natgillin/translations-raw huggingface dataset:
Hvis en patient udvikler symptomer, som tyder på hepatisk dysfunktion, herunder uforklarlig kvalme, opkastninger, abdominal smerte, træthed, anoreksi og/eller mørk urin, bør leverenzymerne kontrolleres.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked.
I undersøgelser med en maksimal varighed på 3 år medførte rosiglitazon, indgivet en eller to gange daglig i oral kombinationsbehandling med metformin, en vedvarende forbedring af den glykæmiske kontrol (FPG og HbA1c).
In studies with a maximal duration of three years, rosiglitazone given once or twice daily in dual oral therapy with metformin produced a sustained improvement in glycaemic control (FPG and HbA1c).
De aktive stoffer er rosiglitazon og metformin.
The active substances are rosiglitazone and metformin.
Patienter, som får AVANDAMET i kombination med et sulfonylurinstof eller insulin, har risiko for dosisrelateret hypoglykæmi.
Patients receiving AVANDAMET in combination with a sulphonylurea or insulin may be at risk for dose-related hypoglycaemia.
For dosisrelaterede bivirkninger vil frekvensen afspejle den høje dosis af rosiglitazon.
For dose-related adverse reactions the frequency category reflects the higher dose of rosiglitazone.
Der er ikke rapporteret om tilfælde af overdosering med AVANDAMET.
No data are available with regard to overdose of AVANDAMET.
Tabel 1 viser de bivirkninger, der er angivet i en oversigt over kliniske undersøgelser med mere end 5000 patienter i behandling med rosiglitazon.
Table 1 lists adverse reactions identified from an overview of clinical trials involving over 5,000 rosiglitazone-treated patients.
En stor overdosis metformin (eller samtidig eksisterende risikofaktorer for udvikling af lactacidose) kan føre til lactacidose, som er en kritisk tilstand, og skal behandles på hospitalet.
A large overdose of metformin (or coexisting risks of lactic acidosis) may lead to lactic acidosis which is a medical emergency and must be treated in hospital.
Rapporterede tilfælde af lactacidose hos patienter behandlet med metformin er primært forekommet hos diabetespatienter med betydeligt nedsat nyrefunktion.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Akkumulering af metabolitter 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 (a para-hydroxy-sulphate) for which an 8-fold accumulation is anticipated.
Et aktivt kontrolleret klinisk forsøg (rosiglitazon op til 8 mg daglig eller metformin op til 2000 mg daglig) blev udført med 197 børn i alderen 10-17 år med type 2-diabetes i 24 uger.
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.
Mave-tarmkanalen Gastrointestinale symptomer6
Gastrointestinal disorders gastrointestinal symptoms6
Dosistitrering med rosiglitazon (som tillægsbehandling til den optimale dosis metformin) kan overvejes, før patienten skifter til AVANDAMET.
Dose titration with rosiglitazone (added to the optimal dose of metformin) may be considered before the patient is switched to AVANDAMET.
Desuden fandtes rosiglitazon ikke genotoksisk i en række af in vivo og in vitro genotoksicitetsstudier, 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.
5Der er rapporteret sjældne tilfælde af forhøjede leverenzymer og hepatocellulær dysfunktion.
5 Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported.
14 tabletter 28 tabletter 56 tabletter 180 tabletter
14 tablets 28 tablets 56 tablets 180 tablets
Din læge vil vejlede dig til ikke at tage Avandamet i mindst 48 timer før og efter operationen.
Your doctor will advise you to stop taking Avandamet for at least 48 hours before and after the operation.
En øgning af rosiglitazon til 8 mg/dag bør foretages med forsigtighed og i forbindelse med passende klinisk evaluering for at vurdere patientens risiko for at udvikle bivirkninger, der er relateret til væskeretention (se afsnit 4.4 og 4.8).
An increase in the rosiglitazone component 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 sections 4.4 and 4.8).
I dette studie var de observerede bivirkninger i overensstemmelse med den kendte bivirkningsprofil for hver af behandlingerne, inklusive 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.
Frekvenskategorier gør ikke rede for andre faktorer, herunder varighed af undersøgelsen, allerede kendte fysiske tilstande og baseline karakteristika for patienterne.
Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Lægemiddelovervågningssystem
Pharmacovigilance system
Frekvenskategorierne er baseret på information fra produktresuméet for metformin godkendt i EU.
Frequency categories are based on information available from metformin Summary of Product Characteristics available in the EU.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
Any unused product should be disposed of in accordance with local requirements.
I kliniske undersøgelser blandt frivillige blev rosiglitazon givet som enkeltdoser af op til 20 mg og var vel tålt.
