FrancophonIA/ELRC3.0 huggingface dataset:
English: • in patients on their maximally tolerated doses of metformin along with other glucose-lowering medicinal products including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5, and 5.1 for available data on different add-on therapies)
Danish: • hos patienter, der får den maksimale tolererede dosis metformin sammen med andre glucosesænkende lægemidler inklusive insulin, når disse ikke giver tilstrækkelig glykæmisk kontrol (se pkt.
English: Canagliflozin should not be initiated.
Danish: Behanding med canagliflozin bør ikke opstartes.
English: Statistically significant (p < 0.001) changes from baseline HbA1c relative to placebo of -0.57% and -0.70% were observed for 100 mg once daily and 300 mg once daily, respectively (see sections 4.2 and 4.8).
Danish: Der observeredes statistisk signifikante (p < 0,001) ændringer fra baseline HbA1c i forhold til placebo på -0,57 % og -0,70 % for henholdsvis 100 mg en gang dagligt og 300 mg en gang dagligt (se pkt.
English: Urine glucose
Danish: Glucose i urinen
English: • a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p = 0.017
Danish: • en signifikant reduktion i den absolutte risiko for enhver diabetes-relateret mortalitet: metformin 7,5 hændelser/1.000 patientår, diæt alene 12,7 hændelser/1.000 patientår, p = 0,017
English: • Hepatic impairment, acute alcohol intoxication, alcoholism (see sections 4.2 and 4.5).
Danish: • Nedsat leverfunktion, akut alkoholforgiftning, alkoholisme (se pkt.
English: Vulvovaginal candidiasis (including vulvovaginitis and vulvovaginal mycotic infection) was reported in 10.4% and 11.4% of female patients treated with canagliflozin 100 mg once daily and canagliflozin 300 mg once daily, respectively, compared to 3.2% in placebo-treated female patients.
Danish: Vulvovaginal candidiasis (inklusive vulvovaginitis og vulvovaginal svampeinfektion) blev rapporteret hos 10,4 % og 11,4 % af de kvindelige patienter, der blev behandlet med henholdsvis canagliflozin 100 mg en gang dagligt og canagliflozin 300 mg en gang dagligt, sammenlignet med 3,2 % af kvinderne i placebo-armen.
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Danish: Laktatacidose er en kritisk tilstand, der skal behandles på hospitalet.
English: In a pooled analysis of patients (N = 721) with a baseline GFR 45 mL/min to < 60 mL/min, canagliflozin provided clinically meaningful reduction in HbA1c compared to placebo, with -0.47% for canagliflozin 100 mg and -0.52% for canagliflozin 300 mg.
Danish: I en samlet analyse af patienter (N = 721) med GFR 45 ml/min til < 60 ml/min ved baseline gav canagliflozin en klinisk betydningsfuld reduktion i HbA1c på -0,47 % for canagliflozin 100 mg og0,52 % for canagliflozin 300 mg sammenlignet med placebo.
English: Drug/laboratory test interference
Danish: Interferens mellem lægemidlet og laboratorieprøver 1,5-AG-test
English: Regular assessment of renal function is necessary to aid in prevention of metformin-associated lactic acidosis,
Danish: Regelmæssig kontrol af nyrefunktionen er nødvendig, da det er med til at forebygge laktatacidose associeret med metformin, især hos ældre patienter.
English: Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
Danish: hurtig og dyb vejrtrækning og søvnighed, og din ånde kan få en usædvanlig frugtagtig lugt
English: Decreases in GFR (-3.6% and -5.2%) were reported with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to the control group (-3.0%) (see sections 4.2 and 4.4).
Danish: Der blev observeret fald i GFR (-3,6 %, henholdsvis -5,2 %) for canagliflozin 100 mg og 300 mg sammenlignet med kontrolgruppen (-3,0 %) (se pkt.
