FrancophonIA/ELRC3.0 huggingface dataset:
English: • blood tests may show changes in blood fat (cholesterol) levels and increases in amount of red blood cells in your blood (haematocrit).
Danish: • blodprøver kan vise ændringer i blodets fedtindhold (kolesteroltal) og et øget antal røde blodlegemer i blodet (hæmatokrit)
English: Polyuria or Pollakiuriaf, Urinary tract infection (pyelonephritis and urosepsis have been reported postmarketing)
Danish: Polyuri eller pollakisurif, urinvejsinfektion (pyelonephritis og urosepsis er blevet indberettet efter markedsføringen)
English: Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n=2,313) described above.
Danish: Bivirkningerne i tabel 1 er baseret på den poolede analyse af de fire placebo-kontrollerede studier fra uge 26 (n = 2.313) beskrevet ovenfor.
English: Two hundred eleven (211) patients from the clinical study in older patients participated in a body composition substudy using DXA body composition analysis.
Danish: 211 patienter fra det kliniske studie med ældre patienter, deltog i et delstudie af kroppens sammensætning ved hjælp af DXA-analyse af kropssammensætning.
English: b Thirst includes the terms thirst, dry mouth, and polydipsia.
Danish: b Tørst omfatter termerne tørst, mundtørhed og polydipsi.
English: Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor treatment is not recommended unless another clear precipitating factor is identified and resolved.
Danish: Genoptagelse af behandling med SGLT2-hæmmer hos patienter med fortilfælde af DKA under behandling med SGLT2-hæmmer frarådes, medmindre en anden tydelig medvirkende faktor identificeres og afhjælpes.
English: This effect at the 300 mg dose of canagliflozin may, in part, be due to local inhibition of intestinal SGLT1 (an important intestinal glucose transporter) related to transient high concentrations of canagliflozin in the intestinal lumen prior to medicinal product absorption (canagliflozin is a low potency inhibitor of the SGLT1 transporter).
Danish: Denne virkning af en dosis på 300 mg canagliflozin kan muligvis delvist henføres til lokal hæmning af intestinal SGLT1 (en vigtig intestinal glucosetransportør) relateret til forbigående høje koncentrationer af canagliflozin i tarmlumen før absorption af lægemidlet (canagliflozin er en svag hæmmer af SGLT1-transportøren).
English: Among female patients taking canagliflozin, 2.3% experienced more than one infection.
Danish: Blandt de kvindelige patienter, der fik canagliflozin, oplevede 2,3 % flere end én infektion.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet (se pkt.
English: Because of how this medicine works, your urine will test positive for sugar (glucose) while you are on this medicine.
Danish: På grund af medicinens virkemåde vil en urinprøve vise, at du har sukker (glucose) i urinen, mens du får dette lægemiddel.
English: d Canagliflozin as add-on therapy to insulin (with or without other glucose-lowering medicinal products).
Danish: d Canagliflozin som tillægsbehandling til insulin (med eller uden andre glucosesænkende lægemidler).
English: Due to its mechanism of action, patients taking canagliflozin will test positive for glucose in their urine.
Danish: På grund af canagliflozins virkningsmekanisme vil patienter, der tager dette lægemiddel, teste positivt for glucose i urinen.
English: The mean steady-state volume of distribution of canagliflozin following a single intravenous infusion in healthy subjects was 119 litres, suggesting extensive tissue distribution.
Danish: Canagliflozins gennemsnitlige fordelingsvolumen ved steady state efter en enkelt intravenøs infusion til raske forsøgspersoner var 119 liter, hvilket tyder på omfattende fordeling i væv.
English: • blood tests may show changes related to kidney function (creatinine or urea) or potassium
Danish: • blodprøver kan vise forandringer i nyrefunktionen (kreatinin eller urinstof) eller kalium
English: Talk to your doctor about the best way to discontinue Invokana and control your blood sugar as soon as you know that you are pregnant.
Danish: Tal med din læge, så snart du ved, at du er gravid, om hvordan du bedst kan stoppe med Invokana og kontrollere dit blodsukker.
English: • The active substance is canagliflozin.
Danish: • Aktivt stof: canagliflozin.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel og under behandlingen:
English: Canagliflozin may add to the effect of diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Danish: Canagliflozin kan forstærke virkningen af diuretika samt øge risikoen for dehydrering og hypotension (se pkt.
English: Reproductive system and breast disorders very common
Danish: Det reproduktive system og mammae Meget almindelig
English: In rare instances, phimosis was reported and sometimes circumcision was performed.
