FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, Synjardy can be used as an alternative to taking both empagliflozin and metformin as single tablets.
Slovenian: Zdravilo Synjardy se lahko uporablja tudi kot alternativna možnost za kombinacijo empagliflozina in metformina v ločenih tabletah.
English: In patients with mild, moderate or severe renal impairment (creatinine clearance <30 - <90 ml/min) 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 (kreatininski očistek < 30 - < 90 ml/min) 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 s preizkušanci z normalnim delovanjem ledvic.
English: Consistently, in the EMPA-REG OUTCOME study, patients treated with empagliflozin experienced an initial fall in eGFR (mean: 3 ml/min/1.73 m2).
Slovenian: Skladno s tem je v študiji EMPA-REG-OUTCOME pri bolnikih, ki so prejemali empagliflozin, vrednost eGFR na začetku zdravljenja padla (povprečje: 3 ml/min/1,73 m2).
English: Stop taking Synjardy and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Slovenian: Takoj prenehajte jemati zdravilo Synjardy in se obrnite na zdravnika ali najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
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 bolniki s pankreatitisom v anamnezi), bolniki s stanji, ki vodijo v 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: Patients with heart failure are more at risk of hypoxia and renal insufficiency.
Slovenian: Pri bolnikih s srčnim popuščanjem obstaja večje tveganje za hipoksijo in ledvično okvaro.
English: • necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus
Slovenian: • nekrotizirajoči fasciitis presredka ali Fournierjeva gangrena, resna okužba mehkega tkiva spolovil ali predela med spolovili in zadnjikom.
English: Empagliflozin does not inhibit human uptake transporters such as OAT3, OATP1B1, and OATP1B3 in vitro at clinically relevant plasma concentrations and, as such, drug-drug interactions with substrates of these uptake transporters are considered unlikely.
Slovenian: Empagliflozin in vitro ne zavira humanih privzemnih prenašalcev, kot so OAT3, OATP1B1 in OATP1B3 v klinično pomembnih plazemskih koncentracijah, zato medsebojno delovanje zdravila s substrati teh privzemnih prenašalcev ni verjetno.
English: If you need to have major surgery you must stop taking Synjardy during and for some time after the procedure.
Slovenian: Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila Synjardy.
English: Empagliflozin should not be initiated.
Slovenian: Empagliflozina se ne sme uvesti.
English: As Synjardy contains empagliflozin it 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: Zdravilo Synjardy vsebuje empagliflozin, ki lahko okrepi diuretični učinek tiazida in diuretikov Henlejeve zanke ter poveča tveganje za dehidracijo in hipotenzijo (glejte poglavje 4.4).
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: Caution is therefore advised, especially in patients with renal impairment, when these drugs are coadministered with metformin, as metformin plasma concentration may increase.
Slovenian: Tako je priporočena previdnost pri sočasni uporabi metformina z navedenimi zdravili, še zlasti pri bolnikih z ledvično okvaro, ker lahko pride do povečanja koncentracije metformina v plazmi.
English: Temporary interruption of treatment with Synjardy should be considered until the fluid loss is corrected.
Slovenian: Presoditi je treba o začasni prekinitvi zdravljenja z zdravilom Synjardy do ponovne vzpostavitve tekočinskega ravnovesja.
English: A paediatric Phase 1 study examined the pharmacokinetics and pharmacodynamics of empagliflozin (5 mg, 10 mg and 25 mg) in children and adolescents ≥10 to <18 years of age with type 2 diabetes mellitus.
Slovenian: V pediatrični študiji faze 1 so preučevali farmakokinetiko in farmakodinamiko empagliflozina (5 mg, 10 mg in 25 mg) pri otrocih in mladostnikih s sladkorno boleznijo tipa 2, starih ≥ 10 do < 18 let.
English: In addition, urinary glucose excretion triggers calorie loss, associated with body fat loss and body weight reduction.
Slovenian: Izločanje glukoze z urinom povzroči tudi izgubo kalorij, ki je povezana z izgubo telesne maščobe in zmanjšanjem telesne mase.
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 povzročilo 6-odstotno povečanje AUC in 14-odstotno povečanje Cmax digoksina.
English: 10 x 1 film-coated tablets 14 x 1 film-coated tablets 30 x 1 film-coated tablets 56 x 1 film-coated tablets 60 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Slovenian: 10 x 1 filmsko obložena tableta 14 x 1 filmsko obložena tableta 30 x 1 filmsko obložena tableta 56 x 1 filmsko obložena tableta 60 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta 100 x 1 filmsko obložena tableta
English: Metformin passes into human milk in small amounts.