English: • a significant reduction of the absolute risk of any diabetesrelated complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p = 0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p = 0.0034
Danish: • en signifikant reduktion i den absolutte risiko for enhver diabetesrelateret komplikation i metformin-gruppen (29,8 hændelser/1.000 patientår) versus diæt alene (43,3 hændelser/1.000 patientår), p = 0,0023, og versus de samlede grupper, der fik monoterapi med et sulfonylurinstof eller insulin (40,1 hændelser/1.000 patientår), p = 0,0034
English: 150 mg twice daily (N = 93)
Danish: 150 mg to gange dagligt (N = 93)
English: In this pooled analysis, patients on loop diuretics, patients with a baseline GFR 30 mL/min to < 60 mL/min, and patients ≥ 75 years of age had generally higher incidences of these adverse reactions.
Danish: I denne poolede analyse sås generelt en større incidens af disse bivirkninger hos patienter, der fik loop-diuretika, patienter med GFR 30 ml/min til < 60 ml/min ved baseline og patienter ≥ 75 år.
English: The hazard ratios for the canagliflozin 100 mg and 300 mg once daily doses were similar.
Danish: Der sås omtrent samme hazard ratio for canagliflozin 100 mg og 300 mg en gang dagligt.
English: Temporary interruption of treatment with Vokanamet may be considered for patients who develop volume depletion while on Vokanamet therapy until the condition is corrected.
Danish: Hos patienter, der får volumendepletering under behandling med Vokanamet, kan behandlingen midlertidigt afbrydes, indtil dette er korrigeret.
English: Lower limb amputations
Danish: Amputationer af underekstremiteter
English: (18 weeks) Canagliflozin + insulin
Danish: Tillægsbehandling med insulind (18 uger) Canagliflozin + insulin
English: A substudy of patients with baseline HbA1c > 10% to ≤ 12% with canagliflozin as monotherapy resulted in reductions from baseline in HbA1c (not-placebo-adjusted) of -2.13% and -2.56% for canagliflozin 100 mg and 300 mg once daily, respectively.
Danish: Patienter med baseline HbA1c > 10 % til ≤ 12 % Et delstudie af patienter med HbA1c > 10 til ≤ 12 % ved baseline, der fik canagliflozin som monoterapi, resulterede i reduktioner fra baseline i HbA1c (ikke-placebojusterede) på -2,13 % og -2,56 % for henholdsvis canagliflozin 100 mg og 300 mg en gang dagligt.
English: For patients with a baseline GFR 30 mL/min to < 60 mL/min or CrCl 30 to < 60 mL/min, the incidences were 4.8% on canagliflozin 100 mg once daily and 8.1% on canagliflozin 300 mg once daily compared to 2.6% in the control group.
Danish: Hos patienter med GFR 30 ml/min til < 60 ml/min eller CrCl 30 til < 60 ml/min ved baseline var incidensen 4,8 % for canagliflozin 100 mg en gang dagligt og 8,1 % for canagliflozin 300 mg en gang dagligt sammenlignet med 2,6 % i kontrolgruppen.
English: For patients who are tolerating a Vokanamet dose containing canagliflozin 50 mg who need tighter glycemic control, the dose can be increased to Vokanamet containing 150 mg canagliflozin twice daily (see below and section 4.4).
Danish: Til patienter, der tolererer Vokanamet i en dosis med 50 mg canagliflozin, men som har behov for skærpet glykæmisk kontrol, kan dosen øges til Vokanamet med 150 mg canagliflozin to gange dagligt (se nedenfor og pkt.
English: Vokanamet is not recommended in patients with hepatic impairment due to the active substance metformin (see sections 4.3 and 5.2).
Danish: Vokanamet bør ikke anvendes til patienter med nedsat leverfunktion på grund af det aktive stof metformin (se pkt.
English: • a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p = 0.01).
Danish: • en signifikant reduktion af den absolutte risiko for myokardieinfarkt: metformin 11 hændelser/1.000 patientår, diæt alene 18 hændelser/1.000 patientår, (p = 0,01)
English: • if you have recently had a heart attack or have severe blood circulation problems, such as ‘shock' or breathing difficulties
Danish: • hvis du for nylig har haft et hjerteanfald eller har alvorlige kredsløbsproblemer, for eksempel
English: A total of 10,285 patients with type 2 diabetes participated in nine double-blind, controlled clinical efficacy and safety studies conducted to evaluate the effects of canagliflozin on glycaemic control, including 5,151 patients treated with canagliflozin in combination with metformin.
