FrancophonIA/ELRC3.0 huggingface dataset:
English: Insulin should only be added to established rosiglitazone therapy in exceptional cases and under close supervision.
Danish: Insulin bør kun tilføjes til etableret behandling med rosiglitazon i exceptionelle tilfælde og under tæt overvågning.
English: Avandia can be used alone or in combination with other medicines to treat diabetes (such as metformin or a sulphonylurea).
Danish: Avandia kan anvendes alene eller sammen med andre lægemidler til behandling af diabetes (såsom metformin eller et sulfonylurinstof).
English: The elevated total cholesterol levels were associated with increase in both LDLc and HDLc, but the ratio of total cholesterol:HDLc was unchanged or improved in long term studies.
Danish: Det forhøjede totale cholesterolniveau blev forbundet med en forøgelse i både LDLc og HDLc, men forholdet af total cholesterol:HDLc var uændret eller forbedret i langtidsundersøgelser.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Danish: Som angivet i CHMP's retningslinjer for risikohåndteringssystemer for humane lægemidler skal en opdateret RMP indsendes samtidig med den næste periodiske sikkerhedsopdatering (Periodic Safety Update Report, PSUR).
English: The available data do not support efficacy in the paediatric population and therefore such use is not recommended.
Danish: De tilgængelige data støtter ikke virkningen hos børn, og derfor anbefales brugen ikke.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse
English: Avandia tablets contain a small amount of lactose.
Danish: Avandia-tabletter indeholder en lille mængde lactose.
English: Opaque blister packs (PVC/ aluminium).
Danish: Uigennemsigtige blisterpakninger (PVC/Aluminium).
English: RSG + SU RSG +MET +SU
Danish: RSG + MET RSG + SU RSG +MET +SU
English: Increases in liver weight, plasma ALT (dog only) and fat tissue were also observed.
Danish: Stigning i levervægten, plasma ALAT (kun hos hunde) og fedtvæv observeredes også.
English: Children and adolescents: Population pharmacokinetic analysis including 96 paediatric patients aged 10 to 18 years and weighing 35 to 178 kg suggested similar mean CL/F in children and adults.
Danish: Børn og unge: Farmakokinetiske analyser, inkluderede 96 pædiatriske patienter mellem 10 og 18 år som vejede fra 35 til 178 kg, foreslog samme gennemsnits CL/F hos børn og voksne.
English: In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated, as dictated by the patient's clinical status.
Danish: I tilfælde af overdosis anbefales det, at der gives støttende behandling afhængig af patientens kliniske status.
English: In studies with a maximal duration of three years, rosiglitazone given once or twice daily produced a sustained improvement in glycaemic control (FPG and HbA1c).
Danish: I studier med en varighed på maksimum 3 år medførte rosiglitazon indgivet en eller to gange daglig en vedvarende forbedring i glykæmisk kontrol (FPG og HbA1c).
English: • Avandia is not recommended during pregnancy.
Danish: • Avandia bør ikke anvendes under graviditet.
English: This can be taken as one 4 mg tablet once a day, or as one 2 mg tablet taken twice a day.
Danish: Denne dosis kan tages som en 4 mg tablet en gang daglig eller som en 2 mg tablet to gange daglig.
English: • if you are allergic (hypersensitive) to rosiglitazone or any of the other ingredients of
Danish: • hvis du er overfølsom (allergisk) over for rosiglitazon eller et af de øvrige indholdsstoffer i
English: Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Danish: Bivirkninger fra hvert behandlingsregime er listet under organklasser og absolutte frekvenser.
English: Adverse effects observed in animal studies with possible relevance to clinical use were as follows: An increase in plasma volume accompanied by decrease in red cell parameters and increase in heart weight.
Danish: Bivirkninger observeret i dyrestudier med mulig relevans for klinisk brug var følgende: En stigning i plasmavolumen ledsaget af et fald i parametre vedrørende røde blodlegemer samt en stigning i hjertevægten.
English: The impact of these findings on disease progression or on microvascular or macrovascular outcomes has not been determined (see section 4.8).
Danish: Betydningen af disse resultater for sygdomsprogressionen eller for mikrovaskulære eller makrovaskulære hændelser er ikke blevet bestemt (se afsnit 4.8).
English: Î Tell your doctor as soon as possible if you get any of these symptoms - either for the first time or if they get worse.
