FrancophonIA/ELRC3.0 huggingface dataset:
English: The following statements reflect the pharmacokinetic properties of the individual active substances of AVANDAMET.
Danish: De følgende oplysninger vedrører de farmakokinetiske forhold af de individuelle aktive stoffer i AVANDAMET.
English: Acute Coronary Syndrome (ACS)
Danish: Akut koronarsyndrom (AKS)
English: This most often affects people who have severe kidney disease.
Danish: Det er som oftest personer med alvorlige nyresygdomme, der påvirkes.
English: Since there is no significant in vitro inhibition of CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A or 4A with rosiglitazone, there is a low probability of significant metabolism-based interactions with substances metabolised by these P450 enzymes.
Danish: Idet der ikke ses nogen væsentlig in vitro hæmning af CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A eller 4A med rosiglitazon, er der lille sandsynlighed for signifikant metabolismebaserede interaktioner med substanser, der metaboliseres af disse P450-enzymer.
English: Undesirable 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: Bivirkningerne, der blev observeret i dyreforsøg 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 prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Den prospektive randomiserede undersøgelse (UKPDS) har påvist langtidsfordele af intensiv blodsukkerkontrol ved type 2-diabetes.
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 endnu ikke blevet fastlagt (se afsnit 4.8).
English: An adverse reaction is only presented for the fixed dose combination if it has not been seen in one of the component parts of AVANDAMET or if it occurred at a higher frequency than that listed for a component part.
Danish: En bivirkning vil kun være at finde under den faste dosiskombination, hvis den ikke er set under en af komponenterne i AVANDAMET eller hvis bivirkningen forekommer i en højere frekvens end for den, der er opstillet for den enkelte komponent.
English: The clinical relevance of this decrease is unknown.
Danish: Den kliniske relevans af denne mindskelse er ukendt.
English: • small increases in blood cholesterol, increased amount of fats in the blood
Danish: • lille stigning af kolesterol i blodet, øget fedtindhold i blodet
English: Avandamet tablets are a combination of two different medicines called rosiglitazone and metformin.
Danish: Avandamet-tabletter er en kombination af to forskellige lægemidler kaldet rosiglitazon og metformin.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.ema.europa.eu/
English: ACE-inhibitors may decrease the blood glucose levels.
Danish: ACE-hæmmere kan mindske blodsukkerniveauet.
English: • if you have heart failure, or have had heart failure in the past
Danish: • hvis du har en hjertelidelse eller tidligere har haft det
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Renal clearance af metformin er > 400 ml/min, hvilket tyder på, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
English: Non-clinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: Ikke-kliniske data for metformin viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet og toksicitet i forbindelse med reproduktion.
English: No intact active substance is excreted in urine or faeces.
Danish: Intet intakt aktivt stof udskilles i urin eller fæces.
English: • if you are going to have an operation under general anaesthetic.
Danish: • hvis du skal have foretaget en operation under narkose.
English: If ALT levels remain > 3 times the upper limit of normal, therapy should be discontinued.
Danish: Hvis ALAT-niveauet forbliver > 3 gange den øvre grænse for normal, bør behandlingen afbrydes.
English: 1995.5 (682.6) mg *Similar relative effective doses (i.e approximately half maximal dose) for other sulphonylureas (glibenclamide and glicazide).
Danish: 1995,5 (682,6) mg * Identiske virksomme doser (dvs. ca. halv maksimumdosis) af andre SU (glibenclamid og glicazid).
English: As a consequence of improving insulin sensitivity, resumption of ovulation may occur in patients who are anovulatory due to insulin resistance.
Danish: Som en konsekvens af forbedret insulinsensitivitet kan ovulationen genetableres hos patienter, som er anovulatoriske på grund af insulinresistens.
English: The possible contribution of fluid retention to weight gain should be individually assessed as rapid and excessive weight gain has been reported very rarely as a sign of fluid retention.
Danish: Væskeretentionens mulige medvirken til vægtøgning bør vurderes individuelt, da hurtig og voldsom vægtøgning i meget sjældne tilfælde er rapporteret som tegn på væskeretention.
English: Rosiglitazone (either SU or metformin)
Danish: Rosiglitazon (enten SU eller metformin)
English: The Marketing Authorisation Holder (MAH) must ensure that the system of pharmacovigilance, as described in version 7.2 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet, som beskrevet i version 7.2 i Modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer, før produktet kommer på markedet, og så længe produktet er markedsført.
