FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding the interaction observed between atorvastatin and amlodipine, the body of data assessed indicates that this interaction is of questionable clinical relevance, if it exists at all, and does not warrant regulatory action dictating the prescription of the product.
Danish: Hvad angår den iagttagne interaktion mellem atorvastatin og amlodipin tyder hovedparten af de vurderede data på, at denne interaktion er af tvivlsom klinisk relevans, hvis den overhovedet findes, og at den ikke kræver indgriben fra de kontrollerende myndigheder med krav til ordination af produktet.
English: Rare: myositis, rhabdomyolysis.
Danish: Sjælden: Myositis, rhabdomyolyse.
English: The possible interaction with other substrates of this isozyme is unknown but should be considered for other medicinal products with a narrow therapeutic index, for example, antiarrhythmic agents Class III including amiodarone.
Danish: Den mulige interaktion med andre substrater af dette isoenzym er ukendt, men bør overvejes for andre stoffer med snævert terapeutisk indeks, f.eks. klasse III antiarytmika herunder amiodaron.
English: Atorvastatin did not demonstrate mutagenic or clastogenic potential in 4 in vitro tests with and without metabolic activation and in 1 in vivo assay.
Danish: Atorvastatin udviste ikke mutagent eller klastogent potentiale i 4 in vitro forsøg med og uden metabolisk aktivering eller i et in vivo assay.
English: Do not drive if this medicine affects your ability to drive.
Danish: Kør ikke bil, hvis denne medicin påvirker Deres evne til at køre bil.
English: In the atorvastatin group (n=253), there was no progression of atherosclerosis.
Danish: I atorvastatingruppen (n=253) er der ingen progression af aterosclerose.
English: Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed.
Danish: Patienter, som udvikler tegn eller symptomer på leverskade, bør have taget leverprøver.
English: Extent of absorption increases in proportion to atorvastatin dose.
Danish: Absorptionsgraden øges proportionalt med dosis af atorvastatin.
English: The physician should bear in mind that the decision to treat women should be based not only on clinical treatment guidelines but also on the determination of the absolute CV risk taking into account gender, age, smoking, blood pressure, cholesterol, etc (e.g. using Score and Framingham).
Danish: Lægen bør have for øje, at beslutningen om at behandle kvinder ikke kun skal bygge på guidelines for klinisk behandling, men også på den absolutte kardiovaskulære sygdomsrisiko, fastlagt ud fra køn, alder rygning, blodtryk, kolesterol osv. (f.eks. med Framingham score).
English: Doses should be individualised and adjusted every 4 weeks to 40 mg daily.
Danish: Dosis bør individualiseres og indstilles hver 4. uge op til 40 mg dagligt.
English: It is not known whether this medicinal product or its metabolites are excreted in human milk.
Danish: Det vides ikke, om dette lægemiddel eller dets metabolitter udskilles i modermælk hos mennesker.
English: − This medicine has been prescribed for you.
Danish: Lægen har ordineret denne medicin til Dem personligt.
English: However, if there is too much cholesterol in your blood it can be deposited on the walls of the blood vessels, which may eventually become blocked.
Danish: Hvis der imidlertid er for meget kolesterol i blodet, kan fedtstoffer aflejres i blodkarrene, som derved forsnævres.
English: However, the medicinal product does not appear to undergo significant enterohepatic recirculation.
Danish: Lægemidlet undergår imidlertid ikke signifikant enterohepatisk recirkulation.
English: The absolute bioavailability of atorvastatin is approximately 12% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%.
Danish: Den absolutte biotilgængelighed af atorvastatin er ca. 12% ,og den systemiske tilgængelighed af den HMG-CoAreduktasehæmmende aktivitet er ca. 30%.
English: Specific treatment is not available for {PRODUCT NAME} overdosage.
Danish: Der findes ingen specifik behandling ved overdosering med {(Sær)navn}.
English: Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Danish: I tilfælde af overdosering bør patienten behandles symptomatisk, og de nødvendige understøttende forholdsregler institueres.
English: Recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention” in Atherosclerosis 140 (1998) 199-270.
Danish: Bearbejdet efter "Prevention of coronary heart disease in clinical practice: Recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention" publiceret i Atherosclerosis 140 (1998) 199-270.
English: Absolute Risk Reduction p-value
Danish: Absolut risikoreduktion p-værdi
English: To what extent the claimed therapeutic indication could be applied to atorvastatin doses other than the one tested in the CARDS and ASCOT-LLA trials.
