FrancophonIA/ELRC3.0 huggingface dataset:
English: Atorvastatin has been shown to reduce concentrations of total-C (30% - 46%), LDL-C (41% - 61%), apolipoprotein B (34% - 50%), and triglycerides (14% - 33%) while producing variable increases in HDL-C and apolipoprotein A1 in a dose response study.
Danish: Atorvastatin reducerede koncentrationen af total-kolesterol (30-46%), LDL-kolesterol (41-61%), apolipoprotein B (34-50%) og triglycerider (14-33%), men forårsagede variable stigninger i HDLkolesterol og apolipoprotein A1 i et dosis-respons-studie.
English: − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
Danish: Hvis sådanne symptomer opstår under behandling med atorvastatin, bør CK-værdien måles.
English: BATCH NUMBER Batch :
Danish: FREMSTILLERENS BATCHNUMMER Batch:
English: Dosage in patients with renal insufficiency
Danish: Patienter med nyreinsufficiens
English: If CPK 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: − 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 virkning på atorvastatins eller dets aktive metabolitters plasmakoncentration eller på deres effekt på lipiderne.
English: For patients with established coronary heart disease or other patients at increased risk of ischemic events, the treatment goal is LDL-C < 3 mmol/l (or < 115 mg/dl) and total cholesterol < 5 mmol/l (or < 190 mg/dl).
Danish: Hos patienter med manifest iskæmisk hjertesygdom eller andre patienter med øget risiko for iskæmiske hændelser er behandlingsmålet LDL-kolesterol <3 mmol/l (eller <115 mg/dl) og total-kolesterol <5 mmol/l (eller <190 mg/dl).
English: thus restricting the indication to the population included in the CARDs trial and relegating the results of the ASCOT-LLA trial to a description in section 5.1. of the SPC, based on the lack of demonstrated efficacy in the female subgroup.
Danish: hvorved indikationen blev indskrænket til den population, der indgik i CARDs-forsøget, mens resultaterne af ASCOT-LLA-forsøget blev rykket ned til en beskrivelse i afsnit 5.1. af produktresuméet, eftersom der ikke var påvist klinisk virkning i den kvindelige undergruppe.
English: The blisters consist of a forming film made of polyamide/aluminum foil/polyvinyl chloride and a backing made of either paper/polyester/aluminum foil/vinyl heat-seal coating or aluminum foil/vinyl heat-seal coating.
Danish: Blisterformen består af polyamid/aluminium folie/polyvinylchlorid og blisterfolien består af enten af varmeforsegling med papir/polyester/aluminium folie/vinyl eller aluminium folie/vinyl.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ } <[Udfyldes nationalt]>
English: Should an increase in transaminases of greater than 3 times the upper limit of normal persist, reduction of dose or withdrawal of {PRODUCT NAME} is recommended (see section 4.8).
Danish: Ved vedvarende stigning i transaminaserne på mere end 3 gange den øvre referenceværdi, anbefales dosisreduktion eller seponering af {(Sær)navn} (se pkt.
English: Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on {PRODUCT NAME}.
Danish: Klinisk relevante (>3 gange den øvre referenceværdi) forhøjelser i serumtransaminaser er set hos 0,8% af de patienter, som behandles med {(Sær)navn}.
English: The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
Danish: Størstedelen af patienterne er velkontrollerede på 10 mg {(Sær)navn} 1 gang dagligt.
English: Date:} which is stated on the container and outer packaging.
Danish: senest), som står på beholderen eller kartonen.
English: Nervous system disorders
Danish: Lidelser i nervesystemet
English: In the primary prevention trials, the dose was 10 mg/day.
Danish: I de primære forebyggelsesstudier var dosis 10 mg/døgn.
English: NAME OF THE MARKETING AUTHORISATION HOLDER <[To be completed nationally]> {Name}
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN <[Udfyldes nationalt]> {Navn}
English: Hypromellose Polyethylene glycol Titanium dioxide (E171) Talc
Danish: Hypromellose Macrogol Titandioxid (E171) Talkum
English: Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable.
Danish: Atorvastatin gives som supplement til anden lipidsænkende behandling (f.eks. LDL-aferese) eller hvis sådan behandling ikke er tilgængelig.
English: Inhibitors of P-glycoprotein
Danish: P-glycoprotein-hæmmere
English: Rare: hepatitis, cholestatic jaundice.
