FrancophonIA/ELRC3.0 huggingface dataset:
English: Your blood sugar levels may become too high or too low (see ‘Low blood sugar' in Section 4).
Danish: Dit blodsukker kan blive for højt eller for lavt (se ”Lavt blodsukker” i afsnit 4).
English: If you stop taking Avaglim, your blood sugar will not be controlled, and you may become unwell.
Danish: Hvis du holder op med at tage Avaglim, vil dit blodsukker ikke længere være under kontrol, og du kan blive utilpas.
English: • lower blood sugar than normal (hypoglycaemia)
Danish: • lavere blodsukker end normalt (hypoglykæmi)
English: Take Avaglim for as long as your doctor recommends.
Danish: Tag Avaglim så længe som lægen anbefaler det.
English: Contains lactose, see leaflet for further information
Danish: Indeholder lactose, se indlægsseddel for yderligere information
English: AVAGLIM dose adjustment within the recommended posology or changes in diabetic treatment should be considered.
Danish: Justering af AVAGLIM dosis inden for den anbefalede dosering eller ændringer i diabetisk behandling bør overvejes.
English: You may be at risk of having low blood sugar and need hospital treatment.
Danish: Der kan være risiko for, at du får for lavt blodsukker, som kan kræve hospitalsbehandling.
English: It is not known whether breast-feeding will lead to exposure of the infant to medicinal product.
Danish: Det vides ikke, om amning vil kunne medføre, at barnet eksponeres for lægemidlet.
English: Appropriate monitoring is advised.
Danish: Korrekt monitorering er tilrådet.
English: The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.
Danish: Den interpersonelle variation var stor med en 7-fold forskel i ubundet AUC mellem patienterne.
English: • if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight
Danish: • hvis du har haft diabetisk ketoacidose (en komplikation til diabetes, der medfører hurtigt
English: Glimepiride AUC0-t, AUC0-inf and Cmax were increased by 30%, 19% and 55% respectively, on average.
Danish: Glimepirid AUC0-t, AUC0-inf og Cmax blev i gennemsnit forøget med henholdsvis 30 %, 19 % og 55 %.
English: Limited data with AVAGLIM is also consistent with this combined adverse reaction profile.
Danish: Begrænsede data for AVAGLIM er også konsistente med denne kombinerede bivirkningsprofil.
English: If you have kidney disease, or are over 65, your kidney function should be checked while you are
Danish: Hvis du har en nyresygdom eller hvis du er over 65 år, bør du få tjekket din nyrefunktion, mens du er i
English: Rarely hypoglycaemic reactions can occur immediately and may be severe and not always easy to correct.
Danish: Sjældne hypoglykæmiske reaktioner kan forekomme øjeblikkeligt, og disse kan være alvorlige og er ikke altid
English: There have been no formal interaction studies for AVAGLIM.
Danish: Der er ikke udført formelle interaktionsundersøgelser for AVAGLIM.
English: The dose of the rosiglitazone component can be increased after 8 weeks if required.
Danish: Dosis af rosiglitazon-komponenten kan om nødvendigt øges efter 8 uger.
English: For this reason, other medicines should only be taken with the knowledge (or at the prescription) of the doctor.
Danish: På grund af dette bør andre lægemidler kun indtages med lægens viden eller efter dennes ordination.
English: Packs of 14, 28, 56, 84 or 112 tablets.
Danish: Pakninger med 14, 28, 56, 84 eller 112 tabletter.
English: If a patient wishes to become pregnant or if pregnancy occurs, treatment with AVAGLIM should be
Danish: Hvis en patient ønsker at blive gravid eller bliver gravid, bør behandling med AVAGLIM seponeres.
English: AVAGLIM should be taken once daily shortly before or during a meal (usually the first main meal of the day).
Danish: AVAGLIM bør tages en gang daglig lige før et måltid (som regel før det første hovedmåltid på dagen).
English: Periodic haematological monitoring (especially leucocytes and thrombocytes) are required during
Danish: Periodisk hæmotologisk monitorering (specielt leukocytter og trombocytter) er nødvendigt under
English: The elevated total cholesterol levels were associated with increase in both LDLc and HDLc, but the ratio of total cholesterol:HDLc was unchanged or improved in long term studies.
