FrancophonIA/ELRC3.0 huggingface dataset:
English: This can be avoided if your doctor stops your treatment with fluvastatin as quickly as possible.
Danish: Det kan undgås, hvis din læge afbryder din behandling med fluvastatin så hurtigt som muligt.
English: However, enhanced treatment response was observed in women and in elderly people.
Danish: Der er dog observeret øget behandlingsrespons hos kvinder og ældre mennesker.
English: Take one dose as soon as you remember.
Danish: Tag én dosis, så snart du kommer i tanke om det.
English: Your cholesterol levels need to be checked regularly to monitor your progress.
Danish: Det er nødvendigt at kontrollere dine kolesteroltal regelmæssigt for at følge dine fremskridt.
English: You may need medical attention.
Danish: Du kan have behov for lægebehandling.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Danish: INDLÆGSSEDDEL : INFORMATION TIL BRUGEREN
English: Significant increases in HDL-C were also observed.
Danish: Der sås også signifikante stigninger i HDL-C.
English: The absolute bioavailability assessed from systemic blood concentrations is 24%.
Danish: Den absolutte biotilgængelighed vurderet ud fra systemiske blodkoncentrationer er 24%.
English: They may differ from the information contained in this leaflet.
Danish: De kan være forskellige fra oplysningerne i denne indlægsseddel.
English: Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
Danish: Alt efter hvordan du reagerer på behandlingen, vil din læge måske foreslå en højere eller lavere dosis.
English: The broad recommendation of “supportive measures” would cover gastrointestinal decontamination measures, if appropriate.
Danish: Den brede anbefaling om "støtteforanstaltninger" dækker gastrointestinale dekontamineringsforanstaltninger, hvis der er behov herfor.
English: Swallow whole with a glass of water.
Danish: De skal synkes hele med et glas vand.
English: • Sexual dysfunction
Danish: • Seksuel dysfunktion
English: The ability of the trials to detect any effect of treatment in this area was however low.
Danish: Forsøgenes evne til at påvise eventuel effekt af behandlingen på dette område var dog lille.
English: These might be early signs of a potentially severe muscle degradation.
Danish: Dette kan være tidlige tegn på en muskelnedbrydning, som kan være alvorlig.
English: Other side effects: tell your doctor if they worry you.
Danish: Andre bivirkninger: Tal med din læge, hvis du er bekymret.
English: These beneficial effects were particularly noteworthy in patients with diabetes mellitus and in patients with multivessel disease.
Danish: Disse gavnlige virkninger var særligt bemærkelsesværdige hos patienter med diabetes mellitus og patienter med multikarsygdom.
English: The apparent volume of distribution (Vz/f) for the drug is 330 litres.
Danish: Det tilsyneladende fordelingsvolumen (Vd/f) for lægemidlet er 330 liter.
English: Results at 24-week from both programs have been presented in a single table with limited repetition in the text, in order to improve clarity of information and ease of use.
Danish: Resultaterne ved 24 timer fra begge programmer er blevet præsenteret i en enkelt tabel med begrænsede gentagelser i teksten for at forbedre informationens tydelighed og brugervenlighed.
English: In this case take your next dose at the usual time.
Danish: I så fald skal du tage din næste dosis på det sædvanlige tidspunkt.
English: In such situations, the risk of treatment should be considered in relation to the possible benefit and clinical monitoring is recommended.
Danish: I sådanne tilfælde skal risikoen ved behandling overvejes i forhold til de mulige fordele, og klinisk monitorering anbefales.
English: However appropriate wording for the paediatric population were included in the sections agreed during the EU Worksharing procedure; sections 4.2, 4.4, 4.8, 5.1 and 5.2.
Danish: Den relevante ordlyd for den pædiatriske population blev dog medtaget i de afsnit, der blev opnået enighed om under arbejdsdelingsproceduren på EU-plan, nemlig afsnit 4.2, 4.4, 4.8, 5.1 og 5.2.
English: They are used in patients whose conditions cannot be controlled by diet and exercise alone.
Danish: Statiner bruges til patienter, hvor tilstanden ikke kan kontrolleres udelukkende ved diæt og motion.
English: To date there has been limited experience with overdose of fluvastatin.
Danish: Der har til dato været begrænset erfaring med overdosering af fluvastatin.
English: 6.6 Special precautions for disposal <and other handling> No special requirements.
Danish: 6.6 Regler for destruktion <og anden håndtering> Ingen særlige forholdsregler.
