FrancophonIA/ELRC3.0 huggingface dataset:
English: If an enzyme inducer (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) must be co-administered with sotagliflozin, consider frequent monitoring of glucose level.
Danish: I tilfælde af at en enzyminducer (f.eks. rifampicin, phenytoin, phenobarbital, ritonavir) skal administreres samtidigt med sotagliflozin, skal hyppigere monitorering af glucoseniveauet overvejes.
English: Talk to your doctor before taking this medicine if you would like to breast-feed or if you are breastfeeding.
Danish: Tal med din læge, før du tager dette lægemiddel, hvis du ammer eller ønsker at amme.
English: Table 5: Results of CGM sub study at week 24 (Pooled data, study 1 and study 2) Characteristic
Danish: Tabel 5: Resultater fra CGM-delstudie ved uge 24 (samlede data, studie 1 og studie 2) Karakteristika
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.
Danish: I embryoføtale udviklingsstudier med rotter og kaniner blev sotagliflozin administreret oralt ved doser på op til 350 mg/kg hos rotter og 200 mg/kg hos kaniner.
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.
Danish: Som det gælder for alle diabetespatienter, er det vigtigt, at du får kontrolleret dine fødder regelmæssigt og overholder lægens eller sundhedspersonalets anbefalinger vedr.
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès et Lagrave F - 33565 Carbon Blanc France
Danish: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès et Lagrave F - 33565 Carbon Blanc Frankrig
English: • Guide for Health Care Professionals including a prescriber's checklist
Danish: • Vejledning til læger og sundhedspersonale inklusive tjekliste til den ordinerede læge
English: Reduction in risk of documented hypoglycaemia, compared to insulin alone at threshold of ≤3.1 mmol/L (%)
Danish: Reduktion i risiko for dokumenteret hypoglykæmi sammenlignet med insulin alene ved tærskel på ≤3,1 mmol/l (%)
English: In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Danish: Ved overdosering skal de sædvanlige understøttende foranstaltninger iværksættes afhængig af patientens kliniske status.
English: If you have any of these symptoms, or if you are in a situation that could increase your risk for DKA, you must check your ketones, either in the blood or in the urine.
Danish: Hvis du får en eller flere af disse symptomer, eller hvis du befinder dig i en situation, som øger din risiko for at få DKA, skal du kontrollere indholdet af ketonstoffer i enten din urin eller dit blod.
English: Management of DKA risk
Danish: Håndtering af risikoen for DKA
English: The adverse effects on embryo-fetal development at 350 mg/kg/day were associated with maternal toxicity (body weight loss/decreased body weight gain and decreased food consumption during gestation day (GD) 6 to 8).
Danish: De skadelige virkninger på embryoføtal udvikling ved 350 mg/kg/dag var associeret med maternel toksicitet (tab af legemsvægt/nedsat vægtstigning og nedsat fødeindtagelse fra gestationsdag (GD) 6-8).
English: Due to its mechanism of action, patients taking sotagliflozin will test positive for glucose in their urine.
Danish: På grund af lægemidlets virkningsmekanisme vil patienter, der tager sotagliflozin, få et positivt analyseresultat for glucose i urinen.
English: • ritonavir (a medicine used to treat HIV infection)
Danish: • ritonavir (medicin til behandling af hiv-infektion)
English: Therapy with Zynquista should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus.
Danish: Behandling med Zynquista bør initieres og superviseres af en læge med erfaring i behandling af type 1-diabetes mellitus.
English: Diabetes Distress Screening Scale Baseline score, mean
Danish: Diabetes Distress Screening Scale Baseline-score, gennemsnit
English: Based on in-vitro data, induction of CYP2C9, CYP2B6 and CYP1A2 cannot be ruled out.
Danish: Baseret på in-vitro data kan induktion af CYP2C9, CYP2B6 og CYP1A2 ikke udelukkes.
English: Pharmacotherapeutic group: Drugs used in diabetes, sodium-glucose co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK06
Danish: Farmakoterapeutisk klassifikation: Antidiabetica, natrium-glucose co-transporter 2 (SGLT2)inhibitorer, ATC-kode: A10BK06
English: The apparent volume of distribution of sotagliflozin following administration of a single 400 mg oral dose of [14C]-sotagliflozin was found to be very high with a mean value of 9392 L.