Danish: I alt 10.285 patienter med type 2-diabetes deltog i ni dobbeltblinde, kontrollerede kliniske studier af sikkerhed og virkning til evaluering af canagliflozins virkning på glykæmisk kontrol.
English: In two 52-week active-controlled studies comparing canagliflozin to glimepiride and sitagliptin, sustained and statistically significant mean reductions in the percentage of body weight for canagliflozin as add-on therapy to metformin were -4.2% and -4.7% for canagliflozin 100 mg and 300 mg once daily, respectively, compared to the combination of glimepiride and metformin (1.0%) and -2.5% for canagliflozin 300 mg once daily in combination with metformin and a sulphonylurea compared to sitagliptin in combination with metformin and a sulphonylurea (0.3%).
Danish: I to 52-ugers aktivt kontrollerede studier, hvor canagliflozin blev sammenlignet med glimepirid og sitagliptin, var de vedvarende og statistisk signifikante middelreduktioner i legemsvægt udtrykt i procent for canagliflozin som tillægsbehandling til metformin -4,2 % og -4,7 % for henholdsvis canagliflozin 100 mg og 300 mg en gang dagligt sammenlignet med kombinationen af glimepirid og metformin (1,0 %) og -2,5 % for canagliflozin 300 mg en gang dagligt i kombination med metformin og et sulfonylurinstof sammenlignet med sitagliptin i kombination med metformin og et sulfonylurinstof (0,3 %).
English: In addition, in such patients greater decreases in GFR were reported (see sections 4.2 and 4.8).
Danish: Derudover blev der rapporteret større fald i GFR hos denne patientgruppe (se pkt.
English: In four placebo-controlled studies, treatment with canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products resulted in mean changes from baseline relative to placebo in FPG of -1.2 mmol/L to -1.9 mmol/L for canagliflozin 100 mg once daily and -1.9 mmol/L to -2.4 mmol/L for canagliflozin 300 mg once daily, respectively.
Danish: I fire placebokontrollerede studier førte behandling med canagliflozin som monoterapi eller som tillægsbehandling til et eller to orale glucosesænkende lægemidler til gennemsnitlige ændringer i FPG fra baseline i forhold til placebo på -1,2 mmol/l til -1,9 mmol/l for canagliflozin 100 mg en gang dagligt og -1,9 mmol/l til -2,4 mmol/l for canagliflozin 300 mg en gang dagligt.
English: Candidal balanitis or balanoposthitis was reported in 4.2% and 3.7% of male patients treated with canagliflozin 100 mg once daily and canagliflozin 300 mg once daily, respectively, compared to 0.6% in placebo-treated male patients.
Danish: Candida-forårsaget balanitis eller balanopostitis blev rapporteret hos 4,2 % og 3,7 % af de mandlige patienter, der blev behandlet med henholdsvis canagliflozin 100 mg en gang dagligt og canagliflozin 300 mg en gang dagligt sammenlignet med 0,6 % af de mænd, der fik placebo.
English: In an analysis of four 26-week, placebo-controlled studies (N = 2,313), treatment with canagliflozin 100 mg and 300 mg once daily resulted in mean reductions in systolic blood pressure of -3.9 mmHg and -5.3 mmHg, respectively, compared to placebo (-0.1 mmHg) and a smaller effect on diastolic blood pressure with mean changes for canagliflozin 100 mg once daily and 300 mg once daily of -2.1 mmHg and -2.5 mmHg, respectively, compared to placebo (-0.3 mmHg).
Danish: I en analyse af fire 26-ugers placebokontrollerede studier (N = 2.313) resulterede behandling med canagliflozin 100 mg og 300 mg en gang dagligt i gennemsnitlige reduktioner i systolisk blodtryk på henholdsvis -3,9 mmHg og -5,3 mmHg sammenlignet med placebo (-0,1 mmHg) og en mindre virkning på diastolisk blodtryk med gennemsnitlige ændringer for canagliflozin 100 mg en gang dagligt og 300 mg en gang dagligt på henholdsvis -2,1 mmHg og -2,5 mmHg sammenlignet med placebo (-0,3 mmHg).
