FrancophonIA/ELRC3.0 huggingface dataset:
English: * Defined as an event consistent with hypoglycaemia where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained).
Danish: * Defineret som en hændelse, der er konsistent med hypoglykæmi, hvor patienten krævede hjælp fra en anden person for at komme sig, mistede bevidstheden eller oplevede et krampeanfald (uanset om der fandtes biokemisk dokumentation for en lav glucoseværdi).
English: No dosage adjustment is recommended based on age.
Danish: Dosisjustering på grund af alder anbefales ikke.
English: All severe hypoglycaemia presented were positively adjudicated.
Danish: Alle tilfælde af svær hypoglykæmi blev dømt positive.
English: No reduction in basal insulin is recommended when initiating sotagliflozin.
Danish: Reduktion af basalinsulin anbefales ikke, når sotagliflozin påbegyndes.
English: Before starting treatment, patients should be evaluated with respect to DKA risk.
Danish: Før behandlingsstart skal patienter evalueres med henblik på risikoen for DKA.
English: • if you have liver problems
Danish: • hvis du har problemer med din lever
English: Sotagliflozin must only be administered as an adjunct to insulin.
Danish: Sotagliflozin må udelukkende administreres som et supplement til insulin.
English: The MAH shall ensure that in each Member State where sotagliflozin is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense or use the product have access to:
Danish: Indehaveren af markedsføringstilladelsen skal i hvert medlemsland, hvor sotagliflozin markedsføres, sikre, at alle læger og sundhedspersonale og patienter/omsorgspersoner, som forventes at ordinere, udlevere eller anvende produktet, har adgang til:
English: Manufacturer :
Danish: Fremstiller:
English: - Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter.
Danish: - Før behandlingsstart med samtidige lægemidler, der kan nedsætte nyrefunktionen, og derefter regelmæssigt.
English: Alternative methods should be used to monitor glycaemic control.
Danish: Der bør anvendes alternative metoder til overvågning af den glykæmiske kontrol.
English: • if you are allergic to sotagliflozin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for sotagliflozin eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: • Summary of the recommendations for patients, particularly regarding blood ketone measurement and managing sick days.
Danish: • Oversigt over anbefalinger til patienten, især vedrørende måling af ketonniveau i blodet og håndtering af sygedage.
English: Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Danish: Kontakt straks en læge eller tag til nærmeste hospital, hvis du får en eller flere af følgende bivirkninger:
English: The patient may need to take extra rapid-acting insulin and drink water.
Danish: Det kan være nødvendigt, at patienten tager supplerende hurtigtvirkende insulin og drikker vand.
English: Most of the events were mild or moderate and no serious case was reported.
Danish: Størstedelen af hændelserne var milde til moderate, og ingen alvorlige tilfælde blev rapporteret.
English: • Signs/symptoms of DKA - if not adequately managed DKA can be severe and fatal.
Danish: • Tegn/symptomer på DKA - hvis DKA ikke behandles i tilstrækkelig grad, kan det være alvorligt og livsfarligt.
English: It is not known if this medicine passes into breast milk.
Danish: Man ved ikke, om dette lægemiddel udskilles i modermælken.
English: Study 1 and study 2
Danish: Studie 1 og studie 2
English: o Is willing/able to perform ketone testing as prescribed.
Danish: o Er villig/i stand til at udføre måling af ketonniveau som foreskrevet.
English: • The active substance is sotagliflozin.
Danish: • Aktivt stof: Sotagliflozin.
English: Talc Indigo carmine aluminium lake (E132).
Danish: Indigo carmine aluminium lake (E132).
English: Table 2: Tabulated list of adverse reactions System Organ class
Danish: Tabel 2: Tabel over bivirkninger Systemorganklasse
English: Information for healthcare professionals:
Danish: Information til læger og sundhedspersonale:
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.
Danish: Denne æske indeholder, udover indlægssedlen, også et patientkort med vigtige sikkerhedsoplysninger, som du har brug for før og under behandlingen med Zynquista.
English: • if you had a recent or recurrent history of diabetic ketoacidosis (e.g. 1 episode in the past 3 months or more than 1 episode in the past 6 months)
Danish: • hvis du for nyligt har haft eller har tilbagevendende diabetisk ketoacidose (1 episode i de sidste 3 måneder eller mere end 1 episode i de sidste 6 måneder).
English: Insulin injections should be given within 2 hours of an unexplained high blood glucose value and sotagliflozin treatment should be interrupted.
