natgillin/translations-raw huggingface dataset:
Det må heller ikke anvendes til patienter med hjerteinsufficiens, leverproblemer, akut koronarsyndrom såsom ustabil angina (en svær form for brystsmerter, der varierer i intensitet) visse typer af hjertetilfælde eller diabeteskomplikationer (diabetisk ketoacidose eller diabetisk koma).
It should not be used in patients who have heart failure, problems with their liver, an ‘ acute coronary syndrome’ such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, or complications of diabetes (diabetic ketoacidosis or diabetic precoma).
Det kan desuden være nødvendigt at justere Avandia - doserne, når Avandia gives sammen med visse lægemidler såsom gemfibrozil eller rifampicin.
The doses of Avandia may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Den fuldstændige liste over disse lægemidler fremgår af indlægssedlen.
The full list is available in the Package Leaflet.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Avandia A er større end risiciene ved behandling af type 2- diabetes.
The Committee for Medicinal Products for Human Use (CHMP) decided that Avandia’ s benefits are greater than its risks for the treatment of type 2 diabetes mellitus.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Avandia.
The Committee recommended that Avandia be given marketing authorisation.
Andre oplysninger om Avandia A:
Other information about Avandia:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Avandia til SmithKline Beecham plc den 11. juli 2000.
The European Commission granted a marketing authorisation valid throughout the European Union for Avandia to SmithKline Beecham plc on 11 July 2000.
Markedsføringstilladelsen blev fornyet den 11. juli 2005.
The marketing authorisation was renewed on 11 July 2005.
Den fuldstændige EPAR om Avandia findes her
The full EPAR for Avandia can be found here.
Dette sammendrag blev sidst ajourført i 03- 2008
This summary was last updated in 02-2008.
108 mg).
Excipient Contains lactose (approximately 108 mg).
Lyserøde filmovertrukne tabletter præget med "GSK" på den ene side og "2" på den anden side.
Pink film-coated tablets debossed with “ GSK” on one side and "2" on the other side.
Rosiglitazon er indiceret ved behandling af type 2- diabetes:
Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:
- metformin, til patienter (særligt overvægtige patienter) med insufficient glykæmisk kontrol
as monotherapy – in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance
et sulfonylurinstof, og som har udvist intolerance over for metformin eller for hvem metformin er kontraindiceret.
as dual oral therapy in combination with – metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin – a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea
- metformin og et sulfonylurinstof, til patienter (særligt overvægtige patienter) med insufficient
as triple oral therapy in combination with – metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).
Erfaringer fra kliniske forsøg med rosiglitazon er foreløbig begrænsede til tre år.
Experience from clinical trials with rosiglitazone is currently limited to three years.
Langtidsfordelene ved terapi med rosiglitazon er ikke blevet demonstreret (se afsnit 5. 1).
The long-term benefits of therapy with rosiglitazone have not been demonstrated (see section 5.1).
Rosiglitazonbehandling påbegyndes sædvanligvist med 4 mg/ dag.
Rosiglitazone therapy is usually initiated at 4 mg/ day.
Denne dosis kan øges til 8 mg/ dag efter 8 uger, hvis en bedre glykæmisk kontrol er påkrævet.
This dose can be increased to 8 mg/ day after eight weeks if greater glycaemic control is required.
Til patienter, som får rosiglitazon i kombination med et sulfonylurinstof, bør øgning af rosiglitazon til 8 mg/ dag foretages med forsigtighed og i forbindelse med passende kliniske evaluering for at vurdere patientens risiko for at udvikle bivirkninger, der er relateret til væskeretention (se afsnit 4. 4 og 4. 8).
In patients administered rosiglitazone in combination with a sulphonylurea, an increase in rosiglitazone to 8 mg/ day should be undertaken cautiously following appropriate clinical evaluation to assess the patient's risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8).
2 Rosiglitazon kan tages sammen med eller uden mad.
Rosiglitazone may be taken with or without food.
Dosisjustering er ikke påkrævet hos ældre.
2 Elderly (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in the elderly.
Dosisjustering er ikke påkrævet hos patienter med mild og moderat renal insufficiens.
Patients with renal impairment (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in patients with mild and moderate renal insufficiency.
Rosiglitazon bør derfor anvendes med forsigtighed hos disse patienter.
Limited data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/ min) and therefore rosiglitazone should be used with caution in these patients.
Rosiglitazon bør ikke anvendes til patienter med nedsat leverfunktion.
Patients with hepatic impairment Rosiglitazone should not be used in patients with hepatic impairment.
Der er ingen tilgængelige oplysninger om brugen af rosiglitazon hos personer under 10 år.
Children and adolescents There are no data available on the use of rosiglitazone in patients under 10 years of age.
For børn mellem 10 og 17 år er der begrænsede data om rosiglitazon som monoterapi (se afsnit 5. 1 og 5. 2).
For children aged 10 to 17 years, there are limited data on rosiglitazone as monotherapy (see sections 5.1 and 5.2).
Brug af rosiglitazon er kontraindiceret hos patienter med:
Use of rosiglitazone is contraindicated in patients with:
− akut koronarsyndrom (ustabil angina, NSTEMI og STEMI) (se afsnit 4. 4)
− an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4)
− nedsat leverfunktion
− hepatic impairment
− diabetisk ketoacidose eller diabetisk præ- koma.
- diabetic ketoacidosis or diabetic pre-coma.
Væskeretention og hjerteinsufficiens Thiazolidinedioner kan forårsage væskeretention, som kan forværre eller fremskynde tegn og symptomer på kongestivt hjertesvigt.
Fluid retention and cardiac failure Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
Rosiglitazon kan forårsage dosis- afhængig væskeretention.
Rosiglitazone can cause dose-dependent fluid retention.
Alle patienter, specielt patienter som samtidigt behandles med insulin eller et sulfonylurinstof, patienter med risiko for hjertesvigt og patienter med reducerede kardiale reserver, bør overvåges for tegn og symptomer på bivirkninger, der er relateret til væskeretention, herunder vægtøgning og hjertesvigt.
All patients, particularly those receiving concurrent insulin or sulphonylurea therapy, those at risk for heart failure, and those with reduced cardiac reserve, should be monitored for signs and symptoms of adverse reactions relating to fluid retention, including weight gain and heart failure.
Hjertesvigt blev også rapporteret hyppigere hos patienter, der tidligere har haft hjertesvigt, ligesom ødem og hjertesvigt 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.
Kombination med insulin I kliniske undersøgelser er der observeret en øget forekomst af hjertesvigt, når rosiglitazon anvendes i kombination med insulin.
Combination with insulin An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
3 Myokardieiskæmi Tilgængelig litteratur tyder på, at behandling med rosiglitazon kan sættes i forbindelse med øget risiko for myokardieiskæmi (se afsnit 4. 8).
3 Myocardial Ischaemia The available data indicate that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events (see section 4.8).
Monitorering af leverfunktionen Der har været sjældne rapporter med hepatocellulær dysfunktion, set under erfaringerne efter markedsføringen (se afsnit 4. 8).
Monitoring of liver function There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Der er begrænset erfaring med rosiglitazon hos patienter med forhøjede leverenzymer (ALAT > 2. 5X øvre grænse for normal).
There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT > 2.5X upper limit of normal).
Herefter kontrolleres lever - enzymerne, af og til, baseret på klinisk vurdering.
Therefore, liver enzymes should be checked prior to the initiation of therapy with rosiglitazone in all patients and periodically thereafter based on clinical judgement.
Terapi med rosiglitazon bør ikke indledes hos patienter med forhøjet baselineniveau af leverenzymer (ALAT > 2. 5x øvre grænse for normal) eller med hvilken som helst anden evidens på leversygdom.
Therapy with rosiglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5X upper limit of normal) or with any other evidence of liver disease.
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.
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.
Øjenlidelser Nye tilfælde og forværring af diabetisk maculaødem med synsforstyrrelser, er beskrevet i post - marketing rapporter hos patienter i behandling med thiazolider, herunder rosiglitazon.
Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including 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.
Vægtøgningen var større, når rosiglitazon blev anvendt i kombination med insulin.
Weight gain In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Vægten skal nøje overvåges, da vægtøgning kan medføre væskeretention, der kan være associeret med hjertesvigt.
Therefore weight should be closely monitored, given that it may be attributable to fluid retention, which may be associated with cardiac failure.
Anæmi Behandling med rosiglitazon er associeret med en dosis- relateret reduktion i hæmoglobinniveauet.
