natgillin/translations-raw huggingface dataset:
Exposure of sotagliflozin was evaluated in a dedicated study of subjects with mild (creatinine clearance [CLcr]: 60 to less than 90 mL/min) and moderate (CLcr: 30 to less than 60 mL/min) renal impairment and with normal renal function. 
Izpostavljenost sotagliflozinu so ocenili v namenskih preskušanjih pri preiskovancih z blago (kreatininski očistek [CLcr]: od 60 do manj kot 90 ml/min) in zmerno ([CLcr]: od 30 do manj kot 60 ml/min) okvaro ledvic in z normalnim delovanjem ledvic.
Reduction in risk of documented hypoglycaemia, compared to insulin alone at threshold of ≤3.1 mmol/L (%) 
Zmanjšanje tveganja za dokumentirano hipoglikemijo, v primerjavi z insulinom samim ob pragu ≤ 3,1 mmol/l (%)
It is possible that adverse effects occurring with sotagliflozin may be similar to presenting symptoms of DKA. 
Neželeni učinki, ki se lahko pojavijo med uporabo sotagliflozina, so lahko podobni kliničnim simptomom DKA.
In patients 65 years and older, renal function and an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8). 
Pri bolnikih, starih 65 let ali več, je treba upoštevati delovanje ledvic ter večje tveganje za hipovolemijo (glejte poglavji 4.4 in 4.8).
Sotagliflozin is a dual inhibitor of sodium glucose cotransporter type 1 (SGLT1) and SGLT2. 
Sotagliflozin je dvojni zaviralec od natrijevih ionov odvisnega glukoznega soprenašalca tipa 1 (SGLT1) in SGLT2.
Diabetic ketoacidosis (DKA) is a potentially life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests. 
Diabetična ketoacidoza (DKA) je potencialno smrtno nevarna težava, ki se pri sladkorni bolezni lahko pojavi zaradi zvišane ravni "ketonskih teles" v urinu ali krvi; pokaže se na laboratorijskih preiskavah.
Ketones should be measured repetitively when any signs or symptoms consistent with DKA or euglycaemic DKA are present. 
Merjenje ketonov je treba ponavljati, ob prisotnosti znakov ali simptomov skladnimi z DKA ali evglikemično
Patients should be monitored for signs and symptoms of hypotension after initiating therapy. 
Bolnike je treba po uvedbi zdravljenja nadzorovati glede znakov in simptomov hipotenzije.
The primary route of metabolism of sotagliflozin in humans is glucuronidation by the uridine 5'diphospho-glucuronosyltransferases primarly by UGT1A9, and to a much lesser extent by UGT1A1 and UGT2B7 as well as oxidation, by CYP3A4. 
Primarna pot presnove sotagliflozina pri človeku je glukuronidacija z uridin-5'-difosfo glukuronoziltransferazami primarno z UGT1A9 in, v manjši meri, z UGT1A1 in UGT2B7 kot tudi z oksidacijo s CYP3A4.
The recommended dose of Zynquista is one 200-mg tablet once a day before the first meal of the day. 
Priporočeni odmerek zdravila Zynquista je ena 200-mg tableta enkrat na dan pred prvim obrokom tisti dan.
Therapy with Zynquista should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus. 
Zdravljenje z zdravilom Zynquista se mora začeti in potekati pod nadzorom zdravnika, izkušenega z vodenjem sladkorne bolezni tipa 1.
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. 
Znižanje HbA1c se ni razlikovalo med podskupinami vključno s starostjo, spolom, raso, geografsko regijo, izhodiščnim ITM, starostjo ob diagnozi, izhodiščnim HbA1c, eGFR, trajanjem bolezni in načinom dajanja insulina.
As sotagliflozin is taken together with insulin, hypoglycaemia may occur during treatment. 
Ker se sotagliflozin uporablja skupaj z insulinom, se lahko med zdravljenjem pojavi hipoglikemija.
In placebo-controlled clinical trials of sotagliflozin, patients were advised to monitor urine or blood ketones in case of suspected symptoms of DKA and seek medical advice/attention if their selfmeasured blood ketone reading was > 0.6 mmol/l. 