Danish: Sjælden: Hepatitis, kolestatisk icterus.
English: Patients were hypertensive, 40-79 years of age, with no previous myocardial infarction or treatment for angina, and with TC levels ≤6.5 mmol/l (251 mg/dl).
Danish: Der er tale om patienter med hypertension i alderen 40-79 år uden tidligere myokardieinfarkt eller behandling for angina og med totalkolesterol (TC) ≤ 6,5 mmol/l (251 mg/dl).
English: The median percent change, from baseline, in total atheroma volume (the primary study criteria) was0.4% (p=0.98) in the atorvastatin group and +2.7% (p=0.001) in the pravastatin group (n=249).
Danish: Middel procentændring i total atheromavolumen (primært studiekriterie) fra baseline er -0,4% (p=0,98) i atorvastatingruppen, og +2,7% (p=0,001) i pravastatingruppen (n=249).
English: Patients should be started with {PRODUCT NAME} 10 mg daily.
Danish: Patienter bør starte med {(Sær)navn} 10 mg dagligt.
English: Coadministration of atorvastatin and protease inhibitors, known inhibitors of cytochrome P450 3A4, was associated with increased plasma concentrations of atorvastatin.
Danish: Samtidig administration af atorvastatin og proteasehæmmere, kendte cytochrom P450 3A4-hæmmere, er forbundet med forhøjede plasmakoncentrationer af atorvastatin.
English: Women of child-bearing age must take appropriate contraceptive measures.
Danish: Kvinder i den fertile alder bør anvende sikker antikonception.
English: However, 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, and overall mortality and CV mortality were numerically higher (not significant) in the female patients.
Danish: Ved undergruppeanalyse efter køn (81 % mænd, 19 % kvinder) kunne en gavnlig virkning af atorvastatin imidlertid kun påvises hos mænd, men ikke hos kvinder, og den samlede dødelighed og kardiovaskulære dødelighed var numerisk højere (ikke signifikant) hos de kvindelige patienter.
English: Do not use, if package has already been opened.
Danish: Må ikke anvendes hvis forseglingen er brudt.
English: Coadministration of atorvastatin 10 mg OD and erythromycin (500 mg QID), or atorvastatin 10 mg OD and clarithromycin (500 mg BID), known inhibitors of cytochrome P450 3A4, were associated with higher plasma concentrations of atorvastatin.
Danish: Samtidig anvendelse af atorvastatin 10 mg 1 gang dagligt og erythromycin (500 mg 4 gange dagligt) eller atorvastatin 10 mg 1 gang dagligt og clarithromycin (500 mg 2 gange dagligt), kendte hæmmere af cytokrom P450 3A4, var forbundet med højere plasmakoncentrationer af atorvastatin.
English: In the light of the above the CHMP concludes that the indication for atorvastatin “Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.” adequately reflects the available data.
Danish: På baggrund af ovenstående konkluderer CHMP, at de foreliggende oplysninger om atorvastatin passende vil afspejles af indikationen "Forebyggelse af kardiovaskulære hændelser hos patienter, der skønnes at have høj risiko for en første kardiovaskulær hændelse, som supplement til korrektion af andre risikofaktorer".
English: Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites.
Danish: Ca. 70% af hæmningen af HMG-CoA-reduktase skyldes aktive metabolitter.
English: Interaction may occur when {PRODUCT NAME} is administered with inhibitors of cytochrome P450 3A4 (e.g. ciclosporin, macrolide antibiotics including erythromycin and clarithromycin, nefazodone, azole antifungals including itraconazole and HIV protease inhibitors).
Danish: Interaktion kan opstå, når atorvastatin gives sammen med cytokrom P450 3A4-hæmmere (f.eks. ciclosporin, makrolidantibiotika, herunder erythromycin og clarithromycin, nefazodon, azol-antimykotika herunder itraconazol og HIV-proteasehæmmere).
English: PHARMACEUTICAL FORM
Danish: Lægemiddelform
English: You should always tell your doctor if you are taking or have recently taken any other medicine, even those not prescribed, because they might interact.
Danish: Hvis De tager eller for nylig har taget andre lægemidler, bør De oplyse Deres læge herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: Simethicone Stearate emulsifiers Sorbic acid
Danish: Simethicon Stearat emulgatorer
English: No. of Events (Sortis vs Placebo)
Danish: Antal hændelser (Sortis mod placebo)
English: In order to get the same absolute efficacy of atorvastatin in both sexes, it is therefore necessary to treat women who have the same absolute risk as men, i.e. women with more additional risk factors, such as higher age, menopause, etc.