Danish: Fortæl det til lægen så hurtigt som muligt, hvis du får nogen af disse symptomer - både hvis symptomerne forekommer for første gang eller hvis de bliver værre.
English: AVANDIA has no or negligible influence on the ability to drive and use machines.
Danish: AVANDIA påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The incidence of all adverse events relating to liver and biliary systems was < 1.5% in any treatment group and similar to placebo.
Danish: Incidensen af alle bivirkninger relateret til lever- og galdesystemerne var < 1,5 % i alle behandlingsgrupper og ens med placebo.
English: There are no adequate data from the use of rosiglitazone in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data fra brugen af rosiglitazon hos gravide kvinder.
English: Rosiglitazone has been detected in the milk of experimental animals.
Danish: Rosiglitazon er blevet påvist i mælken hos forsøgsdyr.
English: In mechanistic studies, the weight increase was predominantly shown to be due to increased subcutaneous fat with decreased visceral and intra-hepatic fat.
Danish: Mekanistiske undersøgelser har vist, at vægtøgningen overvejende skyldtes en stigning i subkutant fedt med mindsket visceralt og intra-hepatisk fedt.
English: Rosiglitazone should not be used during pregnancy.
Danish: Rosiglitazon bør ikke anvendes under graviditet.
English: The contribution of the major metabolite (para-hydroxy-sulphate) to the overall anti-diabetic activity of rosiglitazone has not been fully elucidated in man and it cannot be ruled out that the metabolite may contribute to the activity.
Danish: Bidraget fra den hyppigst forekommende metabolit (para-hydroxy-sulfat) til den samlede antidiabetiske aktivitet af rosiglitazon er ikke fuldt ud belyst hos mennesket, og det kan ikke udelukkes, at metabolitten bidrager til aktiviteten.
English: Sími: + 354 530 3700
Danish: Sìmi: + 354 530 3700
English: There are no data available on the use of rosiglitazone in patients under 10 years of age.
Danish: Der er ingen tilgængelige oplysninger om brugen af rosiglitazon hos personer under 10 år.
English: LIST OF EXCIPIENTS Contains lactose, see leaflet for further information
Danish: Indeholder lactose, se indlægsseddel for yderligere information
English: Total plasma clearance of rosiglitazone is around 3 l/h and the terminal elimination half-life of rosiglitazone is approximately 3 to 4 hours.
Danish: Total plasmaclearance af rosiglitazon er omkring 3 l/time, og den endelige halveringstid er ca. 3-4 timer.
English: The maximum dose is 8 mg of Avandia a day.
Danish: Den maksimale dosis er 8 mg Avandia pr. dag.
English: 5 Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported.
Danish: 5Sjældne tilfælde af forhøjede leverenzymer og hepatocellulær dysfunktion er rapporteret.
English: Low blood sugar (hypoglycaemia): If you are taking Avandia with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level.
Danish: Lavt blodsukker (hypoglykæmi): Hvis du tager Avandia i kombination med andre lægemidler til behandling af diabetes, er der risiko for, at dit blodsukker falder ned under det normale niveau.
English: Use of rosiglitazone is contraindicated in patients with:
Danish: Brug af rosiglitazon er kontraindiceret til patienter med:
English: Don't take Avandia:
Danish: Tag ikke Avandia:
English: There is no evidence for unexpected accumulation of rosiglitazone after once or twice daily dosing.
Danish: Der er ikke set uventet akkumulation af rosiglitazon ved en dosering på en eller to gange dagligt.
English: If ALT levels remain >3X the upper limit of normal, therapy should be discontinued.
Danish: Hvis ALAT niveauet forbliver >3x øvre grænse for normal, bør terapien seponeres.
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Danish: Der har været sjældne rapporter med hepatocellulær dysfunktion, set under erfaringerne efter markedsføringen (se afsnit 4.8).
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apoteket.
English: What Avandia contains
Danish: Avandia indeholder
English: Rosiglitazone is a selective agonist at the PPARγ (peroxisomal proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of anti-diabetic agents.
Danish: Rosiglitazon er en selektiv agonist ved PPARγ (peroxisomal proliferator aktiveret gamma) nuklearreceptor og hører hjemme i antidiabetikumgruppen thiazolidinedioner.
English: A more pronounced glucose-lowering effect was observed in obese patients.
Danish: En mere udtalt glucosesænkende effekt blev observeret i overvægtige patienter.
English: The decision to initiate triple oral therapy should include consideration of the alternative to switch the patient to insulin.
Danish: Beslutningen om at påbegynde tripelkombinationsbehanding bør inkludere en overvejelse om alternativt at skifte patienter over på insulin.
English: • if you have had a heart attack or severe angina, that's being treated in hospital
Danish: • hvis du har haft et hjertetilfælde eller alvorlige hjertekramper, som behandles på hospital
English: No intact drug is excreted in urine or faeces.
Danish: Intet intakt lægemiddel udskilles i urin eller fæces.
English: Rosiglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Danish: Justering af rosiglitazon dosis inden for den anbefalede dosering eller ændringer i diabetisk behandling bør overvejes (se afsnit 4.5).
English: In reproductive toxicity studies, administration of rosiglitazone to rats during mid-late gestation was associated with foetal death and retarded foetal development.
Danish: I reproduktionstoxicitetsstudier var administration af rosiglitazon til rotter i anden halvdel af dræktighedsperioden associeret til fosterdød og forsinket fosterudvikling.
English: − an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4)
Danish: − akut koronarsyndrom (ustabil angina, NSTEMI og STEMI) (se afsnit 4.4)
English: Manufacturer: Glaxo Wellcome Production, ZI du Terras, 53100 Mayenne, France.
Danish: Fremstiller: Glaxo Wellcome Production, ZI du Terras, 53100 Mayenne, Frankrig.
English: Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
Danish: Frekvenskategorierne tildelt bivirkninger baseret på erfaringer fra kliniske undersøgelser afspejler ikke nødvendigvis frekvensen af bivirkninger opstået under normal klinisk praksis.
English: • shortness of breath, waking up short of breath at night
Danish: • åndenød og opvågnen i løbet af natten pga. åndenød
English: Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
Danish: Thiazolidinedioner kan forårsage væskeretention, som kan forværre eller fremskynde tegn og symptomer på kongestivt hjerteinsufficiens.
English: An active controlled clinical trial (rosiglitazone up to 8 mg daily or metformin up to 2,000 mg daily) of 24 weeks duration was performed in 197 children (10-17 years of age) with type 2 diabetes.
Danish: Et aktivt kontrolleret klinisk studie (rosiglitazon op til 8 mg daglig eller metformin op til 2000 mg daglig) af 24 ugers varighed blev udført med 197 børn (mellem 10 og 17 år) med type 2-diabetes.
English: Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
Danish: Rosiglitazon udviste moderat inhibition af CYP2C8 (IC50 8 µM) og lav inhibition af CYP2C9 (IC50 50 µM) in vitro (se afsnit 4.5).
English: • rapid and excessive weight gain caused by fluid retention.
Danish: • hurtig og voldsom vægtøgning på grund af væskeophobning.
English: Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
Danish: Klinisk signifikante interaktioner med CYP2C9-substrater eller inhibitorer kan ikke forventes.
English: Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Danish: Rosiglitazons absolutte biotilgængelighed efter både en 4 mg og 8 mg oral dosis er ca. 99 %.
English: In patients with low haemoglobin levels before initiating therapy, there is an increased risk of anaemia during treatment with rosiglitazone.
Danish: Hos patienter med lavt baselineniveau for hæmoglobin før indledning af terapi findes en forhøjet risiko for anæmi under behandling med rosiglitazon.
English: • Don't breast-feed while you are taking Avandia.
Danish: • Du må ikke amme, mens du tager Avandia.
English: If jaundice is observed, drug therapy should be discontinued.
Danish: Hvis gulsot observeres, bør terapien med lægemidlet seponeres.
English: Avandia is used to treat type 2 diabetes.
Danish: Avandia anvendes til behandling af type 2-diabetes.
English: An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control have not been demonstrated.
Danish: Et morbiditets/mortalitetsstudie er endnu ikke blevet tilendebragt med rosiglitazon, hvorfor langtidsfordelene associeret med forbedret glykæmisk kontrol ikke er blevet demonstreret.
English: The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
Danish: Forekomsten af hjerteinsufficiens ved kombination med insulin (rosiglitazon gives for at understøtte insulinbehandling) var 2,4 % sammenlignet med 1,1 % for insulin givet alene.
English: The decision whether to continue the patient on therapy with rosiglitazone should be guided by clinical judgement pending laboratory evaluations.
Danish: Beslutningen om at lade patienten fortsætte i terapi med rosiglitazon bør styres af en klinisk vurdering baseret på løbende laboratorieundersøgelser.
English: Avandia and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Danish: Avandia kan, ligesom andre lægemidler til behandling af diabetes, forværre eksisterende tilstande eller forårsage alvorlige bivirkninger.
English: Frequencies are defined as: very common ≥ 1/10; common ≥ 1/100, < 1/10; and uncommon ≥ 1/1000, < 1/100.
Danish: Frekvensen er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100, < 1/10) og ikke almindelig (≥ 1/1.000, < 1/100)
English: Heart failure was also reported more frequently in patients with a history of heart failure; oedema and heart failure was also reported more frequently in elderly patients and in patients with mild or moderate renal failure.
Danish: Hjerteinsufficiens blev også rapporteret hyppigere hos patienter, der tidligere har haft hjerteinsufficiens, ligesom ødem og hjerteinsufficiens blev rapporteret hyppigere hos ældre patienter og hos patienter med mild eller moderat nyresvigt.
English: The usual starting dose is 4 mg a day.
Danish: Den sædvanlige startdosis er 4 mg pr. dag.
English: Consistent with the mechanism of action, rosiglitazone reduced insulin resistance and improved pancreatic ß-cell function.
Danish: I overensstemmelse med virkningsmekanismen reducerede rosiglitazon insulinresistens og forbedrede pankreatisk β-celle funktion.
English: The chances of this happening may be higher in people, particularly women, taking Avandia for more than one year.
Danish: Risikoen kan være større hos patienter, der har taget Avandia i mere end et år, især hos kvinder.
English: • swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Danish: • hævelse, nogen gange af ansigt eller mund (angioødem), hvilket kan medføre
English: Improved glycaemic control was also associated with significant decreases in free fatty acids.
Danish: Forbedret glykæmisk kontrol var også associeret med et signifikant fald i frie fede syrer.
English: Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20% to 28%) and a delay in tmax (ca.1.75 h) were observed compared to dosing in the fasting state.
Danish: Administration af rosiglitazon sammen med fødevarer resulterede ikke i nogen ændring i den generelle optagelse (AUC), selvom der sås et svagt fald i Cmax (cirka 20 % til 28 %) og en forsinkelse i tmax (ca. 1,75 time) sammenlignet med administration i fastende tilstand.
English: In this study, the adverse events observed were consistent with the known adverse event profile for each of the treatments, including continuing weight gain with rosiglitazone.
Danish: I dette studie var de observerede bivirkninger i overensstemmelse med den kendte bivirkningsprofil for hver af behandlingerne, inklusiv vedvarende vægtøgning ved rosiglitazon.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de studier og lægemiddelovervågningsaktiviteter, der er beskrevet i lægemiddelovervågningsplanen, som aftalt i version 4 af Risikohåndteringsplanen (RMP) anført i modul 1.8.2. i markedsføringstilladelsen, og i efterfølgende opdateringer af RMP, godkendt af CHMP.
English: Accumulation of the metabolites in plasma is expected upon repeated dosing, especially that of the major metabolite (para-hydroxy-sulphate) for which an 8-fold accumulation is anticipated.
Danish: Akkumulation af metabolitterne i plasma kan forventes efter gentagen dosering, specielt hvad angår den hyppigste metabolit (para-hydroxy-sulfat), hvor en 8-dobling kan forventes.
English: The other ingredients are: sodium starch glycollate (Type A), hypromellose, hypromellose 6cP, microcrystalline cellulose, lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 3000, glycerol triacetate and iron oxide red (E172).
Danish: De øvrige indholdsstoffer er natriumstivelsesglycollat (type A), hypromellose, hypromellose 6cP, mikrokrystallinsk cellulose, lactosemonohydrat, magnesiumstearat, titandioxid (E171), macrogol 3000, glyceroltriacetat og rød jernoxid (E172).
English: Do not pass it on to others.
Danish: Lad derfor være med at give Avandia til andre.
English: Rosiglitazone failed to demonstrate non-inferiority to metformin.
Danish: Rosiglitazon viste ikke non-inferiority i forhold til metformin.
English: An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo.
Danish: Et in vivo interaktionsstudie med warfarin indikerede, at rosiglitazon ikke interagerer med CYP2C9-substrater in vivo.
English: Each tablet contains either: 2 mg, 4 mg or 8 mg rosiglitazone.
Danish: Hver tablet indeholder enten 2 mg, 4 mg eller 8 mg rosiglitazon.
