natgillin/translations-raw huggingface dataset:
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. 
V okoliščinah optimiziranega insulina so učinkovitost in varnost 200 mg in 400 mg sotagliflozina enkrat na dan v primerjavi s samim insulinom, ocenili v dveh dvojno slepih, s placebom kontroliranih preskušanjih (študiji 1 in 2), izvedenih pri 1575 bolnikih s sladkorno boleznijo tipa 1, kjer so uporabljali insulinsko črpalko ali zdravljenje z injiciranjem večkrat na dan.
Based on a population PK analysis, sotagliflozin exposure was found to decrease with increased body weight. 
Na podlagi populacijske farmakokinetične analize je ugotovljeno, da se izpostavljenost sotagliflozinu s povečevanjem telesne mase zmanjšuje.
- More frequent, at least 2 to 4 times per year, renal function monitoring is recommended in patients with an eGFR below 60 mL/min/1.73 m2. 
- Pogostejše kontrole delovanja ledvic, vsaj 2 do 4-krat na leto, so priporočljive pri bolnikih z eGFR pod 60 ml/min/1,73 m2.
Each tablet contains 200 mg sotagliflozin. 
Ena tableta vsebuje 200 mg sotagliflozina.
At the end of 52 weeks the reduction in body weight, mean daily bolus insulin dose, FPG were sustained compared to insulin alone. 
Ob koncu 52 tednov so se zmanjšanje telesne mase, povprečni dnevni odmerek bolusnega insulina in glukoza v plazmi na tešče ohranili v primerjavi s samim insulinom.
- Patient not on optimal insulin dose or who have recent issues with noncompliance or recurrent errors with insulin dosing and who are unlikely to maintain adequate insulin dosing. 
- ki ne prejemajo optimalnega odmerka insulina, ali so pred kratkim imeli težave s sodelovanjem pri zdravljenju, ponavljajo napake ob odmerjanju insulina, oz. bolniki, ki neustrezno odmerjajo insulin.
• Do not start caloric restriction or carbohydrate restriction while treated with sotagliflozin. 
• Med zdravljenjem s sotagliflozinom ne začnite z omejevanjem kalorij ali z omejevanjem ogljikovih hidratov.
• The active substance is sotagliflozin. 
• Učinkovina je sotagliflozin.
Mean duration of diabetes was 24.4 years, 60% of patients were using insulin pump and 40% were using multiple daily injections. 
Povprečno trajanje sladkorne bolezni je bilo 24,4 leta, 60 % bolnikov je uporabljalo insulinsko črpalko, 40 % pa injiciranje večkrat na dan.
This card contains important safety information about diabetic ketoacidosis (DKA) ▼This medicinal product is subject to additional monitoring. 
Kartica vsebuje pomembne varnostne informacije o diabetični ketoacidozi (DKA) ▼Za to zdravilo se izvaja dodatno spremljanje varnosti, kar označuje navzdol obrnjen črn trikotnik.
The removal of sotagliflozin by haemodialysis has not been studied. 
Odstranjevanje sotagliflozina s hemodializo ni raziskano.
Titanium dioxide (E171) 
Titanov dioksid (E171) Smukec
In healthy subjects following the administration of a single dose of 400 mg [14C]-sotagliflozin indicated that sotagliflozin was extensively metabolized predominantly to M19 which represented 94% of the radioactivity in plasma. 
Pri zdravih preiskovancih se je po uporabi enkratnega 400-mg odmerka [14C]-sotagliflozina izkazalo, da se sotagliflozin v veliki meri presnovi, predvsem v M19, ki je predstavljal 94 % radioaktivnosti v plazmi.
• Follow your doctor's instructions about insulin dose while taking Zynquista. 
• Med jemanjem zdravila Zynquista upoštevajte zdravnikova navodila o odmerku insulina.
Mean duration of diabetes was 18 years, 26% of patients were using insulin pump and 74% were using multiple daily injections. 
Povprečno trajanje sladkorne bolezni je bilo 18 let, 26 % bolnikov je uporabljalo insulinsko črpalko, 74 % pa injiciranje večkrat na dan.