V s placebom kontroliranih kliničnih preskušanjih sotagliflozina so bolnikom naročili, naj v primeru simptomov, sumljivih za DKA, kontrolirajo ketone v urinu ali krvi ter naj poiščejo zdravniški nasvet/pomoč, če je samoizmerjena vrednost ketonov v krvi > 0,6 mmol/l.
Alternative methods should be used to monitor glycaemic control. 
Za spremljanje urejenosti glikemije je treba uporabiti drugačne metode.
• Sotagliflozin is not a substitute for insulin. 
• Sotagliflozin ni nadomestilo za insulin.
The recommended dose is 200 mg sotagliflozin once daily before the first meal of the day. 
Priporočeni odmerek je 200 mg sotagliflozina enkrat na dan pred prvim dnevnim obrokom.
† Defined as a documented SMBG or laboratory blood glucose value below or equal to threshold of 3.1 or 3.9 mmol/L. 
† Opredeljeno kot dokumentirana SIGK ali laboratorijsko izmerjena vrednost glukoze v krvi enaka ali nižja od praga 3,1 ali 3,9 mmol/l.
Before initiating treatment with sotagliflozin 200 mg and before increasing dose to sotagliflozin 400 mg: 
Pred uvedbo zdravljenja z 200 mg sotagliflozina in pred povečanjem odmerka na 400 mg sotagliflozina:
What you need to know before you take Zynquista Do not take Zynquista: 
Kaj morate vedeti, preden boste vzeli zdravilo Zynquista Ne jemljite zdravila Zynquista:
The most frequently reported adverse reactions were genital mycotic infections, diabetic ketoacidosis and diarrhoea. 
Neželeni učinki, o katerih so najpogosteje poročali, so bile glivične okužbe spolovil, diabetična ketoacidoza in driska.
Pack sizes of 10, 20, 30, 60, 90, 100, 180 film-coated tablets, and a multipack of 200 film-coated tablets (2 packs of 100 film-coated tablets). 
Velikosti pakiranj 10, 20, 30, 60, 90, 100, 180 filmsko obloženih tablet in pakiranje po več enot z 200 filmsko obloženimi tabletami (2 pakiranji po 100 filmsko obloženih tablet).
For the first meal on Day 1, patients were instructed to decrease their calculated (or usual) mealtime carbohydrate bolus insulin by 30%. 
Bolnikom so naročili, naj pri prvem obroku 1. dan zmanjšajo svoj izračunani (ali običajni) bolus insulina za ogljikove hidrate ob obroku za 30 %.
Because of how Zynquista works, your urine will test positive for sugar while you are on this medicine. 
Zaradi načina delovanja zdravila Zynquista bo med zdravljenjem s tem zdravilom vaš urin pozitiven v preiskavah za prisotnost sladkorja.
If you develop symptoms contact your doctor or go to the nearest hospital right away. 
Če se vam pojavijo simptomi, se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
No developmental toxicity was observed at doses up to 200 mg/kg/day in the rabbit, which was up to 9-times the human exposure at the MRHD. 
Pri kuncih niso opažali toksičnih učinkov na razvoj v odmerkih do 200 mg/kg/dan, kar je do 9-kratnik izpostavljenosti med uporabo MRHD pri človeku.
Sotagliflozin works by slowing and reducing the absorption of glucose from food, and by increasing the amount of glucose that is passed out in urine. 
Sotagliflozin deluje tako, da upočasni in zmanjša absorpcijo glukoze iz hrane ter poveča količino glukoze, ki se izloči v urinu.
What Zynquista is and what it is used for 
Kaj je zdravilo Zynquista in za kaj ga uporabljamo
• Guidance to the physician for assessing whether the patient is eligible for sotagliflozin prescription, e.g. patient selection criteria including adherence to insulin treatment and insulin thresholds, patient's beta-hydroxybutyrate (BHB) < 0.6 mmol/L or urine ketones < 1+, BMI ≥ 27 kg/m2, absence of DKA risk factors. 