Danish: Der sås sjældne tilfælde af phimosis, og somme tider blev der udført omskæring.
English: By inhibiting SGLT2, canagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose (RTG), and thereby increases UGE, lowering elevated plasma glucose concentrations by this insulin-independent mechanism in patients with type 2 diabetes.
Danish: Gennem hæmning af SGLT2 reducerer canagliflozin reabsorption af filtreret glucose og sænker nyrens grænse for glucose (RTG), hvorved UGE øges, og plasmakoncentrationen af glucose sænkes med denne insulin-uafhængige mekanisme hos patienter med type 2-diabetes.
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Danish: Plasmaproteinbinding ændres ikke i væsentlig grad hos patienter med nedsat nyre- eller leverfunktion.
English: Invokana should not be used to treat this condition.
Danish: Invokana må ikke anvendes til behandling af denne sygdom
English: Canagliflozin is an orally-active inhibitor of SGLT2.
Danish: Canagliflozin er en oralt aktiv SGLT2-hæmmer.
English: A total of 714 patients ≥ 55 years of age to ≤ 80 years of age (227 patients 65 years of age to < 75 years of age and 46 patients 75 years of age to ≤ 80 years of age) with inadequate glycaemic control on current diabetes treatment (glucose-lowering medicinal products and/or diet and exercise) participated in a double-blind, placebo-controlled study over 26 weeks.
Danish: I alt 714 patienter i alderen ≥ 55 år til ≤ 80 år (227 patienter i alderen 65 år til < 75 og 46 patienter i alderen 75 år til ≤ 80 år) med utilstrækkelig glykæmisk kontrol og igangværende diabetesbehandling (glucosesænkende lægemidler og/eller kost og motion) deltog i et dobbeltblindt, placebokontrolleret studie af 26 ugers varighed.
English: Dabigatran: The effect of concomitant administration of canagliflozin (a weak P-gp inhibitor) on dabigatran etexilate (a P-gp substrate) has not been studied.
Danish: Dabigatran: Virkningen ved samtidig administration af canagliflozin (svag hæmmer af P-gp) og dabigatranetexilat (substrat for P-gp) er ikke undersøgt.
English: Subjects responded to standard treatments while continuing canagliflozin treatment.
Danish: Forsøgspersoner reagerede på standardbehandling under den fortsatte behandling med canagliflozin.
English: Table 3: Efficacy results from active-controlled clinical studiesa
Danish: Tabel 3: Effektresultater fra aktivt kontrollerede kliniske studiera
English: Nervous system disorders uncommon
Danish: Nervesystemet Ikke almindelig
English: Studies have shown no glucose malabsorption with canagliflozin.
Danish: Studier viser ikke glucosemalabsorption i forbindelse med canagliflozin.
English: Elderly (≥ 65 years old) Renal function and risk of volume depletion should be taken into account (see section 4.4).
Danish: Ældre (i alderen ≥ 65 år) Der bør tages højde for nyrefunktionen og risikoen for volumendepletering (se pkt.
English: Polyvinyl chloride/Aluminum (PVC/Alu) perforated unit dose blister.
Danish: Polyvinylchlorid/aluminium (PVC/Alu) perforeret enkeltdosisblister.
English: In in vitro studies, canagliflozin neither inhibited cytochrome P450 CYP1A2,CYP2A6, CYP2C19, CYP2D6, or CYP2E1, CYP2B6, CYP2C8, CYP2C9, nor induced CYP1A2, CYP2C19, CYP2B6, CYP3A4 at higher than therapeutic concentrations.
Danish: I in vitro-studier udvirkede canagliflozin hverken hæmning af cytokrom P450 CYP1A2, CYP2A6, CYP2C19, CYP2D6 og CYP2E1, CYP2B6, CYP2C8 og CYP2C9 eller induktion af CYP1A2,
English: No clinically relevant effect on CYP3A4 was observed in vivo (see section 4.5).
Danish: Der sås ingen klinisk relevant in vivo-påvirkning af CYP3A4 (se pkt.
English: However, dilatation of the renal pelvis was noticed with a No Observed Effect Level (NOEL) at exposures 2.4 times and 0.6 times the clinical exposures at 100 mg and 300 mg doses, respectively, and did not fully reverse within the approximately 1-month recovery period.
Danish: Der sås dog dilatation af nyrebækkenet med et niveau for ingen observeret effekt (NOEL) efter eksponering for henholdsvis 2,4 gange og 0,6 gange den kliniske eksponering ved doser på 100 mg og 300 mg, og det gik ikke helt over inden for restitutionsperioden på ca. 1 måned.
