FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic impairment: In cirrhotic patients with moderate (Child-Pugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
Danish: Nedsat leverfunktion: Hos cirrhotiske patienter med moderat (Child-Pugh B) nedsat leverfunktion var ubundet Cmax og AUC 2-3 gange højere end hos normale personer.
English: Since NSAIDs, insulin and rosiglitazone are all associated with fluid retention, concomitant administration may increase the risk of oedema.
Danish: Eftersom både NSAID, insulin og rosiglitazon er associeret med væskeretention, kan samtidig administration forhøje risikoen for ødem.
English: Avandamet contains lactose
Danish: Avandamet indeholder Lactose
English: In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Danish: I kliniske undersøgelser med rosiglitazon har der været tegn på dosisrelateret vægtforøgelse, som var større ved kombinationsbehandling med insulin.
English: The majority of the fractures were reported in the upper limbs and distal lower limbs (see section 4.4).
Danish: Hovedparten af frakturerne var i overekstremiteterne og de distale underekstremiteter (se afsnit 4.4).
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Danish: Metformin stimulerer intracellulær glycogensyntese ved at påvirke glycogensyntesen.
English: Avandamet can be used alone or with a sulphonylurea, another medicine for diabetes.
Danish: Avandamet kan anvendes alene eller i kombination med et sulfonylurinstof (et andet lægemiddel til behandling af diabetes).
English: Renal insufficiency: There are no clinically significant differences in the pharmacokinetics of rosiglitazone in patients with renal impairment or end stage renal disease on chronic dialysis.
Danish: Nyreinsufficiens: Der ses ingen klinisk signifikante forskelle i rosiglitazons farmakokinetik hos patienter med nyresvigt eller terminal nyresygdom i kronisk dialyse.
English: Rosiglitazone is a selective agonist at the PPARγ (peroxisome proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of antihyperglycaemic agents.
Danish: Rosiglitazon er en selektiv agonist ved de specifikke kernereceptorer PPARγ (peroxisomal proliferator-aktiveret receptor gamma) og tilhører antidiabetikumgruppen thiazolidinedioner.
English: - in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).
Danish: - som oral tripel-kombinationsbehandling med et sulfonylurinstof hos patienter med insufficient glykæmisk kontrol trods oral kombinationsbehandling med maksimalt tolereret dosis af metformin og sulfonylurinstof (se afsnit 4.4).
English: Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Danish: Behandling med rosiglitazon er forbundet med en dosisrelateret reduktion i hæmoglobinniveauet.
English: (You can also take this dose as two 1 mg/500 mg tablets, twice a day.)
Danish: (Du kan også tage denne dosis som to 1 mg/500 mg tabletter to gange daglig.)
English: The decision whether to continue the patient on therapy with AVANDAMET should be guided by clinical judgement pending laboratory evaluations.
Danish: Beslutningen om at lade patienten fortsætte behandling med AVANDAMET bør tages på baggrund af en klinisk vurdering baseret på løbende laboratorieundersøgelser.
English: Rosiglitazone with metformin
Danish: Rosiglitazon med metformin
English: Clinical trial data (addition of insulin to established AVANDAMET therapy) In a single study (n=322) where insulin was added to patients established on AVANDAMET, no new adverse events were observed in excess of those already defined for either AVANDAMET or rosiglitazone combination therapies.
Danish: Data fra kliniske undersøgelser (insulin som supplement til behandling med AVANDAMET) I en enkel undersøgelse (n = 322), hvor insulin blev tilføjet behandlingen med AVANDAMET, sås ingen nye bivirkninger ud over dem allerede set med kombinationsbehandling med enten AVANDAMET eller rosiglitazon.
English: Î Tell a doctor or pharmacist if you are taking any of these.
Danish: Fortæl det til din læge eller på apoteket, hvis du tager nogen af disse.
English: • lower blood sugar than normal (hypoglycaemia)
Danish: • lavere blodsukker end normalt (hypoglykæmi) • hævelse (ødem) på grund af væskeophobning
English: Stop taking Avandamet.
Danish: Stop med at tage Avandamet.
English: • steroids (used to treat inflammation) such as prednisolone or dexamethasone
Danish: • steroider (anvendes til at behandle betændelse) såsom prednisolon eller dexamethason
English: Speak to your doctor, as you may need to stop taking Avandamet for a short while.
Danish: Det kan være, at du er nødt til at stoppe med at tage Avandamet i en kort periode.
English: It reduces glycaemia by reducing insulin resistance at adipose tissue, skeletal muscle and liver.
Danish: Stoffet reducerer glykæmi ved at nedsætte insulinresistensen i fedtvæv, skeletmuskulatur og lever.
English: • cimetidine (used to reduce stomach acid).
Danish: • cimetidin (anvendes til at nedsætte mængden af mavesyre).
English: The relevance of this finding is unknown.
Danish: Relevansen af denne observation er ukendt.
English: PHARMACEUTICAL FORM AND CONTENTS 112 tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 112 tabletter.
English: Patients who are intolerant to lactose or have a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter, som ikke kan tåle lactose eller som har en sjælden arvelig sygdom med galactoseintolerans, som har Lapps laktase mangel eller glucosegalactose malabsorption, bør ikke anvende dette lægemiddel.
English: Nervous system disorders dizziness*
Danish: Nervesystemet Svimmelhed*
English: ADOPT (A Diabetes Outcome Progression Trial) was a multicentre, double-blind, controlled trial with a treatment duration of 4-6 years (median duration of 4 years), in which rosiglitazone at doses of 4 to 8 mg/day was compared to metformin (500 mg to 2000 mg/day) and glibenclamide (2.5 to 15 mg/day) in 4351 drug naive subjects recently diagnosed (≤3 years) with type 2 diabetes.
Danish: ADOPT (A Diabetes Outcome Progression Trial) var et multicenter, dobbeltblindet, kontrolleret studie med en behandlingsvarighed på 4-6 år (median varighed på 4 år), hvor rosiglitazon i doser på 4-8 mg/dag blev sammenlignet med metformin (500-2.000 mg/dag) og glibenclamid (2,5-15 mg/dag) hos 4.351 stofnaive patienter, der for nyligt var diagnosticeret ( ≤ 3 år) med type 2-diabetes.
English: The other ingredients are: sodium starch glycollate, hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, povidone (E1201), magnesium stearate, titanium dioxide (E171), macrogol, iron oxide yellow or red (E172).
Danish: De øvrige indholdsstoffer er natriumstivelsesglycollat, hypromellose (E464), mikrokrystallinsk cellulose (E460), lactosemonohydrat, povidon (E1201), magnesiumstearat, titandioxid (E171), macrogol og gul eller rød jernoxid (E172).
English: Clinical trial data
Danish: Data fra kliniske undersøgelser
English: To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandamet.
Danish: Det er vigtigt, at du følger din læges råd om diæt og levestil.
English: Rosiglitazone was associated with increases in weight.
Danish: Rosiglitazon var forbundet med en vægtøgning.
English: • fluid in the lungs (pulmonary oedema) causing breathlessness
Danish: • væske i lungerne (lungeødem) som kan forårsage stakåndethed
English: - Patients established on triple oral therapy: when appropriate, AVANDAMET may substitute rosiglitazone and metformin doses already being taken.
Danish: - Patienter, der hidtil har fået oral tripel-kombinationsbehandling: Hvor det er hensigtsmæssigt kan AVANDAMET erstatte de rosiglitazon- og metformindoser, som allerede indtages.
English: Not all pack sizes or tablet strengths may be available in your country.
Danish: Ikke alle pakningsstørrelser eller tabletstyrker er nødvendigvis markedsført.
English: An additional observation of an increased incidence of bone fractures was seen in women with rosiglitazone (see sections 4.4 and 4.8).
Danish: Desuden observeredes en øget forekomst af knoglefrakturer hos kvinder i behandling med rosiglitazon (se afsnit 4.4 og 4.8).
English: Rosiglitazone treatment significantly reduced the risk of reaching monotherapy failure (FPG>10.0 mmol/L) by 63% relative to glibenclamide (HR 0.37, CI 0.30-0.45) and by 32% relative to metformin (HR 0.68, CI 0.55-0.85) during the course of the study (up to 72 months of treatment).
Danish: Rosiglitazon reducerede signifikant risikoen for monoterapisvigt (FPG > 10,0 mmol/l) med 63 % i forhold til glibenclamid (HR 0,37; CI 0,30-0,45) og med 32 % i forhold til metformin (HR 0,68; CI 0,55-0,85) i studieforløbet (op til 72 måneders behandling).
English: No animal studies have been conducted with the combined products in AVANDAMET.
Danish: Der er ikke udført dyreforsøg med kombinationen af stofferne i AVANDAMET.
English: However, in their entirety the available data on the risk of cardiac ischaemia are inconclusive (see section 4.8).
Danish: Men alt i alt er foreliggende data om risikoen for myokardieiskæmi inkonklusive (se afsnit 4.8).
English: Rosiglitazone did not stimulate pancreatic insulin secretion or induce hypoglycaemia in rats and mice.
Danish: Rosiglitazon stimulerede ikke udskillelsen af insulin fra pankreas eller induktion af hypoglykæmi hos rotter og mus.
English: Each tablet contains either: 1 mg rosiglitazone and 500 mg metformin; 2 mg rosiglitazone and 500 mg metformin; 2 mg rosiglitazone and 1000 mg metformin or 4 mg rosiglitazone and 1000 mg metformin.
Danish: En tablet indeholder enten: 1 mg rosiglitazon og 500 mg metformin; 2 mg rosiglitazon og 500 mg metformin; 2 mg rosiglitazon og 1000 mg metformin eller 4 mg rosiglitazon og 1000 mg metformin.
English: In double-blind clinical trials with rosiglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo (0.2%) and less than that of the active comparators (0.5% metformin/sulphonylureas).
Danish: I dobbeltblinde kliniske undersøgelser med rosiglitazon var forekomsten af stigninger i ALAT på mere end tre gange den øvre normale grænse af samme størrelse som for placebo (0,2 %) og mindre end ved behandling med de lægemidler, som rosiglitazon blev sammenlignet med (0,5 % metformin/sulfonylurinstof).
English: − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: farmakovigilanceplanen eller aktiviteterne for risikominimering, modtages - inden for 60 dage efter en vigtig milepæl er nået (farmakovigilance eller risikominimering) - efter forespørgsel fra EMEA.
English: Intravascular administration of iodinated contrast agents may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis.
Danish: Intravaskulær administration af jodholdige kontrastmidler kan føre til nyreinsufficiens, som kan betyde ophobning af metformin og risiko for lactacidose.
English: The following data are findings in studies performed with rosiglitazone or metformin individually.
Danish: De følgende data er baseret på baggrund af forsøg med rosiglitazon og metformin individuelt.
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see section 4.4).
Danish: Derfor bør tæt monitorering af glykæmisk kontrol, dosisjustering inden for den anbefalede dosering og ændringer i diabetesbehandling overvejes ved samtidig administration af kationiske lægemidler, der udskilles via renal tubulær sekretion.
English: Frequency
Danish: Frekvens
English: Adverse reactions are presented below for each of the component parts of AVANDAMET.
Danish: Bivirkningerne for hver af delkomponenterne i AVANDAMET er beskrevet nedenfor.
English: As a consequence of different but complementary mechanisms of action, combination therapy of rosiglitazone with metformin resulted in additive effects on glycaemic control in type 2 diabetic patients.
Danish: Som en konsekvens af forskellige, men komplementære, virkningsmekanismer, resulterede kombinationsbehandling med rosiglitazon og metformin i additiv effekt på den glykæmiske kontrol hos patienter med type 2-diabetes.
English: This helps to reduce any problems with your stomach (including indigestion, nausea, vomiting and diarrhoea).
Danish: Dette vil mindske risikoen for mavegener (herunder forstoppelse, kvalme, opkastning og diare).
English: There have been no formal interaction studies for AVANDAMET, however the concomitant use of the active substances in patients in clinical studies and in widespread clinical use has not resulted in any unexpected interactions.
Danish: Samtidig brug af de enkelte aktive indholdsstoffer hos patienter i kliniske undersøgelser, samt omfattende klinisk brug, har ikke vist uventede interaktioner.
English: For AVANDAMET no preclinical or clinical data on exposed pregnancies or lactation are available.
Danish: Der foreligger ikke prækliniske eller kliniske data om eksponering for AVANDAMET under graviditet.
English: • if you have liver disease
Danish: • hvis du har en leversygdom
English: Co-administration of rosiglitazone with rifampicin (an inducer of CYP2C8) resulted in a 66% decrease in rosiglitazone plasma concentrations.
Danish: Samtidig administration af rosiglitazon og rifampicin (en inducer af CYP2C8) resulterede i et fald på 66 % i rosiglitazon plasmakoncentrationer.
English: 2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
Danish: 2Der er set en stigning i antallet af hjerteinsufficiens, når rosiglitazon gives i kombination med sulfonylurinstof (enten i kombinations- eller i tripel-kombinationsbehandling), og forekomsten er højere med 8 mg rosiglitazon sammenlignet med 4 mg rosiglitazon (som total daglig dosis).
