FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that patients obtain several baseline blood or urine ketone levels over one to two weeks period prior to initiation of sotagliflozin therapy, and patients should become familiar with the behaviours/circumstances associated with elevated ketone levels and how to address them.
Croatian: Preporučuje se da bolesnici nekoliko puta izmjere početne vrijednosti ketona u krvi ili mokraći tijekom jednoga do dva tjedna prije uvođenja liječenja sotagliflozinom te da prepoznaju koja su ponašanja/okolnosti povezani s povišenim vrijednostima ketona i kako na to mogu utjecati.
English: Clinical stage
Croatian: KLINIČKI PODACI
English: - It is recommended that patients obtain several baseline blood or urine ketone levels over one to two weeks prior to initiation of sotagliflozin therapy, and, patients should become familiar with how their behaviours and circumstances affect their ketone levels.
Croatian: - Preporučuje se da bolesnici nekoliko puta izmjere početne vrijednosti ketona u krvi ili mokraći tijekom jednoga do dva tjedna prije uvođenja liječenja sotagliflozinom te da prepoznaju kako njihovo ponašanje i okolnosti utječu na vrijednosti ketona.
English: • yeast infection (thrush) of the penis (signs may include irritation, itching, unusual discharge or odour)
Croatian: • gljivična infekcija penisa kandidom (znakovi mogu uključivati nadraženost, svrbež, neobičan iscjedak ili neugodan miris)
English: In the 3 Phase 3 randomized clinical studies in patients with type 1 diabetes, patients with eGFR < 45 mL/min/1.73 m2 were excluded, 79 patients exposed to sotagliflozin had an eGFR < 60 mL/min/1.73 m2 and 841 patients had an eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2.
Croatian: U tri randomizirana klinička ispitivanja faze 3 provedena u bolesnika sa šećernom bolešću tipa 1 nisu bili uključeni bolesnici kojima je eGFR iznosio < 45 ml/min/1,73 m2, dok je 79 bolesnika izloženih sotagliflozinu imalo eGFR < 60 ml/min/1,73 m2, a 841 bolesnik imao je eGFR ≥ 60 i ≤ 90 ml/min/1,73 m2.
English: N/A -1.98 *
Croatian: N/P -1,98 *
English: Basal insulin
Croatian: Bazalni inzulin
English: b Adverse event grouping, including, but not limited to, balanoposthitis, genital infections fungal, balanitis candida, epididymitis.
Croatian: b Pojam obuhvaća, između ostaloga, balanopostitis, gljivičnu genitalnu infekciju, kandidni balanitis,
English: o nausea, vomiting, or abdominal pain o excessive thirst o constantly feeling tired o high levels of ketones in urine tests or beta-hydroxybutyrate (BHB) in blood tests o difficulty breathing/rapid, deep breathing o breath with fruity odour o difficulty paying attention, or confusion o rapid weight loss
Croatian: o mučnina, povraćanje ili bol u trbuhu o prekomjerna žeđ o stalan umor o visoke vrijednosti ketona u pretragama mokraće ili beta-hidroksibutirata (BHB) u krvnim pretragama o otežano disanje/brzo, duboko disanje o voćni miris daha o poteškoće s koncentracijom ili smetenost o nagli gubitak tjelesne težine
English: Subsequently, basal insulin should be adjusted based on blood glucose results.
Croatian: Nakon toga dozu bazalnog inzulina treba prilagođavati na temelju vrijednosti glukoze u krvi.
English: Table 5: Results of CGM sub study at week 24 (Pooled data, study 1 and study 2) Characteristic
Croatian: Tablica 5: Rezultati podispitivanja uz kontinuirano praćenje vrijednosti glukoze u 24. tjednu (objedinjeni podaci, ispitivanje 1 i ispitivanje 2)
English: Make sure you carry the Patient Alert Card, that was given to you by your physician and that is also enclosed in the product packaging, with you at all times.
Croatian: Obavezno sa sobom uvijek nosite Karticu s upozorenjima za bolesnika, koju ste dobili od svog liječnika i koja dolazi i u pakiranju lijeka.
English: Treatment with sotagliflozin also resulted in reduction in body weight and systolic blood pressure (in patients with baselines SBP ≥130 mmHg) compared with insulin alone (see Table 6).