Danish: Sotagliflozins tilsyneladende fordelingsvolumen efter administration af en enkelt oral dosis på 400 mg [14C]-sotagliflozin blev fundet at være meget høj med en middelværdi på 9.392 l.
English: Patients with a history of chronic or recurrent genital mycotic infections are more likely to develop genital mycotic infections.
Danish: Patienter med kroniske eller tilbagevendende genitale svampeinfektioner i anamnesen har en øget sandsynlighed for at udvikle genitale svampeinfektioner.
English: Sanofi Winthrop Industrie 1 rue de la Vierge Ambares et Lagrave 33565 Carbon Blanc Cedex France
Danish: Sanofi Winthrop Industrie 1 rue de la Vierge Ambares et Lagrave 33565 Carbon Blanc Cedex Frankrig
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.
Danish: Interferens med 1,5-anhydroglucitol (1,5-AG)-assay Overvågning af glykæmisk kontrol med 1,5-AG-assay kan ikke anbefales, da måling af 1,5-AG er upålidelig til vurdering af den glykæmiske kontrol hos patienter, som tager SGLT2-hæmmere.
English: - Consider discontinuing sotagliflozin if adequate insulinisation cannot be achieved on treatment.
Danish: - Det bør overvejes at seponere sotagliflozin, hvis tilstrækkelig insulinbehandling ikke kan gennemføres i behandlingsforløbet.
English: The predominant metabolite detected in urine was M19, representing a mean of 33% of the administered radioactive dose.
Danish: Den primære metabolit fundet i urin var M19, som udgør i gennemsnit 33 % af den administrerede radioaktive dosis.
English: This atypical presentation of DKA (i.e. normal or slightly elevated blood glucose levels) can delay diagnosis and treatment.
Danish: Når DKA fremstår atypisk (dvs. normal eller let forhøjet blodsukkerniveau), kan det forsinke diagnosen og behandlingen.
English: • For patients taking ZYNQUISTA, glucose is not a reliable marker for DKA and must be supplemented with ketone monitoring
Danish: • Hos patienter, der tager ZYNQUISTA, er glucose ikke en pålidelig markør for DKA og skal derfor suppleres med monitorering af ketonniveauet.
English: - film-coating: poly(vinyl alcohol); macrogol; titanium dioxide (E 171); talc; indigo carmine aluminium lake (E132).
Danish: - Filmovertræk: polyvinylalkohol; macrogol; titandioxid (E 171); talcum; indigo carmine aluminium lake (E132).
English: For the first meal on Day 1, patients were instructed to decrease their calculated (or usual) mealtime carbohydrate bolus insulin by 30%.
Danish: Til det første måltid på dag 1 blev patienterne instrueret i at sænke deres beregnede (eller sædvanlige) måltidskulhydrat-bolusinsulin med 30 %.
English: Table 1: Actions to take in case of elevated ketone levels
Danish: Tabel 1: Foranstaltninger der skal tages ved forhøjet ketonniveau Klinisk stadie
English: Paediatric patients No data are available.
Danish: Pædiatriske patienter Der foreligger ingen data.
English: Mean terminal T1/2 ranged from 21 to 35 hours for sotagliflozin and from 19 to 26 hours for M19.
Danish: Den gennemsnitlige terminale halveringstid (T1/2) spændte fra 21 til 35 timer for sotagliflozin og fra 19 til 26 timer for M19.
English: Ketone monitoring during treatment
Danish: Monitorering af ketonniveau under behandling
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.
Danish: Sotagliflozins virkning og sikkerhed hos patienter med type 1-diabetes, som ikke havde opnået tilstrækkelig kontrol med deres insulinbehandling, blev undersøgt i tre dobbeltblindede, placebokontrollerede studier.
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.
Danish: I forbindelse med den første ordination af sotagliflozin bør patienten under en særskilt rådgivningssamtale få udleveret Vejledning til patienten/omsorgspersonen og Patientkortet, som også er tilgængelige via QR-koden eller hjemmesiden.