English: Gender: In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone between males and females.
Danish: Køn: I den farmakokinetiske analyse med poolet population sås ingen klar forskel i rosiglitazons farmakokinetik hos kvinder og mænd.
English: AVANDAMET should be used with caution during concomitant administration of CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin), due to the effect on rosiglitazone pharmacokinetics (see section 4.5).
Danish: AVANDAMET bør anvendes med forsigtighed under samtidig administration af CYP2C8-inhibitorer (f.eks. gemfibrozil) eller inducerende stoffer (f.eks. rifampicin), pga. effekten på rosiglitazons farmakokinetik (se afsnit 4.5).
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antidiabetisk virkninger, som sænker både basal og postprandial plasmaglucose.
English: MULTIPACKS ONLY (2x56 TABLETS, WRAPPED IN CLEAR PLASTIC) MULTIPACKS ONLY (3x56 TABLETS, PACKED IN BOX)
Danish: KUN MULTIPAKNINGER (2x56 TABLETTER, BEKLÆDT MED KLAR PLASTIK) KUN MULTIPAKNINGER (3x56 TABLETTER, PAKKET I BOKS)
English: • nausea and vomiting
Danish: • kvalme og opkastning
English: Driving and using machines This medicine should not affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Dette lægemiddel påvirker ikke evnen til at færdes sikkert i trafikken eller bruge maskiner.
English: A total of 564 patients withdrew from cardiovascular follow-up, which accounted for 12.3% of rosiglitazone patients and 13% of control patients; representing 7.2% of patient-years lost for cardiovascular events follow-up and 2.0% of patient-years lost for all cause mortality follow-up.
Danish: I alt 564 patienter trak sig ud af den kardiovaskulære opfølgning, 12,3 % af patienterne på rosiglitazon og 13 % of patienterne i kontrolgruppen; det betyder, at 7,2 % patientår er blevet mistet mht. kardiovaskulær opfølgning og 2,0 % patientår mht. opfølgning af død uanset årsag.
English: Fluid retention and heart failure: Avandamet can cause you to retain water (fluid retention) which leads to swelling and weight gain.
Danish: Væskeophobning og hjerteinsufficiens: Avandamet kan være årsag til, at der ophobes væske i din krop, hvilket medfører hævelse og vægtøgning.
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Furthermore, AVANDAMET should be used with caution during concomitant administration of cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) due to the effect on metformin pharmacokinetics (see section 4.5).
Danish: Endvidere bør der udvises forsigtighed ved samtidig brug af AVANDAMET og kationiske lægemidler, der elimineres via renal tubulær sekretion (f.eks. cimetidin), pga. effekten på metformins farmakokinetik (se afsnit 4.5).
English: • if you are going to have an X-ray using an injected dye.
Danish: • hvis du skal have foretaget røntgen med injicerbart farvestof.
English: The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with sulphate and glucuronic acid.
Danish: Metabolismen sker primært gennem N-demetylation og hydroxylation, efterfulgt af konjugation med sulfat og glukoronsyre.
English: Therefore weight should be closely monitored, given that it may be attributable to fluid retention, which may be associated with cardiac failure.
Danish: Derfor bør vægten monitoreres tæt hos patienterne, idet vægtforøgelsen kan skyldes væskeretention, som kan sættes i forbindelse med hjerteinsufficiens.
English: A retrospective analysis of data from 42 pooled short-term clinical studies indicated that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events.
Danish: En retrospektiv analyse af de samlede data fra 42 kortvarige kliniske forsøg antydede, at behandling med rosiglitazon kan sættes i forbindelse med en øget risiko for myokardieiskæmi.
English: • stomach pain, nausea and vomiting.
Danish: • mavesmerter, kvalme og opkastning.
English: The major route of excretion is the urine with approximately two-thirds of the dose being eliminated by this route, whereas faecal elimination accounts for approximately 25% of dose.
Danish: Udskillelse sker primært i urinen med cirka 2/3, og gennem fæces med cirka 25 % af doseringen.
English: Rosiglitazone plasma concentrations peak at around 1 h after dosing.
Danish: Rosiglitazons maksimale plasmakoncentration ses cirka 1 time efter administration.
English: In a monotherapy study, the incidence in females for rosiglitazone was 9.3% (2.7 patients per 100 patient years) vs 5.1% (1.5 patients per 100 patient years) for metformin or 3.5% (1.3 patients per 100 patient years) for glibenclamide.
