zmanjšane vrednosti HbA1c, telesne mase in krvnega tlaka ohranile do 52. tedna.
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.
Slovenian: V dvojno slepem, s placebom nadzorovanem podaljšku te študije, so se zmanjšane vrednosti HbA1c, telesna masa in krvni tlak ohranili do 52. tedna.
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.
Slovenian: Podatki in vitro kažejo, da je glavna presnovna pot empagliflozina pri ljudeh glukuronidacija z uridinom 5‘-difosfo-glukuronoziltransferazami UGT1A3, UGT1A8, UGT1A9 in UGT2B7.
English: An urge to pass urine or more frequent urination may be due to the way Jardiance works, but as they can also be signs of urinary tract infection, if you note an increase in such symptoms, you should also contact your doctor.
Slovenian: Jardiance, vendar so lahko tudi znak okužbe sečil, zato se morate z zdravnikom posvetovati tudi, če se število teh simptomov poveča.
English: The genital tract infections were mild or moderate in intensity.
Slovenian: Okužbe spolovil so bile blage do zmerne.
English: At Week 18, empagliflozin provided statistically significant improvement in HbA1c compared with placebo (Table 5).
Slovenian: V 18. tednu je pri empagliflozinu prišlo do statistično značilnega izboljšanja vrednosti HbA1c v primerjavi s placebom (preglednica 5).
English: In this analysis, AUC was estimated to be 5.82%, 10.4%, and 17.3% lower in subjects with BMI of 30, 35, and 45 kg/m2, respectively, compared to subjects with a body mass index of 25 kg/m2.
Slovenian: 10,4 % oz. 17,3 % nižja pri osebah z BMI 30, 35 oz. 45 kg/m v primerjavi z osebami z indeksom telesne mase 25 kg/m2.
English: Available toxicological data in animals have shown excretion of empagliflozin in milk.
Slovenian: Podatkov o izločanju empagliflozina v mleko pri ljudeh ni. Razpoložljivi toksikološki podatki pri živalih kažejo na izločanje empagliflozina v mleko.
English: N HbA1c (%) at week 121
Slovenian: N Vrednost HbA1c (%) v 12. tednu1
English: Česká republika Boehringer Ingelheim spol.
Slovenian: Boehringer Ingelheim spol.
English: Titanium dioxide (E171)
Slovenian: Filmska obloga hipromeloza titanov dioksid (E171) smukec makrogol (400) rumeni železov oksid (E172)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, fertility and early embryonic development.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti, vpliva na sposobnost razmnoževanja in zgodnjega razvoja embrija ne kažejo posebnega tveganja za človeka.
English: Cases of hepatic injury have been reported with empagliflozin in clinical trials.
Slovenian: V kliničnih preskušanjih z empagliflozinom so poročali o primerih poškodb jeter.
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.
Slovenian: Empagliflozin ni povečal incidence tumorjev pri mišjih samicah pri odmerkih do 1.000 mg/kg/dan, kar ustreza približno 62-kratni največji klinični izpostavljenosti empagliflozinu.
English: These infections were reported more frequently in females treated with empagliflozin compared to placebo, and the difference in frequency was less pronounced in males.
Slovenian: zdravljenih z empagliflozinom v primerjavi s placebom, razlika v pogostnosti pa je bila manj izrazita pri moških.
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.
Slovenian: AUC 1.870 nmol.h in vrednost Cmax 259 nmol/l za empagliflozin 10 mg ter AUC 4.740 nmol.h in vrednost Cmax 687 nmol/l za empagliflozin 25 mg. Sistemska izpostavljenost empagliflozinu se je večala sorazmerno z odmerkom.
English: Body Weight (kg)2
Slovenian: N Telesna masa (kg)2
English: <60 ml/min/1.73 m²
Slovenian: Vrednost eGFR ≥ 60 do < 90 ml/min/1,73 m²
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim
English: Empagliflozin induced renal tumours in male mice at 1000 mg/kg/day, but not at 300 mg/kg/day, which corresponds to approximately 11-times the maximal clinical exposure to empagliflozin.
Slovenian: Empagliflozin je pri mišjih samcih pri 1.000 mg/kg/dan povzročil ledvične tumorje, ne pa tudi pri 300 mg/kg/dan, kar ustreza približno 11-kratni največji klinični izpostavljenosti empagliflozinu.
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
Slovenian: 4 Povprečje, prilagojeno za vrednost sistoličnega krvnega tlaka ob izhodišču, vrednost HbA1c ob izhodišču, vrednost eGFR ob izhodišču, geografsko regijo in število antihipertenzivnih zdravil 5 Povprečje, prilagojeno za vrednost diastoličnega krvnega tlaka ob izhodišču, vrednost HbA1c ob izhodišču, vrednost eGFR ob izhodišču, geografsko regijo in število antihipertenzivnih zdravil
English: How to store Jardiance
Slovenian: Shranjevanje zdravila Jardiance
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.
Slovenian: Empagliflozin kot dodatno zdravljenje k bazalnemu insulinu Učinkovitost in varnost empagliflozina kot dodatnega zdravljenja k bazalnemu insulinu z metforminom ali brez njega in/ali sulfonilsečnino so ocenili v dvojno slepem, s placebom nadzorovanem 78-tedenskem preskušanju.
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).
Slovenian: Okužbe sečil Celokupna pogostnost okužb sečil, o kateri so poročali kot o neželenem učinku, je bila podobna pri bolnikih, zdravljenih z empagliflozinom 25 mg in placebom in višja pri bolnikih, zdravljenih z empagliflozinom 10 mg (glejte poglavje 4.8).
English: Each tablet contains 10 mg empagliflozin.
Slovenian: Ena tableta vsebuje 10 mg empagliflozina.
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).
Slovenian: Večjo pogostnost so opazili pri uporabi kot dodatno zdravljenje z insulinom z metforminom ali brez njega ali s sulfonilsečnino ali brez nje (empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1,3 %, placebo: 0 % v prvih 18 tednih zdravljenja, ko insulina ni bilo mogoče prilagoditi;
English: Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Slovenian: Študije medsebojnega delovanja pri zdravih prostovoljcih kažejo, da empagliflozin nima klinično pomembnega učinka na farmakokinetiko metformina, glimepirida, pioglitazona, sitagliptina,
English: Hepatic injury
Slovenian: Poškodba jeter
English: No such effect was seen at systemic exposure equal to the maximal clinical exposure to empagliflozin.
Slovenian: Po sistemski izpostavljenosti, enaki največji klinični izpostavljenosti empagliflozinu, teh učinkov niso opazili.
English: Each tablet contains 25 mg empagliflozin.
Slovenian: Ena tableta vsebuje 25 mg empagliflozina.
English: PVC/aluminium perforated unit dose blisters.
Slovenian: Perforirani PVC/aluminij pretisni omot za enkratni odmerek.
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Slovenian: Indeks telesne mase ni imel klinično pomembnega učinka na farmakokinetiko empagliflozina na podlagi populacijske farmakokinetične analize.
English: Table 4: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformina
Slovenian: Preglednica 4: Rezultati učinkovitosti v 104. tednu v z zdravilno učinkovino nadzorovani študiji, v kateri so empagliflozin primerjali z glimepiridom kot dodatnim zdravljenjem k metforminua empagliflozin 25 mg glimepiridb
English: In patients tolerating empagliflozin whose eGFR falls persistently below 60 ml/min/1.73 m2 or CrCl below 60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily.
Slovenian: Pri bolnikih, ki empagliflozin prenašajo in pri katerih eGFR trajno pade pod 60 ml/min/1,73 m2 ali CrCl pod 60 ml/min, je treba odmerek empagliflozina prilagoditi na 10 mg enkrat na dan ali ta odmerek ohraniti.
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%).
Slovenian: Okužbe sečil Celokupna pogostnost okužb sečil, o kateri so poročali kot o neželenem učinku, je bila podobna pri bolnikih, zdravljenih z empagliflozinom 25 mg in s placebom (7,6 %), za empagliflozin 10 mg pa je bila višja (9,3 %).
English: * p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Slovenian: 2 LOCF, vrednosti po cenzuriranju antihipertenzivnega reševanja * vrednost p < 0,0001 za enakovrednost, in vrednost p = 0,0153 za superiornost ** vrednost p < 0,0001
English: Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Slovenian: Spol ni imel klinično pomembnega učinka na farmakokinetiko empagliflozina na podlagi populacijske farmakokinetične analize.
English: 1 LOCF, values after taking antidiabetic rescue therapy censored
Slovenian: 3 LOCF, vrednosti po cenzuriranju uporabe antidiabetičnega reševalnega zdravljenja ali spremembe antihipertenzivnega reševalnega zdravljenja
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Slovenian: Starost ni imela klinično pomembnega učinka na farmakokinetiko empagliflozina na podlagi populacijske farmakokinetične analize.
English: Empagliflozin as add on to metformin, sulphonylurea, pioglitazone Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone with or without metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 3).
Slovenian: Empagliflozin kot dodatno zdravljenje k metforminu, sulfonilsečnini, pioglitazonu Empagliflozin kot dodatno zdravljenje k metforminu, metforminu s sulfonilsečnino ali pioglitazonu z metforminom ali brez njega je povzročilo statistično značilno (p < 0,0001) zmanjšanje vrednosti
English: Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Slovenian: Znižanje je bilo večje pri bolnikih z višjo izhodiščno vrednostjo HbA1c.
English: Table 8 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressurea
Slovenian: Preglednica 8: Rezultati učinkovitosti v 12. tednu v s placebom nadzorovani študiji empagliflozina pri bolnikih s sladkorno boleznijo tipa 2 in nekontroliranim krvnim tlakoma placebo zdravilo Jardiance 10 mg
English: Add-on to insulin therapy
Slovenian: Dodatno zdravljenje k insulinu
English: Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min.
Slovenian: Empagliflozin je treba ukiniti pri bolnikih, pri katerih eGFR trajno pade pod 45 ml/min/1,73 m2 ali pri katerih CrCl trajno pade pod 45 ml/min.
English: What you need to know before you take Jardiance
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Jardiance Ne jemljite zdravila Jardiance:
English: However, temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections.
Slovenian: Vendar pa je treba pri bolnikih z zapleteno okužbo sečil razmisliti o začasni prekinitvi empagliflozina.
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.
Slovenian: OATP1B3 v klinično pomembnih plazemskih koncentracijah, zato medsebojno delovanje zdravila s substrati teh prenašalcev privzema ni verjetno.
English: Low blood sugar (hypoglycemia), 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.
Slovenian: Če jemljete zdravilo Jardiance skupaj s še enim zdravilom, ki lahko zniža krvni sladkor, kot je sulfonilsečnina ali insulin, je vaše tveganje za nizek krvni sladkor večje.
English: Boehringer Ingelheim International GmbH Binger Str. 173
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Boehringer Ingelheim International GmbH Binger Str. 173
English: Table 6 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with or without metformin or a sulphonylureaa
Slovenian: Preglednica 6: Rezultati učinkovitosti v 18. in 78 tednu v s placebom nadzorovani študiji empagliflozina kot dodatnega zdravljenja k bazalnemu insulinu z metforminom ali brez njega ali s sulfonilsečninoa ali brez nje placebo empagliflozin 10 mg empagliflozin 25 mg
English: Boehringer Ingelheim Sp. z o.o.
Slovenian: Boehringer Ingelheim Sp.zo.o.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Slovenian: Pred začetkom jemanja tega zdravila in med zdravljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Table 2: Efficacy results of a 24 week placebo-controlled study of empagliflozin as monotherapya
Slovenian: Preglednica 2: Rezultati učinkovitosti 24-tedenske, s placebom nadzorovane študije empagliflozina kot samostojnega zdravljenjaa placebo zdravilo Jardiance sitagliptin
English: Jardiance 25 mg film-coated tablets are oval, pale yellow and biconvex.
Slovenian: Zdravilo Jardiance 25 mg filmsko obložene tablete so ovalne, svetlorumene, bikonveksne tablete.
English: Table 3: Efficacy results of 24 week placebo-controlled studiesa Add-on to metformin therapy Placebo
Slovenian: Rezultati učinkovitosti 24-tedenskih s placebom nadzorovanih študija Dodatno zdravljenje k metforminu placebo zdravilo Jardiance 10 mg
English: The frequency of volume depletion events was increased in patients 75 years and older treated with empagliflozin 10 mg (2.3%) or empagliflozin 25 mg (4.4%) compared to placebo (2.1%).
Slovenian: primerjavi s placebom (2,1 %) je bila pogostnost dogodkov zmanjšanja volumna povečana pri bolnikih, starih 75 let ali več, zdravljenih z empagliflozinom 10 mg (2,3 %) ali empagliflozinom 25 mg (4,4 %).
English: An interaction study with gemfibrozil, an in vitro inhibitor of OAT3 and OATP1B1/1B3 transporters, showed that empagliflozin Cmax increased by 15% and AUC increased by 59% following coadministration.
Slovenian: OATP1B1/1B3, je pokazala, da se je po sočasni uporabi Cmax empagliflozina povečal za 15 %, AUC pa za 59 %.
English: Pruritus (generalised)
Slovenian: Bolezni kože in podkožja pruritus (generaliziran)
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%).
Slovenian: V primerjavi s placebom (1,0 %) so pogostejše uriniranje (vključno s predhodno opredeljenimi pojmi polakiurija, poliurija in nokturija) z večjo pogostnostjo opazili pri bolnikih, zdravljenih z empagliflozinom (empagliflozin 10 mg: 3,4 %, empagliflozin 25 mg: 3,2 %).
English: The efficacy and safety of empagliflozin as add-on to multiple daily insulin with or without concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 52 weeks duration.
Slovenian: Empagliflozin kot dodatno zdravljenje k večkratnim dnevim odmerkom insulina Učinkovitost in varnost empagliflozina kot dodatno zdravljenje k večkratnim dnevnim odmerkom insulina s sočasnim zdravljenjem z metforminom ali brez njega so ocenili v dvojno slepem, s placebom nadzorovanem 52-tedenskem preskušanju.
English: Jardiance should not be initiated in patients with an eGFR below 60 ml/min/1.73 m2 or
Slovenian: Zdravila Jardiance se ne sme uvesti pri bolnikih z eGFR pod 60 ml/min/1,73 m2 ali CrCl < 60 ml/min.
English: Body Weight (kg) at week 522
Slovenian: Telesna masa (kg) v 52. tednu2
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Slovenian: Bolniki (%), ki so dosegli vrednost HbA1c < 7 % z izhodiščno vrednostjo
English: N SBP (mmHg)2
Slovenian: N Vrednost SBP (mmHg)2
English: Boehringer Ingelheim International GmbH Binger Strasse 173
Slovenian: Imetnik dovoljenja za promet z zdravilom Boehringer Ingelheim International GmbH Binger Strasse 173
English: 12 phase 2 and 3 clinical studies involving 10,036 patients with type 2 diabetes, empagliflozin did not increase cardiovascular risk.
Slovenian: V prospektivni, vnaprej specificirani metaanalizi neodvisno ovrednotenih srčno-žilnih dogodkov v 12 kliničnih študija 2. in 3. faze, ki so zajele 10.036 bolnikov s sladkorno boleznijo tipa 2,
English: Urine laboratory assessments
Slovenian: Laboratorijska ocena seča
English: Empagliflozin should not be initiated in patients with an eGFR <60 ml/min/1.73 m or
Slovenian: Empagliflozina se ne sme uvesti pri bolnikih z eGFR < 60 ml/min/1,73 m2 ali CrCl < 60 ml/min.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters (perforated)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU pretisni omot (perforiran)
English: At week 18, empagliflozin provided statistically significant improvement in HbA1c (Table 6).
Slovenian: V 18. tednu je pri empagliflozinu prišlo do statistično značilnega izboljšanja vrednosti HbA1c
English: Jardiance 10 mg film-coated tablets
Slovenian: Jardiance 10 mg filmsko obložene tablete
English: There were no clinically relevant differences in empagliflozin pharmacokinetics between healthy volunteers and patients with type 2 diabetes.
Slovenian: Med zdravimi prostovoljci in bolniki s sladkorno boleznijo tipa 2 ni bilo klinično pomembnih razlik v farmakokinetiki empagliflozina.
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'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Slovenian: To so znaki diabetične ketoacidoze (glejte tudi poglavje 2 »Opozorila in previdnostni ukrepi«): - povišane ravni “ketonskih teles” v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje
English: Tel: +34 91 663 50 00
Slovenian: Lilly S.A. Tel: +34 91 663 50 00
English: Jardiance 25 mg film-coated tablets
Slovenian: Jardiance 25 mg filmsko obložene tablete
English: 1 Mean adjusted for baseline value
Slovenian: 1 Povprečje, prilagojeno za izhodiščne vrednosti
English: 5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001
Slovenian: 2 Povprečje, prilagojeno za vrednost HbA1c ob izhodišču, vrednost eGFR ob izhodišču, geografsko regijo in število antihipertenzivnih zdravil