English: N/Ac a Intent-to-treat population using last observation in study prior to glycaemic rescue therapy.
Danish: Intet svarc a Intent-to-treat-population under anvendelse af den sidste observation i studiet før glykæmisk nødmedicin.
English: Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Danish: Bivirkningerne er opstillet efter hyppighed og systemorganklasse.
English: Among male patients taking canagliflozin, 0.9% had more than one infection.
Danish: Blandt de mandlige patienter, der fik canagliflozin, fik over 0,9 % flere end én infektion.
English: In a single-dose study in patients with type 2 diabetes, treatment with 300 mg before a mixed meal delayed intestinal glucose absorption and reduced postprandial glucose through both a renal and a non-renal mechanism.
Danish: I et studie, hvor patienter med type 2-diabetes fik en enkelt dosis, forsinkede behandling med 300 mg før et blandet måltid glucoseabsorption i tarmsystemet og reducerede postprandial glucose i kraft af såvel en renal som en ikke-renal mekanisme.
English: Following single and multiple oral doses of canagliflozin to patients with type 2 diabetes, dose-dependent decreases in RTG and increases in UGE were observed.
Danish: Efter orale enkeltdoser og gentagne doser af canagliflozin til patienter med type 2-diabetes observeredes dosisafhængige fald i RTG og stigninger i UGE.
English: Taking this medicine
Danish: Sådan skal du tage medicinen
English: Urine laboratory assessments
Danish: Laboratorieundersøgelser af urin
English: rare
Danish: Sjælden
English: 300 mg exhibited mean improvements in percent change in body weight relative to placebo of -1.8% and -2.0%, respectively.
Danish: 300 mg, udviste gennemsnitlige forbedringer i procentvis ændringer af legemsvægten i forhold til placebo på henholdsvis -1,8 % og -2,0 %.
English: • medicines used to lower your blood pressure (anti-hypertensives), including diuretics (medicines used to remove levels of excess water in the body, also known as water tablets) since this medicine can also lower your blood pressure by removing levels of excess water in the body.
Danish: • lægemidler til at sænke blodtrykket (antihypertensiva), herunder vanddrivende midler (diuretika), da dette lægemiddel også kan sænke blodtrykket ved at fjerne for meget væske i kroppen.
English: Urinary uric acid excretion was transiently increased by canagliflozin (increased by 19% compared to baseline on day 1 and then attenuating to 6% on day 2 and 1% on day 13).
Danish: Der sås forbigående stigning i udskillelse af urinsyre pga. canagliflozin (stigning på 19 % i forhold til baseline på dag 1, hvorefter stigningen blev dæmpet til 6 % på dag 2 og 1 % på dag 13).
English: Canagliflozin 100 mg and 300 mg as monotherapy and as dual or triple add-on therapy resulted in statistically significant reductions in the percentage of body weight at 26 weeks relative to placebo.
Danish: Canagliflozin 100 mg og 300 mg som monoterapi og som dobbelt- eller trippel-tillægsbehandling førte til statistisk signifikante reduktioner udtrykt i procent i tab af legemsvægt efter 26 uger i forhold til placebo.
English: Canagliflozin should not be used during pregnancy.
Danish: Canagliflozin bør ikke anvendes under graviditeten.
English: • low blood sugar levels (hypoglycaemia) - when taking this medicine with insulin or a sulphonylurea (such as glimepiride or glipizide).
Danish: • lavt blodsukker (hypoglykæmi), når dette lægemiddel tages sammen med insulin eller et sulfonylurinstof (såsom glimepirid eller glipizid).
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Danish: Begrænsede data fra kliniske studier tyder på, at diabetisk ketoacidose optræder med hyppigheden ”almindelig”, når patienter med type 1diabetes behandles med SGLT2-hæmmere.
English: In addition to the studies presented above, glycaemic efficacy results observed in an 18-week dual therapy sub-study with a sulphonylurea and a 26-week triple therapy study with metformin and pioglitazone were generally comparable with those observed in other studies.
Danish: Ud over de ovenfor omtalte studier var de glykæmiske virkninger, som blev observeret i et 18-ugers delstudie med dobbeltbehandling med et sulfonylurinstof og et 26-ugers studie med trippelbehandling med metformin og pioglitazon, generelt sammenlignelige med resultaterne fra andre studier.
English: From a starting value of RTG of approximately 13 mmol/L, maximal suppression of 24-hour mean RTG was seen with the 300 mg daily dose to approximately 4 mmol/L to 5 mmol/L in patients with type 2 diabetes in phase 1 studies, suggesting a low risk for treatment-induced hypoglycaemia.
Danish: Fra en startværdi af RTG på ca. 13 mmol/l opstod der maksimal undertrykkelse af 24-timers middeltal for RTG med dosen på 300 mg dagligt til ca. 4 mmol/l til5 mmol/l hos patienter med type 2-diabetes i fase 1-studier, hvilket tyder på, at risikoen for behandlingsinduceret hypoglykæmi er lav.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g., type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Danish: Patienter, der kan have en højere risiko for DKA, omfatter patienter med lav restfunktion af betaceller (f.eks. patienter med type 2-diabetes med lavt C-peptid, latent autoimmun diabetes hos voksne (LADA) eller patienter med pancreatitis i anamnesen), patienter med tilstande, der medfører lav fødeindtagelse eller svær dehydrering, patienter, hvis insulindosis er blevet nedsat, samt patienter med øget insulinbehov på grund af akut sygdom, kirurgi eller alkoholmisbrug.
English: Your doctor will decide whether to increase your dose to 300 mg.
Danish: Din læge afgør, om du skal øge dosis til
English: The level of digoxin or digitoxin in your blood may need to be checked if taken with Invokana.
Danish: Du skal måske have målt blodets indhold af digoxin eller digitoxin, hvis du tager disse midler sammen med Invokana
English: Insulin and insulin secretagogues, such as sulphonylureas, can cause hypoglycaemia.
Danish: Insulin og ß-cellestimulerende midler såsom sulfonylurinstoffer kan medføre hypoglykæmi.
English: Canagliflozin is a low-clearance substance, with a mean systemic clearance of approximately 192 mL/min in healthy subjects following intravenous administration.
Danish: Canagliflozin er et stof med lav clearance og gennemsnitlig systemisk clearance på ca. 192 ml/min hos raske forsøgspersoner efter intravenøs administration.
English: Overall, 0.7% of all female patients discontinued canagliflozin due to vulvovaginal candidiasis (see section 4.4).
Danish: Samlet set stoppede 0,7 % af alle kvindelige patienter med canagliflozin på grund af vulvovaginal candidiasis (se pkt.
English: CYP3A4-mediated (oxidative) metabolism of canagliflozin is minimal (approximately 7%) in humans.
Danish: Hos mennesker ses der kun minimal CYP3A4-medieret (oxidativ) metabolisme af canagliflozin (ca. 7 %).
English: To assess risk factors for these adverse reactions, a larger pooled analysis (N=9,439) of patients from eight controlled phase 3 studies including both doses of canagliflozin was conducted.
Danish: Til vurdering af risikofaktorerne for disse bivirkninger blev der gennemført en større poolet analyse (N = 9.439) af patienter fra otte kontrollerede fase 3-studier, der omfattede begge doser canagliflozin.
English: Invokana can be used by itself or along with other medicines you may be using to treat your type 2 diabetes (such as metformin, insulin, a DPP-4 inhibitor [such as sitagliptin, saxagliptin, or linagliptin], a sulphonylurea [such as glimepiride or glipizide], or pioglitazone) that lower blood sugar levels.
Danish: Invokana kan bruges alene eller sammen med andre lægemidler, som du kan anvende til behandling af type 2-diabetes (f.eks. metformin, insulin, en DPP-IV-hæmmer [f.eks. sitagliptin, saxagliptin eller linagliptin], et sulfonylurinstof [f.eks. glimepirid eller glipizid] eller pioglitazon) for at sænke blodsukkeret.
English: The incidence of hypoglycaemia episodes/events with canagliflozin 300 mg and sitagliptin 100 mg was 40.7% and 43.2%, respectively.
Danish: Incidensen af hypoglykæmiske episoder/hændelser med canagliflozin 300 mg og sitagliptin 100 mg var henholdsvis 40,7 % og 43,2 %.
English: The pharmacokinetics of canagliflozin are essentially similar in healthy subjects and patients with type 2 diabetes.
Danish: Canagliflozin udviser i det væsentlige samme farmakokinetik hos raske forsøgspersoner og patienter med type 2-diabetes.
English: In patients ≥ 75 years of age, a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) was reported.
Danish: Hos patienter ≥ 75 år blev der rapporteret en større incidens af bivirkninger associeret med volumendepletering (f.eks. postural svimmelhed, ortostatisk hypotension, hypotension).
English: Single doses up to 1,600 mg of canagliflozin in healthy subjects and canagliflozin 300 mg twice daily for 12 weeks in patients with type 2 diabetes were generally well-tolerated.