English: No acyl glucuronides of sotagliflozin were identified.
Danish: Der blev ikke fundet acylglucuronider af sotagliflozin.
English: DKA episodes during sotagliflozin use can be atypical, with patients not having blood sugar levels as high as expected.
Danish: Tilfælde af DKA under behandling med sotagliflozin kan være atypiske i og med, at patientens blodsukkerniveau ikke er så højt som forventet.
English: The patient should immediately seek medical advice and stop taking sotagliflozin if levels persist and symptoms present.
Danish: Patienten skal straks søge lægehjælp og stoppe med at tage sotagliflozin, hvis niveauet forbliver forhøjet, eller hvis der opstår symptomer.
English: • Guidance to the physician for assessing whether the patient is prepared and engaged to perform self-ketone testing before and during therapy.
Danish: • Vejledning til lægen om hvordan det vurderes, om patienten er tilstrækkeligt rustet og engageret til at udføre egenmåling af ketonniveau før og under behandling.
English: M19 demonstrated inhibitory effects against OATP1B1/B3 and MRP2 in-vitro.
Danish: M19 udviste hæmmende virkning på OATP1B1/B3 og MRP2 in-vitro.
English: There is limited experience in clinical trials in patients with moderate and severe hepatic impairment.
Danish: Der er begrænset erfaring i kliniske studier med patienter med moderat og svært nedsat leverfunktion.
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.
Danish: Den primære metaboliseringsvej for sotagliflozin hos mennesker sker via glukuronidering medieret af uridin 5'-diphospho-glucuronosyltransferaser primært via UGT1A9 og, i væsentligt mindre grad, via UGT1A1 og UGT2B7 samt oxidation via CYP3A4.
English: PVC/PCTFE/Aluminium opaque blisters.
Danish: PVC/PCTFE/aluminium uigennemsigtige blisterpakninger.
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.
Danish: Både sotagliflozin og dets vigtigste metabolit (3-O-glucuronid (M19)) udviste høj binding til humane plasmaproteiner in vitro (ubunden fraktion ca. 2 %), som ikke var afhængig af koncentrationen af sotagliflozin og M19.
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).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Zynquista i en eller flere undergrupper af den pædiatriske population med type 1-diabetes mellitus (se pkt.
English: Before initiating sotagliflozin
Danish: Før behandling med sotagliflozin initieres
English: Exposure at the rat no-observedeffect level was 40-times the exposure at the MRHD.
Danish: Eksponering ved niveauet for ingen observerede bivirkninger hos rotter var 40 gange større end eksponering ved MRHD.
English: Do not stop taking Zynquista without first checking with your doctor.
Danish: Du må ikke stoppe med at tage Zynquista uden at have talt med lægen.
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.
Danish: I placebokontrollerede kliniske studier med sotagliflozin blev patienterne opfordret til at monitorere urin- eller blodketoner, hvis de fik symptomer, der gav mistanke om DKA og søge lægehjælp, hvis deres selvmålte blodketoner var > 0,6 mmol/l.
English: The median Tmax ranged from 1.25 to 3 hours, over a single-dose range of 400 to 2000 mg.
Danish: Median Tmax var fra 1,25-3 timer over et enkeltdosisområde på 400 mg til 2.000 mg.
English: In particular, tell your doctor if you are taking any of the following medicines:
Danish: Det er især vigtigt, at du fortæller det til lægen, hvis du tager en eller flere slags anden medicin:
English: In a fertility study in rats, sotagliflozin had no effect on reproductive performance, fertility, and embryo/fetal viability.
Danish: I et fertilitetsstudie med rotter havde sotagliflozin ingen indvirkning på reproduktionsevne, fertilitet eller embryoets/fosterets levedygtighed.
English: • raised ketone levels in your blood
Danish: • forhøjet indhold af ketonstoffer i blodet
English: In clinical studies the high protein binding was confirmed and was not influenced by reduced renal or hepatic function.
Danish: Den høje proteinbinding blev bekræftet i kliniske studier og var uafhængig af nedsat nyre- eller leverfunktion.
