FrancophonIA/ELRC3.0 huggingface dataset:
English: Sotagliflozin should not be initiated when patients are at a higher risk of DKA, such as: - Patients with low insulin needs.
Slovenian: Sotagliflozina se ne sme uvesti, če imajo bolniki večje tveganje za DKA; to so bolniki:
English: 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).
Slovenian: Zynquista za eno ali več skupin pediatrične populacije pri sladkorni bolezni tipa 1 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Other side effects: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb)
English: 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.
Slovenian: 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.
English: Bolus insulin
Slovenian: Bolusni insulin
English: In the study 48% were male and 92% were White and 84% of randomised patients completed the study.
Slovenian: V študiji je bilo 48 % moških in 92 % belcev; študijo je dokončalo 84 % randomiziranih bolnikov.
English: Before initiating sotagliflozin, volume contraction should be assessed and volume status should be corrected if indicated.
Slovenian: Pred uvedbo sotagliflozina je treba oceniti zmanjšanje intravaskularnega volumna in po potrebi korigirati volumsko stanje.
English: Sotagliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion.
Slovenian: Sotagliflozin povzroči osmotsko diurezo; to lahko povzroči zmanjšanje intravaskularnega volumna in neželene učinke, povezane s hipovolemijo.
English: 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.
Slovenian: 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 .
English: • 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).
Slovenian: • 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).
English: • if you are on caloric restriction, carbohydrate restriction or ketogenic diet
Slovenian: • če uporabljate majhen odmerek insulina, • če v prehrani omejujete kalorije ali ogljikove hidrate, ali če uživate ketogeno dieto
English: If a dose is missed, it should be taken as soon as the patient remembers the missed dose.
Slovenian: Če bolnik pozabi vzeti odmerek, vzame pozabljeni odmerek, takoj ko se spomni.
English: M19 demonstrated inhibitory effects against OATP1B1/B3 and MRP2 in-vitro.
Slovenian: M19 je in vitro inhibiral OATP1B1/B3 in MRP2.
English: • 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).
Slovenian: • 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
English: Based on a population PK analysis, age had no clinically meaningful effect on the pharmacokinetics of sotagliflozin.
Slovenian: Na podlagi populacijske farmakokinetične analize starost ne vpliva klinično pomembno na farmakokinetiko sotagliflozina.
English: Patients should be assessed for ketoacidosis immediately if these symptoms occur, by measuring the urine or blood ketones, regardless of blood glucose level.
Slovenian: 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.
English: With sotagliflozin DKA may be present with low, normal or high blood glucose levels.
Slovenian: Med zdravljenjem s sotagliflozinom se lahko DKA pojavi ob nizki, normalni ali visoki koncentraciji glukoze v krvi.
English: It may harm them,
Slovenian: o prekomerna žeja,
English: The mean age of patients was 46 years, 8.1% were 65 years or older.
Slovenian: Povprečna starost bolnikov je bila 46 let, 8,1 % je bilo starih 65 let ali več.
English: • if you have a history of chronic or recurrent yeast infections of the genitals (thrush)
Slovenian: • če ste kdaj imeli kronično ali ponavljajočo se glivično okužbo ("gobice") spolovil,
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Zynquista is available in PVC/PCTFE/Aluminium opaque blisters.
Slovenian: Zdravilo Zynquista je na voljo v motnih pretisnih omotih iz PVC/PCTFE/aluminija.
English: The following adverse reactions have been identified in the pool of two 52-week placebo-controlled clinical trials described above.
Slovenian: Kumulativno so v dveh 52-tedenskih, s placebom kontroliranih kliničnih preskušanjih, ki sta opisani v nadaljevanju, ugotovili naslednje neželene učinke.
English: • 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.
Slovenian: • 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.
English: The mean age of patients was 41 years, 4.2% were 65 years or older.
Slovenian: Povprečna starost bolnikov je bila 41 let, 4,2 % je bilo starih 65 let ali več.
English: Elderly may be at an increased risk of volume depletion (see section 4.2).
