natgillin/translations-raw huggingface dataset:
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).
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).
De tilgængelige data støtter ikke virkningen hos børn, og derfor anbefales brugen ikke.
The available data do not support efficacy in the paediatric population and therefore such use is not recommended.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse
METHOD AND ROUTE(S) OF ADMINISTRATION For oral use
Avandia-tabletter indeholder en lille mængde lactose.
Avandia tablets contain a small amount of lactose.
Uigennemsigtige blisterpakninger (PVC/Aluminium).
Opaque blister packs (PVC/ aluminium).
RSG + MET RSG + SU RSG +MET +SU
RSG + SU RSG +MET +SU
Stigning i levervægten, plasma ALAT (kun hos hunde) og fedtvæv observeredes også.
Increases in liver weight, plasma ALT (dog only) and fat tissue were also observed.
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.
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.
I tilfælde af overdosis anbefales det, at der gives støttende behandling afhængig af patientens kliniske status.
In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated, as dictated by the patient's clinical status.
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).
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).
• Avandia bør ikke anvendes under graviditet.
• Avandia is not recommended during pregnancy.
Denne dosis kan tages som en 4 mg tablet en gang daglig eller som en 2 mg tablet to gange daglig.
This can be taken as one 4 mg tablet once a day, or as one 2 mg tablet taken twice a day.
• hvis du er overfølsom (allergisk) over for rosiglitazon eller et af de øvrige indholdsstoffer i
• if you are allergic (hypersensitive) to rosiglitazone or any of the other ingredients of
Bivirkninger fra hvert behandlingsregime er listet under organklasser og absolutte frekvenser.
Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
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.
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.
Betydningen af disse resultater for sygdomsprogressionen eller for mikrovaskulære eller makrovaskulære hændelser er ikke blevet bestemt (se afsnit 4.8).
The impact of these findings on disease progression or on microvascular or macrovascular outcomes has not been determined (see section 4.8).
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.
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.
AVANDIA påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
AVANDIA has no or negligible influence on the ability to drive and use machines.
Incidensen af alle bivirkninger relateret til lever- og galdesystemerne var < 1,5 % i alle behandlingsgrupper og ens med placebo.
The incidence of all adverse events relating to liver and biliary systems was < 1.5% in any treatment group and similar to placebo.
Der foreligger ikke tilstrækkelige data fra brugen af rosiglitazon hos gravide kvinder.
There are no adequate data from the use of rosiglitazone in pregnant women.
Rosiglitazon er blevet påvist i mælken hos forsøgsdyr.
Rosiglitazone has been detected in the milk of experimental animals.
Mekanistiske undersøgelser har vist, at vægtøgningen overvejende skyldtes en stigning i subkutant fedt med mindsket visceralt og intra-hepatisk fedt.
In mechanistic studies, the weight increase was predominantly shown to be due to increased subcutaneous fat with decreased visceral and intra-hepatic fat.
Rosiglitazon bør ikke anvendes under graviditet.
Rosiglitazone should not be used during pregnancy.
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.
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.
Sìmi: + 354 530 3700
Sími: + 354 530 3700
Der er ingen tilgængelige oplysninger om brugen af rosiglitazon hos personer under 10 år.
There are no data available on the use of rosiglitazone in patients under 10 years of age.
Indeholder lactose, se indlægsseddel for yderligere information
LIST OF EXCIPIENTS Contains lactose, see leaflet for further information
Total plasmaclearance af rosiglitazon er omkring 3 l/time, og den endelige halveringstid er ca. 3-4 timer.
Total plasma clearance of rosiglitazone is around 3 l/h and the terminal elimination half-life of rosiglitazone is approximately 3 to 4 hours.
Den maksimale dosis er 8 mg Avandia pr. dag.
The maximum dose is 8 mg of Avandia a day.
5Sjældne tilfælde af forhøjede leverenzymer og hepatocellulær dysfunktion er rapporteret.
5 Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported.
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.
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.
Brug af rosiglitazon er kontraindiceret til patienter med:
Use of rosiglitazone is contraindicated in patients with:
Tag ikke Avandia:
Don't take Avandia:
Der er ikke set uventet akkumulation af rosiglitazon ved en dosering på en eller to gange dagligt.
There is no evidence for unexpected accumulation of rosiglitazone after once or twice daily dosing.
Hvis ALAT niveauet forbliver >3x øvre grænse for normal, bør terapien seponeres.
If ALT levels remain >3X the upper limit of normal, therapy should be discontinued.
Der har været sjældne rapporter med hepatocellulær dysfunktion, set under erfaringerne efter markedsføringen (se afsnit 4.8).
There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Er du i tvivl, så spørg lægen eller apoteket.
- If you have any further questions, ask your doctor or pharmacist.
Avandia indeholder
What Avandia contains
Rosiglitazon er en selektiv agonist ved PPARγ (peroxisomal proliferator aktiveret gamma) nuklearreceptor og hører hjemme i antidiabetikumgruppen thiazolidinedioner.
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.
En mere udtalt glucosesænkende effekt blev observeret i overvægtige patienter.
A more pronounced glucose-lowering effect was observed in obese patients.
Beslutningen om at påbegynde tripelkombinationsbehanding bør inkludere en overvejelse om alternativt at skifte patienter over på insulin.
The decision to initiate triple oral therapy should include consideration of the alternative to switch the patient to insulin.
• hvis du har haft et hjertetilfælde eller alvorlige hjertekramper, som behandles på hospital
• if you have had a heart attack or severe angina, that's being treated in hospital
Intet intakt lægemiddel udskilles i urin eller fæces.
No intact drug is excreted in urine or faeces.
Justering af rosiglitazon dosis inden for den anbefalede dosering eller ændringer i diabetisk behandling bør overvejes (se afsnit 4.5).
Rosiglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
I reproduktionstoxicitetsstudier var administration af rosiglitazon til rotter i anden halvdel af dræktighedsperioden associeret til fosterdød og forsinket fosterudvikling.
In reproductive toxicity studies, administration of rosiglitazone to rats during mid-late gestation was associated with foetal death and retarded foetal development.
− akut koronarsyndrom (ustabil angina, NSTEMI og STEMI) (se afsnit 4.4)
− an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4)
Fremstiller: Glaxo Wellcome Production, ZI du Terras, 53100 Mayenne, Frankrig.
Manufacturer: Glaxo Wellcome Production, ZI du Terras, 53100 Mayenne, France.
Frekvenskategorierne tildelt bivirkninger baseret på erfaringer fra kliniske undersøgelser afspejler ikke nødvendigvis frekvensen af bivirkninger opstået under normal klinisk praksis.
Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
• åndenød og opvågnen i løbet af natten pga. åndenød
• shortness of breath, waking up short of breath at night
Thiazolidinedioner kan forårsage væskeretention, som kan forværre eller fremskynde tegn og symptomer på kongestivt hjerteinsufficiens.
Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
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.
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.
Rosiglitazon udviste moderat inhibition af CYP2C8 (IC50 8 µM) og lav inhibition af CYP2C9 (IC50 50 µM) in vitro (se afsnit 4.5).
Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
• hurtig og voldsom vægtøgning på grund af væskeophobning.
• rapid and excessive weight gain caused by fluid retention.
Klinisk signifikante interaktioner med CYP2C9-substrater eller inhibitorer kan ikke forventes.
Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
Rosiglitazons absolutte biotilgængelighed efter både en 4 mg og 8 mg oral dosis er ca. 99 %.
Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Hos patienter med lavt baselineniveau for hæmoglobin før indledning af terapi findes en forhøjet risiko for anæmi under behandling med rosiglitazon.
In patients with low haemoglobin levels before initiating therapy, there is an increased risk of anaemia during treatment with rosiglitazone.
• Du må ikke amme, mens du tager Avandia.
