FrancophonIA/ELRC3.0 huggingface dataset:
English: Investigations common
Danish: Undersøgelser Almindelig
English: In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking this medicine.
Danish: Hvis du er på diabetesdiæt med vægtkontrol, skal du fortsat følge diæten, mens du tager dette lægemiddel.
English: Patients had an overall mean age of 59.6 years (range 21 years to 96 years), with 3,082 patients ≥ 65 years of age and 510 patients ≥ 75 years of age.
Danish: Patienternes samlede gennemsnitsalder var 59,6 år (interval 21 år til 96 år), med 3.082 patienter i alderen ≥ 65 år og 510 patienter ≥ 75 år.
English: This demonstrated that approximately two-thirds of the weight loss associated with canagliflozin was due to loss of fat mass relative to placebo.
Danish: Den viste, at næsten to tredjedel af vægttabet forbundet med canagliflozin i forhold til placebo skyldtes tab af fedtmasse.
English: In particular, tell your doctor if you are taking any of the following medicines:
Danish: Det er særlig vigtigt, at du fortæller det til lægen, hvis du tager et af følgende midler:
English: Both UGT1A9 and UGT2B4 are subject to genetic polymorphism.
Danish: Både UGT1A9 og UGT2B4 gennemgår genetisk polymorfisme.
English: In other type 2 diabetes studies with canagliflozin, which enrolled a general diabetes population of approximately 5,800 patients, no difference in fracture risk was observed relative to control.
Danish: I andre type 2-diabetesstudier med canagliflozin, hvori der indgik en generel diabetespopulation på ca. 5.800 patienter, sås der ingen forskel i risiko for fraktur sammenlignet med kontrolgruppen.
English: Most reports of vulvovaginal candidiasis occurred during the first four months of treatment with canagliflozin.
Danish: De fleste rapporter om vulvovaginal candidiasis forekom under de første fire måneders behandling med canagliflozin.
English: Patients with baseline HbA1c > 10% to ≤ 12%
Danish: Patienter med baseline HbA1c > 10 % til ≤ 12 %
English: Approximately 33% of the administered radioactive dose was excreted in urine, mainly as O-glucuronide metabolites (30.5%).
Danish: Ca. 33 % af den administrerede radioaktive dosis blev udskilt i urinen, hovedsageligt som O-glucuronidmetabolitter (30,5 %).
English: * Related to volume depletion; see section 4.4.
Danish: * Relateret til volumendepletering, se pkt.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Danish: I en række af disse tilfælde fremstod tilstanden atypisk med kun moderat forhøjet blodglucose, under 14 mml/l (250 mg/dl).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2. i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Most infections were mild to moderate with no increase in the occurrence of serious adverse reactions.
Danish: De fleste infektioner var milde til moderate, og der sås ingen stigning i forekomsten af alvorlige bivirkninger.
English: Invokana should not be used for the treatment of diabetic ketoacidosis as it is not effective in this setting.
Danish: Invokana bør ikke anvendes til behandling af diabetisk ketoacidose, da det ikke ville opnå virkning under disse omstændigheder.
English: In a 12-week clinical study, unstimulated LH did not increase in male patients treated with canagliflozin.
Danish: I et 12-ugers kliniske studie steg ustimuleret LH ikke hos mandlige patienter, der blev behandlet med canagliflozin.
English: Invokana contains the active substance canagliflozin which belongs to a group of medicines called “blood-glucose lowering drugs.”
Danish: Invokana indeholder det aktive stof canagliflozin, som hører til en gruppe lægemidler, der kaldes “blodglucosesænkende midler".
English: 5.3 Pre-clinical safety data
Danish: 5.3 Prækliniske sikkerhedsdata
English: Inhibition of BCRP by canagliflozin cannot be excluded at an intestinal level and increased exposure may therefore occur for medicinal products transported by BCRP, e.g. certain statins like rosuvastatin and some anti-cancer medicinal products.
Danish: Det kan ikke udelukkes, at canagliflozin hæmmer BCRP i tarmene, og der kan derfor forekomme øget eksponering for lægemidler, der transporteres af BCRP, f.eks. visse statiner som rosuvastatin og visse lægemidler mod cancer.
English: A study in juvenile rats administered canagliflozin from day 1 through day 90 postnatal did not show increased sensitivity compared to effects observed in adults rats.
Danish: Et studie i unge rotter, der fik administreret canagliflozin postnatalt fra dag 1 til dag 90, viste ingen øget følsomhed sammenlignet med de virkninger, der var observeret hos voksne rotter.
English: Invokana has not been studied in patients with type 1 diabetes and is therefore not recommended for use in these patients.
Danish: Invokana er ikke undersøgt hos patienter med type 1-diabetes og kan derfor ikke anbefales til denne patientgruppe.
English: It is unknown whether ossification delays can be attributed to effects of canagliflozin on calcium homeostasis observed in adult rats.
Danish: Det vides ikke, om forsinkelser i ossifikation kan tilskrives canagliflozins observerede virkninger på calciumhomeostase i voksne rotter.
English: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute clinical measures if required.
Danish: I tilfælde af overdosering er det fornuftigt at anvende sædvanlig understøttende behandling og f.eks. fjerne ikke absorberet materiale fra mave-tarm-kanalen, anvende klinisk monitorering og iværksætte kliniske foranstaltninger efter behov.
English: • digoxin or digitoxin (medicines used for certain heart problems).
Danish: • digoxin eller digitoxin (middel mod visse hjerteproblemer).
English: • if you have diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea, or vomiting).
Danish: • hvis du har diabetisk ketoacidose (en følgesygdom til diabetes med højt blodsukker, hurtigt vægttab, kvalme eller opkastning).
English: Due to volume depletion, generally small mean decreases in eGFR were seen within the first 6 weeks of treatment initiation with canagliflozin.
Danish: På grund af volumendepletering sås der generelt små gennemsnitlige fald i eGFR i løbet af de første 6 uger efter indledning af behandling med canagliflozin.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Danish: Polyvinylalkohol Titandioxid (E171) Macrogol 3350
English: Canagliflozin is transported by P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP).
Danish: Canagliflozin transporteres af P-glykoprotein (P-gp) og brystcancer-resistensprotein (BCRP).
English: Adverse reactions reported from world-wide postmarketing use of canagliflozin are also included in this tabulation.
Danish: Bivirkninger, som er indberettet på baggrund af global brug af canagliflozin efter markedsføringen, er ligeledes medtaget i denne tabel.
English: • The starting dose of Invokana is one 100 mg tablet each day.
Danish: • Startdosis af Invokana er 1 tablet a 100 mg om dagen.
English: Protein binding is independent of canagliflozin plasma concentrations.
Danish: Proteinbindingen er uafhængig af canagliflozins plasmakoncentration.
English: Diabetic ketoacidosis**
Danish: Diabetisk ketoacidose**
English: The reductions in RTG and increases in UGE were sustained over a 26-week dosing period in patients with type 2 diabetes.
Danish: Faldene i RTG og stigningerne i UGE blev opretholdt under en behandlingsperiode på 26 uger hos patienter med type 2-diabetes.
English: Before initiating canagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered.
Danish: Før indledning af behandling med canagliflozin skal faktorer i patientens anamnese, som kan prædisponere for ketoacidose, tages i betragtning.
English: The Leydig cell tumours are associated with an increase in luteinizing hormone (LH), which is a known mechanism of Leydig cell tumour formation in rats.
Danish: Leydig-celletumorerne associeres med stigning i luteiniseringshormon (LH), som er en kendt mekanisme bag dannelse af Leydigcelletumorer hos rotter.
English: Patients taking digoxin or other cardiac glycosides (e.g., digitoxin) should be monitored appropriately.
Danish: Patienter, der tager digoxin eller andre hjerteglykosider (f.eks. digitoxin), skal have passende monitorering.
English: In addition, reductions in body weight and systolic blood pressure relative to placebo were observed.
Danish: Endvidere blev der observeret fald i legemsvægt og i systolisk blodtryk i forhold til placebo.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for 6 måneder efter godkendelsen.
English: This can lead to serious medical conditions such as heart disease, kidney disease, blindness, and amputation.
Danish: Det kan føre til en række alvorlige lidelser såsom hjertesygdom, nyresygdom, blindhed og amputation.
English: See bone fracture section below for additional information.
Danish: Se afsnittet om knoglebrud nedenfor for yderligere oplysninger.
English: “CFZ” on one side and “300” on the other side.
Danish: “CFZ” på den ene side og “300” på den anden side.
English: Metabolism and nutrition disorders very common
Danish: Metabolisme og ernæring Meget almindelig
English: The increases in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Danish: Den øgede eksponering for simvastatin og simvastatinsyre anses ikke for klinisk relevante.
English: • changes in urination (including urinating more frequently or in larger amounts, urgent need to urinate, need to urinate at night)
Danish: • ændringer i vandladning (herunder hyppigere vandladning eller større urinmængde, akut trang til at lade vandet, natlig trang til at lade vandet)
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 Invokana on glycaemic control.
Danish: I alt 10.285 patienter med type 2 diabetes deltog i ni dobbeltblinde, kontrollerede kliniske studier af sikkerhed og virkning for at evaluere Invokanas virkninger på glykæmisk kontrol.
English: Patients with diabetes have been shown to have elevated renal glucose reabsorption which may contribute to persistent elevated blood glucose concentrations.
Danish: Det er påvist, at patienter med diabetes har forhøjet reabsorption af glucose i nyrerne, som kan bidrage til vedvarende forhøjet blodglucose.
English: Children and adolescents Invokana is not recommended for children and adolescents under 18 years.
Danish: Børn og unge Børn og unge under 18 år må normalt ikke få Invokana.
English: Significant improvements in body weight and reductions in systolic blood pressure compared to both glimepiride and sitagliptin were also observed.
Danish: Desuden blev der observeret signifikante forbedringer i legemsvægt og reduktioner i systolisk blodtryk sammenlignet med såvel glimepirid og sitagliptin.
English: • blood tests may show increases in your blood phosphate level
Danish: • blodprøver kan vise stigninger i blodets indhold af fosfat
English: System organ class
Danish: Systemorganklasse Hyppighed
English: Canagliflozin has no or negligible influence on the ability to drive and use machines.
Danish: Canagliflozin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Talk to your doctor about whether to stop taking this medicine or to stop breast-feeding.
Danish: Tal med din læge om at holde op med at tage medicinen eller stoppe amningen.
English: Therefore, 1,5-AG assays should not be used for assessment of glycemic control in patients on canagliflozin.
Danish: Derfor bør 1,5-AG-analyser ikke anvendes til vurdering af glykæmisk kontrol hos patienter, der får canagliflozin.
English: Increases in urinary glucose excretion with Invokana can falsely lower 1,5-anhydroglucitol (1,5-AG) levels and make measurements of 1,5-AG unreliable in assessing glycemic control.
Danish: Øget udskillelse af glucose i urin i forbindelse med Invokana kan medføre falsk nedsat niveau af 1,5anhydroglucitol (1,5-AG), hvilket kan medføre, at målinger af 1,5-AG ikke er pålidelige ved vurdering af glykæmisk kontrol.
English: Adverse reactions related to volume depletion
Danish: Bivirkninger relateret til volumendepletering
English: The European Medicines Agency has deferred the obligation to submit the results of studies with canagliflozin in one or more subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med canagliflozin i en eller flere undergrupper af den pædiatriske population ved type 2-diabetes (se pkt.
English: Gender, race/ethnicity, or body mass index had no clinically meaningful effect on the pharmacokinetics of canagliflozin based on a population pharmacokinetic analysis.
Danish: Køn, race/etnisk baggrund eller body mass index har ingen klinisk relevant virkning på canagliflozins farmakokinetik ud fra en farmakokinetisk analyse af populationen.
English: This happens more often in elderly people (aged 75 and over), people with kidney problems, and people taking water tablets (diuretics).
Danish: Det forekommer oftere hos ældre (over 75 år), personer med nyreproblemer og personer, der får vanddrivende medicin (diuretika).
English: “CFZ” on one side and “100” on the other side.
Danish: “CFZ” på den ene side og “100” på den anden side.
English: • carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
Danish: • carbamazepin, phenytoin eller phenobarbital (midler til kontrol af krampeanfald)
English: The safety and efficacy of canagliflozin in patients with type 1 diabetes have not been established and canagliflozin should not be used for treatment of patients with type 1 diabetes.
Danish: Canagliflozins sikkerhed og virkning hos patienter med type 1-diabetes er ikke blevet klarlagt, og canagliflozin bør ikke anvendes til patienter med type 1-diabetes.
English: Increases in serum creatinine of 10-11% and BUN of approximately 12% were observed with both doses of canagliflozin.
Danish: Der blev observeret stigning i serumkreatinin på 10-11% og i P-karbamid på ca. 12 % for begge doser af canagliflozin.
English: Film-coated tablet.
Danish: Filmovertrukkket tablet.
English: These increases in canagliflozin exposure are not expected to be clinically relevant.
Danish: Disse stigninger i eksponeringen for canagliflozin forventes ikke at være klinisk relevante.
English: Plasma Cmax and AUC of canagliflozin increased in a dose-proportional manner from 50 mg to 300 mg.
Danish: Plasma Cmax og AUC for canagliflozin steg dosisproportionalt fra 50 mg til 300 mg.
English: The recommended starting dose of canagliflozin is 100 mg once daily.
Danish: Den anbefalede initialdosis af canagliflozin er 100 mg en gang dagligt.
English: • efavirenz or ritonavir (a medicine used to treat HIV infection)
Danish: • efavirenz eller ritonavir (middel til at behandle hiv-infektion)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • rifampicin (an antibiotic used to treat tuberculosis)
Danish: • rifampicin (antibiotikum til at behandle tuberkulose)
English: • dabigatran (blood thinner medicine that lowers the risk of blood clot formation).
Danish: • dabigatran (blodfortyndende middel, der nedsætter risikoen for at danne blodpropper).
English: It is also important to keep following advice about diet and exercise given by your doctor or nurse.
Danish: Det er også vigtigt, at du altid følger de råd om kost og motion, som du får af din læge eller sundhedspersonalet.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: b p<0.001 compared to placebo.
Danish: b p < 0,001 sammenlignet med placebo.
English: The majority of genital mycotic infections were treated with topical antifungal treatments, either prescribed by a healthcare professional or self-treated while continuing therapy with Invokana.
Danish: De fleste svampeinfektioner i kønsorganerne blev behandlet udvortes med antimykotika, enten efter ordination af en læge eller som egenbehandling under den fortsatte behandling med Invokana.
English: Canagliflozin showed no effects on fertility and early embryonic development in the rat at exposures up to 19 times the human exposure at the maximum recommended human dose (MRHD).
Danish: Canagliflozin påvirkede ikke fertilitet og tidlig udvikling af embryoet hos rotter efter eksponering for op til 19 gange den humane eksponering ved den maksimale anbefalede dosis til mennesker (MRHD).
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Danish: Risikoen for diabetisk ketoacidose skal overvejes i tilfælde af ikke-specifikke symptomer som f.eks. kvalme, opkastning, anoreksi, abdominalsmerter, udtalt tørst, vejrtrækningsbesvær, forvirring, usædvanlig træthed eller søvnighed.
English: The 100 mg tablet also contains iron oxide yellow (E172).
Danish: Tabletten på 100 mg indeholder også gul jernoxid (E172).
English: The SGLT2 transporter, expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
Danish: SGLT2-transportøren udtrykkes i de proksimale nyretubuli og er ansvarlig for hovedparten af reabsorptionen af filtreret glucose fra det tubulære lumen.
English: Balanitis or balanoposthitis occurred primarily in uncircumcised male patients.
Danish: Balanitis og balanopostitis optrådte primært hos mandlige patienter, der ikke var omskåret.
English: In patients susceptible to greater reductions in intravascular volume as described above, larger decreases in eGFR (> 30%) were sometimes seen, which subsequently improved, and infrequently required interruption of treatment with canagliflozin (see section 4.8).
Danish: Hos patienter, der var modtagelige over for større reduktioner i intravaskulært volumen som beskrevet ovenfor, forekom der somme tider større fald i eGFR (> 30 %), som senere atter blev bedre og kun sjældent krævede afbrydelse af behandlingen med canagliflozin (se pkt.
English: No effects on fertility were observed in animal studies (see section 5.3).
Danish: Der sås ingen virkninger på fertilitet i dyrestudier (se pkt.
English: Dizziness postural*, Syncope*
Danish: Postural svimmelhed*, synkope*
English: INFORMATION IN BRAILLE invokana 100 mg invokana 300 mg
Danish: INFORMATION I BRAILLESKRIFT invokana 100 mg invokana 300 mg
English: Experience in New York Heart Association (NYHA) class III is limited, and there is no experience in clinical studies with canagliflozin in NYHA class IV.
Danish: Der er begrænsede erfaringer med patienter i NYHA-klasse III (defineret af New York Heart Association), og der er ingen erfaringer med NYHA-klasse IV fra kliniske studier af canagliflozin.
English: To control your diabetes, you still need to follow the advice about diet and exercise from your doctor, pharmacist or nurse.
Danish: For at kontrollere din diabetes skal du samtidig følge de råd, du får om kost og motion fra din læge, apotekspersonalet eller sundhedspersonalet.
English: In the dedicated cardiovascular study and the larger pooled analysis, discontinuations due to adverse reactions related to volume depletion and serious adverse reactions related to volume depletion were not increased with canagliflozin.
Danish: I det dedikerede kardiovaskulære studie og den større poolede analyse steg antallet af seponeringer på grund af bivirkninger relateret til volumendepletering og alvorlige bivirkninger relateret til volumendepletering ikke ved behandling med canagliflozin.
English: • kidney failure (mainly as a consequence of loss of too much fluid from your body).
Danish: • nyresvigt (hovedsageligt som en konsekvens af et forhøjet væsketab fra kroppen)
English: Enzyme inducers (such as St. John's wort [Hypericum perforatum], rifampicin, barbiturates, phenytoin, carbamazepine, ritonavir, efavirenz) may give rise to decreased exposure of canagliflozin.
Danish: Enzyminduktorer (såsom perikon [Hypericum perforatum], rifampicin, barbiturater, phenytoin, carbamazepin, ritonavir, efavirenz) kan give anledning til nedsat eksponering for canagliflozin.
English: Tell your doctor as soon as possible if you have any of the following side effects: Hypoglycaemia (very common, may affect more than 1 in 10 people)
Danish: Tal med lægen snarest muligt, hvis du får en eller flere af følgende symptomer: Hypoglykæmi (meget almindelig, kan berøre flere end 1 ud af 10 personer):
English: • If your doctor has prescribed canagliflozin along with any bile acid sequestrant such as cholestyramine (medicines for lowering cholesterol) you should take canagliflozin at least 1 hour before or 4 hours to 6 hours after the bile acid sequestrant.
Danish: • Hvis din læge har foreskrevet canagliflozin sammen med en galdesyrebindende ionbytter såsom colestyramin (middel til sænkning af kolesteroltallet), skal du tage canagliflozin mindst 1 time før eller 4-6 timer efter ionbytteren.
English: A pre-specified interim meta-analysis was conducted of adjudicated major cardiovascular events in the phase 2 and 3 clinical studies in 9,632 patients with type 2 diabetes, including 4,327 patients (44.9%) with cardiovascular disease or at high risk for cardiovascular disease who are participating in an ongoing cardiovascular study.
Danish: Der udførtes en præspecificeret interim-metaanalyse af evaluerede større kardiovaskulære hændelser i kliniske fase 2- og 3-studier med 9.632 patienter med type 2-diabetes, herunder 4.327 patienter (44,9 %) med kardiovaskulær sygdom eller i højrisikogruppen for kardiovaskulær sygdom, som deltager i et igangværende kardiovaskulært studie.
English: The tablets contain lactose.
Danish: Tabletterne indeholder lactose.
English: After 104 weeks of treatment, canagliflozin did not adversely affect bone mineral density.
Danish: Efter 104 ugers behandling påvirkede canagliflozin ikke knoglemineraltætheden negativt.
English: • The other ingredients are: tablet core: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose film-coating: macrogol (3350), polyvinyl alcohol, talc, and titanium dioxide (E171).
Danish: • Øvrige indholdsstoffer: tabletkerne: croscarmellosenatrium, hydroxypropylcellulose, vandfri lactose, magnesiumstearat og mikrokrystallinsk cellulose filmovertræk: macrogol (3350), polyvinylalkohol, talcum og titandioxid (E171).
English: These symptoms could be a sign of “diabetic ketoacidosis” - a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Danish: Symptomerne kan være tegn på “diabetisk ketoacidose”, som er en komplikation, du kan få ved sukkersyge på grund af forhøjet niveau af “ketonstoffer” i urinen eller blodet.