FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration with other potent inducers of P-gp and CYP3A4, such as carbamazepine, phenobarbital and phenytoin, has not been studied.
Slovenian: Sočasno dajanje z drugimi močnimi induktorji P-gp in CYP3A4, na primer s karbamazepinom, fenobarbitalom in fenitoinom, ni raziskano.
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 (see section 4.2).
Slovenian: Populacijska farmakokinetična analiza je pokazala, da se je navidezni peroralni očistek empagliflozina zmanjšal z zmanjševanjem eGFR, kar je povzročilo večjo izpostavljenost zdravilu (glejte poglavje 4.2).
English: Taking this medicine in combination with sulphonylureas or insulin, can cause your blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and changes in vision, and may affect your ability to drive and use machines.
Slovenian: Jemanje tega zdravila skupaj s sulfonilsečninami 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: C]-empagliflozin solution to healthy volunteers, approximately 96 % of the drug-related radioactivity was eliminated in faeces (41 %) or urine (54 %).
Slovenian: C]-empagliflozina se je pri zdravih prostovoljcih približno 96 % radioaktivnosti, povezane z zdravilom, izločilo z blatom (41 %) ali urinom (54 %).
English: Liver, kidneys and gastrointestinal tract are the principal target organs of toxicity in mice and rats.
Slovenian: Jetra, ledvice in prebavila so glavni ciljni organi za toksičnost pri miših in podganah.
English: The reduction of cardiovascular death was comparable for empagliflozin 10 mg and 25 mg and confirmed by an improved overall survival (see Table 5).
Slovenian: Znižanje srčno-žilne smrtnosti je bilo primerljivo za empagliflozin 10 mg in 25 mg in dokazano z izboljšanjem celokupnega preživetja (glejte preglednico 5).
English: Pharmacokinetics were generally similar in healthy subjects and in patients with type 2 diabetes.
Slovenian: Farmakokinetika je bila pri zdravih preizkušancih in bolnikih s sladkorno boleznijo tipa 2 v glavnem podobna.
English: • Do not take a double dose of this medicine to make up for a forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka tega zdravila, če ste pozabili vzeti prejšnjega.
English: Elderly subjects (65 to 80 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Slovenian: Starejši bolniki (65 do 80 let) in mlajši preizkušanci so imeli primerljive plazemske koncentracije linagliptina.
English: SGLT2 prevents glucose from being excreted in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys.
Slovenian: SGLT2 preprečuje izločanje glukoze z urinom, tako da jo absorbira nazaj v krvni obtok, saj se kri filtrira v ledvicah.
English: • laboratory blood tests may show changes in blood fat levels, an increase in the amount of red blood cells (increase in haematocrit), and changes related to kidney function (decrease in filtration rate and increase in blood creatinine)
Slovenian: • laboratorijske preiskave krvi lahko pokažejo spremembe ravni maščobe v krvi, povečane vrednosti eritrocitov (zvišan hematokrit) in spremembe povezane z delovanjem ledvic
English: Due to the concentration dependent binding of linagliptin to DPP-4, the pharmacokinetics of linagliptin based on total exposure is not linear; indeed total plasma AUC of linagliptin increased in a less than dose-proportional manner while unbound AUC increases in a roughly dose-proportional manner.
Slovenian: Zaradi od koncentracij odvisne vezave linagliptina na DPP-4, farmakokinetika linagliptina na osnovi celotne izpostavitve ni linearna; celokupni AUC linagliptina v plazmi se je povečeval manj kot bi sicer bilo sorazmerno z odmerkom, medtem ko se AUC nevezane učinkovine povečuje približno sorazmerno z odmerkom.
English: • Linagliptin works in a different way, namely by enabling the pancreas to produce more insulin to lower blood glucose levels.
Slovenian: • Linagliptin deluje drugače, trebušni slinavki omogoča, da proizvede več insulina za zniževanje ravni glukoze v krvi.
English: In patients with type 2 diabetes, urinary glucose excretion increased immediately following the first dose of empagliflozin and was continuous over the 24-hour dosing interval.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 se je izločanje glukoze z urinom povečalo takoj po prvem odmerku empagliflozina in je ostalo v 24-urnem intervalu odmerjanja stalno.
English: Your doctor may ask you to stop taking Glyxambi until you recover, to prevent loss of too much body fluid.
Slovenian: Vaš zdravnik vam bo morda naročil, da zdravilo Glyxambi prenehate jemati, dokler ne okrevate, da preprečite izgubo prevelike količine telesnih tekočin.
English: Glyxambi should not be used for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Glyxambi ne smejo uporabljati za zdravljenje diabetične ketoacidoze.
