FrancophonIA/ELRC3.0 huggingface dataset:
English: As a result of tissue binding, the mean apparent volume of distribution at steady-state following a single 5 mg intravenous dose of linagliptin to healthy subjects is approximately 1,110 litres, indicating that linagliptin extensively distributes to the tissues.
Slovenian: Zaradi vezave v tkiva je srednji navidezni volumen porazdelitve v stanju dinamičnega ravnovesja po intravenskem odmerku linagliptina po 5 mg pri zdravih preizkušancih približno 1.110 litrov, kar kaže, da se linagliptin obsežno porazdeli v tkiva.
English: Co-administration of rifampicin decreased linagliptin exposure by 40 %, suggesting that the efficacy of linagliptin may be reduced when administered in combination with a strong P-glycoprotein (P-gp) or cytochrome P450 (CYP) isozyme CYP3A4 inducer, particularly if these are administed long-term (see section 5.2).
Slovenian: Sočasno dajanje rifampicina je za 40 % zmanjšalo izpostavljenost linagliptinu, kar nakazuje, da se lahko učinkovitost linagliptina v kombinaciji z močnimi induktorji P-glikoproteina (P-gp) ali izocima CYP3A4 citokroma P450 (CYP), zlasti v primeru dolgotrajne uporabe, zmanjša (glejte poglavje 5.2).
English: Your doctor may want to reduce your dose of these medicines when you take them together with Glyxambi, in order to avoid too low blood sugar (hypoglycaemia).
Slovenian: Zdravnik vam bo v tem primeru mogoče znižal odmerek teh zdravil, če jih boste jemali hkrati z zdravilom Glyxambi, da bi tako preprečil, da bi se raven krvnega sladkorja preveč znižala (hipoglikemija);
English: Due to the mechanism of action, the glycaemic efficacy of empagliflozin is dependent on renal function (see sections 4.2, 5.1 and 5.2).
Slovenian: Zaradi mehanizma delovanja je glikemična učinkovitost empagliflozina odvisna od delovanja ledvic (glejte poglavja 4.2, 5.1 in 5.2).
English: In analyses for albuminuria progression (change from normoalbuminuria to micro-or macroalbuminuria, or from microalbuminuria to macroalbuminuria) the estimated hazard ratio was 0.86 (95 % CI 0.78, 0.95) for linagliptin versus placebo.
Slovenian: Pri analizah napredovanja albuminurije (sprememba z normoalbuminurije v mikro- ali makroalbuminurijo ali z mikroalbuminurije v makroalbuminurijo) je bilo ocenjeno razmerje tveganja 0,86 (95-% IZ 0,78; 0,95) za linagliptin v primerjavi s placebom.
English: • Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2).
Slovenian: • empagliflozin deluje tako, da v ledvicah zavira beljakovino, imenovano natrijev glukozni prenašalec 2 (SGLT2).
English: • You can take Glyxambi with or without food.
Slovenian: • Zdravilo Glyxambi lahko jemljete s hrano ali brez nje.
English: Empagliflozin is a substrate of the human uptake transporters OAT3, OATP1B1, and OATP1B3, but not Organic Anion Transporter 1 (OAT1) and Organic Cation Transporter 2 (OCT2).
Slovenian: Empagliflozin je substrat humanih privzemnih prenašalcev OAT3, OATP1B1 in OATP1B3, ne pa tudi organskega anionskega prenašalca 1 (OAT1) in organskega kationskega prenašalca 2 (OCT2).
English: Plasma protein binding of linagliptin is concentration-dependent, decreasing from about 99 % at 1 nmol/L to 75-89 % at ≥30 nmol/L, reflecting saturation of binding to DPP-4 with increasing concentration of linagliptin.
Slovenian: Vezava linagliptina na beljakovine v plazmi je odvisna od koncentracije in se zmanjša od približno 99 % pri 1 nmol/l, na 75 do 89 % pri ≥ 30 nmol/l ali več, kar priča o zasičenosti vezave na DPP-4 pri večanju koncentracije linagliptina.