Danish: I et monoterapistudie var forekomsten hos kvinder på rosiglitazon 9,3 % (2,7 patienter pr. 100 patientår) versus 5,1 % (1,5 patient pr. 100 patientår) kvinder på metformin eller 3,5 % (1,3 patient pr. 100 patientår) på glibenclamid.
English: In the fed state, Cmax was lower (22% rosiglitazone and 15% metformin) and tmax delayed (by approximately 1.5 h rosiglitazone and 0.5 h metformin).
Danish: Fødeindtagelse medførte en lavere Cmax (22 % for rosiglitazon og 15 % for metformin) samt forsinket tmax (med cirka 1,5 time for rosiglitazon og 0,5 time for metformin).
English: • stomach pain, feeling sick (nausea), vomiting, diarrhoea or loss of appetite.
Danish: • mavesmerter, kvalme, opkastning, diare eller nedsat appetit.
English: The majority of the fractures have occurred in the upper limbs and distal lower limbs.
Danish: De fleste frakturer forekom i overekstremiteter og distale underekstremiteter.
English: If you forget to take Avandamet Don't take extra tablets to make up for a missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: Rosiglitazone and metformin work together so your body makes better use of the insulin it produces, and this helps reduce your blood sugar to a normal level.
Danish: Rosiglitazon og metformin virker i fællesskab således, at din krop bedre kan udnytte den insulin, den producerer.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
English: Insulin and rosiglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema and could increase the risk of ischaemic heart disease.
Danish: Både insulin og rosiglitazon er associeret med væskeretention, og samtidig administration kan øge risikoen for ødem og iskæmisk hjertesygdom.
English: Ask your pharmacist how to dispose of tablets you don't need.
Danish: Spørg på apoteket, hvordan du skal aflevere medicinrester.
English: No difference in the number of adjudicated primary endpoint events for rosiglitazone (321/2220) versus active control (323/2227) (HR 0.99, CI 0.85-1.16) was observed, meeting the pre-defined noninferiority criterion of 1.20 (non-inferiority p = 0.02).
Danish: Der sås ingen forskel i antallet af vigtigste primære endepunkt-hændelser efter behandling med rosiglitazon (321/2220) over for den aktive kontrolgruppe (323/2227) (HR 0,99, CI 0,85-1,16), der lever op til det forud definerede non-inferiøritetskriterium på 1,20 (non-inferiøritet p = 0,02).
English: • diuretics (used to get rid of water), such as furosemide or indapamide
Danish: • diuretika (anvendes til at fjerne vand) såsom furosemid eller indapamid
English: AVANDAMET must be discontinued if any deterioration in cardiac status occurs.
Danish: Behandling med AVANDAMET skal seponeres ved klinisk forringelse i den kardiale status.
English: • if you have kidney disease
Danish: • hvis du har en nyresygdom
English: Don't take Avandamet.
Danish: Tag ikke Avandamet.
English: In a sub-study at 18 months, add-on rosiglitazone dual therapy was non-inferior to the combination of sulphonylurea plus metformin for lowering HbA1c.
Danish: I en sub-analyse ved 18 måneder i den gruppe, hvor rosiglitazon blev givet i tostofbehandling,var denne kombinationsbehandling non-inferiør i forhold til kombinationen af SU og metformin til reducere HbA1c.
English: • if you are going to have an X-ray using an injected dye (see ‘While you take
Danish: • hvis du skal have foretaget røntgen med injicerbart farvestof (se ”Når du tager Avandamet,
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Danish: Hos mennesker har metformin, uafhængigt af stoffets virkning på blodsukkeret, en gunstig virkning på lipidmetabolismen.
English: Cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Danish: Kationiske lægemidler, der elimineres via renal tubulær sekretion (f.eks. cimetidin), kan interagere med metformin ved at konkurrere om almindelige renale tubulære transportsystemer.
English: The incidence of heart failure on triple oral therapy was 1.4% in the main double blind study, compared to 0.4% for metformin plus sulphonylurea dual therapy.
Danish: Forekomsten af hjerteinsufficiens i det dobbeltblinde hovedstudie var 1,4 % ved tripelkombinationsbehandling, sammenlignet med 0,4 % for kombinationsbehandling med metformin og sulfonylurinstof.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Under hver frekvensgruppering er bivirkningerne stillet op efter faldende alvorlighed.