FrancophonIA/ELRC3.0 huggingface dataset:
English: − Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever.
Danish: Patienter skal opfordres til omgående at rapportere muskelsmerter, -kramper eller -svaghed, især hvis disse er ledsaget af utilpashed eller feber.
English: Doses should be individualised and adjusted every 4 weeks to 40 mg daily.
Danish: Dosis skal individualiseres og justeres hver 4. uge til 40 mg dagligt.
English: The absolute and relative risk reduction effect of atorvastatin was as follows:
Danish: Den absolutte og relative risikoreduktion i atorvastatingruppen var følgende:
English: Appropriate clinical monitoring of these patients is recommended.
Danish: Passende klinisk monitorering af disse patienter anbefales.
English: Developmental safety data in this population have not been evaluated.
Danish: Sikkerhedsdata i forbindelse med børnenes udvikling er ikke blevet vurderet.
English: In this randomised, double- blind, multicenter, controlled clinical trial, IVUS was performed at baseline and at 18 months in 502 patients.
Danish: I dette randomiserede, dobbelt-blinde, multicenter, kontrollerede kliniske studie blev IVUS udført ved baseline og ved 18 måneder hos 502 patienter.
English: If you forget to take a dose, just take your next scheduled dose at the correct time.
Danish: Hvis De har glemt at tage en dosis, skal De blot tage den næste dosis som planlagt.
English: There was significant treatment interaction by antihypertensive baseline therapy.
Danish: Der var en signifikant behandlingsinteraktion ved antihypertensiv baseline behandling.
English: The safety profile of atorvastatin in the MIRACL study was consistent with what is described in section
Danish: Sikkerhedsprofilen af atorvastatin i MIRACL-studiet var i overenstemmelse med det, der er beskrevet i pkt.
English: Only limited data are available (see section 5.1).
Danish: Kun begrænsede data er tilgængelige (se pkt.
English: The absolute bioavailability of atorvastatin is approximately 12% and the systemic availability of HMGCoA reductase inhibitory activity is approximately 30%.
Danish: Den absolutte biotilgængelighed af atorvastatin er ca. 12 %, og den systemiske tilgængelighed af den HMG-CoA-reduktasehæmmende aktivitet er ca. 30 %.
English: Concomitant treatment with other medicinal products
Danish: Samtidig behandling med andre lægemidler
English: • Sexual difficulties
Danish: • Seksuelle problemer
English: Belgium, Cyprus, Finland, Greece, Ireland, Luxembourg, Malta, Netherlands, Norway, Sweden, UK
Danish: Belgien, Cypern, Finland, Grækenland, Irland, Luxembourg, Malta, Holland, Norge, Sverige, Storbritannien
English: BATCH NUMBER Batch
Danish: BATCHNUMMER Batch:
English: Atorvastatin was administered at doses up to 80 mg/day.
Danish: Atorvastatin blev administreret i doser op til 80 mg/dag.
English: The effect of rifampin on atorvastatin concentrations in hepatocytes is, however, unknown and if concomitant administration cannot be avoided, patients should be carefully monitored for efficacy.
Danish: Virkningen af rifampicin på atorvastatinkoncentrationen i hepatocytter er derimod ukendt, og hvis samtidig behandling ikke kan undgås, bør patienterne monitoreres nøje for effekt.
English: Patients taking digoxin should be monitored appropriately.
Danish: Patienter i digoxinbehandling bør monitoreres passende.
English: Atorvastatin reduces LDL production and the number of LDL particles.
Danish: Atorvastatin reducerer LDL-produktionen og antallet af LDL-partikler.
English: Not all included patients were estimated to have a high risk for a first cardiovascular event.
Danish: Ikke alle inkluderede patienter blev vurderet til at have en høj risiko for debut af kardiovaskulær hændelse.
English: In the subgroup analyses by gender (81% males, 19% females), a beneficial effect of atorvastatin was seen in males but could not be established in females possibly due to the low event rate in the female subgroup.
Danish: I subgruppeanalyserne af køn (81 % mænd, 19 % kvinder) blev atorvastatins gavnlige effekt bekræftet blandt mænd, men ikke blandt kvinder, muligvis på grund af det lille antal observerede hændelser hos kvinder i subgruppenn.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Danish: Dette produktresumé, denne etikettering og denne indlægsseddel er den udgave, som er gyldig på tidspunktet for Kommissionens afgørelse.