Anaemia Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Hypoglykæmi Patienter, der får rosiglitazon i kombination med et sulfonylurinstof eller insulin, kan have risiko for dosis- relateret hypoglykæmi.
Hypoglycaemia Patients receiving rosiglitazone in combination therapy with a sulphonylurea or with insulin, may be at risk for dose-related hypoglycaemia.
Det kan være nødvendigt at øge overvågningen af patienten og at reducere dosis af sulfonylurinstof/ insulin.
Increased monitoring of the patient and a reduction in the dose of the concomitant agent may be necessary.
Tripel- kombinationsbehandling Brug af rosiglitazon som tripel- kombinationsbehandling, i kombination med metformin og et sulfonylurinstof, kan være associeret med øget risiko for væskeretention og hjerteinsufficiens, såvel som hypoglykæmi (se afsnit 4. 8).
Triple oral therapy The use of rosiglitazone in triple oral therapy, in combination with metformin and a sulphonylurea, may be associated with increased risks for fluid retention and heart failure, as well as hypoglycaemia (see section 4.8).
Beslutningen om at påbegynde tripel - kombinationsbehandling 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.
4 Knoglelidelser I et langtidsstudie blev der observeret en øget forekomst af frakturer (fødder, hænder og arme) hos kvindelige patienter, der blev behandlet med rosiglitazon som monoterapi (se afsnit 4. 8).
4 Bone disorders In a long-term study an increased incidence of bone fractures (foot, hand and arm) was observed in female patients taking rosiglitazone as monotherapy (see section 4.8).
Andet Der er blevet givet rosiglitazon til præmenopausale kvinder i kliniske undersøgelser.
Others Premenopausal women have received rosiglitazone during clinical studies.
Patienter bør være opmærksomme på risikoen for graviditet, og hvis en patient ønsker at blive gravid, eller hvis graviditet opstår, bør behandlingen seponeres (se afsnit 4. 6).
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).
Rosiglitazon bør anvendes med forsigtighed hos patienter med alvorlig nyreinsufficiens (kreatinin clearance < 30 ml/ min).
Rosiglitazone should be used with caution in patients with severe renal insufficiency (creatinine clearance < 30 ml/ min).
Rosiglitazon bør anvendes med forsigtighed under samtidig administration af CYP2C8 inhibitorer (f. eks. gemfibrozil) eller inducerende stoffer (f. eks. rifampicin).
Rosiglitazone should be used with caution during concomitant administration of CYP2C8 inhibitors (e. g. gemfibrozil) or inducers (e. g. rifampicin).
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).
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.
In vitro- studier har vist, at rosiglitazon primært metaboliseres af CYP2C8 og af CYP2C9 i mindre omfang.
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
5 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Der foreligger ikke tilstrækkelige data fra brugen af rosiglitazon hos gravide kvinder.
Studies in animals have
Dyreforsøg har påvist reproduktionstoksicitet (se afsnit 5. 3).
5 shown reproductive toxicity (see section 5.3).
4. 8 Bivirkninger
Clinical trial data
Data fra kliniske undersøgelser 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.
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.
I Tabel 1 er listet bivirkninger identificeret fra en population af mere end 5000 patienter behandlet med rosiglitazon i integrerede kliniske undersøgelser.
Table 1 lists adverse reactions identified from an integrated clinical trial population of over 5,000 rosiglitazone-treated patients.
Under hver organklasse er bivirkninger listet med faldende frekvens for monoterapeutisk rosiglitazon behandlingsregime.
Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
Under hver frekvensgruppering er bivirkningerne listet efter faldende alvorlighed.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