Croatian: Također, liječenje sotagliflozinom dovelo je do smanjenja tjelesne težine i sistoličkog krvnog tlaka (u bolesnika kojima je sistolički krvni tlak na početku ispitivanja iznosio ≥ 130 mmHg) u odnosu na liječenje samo inzulinom (vidjeti Tablicu 6).
English: The PK of sotagliflozin appeared to be dose proportional in the therapeutic dose range of 200 mg to 400 mg QD.
Croatian: Farmakokinetika sotagliflozina činila se proporcionalnom dozi u rasponu terapijskih doza od 200 mg do 400 mg jedanput na dan.
English: In the study 48% were male and 92% were White and 84% of randomised patients completed the study.
Croatian: U tom je ispitivanju 48% ispitanika bilo muškog spola, 92% ispitanika bili su bijelci, a ispitivanje je završilo 84% randomiziranih bolesnika.
English: - Patients who insist on maintaining caloric restriction, carbohydrate restriction or ketogenic diet or who chronically under-dose insulin (e.g. in order to remain in a lipolytic state).
Croatian: - bolesnici koji ustraju na ograničenom unosu kalorija, ograničenom unosu ugljikohidrata ili ketogenoj dijeti ili koji kontinuirano primjenjuju premale doze inzulina (npr. da bi se održali u stanju lipolize) - bolesnici koji konzumiraju prekomjerne količine alkohola ili uzimaju nedopuštene droge
English: On a background of optimised insulin, the efficacy and safety of sotagliflozin 200 mg or 400 mg once daily versus insulin alone were evaluated in two double-blind, placebo controlled studies (study 1 and 2) performed in 1575 patients with type 1 diabetes on insulin pump or multiple daily injection therapy.
Croatian: Djelotvornost i sigurnost sotagliflozina u dozi od 200 mg ili 400 mg jedanput na dan uz optimizirani inzulinski režim kao osnovnu terapiju u odnosu na inzulin primijenjen samostalno ocjenjivale su se u dvama dvostruko slijepim, placebom kontroliranim ispitivanjima (ispitivanje 1 i ispitivanje 2), provedenima u 1575 bolesnika sa šećernom bolešću tipa 1 koji su koristili inzulinsku pumpu ili primjenjivali više injekcija na dan.
English: By inhibiting SGLT2, sotagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Croatian: Inhibiranjem SGLT2 sotagliflozin smanjuje bubrežnu reapsorpciju filtrirane glukoze i snizuje bubrežni prag za glukozu te tako povećava izlučivanje glukoze u mokraću.
English: The mean age of patients was 46 years, 8.1% were 65 years or older.
Croatian: Srednja vrijednost dobi bolesnika iznosila je 46 godina, a njih 8,1% bilo je u dobi od 65 ili više godina.
English: Following the administration of a single dose of 400 mg [14C]-sotagliflozin, showed 57% and 37% of the radioactivity were excreted in the urine and faeces, respectively.
Croatian: Nakon primjene jedne doze [14C]-sotagliflozina od 400 mg, 57% radioaktivnosti izlučilo se u mokraću, a 37% u feces.
English: Be aware that either uro-genital infection or perineal abscess may precede necrotizing fasciitis.
Croatian: Treba imati na umu da nekrotizirajućem fasciitisu mogu prethoditi urogenitalna infekcija ili perinealni apsces.
English: • DKA may occur in patients treated with sotagliflozin even if blood glucose levels are below 14 mmol/l (250 mg/dl), i.e. an explanation of the concept of euglycaemic DKA.
Croatian: • Napomenu da u bolesnika koji se liječe sotagliflozinom DKA može nastupiti čak i ako su vrijednosti glukoze u krvi ispod 14 mmol/l (250 mg/dl), tj. objašnjenje koncepta euglikemijske DKA.
English: The apparent clearance of sotagliflozin decreases with decreasing renal function.
Croatian: Prividni klirens sotagliflozina smanjuje se sa smanjenjem funkcije bubrega.
English: Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Primjena sotagliflozina ne preporučuje se u bolesnika s umjerenim i teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: In the pooled 52-week data, the incidence of DKA was increased in a dose-dependent manner for sotagliflozin (2.9% and 3.8% for sotagliflozin 200 mg and 400 mg, respectively) compared to placebo (0.2%).
