FrancophonIA/ELRC3.0 huggingface dataset:
English: In a pre-/post-natal development study, no sotagliflozin-related adverse effects in pregnant and lactating females and offspring development were observed in rats In a study evaluating the potential effects of sotagliflozin on the development of juvenile rats, no sotagliflozin-related toxicity was observed following the administration of oral doses up to approximately 18 and 31 fold that of the MRHD (400 mg/day) for males and females, respectively.
Croatian: U ispitivanju u kojem su se ocjenjivali potencijalni učinci sotagliflozina na razvoj juvenilnih štakora nije opažena toksičnost povezana sa sotagliflozinom nakon primjene oralnih doza kojima se u mužjaka i ženki postiže izloženost do približno 18 odnosno 31 puta veća od one nakon primjene maksimalne preporučene doze u ljudi (400 mg/dan).
English: Zynquista 200 mg tablets sotagliflozin
Croatian: Zynquista 200 mg tablete sotagliflozin
English: - Correction of volume depletion prior to initiation of sotagliflozin is recommended in patients with this condition (see section 4.4).
Croatian: U bolesnika s tim stanjem preporučuje se korekcija deplecije volumena prije uvođenja sotagliflozina (vidjeti dio 4.4).
English: Table 2: Tabulated list of adverse reactions System Organ class
Croatian: Tablica 2: Tablični prikaz nuspojava
English: Characteristic
Croatian: Značajka
English: At screening the HbA1c was 8.21%, 8.26% and 8.20% for insulin, insulin+sotagliflozin 200 mg and insulin+sotagliflozin 400 mg.
Croatian: Vrijednost HbA1c pri probiru iznosila je 8,21% za inzulin, 8,26% za inzulin + sotagliflozin u dozi od 200 mg te 8,20% za inzulin + sotagliflozin u dozi od 400 mg.
English: These results indicate that the main route of elimination of drug related material was renal.
Croatian: Ti nalazi ukazuju na to da se materijali povezani s lijekom prvenstveno eliminiraju putem bubrega.
English: N/A -0.37*
Croatian: N/P -0,37*
English: Diarrhoea, flatulence
Croatian: Poremećaji probavnog sustava proljev, flatulencija
English: • Patients with euglycaemic DKA should receive glucose, insulin and fluids for DKA, sotagliflozin should be discontinued.
Croatian: • Bolesnici s euglikemijskom DKA trebaju primiti glukozu, inzulin i tekućine za DKA, a liječenje sotagliflozinom treba prekinuti.
English: a Adverse event grouping, including, but not limited to, vulvovaginal mycotic infection, vaginal infection, vulvitis, vulvovaginal candidiasis, genital infection, genital candidiasis, genital infection fungal, vulvovaginitis, urogenital infection fungal.
Croatian: a Pojam obuhvaća, između ostaloga, vulvovaginalnu gljivičnu infekciju, vaginalnu infekciju, vulvitis,
English: No data in humans are available on excretion of sotagliflozin into milk.
Croatian: Nisu dostupni podaci o izlučivanju sotagliflozina u majčino mlijeko.
English: This treatment is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with T1DM with a BMI ≥27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.
Croatian: Ovaj je lijek indiciran 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: • Patients with euglycaemic DKA should receive glucose, insulin and fluids for DKA management, sotagliflozin should be discontinued.
Croatian: • Bolesnici koji imaju euglikemijsku DKA trebaju primiti glukozu, inzulin i tekućine za zbrinjavanje DKA, a primjenu sotagliflozina treba obustaviti.
English: In a 12 week dose ranging study, consistent with SGLT1 inhibition, placebo corrected change from baseline 2-hour post prandial glucose (PPG), measured after a standardised mixed meal, was reduced by 1.52 mmol/L (p=0.15) and 2.73 mmol/L (p=0.006) in patients taking 200 mg and 400 mg sotagliflozin respectively, which is consistent with SGLT1 inhibition.
Croatian: U 12-tjednom ispitivanju provedenom radi utvrđivanja raspona doza, smanjenje početne postprandijalne vrijednosti glukoze izmjerene 2 sata nakon standardiziranog miješanog obroka korigirano za placebo iznosilo je 1,52 mmol/l (p=0,15) i 2,73 mmol/l (p=0,006) u bolesnika koji su uzimali sotagliflozin u dozi od 200 mg odnosno 400 mg, što je u skladu s inhibicijom SGLT1.
