FrancophonIA/ELRC3.0 huggingface dataset:
English: Glibenclamide (5 to 20 mg daily) increased the mean Cmax and AUC of fluvastatin by 44% and 51%, respectively.
Danish: Glibenclamid (5 til 20 mg dagligt) øgede den gennemsnitlige Cmax og AUC for fluvastatin med henholdsvis 44 % og 51 %.
English: Lescol was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Danish: Lescol stod på den liste over lægemidler, for hvilke produktresuméerne skulle harmoniseres, som koordinationsgruppen for gensidig anerkendelse og decentrale procedurer - humanmedicinske anliggender (CMD(h)) havde udarbejdet i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF, med senere ændringer.
English: The Product Information (PI) has also been updated according to the CHMP PhVWP Report on HMG CoA reductase inhibitors to include the following adverse events that have been reported with some statins: sleep disturbances, including insomnia and nightmares, memory loss, sexual dysfunction, depression, exceptional cases of interstitial lung disease,
Danish: Produktinformationen er også blevet ajourført i overensstemmelse med rapporten fra CHMP's arbejdsgruppe vedrørende lægemiddelovervågning om HMG-CoA-reduktasehæmmere for at medtage følgende bivirkninger, der er blevet indberettet i forbindelse med visse statiner: søvnforstyrrelser, herunder søvnløshed og mareridt, hukommelsestab, seksuel dysfunktion, depression, særlige tilfælde af interstitiel lungesygdom, særlig ved langvarig behandling.
English: Important information about some of the ingredients of Lescol/Lescol XL [To be completed nationally]
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Lescol/Lescol XL [Udfyldes nationalt]
English: During the procedure, the MAH was requested to summarise this section, describing the results of the preclinical studies in brief and qualitative statements, according to the Guideline on the Summary of Product Characteristics.
Danish: Under proceduren blev indehaveren af markedsføringstilladelsen anmodet om at sammenfatte dette afsnit, og kort redegøre for resultaterne af de prækliniske undersøgelser og kvalitative erklæringer i overensstemmelse med retningslinjerne for produktresuméer.
English: − in adult patients with high blood levels of cholesterol
Danish: − hos voksne patienter med et højt indhold af kolesterol i blodet
English: Paraesthesia, dysaesthesia, hypoaesthesia also known to be associated with the underlying hyperlipidaemic disorders
Danish: Paræstesi, dysæstesi, hypæstesi, som også vides at have forbindelse med den underliggende hyperlipidæmi.
English: Fluvastatin is mainly metabolised in the liver.
Danish: Fluvastatin metaboliseres hovedsagelig i leveren.
English: From an efficacy perspective the 80 mg dose provided reliable LDL-C lowering of at least 30% vs baseline at 24 weeks.
Danish: Ud fra et effektivitetsperspektiv gav dosen på 80 mg en pålidelig nedsættelse af LDL-kolesterol på mindst 30 % i forhold til baseline efter 24 uger.
English: The inhibition of cholesterol biosynthesis reduces the cholesterol in hepatic cells, which stimulates the synthesis of LDL receptors and thereby increases the uptake of LDL particles.
Danish: Hæmning af kolesterolbiosyntesen reducerer mængden af kolesterol i levercellerne, hvilket stimulerer syntesen af LDL-receptorer, hvorved optagelsen af LDL-partikler forøges.
English: ‘The maximum lipid-lowering effect with a given dose is achieved within 4 weeks.
Danish: "Den maksimale lipidsænkende virkning ved en bestemt dosis opnås inden for fire uger.
English: Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR,
Danish: Frimley Business Park Frimley, Camberley Surrey GU16 7SR Storbritannien
English: This result was independent of baseline total cholesterol levels.
Danish: Dette resultat var uafhængigt af de samlede baselinekolesterolværdier.
English: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
Danish: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013 Barcelona Spanien
English: • Memory loss
Danish: • Hukommelsestab
English: The results from another study in which Lescol XL tablets (80 mg fluvastatin) was administered to renal transplant patients who were on stable ciclosporin regimen showed that fluvastatin exposure (AUC) and maximum concentration (Cmax) were increased 2-fold compared to historical data in healthy subjects.
Danish: Resultaterne fra en anden undersøgelse, hvor Lescol XL-depottabletter (80 mg fluvastatin) blev administreret til nyretransplanterede patienter i stabil ciclosporinbehandling, viste, at fluvastatineksponering (AUC) og maksimal koncentration (Cmax) fordobledes sammenlignet med historiske data fra raske personer.
English: ITALFARMACO S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Danish: Viale Fulvio Testi, 330 20126 Milano Italien
English: Due to the heterogeneity in the presentation of the clinical trial data for dyslipidaemia across the various Member States, a concise approach including data on Lescol IR from the pooled placebo-controlled studies and data from the Lescol XL development program has been proposed.
Danish: På grund af mangfoldigheden i præsentationen af kliniske data for dyslipidæmi i medlemsstaterne er der blevet foreslået en koncis fremgangsmåde omfattende data om Lescol IR fra de samlede placebokontrollerede undersøgelser og data fra Lescol XL-udviklingsprogrammet.
English: The data on LDL-C lowering at different time points based on the pooled efficacy analysis from the Lescol XL registration program supports the following recommendation:
Danish: Dataene om sænkningen af LDL-kolesterol på forskellige tidspunkter baseret på den samlede effektivitetsanalyse fra Lescol XL-registreringsprogrammet støtter følgende anbefaling:
English: Lescol/Lescol XL is contraindicated:
Danish: Lescol/Lescol XL er kontraindiceret:
English: Prior to initiating treatment with Lescol/Lescol XL, patients should be placed on a standard cholesterollowering diet, which should be continued during treatment.
Danish: Forud for behandlingen med Lescol/Lescol XL bør patienten sættes på en kolesterolsænkende standarddiæt, som bør fortsættes under behandlingen.
English: The plasma clearance (CL/f) for fluvastatin in man is calculated to be 1.8 ± 0.8 l/min.
Danish: Plasmaclearance for fluvastatin er beregnet til 1,8 ±0,8 l/min.
English: Despite the theoretical considerations concerning the role of cholesterol in embryo development, animal studies did not suggest an embryotoxic and teratogenic potential of fluvastatin.'
Danish: Til trods for de teoretiske betragtninger vedrørende kolesterols rolle i embryoets udvikling tydede dyreforsøg ikke på, at fluvastatin har et embryotoksisk eller teratogent potentiale."
English: 8 , Quinta de Beloura 2710-444, Sintra, Portugal
Danish: 8 Quinta de Beloura 2710-444 Sintra
English: Concomitant treatment with other lipid modifying drugs The MAH submitted published data to support the efficacy and safety of Lescol/Lescol XL in combination with nicotinic acid, cholestyramine, or fibrates.
Danish: Samtidig behandling med andre lipidmodificerende lægemidler Indehaveren af markedsføringstilladelsen indsendte offentliggjorte data til støtte for effektiviteten og sikkerheden af Lescol/Lescol XL i kombination med nikotinsyre, kolestyramin eller fibrater.
English: Pregnancy There is insufficient data on the use of fluvastatin during pregnancy.
Danish: Der er utilstrækkelige data fra anvendelse af fluvastatin til gravide kvinder.
English: Presenting features can include dyspnoea, non productive cough and deterioration in general health (fatigue, weight loss and fever).
Danish: Symptomer kan inkludere dyspnø, tør hoste og forværring af den generelle helbredsstatus (træthed, vægttab og feber).
English: After intake of a resin, e.g. cholestyramine (primarily used to treat high cholesterol) wait at least 4 hours before taking Lescol/Lescol XL.
Danish: Hvis du har taget et resin, fx colestyramin (bruges hovedsageligt til at behandle forhøjet kolesterol), skal du vente mindst 4 timer, før du tager Lescol/Lescol XL.
English: Administration of fluvastatin to healthy volunteers pre-treated with fluconazole (CYP 2C9 inhibitor) resulted in an increase in the exposure and peak concentration of fluvastatin by about 84% and 44%.
Danish: Administration af fluvastatin til raske frivillige, som var behandlet med fluconazol (CYP 2C9hæmmer), resulterede i en stigning i eksponering og maksimalkoncentration af fluvastatin på henholdsvis ca. 84 % og 44 %.
English: - The other ingredients of Lescol 20 mg capsules are: [To be completed nationally]
Danish: - Øvrige indholdsstoffer i Lescol 20 mg kapsler: [Udfyldes nationalt]
English: It is recommended that prothrombin times are monitored when fluvastatin treatment is initiated, discontinued, or the dosage changes in patients receiving warfarin or other coumarin derivatives.
Danish: Det anbefales, at protrombintiden monitoreres, når fluvastatinbehandling initieres eller afbrydes, eller dosis ændres hos patienter i samtidig behandling med warfarin eller andre coumarinderivater.
English: For patients receiving oral sulfonylureas (glibenclamide (glyburide), tolbutamide) for the treatment of noninsulin-dependent (type 2) diabetes mellitus (NIDDM), addition of fluvastatin does not lead to clinically significant changes in glycaemic control.
Danish: For patienter i behandling med orale sulfonylurinstoffer (glibenclamid, tolbutamid) mod ikkeinsulinafhængig type 2-diabetes mellitus (NIDDM) fører tillæg af fluvastatin ikke til klinisk signifikant ændring af den glykæmiske kontrol.
English: • Primary hypercholesterolaemia and mixed dyslipidaemia The CHMP agreed with the MAH that additional statements on the exclusion of certain lipoprotein disorders (e.g homozygous variants of familial hypercholesterolaemia and other Fredrickson types with predominant hypertriglyceridemia, or secondary forms of hypercholesterolaemia) are not required in the indication section.
Danish: • Primær hyperkolesterolæmi og blandet dyslipidæmi CHMP var enig med indehaveren af markedsføringstilladelsen i, at der ikke var behov for supplerende erklæringer om udelukkelse af visse lipoproteinlidelser (f.eks. homozygote varianter af familiær hyperkolesterolæmi og andre Fredrickson-typer med prædominant hypertriglyceridæmi eller sekundære former for hyperkolesterolæmi) i indikationsafsnittet.
English: The MAH agreed that the contraindication is medically justified as a harm to the fetus (or to the breastfed newborn) with statins cannot be excluded.
Danish: Indehaveren af markedsføringstilladelsen var enig i, at kontraindikationen er lægeligt begrundet, da fosterskader (eller skader på nyfødte, der ammes) i tilknytning til statiner ikke kan udelukkes.
English: The following wording proposed by the MAH was considered to be acceptable for the CHMP: ‘Lescol is efficacious in monotherapy.
Danish: CHMP fandt følgende ordlyd, som indehaveren af markedsføringstilladelsen havde foreslået, acceptabel: "Lescol er effektivt som monoterapi.
English: 1 Data for Lescol from 12 placebo-controlled trials Data for Lescol XL 80 mg tablet from three 24-week controlled trials
Danish: 1 Data for Lescol fra 12 placebokontrollerede forsøg 2 Data for Lescol XL 80 mg depottablet fra tre kontrollerede forsøg af 24 ugers varighed
English: Like all medicines, Lescol/Lescol XL can cause side effects, although not everybody gets them.
Danish: Lescol/Lescol XL kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Austria, Germany
Danish: Tyskland, Østrig
English: As with all other statins physicians should prescribe fluvastatin with caution in patients with predisposing factors for rhabdomyolysis and its complications.
Danish: Som med alle andre statiner skal der udvises forsigtighed ved ordination af fluvastatin til patienter med disponerende faktorer for rabdomyolyse og komplikationer i forbindelse hermed.
English: The CHMP agreed with the following wording proposed by the MAH for this indication:
Danish: CHMP godkendte følgende ordlyd foreslået af indehaveren af markedsføringstilladelsen for denne indikation:
English: The conventional studies, including safety pharmacology, genotoxicity, repeated dose toxicity, carcinogenicity and toxicity on reproduction studies did not indicate other risks for the patient than those expected due to the pharmacological mechanism of action.
Danish: De konventionelle undersøgelser, herunder sikkerhedsfarmakologi, genotoksicitet, toksicitet efter gentagne doser, karcinogenicitet og reproduktionstoksicitet, indikerede ikke andre risci for patienten end dem, der forventes grundet den farmakologiske virkningsmekanisme.
English: Tingling or numbness of the hands or feet, disturbed or decreased sensibility.
Danish: Snurren eller følelsesløshed i hænder og fødder, unormal eller nedsat følesans.
English: • in patients with known hypersensitivity to fluvastatin or any of the excipients.
Danish: • til patienter med overfølsomhed over for fluvastatin eller over for et eller flere af hjælpestofferne.
English: In cases where coadministration with a fibrate or niacin is necessary, the benefit and the risk of concurrent treatment should be carefully considered (for use with fibrates or niacin see section 4.5).'
Danish: I tilfælde, hvor samtidig administration af et fibrat eller niacin er nødvendig, bør fordele og risici ved samtidig behandling nøje overvejes (for brug sammen med fibrater eller niacin se afsnit 4.5)."
English: The recommendation that Lescol capsules can be taken regardless of meals is largely consistent across the EU Member States.
Danish: Tidspunkt for indtagelse af medicin og måltider Den anbefaling, at Lescol kan tages uden hensyntagen til måltider, er almindeligt anerkendt i EU's medlemsstater.
English: The maximum lipid-lowering effect with a given dose is achieved within 4 weeks.
Danish: Den maksimale lipidsænkende effekt ved en given dosis nås inden for 4 uger.
English: After oral administration of Lescol XL, and in comparison with the capsules, the absorption rate of fluvastatin is almost 60% slower while the mean residence time of fluvastatin is increased by approximately 4 hours.
Danish: Sammenlignet med kapsler er absorptionshastigheden af fluvastatin efter oral administration af Lescol XL næsten 60 % langsommere, mens middelopholdstiden for fluvastatin er forøget med ca. 4 timer.
English: The CHMP concluded that the following indications are supported by the available data submitted by the MAH:
Danish: CHMP konkluderede, at følgende indikationer underbygges af de foreliggende data, som indehaveren af markedsføringstilladelsen har fremlagt:
English: The risk ratios of cardiac death (RR 0.53) and cardiac death or nonfatal MI (RR 0.69) were also less than 1 but the study was not powered for these endpoints.
Danish: Risikoforholdet for hjertedød (0,53) og hjertedød eller non-fatalt myokardieinfarkt var også mindre end 1, men undersøgelsen havde ikke tilstrækkelig statistisk vægt med hensyn til disse effektmål.
English: Take special care with Lescol/Lescol XL - if you previously had a liver disease.
Danish: Vær ekstra forsigtig med at tage Lescol/Lescol XL - hvis du tidligere har haft en leversygdom.
English: The analyses from the Lescol pooled clinical trial database and the ALERT study presented by the MAH has provided further data regarding the efficacy and safety of fluvastatin 40-80mg in patients with renal impairment.
Danish: Analyserne fra den samlede kliniske undersøgelsesdatabase for Lescol og ALERT-undersøgelsen, som indehaveren af markedsføringstilladelsen fremlagde, har givet yderligere data om effektiviteten af og sikkerheden ved fluvastatin 40-80 mg hos patienter med nyreinsufficiens.
English: When Lescol is used in combination with cholestyramine or other resins, it should be administered at least 4 hours after the resin to avoid significant interaction due to binding of the drug to the resin.
Danish: Når Lescol anvendes i kombination med colestyramin eller andre resiner, bør det administreres mindst 4 timer efter resinen for at undgå væsentlige interaktioner pga. binding af lægemidlet til resinen.
English: - Phenytoin (a medicine used to treat epilepsy).
Danish: - Phenytoin (medicin, der bruges mod epilepsi).
English: A summary of the clinical trial data from the Lipoprotein and Coronary Atherosclerosis Study (LCAS) has been proposed by the MAH, including a statement that the significance of angiographic findings was not known.
Danish: Indehaveren af markedsføringstilladelsen har indsendt et resumé af de kliniske undersøgelsesdata fra Lipoprotein and Coronary Atherosclerosis Study (LCAS), herunder en erklæring om, at betydningen af angiografiske resultater var ukendt.
English: ‘The conventional studies, including safety pharmacology, genotoxicity, repeated dose toxicity, carcinogenicity and toxicity on reproduction studies did not indicate other risks for the patient than those expected due to the pharmacological mechanism of action.
Danish: "De konventionelle undersøgelser af sikkerhedsfarmakologi, genotoksicitet, toksicitet efter gentagne doser, carcinogenecitet og reproduktionstoksicitet indicerede ikke andre risici for patienten end dem, der forventedes som følge af den farmakologiske virkningsmekanisme.
English: Section 4.6 - Pregnancy and lactation
Danish: Afsnit 4.6 - Graviditet og amning
English: Other skin reactions (e.g. eczema, dermatitis, bullous exanthema), face oedema, angioedema Musculoskeletal and connective tissue disorders Rare:
Danish: Andre hudreaktioner (fx eksem, dermatitis, bulløs eksantem), ansigtsødem, angioødem Knogler, led, muskler og bindevæv Sjælden:
English: Lescol 20 mg, 40 mg are hard gelatine capsules and Lescol 80 mg is a modified release film coated tablet.
Danish: Lescol 20 mg og 40 mg er hårde gelatinekapsler, og Lescol 80 mg er en filmovertrukken tablet med modificeret frigivelse.
English: Since fluvastatin is eliminated primarily via the biliary route and is subject to significant presystemic metabolism, the potential exists for drug accumulation in patients with hepatic insufficiency (see sections 4.3 and 4.4).
Danish: Eftersom fluvastatin primært elimineres via galdevejene og er udsat for betydelig præsystemisk metabolisme, eksisterer muligheden for akkumulation hos patienter med leverinsufficiens (se pkt.
English: A statement that Lescol/Lescol XL is contraindicated in patients with active liver disease, or unexplained, persistent elevations in serum transaminases is included in this section 4.2 as well as in sections 4.3, 4.4 and
Danish: En erklæring om, at Lescol/Lescol XL er kontraindiceret hos patienter med aktiv leversygdom eller et uforklaret vedvarende højt niveau af serumtransaminase, er medtaget i dette afsnit 4.2 samt i afsnit 4.3, 4.4 og 5.2.
English: Administration of fluvastatin to healthy volunteers pre-treated with rifampicin (rifampin) resulted in a reduction of the bioavailability of fluvastatin by about 50%.
Danish: Administration af fluvastatin til raske frivillige, der var behandlet med rifampicin, resulterede i en 50 % reduktion i fluvastatins biotilgængelighed.
English: However, patients on concomitant therapy with glibenclamide (glyburide) and fluvastatin should continue to be monitored appropriately when their fluvastatin dose is increased to 80 mg per day.
Danish: Alligevel skal passende monitorering fortsættes for patienter, der samtidigt behandles med glibenclamid og fluvastatin, når deres fluvastatindosis øges til 80 mg/dag.
English: Lescol/Lescol XL is cleared by the liver, with less than 6% of the administered dose excreted into the urine.
Danish: Lescol/Lescol XL udskilles via leveren, og mindre end 6 % af den administrerede dosis udskilles i urinen.
English: Specific treatment is not available for Lescol/Lescol XL overdose.
Danish: Der findes ingen specifik behandling for overdosering med Lescol/Lescol XL.
English: If you are taking Lescol twice per day, take one capsule in the morning and one in the evening or at bedtime.
Danish: Hvis du tager Lescol to gange daglig, skal du tage en kapsel om morgnen og en kapsel om aftenen ved sengetid.
English: Thus routine monitoring of phenytoin plasma levels is sufficient during co-administration with fluvastatin.
Danish: Rutinemonitorering af phenytoins plasmaniveauer er således tilstrækkeligt under samtidig administration.
English: Both Lescol capsules(40 mg fluvastatin) and Lescol XL tablets (80 mg fluvastatin) had no effect on the bioavailability of ciclosporin when co-administered.
Danish: Hverken Lescol-kapsler (40 mg fluvastatin) eller Lescol XL-depottabletter (80 mg fluvastatin) havde effekt på biotilgængeligheden af ciclosporin, når de blev givet samtidigt.
English: - Oral anticoagulants like warfarin (medicines used to reduce blood clotting).
Danish: - Blodfortyndende medicin (orale antikoagulanter) som warfarin (medicin, der forhindrer blodet i at størkne).
English: Women of childbearing potential have to use effective contraception.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen.
English: The second study enrolled 85 male and female patients, 10 to 16 years of age, who had an LDL-C > 190 mg/dl (equivalent to 4.9 mmol/l) or LDL-C > 160 mg/dl (equivalent to 4.1 mmol/l) and one or more risk factors for coronary heart disease, or LDL-C > 160 mg/dl (equivalent to 4.1 mmol/l) and a proven LDLreceptor defect.
Danish: I det andet studie blev der inkluderet 85 mandlige og kvindelige patienter på 10-16 år, som havde en LDL-C-koncentration >190 mg/dl (svarende til 4,9 mmol/l) eller LDL-C >160 mg/dl (svarende til 4,1 mmol/l) og en eller flere risikofaktorer for koronar hjertesygdom, eller LDL-C >160 mg/dl (svarende til 4,1 mmol/l) og med verificeret LDL-receptorfejl.
English: The majority of patients in both studies (83% in the first study and 89% in the second study) were titrated to the maximum daily dose of 80 mg. At study endpoint, 26 to 30% of patients in both studies achieved a targeted LDL-C goal of < 130 mg/dl (3.4 mmol/l).
Danish: Størstedelen af patienterne i begge studier (83 % i det første studie og 89 % i det andet studie) blev titreret til den højeste daglige dosis på 80 mg. Ved studieendepunktet havde 26 til 30 % af patienterne i begge studier opnået LDL-C-målkoncentrationen < 130 mg/dl (3,4 mmol/l).
English: However, since an increased risk of myopathy has been observed in patients receiving other HMG-CoA reductase inhibitors together with fibrates or niacin, these combinations should be used with caution.
Danish: Da der imidlertid er observeret en øget risiko for myopati hos patienter, der får andre HMG-CoAreduktasehæmmere sammen med fibrater eller niacin, bør disse kombinationer anvendes med forsigtighed.
English: - if you have unusual tiredness or fever, yellowing of the skin and eyes, dark coloured urine (signs of hepatitis).
Danish: - hvis du bliver usædvanligt træt eller får feber, får gulfarvning af hud og øjne eller mørkfarvet urin (tegn på leverbetændelse).
English: Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea.
Danish: Søvnbesvær, hovedpine, mavebesvær, mavesmerter, kvalme.
English: If you are taking Lescol, take your dose in the evening or at bedtime.
Danish: Hvis du tager Lescol en gang daglig, skal du tage din dosis om aftenen eller ved sengetid.
English: However, isolated incidences of bleeding episodes and/or increases prothrombin times have been reported very rarely in patients on fluvastatin receiving concomitant warfarin or other coumarin derivatives.
Danish: Enkeltstående blødningstilfælde og/eller forlænget protrombintid er dog meget sjældent rapporteret hos patienter i samtidig behandling med fluvastatin og warfarin eller andre coumarinderivater.
English: There is consistency across all EU Member States in contraindicating Lescol/Lescol XL for patients with known hypersensitivity to fluvastatin or any of the excipients and in patients with active liver disease, or unexplained, persistent elevations in serum transaminases.
Danish: I alle EU's medlemsstater kontraindiceres Lescol/Lescol XL hos patienter med kendt overfølsomhed over for fluvastatin eller nogen af hjælpestofferne og hos patienter med aktiv leversygdom eller uforklaret vedvarende højt niveau af serumtransaminase.