English: Animal studies with empagliflozin have shown adverse effects on postnatal development (see section 5.3).
Slovenian: Študije na živalih so pokazale neželene učinke empagliflozina na postnatalni razvoj (glejte poglavje 5.3).
English: Linagliptin is an inhibitor of the enzyme DPP-4 an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide¬1, glucose-dependent insulinotropic polypeptide).
Slovenian: Linagliptin je zaviralec DPP-4, encima, ki sodeluje pri inaktivaciji dveh inkretinskih hormonov GLP-1 in GIP (glukagonu podoben peptid 1, od glukoze odvisni insulinotropni polipeptid).
English: Glyxambi has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Glyxambi ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: There are no data from the use of empagliflozin and linagliptin in pregnant women.
Slovenian: Podatkov o uporabi empagliflozina in linagliptina pri nosečnicah ni.
English: For FPG, baseline FPG is also included.
Slovenian: Raven FPG vključuje tudi izhodiščno raven FPG.
English: Do not use this medicine if you are breast-feeding.
Slovenian: Ne uporabljajte tega zdravila, če dojite.
English: The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to <80 mL/min), moderate (30 to <50 mL/min), and severe (<30 mL/min), as well as patients with ESRD on haemodialysis.
Slovenian: Študija je zajela bolnike, pri katerih so ledvično okvare na podlagi kreatininskega očistka opredelili kot blago (50 do < 80 ml/min), zmerno (30 do < 50 ml/min) in hudo (< 30 ml/min) ter bolnike s končno ledvično okvaro na hemodializi.
English: Your doctor may prescribe Glyxambi together with another anti-diabetic medicine.
Slovenian: Zdravnik vam lahko predpiše jemanje zdravila Glyxambi hkrati z drugim antidiabetikom.
English: Linagliptin cardiovascular safety (CAROLINA) study
Slovenian: Študija o srčno-žilni varnosti linagliptina (CAROLINA)
English: The most frequently reported adverse event in clinical trials with linagliptin was hypoglycaemia observed under the triple combination, linagliptin plus metformin plus sulphonylurea (22.9 % vs 14.8 % in placebo).
Slovenian: Najpogostnejši neželeni učinek v kliničnih preskušanjih z linagliptinom je bil hipoglikemija pri jemanju trojne kombinacije, ki je vsebovala linagliptin, metformin in sulfonilsečnino (22,9 % v primerjavi s 14,8 % pri placebu).
English: What you need to know before you take Glyxambi
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Glyxambi
English: • thirst
Slovenian: • žeja.
English: 45 mL/min.
Slovenian: CrCl < 60 ml/min.
English: In the EMPA-REG OUTCOME study, 10.1 % of the patients were reported with cardiac failure at baseline.
Slovenian: V študiji EMPA-REG OUTCOME so pri 10,1 % bolnikih poročali o srčnem popuščanju na začetku študije.
English: These infections were reported more frequently for empagliflozin compared to placebo in female patients, and the difference in frequency was less pronounced in male patients.
Slovenian: O teh okužbah so v primerjavi s placebom pogosteje poročali pri ženskah, ki so prejemale empagliflozin, razlika v pogostnosti pa je bila manj izrazita pri moških.
English: The adverse reactions shown in the table below (see Table 1) are listed by system organ class and are based on the safety profiles of empagliflozin and linagliptin monotherapy.
Slovenian: Neželeni učinki, prikazani v spodnji preglednici (glejte Preglednica 1), so navedeni po organskih sistemih ter temeljijo na varnostnih profilih empagliflozina in linagliptina kot samostojnih zdravil.
English: The information about adverse reactions not reported in Glyxambi clinical trials is based on the experience from empagliflozin and linagliptin.
Slovenian: Informacije o neželenih učinkih, o katerih niso poročali v kliničnih preskušanjih z zdravilom Glyxambi, temeljijo na izkušnjah z empagliflozinom in linagliptinom.