Infections and infestations Female genital mycotic infections*,a, † 
Infekcijske in parazitske bolezni glivične okužbe ženskih spolovil*, a, †
Volume depletion*, c, † 
Žilne bolezni hipovolemija*, c, †
- film-coating: poly(vinyl alcohol); macrogol; titanium dioxide (E 171); talc; indigo carmine aluminium lake (E132). 
- Filmska obloga: polivinilalkohol, makrogol, titanov dioksid (E 171), smukec, indigotin (E132).
Table 6: Efficacy results of a 24 week placebo-controlled study of sotagliflozin as add-on to insulin therapy in patients not at HbA1c goal (Study 3): 
Preglednica 6: Rezultati učinkovitosti 24-tedenske s placebom kontrolirane študija sotagliflozina kot dodatka zdravljenju z insulinom pri bolnikih, ki niso dosegali ciljnega HbA1c (študija 3):
Read the Zynquista package leaflet for full information and instructions for use. 
Za celotne informacije in napotke za uporabo zdravila Zynquista preberite Navodilo za uporabo.
If you forget to take Zynquista 
Če ste pozabili vzeti zdravilo Zynquista
Interaction studies conducted in healthy volunteers show that sotagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, metoprolol, midazolam and oral contraceptives. 
Študije medsebojnega delovanja pri zdravih prostovoljcih kažejo, da sotagliflozin ne vpliva klinično pomembno na farmakokinetiko metformina, metoprolola, midazolama in peroralnih kontraceptivov.
No acyl glucuronides of sotagliflozin were identified. 
Acilnih glukuronidov sotagliflozina niso ugotovili.
Table 5: Results of CGM sub study at week 24 (Pooled data, study 1 and study 2) Characteristic 
Preglednica 5: Rezultati podštudije CGM po 24 tednih (združeni podatki študije 1 in študije 2)
By inhibiting SGLT2, sotagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. 
Z zavrtjem SGLT2 sotagliflozin zmanjša reabsorpcijo v ledvicah filtrirane glukoze, zniža ledvični prag za glukozo in s tem poveča izločanje glukoze v urinu.
OUTER CARTON multipack (with Blue Box) 
ZUNANJA ŠKATLA skupnega pakiranja (s podatki za modro okence)
Treatment with sotagliflozin should be stopped in patients who are hospitalized for major surgical procedures or acute serious medical illnesses. 
Zdravljenje s sotagliflozinom je treba prekiniti pri bolnikih, sprejetih v bolnišnico za večje operacije ali zaradi akutnih resnih internističnih bolezni.
Sotagliflozin must only be administered as an adjunct to insulin. 
Sotagliflozin se sme uporabljati le kot dodatek k insulinu.
The mean age of patients was 43 years, 7.2% were 65 years or older. 
Povprečna starost bolnikov je bila 43 let, 7,2 % je bilo starih 65 let ali več.
The patient's/carer's guide should contain the following key elements: 
Vodnik za bolnike/skrbnike mora vsebovati naslednje ključne elemente:
Basal insulin 
Bazalni insulin
c Adverse events grouping, including dehydration, hypovolaemia, postural dizziness, orthostatic hypotension, hypotension, syncope and presyncope when reported in context of volume depletion. 
c Skupina neželenih učinkov vključno z dehidracijo, hipovolemijo, posturalno omotico, ortostatsko hipotenzijo, hipotenzijo, sinkopo in presinkopo v okviru hipovolemije.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking medicinal products that inhibit SGLT2. 
Spremljanje urejenosti glikemije s preiskavo določanja ravni 1,5-AG ni priporočljivo, ker so le te meritve nezanesljive za ocenjevanje urejenosti glikemije pri bolnikih, ki prejemajo zdravila z zaviralci
• The risk of DKA is increased with sotagliflozin treatment. 
• Tveganje za diabetično ketoacidozo se med zdravljenjem s sotagliflozinom poveča.
After at least three months, if additional glycaemic control is needed, in patients tolerating sotagliflozin 200 mg, the dose may be increased to 400 mg once daily. 
Če je treba glikemijo dodatno urediti, je mogoče bolnikom, ki prenesejo 200 mg sotagliflozina, odmerek po najmanj treh mesecih povečati na 400 mg enkrat na dan.
