FrancophonIA/ELRC3.0 huggingface dataset:
English: Should the symptoms resolve and CK levels return to normal, then re-introduction of fluvastatin or another statin may be considered at the lowest dose and under close monitoring.
Danish: Hvis symptomerne svinder, og CK-niveauet normaliseres, kan det overvejes at genoptage behandlingen med fluvastatin eller et andet statin ved laveste dosis og under tæt monitorering.
English: After four weeks of therapy, the median decrease in LDL-C was 38% and at week 24 (endpoint) the median LDL-C decrease was 35%.
Danish: Efter fire ugers behandling var det mediane fald i LDL-C 38 %, og ved uge 24 (endepunktet) var den mediane LDL-C-reduktion 35 %.
English: Section 5.2 - Pharmacokinetic properties The CHMP agreed with the wording proposed by the MAH.
Danish: Afsnit 5.2 - Farmakokinetiske egenskaber CHMP godkendte den ordlyd, der var foreslået af indehaveren af markedsføringstilladelsen.
English: Do not exceed the recommended dose.
Danish: Den anbefalede dosis må ikke overskrides.
English: Hypersensitivity reactions such as rash, urticaria
Danish: Overfølsomhedsreaktioner såsom udslæt, urticaria
English: The recommendations that women of childbearing potential have to use effective contraception and that treatment should be discontinued from women who become pregnant while taking Lescol/Lescol XL, has been included.
Danish: Anbefalingerne om, at kvinder i den fødedygtige alder skal anvende sikre kontraceptionsmetoder, og at behandlingen bør indstilles hos kvinder, der bliver gravide, mens de tager Lescol/Lescol XL, er medtaget.
English: Treatment should be stopped if these levels are found to be significantly elevated (> 5x ULN).
Danish: Behandlingen bør seponeres, hvis niveauet er signifikant forhøjet (>5 x øvre normalgrænse).
English: Based on the lack of interaction of fluvastatin with other CYP3A4 substrates, fluvastatin is not expected to interact with grapefruit juice.
Danish: Baseret på manglende interaktion af fluvastatin med andre CYP3A4-substrater, forventes fluvastatin ikke at interagere med grapefrugtjuice.
English: Do not take Lescol / Lescol XL if you are pregnant or breast-feeding as the active ingredient may lead to harm to your unborn child, and it is not known whether the active ingredient is excreted in human breast milk.
Danish: Du må ikke tage Lescol/Lescol XL, hvis du er gravid eller ammer, da det aktive stof kan skade dit ufødte barn, og det ikke vides, om det udskilles i modermælk.
English: Do not take a double dose to make up for the one that you missed.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
Danish: Hvis der er mistanke om, at patienten har udviklet interstitiel lungesygdom skal statin behandling afbrydes.
English: The overall magnitude of the changes in phenytoin pharmacokinetics during co-administration with fluvastatin is relatively small and not clinically significant.
Danish: Den overordnede størrelse af ændringerne i phenytoins farmakokinetik under samtidig administration med fluvastatin er relativt lille og ikke klinisk signifikant.
English: Since no new data was submitted during this harmonisation referral, the CHMP confirmed that a paediatric indication could not be granted during this Article 30 harmonisation referral.
Danish: Da der ikke blev indsendt nogen nye data under denne indbringelse med henblik på harmonisering, bekræftede CHMP, at en pædiatrisk indikation ikke kunne godkendes under denne indbringelse med henblik på harmonisering i henhold til artikel 30.
English: Patients should therefore be advised to promptly report unexplained muscle pain, muscle tenderness or muscle weakness, particularly if accompanied by malaise or fever.
Danish: Patienterne bør derfor tilrådes straks at indberette uforklarlige muskelsmerter, muskelømhed eller muskelsvaghed, særligt hvis dette er ledsaget af utilpashed eller feber.
English: Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Danish: Skulle overdosering forekomme, bør patienten behandles symptomatisk, og der bør iværksættes understøttende behandling efter behov.
