FrancophonIA/ELRC3.0 huggingface dataset:
English: They have “S25” on one side and the Boehringer Ingelheim logo on the other side.
Danish: De har “S25” på den ene side og Boehringer Ingelheims logo på den anden side.
English: Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Danish: Interaktionsstudier udført med raske frivillige tyder på, at empagliflozin ikke havde nogen klinisk relevant indvirkning på farmakokinetikken for metformin, glimepirid, pioglitazon, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretika og orale kontraceptiva.
English: Urine laboratory assessments
Danish: Laboratorievurdering af urin
English: The frequency of patients with minor hypoglycaemia was similar for empagliflozin and placebo as monotherapy, add-on to metformin, and add-on to pioglitazone with or without metformin.
Danish: Hyppigheden af patienter med mild hypoglykæmi var den samme for empagliflozin og placebo som monoterapi, supplement til metformin og supplement til pioglitazon med eller uden metformin.
English: Empagliflozin 24 months data, as add on to metformin in comparison to glimepiride In a study comparing the efficacy and safety of empagliflozin 25 mg versus glimepiride (up to 4 mg per day) in patients with inadequate glycaemic control on metformin alone, treatment with empagliflozin daily resulted in superior reduction in HbA1c (Table 4), and a clinically meaningful reduction in FPG, compared to glimepiride.
Danish: 24 måneders data for empagliflozin som supplement til metformin, sammenlignet med glimepirid I et studie hvor man sammenlignede virkning og sikkerhed af empagliflozin 25 mg versus glimepirid (op til 4 mg pr. dag), hos patienter med utilstrækkelig glykæmisk kontrol på metformin alene, gav daglig behandling med empagliflozin en større reduktion i HbA1c (tabel 4) og en klinisk relevant reduktion i FPG sammenlignet med glimepirid.
English: EU/1/14/930/010 7 tablets EU/1/14/930/011 10 tablets EU/1/14/930/012 14 tablets EU/1/14/930/013 28 tablets EU/1/14/930/014 30 tablets EU/1/14/930/015 60 tablets EU/1/14/930/016 70 tablets EU/1/14/930/017 90 tablets EU/1/14/930/018 100 tablets
Danish: EU/1/14/930/010 7 tabletter EU/1/14/930/011 10 tabletter EU/1/14/930/012 14 tabletter EU/1/14/930/013 28 tabletter EU/1/14/930/014 30 tabletter EU/1/14/930/015 60 tabletter EU/1/14/930/016 70 tabletter EU/1/14/930/017 90 tabletter EU/1/14/930/018 100 tabletter
English: In pre- and postnatal toxicity studies in rats, reduced weight gain of offspring was observed at maternal exposures approximately 4-times the maximal clinical exposure to empagliflozin.
Danish: I præ- og postnatale toksicitetsstudier hos rotter blev der observeret nedsat vægtøgning hos afkommet ved maternelle eksponeringer på ca. 4 gange den maksimale kliniske eksponering for empagliflozin.
English: Microscopic evidence of the effects of exaggerated pharmacology on the kidney observed in some species included tubular dilatation, and tubular and pelvic mineralisation at approximately 4-times the clinical AUC exposure of empagliflozin associated with the 25 mg dose.
Danish: Den mikroskopiske evidens for virkningerne af overdreven farmakologi på nyrerne, der blev observeret hos visse arter, omfattede tubulær dilatation og mineralisering i tubuli og pelvis ved ca. 4 gange den kliniske AUC-eksponering for empagliflozin, der er forbundet med en dosis på 25 mg.
English: Your doctor may ask you to stop taking Jardiance until you have recovered.
Danish: Din læge vil måske sige, at du skal holde op med at tage Jardiance, indtil du er blevet rask.
English: Driving and using machines Jardiance has minor influence on the ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Jardiance påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Insulin dose (IU/day) at week 522
Danish: Insulindosis (IE/dag) ved uge 522
English: The intensity (mild, moderate, severe) of urinary tract infection was similar in patients treated with empagliflozin and placebo.
Danish: Intensiteten (mild, moderat, svær) af urinvejsinfektionerne var den samme for empagliflozinbehandlede og for placebo.
English: 2 Week 19-40: treat-to-target regimen for insulin dose adjustment to achieve pre-defined glucose target levels (pre-prandial <100 mg/dl (5.5 mmol/l), post-prandial <140 mg/dl (7.8 mmol/l) * p-value <0.0001 ** p-value = 0.0003 *** p-value = 0.0005 # p-value = 0.0040
Danish: 2 Uge 19-40: treat to target-regimen for insulindosisjustering for at opnå foruddefinerede glucosemålværdier (præprandial <100 mg/dl (5,5 mmol/l), postprandial <140 mg/dl (7,8 mmol/l) * p-værdi <0,0001 ** p-værdi = 0,0003 *** p-værdi = 0,0005 # p-værdi = 0,0040
English: Table 4: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformina
Danish: Tabel 4: Effektresultater ved uge 104 i et aktivkontrolleret studie til sammenligning af empagliflozin med glimepirid som supplement til metformina
English: EU/1/14/930/001 7 tablets EU/1/14/930/002 10 tablets EU/1/14/930/003 14 tablets EU/1/14/930/004 28 tablets EU/1/14/930/005 30 tablets EU/1/14/930/006 60 tablets EU/1/14/930/007 70 tablets EU/1/14/930/008 90 tablets EU/1/14/930/009 100 tablets
Danish: EU/1/14/930/001 7 tabletter EU/1/14/930/002 10 tabletter EU/1/14/930/003 14 tabletter EU/1/14/930/004 28 tabletter EU/1/14/930/005 30 tabletter EU/1/14/930/006 60 tabletter EU/1/14/930/007 70 tabletter EU/1/14/930/008 90 tabletter EU/1/14/930/009 100 tabletter
English: Round, pale yellow, biconvex, bevel-edged film-coated tablet debossed with “S10” on one side and the Boehringer Ingelheim logo on the other (tablet diameter: 9.1 mm).
Danish: Rund, gullig, bikonveks, filmovertrukken tablet med affaset kant og præget med “S10” på den ene side og Boehringer Ingelheims logo på den anden (tabletdiameter: 9,1 mm).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim International GmbH
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Boehringer Ingelheim International GmbH
English: In patients 75 years and older, an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8).
Danish: Hos patienter på 75 år og derover, skal en forhøjet risiko for volumendepletering tages i betragtning (se pkt.
English: Jardiance tablets are available in PVC/aluminium perforated unit dose blisters.
Danish: Jardiance-tabletter fås i perforerede enkeltdosisblistere af PVC/aluminium.
English: • if you are taking a medicine used to remove water from the body (diuretic).
Danish: • hvis du tager vanddrivende medicin (diuretika).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Boehringer Ingelheim
English: 12 phase 2 and 3 clinical studies involving 10,036 patients with type 2 diabetes, empagliflozin did not increase cardiovascular risk.
Danish: I en prospektiv, præspecificeret metaanalyse af uafhængigt bedømte kardiovaskulære hændelser fra 12 kliniske fase II- og III-studier, som omfattede 10.036 patienter med type 2-diabetes, øgede empagliflozin ikke den kardiovaskulære risiko.
English: Administration of empagliflozin 25 mg resulted in a higher proportion of patients achieving HbA1c goal of less than 7% and fewer patients needing glycaemic rescue compared to empagliflozin 10 mg and placebo.
Danish: Administration af empagliflozin 25 mg medførte, at en højere andel af patienterne opnåede HbA1c-mål på under 7 %, og at færre patienter havde behov for akut blodsukkerregulerende behandling, sammenlignet med empagliflozin 10 mg og placebo.
English: Difference from glimepiride1 (97.5% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy b Up to 4 mg glimepiride
Danish: Forskel fra glimepirid1 (97,5 % CI) a Full analysis set (FAS) ved brug af last observation carried forward (LOCF) forud for akut blodsukkerregulerende behandling b Op til 4 mg glimepirid
English: Treatment with empagliflozin as monotherapy and in combination with metformin, pioglitazone, a sulphonylurea, DPP-4 inhibitors, and insulin lead to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, and systolic and diastolic blood pressure.
Danish: Behandling med empagliflozin som monoterapi og i kombination med metformin, pioglitazon, et sulfonylurinstof, DPP-4-hæmmere og insulin medførte klinisk relevante forbedringer i HbA1c, fasteplasma-glucose (FPG), kropsvægt og systolisk og diastolisk blodtryk.
English: Empagliflozin does not inhibit UGT1A1, UGT1A3, UGT1A8, UGT1A9, or UGT2B7.
Danish: Empagliflozin hæmmer ikke UGT1A1, UGT1A3, UGT1A8, UGT1A9 eller UGT2B7.
English: Empagliflozin increased urine glucose excretion leading to an increase in urine volume.
Danish: Empagliflozin øgede urinudskillelsen af glucose og førte dermed til øget urinvolumen.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVRING OG ANVENDELSE
English: Lilly S.A.
Danish: Eli Lilly Italia S.p.A.
English: Jardiance contains lactose
Danish: Jardiance indeholder lactose
English: 7 x 1 film-coated tablets 10 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 60 x 1 film-coated tablets 70 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Danish: 7 x 1 filmovertrukne tabletter 10 x 1 filmovertrukne tabletter 14 x 1 filmovertrukne tabletter 28 x 1 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 60 x 1 filmovertrukne tabletter 70 x 1 filmovertrukne tabletter 90 x 1 filmovertrukne tabletter 100 x 1 filmovertrukne tabletter
English: Oval, pale yellow, biconvex film-coated tablet debossed with “S25” on one side and the Boehringer Ingelheim logo on the other (tablet length: 11.1 mm, tablet width: 5.6 mm).
Danish: Oval, gullig, bikonveks filmovertrukken tablet præget med “S25” på den ene side og Boehringer Ingelheims logo på den anden (tabletlængde: 11,1 mm, tabletbredde: 5,6 mm).
English: At Week 52, treatment with empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared with placebo and a reduction in FPG and body weight.
Danish: Ved uge 52 gav behandling med empagliflozin en statistisk signifikant reduktion i HbA1c og insulinbesparelse sammenlignet med placebo samt en reduktion i FPG og kropsvægt.
English: In a prespecified analysis of patients (N=201) with a baseline HbA1c ≥8.5%, treatment resulted in a reduction in HbA1c from baseline of -1.44% for empagliflozin 10 mg, -1.43% for empagliflozin 25 mg, -1.04% for sitagliptin, and an increase of 0.01% for placebo.
Danish: I en præspecificeret analyse af patienter (N=201) med et baseline-HbA1c ≥8,5 % medførte behandling en reduktion i HbA1c fra baseline på -1,44 % for empagliflozin 10 mg, -1,43 % for empagliflozin 25 mg og -1,04-% for sitagliptin og en stigning på 0,01 % for placebo.
English: Empagliflozin improves glycaemic control in patients with type 2 diabetes by reducing renal glucose reabsorption.
Danish: Empagliflozin forbedrer den glykæmiske kontrol hos patienter med type 2-diabetes ved at nedsætte reabsorptionen af glucose i nyrerne.
English: If a dose is missed, it should be taken as soon as the patient remembers.
Danish: Glemt dosis bør tages, når patienten kommer i tanker om dette.
English: Each tablet contains 10 mg or 25 mg empagliflozin.
Danish: - Hver tablet indeholder 10 mg eller 25 mg empagliflozin.
English: Fasting plasma glucose
Danish: Faste-plasma-glucose
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently in patients treated with empagliflozin (empagliflozin 10 mg: 4.1%, empagliflozin 25 mg: 3.7%) compared to placebo (0.9%).
Danish: Vaginal moniliasis, vulvovaginitis, balanitis og andre genitale infekioner Vaginal moniliasis, vulvovaginitis, balanitis og andre genitale infektioner blev indberettet hyppigere hos empagiflozinpatienter (empagliflozin 10 mg: 4,1 %, empagliflozin 25 mg: 3,7 %), sammenlignet med placebo (0,9 %).
English: In addition, urinary glucose excretion triggers calorie loss, associated with body fat loss and body weight reduction.
Danish: Udskillelse af glucose i urinen udløser desuden kalorietab, som er forbundet med tab af kropsfedt og vægtreduktion.
English: Cardiac failure
Danish: Hjerteinsufficiens
English: 2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure 3 LOCF, values after antihypertensive rescue censored
Danish: 2 Ikke evalueret med hensyn til statistisk signifikans på grund af den sekventielt bekræftende testprocedure 3 LOCF, værdier efter yderligere antihypertensiv regulering er censureret fra
English: Add-on to metformin and a sulphonylurea therapy Placebo
Danish: Supplement til metformin og en sulfonylurinstofbehandling Placebo
English: Therefore assessment of renal function is recommended as follows: - Prior to empagliflozin initiation and periodically during treatment, i.e. at least yearly (see sections 4.2, 5.1 and 5.2).
Danish: - Før initiering af empagliflozin og periodisk under behandlingen, dvs. mindst årligt (se pkt.
English: Empagliflozin exposure was similar with and without co-administration with verapamil, a P-gp inhibitor, indicating that inhibition of P-gp does not have any clinically relevant effect on empagliflozin.
Danish: Administration af verapamil, en P-gp-hæmmer, ændrede ikke eksponeringen for empagliflozin, hvilket tyder på, at hæmning af P-gp ikke har nogen klinisk relevant virkning på empagliflozin.
English: Table 6 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with or without metformin or a sulphonylureaa
Danish: Tabel 6 Resultater ved 18 og 78 uger i et placebokontrolleret studie af empagliflozin som supplement til basal insulin med eller uden metformin eller et sulfonylurinstofa
English: Inhibition of SGLT2 in patients with type 2 diabetes and hyperglycaemia leads to excess glucose excretion in the urine.
Danish: Hæmning af SGLT2 hos patienter med type 2-diabetes og hyperglykæmi medfører forhøjet udskillelse af glucose i urinen.
English: The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.3%) and placebo (0.3%).
Danish: Den overordnede hyppighed af volumendepletering (inklusive de foruddefinerede betegnelser nedsat blodtryk (ambulatorisk), nedsat systolisk blodtryk, dehydrering, hypotension, volumendepletering, ortostatisk hypotension og synkope) var den samme hos patienter, der blev behandlet med empagliflozin (empagliflozin 10 mg: 0,5 %, empagliflozin 25 mg: 0,3 %) og placebo (0,3 %).
English: • burning sensation when passing urine
Danish: • en sviende fornemmelse ved vandladning
English: Urinary tract infection was reported more frequently in females treated with empagliflozin compared to placebo; there was no difference in males.
Danish: Urinvejsinfektion blev indberettet hyppigere hos kvinder, der blev behandlet med empagliflozin, sammenlignet med placebo, mens der ingen forskel var hos mænd.
English: Empagliflozin should not be used in patients with end stage renal disease (ESRD) or in patients on dialysis as it is not expected to be effective in these patients (see sections 4.4 and 5.2).
Danish: Patienter med terminal nyresygdom (ESRD) eller patienter, der er i dialyse, bør ikke anvende empagliflozin, da det ikke forventes at virke hos disse patienter (se pkt.
English: Treatment with empagliflozin led to a statistically significant reduction of HbA1c (Table 7) and clinically meaningful improvement in FPG compared to placebo at Week 24.
Danish: Behandling med empagliflozin førte til en statistisk signifikant reduktion i HbA1c (tabel 7) og en klinisk relevant forbedring af FPG sammenlignet med placebo ved uge 24.
English: 1 Mean adjusted for baseline value 2 LOCF, values after antihypertensive rescue censored
Danish: 1 Middelværdi justeret for baselineværdi 2 LOCF, værdier efter yderligere antihypertensiv regulering er censureret fra
English: A higher number of these patients treated with empagliflozin had adverse reactions related to volume depletion as compared to placebo (see section 4.8).
Danish: Et højere antal af disse patienter, der blev behandlet med empagliflozin, fik bivirkninger, der var relateret til volumendepletering, sammenlignet med placebo (se pkt.
English: Treatment with empagliflozin resulted in a statistically significant (p<0.0001) reduction in HbA1c compared to placebo (Table 2) and a clinically meaningful decrease in FPG.
Danish: Behandling med empagliflozin medførte en statistisk signifikant (p<0,0001) reduktion i HbA1c sammenlignet med placebo (tabel 2) og en klinisk relevant reduktion i FPG.
English: INFORMATION IN BRAILLE Jardiance 25 mg
Danish: INFORMATION I BRAILLESKRIFT Jardiance 25 mg
English: At Week 18, empagliflozin provided statistically significant improvement in HbA1c compared with placebo (Table 5).
Danish: Ved uge 18 gav empagliflozin statistisk signifikant forbedring af HbA1c sammenlignet med placebo (tabel 5).
English: CrCl <60 ml/min.
Danish: 45 ml/min.
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
Danish: I kliniske studier og efter markedsføringen er der rapporteret om sjældne tilfælde af diabetisk ketoacidose, herunder livstruende tilfælde, hos patienter, der har fået behandling med SGLT2-hæmmere, herunder empagliflozin.
English: N HbA1c (%) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2 N Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N SBP (mmHg)2 Baseline (mean) Change from baseline1 Difference from placebo1 (95% CI)
Danish: N HbA1c (%) Baseline (middelværdi) Ændring fra baseline1 Forskel fra placebo1 (97,5 % CI) N Patienter (%), der opnåede HbA1c <7 % med baselineHbA1c ≥7 %2 N Kropsvægt (kg) Baseline (middelværdi) Ændring fra baseline1 Forskel fra placebo1 (97,5 % CI) N SBP (mmHg)2 Baseline (middelværdi) Ændring fra baseline1 Forskel fra placebo1 (95 % CI)
English: Table 5: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add on to multiple daily doses of insulin with or without metformin
Danish: Tabel 5: Effektresultater ved 18 og 52 uger i et placebokontrolleret studie med empagliflozin som supplement til gentagen administration af daglige doser insulin med eller uden metformin
English: INFORMATION IN BRAILLE Jardiance 10 mg
Danish: INFORMATION I BRAILLESKRIFT Jardiance 10 mg
English: In patients aged 85 years and older, initiation of empagliflozin therapy is not recommended due to the limited therapeutic experience (see section 4.4).
Danish: Er patienten 85 år og derover, er den kliniske erfaring begrænset og behandling med empagliflozin kan ikke anbefales (se pkt.
English: Peak plasma levels of empagliflozin were similar in subjects with moderate renal impairment and kidney failure/ESRD compared to patients with normal renal function.
Danish: Peakplasmakoncentrationer af empagliflozin var de samme hos patienter med moderat nedsat nyrefunktion og nyresvigt/ESRD sammenlignet med patienter med normal nyrefunktion.
English: How to take Jardiance
Danish: Sådan skal du tage Jardiance
English: In a juvenile toxicity study in the rat, when empagliflozin was administered from postnatal day 21 until postnatal day 90, non-adverse, minimal to mild renal tubular and pelvic dilation in juvenile rats was seen only at 100 mg/kg/day, which approximates 11-times the maximum clinical dose of 25 mg.
Danish: I et toksicitetsstudie hos unge rotter, hvor empagliflozin blev administreret fra dag 21 til dag 90 postnatalt, sås der kun minimal til let dilatation af nyretubuli og nyrepelvis ved en dosis på 100 mg/kg/dag, hvilket svarer til ca. 11 gange den maksimale kliniske dosis på 25 mg.
English: In the double-blind placebo-controlled extension of these studies, reduction of HbA1c, body weight and blood pressure were sustained up to Week 52.
Danish: I den dobbeltblindede, placebokontrollerede forlængelse af disse studier blev reduktionen i HbA1c, kropsvægt og blodtryk bevaret op til uge 52.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på fremstiller, der er ansvarlig for batchfrigivelse Boehringer Ingelheim Pharma GmbH & Co.
English: In a pre-specified pooled analysis of three phase 3 studies, treatment with open-label empagliflozin 25 mg in patients with severe hyperglycaemia (N=184, mean baseline HbA1c 11.15%) resulted in a clinically meaningful reduction in HbA1c from baseline of 3.27% at week 24; no placebo or empagliflozin 10 mg arms were included in these studies.
Danish: I en præspecificeret poolet analyse af tre fase 3-studier gav behandling med open-label empagliflozin 25 mg hos patienter med svær hyperglykæmi (N=184, gennemsnitlig HbA1c 11,15 % ved baseline) en klinisk relevant reduktion i HbA1c fra baseline på 3,27 % i uge 24; hverken placebo eller empagliflozin 10 mg indgik som behandlingsarme i dette studie.
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Danish: Middel-AUC for plasma i steady state og Cmax var 1870 nmol x time og 259 nmol/l for empagliflozin 10 mg én gang dagligt og 4740 nmol x time og 687 nmol/l for empagliflozin 25 mg og én gang dagligt.
English: Peak plasma levels of empagliflozin were roughly 20% higher in subjects with mild and severe renal impairment as compared to subjects with normal renal function.
Danish: Peakplasmakoncentrationer af empagliflozin var omtrent 20 % højere hos patienter med mild og svær nedsat nyrefunktion sammenlignet med patienter med normal nyrefunktion.
English: The frequency of volume depletion events was increased in patients 75 years and older treated with empagliflozin 10 mg (2.3%) or empagliflozin 25 mg (4.4%) compared to placebo (2.1%).
Danish: Hyppigheden af volumendepletering var forøget hos patienter på 75 år og derover, som blev behandlet med empagliflozin 10 mg (2,3 %) eller empagliflozin 25 mg (4,4 %), sammenlignet med placebo
English: No dose adjustment is recommended based on age.
Danish: Dosisjustering anbefales ikke.
English: The removal of empagliflozin by haemodialysis has not been studied.
Danish: Fjernelse af empagliflozin ved hæmodialyse er ikke undersøgt.
English: Based on the mode of action of SGLT-2 inhibitors, osmotic diuresis accompanying therapeutic glucosuria may lead to a modest decrease in blood pressure (see section 5.1).
Danish: Den osmotiske diurese, som ledsager terapeutisk glucosuri, kan medføre et beskedent blodtryksfald (se pkt.
English: The efficacy and safety of empagliflozin was evaluated in a double-blind, placebo controlled study of 12 weeks duration in patients with type 2 diabetes and high blood pressure on different antidiabetic and up to 2 antihypertensive therapies.
Danish: I et 12 ugers dobbeltblindet, placebokontrolleret studie undersøgtes empagliflozins virkning og sikkerhed hos patienter med type 2-diabetes og højt blodtryk på forskellige antidiabetika og op til 2 antihypertensive behandlinger.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.