Danish: Der skal gives insulininjektioner inden for 2 timer efter en uforklarlig forhøjet blodglucosemåling, og sotagliflozin-behandlingen bør afbrydes.
English: Sotagliflozin should be taken once daily before the first meal of the day.
Danish: Sotagliflozin bør tages en gang dagligt før dagens første måltid.
English: Diabetic ketoacidosis*' †
Danish: Diabetisk ketoacidose*' †
English: Sotagliflozin should not be initiated when patients are at a higher risk of DKA, such as: - Patients with low insulin needs.
Danish: Sotagliflozin må ikke initieres, hvis patienten har en forhøjet risiko for DKA såsom: - Patienter med lavt insulinbehov.
English: The CL/F estimated using a population PK, which mostly evaluated T1DM patients, was 239 L/hr.
Danish: CL/F estimeret ved en farmakokinetisk populationsanalyse, som hovedsageligt evaluerede T1DM-patienter, var 239 l/t.
English: Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Danish: Brug ikke lægemidlet, hvis pakningen er beskadiget eller viser tegn på, at den har været åbnet.
English: • The risk of DKA is increased with sotagliflozin treatment.
Danish: • Risikoen for DKA er øget ved behandling med sotagliflozin.
English: Sotagliflozin was not mutagenic or clastogenic.
Danish: Sotagliflozin var ikke mutagent eller clastogent.
English: This card contains important safety information about diabetic ketoacidosis (DKA) ▼This medicinal product is subject to additional monitoring.
Danish: Dette kort indeholder vigtige sikkerhedsoplysninger om diabetisk ketoacidose (DKA) ▼ Dette lægemiddel er underlagt supplerende overvågning.
English: Therefore, glucose monitoring must be supplemented by ketone monitoring.
Danish: Derfor skal glucosemonitorering suppleres af ketonmonitorering.
English: There are no data from the use of sotagliflozin in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af sotagliflozin til gravide kvinder.
English: light-headed, or weak, especially when you stand up, fainting)
Danish: svimmelhed, følelse af være ør eller svag, især når du rejser dig op, besvimelse)
English: When sotagliflozin is incubated with UGT1A9, M19 was the main conjugate observed.
Danish: Når sotagliflozin inkuberes med UGT1A9, var M19 det primære observerede konjugat.
English: Exposure was approximately 5 times (males) and 11 times (females) the clinical exposure at the Maximum Recommended Human Dose (MRHD) and caused reversible renal tubular dilation.
Danish: Eksponering var ca. 5 gange (hanner) og 11 gange (hunner) større end den kliniske eksponering ved Maximum Recommended Human Dose (MRHD) og forårsagede reversibel tubulær dilatation af nyrerne.
English: Patients taking sotagliflozin with concomitant digoxin should be monitored appropriately.
Danish: Patienter, der tager sotagliflozin og digoxin samtidigt, bør monitoreres på passende vis.
English: In study 1, a total of 793 patients entered the study.
Danish: I alt 793 patienter indgik i studie 1.
English: Be aware that either uro-genital infection or perineal abscess may precede necrotizing fasciitis.
Danish: Man bør være opmærksom på at enten urogenital infektion eller perineal absces kan optræde forud for nekrotiserende fasciitis.
English: The educational materials are aimed at providing guidance on how to manage risk of diabetic ketoacidosis (DKA) in patients with type 1 diabetes.
Danish: Undervisningsmaterialet har til formål at give retningslinjer for, hvordan risikoen for diabetisk ketoacidise (DKA) håndteres hos patienter med type 1-diabetes.
English: The most frequently reported adverse reactions were genital mycotic infections, diabetic ketoacidosis and diarrhoea.
Danish: De hyppigst rapporterede bivirkninger var genitale svampeinfektioner, diabetisk ketoacidose og diarré.
English: Do not drive or use any tools or machines, if you feel dizzy during diabetes treatment.
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, hvis du oplever svimmelhed under din diabetesbehandling.
English: • Follow your doctor's instructions about insulin dose while taking Zynquista.
Danish: • Følg lægens anvisninger om insulindosis, mens du tager Zynquista.
English: • digoxin or digitoxin (medicines used for heart problems).
Danish: • digoxin eller digitoxin (medicin mod hjerteproblemer).
English: This decrease in exposure to sotagliflozin may decrease efficacy.
Danish: Denne reduktion i eksponering for sotagliflozin kan reducere virkningen.
