FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The doctor may decide to temporarily stop the treatment with Zynquista.
Slovenian: Zdravnik se lahko odloči za začasno prenehanje zdravljenja z zdravilom
English: Blood Ketone (betahydroxybutyrate)
Slovenian: (beta-hidroksibutirat)
English: 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.
Slovenian: 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.
English: Animal studies have shown that sotagliflozin crosses the placenta.
Slovenian: Študije na živalih so pokazale, da sotagliflozin prehaja skozi placento.
English: - Patients should be informed, in a dedicated education session, on the risk of DKA, how to recognize DKA risk factors, signs or symptoms, how and when to monitor ketone levels and what actions to take when ketone levels are elevated (see section 4.4).
Slovenian: - 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).
English: Before initiating sotagliflozin
Slovenian: Pred uvedbo sotagliflozina
English: In a fertility study in rats, sotagliflozin had no effect on reproductive performance, fertility, and embryo/fetal viability.
Slovenian: V študiji plodnosti pri podganah sotagliflozin ni vplival na sposobnost razmnoževanja, plodnost ali embrio-fetalno sposobnost preživetja.
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)
Slovenian: Preglednica 4: Rezultati 24-tedenskega preskušanja sotagliflozina pri bolnikih s sladkorno boleznijo tipa 1, neustrezno urejenih z insulinom (študija 1 - študija 2)
English: There are no data from the use of sotagliflozin in pregnant women.
Slovenian: O uporabi sotagliflozina pri nosečnicah ni podatkov.
English: Ketone monitoring during treatment
Slovenian: Merjenje ketonov med zdravljenjem
English: During a dedicated session your doctor may schedule, discuss how to manage elevated ketone levels to prevent DKA (see section 2).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Unchanged [14C]-sotagliflozin was the predominant radioactive peak detected in faecal extracts representing a mean of 23% of the total administered radioactive dose.
Slovenian: Nespremenjeni [14C]-sotagliflozin je bil pretežni radioaktivni vrh, ugotovljen v fekalnih ekstraktih, in je predstavljal povprečno 23 % celotnega uporabljenega radioaktivnega odmerka.
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors should be used with caution in patients with increased risk of DKA.
Slovenian: Zaviralce od natrijevih ionov odvisnegaglukoznega soprenašalca 2 (SGLT2, sodium-glucose linked transporter 2) je treba previdno uporabljati pri bolnikih z večjim tveganjem za DKA.
English: How to store Zynquista 6.
Slovenian: Shranjevanje zdravila Zynquista 6.
English: Mean duration of diabetes was 20 years, 39% of patients were using insulin pump and 61 % were using non-pump insulin therapy.
Slovenian: Povprečno trajanje sladkorne bolezni je bilo 20 let, 39 % bolnikov je uporabljalo insulinsko črpalko, 61 % pa jih je uporabljalo insulinsko zdravljenje brez črpalke.
English: • phenytoin or phenobarbital (epilepsy medicines used to control fits)
Slovenian: • fenitoin ali fenobarbital (zdravili za epilepsijo, ki se uporabljata za obvladovanje napadov).
English: • Ensure the patient is on optimal insulin therapy prior to initiation of sotagliflozin treatment.
Slovenian: • Zagotovite, da je bolnik pred začetkom zdravljenja s sotagliflozinom na optimalnem zdravljenju z insulinom.
English: Zynquista contains the active substance sotagliflozin, a medicine which lowers blood glucose (blood sugar) levels.
Slovenian: Zdravilo Zynquista vsebuje učinkovino sotagliflozin, ki znižuje koncentracijo glukoze v krvi (koncentracijo krvnega sladkorja).
English: 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.
Slovenian: 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.
English: In studies 1 and 2 combined, patient 24-week completion rates were 89.5% among insulin alone patients, and 91.4% and 90.7% among patients receiving 200 mg and 400 mg of sotagliflozin, respectively.
Slovenian: 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.
English: • The other ingredients are: - tablet core: microcrystalline cellulose (E460i), croscarmellose sodium, colloidal anhydrous silica; magnesium stearate; talc.
