FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of empagliflozin with probenecid, an inhibitor of UGT enzymes and OAT3, resulted in a 26% increase in peak empagliflozin plasma concentrations (Cmax) and a 53% increase in area under the concentration-time curve (AUC).
Danish: Probenecid, en hæmmer af UGT-enzymer og OAT3, medførte en 26 % stigning i peakplasmakoncentrationer af empagliflozin (Cmax) og en 53 % stigning i arealet under koncentration/tidkurven (AUC).
English: Inhibition of OATP1B1/1B3 transporters by co-administration with rifampicin resulted in a 75% increase in Cmax and a 35% increase in AUC of empagliflozin.
Danish: Rifampicin, som hæmmer af transportproteinerne OATP1B1/1B3, medførte en 75 % stigning i Cmax og en 35 % stigning i AUC for empagliflozin.
English: The pharmacokinetics of empagliflozin have been extensively characterised in healthy volunteers and patients with type 2 diabetes.
Danish: Empagliflozins farmakokinetik er udførligt undersøgt hos raske frivillige og hos type 2-diabetespatienter.
English: Each tablet contains lactose monohydrate equivalent to 154.3 mg lactose anhydrous.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder lactosemonohydrat svarende til 154,3 mg lactose, vandfri.
English: In vitro studies suggested that the primary route of metabolism of empagliflozin in humans is glucuronidation by the uridine 5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, and UGT1A9.
Danish: In vitroforsøg tyder på, at den primære metaboliseringsvej for empagliflozin hos mennesker er glucuronidering ved uridin 5'-diphospho-glucuronosyltransferase UGT2B7, UGT1A3, UGT1A8 og UGT1A9.
English: Pack sizes of 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1, and 100 x 1 film-coated tablets.
Danish: Pakningsstørrelser på 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1 og 100 x 1 filmovertrukne tabletter.
English: Jardiance is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as:
Danish: Jardiance er indiceret til forbedring af den glykæmiske kontrol hos voksne patienter med type 2-diabetes mellitus som:
English: Drug-drug interactions involving the major CYP450 and UGT isoforms with empagliflozin and concomitantly administered substrates of these enzymes are therefore considered unlikely.
Danish: Lægemiddel-lægemiddelinteraktioner mellem empagliflozin og samtidigt administrerede substrater for de vigtigste CYP-isoformer og UGTisoformer anses derfor for at være usandsynlige.
English: Baseline (mean)
Danish: Baseline (middelværdi)
English: 4 LOCF, values after antihypertensive rescue censored
Danish: 4 LOCF, værdier efter yderligere antihypertensiv regulering er censureret fra
English: The pack sizes are 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1, and 100 x 1 film-coated tablets.
Danish: Pakningsstørrelserne er 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1 og 100 x 1 filmovertrukne tabletter.
English: An urge to pass urine or more frequent urination may be due to the way Jardiance works, but as they can also be signs of urinary tract infection, if you note an increase in such symptoms, you should also contact your doctor.
Danish: Stærk vandladningstrang eller hyppigere vandladning kan skyldes måden Jardiance virker på, men kan også være et tegn på urinvejsinfektion.
English: Table 8 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressurea
Danish: Tabel 8: Effektresultater ved 12 uger i et placebokontrolleret studie med empagliflozin hos patienter med type 2-diabetes og ikke-kontrolleret blodtryka
English: In a pre-specified pooled analysis of 4 placebo controlled studies, treatment with empagliflozin resulted in body weight reduction (-0.24 kg for placebo, -2.04 kg for empagliflozin 10 mg and -2.26 kg for empagliflozin 25 mg) at week 24 that was maintained up to week 52 (-0.16 kg for placebo, -1.96 kg for empagliflozin 10 mg and -2.25 kg for empagliflozin 25 mg).
Danish: I en præspecificeret poolet analyse af 4 placebokontrollerede studier gav behandling med empagliflozin en reduktion i kropsvægt (-0,24 kg for placebo, -2,04 kg for empagliflozin 10 mg og -2,26 kg for empagliflozin 25 mg) ved uge 24, som blev opretholdt op til uge 52 (-0,16 kg for placebo, -1,96 kg for empagliflozin 10 mg og -2,25 kg for empagliflozin 25 mg).
English: Table 7 Results at 24 week in a placebo-controlled study of empagliflozin in renally impaired type 2 diabetes patientsa
Danish: Tabel 7 Resultater ved 24 uger i et placebokontrolleret studie med empagliflozin hos type 2-diabetespatienter med nedsat nyrefunktiona
English: Each tablet contains lactose monohydrate equivalent to 107.4 mg lactose anhydrous.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder lactosemonohydrat svarende til 107,4 mg lactose, vandfri.
English: 1 Mean adjusted for baseline value
Danish: 1 Middelværdi justeret for baselineværdi
English: Monotherapy and add-on combination
Danish: Monoterapi og kombinationsbehandling
English: The most frequently reported adverse reaction was hypoglycaemia when used with sulphonylurea or insulin (see description of selected adverse reactions).
Danish: Ved anvendelse sammen med sulfonylurinstof eller insulin var den hyppigst indberettede bivirkning hypoglykæmi (se beskrivelsen af udvalgte bivirkninger).
English: An interaction study with gemfibrozil, an in vitro inhibitor of OAT3 and OATP1B1/1B3 transporters, showed that empagliflozin Cmax increased by 15% and AUC increased by 59% following coadministration.
Danish: Gemfibrozil, en in vitro-hæmmer af transportproteinerne OAT3 og OATP1B1/1B3, medførte i et interaktionsstudie, at Cmax for empagliflozin steg med 15 %, og AUC steg med 59 %.
English: SGLT2 prevents glucose from being excreted in urine by absorbing glucose into the bloodstream as blood is being filtered in the kidneys.
Danish: Proteinet SGLT2 binder glucose til blodbanen, og forhindrer dermed glucose i at blive filtreret i nyrerne og derefter udskilt i urinen.
English: Interstitial cell tumours in the testes were observed with a higher incidence in rats at 300 mg/kg/day and above, but not at 100 mg/kg/day which corresponds to approximately 18-times the maximal clinical exposure to empagliflozin.
Danish: Interstitielle celletumorer i testes blev observeret med en højere forekomst hos rotter ved 300 mg/kg/dag og derover, men ikke ved 100 mg/kg/dag, hvilket svarer til ca. 18 gange den maksimale kliniske eksponering for empagliflozin.
English: Table 3: Efficacy results of 24 week placebo-controlled studiesa Add-on to metformin therapy Placebo
Danish: Tabel 3: Effektresultater af 24 ugers placebokontrollerede studiera Supplement til metforminbehandling Placebo
English: Difference from placebo4
Danish: Forskel fra placebo4
English: In the double-blind placebo-controlled extension of this study, reductions of HbA1c, body weight and blood pressure were sustained up to Week 52.
Danish: I en dobbeltblindet, placebokontrolleret forlængelse af dette studie blev reduktion i HbA1c, kropsvægt og blodtryk opretholdt op til uge 52.
English: In a 2 year carcinogenicity study, empagliflozin did not increase the incidence of tumours in female rats up to the highest dose of 700 mg/kg/day, which corresponds to approximately 72-times the maximal clinical AUC exposure to empagliflozin.
Danish: I et 2-årigt carcinogenicitetsstudie øgede empagliflozin ikke forekomsten af tumorer hos hunrotter op til den højeste dosis på 700 mg/kg/dag, hvilket svarer til ca. 72 gange den maksimale kliniske AUCeksponering for empagliflozin.
English: At week 18, empagliflozin provided statistically significant improvement in HbA1c (Table 6).
Danish: Ved uge 18 opnåedes en statistisk signifikant forbedring af HbA1c (tabel 6).
English: Jardiance 25 mg film-coated tablets are oval, pale yellow and biconvex.
Danish: Jardiance 25 mg filmovertrukne tabletter er ovale, lysegule og bikonvekse.
English: An increased frequency was noted when given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), and as add-on to insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 27.1%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 36.1%, empagliflozin 25 mg: 34.8%, placebo 35.3% over the 78-week trial).
Danish: En øget hyppighed blev bemærket ved administration som supplement til metformin og et sulfonylurinstof (empagliflozin 10 mg: 16,1 %, empagliflozin 25 mg: 11,5 %, placebo: 8,4 %), og som supplement til insulin med eller uden metformin og med eller uden et sulfonylurinstof (empagliflozin 10 mg: 19,5 %, empagliflozin 25 mg: 27,1 %, placebo: 20,6 % under de indledende 18 ugers behandling, hvor insulin ikke kunne justeres; empagliflozin 10 mg: 36,1 %, empagliflozin 25 mg: 34,8 %, placebo 35,3 % over det 78 uger lange studier).