Slovenian: Starejši bolniki Starejše osebe imajo lahko večje tveganje za hipovolemijo (glejte poglavje 4.2).
English: Rate of documented hypoglycaemia† (events per patient year) at thresholds of ≤3.1 or ≤3.9 mmol/L
Slovenian: Delež nočnih‡ dokumentiranih hipoglikemij† (dogodki na bolnika in leto) s pragom ≤ 3,1 ali ≤ 3,9 mmol/l
English: The pharmacokinetics (PK) of sotagliflozin has been characterized in healthy subjects and in diabetic patients.
Slovenian: 5.2 Farmakokinetične lastnosti Farmakokinetiko (FK) sotagliflozina so proučili pri zdravih osebah in bolnikih s sladkorno boleznijo.
English: Incidence of severe hypoglycaemia (%)* Reduction in risk of severe hypoglycaemia compared to insulin alone (%)
Slovenian: Zmanjšanje tveganja za hude hipoglikemije v primerjavi s samim insulinom (%)
English: • 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)
Slovenian: • okužbe sečil; med znaki so pekoč občutek pri uriniranju, moten urin, bolečine v medenici ali bolečine v ledvenem predelu (če so okužene ledvice).
English: • Insulin dose reduction during treatment should only be done when needed to prevent hypoglycaemia and should be done cautiously to avoid ketosis and DKA.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: • blood tests may show increase in the amount of bad cholesterol (called LDL - a type of fat in your blood)
Slovenian: • 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)
English: 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.
Slovenian: Zdravilo Zynquista se uporablja kot dodatek zdravljenju z insulinom pri odraslih s sladkorno boleznijo tipa 1 z indeksom telesne mase (ITM) 27 ali več.
English: 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%).
Slovenian: 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 %).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: (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).
English: Sotagliflozin may cause intravascular volume contraction (see section 4.8).
Slovenian: Sotagliflozin lahko povzroči zmanjšanje intravaskularnega volumna (glejte poglavje 4.8).
English: Supplemental carbohydrate may be required based on glucose levels in addition to hydration and additional rapid acting insulin (see Table 1 in section 4.2).
Slovenian: Glede na koncentracijo glukoze v krvi so lahko poleg hidracije in dodatnega hitrodelujočega insulina potrebni dodatni ogljikovi hidrati (glejte preglednico 1 in poglavje 4.2).
English: In the study 50% were male and 88 % were White and 87% of randomised patients completed the study.
Slovenian: V študiji je bilo 50 % moških in 88 % belcev; študijo je dokončalo 87 % randomiziranih bolnikov.
English: EU/1/19/1363/008 200 film-coated tablets (2 packs of 100)
Slovenian: EU/0/00/000/008 200 filmsko obloženih tablet (2 pakiranji po 100)
English: • Patient Alert Card
Slovenian: • Opozorilne kartice za bolnika
English: • Sotagliflozin treatment should be temporarily stopped before surgical procedures or in case of hospitalisation for acute serious illness.
Slovenian: • Zdravljenje s sotagliflozinom je treba začasno prekiniti pred kirurškimi posegi ali v primeru hospitalizacije zaradi akutne resne bolezni.
English: Oval, blue, film-coated tablet printed with “2456” on one side in black ink (tablet length: 14.2 mm, tablet width: 8.7 mm).
Slovenian: Filmsko obložene tablete ovalne oblike in modre barve, ki imajo na eni strani s črnim črnilom natisnjeno oznako "2456" (dolžina tablete 14,2 mm, širina tablete: 8,7 mm).
English: Table 2: Tabulated list of adverse reactions System Organ class
Slovenian: Preglednica 2: Seznam neželenih učinkov v preglednici
English: Table 7: Incidence of severe hypoglycaemia and rates of documented, (overall and nocturnal) hypoglycaemic events in the pool of two 52-week placebo-controlled clinical studies Insulin (N=526)
Slovenian: Preglednica 7: Pojavnost hudih hipoglikemij in deleži dokumentiranih (vseh in nočnih) hipoglikemij v združenih podatkih dveh 52-tedenskih, s placebom kontroliranih kliničnih študij
English: No data in humans are available on excretion of sotagliflozin into milk.
Slovenian: Pri človeku ni podatkov o izločanju sotagliflozina v materino mleko.
English: - When needed to prevent hypoglycaemia, insulin dose reduction should be done cautiously to avoid ketosis and DKA (see section 4.2).
Slovenian: - Če je treba odmerek insulina za preprečitev hipoglikemij zmanjšati, je zmanjšanje treba izvesti previdno, da bi se izognili ketozi in DKA (glejte poglavje 4.2).
English: o Is adequately informed about managing sick days.
Slovenian: o ustrezno obveščen z vodenjem bolniških odsotnosti.
English: The overall frequency of urinary tract infections reported were 7.1% and 5.5% for sotagliflozin 200 mg and sotagliflozin 400 mg compared to 6.1% for placebo.
Slovenian: Okužbe sečil Celokupna pogostnost poročanih okužb sečil je bila 7,1 % in 5,5 % z 200 mg sotagliflozina in 400 mg sotagliflozina, v primerjavi s 6,1 % s placebom.
English: Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment, as sotagliflozin exposure is increased in these patients (see sections 4.2 and 5.2).
Slovenian: Za bolnike z zmerno in hudo okvaro jeter sotagliflozin ni priporočljiv, ker je izpostavljenost sotagliflozinu pri teh bolnikih večja (glejte poglavji 4.2 in 5.2).
English: In a rat carcinogenicity study, a statistically significant increase in thyroid follicular cell carcinoma was observed in males at 75 mg/kg/day, approx. 14 times the MRHD, the highest dose evaluated.
Slovenian: 5.3 Predklinični podatki o varnosti V študiji karcinogenosti pri podganah so opažali statistično značilno povečanje karcinoma ščitničnih folikularnih celic pri samcih z odmerkom 75 mg/kg/dan, kar je približno 14-krat toliko kot največji priporočeni odmerek za človeka (MRHD - maximum recommended human dose), ki je bil največji ocenjevani odmerek.
English: When needed, insulin dose reduction should be done cautiously to avoid ketosis and DKA.
Slovenian: Ko je zmanjšanje odmerka insulina potrebno, ga je treba izvesti previdno, da bi preprečili nastanek ketoze in DKA.
English: The median Tmax ranged from 1.25 to 3 hours, over a single-dose range of 400 to 2000 mg.
Slovenian: Mediani tmax je v razponu enkratnih odmerkov od 400 do 2000 mg segal od 1,25 do 3 ure.
English: EU/1/19/1363/001 (200 mg - 10 film coated tablets) EU/1/19/1363/002 (200 mg - 20 film coated tablets) EU/1/19/1363/003 (200 mg - 30 film coated tablets) EU/1/19/1363/004 (200 mg - 60 film coated tablets) EU/1/19/1363/005 (200 mg - 90 film coated tablets) EU/1/19/1363/006 (200 mg - 100 film coated tablets) EU/1/19/1363/007 (200 mg - 180 film coated tablets)
Slovenian: EU/0/00/000/001 (200 mg - 10 filmsko obloženih tablet) EU/0/00/000/002 (200 mg - 20 filmsko obloženih tablet) EU/0/00/000/003 (200 mg - 30 filmsko obloženih tablet) EU/0/00/000/004 (200 mg - 60 filmsko obloženih tablet) EU/0/00/000/005 (200 mg - 90 filmsko obloženih tablet) EU/0/00/000/006 (200 mg - 100 filmsko obloženih tablet) EU/0/00/000/007 (200 mg - 180 filmsko obloženih tablet)
English: Exposure at the rat no-observedeffect level was 40-times the exposure at the MRHD.
Slovenian: je bila pri podganah 40-kratnik izpostavljenosti med uporabo MRHD.
English: - Patients with recent or recurrent history of DKA (e.g.1 episode in the past 3 months or more than
Slovenian: - z nedavno DKA ali anamnezo ponavljajočih se DKA (npr. 1 pojav v preteklih 3 mesecih ali več kot 1 pojav v preteklih 6 mesecih).
English: • DKA may occur in patients treated with sotagliflozin even if blood glucose levels are below 14 mmol/l (250 mg/dl), i.e. an explanation of the concept of euglycaemic DKA.
Slovenian: • DKA se lahko pojavi pri bolnikih, ki se zdravijo s sotagliflozinom, tudi če je koncentracija glukoze v krvi pod 14 mmol/l (250 mg/dl), tj. razlaga koncepta evglikemične DKA.
English: In patients where DKA is suspected or diagnosed, treatment with sotagliflozin should be discontinued immediately.
Slovenian: V primeru suma na DKA ali potrjene DKA je treba zdravljenje s sotagliflozinom takoj prekiniti.
English: Blood creatinine increased/Glomerular filtration decreased and renal-related events Sotagliflozin was associated with decreases in mean eGFR at week 4 (-4.0% and -4.3% for sotagliflozin 200 mg and 400 mg) versus placebo (-1.3%) that were generally reversible during continuous treatment.
Slovenian: Zvišanje kreatinina v krvi/zmanjšanje glomerularne filtracije in z ledvicami povezani dogodki Sotagliflozin je bil povezan z zmanjšanjem povprečne eGFR po 4 tednih (-4,0 % z 200 mg sotagliflozina in -4,3 % s 400 mg sotagliflozina) v primerjavi s placebom (-1,3 %); ta zmanjšanja so bila med neprekinjenim zdravljenjem na splošno reverzibilna.
English: In addition to this leaflet, a patient alert card is included in the packaging which contains important safety information that you need before and during treatment with Zynquista.
Slovenian: Kartica obsega pomembne informacije o varnosti, s katerimi morate biti seznanjeni pred zdravljenjem z zdravilom Zynquista in med takšnim zdravljenjem.
English: In InTandem1 (study 1) and in InTandem2 (study 2) sotagliflozin was used as add on to optimised insulin and in InTandem3 (Study 3) sotagliflozin was used as add on to any existing insulin regimen in patients not on HbA1c goal.
Slovenian: V InTandem1 (študija 1) in v InTandem2 (študija 2) preskušanju, so sotagliflozin uporabili kot dodatek k optimalnemu zdravljenju z insulinom.
English: Treatment with sotagliflozin also resulted in reduction in body weight and systolic blood pressure (in patients with baselines SBP ≥130 mmHg) compared with insulin alone (see Table 6).
Slovenian: Zdravljenje s sotagliflozinom je v primerjavi s samim insulinom povzročilo tudi zmanjšanje telesne mase in znižanje sistoličnega krvnega tlaka (pri bolnikih z izhodiščnim SKT ≥ 130 mmHg) (glejte preglednico 6).
English: The PK of sotagliflozin appeared to be dose proportional in the therapeutic dose range of 200 mg to 400 mg QD.
Slovenian: Farmakokinetika sotagliflozina je bila v razponu terapevtskih odmerkov od 200 do 400 mg na dan sorazmerna odmerku.
English: Adverse reactions related to volume depletion (e.g., hypovolemia, blood pressure decreased, blood pressure systolic decreased, dehydration, hypotension, orthostatic hypotension, and syncope) were reported by 2.7%, 1.1% and 1.0% of patients treated with sotagliflozin 200mg, sotagliflozin 400 mg and placebo.
Slovenian: O neželenih učinkih, povezanih s hipovolemijo (npr. pomanjkanje volumna, znižanje krvnega tlaka, znižanje sistoličnega krvnega tlaka, dehidracija, hipotenzija, ortostatska hipotenzija in sinkopa), so poročali pri 2,7 %, 1,1 % in 1,0 % bolnikov, ki so prejemali 200 mg sotagliflozina, 400 mg sotagliflozina in placebo.. Sotagliflozin lahko poveča tveganje za hipotenzijo pri bolnikih s tveganjem za zmanjšanje volumna (glejte poglavje 4.4).
English: Placebo (N=526)
Slovenian: Insulin (N = 526)
English: No reduction in basal insulin is recommended when initiating sotagliflozin.
Slovenian: Odmerek bazalnega insulina ob uvedbi sotagliflozina ni treba zmanjšati.
English: • Patients with euglycaemic DKA may need glucose in addition to standard of care for DKA and sotagliflozin should be discontinued if DKA occurs.
Slovenian: • Bolniki z evglikemično DKA lahko poleg standardnega zdravljenja DKA potrebujejo tudi glukozo, zdravljenje s sotagliflozinom pa je treba prekiniti, če se pojavi DKA.
English: In subjects with renal impairment, exposure to sotagliflozin following a single dose of 400 mg was approximately 1.7 fold higher in subjects with mild and up to 2.7 fold higher in subjects with moderate renal impairment compared to subjects with normal renal function.
Slovenian: Izpostavljenost sotagliflozinu je bila po enkratnem 400-mg odmerku pri preiskovancih z blago okvaro ledvic približno 1,7-krat večja in pri preiskovancih z zmerno okvaro ledvic približno 2,7-krat večja kot pri tistih z normalnim delovanjem ledvic.
English: While treated with Zynquista the risk of DKA is increased and may occur with low, normal or high blood glucose level.
Slovenian: Med zdravljenjem z zdravilom Zynquista je tveganje za DKA večje; DKA se lahko pojavi ne glede na to, ali imate koncentracijo glukoze v krvi nizko, normalno ali visoko.
English: Based on a population PK analysis gender and race had no clinically meaningful effect on the PK of sotagliflozin.
Slovenian: Na podlagi populacijske farmakokinetične analize spol in rasa ne vplivata klinično pomembno na farmakokinetiko sotagliflozina.
English: In the pooled 52-week data, the incidence of DKA was increased in a dose-dependent manner for sotagliflozin (2.9% and 3.8% for sotagliflozin 200 mg and 400 mg, respectively) compared to placebo (0.2%).
Slovenian: Pojavnost DKA se je v združenih 52-tedenskih podatkih s sotagliflozinom povečevala od odmerka odvisno (2,9 % z 200 mg in 3,8 % s 400 mg sotagliflozina) v primerjavi s placebom (0,2 %).
English: • if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell.
Slovenian: • če se vam pojavi kombinacija simptomov bolečin, občutljivosti, pordelosti ali oteklosti spolovil ali predela med splovili in zadnjikom (presredka) skupaj z zvišano telesno temperaturo ali splošnim slabim počutjem.
English: Ketone monitoring during treatment:
Slovenian: Vodenje ketonov med zdravljenjem
English: How to take Zynquista
Slovenian: Kako jemati zdravilo Zynquista
English: • Patient's/Carer's Guide
Slovenian: • Vodnika za bolnike/skrbnike
English: Pooled analysis of change in SBP in patients with baseline SBP ≥130 mmHg showed greater reduction in SBP at week 12 (-5.4 mmHg for placebo, -9.0 mmHg for sotagliflozin 200 mg and -10.7 mmHg for sotagliflozin 400 mg).
Slovenian: Združena analiza spremembe SKT pri bolnikih z izhodiščnim SKT ≥ 130 mmHg je pokazala večje znižanje SKT po 12 tednih (-5,4 mmHg s placebom, -9,0 mmHg z 200 mg sotagliflozina in -10,7 mmHg s 400 mg sotagliflozina).
English: Patients using an insulin infusion pump have a higher risk of DKA and should be experienced with pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur (issues with insertion site, clogged tubing, empty reservoir, etc.) and use of supplemental insulin injections with pen or syringe as needed in case of pump failure.
Slovenian: Imeti morajo izkušnje z uporabo črpalke, običajnimi načini odpravljanja težav v primeru prekinitve dovajanja insulina iz črpalke (težave na mestu vstavitve, zamašen kateter, prazen rezervoar itn.) ter z uporabo dodatnih injekcij insulina s peresnikom ali brizgo v primeru odpovedi črpalke.
English: Mean change from baseline at week 4
Slovenian: Povprečna sprememba od izhodišča 4. teden