English: For dose information in children and adolescents over 9 years, see section 3.
Danish: For information om dosering til børn og unge over 9 år, se afsnit 3.
English: • Sleep disturbances, including insomnia and nightmares
Danish: • Søvnforstyrrelser, herunder søvnløshed og mareridt
English: Before treatment
Danish: Før behandlingen
English: Minor modifications from the Worksharing Project wording reflect the paediatric data and were considered to be acceptable.
Danish: Mindre ændringer fra arbejdsdelingsprojektets formulering afspejler de pædiatriske data og blev anset for at være acceptable.
English: Fluvastatin is absorbed rapidly and completely (98%) after oral administration of a solution to fasted volunteers.
Danish: Fluvastatin absorberes hurtigt og fuldstændigt (98 %) efter oral administration af en opløsning til fastende frivillige.
English: The ultimate result of these mechanisms is a reduction in the plasma cholesterol concentration.
Danish: Det endelige resultat af denne mekanisme er en reduktion i plasma-kolesterolkoncentrationen.
English: The particular reference to heart transplant conditions and ciclosporin seems sufficiently covered by the general statement for immunosuppressive drugs.
Danish: Den særlige henvisning til hjertetransplantation og ciclosporin ser ud til at være tilstrækkeligt dækket af den generelle erklæring vedrørende immunosuppressive lægemidler.
English: The majority of patients with these abnormal biochemical findings were asymptomatic.
Danish: Størstedelen af patienterne med disse unormale biokemiske fund var asymptomatiske.
English: Plasma concentrations of fluvastatin do not vary as a function of either age or gender in the general population.
Danish: Plasmakoncentrationen af fluvastatin varierer ikke som funktion af alder eller køn i populationen som helhed.
English: Liver function tests and serum CK levels should be monitored.
Danish: Leverfunktionstest og serum-CK-niveau bør monitoreres.
English: No data are available about the physical, intellectual and sexual maturation for prolonged treatment period.
Danish: Der foreligger ingen data vedrørende fysisk, intellektuel eller seksuel modning ved længerevarende behandling.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: Overall Lescol was safe and well tolerated and the observed safety profile consistent with the known adverse event profile.
Danish: Generelt var Lescol sikkert og veltolereret, og den observerede sikkerhedsprofil stemte overens med den kendte bivirkningsprofil.
English: Therapeutic response is well established within two weeks, and a maximum response is achieved within four weeks.
Danish: Terapeutisk respons er veletableret inden for to uger, og maksimal respons opnås inden for fire uger.
English: Active substance: fluvastatin (as fluvastatin sodium)
Danish: Aktivt stof: fluvastatin (som fluvastatinnatrium)
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LESCOL AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF LESCOL OG TILKNYTTEDE NAVNE (SE BILAG I)
English: The open-label design and the lack of a placebo control group did not allow a solid conclusion to be drafted regarding the efficacy and safety in this population due to some methodological limitations.
Danish: Det åbne undersøgelsesdesign og fraværet af en placebokontrolgruppe umuliggjorde en pålidelig konklusion om effektiviteten og sikkerheden for denne population på grund af nogle metodologiske begrænsninger.
English: No direct correlation between the angiographic findings and the risk of cardiovascular events has been demonstrated.
Danish: Der er ikke vist en direkte korrelation mellem resultater fraangiografierne og risikoen for kardiovaskulære hændelser.
English: • In elderly (age > 70 years), the necessity of such measurement should be considered, according to the presence of other predisposing factors for rhabdomyolysis.
Danish: • Hos ældre patienter (alder >70 år) bør nødvendigheden af sådanne målinger overvejes ud fra tilstedeværelsen af andre disponerende faktorer for rabdomyolyse.
English: Quantitative coronary angiograms were evaluated at baseline and after 2.5 years of treatment and were evaluable in 340 out of 429 patients.
Danish: Kvantitative koronorangiogrammer blev vurderet ved baseline og efter 2,5 års behandling og kunne evalueres hos 340 ud af 429 patienter.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction Food interactions were restricted to grapefruit juice only.
Danish: Afsnit 4.5 - Interaktion med andre lægemidler og andre former for interaktion Interaktion med fødevarer var begrænset til grapefrugtjuice.
English: Box 241
Danish: P.O. Box 241
English: Starting and maintenance dose of fluvastatin should be as low as possible when combined with ciclosporin.
Danish: Initial- og vedligeholdelsesdosis af fluvastatin bør være mindst mulig, når det kombineres med cicloporin.