Danish: Det er indlysende, at den aldersjusterede, absolutte gavnlige virkning af primær forebyggelse af koronar vaskulær sygdom er langt lavere hos kvinder end hos mænd, da kvinder har lavere risiko for koronar vaskulær sygdom i samme alder. For at opnå samme absolutte virkning af atorvastatin hos begge køn må man derfor behandle kvinder, der har samme absolutte risiko som mænd, dvs. kvinder med flere ekstra risikofaktorer som højere alder, menopause osv.
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 er set en favorabel tendens med hensyn til mortalitetsrate (82 dødsfald i placebogruppen vs. 61 dødsfald i atorvastatingruppen, p=0,0592).
English: For oral use only.
Danish: Oral anvendelse.
English: The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of ciclosporin, fibric acid derivatives, macrolide antibiotics including erythromycin, azole antifungals, or niacin and on rare occasions has resulted in rhabdomyolysis with renal dysfunction secondary to myoglobinuria.
Danish: Risiko for myopati under behandling med HMG-CoA-reduktasehæmmere øges ved samtidig anvendelse af ciclosporin, fibrater, niacin, makrolidantibiotika herunder erythromycin, azol-antimykotika og har ved sjældne lejligheder resulteret i rhabdomyolyse med nedsat nyrefunktion sekundært til myoglobinuri.
English: Uncommon: myopathy.
Danish: Ikke almindelig: Myopati.
English: The maximum dose is 80 mg once a day.
Danish: Den maksimale dosis er 80 mg én gang daglig.
English: Atorvastatin is effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipidlowering medication.
Danish: Atorvastatin reducerer effektivt LDL-kolesterol hos patienter med homozygot familiær hyperkolesterolæmi, en patientgruppe, som ikke sædvanligvis responderer på lipidsænkende behandling.
English: The half-life of inhibitory activity for HMG-CoA reductase is approximately 20 to 30 hours due to the contribution of active metabolites.
Danish: Halveringstiden for hæmmende aktivitet over for HMG-CoA-reduktase som følge af aktive metabolitter er ca. 20-30 timer.
English: Total mortality and cardiovascular mortality were not significantly reduced (185 vs. 212 events, p=0.17 and 74 vs. 82 events, p=0.51).
Danish: Mortaliteten af alle årsager og den kardiovaskulære mortalitet blev ikke signifikant nedsat (185 vs. 212 hændelser, p=0,17 og 74 vs. 82 hændelser, p=0,51).
English: In vitro, inhibition of HMG-CoA reductase by ortho- and parahydroxylated metabolites is equivalent to that of atorvastatin.
Danish: In vitro hæmmer orto- og parahydroxylerede metabolitter HMG-CoA-reduktase i samme grad som atorvastatin.
English: − Gender: Concentrations of atorvastatin and its active metabolites in women differ from those in men (Women: approx. 20% higher for Cmax and approx. 10% lower for AUC).
Danish: Køn: Koncentrationen af atorvastatin og dets aktive metabolitter hos kvinder afviger (ca. 20% højere for Cmax og 10% lavere for AUC) fra koncentrationerne hos mænd.
English: Uncommon: anorexia, vomiting.
Danish: Ikke almindelig: Anoreksi, opkastning.
English: A standard cholesterol lowering diet should be continued during treatment.
Danish: Under behandling skal De fortsætte med en standard kolesterolsænkende diæt.
English: Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated CPK levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure.
Danish: Atorvastatin kan som andre HMG-CoA-reduktasehæmmere i sjældne tilfælde have en effekt på skeletmuskulaturen og kan forårsage myalgi, myositis, og myopati som kan udvikle sig til rhabdomyolyse, en potentielt livstruende tilstand, som kendetegnes ved markant forhøjet CK-værdi (> 10 gange den øvre referenceværdi), myoglobinæmi og myoglobinuri, som kan føre til nyresvigt.
English: A relative risk reduction in death of 27% (82 deaths in the placebo group compared to 61 deaths in the atorvastatin group) was observed with a borderline statistical significance (p=0.0592).
Danish: Der iagttoges en relativ reduktion i dødeligheden på 27 % (82 dødsfald i placebo-gruppen mod 61 dødsfald i atorvastatin-gruppen), som var på grænsen til statistisk signifikans (p=0,0592).
