natgillin/translations-raw huggingface dataset:
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 
Izhodiščna povprečna vrednost po mNK, povprečne razlike po mNK, 95 % IKr in vrednosti p za vsako posamezno študijo so dobljeni z upoštevanjem manjkajočih podatkov
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. 
V vnaprej določeni združeni analizi podatkov študije 1 in študije 2 je zdravljenje s sotagliflozinom kot dodatkom insulinu po 24 tednih doseglo povprečno spremembo glukoze v plazmi na tešče po mNK v primerjavi z izhodiščem za -0,56 mmol/l z 200 mg sotagliflozina in za -0,87 mmol/l s 400 mg sotagliflozina v primerjavi s samim insulinom (0,32 mmol/l).
In the clinical trials (pool of two 52-week placebo-controlled trials) of sotagliflozin, the incidence of diabetic ketoacidosis (DKA) was higher in the sotagliflozin treatment group compared with the placebo group (see section 4.8). 
sotagliflozina je bila pojavnost diabetične ketoacidoze (DKA) v skupini prejemnikov sotagliflozina večja kot v skupini prejemnikov placeba (glejte poglavje 4.8).
The incidence of UTI in female subjects was 12%, 7.0% and 11% and the incidence of UTI in male subjects was 2.3%, 4.0% and 1.8% for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively. 
Pojavnost okužb sečil pri preiskovankah je bila 12 %, 7,0 % in 11 % pri preiskovancih pa 2,3 %, 4,0 % in 1,8 % z 200 mg sotagliflozina, s 400 mg sotagliflozina in s placebom.
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. 
Po 24 tednih se je HbA1c znižal za -0,36 % in za -0,38 % in po 52 tednih za -0,23 % in za -0,32 % s sotagliflozinom 200 mg in 400 mg; delež bolnikov z A1C < 7,0 % je bil po 24 tednih 19 % za placebo, 35,1 % za sotagliflozin 200 mg, 40,4 % za sotagliflozin 400 mg in po 52 tednih 18,3 % za placebo, 28,6 % z 200 mg in 31,6 % s 400 mg sotagliflozina.
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. 
V potekajočih dolgotrajnih kliničnih preskušanjih z nekim drugim zaviralcem SGLT2 so opazili številne primere amputacij spodnjih okončin (predvsem prstov nog).
How to store Zynquista 
Shranjevanje zdravila Zynquista
After initiating sotagliflozin ketones should be monitored on a regular basis during the initial one to two weeks, then the frequency of ketone level testing should be individualised, according to the patient's lifestyle and/or risk factors. 
pogostnost kontrol koncentracije ketonov je treba prilagoditi individualno, glede na bolnikov življenjski slog in/ali dejavnike tveganja.
Diabetic ketoacidosis*' † 
Presnovne in prehranske motnje diabetična ketoacidoza*' †
The mean BMI was 30 kg/m2 and 23% of patients had SBP ≥ 130 mmHg. 
Povprečni ITM je bil 30 kg/m2 in 23 % bolnikov je imelo SKT ≥ 130 mmHg.
Elderly patients 
Starejše osebe
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. 
Tri randomizirane klinične študije 3. faze pri bolnikih s sladkorno boleznijo tipa 1 niso vključile bolnikov z eGFR < 45 ml/min/1,73 m2; 79 bolnikov, izpostavljenih sotagliflozinu, je imelo eGFR
These are the signs and symptoms of diabetic ketoacidosis (see also section 2 under ‘Warnings and precautions'): 
Diabetično ketoacidozo (DKA), ki je pogosta (pojavi se lahko pri največ 1 od 100 oseb) To so lahko znaki in simptomi diabetične ketoacidoze (glejte tudi poglavje 2, "Opozorila in previdnostni ukrepi"):
• yeast infection (thrush) of the vagina (signs may include irritation, itching, unusual discharge or odour) 
• glivična okužba ("gobice") spolnega uda (med znaki so lahko draženje, srbenje, nenavaden izcedek ali vonj)
Please consult the Patient/Carer's Guide for more information discussed with your doctor about taking Zynquista and the risk of DKA. 
Za več informacij o jemanju zdravila Zynquista in tveganju za DKA, o čemer ste se pogovarjli z zdravnikom, glejte Vodnik za bolnike/skrbnike,.
No dosage adjustment is recommended based on age. 
Odmerek sotagliflozina ni treba prilagajati glede na starost.
Difference from placebo, 
s placebom.
The mean BMI was 28 kg/m2 and 32% of patients had SBP ≥ 130 mmHg. 