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Danish: Hos ældre patienter forekommer nedsat nyrefunktion hyppigt og uden symptomer.
English: • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
Danish: • lægemidler mod smerter og betændelseslignende tilstande (NSAID'er og COX-2-hæmmere,
English: The hazard ratio for the composite primary endpoint (time to event of cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and unstable angina requiring hospitalisation) for canagliflozin (both doses pooled) versus combined active and placebo comparators was 0.91 (95% CI: 0.68; 1.22); therefore, there was no evidence of an increase in cardiovascular risk with canagliflozin relative to comparators.
Danish: Hazard ratio for det sammensatte primære endepunkt (tid til en af følgende hændelser: kardiovaskulær død, ikke-dødelig apopleksi, ikke-dødelig myokardieinfarkt og ustabil angina pectoris, der kræver hospitalsindlæggelse) for canagliflozin (med pooling af begge doser) versus kombinerede aktive komparatorer og placebo var 0,91 (95 % CI: 0,68; 1,22).
English: • rash or redness of the penis or foreskin (yeast infection)
Danish: • udslæt eller rødme på penis eller forhuden (svampeinfektion)
English: Canagliflozin has not been studied in severe renal impairment.
Danish: Canagliflozin er ikke blevet undersøgt ved svært nedsat nyrefunktion.
English: Patients with a baseline GFR 45 mL/min to < 60 mL/min treated with canagliflozin 100 mg and 300 mg exhibited mean improvements in percent change in body weight relative to placebo of -1.8% and -2.0%, respectively.
Danish: Patienter med GFR 45 ml/min til < 60 ml/min ved baseline, der blev behandlet med canagliflozin 100 mg eller 300 mg, udviste gennemsnitlige forbedringer i procentvis ændring i legemsvægt på hhv. -1,8 % og -2,0 % i forhold til placebo.
English: Additional safety analyses (including long-term data) from data across the entire canagliflozin programme (placebo- and active-controlled studies) were conducted to assess reported adverse events in order to identify adverse reactions (see table 1) (see sections 4.2 and 4.4).
Danish: For at vurdere de indberettede hændelser og derigennem identificere bivirkninger (se tabel 1) blev der udført supplerende sikkerhedsanalyser af data inklusive langtidsdata fra hele canagliflozin-programmet (placebokontrollerede og aktivt kontrollerede studier) (se pkt.
English: • Hypersensitivity to the active substances or any of the excipients (see section 6.1);
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: EU/1/14/918/001 (50 mg/850 mg - 20 tablets) EU/1/14/918/002 (50 mg/850 mg - 60 tablets) EU/1/14/918/003 (50 mg/850 mg - 180 tablets) EU/1/14/918/004 (50 mg/1000 mg - 20 tablets) EU/1/14/918/005 (50 mg/1000 mg - 60 tablets) EU/1/14/918/006 (50 mg/1000 mg - 180 tablets) EU/1/14/918/007 (150 mg/850 mg - 20 tablets) EU/1/14/918/008 (150 mg/850 mg - 60 tablets) EU/1/14/918/009 (150 mg/850 mg - 180 tablets) EU/1/14/918/010 (150 mg/1000 mg - 20 tablets) EU/1/14/918/011 (150 mg/1000 mg - 60 tablets) EU/1/14/918/012 (150 mg/1000 mg - 180 tablets)
Danish: EU/1/14/918/001 (50 mg/850 mg - 20 tabletter) EU/1/14/918/002 (50 mg/850 mg - 60 tabletter) EU/1/14/918/003 (50 mg/850 mg - 180 tabletter) EU/1/14/918/004 (50 mg/1000 mg - 20 tabletter) EU/1/14/918/005 (50 mg/1000 mg - 60 tabletter) EU/1/14/918/006 (50 mg/1000 mg - 180 tabletter) EU/1/14/918/007 (150 mg/850 mg - 20 tabletter) EU/1/14/918/008 (150 mg/850 mg - 60 tabletter) EU/1/14/918/009 (150 mg/850 mg - 180 tabletter EU/1/14/918/010 (150 mg/1000 mg - 20 tabletter) EU/1/14/918/011 (150 mg/1000 mg - 60 tabletter) EU/1/14/918/012 (150 mg/1000 mg - 180 tabletter)
English: Stop taking Vokanamet immediately and contact a doctor or go to the nearest hospital straight away if you have any of the following serious side effects:
Danish: Hold straks op med at tage Vokanamet og kontakt straks lægen eller nærmeste skadestue, hvis du får en af følgende alvorlige bivirkninger:
English: The highest dose of 100 mg/kg provided up to 14 times the clinical dose of 300 mg based on AUC exposure.
Danish: Den laveste dosis på 10 mg/kg er ca. 1,5 gange eksponeringen ved den kliniske dosis på 300 mg målt som AUC.
English: Canagliflozin is a low-clearance substance, with a mean systemic clearance of approximately 192 mL/min in healthy subjects following intravenous administration.
Danish: Den gennemsnitlige systemiske clearance er ca. 192 ml/min hos raske forsøgspersoner efter intravenøs administration.
English: liver function test disorders, hepatitis (a problem with your liver), and itching.
Danish: unormale prøver for leverfunktion, leverbetændelse (hepatitis) og kløe
English: e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3% for placebo.
Danish: e .Knoglefraktur rapporteredes hos henholdsvis 0,7 % og 0,6 % for canagliflozin 100 mg og 300 mg sammenlignet med 0,3 % for placebo.
English: Difference from placebo (adjusted mean) (97.5% CI)
Danish: placebo (justeret middelændring) (97,5 % CI)
English: Using a mixed-meal challenge, canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products reduced postprandial glucose from baseline relative to placebo by -1.5 mmol/L to -2.7 mmol/L for canagliflozin 100 mg once daily and -2.1 mmol/L to -3.5 mmol/L for canagliflozin 300 mg once daily, respectively, due to reductions in the pre-meal glucose concentration and reduced postprandial glucose excursions.
Danish: Under provokation med et blandet måltid reducerede canagliflozin som monoterapi eller som tillægsbehandling til et eller to orale glucosesænkende lægemidler postprandial glucose fra baseline i forhold til placebo med henholdsvis -1,5 mmol/l til -2,7 mmol/l for canagliflozin 100 mg en gang dagligt og -2,1 mmol/l til -3,5 mmol/l for 300 mg en gang dagligt som følge af reduktion i glucosekoncentrationen før måltidet samt reducerede udsving i postprandial glucose.
English: When canagliflozin was added to insulin therapy, hypoglycaemia was observed in 49.3%, 48.2%, and 36.8% of patients treated with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and placebo, respectively, and severe hypoglycaemia occurred in 1.8%, 2.7%, and 2.5% of patients treated with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and placebo, respectively.
Danish: Når canagliflozin blev givet som tillæg til insulin, forekom hypoglykæmi hos 49,3 %, 48,2 % og 36,8 % af de patienter, der fik henholdsvis canagliflozin 100 mg en gang dagligt, canagliflozin 300 mg en gang dagligt og placebo, og der blev observeret svær hypoglykæmi hos 1,8 %, 2,7 % og 2,5 % af de patienter, der fik henholdsvis canagliflozin 100 mg en gang dagligt, canagliflozin 300 mg en gang dagligt og placebo.
English: Patients (%) achieving HbA1c < 7% Body weight
Danish: Patienter (%), der opnåede HbA1c
English: • rash or red skin - this may be itchy and include raised bumps, oozing fluid or blisters.
Danish: • udslæt eller hudrødme, som kan være ledsaget af kløe og omfatte hævede områder i huden, udsivende væske eller blærer
English: Consistent with the mechanism of sodium glucose co-transporter 2 (SGLT2) inhibition with increased UGE, vulvovaginal candidiasis in females and balanitis or balanoposthitis in males were reported in clinical trials with canagliflozin (see section 4.8).