English: Rosiglitazone can cause dose-dependent fluid retention.
Danish: Rosiglitazon kan forårsage dosis-afhængig væskeretention.
English: Common Common Very common Very common RSG - Rosiglitazone monotherapy; RSG + MET - Rosiglitazone with metformin; RSG + SURosiglitazone with sulphonylurea; RSG + MET + SU - Rosiglitazone with metformin and sulphonylurea
Danish: RSG - Rosiglitazon monoterapi; RSG + MET - Rosiglitazon med metformin; RSG + SURosiglitazon med sulfonylurinstof; RSG + MET + SU - Rosiglitazon med metformin og sulfonylurinstof
English: Always take Avandia tablets exactly as your doctor has told you.
Danish: Tag altid Avandia tabletter nøjagtigt efter lægens anvisning.
English: Rosiglitazone should be discontinued if any deterioration in cardiac status occurs.
Danish: Rosiglitazon bør seponeres, såfremt der opstår klinisk forringelse i den kardiale status.
English: If ALT levels are increased to >3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Danish: Hvis ALAT niveauet stiger til >3x øvre grænse for normal under rosiglitazon terapi, bør leverenzymerne kontrolleres igen så hurtigt som muligt.
English: Concomitant administration with the oral anti-diabetic agents metformin, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions with rosiglitazone.
Danish: Samtidig administration af de orale antidiabetiske præparater metformin, glibenclamid og acarbose resulterede ikke i nogen klinisk relevant farmakokinetisk interaktion med rosiglitazon.
English: It is unclear whether or not there is a direct association between rosiglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity and appropriate ophthalmologic referral should be considered.
Danish: Det er usikkert, om der er en direkte sammenhæng mellem behandling med rosiglitazon og makulaødem, men den udskrivende læge bør være advaret om muligheden for makulaødem, hvis patienterne klager over synsforstyrrelser, og henvisning til øjenlæge bør overvejes.
English: It reduces glycaemia by reducing insulin resistance at adipose tissue, skeletal muscle and liver.
Danish: Det reducerer glykæmi ved at nedsætte insulinresistens i fedtvæv, skeletmuskulatur og levervæv.
English: In addition, rosiglitazone was not genotoxic in a battery of in vivo and in vitro genotoxicity studies and there was no evidence of colon tumours in lifetime studies of rosiglitazone in two rodent species.
Danish: Desuden fandtes rosiglitazon ikke gentoxisk i en række af in vivo og in vitro genotoxicitetsstudier, og der var ikke nogen evidens på colontumorer i livstidsstudier af rosiglitazon hos to gnaverarter.
English: The 4 mg tablet also contains purified talc and iron oxide yellow (E172).
Danish: 4 mg tabletten indeholder desuden renset talkum og gul jernoxid (E172).
English: The major metabolite (para-hydroxy-sulphate) with high affinity to the soluble human PPARγ, exhibited relatively high potency in a glucose tolerance assay in obese mouse.
Danish: Den hyppigst forekommende metabolit (para-hydroxysulfat) med høj affinitet til det opløselige humane PPARγ udviste relativ høj potens i en glucosetolerance-assay hos overvægtige mus.
English: Patients receiving rosiglitazone in combination therapy with a sulphonylurea or with insulin, may be at risk for dose-related hypoglycaemia.
Danish: Patienter, der får rosiglitazon i kombination med et sulfonylurinstof eller insulin, kan have risiko for dosis-relateret hypoglykæmi.
English: Increased monitoring of the patient is recommended and adjustment of the dose of sulphonylurea may be necessary.
Danish: Øget monitorering af patienten anbefales og justering af sulfonylurinstof dosis kan være nødvendig.
English: • small increases in blood cholesterol, increased amount of fats in the blood
Danish: • fald i antallet af røde blodlegemer (anæmi) • lille stigning af kolesterol i blodet, øget fedtindhold i blodet
English: Moderate ingestion of alcohol with rosiglitazone has no effect on glycaemic control.
Danish: Moderat indtagelse af alkohol sammen med rosiglitazon har ingen effekt på den glykæmiske kontrol.
English: Pharmacotherapeutic group: oral blood glucose lowering drugs, thiazolidinediones, ATC code: A10 BG 02
Danish: Farmakoterapeutisk gruppe: Oral blodsukker sænkende lægemiddel; thiazolidinedioner ATCkode: A10 BG 02