Povprečni ITM je bil 28 kg/m2 in 32 % bolnikov je imelo SKT ≥ 130 mmHg.
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. 
V študiji na podganah so pri izpostavljenosti, ki je bila 158-kratnik izpostavljenosti človeka med uporabo odmerka 400 mg/dan, opažali embrioletalnost, učinke na rast plodov in srčno-žilne in skeletne nepravilnosti.
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. 
Bolnike je treba poučiti: - kako prepoznajo dejavnike tveganja, ki lahko povečajo nagnjenost h ketozi in DKA (takšni so med drugim nedavna ali ponavljajoča se DKA, izpuščeni ali zmanjšani odmerki insulina, manjši kalorični vnos ali huda dehidracija, naporna telesna dejavnost, trenutne bolezni, kirurški poseg, zloraba alkohola ter, pri uporabnikih insulinske črpalke, prekinitev dovajanja insulina),
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with blue box 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA s podatki za modro okence
Renal function abnormalities (increased serum creatinine and decreased eGFR) can occur after initiating sotagliflozin (see section 4.8). 
Po uvedbi sotagliflozina se lahko pojavijo nepravilnosti delovanja ledvic (zvišan kreatinin v serumu in zmanjšanje eGFR) (glejte poglavje 4.8).
- Correction of volume depletion prior to initiation of sotagliflozin is recommended in patients with this condition (see section 4.4). 
- Pred uvedbo sotagliflozina je priporočljivo bolnikom s hipovolemijo odpraviti motnjo (glejte poglavje 4.4).
mL/min/1.73 m2) that sotagliflozin exposures were 1.5 fold higher compared to subjects with normal renal function. 
≥ 45 in < 60 ml/min/1,73 m2) pokazal izpostavljenost sotagliflozinu, ki je bila za ene in druge 1,5-krat večja kot pri preiskovancih z normalnim delovanjem ledvic.
DKA may occur in patients treated with Zynquista even if blood glucose levels are below 14 mmol/l (250 mg/dl). 
Pri bolnikih, ki prejemajo zdravilo Zynquista, se DKA lahko pojavi, tudi če imajo koncentracijo glukoze v krvi pod 14 mmol/l (250 mg/dl).
• Patients with euglycaemic DKA should receive glucose, insulin and fluids for DKA management, sotagliflozin should be discontinued. 
• Bolniki z evglikemično DKA morajo za obvladovanje DKA prejemati glukozo, insulin in tekočine; z uporabo sotagliflozina je treba prenehati.
No dose adjustment is needed in patients with mild hepatic impairment. 
Bolnikom z blago jetrno okvaro odmerka ni treba prilagajati.
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. 
Povprečno zvišanje kreatinina v serumu od izhodišča do 4. tedna je bilo 4,0 % z 200 mg sotagliflozina, 4,3 % s 400 mg sotagliflozina in 1,4 %
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. 
Pri bolnicah in bolnikih, ki so jemali druge zaviralce SGLT2, so v obdobju po prihodu zdravila na trg poročali o primerih nekrotizirajočega fascitisa perineja (imenovanega tudi Fournierjeva gangrena).
A lower dose of insulin may be required to minimise the risk of hypoglycaemia when used in combination with sotagliflozin (see section 4.2). 
Ob sočasni uporabi sotagliflozina je potreben manjši odmerek insulina, da zmanjšamo tveganje za hipoglikemijo (glejte poglavje 4.2).
- 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. 
- Priporočljivo je, da bolniki v enem do dveh tednih pred uvedbo zdravljenja s sotagliflozinom večkrat opravijo meritev izhodiščne vrednosti ketonov v krvi ali urinu.
At screening the HbA1c was 8.42%, 8.35% and 8.38% for insulin, insulin+sotagliflozin 200 mg and insulin+sotagliflozin 400 mg. 
HbA1c v skupini z insulinom 8,42%, v skupini z insulinom + 200 mg sotagliflozina 8,35 % in v skupini z insulinom + 400 mg sotagliflozina je bil HbA1c 8,38 %.
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. 
Delež prenehanja uporabe zdravila zaradi mikotičnih okužb spolovil je bil 0 %, 0,4 % in 0,4 % med prejemniki 200 mg sotagliflozina, 400 mg sotagliflozina in med prejemniki placeba.
> 3.0 mmol/L 
Verjetna DKA > 3,0 mmol/l
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%. 
e Povprečne odstotne spremembe od izhodišča za 200 mg oz. 400 mg sotagliflozina v primerjavi s placebom so bile: holesterol HDL 3,3 % oz. 4,2 % v primerjavi z 0,5 %, holesterol LDL 5,0 % oz. 6,1 % v primerjavi z 3,3 %, trigliceridi 5,7 % oz. 5,4 % v primerjavi z 2,7 %.
