FrancophonIA/ELRC3.0 huggingface dataset:
English: - Prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
Slovenian: - Pred uvedbo katerega koli sočasnega zdravila, ki lahko negativno vpliva na delovanje ledvic.
English: Co-medication with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Slovenian: Sočasni uporabi z znanimi induktorji encimov UGT se je treba izogniti zaradi možnega tveganja za zmanjšano učinkovitost.
English: This may occur regardless of blood glucose level.
Slovenian: Pojavijo se lahko ne glede na raven glukoze v krvi.
English: Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects'.
Slovenian: Možni znaki pretirane izgube tekočine iz telesa so našteti v poglavju 4, »Možni neželeni učinki«.
English: Four studies had treatment durations of 24 weeks; extensions of those and other studies had patients exposed to empagliflozin for up to 102 weeks.
Slovenian: V štirih študijah je zdravljenje trajalo 24 tednov; v podaljških teh in drugih študij so bili bolniki empagliflozinu izpostavljeni do 102. tedna.
English: Possible signs are listed in section 4, ‘Possible side effects' under ‘dehydration'.
Slovenian: Možni znaki so našteti v poglavju 4, »Možni neželeni učinki« pod “dehidracija”.
English: The safety and efficacy of empagliflozin in children and adolescents has not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost empagliflozina pri otrocih in mladostnikih še nista bili dokazani.
English: If you take more Jardiance than you should If you take more Jardiance than you should, talk to a doctor immediately or go to a hospital immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Jardiance, kot bi smeli Če ste vzeli večji odmerek zdravila Jardiance, kot bi smeli, se takoj posvetujte z zdravnikom ali pojdite takoj v bolnišnico.
English: If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively.
Slovenian: Če imate sladkorno bolezen tipa 2, vaša trebušna slinavka ne tvori dovolj insulina za ureditev ravni glukoze v krvi, vaše telo pa lastnega insulina ne more učinkovito uporabiti.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Slovenian: • če jemljete druga zdravila, ki zmanjšujejo količino krvnega sladkorja, kot so insulin ali »sulfonilsečninska« zdravila.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Jardiance in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Jardiance za eno ali več podskupin pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If a dose is missed, it should be taken as soon as the patient remembers.
Slovenian: Če bolnik odmerek izpusti, ga mora vzeti takoj, ko se spomni.
English: The observed increase in urine volume was not dose-dependent and is not clinically meaningful.
Slovenian: Povečanje volumna urina, ki so ga opazili, ni bilo odvisno od odmerka in klinično ni pomembno.
English: • if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink.
Slovenian: • če vam je slabo, imate drisko ali povišano telesno temperaturo ali ne morete jesti ali piti.
English: • Jardiance is used to treat type 2 diabetes in adult patients (aged 18 years and older) that cannot be controlled by diet and exercise alone.
Slovenian: • Zdravilo Jardiance se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih bolnikih (starih 18 let in več), ki je ne moremo obvladovati samo z dieto in telesno vadbo.
English: • You can take the tablet with or without food
Slovenian: • Tableto lahko vzamete s hrano ali brez nje.
English: Both tumours are common in rats and are unlikely to be relevant to humans.
Slovenian: Obe vrsti tumorjev sta pri podganah pogosti in ni verjetno, da bi bili za človeka pomembni.
English: • passing more urine than usual or needing to pass urine more often
Slovenian: • večje količine seča od običajnih ali potreba po pogostejšem uriniranju
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Jardiance is used in combination with a sulphonylurea and/or insulin.
Slovenian: Bolnikom je treba svetovati, naj s preventivnimi ukrepi preprečijo hipoglikemijo med vožnjo in upravljanjem strojev, zlasti pri uporabi zdravila Jardiance v kombinaciji s sulfonilsečnino in/ali insulinom.
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.