English: Low blood sugar (hypoglycaemia), seen commonly (may affect up to 1 in 10 people) If you take Glyxambi with another medicine that can cause low blood sugar, such as a sulphonylurea or insulin, you are at risk of getting too low blood sugar (hypoglycaemia).
Slovenian: Nizek krvni sladkor (hipoglikemija), pogost (pojavi se lahko pri največ 1 od 10 bolnikov) Če jemljete zdravilo Glyxambi skupaj s še enim zdravilom, ki lahko zniža krvni sladkor, kot je sulfonilsečnina ali insulin, pri vas obstaja tveganje za prenizek krvni sladkor (hipoglikemijo).
English: Based on the mode of action of SGLT2 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: Hypoglycaemias in the placebo-controlled studies (10.9 %; N=471) were mild (80 %; N=384), moderate (16.6 %; N=78) or severe (1.9 %; N=9) in intensity.
Slovenian: Hipoglikemije, o katerih so poročali v s placebom nadzorovanih študijah (10,9 %; N = 471) so bile po intenzivnosti blage (80 %; N = 384), zmerne (16,6 %; N = 78) ali hude (1,9 %; N = 9).
English: Based on results of pharmacokinetic studies, no dose adjustment of Glyxambi is recommended when co-administered with commonly prescribed medicinal products, except those mentioned below.
Slovenian: Rezultati farmakokinetičnih študij kažejo, da odmerka zdravila Glyxambi ni priporočeno prilagajati, kadar je uporabljen sočasno s pogosto uporabljenimi zdravili, z izjemo tistih, navedenih spodaj.
English: Empagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is 5,000 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 5000-krat bolj selektiven za SGLT2 v primerjavi s SGLT1, glavnim prenašalcem, odgovornim za absorpcijo glukoze v črevesju.
English: The unbound concentrations, which are usually less than 1 % at the therapeutic dose of linagliptin, were increased 4 to 5-fold after co-administration with ritonavir.
Slovenian: Nevezane koncentracije, ki so običajno pri terapevtskem odmerjanju linagliptina manjše od 1 %, so se po sočasnem dajanju z ritonavirjem povečale za 4 do 5-krat.
English: Glyxambi is not recommended and your doctor may decide to use an alternative medicine.
Slovenian: Uporaba zdravila Glyxambi ni priporočljiva, zdravnik pa se lahko odloči za uporabo drugega zdravila.
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 enkratni odmerki do 800 mg empagliflozina (kar ustreza 32-kratnemu največjemu priporočenemu dnevnemu odmerku) pri zdravih prostovoljcih in večkratni dnevni odmerki do 100 mg empagliflozina (kar ustreza 4-kratnemu največjemu priporočenemu dnevnemu odmerku) pri bolnikih s sladkorno boleznijo tipa 2 niso pokazali toksičnosti.
English: The genital tract infections were mild and moderate in intensity, none was severe in intensity.
Slovenian: Okužbe spolovil so bile po jakosti blage do zmerne, nobena pa ni bila huda.
English: The amount of glucose removed by the kidney through this glucuretic mechanism is dependent upon the 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 (GFR).
English: Available non-clinical data in animals have shown excretion of empagliflozin and linagliptin in milk.
Slovenian: Razpoložljivi neklinični podatki pri živalih kažejo na izločanje empagliflozina in linagliptina v mleko.
English: The effect of Glyxambi may be reduced.
Slovenian: Ta lahko zmanjšajo učinek zdravila Glyxambi.
English: The inter subject and residual variabilities for empagliflozin oral clearance were 39.1 % and 35.8 %, respectively.
Slovenian: Za peroralni očistek je bila variabilnost empagliflozina med posamezniki 39,1 %, rezidualna variabilnost pa 35,8 %.
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, ki odražajo povečano presnovo beljakovin in glukoneogenezo; spremembami urina, kot so poliurija in glukozurija, in mikroskopskimi spremembami, vključno z mineralizacijo v ledvicah in delno v mehkem in žilnem tkivu.
English: If a dose is missed, and it is less than 12 hours until the next dose, the dose should be skipped and the next dose should be taken at the usual time.
Slovenian: Če bolnik odmerek pozabi in je do naslednjega odmerka manj kot 12 ur, naj odmerek izpusti in naslednji odmerek vzame ob običajnem času.
English: There are no data about the hypoglycaemic risk of Glyxambi when used with insulin and/or sulphonylurea.
Slovenian: Ni podatkov o tveganju za pojav hipoglikemije pri uporabi zdravila Glyxambi v kombinaciji z insulinom in/ali sulfonilsečnino.