If a dose is missed, it should be taken as soon as you remember the missed dose. 
Če ste izpustili odmerek, ga vzemite, čim se spomnite.
• For patients taking ZYNQUISTA, glucose is not a reliable marker for DKA and must be supplemented with ketone monitoring 
• Pri bolnikih, ki jemljejo zdravilo Zynquista, glukoza ni zanesljiv označevalec DKA in jo je treba dopolniti s spremljanjem ketonov • Znaki in simptomi DKA vključujejo:
Sotagliflozin was not mutagenic or clastogenic. 
Sotagliflozin ni bil mutagen ali klastogen.
Film-coated tablet Multipack: 200 (2 packs of 100) film-coated tablets 
Pakiranje po več enot: 200 (2 pakiranji po 100) filmsko obloženih tablet
As a precautionary measure, when pregnancy is detected, treatment with sotagliflozin should be discontinued. 
V primeru ugotovljene nosečnosti je treba kot previdnostni ukrep prenehati zdravljenje s sotagliflozinom.
If you stop taking Zynquista 
Če ste prenehali jemati zdravilo Zynquista
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). 
Če so ketoni zvišani (koncentracija BHB v krvi več kot 0,6 mmol/l), se zdravljenja z sotagliflozinom ne sme uvesti, dokler koncentracija ketonov ni normalna (glejte poglavje 4.2).
M19 is an inducer and inhibitor of CYP3A4 and an inhibitor of CYP2D6. 
M19 inducira in zavira CYP3A4 ter zavira CYP2D6.
The patient should immediately seek medical advice and stop taking sotagliflozin. 
Bolnik mora nemudoma poiskati zdravniški nasvet in prenehati jemati sotagliflozin.
Beginning 6 weeks prior to randomization, insulin dose was adjusted (optimised) to achieve the following glycaemic goals fasting/preprandial, self-monitored blood glucose (SMBG) 4.4-7.2 mmol/L and 2-hour/peak postprandial SMBG glucose <10 mmol/L. 
6 tednov pred randomizacijo so bolnikom odmerek insulina prilagodili (optimizirali), da so dosegli glikemični cilj samoizmerjene glukoze v krvi (SMBG - self monitored blood glucose) na tešče/pred obroki med 4,4 do 7,2 mmol/l in 2-urno/najvišjo postprandialno SMBG < 10 mmol/l.
- Patients with elevated ketones levels (BHB reading is greater than 0.6 mmol/L or urine ketones one plus (+)). 
- z zvišano koncentracijo ketonov (izvid BHB več kot 0,6 mmol/l ali ketoni v urinu en plus (+)).
• raised ketone levels in your blood 
• driska • zvišana koncentracija ketonov v krvi
The level of digoxin or digitoxin in your blood may need to be checked if you take these medicines with Zynquista. 
Če digoksin ali digitoksin jemljete skupaj z zdravilom Zynquista, bo morda treba kontrolirati njuno koncentracijo v krvi.
Assessment of renal function is recommended prior to initiation of sotagliflozin and periodically thereafter (see section 4.4). 
Pred uvedbo sotagliflozina je priporočljivo oceniti delovanje ledvic in kasneje tudi redno periodično spremljati (glejte poglavje 4.4).
It cannot be ruled out that sotagliflozin may interact with other sensitive OAT3, OATP- and/or BCRPsubstrates (e.g.: fexofenadine, paclitaxel, bosentan, methotrexate, furosemide, benzylpenicillin) resulting in potentially larger increases of exposure than seen for rosuvastatin. 
Medsebojnega delovanja sotagliflozina z drugimi občutljivimi substrati OAT3, OATP in/ali BCRP (npr. s feksofenadinom, paklitakselom, bosentanom, metotreksatom, furosemidom, benzilpenicilinom) ni mogoče izključiti.
• if you have no access to ketone testing materials or no immediate access to a doctor if blood or urine ketones are elevated 
• če imate kakšno akutno internistično bolezen ali operacijo, • če nimate dostopa do materialov za testiranje ketonov in nimate takojšnjega dostopa do zdravnika v primeru, da imate koncentracijo ketonov v krvi ali urinu zvišano,
Patients should consider monitoring ketones levels three to four hours after changing pump materials. 