English: If CK levels are still significantly elevated (> 5x ULN) at baseline, treatment should not be started.
Danish: Hvis CK-niveauet stadig er signifikant forhøjet (>5 x øvre normalgrænse) ved baseline, bør behandling ikke påbegyndes.
English: There is no obvious reason therefore, to contraindicate doses>40mg in severe renal impairment, but it would be more appropriate to initiate these high doses with caution.
Danish: Der er derfor ingen indlysende begrundelse for at kontraindicere doser >40mg ved svær nyreinsufficiens, men det ville være mere hensigtsmæssigt, at disse høje doser initieres med forsigtighed.
English: There is insufficient information on the effects of fluvastatin in newborns / infants.
Danish: Der er mangelfuld information vedrørende fluvastatins påvirkning af nyfødte/spædbørn.
English: UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italy
Danish: UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italien
English: Other possible side effects - Sleep disturbances, including insomnia and nightmares - Memory loss - Sexual difficulties - Depression - Breathing problems including persistent cough and/or shortness of breath or fever
Danish: Andre bivirkninger: - Søvnforstyrrelser herunder søvnløshed og mareridt - Hukommelsestab - Seksuelle problemer - Depression - Vejrtrækningsproblemer herunder vedvarende hoste og/eller åndenød eller feber
English: Following oral administration of 40 mg Lescol, the terminal disposition half-life for fluvastatin is 2.3 ± 0.9 hours.
Danish: Ved oral administration af 40 mg Lescol er den terminale halveringstid for fluvastatin 2,3 ±0,9 timer.
English: Furthermore, no paediatric indication was granted through the EU Paediatric Worksharing project and no new clinical data were submitted for this Art 30 procedure.
Danish: Desuden blev der ikke godkendt nogen pædiatrisk indikation via det pædiatriske arbejdsdelingsprojekt på EU-plan, og der blev ikke indsendt nye kliniske data i forbindelse med denne artikel 30-procedure.
English: The CHMP agreed with the following wording for a flexible initial dosing of 40-80mg: ‘The recommended dosing range is 20 to 80 mg/day.
Danish: CHMP var enig i følgende odlyd for en fleksibel startdosis på 40-80 mg: "Den anbefalede startdosis er 20-80 mg/dag.
English: • Primary hypercholesterolaemia and mixed dyslipidaemia Starting dose recommendation
Danish: • Primær hyperkolesterolæmi og blandet dyslipidæmi Anbefalet startdosis
English: As with other lipid-lowering agents, it is recommended that liver function tests be performed before the initiation of treatment and at 12 weeks following initiation of treatment or elevation in dose and periodically thereafter in all patients.
Danish: Som ved andre lipidsænkende lægemidler anbefales leverfunktionstest før behandlingens start og 12 uger efter behandlingsstart eller ved dosisøgning og herefter periodisk hos alle patienter.
English: Lescol IR (Lescol immediate release) 20 mg and 40 mg capsules were first registered in 1993.
Danish: Lescol IR (Lescol til øjeblikkelig frigivelse) kapsler 20 mg og 40 mg blev første gang registreret i 1993.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: Following the procedure the MAH submitted the approved paediatric wording to all EU member states.
Danish: I overensstemmelse med proceduren indsendte indehaveren af markedsføringstilladelsen den godkendte pædiatriske ordlyd til alle EU-medlemsstater.
English: Novartis Norge AS, Postboks 237 Økern, 0510 Oslo, Norway
Danish: Novartis Norge AS Postboks 237 Økern 0510 Oslo Norge
English: The CHMP also agreed with the MAH's proposal not to include a recommendation to assess causes of secondary hypercholesterolaemia in the indications section.
Danish: CHMP var også enig i forslaget fra indehaveren af markedsføringstilladelsen om ikke at medtage en anbefaling om at vurdere årsagerne til sekundær hyperkolesterolæmi i indikationsafsnittet.
English: No clinically significant pharmacokinetic interactions occur when fluvastatin is concomitantly administered with propranaolol, digoxin, losartan or amlodipine.
Danish: Der forekommer ingen klinisk signifikante farmakokinetiske interaktioner, når fluvastatin gives samtidig med propranolol, digoxin, losartan eller amlodipin.
English: Section 4.7 - Effects on ability to drive and use machines A statement that no studies on the effects on the ability to drive and use machines have been performed has been included.
Danish: Afsnit 4.7 - Virkning på evnen til at føre motorkøretøj og betjene maskiner En erklæring om, at der ikke er foretaget nogen undersøgelser om indvirkningen på trafik- og arbejdssikkerheden, er medtaget.
English: Based on the pharmacokinetic data, no monitoring or dosage adjustments are required when fluvastatin is concomitantly administered with these agents.
Danish: På baggrund af de farmakokinetiske data er monitorering og dosisjustering ikke påkrævet, når fluvastatin administreres samtidigt med disse stoffer.
English: There are multiple, alternative cytochrome P450 (CYP450) pathways for fluvastatin biotransformation and thus fluvastatin metabolism is relatively insensitive to CYP450 inhibition.
Danish: Der findes adskillige, alternative cytokrom P450 (CYP450) veje for biotransformation af fluvastatin, og fluvastatinmetabolisme er dermed relativt upåvirkelig af CYP450-hæmning.
English: Studies in renal transplant patients indicate that the bioavailability of fluvastatin (up to 40 mg/day) is not elevated to a clinically significant extent in patients on stable regimens of ciclosporin.
Danish: Studier med nyretransplanterede patienter indikerer, at biotilgængeligheden af fluvastatin (op til 40 mg/dag) ikke er klinisk signifikant forøget hos patienter i stabil ciclosporinbehandling.
English: Germany, Luxembourg
Danish: Luxembourg, Tyskland
English: • Hypothyroidism.
Danish: • Hypotyroidisme.
English: More than 98% of the circulating drug is bound to plasma proteins, and this binding is not affected either by the concentration of fluvastatin, or by warfarin, salicylic acid or glyburide.
Danish: Mere end 98 % af det cirkulerende lægemiddel er bundet til plasmaproteiner, og denne binding er uafhængig af koncentrationen af fluvastatin, warfarin, salicylsyre og glibenclamid.
English: Based on the recommendation given by the CHMP, the following wording proposed was agreed: ‘Renal Impairment
Danish: På grundlag af anbefalingen fra CHMP blev følgende foreslåede formulering godkendt: "Nedsat nyrefunktion
English: Despite the potential that therefore exists for competitive interaction between fluvastatin and compounds that are CYP2C9 substrates, such as diclofenac, phenytoin, tolbutamide and warfarin, clinical data indicate that this interaction is unlikely.
Danish: På trods af det potentiale, der dermed findes for kompetitiv interaktion mellem fluvastatin og stoffer, der er CYP2C9-substrater, såsom diclofenac, phenytoin, tolbutamid og warfarin, tyder kliniske data på, at en sådan interaktion er usandsynlig.
English: Based on the Cox regression analysis the risk ratio for MACE was estimated at 0.78, equivalent to a statistically significant 22% reduction in the risk of MACE for patients treated in the Lescol group compared to the placebo group.
Danish: Baseret på Cox-regressionsanalysen blev risikoprocenten for alvorlige kardielle hændelser anslået til 0,78, svarende til en statistisk signifikant reduktion på 22 % i risikoen for større kardielle hændelser hos behandlede patienter i Lescol-gruppen sammenlignet med placebo-gruppen.
English: The undesirable effects currently listed are consistently represented in the SPCs of the EU Member States, except for anaphylactic reaction, which was recently included.
Danish: De bivirkninger, der i øjeblikket er opført på listen, er konsekvent medtaget i medlemsstaternes produktresuméer, undtagen anafylaktiske reaktioner, der er medtaget for nylig.
English: Marked elevations of CK levels to more than 5x ULN developed in a very small number of patients (0.3 to 1.0%).
Danish: Markante stigninger i CK-niveauer til mere end 5 x den øvre normalgrænse forekom hos et meget lille antal patienter (0,3 til 1,0 %).
English: - if you have a kidney disease.
Danish: - hvis du har en nyresygdom.
English: However it is still not possible to draw appropriate conclusions regarding the positive benefitrisk of doses >40mg in severe renal impairment, since a direct dose-level comparison between Lescol 40 vs 80mg/day was not possible, and the study population of patients with severe renal impairment was limited.
Danish: Det er dog stadig ikke muligt at drage passende konklusioner med hensyn til det positive benefit-/risk-forhold ved doser >40 mg ved alvorlig nyreinsufficiens, da en direkte dosisniveausammenligning mellem Lescol 40 mg vs. 80 mg/dag ikke var mulig, og undersøgelsespopulationen af patienter med alvorlig nyreinsufficiens var begrænset.
English: Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne France
Danish: Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne Frankrig
English: Your doctor will tell you exactly how many capsules or tablets of Lescol/Lescol XL to take.
Danish: Din læge vil fortælle dig helt nøjagtigt, hvor mange Lescol-kapsler eller Lescol XL-tabletter du skal tage.
English: Following administration of 3H-fluvastatin to healthy volunteers, excretion of radioactivity is about 6% in the urine and 93% in the faeces, and fluvastatin accounts for less than 2% of the total radioactivity excreted.
Danish: Administration af 3H-fluvastatin til raske frivillige medfører en radioaktiv udskillelse på 6 % i urin og 93 % i fæces, og fluvastatin udgør mindre end 2 % af den totale mængde udskilt radioaktivitet.
English: Creatine kinase measurement
Danish: Måling af kreatinkinase
English: Section 4.9 - Overdose
Danish: Afsnit 4.9 - Overdosering
English: No data are available for the use of fluvastatin in patients with the very rare condition of homozygous familial hypercholesterolaemia.
Danish: Der foreligger ingen data for brug af fluvastatin til patienter med den meget sjældne lidelse homozygot familiær hyperkolesterolæmi.
English: Based on the Pharmacovigilance Working Party (PhVWP) Report on the association of HMG CoA reductase inhibitors, this section has also been updated to include interstitial lung disease.
Danish: På grundlag af rapporten fra CHMP's arbejdsgruppe vedrørende lægemiddelovervågning om HMGCoA-reduktasehæmmere er dette afsnit også blevet ajourført for at medtage interstitiel lungesygdom.
English: Myopathy has rarely been reported with fluvastatin.
Danish: Der er sjældent indberettet myopati efter fluvastatin.
English: The primary endpoint of MACE occurred in 21.4% of patients treated with fluvastatin vs 26.7% of patients treated with placebo (absolute risk difference: 5.2%; 95% CI: 1.1 to 9.3).
Danish: Det primære MACE-endepunkt indtraf hos 21,4 % af de fluvastatinbehandlede patienter versus 26,7 % af de placebobehandlede patienter (absolut risikoforskel: 5,2 %; 95 % KI: 1,1 til 9,3).
English: National Road No. 1 (12th Km)
Danish: National Road No. 1 (12th Km), Metamorphosis
English: Lescol/Lescol XL has not been investigated and is not intended for the use in children below 9 years.
Danish: Lescol/Lescol XL er ikke blevet undersøgt og er ikke beregnet til brug hos børn under 9 år.
English: In healthy volunteers, the use of fluvastatin and warfarin (single dose) did not adversely influence warfarin plasma levels and prothrombin times compared to warfarin alone.
Danish: Hos raske frivillige havde anvendelse af fluvastatin og warfarin (enkeltdosis) ingen negativ effekt på plasmakoncentrationen af warfarin og protrombintiden sammenlignet med warfarin alene.
English: The maximum daily dose is 80 mg.
Danish: Den maksimale daglige dosis er 80 mg.
English: The recommended dosing range is 20 to 80 mg/day.
Danish: Det anbefalede dosisinterval er 20 til 80 mg/dag.
English: - if you have unexplained muscle pain, tenderness or weakness.
Danish: - hvis du har uforklarlige muskelsmerter, -ømhed eller -svaghed.
English: Should an increase in aspartate aminotransferase or alanine aminotransferase exceed 3 times the upper limit of normal and persist, therapy should be discontinued.
Danish: Hvis ASAT (aspartataminotransferase) eller ALAT (alaninaminotransferase) vedvarende overstiger 3 gange den øvre normalgrænse, bør behandlingen afbrydes.
English: • during pregnancy and lactation (see section 4.6).
Danish: • under graviditet og amning (se pkt.
English: Since HMG-CoA reductase inhibitors decrease the synthesis of cholesterol and possibly of other biologically active substances derived from cholesterol, they may cause foetal harm when administered to pregnant women.
Danish: Eftersom HMG-CoA-reduktasehæmmere nedsætter syntesen af kolesterol og muligvis også andre biologisk aktive forbindelser, der er afledt af kolesterol, kan de forårsage fosterskader ved administration til gravide kvinder.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
English: Since the available data suggest that there is no serious safety concern for Lescol as compared to placebo, for all renal function categories, the CHMP agreed that doses of >40mg in severe renal impairment would not be contraindicated, but that it would be necessary to initiate these high doses with caution.
Danish: Da de foreliggende data tyder på, at Lescol ikke giver anledning til nogen alvorlige sikkerhedsmæssige bekymringer sammenlignet med placebo for alle nyrefunktionskategorier, var CHMP enig i, at dosis >40 mg ved alvorlig nyreinsufficiens ikke var kontraindicerede, men at disse høje doser skulle initieres forsigtigt.
English: - The dose range for adults is 20 to 80 mg per day and depends on the extent of cholesterol lowering which needs to be achieved.
Danish: − Dosis til voksne er mellem 20 mg og 80 mg daglig og afhænger af, hvor meget dit kolesterol skal sænkes.
English: The benefit and the risk of concurrent treatment should be carefully weighed and these combinations should only be used with caution (see section 4.4).
Danish: Fordelen og risikoen ved samtidig behandling skal omhyggeligt afvejes, og disse kombinationer bør kun anvendes med forsigtighed (se pkt.
English: No clinical data is available for Lescol in patients with homozygous familial hypercholesterolaemia (HoFH) and is stated in this section.
Danish: Der foreligger ingen kliniske data for Lescol hos patienter med homozygot familiær hyperkolesterolæmi (HoFH), og ingen er angivet i dette afsnit.
English: Lescol XL was administered to over 800 patients in three pivotal trials of 24 weeks active treatment duration and compared to Lescol 40 mg once or twice daily.
Danish: Lescol XL blev administreret til over 800 patienter i tre pivotale forsøg, der omfattede aktiv behandling i 24 uger, og sammenlignet med Lescol 40 mg én eller to gange daglig.
English: Lescol is efficacious in monotherapy.
Danish: Lescol er virkningsfuld som monoterapi.
English: − in adult patients with high blood levels of both cholesterol and triglycerides (another sort of blood lipid)
Danish: − hos voksne patienter med et højt indhold af både kolesterol og triglycerider (en anden type af lipid i blodet) i blodet
English: There is no current evidence to require routine monitoring of plasma total CK or other muscle enzyme levels in asymptomatic patients on statins.
Danish: Der er aktuelt intet, der taler for rutinemæssig monitorering af plasmakoncentrationen af total-CK eller andre muskelenzymer hos asymptomatiske patienter i behandling med statiner.
English: The first marketing authorization was issued for Lescol XL (Lescol extended release) 80 mg tablets in 2000.
Danish: Den første markedsføringstilladelse blev udstedt for Lescol XL (Lescol depottablet) tabletter 80 mg i 2000.
English: The recommended starting dose is one 20 mg Lescol capsule.