English: myalgia*
Danish: Myalgi*
English: • if you are allergic (hypersensitive) to rosiglitazone or metformin or any of the other ingredients of Avandamet (listed in Section 6)
Danish: • hvis du er overfølsom (allergisk) over for rosiglitazon eller metformin eller et af de øvrige indholdsstoffer i Avandamet (se afsnit 6)
English: • Don't breast-feed while you are taking Avandamet.
Danish: • Du må ikke amme, mens du tager Avandamet.
English: How to take Swallow the tablets with some water.
Danish: Sådan skal du tage Synk tabletterne med vand.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Avandamet til andre.
English: Symptoms of lactic acidosis include:
Danish: Symptomer på lactacidose omfatter:
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ml, even at maximum doses.
Danish: I kontrollerede kliniske undersøgelser overskred de maksimale metformin plasmakoncentrationer (Cmax) ikke 4 µg/ml, selv ved maksimale doser.
English: In patients with low haemoglobin levels before initiating therapy, there is an increased risk of anaemia during treatment with AVANDAMET.
Danish: Hos patienter med lavt baselineniveau for hæmoglobin før indledning af terapi, findes en forhøjet risiko for anæmi under behandling med AVANDAMET.
English: Tell your doctor or pharmacist if you are taking any other medicines, if you've taken any recently, or if you start taking new ones.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin, har brugt det for nylig eller hvis du starter med at tage ny medicin.
English: Premenopausal women have received rosiglitazone during clinical studies.
Danish: Præmenopausale kvinder har modtaget rosiglitazon i kliniske undersøgelser.
English: In females, this increased incidence was noted after the first year of treatment and persisted during long-term treatment.
Danish: Hos kvinder blev den øgede forekomst observeret efter et års behandling og varede ved gennem resten af langtidsbehandlingen.
English: Just take your next dose at the usual time.
Danish: Tag blot næste tablet på det planlagte tidspunkt.
English: Where appropriate, AVANDAMET may be used to substitute concomitant rosiglitazone and metformin in existing dual or triple oral therapy to simplify treatment.
Danish: Hvor det er hensigtsmæssigt, kan AVANDAMET erstatte samtidig brug af rosiglitazon og metformin i eksisterende oral kombinationsbehandling eller oral tripel-kombinationsbehandling for at simplificere behandlingen.
English: AVANDAMET has no or negligible influence on the ability to drive and use machines.
Danish: AVANDAMET påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The clinical relevance of this observation has not been fully elucidated.
Danish: Den kliniske relevans af denne observation er endnu ikke fuldt klarlagt.
English: Low blood sugar (hypoglycaemia): If you are taking Avandamet 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 Avandamet i kombination med andre lægemidler til behandling af diabetes, er der risiko for at dit blodsukker falder ned under det normale niveau.
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: Yderligere blev der oftere rapporteret om hjerteinsufficiens hos patienter med tidligere hjerteinsufficiens; ødem og hjerteinsufficiens blev også hyppigere rapporteret hos ældre patienter og hos patienter med mild eller moderat renal insufficiens.
English: Rosiglitazone failed to demonstrate non-inferiority to metformin.
Danish: Rosiglitazon viste ikke non-inferioritet over for metformin.
English: NAME OF THE MARKETING AUTHORISATION HOLDER SmithKline Beecham Ltd
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SmithKline Beecham Ltd
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000 including isolated reports).
Danish: Frekvenserne er defineret som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000) herunder isolerede rapporter.
English: The antihyperglycaemic activity of rosiglitazone has been demonstrated in a number of animal models of type 2 diabetes.
Danish: Rosiglitazons antihyperglykæmiske aktivitet er påvist i et antal dyremodeller af type 2-diabetes.
English: Lactic acidosis: An increase in the amount of lactic acid in the blood (lactic acidosis) is a very rare side effect of metformin.
Danish: Lactacidose: En forøget mængde af mælkesyre i blodet (lactacidose) er en meget sjælden bivirkning til metformin.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy (see ‘Pregnancy and breast-feeding' later in Section 2).
Danish: Hvis dette er tilfældet for dig, skal du bruge prævention for at undgå graviditet (se ”Graviditet og amning” senere i afsnit 2).
English: AVANDAMET is not recommended for use in children and adolescents below 18 years of age as there are no data available on its safety and efficacy in this age group (see sections 5.1 and 5.2).
Danish: AVANDAMET bør ikke anvendes til børn og unge under 18 år p.g.a. manglende dokumentation for sikkerhed og virkning (se afsnit 5.1 og 5.2).
English: • dark-coloured urine.
Danish: • mørk urin.
English: Film-coated tablet.
Danish: Filmovertrukne tabletter.
