FrancophonIA/ELRC3.0 huggingface dataset:
English: Difference from glipizide + metforminc
Danish: Forskel fra glipizid + metformin c
English: aThe table shows up to 24-week (short-term) data regardless of glycaemic rescue.
Danish: Tabellen viser op til 24 ugers (korttids)data uanset om patienten fik anden medicin som rescue pga. hyperglykæmi.
English: In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Danish: I kombination med andre glucosesænkende lægemidler inklusive insulin, når disse sammen med diæt og motion ikke giver tilstrækkelig glykæmisk kontrol (se pkt.
English: Results at Week 24 (LOCFa) of a placebo-controlled study of dapagliflozin as monotherapy
Danish: a) af et placebo-kontrolleret studie af dapagliflozin som monoterapi
English: • decrease in kidney function
Danish: • nedsat nyrefunktion
English: Forxiga is not recommended for use in patients with moderate to severe renal impairment (patients with CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2).
Danish: Forxiga bør ikke anvendes til patienter med moderat til svært nedsat nyrefunktion (patienter med CrCl < 60 ml/min eller eGFR < 60 ml/min/1,73 m2).
English: Increases in the amount of glucose excreted in the urine were observed in healthy subjects and in subjects with type 2 diabetes mellitus following the administration of dapagliflozin.
Danish: Der blev observeret øgning i mængden af glucose udskilt i urinen hos raske forsøgspersoner og hos forsøgspersoner med type 2-diabetes mellitus efter indgift af dapagliflozin.
English: The efficacy of dapagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment.
Danish: Den kliniske effekt af dapagliflozin afhænger af nyrefunktionen, og effekten er reduceret hos patienter, som har moderat nedsat nyrefunktion, og udebliver sandsynligvis hos patienter med svært nedsat nyrefunktion.
English: This grouping of reactions was reported in 3.2% and 1.8% of patients who received dapagliflozin 10 mg and placebo, respectively.
Danish: Denne type bivirkninger blev rapporteret hos 3,2 % og 1,8 % af patienter, der fik dapagliflozin 10 mg hhv. placebo.
English: Haematocrit values >55% were reported in 1.3% of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.
Danish: Hæmatokrit værdier > 55 % blev rapporteret hos 1,3 % af forsøgspersonerne behandlet med 10 mg dapagliflozin versus 0,4 % for placebo.
English: Your doctor may ask you to stop taking Forxiga.
Danish: Din læge kan bede dig om at stoppe med
English: When dapagliflozin is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
Danish: Når dapagliflozin anvendes i kombination med insulin eller et ß-cellestimulerende middel såsom et sulfonylurinstof, kan det overvejes at give en lavere dosis af insulinet eller det ß-cellestimulerende middel for at reducere risikoen for hypoglykæmi (se pkt.
English: Urinary tract infections
Danish: Urinvejsinfektioner
English: Dapagliflozin 10 mg as an add-on to metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant body weight reduction at 24 weeks (p < 0.0001, Tables 4 and 5).
Danish: Dapagliflozin 10 mg som tillægsbehandling til metformin, glimepirid, metformin plus et sulfonylurinstof, sitagliptin (med eller uden metformin) eller insulin resulterede i statistisk signifikant reduktion i legemsvægt efter 24 uger (p < 0,0001, tabel 4 og 5).
English: In subjects ≥ 65 years of age, adverse reactions related to renal impairment or failure were reported in 7.7% of subjects treated with dapagliflozin and 3.8% of subjects treated with placebo (see section 4.4).
Danish: Blandt forsøgspersoner ≥ 65 år blev der rapporteret om bivirkninger relateret til nedsat nyrefunktion eller nyresvigt hos 7,7 % af de forsøgspersoner, der fik dapagliflozin, og hos 3,8 % af dem, der fik placebo (se pkt.
English: − film-coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b),
Danish: filmovertræk: polyvinylalkohol (E1203), titandioxid (E171), macrogol 3350, talkum (E553b), gul jernoxid (E172).
English: EU/1/12/795/009 30 x 1 (unit dose) film-coated tablets EU/1/12/795/010 90 x 1 (unit dose) film-coated tablets
Danish: EU/1/12/795/009 30 x 1 (enkeltdosis) filmovertrukne tabletter EU/1/12/795/010 90 x 1 (enkeltdosis) filmovertrukne tabletter
English: No dosage adjustment is indicated in patients with mild renal impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med lettere nedsat nyrefunktion.
English: • Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Neither maternal nor developmental toxicities were observed in rabbits at any dose tested; the highest dose tested is associated with a systemic exposure multiple of approximately 1,191 times the maximum recommended human dose.
Danish: I yderligere studier af embryo-føtal udvikling hos rotter og kaniner blev der givet dapagliflozin i intervaller, der faldt sammen med de vigtigste perioder for organogenesen i hver art. Der blev ikke observeret hverken maternel eller udviklingsmæssig toksicitet hos kaniner ved nogen af de testede doser; den højeste dosis testet er forbundet med en multipel af systemisk eksponering, som er ca. 1.191 gange den maksimale anbefalede humane dosis.
English: Treatment with Forxiga plus metformin showed a numerical decrease in visceral adipose tissue compared with placebo plus metformin treatment in a magnetic resonance imaging substudy.
Danish: I et supplerende studie med MR-scanning viste behandling med Forxiga plus metformin reduktion i mængden af visceralt adipøst væv sammenlignet med behandling med placebo plus metformin.
English: Musculoskeletal and connective tissue disorders
Danish: Rygsmerter muskler og bindevæv Nyrer og urinveje
English: - Keep this leaflet.
Danish: Se i pkt.
English: Dapagliflozin as an add-on with either metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 4, 5 and 6).
Danish: Dapagliflozin som tillægsbehandling til enten metformin, glimepirid, metformin og et sulfonylurinstof, sitagliptin (med eller uden metformin) eller insulin resulterede i statistisk signifikante reduktioner i HbA1c efter 24 uger sammenlignet med forsøgspersoner, der fik placebo (p < 0,0001; tabel 4, 5 og 6).
English: EU/1/12/795/004 30 x 1 (unit dose) film-coated tablets EU/1/12/795/005 90 x 1 (unit dose) film-coated tablets
Danish: EU/1/12/795/004 30 x 1 (enkeltdosis) filmovertrukne tabletter EU/1/12/795/005 90 x 1 (enkeltdosis) filmovertrukne tabletter
English: Glycaemic control
Danish: Glykæmisk kontrol
English: INFORMATION IN BRAILLE forxiga 5 mg
Danish: forxiga 5 mg
English: For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78% and 0.02% adjusted mean change from baseline for 10 mg and placebo, respectively).
Danish: I studiet med tillægsbehandling til metformin var reduktionen i HbA1c vedvarende til og med uge 102 (-0,78 % og 0,02 % justeret gennemsnitlig ændring fra baseline for henholdsvis 10 mg og placebo).
English: Creatinine renal clearance decreasedb
Danish: Nedsat renal kreatininclearance b
English: HbA1c (%) Baseline (mean) Change from baselinec
Danish: HbA1c (%) Baseline (gennemsnitlig) Ændring fra baseline c
English: Your doctor may want to lower the dose of these other medicines,
Danish: Din læge kan ønske at nedsætte dosen af disse andre lægemidler for at undgå at du får for lavt blodsukker (hypoglykæmi).
English: Your doctor may ask you to stop taking Forxiga until you recover to prevent dehydration.
Danish: For at forebygge dehydrering vil din læge måske opfordre dig til at stoppe med Forxiga, indtil du får det bedre.
English: At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products), the HbA1c reductions were -0.71% and -0.06% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively.
Danish: I uge 104 var reduktionen i HbA1c ved insulin (med eller uden tillæg af oral glucosesænkende medicin) -0,71 % og -0,06 % justeret gennemsnitlig ændring fra baseline for henholdsvis dapagliflozin 10 mg og placebo.
English: Τηλ: +30 2 106871500
Danish: AstraZeneca A.E. Τηλ: +30 2 106871500
English: • if you have an increase in the amount of red blood cells in your blood, seen in tests.
Danish: • Hvis du har fået taget blodprøver, som viste et forhøjet antal røde blodlegemer i dit blod.
English: Results of 24-week (LOCFa) placebo-controlled studies of dapagliflozin in add-on combination with metformin or sitagliptin (with or without metformin)
Danish: a) placebokontrollerede studier af dapagliflozin i tillægskombination med metformin eller sitagliptin (med eller uden metformin) Tillægskombination
English: These reactions were more common in patients with baseline eGFR ≥ 30 and < 60 mL/min/1.73m2 (18.5% dapagliflozin 10 mg vs 9.3%
Danish: Disse reaktioner var mere almindelige hos patienter med baseline eGRF ≥ 30 og < 60 ml/min/1,73m
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Tabletterne indeholder vandfri lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Malignancies
Danish: Maligniteter
English: Possible side effects
Danish: "Bivirkninger".
English: Fasting plasma glucose
Danish: Fastende plasmaglucose
English: Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets dapagliflozin
Danish: Forxiga 5 mg filmovertrukne tabletter Forxiga 10 mg filmovertrukne tabletter dapagliflozin
English: At Weeks 24 and 104, minor episodes of hypoglycaemia were reported, respectively, in 40.3% and 53.1% of subjects who received dapagliflozin 10 mg plus insulin and in 34.0% and 41.6% of the subjects who received placebo plus insulin.
Danish: I uge 24 og 104 blev der rapporteret mindre hændelser med hypoglykæmi hos henholdsvis 40,3 % og 53,1 % af forsøgspersonerne, der blev behandlet med dapagliflozin 10 mg og insulin og hos 34,0 % og 41,6 % af forsøgspersonerne, der blev behandlet med placebo og insulin.
English: In an add-on to insulin study, episodes of major hypoglycaemia were reported in 0.5% and 1.0% of subjects treated with dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5% of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
Danish: I et studie med tillægsbehandling til insulin blev der rapporteret om tilfælde af svær hypoglykæmi hos 0,5 % og 1,0 % af forsøgspersonerne, som fik behandling med dapagliflozin 10 mg og insulin, i henholdsvis uge 24 og 104, og hos 0,5 % af forsøgspersonerne, som fik behandling med placebo og insulin, i uge 24 og 104.
English: Studies with add-on sulphonylurea and add-on insulin therapies had higher rates of hypoglycaemia (see section 4.5).
Danish: Studier af tillægsbehandling med sulfonylurinstof og tillægsbehandling med insulin viste en større forekomst af hypoglykæmi (se pkt.
English: At Week 104, adjusted mean change from baseline in HbA1c was -0.32% for dapagliflozin and -0.14% for glipizide.
Danish: I uge 104 var den justerede gennemsnitlige ændring i HbA1c fra baseline -0,32 % for dapagliflozin og -0,14 % for glipizid.
English: In the extension period, HbA1c reductions were sustained through Week 102 (-0.61%, and -0.17% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively).
Danish: HbA1c-reduktionen var opretholdt i op til 102 uger (-0,61 %, og -0,17 % justeret gennemsnitlig ændring fra baseline for henholdsvis dapagliflozin 10 mg og placebo).
English: At Week 208, adjusted mean change from baseline in HbA1c was -0.10% for dapagliflozin and 0.20% for glipizide.
Danish: I uge 208 var den justerede gennemsnitlige ændring i HbA1c i forhold til baseline -0,10 % for dapagliflozin og 0,20 % for glipizid.
English: At Week 12 for both studies, dapagliflozin 10 mg plus usual antidiabetic treatment provided improvement in HbA1c and decreased the placebo-corrected systolic blood pressure on average by 3.1 and 4.3 mmHg, respectively.
Danish: sædvanlig antidiabetisk behandling HbA1c ved uge 12, og det systoliske blodtryk faldt i gennemsnit med hhv. 3,1 og 4,3 mmHg, korrigeret i forhold til placebo.
English: Sulphonylurea + Metformin2
Danish: Sulfonylurinstof + metformin
English: The efficacy of dapagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Danish: Den kliniske effekt af dapagliflozin afhænger af nyrefunktionen, og effekten er reduceret hos patienter, som har moderat nedsat nyrefunktion, og udebliver sandsynligvis hos patienter med svært nedsat nyrefunktion (se pkt.