English: The effect of intensive lipid lowering on major cardiovascular endpoints was not investigated in this study.
Danish: Effekten af den intensive lipidsænkning på de primære kardiovaskulære endepunkter blev ikke undersøgt i dette studie.
English: Mean volume of distribution of atorvastatin is approximately 381 l. Atorvastatin is ≥ 98% bound to plasma proteins.
Danish: Atorvastatins gennemsnitlige fordelingsvolumen er ca. 381 l. Atorvastatin er bundet 98 % til plasmaproteiner.
English: The following adverse events have been reported with some statins:
Danish: Følgende bivirkninger er rapporteret ved brug af nogle statiner:
English: Liver function tests should be performed and serum CK levels should be monitored.
Danish: Leverfunktionsmålinger og serum-CK-niveauet bør monitoreres.
English: Please ask your doctor if you think that the effect of {PRODUCT NAME} is too strong or too weak.
Danish: Fortæl lægen, hvis De føler, at virkningen af Zarator er for kraftig eller for svag.
English: Study results were obtained with the 80 mg dose strength.
Danish: Studieresultaterne blev opnået for styrken 80 mg.
English: {PRODUCT NAME} tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food.
Danish: Zarator tabletter skal synkes hele med et glas vand og kan tages på et hvilket som helst tidspunkt af døgnet med eller uden mad.
English: Estimated frequencies of reactions 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: De estimerede bivirkningsfrekvenser er opstillet i henhold til følgende: 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).
English: * Co-administration of multiple doses of atorvastatin and phenazone showed little or no detectable effect in the clearance of phenazone.
Danish: * Samtidig indgift af multiple doser af atorvastatin og phenazon viste en lille eller ingen målbar virkning på phenazons clearance.
English: There is evidence from animal experimental studies that HMG-CoA reductase inhibitors may affect the development of embryos or fetuses.
Danish: Dyreforsøg har vist, at HMG-CoA-reduktasehæmmere kan påvirke udviklingen af embryoner eller fostre.
English: Liver function tests should be performed before the initiation of treatment and periodically thereafter.
Danish: Der bør tages leverprøver før behandlingens start og periodisk under behandlingen.
English: • unexpected bleeding or bruising
Danish: • uventet blødning eller blå mærker
English: Intake of one 240 ml glass of grapefruit juice also resulted in a decreased AUC of 20.4% for the active orthohydroxy metabolite.
Danish: Indtagelse af et glas (240 ml) grapefruitjuice resulterede også i en reduktion af AUC på 20,4% for den aktive orthohydroxy-metabolit.
English: Ciclosporin 5.2 mg/kg/day, stable dose
Danish: Ciclosporin 5,2 mg/kg/dag, stabil dosering
English: All patients had at least 1 of the following risk factors: hypertension, current smoking, retinopathy, microalbuminuria or macroalbuminuria.
Danish: Alle patienter havde mindst 1 af følgende risikofaktorer: hypertension, ryger, retinopati, mikroalbuminuri eller makroalbuminuri.
English: The other secondary endpoints did not reach statistical significance on their own (overall: Placebo: 22.2%, Atorvastatin: 22.4%).
Danish: De øvrige sekundære endepunkter var ikke selvstændigt signifikante (samlet: placebo: 22,2 %, atorvastatin:
English: Oral contraceptive OD, 2 months - norethindrone 1 mg -ethinyl estradiol 35 µg
Danish: Orale kontraceptiva x 1, 2 måneder - norethisteron 1 mg - ethinylestradiol 35 µg
English: Like all medicines, {PRODUCT NAME} can cause side effects, although not everybody gets them.
Danish: Zarator kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
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 oral opløsning.
English: Overall and cardiovascular mortality were numerically higher in the female patients (38 vs. 30 and 17 vs. 12), but this was not statistically significant.
Danish: Total mortalitet og kardiovaskulær mortalitet var numerisk højere hos kvinder (38 vs. 30 og 17 vs. 12), men det var ikke statistisk signifikant.