English: • inflamed nose or throat (nasopharyngitis)
Slovenian: • vnetje nosu ali grla (nazofaringitis),
English: No dose adjustment is required in patients with mild to moderate hepatic impairment.
Slovenian: Prilagoditev odmerka pri bolnikih z blago do zmerno jetrno okvaro ni potrebna.
English: CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Slovenian: skupina zdravljenih, tj. bolniki, ki so prejeli vsaj en odmerek testnega zdravila združeni odmerki empagliflozina 10 mg in 25 mg * ker so podatke iz študije vključili v vmesno analizo, so uporabili dvostranski 95,02 % interval zaupanja, kar ustreza vrednosti p s stopnjo značilnosti manj kot 0,0498.
English: Therefore, a lower dose of insulin or sulphonylureas may be required to reduce the risk of hypoglycaemia when used in combination with Glyxambi (see sections 4.2, 4.4 and 4.8).
Slovenian: Zato bo morda potreben manjši odmerek insulina ali sulfonilsečnin za zmanjšanje tveganja hipoglikemije, če se uporablja v kombinaciji z zdravilom Glyxambi (glejte poglavja 4.2, 4.4 in 4.8).
English: A total of 6979 patients were treated (linagliptin 5 mg: 3494, placebo: 3485) and followed for a median of 2.2 years.
Slovenian: Zdravljenih je bilo skupno 6979 bolnikov (linagliptin 5 mg: 3494, placebo: 3485), mediana obdobja njihovega spremljanja pa je bila 2,2 leti.
English: Driving and using machines Glyxambi has minor influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Glyxambi ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: Due to the mechanism of action of empagliflozin, patients taking Glyxambi will test positive for glucose in their urine.
Slovenian: Zaradi mehanizma delovanja empagliflozina bodo rezultati testov glukoze v urinu pri bolnikih, ki uporabljajo Glyxambi, pozitivni.
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 tudi pri empagliflozinu pogosteje poročali o okužbah sečil pri bolnikih s kroničnimi ali ponavljajočimi okužbami sečil v anamnezi.
English: Consistent with the half life, up to 22 % accumulation, with respect to plasma AUC, was observed at steady state.
Slovenian: Skladno z razpolovnim časom so v stanju dinamičnega ravnovesja opazili do 22% kopičenje glede na vrednost AUC v plazmi.
English: Inhibition of OATP1B1/1B3 transporters by co-administration with rifampicin resulted in a 75 % increase in Cmax and a 35 % increase in AUC of empagliflozin.
Slovenian: Zaviranje prenašalcev OATP1B1/1B3 zaradi sočasne uporabe rifampicina je povzročilo 75 % povečanje vrednosti Cmax in 35 %povečanje AUC empagliflozina.
English: When used in combination with antidiabetics known to cause hypoglycaemia (e.g. sulphonylureas and/or insulin), the incidence of hypoglycaemia of both agents was increased (see section 4.8).
Slovenian: V kombinaciji z drugimi antidiabetiki, za katere je znano, da povzročajo hipoglikemijo (npr. sulfonilsečnine in/ali insulin), se je pojavnost hipoglikemije pri obeh zdravilnih učinkovinah povečala (glejte poglavje 4.8).
English: Co-administration of a high-fat meal with linagliptin prolonged the time to reach Cmax by 2 hours and lowered Cmax by 15 % but no influence on AUC0-72h was observed.
Slovenian: Pri sočasnem obroku z veliko vsebnostjo maščob se je čas do dosežene Cmax podaljšal za dve uri, vrednost Cmax pa je bila za 15 % manjša, kar pa ni vplivalo na AUC0-72h.
English: There is very little experience in patients aged 75 years or older.
Slovenian: Z bolniki starimi 75 let in več je zelo malo izkušenj.
English: Linagliptin cardiovascular and renal safety (CARMELINA) study
Slovenian: Študija o srčno-žilni in ledvični varnosti linagliptina (CARMELINA)
English: Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:
Slovenian: Zdravilo Glyxambi, fiksna kombinacija empagliflozina in linagliptina, je indicirano pri odraslih bolnikih, starejših od 18 let, s sladkorno boleznijo tipa 2:
English: Focal areas of hepatocellular necrosis were found in the combination groups at ≥15: 30 mg/kg linagliptin: empagliflozin (3.8 times the clinical exposure for linagliptin and 7.8 times the clinical exposure for empagliflozin) as well as in the group treated with empagliflozin alone but not in the control group.
Slovenian: Žarišča jetrne nekroze so našli v kombiniranih skupinah pri odmerkih ≥ 15 : 30 mg/kg linagliptina: empagliflozin (3,8-kratna vrednost klinične izpostavljenosti za linagliptin 7,8-kratna vrednost klinične izpostavljenosti za empagliflozin), kot tudi pri skupini, ki je prejemala le empagliflozin, ne pa tudi pri kontrolni skupini.
English: Body mass index
Slovenian: Indeks telesne mase
English: Linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin, empagliflozin or oral contraceptives providing in vivo evidence of a low propensity for causing drug interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-gp and organic cationic transporter (OCT).
Slovenian: Linagliptin ni klinično pomembno vplival na farmakokinetiko metformina, glibenklamida, simvastatina, pioglitazona, varfarina, digoksina, empagliflozina ali peroralnih kontraceptivov, kar je kazalec in vivo, da je možnost povzročanja interakcij zdravila s substrati encimov CYP3A4, CYP2C9, CYP2C8, P-gp in organskih kationskih prenašalcev (OCT, organic cationic transporter) majhna.
English: They have “25/5” on one side and the Boehringer Ingelheim logo on the other side.
Slovenian: Na eni strani imajo oznako »25/5«, na drugi pa logotip Boehringer Ingelheim.
English: Glyxambi can therefore be taken with or without food.
Slovenian: Zdravilo Glyxambi se lahko jemlje s hrano ali brez nje.
English: In addition patients with T2DM and severe renal impairment (<30 mL/min) were compared to T2DM patients with normal renal function.
Slovenian: Poleg tega so bolnike s sladkorno boleznijo tipa 2 in hudo ledvično okvaro (< 30 ml/min) primerjali z bolniki s sladkorno boleznijo tipa 2 z normalnim delovanjem ledvic.
English: If you take more of this medicine than you should, immediately talk to a doctor or go to a hospital.
Slovenian: Če ste vzeli večji odmerek zdravila Glyxambi, kot bi smeli Če ste vzeli večji odmerek tega zdravila, kot bi smeli, se takoj posvetujte z zdravnikom ali pojdite takoj v bolnišnico.
English: The mean age was 64 years, the mean HbA1c was 7.15 %, and 60 % were male.
Slovenian: Povprečna starost je bila 64 let, povprečna vrednost HbA1c je bila 7,15 %, od tega je bilo 60 % moških.
English: One patient administered Glyxambi experienced a confirmed (investigator-defined), major hypoglycaemic event (defined as an event requiring assistance) in the active- or placebo-controlled trials (overall frequency 0,1 %).
Slovenian: V aktivno ali s placebom nadzorovanih preskušanjih so pri enem bolniku, ki je prejel zdravilo Glyxambi, potrdili (skladno z opredelitvijo raziskovalca) hud hipoglikemični dogodek (opredeljen kot dogodek, zaradi katerega je potrebno posredovanje) (celokupna pogostnost 0,1 %).
English: Other side effects while taking Glyxambi:
Slovenian: Drugi neželeni učinki, ki se pojavijo med jemanjem zdravila Glyxambi:
English: • blistering of skin (bullous pemphigoid)
Slovenian: • mehurji na koži (bulozni pemfigoid),
English: In patients with mild, moderate or severe renal impairment (eGFR <30 to <90 mL/min/1.73 m2) and patients with kidney failure or 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 do < 90 ml/min/1,73 m2) in pri bolnikih z ledvično odpovedjo ali 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: Effects of empagliflozin on other medicinal products
Slovenian: Učinki empagliflozina na druga zdravila
English: A total of 6033 patients were treated (linagliptin 5 mg: 3023, glimepiride 1 mg to 4 mg: 3010) and followed for a median of 6.25 years.