Slovenian: Večina radioaktivnosti v blatu, povezane z zdravilom je bila nespremenjena izhodna učinkovina in približno polovica radioaktivnosti v urinu, povezane z zdravilom je bila nespremenjena izhodna učinkovina.
English: What Jardiance is and what it is used for
Slovenian: Kaj je zdravilo Jardiance in za kaj ga uporabljamo
English: Insulin and insulin secretagogues, such as sulphonylureas, may increase the risk of hypoglycaemia.
Slovenian: Insulin in sekretagogi insulina, kot so sulfonilsečnine, lahko povečajo tveganje za hipoglikemijo.
English: Due to the mechanism of action, the efficacy of empagliflozin is dependent on renal function.
Slovenian: Zaradi mehanizma delovanja je učinkovitost empagliflozina odvisna od delovanja ledvic.
English: Empagliflozin is not genotoxic.
Slovenian: Empagliflozin ni genotoksičen.
English: Your doctor has prescribed this medicine to help lower your blood sugar.
Slovenian: Vaš zdravnik vam je to zdravilo predpisal kot pomoč pri zmanjšanju ravni krvnega sladkorja.
English: Increased urinary glucose excretion was maintained at the end of the 4-week treatment period, averaging approximately 78 g/day.
Slovenian: Večje izločanje glukoze v urinu se je ohranilo do konca 4-tedenskega obdobja zdravljenja in je bilo povprečno 78 g/dan.
English: Your doctor may ask you to stop taking Jardiance until you recover to prevent loss of too much body fluid.
Slovenian: Vaš zdravnik vam bo morda naročil, da zdravilo Jardiance prenehate jemati, dokler ne okrevate, da preprečite izgubo prevelike količine telesnih tekočin.
English: (97.5% CI) N
Slovenian: (97,5-odstotni IZ) N
English: • if you are taking a medicine used to remove water from the body (diuretic).
Slovenian: • če uporabljate zdravilo, ki iz telesa odvaja tekočino (diuretik).
English: Monitoring of renal function
Slovenian: Spremljanje delovanja ledvic
English: The frequency of reported nocturia was similar for placebo and empagliflozin (<1%).
Slovenian: Pogostnost, s katero so poročali o nokturiji, je bila podobna za placebo in za empagliflozin (< 1 %).
English: It is responsible, as the predominant transporter, for the reabsorption of glucose from the glomerular filtrate back into the circulation.
Slovenian: Kot prevladujoči prenašalec je odgovoren za reabsorpcijo glukoze iz glomerularnega filtrata nazaj v obtok.
English: • The starting dose of Jardiance is one 10 mg tablet once a day.
Slovenian: • Začetni odmerek zdravila Jardiance je ena tableta po 10 mg enkrat na dan.
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.
Slovenian: Izkušnje z razredom I-II po funkcijski razvrstitvi Newyorškega združenja za srce (NYHA, New York Heart Association) so omejene, izkušenj iz kliničnih študij z empagliflozinom z razredom III-IV po NYHA pa ni.
English: Your doctor may decide to temporarily or permanently stop your treatment with Jardiance.
Slovenian: Zdravnik se lahko odloči za začasno ali dokončno prekinitev zdravljenja z zdravilom Jardiance.
English: It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.
Slovenian: Pomembno je, da nadaljujete z dieto in vadbo, kot vam je naročil zdravnik, farmacevt ali medicinska sestra.
English: • shaking, sweating, feeling very anxious or confused, fast heart beat
Slovenian: • tresenje, znojenje, občutek tesnobe ali zmedenosti, hiter srčni utrip
English: Empagliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Slovenian: Empagliflozin je substrat P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (BCRP, breast cancer resistance protein).
English: Your doctor may prescribe Jardiance together with another diabetes medicine.
Slovenian: Zdravnik vam lahko predpiše zdravilo Jardiance skupaj z drugim antidiabetičnim zdravilom.
English: However, animal studies have shown adverse effects on postnatal development (see section 5.3).
Slovenian: Vendar pa študije na živalih kažejo neželene učinke na razvoj po rojstvu (glejte poglavje 5.3).