Danish: I kliniske studier med canagliflozin blev der i overensstemmelse med mekanismen bag hæmning af natrium-glucose-cotransportør 2 (SGLT-2-hæmning), der øger UGE, rapporteret om vulvovaginal candidiasis hos kvinder og balanitis eller balanopostitis hos mænd (se pkt.
English: • a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p = 0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p = 0.021)
Danish: • en signifikant reduktion i den absolutte risiko for samlet mortalitet: metformin (13,5 hændelser/1.000 patientår) versus diæt alene (20,6 hændelser/1.000 patientår), p = 0,011, og versus de samlede grupper, der fik monoterapi med et sulfonylurinstof eller insulin 18,9 hændelser/1.000 patientår (p = 0,021)
English: Improvement in homeostasis model assessment for beta-cell function (HOMA beta-cell) and improved beta-cell insulin secretion response to a mixed-meal challenge has been observed in clinical studies with canagliflozin.
Danish: I kliniske studier med canagliflozin er der set forbedringer i en homøostatisk model til vurdering af ß-cellefunktionen (HOMA ß-celle) og forbedret respons af ß-cellernes insulinsekretion ved udsættelse for et blandet måltid.
English: Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin
Danish: Sammenlignet med glimepirid som dualbehandling med metformin (52 uger)
English: For patients on loop diuretics, the incidences were 3.2% on canagliflozin 100 mg once daily and 8.8% on canagliflozin 300 mg once daily compared to 4.7% in the control group.
Danish: Hos patienter, der fik loop-diuretika, var incidensen 3,2 % for canagliflozin 100 mg en gang dagligt og 8,8 % for canagliflozin 300 mg en gang dagligt sammenlignet med 4,7 % i kontrolgruppen.
English: Vokanamet should not be used during breast-feeding.
Danish: Vokanamet bør ikke anvendes under amning.
English: When canagliflozin was added to a sulphonylurea therapy, hypoglycaemia was observed in 4.1%, 12.5%, and 5.8% of patients treated with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and placebo, respectively (see sections 4.2 and 4.5).
Danish: Når canagliflozin blev givet som tillæg til et sulfonylurinstof, blev der observeret hypoglykæmi hos 4,1 %, 12,5 % og 5,8 % af de patienter, der blev behandlet med henholdsvis canagliflozin 100 mg en gang dagligt, canagliflozin 300 mg en gang dagligt og placebo (se pkt.
English: Age had no clinically meaningful effect on the pharmacokinetics of canagliflozin based on a population pharmacokinetic analysis (see sections 4.2, 4.4, and 4.8).
Danish: Alder har ikke en klinisk relevant indvirkning på canagliflozins farmakokinetik ud fra en farmakokinetisk populationsanalyse (se pkt.
English: When Vokanamet is used as add-on therapy with insulin or an insulin secretagogue (e.g., a sulphonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
Danish: Når Vokanamet anvendes som tillæg til insulin eller et ß-cellestimulerende middel (f.eks. 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: (E171), iron oxide red (E172) and iron oxide black (E172).
Danish: (E171), rød jernoxid (E172) og sort jernoxid (E172).
English: Baseline (mean) in kg % change from baseline (adjusted mean)
Danish: Baseline (middelværdi) i kg Procentvis ændring fra baseline (justeret middelændring) Forskel ift.
English: Bone fracture
Danish: Knoglefrakture
English: Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis.
Danish: Ved akut forværring af nyrefunktionen akkumules metformin, hvilket øger risikoen for laktatacidose.
English: Vokanamet should be discontinued prior to, or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.5).
Danish: Behandling med Vokanamet skal afbrydes forud for eller på tidspunktet for en billeddiagnostisk procedure og først genoptages efter 48 timer, forudsat at nyrefunktionen er blevet vurderet og fundet stabil (se pkt.
English: Elimination Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and
Danish: Elimination Efter administration af en enkelt oral dosis [14C-mærket] canagliflozin til raske forsøgspersoner blev