English: Plasma concentrations of linagliptin decline in a triphasic manner with a long terminal half-life (terminal half-life for linagliptin more than 100 hours) that is mostly related to the saturable, tight binding of linagliptin to DPP-4 and does not contribute to the accumulation of the medicinal product.
Slovenian: Plazemska koncentracija linagliptina se zmanjšuje v treh fazah in z dolgim končnim razpolovnim časom (ki za to zdravilo znaša več kot 100 ur), ki je pretežno posledica nasičene, tesne vezave linagliptina na DPP-4 in ne prispeva h kopičenju zdravila.
English: The study population included 1211 (17.4 %) patients ≥ 75 years of age, the mean HbA1c was 8.0 %, 63 % were male.
Slovenian: Študijska populacija je vključevala 1211 (17,4 %) bolnikov, starih ≥ 75 let, povprečna vrednost HbA1c je znašala 8,0 %, 63 % je bilo moških.
English: The next dose should be taken at the usual time.
Slovenian: Naslednji odmerek mora bolnik vzeti ob običajnem času.
English: Allergic reactions, seen uncommonly (may affect up to 1 in 100 people) This medicine may cause allergic reactions, which may be serious, including hives (urticaria) and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema).
Slovenian: Alergijske reakcije, občasne (pojavijo se lahko pri največ 1 od 100 bolnikov) To zdravilo lahko povzroči hude alergijske reakcije, vključno s koprivnico (urtikarija) in otekanje obraza, ustnic, jezika in žrela, ki lahko povzročijo težave pri dihanju ali požiranju (angioedem).
English: In clinical trials, nineteen patients 75 years or older were treated with Glyxambi.
Slovenian: V kliničnih preizkušanjih je bilo z zdravilom Glyxambi zdravljenih 19 bolnikov, starih 75 let ali starejših.
English: Do not take Glyxambi: - if you are allergic to empagliflozin, linagliptin, any other SGLT2 inhibitor (e.g. dapagliflozin, canagliflozin), any other DPP-4 inhibitor (e.g. sitagliptin, vildagliptin), or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Glyxambi: - če ste alergični na empagliflozin, linagliptin, kateri koli zaviralec SGLT2 (npr. dapagliflozin, kanagliflozin), kateri koli zaviralec DPP-4 (npr. sitagliptin, vildagliptin) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The risk of DKA 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 DKA je treba pomisliti, če se pojavijo nespecifični simptomi, kot so slabost, bruhanje, anoreksija, bolečine v trebuhu, prekomerna žeja, oteženo dihanje, zmedenost, neobičajna utrujenost ali zaspanost.
English: In addition, linagliptin did not increase the risk of hospitalization for heart failure [HR=0.90; (95 % CI 0.74, 1.08)].
Slovenian: Poleg tega linagliptin ni povečal tveganja za hospitalizacijo zaradi srčnega popuščanja [HR = 0,90; (95-% IZ 0,74; 1,08)].
English: Initiation of therapy with Glyxambi in this population is not recommended (see section 4.2).
Slovenian: Uvedba zdravljenja z zdravilom Glyxambi pri tej populaciji ni priporočljiva (glejte poglavje 4.2).
English: Overall, the safety profile of Glyxambi was in line with the safety profiles of the individual active substances (empagliflozin and linagliptin).
Slovenian: Celokupno varnostni profil zdravila Glyxambi ustreza varnostnima profiloma njegovih posameznih zdravilnih učinkovin (empagliflozina in linagliptina).
English: Linagliptin administered during the period of organogenesis was not teratogenic.
Slovenian: Linagliptin, uporabljen v obdobju organogeneze, ni bil teratogen.
English: At exposures sufficiently in excess of exposure in humans after therapeutic doses, the combination of empagliflozin and linagliptin was not teratogenic and did not show maternal toxicity.
Slovenian: Pri izpostavljenostih, ki so pomembno večje od izpostavljenostih pri ljudeh po terapevtskih odmerkih, kombinacija empagliflozina in linagliptina ni bila teratogena in ni kazala toksičnosti pri materi.
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 should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Glyxambi is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin and analogues, sulphonylureas).
Slovenian: Bolnikom je treba svetovati, naj s preventivnimi ukrepi preprečijo hipoglikemijo med vožnjo in upravljanjem strojev, zlasti pri uporabi zdravila Glyxambi v kombinaciji z drugimi antidiabetiki, za katere je znano, da povzročajo hipoglikemijo (npr. insulinom in/ali njegovimi analogi, sulfonilsečninami).
English: Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Slovenian: Pri bolnikih, pri katerih se je v preteklosti med zdravljenjem z zaviralcem SGLT2 pojavila DKA, ponovna uvedba zaviralca SGLT2 ni priporočljiva, razen če je ugotovljen in odpravljen kakšen drug nedvomen sprožilni dejavnik.