• Navodila zdravniku za oceno, ali je bolnik primeren za predpisovanje sotagliflozina, npr. merila za izbiro bolnikov, vključno z adherenco insulinskega zdravljenja in pragovi insulina, bolnikovo koncentracijo beta-hidroksibutirata (BHB) < 0,6 mmol/l ali ketoni v urinu < 1+, ITM ≥ 27 kg/m2, odsotnostjo dejavnikov tveganja za DKA.
Main results for insulin dose and Diabetes Treatment Satisfaction Questionnaire and Diabetes Distress Screening Scale are presented in Table 4. 
Glavni rezultati za odmerek insulina ter vprašalnikov DTSQ (Diabetes Treatment Satisfaction Questionnaire) in DDSS (Diabetes Distress Screening Scale) so prikazani v preglednici 4.
Increased urinationd, blood creatinine increased/ glomerular filtration decreased† 
zvišanje kreatinina v krvi/zmanjšanje glomerularne filtracije†
The guide for healthcare professionals including the prescriber's checklist should contain the following key elements: 
Vodnik za zdravstvene delavce, vključno s kontrolnim seznamom za zdravnike, ki predpisujejo zdravilo, mora vsebovati naslednje ključne elemente:
EU/1/19/1363/001 10 film coated tablets EU/1/19/1363/002 20 film coated tablets EU/1/19/1363/003 30 film coated tablets EU/1/19/1363/004 60 film coated tablets EU/1/19/1363/005 90 film coated tablets EU/1/19/1363/006 100 film coated tablets EU/1/19/1363/007 180 film coated tablets EU/1/19/1363/008 200 (2x100) film coated tablets (multipack) 
EU/1/19/1363/001 10 filmsko obloženih tablet EU/1/19/1363/002 20 filmsko obloženih tablet EU/1/19/1363/003 30 filmsko obloženih tablet EU/1/19/1363/004 60 filmsko obloženih tablet EU/1/19/1363/005 90 filmsko obloženih tablet EU/1/19/1363/006 100 filmsko obloženih tablet EU/1/19/1363/007 180 filmsko obloženih tablet EU/1/19/1363/008 200 (2x100) filmsko obloženih tablet (skupno pakiranje)
All events were mild or moderate in intensity and no serious cases. 
Vsi učinki so bili blagi ali zmerni in resnih primerov ni bilo.
Interaction studies in healthy volunteers showed that metformin, metoprolol, midazolam, rosuvastatin and oral contraceptives had no clinically relevant effect on the pharmacokinetics of sotagliflozin. 
Študije medsebojnega delovanja pri zdravih prostovoljcih kažejo, da metformin, metoprolol, midazolam, rosuvastatin in peroralni kontraceptivi nimajo klinično pomembnega vpliva na farmakokinetiko sotagliflozina.
All severe hypoglycaemia presented were positively adjudicated. 
Vsi primeri hude hipoglikemije so bili s presojo opredeljeni pozitivno.
Based on in-vitro data, induction of CYP2C9, CYP2B6 and CYP1A2 cannot be ruled out. 
Na podlagi podatkov in vitro ni mogoče izključiti indukcije CYP2C9, CYP2B6 in CYP1A2.
During the initial one to two weeks of treatment with sotagliflozin, ketones should be monitored on a regular basis. 
V prvem do dveh tednih zdravljenja s sotagliflozinom je treba ketone redno kontrolirati.
The efficacy and safety of sotagliflozin in patients with type 1 diabetes not adequately controlled on their current insulin therapy was evaluated in three double-blind, placebo-controlled studies. 
Klinična učinkovitost in varnost Učinkovitost in varnost sotagliflozina pri bolnikih s sladkorno boleznijo tipa 1, neustrezno urejenih s trenutnim insulinskim zdravljenjem, so ocenili v treh dvojno slepih, s placebom kontroliranih preskušanjih.
Sotagliflozin and M19 have no significant potential to inhibit OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3. 
Sotagliflozin in M19 nimata pomembnega potenciala za zaviranje OCT1, OCT2, OAT1, OAT3, OATP1B1 in OATP1B3.
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. 
Poskrbite, da boste vedno imeli pri sebi opozorilno kartico za bolnika, ki vam jo je dal zdravnik in ki je priložena tudi v pakiranju zdravila.