Bolniki naj bi si tri do štiri ure po menjavi materialov črpalke, kontrolirali koncentracijo ketonov.
Microcrystalline cellulose (E460i) Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Talc 
Mikrokristalna celuloza (E460i) Premreženi natrijev karmelozat Brezvodni koloidni silicijev dioksid Magnezijev stearat Smukec
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON without Blue Box 
PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA brez podatkov za modro okence
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. 
Po uporabi enkratnega odmerka 400 mg [14C]-sotagliflozina se je 57 % radioaktivnosti izločilo v urinu in 37 % v blatu.
EU/1/19/1363/008 (200 mg - 2 packs of 100 film coated tablets) 
EU/0/00/000/008 (200 mg - 2 pakiranji po 100 filmsko obloženih tablet)
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. 
a Skupina neželenih učinkov, ki med drugim obsega vulvovaginalno glivično okužbo, okužbo nožnice, vulvitis, vulvovaginalno kandidozo, okužbo spolovil, kandidozo spolovil, glivično okužbo spolovil, vulvovaginitis, glivno okužbo sečil.
Sotagliflozin should not be initiated when patients are at a higher risk of DKA, such as: - Patients with low insulin needs. 
Sotagliflozina se ne sme uvesti, če imajo bolniki večje tveganje za DKA; to so bolniki:
The European Medicines Agency has deferred the obligation to submit the results of studies with Zynquista in one or more subsets of the paediatric population in type 1 diabetes mellitus (see section 4.2 for information on paediatric use). 
Zynquista za eno ali več skupin pediatrične populacije pri sladkorni bolezni tipa 1 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Other side effects: Very common (may affect more than 1 in 10 people) 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb)
Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. 
Bolnikom je treba naročiti, da morajo poiskati zdravniško pomoč, ob pojavu kombinacije simptomov bolečine, občutljivosti, pordelosti ali otekline v predelu spolovil ali perineja (presredka), ob enem z zvišano telesno temperaturo ali splošnim slabim počutjem.
Bolus insulin 
Bolusni insulin
In the study 48% were male and 92% were White and 84% of randomised patients completed the study. 
V študiji je bilo 48 % moških in 92 % belcev; študijo je dokončalo 84 % randomiziranih bolnikov.
Before initiating sotagliflozin, volume contraction should be assessed and volume status should be corrected if indicated. 
Pred uvedbo sotagliflozina je treba oceniti zmanjšanje intravaskularnega volumna in po potrebi korigirati volumsko stanje.
Sotagliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion. 
Sotagliflozin povzroči osmotsko diurezo; to lahko povzroči zmanjšanje intravaskularnega volumna in neželene učinke, povezane s hipovolemijo.
The fraction of drug absorbed following administration of a single dose of [14C]-sotagliflozin was estimated to be at least 71%, based on the detected percentage of dose of radioactivity in the urine and for the metabolites of sotagliflozin in the faeces. 
Ocenjeni delež zdravila, absorbiranega po uporabi enega odmerka [14C]-sotagliflozina, je vsaj 718 %; ocena temelji na izmerjenem odstotku odmerka radioaktivnosti v urinu in presnovkov sotagliflozina v blatu .
• 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). 
• Med zdravljenjem s sotagliflozinom koncentacija glukoze ne bo ustrezno odražala potrebe po insulinu, DKA pa se lahko pojavi pri bolnikih, ki se zdravijo s sotagliflozinom, tudi če je koncentracija glukoze v krvi pod 14 mmol/l (250 mg/dl).
• if you are on caloric restriction, carbohydrate restriction or ketogenic diet 
• če uporabljate majhen odmerek insulina, • če v prehrani omejujete kalorije ali ogljikove hidrate, ali če uživate ketogeno dieto
If a dose is missed, it should be taken as soon as the patient remembers the missed dose. 
Če bolnik pozabi vzeti odmerek, vzame pozabljeni odmerek, takoj ko se spomni.
M19 demonstrated inhibitory effects against OATP1B1/B3 and MRP2 in-vitro. 
M19 je in vitro inhibiral OATP1B1/B3 in MRP2.
• How to measure ketones, how to interpret the results and what to do in case of hyperketonaemia/DKA (contact HCP immediately if BHB > 0.6 mmol/L with symptoms or if BHB > 1.5 mmol/L with or without symptoms). 
• Kako meriti ketone, kako razložiti rezultate in kako ravnati v primeru hiperketonemije/DKA (takoj se posvetujte z zdravstvenim delavcem, če je BHB > 0,6 mmol/l in so prisotni simptomi ali če je
Based on a population PK analysis, age had no clinically meaningful effect on the pharmacokinetics of sotagliflozin. 
Na podlagi populacijske farmakokinetične analize starost ne vpliva klinično pomembno na farmakokinetiko sotagliflozina.
Patients should be assessed for ketoacidosis immediately if these symptoms occur, by measuring the urine or blood ketones, regardless of blood glucose level. 
Če se pojavijo omenjeni simptomi, morajo bolniki takoj preveriti, ali gre za ketoacidozo, in sicer z izmerjenjem ketonov v urinu ali krvi, ne glede na koncentracijo glukoze v krvi.
With sotagliflozin DKA may be present with low, normal or high blood glucose levels. 
Med zdravljenjem s sotagliflozinom se lahko DKA pojavi ob nizki, normalni ali visoki koncentraciji glukoze v krvi.
It may harm them, 
o prekomerna žeja,
The mean age of patients was 46 years, 8.1% were 65 years or older. 
Povprečna starost bolnikov je bila 46 let, 8,1 % je bilo starih 65 let ali več.
• if you have a history of chronic or recurrent yeast infections of the genitals (thrush) 
• če ste kdaj imeli kronično ali ponavljajočo se glivično okužbo ("gobice") spolovil,
In case of conditions that may lead to fluid loss (e.g., gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving sotagliflozin. 
V primeru bolezni ali motenj, ki lahko povzročijo izgubljanje tekočine (npr. bolezni prebavil), je bolnikom, ki prejemajo sotagliflozin, priporočljivo skrbno kontrolirati intravaskularno volumsko stanje (npr. s kliničnim pregledom, meritvami krvnega tlaka, laboratorijskimi preiskavami, vključno s hematokritom) in elektrolite.
Consistent with the mechanism of SGLT2 inhibition with increased UGE, sotagliflozin increases the risk for genital mycotic infections as reported in clinical trials (see section 4.8). 
Skladno z mehanizmom zaviranja SGLT2 in povečanim izločanjem glukoze v urinu sotagliflozin poveča tveganje za glivične okužbe spolovil, kot je bilo ugotovljeno v kliničnih preskušanjih (glejte poglavje 4.8).
Zynquista is available in PVC/PCTFE/Aluminium opaque blisters. 
Zdravilo Zynquista je na voljo v motnih pretisnih omotih iz PVC/PCTFE/aluminija.
The following adverse reactions have been identified in the pool of two 52-week placebo-controlled clinical trials described above. 
Kumulativno so v dveh 52-tedenskih, s placebom kontroliranih kliničnih preskušanjih, ki sta opisani v nadaljevanju, ugotovili naslednje neželene učinke.
• Hold Zynquista immediately if patient's BHB level is > 0.6 mmol/L (1+ urine ketone) with symptoms or if BHB > 1.5 mmol/L (2+ urine ketone) with or without symptoms. 
• Nemudoma prenehajte uporabljati zdravilo Zynquista, če ima bolnik koncentracijo BHB > 0,6 mmol/l (ketoni v urinu 1+) in prisotne simptome, ali če ima BHB > 1,5 mmol/l (ketoni v urinu 2+), ne glede na to, ali ima simptome ali ne.
The mean age of patients was 41 years, 4.2% were 65 years or older. 
Povprečna starost bolnikov je bila 41 let, 4,2 % je bilo starih 65 let ali več.
Elderly may be at an increased risk of volume depletion (see section 4.2). 
Starejši bolniki Starejše osebe imajo lahko večje tveganje za hipovolemijo (glejte poglavje 4.2).