Danish: I hvilken grad den påberåbte terapeutiske indikation kan gælde andre doseringer af atorvastatin end dem, der er afprøvet i CARDS- og ASCOT-LLA-forsøgene
English: Atorvastatin produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles.
Danish: Atorvastatin giver en væsentlig og vedvarende forøgelse af LDL-receptoraktiviteten forbundet med en fordelagtig ændring i kvaliteten af cirkulerende LDL-partikler.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne information godt igennem, før De begynder at tage medicinen Gem denne information.
English: Liver function tests should be performed before the initiation of treatment and periodically thereafter.
Danish: Der bør tages leverprøver før behandlingens start og med mellemrum under behandlingen.
English: It is accepted that raised cholesterol levels increase the risk of heart disease.
Danish: Det er kendt, at forhøjet kolesterol kan øge risikoen for hjertesygdom.
English: There was significant treatment interaction by antihypertensive baseline therapy.
Danish: Der var signifikant interaktion med den antihypertensive baseline-terapi.
English: After oral administration, atorvastatin film-coated tablets are 95% to 99% bioavailable compared to the oral solution.
Danish: Biotilgængeligheden af atorvastatin filmovertrukne tabletter er 95-99% sammenlignet med den orale opløsning.
English: At the end of the MRP procedure there was a discrepancy between Member States regarding the wording of the proposed indication that adequately reflects the data of the ASCOT-LLA and CARDS studies, effectively excluding treatment in non-diabetics, and an official referral for arbitration was notified by Spain to the CHMP on 1 December 2005.
Danish: Ved afslutningen af den gensidige anerkendelsesprocedure var der uoverensstemmelse mellem medlemsstaterne om, hvordan den foreslåede indikation skulle affattes for passende at afspejle resultaterne af ASCOT-LLA- og CARDS-forsøgene, så at behandling af ikke-diabetikere effektivt udelukkes, og Spanien anmeldte officielt en indbringelse for voldgift til CHMP den 1. december 2005.
English: Not all included patients were estimated to have a high risk for a first cardiovascular event.
Danish: Ikke alle de indgående patienter blev vurderet til at have høj risiko for en første kardiovaskulær hændelse.
English: The dosage of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily.
Danish: Doseringen af atorvastatin til patienter med homozygot familiær hyperkolesterolæmi er 10-80 mg dagligt.
English: The Applicant has presented arguments for the view that the results for women in ASCOT-LLA based on subgroup analyses are most likely chance findings and are not considered scientifically robust enough to form the basis for regulatory actions.
Danish: Ansøgeren har argumenteret for, at resultaterne for kvinder i ASCOT-LLA baseret på undergruppeanalyser sandsynligvis er tilfældige og ikke kan anses for videnskabeligt tilstrækkelig holdbare som grundlag for indgriben fra de kontrollerende myndigheder.
English: Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse event profile for {PRODUCT NAME}.
Danish: På baggrund af data fra kliniske studier og omfattende erfaring efter markedsføring fremgår {(Sær)navn}s sikkerhedsprofil af nedennævnte tabel.
English: Intake of one 240 ml glass of grapefruit juice resulted in an increase in atorvastatin AUC of 37% and a decreased AUC of 20.4% for the active orthohydroxy metabolite.
Danish: Indtagelse af 1 glas på 240 ml grapefrugtjuice fører til en stigning på 37% af AUC for atorvastatin og en reduktion af AUC på 20,4% for den aktive orthohydroxymetabolit.
English: There was no evidence of a difference in the treatment effect by patient's gender, age, or baseline LDL-C level.
Danish: Der var ingen tegn på, at behandlingens virkning afhang af patientens køn, alder eller baseline LDL-C-værdi.
English: This wording was based on the results of 2 randomised controlled trials performed with atorvastatin 10 mg for the primary prevention of cardiovascular disease (CVD).
Danish: Denne ordlyd var baseret på resultaterne af to randomiserede, kontrollerede forsøg med atorvastatin, 10 mg, til primær forebyggelse af kardiovaskulær sygdom.
English: At its meeting of 20-23 March 2006, the CHMP considered the data on efficacy presented by the MAHs and concluded that it had been shown that atorvastatin, as an adjunct to correction of other risk factors, was effective in the prevention of CV events in patients estimated to have a high risk for a first CV event.
Danish: På sit møde den 20.-23. marts 2006 behandlede CHMP de af indehaverne af markedsføringstilladelsen fremlagte oplysninger om virkning, og konkluderede, at det er godtgjort, at atorvastatin som supplement til korrektion af andre risikofaktorer er effektivt til forebyggelse af kardiovaskulære hændelser hos patienter, der skønnes at have høj risiko for en første kardiovaskulær hændelse.
English: Systemic exposure was 6- to 11-fold higher based on AUC(0-24).
Danish: Den systemiske eksponering var 6-11 gange højere baseret på AUC(0-24).
English: The CHMP has recommended the granting of the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and Package Leaflet are set out in Annex III for atorvastatin (Sortis and related names - see Annex I).
Danish: anbefaler CHMP meddelelse af ændring af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for atorvastatin (Sortis og associerede navne - se bilag I).
English: Concomitant administration of atorvastatin 40 mg and itraconazole 200 mg daily resulted in a 3-fold increase in atorvastatin AUC.
Danish: Samtidig anvendelse af atorvastatin 40 mg og itraconazol 200 mg dagligt førte til 3 gange stigning i atorvastatins AUC.
English: The safety profile of atorvastatin in the MIRACL study was consistent with what is described in Section 4.8.
Danish: Sikkerhedsprofilen af atorvastatin i MIRACL-studiet er i overenstemmelse med det, der er beskrevet i pkt.
English: This interaction may be explained by an inhibition of the membrane transport protein, P-glycoprotein.
Danish: Denne interaktion kan forklares ved en hæmning af membrantransportproteinet P-glycoprotein.
English: Pharmacotherapeutic group: HMG-CoA-reductase inhibitors, ATC code: C10AA05
Danish: Farmakoterapeutisk klassifikation: HMG-CoA-reduktasehæmmere, ATC kode C10AA05.
English: Despite agreeing to the Applicant's request not to exclude females and non-diabetics from the indication, the CHMP regards the claimed indication, which mirrors the ASCOT-LLA and CARDS patient populations, to be too broad.
Danish: Skønt CHMP er enig i ansøgerens ønske om ikke at undtage kvinder og ikke-diabetikere fra indikationen, anser udvalget den ansøgte indikation, der afspejler patientpopulationerne i ASCOT-LLA- og CARDS-forsøgene, for at være for bred.
English: If you are at an increased risk of heart disease, {PRODUCT NAME}can also be used to reduce such risk even if your cholesterol levels are normal.
Danish: Hvis De har en øget risiko for udvikling af hjertesygdom, kan {(Sær)navn} også anvendes til at nedsætte en sådan risiko, selv om De har normalt kolesteroltal.
English: Adjustment of dosage should be made at intervals of 4 weeks or more.
Danish: Dosis bør indstilles med intervaller på 4 uger eller mere.
English: An overview of the approved indications for atorvastatin based on the ASCOT-LLA and CARDS studies across the EU.
Danish: En oversigt over de godkendte indikationer for atorvastatin i hele EU, baseret på ASCOT-LLAog CARDS-forsøgene.
English: Estimated frequencies of events are ranked according to the following convention: common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (≤ 1/10,000).
Danish: Anslåede hyppigheder af bivirkninger er opstillet i henhold til følgende: Almindelig (≥1/100, <1/10); ikke almindelig (≥1/1000 og <1/100); sjælden (≥1/10.000 og <1/1000); meget sjælden (≤1/10.000).
English: Inhibitors of the Pglycoprotein (e.g. ciclosporin) can increase the bioavailability of atorvastatin.
Danish: P-glycoprotein-hæmmere (f.eks. ciclosporin) kan forhøje biotilgængeligheden af atorvastatin.
English: Uncommon: thrombocytopenia.
Danish: Ikke almindelig: Thrombocytopeni.
English: Triglycerides and cholesterol in the liver are incorporated into very low-density lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues.
Danish: Triglycerider og kolesterol i leveren optages i very low density lipoprotein (VLDL) og frigøres i plasma med henblik på udnyttelse i det perifere væv.
English: The most commonly expected adverse events are mainly gastrointestinal, including constipation, flatulence, dyspepsia, abdominal pain and usually ameliorate on continued treatment.
Danish: De hyppigste forventede bivirkninger er primært gastrointestinale, herunder obstipation, flatulens, dyspepsi, abdominalsmerter, og som sædvanligvis bedres ved fortsat behandling.
English: Therefore, the CHMP favours restricting the indication to patients who have a high risk for a first cardiovascular event, thus forcing the prescriber to perform an individual risk assessment rather than following an algorithm for decision on treatment.
Danish: CHMP foretrækker derfor at indskrænke indikationerne til patienter med høj risiko for en første kardiovaskulær hændelse, hvorved den ordinerende læge tvinges til at foretage en individuel risikovurdering i stedet for at gå frem efter en fast formel, når der skal tages stilling til behandlingen af en patient.