In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
Risikoen er større især hos kvinder, der har taget rosiglitazon i mere end et år.
The chances of this happening may be higher in people, particularly women, taking rosiglitazone for more than one year.
Risikoen for både væskeretention og hypoglykæmi er dog øget, når AVANDAMET anvendes i kombination med insulin.
However, the risk of both fluid related adverse events and hypoglycaemia are increased when AVANDAMET is used in combination with insulin.
Metabolisme Metfomin udskilles uændret i urinen.
Metabolism Metformin is excreted unchanged in the urine.
Det kan ikke udelukkes at andre inducerende stoffer (f.eks. phenytoin, carbamazepin, phenobarbital og perikum) også påvirker effekten af rosiglitazon.
It cannot be excluded that other inducers (e.g. phenytoin, carbamazepine, phenobarbital, St John's wort) may also affect rosiglitazone exposure.
De efterfølgende oplysninger afspejler de tilgængelige data, som findes for de enkelte aktive stoffer (rosiglitazon og metformin).
The following statements reflect the information available on the individual active substances (rosiglitazone and metformin).
Hvis ALAT-niveauet stiger til > 3 gange den øvre grænse for normal under AVANDAMET-behandlingen, bør leverenzymerne kontrolleres igen så hurtigt som muligt.
If ALT levels are increased to > 3 times the upper limit of normal during AVANDAMET therapy, liver enzyme levels should be reassessed as soon as possible.
Gennemsnitsdoser ved slutningen af den randomiserede behandling ses herunder:
Mean doses at the end of randomised treatment are shown in the following table:
Hovedmetabolitten (pare-hydroxy-sulfat) med høj affinitet til det opløselige humane PPARγ udviste relativ høj potens i et glucosetolerance-assay hos overvægtige mus.
The major metabolite (a para-hydroxy-sulphate) with high affinity to the soluble human PPARγ, exhibited relatively high potency in a glucose tolerance assay in obese mice.
Ekstra kropsvæske kan forværre eksisterende hjertelidelser eller medføre hjerteinsufficiens.
Extra body fluid can make some existing heart problems worse or lead to heart failure.
I betragtning af risikoen for udvikling af hjerteinsufficiens bør behandling med rosiglitazon ikke initieres hos patienter med akut hjertetilfælde, og det bør seponeres i den akutte fase (se afsnit 4.3).
In view of the potential for development of heart failure in these patients, rosiglitazone should therefore not be initiated in patients having an acute coronary event and it should be discontinued during the acute phase (see section 4.3).
Data fra dobbeltblinde undersøgelser bekræfter, at bivirkningsprofilen for samtidig administration af rosiglitazon og metformin er identisk med den kombinerede bivirkningsprofil for de to lægemidler.
Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and metformin is similar to that of the combined adverse reaction profile for the two medicinal products.
Det er usikkert, om der er en direkte sammenhæng mellem behandling med rosiglitazon og maculaødem, men den behandlende læge bør være advaret om muligheden for maculaødem, 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.
Intravaskulær administration af jodholdige kontrastmidler ved radiologiske undersøgelser kan føre til nyreinsufficiens.
The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure.
Vitamin B12 mangel7
Very rare vitamin B12 deficiency7
Metabolisme og ernæring Hurtig og voldsom vægtøgning
Metabolism and nutrition disorders rapid and excessive weight gain
I tillæg bevarede rosiglitazon β-cellefunktionen, demonstreret ved en stigning i antallet af langerhanske øer og insulinindholdet og forhindrede udviklingen af udtalt hyperglykæmi i dyremodeller af type 2diabetes.
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.
Da AVANDAMET indeholder metforminhydrochlorid bør behandlingen afbrydes 48 timer før elektive operationer i universel anæstesi, og bør sædvanligvis ikke genoptages tidligere end 48 timer efter.
As AVANDAMET contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
Administration af rosiglitazon sammen med føde resulterede ikke i nogen ændring i den generelle optagelse (AUC), selvom der sås et svagt fald i Cmax (cirka 20-28 %) og en forsinkelse i tmax (cirka 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 20-28%) and a delay in tmax (approximately 1.75 h) were observed compared to dosing in the fasting state.
De frekvenskategorier, der blev tildelt bivirkningerne baseret på data 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.
En placebokontrolleret, etårig undersøgelse af patienter, der lider af hjerteinsufficiens NYHA-klasse III, har vist en forværring eller mulig forværring af hjerteinsufficiens hos 6,4 % af patienterne i behandling med rosiglitazon, sammenlignet med 3,5 % for placebo.
In a placebo-controlled one-year trial in patients with congestive heart failure NYHA class I-II, worsening or possible worsening of heart failure occurred in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
• Avandamet bør ikke anvendes under graviditet.
• Avandamet is not recommended during pregnancy.
Da der er risiko for en stigning i dosisrelaterede bivirkninger, kan det være nødvendigt at reducere dosis af rosiglitazon.
Since there is a potential for an increase in the risk of dose-related adverse reactions, a decrease in rosiglitazone dose may be needed.
Efter administration af en dosis på 850 mg så man en 40 % lavere maksimal plasmakoncentration, en 25 % mindskelse i AUC og en forlængelse på 35 min før den maksimale plasmakoncentration opnåedes.
Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
En morbiditets/mortalitet undersøgelse er ikke afsluttet med rosiglitazon, og langtidsfordelene forbundet med forbedret glykæmisk kontrol er derfor ikke blevet påvist.
An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control of rosiglitazone have not been demonstrated.
Samtidig administration af rosiglitazon og de orale antidiabetika, glibenclamid og acarbose, resulterede ikke i klinisk relevante farmakokinetiske interaktioner.
Concomitant administration of rosiglitazone with the oral antihyperglycaemic agents glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions.
AVANDAMET-tabletter indeholder lactose og bør derfor ikke gives til patienter med sjælden arvelig galactose intolerans, Lapps laktatmangel eller glucose-galactose malabsorption.
AVANDAMET 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.
Brugen af AVANDAMET i kombination med et sulfonylurinstof eller insulin kan være forbundet med øget risiko for væskeretention og hjerteinsufficiens (se afsnit 4.8).
The use of AVANDAMET in combination with a sulphonylurea or insulin may be associated with increased risks of fluid retention and heart failure (see section 4.8).
Tag ikke mere end lægen har anbefalet.
Do not take more than the recommended dose.
En in vivointeraktionsundersøgelse med warfarin indikerede, at rosiglitazon ikke interagerer med CYP2C9substrater in vivo.
An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo.
Fremstiller: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Manufacturer: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
I overensstemmelse med virkningsmekanisme reducerer rosiglitazon i kombination med metformin insulinresistens og forbedret pankreatisk β-celle.
Consistent with the mechanism of action, rosiglitazone in combination with metformin reduced insulin resistance and improved pancreatic ß-cell function.
• beta-2-agonister (anvendes til at behandle astma) såsom salbutamol eller salmeterol
• beta-2-agonists (used to treat asthma), such as salbutamol or salmeterol
En mere udtalt glucosesænkende effekt er set hos overvægtige patienter.
A more pronounced glucose-lowering effect was observed in obese patients.
Frekvens af bivirkning under behandlingsregime Rosiglitazon monoterapi
Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy
Bivirkninger du skal være opmærksom på
Conditions you need to look out for
Lactacidose er karakteriseret ved acidotisk dyspnø, mavesmerter og hypotermi efterfulgt af koma.
Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Der er ikke observeret klinisk relevante interaktioner med digoxin, CYP2C9-substratet warfarin, CYP3A4-substraterne nifedipine, ethinylestradiol eller norethisteron ved samtidig administration af rosiglitazon.
No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with rosiglitazone.
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 with rosiglitazone (see section 4.8).
Der er ikke set statistisk signifikant forskel på absorptions karakteristika for rosiglitazon og metformin fra AVANDAMET tabletten og data for henholdsvis rosiglitazonmaleat og metforminhydrochlorid.
No statistically significant difference was observed between the absorption characteristics of rosiglitazone and metformin from the AVANDAMET tablet and those obtained from rosiglitazone maleate and metformin hydrochloride tablets, respectively.
Rosiglitazon passerer den humane placenta og er detekterbar i fostervæv.
Rosiglitazone has been reported to cross the human placenta and to be detectable in foetal tissues.
Leverproblemer: Inden og i løbet af behandlingen med Avandamet, vil din læge tage blodprøver for at tjekke din leverfunktion.
Liver problems: Before you start taking Avandamet you will have a blood sample taken to check your liver function.
Filmovertræk: Hypromellose (E464)
Hypromellose (E464)
Avandamet bør ikke anvendes af personer under 18 år, da sikkerheden og virkningen er ukendt hos denne patientgruppe.
Avandamet is not recommended for people aged under 18, as the safety and effectiveness are not known.
Efterfølgende handling med rosiglitazon viste ingen yderligere sikkerhedsproblemer blandt børn i forhold til voksne med type 2-diabetes mellitus.
Following rosiglitazone treatment, there were no new safety concerns noted in children compared to adult patients with type 2 diabetes mellitus.
Insulin bør kun lægges oven i behandling med rosiglitazon i særlige tilfælde, og patienten bør følges tæt.
Insulin should only be added to established rosiglitazone therapy in exceptional cases and under close supervision.
I kliniske undersøgelser er rosiglitazons glucosesænkende effekt indtrådt langsomt med påviselig maksimal reduktion i fastende plasmaglucose (FPG) efter cirka 8 ugers behandling.
In clinical trials, 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.
Behandling med AVANDAMET bør ikke indledes hos patienter med forhøjet baselineniveau af leverenzymer (ALAT > 2,5 gange den øvre grænse for normal) eller enhver anden evidens på leversygdom.
Therapy with AVANDAMET should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 times the upper limit of normal) or with any other evidence of liver disease.
Hvis påkrævet bør dosis af det antidiabetiske lægemiddel justeres under behandling med andre lægemidler og ved dets ophør.
If necessary, the dosage of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Den forbedrede glykæmiske kontrol er forbundet med en reduktion i både det fastende og det post-prandiale glucose.
The improved glycaemic control is associated with reductions in both fasting and postprandial glucose.
Der er begrænset erfaring med rosiglitazon hos patienter med forhøjede leverenzymer (ALAT > 2.5X den øvre grænse for normal).
There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT > 2.5 times the upper limit of normal).
En forhøjet hyppighed af hjerteinsufficiens er blevet observeret i kliniske forsøg, hvor rosiglitazon er anvendt i kombination med insulin.
An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
AVANDAMET Farmakoterapeutisk klassifikation: Antidiabetika, kombinationspræparater, ATC-kode: A10BD03
Pharmacotherapeutic group: Combinations of oral blood glucose lowering medicinal products, ATC code: A10BD03
Alle patienter, specielt patienter, som får Avandamet i kombination med insulin, patienter som får Avandamet i kombination med et sulfonylurinstof, patienter med risiko for hjerteinsufficiens og patienter med reducerede kardiale reserver, bør overvåges for tegn og symptomer på bivirkninger, der er relateret til væskeretention, herunder vægtøgning og hjerteinsufficiens.
All patients, particularly those receiving concurrent insulin but also 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.
(Du kan også tage denne dosis som to 2 mg/500 mg tabletter to gange daglig.)
(You can also take this dose as two 2 mg/500 mg tablets, twice a day.)
Nyrefunktionen skal kontrolleres inden behandlingen genoptages.
The doctor will check your kidney function before restarting treatment.
Rosiglitazon kan forårsage dosisafhængig væskeretention.
Rosiglitazone can cause dose-dependent fluid retention.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERKORT
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Risikoen var øget i de tilfælde, hvor rosiglitazon blev lagt oven i insulinbehandling, og hos patienter i nitratbehandling for iskæmisk hjertesygdom.
This risk was increased when rosiglitazone was added to established insulin and in patients receiving nitrates for known ischaemic heart disease.
• hvis du har et overdrevent alkoholforbrug - både hvis du drikker meget hver dag eller i perioder
• if you are a heavy drinker of alcohol - if you regularly drink a lot, or if you have occasional sessions of heavy drinking (binge drinking)
28 tabletter 56 tabletter 112 tabletter 360 tabletter
28 tablets 56 tablets 112 tablets 360 tablets
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.
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.
Eftersom både NSAID, insulin og rosiglitazon er associeret med væskeretention, kan samtidig administration forhøje risikoen for ødem.
Since NSAIDs, insulin and rosiglitazone are all associated with fluid retention, concomitant administration may increase the risk of oedema.
Avandamet indeholder Lactose
Avandamet contains lactose
I kliniske undersøgelser med rosiglitazon har der været tegn på dosisrelateret vægtforøgelse, som var større ved kombinationsbehandling med insulin.
In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Hovedparten af frakturerne var i overekstremiteterne og de distale underekstremiteter (se afsnit 4.4).
The majority of the fractures were reported in the upper limbs and distal lower limbs (see section 4.4).
Metformin stimulerer intracellulær glycogensyntese ved at påvirke glycogensyntesen.
Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Avandamet kan anvendes alene eller i kombination med et sulfonylurinstof (et andet lægemiddel til behandling af diabetes).
Avandamet can be used alone or with a sulphonylurea, another medicine for diabetes.
Nyreinsufficiens: Der ses ingen klinisk signifikante forskelle i rosiglitazons farmakokinetik hos patienter med nyresvigt eller terminal nyresygdom i kronisk dialyse.
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.