Slovenian: Zdravljenih je bilo skupno 6033 bolnikov (linagliptin 5 mg: 3023, glimepiridin 1 mg do 4 mg: 3010), mediana obdobja njihovega spremljanja pa je bila 6,25 let.
English: Hypersensitivity to the active substances, to any other Sodium-Glucose-Co-Transporter-2 (SGLT2) inhibitor, to any other Dipeptidyl-Peptidase-4 (DPP-4) inhibitor, or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilni učinkovini, kateri koli drug zaviralec natrijevega glukoznega koprenašalca 2 (SGLT2), kateri koli drug zaviralec encima dipeptidil peptidaze-4 (DPP-4) ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Glyxambi can also be used as an alternative to taking both empagliflozin and linagliptin as single tablets.
Slovenian: Zdravilo Glyxambi se lahko uporablja tudi namesto jemanja empagliflozina in linagliptina kot ločenih tablet.
English: Co-administration of a single 5 mg oral dose of linagliptin and multiple 200 mg oral doses of ritonavir, a potent inhibitor of P-glycoprotein and CYP3A4, increased the AUC and Cmax of linagliptin approximately twofold and threefold, respectively.
Slovenian: Pri sočasnem dajanju enkratnega peroralnega odmerka linagliptina po 5 mg in večkratnih peroralnih odmerkov ritonavirja, močnega zaviralca P-glikoproteina in CYP3A4, po 200 mg, sta se povečali AUC in Cmax linagliptina, in sicer za približno dvakrat oziroma trikrat.
English: If pancreatitis is suspected, Glyxambi should be discontinued; if acute pancreatitis is confirmed, Glyxambi should not be restarted.
Slovenian: Pri sumu na pankreatitis je treba zdravljenje z zdravilom Glyxambi prekiniti; če je akutni pankreatitis potrjen, zdravljenja ni dovoljeno nadaljevati.
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: After 24 weeks, rescue therapy was used in 4 (3.6 %) patients treated with empagliflozin 25 mg and in 2 (1.8 %) patients treated with empagliflozin 10 mg, compared to 13 (12.0 %) patients treated with placebo (all patients on background metformin + linagliptin 5 mg).
Slovenian: Po 24 tednih je bilo reševalno zdravljenje uporabljeno pri 4 bolnikih (3,6 %), zdravljenih z empagliflozinom 25 mg, in 2 bolnikih (1,8 %), zdravljenih z empagliflozinom 10 mg, v primerjavi s 13 bolniki (12,0 %), ki so prejemali placebo (vsi bolniki so prejemali osnovno zdravljenje z metforminom in linagliptinom 5 mg).
English: Hypoglycaemia with empagliflozin
Slovenian: Hipoglikemija pri empagliflozinu
English: In moderate renal impairment, a moderate increase in exposure of about 1.7-fold was observed compared with control.
Slovenian: Pri zmerni ledvični okvari je bila izpostavljenost v primerjavi s kontrolo zmerno povečana, in sicer za 1,7-krat.
English: What Glyxambi looks like and contents of the pack
Slovenian: Izgled zdravila Glyxambi in vsebina pakiranja
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: Študija medsebojnega delovanja z gemfibrozilom, ki je in vitro zaviralec prenašalcev OAT3 in OATP1B1/1B3, je pokazala, da se je po sočasni uporabi Cmax empagliflozina povečal za 15 %, AUC pa za 59 %.
English: Therefore, special attention should be given to their volume intake in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE inhibitors).
Slovenian: Zato je treba pri teh bolnikih posebno pozornost nameniti vnosu tekočin v primeru sočasnega zdravljenja z zdravili, ki lahko povzročijo zmanjšanje volumna (npr. diuretiki, zaviralci ACE).
English: The frequencies have been comparable to those reported from the empagliflozin clinical trials (see also section 4.4).
Slovenian: Pogostnosti so bile primerljive s pogostnostmi, o katerih so poročali iz kliničnih preskušanj z empagliflozinom (glejte tudi poglavje 4.4).
English: At exposures greater than 1,500-times the clinical exposure, side effects on reproductive organs, thyroid and the lymphoid organs were seen in rats.
Slovenian: Pri izpostavljenosti, ki je bila več kot 1500-krat večja od klinične izpostavljenosti, so pri podganah opazili neželene učinke na reproduktivne organe, ščitnico in limfne organe.
English: A dose reduction of the sulphonylurea or insulin may be considered (see section 4.2 and 4.5).
Slovenian: Morda bo treba odmerek sulfonilsečnine ali insulina zmanjšati (glejte poglavji 4.2 in 4.5).
English: Glyxambi should not be used during breast-feeding.
Slovenian: Zdravila Glyxambi se med dojenjem ne sme uporabljati.
English: Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low.
Slovenian: Zdravnik bo morda zmanjšal odmerek teh zdravil, da prepreči pojav prenizke ravni krvnega sladkorja;
English: A causal relationship between empagliflozin and hepatic injury has not been established.
Slovenian: Vzročne povezanosti med empagliflozinom in poškodbami jeter niso ugotovili.
English: Glyxambi is added to metformin and/or sulphonylurea (SU) to treat type 2 diabetes in adult patients whose diabetes cannot be controlled when treated with metformin and/or sulphonylurea in combination with empagliflozin, or when treated with metformin and/or sulphonylurea in combination with linagliptin.
Slovenian: Zdravilo Glyxambi se uporablja kot dodatek k metforminu in/ali sulfonilsečnini za zdravljenje sladkorne bolezni tipa 2 pri odraslih bolnikih, pri katerih z metforminom in/ali sulfonilsečnino v kombinaciji z empagliflozinom, ali pri zdravljenju z metforminom in sulfonilsečnino v kombinaciji z linagliptinom, ni mogoče doseči ustrezne urejenosti bolezni.
English: Warnings and precautions Talk to your doctor, before taking this medicine, and during treatment:
Slovenian: Pred začetkom jemanja tega zdravila in med zdravljenjem se posvetujte z zdravnikom:
English: Linagliptin is not expected to be eliminated to a therapeutically significant degree by haemodialysis or peritoneal dialysis.
Slovenian: Linagliptin se med hemodializo ali peritonealno dializo predvidoma ne odstrani v terapevtsko pomembnem obsegu.
English: Glyxambi is an anti-diabetic medicine that contains two active substances called empagliflozin and linagliptin:
Slovenian: Zdravilo Glyxambi je antidiabetik, ki vsebuje dve zdravilni učinkovini, tj. empagliflozin in linagliptin:
English: Inhibition of SGLT2 in patients with type 2 diabetes mellitus and hyperglycaemia leads to excess glucose excretion in the urine.
Slovenian: Zaviranje SGLT2 pri bolnikih s sladkorno boleznijo tipa 2 in hiperglikemijo povzroči izločanje presežne glukoze z urinom.
English: Animal studies show that empagliflozin and linagliptin cross the placenta during late gestation, but do not indicate direct or indirect harmful effects with respect to early embryonic development with either empagliflozin or linagliptin (see section 5.3).
Slovenian: Študije na živalih kažejo, da empagliflozin in linagliptin v pozni dobi gestacije prehajata preko posteljice, vendar tako empagliflozin kot linagliptin ne kažeta neposrednih ali posrednih škodljivih učinkov na embrionalni razvoj (glejte poglavje 5.3).
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: Body Weight-24 weeks
Slovenian: Telesna masa - 24 tednov
English: Temporary interruption of treatment with Glyxambi should be considered until the fluid loss is corrected.
Slovenian: Presoditi je treba o začasni prekinitvi zdravljenja z zdravilom Glyxambi do ponovne vzpostavitve tekočinskega ravnovesja.