English: Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
Danish: På grund af udpræget lægemiddelbinding til plasmaproteinerne forventes hæmodialyse ikke at forhøje atorvastatins clearance signifikant.
English: Atorvastatin and atorvastatin-metabolites are substrates of P-glycoprotein.
Danish: Atorvastatin og atorvastatinmetabolitter er substrater for P-glycoprotein.
English: An interaction study with cimetidine and {PRODUCT NAME} was conducted, and no interaction was seen.
Danish: Et interaktionsstudie med cimetidin og {(Sær)navn} viste ingen interaktion.
English: Whether to exclude the target population of the ASCOT-LLA study from the proposed indication, thus precluding the treatment of non-diabetic patients at high cardiovascular risk.
Danish: Hvorvidt målpopulationen i ASCOT-LLA-forsøget skal udelades i den foreslåede indikation, så at behandling af ikke-diabetiske patienter med høj kardiovaskulær risiko bliver undtaget
English: Use as directed by your doctor.
Danish: Følg lægens anvisning.
English: {PRODUCT NAME} should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Danish: {(Sær)navn} bør bruges med forsigtighed hos patienter, som indtager store mængder alkohol og/eller med leversygdom i anamnesen.
English: How to adequately reflect in the SPC the lack of a significant effect in favour of atorvastatin for the composite primary endpoint and several secondary endpoints in the female subgroup.
Danish: Hvordan produktresuméet passende skal afspejle den manglende signifikant gunstige virkning af atorvastatin på det sammensatte primære endepunkt og flere sekundære endepunkter i den kvindelige undergruppe
English: The main concern relates to the “risk of CVD”.
Danish: Den vigtigste betænkelighed vedrører "risiko for koronar vaskulær sygdom".
English: Evaluation of Clinical Efficacy
Danish: Bedømmelse af klinisk virkning
English: Concomitant administration can lead to increased plasma concentrations of atorvastatin.
Danish: Samtidig administration kan føre til forhøjede plasmakoncentrationer af atorvastatin.
English: When multiple doses of digoxin and 10 mg atorvastatin were coadministered, steady-state plasma digoxin concentrations were unaffected.
Danish: Når flere doser af digoxin og 10 mg atorvastatin blev givet samtidigt, blev steady state plasmakoncentrationerne af digoxin ikke påvirket.
English: Strokes (Fatal and non-fatal)
Danish: Slagtilfælde (fatal og ikkefatal)
English: This may be increased if necessary by your doctor until you are taking the amount you need.
Danish: Hvis lægen finder det nødvendigt, vil denne dosis måske blive øget, indtil De får den dosis, der er behov for.
English: Relative Risk
Danish: Relativ risikoreduktion
English: Atorvastatin pharmacokinetics were not altered by the coadministration of atorvastatin 80 mg and amlodipine 10 mg at steady state.
Danish: Atorvastatins farmakokinetik var uændret ved samtidig anvendelse af atorvastatin 80 mg og amlodipin 10 mg ved steady state.
English: In order to put the results from ASCOT-LLA into a wider perspective and to further support the safety and benefit of atorvastatin in the primary prevention of CV events, regardless of gender, the Applicant has provided i) a brief review of data with respect to gender from other statin clinical trials, ii) the current position of scientific societies on the recommended management of CVD in women, iii) key results by gender for ASCOT-LLA and CARDS, highlighting similarities between the studies, and iv) reference to current regulatory guidance and scientific limitations in interpreting results from subgroup analyses.
Danish: For at sætte resultaterne af ASCOT-LLA i et bredere perspektiv og yderligere underbygge sikkerheden og den gavnlige virkning af atorvastatin til primær forebyggelse af kardiovaskulære hændelser uanset køn har ansøgeren forelagt i) en kortfattet gennemgang af kønsspecifikke data fra andre kliniske forsøg med statiner, ii) den nuværende holdning hos videnskabelige sammenslutninger vedrørende den anbefalede behandling af kardiovaskulær sygdom hos kvinder, iii) kønsbestemte hovedresultater for ASCOT-LLA og CARDS, hvor ligheden mellem forsøgene fremhæves og iv) henvisning til vejledninger i aktuelle myndighedsbestemmelser og videnskabelige begrænsninger i fortolkning af resultater af undergruppeanalyser.
English: Whether the cardioprotective effect of atorvastatin is higher when used in combination with particular antihipertensive therapy(ies) and whether this should be reflected in the SPC.