Danish: Den anbefalede startdosis er én 20 mg Lescol-kapsel.
English: The information that the study was conducted in patients after PCI was added.
Danish: Information om, at undersøgelsen var gennemført på patienter efter perkutan koronar intervention, blev tilføjet.
English: Some rare or very rare effects could be serious: get medical help immediately.
Danish: Nogle sjældne eller meget sjældne bivirkninger kan være alvorlige.
English: Metamorphosis GR-144 51 Athens, Greece
Danish: GR-144 51 Athens
English: In patients with unexplained diffuse myalgias, muscle tenderness or muscle weakness, and/or marked elevation of creatine kinase (CK) values, myopathy, myositis or rhabdomyolysis have to be considered.
Danish: Hos patienter med uforklarlig diffus myalgi, muskelømhed eller muskelsvaghed og/eller udtalt forhøjede kreatinkinaseværdier (CK) bør myopati, myositis eller rabdomyolyse overvejes.
English: Although there was no clinical evidence that the safety profile of fluvastatin was altered in patients pretreated with fluconazole for 4 days, caution should be exercised when fluvastatin is administered concomitantly with fluconazole.
Danish: Selvom der ikke var kliniske beviser for, at fluvastatins sikkerhedsprofil ændredes hos patienter, der er behandlet med fluconazol i 4 dage, bør der udvises forsigtighed ved samtidig administration af fluvastatin og fluconazol.
English: Children and adolescents with heterozygous familial hypercholesterolaemia No pharmacokinetic data in children are available.
Danish: Børn og unge med heterozygot familiær hyperkolesterolæmi Der foreligger ingen farmakokinetiske data for børn.
English: In this randomised, double-blind, placebo-controlled trial fluvastatin (n=844), given as 80 mg daily over 4 years, significantly reduced the risk of the first MACE by 22% (p=0.013) as compared to placebo (n=833).
Danish: I dette randomiserede, dobbeltblindede, placebokontrollerede forsøg reducerede fluvastatin (n=844) givet som 80 mg daglig over 4 år signifikant risikoen for første MACE med 22 % (p=0,013) sammenlignet med placebo (n=833).
English: Lescol/Lescol XL can be taken on its own or with other cholesterol-lowering medicines prescribed by your doctor.
Danish: Lescol/Lescol XL kan tages alene eller sammen med andre kolesterolsænkende lægemidler, som din læge ordinerer.
English: Oral antidiabetic agents
Danish: Orale antidiabetika
English: The CHMP agreed that the proposed starting dose of 40 mg in patients requiring LDL-C reductions of ≥25% is justified by the clinical data provided.
Danish: CHMP var enig i, at den foreslåede startdosis på 40 mg hos patienter, der har behov for en nedsættelse af LDL-kolesterol på ≥25 %, underbygges af de fremlagte kliniske data.
English: Lescol capsules and Lescol XL tablets can be taken with or without meals and should be swallowed as whole with a glass of water.
Danish: Lescol-kapsler og Lescol XL-depottabletter kan tages med eller uden et måltid og bør synkes hele med et glas vand.
English: The CHMP was of the opinion that the data submitted by the MAH intended to support the indication “Lescol/Lescol XL is indicated to slow the progression of coronary atherosclerosis in adults with primary hypercholesterolaemia and coronary heart disease” was not clinically meaningful and therefore a positive benefit/risk could not be established.
Danish: CHMP mente, at de data, som indehaveren af markedsføringstilladelsen havde indsendt som støtte for indikationen "Lescol/Lescol XL er indiceret til at forsinke progressionshastigheden af koronar arterosklerose hos voksne med primær hyperkolesterolæmi og koronar hjertesygdom" ikke var klinisk signifikante, og at der derfor ikke kunne etableres et positivt benefit-/risk-forhold.
English: 2100 Kopenhagen Ø, Denmark
Danish: 2100 København Ø Danmark
English: Bulgaria, Estonia, Hungary, Slovenia
Danish: Bulgarien, Estland, Slovenien, Ungarn