FrancophonIA/ELRC3.0 huggingface dataset:
English: Restarting sotagliflozin is not recommended, unless a cause for the ketoacidosis is identified and resolved (e.g., pump malfunction, acute intercurrent illness, excessive reduction of insulin).
Slovenian: Ponovna uvedba sotagliflozina ni priporočljiva, če ni ugotovljen in odpravljen vzrok ketoacidoze (npr. nepravilno delovanje črpalke, akutna sočasna bolezen, prekomerno zmanjšanje odmerka insulina).
English: • Counsel the patient and evaluate their adherence to ketone monitoring while establishing their baseline ketone level 1 to 2 weeks before treatment initiation and ensure the patient o Has received education/training in ketone testing and interpreting/acting upon test results.
Slovenian: • Svetujte bolnikom in ocenite njihovo adherenco spremljanja ketonov, pri tem pa 1 do 2 tedna pred začetkom zdravljenja določite osnovno raven ketonov in zagotovite, da je bolnik o prejel izobraževanje/usposabljanje glede testiranja ketonov in interpretacijo/ukrepanje v povezavi z rezultati teh testov.
English: Management of DKA risk
Slovenian: Obvladovanje DKA tveganja
English: The patient alert card should contain the following key elements:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednje ključne elemente:
English: After starting therapy, the frequency of ketone level testing (either blood or urine) should be individualized, according to the patient's lifestyle and/or risk factors (see section 4.4).
Slovenian: Po začetku zdravljenja je treba pogostnost meritev koncentracije ketonov (v krvi ali urinu) prilagoditi individualno, glede na bolnikov življenjski slog in/ali dejavnike tveganja (glejte poglavje 4.4).
English: Do not stop taking Zynquista without first checking with your doctor.
Slovenian: Ne prenehajte jemati zdravila Zynquista, ne da bi se prej posvetovali z zdravnikom.
English: When sotagliflozin is incubated with UGT1A9, M19 was the main conjugate observed.
Slovenian: V primeru inkubacije sotagliflozina z UGT1A9, je bil glavni opaženi konjugat M19.
English: Following administration of multiple doses (400 and 800 mg dose), the median Tmax values ranged from 2.5 to 4 hours.
Slovenian: Po uporabi večkratnih odmerkov (odmerek 400 mg in 800 mg) je mediani tmax segal od 2,5 do 4 ure.
English: If ketones are high follow instructions given above in Table 1 (see section 4.2).
Slovenian: Če so ketoni visoki, upoštevajte navodila, v zgoraj navedeni preglednici 1 (glejte poglavje 4.2).
English: Ketonaemia or Ketonuria
Slovenian: Ketonemija ali ketonurija
English: • ritonavir (a medicine used to treat HIV infection)
Slovenian: • ritonavir (zdravilo, ki se uporablja za zdravljenje okužbe s HIV).
English: • The patient alert card should be presented to any HCP consulted.
Slovenian: • Opozorilno kartico za bolnika je treba pokazati vsakemu zdravstvenemu delavcu, s katerim se bolnik posvetuje.
English: Contents of the pack and other information What Zynquista contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zynquista
English: Do not take a double dose of Zynquista o make up the forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka zdravila Zynquista, če ste pozabili vzeti prejšnji odmerek.
English: For all patients with diabetes it is important to check your feet regularly and follow any other advice on foot care from your doctor or nurse.
Slovenian: Za vse osebe s sladkorno boleznijo je pomembno redno pregledovanje stopal in upoštevanje vseh drugih nasvetov za oskrbo stopal, ki jih da zdravnik ali medicinska sestra.
English: Your doctor will prescribe Zynquista together with insulin treatment to lower the amount of sugar in your blood.
Slovenian: Zdravnik vam bo zdravilo Zynquista predpisal skupaj z insulinom za znižanje sladkorja v krvi.
English: N/A -1.93 (0.004) -2.27 (<0.001)
Slovenian: NP -1,93 (0,004) -2,27 (< 0,001)
English: Film-coated tablet 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets 180 film-coated tablets
Slovenian: Filmsko obložena tableta 10 filmsko obloženih tablet 20 filmsko obloženih tablet 30 filmsko obloženih tablet 60 filmsko obloženih tablet 90 filmsko obloženih tablet 100 filmsko obloženih tablet 180 filmsko obloženih tablet
English: Zynquista is not likely to affect your ability to drive and use machines.
Slovenian: Ni verjetno, da bi zdravilo Zynquista vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: Due to its mechanism of action, patients taking sotagliflozin will test positive for glucose in their urine.
Slovenian: Zaradi mehanizma delovanja zdravila imajo bolniki, ki jemljejo sotagliflozin, pozitiven izvid testa za glukozo v urinu.