Croatian: 52-tjednim podacima incidencija DKA uz sotagliflozin povećavala se ovisno o dozi (za 2,9% uz dozu od 200 mg i 3,8% uz dozu od 400 mg) u odnosu na placebo (0,2%).
English: In the study 52% were male and 96.2% were White and 87% of randomised patients completed the study.
Croatian: U tom je ispitivanju 52% ispitanika bilo muškog spola, 96,2% ispitanika bili su bijelci, a ispitivanje je završilo 87% randomiziranih bolesnika.
English: Table 1: Actions to take in case of elevated ketone levels
Croatian: Tablica 1: Mjere koje treba poduzeti u slučaju povišenih vrijednosti ketona Klinički stadij Ketoni u krvi
English: Therapy with Zynquista should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus.
Croatian: 4.2 Doziranje i način primjene Liječenje lijekom Zynquista mora započeti i nadzirati liječnik koji ima iskustva s liječenjem šećerne bolesti tipa 1.
English: The level of digoxin or digitoxin in your blood may need to be checked if you take these medicines with Zynquista.
Croatian: možda će trebati provjeriti vrijednost digoksina ili digitoksina u krvi.
English: In the broader pool, including all type 1 diabetes mellitus patients in phase 2 and 3 studies, the exposure-adjusted incidence rate was 3.07, 5.29 and 0.76 subjects per 100 patient-years for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo (see section 4.4).
Croatian: koji je obuhvatio sve bolesnike sa šećernom bolešću tipa 1 iz ispitivanja faze 2 i 3, stopa incidencije prilagođena za izloženost iznosila je 3,07, 5,29 i 0,76 ispitanika na 100 bolesnik-godina uz sotagliflozin u dozi od 200 mg, sotagliflozin u dozi od 400 mg odnosno placebo (vidjeti dio 4.4).
English: • Do not start caloric restriction or carbohydrate restriction while treated with sotagliflozin.
Croatian: • Tijekom liječenja ne smije se početi s ograničavanjem unosa kalorija ili ugljikohidrata.
English: Patients were then maintained on optimised insulin and randomized to sotagliflozin 200 mg, sotagliflozin 400 mg or insulin alone.
Croatian: Bolesnici su zatim nastavili primati optimiziranu dozu inzulina te su bili randomizirani za primanje sotagliflozina u dozi od 200 mg, sotagliflozina u dozi od 400 mg ili samo inzulina.
English: The mean age of patients was 41 years, 4.2% were 65 years or older.
Croatian: Srednja vrijednost dobi bolesnika iznosila je 41 godinu, a njih 4,2% bilo je u dobi od 65 ili više godina.
English: In studies 1 and 2 combined, patient 24-week completion rates were 89.5% among insulin alone patients, and 91.4% and 90.7% among patients receiving 200 mg and 400 mg of sotagliflozin, respectively.
Croatian: Prema objedinjenim podacima iz ispitivanja 1 i ispitivanja 2, udio bolesnika koji su završili 24 tjedna ispitivanja iznosio je 89,5% u skupini koja je primala samo inzulin te 91,4% i 90,7% u skupinama koje su primale sotagliflozin u dozi od 200 mg odnosno 400 mg.
English: Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment, as sotagliflozin exposure is increased in these patients (see sections 4.2 and 5.2).
Croatian: Primjena sotagliflozina ne preporučuje se u bolesnika s umjerenim i teškim oštećenjem funkcije jetre jer je izloženost sotagliflozinu u tih bolesnika povećana (vidjeti dijelove 4.2 i 5.2).
English: Adverse reactions related to volume depletion (e.g., hypovolemia, blood pressure decreased, blood pressure systolic decreased, dehydration, hypotension, orthostatic hypotension, and syncope) were reported by 2.7%, 1.1% and 1.0% of patients treated with sotagliflozin 200mg, sotagliflozin 400 mg and placebo.
Croatian: hipovolemiju, snižen krvni tlak, snižen sistolički krvni tlak, dehidraciju, hipotenziju, ortostatsku hipotenziju i sinkopu) prijavilo je 2,7% bolesnika liječenih sotagliflozinom u dozi od 200 mg,
English: At week 24, treatment with 200 mg or 400 mg sotagliflozin provided statistically significant reductions in HbA1c (p-value <0.001) compared to insulin alone.