Slovenian: Metformin se v majhnih količinah izloča v materino mleko.
English: If you stop taking Synjardy
Slovenian: Če ste prenehali jemati zdravilo Synjardy
English: Synjardy is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
Slovenian: Zdravilo Synjardy je indicirano za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2 kot dopolnilo k dieti in telesni aktivnosti:
English: Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.
Slovenian: Izboljšanje urejenosti glikemije ter zmanjšanje srčno-žilnih obolenj in umrljivosti sta ključni pri zdravljenju sladkorne bolezni tipa 2.
English: How to store Synjardy 6.
Slovenian: Shranjevanje zdravila Synjardy 6.
English: Necrotising fasciitis of the perineum (Fournier's gangrene) Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors.
Slovenian: Nekrotizirajoči fasciitis presredka (Fournierjeva gangrena) Po začetku trženja so poročali o primerih nekrotizirajočega fasciitisa presredka (znan tudi kot Fournierova gangrena) pri bolnikih in bolnicah, ki so jemali zaviralce SGLT2.
English: • blood tests may show increases in the amount of red blood cells in your blood (haematocrit)
Slovenian: • krvni testi lahko pokažejo povišane vrednosti rdečih krvnih celic (hematokrit).
English: Treatment with empagliflozin in combination with metformin (5 mg and 500 mg; 5 mg and 1000 mg; 12.5 mg and 500 mg, and 12.5 mg and 1000 mg given twice daily) provided statistically significant improvements in HbA1c (Table 4) and led to greater reductions in FPG (compared to the individual components) and body weight (compared to metformin).
Slovenian: Zdravljenje z empagliflozinom v kombinaciji z metforminom (5 mg in 500 mg; 5 mg in 1000 mg; 12,5 mg in 500 mg ter 12,5 mg in 1000 mg dvakrat dnevno) je povzročilo statistično pomembno izboljšanje ravni HbA1c (Preglednica 4) in je vodilo v večje zmanjšanje vrednosti FPG (v primerjavi s posameznimi komponentami) ter telesne mase (v primerjavi z metforminom).
English: In addition, initiation of empagliflozin increases excretion of sodium resulting in osmotic diuresis and reduced intravascular volume.
Slovenian: Dodatno pa zdravljenje z empagliflozinom poveča izločanje natrija, kar povzroči osmotsko diurezo in zmanjšanje intravaskularnega volumna.
English: Synjardy is added to diet and exercise to treat type 2 diabetes in adult patients (aged 18 years and older) whose diabetes cannot be controlled by adding metformin alone or metformin with other medicines for diabetes.
Slovenian: Zdravilo Synjardy se uporablja skupaj z dieto in telesno aktivnostjo za zdravljenje sladkorne bolezni tipa 2 pri odraslih bolnikih (starih 18 let in več), ki je ne moremo obvladovati z metforminom samim ali v kombinaciji z drugimi antidiabetičnimi zdravili.
English: Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Slovenian: Absolutna biološka uporabnost tablet metforminijevega klorida po 500 mg ali 850 mg je pri zdravih preizkušancih približno 50-60 %.
English: The most commonly reported adverse events in clinical trials were hypoglycaemia in combination with insulin and/or sulphonylurea, urinary tract infections, genital tract infections and increased urination (see description of selected side effects).
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali v kliničnih preskušanjih, so bili hipoglikemija (pri kombinaciji z insulinom in/ali sulfonilsečnino), okužba sečil, okužba spolovil in pogostejše uriniranje (glejte opis izbranih neželenih učinkov).
English: The pharmacokinetics of 5 mg empagliflozin twice daily and 10 mg empagliflozin once daily were compared in healthy subjects.
Slovenian: Farmakokinetiko empagliflozina 5 mg dvakrat dnevno in empagliflozina 10 mg enkrat dnevno so primerjali pri zdravih preizkušancih.
English: The observed effect of food on empagliflozin and metformin is not considered to be clinically relevant.
Slovenian: Opazovani učinek hrane na farmakokinetiko empagliflozina in metformina ni bil klinično pomemben.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
English: In addition, empagliflozin showed a higher (HR 1.82, 95 % CI 1.40, 2.37) occurrence of sustained normo- or micro-albuminuria (49.7 %) in patients with baseline macro-albuminuria compared with placebo (28.8 %).