Danish: Generelt var enkeltdoser på op til 1600 mg canagliflozin hos raske forsøgspersoner og canagliflozin 300 mg to gange dagligt i 12 uger hos patienter med type 2-diabetes veltolererede.
English: Simvastatin: The combination of canagliflozin 300 mg once daily for 6 days with a single dose of simvastatin (CYP3A4 substrate) 40 mg resulted in a 12% increase in AUC and a 9% increase in Cmax of simvastatin and an 18% increase in AUC and a 26% increase in Cmax of simvastatin acid.
Danish: Simvastatin: En kombination af canagliflozin 300 mg en gang dagligt i 6 dage med en enkelt dosis simvastatin (substrat for CYP3A4) på 40 mg resulterede i en stigning på 12 % i AUC og en stigning på 9 % i Cmax for simvastatin samt en stigning på 18 % i AUC og en stigning på 26 % i Cmax for simvastatinsyre.
English: d Based on postmarketing experience with canagliflozin.
Danish: d Baseret på erfaringer med canagliflozin efter markedsføringen.
English: 10 x 1 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Danish: 10 x 1 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 90 x 1 filmovertrukne tabletter 100 x 1 filmovertrukne tabletter
English: Persistent renal findings in juvenile rats can most likely be attributed to reduced ability of the developing rat kidney to handle canagliflozin-increased urine volumes, as functional maturation of the rat kidney continues through 6 weeks of age.
Danish: Vedvarende nyrefund hos unge rotter kan efter al sandsynlighed tilskrives, at rottenyrer under udvikling har en nedsat evne til at håndtere de øgede urinmængder pga. canagliflozin, eftersom nyrefunktionens modning hos rotter fortsætter, til de er 6 uger gamle.
English: Skin and subcutaneous tissue disorders uncommon
Danish: Hud og subkutane væv Ikke almindelig
English: This may affect your ability to drive, cycle, and use any tools or machines.
Danish: Det kan påvirke din evne til at køre bil, cykle og bruge værktøj og maskiner.
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (AUC) and peak concentration (Cmax) were observed.
Danish: Efter samtidig administration af canagliflozin og rifampicin (induktor af en række aktive transportører og lægemiddelmetaboliserende enzymer) blev der observeret fald på henholdsvis 51 % og 28 % i systemisk eksponering for canagliflozin (AUC) og maksimal plasmakoncentration (Cmax).
English: Other medicines and Invokana
Danish: Brug af anden medicin sammen med Invokana
English: In phase 3 studies, pre-meal administration of canagliflozin 300 mg provided a greater reduction in postprandial glucose excursion than observed with the 100 mg dose.
Danish: I fase 3-studier med administration af canagliflozin 300 mg før et måltid opnåedes en større reduktion af postprandial glucoseudskillelse end med en dosis på 100 mg.
English: Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Danish: Fremstiller Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italien
English: As dabigatran concentrations may be increased in the presence of canagliflozin, monitoring (looking for signs of bleeding or anaemia) should be exercised when dabigatran is combined with canagliflozin.
Danish: Eftersom der kan forekomme forhøjede koncentrationer af dabigatran ved tilstedeværelse af canagliflozin, bør patienten monitoreres for tegn på blødning eller anæmi ved kombination af dabigatran og canagliflozin.
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Danish: Søg læge med det samme, hvis du får en af følgende bivirkninger: Diabetisk ketoacidose (sjælden, kan berøre op til 1 ud af 1.000 personer) Symptomerne på diabetisk ketoacidose (se også afsnit 2, Advarsler og forholdsregler) er: forhøjet niveau af “ketonstoffer” i urinen eller blodet hurtigt vægttab kvalme eller opkastning mavesmerter voldsom tørst hurtig og dyb vejrtrækning forvirring usædvanlig søvnighed eller træthed dine ånde lugter sødligt, du har en sødlig eller metallisk smag i munden, eller din urin eller sved lugter anderledes
English: Consistent with the expected increase of hypoglycaemia when a medicinal product not associated with hypoglycaemia is added to insulin and/or sulphonylurea, an increase in hypoglycaemia episodes/events was seen when canagliflozin was added to insulin and/or a sulphonylurea (see section 4.8).
Danish: Svarende til den forventede stigning i hypoglykæmi, når et lægemiddel, der ikke associeres med hypoglykæmi, tilsættes behandling med insulin og/eller sulfonylurinstof, kunne der ses en stigning i hypoglykæmiske episoder/hændelser, når canagliflozin blev føjet til behandling med insulin og/eller et sulfonylurinstof (se pkt.