Rosuvastatin is a known OATP, BCRP and OAT3 substrate. 
Rosuvastatin je znan substrat OATP, BCRP in OAT3.
Patient Alert Card Patient Alert Card 
Opozorilna kartica za bolnika Opozorilna kartica za bolnika
In in vitro studies, sotagliflozin did not inhibit CYP 1A2, 2C9, 2C19, 2D6, or 3A4, nor induced CYP 1A2, 2B6, or 3A4. 
V študijah in vitro sotagliflozin ni zavrl CYP 1A2, 2C9, 2C19, 2D6 ali 3A4, niti ni induciral CYP 1A2, 2B6 ali 3A4.
Both sotagliflozin and its major human metabolite 3-O-glucuronide (M19), exhibited high binding to human plasma proteins in vitro (fraction unbound approx. 2%) which was not dependent on the concentration of sotagliflozin and M19. 
Sotagliflozin in 3-O-glukuronid (M19), njegov glavni presnovek pri človeku, sta in vitro pokazala v veliki meri vezavo na človeške plazemske beljakovine (nevezani delež približno 2 %); ta vezava ni bila odvisna od koncentracije sotagliflozina in M19.
• blood tests may show increase related to kidney function (such as ‘creatinine'). 
• preiskave krvi lahko pokažejo zvišano vrednost snovi (kot je "kreatinin"), ki je povezana z delovanjem ledvic.
In vitro sotagliflozin was shown to have inhibitory effects on P-gp and breast cancer resistance protein (BCRP). 
Ugotovljeno je, da sotagliflozin in vitro zavira P-gp in protein odpornosti pri raku dojke (BCRPbreast cancer resistance protein).
The apparent clearance of sotagliflozin decreases with decreasing renal function. 
Navidezni očistek sotagliflozina se z zmanjševanjem delovanja ledvic zmanjšuje.
- Patients with increased insulin requirements due to acute medical illness or surgery. 
- ki imajo povečano potrebo po insulinu zaradi akutne bolezni ali kirurškega posega.
Systolic Blood Pressure in those with baseline SBP ≥ 130 mmHg* 
Sistolični krvni tlak pri bolnikih, ki so imeli izhodiščno SKT ≥ 130 mmHg*
Sotagliflozin should not be used during breast-feeding. 
Sotagliflozina se med obdobjem dojenja ne sme uporabljati.
If an enzyme inducer (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) must be co-administered with sotagliflozin, consider frequent monitoring of glucose level. 
Če je treba skupaj s sotagliflozinom uporabiti kakšen induktor encimov (npr. rifampicin, fenitoin, fenobarbital, ritonavir), razmislite o pogostih meritvah koncentracije glukoze.
Patients must be informed about what actions to take if ketone levels are elevated. 
Bolnike je treba obvestiti, kako naj ravnajo, če so nivoji ketonov zvišani.
- 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). 
- ki vztrajajo na uživanju kalorično omejene prehrane, omejujejo uživanje ogljikovih hidratov ali ketogene prehrane ter bolniki, ki kronično premalo odmerjajo insulin (npr. zaradi vzdrževanja lipolitičnega stanja).
Marketing Authorisation Holder: Navigant Germany GmbH Albrechtstr. 
Imetnik dovoljenja za promet z zdravilom: Navigant Germany GmbH Albrechtstr.
If you take more Zynquista tablets than you should, talk to a doctor or go to a hospital immediately. 
Če ste vzeli večji odmerek zdravila Zynquista, kot bi smeli Če ste vzeli več tablet zdravila Zynquista, kot bi smeli, se nemudoma posvetujte z zdravnikom ali pojdite v bolnišnico.
Your doctor will schedule a dedicated education session, to discuss 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. 
Zdravnik vas bo povabil na namensko izobraževalno srečanje, kjer se boste pogovorili o tveganju za DKA, prepoznavanju dejavnikov tveganja za DKA ter njenih znakov in simptomov, kako in kdaj kontrolirati koncentracijo ketonov in kako ukrepati, če je koncentracija ketonov zvišana.