English: An increase in total exposure and Cmax of rosuvastatin of ca 1.2- and 1.4-fold, respectively, was demonstrated when co-administered with sotagliflozin and is not deemed clinically relevant.
Croatian: Kod istodobne primjene sa sotagliflozinom zabilježeno je povećanje ukupne izloženosti rosuvastatinu i za 1,2 puta i povećanje njegova Cmax za 1,4 puta, ali se to ne smatra klinički značajnim.
English: N/A -0.36 *
Croatian: N/P -0,36*
English: N/A -0.7*
Croatian: N/P -0,7*
English: Sotagliflozin and M19 have no significant potential to inhibit OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3.
Croatian: Sotagliflozin i M19 ne pokazuju značajan potencijal za inhibiciju prijenosnika OCT1, OCT2, OAT1,
English: • Patients with euglycaemic DKA may need glucose in addition to standard of care for DKA and sotagliflozin should be discontinued if DKA occurs.
Croatian: • Bolesnicima s euglikemijskom DKA može uz standardnu skrb za DKA biti potrebna i glukoza, a u slučaju nastupa DKA liječenje sotagliflozinom mora se prekinuti.
English: Treatment with sotagliflozin also resulted in reduction in body weight and bolus insulin dose compared with insulin alone (see Table 6).
Croatian: Liječenje sotagliflozinom također je dovelo do smanjenja tjelesne težine i doze bolusnog inzulina u odnosu na liječenje samo inzulinom (vidjeti Tablicu 6).
English: At week 24 and 52 the change from baseline in creatinine was equal to or less than 0.02 mg/dL for both sotagliflozin 200 and sotagliflozin 400 mg.
Croatian: Promjena vrijednosti kreatinina od početka ispitivanja do 24. i 52. tjedna iznosila je 0,02 mg/dl ili manje uz obje doze sotagliflozina (200 mg i 400 mg).
English: DKA may occur in patients treated with Zynquista even if blood glucose levels are below 14 mmol/l (250 mg/dl).
Croatian: U bolesnika koji se liječe lijekom Zynquista DKA može nastupiti čak i ako su vrijednosti glukoze u krvi ispod 14 mmol/l (250 mg/dl).
English: In a pre-specified pooled analysis of study 1 and study 2, treatment with sotagliflozin as adjunct to insulin resulted in a reduction of SBP (-0.6 mmHg for placebo, -2.6 mmHg for sotagliflozin 200 mg and -4.1 mmHg for sotagliflozin 400 mg) at week 12.
Croatian: Prema unaprijed specificiranoj objedinjenoj analizi podataka iz ispitivanja 1 i ispitivanja 2, liječenje sotagliflozinom kao dodatkom inzulinu dovelo je do sniženja sistoličkog krvnog tlaka u 12. tjednu (-0,6 mmHg uz placebo, -2,6 mmHg uz sotagliflozin u dozi od 200 mg i -4,1 mmHg uz sotagliflozin u dozi od 400 mg).
English: • if you have a history of chronic or recurrent yeast infections of the genitals (thrush)
Croatian: • ako ste u prošlosti imali dugotrajne gljivične infekcije genitalija kandidom ili gljivične infekcije genitalija kandidom koje su se ponavljale
English: Supplemental carbohydrate may be required based on glucose levels in addition to hydration and additional rapid acting insulin (see Table 1 in section 4.2).
Croatian: Uz hidraciju i dodatan brzodjelujući inzulin možda će biti potreban i dodatan unos ugljikohidrata ovisno o vrijednostima glukoze (vidjeti Tablicu 1 u dijelu 4.2).
English: At the end of 52 weeks the reduction in body weight, mean daily bolus insulin dose, FPG were sustained compared to insulin alone.
Croatian: Smanjenje tjelesne težine, srednje vrijednosti dnevne doze bolusnog inzulina i vrijednosti glukoze u plazmi natašte na kraju 52. tjedna bilo je održano u usporedbi s primjenom samo inzulina.
English: At screening the HbA1c was 8.42%, 8.35% and 8.38% for insulin, insulin+sotagliflozin 200 mg and insulin+sotagliflozin 400 mg.
Croatian: Vrijednost HbA1c pri probiru iznosila je 8,42% za inzulin, 8,35% za inzulin + sotagliflozin u dozi od 200 mg te 8,38% za inzulin + sotagliflozin u dozi od 400 mg.