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.
Slovenian: Mehanizem delovanja empagliflozina je neodvisen od delovanja beta celic in poti insulina, kar prispeva k nižjemu tveganju za hipoglikemijo.
English: In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m2.
Slovenian: V populacijski farmakokinetični analizi so ocenili, da je vrednost AUC za 13,5 % večja pri Azijcih z indeksom telesne mase 25 kg/m2 v primerjavi z ne-Azijci z indeksom telesne mase 25 kg/m2.
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.
Slovenian: V prvih 18 tednih je bil odmerek insulina stabilen, a prilagojen tako, da je bila v naslednjih 60 tednih dosežena vrednost FPG < 110 mg/dl.
English: Jardiance contains lactose (milk sugar).
Slovenian: Zdravilo Jardiance vsebuje laktozo (mlečni sladkor).
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost (glejte poglavje 5.3).
English: Jardiance should not be used during breast-feeding.
Slovenian: Zdravila Jardiance se med dojenjem ne sme uporabljati.
English: There are no data from the use of empagliflozin in pregnant women.
Slovenian: Podatkov o uporabi empagliflozina pri nosečnicah ni.
English: Hypoglycaemia The frequency of hypoglycaemia depended on the background therapy in the respective studies.
Slovenian: Hipoglikemija Pogostnost hipoglikemije je bila odvisna od terapije v ozadju v zadevnih študijah.
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.
Slovenian: To povzroči visoke ravni glukoze v krvi, ki imajo lahko za posledico zdravstvene težave, kot so bolezni srca, bolezni ledvic, slepota in slab krvni obtok v okončinah.
English: In the event of an overdose, treatment should be initiated as appropriate to the patient‘s clinical status.
Slovenian: Pri prevelikem odmerjanju je treba uvesti ustrezno zdravljenje glede na klinično stanje bolnika.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred začetkom uporabe tega zdravila posvetujte z zdravnikom.
English: In patients 75 years and older, an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8).
Slovenian: Pri bolnikih, starih 75 let in več, je treba upoštevati večje tveganje za zmanjšanje volumna (glejte poglavji 4.4 in 4.8).
English: Because of how this medicine works, your urine will test positive for sugar while you are taking this medicine.
Slovenian: Zaradi načina delovanja tega zdravila bodo v času njegovega jemanja rezultati preiskav urina pozitivni za sladkor.
English: There is no experience with doses above 800 mg in humans.
Slovenian: Pri ljudeh ni izkušenj z odmerki nad 800 mg. Zdravljenje
English: In patients where DKA is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately.
Slovenian: Pri bolnikih s sumom ali diagnozo DKA je treba nemudoma prekiniti zdravljenje z empagliflozinom.
English: Increased urination was mostly mild or moderate in intensity.
Slovenian: Pogostejše uriniranje je bilo večinoma blago ali zmerno.
English: These symptoms could be a sign of “diabetic ketoacidosis” - a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Slovenian: Ti simptomi so lahko znak “diabetične ketoacidoze”, težave, ki se lahko pojavi pri sladkorni bolezni zaradi povišanih ravni “ketonskih teles” v urinu ali krvi, kar je razvidno iz laboratorijskih preiskav.
English: • Swallow the tablet whole with water
Slovenian: • Tableto pogoltnite celo z vodo.
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Slovenian: Omejeni podatki iz kliničnih preizkušanj nakazujejo, da se DKA pojavlja pogosto, če bolnike s sladkorno boleznijo tipa 1 zdravimo z zaviralci SGLT2.
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.
Slovenian: Izločanje Na podlagi populacijske farmakokinetične analize je bil navidezni končni razpolovni čas empagliflozina ocenjen na 12,4 ure, navidezni peroralni očistek pa je bil 10,6 l/uro.
English: The most frequently reported adverse reaction was hypoglycaemia when used with sulphonylurea or insulin (see description of selected adverse reactions).