Slovenian: Poleg tega je empagliflozin pokazal večjo (RO 1,82; 95-% IZ 1,40; 2,37) pojavnost ohranjene normoin mikroalbuminurije (49,7 %) pri bolnikih z izhodiščno makroalbuminurijo v primerjavi s placebom
English: Of these, 266 or 264 patients were treated with empagliflozin 10 mg or 25 mg as add-on to metformin plus insulin, respectively.
Slovenian: Od teh je bilo 266 ali 264 bolnikov zdravljenih z empagliflozinom 10 mg oziroma z empagliflozinom 25 mg kot dodatnim zdravljenjem k metforminu in insulinu.
English: If you forget to take Synjardy
Slovenian: Če ste pozabili vzeti zdravilo Synjardy
English: Treatment with empagliflozin in combination with metformin with or without other antidiabetic medicinal products (pioglitazone, sulfonylurea, DPP-4 inhibitors, and insulin) led to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, systolic and diastolic blood pressure.
Slovenian: Zdravljenje z empagliflozinom v kombinaciji z metforminom z drugimi antidiabetičnimi zdravili (pioglitazonom, sulfonilsečnino, zaviralci DPP-4 in insulinom) ali brez njih je povzročilo klinično pomembna izboljšanja HbA1c, glukoze v plazmi na tešče (FPG, fasting plasma glucose), telesne mase ter sistoličnega in diastoličnega krvnega tlaka.
English: To avoid overdose, do not continue taking empagliflozin and metformin tablets separately, if you are taking this medicine.
Slovenian: Če jemljete to zdravilo, prenehajte jemati ločene tablete empagliflozina in metformina, da preprečite preveliko odmerjanje.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses.
Slovenian: Največja koncentracija metformina v plazmi (Cmax) v nadzorovanih kliničnih preskušanjih tudi ob največjih odmerkih ni presegla 5 mikrogramov/ml.
English: Mean eGFR returned to baseline after treatment discontinuation suggesting acute haemodynamic changes may play a role in these renal function changes.
Slovenian: Po zaključku zdravljenja so se povprečne vrednosti eGFR vrnile na izhodiščne vrednosti, kar nakazuje na to, da imajo lahko akutne hemodinamske spremembe vlogo pri tovrstnih spremembah delovanja ledvic.
English: • if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see ‘Risk of lactic acidosis' below) or ketoacidosis.
Slovenian: • če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
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: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Urinary tract infection (including pyelonephritis and urosepsis)
Slovenian: Infekcijske in parazitske bolezni vaginalna kandidoza, vulvovaginitis, balanitis in druge okužbe spolovil okužbe sečil (vključno s pielonefritisom in urosepso)
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, povezani z odmerkom 25 mg.
English: Elevated haematocrit Haematocrit increase was observed with empagliflozin treatment (see section 4.8).
Slovenian: Zvišan hematokrit Pri zdravljenju z empagliflozinom so opazili zvišanje hematokrita (glejte poglavje 4.8).
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 prenašalec natrija in glukoze 2 (SGLT2, sodium-glucose co-transporter 2).
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Slovenian: Metformin je bigvanid z antihiperglikemičnimi učinki, ki znižuje raven bazalne glukoze in glukoze v plazmi po jedi.
English: It is not known whether empagliflozin passes into human breast milk.
Slovenian: Ni znano, ali se empagliflozin izloča v materino mleko.
English: In patients tolerating a total daily dose of empagliflozin 10 mg and who need tighter glycaemic control, the dose can be increased to a total daily dose of empagliflozin 25 mg.
Slovenian: Pri bolnikih, ki prenašajo skupni dnevni odmerek empagliflozina 10 mg in ki potrebujejo boljšo urejenost glikemije, se lahko skupni dnevni odmerek empagliflozina poveča na 25 mg.
English: Patients with baseline HbA1c ≥9%
Slovenian: Bolniki z izhodiščno vrednostjo HbA1c ≥ 9 %
English: Following administration of a dose of 850 mg metformin hydrochloride, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 minute prolongation of the time to peak plasma concentration were observed.
Slovenian: Po dajanju odmerka metforminijevega klorida 850 mg so izmerili za 40 % manjšo največjo koncentracijo v plazmi, za 25 % manjšo vrednost AUC in za 35 minut podaljšan čas do največje koncentracije v plazmi.
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 značilno manjši delež bolnikov s hipoglikemičnimi dogodki v primerjavi z glimepiridom (2,5 % za empagliflozin, 24,2 % za glimepirid, p < 0,0001).