English: The rosiglitazone dose may need to be increased.
Danish: Det kan være nødvendigt at øge dosis af rosiglitazon.
English: Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
Danish: Klinisk signifikante interaktioner med CYP2C9-substrater eller inhibitorer forventes ikke.
English: In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
Danish: I en dyremodel for familiær adenomatøs polyposis (FAP) gav behandling med rosiglitazon i doser på 200 gange den farmakologiske aktive dosis anledning til forøget tumormangfoldighed i colon.
English: AVANDAMET must therefore not be used in women who are breast-feeding (see section 4.3).
Danish: AVANDAMET må derfor ikke anvendes af ammende kvinder (se afsnit 4.3).
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: I mekanistiske undersøgelser viste, at vægtøgningen overvejende skyldes en øgning i det subkutane fedtlag med mindsket visceralt og intrahepatisk fedtlag.
English: Food had no effect on the AUC of rosiglitazone or metformin when AVANDAMET was administered to healthy volunteers.
Danish: Fødeindtagelse påvirkede ikke AUC for rosiglitazon eller metformin, når AVANDAMET blev givet til raske frivillige.
English: Metformin partitions into erythrocytes.
Danish: Metformin fordeler sig i erytrocytter.
English: Metabolism
Danish: Metabolisme
English: Mean (SD) dose at end of randomised treatment
Danish: Gennemsnitsdosis (SD) ved afslutning af randomiseret behandling
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: En farmakokinetisk befolkningsanalyse med 96 patienter i alderen 10-18 år i vægtklassen 35-178 kg, viste samme middelværdi for CL/F hos både børn og voksne.
English: Broken bones: Bone fractures can occur in people with diabetes.
Danish: Knoglebrud: Knoglebrud kan forekomme hos patienter med diabetes.
English: Overall, 43%, 47% and 42% of subjects in the rosiglitazone, glibenclamide and metformin groups respectively withdrew due to reasons other than monotherapy failure.
Danish: Henholdsvis 43 %, 47 % og 42 % af patienterne i rosiglitazon-, glibenclamid- og metformingruppen trak sig ud af studiet af grunde, som ikke skyldtes monoterapisvigt.
English: The contribution of the major metabolite (a para-hydroxy-sulphate) to the overall antihyperglycaemic 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: Î Discuss with your doctor any concerns about your eyesight.
Danish: Tal med lægen, hvis du har bekymringer vedrørende dit syn.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se afsnit 5.3).
English: AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients: - who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Danish: AVANDAMET er indiceret til behandling af type 2-diabetes mellitus patienter, særligt hos overvægtige patienter: - som ikke kan opnå tilstrækkelig glykæmisk kontrol ved deres maksimal tolererede dosis af oral
English: If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately (see section 4.9).
Danish: Hvis der er mistanke om metabolisk acidose, bør behandlingen afbrydes, og patienten bør omgående indlægges (se afsnit 4.9).
English: Increased monitoring of the patient is recommended if AVANDAMET is used in combination particularly with insulin but also with a sulphonylurea.
Danish: Øget overvågning af patienten anbefales, hvis AVANDAMET anvendes i kombination med specielt insulin, men også hvis det anvendes i kombination med sulfonylurinstoffer.
English: The decision to initiate AVANDAMET in combination with a sulphonylurea should include consideration of alternative therapies.
Danish: Beslutningen om at påbegynde behandlingen med AVANDAMET i kombination med et sulfonylurinstof, bør omfatte overvejelser af alternative behandlinger.
English: There are limited clinical trial data in patients with ischaemic heart disease and/or peripheral arterial disease.
Danish: Der er begrænsede oplysninger fra kliniske forsøg hos patienter med iskæmisk hjertesygdom og/eller perifer karsygdom.
English: Plasma concentrations are approximately dose proportional over the therapeutic dose range.
Danish: Plasmakoncentrationerne er stort set dosisproportionale inden for det terapeutiske interval.
English: In addition, rosiglitazone inhibited ovarian oestradiol and progesterone synthesis and lowered plasma levels of these hormones resulting in effects on oestrus/menstrual cycles and fertility (see section 4.4).
Danish: Desuden hæmmede rosiglitazon den østradiole og progesterone syntese i ovarierne og sænkede plasmaniveauet af disse hormoner, hvilket resulterede i effekter på østrus/menstruationscyklus og fertilitet (se afsnit 4.4).
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 18 µM) og lav inhibition af CYP2C9 (IC50 50 µM) in vitro (se afsnit 4.5).