English: A lower dose of insulin may be required to minimise the risk of hypoglycaemia when used in combination with sotagliflozin (see section 4.2).
Croatian: Kod primjene u kombinaciji sa sotagliflozinom možda će biti potrebna manja doza inzulina kako bi se minimizirao rizik od hipoglikemije (vidjeti dio 4.2).
English: • Sotagliflozin treatment should be temporarily stopped before surgical procedures or in case of hospitalisation for acute serious illness.
Croatian: • Liječenje sotagliflozinom treba privremeno prekinuti prije kirurških zahvata ili u slučaju hospitalizacije zbog akutne ozbiljne bolesti.
English: Your blood sugar levels may increase when you stop taking Zynquista.
Croatian: Vam porasti kad prestanete uzimati lijek Zynquista.
English: Sotagliflozin should not be used in patients with severe renal impairment, end stage renal disease (ESRD) or in patients on dialysis as it has not been studied in these patients (see section 4.2).
Croatian: Sotagliflozin se ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije bubrega, bolesnika u završnom stadiju bubrežne bolesti niti u bolesnika na dijalizi jer se u tih bolesnika nije ispitivao (vidjeti dio 4.2).
English: Drug/Laboratory test interference
Croatian: Utjecaj lijeka na nalaze laboratorijskih testova
English: In a 12-week dose ranging study, consistent with SGLT2 inhibition, 24-h placebo corrected change from baseline Urinary Glucose Excretion (UGE) increased by 57.7 grams (p<0.001) and 70.5 grams (p<0.001) in patients with type 1 diabetes taking 200 mg and 400 mg sotagliflozin respectively, which is consistent with SGLT2 inhibition.
Croatian: U 12-tjednom ispitivanju provedenom radi utvrđivanja raspona doza, povećanje početne količine glukoze izlučene u mokraću tijekom 24 sata korigirano za placebo iznosilo je 57,7 grama (p < 0,001) i 70,5 grama (p < 0,001) u bolesnika sa šećernom bolešću tipa 1 koji su uzimali sotagliflozin u dozi od 200 mg odnosno 400 mg, što je u skladu s inhibicijom SGLT2.
English: Effects of sotagliflozin on other medicinal products There is an increase in AUC0-inf and Cmax of digoxin (27% and 52% respectively) when coadministered with sotagliflozin 400mg, due to inhibition of P-gp by sotagliflozin.
Croatian: Zbog inhibicije P-gp-a djelovanjem sotagliflozina bilježi se porast AUC0-inf i Cmax digoksina (za 27% odnosno 52%) kada se primjenjuje istodobno sa sotagliflozinom u dozi od 400 mg.
English: fThe proportion of subjects that met the criteria haematocrit >50% was higher in the sotagliflozin 200 mg and 400 mg groups (6.7% and 8.2%) compared to the placebo group (2.7%)
Croatian: (> 50%) bio je veći u skupinama koje su primale sotagliflozin u dozi od 200 mg i 400 mg (6,7% odnosno 8,2%) nego u onoj koja je primala placebo (2,7%).
English: Sotagliflozin should not be initiated when patients are at a higher risk of DKA, such as: - Patients with low insulin needs.
Croatian: Sotagliflozin se ne smije uvesti bolesnicima s većim rizikom od DKA, kao što su:
English: • flatulence
Croatian: • proljev
English: Table 4: Results at 24-week trial with sotagliflozin in patients with type 1 diabetes mellitus inadequately controlled on insulin (Study 1 - Study 2)
Croatian: Tablica 4: Rezultati 24-tjednog ispitivanja sotagliflozina u bolesnika sa šećernom bolešću tipa 1
English: Rate of documented hypoglycaemia† (events per patient year) at thresholds of ≤3.1 or ≤3.9 mmol/L
Croatian: Stopa noćne‡ dokumentirane hipoglikemije† (događaji po bolesnik-godini) pri graničnim vrijednostima od ≤ 3,1 ili
English: OUTER CARTON multipack (with Blue Box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (S PLAVIM OKVIROM)
English: How to store Zynquista
Croatian: Kako čuvati lijek Zynquista
English: • diarrhoea
Croatian: - anoreksiju
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès et Lagrave F - 33565 Carbon Blanc France
Croatian: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès et Lagrave
English: Renal function abnormalities (increased serum creatinine and decreased eGFR) can occur after initiating sotagliflozin (see section 4.8).