Slovenian: • Druge sestavine zdravila so: - Jedro tablete: mikrokristalna celuloza (E460i), premreženi natrijev karmelozat, brezvodni koloidni silicijev dioksid, magnezijev stearat, smukec.
English: What Zynquista looks like and contents of the pack
Slovenian: Izgled zdravila Zynquista in vsebina pakiranja
English: Date of first authorisation: 26 April 2019
Slovenian: Datum prve odobritve: {DD mesec LLLL}
English: No studies on the effect on human fertility have been conducted for sotagliflozin.
Slovenian: Študij o vplivu sotagliflozina na plodnost pri človeku niso izvedli.
English: Diarrhoea, flatulence
Slovenian: Bolezni prebavil driska, flatulenca
English: 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.
Slovenian: prekomernega uživanja alkoholnih pijač, zlorabe zdravil, dehidracije, nenadnega zmanjšanja odmerka insulina ali večje potrebe po insulinu zaradi večje operacije, resne bolezni ali okužbe.
English: • 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.
Slovenian: • 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.
English: Management of DKA
Slovenian: Vodenje DKA
English: Package leaflet: Information for the patientZynquista 200 mg film-coated tablets sotagliflozin This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporaboZynquista 200 mg filmsko obložene tablete sotagliflozin Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: 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.
Slovenian: 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.
English: On a background of optimised insulin, the efficacy and safety of sotagliflozin 200 mg or 400 mg once daily versus insulin alone were evaluated in two double-blind, placebo controlled studies (study 1 and 2) performed in 1575 patients with type 1 diabetes on insulin pump or multiple daily injection therapy.
Slovenian: 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.
English: Based on a population PK analysis, sotagliflozin exposure was found to decrease with increased body weight.
Slovenian: Na podlagi populacijske farmakokinetične analize je ugotovljeno, da se izpostavljenost sotagliflozinu s povečevanjem telesne mase zmanjšuje.
English: - 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.
Slovenian: - Pogostejše kontrole delovanja ledvic, vsaj 2 do 4-krat na leto, so priporočljive pri bolnikih z eGFR pod 60 ml/min/1,73 m2.
English: Each tablet contains 200 mg sotagliflozin.
Slovenian: Ena tableta vsebuje 200 mg sotagliflozina.
English: At the end of 52 weeks the reduction in body weight, mean daily bolus insulin dose, FPG were sustained compared to insulin alone.
Slovenian: 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.
English: - 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.
Slovenian: - 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.
English: • Do not start caloric restriction or carbohydrate restriction while treated with sotagliflozin.
Slovenian: • Med zdravljenjem s sotagliflozinom ne začnite z omejevanjem kalorij ali z omejevanjem ogljikovih hidratov.
English: • The active substance is sotagliflozin.
Slovenian: • Učinkovina je sotagliflozin.
English: Mean duration of diabetes was 24.4 years, 60% of patients were using insulin pump and 40% were using multiple daily injections.
Slovenian: Povprečno trajanje sladkorne bolezni je bilo 24,4 leta, 60 % bolnikov je uporabljalo insulinsko črpalko, 40 % pa injiciranje večkrat na dan.
English: This card contains important safety information about diabetic ketoacidosis (DKA) ▼This medicinal product is subject to additional monitoring.
Slovenian: Kartica vsebuje pomembne varnostne informacije o diabetični ketoacidozi (DKA) ▼Za to zdravilo se izvaja dodatno spremljanje varnosti, kar označuje navzdol obrnjen črn trikotnik.
English: The removal of sotagliflozin by haemodialysis has not been studied.
Slovenian: Odstranjevanje sotagliflozina s hemodializo ni raziskano.
English: Titanium dioxide (E171)
Slovenian: Titanov dioksid (E171) Smukec
English: 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.
Slovenian: 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.
English: • Follow your doctor's instructions about insulin dose while taking Zynquista.
Slovenian: • Med jemanjem zdravila Zynquista upoštevajte zdravnikova navodila o odmerku insulina.