English: Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL)
Danish: Forebyggelse af apopleksi ved aggresiv reduktion af kolesterolniveauerne (Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL))
English: Strokes (Fatal and non-fatal)
Danish: Apopleksi (letal og ikke-letal)
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 koblet med en fordelagtig ændring i kvaliteten af de cirkulerende LDL-partikler.
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, skal have taget leverprøver.
English: Atherosclerosis is a chronic process, and ordinarily discontinuation of lipidlowering medicinal products during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolaemia.
Danish: Aterosklerose er en kronisk proces, og sædvanligvis vil seponering af kolesterolsænkende medicin under graviditet kun have en lille indflydelse på den langsigtede risiko forbundet med primær hyperkolesterolæmi.
English: The low systemic availability is attributed to presystemic clearance in gastrointestinal mucosa and/or hepatic first-pass metabolism
Danish: Den lave systemiske tilgængelighed tilskrives præsystemisk clearance i gastrointestinalslimhinden og/eller first-pass metabolisme i leveren.
English: If the dose of atorvastatin is changed or discontinued, the same procedure should be repeated.
Danish: Hvis atorvastatindosis ændres, eller behandlingen seponeres, bør samme procedure gentages.
English: Atorvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.
Danish: Atorvastatinbehandling er ikke blevet forbundet med blødning eller med ændringer i protrombintid hos patienter, der ikke tager antikoagulantia.
English: When multiple doses of digoxin and 10 mg atorvastatin were co-administered, steady-state digoxin concentrations increased slightly.
Danish: Når multiple doser af digoxin og 10 mg atorvastatin blev givet samtidigt, blev steady state plasmakoncentrationen af digoxin øget en smule.
English: • increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase
Danish: • forhøjet blodsukker (hvis De har sukkersyge (diabetes), skal De kontrollere blodsukkerniveauet omhyggeligt), forhøjet kreatinkinase i blodet
English: AMI = acute myocardial infarction; CABG = coronary artery bypass graft; CHD = coronary heart disease; MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty.
Danish: AMI = akut myokardieinfarkt; CABG = koronararterie bypass graft operation; CHD = koronar hjertesygdom; MI = myokardieinfarkt; PTCA = perkutan transluminal koronar angioplastik.
English: • Breathing problems including persistent cough and/or shortness of breath or fever
Danish: • Vejrtrækningsproblemer herunder vedvarende hoste og/eller åndenød eller feber.
English: Polymorphism in the gene encoding OATP1B1 (SLCO1B1 c.521CC) is associated with a 2.4-fold higher atorvastatin exposure (AUC) than in individuals without this genotype variant (c.521TT).
Danish: Polymorfisme i det gen, der koder for OATP1B1 (SLCO1B1 c.521CC), er forbundet med en 2,4-gange højere atorvastatineksponering (AUC) end hos individer uden denne genotype-variant (c.521TT).
English: For these reasons, {PRODUCT NAME} should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.
Danish: Af disse årsager må Zarator ikke anvendes til kvinder, der er gravide, prøver at blive det eller formoder, at de er det.
English: Experience in paediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Danish: Erfaring med brug hos børn og unge er begrænset til et lille antal patienter (4-17 år) med svær dyslipidæmi som f.eks. homozygot familiær hyperkolesterolæmi.
English: * Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4.
Danish: * Indeholder et eller flere komponenter, der hæmmer CYP3A4, og kan øge plasmakoncentrationen af lægemidler, der metaboliseres via CYP3A4.
English: Your doctor will adapt the dose at intervals of 4 weeks or more.
Danish: Lægen vil justere dosis med intervaller på 4 uger eller mere.
English: Treatment with {PRODUCT NAME} should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant (see section 4.3.)
Danish: Behandling med Zarator skal seponeres under graviditet, eller indtil det er blevet afklaret, at kvinden ikke er gravid (se pkt.
English: • Sexual dysfunction.
Danish: • Seksuel dysfunktion
English: Large quantities of grapefruit juice (over 1.2 l daily for 5 days) increased AUC of atorvastatin 2.5 fold and AUC of active (atorvastatin and metabolites).