English: The removal of dapagliflozin by haemodialysis has not been studied.
Danish: Eliminering af dapagliflozin ved hæmodialyse er ikke undersøgt.
English: Microcrystalline cellulose (E460i) Lactose, anhydrous Crospovidone (E1201) Silicon dioxide (E551) Magnesium stearate (E470b)
Danish: Crospovidon (E1201) Siliciumdioxid (E551) Magnesiumstearat (E470b)
English: Check with your doctor, phamacist or nurse if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: How to take Forxiga
Danish: Sådan skal du tage Forxiga
English: Caution should be exercised in patients for whom a dapagliflozin-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 elderly patients.
Danish: Dette gælder patienter med kendt hjertekarsygdom, patienter i antihypertensiv behandling og med hypotension i anamnesen samt ældre patienter.
English: INFORMATION IN BRAILLE Forxiga 10 mg
Danish: forxiga 10 mg
English: In subjects ≥ 65 years of age, a higher proportion of subjects treated with dapagliflozin had adverse reactions related to volume depletion (see section 4.8).
Danish: Hos forsøgspersoner ≥ 65 år fik en større andel af de forsøgspersoner, der fik dapagliflozin, bivirkninger relateret til volumendepletering (se pkt.
English: The same recommendations for renal function apply to elderly patients as to all patients (see sections 4.2, 4.4, 4.8 and 5.1).
Danish: Der gælder de samme anbefalinger relateret til nyrefunktionen for ældre patienter som for alle andre patienter (se pkt.
English: See section 4.4 *Reported in ≥ 2% of subjects and ≥ 1 % more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Danish: 4.4 *Rapporteret hos ≥ 2 % af forsøgspersonerne og hos ≥ 1 % flere og mindst 3 forsøgspersoner flere behandlet med dapagliflozin 10 mg end med placebo.
English: Film-coating
Danish: Filmovertræk:
English: While a causal relationship between dapagliflozin and bladder cancer is unlikely (see sections 4.8 and 5.3), as a precautionary measure, dapagliflozin is not recommended for use in patients concomitantly treated with pioglitazone.
Danish: 4.8 og 5.3), bør dapagliflozin af forsigtighedsmæssige hensyn ikke anvendes til patienter, der er i samtidig behandling med pioglitazon.
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95% Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis Forxiga is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Danish: Hazard ratio for sammenligning af dapagliflozin med comparator var 0,79 (95 % konfidensinterval [CI]: 0,58, 1,07).
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Danish: Lægemidlet er receptpligtigt.
English: (95% CI) LOCF: Last observation carried forward Randomised and treated subjects with baseline and at least 1 post-baseline efficacy measurement Least squares mean adjusted for baseline value dNon-inferior to glipizide + metformin p-value < 0.0001
Danish: LOCF: Last Observation Carried Forward Randomiserede og behandlede forsøgspersoner med baselineværdi og mindst 1 effektmåling efter baseline Gennemsnit beregnet efter mindste kvadraters metode justeret for baselineværdi Non-inferiority over for glipizid + metformin p-værdi < 0,0001
English: Forxiga is not recommended for use in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.4, 4.8, 5.1 and 5.2).
Danish: Forxiga bør ikke anvendes til patienter med moderat til svært nedsat nyrefunktion (patienter med kreatininclearance [CrCl] < 60 ml/min eller estimeret glomerulær filtrationshastighed [eGFR] < 60 ml/min/1,73 m
English: These differences were not considered to be clinically meaningful.
Danish: Disse ændringer blev ikke betragtet som klinisk relevante.
English: (95% CI) Subjects with mean daily insulin dose reduction of at least 10% (%) LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Danish: LOCF: Last Observation Carried Forward (før eller på datoen for den første optitrering af insulin, hvis nødvendigt) Alle randomiserede forsøgspersoner, som tog mindst én dosis af lægemidlet i den dobbeltblinde periode i korttidsstudierne Gennemsnit beregnet efter mindste kvadraters metode justeret for baselineværdi og tilstedeværelse af oralt glucosesænkende lægemiddel p-værdi < 0,0001 versus placebo + insulin ± oralt glucosesænkende lægemiddel p-værdi < 0,05 versus placebo + insulin ± oralt glucosesænkende lægemiddel Optitrering af insulinregimer (inklusive korttidsvirkende, mellemtidsvirkende og basal insulin) var kun tilladt, hvis forsøgspersonerne opfyldte de foruddefinerede FPG-kriterier.