English: Table 3: Changes from baseline in serum creatinine and eGFR in the pool of two 52-week placebocontrolled studies
Danish: Tabel 3: Ændringer fra baseline i serumkreatinin og eGFR i de to samlede placebokontrollerede kliniske studier af 52 ugers varighed
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).
Danish: - Patienter der insisterer på at følge en diæt med begrænset kalorieindtag, begrænset kulhydratindtag eller en ketogen diæt, eller patienter der kronisk underdoserer insulin (f.eks. for at forblive i tilstand med lipolyse).
English: • The tablet should be taken before the first meal of the day
Danish: • Tag tabletten før dagens første måltid.
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).
Danish: Efter behandlingsstart bør hyppigheden af måling af ketonniveau (enten blod eller urin) tilpasses individuelt afhængigt af patientens livsstil og/eller risikofaktorer (se pkt.
English: Film-coated tablet Multipack: 200 (2 packs of 100) film-coated tablets
Danish: Filmovertrukne tabletter Multipakning: 200 (2 pakninger á 100) filmovertrukne tabletter
English: Trace or Small
Danish: Spormængde eller lavt
English: DKA should be treated as per standard of care.
Danish: DKA bør behandles i overensstemmelse med standard praksis.
English: Sotagliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion.
Danish: Sotagliflozin forårsager osmotisk diurese, der kan føre til intravaskulær volumenreduktion og bivirkninger forbundet med volumendepletering.
English: • Sotagliflozin is not a substitute for insulin.
Danish: • Sotagliflozin kan ikke erstatte insulin.
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.
Danish: Eksponering for sotagliflozin blev undersøgt i et specifikt studie med forsøgspersoner med let (kreatinin-clearance [CLcr]: 60 til mindre end 90 ml/min) og moderat (CLcr: 30 til mindre end 60 ml/min) nedsat nyrefunktion og med normal nyrefunktion.
English: Patients were then maintained on optimised insulin and randomized to sotagliflozin 200 mg, sotagliflozin 400 mg or insulin alone.
Danish: Patienterne blev derefter fastholdt i optimeret insulinbehandling og randomiseret til sotagliflozin 200 mg, sotagliflozin 400 mg eller insulin alene.
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.
Danish: Ved tilstande med risiko for væsketab (f.eks. gastrointestinal sygdom), anbefales nøje monitorering af volumenstatus (f.eks. fysisk undersøgelse, blodtryksmålinger, laboratorieprøver, herunder hæmatokrit) og elektrolytter hos patienter, der får sotagliflozin.
English: The patient alert card should contain the following key elements:
Danish: Patientkortet skal indeholde følgende hovedpunkter:
English: • if you have an infection of the kidney or the urinary tract.
Danish: • hvis du har en infektion i nyrerne eller urinrøret.
English: The recommended dose is 200 mg sotagliflozin once daily before the first meal of the day.
Danish: Den anbefalede dosis er 200 mg sotagliflozin en gang dagligt før dagens første måltid.
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).
Danish: Genstart af behandling med sotagliflozin frarådes, medmindre en anden klar årsag til ketoacidose identificeres og afklares (f.eks. fejl ved pumpen, akut samtidig sygdom, kraftig reduktion i insulin).
English: Marketing Authorisation Holder: Navigant Germany GmbH Albrechtstr.
Danish: Indehaver af markedsføringstilladelsen: Navigant Germany GmbH Albrechtstr.
English: Together these actions help to lower the increased amount of glucose in the blood that occurs in patients with diabetes.
Danish: Tilsammen kan disse to virkningsmekanismer hjælpe med at sænke det forhøjede indhold af glucose i blodet hos personer med diabetes.
English: Each tablet contains 200 mg sotagliflozin.
Danish: Hver tablet indeholder 200 mg sotagliflozin.
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.
Danish: a Bivirkningsgruppe, inklusive men ikke begrænset til vulvovaginal svampeinfektion, vaginal infektion, vulvitis, vulvovaginal candidiasis, genital infektion, genital candidiasis, genital svampeinfektion, vulvovaginitis, urogenital svampeinfektion.