English: In case of a potential DKA or elevated ketone levels are elevated contact your doctor immediately or go to the nearest hospital right away.
Slovenian: V primeru možne DKA ali zvišanih nivojev ketonov se nemudoma posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
English: Check glucose levels frequently to avoid hyperglycaemia or hypoglycaemia.
Slovenian: Pogosto izmerite koncentracijo glukoze, da boste preprečili hiperglikemijo ali hipoglikemijo.
English: In a repeat-dose study evaluating potential mechanisms responsible for the increase incidence of thyroid carcinoma observed in the rat carcinogenicity study, it was concluded that the increase was associated with a sotagliflozin-related increase in thyroid stimulating hormone (TSH).
Slovenian: V študiji ponavljajočih se odmerkov, ki je proučevala možne mehanizme, odgovorne za večjo pojavnost ščitničnega karcinoma, opaženega v študiji karcinogenosti pri podganah, so ugotovili, da je bilo povečanje pojavnosti povezano z zvišanjem tiroid-stimulirajočega hormona (TSH) zaradi sotagliflozina.
English: • If addition of sotagliflozin leads to marked reduction of insulin need, discontinuation of sotagliflozin should be considered to avoid high risk of DKA.
Slovenian: • Če dodatek sotagliflozina povzroči izrazito zmanjšanje potrebe po insulinu, je treba razmisliti o ukinitvi sotagliflozina, da bi se izognili visokemu tveganju za DKA.
English: In clinical studies the high protein binding was confirmed and was not influenced by reduced renal or hepatic function.
Slovenian: V kliničnih študijah so veliko vezavo na beljakovine potrdili in nanjo nista vplivala niti zmanjšano delovanje ledvic niti jeter.
English: Fifteen of the 35 cases (43%) experienced DKA with glucose values in the glycaemic range 8 to 14 mmol/L.
Slovenian: V 15 od 35 primerov (43 %) se je DKA pojavila ob vrednostih glukoze v razponu od 8 do 14 mmol/l.
English: The patient should immediately seek medical advice and stop taking sotagliflozin if levels persist and symptoms present.
Slovenian: Bolnik mora nemudoma poiskati zdravniški nasvet in prenehati jemati sotagliflozin, če je koncentracija še naprej zvišana in so prisotni simptomi.
English: The CL/F estimated using a population PK, which mostly evaluated T1DM patients, was 239 L/hr.
Slovenian: CL/F ocenjen s populacijsko farmakokinetiko, pri čemer so bili večinoma ocenjeni bolniki s sladkorno boleznijo tipa 1, je bil 239 l/uro.
English: DKA episodes during sotagliflozin use can be atypical, with patients not having blood sugar levels as high as expected.
Slovenian: Epizode DKA so med uporabo sotagliflozina lahko netipične in bolniki nimajo tako visoke koncentracije krvnega sladkorja, kot bi pričakovali.
English: During a dedicated counselling session with the patient at the time of first prescription of sotagliflozin the Patient/Carer Guide and Patient Alert card, also available via the QRcode or website, should be presented.
Slovenian: Med namenskim svetovalnim srečanjem z bolnikom ob času, ko je bolniku prvič predpisan sotagliflozin, je potrebno bolniku izročiti Vodnik za bolnike in negovalce ter Opozorilno kartico za bolnika; oba sta na voljo tudi preko kode QR ali na spletnem mestu.
English: Symptomatic hypotension may occur after initiating sotagliflozin particularly in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics.
Slovenian: Po uvedbi sotagliflozina se lahko pojavi simptomatska hipotenzija, zlasti pri bolnikih z okvaro ledvic, starejših osebah, bolnikih z nizkim sistoličnim krvnim tlakom in bolnikih, ki prejemajo diuretike.
English: 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.
Slovenian: 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.
English: Reduction in risk of documented hypoglycaemia, compared to insulin alone at threshold of ≤3.1 mmol/L (%)
Slovenian: Zmanjšanje tveganja za dokumentirano hipoglikemijo, v primerjavi z insulinom samim ob pragu ≤ 3,1 mmol/l (%)
English: It is possible that adverse effects occurring with sotagliflozin may be similar to presenting symptoms of DKA.
Slovenian: Neželeni učinki, ki se lahko pojavijo med uporabo sotagliflozina, so lahko podobni kliničnim simptomom DKA.
English: 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).
Slovenian: Pri bolnikih, starih 65 let ali več, je treba upoštevati delovanje ledvic ter večje tveganje za hipovolemijo (glejte poglavji 4.4 in 4.8).
English: Sotagliflozin is a dual inhibitor of sodium glucose cotransporter type 1 (SGLT1) and SGLT2.
Slovenian: Sotagliflozin je dvojni zaviralec od natrijevih ionov odvisnega glukoznega soprenašalca tipa 1 (SGLT1) in SGLT2.