English: As expected, empagliflozin 5 mg administered twice daily compared with 10 mg empagliflozin once daily resulted in lower Cmax and higher trough plasma empagliflozin concentrations (Cmin).
Slovenian: Kot je pričakovano, je empagliflozin 5 mg dvakrat dnevno v primerjavi z empagliflozinom 10 mg enkrat dnevno povzročil nižjo Cmax in višje plazemske koncentracije empagliflozina pred naslednjim odmerjanjem (Cmin).
English: The male mouse renal tumours are considered not relevant to humans.
Slovenian: Ledvični tumorji pri mišjih samcih ne veljajo za pomembne pri človeku.
English: Metformin is excreted into human milk.
Slovenian: Metformin se izloča v materino mleko.
English: At week 18, empagliflozin provided statistically significant improvement in HbA1c.
Slovenian: V 18. tednu je pri empagliflozinu prišlo do statistično značilnega izboljšanja vrednosti HbA1c.
English: In patients ≥75 years of age volume depletion events have been reported in a single patient treated with empagliflozin 25 mg as add-on to metformin therapy.
Slovenian: Pri bolnikih starosti ≥ 75 let so o dogodkih, povezanih z zmanjšanjem volumna, poročali pri samo enem bolniku, ki je prejemal empagliflozin 25 mg kot dodatno zdravljenje k metforminu.
English: Synjardy has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Synjardy ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Slovenian: Študije medsebojnega delovanja pri zdravih prostovoljcih kažejo, da empagliflozin nima klinično pomembnega učinka na farmakokinetiko metformina, glimepirida, pioglitazona, sitagliptina, linagliptina, simvastatina, varfarina, ramiprila, digoksina, diuretikov in peroralnih kontraceptivov.
English: Driving and using machines Synjardy has minor influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Synjardy ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
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 co-administration.
Slovenian: Študija medsebojnega delovanja z gemfibrozilom, ki je in vitro zaviralec OAT3 in prenašalcev OATP1B1/1B3, je pokazala, da se je po sočasni uporabi Cmax empagliflozina povečal za 15 %, AUC pa za 59 %.
English: Empagliflozin in combination with metformin in drug-naïve patients A factorial design study of 24 weeks duration was conducted to evaluate the efficacy and safety of empagliflozin in drug-naïve patients.
Slovenian: Empagliflozin v kombinaciji z metforminom pri predhodno nezdravljenih bolnikih Izvedena je bila 24-tedenska študija s faktorsko analizo za oceno učinkovitosti in varnosti empagliflozina pri predhodno nezdravljenih bolnikih.
English: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart diseases).
Slovenian: Tveganje za razvoj laktacidoze je večje tudi ob sočasni nenadzorovani sladkorni bolezni, resnih okužbah, dolgotrajnem postenju ali čezmernem uživanju alkohola, dehidraciji (glejte dodatne informacije spodaj), težavah z jetri ali katerih koli bolezenskih stanjih, pri katerih je oskrba dela telesa s kisikom zmanjšana (na primer akutna huda bolezen srca).
English: In patients age 75 years and older, numerically lower reductions in HbA1c were observed with empagliflozin treatment.
Slovenian: Pri bolnikih, starih 75 let in več, so pri zdravljenju z empagliflozinom opazili številčno manjše zmanjšanje HbA1c.
English: When Synjardy is used in combination with a sulphonylurea and/or insulin, a lower dose of sulphonylurea and/or insulin may be required to reduce the risk of hypoglycemia (see sections 4.5 and
Slovenian: Če se zdravilo Synjardy uporablja v kombinaciji s sulfonilsečnino in/ali insulinom, bo morda treba zmanjšati odmerek sulfonilsečnine ali insulina, da bi zmanjšali tveganje za hipoglikemijo (glejte poglavji 4.5 in 4.8).
English: Therefore, special attention should be given to their volume intake in case of coadministered 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: Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see sections 4.3 and 4.4).
Slovenian: Za preprečevanje z metforminom povezane laktacidoze je zlasti pri starejših bolnikih treba spremljati delovanje ledvic (glejte poglavji 4.3 in 4.4).
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 4kratnemu največjemu priporočenemu dnevnemu odmerku) niso pokazali toksičnosti.
English: If this happens you must stop taking Synjardy and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Slovenian: V tem primeru morate prenehati jemati zdravilo Synjardy in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo.