FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients and/or care-givers should be informed on the risk of lactic acidosis.
Danish: Patienter og/eller omsorgspersoner skal informeres om risikoen for laktatacidose.
English: If you are following a special diet for diabetes, you should continue with this while you are taking Glubrava.
Danish: Hvis De følger en speciel diabetesdiæt, skal De fortsætte med denne, mens De tager Glubrava.
English: The safety and efficacy of Glubrava in children and adolescents under 18 years of age have not been established.
Danish: Glubravas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Your blood sugar could fall below the normal level and can be increased by taking sugar.
Danish: Blodsukkeret kan falde til under det normale niveau, men kan bringes til at stige igen ved indtagelse af sukker.
English: Do not take Glubrava: if you are allergic to pioglitazone, metformin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Glubrava: - hvis De er allergisk over for pioglitazon, metformin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Danish: - hvis De har vand i kroppen (ødemer) eller har problemer med hjertesvigt, specielt hvis De er over 75 år.
English: Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Danish: Den totale plasmakoncentration af pioglitazon er uændret, men med øget fordelingsvolumen.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
Danish: Hvis dette er relevant for Dem, skal De anvende sikker prævention, så De undgår uønsket graviditet.
English: Glubrava should be discontinued if any deterioration in cardiac status occurs.
Danish: Glubrava bør seponeres, hvis der opstår en forværring i kardiel status.
English: Pregnancy and breast-feeding - you must tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: Graviditet og amning - Fortæl Deres læge, hvis De er gravid, har mistanke om, at De er gravid eller planlægger at blive gravid.
English: During treatment with Glubrava, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Under behandlingen med Glubrava vil lægen kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, og/eller hvis din nyrefunktion bliver dårligere.
English: if you have severely reduced kidney function.
Danish: - hvis du har alvorligt nedsat nyrefunktion.
English: Frequencies are defined as: 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: Hyppigheden er defineret som: 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: Tablets should be swallowed with a glass of water.
Danish: Tabletterne skal tages med et glas vand.
English: Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Danish: Pioglitazon og alle aktive metabolitter har en høj bindingsgrad til plasmaprotein (> 99 %).
English: No dose adjustment.
Danish: Ingen dosisjustering.
English: If no adequate strength of Glubrava is available, individual monocomponents should be used instead of the fixed dose combination.
Danish: Hvis der ikke findes en passende styrke af Glubrava, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Danish: Næsten halvdelen af patienterne havde tidligere haft et hjerteinfarkt, og omkring 20 % havde haft et slagtilfælde.
English: However patients who experience visual disturbance should be cautious when driving or using machines.
Danish: Patienter, som får synsforstyrrelser, skal dog udvise forsigtighed, når de færdes i trafikken eller betjener maskiner.
English: Women of childbearing potential / Contraception in males and females
Danish: Kvinder i den fertile alder / kontraception hos mænd og kvinder
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain
Danish: de la Industria 30, 28108 Alcobendas, Madrid, Spanien
English: In patients who fail to show an adequate response, pioglitazone should be discontinued.
Danish: Hos patienter, der ikke udviser et acceptabelt respons, bør pioglitazon seponeres.
English: There have been no formal interaction studies for Glubrava.
Danish: Der er ikke udført formelle interaktionsstudier med Glubrava.
English: The estimated volume of distribution in humans is 0.25 L/kg.
Danish: Fordeling Det beregnede fordelingsvolumen hos mennesker er 0,25 1/kg.
English: These findings were observed across species at plasma concentrations ≤4 times the clinical exposure.
Danish: Disse fund blev observeret i forskellige dyrearter ved plasmakoncentrationer  4 gange den kliniske eksponering.
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/mL.
Danish: Ved de sædvanlige metformindoser og doseringsskemaer nås steady state plasmakoncentrationer inden for 24-48 timer, og de er sædvanligvis mindre end 1 µg/ml.
English: This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
Danish: Dette studie viste et øget antal rapporter om hjertesvigt; det førte imidlertid ikke til en øget dødelighed i studiet.
English: Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Danish: Ældre Steady-state-farmakokinetik er ens hos patienter på 65 år og derover og unge personer.
English: Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Danish: Pioglitazon eller placebo blev føjet til eksisterende antidiabetisk og kardiovaskulær behandling i op til 3,5 år.
English: When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Danish: Når aktivitet, koncentrationer og proteinbinding tages med i betragtning, bidrager pioglitazon og metabolit M-III ligeligt til effekten.
English: It is unknown whether pioglitazone and metformin are excreted in human milk.
Danish: Det er ukendt, om pioglitazon og metformin udskilles i human mælk.
English: Your doctor will take this into account when treating your diabetes.
Danish: Deres læge vil tage dette i betragtning ved planlægning af Deres behandling.
English: A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
Danish: Der er set et øget antal knoglebrud hos patienter, særligt kvinder, der tog pioglitazon.
English: Packs of 14, 28, 30, 50, 56, 60, 90, 98 and 180 tablets.
Danish: Pakninger med 14, 28, 30, 50, 56, 60, 90, 98, og 180 tabletter.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda (logo)
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Takeda (logo)
English: Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).
Danish: Patienterne skal være opmærksomme på risikoen for graviditet, og hvis en patient ønsker at blive gravid, eller hvis graviditet forekommer, bør behandlingen seponeres (se pkt.
English: Epidemiological studies have also suggested a small increased risk of bladder cancer in diabetic patients treated with pioglitazone, although not all studies identified a statistically significant increased risk.
Danish: Epidemiologiske studier har også antydet en let øget risiko for blærecancer hos diabetespatienter behandlet med pioglitazon, selv om ikke alle studier fandt en statistisk signifikant øget risiko.
English: The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Danish: Den maksimale daglige metformindosis skal helst fordeles på 2-3 doser.
English: Animal studies have not revealed teratogenic effects or do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har ikke afsløret teratogen effekt eller indikerer ingen direkte eller indirekte skadelige effekter med hensyn til reproduktionstoksicitet (se pkt.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g every 3-6 months.
Danish: Hos patienter med øget risiko for yderligere progression af nyreinsufficiens og hos ældre bør nyrefunktionen vurderes oftere, f.eks. hver 3.-6. måned.
English: You should swallow the tablets with a glass of water.
Danish: De skal tage tabletterne med et glas vand.
English: Many of these patients reported concurrent peripheral oedema.
Danish: Mange af disse patienter rapporterede om samtidigt perifert ødem.
English: Visceral fat was significantly decreased, while there was an increase in extra-abdominal fat mass.
Danish: Mængden af visceralt fedt blev signifikant reduceret, mens der sås en stigning i den ekstraabdominale fedtmasse.
English: Combinations requiring precautions for use
Danish: Kombinationer, der kræver forsigtighed
English: Your doctor will ask you to have blood tests periodically during treatment with Glubrava.
Danish: Deres læge vil bede Dem om at få taget blodprøver periodevis, mens De er i behandling med Glubrava.
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Danish: I kliniske forsøg har patienter taget pioglitazon i højere doser end den anbefalede maksimale dosis på 45 mg dagligt.
English: Combination use with insulin should be considered with caution in the elderly because of increased risk of serious heart failure.
Danish: Kombinationsbehandling med insulin bør overvejes nøje hos ældre på grund af øget risiko for svær hjerteinsufficiens.
English: Based on the data presented, the risk minimisation measures in the approved product information are considered adequate for the listed safety concerns.
Danish: På baggrund af de forelagte data anses risikominimeringsforanstaltningerne i den godkendte produktinformation for at være tilstrækkelige for de anførte sikkerhedsmæssige betænkeligheder.
English: There are no adequate human data from the use of pioglitazone in pregnant women.
Danish: Der foreligger ikke tilstrækkelige humane data om brugen af pioglitazon hos gravide kvinder.
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Danish: De rapporterede ødemer var generelt lette til moderate og krævede sædvanligvis ikke seponering af behandlingen.
English: if you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties.
Danish: - hvis De for nyligt har haft et hjertetilfælde, eller har haft alvorlige kredsløbsproblemer, herunder chok og vejrtrækningsproblemer.
English: In light of age- related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly.
Danish: I lyset af aldersrelaterede risici (især blærecancer, knoglebrud og hjerteinsufficiens) bør forholdet mellem fordele og risici overvejes nøje både før og under behandlingen hos ældre.
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Renal clearance af metformin er > 400 ml/min, hvilket tyder på, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
English: If you stop using Glubrava, your blood sugar may go up.
Danish: Hvis De holder op med at tage Glubrava, kan Deres blodsukker stige.
English: If ALT levels remain > 3 x the upper limit of normal, therapy should be discontinued.
Danish: Hvis ALAT-niveauer forbliver > 3 x den øvre, normale grænse, bør behandlingen seponeres.
English: Glubrava has no or negligible influence on the ability to drive and use machines.
Danish: Glubrava påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: They are supplied in aluminium/aluminium blister in packs of 14, 28, 30, 50, 56, 60, 90, 98 or 180 tablets.
Danish: De leveres i aluminium/aluminium blister i pakninger med 14, 28, 30, 50, 56, 60, 90, 98, 180 tabletter.
English: FOR CALENDARISED PACKS: Mon. 1
Danish: FORKORTELSER FOR UGEDAGE TIL KALENDERPAKNINGER: Man. 1 Man. 2
English: The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Danish: Den gennemsnitlige plasmahalveringstid for uomdannet pioglitazon er hos mennesket 5-6 timer og for dets samlede, aktive metabolitter 16-23 timer.
English: Maximum daily dose is 45 mg
Danish: Maksimal daglig dosis er 45 mg.
English: These effects were independent of pioglitazone's effects on glycaemia and were statistically significantly different to glibenclamide.
Danish: Disse effekter var uafhængige af pioglitazons virkning på glykæmi og var statistisk signifikant forskellige fra glibenclamid.
English: After oral administration, metformin absorption is saturable and incomplete.
Danish: Efter oral administration er metforminabsorptionen mættelig og ufuldstændig.
English: Ask your doctor or pharmacist for more information if you are not sure how to recognise this.
Danish: Spørg lægen eller apotekspersonalet om flere oplysninger, hvis De ikke er sikker på, hvordan de genkender disse symptomer.
English: Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Danish: Omkring halvdelen af forsøgspopulationen opfyldte mindst to af de kardiovaskulære inklusionskriterier.
English: Thus free (unbound) pioglitazone concentration is unchanged.
Danish: Koncentrationen af frit (ubundet) pioglitazon er således uændret.
English: The safety profile seen in this study reflected the known adverse reactions seen with the individual products and did not suggest any new safety issues.
Danish: Den observerede sikkerhedsprofil i dette forsøg afspejlede de kendte bivirkninger, der ses i forbindelse med de enkelte præparater, og tydede ikke på nye problemer vedrørende sikkerheden.
English: Consideration of such aetiology is recommended if a patient presents with megaloplastic anaemia.
Danish: En sådan ætiologi bør overvejes, hvis en patient fremviser megaloplastisk anæmi.
English: Glubrava should not be used during pregnancy.
Danish: Glubrava må ikke anvendes under graviditet.
English: There is no clinical experience of pioglitazone in triple combination with other oral antidiabetic medicinal products.
Danish: Der er ingen klinisk erfaring med pioglitazon i triple-kombination med andre orale antidiabetika.
English: Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Denmark
Danish: Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Danmark
English: if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision.
Danish: - hvis De lider af en særlig øjenlidelse hos diabetikere, som hedder makulaødem (væskeansamling i det bagerste af øjet), skal De tale med Deres læge, hvis De bemærker ændringer i Deres syn.
English: Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Danish: Efter oral indgivelse af radioaktivt mærket pioglitazon hos mennesker genfandtes den mærkede del hovedsagelig i fæces (55 %) og i en mindre mængde i urin (45 %).
English: Monitoring of liver function
Danish: Monitorering af leverfunktion
English: Tmax was delayed by food by approximately 1.9 h for pioglitazone and 0.8 h for metformin.
Danish: Tmax forsinkedes cirka 1,9 timer ved fødeindtagelse ved pioglitazon og 0,8 timer ved metformin.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
English: It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Danish: Det anbefales, at De altid medbringer sukkerknalder, slik, kiks eller sød frugtjuice.
English: In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Danish: I en dyremodel af familiær adenomatøs polyposis (FAP), der var blevet behandlet med to andre thiazolidindioner øgedes tumor mangfoldigheden i kolon.
English: If you take Glubrava with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Danish: Hvis De tager Glubrava sammen med anden diabetesmedicin, er der en større risiko for, at Deres blodsukker falder til under det normale niveau (hypoglykæmi).
English: Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Danish: Inden for hver enkelt systemorganklasse er bivirkningerne opstillet efter faldende forekomst efterfulgt af, hvor alvorlige de er.
English: if you have heart failure or have had heart failure in the past.
Danish: - hvis De lider af hjertesvigt eller tidligere har haft hjertesvigt.
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Danish: En undersøgelse med syv normale, raske frivillige viste, at cimetidin, givet i doser på 400 mg to gange dagligt, forøgede metformins systemiske eksponering (AUC) med 50 % og Cmax med 81 %.
English: After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Danish: Efter påbegyndelse af behandling med pioglitazon bør patienten monitoreres efter 3-6 måneder for at vurdere, om behandlingsresponset er acceptabelt (f.eks. reduktion i HbA1c).
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Danish: Dette er påvist ved terapeutiske doser i kontrollerede, mellemlange eller langvarige kliniske studier: metformin reducerer total-kolesterol, LDLc og triglyceridniveauer.
English: After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Danish: Efter eksklusion af de patienter, som var blevet eksponeret for studiemedicinen i mindre end et år på tidspunktet for diagnosticering af blærecancer, var der 7 tilfælde (0,06 %) i pioglitazongruppen og 2 tilfælde (0,02 %) i kontrolgruppen.
English: Before you start taking Glubrava you will have a blood sample taken to check your liver function.
Danish: Før De begynder at tage Glubrava, vil De få taget en blodprøve til kontrol af leverfunktionen.
English: Pioglitazone was associated with significant weight gain.
Danish: Pioglitazon blev forbundet med en signifikant vægtstigning.
English: 4 Gastrointestinal disorders occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Danish: Gastrointestinale forstyrrelser opstår hyppigst i starten af behandlingen og forsvinder i de fleste tilfælde spontant.
English: Glubrava may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Glubrava kan forårsage en meget sjælden, men meget alvorlig bivirkning, som kaldes laktatacidose, især hvis dine nyrer ikke fungerer korrekt.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Glubrava (also see section 4) if you have a problem with your heart.
Danish: Kontakt lægen eller apoteket, før De tager Glubrava (se også punkt 4) - hvis De har problemer med hjertet.
English: Glubrava with alcohol
Danish: Brug af Glubrava sammen med alkohol
English: Repeated dosing does not result in accumulation of the compound or metabolites.
Danish: Gentaget dosering resulterer ikke i akkumulation af dette stof eller af metabolitter.
English: The MAH provided updates on new information related to the important identified and important potential risks as listed in the summary of safety concerns.
Danish: Indehaveren af markedsføringstilladelsen har tilvejebragt opdateringer om nye oplysninger vedrørende de vigtige identificerede og de vigtige potentielle risici som anført i oversigten over sikkerhedsmæssige betænkeligheder.
English: The relevance of this finding is unknown.
Danish: Relevansen af disse fund er ukendt.
English: When starting or using such products in combination with Glubrava, close monitoring of renal function is necessary.
Danish: Ved initiering eller brug af sådanne præparater i kombination med Glubrava skal nyrefunktionen monitoreres tæt.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/mL, even at maximum doses.
Danish: I kontrollerede kliniske studier overskred de maksimale metformin-plasmakoncentrationer (Cmax) ikke 4 µg/ml, selv ved maksimale doser.
English: Glubrava contains pioglitazone and metformin which are anti-diabetic medicines, used to control blood sugar level.
Danish: Glubrava indeholder pioglitazon og metformin, som er lægemidler mod diabetes, som anvendes til at kontrollere blodsukkerniveauet.
English: It is used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient.
Danish: Det anvendes til behandling af type 2 (ikke-insulinkrævende) diabetes mellitus hos voksne, hvor behandling med metformin alene ikke er tilstrækkelig.
English: No increase in mortality from heart failure was observed.
Danish: Der sås ingen stigning i dødeligheden som følge af hjertesvigt.
English: Denmark.
Danish: Danmark.
English: HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Danish: En HOMA-analyse viste, at pioglitazon forbedrer beta-cellefunktionen samt øger insulinfølsomheden.
English: In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces.
Danish: Hos dyr kan der kun påvises en lille mængde uomdannet pioglitazon i enten urin eller fæces.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken og blisterkortet efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: if you have cysts on your ovaries (polycystic ovary syndrome).
Danish: - hvis De har cyster på æggestokkene (polycystisk ovariesyndrom).
English: - do not use this medicine if you are breastfeeding or are planning to breast-feed (see section “Do not take Glubrava”).
Danish: - Tag ikke dette lægemiddel, hvis De ammer eller ønsker at amme (se afsnittet “Tag ikke Glubrava”).
English: Your doctor may take blood tests to monitor your blood cell levels and liver function.
Danish: Deres læge kan tage en blodprøve for at måle niveauet for Deres blodlegemer samt leverfunktion.
English: very rare very rare lactic acidosis very rare very rare
Danish: meget sjælden meget sjælden laktacidose meget sjælden meget sjælden