English: Therefore, caution should be exercised in patients for whom an empagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or patients aged 75 years and older.
Danish: For patienter med kendt hjerte-karsygdom, patienter i antihypertensiv terapi med hypotension i anamnesen eller patienter på 75 år og derover, hvor et blodtryksfald kan udgøre en risiko, skal der udvises forsigtighed.
English: Difference from placebo5
Danish: Forskel fra placebo5
English: Increased urination (including the predefined terms pollakiuria, polyuria, and nocturia) was observed at higher frequencies in patients treated with empagliflozin (empagliflozin 10 mg: 3.4%, empagliflozin 25 mg: 3.2%) compared to placebo (1.0%).
Danish: Øget vandladning Hyppigheden af øget vandladning (inklusive de foruddefinerede betegnelser pollakiuri, polyuri og nocturi) var større hos empagliflozinbehandlede patienter (empagliflozin 10 mg: 3,4 %, empagliflozin 25 mg: 3,2 %) end for placebo (1,0 %).
English: Česká republika Boehringer Ingelheim spol.
Danish: Boehringer Ingelheim spol.
English: 5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001
Danish: 4 Middelværdi justeret for baseline-SBP, baseline-HbA1c, baseline-eGFR, geografisk region og antal antihypertensive lægemidler 5 Middelværdi justeret for baseline-DBP, baseline-HbA1c, baseline-eGFR, geografisk region og antal antihypertensive lægemidler * p-værdi <0,0001
English: In a pre-specified pooled analysis of 4 placebo-controlled studies, treatment with empagliflozin resulted in a reduction in systolic blood pressure (empagliflozin 10 mg: -3.9 mmHg; empagliflozin 25 mg: -4.3 mmHg) compared with placebo (-0.5 mmHg) and in diastolic blood pressure (empagliflozin 10 mg: -1.8 mmHg; empagliflozin 25 mg: -2.0 mmHg) compared with placebo (-0.5 mmHg) at week 24 that were maintained up to week 52.
Danish: I en præspecificeret poolet analyse af 4 placebokontrollerede studier gav behandling med empagliflozin et fald i systolisk blodtryk (empagliflozin 10 mg: -3,9 mmHg; empagliflozin 25 mg: -4,3 mmHg) sammenlignet med placebo (-0,5 mmHg) og i diastolisk blodtryk (empagliflozin 10 mg: -1,8 mmHg; empagliflozin 25 mg: -2,0 mmHg) sammenlignet med placebo (-0,5 mmHg) ved uge 24, som blev bevaret op til uge 52.
English: Table 2: Efficacy results of a 24 week placebo-controlled study of empagliflozin as monotherapya
Danish: Tabel 2: Effektresultater af et 24 ugers placebokontrolleret studie med empagliflozin som monoterapia Placebo
English: Empagliflozin did not increase the incidence of tumours in female mice at doses up to 1000 mg/kg/day, which corresponds to approximately 62-times the maximal clinical exposure to empagliflozin.
Danish: Empagliflozin øgede ikke forekomsten af tumorer hos hunmus ved doser på op til 1000 mg/kg/dag, hvilket svarer til ca. 62 gange den maksimale kliniske eksponering for empagliflozin.
English: If you take more Jardiance than you should If you take more Jardiance than you should, talk to a doctor immediately or go to a hospital immediately.
Danish: Hvis du har taget for meget Jardiance Kontakt straks en læge, hvis du har taget for meget Jardiance.
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 empagliflozin.
Danish: Passende monitorering af volumenstatus (f.eks. objektiv undersøgelse, blodtryksmålinger, laboratorietest omfattende hæmatokrit) og elektrolytter bør overvejes ved tilstande med risiko for væsketab (f.eks. mave-tarmsygdom).
English: Effects of other medicinal products on empagliflozin In vitro data suggest that the primary route of metabolism of empagliflozin in humans is glucuronidation by uridine 5'-diphosphoglucuronosyltransferases UGT1A3, UGT1A8, UGT1A9, and UGT2B7.
Danish: In vitro-data tyder på, at den primære metaboliseringsvej for empagliflozin hos mennesker er glucuronidering via uridin 5'-diphosphoglucuronosyltransferase UGT1A3, UGT1A8, UGT1A9 og UGT2B7.
English: Effects of empagliflozin on other medicinal products Based on in vitro studies, empagliflozin does not inhibit, inactivate, or induce CYP450 isoforms.
Danish: Empagliflozin hverken hæmmer, inaktiverer eller inducerer CYP-isoformer.
English: In patients tolerating empagliflozin whose eGFR falls persistently below 60 ml/min/1.73 m2 or CrCl below 60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily.
Danish: Hos patienter hvis eGFR vedvarende falder under 60 ml/min/1,73 m2 eller CrCl under 60 ml/min, bør dosis justeres til eller vedligeholdes på 10 mg en gang daglig.
English: Patients with renal impairment, 52 week placebo controlled data The efficacy and safety of empagliflozin as add on to antidiabetic therapy was evaluated in patients with renal impairment in a double-blind, placebo-controlled study for 52 weeks.
Danish: Patienter med nedsat nyrefunktion, 52 ugers placebokontrollerede data I et 52 ugers dobbeltblindet, placebokontrolleret studie undersøgtes empagliflozins virkning og sikkerhed som supplement til anti-diabetisk behandling hos patienter med nedsat nyrefunktion.
English: In male rats, treatment-related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26-times the maximal clinical exposure to empagliflozin.
Danish: Hos hanrotter blev der observeret behandlingsrelaterede benigne vaskulære proliferative læsioner (hæmangiomer) i den mesenteriske lymfekirtel ved den højeste dosis, men ikke ved 300 mg/kg/dag, hvilket svarer til ca. 26 gange den maksimale kliniske eksponering for empagliflozin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of empagliflozin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg empagliflozin.
English: At 78 weeks, empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared to placebo.
Danish: Ved 78 uger opnåedes en statistisk signifikant forbedring af HbA1c samt en insulinbesparelse sammenlignet med placebo.
English: The overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo (7.6%) and higher in empagliflozin 10 mg (9.3%).
Danish: Den overordnede hyppighed af urinvejsinfektion var den samme hos empagliflozinbehandlede patienter, behandlet med 25 mg og placebo (7,6 %) og højere for empagliflozin 10 mg (9,3 %).
English: Difference from placebo2
Danish: Forskel fra placebo2
English: Very common Common
Danish: Almindeligt forekomne
English: No dose adjustment is required for patients with an eGFR ≥60 ml/min/1.73 m2 or CrCl ≥60 ml/min.
Danish: Dosisjustering er ikke nødvendig for patienter med en eGFR ≥60 ml/min/1,73 m2 eller CrCl ≥60 ml/min.
English: Empagliflozin as add on to metformin, sulphonylurea, pioglitazone Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone with or without metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 3).
Danish: Empagliflozin som supplement til metformin, sulfonylurinstof, pioglitazon Der sås statistisk signifikante (p<0,0001) fald i HbA1c og kropsvægt sammenlignet med placebo (tabel 3), når empagliflozin blev givet som supplement til metformin, metformin og et sulfonylurinstof eller til pioglitazon med eller uden metformin.
English: Empagliflozin induced renal tumours in male mice at 1000 mg/kg/day, but not at 300 mg/kg/day, which corresponds to approximately 11-times the maximal clinical exposure to empagliflozin.
Danish: Empagliflozin inducerede nyretumorer hos hanmus ved 1000 mg/kg/dag, men ikke ved 300 mg/kg/dag, hvilket svarer til ca. 11 gange den maksimale kliniske eksponering for empagliflozin.
English: These may be medicines taken by mouth or insulin given by injection.
Danish: • Jardiance kan også bruges sammen med andre diabeteslægemidler - enten lægemidler, der tages gennem munden, eller insulin, der gives som indsprøjtning.
English: HbA1c (%) at week 18 Baseline (mean) Change from baseline1 Difference from placebo1
Danish: HbA1c (%) ved uge 18 Baseline (middelværdi) Ændring fra baseline1 Forskel fra placebo1
English: The overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo and higher in patients treated with empagliflozin 10 mg (see section 4.8).
Danish: Den overordnede frekvens af urinvejsinfektion, indberettet som utilsigtet hændelse, var den samme for empagliflozin 25 mg og for placebo, og højere hos patienter, der blev behandlet med empagliflozin 10 mg (se pkt.
English: An increased frequency was noted when given as add-on to insulin with or without metformin and with or without a sulfonylurea (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo: 0% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo 0% over the 78-week trial).