Rate of documented hypoglycaemia† (events per patient year) at thresholds of ≤3.1 or ≤3.9 mmol/L 
Delež nočnih‡ dokumentiranih hipoglikemij† (dogodki na bolnika in leto) s pragom ≤ 3,1 ali ≤ 3,9 mmol/l
The pharmacokinetics (PK) of sotagliflozin has been characterized in healthy subjects and in diabetic patients. 
5.2 Farmakokinetične lastnosti Farmakokinetiko (FK) sotagliflozina so proučili pri zdravih osebah in bolnikih s sladkorno boleznijo.
Incidence of severe hypoglycaemia (%)* Reduction in risk of severe hypoglycaemia compared to insulin alone (%) 
Zmanjšanje tveganja za hude hipoglikemije v primerjavi s samim insulinom (%)
• urinary tract infection, signs include burning sensation when passing urine, urine that appears cloudy, pain in the pelvis, or mid back pain (when kidneys are infected) 
• okužbe sečil; med znaki so pekoč občutek pri uriniranju, moten urin, bolečine v medenici ali bolečine v ledvenem predelu (če so okužene ledvice).
• Insulin dose reduction during treatment should only be done when needed to prevent hypoglycaemia and should be done cautiously to avoid ketosis and DKA. 
• Med zdravljenjem je treba odmerek insulina zmanjšati le, kadar je to potrebno, da se prepreči hipoglikemija; zmanjšanje je treba opraviti previdno, da se prepreči ketoza in DKA.
Effects of other medicinal products on sotagliflozin The coadministration of a multiple dosing regimen of rifampicin, an inducer of various UGT and CYP metabolizing enzymes, with a single dose of 400 mg sotagliflozin resulted in a decrease in the AUC0-inf (60%) and Cmax (40%) of sotagliflozin. 
Sočasna uporaba več odmernih shem rifampicina, induktorja različnih presnovnih encimov UGT in CYP, z enim odmerkom 400 mg sotagliflozina je povzročila zmanjšanje AUC0-inf (60 %) in Cmax (40 %) sotagliflozina.
• blood tests may show increase in the amount of bad cholesterol (called LDL - a type of fat in your blood) 
• preiskave krvi lahko pokažejo zvišanje slabega holesterola (t.i. holesterola LDL - to je vrsta maščobe v krvi) • preiskave krvi lahko pokažejo povečanje števila rdečih krvnih celic v krvi (imenovanih hematokrit)
Zynquista is used as an addition to insulin treatment in adults with type 1 diabetes with a body mass index (BMI) greater than or equal to 27. 
Zdravilo Zynquista se uporablja kot dodatek zdravljenju z insulinom pri odraslih s sladkorno boleznijo tipa 1 z indeksom telesne mase (ITM) 27 ali več.
The incidence of male genital infections (e.g. balanoposthitis, genital infection fungal) was increased for sotagliflozin 200 mg (3.0%), sotagliflozin 400 mg (6.3%) compared to placebo (1.1%). 
Pojavnost okužb spolovil pri moških (npr. balanopostitisa, glivične okužbe spolovil) je bila z 200 mg sotagliflozina (3,0 %) oz. 400 mg sotagliflozina (6,3 %) večja kot s placebom (1,1 %).
When sotagliflozin tablets were administered with a high-caloric breakfast, plasma exposure to sotagliflozin as measured by Cmax and AUC0 inf was about 2.5- and 1.5-fold higher, respectively, compared to fasted condition. 
Če so tablete sotagliflozina uporabili z visokokaloričnim zajtrkom, je bila Cmax 2,5-krat in AUC0 inf 1,5-krat višja v primerjavi z uporabo na tešče.
Based on the mode of action of sodium glucose co-transporter 2 (SGLT-2) inhibitors, by increasing urinary glucose excretion (UGE), sotagliflozin induces an osmotic diuresis which may reduce intravascular volume and decrease blood pressure (see sections 4.8 and 5.1). 
(SGLT-2), sotagliflozin s povečanjem izločanja glukoze v urinu povzroči osmotsko diurezo, ki lahko zmanjša intravaskularni volumen in zniža krvni tlak (glejte poglavje 4.8 in 5.1).
Sotagliflozin may cause intravascular volume contraction (see section 4.8). 
Sotagliflozin lahko povzroči zmanjšanje intravaskularnega volumna (glejte poglavje 4.8).