Danish: Store mængder grapefruitjuice (over 1,2 l dagligt i 5 dage) øgede AUC for atorvastatin 2,5 gange og AUC for aktive (atorvastatin og metabolitter).
English: No controlled clinical trials with atorvastatin have been conducted in pregnant women.
Danish: Der er ikke udført kontrollerede kliniske forsøg med atorvastatin hos gravide kvinder.
English: It is not known whether atorvastatin or its metabolites are excreted in human milk.
Danish: Det er ukendt, om atorvastatin eller dets metabolitter udskilles i human mælk.
English: Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
Danish: Derefter kan dosis enten øges til maksimalt 80 mg dagligt, eller en galdesyrebinder kan kombineres med 40 mg atorvastatin 1 gang dagligt.
English: If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
Danish: Hvis der er mistanke om, at en patient har udviklet interstitiel lungesygdom, skal statinbehandlingen afbrydes.
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 ikke bevis for en forskel i behandlingseffekten på grund af patienternes køn, alder eller baselineværdien for LDL-kolesterol.
English: Normally this medicine does not affect your ability to drive or operate machines.
Danish: Normalt vil denne medicin ikke påvirke Deres evne til at færdes sikkert i trafikken eller betjene maskiner.
English: Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Danish: I tilfælde af overdosering skal patienten behandles symptomatisk, og de nødvendige understøttende forholdsregler institueres.
English: In rats, rabbits and dogs atorvastatin had no effect on fertility and was not teratogenic, however, at maternally toxic doses fetal toxicity was observed in rats and rabbits.
Danish: Hos rotter, kaniner og hunde havde atorvastatin ingen effekt på fertiliteten og var ikke teratogent, dog blev der set føtal toksicitet hos rotter og kaniner ved doser, der var toksiske for moderdyret.
English: Paediatric use should only be carried out by specialists.
Danish: Børn og unge bør kun behandles af specialister.
English: If CK levels are significantly elevated at baseline (> 5 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results.
Danish: Hvis CK-værdien er signifikant forhøjet ved baseline (>5 gange den øvre referenceværdi), bør den måles igen inden for 5-7 dage for at bekræfte resultatet.
English: Triglycerides and cholesterol in the liver are incorporated into very lowdensity lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues.
Danish: Triglycerider og kolesterol i leveren inkorporeres i very low-density lipoproteiner (VLDL) og frigøres til plasma med henblik på frigivelse til perifere væv.
English: If you forget to take {PRODUCT NAME}
Danish: Hvis De har glemt at tage Zarator
English: Although only very rare cases of clinically significant anticoagulant interactions have been reported, prothrombin time should be determined before starting atorvastatin in patients taking coumarin anticoagulants and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs.
Danish: Selvom der kun er set meget sjældne tilfælde af klinisk signifikante interaktioner med antikoagulantia, bør protrombintid bestemmes inden atorvastatinbehandling igangsættes hos patienter, der tager coumarin-antikoagulantia, samt tilstrækkeligt hyppigt i starten af behandlingen til at sikre, at der ikke forekommer signifikant ændring i protrombintid.
English: Psychiatric disorders Uncommon: nightmare, insomnia.
Danish: Psykiske forstyrrelser Ikke almindelig: Mareridt, søvnløshed.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen Gem indlægssedlen.
English: Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
Danish: På grund af udpræget binding af atorvastatin til plasmaproteiner forventes hæmodialyse ikke at forhøje atorvastatins clearance signifikant.
English: − Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems.
Danish: Muskelsvaghed, muskelømhed eller muskelsmerter kan, især hvis du samtidig er utilpas eller får høj temperatur, skyldes en unormal nedbrydning af musklerne, som kan være livstruende og medføre nyreproblemer (rabdomyolyse).
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-letalt myokardieinfarkt (MI), koronar død) blev ikke undersøgt i dette studie.
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 Zarator også anvendes til at nedsætte risikoen, selv om De har normalt kolesteroltal.
English: Mean plasma elimination half-life of atorvastatin in humans is approximately 14 hours.
Danish: Den gennemsnitlige plasma-halveringstid hos mennesker er ca. 14 timer.
English: Elderly: Plasma concentrations of atorvastatin and its active metabolites are higher in healthy elderly subjects than in young adults while the lipid effects were comparable to those seen in younger patient populations.