Danish: Det forhøjede totale cholesterolniveau blev forbundet med en forøgelse i både LDLc og HDLc, men forholdet total cholesterol:HDLc var uændret eller forbedret i langtidsundersøgelser.
English: However, this raises no safety concern regarding target or special populations as hepatic impairment is contraindicated and the phase III clinical studies included a considerable number of elderly patients and patients with mild to
Danish: Dette udgør dog ikke noget sikkerhedsproblem for patientpopulationen eller for specielle populationer, eftersom nedsat leverfunktion er kontraindiceret, og de kliniske fase III undersøgelser omfattede et betragteligt antal ældre patienter og patienter med
English: Nevertheless, the potential for hypoglycaemia should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (e.g. driving).
Danish: Dog skal risikoen for hypoglykæmi tages i betragtning, når en patients kapacitet til at udføre opgaver, der kræver bedømmelsesformåen samt motoriske og kognitive evner (f.eks. bilkørsel)
English: Avaglim tablets contain a small amount of lactose.
Danish: Avaglim-tabletter indeholder en lille mængde lactose.
English: Like all medicines, Avaglim can cause side effects, but not everybody gets them.
Danish: Avaglim kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Avaglim can also strengthen or weaken the effects of medicines to prevent blood clots (anticoagulants such as warfarin).
Danish: Avaglim kan også forstærke eller formindske effekten af medicin til forebyggelse af blodpropper (antikoagulanter såsom warfarin)
English: M1, but not M2, possesses about 1/3 of the pharmacological activity as compared to its parent in an animal model.
Danish: M1, men ikke M2, besidder ca. 1/3 af den farmakologiske aktivitet sammenlignet med det uomdannede stof.
English: Take your tablets around the same time every day and follow any dietary advice that your doctor has
Danish: Tag tabletterne på samme tidspunkt hver dag og følg din læges råd om diæt.
English: This leads to a release of insulin by exocytosis.
Danish: Dette fører til insulinfrigivelse ved exocytose.
English: Opaque blisters (PVC/PVDC/aluminium).
Danish: Uigennemsigtige blisterpakninger (PVC/PVDC/aluminium).
English: However, the concomitant use of the active substances in patients in clinical studies and in widespread clinical use has not resulted in any unexpected interactions.
Danish: Derimod har samtidig brug af de to aktive substanser til patienter i kliniske undersøgelser og i omfattende klinisk brug ikke vist uventede interaktioner.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report
Danish: Som angivet i CHMP's retningslinjer for risikohåndteringssystemer for humane lægemidler skal en opdateret RMP indsendes samtidig med den næste periodiske sikkerhedsopdatering (Periodic Safety
English: There are no adequate data from the use of either active substance (rosiglitazone and glimepiride) in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data fra brug af de aktive substanser (rosiglitazon og glimepirid) hos gravide kvinder.
English: It may be used in non-insulin dependent diabetes mellitus.
Danish: Det kan anvendes til behandling af ikke-insulinkrævende diabetes mellitus.
English: Stop taking Avaglim.
Danish: Stop med at tage Avaglim.
English: The symptoms may be delayed for up to 24 hours after ingestion.
Danish: Symptomerne kan optræde op til 24 timer efter indtagelse.
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: Bivirkninger observeret i dyrestudier med mulig relevans for klinisk brug var følgende: En stigning i plasmavolumen ledsaget af et fald i parametre vedrørende røde blodlegemer samt en stigning i hjertevægten.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs
English: In studies with a maximal duration of three years, rosiglitazone given once or twice daily produced a sustained improvement in glycaemic control (FPG and HbA1c).
Danish: I undersøgelser med en varighed på maksimum 3 år medførte rosiglitazon indgivet en eller to gange dagligt en vedvarende forbedring i glykæmisk kontrol (FPG og HbA1c).
English: Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Danish: Frekvenskategorier gør ikke rede for andre faktorer, herunder varighed af undersøgelsen, allerede kendte fysiske tilstande og baseline-karakteristika for patienterne.