English: • gemfibrozil (used to lower cholesterol)
Danish: • gemfibrozil (anvendes til at sænke kolesterol)
English: • swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Danish: • hævelse, nogen gange af ansigt og mund (angioødem), hvilket kan medføre vejrtrækningsproblemer
English: Increases in liver weight, plasma ALT (dog only) and fat tissue were also observed.
Danish: Ligeledes observeredes en stigning i levervægten, plasma ALAT (kun hos hunde) og fedtvæv.
English: The Marketing Authorisation Holder 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 Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at udføre de studier og ekstra farmakovigilanceaktiviteter, som er beskrevet i farmakovigilanceplanen, som aftalt i version 4 af risikohåndteringsplanen (Risk Management Plan, RMP) anført i Modul 1.8.2 i ansøgningen om markedsføringstilladelsen og efterfølgende CHMP-krav til opdateringer af RMP.
English: As metformin is excreted by the kidney, serum creatinine concentrations should be determined regularly: - at least once a year in patients with normal renal function - at least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly patients.
Danish: Da metformin udskilles via nyrerne bør serum-kreatininkoncentrationen bestemmes regelmæssigt: - mindst en gang årligt hos patienter med normal nyrefunktion - mindst to til fire gange årligt hos patienter med serum-kreatininkoncentrationer ved den øvre
English: No long-term efficacy and safety data are available in paediatric patients.
Danish: Der er ingen langvarige effekt- og sikkerhedsdata tilgængelig hos børn.
English: CL/F seemed to be independent of age, but increased with weight in the paediatric population.
Danish: CL/F forekom uafhængig af alder, men blev forøget med vægten hos patienterne mellem 10 og 18 år.
English: The severity can increase, leading to confusion and loss of consciousness.
Danish: Symptomerne kan blive alvorlige og medføre forvirring og bevidstløshed.
English: Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Danish: Til trods for, at en hormonel ubalance er set i de prækliniske undersøgelser (se afsnit 5.3), er der ikke set signifikante bivirkninger i forbindelse med menstruelle forstyrrelser.
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 reproduktionstoxicitetsforsøg var administration af rosiglitazon til rotter i anden halvdel af drægtighedsperioden forbundet med fosterdød og forsinket fosterudvikling.
English: Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will submit yearly PSURs until otherwise decided by the CHMP.
Danish: Efter fornyelse af markedsføringtilladelsen, og indtil andet er besluttet af CHMP, skal indehaveren af markedsføringstilladelsen indsende årlige PSUR'er.
English: Signs include:
Danish: Symptomerne omfatter:
English: • if you are breast-feeding (see ‘Pregnancy and breast-feeding' later in Section 2).
Danish: • hvis du ammer (se ”Graviditet og amning” senere i afsnit 2).
English: Avandamet and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Danish: Avandamet kan, ligesom andre lægemidler til behandling af diabetes, forværre eksisterende tilstande eller forårsage alvorlige bivirkninger.
English: y if you become dehydrated - for example, after severe vomiting, diarrhoea or fever.
Danish: • hvis du bliver dehydreret - for eksempel efter alvorlig opkastning, diare eller feber.
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 kongestiv hjerteinsufficiens.
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Danish: En klinisk undersøgelse af 7 normale, raske personer viste, at cimetidin, administreret som 400 mg to gange daglig, forøger den systemiske eksponering af metformin (AUC) med 50 % og Cmax med 81 %.
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 cirka 99 %.
English: Many of these patients reported concurrent peripheral oedema.
Danish: Størstedelen af disse patienter har endvidere rapporteret perifert ødem.
English: • rapid and excessive weight gain caused by fluid retention
Danish: • hurtig og voldsom vægtøgning på grund af væskeophobning
English: • if you have had a heart attack or severe angina, that's being treated in hospital
Danish: • hvis har haft et hjertetilfælde eller alvorlige hjertekramper, som behandles på hospital
English: • shortness of breath, waking up short of breath at night
Danish: • Åndenød og opvågnen i løbet af natten pga. åndenød
English: Improved glycaemic control was also associated with significant decreases in free fatty acids.
Danish: Forbedret glykæmisk kontrol var også forbundet med et signifikant fald i frie fede syrer.
English: Thiazolidinediones act primarily by reducing insulin resistance and biguanides act primarily by decreasing endogenous hepatic glucose production.
Danish: Thiazolidinedionerne virker primært ved at reducere insulinresistens og biguaniderne virker primært ved at mindske den endogene hepatiske glucoseproduktion.
English: • swelling of the retina at the back of the eye (macular oedema)
Danish: • hævelse af retina i det bagerste af øjet (maculaødem)