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).
Danish: I et studie med gentagne doser, der undersøgte potentielle mekanismer bag den øgede forekomst af follikelcellekarcinom i skjoldbruskkirtlen i karcinogenicitetsstudiet med rotter, blev det konkluderet, at den øgede forekomst var associeret med en sotagliflozin-relateret stigning i thyreoideastimulerende hormon (TSH).
English: Temporary interruption of treatment with sotagliflozin should be considered until the fluid loss is corrected.
Danish: Midlertidig afbrydelse af behandlingen med sotagliflozin skal overvejes, indtil væsketabet er afhjulpet.
English: In healthy volunteers, mean apparent total body clearance (CL/F) of sotagliflozin ranged from 261 to 374 L/hr.
Danish: Hos raske forsøgspersoner var gennemsnitlig, tilsyneladende, total clearance for kroppen (CL/F) af sotagliflozin 261-374 l/t.
English: Measurement of blood ketone levels is preferred over urine.
Danish: Det anbefales, at ketonniveauet måles i blod i stedet for urin.
English: Sotagliflozin and M19 have no significant potential to inhibit OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3.
Danish: Sotagliflozin og M19 har ikke noget signifikant potentiale til at hæmme OCT1, OCT2, OAT1, OAT3, OATP1B1 eller OATP1B3.
English: Sotagliflozin should only be given to patients: - with access to ketone testing materials and immediate access to a clinician if blood or urine ketones are elevated.
Danish: Sotagliflozin bør kun ordineres til patienter: - med adgang til keton-måleudstyr og direkte adgang til en læge, hvis blod- eller urinketonniveauet er forhøjet.
English: • If addition of sotagliflozin leads to marked reduction of insulin need, discontinuation of sotagliflozin should be considered to avoid high risk of DKA.
Danish: • Hvis supplerende behandling med sotagliflozin medfører markant nedsat insulinbehov, bør det overvejes at seponere sotagliflozin for at undgå den høje risiko for DKA.
English: Large to very large
Danish: Højt eller meget højt
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.
Danish: I InTandem1 (studie 1) og i InTandem2 (studie 2) blev sotagliflozin anvendt som supplement til en optimeret insulinbehandling, og i InTandem3 (studie 3) blev sotagliflozin anvendt som supplement til eksisterende insulinbehandling hos patienter, som ikke havde opnået deres HbA1c-mål.
English: The apparent clearance of sotagliflozin decreases with decreasing renal function.
Danish: Tilsyneladende clearance af sotagliflozin mindskes med aftagende nyrefunktion.
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).
Danish: Hos patienter, der er 65 år og derover, bør nyrefunktion og en øget risiko for volumendepletering tages i betragtning (se pkt.
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.
Danish: Hvis der efter minimum tre måneder er behov for yderligere glykæmisk kontrol, kan dosis øges til 400 mg en gang dagligt hos patienter, der tolererer sotagliflozin 200 mg.
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).
Danish: Pakningsstørrelser med 10, 20, 30, 60, 90, 100, 180 filmovertrukne tabletter og en multipakning med 200 filmovertrukne tabletter (2 pakninger med hver 100 filmovertrukne tabletter).
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
Danish: Filmovertrukne tabletter 10 filmovertrukne tabletter 20 filmovertrukne tabletter 30 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter 180 filmovertrukne tabletter
English: Patients must be informed about what actions to take if ketone levels are elevated.
Danish: Patienten skal informeres om hvilke foranstaltninger, der skal tages ved forhøjet ketonniveau.
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.
Danish: Når sotagliflozin tabletter blev administreret med et morgenmåltid med højt kalorieindhold var plasma-eksponering for sotagliflozin målt ved Cmax og AUC0 inf ca. henholdsvis 2,5 og 1,5 gange højere sammenlignet med fastende tilstand.
English: • blood tests may show increase in the amount of bad cholesterol (called LDL - a type of fat in your blood)
Danish: • blodprøver kan vise forhøjet indhold af ”dårligt” kolesterol (kaldet LDL - en type fedtstof i blodet)