6 Tabel 1.
6 Table 1.
Frekvens af bivirkning under behandlingsregime RSG RSG + MET RSG + SU
Frequency of adverse reaction by treatment regimen
RSG +MET +SU
RSG + MET
Blod og lymfesystem
RSG +MET +SU
anæmi leukopeni trombocytopeni granulocytopeni
Blood and the lymphatic system disorders anaemia leucopaenia thrombocytopaenia granulocytopaenia
Metabolisme og ernæring
Metabolism and nutrition disorders hypercholesterolaemia1 hypertriglyceridaemia
Almindelig Almindelig
Common Common Common
hyperlipidæmi vægtøgning øget appetit
hyperlipaemia weight increase increased appetite
Almindelig Almindelig Almindelig
Common Common Common Common Common
Almindelig Almindelig
Common Common Uncommon
Nervesystemet
Very common
svimmelhed * hovedpine *
Nervous system disorders dizziness* headache*
Almindelig
Common Common
Almindelig
Cardiac disorders
hjertesvigt2
cardiac failure2
hjerteiskæmi3 *
cardiac ischaemia3*
obstipation
constipation
Knogler, led, muskler og bindevæv
Musculoskeletal and connective tissue disorders bone fractures myalgia*
Almindelig Almindelig
Common Common Very common Very common
* Frekvenskategorien for baggrundshyppigheden af disse bivirkninger, som er taget fra placebo gruppe data fra kliniske undersøgelser, er ” Almindelig ”.
*The frequency category for the background incidence of these events, as taken from placebo group data from clinical trials, is'common '.
1 Hypercholesterolæmi var rapporteret hos op til 5, 3% af patienter behandlet med rosiglitazon (monoterapi, dobbelt - eller tripelterapi).
1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone (monotherapy, dual or triple oral therapy).
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.
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.
7 Forekomsten af hjertesvigt i det dobbeltblinde hovedstudie var 1, 4% ved tripel - kombinationsbehandling, sammenlignet med 0, 4% for metformin og sulfonylurinstof kombinationsbehandling.
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 7 sulphonylurea dual therapy.
Forekomsten af hjertesvigt 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%.
Ydermere har en placebokontrolleret etårig undersøgelse af patienter, der lider af kongestiv hjertesvigt NYHA klasse I- II, vist en forværring eller mulig forværring af hjertesvigt 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.
Hovedparten af frakturerne hos de kvindelige patienter, der blev behandlet med rosiglitazon, var i fødderne, hænderne og armene.
The majority of the fractures in the females who received rosiglitazone were reported in the foot, hand and arm.
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).
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.
Post- marketing data I forlængelse af bivirkningsdata fundet i kliniske undersøgelser er data fundet efter markedsføring af rosiglitazon listet i tabellen nedenfor.
Post-marketing data In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Frekvensen er defineret som: sjælden (≥ 1/ 10. 000, < 1/ 1. 000) og meget sjælden (< 1/ 10. 000) herunder isolerede rapporter.
Frequencies are defined as: rare ≥ 1/ 10,000, < 1/ 1000 and very rare < 1/ 10,000 including isolated reports.
8 Tabel 2.
8 Table 2.
Immunsystemet (se Hud og subkutane væv)
Immune system disorders (see Skin and subcutaneous tissue disorders) anaphylactic reaction
Makulaødem
macular oedema
Kongestiv hjerteinsufficiens / lungeødem
Cardiac disorders congestive heart failure/ pulmonary oedema
Angiødem Hudreaktioner (for eksempel nældefeber, kløe, udslæt)
Skin and subcutaneous tissue disorders (see Immune system disorders) angioedema skin reactions (e. g. urticaria, pruritus, rash) 5
Sjældne tilfælde af forhøjede leverenzymer og hepatocellulær dysfunktion er rapporteret.
Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported.
Oral blodsukker sænkende lægemiddel; thiazolidinedioner ATC - kode:
Pharmacotherapeutic group: oral blood glucose lowering drugs, thiazolidinediones, ATC code:
Prækliniske data Rosiglitazons antihyperglykæmiske aktivitet er påvist i et antal dyremodeller med diabetes type 2.
Preclinical data The antihyperglycaemic activity of rosiglitazone has been demonstrated in a number of animal models of type 2 diabetes.
Herudover bevarede rosiglitazon β- cellefunktion demonstreret ved stigning i antallet af de langerhanske øer og insulinindholdet og forhindrede udviklingen af udtalt hyperglykæmi i dyremodeller med diabetes type 2.
In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.
Den hyppigst forekommende metabolit (para- hydroxy - sulfat) med høj affinitet til det opløselige humane PPARγ udviste relativ høj potens i en
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.
8 ugers behandling.
9 Clinical trials data The glucose lowering effects observed with rosiglitazone are gradual in onset with near maximal reductions in fasting plasma glucose (FPG) evident following approximately 8 weeks of therapy.