English: 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.
Slovenian: 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.
English: Ketones should be measured repetitively when any signs or symptoms consistent with DKA or euglycaemic DKA are present.
Slovenian: Merjenje ketonov je treba ponavljati, ob prisotnosti znakov ali simptomov skladnimi z DKA ali evglikemično
English: Patients should be monitored for signs and symptoms of hypotension after initiating therapy.
Slovenian: Bolnike je treba po uvedbi zdravljenja nadzorovati glede znakov in simptomov hipotenzije.
English: 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.
Slovenian: 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.
English: The recommended dose of Zynquista is one 200-mg tablet once a day before the first meal of the day.
Slovenian: Priporočeni odmerek zdravila Zynquista je ena 200-mg tableta enkrat na dan pred prvim obrokom tisti dan.
English: Therapy with Zynquista should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus.
Slovenian: Zdravljenje z zdravilom Zynquista se mora začeti in potekati pod nadzorom zdravnika, izkušenega z vodenjem sladkorne bolezni tipa 1.
English: 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.
Slovenian: 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.
English: As sotagliflozin is taken together with insulin, hypoglycaemia may occur during treatment.
Slovenian: Ker se sotagliflozin uporablja skupaj z insulinom, se lahko med zdravljenjem pojavi hipoglikemija.
English: 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.
Slovenian: 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.
English: Alternative methods should be used to monitor glycaemic control.
Slovenian: Za spremljanje urejenosti glikemije je treba uporabiti drugačne metode.
English: • Sotagliflozin is not a substitute for insulin.
Slovenian: • Sotagliflozin ni nadomestilo za insulin.
English: The recommended dose is 200 mg sotagliflozin once daily before the first meal of the day.
Slovenian: Priporočeni odmerek je 200 mg sotagliflozina enkrat na dan pred prvim dnevnim obrokom.
English: † Defined as a documented SMBG or laboratory blood glucose value below or equal to threshold of 3.1 or 3.9 mmol/L.
Slovenian: † Opredeljeno kot dokumentirana SIGK ali laboratorijsko izmerjena vrednost glukoze v krvi enaka ali nižja od praga 3,1 ali 3,9 mmol/l.
English: Before initiating treatment with sotagliflozin 200 mg and before increasing dose to sotagliflozin 400 mg:
Slovenian: Pred uvedbo zdravljenja z 200 mg sotagliflozina in pred povečanjem odmerka na 400 mg sotagliflozina:
English: What you need to know before you take Zynquista Do not take Zynquista:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zynquista Ne jemljite zdravila Zynquista:
English: The most frequently reported adverse reactions were genital mycotic infections, diabetic ketoacidosis and diarrhoea.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so bile glivične okužbe spolovil, diabetična ketoacidoza in driska.
English: 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).
Slovenian: 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).
English: For the first meal on Day 1, patients were instructed to decrease their calculated (or usual) mealtime carbohydrate bolus insulin by 30%.
Slovenian: Bolnikom so naročili, naj pri prvem obroku 1. dan zmanjšajo svoj izračunani (ali običajni) bolus insulina za ogljikove hidrate ob obroku za 30 %.
English: Because of how Zynquista works, your urine will test positive for sugar while you are on this medicine.
Slovenian: Zaradi načina delovanja zdravila Zynquista bo med zdravljenjem s tem zdravilom vaš urin pozitiven v preiskavah za prisotnost sladkorja.
English: If you develop symptoms contact your doctor or go to the nearest hospital right away.
Slovenian: Če se vam pojavijo simptomi, se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Sotagliflozin deluje tako, da upočasni in zmanjša absorpcijo glukoze iz hrane ter poveča količino glukoze, ki se izloči v urinu.
English: What Zynquista is and what it is used for
Slovenian: Kaj je zdravilo Zynquista in za kaj ga uporabljamo
English: • 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.
Slovenian: • 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.
English: Main results for insulin dose and Diabetes Treatment Satisfaction Questionnaire and Diabetes Distress Screening Scale are presented in Table 4.
Slovenian: Glavni rezultati za odmerek insulina ter vprašalnikov DTSQ (Diabetes Treatment Satisfaction Questionnaire) in DDSS (Diabetes Distress Screening Scale) so prikazani v preglednici 4.
English: Increased urinationd, blood creatinine increased/ glomerular filtration decreased†
Slovenian: zvišanje kreatinina v krvi/zmanjšanje glomerularne filtracije†
English: The guide for healthcare professionals including the prescriber's checklist should contain the following key elements:
Slovenian: Vodnik za zdravstvene delavce, vključno s kontrolnim seznamom za zdravnike, ki predpisujejo zdravilo, mora vsebovati naslednje ključne elemente:
English: 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)
Slovenian: 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)
English: Creatinine (mg/dL) eGFR (mL/min/1.73 m2)
Slovenian: Kreatinin (mg/dl) eGFR (ml/min/1,73 m2)
English: All events were mild or moderate in intensity and no serious cases.