Croatian: Liječenje sotagliflozinom u dozi od 200 mg ili 400 mg ostvarilo je u 24. tjednu statistički značajna sniženja vrijednosti HbA1c (p-vrijednost < 0,001) u odnosu na liječenje samo inzulinom.
English: In a rat carcinogenicity study, a statistically significant increase in thyroid follicular cell carcinoma was observed in males at 75 mg/kg/day, approx. 14 times the MRHD, the highest dose evaluated.
Croatian: U ispitivanju kancerogenosti provedenom na štakorima opažen je statistički značajan porast stope karcinoma folikularnih stanica štitnjače u mužjaka pri dozi od 75 mg/kg na dan, kojom se postiže razina izloženosti približno 14 puta veća od one nakon primjene maksimalne preporučene doze u ljudi
English: For all patients, it is recommended that ketones should be measured with changes to the normal routine, including reduced carbohydrate intake, intercurrent illness, reductions in total daily insulin dosing, physical activity and stress.
Croatian: U svih se bolesnika preporučuje izmjeriti vrijednosti ketona kod promjena u uobičajenoj rutini, uključujući smanjen unos ugljikohidrata, interkurentnu bolest,
English: Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.
Croatian: Zynquista je indicirana kao dodatak inzulinskoj terapiji za poboljšanje kontrole glikemije u odraslih osoba sa šećernom bolešću tipa 1 i indeksom tjelesne mase (ITM) ≥ 27 kg/m2 u kojih nije postignuta odgovarajuća kontrola glikemije unatoč optimalnoj inzulinskoj terapiji.
English: Based on a population PK analysis gender and race had no clinically meaningful effect on the PK of sotagliflozin.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, spol i rasa nisu imale klinički značajnog učinka na farmakokinetiku sotagliflozina.
English: Patients with a history of chronic or recurrent genital mycotic infections are more likely to develop genital mycotic infections.
Croatian: Vjerojatnost razvoja genitalnih gljivičnih infekcija veća je u bolesnika koji imaju kronične ili rekurentne genitalne gljivične infekcije u anamnezi.
English: Patients should be assessed for ketoacidosis immediately if these symptoms occur, by measuring the urine or blood ketones, regardless of blood glucose level.
Croatian: Ako se pojave ti simptomi, potrebno je odmah ocijeniti ima li bolesnik ketoacidozu, i to mjerenjem vrijednosti ketona u mokraći ili krvi neovisno o vrijednosti glukoze u krvi.
English: Initiation of sotagliflozin is not recommended when eGFR is less than 60 ml/min/1.73 m2 and should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2 (see sections 4.4 and 4.8).
Croatian: Ne preporučuje se uvoditi sotagliflozin ako je procijenjena brzina glomerularne filtracije (engl. estimated glomerular filtration rate, eGFR) ispod 60 ml/min/1,73 m2, a njegovu primjenu treba prekinuti ako je eGFR stalno ispod 45 ml/min/1,73 m2 (vidjeti dijelove 4.4 i 4.8).
English: In the study 50% were male and 88 % were White and 87% of randomised patients completed the study.
Croatian: 50% ispitanika bilo muškog spola, 88% ispitanika bili su bijelci, a ispitivanje je završilo 87% randomiziranih bolesnika.
English: The apparent volume of distribution of sotagliflozin following administration of a single 400 mg oral dose of [14C]-sotagliflozin was found to be very high with a mean value of 9392 L.
Croatian: Nakon primjene jedne peroralne doze [14C]-sotagliflozina od 400 mg utvrđen je vrlo velik prividni volumen distribucije sotagliflozina, čija je srednja vrijednost iznosila 9392 l.
English: Fournier´s gangrene has to be treated immediately.
Croatian: Fournierova gangrena uništava tkivo ispod kože i mora se odmah liječiti.
English: - Patients should be informed, in a dedicated education session, on the risk of DKA, how to recognize DKA risk factors, signs or symptoms, how and when to monitor ketone levels and what actions to take when ketone levels are elevated (see section 4.4).