Danish: Hvorvidt den kardioprotektive virkning af atorvastatin er større, når det anvendes i kombination med et eller flere bestemte antihypertensive midler, og om dette skal afspejles i produktresuméet
English: Uncommon: alopecia, hyperglycaemia, hypoglycaemia, pancreatitis.
Danish: Ikke almindelige: Alopeci, hyperglykæmi, hypoglykæmi, pancreatitis.
English: Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4.
Danish: Indeholder en eller flere stoffer, der kan hæmme CYP34A og kan øge plasmaniveauer af lægemidler, der metaboliseres via CYP3A4.
English: In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk.
Danish: Hos rotter er plasmakoncentrationerne af atorvastatin og dets aktive metabolitter den samme som i mælk.
English: Atorvastatin increased mean HDL-C by 2.9% (pravastatin: +5.6%, p=NS).
Danish: Atorvastatin øger gennemsnit HDL-kolesterol med 2,9% (pravastatin: +5,6%, p=NS).
English: Higher dosages may be necessary in order to attain (LDL-)cholesterol levels according to current guidelines.
Danish: Højere dosis kan være nødvendigt for at opnå (LDL)-kolesterolniveauer i henhold til gældende guidelines.
English: Reductions in total-C, LDL-C, and apolipoprotein B have been proven to reduce risk for cardiovascular events and cardiovascular mortality.
Danish: Der er vist, at reduktion i total-kolesterol, LDL-kolesterol og apolipoprotein B reducerer risikoen for kardiovaskulære hændelser og kardiovaskulær mortalitet.
English: Other factors that will increase the risk of heart disease include high blood pressure, diabetes, increased weight, lack of exercise, smoking, or a family history of heart disease.
Danish: Andre faktorer, som kan øge risikoen for hjertesygdom, omfatter højt blodtryk, diabetes, overvægt, manglende motion, rygning eller hjertesygdom hos den nærmeste biologiske familie.
English: 4 tablets 7 tablets 10 tablets 14 tablets 20 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 98 tablets 100 tablets 200 tablets 500 tablets
Danish: 4 tabletter 7 tabletter 10 tabletter 14 tabletter 20 tabletter 28 tabletter 30 tabletter 50 tabletter 56 tabletter 84 tabletter 98 tabletter 100 tabletter 200 tabletter 500 tabletter
English: The effect of intensive lipid lowering on cardiovascular endpoints (e.g. need for revascularisation, non fatal myocardial infarction, coronary death) was not investigated in this study.
Danish: Effekten af intensiv lipidsænkning på kardiovaskulære endepunkter (dvs. behov for revaskularisering, ikke-fatalt myokardieinfarkt, koronardød) blev ikke undersøgt i dette studie.
English: Hospital packs containing 200 (10 x 20) or 500 film-coated tablets.
Danish: Hospitalspakninger med 200 (10x20) eller 500 filmovertrukne tabletter.
English: The main issue discussed by the CHMP has been the results of the ASCOT-LLA trial, most importantly the lack of established benefit and adverse mortality trends in the female subgroup and, secondly, the impact of the observed interaction between the antihypertensive amlodipine and atorvastatin on the main trial outcomes for certain subgroups.
Danish: Hovedemnet for drøftelserne i CHMP har været resultaterne af ASCOT-LLA-forsøget, først og fremmest den manglende påvisning af gavnlig virkning og de ugunstige tendenser til dødelighed i den kvindelige undergruppe, hvortil kommer betydningen af den iagttagne interaktion mellem antihypertensionsmidlet amlodipin og atorvastatin på forsøgets hovedresultater for visse undergrupper.
English: • no untoward safety findings related to the extension of the indication have been identified.
Danish: • der har ikke været ugunstige resultater af sikkerhedsmæssig art i forbindelse med indikationsudvidelsen.
English: The maximum dose used was 63-fold higher than the highest human dose (80 mg/day) on a mg/kg body-weight basis and 8- to 16-fold higher based on AUC(0-24) values as determined by total inhibitory activity.
Danish: Den maksimale dosis var 63 gange højere end den højeste humane dosis (80 mg/døgn) udregnet på baggrund af mg/kg legemsvægt og 8-16 gange højere baseret på AUC(0-24) bestemt ved total hæmmende aktivitet.
English: From these 46 patients, the mean percent reduction in LDL-C was approximately 21%.
Danish: Hos disse 46 patienter var den gennemsnitlige nedsættelse af LDL-kolesterol på ca. 21 %.