English: These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotizing fasciitis of the perineum or Fournier's gangrene which destroys the tissue under the skin.
Danish: Disse symptomer kan være tegn på en sjælden, men alvorlig og i nogle tilfælde livstruende infektion, der hedder nekrotiserende fasciitis i mellemkødet eller Fourniers gangræn og som nedbryder vævet under huden.
English: Extra carbohydrates should be taken if the glucose levels are normal or low.
Danish: Ekstra kulhydrater indtages, hvis glucoseniveauet er normalt eller lavt.
English: In vitro sotagliflozin was shown to have inhibitory effects on P-gp and breast cancer resistance protein (BCRP).
Danish: In vitro-sotagliflozin er vist at have en hæmmende effekt på P-gp og brystcancer-resistent protein (BCRP).
English: Diabetes Treatment Satisfaction Questionnaire Baseline, mean
Danish: Diabetes Treatment Satisfaction Questionnaire Baseline, gennemsnit
English: Diabetic ketoacidosis (DKA), seen commonly (may affect up to 1 in 100 people)
Danish: Diabetisk ketoacidose (DKA), almindeligt forekommende (kan forekomme hos op til 1 ud af 100 personer)
English: - Patients must be able to perform self-management of the day-to-day aspects of their disease including self-monitoring of glucose and ketones.
Danish: - Patienten skal selv være i stand til at varetage de daglige aspekter ved sygdommen, herunder at foretage måling af glucose og ketoner.
English: The Patient Alert Card is also provided in the product packaging.
Danish: Patientkortet er også indeholdt i lægemiddelpakningen.
English: Two cases (2 cases of cystitis) were serious; both occurred in male subjects in the sotagliflozin 400 mg group.
Danish: To tilfælde (2 tilfælde af cystitis) var alvorlige og begge tilfælde forekom hos mandlige forsøgspersoner i gruppen med sotagliflozin 400 mg.
English: Following administration of multiple doses (400 and 800 mg dose), the median Tmax values ranged from 2.5 to 4 hours.
Danish: Efter administration af flere doser (dosis på 400 mg og 800 mg) var median Tmax -værdier 2,5-4 timer.
English: Other side effects: Very common (may affect more than 1 in 10 people)
Danish: Andre bivirkninger: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer)
English: If Fournier's gangrene is suspected, sotagliflozin should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Ved mistanke om Fourniers gangræn skal sotagliflozin seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridering) skal iværksættes.
English: In study 2, a total of 782 patients entered the study.
Danish: I alt 782 patienter indgik i studie 2.
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.
Danish: Der kunne ikke påvises forskel i HbA1c-reduktion på tværs af undergrupper, herunder alder, køn, race, geografisk område, baseline-BMI, alder ved diagnose, baseline-HbA1c, eGFR, sygdomsvarighed og insulin-indgivelsesmetode.
English: Ketone monitoring during treatment:
Danish: Monitorering af ketonniveau under behandling:
English: Common (may affect more than 1 in 100 people)
Danish: Almindelig (kan forekomme hos flere end 1 ud af 100 personer)
English: Subsequently, basal insulin should be adjusted based on blood glucose results.
Danish: Efterfølgende bør basalinsulin justeres baseret på blodglucose-resultater.
English: Available toxicological data in animals have shown excretion of sotagliflozin into milk.
Danish: Tilgængelige toksikologiske data fra dyr har vist udskillelse af sotagliflozin i mælk.
English: Due to the limited therapeutic experience in patients aged 75 years and older, initiation of sotagliflozin therapy is not recommended.
Danish: På grund af den begrænsede terapeutiske erfaring hos patienter på 75 år og derover kan behandling med sotagliflozin ikke anbefales.
English: If you are using an insulin pump, monitor your ketones levels three to four hours after changing pump materials.
Danish: Hvis du bruger insulinpumpe, skal du måle dit ketonniveau 3-4 timer efter du har udskiftet pumpeudstyr.
English: It is possible that adverse effects occurring with sotagliflozin may be similar to presenting symptoms of DKA.
Danish: Det er muligt, at bivirkninger ved sotagliflozin kan ligne symptomerne på DKA.
English: Fifteen of the 35 cases (43%) experienced DKA with glucose values in the glycaemic range 8 to 14 mmol/L.
Danish: Femten af de 35 tilfælde (43 %) oplevede DKA med glucoseværdier inden for det glykæmiske område 8-14 mmol/l.
English: - Patients with increased insulin requirements due to acute medical illness or surgery.