Croatian: - Bolesnicima treba održati posebnu edukaciju na kojoj ih treba informirati o riziku od DKA, o tome kako će prepoznati faktore rizika za DKA te znakove ili simptome DKA, kako i kada trebaju pratiti vrijednosti ketona i što trebaju učiniti u slučaju povišenih vrijednosti ketona
English: The HbA1c reduction observed in patients with eGFR ≥60 to <90 mL/min/1.73 m2 was comparable to the HbA1c reduction observed in patients with eGFR ≥90 mL/min/1.73 m2.
Croatian: Sniženje vrijednosti HbA1c opaženo u bolesnika kojima je eGFR iznosio ≥ 60 i < 90 ml/min/1,73 m2 bilo je usporedivo sa sniženjem vrijednosti HbA1c u bolesnika kojima je eGFR iznosio ≥ 90 ml/min/1,73 m2.
English: • If treated with sotagliflozin, glucose levels will not adequately reflect insulin needs, and DKA may occur in patients treated with sotagliflozin even if blood glucose levels are below 14 mmol/l (250 mg/dl).
Croatian: • U bolesnika liječenih sotagliflozinom vrijednosti glukoze neće na odgovarajući način odražavati potrebe za inzulinom, pa u bolesnika koji se liječe sotagliflozinom DKA može nastupiti čak i ako su vrijednosti glukoze u krvi ispod 14 mmol/l (250 mg/dl).
English: At the end of 24 weeks the reduction in HbA1c was -0.36% and -0.38% and at 52 weeks it was -0.23% and -0.32% with sotagliflozin 200mg and 400 mg, respectively.
Croatian: Sniženje vrijednosti HbA1c iznosilo je -0,36% i -0,38% nakon 24 tjedna te -0,23% i -0,32% nakon 52 tjedna uz sotagliflozin u dozi od 200 mg odnosno 400 mg.
English: In study 3 at 24 weeks incidences of severe hypoglycaemia were 2.4% and 3.0% on placebo and sotagliflozin 400 mg, respectively and the reduction in the rate of hypoglycaemic events at 24 weeks (blood glucose ≤3.1 mmol/L) for sotagliflozin 400 mg was 22% (p<0.001) compared to insulin alone.
Croatian: U ispitivanju 3, incidencija teške hipoglikemije u 24. tjednu iznosila je 2,4% uz placebo i 3,0% uz sotagliflozin u dozi od 400 mg, a smanjenje stope događaja hipoglikemije u 24. tjednu (glukoza u krvi ≤ 3,1 mmol/l) uz sotagliflozin u dozi od 400 mg iznosilo je 22% (p < 0,001) u odnosu na primjenu samo inzulina.
English: No dose adjustment is recommended in patients with mild hepatic impairment.
Croatian: Ne preporučuje se prilagođavati dozu u bolesnika s blagim oštećenjem funkcije jetre.
English: 7.0% at week 24, n (%) Body Weight (kg) Baseline, mean
Croatian: HbA1c < 7,0% u 24. tjednu, n (%) Tjelesna težina (kg)
English: How to take Zynquista
Croatian: Kako uzimati lijek Zynquista
English: The incidence of renal-related events was low and similar across the groups (1.5%, 1.5% and 1.3% for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo).
Croatian: Incidencija događaja povezanih s bubrezima bila je niska i slična u svim skupinama (1,5% uz sotagliflozin u dozi od 200 mg, 1,5% uz sotagliflozin u dozi od 400 mg i 1,3% uz placebo).
English: • For patients taking ZYNQUISTA, glucose is not a reliable marker for DKA and must be supplemented with ketone monitoring
Croatian: • U bolesnika koji uzimaju lijek ZYNQUISTA glukoza nije pouzdan biljeg za DKA, pa se uz vrijednosti glukoze moraju pratiti i vrijednosti ketona.
English: After starting therapy, the frequency of ketone level testing (either blood or urine) should be individualized, according to the patient's lifestyle and/or risk factors (see section 4.4).
Croatian: Učestalost određivanja vrijednosti ketona (bilo u krvi ili mokraći) nakon započinjanja liječenja treba individualno prilagoditi u skladu s načinom života i/ili faktorima rizika kod pojedinog bolesnika
English: During a dedicated counselling session with the patient at the time of first prescription of sotagliflozin the Patient/Carer Guide and Patient Alert card, also available via the QRcode or website, should be presented.
Croatian: - koji su sposobni pratiti vrijednosti ketona i prošli su edukaciju o tome kada je najbolje vrijeme da to učine Tijekom posebnog savjetovanja pri prvom propisivanju sotagliflozina bolesniku treba dati Vodič za bolesnika/njegovatelja i Karticu s upozorenjima za bolesnika, koji su dostupni i putem QR kôda ili internetske stranice.
English: The patient should be informed: - how to recognize the risk factors which can predispose to ketosis and DKA (including, but not limited to, recent or recurrent history of DKA, missed or reduced insulin doses, decreased caloric intake or severe dehydration, vigorous exercise, intercurrent illness, surgery, alcohol abuse, and in patients using an insulin infusion pump, insulin infusion interruption), - how to recognize DKA signs or symptoms, emphasizing that DKA could occur even when blood glucose levels are below 14 mmol/L (250 mg/dL), - when to discontinue sotagliflozin therapy (see section 4.2), - what actions to take when ketosis/DKA is suspected.
Croatian: Bolesnike treba uputiti: - kako prepoznati faktore rizika koji mogu biti predispozicija za ketozu i DKA (što uključuje, ali nije ograničeno na nedavnu DKA ili rekurentnu DKA u anamnezi, propuštene ili smanjene doze inzulina, smanjen kalorijski unos ili tešku dehidraciju, žustru tjelovježbu, interkurentnu bolest, kirurški zahvat, prekomjerno uživanje alkohola te privremeni prekid infuzije inzulina u bolesnika koji koriste inzulinsku infuzijsku pumpu)
English: The overall frequency of urinary tract infections reported were 7.1% and 5.5% for sotagliflozin 200 mg and sotagliflozin 400 mg compared to 6.1% for placebo.
Croatian: Infekcije mokraćnih putova Ukupna učestalost prijavljenih infekcija mokraćnih putova iznosila je 7,1% i 5,5% uz sotagliflozin u dozi od 200 mg odnosno 400 mg, u usporedbi sa 6,1% uz placebo.
English: No dose adjustment is needed in patients with mild hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem funkcije jetre.
English: The proportion of patients with A1C <7.0% at 24 weeks was 19.0% for placebo, 35.1% for sotagliflozin 200mg, 40.4% for sotagliflozin 400mg and at 52 weeks was 18.3%, 28.6% and 31.6% for placebo, sotagliflozin 200 mg and 400 mg respectively.
Croatian: Udio bolesnika s vrijednošću HbA1c < 7,0% u 24. tjednu iznosio je 19,0% uz placebo, 35,1% uz sotagliflozin u dozi od 200 mg te 40,4% uz sotagliflozin u dozi od 400 mg, dok je u 52. tjednu iznosio 18,3%, 28,6% i 31,6% uz placebo, sotagliflozin u dozi od 200 mg odnosno sotagliflozin u dozi od 400 mg.
English: • Counsel the patient and evaluate their adherence to ketone monitoring while establishing their baseline ketone level 1 to 2 weeks before treatment initiation and ensure the patient o Has received education/training in ketone testing and interpreting/acting upon test results.
Croatian: • Potrebno je savjetovati bolesnika i ocijeniti njegovo pridržavanje uputa za praćenje vrijednosti ketona za vrijeme utvrđivanja njihove početne vrijednosti ketona tijekom 1 - 2 tjedna prije početka liječenja i osigurati da je bolesnik:
English: An increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing long-term, clinical studies with another SGLT2 inhibitor.
Croatian: U dugoročnim kliničkim ispitivanjima jednog drugog inhibitora SGLT2 koja su još u tijeku opažen je porast broja slučajeva amputacije donjih ekstremiteta (prvenstveno nožnog prsta).
English: No differences in HbA1c decrease could be detected across subgroups including age, gender, race, geographic region, baseline BMI, age at diagnosis, baseline HbA1c, eGFR, duration of disease and insulin delivery method.
Croatian: geografskoj regiji, početnom ITM-u, dobi pri dijagnozi, početnoj vrijednosti HbA1c, eGFR-u, trajanju bolesti i metodi primjene inzulina.