English: Table 1 Adverse reactions System organ class
Slovenian: Preglednica 1 Neželeni učinki Organski sistem
English: A minor fraction is metabolised via uridine 5'diphosphoglucuronosyltransferases (UGT); therefore, a clinically relevant effect of UGT inhibitors on empagliflozin is not expected (see section 5.2).
Slovenian: Manjši del se presnovi prek uridin 5‘-difosfoglukuroniltransferaze (UGT), zato ni pričakovati klinično pomembnega učinka zaviralcev UGT na empagliflozin (glejte poglavje 5.2).
English: C] linagliptin dose to healthy subjects, approximately 85 % of the administered radioactivity was eliminated in faeces (80 %) or urine (5 %) within 4 days of dosing.
Slovenian: C] linagliptina se je pri zdravih preizkušancih približno 85 % radioaktivnosti izločilo z blatom (80 %) ali urinom (5 %) v 4 dneh po dajanju.
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: Diabetična ketoacidoza, redka (pojavi se lahko pri največ 1 od 1.000 bolnikov) 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, - bolečine v želodcu, - prekomerna žeja, - hitro in globoko dihanje, - zmedenost, - neobičajna zaspanost ali utrujenost, - sladek zadah, sladek ali kovinski okus v ustih ali drugačen vonj urina ali znoja.
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.
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.
English: Approximately 19 % of the population had an eGFR <60 mL/min/1.73 m
Slovenian: Približno 19 % populacije je imelo eGFR < 60 ml/min/1,73 m
English: Renal clearance at steady-state was approximately 70 mL/min.
Slovenian: Ledvični očistek v stanju dinamičnega ravnovesja je bil približno 70 ml/min.
English: If a dose is missed, and it is 12 hours or more until the next dose, the dose should be taken as soon as the patient remembers.
Slovenian: Če bolnik odmerek pozabi in je do naslednjega odmerka 12 ur ali več, ga mora vzeti takoj, ko se spomni.
English: Effects of other medicinal products on linagliptin
Slovenian: Učinki drugih zdravil na linagliptin
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 latentnim avtoimunim diabetesom odraslih (LADA - latent autoimmune diabetes in adults) ali bolniki 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: What Glyxambi is and what it is used for What you need to know before you take Glyxambi How to take Glyxambi
Slovenian: Kaj je zdravilo Glyxambi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Glyxambi Kako jemati zdravilo Glyxambi Možni neželeni učinki
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection
Slovenian: Vaginalna kandidoza, vulvovaginitis, balanitis in druge okužbe spolovil
English: Non-clinical studies with empagliflozin and linagliptin as single agents do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Slovenian: Neklinične študije z empagliflozinom in linagliptinom kot samostojnima zdraviloma ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost (glejte poglavje 5.3).
English: A significantly higher incidence of malignant lymphomas only in female mice at the highest dose (>200-times human exposure) is not considered relevant for humans.
Slovenian: Pomembno večja pojavnost malignih limfomov, ki so jo odkrili samo pri mišjih samicah, ki so prejemale največje odmerke (več kot 200-krat večje kot za človeka na podlagi izpostavljenosti), pa ni pomembna za ljudi.
English: One main metabolite with a relative exposure of 13.3 % of linagliptin at steady-state was detected which was found to be pharmacologically inactive and thus to not contribute to the plasma DPP-4 inhibitory activity of linagliptin.
Slovenian: Odkrili so en glavni presnovek s 13,3 % relativno izpostavljenostjo linagliptina v stanju dinamičnega ravnovesja, ki pa je bil farmakološko neaktiven in ni prispeval h zaviralnemu delovanju linagliptina na DPP-4 v plazmi.
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 ledvičnega meha pri približno 4-kratni klinični izpostavljenosti empagliflozinu na podlagi vrednosti AUC, povezani z odmerkom 25 mg.
English: No drug interaction studies have been performed with Glyxambi and other medicinal products; however, such studies have been conducted with the individual active substances.
Slovenian: Študij medsebojnega delovanja z zdravilom Glyxambi in drugimi zdravili niso izvedli, vendar pa so jih izvedli s posameznima zdravilnima učinkovinama.
English: Coadministration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6 % increase in AUC and 14 % increase in Cmax of digoxin.
Slovenian: Sočasna uporaba digoksina, substrata P-gp, z empagliflozinom je povzročila 6 % povečanje AUC in 14 % povečanje Cmax digoksina.
English: Use in patients at risk for volume depletion
Slovenian: Uporaba pri bolnikih, pri katerih obstaja tveganje za zmanjšanje volumna