Slovenian: Neželeni učinek, o katerem so najpogosteje poročali, je bila hipoglikemija pri sočasni uporabi s sulfonilsečnino ali insulinom (glejte opis izbranih neželenih učinkov).
English: Other medicines and Jardiance Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The glucosuria observed with empagliflozin is accompanied by mild diuresis which may contribute to sustained and moderate reduction of blood pressure.
Slovenian: Glukozurijo, ki so jo opazili pri empagliflozinu, spremlja blaga diureza, ki lahko prispeva k trajnemu in zmernemu znižanju krvnega tlaka.
English: Contact your doctor as soon as possible if you notice the following side effects:
Slovenian: Takoj se posvetujte z zdravnikom, če opazite katerega od naslednjih neželenih učinkov:
English: Initiation of empagliflozin therapy in this population is not recommended (see section 4.2).
Slovenian: Uvedba zdravljenja z empagliflozinom se pri tej populaciji ne priporoča (glejte poglavje 4.2).
English: (97.5% CI)
Slovenian: (97,5-odstotni
English: Drug-drug interactions involving the major CYP450 and UGT isoforms with empagliflozin and concomitantly administered substrates of these enzymes are therefore considered unlikely.
Slovenian: Zato medsebojno delovanje, pri katerem sodelujejo glavne izooblike CYP450 in UGT, med empagliflozinom in sočasno uporabljenimi substrati teh encimov, ni verjetno.
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.
Slovenian: V 5 s placebom nadzorovanih preskušanjih, ki so trajala 18 do 24 tednov, je bilo vključenih 2.971 bolnikov, od katerih jih je 995 prejemalo placebo, 1.976 pa empagliflozin.
English: Jardiance 10 mg film-coated tablets EU/1/14/930/010
Slovenian: Jardiance 10 mg filmsko obložene tablete EU/1/14/930/010
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Slovenian: V številnih primerih je bila klinična slika atipična, s samo zmerno zvišanimi vrednostmi glukoze v krvi, ki so bile pod 14 mmol/l (250 mg/dl).
English: Empagliflozin exposure is increased in patients with severe hepatic impairment.
Slovenian: Izpostavljenost empagliflozinu je pri bolnikih s hudo jetrno okvaro povečana.
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).
Slovenian: Zato bo morda potreben manjši odmerek insulina ali sekretagoga insulina za zmanjšanje tveganja hipoglikemije, če se uporablja v kombinaciji z empagliflozinom (glejte poglavji 4.2 in 4.8).
English: The safety and efficacy of empagliflozin in patients with type 1 diabetes have not been established and empagliflozin should not be used for treatment of patients with type 1 diabetes.
Slovenian: Varnost in učinkovitost empagliflozina pri bolnikih s sladkorno boleznijo tipa 1 nista bili dokazani, zato empagliflozina ni priporočljivo uporabljati za zdravljenje bolnikov s sladkorno boleznijo tipa 1.
English: Jardiance 25 mg film-coated tablets EU/1/14/930/001
Slovenian: Jardiance 25 mg filmsko obložene tablete EU/1/14/930/001
English: If you stop taking Jardiance
Slovenian: Če ste prenehali jemati zdravilo Jardiance
English: In addition it resulted in a clinically meaningful reduction in FPG, systolic and diastolic blood pressure compared to placebo.
Slovenian: Povzročilo je tudi klinično pomembno zmanjšanje vrednosti FPG, sistoličnega in diastoličnega krvnega tlaka v primerjavi s placebom.
English: Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Slovenian: Ob pojavu teh simptomov je potrebno nemudoma preveriti, ali gre za ketoacidozo, ne glede na raven glukoze v krvi.
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.
Slovenian: Študije na živalih kažejo, da empagliflozin v pozni dobi gestacije v zelo omejenem obsegu prehaja preko posteljice, vendar ne kažejo neposrednih ali posrednih škodljivih učinkov na razvoj zarodka.
English: Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with drugs that are P-gp substrates.
Slovenian: Na podlagi študij in vitro ni verjetno, da bi empagliflozin povzročil medsebojno delovanje z zdravili, ki so substrati P-gp.
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.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da se je navidezni peroralni očistek empagliflozina zmanjšal z zmanjšanjem eGFR, kar je povzročilo večjo izpostavljenost zdravilu.
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excl. insulins, ATC code: A10BX12
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje sladkorne bolezni, druga zdravila za zniževanje glukoze v krvi, brez insulinov, oznaka ATC: A10BX12
English: SGLT2 prevents glucose from being excreted in urine by absorbing glucose into the bloodstream as blood is being filtered in the kidneys.
Slovenian: SGLT2 preprečuje izločanje glukoze v urinu z absorpcijo glukoze v krvni obtok, saj kri filtrira v ledvicah.
English: Do not take Jardiance: - if you are allergic to empagliflozin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na empagliflozin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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%).
Slovenian: Po peroralnem zaužitju raztopine [14C]-empagliflozina se je pri zdravih prostovoljcih približno 96 % radioaktivnosti, povezane z zdravilom, izločilo v blato (41 %) ali urin (54 %).
English: In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Slovenian: V kombinaciji z drugimi zdravili, ki nižajo raven glukoze, vključno z insulinom, kadar jemanje teh zdravil, skupaj z dieto in telesno aktivnostjo, ne zadošča za ustrezno urejenost glikemije (glejte poglavja 4.4, 4.5 in 5.1 za podatke o različnih kombinacijah).
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.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 se je izločanje glukoze v urinu povečalo takoj po prvem odmerku empagliflozina in je ostalo v 24-urnem intervalu odmerjanja stalno.
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).
Slovenian: Na podlagi načina delovanja zaviralcev SGLT2 lahko osmotska diureza, ki spremlja terapevtsko glukozurijo, povzroči manjše znižanje krvnega tlaka (glejte poglavje 5.1).
English: The inter-subject and residual variabilities for empagliflozin oral clearance were 39.1% and 35.8%,
Slovenian: Za peroralni očistek je bila variabilnost empagliflozina med posamezniki 39,1 %, rezidualna variabilnost pa 35,8 %.
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.
Slovenian: Če dieta in telesna aktivnost ne zadoščata za ustrezno urejenost glikemije pri bolnikih, pri katerih metformin ni primerno zdravilo, ker ga bolniki ne prenašajo.
English: Before initiating empagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered.
Slovenian: Pred uvedbo empagliflozina je treba oceniti dejavnike v bolnikovi anamnezi, ki bi lahko povečali nagnjenost h ketoacidozi.
English: It is not known if Jardiance passes into human breast milk.
Slovenian: Ni znano, ali se zdravilo Jardiance izloča v mleko pri ljudeh.
English: How to store Jardiance 6.
Slovenian: Shranjevanje zdravila Jardiance 6.
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
Slovenian: Tveganje za nastanek diabetične ketoacidoze lahko povečajo dolgotrajnejše stradanje, prekomerno uživanje alkohola, dehidracija, nenadno zmanjšanje odmerka insulina ali povečana potreba po insulinu zaradi večje operacije ali resne bolezni.
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.
Slovenian: Način delovanja za te tumorje je odvisen od naravne nagnjenosti mišjih samcev k boleznim ledvic in presnovne poti, ki pri človeku ni prisotna.
English: Patients aged 75 years and older may be at an increased risk of volume depletion.
Slovenian: Pri bolnikih, starih 75 let in več, obstaja povečano tveganje za zmanjšanje volumna.
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).
Slovenian: Neželeni učinki, razvrščeni po organskih sistemih in navedeni po priporočenih izrazih MedDRA, o katerih so poročali pri bolnikih, ki so v s placebom nadzorovanih študijah prejemali empagliflozin, so predstavljeni v spodnji preglednici (preglednica 1).