English: Mean duration of diabetes was 18 years, 26% of patients were using insulin pump and 74% were using multiple daily injections.
Slovenian: Povprečno trajanje sladkorne bolezni je bilo 18 let, 26 % bolnikov je uporabljalo insulinsko črpalko, 74 % pa injiciranje večkrat na dan.
English: Infections and infestations Female genital mycotic infections*,a, †
Slovenian: Infekcijske in parazitske bolezni glivične okužbe ženskih spolovil*, a, †
English: Volume depletion*, c, †
Slovenian: Žilne bolezni hipovolemija*, c, †
English: - film-coating: poly(vinyl alcohol); macrogol; titanium dioxide (E 171); talc; indigo carmine aluminium lake (E132).
Slovenian: - Filmska obloga: polivinilalkohol, makrogol, titanov dioksid (E 171), smukec, indigotin (E132).
English: 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):
Slovenian: 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):
English: Read the Zynquista package leaflet for full information and instructions for use.
Slovenian: Za celotne informacije in napotke za uporabo zdravila Zynquista preberite Navodilo za uporabo.
English: If you forget to take Zynquista
Slovenian: Če ste pozabili vzeti zdravilo Zynquista
English: Interaction studies conducted in healthy volunteers show that sotagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, metoprolol, midazolam and oral contraceptives.
Slovenian: Študije medsebojnega delovanja pri zdravih prostovoljcih kažejo, da sotagliflozin ne vpliva klinično pomembno na farmakokinetiko metformina, metoprolola, midazolama in peroralnih kontraceptivov.
English: No acyl glucuronides of sotagliflozin were identified.
Slovenian: Acilnih glukuronidov sotagliflozina niso ugotovili.
English: Table 5: Results of CGM sub study at week 24 (Pooled data, study 1 and study 2) Characteristic
Slovenian: Preglednica 5: Rezultati podštudije CGM po 24 tednih (združeni podatki študije 1 in študije 2)
English: By inhibiting SGLT2, sotagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Slovenian: Z zavrtjem SGLT2 sotagliflozin zmanjša reabsorpcijo v ledvicah filtrirane glukoze, zniža ledvični prag za glukozo in s tem poveča izločanje glukoze v urinu.
English: OUTER CARTON multipack (with Blue Box)
Slovenian: ZUNANJA ŠKATLA skupnega pakiranja (s podatki za modro okence)
English: Treatment with sotagliflozin should be stopped in patients who are hospitalized for major surgical procedures or acute serious medical illnesses.
Slovenian: Zdravljenje s sotagliflozinom je treba prekiniti pri bolnikih, sprejetih v bolnišnico za večje operacije ali zaradi akutnih resnih internističnih bolezni.
English: Sotagliflozin must only be administered as an adjunct to insulin.
Slovenian: Sotagliflozin se sme uporabljati le kot dodatek k insulinu.
English: The mean age of patients was 43 years, 7.2% were 65 years or older.
Slovenian: Povprečna starost bolnikov je bila 43 let, 7,2 % je bilo starih 65 let ali več.
English: The patient's/carer's guide should contain the following key elements:
Slovenian: Vodnik za bolnike/skrbnike mora vsebovati naslednje ključne elemente:
English: Basal insulin
Slovenian: Bazalni insulin
English: c Adverse events grouping, including dehydration, hypovolaemia, postural dizziness, orthostatic hypotension, hypotension, syncope and presyncope when reported in context of volume depletion.
Slovenian: c Skupina neželenih učinkov vključno z dehidracijo, hipovolemijo, posturalno omotico, ortostatsko hipotenzijo, hipotenzijo, sinkopo in presinkopo v okviru hipovolemije.
English: 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.
Slovenian: 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
English: • The risk of DKA is increased with sotagliflozin treatment.
Slovenian: • Tveganje za diabetično ketoacidozo se med zdravljenjem s sotagliflozinom poveča.
English: 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.
Slovenian: 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.
English: If a dose is missed, it should be taken as soon as you remember the missed dose.
Slovenian: Če ste izpustili odmerek, ga vzemite, čim se spomnite.
English: • For patients taking ZYNQUISTA, glucose is not a reliable marker for DKA and must be supplemented with ketone monitoring
Slovenian: • Pri bolnikih, ki jemljejo zdravilo Zynquista, glukoza ni zanesljiv označevalec DKA in jo je treba dopolniti s spremljanjem ketonov • Znaki in simptomi DKA vključujejo:
English: Sotagliflozin was not mutagenic or clastogenic.
Slovenian: Sotagliflozin ni bil mutagen ali klastogen.
English: Film-coated tablet Multipack: 200 (2 packs of 100) film-coated tablets
Slovenian: Pakiranje po več enot: 200 (2 pakiranji po 100) filmsko obloženih tablet
English: As a precautionary measure, when pregnancy is detected, treatment with sotagliflozin should be discontinued.
Slovenian: V primeru ugotovljene nosečnosti je treba kot previdnostni ukrep prenehati zdravljenje s sotagliflozinom.
English: If you stop taking Zynquista
Slovenian: Če ste prenehali jemati zdravilo Zynquista
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).
Slovenian: 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).
English: M19 is an inducer and inhibitor of CYP3A4 and an inhibitor of CYP2D6.
Slovenian: M19 inducira in zavira CYP3A4 ter zavira CYP2D6.
English: The patient should immediately seek medical advice and stop taking sotagliflozin.
Slovenian: Bolnik mora nemudoma poiskati zdravniški nasvet in prenehati jemati sotagliflozin.
English: 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.
Slovenian: 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.
English: - Patients with elevated ketones levels (BHB reading is greater than 0.6 mmol/L or urine ketones one plus (+)).
Slovenian: - z zvišano koncentracijo ketonov (izvid BHB več kot 0,6 mmol/l ali ketoni v urinu en plus (+)).
English: • raised ketone levels in your blood
Slovenian: • driska • zvišana koncentracija ketonov v krvi
English: The level of digoxin or digitoxin in your blood may need to be checked if you take these medicines with Zynquista.
Slovenian: Če digoksin ali digitoksin jemljete skupaj z zdravilom Zynquista, bo morda treba kontrolirati njuno koncentracijo v krvi.
English: Assessment of renal function is recommended prior to initiation of sotagliflozin and periodically thereafter (see section 4.4).
Slovenian: Pred uvedbo sotagliflozina je priporočljivo oceniti delovanje ledvic in kasneje tudi redno periodično spremljati (glejte poglavje 4.4).
English: 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.
Slovenian: Medsebojnega delovanja sotagliflozina z drugimi občutljivimi substrati OAT3, OATP in/ali BCRP (npr. s feksofenadinom, paklitakselom, bosentanom, metotreksatom, furosemidom, benzilpenicilinom) ni mogoče izključiti.
English: • if you have no access to ketone testing materials or no immediate access to a doctor if blood or urine ketones are elevated
Slovenian: • 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,
English: Patients should consider monitoring ketones levels three to four hours after changing pump materials.
Slovenian: Bolniki naj bi si tri do štiri ure po menjavi materialov črpalke, kontrolirali koncentracijo ketonov.
English: Microcrystalline cellulose (E460i) Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Talc
Slovenian: Mikrokristalna celuloza (E460i) Premreženi natrijev karmelozat Brezvodni koloidni silicijev dioksid Magnezijev stearat Smukec
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON without Blue Box
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA brez podatkov za modro okence
English: Following the administration of a single dose of 400 mg [14C]-sotagliflozin, showed 57% and 37% of the radioactivity were excreted in the urine and faeces, respectively.
Slovenian: Po uporabi enkratnega odmerka 400 mg [14C]-sotagliflozina se je 57 % radioaktivnosti izločilo v urinu in 37 % v blatu.
English: EU/1/19/1363/008 (200 mg - 2 packs of 100 film coated tablets)
Slovenian: EU/0/00/000/008 (200 mg - 2 pakiranji po 100 filmsko obloženih tablet)
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.
Slovenian: 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.