In embryo-fetal development studies in rats and rabbits, sotagliflozin was orally administered at doses up to 350 mg/kg in rats and 200 mg/kg in rabbits. 
V študijah embrio-fetalnega razvoja pri podganah in kuncih so živali dobivale sotagliflozin peroralno, in sicer podgane odmerke do 350 mg/kg in kunci odmerke do 200 mg/kg.
The doctor may decide to temporarily stop the treatment with Zynquista. 
Zdravnik se lahko odloči za začasno prenehanje zdravljenja z zdravilom
In a juvenile toxicology study in rats, renal changes were observed when sotagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. 
V toksikološki študiji pri mladih podganah so opažali ledvične spremembe, če je bil sotagliflozin uporabljen med obdobjem razvoja ledvic, kar ustreza poznemu drugemu trimesečju in tretjemu trimesečju nosečnosti pri človeku.
Animal studies have shown that sotagliflozin crosses the placenta. 
Študije na živalih so pokazale, da sotagliflozin prehaja skozi placento.
- 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). 
- Bolnike je treba na namenskem izobraževalnem srečanju seznaniti s tveganjem za DKA, kako prepoznati dejavnike tveganja za DKA ter njenih znakov ali simptomov, kako in kdaj morajo kontrolirati koncentracijo ketonov in kako ukrepati, če je koncentracija ketonov zvišana (glejte poglavje 4.4).
Before initiating sotagliflozin 
Pred uvedbo sotagliflozina
In a fertility study in rats, sotagliflozin had no effect on reproductive performance, fertility, and embryo/fetal viability. 
V študiji plodnosti pri podganah sotagliflozin ni vplival na sposobnost razmnoževanja, plodnost ali embrio-fetalno sposobnost preživetja.
Table 4: Results at 24-week trial with sotagliflozin in patients with type 1 diabetes mellitus inadequately controlled on insulin (Study 1 - Study 2) 
Preglednica 4: Rezultati 24-tedenskega preskušanja sotagliflozina pri bolnikih s sladkorno boleznijo tipa 1, neustrezno urejenih z insulinom (študija 1 - študija 2)
There are no data from the use of sotagliflozin in pregnant women. 
O uporabi sotagliflozina pri nosečnicah ni podatkov.
Ketone monitoring during treatment 
Merjenje ketonov med zdravljenjem
During a dedicated session your doctor may schedule, discuss how to manage elevated ketone levels to prevent DKA (see section 2). 
Na namenskem izobraževalnem srečanju vam lahko zdravnikom oblikuje in se z vami pogovori glede načrta za obvladovanje zvišane koncentracije ketonov, da boste preprečili DKA (glejte poglavje 2).
Prior to launch of Zynquista (sotagliflozin), 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, in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of educational materials for sotagliflozin, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred prihodom zdravila Zynquista (sotagliflozin) na trg kot dodatek zdravljenju z insulinom za izboljšanje urejenosti glikemije pri odraslih s sladkorno boleznijo tipa 1 z indeksom telesne mase (ITM) ≥ 27 kg/m2, ki kljub optimalnemu zdravljenju z insulinom niso dosegli urejenosti glikemije, se mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega gradiva za sotagliflozin, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
Unchanged [14C]-sotagliflozin was the predominant radioactive peak detected in faecal extracts representing a mean of 23% of the total administered radioactive dose. 
Nespremenjeni [14C]-sotagliflozin je bil pretežni radioaktivni vrh, ugotovljen v fekalnih ekstraktih, in je predstavljal povprečno 23 % celotnega uporabljenega radioaktivnega odmerka.
Sodium-glucose co-transporter 2 (SGLT2) inhibitors should be used with caution in patients with increased risk of DKA. 
Zaviralce od natrijevih ionov odvisnegaglukoznega soprenašalca 2 (SGLT2, sodium-glucose linked transporter 2) je treba previdno uporabljati pri bolnikih z večjim tveganjem za DKA.
How to store Zynquista 6. 
Shranjevanje zdravila Zynquista 6.
Mean duration of diabetes was 20 years, 39% of patients were using insulin pump and 61 % were using non-pump insulin therapy. 