LS mean [95%CI] 
povprečna vrednost po mNK [95 % IZ]
The mean BMI was 28 kg/m2 and 29% had SBP ≥ 130 mmHg. 
Povprečni ITM je bil 28 kg/m2 in 29 % bolnikov je imelo SKT ≥ 130 mmHg.
Foot care 
Skrb za stopala
7.0% at week 24, n (%) Body Weight (kg) Baseline, mean 
HbA1c < 7,0 % po 24 tednih, n (%) Telesna masa (kg)
Diabetes Treatment Satisfaction Questionnaire Baseline, mean 
Vprašalnik zadovoljstva z zdravljenjem sladkorne bolezni (DTSQ)
Your doctor may ask you to stop taking Zynquista until you have recovered 
Zdravnik vam bo morda naročil, da prenehate jemati zdravilo
Diabetes Distress Screening Scale Baseline score, mean 
DDSS (Diabetes Distress Screening Scale)
The mean eGFR was 92 mL/min/1.73 m2 and 3.3% had eGFR between 45 and 60 mL/min/1.73 m2. 
Povprečna eGFR je bila 92 ml/min/1,73 m2 in 3,3 % je imelo eGFR med 45 in 60 ml/min/1,73 m2.
Difference from insulin alone, LS mean [95%CI] 
Razlika od insulina samega, povprečna vrednost [95 % IZ]
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. 
87 ml/min/1,73 m2 in 5,7 % bolnikov je imelo eGFR med 45 in 60 ml/min/1,73 m2.
Iron oxide black (E172) Propylene glycol 
Črni železov oksid (E172)
If Fournier's gangrene is suspected, sotagliflozin should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted. 
Fournierjevo gangreno je treba zdravljenje s sotagliflozinom ukiniti in nemudoma uvesti zdravljenje
In the rat, TSH was considered the primary carcinogen with sotagliflozin functioning as a secondary carcinogen. 
sotagliflozin pa deluje kot sekundarni karcinogen.
Sotagliflozin should only be given to patients: - with access to ketone testing materials and immediate access to a clinician if blood or urine ketones are elevated. 
- ki imajo dostop do pripomočkov za testiranje ketonov ter takojšen dostop do zdravnika, v primeru, da je koncentracija ketonov v krvi ali urinu povišana.
A. 
DKA.
This patient is using ZYNQUISTA for the treatment of Type 1 Diabetes Mellitus (T1DM). 
Bolnik za zdravljenje sladkorne bolezni tipa 1 uporablja zdravilo Zynquista.
Blood ketone body increased, serum lipids increasede, haematocrit increasedf 
Preiskave zvišanje ketonskih teles, zvišanje lipidov v serumue, zvišanje hematokritaf
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%) 
mg sotagliflozina večji (6,7 % in 8,2 %) kot v skupini s placebom (2,7 %).
Patients with a history of chronic or recurrent genital mycotic infections are more likely to develop genital mycotic infections. 
Verjetnost za nastanek glivičnih okužb spolovil je večja pri bolnikih, ki imajo v anamnezi kronične ali ponavljajoče se glivične okužbe spolovil.
Extra carbohydrates should be taken if the glucose levels are normal or low. 
Če je koncentracija glukoze normalna ali nizka, mora bolnik zaužiti dodatne ogljikove hidrate.
Stage IV (eGFR ≥15 and <30 mL/min/1.73 m2) sotagliflozin exposures were 1.95 and 2.25 fold higher compared to subjects with normal renal function. 
Pri preiskovancih s kronično ledvično boleznijo v stadiju IIIb (eGFR ≥ 30 in < 45 ml/min/1,73 m2) je bila izpostavljenost sotagliflozinu 1,95-krat večja in pri tistih v stadiju IV (eGFR ≥ 15 in < 30 ml/min/1,73 m2) 2,25-krat večja kot pri preiskovancih z normalnim delovanjem ledvic.
Zynquista 200 mg film coated tablets: 
Zynquista 200 mg filmsko obložene tablete:
Baseline, mean in units % change from baseline, LS mean % difference from insulin alone, LS mean 
Izhodiščno, povprečna vrednost % spremembe od izhodišča, povprečna vrednost po mNK % razlike od insulina samega,
Treatment with sotagliflozin also resulted in reduction in body weight and FPG compared with insulin alone (see Table 4). 
Zdravljenje s sotagliflozinom je v primerjavi s skupino s samim insulinom privedlo do zmanjšanja telesne teže in glukoze v plazmi na tešče (glejte preglednico 4).
• Signs and symptoms of DKA include: - nausea, vomiting, or abdominal pain - anorexia - excessive thirst - unusual fatigue or sleepiness - difficulty breathing - confusion 
- prekomerno žejo - nenavadno utrujenost ali zaspanost - težko dihanje - zmedenost
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. 
Med sočasno uporabo rosuvastatina s sotagliflozinom so ugotovili približno 1,2-kratno večjo izpostavljenost rosuvastatinu in približno 1,4-kratno povečanje njegove Cmax, vendar klinično nepomembno.
Your blood sugar levels may increase when you stop taking Zynquista. 
Če prenehate jemati zdravilo Zynquista, se vam koncentracija krvnega sladkorja lahko zviša.
Local intestinal inhibition of SGLT1, the major transporter for glucose absorption, delays and reduces glucose absorption in the proximal intestine, resulting in a blunting and delay of postprandial hyperglycaemia. 
upočasni in zmanjša absorpcijo glukoze v proksimalnem delu črevesja; posledica je zakasnjena in upočasnjena postprandialna hiperglikemija.
Zynquista 200 mg film-coated tablets 
Zynquista 200 mg filmsko obložene tablete
The mean eGFR was 92 mL/min/1.73 m2 and 5 % had eGFR between 45 and 60 mL/min/1.73 m2. 
Povprečna eGFR je bila 92 ml/min/1,73 m2 in 5 % bolnikov je imelo eGFR med 45 in 60 ml/min/1,73 m2.
You can also get the Patient Alert Card by scanning the QR code or by visiting the website below: 
QR-kodo, ali če obiščete to spletno mesto:
Insulin Insulin + sotagliflozi n 200 mg 
Insulin Insulin + 200 mg sotagliflozi na
Temporary interruption of sotagliflozin should be considered when treating pyelonephritis and urosepsis. 
V primeru zdravljenja pielonefritisa ali urosepse je treba razmisliti o začasnem prenehanju uporabe sotagliflozina.
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. 
24 tednih pa so se hipoglikemični dogodki (glukoza v krvi ≤ 3,1 mmol/l) s 400 mg sotagliflozina zmanjšali za 22 % v primerjavi s samim insulinom (p < 0,001).
Zynquista 200 mg film-coated tablets sotagliflozin 
Zynquista 200 mg filmsko obložene tablete sotagliflozin
There is limited experience in clinical trials in patients with moderate and severe hepatic impairment. 
Pri bolnikih z zmerno in hudo okvaro jeter so klinične izkušnje uporabe sotagliflozina omejene.
LS mean % Difference from insulin alone, adjusted mean [95%CI] 
Razlika od insulina samega, povprečna vrednost po mNK [95 % IZ]
b Adverse event grouping, including, but not limited to, balanoposthitis, genital infections fungal, balanitis candida, epididymitis. 
b Skupina neželenih učinkov, ki med drugim obsega balanopostitis, glivične okužbe spolovil,
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. 
Po 24 in 52 tednih je bila sprememba kreatinina od izhodišča 0,02 mg/dl ali manj tako z
Urinary glucose excretion 
Farmakodinamični učinki Izločanje glukoze v urinu
Baseline (after 6-week insulin optimisation), mean Change from baseline, LS mean Difference from insulin alone, LS mean (p-value) 
Izhodiščne (po 6-tedenski optimizaciji insulina), povprečna vrednost po mNK
In study 3 there was a significant reduction in FPG of 0.79 mmol/L (p<0.001) with sotagliflozin 400 mg at 24 weeks compared to insulin alone. 
V študiji 3 se je glukoza v plazmi na tešče po 24 tednih s 400 mg sotagliflozina statistično značilno znižala za 0,79 mmol/l (p < 0,001) v primerjavi s samim insulinom.
Patients were then maintained on optimised insulin and randomized to sotagliflozin 200 mg, sotagliflozin 400 mg or insulin alone. 
Bolnike so vzdrževali na optimalnih odmerkih insulina, nato so jih razdelili v skupine: sotagliflozin
- Consider discontinuing sotagliflozin if adequate insulinisation cannot be achieved on treatment. 
- Če med zdravljenjem ni mogoče doseči ustrezne insulinizacije, razmislite o prenehanju uporabe sotagliflozina.
Rate of nocturnal‡ documented hypoglycaemia† (events per patient year) at thresholds of 
Delež dokumentiranih hipoglikemij† (dogodki na bolnika in leto) s pragom ≤ 3,1
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. 
Priporočljivo je, da bolniki v obdobju tedna do dveh pred uvedbo zdravljenja s sotagliflozinom večkrat izmerijo izhodiščne vrednosti ketonov v krvi ali urinu.
Temporary interruption of treatment with sotagliflozin should be considered until the fluid loss is corrected. 
Dokler izguba tekočine ni odpravljena, pride v poštev začasna prekinitev zdravljenja s sotagliflozinom.
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. 
Med sočasno uporabo digoksina s 400 mg sotagliflozina se zaradi zavrtja P-gp, ki ga povzroči sotagliflozin, povečata AUC0-inf (27 %) in Cmax (52 %) digoksina.
The adverse effects on embryo-fetal development at 350 mg/kg/day were associated with maternal toxicity (body weight loss/decreased body weight gain and decreased food consumption during gestation day (GD) 6 to 8). 
Neželeni učinki na embrio-fetalni razvoj ob odmerku 350 mg/kg/dan so bili povezani z maternalno toksičnostjo
Baseline, mean in units/day % change from baseline, LS mean % difference from insulin alone, LS mean 
Izhodiščno, povprečna vrednost, % spremembe od izhodišča, povprečna vrednost po mNK % razlike od insulina
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). 
5,29 in 0,76 preiskovanca na 100 bolnikov-let za 200 mg sotagliflozina, 400 mg sotagliflozina in placebo (glejte poglavje 4.4).
≤3.1 or ≤3.9 mmol/L 
ali ≤ 3,9 mmol/l
Insulin Insulin + sotagliflozin 200 mg 
Insulin Insulin + 200 mg sotagliflozina
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. 
[14C]-sotagliflozina je bil izredno velik; njegova povprečna vrednost je bila 9392 l.
Male genital mycotic infections*,b, † urinary tract infections*' † 
glivične okužbe moških spolovil*,b, †
Insulin + sotagliflozin 400 mg 
Insulin + 400 mg sotagliflozina
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). 
(KOL) in pri bolnikih na dializi, ker pri teh bolnikih ni raziskan (glejte poglavje 4.2).
However, the mechanism behind the limited increase in exposure is not completely elucidated as sotagliflozin and M19 (sotagliflozin 3-O-glucuronide) are characterized as BCRP inhibitors in vitro and M19 also as an inhibitor OATP1B3 and OAT3. 
(sotagliflozin-3-O-glukuronid) in vitro zavirata BCRP, M19 pa zavira tudi OATP1B3 in OAT3.
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. 
57,7 gramov (p <0,001) in 70,5 gramov (p <0,001) pri bolnikih s sladkorno boleznijo tipa 1, ki so prejemali 200 mg in 400 mg sotagliflozina, kar je skladno z zaviranjem SGLT2.
Talk to your doctor, pharmacist or nurse before taking Zynquista, and during treatment: • if you have the following symptoms, which may be a sign of a serious condition, diabetic ketoacidosis (see also section 4): 
• če se vam pojavijo naslednji simptomi, ki so lahko znaki redke, toda resne motnje, imenovane diabetična ketoacidoza (glejte tudi poglavje 4):
Insulin + sotagliflozin 
Insulin + 200 mg sotagliflozin
> 1.5-3.0 mmol/L Moderate 
Grozeča DKA > 1,5-3,0 mmol/l
Hepatic impairment 
Pojavnost hudih hipoglikemij
HbA1c (%) Baseline (after 6-week insulin optimisation), mean 
Izhodišče (po 6-tedenski optimizaciji insulina), povprečna vrednost
At Week 24, mean 
povprečna vrednost Po 24 tednih,
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. 
Po 24 tednih je zdravljenje z 200 mg ali 400 mg sotagliflozina doseglo statistično značilno znižanje
No overall differences in safety were observed with sotagliflozin treatment as compared to insulin alone in subjects with eGFR between 45 and 60 mL/min/1.73 m2. 
Pri preiskovancih z eGFR med 45 in 60 ml/min/1,73 m2 na splošno niso opazili razlik v varnosti med zdravljenjem s sotagliflozinom v primerjavi s samim insulinom.
• if you are using a low dose of insulin 
- z nizko potrebo po insulinu.
No dose adjustment is recommended in patients with mild hepatic impairment. 
Bolnikom z blago okvaro jeter odmerka ni treba prilagoditi.
Bolus insulin dose (units/day) Baseline, mean % Change from baseline, 
Odmerek bazalnega insulina (enote/dan)
400 mg (N=525) 
(N = 525)
200 mg (N=524) 
(N = 524)