Danish: - Patienter med øget insulinbehov på grund af akut sygdom eller operation.
English: • Ensure the patient is on optimal insulin therapy prior to initiation of sotagliflozin treatment.
Danish: • Det skal sikres, at patienten er i optimal insulinbehandling, før behandling med sotagliflozin påbegyndes.
English: The level of digoxin or digitoxin in your blood may need to be checked if you take these medicines with Zynquista.
Danish: Det kan være nødvendigt at kontrollere indholdet af digoxin eller digitoxin i blodet, hvis du tager disse lægemidler sammen med
English: Temporary interruption of sotagliflozin should be considered when treating pyelonephritis and urosepsis.
Danish: En midlertidig afbrydelse af behandlingen med sotagliflozin bør overvejes ved behandling af pyelonefritis og urosepsis.
English: Systolic Blood Pressure in those with baseline SBP ≥ 130 mmHg*
Danish: Systolisk blodtryk hos patienter med baseline SBP ≥ 130 mmHg*
English: Your doctor will prescribe Zynquista together with insulin treatment to lower the amount of sugar in your blood.
Danish: Din læge har ordineret Zynquista sammen med insulinbehandling for at sænke sukkerindholdet i dit blod.
English: During the initial one to two weeks of treatment with sotagliflozin, ketones should be monitored on a regular basis.
Danish: I de første 1-2 ugers behandling med sotagliflozin bør ketonniveauet monitoreres regelmæssigt.
English: Subsequent bolus doses should be adjusted individually based on blood glucose results.
Danish: Efterfølgende bolusdoser bør justeres individuelt baseret på blodglucose-resultater.
English: During treatment with sotagliflozin - The patient should remain on optimal insulin dosing.
Danish: Under behandlingen med sotagliflozin - Patienten skal forblive på en optimal insulindosis.
English: However, patients should be alerted to the risk of hypoglycaemia as sotagliflozin is used in combination with insulin.
Danish: Patienterne bør advares om risikoen for hypoglykæmi, da sotagliflozin anvendes i kombination med insulin.
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.
Danish: Der blev ikke observeret udviklingstoksicitet ved doser på op til 200 mg/kg/dag hos kaniner, hvilket var op til 9 gange større end human eksponering ved MRHD.
English: In the rat, TSH was considered the primary carcinogen with sotagliflozin functioning as a secondary carcinogen.
Danish: Hos rotter blev TSH anset som det primære carcinogen og sotagliflozin som det sekundære carcinogen.
English: Always take this medicine exactly as your doctor has told you.
Danish: Du skal tage disse andre lægemidler, som din læge har fortalt dig.
English: The recommended actions are listed in Table 1.
Danish: De anbefalede foranstaltninger er vist i tabel 1.
English: As sotagliflozin is taken together with insulin, hypoglycaemia may occur during treatment.
Danish: Da sotagliflozin anvendes sammen med insulin, kan der opstå hypoglykæmi under behandlingen.
English: Patients using a pump should also check their ketone levels with any suspected insulin interruption, regardless of blood glucose levels.
Danish: Patienter, der anvender insulinpumpe, bør ligeledes kontrollere deres ketonniveau ved enhver mistanke om afbrudt insulintilførsel, uanset blodglucoseniveau.
English: • rifampicin (an antibiotic used to treat tuberculosis and some other infections).
Danish: • rifampicin (antibiotikum til behandling af tuberkulose og bestemte infektioner).
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.
Danish: Det kan ikke udelukkes, at sotagliflozin kan interagere med andre følsomme OAT3-, OATP- og/eller BCRPsubstrater (f.eks.: fexofenadin, paclitaxel, bosentan, methotrexat, furosemid, benzylpenicillin), hvilket medfører en potentiel større stigning i eksponering end den, der er observeret med rosuvastatin.
English: Please consult the Patient/Carer's Guide for more information discussed with your doctor about taking Zynquista and the risk of DKA.
Danish: Se Vejledning til patienten/omsorgspersonen for at læse mere om de oplysninger, du har fået fortalt af lægen om at tage Zynquista og risikoen for DKA.
English: † Defined as a documented SMBG or laboratory blood glucose value below or equal to threshold of 3.1 or 3.9 mmol/L.
Danish: † Defineret som dokumenteret SMBG eller laboratorie-blodglucoseværdier under eller lig med grænseværdier på 3,1 eller 3,9 mmol/l.
English: Check glucose levels frequently to avoid hyperglycaemia or hypoglycaemia.