English: (95% CI) Body weight (kg) Baseline (mean) Change from baselinec Difference from placeboc
Danish: (95 % CI) Gennemsnitlig daglig insulindosis (IE) Baseline (gennemsnitlig) Ændring fra baselinec Forskel fra placebo c
English: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight reduction compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 3) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Danish: I et aktivt kontrolleret non-inferioritetsstudie resulterede dapagliflozin som tillægsbehandling til metformin i et statistisk signifikant vægttab sammenlignet med glipizid på -4,65 kg efter 52 uger (p < 0,0001, tabel 3).
English: Body weight (kg) Baseline (mean) Change from baseline c
Danish: Legemsvægt (kg) Baseline (gennemsnitlig) Ændringer fra baseline c
English: Each Forxiga 10 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Danish: Hver Forxiga 10 mg filmovertrukket tablet (tablet) indeholder dapagliflozinpropanediolmonohydrat svarende til 10 mg dapagliflozin.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt din læge, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerstoffer.
English: Each Forxiga 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Danish: Hver Forxiga 5 mg filmovertrukket tablet (tablet) indeholder dapagliflozinpropanediolmonohydrat svarende til 5 mg dapagliflozin.
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excluding insulins, ATC code: A10BX09
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, andre blodglucosesænkende midler, ekskl.
English: Hypoglycaemia (when used with
Danish: Hypoglykæmi (ved samtidig anvendelse af SU eller insulin)
English: Glipizide + metformin
Danish: Glipizid + metformin b
English: Tablet core
Danish: Tabletkerne:
English: Diuretics
Danish: Diuretika
English: LIST OF EXCIPIENTS Contains lactose.
Danish: Indeholder lactose.
English: Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1% and 0.7% of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2% of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4).
Danish: Bivirkninger relateret til volumendepletering (inklusive indberetninger om dehydrering, hypovolæmi eller hypotension) blev rapporteret hos 1,1 % og 0,7 % af forsøgspersoner, som fik behandling med henholdsvis dapagliflozin 10 mg og placebo.
English: Dapagliflozin exposure is increased in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Danish: Eksponeringen for dapagliflozin er forhøjet hos patienter med svært nedsat leverfunktion (se pkt.
English: Use in patients with renal impairment
Danish: Anvendelse til patienter med nedsat nyrefunktion
English: Renal and urinary disorders
Danish: Glucose i urinen
English: Dizziness
Danish: Vægttab
English: • Keep this medicine out of the sight and reach of children.
Danish: • Opbevares utilgængeligt for børn.
English: Results at Week 52 (LOCFa) in an active-controlled study comparing dapagliflozin to glipizide as add-on to metformin
Danish: a) i et aktivt kontrolleret studie, der havde til formål at sammenligne dapagliflozin med glipizid som tillægsbehandling til metformin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED 5 mg
Danish: IKKE-PERFOREREDE KALENDERBLISTERKORT 5 mg
English: (95% CI) Subjects (%) achieving: HbA1c < 7% (LOCF)d Adjusted for baseline Body weight (kg) (LOCF)d Baseline (mean) Change from baselinec Difference from placeboc (95% CI) 1glimepiride 4 mg/day; 2Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrollment.
Danish: 2Metformin (formulering med umiddelbar (IR) eller forlænget frigivelse (XR)) ≥1500 mg/dag plus maksimal tolereret dosis, som skal være mindst halvdelen af den maksimale dosis, af et sulfonylurinstof i mindst 8 uger inden inkludering i studiet.
English: Vulvovaginitis, balanitis and related genital infections*,b,c Urinary tract infection*,b,d
Danish: Vulvovaginitis, balanitis og relaterede genitale infektioner
English: HbA1c < 7%
Danish: HbA1c < 7 % (LOCF)
English: • dizziness
Danish: • vægttab
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED 10 mg
Danish: IKKE-PERFOREREDE KALENDERBLISTERKORT 10 mg