English: These side effects have also been found with similar medicines of this class (statins).
Danish: Disse bivrkninger er også set med anden medicin af denne type (statiner).
English: Although these increases in fluvastatin levels were not clinically significant, this combination should be used with caution.
Danish: Selvom disse stigninger i fluvastatinniveau ikke var klinisk signifikante, bør kombinationen anvendes med forsigtighed.
English: • Personal or familial history of hereditary muscular disorders.
Danish: • Personlig eller familiær anamnese med arvelige muskelsygdomme.
English: Steady-state plasma concentrations show no evidence of fluvastatin accumulation following administration of 80 mg daily.
Danish: Steady-state plasmakoncentrationen viser ingen tegn på akkumulation af fluvastatin efter administration af 80 mg daglig.
English: Itraconazole and erythromycin
Danish: Itraconazol og erythromycin
English: 70 patients were pubertal or postpubertal (n=69 evaluated for efficacy).
Danish: 70 patienter var i puberteten eller havde passeret puberteten (n=69 evalueret for effekt).
English: In both clinical trials no effect was observed on growth and sexual maturation.
Danish: De to kliniske forsøg viste ingen påvirkning af vækst og seksuel modning.
English: À Av. da Siderurgia Nacional - 4745-457 S. Mamede do Coronado
Danish: À Av. da Siderurgia Nacional4745-457 S. Mamede do Coronado Portugal
English: Section 4.4 - Special warnings and precautions for use The CHMP considered it reasonable to maintain the recommendations on liver function testing which have been implemented in clinical practice over the last decade(s), although routine monitoring of transaminases has been discouraged more recently by various experts.
Danish: Afsnit 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen CHMP fandt det rimeligt at opretholde anbefalingerne om leverfunktionstest, der er blevet gennemført i klinisk praksis i det/de seneste tiår, selv om forskellige eksperter på det seneste har frarådet rutinemæssig kontrol af transaminaser.
English: The MAH Novartis completed the EU Work Sharing Project on paediatric wording on 24 July 2007.
Danish: Indehaveren af markedsføringstilladelsen, Novartis, fuldførte arbejdsdelingsprojektet på EU-plan om en pædiatrisk ordlyd den 24. juli 2007.
English: Tell your doctor and pharmacist if you are taking any of the following: - Ciclosporin (a medicine used to suppress the immune system).
Danish: Fortæl det til lægen eller på apoteket, hvis du tager nogen af disse lægemidler: - Ciclosporin (medicin, der bruges til at undertrykke immunsystemet).
English: The hydroxylated metabolites have pharmacological activity but do not circulate systemically.
Danish: De hydroxylerede metabolitter er farmakologisk aktive, men cirkulerer ikke systemisk.
English: Therefore it was the recommendation of the CHMP that the starting dose of 40mg uptitrated to 80mg/day, taking into account patient response would be more appropriate from an efficacy and safety perspective.
Danish: Derfor anbefalede CHMP, at en startdosis på 40 mg øget til 80 mg/dag under hensyntagen til patientens respons ville være mere hensigtsmæssig ud fra et effektivitets- og sikkerhedsperspektiv.
English: - if you bleed or bruise more easily than normal (signs of decreased number of blood platelets).
Danish: - hvis du bløder eller får blå mærker lettere end normalt (tegn på nedsat antal blodplader).
English: The text proposed regarding recommendations regarding skeletal muscle reflects the wording that is currently implemented in the majority of EU Member States and is in line with various published recommendations on warnings and precautions on skeletal muscle.
Danish: Den foreslåede tekst til anbefalingerne vedrørende skeletmuskulatur afspejler den ordlyd, der i øjeblikket gennemføres i størstedelen af EU's medlemsstater, og er i overensstemmelse med forskellige offentliggjorte anbefalinger vedrørende advarsler og forsigtighedsbestemmelser i tilknytning til skeletmuskulaturen.
English: Fluvastatin inhibited only the metabolism of compounds that are metabolised by CYP2C9.
Danish: Fluvastatin hæmmede kun metabolismen af stoffer, der metaboliseres af CYP2C9.
English: The paediatric information from the EU Worksharing Project has also been implemented with minor editorial changes.
Danish: Den pædiatriske information fra arbejdsdelingsprojektet på EU-plan er også blevet indført med mindre redaktionelle ændringer.
English: In this study there were no changes in glucose, insulin, and C-peptide levels.
Danish: I dette studie var der ingen ændringer i glucose-, insulin- og C-peptid-niveauer.
English: - For children (aged 9 years and older) the usual starting dose is 20 mg per day.
Danish: − Til børn (9 år og derover) er den sædvanlige startdosis 20 mg daglig.
English: U Nákladového nádraží 10, 13000 Prague 3, Czech Republic
Danish: U Nákladového nádraží 10 13000 Prague 3
English: Rhabdomyolysis, myositis, lupus erythematosus-like reactions
Danish: Rabdomyolyse, myositis, lupus erythematosus-lignende reaktioner
English: An overall recommendation to monitor liver function and CK levels seemed a reasonable approach considering that effects on liver and muscle may be generally expected in statin overdosage.
Danish: En generel anbefaling om at kontrollere leverfunktionen og kreatinkinaseniveauet forekom at være en hensigtsmæssig fremgangsmåde, da virkninger på lever og muskler generelt kan forventes ved overdosering af statin.
English: The CHMP agreed with the wording proposed for the paediatric population in line with the wording agreed during the EU Worksharing Project.
Danish: CHMP godkendte den foreslåede formulering for den pædiatriske population i overensstemmelse med den ordlyd, der blev godkendt under arbejdsdelingsprojektet på EU-plan.
English: In this randomised, double-blind, controlled clinical study, 429 patients were treated with either fluvastatin 40 mg/day or placebo.
Danish: I dette randomiserede, dobbeltblindede, kontrollerede kliniske studie blev 429 patienter behandlet med enten fluvastatin 40 mg daglig eller placebo.
English: Based on clinical observations, liver function tests are already recommended (see section 4.4).
Danish: På grundlag af kliniske observationer anbefales der allerede leverfunktionstest (jf. afsnit 4.4).
English: A creatine kinase level should be measured before starting fluvastatin treatment in the following situations:
Danish: Der bør måles CK-værdier inden initiering af fluvastatinbehandling i følgende tilfælde:
English: The dosage recommendations in elderly patients are consistent across the Member States in stating that no dose adjustments are required.
Danish: Doseringsanbefalingerne hos ældre patienter er ens i medlemsstaterne, idet det anføres, at ingen dosisjusteringer er påkrævet.
English: Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
Danish: Bivirkningerne (tabel 1) er anivet efter frekvenskategorier med den hyppigste først og med følgende definition: 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); meget sjælden (<1/10.000), inklusive enkeltstående rapporter.
English: The most commonly reported adverse reactions are mild gastrointestinal symptoms, insomnia and headache.
Danish: De mest almindeligt rapporterede bivirkninger er milde gastrointestinale symptomer, søvnløshed og hovedpine.
English: Therefore the CHMP agreed that the available clinical data could not be considered as adequate information to support a paediatric indication statement.
Danish: CHMP erklærede sig derfor enig i, at de foreliggende kliniske data ikke kunne anses for at være tilstrækkelig information til underbygning af de pædiatriske indikationsoplysninger.
English: 6800 LZ Arnhem The Netherlands
Danish: 6800 LZ Arnhem Holland
English: If you experience any of these, tell your doctor straight away.
Danish: Hvis du oplever nogen af disse bivirkninger, skal du omgående fortælle det til din læge.
English: The paediatric indication was not granted during the assessment of paediatric data through the EU worksharing procedure.
Danish: Den pædiatriske indikation blev ikke godkendt under vurderingen af de pædiatriske data via arbejdsdelingsproceduren på EU-plan.
English: - the Summary of Products Characteristics, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets faglige drøftelse,
English: Nevertheless, the available data suggest that no serious safety concern is present for Lescol as compared to placebo, for all renal function categories.
Danish: De tilgængelige data tyder dog på, at der ikke er nogen alvorlige sikkerhedsmæssige betænkeligheder i tilknytning til Lescol sammenlignet med placebo for alle nyrefunktionskategorier.
English: • Previous history of muscular toxicity with a statin or fibrate.
Danish: • Tidligere muskeltoksicitet i forbindelse med et statin eller fibrat.
English: Pharmacotherapeutic group: HMG-CoA reductase inhibitors, ATC code: C10A A04
Danish: Farmakoterapeutisk klassifikation: HMG-CoA-reduktasehæmmere, ATC-kode: C10A A04
English: If you are taking Lescol XL tablets you can take your dose at any time of the day.
Danish: Hvis du tager Lescol XL-depottabletter, kan du tage din dosis når som helst på dagen.
English: Elderly population No dose adjustments are necessary in this population.
Danish: Ældre patienter Der kræves ingen dosisjustering hos denne population.
English: Fluvastatin exerts its main effect in the liver and is mainly a racemate of the two erythro enantiomers of which one exerts the pharmacological activity.
Danish: Fluvastatin udøver sin primære effekt i leveren og er hovedsageligt et racemat af de to erytroenantiomerer, hvoraf den ene har farmakologisk aktivitet.
English: Considering the possibility of teratogenicity with statins as a class, the benefit risk for the use in pregnancy has been considered as negative for statins including fluvastatin and the contraindication in pregnancy justified.
Danish: På grund af muligheden for teratogenicitet med statiner som klasse anses benefit-/risk-forholdet ved brug under graviditet for at være negativt for statiner, herunder fluvastatin, og kontraindikationen under graviditet anses for at være berettiget.
English: If CK levels are significantly elevated at baseline (> 5x ULN), levels should be re-measured within 5 to 7 days later to confirm the results.
Danish: Hvis CK-niveauet er signifikant forhøjet ved baseline (>5 x øvre normalgrænse), skal niveauet måles igen efter 5 til 7 dage for at bekræfte resultatet.
English: Based on preclinical data, it is expected that fluvastatin is excreted into human milk.
Danish: Baseret på prækliniske data forventes det, at fluvastatin udskilles i human modermælk.
English: Further toxicity seen in animals was either not relevant for human use or occurred at exposure levels sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Andre toksicitetsobservationer set hos dyr var enten ikke relevante ved human anvendelse eller forekom ved eksponeringsniveauer tilstrækkeligt over den maksimale humane eksponering til at indikere lille relevans ved klinisk anvendelse.
English: The major components circulating in the blood are fluvastatin and the pharmacologically inactive N-desisopropyl-propionic acid metabolite.
Danish: De væsentligste cirkulerende komponenter i blodet er fluvastatin og dets farmakologisk inaktive N-desisopropyl-propionsyre-metabolit.
English: In very rare cases, possibly drug-related hepatitis was observed that resolved upon discontinuation of treatment.
Danish: Der er i meget sjældne tilfælde set hepatitis, som muligvis var lægemiddelrelateret, men som forsvandt efter seponering af behandlingen.
English: Lescol/ Lescol XL will not cure your condition but it does help control it.
Danish: Lescol/Lescol XL vil ikke helbrede din tilstand, men det hjælper med at kontrollere den.
English: - Rifampicin (an antibiotic).
Danish: - Rifampicin (et antibiotikum).
English: The secondary prevention indication in patients after PCI is based on the Lescol Intervention Prevention Study (LIPS).
Danish: Den sekundære forebyggelsesindikation hos patienter efter perkutan koronar intervention er baseret på Lescol Intervention Prevention Study (LIPS).
English: - if you currently have liver problems, or if you have unexplained, persistently high level of certain liver enzymes (transaminases).
Danish: - hvis du på nuværende tidspunkt har leverproblemer, eller hvis du har vedvarende uforklarlige forhøjede niveauer af visse leverenzymer (transaminaser).
English: If CK has to be measured it should not be done following strenuous exercise or in the presence of any plausible alternative cause of CK increase as this makes the value interpretation difficult.
Danish: Hvis CK skal måles, bør det ikke gøres umiddelbart efter anstrengende fysisk aktivitet eller andre mulige alternative årsager til øgning af CK-niveauet, da dette kan besværliggøre fortolkning af resultatet.
English: - if you had muscle problems with another lipid-lowering medicine.
Danish: - hvis du har oplevet muskelproblemer med anden lipidsænkende medicin.
English: The MAH's proposal to include response to diet and other measures (e.g. exercise, weight reduction) was also considered to be acceptable as it is in line with other statin product information texts.
Danish: Forslaget fra indehaveren af markedsføringstilladelsen om at medtage responsen på diæt og andre foranstaltninger (f.eks. motion og vægttab) blev også anset for at være acceptabelt, da det var i overensstemmelse med andre produktinformationstekster om statiner.
English: The incidence of MACE was 21.4% on fluvastatin and 26.7% on placebo.
Danish: Forekomsten af større kardielle hændelser var 21,4 % for fluvastatin og 26,7 % for placebo.
English: Myositis and rhabdomyolysis have been reported very rarely.
Danish: Myositis og rabdomyolyse er indberettet meget sjældent.