English: 7 Mild hypersensitivity reactions may develop into serious reactions with dyspnoea, fall in blood
Danish: 7Milde overfølsomhedsreaktioner kan udvikle sig til alvorlige reaktioner med dyspnø, blodtryksfald og
English: The volume of distribution of rosiglitazone is approximately 14 l in healthy volunteers.
Danish: Rosiglitazons distributionsvolumen er ca. 14 liter hos raske frivillige.
English: Therefore, AVAGLIM should not be used during pregnancy and the use of insulin is recommended.
Danish: AVAGLIM bør derfor ikke anvendes ved graviditet og behandling med insulin anbefales.
English: • Don't breast-feed while you are taking Avaglim.
Danish: • Du må ikke amme, mens du tager Avaglim.
English: The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2).
Danish: De vigtigste metabolitter er et cyklohexylhydroxymethyl derivat (M1) og et carboxyderivat (M2).
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 AVAGLIM 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 AVAGLIM, eller hvis bivirkningen forekommer i en højere frekvens end for den, der er opstillet for den enkelte komponent.
English: If ALT levels remain >3X the upper limit of normal, therapy should be discontinued.
Danish: Hvis ALAT niveauet forbliver > 3 gange den øvre normalgrænse, bør behandlingen afbrydes.
English: Heart failure was also reported more frequently in patients with a history of heart failure; oedema and heart failure was also reported more frequently in elderly patients and in patients with mild or moderate renal failure.
Danish: Hjerteinsufficiens blev også rapporteret oftere hos patienter med tidligere hjerteinsufficiens; ødem og hjerteinsufficiens blev også hyppigere rapporteret hos ældre patienter og hos patienter med mild eller moderat nedsat nyrefunktion.
English: Don't take Avaglim.
Danish: Tag ikke Avaglim.
English: Î Tell your doctor or pharmacist if you are taking anticoagulants.
Danish: Fortæl det til din læge eller på apoteket, hvis du tager antikoagulanter.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksisitet (se afsnit 5.3).
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 sandsynligheden for signifikant metabolismebaserede interaktioner med substanser, der metaboliseres af disse P450-enzymer lille.
English: Both rosiglitazone and glimepiride have been detected in the milk of experimental animals.
Danish: Både rosiglitazon og glimepirid er påvist i mælken hos forsøgsdyr.
English: Low blood sugar (hypoglycaemia): Certain conditions can make you more likely to suffer from low blood sugar while you are taking Avaglim.
Danish: Lavt blodsukker (hypoglykæmi): Særlige forhold gør dig mere udsat for at få for lavt blodsukker, mens du er i behandling med Avaglim.
English: The physiological response to acute physical exercise, a reduction in insulin secretion, is maintained during treatment with glimepiride.
Danish: Det fysiologiske respons på akut fysisk træning, dvs. reduceret insulinsekretion, fortsætter under glimepiridbehandling.
English: What Avaglim contains
Danish: Avaglim indeholder
English: This was based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, and fertility.
Danish: Disse observationer er baseret på konventionelle farmakologiske sikkerhedsundersøgelser, gentagen dosis-toxicitet, genotoxicitet, carcinogenicitet og reproduktionstoxicitetsstudier.
English: Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Danish: Bivirkningerne fra hvert behandlingsregime er opstillet nedenfor efter organklasse og absolut frekvens.
English: There was no significant difference in the effect regardless of whether the drug was taken 30 minutes before or immediately before a meal.
Danish: Der var ingen signifikant forskel i virkningen, hvad enten glimepirid blev givet 30 min. før eller kort før et måltid.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Avaglim til andre.
English: Many of these patients reported concurrent peripheral oedema.
Danish: Størstedelen af disse patienter har endvidere rapporteret om perifert ødem.
English: Limited data are available with regard to overdose of rosiglitazone in humans.
Danish: Der er begrænset datamateriale til rådighed i forbindelse med overdosering af rosiglitazon hos mennesker.
English: Although the hydroxy metabolite of glimepiride caused a small but significant reduction in serum glucose, it accounts for only a minor part of the total drug effect.