Danish: Glucoseniveauet skal måles hyppigt for at undgå hyperglykæmi eller hypoglykæmi.
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.
Danish: Der kan opstå symptomatisk hypotension efter behandlingsstart med sotagliflozin, især hos patienter med nedsat nyrefunktion, hos ældre, hos patienter med lavt systolisk blodtryk og hos patienter, der behandles med diuretika.
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors should be used with caution in patients with increased risk of DKA.
Danish: Natrium-glucose co-transporter 2 (SGLT2)-hæmmere bør anvendes med forsigtighed hos patienter med en øget risiko for DKA.
English: Package leaflet: Information for the patientZynquista 200 mg film-coated tablets sotagliflozin This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patientenZynquista 200 mg filmovertrukne tabletter sotagliflozin Dette lægemiddel er underlagt supplerende overvågning.
English: For all patients, it is recommended that ketones should be measured with changes to the normal routine, including reduced carbohydrate intake, intercurrent illness, reductions in total daily insulin dosing, physical activity and stress.
Danish: For alle patienter anbefales det at ketonniveauet måles i forbindelse med en ændring i den normale rutine, inklusive nedsat kulhydratindtag, anden samtidig sygdom, reduktion i total daglig insulindosis, fysisk aktivitet og stressniveau.
English: In order to avoid hypoglycaemia with the first dose of sotagliflozin a 20% reduction in the first mealtime bolus insulin may be considered.
Danish: For at undgå hypoglykæmi i forbindelse med den første dosis sotagliflozin, bør det overvejes at reducere den første bolus måltidsinsulin med 20 %.
English: Main results regarding insulin dose are presented in Table 6.
Danish: De vigtigste resultater vedrørende insulindoser er vist i tabel 6.
English: Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking other SGLT2 inhibitors.
Danish: Efter markedsføring er der rapporteret tilfælde af nekrotiserende fasciitis i perineum (også kendt som Fourniers gangræn) hos kvindelige og mandlige patienter, der har taget andre SGLT2-hæmmere.
English: Zynquista contains the active substance sotagliflozin, a medicine which lowers blood glucose (blood sugar) levels.
Danish: Zynquista indeholder det aktive stof sotagliflozin, som er et lægemiddel, der sænker blodsukkerniveauet (glucoseniveauet) i blodet.
English: Mean baseline values
Danish: Gennemsnitlige baseline-værdier
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.
Danish: - Patienter på en ikke optimal insulindosis, eller som for nylig har haft problemer med manglende compliance eller gentagne doseringsfejl med insulin og som ikke er i stand til at opretholde en tilstrækkelig insulindosering.
English: • if you are on caloric restriction, carbohydrate restriction or ketogenic diet
Danish: • hvis du er på en kaloriefattig diæt, kulhydratfattig diæt eller ketogen diæt
English: Rosuvastatin is a known OATP, BCRP and OAT3 substrate.
Danish: Rosuvastatin er et kendt OATP-, BCRP- og OAT3-substrat.
English: Main results for insulin dose and Diabetes Treatment Satisfaction Questionnaire and Diabetes Distress Screening Scale are presented in Table 4.
Danish: De vigtigste resultater for insulindosering og Tilfredshedsspørgeskema for diabetesbehandling (Diabetes Treatment Satisfaction Questionnaire) og Skala til bedømmelse af gener ved diabetes (Diabetes Distress Screening Scale) er vist i tabel 4.
English: Patients should consider monitoring ketones levels three to four hours after changing pump materials.
Danish: Patienter bør måle ketonniveauet 3-4 timer efter udskiftning af pumpeudstyr.
English: • if you have an acute medical illness or surgery
Danish: • hvis du får en pludselig sygdom eller skal opereres
English: Before initiating sotagliflozin, volume contraction should be assessed and volume status should be corrected if indicated.
Danish: Før behandling med sotagliflozin initieres, skal volumenreduktion vurderes og volumenstatus afhjælpes hvis påkrævet.
English: Ketones should be measured repetitively when any signs or symptoms consistent with DKA or euglycaemic DKA are present.
Danish: Ketoner skal måles gentagne gange i tilfælde af tegn eller symptomer på DKA eller euglykæmisk DKA.
English: This patient is using ZYNQUISTA for the treatment of Type 1 Diabetes Mellitus (T1DM).
Danish: Denne patient tager ZYNQUISTA til behandling af type 1-Diabetes Mellitus (T1DM).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu