FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Slovenian: Jemanje zdravila Jardiance skupaj z zdravili, imenovanimi sulfonilsečnine, ali z insulinom lahko povzroči znižanje ravni krvnega sladkorja (hipoglikemijo), ki lahko povzroči simptome, kot so tresenje, znojenje in spremembe vida, in lahko vpliva na vašo sposobnost vožnje in upravljanja s stroji.
English: Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2).
Slovenian: Empagliflozin je reverzibilen, izjemno močan (IC50 1,3 nmol) in selektiven kompetitiven zaviralec natrijevega glukoznega prenašalca 2 (SGLT2, sodium-glucose co-transporter 2).
English: The pharmacokinetics of empagliflozin have been extensively characterised in healthy volunteers and patients with type 2 diabetes.
Slovenian: Farmakokinetika empagliflozina je bila izčrpno opisana pri zdravih prostovoljcih in bolnikih s sladkorno boleznijo tipa 2.
English: Empagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is 5000 times more selective for SGLT2 versus SGLT1, the major transporter responsible for glucose absorption in the gut.
Slovenian: Empagliflozin ne zavira drugih prenašalcev glukoze, pomembnih za prenašanje glukoze v periferna tkiva, in je 5.000 krat bolj selektiven za SGLT2 v primerjavi z SGLT1, glavnim prenašalcem, odgovornim za absorpcijo glukoze v črevesju.
English: Empagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Slovenian: Empagliflozin lahko okrepi diuretični učinek tiazida in diuretikov Henlejeve zanke in poveča tveganje za dehidracijo in hipotenzijo (glejte poglavje 4.4).
English: The observed effect of food on empagliflozin pharmacokinetics was not considered clinically relevant and empagliflozin may be administered with or without food.
Slovenian: Opazovani učinek hrane na farmakokinetiko empagliflozina ni bil klinično pomemben, zato se empagliflozin lahko jemlje s hrano ali brez nje.
English: Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia).
Slovenian: Vaš zdravnik bo morda zmanjšal odmerek teh zdravil, da prepreči pojav prenizke ravni krvnega sladkorja (hipoglikemija).
English: HbA1c ≥7%2
Slovenian: HbA1c ≥ 7 %2 N
English: Your doctor may ask you to stop taking Jardiance.
Slovenian: Vaš zdravnik vam bo morda naročil, da prenehate jemati zdravilo Jardiance.
English: 4.9 Overdose
Slovenian: 4.9 Preveliko odmerjanje Simptomi
English: Most toxicity was consistent with secondary pharmacology related to urinary glucose loss and electrolyte imbalances including decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism and gluconeogenesis, urinary changes such as polyuria and glucosuria, and microscopic changes including mineralisation in kidney and some soft and vascular tissues.
Slovenian: Toksičnost je bila povečini skladna s sekundarno farmakologijo, povezano z izgubo glukoze z urinom, in neravnovesjem elektrolitov, vključno z zmanjšanjem telesne mase in telesne maščobe, povečanim uživanjem hrane, drisko, dehidracijo, zmanjšanjem glukoze v serumu in povečanjem drugih serumskih parametrov, kar nakazuje na večjo presnovo beljakovin in glukoneogenezo, spremembe urina, kot so poliurija in glukozurija, in mikroskopskimi spremembami, vključno z mineralizacijo v ledvicah in delno v mehkem in žilnem tkivu.
English: After oral administration, empagliflozin was rapidly absorbed with peak plasma concentrations occurring at a median tmax of 1.5 hours post-dose.
Slovenian: Po peroralnem jemanju se je empagliflozin hitro absorbiral in dosegel največjo koncentracijo v plazmi z mediano Tmax 1,5 ure po odmerku.
English: • if you experience 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, contact a doctor or the nearest hospital straight away.
Slovenian: • če pride do hitre izgube telesne mase, občutka slabosti ali bruhanja, bolečin v želodcu, prekomerne žeje, hitrega in globokega dihanja, zmedenosti, neobičajne zaspanosti ali utrujenosti, sladkastega zadaha, sladkega ali kovinskega okusa v ustih ali drugačnega vonja urina ali znoja, se nemudoma posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
English: At exposures sufficiently in excess of exposure in humans after therapeutic doses, empagliflozin had no adverse effects on fertility or early embryonic development.
Slovenian: Pri izpostavljenostih, ki so veliko večje od izpostavljenostih pri ljudeh po terapevtskih odmerkih, empagliflozin ni imel neželenih učinkov na sposobnost razmnoževanja ali zgodnji razvoj zarodka.