Povprečno trajanje sladkorne bolezni je bilo 20 let, 39 % bolnikov je uporabljalo insulinsko črpalko, 61 % pa jih je uporabljalo insulinsko zdravljenje brez črpalke.
• phenytoin or phenobarbital (epilepsy medicines used to control fits) 
• fenitoin ali fenobarbital (zdravili za epilepsijo, ki se uporabljata za obvladovanje napadov).
• Ensure the patient is on optimal insulin therapy prior to initiation of sotagliflozin treatment. 
• Zagotovite, da je bolnik pred začetkom zdravljenja s sotagliflozinom na optimalnem zdravljenju z insulinom.
Zynquista contains the active substance sotagliflozin, a medicine which lowers blood glucose (blood sugar) levels. 
Zdravilo Zynquista vsebuje učinkovino sotagliflozin, ki znižuje koncentracijo glukoze v krvi (koncentracijo krvnega sladkorja).
In a study with subjects with reduced hepatic function, AUC of sotagliflozin was not increased in mild (Child Pugh A) hepatic impaired subjects, but was increased by ~3 fold in moderate (Child Pugh B) and ~ 6 fold in severe (Child Pugh C) hepatic impaired subjects. 
V študiji preiskovancev z zmanjšanim delovanjem jeter AUC sotagliflozina ni bila večja v primeru blage okvare jeter (Child Pugh A), v primeru zmerne okvare (Child Pugh B) je bila ~3-krat večja in v primeru hude okvare (Child Pugh C) ~6-krat večja.
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. 
V študiji 1 in 2 skupaj je bil delež bolnikov, ki so dokončali 24 tednov študije, 89,5 % med tistimi, ki so prejemali samo insulin ter 91,4 % oz. 90,7 % med tistimi, ki so prejemali 200 mg oz. 400 mg sotagliflozina.
• The other ingredients are: - tablet core: microcrystalline cellulose (E460i), croscarmellose sodium, colloidal anhydrous silica; magnesium stearate; talc. 
• Druge sestavine zdravila so: - Jedro tablete: mikrokristalna celuloza (E460i), premreženi natrijev karmelozat, brezvodni koloidni silicijev dioksid, magnezijev stearat, smukec.
What Zynquista looks like and contents of the pack 
Izgled zdravila Zynquista in vsebina pakiranja
Date of first authorisation: 26 April 2019 
Datum prve odobritve: {DD mesec LLLL}
No studies on the effect on human fertility have been conducted for sotagliflozin. 
Študij o vplivu sotagliflozina na plodnost pri človeku niso izvedli.
Diarrhoea, flatulence 
Bolezni prebavil driska, flatulenca
The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, drug abuse, dehydration, sudden reductions in insulin dose, or a higher need for insulin due to major surgery, serious illness or infection. 
prekomernega uživanja alkoholnih pijač, zlorabe zdravil, dehidracije, nenadnega zmanjšanja odmerka insulina ali večje potrebe po insulinu zaradi večje operacije, resne bolezni ali okužbe.
• For pump users: restrict sotagliflozin prescription to patients experienced in pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur in case of pump failure. 
• Za uporabnike črpalke: predpisovanje sotagliflozina omejite na bolnike, ki imajo izkušnje z uporabo črpalke, običajnimi načini odpravljanja težav, če se v primeru okvare črpalke prekine dovajanje insulina iz nje.
Management of DKA 
Vodenje DKA
Package leaflet: Information for the patientZynquista 200 mg film-coated tablets sotagliflozin This medicine is subject to additional monitoring. 
Navodilo za uporaboZynquista 200 mg filmsko obložene tablete sotagliflozin Za to zdravilo se izvaja dodatno spremljanje varnosti.
The incidence of severe hypoglycaemia and rates of documented hypoglycaemia (overall and nocturnal) were lower on sotagliflozin compared to insulin alone in the 52-week studies, as shown in Table 7. 
Pojavnost hudih hipoglikemij in deleži dokumentiranih hipoglikemij (vseh in nočnih) so bili v 52tedenskih študijah manjši s sotagliflozinom kot s samim insulinom, kot prikazuje preglednica 7.