Croatian: Nakon uvođenja sotagliflozina moguća su odstupanja parametara funkcije bubrega (povišene vrijednosti kreatinina u serumu i smanjen eGFR) (vidjeti dio 4.8).
English: Post prandial glucose reduction
Croatian: Sniženje postprandijalne vrijednosti glukoze
English: Mean change from baseline at week 52
Croatian: Srednja vrijednost promjene od početka ispitivanja do 52. tjedna
English: • if you have kidney problems
Croatian: • ako imate bubrežnih tegoba
English: Temporary interruption of sotagliflozin should be considered when treating pyelonephritis and urosepsis.
Croatian: Infekcije mokraćnih putova Kod liječenja pijelonefritisa i urosepse treba razmotriti privremeni prekid primjene sotagliflozina.
English: Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking other SGLT2 inhibitors.
Croatian: U žena i muškaraca koji su uzimali druge inhibitore SGLT2 prijavljeni su slučajevi nekrotizirajućeg fasciitisa perineuma (Fournierove gangrene) nakon stavljanja lijeka u promet.
English: Your doctor may ask you to stop taking Zynquista until you have recovered
Croatian: • ako imate infekciju bubrega ili mokraćnih putova; liječnik će Vas možda zamoliti da prestanete uzimati lijek Zynquista dok se ne oporavite
English: In the rat study, embryo-lethality, effects on fetal growth along with cardiovascular and skeletal abnormalities were observed at an exposure multiple of 158-times the human exposure at 400 mg/day.
Croatian: U ispitivanju na štakorima opažena je smrt zametka te učinci na rast ploda uz kardiovaskularne i koštane abnormalnosti pri razini izloženosti koja je bila 158 puta veća od one koja se postiže u ljudi nakon primjene doze od
English: Microcrystalline cellulose (E460i) Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Talc
Croatian: karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni magnezijev stearat talk
English: If ketones are elevated (BHB reading is greater than 0.6 mmol/L), treatment with sotagliflozin should not be started until the ketone levels are normal (see section 4.2).
Croatian: Ako su vrijednosti ketona povišene (izmjerena vrijednost BHB-a iznad 0,6 mmol/l), liječenje sotagliflozinom ne smije se uvesti dok se vrijednosti ketona ne vrate u normalu (vidjeti dio 4.2). - bolesnici koji nisu u stanju ili koji nisu voljni pratiti vrijednosti ketona
English: For subjects with CKD Stage IIIb (eGFR ≥30 and <45 mL/min/1.73 m2) and CKD
Croatian: Izloženost sotagliflozinu u ispitanika s kroničnom bubrežnom bolešću stadija IIIb (eGFR ≥ 30 i < 45 ml/min/1,73 m2) i stadija IV (eGFR > 15 i < 30 ml/min/1,73 m2) bila je
English: • ZYNQUISTA should be temporarily stopped before surgical procedures or hospitalisation for acute serious illness.
Croatian: • Primjenu lijeka ZYNQUISTA treba privremeno prekinuti prije kirurških zahvata ili u slučaju hospitalizacije zbog ozbiljne akutne bolesti.
English: Mean increases in serum creatinine from baseline to week 4 was 4.0%, 4.3% and 1.4% for sotagliflozin 200mg, sotagliflozin 400 mg and placebo, respectively.
Croatian: Srednja vrijednost porasta serumskih vrijednosti kreatinina od početka ispitivanja do 4. tjedna iznosila je 4,0% uz sotagliflozin u dozi od 200 mg, 4,3% uz sotagliflozin u dozi od 400 mg i 1,4% uz placebo.
English: The mean BMI was 30 kg/m2 and 23% of patients had SBP ≥ 130 mmHg.
Croatian: Srednja vrijednost ITM-a iznosila je 30 kg/m2, a 23% bolesnika imalo je sistolički krvni tlak ≥ 130 mmHg.
English: Mean change from baseline at week 4
Croatian: Srednja vrijednost promjene od početka ispitivanja do 4. tjedna
English: Insulin + sotagliflozin 400 mg
Croatian: Inzulin + sotagliflozin 400 mg
English: The mean eGFR was 87 mL/min/1.73 m2 and 5.7% of patients had eGFR between 45 and 60 mL/min/1.73 m2.
Croatian: Srednja vrijednost eGFR-a iznosila je 87 ml/min/1,73 m2, a 5,7% bolesnika imalo je eGFR između 45 i 60 ml/min/1,73 m2.