Slovenian: Vsi učinki so bili blagi ali zmerni in resnih primerov ni bilo.
English: Interaction studies in healthy volunteers showed that metformin, metoprolol, midazolam, rosuvastatin and oral contraceptives had no clinically relevant effect on the pharmacokinetics of sotagliflozin.
Slovenian: Študije medsebojnega delovanja pri zdravih prostovoljcih kažejo, da metformin, metoprolol, midazolam, rosuvastatin in peroralni kontraceptivi nimajo klinično pomembnega vpliva na farmakokinetiko sotagliflozina.
English: All severe hypoglycaemia presented were positively adjudicated.
Slovenian: Vsi primeri hude hipoglikemije so bili s presojo opredeljeni pozitivno.
English: Based on in-vitro data, induction of CYP2C9, CYP2B6 and CYP1A2 cannot be ruled out.
Slovenian: Na podlagi podatkov in vitro ni mogoče izključiti indukcije CYP2C9, CYP2B6 in CYP1A2.
English: During the initial one to two weeks of treatment with sotagliflozin, ketones should be monitored on a regular basis.
Slovenian: V prvem do dveh tednih zdravljenja s sotagliflozinom je treba ketone redno kontrolirati.
English: 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.
Slovenian: 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.
English: Sotagliflozin and M19 have no significant potential to inhibit OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3.
Slovenian: Sotagliflozin in M19 nimata pomembnega potenciala za zaviranje OCT1, OCT2, OAT1, OAT3, OATP1B1 in OATP1B3.
English: 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.
Slovenian: 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.
English: Rosuvastatin is a known OATP, BCRP and OAT3 substrate.
Slovenian: Rosuvastatin je znan substrat OATP, BCRP in OAT3.
English: Patient Alert Card Patient Alert Card
Slovenian: Opozorilna kartica za bolnika Opozorilna kartica za bolnika
English: In in vitro studies, sotagliflozin did not inhibit CYP 1A2, 2C9, 2C19, 2D6, or 3A4, nor induced CYP 1A2, 2B6, or 3A4.
Slovenian: V študijah in vitro sotagliflozin ni zavrl CYP 1A2, 2C9, 2C19, 2D6 ali 3A4, niti ni induciral CYP 1A2, 2B6 ali 3A4.
English: 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.
Slovenian: 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.
English: • blood tests may show increase related to kidney function (such as ‘creatinine').
Slovenian: • preiskave krvi lahko pokažejo zvišano vrednost snovi (kot je "kreatinin"), ki je povezana z delovanjem ledvic.
English: In vitro sotagliflozin was shown to have inhibitory effects on P-gp and breast cancer resistance protein (BCRP).
Slovenian: Ugotovljeno je, da sotagliflozin in vitro zavira P-gp in protein odpornosti pri raku dojke (BCRPbreast cancer resistance protein).
English: The apparent clearance of sotagliflozin decreases with decreasing renal function.
Slovenian: Navidezni očistek sotagliflozina se z zmanjševanjem delovanja ledvic zmanjšuje.
English: - Patients with increased insulin requirements due to acute medical illness or surgery.
Slovenian: - ki imajo povečano potrebo po insulinu zaradi akutne bolezni ali kirurškega posega.
English: Systolic Blood Pressure in those with baseline SBP ≥ 130 mmHg*
Slovenian: Sistolični krvni tlak pri bolnikih, ki so imeli izhodiščno SKT ≥ 130 mmHg*
English: Sotagliflozin should not be used during breast-feeding.
Slovenian: Sotagliflozina se med obdobjem dojenja ne sme uporabljati.
English: If an enzyme inducer (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) must be co-administered with sotagliflozin, consider frequent monitoring of glucose level.
Slovenian: Če je treba skupaj s sotagliflozinom uporabiti kakšen induktor encimov (npr. rifampicin, fenitoin, fenobarbital, ritonavir), razmislite o pogostih meritvah koncentracije glukoze.
English: Patients must be informed about what actions to take if ketone levels are elevated.
Slovenian: Bolnike je treba obvestiti, kako naj ravnajo, če so nivoji ketonov zvišani.
English: - 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).
Slovenian: - 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).
English: Marketing Authorisation Holder: Navigant Germany GmbH Albrechtstr.
Slovenian: Imetnik dovoljenja za promet z zdravilom: Navigant Germany GmbH Albrechtstr.
English: If you take more Zynquista tablets than you should, talk to a doctor or go to a hospital immediately.
Slovenian: 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.