Danish: Selv om glimepirids hydroxymetabolit gav et lille men signifikant fald i serumglukose, er denne metabolit kun ansvarlig for en mindre del af den totale virkning.
English: The tablets are supplied in blister packs containing 14, 28, 56, 84 or 112 film-coated tablets.
Danish: Tabletterne findes i blisterpakninger indeholdende 14, 28, 56, 84 og 112 filmovertrukne tabletter.
English: No animal studies have been conducted with the combined products in AVAGLIM.
Danish: Der er ikke udført dyreundersøgelser med kombinationen af stoffer i AVAGLIM.
English: *The frequency category for the background incidence of this event, as taken from placebo group data from clinical trials, is 'common'.
Danish: *Frekvenskategorien for baggrundshyppigheden af disse bivirkninger, som er taget fra data fra placebo-grupper fra kliniske undersøgelser, er ”Almindelig”.
English: Haemolytic anaemia: If you have an inherited condition where your red blood cells don't produce enough of the enzyme G6PD, Avaglim may cause your red blood cells to be destroyed too quickly (haemolytic anaemia).
Danish: Hæmolytisk anæmi: Hvis du har en arvelig sygdom, hvor dine røde blodlegemer ikke producerer tilstrækkeligt af enzymet G6PD, kan Avaglim forårsage en for hurtig nedbrydning af dine røde
English: Approximately 40% of the total radioactivity was recovered in faeces and M1 and M2 (predominant) accounted for about 70% of that recovered in faeces.
Danish: Ca. 40 % af radioaktiviteten blev genvundet i fæces, og M1 og M2 (fremherskende) udgjorde 70 % af det i fæces genvundne.
English: No clinically significant reductions in glimepiride AUC and Cmax were observed after repeat doses of rosiglitazone for eight days in healthy adult
Danish: Ingen klinisk signifikant reduktion i glimepirid AUC og Cmax blev observeret efter gentagne doser af rosiglitazon i 8 dage hos raske voksne personer.
English: 6 Cross-allergenicity with sulphonylureas, sulphonamides or related substances is possible.
Danish: 6Der kan forekomme krydsallergi med sulfonylurinstoffer, sulfonamider og beslægtede stoffer.
English: In mechanistic studies, the weight increase was predominantly shown to be due to increased subcutaneous fat with decreased visceral and intra-hepatic
Danish: Mekanistiske undersøgelser har vist, at vægtøgningen overvejende skyldtes en stigning i subkutant fedt med mindsket visceralt og intra-hepatisk fedt.
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 mennesker, og det kan ikke udelukkes, at metabolitten bidrager til aktiviteten.
English: The incidence of all adverse events relating to liver and biliary systems was < 1.5% in any treatment group and similar to placebo.
Danish: Forekomsten af alle bivirkninger relateret til lever- og galdesystemerne var < 1,5 % i alle behandlingsgrupper og svarende til placebo.
English: • Avaglim is not recommended during pregnancy.
Danish: • Avaglim bør ikke anvendes under graviditet.
English: • fluconazole (used to treat fungal infections).
Danish: • fluconazol (anvendes til at behandle svampeinfektioner).
English: In reproductive toxicity studies, administration of rosiglitazone to rats during mid-late gestation was associated with foetal death and retarded foetal development.
Danish: I reproduktionstoxicitetsstudier var administration af rosiglitazon til rotter i anden halvdel af drægtighedsperioden forbundet med fosterdød og forsinket fosterudvikling.
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 syntese og progesteronsyntesen i ovarierne og sænkede plasmaniveauet af disse hormoner, hvilket indvirkede på brunst/menstruationscyklus og fertilitet (se afsnit 4.4).
English: 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.
Danish: Akkumulering af metabolitterne i plasma kan forventes efter gentagen dosering, specielt hvad angår den hyppigste metabolit (para-hydroxy-sulfat), hvor en 8-dobling kan forventes.
English: In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Danish: I tilfælde af overdosis anbefales det, at der gives støttende behandling, alt afhængig af patientens kliniske status.
English: Improved glycaemic control was also associated with significant decreases in free fatty acids.
Danish: Forbedret glykæmisk kontrol var også associeret med et signifikant fald i frie fedtsyrer.
English: • allergic reactions, inflammation of blood vessels (allergic vasculitis)
Danish: • allergiske reaktioner, betændelse af blodkar (allergisk vaskulit)
English: Avaglim tablets are a combination of two different medicines called rosiglitazone and glimepiride.
Danish: Avaglim-tabletter er en kombination af to forskellige lægemidler kaldet rosiglitazon og glimepirid.
English: The chances of this happening may be higher in people, particularly women, taking rosiglitazone for more than one year.
Danish: Risikoen er større hos især kvinder, der har taget rosiglitazon i mere end et år.
English: Glimepiride may either potentiate or weaken the effects of coumarin derivatives.
Danish: Glimepirid kan enten forstærke eller svække virkningen af kumarinderivater.
English: 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 fasted state.
Danish: Administration af rosiglitazon sammen med fødevarer resulterede ikke i nogen ændring i den generelle optagelse (AUC), selvom der sås et svagt fald i Cmax (cirka 20 % til 28 %) og en forsinkelse i tmax (ca. 1,75 time) sammenlignet med administration i fastende tilstand.
English: 8 Based on what is known of other sulphonylureas, hypoglycaemia may be prolonged.
Danish: 8Baseret på viden om andre sulfonylurinstoffer, kan hyoglykæmi være længerevarende.
English: Where clinically appropriate, direct change from glimepiride monotherapy to AVAGLIM may be considered.
Danish: Hvor det vurderes klinisk passende, kan et direkte skift fra glimepirid monoterapi til AVAGLIM overvejes.
English: The active substances are rosiglitazone and glimepiride.
Danish: De aktive stoffer er rosiglitazon og glimepirid.
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: Avaglim and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Danish: Avaglim kan, ligesom andre lægemidler til behandling af diabetes, forværre eksisterende tilstande eller forårsage alvorlige bivirkninger.
English: Manufacturer: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos,
Danish: Fremstiller: Glaxo Wellcome S.A., Avenida de Extremadura, 3, 09400 Aranda de Duero, Burgos,
English: AVAGLIM is not recommended for use in children below 18 years of age as there are no data available on its safety and efficacy.
Danish: AVAGLIM bør ikke anvendes til personer under 18 år, da der ikke er tilgængelige data om sikkerhed
English: In addition, rosiglitazone was not genotoxic in a battery of in vivo and in vitro genotoxicity studies and there was no evidence of colon tumours in lifetime studies of rosiglitazone in two rodent species.
Danish: Desuden fandtes rosiglitazon ikke gentoxisk i en række in vivo og in vitro genotoxicitetsundersøgelser, og der var ikke nogen evidens på colontumorer i livstidsundersøgelser af rosiglitazon hos to gnaverarter.
English: Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable
Danish: Indtagelse af alkohol kan forstærke eller svække glimepirids hypoglykæmiske virkning på uforudsigelig
English: Treatment of patients with G6PD-deficiency with sulphonylurea agents can lead to haemolytic anaemia.
Danish: Behandling af patienter som har G6PD-mangel med sulfonylurinstoffer kan medføre hæmolytisk anæmi.
English: A more pronounced glucose-lowering effect was observed in obese patients.
Danish: En mere udtalt glucosesænkende effekt blev observeret hos overvægtige patienter.
English: AVAGLIM therapy should be individualised for each patient.
Danish: Behandling med AVAGLIM bør være individuelt tilpasset den enkelte patient.
English: The clinical relevance of this observation has not been fully elucidated.
Danish: Den kliniske relevans af denne observation er endnu
English: Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9).
Danish: Glimepirid metaboliseres af cytochrome P450 2C9 (CYP2C9).
English: It is advised that patients established on rosiglitazone and chlorpropamide concomitant therapy should not switch to AVAGLIM as chlorpropamide has a long half-life which may increase the risk of hypoglycaemia.
Danish: Det tilrådes, at patienter i behandling med rosiglitazon og chlorpropamid ikke skiftes til AVAGLIM, da chlorpropamid har en lang halveringstid, hvilket øger risikoen for hypoglykæmi.