English: Empagliflozin administered during the period of organogenesis was not teratogenic.
Slovenian: Empagliflozin, dajan v obdobju organogeneze, ni bil teratogen.
English: Empagliflozin is a substrate of the human uptake transporters OAT3, OATP1B1, and OATP1B3, but not OAT1 and OCT2.
Slovenian: Empagliflozin je substrat humanih prenašalcev privzema OAT3, OATP1B1 in OATP1B3, ne pa tudi OAT1 in OCT2.
English: Other side effects while taking Jardiance:
Slovenian: Drugi neželeni učinki, ki se lahko pojavijo med jemanjem zdravila Jardiance:
English: Jardiance should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Jardiance ne smejo uporabljati bolniki s sladkorno boleznijo tipa 1, prav tako z njim ne smemo zdraviti diabetične ketoacidoze.
English: Urine glucose
Slovenian: Glukoza v urinu
English: The overall incidence of adverse events in patients treated with empagliflozin was similar to placebo.
Slovenian: Celokupna pojavnost neželenih učinkov pri bolnikih, zdravljenih z empagliflozinom, je bila podobna kot pri placebu.
English: In addition, urinary glucose excretion triggers calorie loss, associated with body fat loss and body weight reduction.
Slovenian: Izločanje glukoze v urinu povzroči tudi izgubo kalorij, ki je povezana z izgubo telesne maščobe in zmanjšanjem telesne mase.
English: By blocking this protein, the medicine causes glucose (blood sugar), to be removed via the urine and blood glucose levels, which are too high because of your type 2 diabetes, are thereby reduced.
Slovenian: Z zaviranjem te beljakovine zdravilo povzroča izločanje glukoze (krvnega sladkorja) prek urina, zato se raven glukoze v krvi, ki je previsoka zaradi sladkorne bolezni tipa 2, zmanjša.
English: Empagliflozin does not inhibit P-gp at therapeutic doses.
Slovenian: Empagliflozin v terapevtskih odmerkih ne zavira P-gp.
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and Cmax by approximately 37% compared to fasted condition.
Slovenian: Uporaba empagliflozina 25 mg po zaužitju visokokaloričnega obroka z visoko vsebnostjo maščob je povzročila nekoliko nižjo izpostavljenost; vrednost AUC se je zmanjšala za približno 16 %, vrednost Cmax pa za približno 37 % v primerjavi s stanjem na tešče.
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.
Slovenian: Med bolniki z morebitnim povečanim tveganjem za pojav DKA so tisti z nizko funkcijsko rezervo celic beta (npr. bolniki s sladkorno boleznijo tipa 2 in nizko vrednostjo C-peptida ali latentno avtoimuno sladkorno boleznijo pri odraslih (LADA - latent autoimmune diabetes in adults) ali pri bolnikih s pankreatitisom v anamnezi), bolniki s stanji, ki povzročajo omejen vnos hrane ali hudo dehidracijo, bolniki po zmanjšanem odmerku insulina in bolniki s povečanimi potrebami po insulinu zaradi akutne bolezni, kirurškega posega ali zlorabe alkohola.
English: Insulin and insulin secretagogues
Slovenian: Insulin in sekretagogi insulina
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Slovenian: • pretirana lakota, glavobol Vaš zdravnik vam bo povedal, kako lahko zdravite nizke ravni krvnega sladkorja in kaj morate narediti, če se pojavi kateri od zgornjih znakov.
English: Patients with high baseline HbA1c >10%
Slovenian: Bolniki z visoko izhodiščno vrednostjo HbA1c >10 %
English: No studies on the effect on human fertility have been conducted for Jardiance.
Slovenian: Z zdravilom Jardiance niso izvedli študij o učinku na plodnost pri človeku.
English: These may be medicines taken by mouth or insulin given by injection.
Slovenian: Ta zdravila se lahko jemljejo peroralno ali pa je to insulin, ki se injicira.
English: In long term toxicity studies in rodents and dogs, signs of toxicity were observed at exposures greater than or equal to 10-times the clinical dose of empagliflozin.
Slovenian: V dolgotrajnih študijah toksičnosti pri glodavcih in psih so opazili znake toksičnosti pri izpostavljenosti, ki je bila višja ali enaka kot 10-kratni klinični odmerek empagliflozina.
English: The effect of empagliflozin on urinary glucose excretion is associated with osmotic diuresis, which could affect the hydration status.
Slovenian: Učinek empagliflozina na izločanje glukoze v seču je povezan z osmotsko diurezo, kar lahko vpliva na stanje hidracije.
English: • burning sensation when passing urine
Slovenian: • pekoč občutek pri uriniranju
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)
Slovenian: - Druge sestavine zdravila so: - jedro tablete: laktoza monohidrat (glejte na koncu poglavja 2 pod »Zdravilo Jardiance vsebuje laktozo«), mikrokristalna celuloza, hidroksipropilceluloza, premreženi natrijev karmelozat, koloidni brezvodni silicijev dioksid, magnezijev stearat - filmska obloga: hipromeloza, titanov dioksid (E171), smukec, makrogol (400), rumeni železov oksid (E172)
English: Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT-2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Slovenian: Pri bolikih, pri katerih se je v preteklosti med zdravljenjem z zaviralcem SGLT2 pojavila diabetična ketoacidoza, ponovna uvedba zaviralca SGLT2 ni priporočljiva, razen če je ugotovljen in odpravljen kakšen drug nedvomen sprožilni dejavnik.
English: The improvement in HbA1c, body weight, and blood pressure was sustained up to 52 weeks.
Slovenian: Izboljšanje vrednosti HbA1c, telesne mase in krvnega tlaka se je ohranilo do 52 tednov.
English: Therapeutic experience in patients with severe hepatic impairment is limited and therefore not recommended for use in this population (see section
Slovenian: Terapevtske izkušnje pri bolnikih s hudo jetrno okvaro so omejene, zato se uporabe pri tej populaciji ne priporoča (glejte poglavje 5.2).
English: The male mouse renal tumours are considered not relevant to humans.
Slovenian: Ledvični tumorji pri mišjih samcih se ne smatrajo za pomembne pri človeku.
English: Empagliflozin daily resulted in a statistically significant reduction in body weight, systolic and diastolic blood pressure and a statistically significantly lower proportion of patients with hypoglycaemic events compared to glimepiride (2.5% for empagliflozin, 24.2% for glimepiride, p<0.0001).
Slovenian: Dnevno zdravljenje z empagliflozinom je povzročilo statistično značilno zmanjšanje telesne mase, sistoličnega in diastoličnega krvnega tlaka in statistično pomembno manjši delež bolnikov s hipoglikemičnimi dogodki v primerjavi z glimepiridom (2,5 % za empagliflozin, 24,2 % za glimepirid, p < 0,0001).
English: Treatment with empagliflozin once daily resulted in statistically significant improvement in HbA1c, and 24 hour mean systolic and diastolic blood pressure as determined by ambulatory blood pressure monitoring (Table 8).
Slovenian: Zdravljenje z empagliflozinom enkrat na dan je povzročilo statistično značilno izboljšanje HbA1c in 24-urnega povprečnega sistoličnega in diastoličnega krvnega tlaka, kot je bilo ugotovljeno z ambulantnim spremljanjem krvnega tlaka (preglednica 8).
English: Similar to placebo, urinary tract infection was reported more frequently for empagliflozin in patients with a history of chronic or recurrent urinary tract infections.
Slovenian: Podobno kot pri placebu so o okužbah sečil pogosteje poročali pri empagliflozinu pri bolnikih s kroničnimi ali ponavljajočimi okužbami sečil v anamnezi.
English: • unusual thirst
Slovenian: • neobičajno žejo
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Slovenian: Na možnost diabetične ketoacidoze je treba pomisliti, če se pojavijo nespecifični simptomi, kot so slabost, bruhanje, anoreksija, bolečine v trebuhu, prekomerna žeja, oteženo dihanje, zmedenost,
English: Co-administration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6% increase in AUC and 14% increase in Cmax of digoxin.
Slovenian: Sočasno dajanje digoksina, substrata P-gp, z empagliflozinom je povzročila 6-odstotno povečanje AUC in 14-odstotno povečanje Cmax digoksina.
English: During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels <140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
Slovenian: V prvih 18 tednih in zadnjih 12 tednih je bil odmerek insulina stabilen, a je bil med 19. in 40. tednom prilagojen za doseganje preprandialnih ravni glukoze < 100 mg/dl [5,5 mmol/l] in postprandialnih ravni glukoze < 140 mg/dl [7,8 mmol/l].
English: Urinary tract infection was reported more frequently in females treated with empagliflozin compared to placebo; there was no difference in males.
Slovenian: okužbah sečil so pogosteje poročali pri ženskah, zdravljenih z empagliflozinom, v primerjavi s placebom; pri moških ni bilo razlike.
English: The tablets are 9.1 mm in diameter.
Slovenian: Premer tablet je 9,1 mm.
English: The efficacy and safety of empagliflozin was evaluated in a double-blind, placebo controlled study of 12 weeks duration in patients with type 2 diabetes and high blood pressure on different antidiabetic and up to 2 antihypertensive therapies.
Slovenian: Učinkovitost in varnost empagliflozina so ocenili v dvojno slepi, s placebom nadzorovani 12-tedenski študiji pri bolnikih s sladkorno boleznijo tipa 2 in visokim krvnim tlakom, ki so uporabljali različne antidiabetike in do 2 antihipertenzivni zdravili.
English: Your doctor may ask you to stop taking Jardiance until you have recovered.
Slovenian: Vaš zdravnik vam bo morda naročil, da zdravilo Jardiance prenehate jemati, dokler ne okrevate.
English: In patients with mild, moderate or severe renal impairment (eGFR <30 - <90 ml/min/1.73 m2) and patients with kidney failure/end stage renal disease (ESRD), AUC of empagliflozin increased by approximately 18%, 20%, 66%, and 48%, respectively compared to subjects with normal renal function.
Slovenian: Pri bolnikih z blago, zmerno ali hudo ledvično okvaro (eGFR < 30 - < 90 ml/min/1,73 m2) in pri bolnikih z ledvično odpovedjo/ledvično boleznijo v končnem stadiju (ESRD, end stage renal disease), se je vrednost AUC empagliflozina povečala za približno 18 %, 20 %, 66 % oz. 48 % v primerjavi z osebami z normalnim delovanjem ledvic.
English: Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza hidroksipropilceluloza premreženi natrijev karmelozat koloidni brezvodni silicijev dioksid magnezijev stearat
English: The removal of empagliflozin by haemodialysis has not been studied.
Slovenian: Odstranitve empagliflozina s hemodializo niso preučili.
English: In case of conditions that may lead to fluid loss (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving empagliflozin.
Slovenian: V primeru stanj, ki lahko povzročijo izgubo tekočine (npr. bolezen prebavil), se pri bolnikih, ki dobivajo empagliflozin, priporoča skrbno spremljanje stanja volumna (npr. zdravniški pregledi, merjenje krvnega tlaka, laboratorijske preiskave, vključno s hematokritom) in elektrolitov.
English: Jardiance is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as:
Slovenian: Zdravilo Jardiance je indicirano za zdravljenje sladkorne bolezni tipa 2 pri odraslih bolnikih za izboljšanje urejenosti glikemije kot:
English: Each tablet contains lactose monohydrate equivalent to 154.3 mg lactose anhydrous.
Slovenian: Ena tableta vsebuje laktozo monohidrat v količini, ki ustreza 154,3 mg brezvodne laktoze.
English: • Do not take a double dose of Jardiance to make up for a forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjega.
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
Slovenian: EU/1/14/930/010 7 tablet EU/1/14/930/011 10 tablet EU/1/14/930/012 14 tablet EU/1/14/930/013 28 tablet EU/1/14/930/014 30 tablet EU/1/14/930/015 60 tablet EU/1/14/930/016 70 tablet EU/1/14/930/017 90 tablet EU/1/14/930/018 100 tablet
English: In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32 times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin (equivalent to 4 times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity.
Slovenian: V nadzorovanih kliničnih študijah pri bolnikih s sladkorno boleznijo tipa 2 enkratni odmerki do 800 mg empagliflozina (kar ustreza 32-kratnemu največjemu priporočenemu dnevnemu odmerku) pri zdravih prostovoljcih in večkratnih dnevnih odmerkih do 100 mg empagliflozina (kar ustreza 4-kratnemu največjemu priporočenemu dnevnemu odmerku) niso pokazali toksičnosti.
English: Due to its mechanism of action, patients taking Jardiance will test positive for glucose in their urine.
Slovenian: Zaradi mehanizma delovanja bodo rezultati testov glukoze v urinu pri bolnikih, ki uporabljajo Jardiance, pozitivni.
English: The amount of glucose removed by the kidney through this glucuretic mechanism is dependent on blood glucose concentration and GFR.
Slovenian: Količina glukoze, ki jo ledvice izločijo s pomočjo tega glukuretičnega mehanizma, je odvisna od koncentracije glukoze v krvi in hitrosti glomerulne filtracije
English: Temporary interruption of treatment with empagliflozin should be considered until the fluid loss is corrected.
Slovenian: Presoditi je treba o začasni prekinitvi zdravljenja z empagliflozinom do ponovne vzpostavitve tekočinskega ravnovesja.
English: No dose adjustment is recommended based on age.
Slovenian: Starejši Prilagoditev odmerka glede na starost ni potrebna.
English: 2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure
Slovenian: 1 Povprečje, prilagojeno za izhodiščne vrednosti 2 Statistična značilnost ni bila ocenjena zaradi zaporednega potrditvenega postopka testiranja
English: How to take Jardiance
Slovenian: Kako jemati zdravilo Jardiance
English: EU/1/14/930/001 7 tablets EU/1/14/930/002 10 tablets EU/1/14/930/003 14 tablets EU/1/14/930/004 28 tablets EU/1/14/930/005 30 tablets EU/1/14/930/006 60 tablets EU/1/14/930/007 70 tablets EU/1/14/930/008 90 tablets EU/1/14/930/009 100 tablets
Slovenian: EU/1/14/930/001 7 tablet EU/1/14/930/002 10 tablet EU/1/14/930/003 14 tablet EU/1/14/930/004 28 tablet EU/1/14/930/005 30 tablet EU/1/14/930/006 60 tablet EU/1/14/930/007 70 tablet EU/1/14/930/008 90 tablet EU/1/14/930/009 100 tablet
English: It is not known if DKA is more likely to occur with higher doses of empagliflozin.
Slovenian: Ni znano, ali je pri večjih odmerkih empagliflozina verjetnost za pojav DKA povečana.
English: 7 x 1 film-coated tablets 10 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 60 x 1 film-coated tablets 70 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Slovenian: 7 x 1 filmsko obložena tableta 10 x 1 filmsko obložena tableta 14 x 1 filmsko obložena tableta 28 x 1 filmsko obložena tableta 30 x 1 filmsko obložena tableta 60 x 1 filmsko obložena tableta 70 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta 100 x 1 filmsko obložena tableta
English: Furthermore, empagliflozin resulted in a reduction in FPG, body weight, and blood pressure.
Slovenian: Empagliflozin je nadalje povzročil zmanjšanje vrednosti FPG, telesne mase in krvnega tlaka.
English: The single-dose and steady-state pharmacokinetic parameters of empagliflozin were similar suggesting linear pharmacokinetics with respect to time.
Slovenian: Farmakokinetični parametri po enkratnem odmerku empagliflozina in v stanju dinamičnega ravnovesja so bili podobni, kar kaže na linearno farmakokinetiko glede na čas.
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
Slovenian: 2 19.-40. teden: usmerjen (treat-to-target) režim prilagajanja odmerka insulina za doseganje vnaprej določenih ciljnih ravni glukoze (preprandialna < 100 mg/dl (5,5 mmol/l), postprandialna < 140 mg/dl (7,8 mmol/l) * vrednost p < 0,0001 ** vrednost p = 0,0003 *** vrednost p = 0,0005 # vrednost p = 0,0040
English: LIST OF EXCIPIENTS Contains lactose, see leaflet for further information.
Slovenian: Vsebuje laktozo, za več informacij glejte navodilo za uporabo.
English: Microscopic evidence of the effects of exaggerated pharmacology on the kidney observed in some species included tubular dilatation, and tubular and pelvic mineralisation at approximately 4-times the clinical AUC exposure of empagliflozin associated with the 25 mg dose.
Slovenian: Mikroskopski dokazi učinkov pretirane farmakologije na ledvice, ki so jih opazili pri nekaterih vrstah, so vključevali tubularno dilatacijo in mineralizacijo tubulov in medenice pri približno 4-kratni klinični izpostavljenosti empagliflozinu na podlagi vrednosti AUC,
English: • if you have a serious infection of the kidney or the urinary tract with fever.
Slovenian: • če imate resno okužbo ledvic ali sečil s povišano telesno temperaturo.
English: Jardiance contains the active substance empagliflozin which works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Slovenian: Zdravilo Jardiance vsebuje zdravilno učinkovino empagliflozin, ki deluje tako, da v ledvicah zavira beljakovino, imenovano natrijev glukozni prenašalec 2 (SGLT2, sodium-glucose co-transporter 2).