Danish: Ældre: Plasmakoncentrationerne af atorvastatin og dets aktive metabolitter er højere hos raske ældre end hos yngre, mens virkningen på lipiderne er sammenlignelig med den, som ses hos yngre patientgrupper.
English: Because of the potential for serious adverse reactions, women taking {PRODUCT NAME} should not breast-feed their infants (see section 4.3).
Danish: På grund af risko for alvorlige bivirkninger må kvinder, der tager Zarator, ikke amme deres børn (se pkt.
English: This may be increased if necessary by your doctor until you are taking the amount you need.
Danish: Hvis lægen finder det nødvendigt, kan denne dosis øges, indtil De får den dosis, der er behov for.
English: Inhibitors of transport proteins (e.g. ciclosporin) can increase the systemic exposure of atorvastatin (see Table 1).
Danish: Hæmmere af transportproteiner (f.eks. ciclosporin) kan øge den systemiske atorvastatineksponering (se tabel 1).
English: Efavirenz 600 mg OD, 14 days 10 mg for 3 days ↓ 41% No specific recommendation.
Danish: Efavirenz 600 mg x 1, 14 dage 10 mg i 3 dage ↓ 41% Ingen særlig rekommandation.
English: Extent of absorption increases in proportion to atorvastatin dose.
Danish: Mængden, der absorberes, øges proportionalt med atorvastatindosis.
English: ^ Total atorvastatin equivalent activity
Danish: ^ Total-atorvastatin ækvivalent aktivitet.
English: Creatine kinase (CK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CK increase as this makes value interpretation difficult.
Danish: CK bør ikke måles efter kraftig, fysisk anstrengelse, eller hvis der er en anden grund til, at CK kan være forhøjet, da det vanskeliggør fortolkningen af værdien.
English: A favourable trend was observed regarding the mortality rate (82 deaths in the placebo group vs. 61 deaths in the atorvastatin group, p=0.0592).
Danish: Der blev set en favorabel tendens med hensyn til mortalitetsrate (82 dødsfald i placebogruppen vs. 61 dødsfald i atorvastatingruppen, p=0,0592).
English: This was mainly due to a 26% reduction in re-hospitalisation for angina pectoris with evidence of myocardial ischaemia (p=0.018).
Danish: Dette skyldes primært en risikoreduktion på 26 % i genindlæggelse for angina pectoris med tegn på myokardieiskæmi (p=0,018).
English: You should maintain a standard cholesterol lowering diet during treatment.
Danish: De skal fortsætte med en standard kolesterolsænkende diæt under behandlingen.
English: Common: headache.
Danish: Almindelig: Hovedpine
English: Denmark, Greece, Iceland, Portugal, Spain
Danish: Danmark, Grækenland, Island, Portugal, Spanien Zarator Finland
English: • having nightmares, insomnia
Danish: • mareridt, søvnløshed
English: − Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing.
Danish: En alvorlig, allergisk reaktion, som kan medføre hævelse af ansigt, tunge og hals, hvilket kan give åndedrætsbesvær.
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 nedsætter risikoen for kardiovaskulære hændelser og kardiovaskulær mortalitet.
English: − If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint.
Danish: Hvis De oplever problemer med uventet eller usædvanlig blødning eller blå mærker, kan det skyldes leverproblemer.
English: * Phenazone, 600 mg SD ↑ 3% No specific recommendation
Danish: * Phenazon, 600 mg enkeltdosis ↑ 3% Ingen særlig rekommandation.
English: Renal insufficiency: Renal disease has no influence on the plasma concentrations or lipid effects of atorvastatin and its active metabolites.
Danish: Nyreinsufficiens: Nyresygdomme har ingen indflydelse på plasmakoncentrationerne af atorvastatin eller dets aktive metabolitter eller på deres effekt på lipiderne.
English: Low-density lipoprotein (LDL) is formed from VLDL and is catabolized primarily through the receptor with high affinity to LDL (LDL receptor).
Danish: Low-density lipoprotein (LDL) dannes fra VLDL og kataboliseres primært ved hjælp af receptorer med høj affinitet til LDL (LDLreceptorer).