English: The mean BMI was 28 kg/m2 and 32% of patients had SBP ≥ 130 mmHg.
Croatian: Srednja vrijednost ITM-a iznosila je 28 kg/m2, a 32% bolesnika imalo je sistolički krvni tlak ≥ 130 mmHg.
English: Blood ketone body increased, serum lipids increasede, haematocrit increasedf
Croatian: Pretrage povišene vrijednosti ketonskih tijela u krvi, povišene vrijednosti lipida u serumue, povišene vrijednosti hematokritaf
English: Male genital mycotic infections*,b, † urinary tract infections*' †
Croatian: genitalne gljivične infekcije u muškaraca*,b, †
English: Post-Baseline LS means, LS mean differences, 95% CLs, and p-values for each individual study were obtained from accounting for missing data *p <0.001 † p 0.12 ‡ p=0.034
Croatian: Srednje vrijednosti (LS) nakon početka ispitivanja, srednje vrijednosti (LS) razlika, razine pouzdanosti (engl. confidence level, CL) od 95% i p-vrijednosti za svako pojedinačno ispitivanje određene su uzimajući u obzir podatke koji su nedostajali
English: Treatment with sotagliflozin also resulted in reduction in body weight and FPG compared with insulin alone (see Table 4).
Croatian: Liječenje sotagliflozinom također je dovelo do smanjenja tjelesne težine i sniženja vrijednosti glukoze u plazmi natašte u usporedbi s inzulinom primijenjenim samostalno (vidjeti Tablicu 4).
English: Discontinuation due to genital mycotic infections occurred in 0%, 0.4% and 0.4% of patients treated with sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.
Croatian: Liječenje je zbog genitalnih gljivičnih infekcija prekinulo 0% bolesnika liječenih sotagliflozinom u dozi od 200 mg, 0,4% onih koji su primali dozu od 400 mg i 0,4% bolesnika koji su primali placebo.
English: Sotagliflozin should not be used in patients with severe renal impairment, end stage renal disease (ESRD) or in patients on dialysis as it has not been studied in these patients (see sections 4.4 and 5.2).
Croatian: Sotagliflozin se ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije bubrega, bolesnika u završnom stadiju bubrežne bolesti ni bolesnika na dijalizi jer se u tih bolesnika nije ispitivao (vidjeti dijelove 4.4 i 5.2).
English: Zynquista 200 mg film coated tablets:
Croatian: Zynquista 200 mg filmom obloženih tableta:
English: Management of DKA
Croatian: Liječenje DKA
English: Mean change from baseline at week 24
Croatian: Srednja vrijednost promjene od početka ispitivanja do 24. tjedna
English: Exposure at the rat no-observedeffect level was 40-times the exposure at the MRHD.
Croatian: Razina izloženosti pri kojoj nisu opaženi štetni učinci u štakora bila je 40 puta veća od one koja se postiže nakon primjene maksimalne preporučene doze u ljudi.
English: • Signs and symptoms of DKA include: - nausea, vomiting, or abdominal pain - anorexia - excessive thirst - unusual fatigue or sleepiness - difficulty breathing - confusion
Croatian: • Znakovi i simptomi DKA uključuju: - mučninu, povraćanje ili bol u abdomenu
English: dAdverse events grouping, including urine output increased, polydipsia, micturition urgency, nocturia, pollakiuria and polyuria eMean percent changes from baseline for sotagliflozin 200 mg and 400 mg versus placebo, respectively, were HDL-C 3.3% and 4.2% versus 0.5%; LDL-C 5.0% and 6.1% versus 3.3%; triglycerides 5.7% and 5.4% versus 2.7%.
Croatian: e Srednja vrijednost promjene od početne vrijednosti uz sotagliflozin u dozi od 200 mg i 400 mg u odnosu na placebo: 3,3% odnosno 4,2% naspram 0,5% za HDL-kolesterol, 5,0% odnosno 6,1% naspram 3,3% za LDL-kolesterol, 5,7% odnosno 5,4% naspram 2,7% za trigliceride.
English: The CL/F estimated using a population PK, which mostly evaluated T1DM patients, was 239 L/hr.
Croatian: CL/F procijenjen na temelju populacijskih farmakokinetičkih ispitivanja, koja su prvenstveno ocjenjivala bolesnike sa šećernom bolešću tipa 1,
English: Main results for insulin dose and Diabetes Treatment Satisfaction Questionnaire and Diabetes Distress Screening Scale are presented in Table 4.