• Don't breast-feed while you are taking Avandia.
Hvis gulsot observeres, bør terapien med lægemidlet seponeres.
If jaundice is observed, drug therapy should be discontinued.
Avandia anvendes til behandling af type 2-diabetes.
Avandia is used to treat type 2 diabetes.
Et morbiditets/mortalitetsstudie er endnu ikke blevet tilendebragt med rosiglitazon, hvorfor langtidsfordelene associeret med forbedret glykæmisk kontrol ikke er blevet demonstreret.
An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control have not been demonstrated.
Forekomsten af hjerteinsufficiens ved kombination med insulin (rosiglitazon gives for at understøtte insulinbehandling) var 2,4 % sammenlignet med 1,1 % for insulin givet alene.
The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
Beslutningen om at lade patienten fortsætte i terapi med rosiglitazon bør styres af en klinisk vurdering baseret på løbende laboratorieundersøgelser.
The decision whether to continue the patient on therapy with rosiglitazone should be guided by clinical judgement pending laboratory evaluations.
Avandia kan, ligesom andre lægemidler til behandling af diabetes, forværre eksisterende tilstande eller forårsage alvorlige bivirkninger.
Avandia and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Frekvensen er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100, < 1/10) og ikke almindelig (≥ 1/1.000, < 1/100)
Frequencies are defined as: very common ≥ 1/10; common ≥ 1/100, < 1/10; and uncommon ≥ 1/1000, < 1/100.
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.
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.
Den sædvanlige startdosis er 4 mg pr. dag.
The usual starting dose is 4 mg a day.
I overensstemmelse med virkningsmekanismen reducerede rosiglitazon insulinresistens og forbedrede pankreatisk β-celle funktion.
Consistent with the mechanism of action, rosiglitazone reduced insulin resistance and improved pancreatic ß-cell function.
Risikoen kan være større hos patienter, der har taget Avandia i mere end et år, især hos kvinder.
The chances of this happening may be higher in people, particularly women, taking Avandia for more than one year.
• hævelse, nogen gange af ansigt eller mund (angioødem), hvilket kan medføre
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Forbedret glykæmisk kontrol var også associeret med et signifikant fald i frie fede syrer.
Improved glycaemic control was also associated with significant decreases in free fatty acids.
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.
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.
I dette studie var de observerede bivirkninger i overensstemmelse med den kendte bivirkningsprofil for hver af behandlingerne, inklusiv vedvarende vægtøgning ved rosiglitazon.
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.
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.
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.
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.
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.
De øvrige indholdsstoffer er natriumstivelsesglycollat (type A), hypromellose, hypromellose 6cP, mikrokrystallinsk cellulose, lactosemonohydrat, magnesiumstearat, titandioxid (E171), macrogol 3000, glyceroltriacetat og rød jernoxid (E172).
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).
Lad derfor være med at give Avandia til andre.
Do not pass it on to others.
Rosiglitazon viste ikke non-inferiority i forhold til metformin.
Rosiglitazone failed to demonstrate non-inferiority to metformin.
Et in vivo interaktionsstudie med warfarin indikerede, at rosiglitazon ikke interagerer med CYP2C9-substrater in vivo.
An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo.
Hver tablet indeholder enten 2 mg, 4 mg eller 8 mg rosiglitazon.
Each tablet contains either: 2 mg, 4 mg or 8 mg rosiglitazone.
Rosiglitazon kan forårsage dosis-afhængig væskeretention.
Rosiglitazone can cause dose-dependent fluid retention.
RSG - Rosiglitazon monoterapi; RSG + MET - Rosiglitazon med metformin; RSG + SURosiglitazon med sulfonylurinstof; RSG + MET + SU - Rosiglitazon med metformin og sulfonylurinstof
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
Tag altid Avandia tabletter nøjagtigt efter lægens anvisning.
Always take Avandia tablets exactly as your doctor has told you.
Rosiglitazon bør seponeres, såfremt der opstår klinisk forringelse i den kardiale status.
