FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighedskategorier inddeles efter følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In both cases, treatment with dapagliflozin may be restarted once the patient's condition has stabilised.
Danish: I begge tilfælde kan behandlingen med dapagliflozin genoptages, når patientens tilstand er stabiliseret.
English: The increases in creatinine were generally transient during continuous treatment or reversible after discontinuation of treatment.
Danish: Stigningen i kreatinin var generelt forbigående ved kontinuerlig behandling eller reversibel efter seponering af behandlingen.
English: (A satellite study was conducted to assess dapagliflozin exposures in milk and pups.)
Danish: (Der blev udført et satellitstudie for at vurdere dapagliflozin-eksponeringer i mælk og unger).
English: Fifty-one percent (51%) of the subjects were men, 84% were White, 9% were Asian, 3% were Black and 4% were of other racial groups.
Danish: 51 % af forsøgspersonerne var mænd, 84 % var hvide, 9 % var asiatiske, 3 % var sorte og 4 % kom fra andre racegrupper.
English: If you take more Forxiga tablets than you should, talk to a doctor or go to a hospital immediately.
Danish: Hvis du har taget flere Forxiga tabletter, end du skulle, skal du straks tale med lægen eller tage på hospitalet.
English: This may occur regardless of blood glucose level.
Danish: Dette kan forekomme uanset niveauet af blodsukker.
English: Do not take Forxiga:
Danish: Tag ikke Forxiga:
English: There are no data from the use of dapagliflozin in pregnant women.
Danish: Der er ingen data fra anvendelse af dapagliflozin til gravide kvinder.
English: Possible signs of dehydration are listed at the top of section 4, ‘Possible side effects'.
Danish: Mulige tegn på dehydrering er anført øverst i punkt 4, "Bivirkninger".
English: Eighty percent (80%) of the subjects had a body mass index (BMI) ≥ 27.
Danish: 80 % af forsøgspersonerne havde et body mass index (BMI) på  27.
English: Cardiovascular episodes were adjudicated by an independent adjudication committee.
Danish: Kardiovaskulære tilfælde blev bedømt af en uafhængig bedømmelseskomité.
English: Metabolism and nutrition
Danish: Metabolisme og ernæring
English: • if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink.
Danish: • Hvis du har eller senere får kvalme, opkastning eller feber, eller hvis du ikke er i stand til at spise eller drikke.
English: Experience in NYHA class I-II is limited, and there is no experience in clinical studies with dapagliflozin in NYHA class III-IV.
Danish: Erfaringer i NYHA-klasse I-II er begrænsede, og der er ingen erfaringer fra kliniske studier med dapagliflozin i NYHA-klasse III-IV.
English: • if you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking Forxiga.
Danish: • Hvis du tager et andet lægemiddel mod diabetes, der indeholder pioglitazon, bør du ikke begynde at tage Forxiga.
English: • if you have very high levels of glucose in your blood which may make you dehydrated (lose too much body fluid).
Danish: • Hvis du har meget høje niveauer af glucose (sukker) i blodet, som kan gøre dig dehydreret (få dig til at tabe for meget kropsvæske).
English: Forxiga works by removing excess sugar from your body via your urine.
Danish: Forxiga virker ved at fjerne det overskydende sukker fra kroppen via urinen.
English: Forxiga has no or negligible influence on the ability to drive and use machines.
Danish: Forxiga påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Therefore, the use of dapagliflozin is not recommended during the second and third trimesters of pregnancy.
Danish: Derfor anbefales det ikke at anvende dapagliflozin i løbet af det andet og tredje trimester af graviditeten.
English: Dapagliflozin is approximately 91% protein bound.
Danish: Dapagliflozin er ca. 91 % proteinbundet.
English: Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Danish: Behandlingen bør afbrydes hos patienter, som hospitalindlægges på grund af større operationer eller alvorlige akutte sygdomme.
English: • if you often get infections of the urinary tract.
Danish: • Hvis du ofte får urinvejsinfektioner.
English: Elderly (≥ 65 years)
Danish: Ældre (≥ 65 år)
English: Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with Forxiga.
Danish: Der er blevet observeret forbedring i homeostasemodelvurdering for betacellefunktion (HOMA beta-cell) i kliniske studier med Forxiga.
English: SE-151 85 Södertälje Sweden
Danish: SE-151 85 Södertälje Sverige
English: They have “10” on one side and “1428” on the other side.
Danish: Der står "10" på den ene side og "1428" på den anden side.
English: Effect of dapagliflozin on other medicinal products
Danish: Virkning af dapagliflozin på andre lægemidler
English: Your blood sugar may increase without this medicine.
Danish: Dit blodsukker kan stige, hvis du ikke tager din medicin.
English: In patients with severe hepatic impairment, a starting dose of 5 mg is recommended.
Danish: Hos patienter med svært nedsat leverfunktion anbefales en startdosis på 5 mg.
English: The amount of glucose removed by the kidney through this mechanism is dependent upon the blood glucose concentration and GFR.
Danish: Mængden af glucose elimineret af nyrerne via denne mekanisme afhænger af glucosekoncentrationen i blodet og af GFR.
English: Remember to take these other medicine(s) as your doctor has told you.
Danish: Husk at tage denne anden medicin, som din læge har fortalt dig.
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Danish: Når diæt og motion alene ikke giver tilstrækkelig glykæmisk kontrol hos patienter, hvor anvendelse af metformin ikke anses for velegnet på grund af intolerance.
English: A meta-analysis of cardiovascular events in the clinical program was performed.
Danish: Der blev udført en meta-analyse af kardiovaskulære bivirkninger i det kliniske udviklingsprogram.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Forxiga, and during treatment:
Danish: Advarsler og forsigtighedsregler Tal med din læge, apotekspersonalet eller sundhedspersonalet, før du begynder at tage Forxiga og under behandlingen:
English: It is not known if this medicine passes into human breast milk.
Danish: Det vides ikke, om dette lægemiddel går over i modermælken.
English: Since the numerical imbalance of breast, bladder and prostate tumours must be considered with caution, it will be further investigated in post-authorisation studies.
Danish: Da uligevægten mellem antallet af bryst-, blære- og prostatatumorer skal betragtes med forbehold, vil dette blive videre undersøgt i studier efter markedsføring.
English: In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking Forxiga.
Danish: Især hvis du følger en diabetesdiæt med vægtkontrol, skal du fortsat følge denne, mens du tager Forxiga.
English: Your doctor may decide to temporarily or permanently stop your treatment with Forxiga.
Danish: Lægen kan beslutte at stoppe behandlingen med Forxiga midlertidigt eller permanent.
English: Parathyroid hormone (PTH)
Danish: Parathyroideahormon (PTH)
English: • if you are are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension).
Danish: • Hvis du tager medicin, der skal sænke dit blodtryk (anti-hypertensiva) og har en sygehistorie med for lavt blodtryk (hypotension).
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: Disse symptomer kan være tegn på ”diabetisk ketoacidose” - en komplikation, du kan få ved diabetes på grund af forhøjet niveau af ”ketonstoffer” i urinen eller blodet, som kan ses i laboratorieanalyser.
English: • if you have a kidney problem - your doctor may ask you to take a different medicine.
Danish: • Hvis du har et nyreproblem - din læge vil måske bede dig om at tage en anden medicin.
English: Taking this medicine
Danish: Sådan tages denne medicin
English: Package leaflet: Information for the patient
Danish: Indlægsseddel: Information til brugeren
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: In the clinical program, 34.4% of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9% had hypertension.
Danish: I det kliniske udviklingsprogram havde 34,4 % af forsøgspersonerne en anamnese med kardiovaskulær sygdom (eksklusive hypertension) ved baseline, og 67,9 % havde hypertension.
English: Despite the presence of hyperglycaemia in type 2 diabetes, reabsorption of filtered glucose continues.
Danish: På trods af tilstedeværelsen af hyperglykæmi i type 2-diabetes fortsætter reabsorptionen af filtreret glucose.
English: approximately 15% of the dose was excreted as parent drug.
Danish: I afføringen blev ca. 15 % af dosen udskilt som det oprindelige lægemiddel.
English: • This medicine does not require any special storage conditions.
Danish: • Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Other side effects when taking Forxiga:
Danish: Andre bivirkninger, når du tager Forxiga:
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Forxiga kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Diet and exercise
Danish: diæt og motion.
English: Consequently, low-weight patients may have somewhat increased exposure and patients with high weight somewhat decreased exposure.
Danish: Som følge heraf kan patienter med lav vægt have en noget højere eksponering, og patienter med høj vægt en noget lavere eksponering.
English: Furthermore, two 12week, placebo-controlled studies were conducted in patients with inadequately controlled type 2 diabetes and hypertension.
Danish: Desuden blev to 12-ugers placebokontrollerede studier udført med patienter med utilstrækkeligt kontrolleret type 2-diabetes og hypertension.
English: Elderly patients may be at a greater risk for volume depletion and are more likely to be treated with diuretics.
Danish: Ældre patienter kan have en øget risiko for volumendepletering og en større sandsynlighed for at være i behandling med diuretika.
English: You should stop taking this medicine if you become pregnant, since it is not recommended during the second and third trimesters of pregnancy.
Danish: Hold op med at tage dette lægemiddel, hvis du bliver gravid, da det ikke bør tages i de sidste seks måneder af graviditeten.
English: Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italy
Danish: Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italien
English: To control your diabetes, you still need to keep to diet and exercise, even when you are taking this medicine.
Danish: For at kontrollere din diabetes skal du stadig følge kostrådene og motionere, også selvom du tager denne medicin.
English: Urinary uric acid excretion was also increased transiently (for 3-7 days) and accompanied by a sustained reduction in serum uric acid concentration.
Danish: Udskillelsen af urinsyre i urinen øgedes ligeledes forbigående (i 3-7 dage) ledsaget af en vedvarende reduktion i koncentrationen af serumurinsyre.
English: Take the medicine pack with you.
Danish: Medbring medicinens emballage.
English: It is not known if DKA is more likely to occur with higher doses of dapagliflozin.
Danish: Det er ukendt, om der er større sandsynlighed for DKA ved højere doser af dapagliflozin.
English: Volume depletion includes, e.g. the predefined preferred terms: dehydration, hypovolaemia, hypotension.
Danish: Volumendepletering omfatter de foruddefinerede foretrukne termer: dehydrering, hypovolæmi, hypotension.
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 lægemiddelovervågningsaktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: The following adverse reactions have been identified in the placebo-controlled clinical trials.
Danish: Følgende bivirkninger er identificeret i de placebokontrollerede kliniske studier.
English: This may be another medicine taken by mouth and/or insulin given by injection.
Danish: Det kan være et andet lægemiddel indtaget gennem munden, og/eller insulin indgivet ved injektion.
English: • They work by lowering the amount of sugar (glucose) in your blood.
Danish: • Det virker ved at sænke indholdet af sukker (glucose) i blodet.
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 et antal tilfælde fremstod tilstanden atypisk, idet der kun var moderat forhøjet blodglucose, under 14 mmol/l (250 mg/dl).
English: Post-prandial glucose
Danish: Postprandial glucose
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Danish: Forøgelsen i simvastatin- og simvastatinsyreeksponeringer betragtes ikke som klinisk relevante.
English: Do not drive or use any tools or machines, if you feel dizzy taking Forxiga.
Danish: Lad være med at arbejde med værktøj eller maskiner, hvis du bliver svimmel, når du tager Forxiga.
English: Dapagliflozin did not induce tumours in either mice or rats at any of the doses evaluated in two-year carcinogenicity studies.
Danish: Dapagliflozin inducerede hverken tumorer hos mus eller rotter ved nogle af de doser, der blev evalueret i toårige karcinogenicitetsstudier.
English: The effects of smoking, diet, herbal products and alcohol use on the pharmacokinetics of dapagliflozin have not been studied.
Danish: Virkningerne af rygning, diæt, naturlægemidler og alkoholforbrug på farmakokinetikken af dapagliflozin er ikke blevet undersøgt.
English: These findings were associated with dose-related increases in kidney weight and macroscopic kidney enlargement observed at all doses.
Danish: Disse resultater var forbundet med dosisrelaterede øgning af nyrernes vægt og makroskopisk nyreforstørrelse observeret ved alle doser.
English: Hence, Forxiga can be administered with or without food.
Danish: Derfor kan Forxiga indgives med eller uden mad.
English: Paediatric population Pharmacokinetics in the paediatric population have not been studied.
Danish: Pædiatrisk population Farmakokinetikken i den pædiatriske population er ikke blevet undersøgt.
English: Cardiovascular safety
Danish: Kardiovaskulær sikkerhed
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger - Gem indlægssedlen.
English: Forxiga should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Danish: Forxiga må ikke anvendes til patienter med type 1-diabetes mellitus eller til behandling af diabetisk ketoacidose.
English: The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78%.
Danish: Den absolutte orale biotilgængelighed af dapagliflozin efter indgivelse af en dosis på 10 mg er 78 %.
English: Considering the lack of tumour findings in non-clinical studies as well as the short latency between first drug exposure and tumour diagnosis, a causal relationship is considered unlikely.
Danish: Ved vurdering af de manglende tumorfund i prækliniske studier samt den korte latensperiode mellem første eksponering for lægemidlet og tumordiagnosen, anses en kausal sammenhæng for værende usandsynlig.
English: The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within the approximate 1-month recovery period.
Danish: Dilatation af nyrebækken og -tubuli observeret hos unge dyr var ikke reversible inden for den omtrentlige restitutionsperiode på 1 måned.
English: What to do if you forget to take a tablet depends on how long it is until your next dose.
Danish: Hvis du har glemt at tage en tablet, skal du gøre som beskrevet nedenfor (afhængigt af hvor længe, der er til næste dosis):
English: Therefore, dapagliflozin is not expected to alter the metabolic clearance of coadministered medicinal products that are metabolised by these enzymes.
Danish: Dapagliflozin forventes således ikke at ændre den metaboliske clearance af samtidigt administrerede lægemidler, der metaboliseres af disse enzymer.
English: In a separate study of pre- and postnatal development, maternal rats were dosed from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation.
Danish: I et separat studie af præ- og postnatal udvikling blev moderrotter doseret fra gestationsdag 6 til og med postnatal dag 21, og unger blev indirekte eksponeret in utero og igennem hele ammeperioden.
English: When pregnancy is detected, treatment with dapagliflozin should be discontinued.
Danish: Når der konstateres graviditet, bør behandling med dapagliflozin seponeres.
English: Further evaluation of patients who had renal-related adverse events showed that most had serum creatinine changes of ≤ 0.5 mg/dL from baseline.
Danish: Yderligere undersøgelse af patienter, som havde bivirkninger relateret til nyrerne, viste, at de fleste havde en ændring i serumkreatinin på ≤ 0,5 mg/dl fra baseline.
English: The increase in urinary volume was associated with a small and transient increase in urinary sodium excretion that was not associated with changes in serum sodium concentrations.
Danish: Øgningen af urinmængden var forbundet med en lille og forbigående øgning i udskillelsen af natrium i urinen, som ikke var forbundet med ændringer i serumnatrium koncentrationen
English: Forxiga is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
Danish: Forxiga er indiceret til voksne personer på 18 år eller ældre med type 2-diabetes mellitus for at forbedre den glykæmiske kontrol, som:
English: Use in patients treated with pioglitazone
Danish: Patienter i behandling med pioglitazon
English: Patients should be alerted to the risk of hypoglycaemia when dapagliflozin is used in combination with a sulphonylurea or insulin.
Danish: Patienterne bør advares om risikoen for hypoglykæmi, når dapagliflozin anvendes i kombination med et sulfonylurinstof eller insulin.
English: Stop taking Forxiga and see a doctor as soon as possible if you notice any of the following serious side effects:
Danish: Stop med at tage Forxiga og opsøg hurtigst muligt en læge, hvis du får nogen af følgende alvorlige bivirkninger:
English: It is unknown whether dapagliflozin and/or its metabolites are excreted in human milk.
Danish: Det vides ikke, om dapagliflozin og/eller dets metabolitter udskilles i human mælk.
English: • Do not use this medicine after the expiry date, which is stated on the blister or carton after ‘EXP'.
Danish: • Brug ikke Forxiga efter den udløbsdato ("EXP"), der står på blisterkort og pakning.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Danish: • Hvis du tager anden medicin, som sænker sukkerindholdet i blodet, som f.eks. insulin eller en medicin med "sulfonylurinstof".
English: A clinically relevant effect with other inducers (e.g. carbamazepine, phenytoin, phenobarbital) is not expected.
Danish: Der forventes ingen klinisk relevant effekt ved samtidig brug af andre induktorer (f.eks. carbamazepin, phenytoin, phenobarbital).
English: Gender The mean dapagliflozin AUCss in females was estimated to be about 22% higher than in males.
Danish: Den gennemsnitlige dapagliflozin AUCss hos kvinder blev vurderet til at være ca. 22 % højere end hos mænd.
English: aRandomized and treated patients with baseline and at least 1 post-baseline efficacy measurement.
Danish: Randomiserede og behandlede patienter med baseline og mindst 1 post-baseline-effektmåling.
English: Combinations not studied Dapagliflozin has not been studied in combination with glucagon-like peptide 1 (GLP-1) analogues.
Danish: Ikke undersøgte kombinationer Dapagliflozin er ikke undersøgt i kombination med glucagon-lignende peptid 1 (GLP-1)-analoger.
English: Forxiga is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years and older).
Danish: Forxiga anvendes til en type diabetes kaldet "type 2-diabetes mellitus" hos voksne patienter (over 18 år).
English: Maximum dapagliflozin plasma concentrations (Cmax) were usually attained within 2 hours after administration in the fasted state.
Danish: De maksimale plasmakoncentrationer af dapagliflozin (Cmax) blev som regel opnået inden for 2 timer efter indgivelse i fastende tilstand.
English: Dapagliflozin exposure was found to decrease with increased weight.
Danish: Eksponeringen for dapagliflozin viste sig at falde med øget vægt.
English: If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Forxiga.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), så tal med din læge, apotekspersonalet eller sundhedspersonalet, før du begynder at tage Forxiga.
English: Cardiovascular death, MI and stroke were observed with a hazard ratio of 0.77 (95% CI: 0.54, 1.10).
Danish: For kardiovaskulær død, MI og stroke observeredes en hazard ratio på 0,77 (95 % CI: 0,54, 1,10).
English: These subjects had detectable glucose in the urine for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension or electrolyte imbalance, and with no clinically meaningful effect on QTc interval.
Danish: Disse forsøgspersoner havde påviselig glucose i urinen i en dosisrelateret periode (mindst 5 dage for dosis på 500 mg) uden nogen indberetninger om dehydrering, hypotension eller elektrolytubalance, og ingen klinisk relevant virkning på QTc-interval.
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: Genstart af behandling med SGLT2-hæmmer hos patienter med fortilfælde af DKA under behandling med SGLT2-hæmmer frarådes, medmindre en anden klar medvirkende faktor identificeres og afklares.
English: These infections were more frequent in females, and subjects with a prior history were more likely to have a recurrent infection.
Danish: Disse infektioner sås hyppigere hos kvinder, og forsøgspersoner med tidligere infektion var mere tilbøjelige til at få en recidiverende infektion.
English: • Your doctor may ask you to take Forxiga on its own if you are intolerant to metformin or together with other medicines to treat diabetes.
Danish: • Lægen kan bede dig om at tage Forxiga alene, hvis du ikke kan tåle metformin, eller sammen med anden medicin til behandling af diabetes.