Croatian: Diabetes Distress Screening Scale, DDSS) prikazani su u Tablici 4.
English: Navigant Germany GmbH Albrechtstr.
Croatian: Navigant Germany GmbH Albrechtstr. 10c 10117 Berlin
English: In subjects with renal impairment, exposure to sotagliflozin following a single dose of 400 mg was approximately 1.7 fold higher in subjects with mild and up to 2.7 fold higher in subjects with moderate renal impairment compared to subjects with normal renal function.
Croatian: 1,7 puta veća u ispitanika s blagim oštećenjem funkcije bubrega te do 2,7 puta veća u ispitanika s umjerenim oštećenjem funkcije bubrega nego u ispitanika s normalnom funkcijom bubrega.
English: In a pre-specified pooled analysis of study 1 and study 2, treatment with sotagliflozin as adjunct to insulin resulted in LS mean changes from baseline in FPG of -0.56 mmol/l for sotagliflozin 200 mg and -0.87 mmol/l for sotagliflozin 400 mg compared to insulin alone (0.32 mmol/l) at week 24.
Croatian: Prema unaprijed specificiranoj objedinjenoj analizi podataka iz ispitivanja 1 i ispitivanja 2, liječenje sotagliflozinom kao dodatkom inzulinu dovelo je do promjene srednje vrijednosti glukoze u plazmi natašte od početka ispitivanja do 24. tjedna (prema metodi najmanjih kvadrata) od -0,56 mmol/l uz sotagliflozin u dozi od 200 mg i -0,87 mmol/l uz sotagliflozin u dozi od 400 mg u odnosu na inzulin primijenjen samostalno (0,32 mmol/l).
English: • Sotagliflozin should be temporarily stopped before surgical procedures or hospitalisation for acute serious illness.
Croatian: • Primjenu sotagliflozina treba privremeno prekinuti prije kirurških zahvata ili hospitalizacije zbog ozbiljne akutne bolesti.
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane dijabetička ketoacidoza*' †
English: Urine Ketone
Croatian: Ketoni u mokraći Mjere
English: • rifampicin (an antibiotic used to treat tuberculosis and some other infections).
Croatian: • rifampicin (antibiotik za liječenje tuberkuloze i nekih drugih infekcija) Budući da se sotagliflozin uzima zajedno s inzulinom, tijekom liječenja može doći do hipoglikemije.
English: • The risk of DKA is increased with sotagliflozin treatment.
Croatian: • Kod liječenja sotagliflozinom povećan je rizik od DKA.
English: Blood creatinine increased/Glomerular filtration decreased and renal-related events Sotagliflozin was associated with decreases in mean eGFR at week 4 (-4.0% and -4.3% for sotagliflozin 200 mg and 400 mg) versus placebo (-1.3%) that were generally reversible during continuous treatment.
Croatian: Sotagliflozin je bio povezan sa smanjenjima srednje vrijednosti eGFR-a u 4. tjednu (-4,0% i -4,3% uz sotagliflozin u dozi od 200 mg odnosno 400 mg) u odnosu na placebo (-1,3%), a ta su se smanjenja u načelu povukla s nastavkom liječenja.
English: Exposure was approximately 5 times (males) and 11 times (females) the clinical exposure at the Maximum Recommended Human Dose (MRHD) and caused reversible renal tubular dilation.
Croatian: (ženke) veća od kliničke izloženosti nakon primjene maksimalne preporučene doze za ljude, a uzrokovala je reverzibilnu dilataciju bubrežnih tubula.
English: c Adverse events grouping, including dehydration, hypovolaemia, postural dizziness, orthostatic hypotension, hypotension, syncope and presyncope when reported in context of volume depletion.
Croatian: hipotenziju, sinkopu i presinkopu prijavljenu u kontekstu deplecije volumena.
English: The mean eGFR was 92 mL/min/1.73 m2 and 3.3% had eGFR between 45 and 60 mL/min/1.73 m2.
Croatian: Srednja vrijednost eGFR-a iznosila je 92 ml/min/1,73 m2, a 3,3% bolesnika imalo je eGFR između 45 i 60 ml/min/1,73 m2.
English: Zynquista 200 mg film-coated tablets sotagliflozin
Croatian: Zynquista 200 mg filmom obložene tablete sotagliflozin