Danish: Som supplement til insulin med eller uden metformin samt insulin med eller uden et sulfonylurinstof, sås en øget hyppighed af svær hypoglykæmi (under de indledende 18 ugers behandling, hvor insulin ikke kunne justeres: empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1,3 %, placebo: 0 %; henover det 78 uger lange studie: empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1,3 %, placebo 0 %).
English: ** p-value <0.001
Danish: ** p-værdi <0,001
English: 2 Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 3 LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored 4 Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products
Danish: 2 Middelværdi justeret for baseline-HbA1c, baseline-eGFR, geografisk region og antal antihypertensive lægemidler 3 LOCF, værdier efter akut blodsukkerregulerende eller ændret antihypertensiv -behandling, er censureret fra
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg of empagliflozin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 25 mg empagliflozin.
English: Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1
Danish: Kropsvægt (kg) Baseline (middelværdi) Ændring fra baseline1 Forskel fra placebo1
English: Boehringer Ingelheim Sp. z o.o.
Danish: Boehringer Ingelheim Sp.zo.o.
English: Iron oxide yellow (E172)
Danish: Macrogol (400) Jernoxid, gul (E172)
English: Low blood sugar (hypoglycemia), seen very commonly (may affect more than 1 in 10 people) If you take Jardiance with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher.
Danish: Hvis du tager Jardiance sammen med andre lægemidler, der kan give for lavt blodsukker, som for eksempel et sulfonylurinstof eller insulin, har du højere risiko for at få for lavt blodsukker.
English: Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min.
Danish: Empagliflozin bør seponeres, hvis eGFR vedvarende ligger på under 45 ml/min/1,73 m2 eller CrCl vedvarende ligger under 45 ml/min (se pkt.
English: The safety and efficacy of empagliflozin in children and adolescents has not yet been established.
Danish: Empagliflozin bør ikke anvendes til børn og unge p.g.a. manglende dokumentation for sikkerhed og virkning.
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Danish: Patienter (%), der opnåede HbA1c <7 % med baseline-HbA1c ≥7 %2
English: (97.5% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy
Danish: (97,5 % CI) a Full analysis set (FAS) ved brug af last observation carried forward (LOCF) forud for akut blodsukkerregulerende behandling
English: Add-on to insulin therapy
Danish: Supplement til insulinbehandling
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excl. insulins, ATC code: A10BX12
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, andre blodglucosesænkende midler, ekskl.
English: In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥60 ml/min/1.73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily.
Danish: Dosis kan øges til 25 mg en gang daglig hos patienter, der tåler empagliflozin 10 mg én gang daglig og som har en eGFR ≥60 ml/min/1,73 m2 og har behov for bedre glykæmisk kontrol.
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% at week 52
Danish: Patienter (%), der opnåede HbA1c <7 % med baselineHbA1c ≥7 % ved uge 52 N
English: 1 LOCF, values after taking antidiabetic rescue therapy censored
Danish: 1 LOCF, værdier efter akut blodsukkerregulerende behandling er censureret fra
English: 2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure 3 95% CI
Danish: 2 Ikke evalueret med hensyn til statistisk signifikans på grund af den sekventielle bekræftende testprocedure * p <0,0001
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and Cmax by approximately 37% compared to fasted condition.
Danish: Administration af empagliflozin 25 mg efter indtagelse af et fedt- og kalorierigt måltid resulterede i en lidt lavere eksponering.
English: (95% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy
Danish: (95 % CI) a Full analysis set (FAS) ved brug af last observation carried forward (LOCF) forud for akut blodsukkerregulerende behandling
English: Jardiance 10 mg film-coated tablets
Danish: Jardiance 10 mg filmovertrukne tabletter
English: *p-value <0.0001
Danish: *p-værdi <0,0001
English: * p-value <0.0001
Danish: * p-værdi <0,0001
English: Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets empagliflozin
Danish: Jardiance 10 mg filmovertrukne tabletter Jardiance 25 mg filmovertrukne tabletter empagliflozin
English: PVC/aluminium perforated unit dose blisters.
Danish: Perforerede enkeltdosisblistere af PVC/aluminium.
English: The efficacy and safety of empagliflozin as monotherapy was evaluated in a double-blind, placebo- and active-controlled study of 24 weeks duration in treatment-naïve patients.
Danish: I et 24 ugers dobbeltblindet, placebo-og aktivkontrolleret studie undersøgtes empagliflozins virkning og sikkerhed som monoterapi hos behandlingsnaive patienter.