English: If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your {PRODUCT NAME} treatment to predict your risk of muscle related side effects.
Danish: Hvis De har haft nogle af ovenstående problemer, vil Deres læge tage en blodprøve før og muligvis i løbet af behandlingen med {(Sær)navn}.
English: If CPK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started.
Danish: Hvis CK-værdien er signifikant forhøjet (> 5 gange den øvre referenceværdi) ved baseline, bør behandlingen ikke startes.
English: − If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint.
Danish: Kontakt omgående lægen, hvis De oplever problemer med uventet eller usædvanlig blødning eller blå mærker, da dette kan betyde leverproblemer.
English: Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicaments such as: ciclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid derivates or HIV-protease inhibitors (see section 4.5 and section 4.8).
Danish: Risiko for rhabdomyolyse er øget, hvis atorvastatin gives samtidig med visse lægemidler som f.eks.: Ciclosporin, erythromycin, clarithromycin, itraconazol, ketoconazol, nefazodon, niacin, gemfibrozil, andre fibrater eller HIV-proteasehæmmere (se pkt.
English: {PRODUCT NAME} belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.
Danish: {(Sær)navn } tilhører den gruppe af medicin, som hedder statiner, og som er en type kolesterolsænkende medicin.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA, revascularization, stroke) MI (fatal and non-fatal AMI, silent MI)
Danish: Alvorlige kardiovaskulære hændelser (dødeligt og ikke-dødeligt AMI, asymptomatisk MI, akut dødelig CHD, ustabil angina, CABG, PTCA, revaskularisering, slagtilfælde) MI (dødeligt og ikke-dødeligt AMI, asymptomatisk MI)
English: GENERAL CLASSIFICATION FOR SUPPLY <[To be completed nationally]> Medicinal product subject to medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel.
English: Atorvastatin also significantly reduced mean TC by 34.1% (pravastatin: -18.4%, p<0.0001), mean TG levels by 20% (pravastatin: -6.8%, p<0.0009), and mean apolipoprotein B by 39.1% (pravastatin: -22.0%, p<0.0001).
Danish: Atorvastatin reducerer også signifikant gennemsnit total-kolesterol (TC) med 34,1 % (pravastatin: -18,4%, p<0,0001), gennemsnit triglycerid (TG) niveauer med 20% (pravastatin: -6,8%, p<0,0009), og gennemsnit apolipoprotein B med 39,1% pravastatin: -22,0%, p<0,0001).
English: The effect of atorvastatin on fatal and non-fatal coronary heart disease was assessed in a randomised, double-blind, placebo-controlled study, the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA).
Danish: Virkningen af atorvastatin på dødelig og ikke-dødelig koronar hjertesygdom er vurderet i et randomiseret, dobbeltblindt, placebokontrolleret forsøg, den lipidsænkende arm af det angloskandinaviske forsøg vedrørende kardial prognose (Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA)).
English: {PRODUCT NAME} tablets also contain the inactive ingredients: calcium carbonate, microcrystalline cellulose, lactose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose and magnesium stearate.
Danish: De øvrige indholdsstoffer i {(Sær)navn} er: calciumcarbonat, mikrokrystallinsk cellulose, lactose, croscarmellosenatrium, polysorbat 80, hydroxypropylcellulose og magnesiumstearat.
English: Very rare: anaphylaxis.
Danish: Meget sjælden: Anafylaksi.
English: − Angioneurotic oedema (swelling of the face, tongue and windpipe which can cause great difficulty in breathing), Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals), erythema multiforme (patchy red rash).
Danish: Disse omfatter: Angioneurotisk ødem (hævelse af ansigt, tunge og hals, som kan give åndedrætsbesvær), Stevens-Johnson syndrom (alvorlig blæredannelse af huden, munden og kønsorganer), erythema multiforme (pletformet rødt udslæt).
English: Background information on the type II variation through the MRP
Danish: Baggrundsinformation vedrørende denne type II-ændring under den gensidige anerkendelsesprocedure
English: All patients had at least 3 of the pre-defined cardiovascular risk factors: male gender, age ≥55 years, smoking, diabetes, history of CHD in a first-degree relative, TC:HDL-C >6, peripheral vascular disease, left ventricular hypertrophy, prior cerebrovascular event, specific ECG abnormality, proteinuria/albuminuria.
Danish: Alle patienterne havde mindst tre af de prædefinerede kardiovaskulære risikofaktorer: hankøn, alder ≥ 55 år, ryger, diabetiker, tidligere koronar hjertesygdom hos en nærtbeslægtet, TC:HDL-C >6, perifer vaskulær sygdom, hypertrofi af venstre ventrikel, tidligere cerebrovaskulær hændelse, specifik EKGforandring, proteinuri/albuminuri.
English: Reproductive system disorders
Danish: Forstyrrelser i reproduktionen
English: Study results were obtained with the 80 mg dose strength.
Danish: Studieresultaterne blev opnået for styrken 80 mg, hvorfor disse ikke kan ekstrapoleres til de lavere doser.
English: The absolute and relative risk reduction effect of atorvastatin was as follows:
Danish: Den absolutte og relative risikoreduktion med atorvastatin er følgende: Hændelse
English: In a 2-year study in mice, incidences of hepatocellular adenoma in males and hepatocellular carcinomas in females were increased at the maximum dose used, and the maximum dose used was 250-fold higher than the highest human dose on a mg/kg body-weight basis.
Danish: I et 2-årsstudie med mus steg forekomsten af hepatocellulære adenomer hos hanner og hepatocellulære karcinomer hos hunner efter anvendelse af maksimal dosis.
English: {PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Danish: Hyperkolesterolæmi {(Sær)navn} er indiceret som supplement til diæt ved forhøjet total-kolesterol, LDL-kolesterol, apolipoprotein B og triglycerider hos patienter med primær hyperkolesterolæmi inklusiv familiær hyperkolesterolæmi (heterozygot variant) eller kombineret hyperlipidæmi (svarende til type IIa og IIb i Fredericksons klassifikation), hvor diæt og andre ikke farmakologiske foranstaltninger er utilstrækkelige.
English: Therefore, the benefit and the risk of concurrent treatment should be carefully weighed (see section 4.4).
Danish: Derfor bør fordele og risici omhyggeligt vurderes ved samtidig medicinering med ovennævnte stoffer (se pkt.
English: In clinical studies in which {PRODUCT NAME} was administered with antihypertensives or hypoglycaemic agents no clinically significant interactions were seen.
Danish: Der er ikke set klinisk signifikante interaktioner i kliniske studier, hvor {(Sær)navn} blev givet sammen med antihypertensiva eller hypoglykæmiske midler.
English: However, digoxin concentrations increased approximately 20% following administration of digoxin with 80 mg atorvastatin daily.
Danish: Efter indgift af digoxin og 80 mg atorvastatin dagligt øges plasmakoncentrationerne af digoxin imidlertid med ca. 20%.
English: Atorvastatin is metabolized by cytochrome P450 3A4.
Danish: Atorvastatin metaboliseres via cytokrom P450 3A4.
English: Skin/Appendages
Danish: Hud og adneks
English: In the initial type II variation dossier submitted by MRP, the Applicant claimed the following indication: “Prevention of cardiovascular events in patients with multiple risk factors (e.g. type 2 diabetics with one risk factor and hypertensive patients with 3 risk factors) with normal or elevated cholesterol levels but without clinically evident coronary heart disease (CHD)”.
Danish: "Forebyggelse af kardiovaskulære hændelser hos patienter med flere risikofaktorer (f.eks. type 2diabetikere med én risikofaktor og hypertensive patienter med tre risikofaktorer) med normalt eller forhøjet kolesteroltal, men uden klinisk evident koronar hjertesygdom".
English: − Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, ketoconazole,
Danish: Medicin, der hæmmer immunsystemet, f.eks. ciclosporin Visse antibiotika eller svampemidler f.eks. erythromycin, clarithromycin, itraconazol, ketoconazol; rifampicin
English: 83 vs. 127 38 vs 64 21 vs. 39 Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Danish: Totale koronare hændelser 29% 178 vs. 247 1,4% 0,0006 1På baggrund af forskelle i de samlede hændelseshyppigheder opstået over en middelopfølgningsperiode på 3,3 år
English: 100 vs. 154 389 vs. 483
Danish: 20% 389 vs. 483 1,9% 0,0008
English: − if you have a muscle disorder called myopathy (repeated or unexplained muscle aches or pains)
Danish: hvis De er gravid, ønsker at være gravid eller ammer hvis De har en muskelsygdom, som hedder myopati (vedvarende eller uforklarlige muskelsmerter)