Rosiglitazone should be discontinued if any deterioration in cardiac status occurs.
Hvis ALAT niveauet stiger til >3x øvre grænse for normal under rosiglitazon terapi, bør leverenzymerne kontrolleres igen så hurtigt som muligt.
If ALT levels are increased to >3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Samtidig administration af de orale antidiabetiske præparater metformin, glibenclamid og acarbose resulterede ikke i nogen klinisk relevant farmakokinetisk interaktion med rosiglitazon.
Concomitant administration with the oral anti-diabetic agents metformin, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions with rosiglitazone.
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.
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.
Det reducerer glykæmi ved at nedsætte insulinresistens i fedtvæv, skeletmuskulatur og levervæv.
It reduces glycaemia by reducing insulin resistance at adipose tissue, skeletal muscle and liver.
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.
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.
4 mg tabletten indeholder desuden renset talkum og gul jernoxid (E172).
The 4 mg tablet also contains purified talc and iron oxide yellow (E172).
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.
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.
Patienter, der får rosiglitazon i kombination med et sulfonylurinstof eller insulin, kan have risiko for dosis-relateret hypoglykæmi.
Patients receiving rosiglitazone in combination therapy with a sulphonylurea or with insulin, may be at risk for dose-related hypoglycaemia.
Øget monitorering af patienten anbefales og justering af sulfonylurinstof dosis kan være nødvendig.
Increased monitoring of the patient is recommended and adjustment of the dose of sulphonylurea may be necessary.
• fald i antallet af røde blodlegemer (anæmi) • lille stigning af kolesterol i blodet, øget fedtindhold i blodet
• small increases in blood cholesterol, increased amount of fats in the blood
Moderat indtagelse af alkohol sammen med rosiglitazon har ingen effekt på den glykæmiske kontrol.
Moderate ingestion of alcohol with rosiglitazone has no effect on glycaemic control.
Farmakoterapeutisk gruppe: Oral blodsukker sænkende lægemiddel; thiazolidinedioner ATCkode: A10 BG 02
Pharmacotherapeutic group: oral blood glucose lowering drugs, thiazolidinediones, ATC code: A10 BG 02
Ældre (se afsnit 4.4 Væskeretention og hjerteinsufficiens): Dosisjustering er ikke påkrævet hos ældre.
Elderly (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in the elderly.
Ydermere har en placebokontrolleret etårig undersøgelse af patienter, der lider af kongestiv hjerteinsufficiens NYHA klasse I-II, vist en forværring eller mulig forværring af hjerteinsufficiens hos 6,4 % af patienterne i behandling med rosiglitazon, sammenlignet med 3,5 % for placebo.
Moreover in patients with congestive heart failure NYHA class I-II, a placebo-controlled one-year trial demonstrated worsening or possible worsening of heart failure in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
I dobbeltblinde kliniske forsøg med rosiglitazon var incidensen af stigninger i ALAT, på mere end tre gange den øvre normale grænse, af samme størrelse som ved placebo (0,2 %) og mindre end værdien for de aktive komparatorer (0,5 % metformin/sulfonylurinstof).
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).
• væske i lungerne (lungeødem), som kan forårsage stakåndethed
• fluid in the lungs (pulmonary oedema) causing breathlessness
Den forbedrede glykæmiske kontrol er forbundet med en reduktion i både fastende og postprandial glucose.
The improved glycaemic control is associated with reductions in both fasting and post-prandial glucose.
AVANDIA tabletter indeholder lactose og bør derfor ikke anvendes til patienter med sjældne arvelige problemer med galactoseintolerance, Lapp lactasemangel eller glucose-galactose malabsorption.
AVANDIA tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Rosiglitazons antihyperglykæmiske aktivitet er påvist i et antal dyremodeller med diabetes type 2.
The antihyperglycaemic activity of rosiglitazone has been demonstrated in a number of animal models of type 2 diabetes.