FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 36-week study involving 820 patients with ischaemic left ventricular dysfunction, no changes in ventricular remodelling as assessed by left ventricular end systolic volume were detected with aliskiren compared to placebo on top of background therapy.
Danish: I et 36-ugers studie med 820 patienter med iskæmisk venstre ventrikeldysfunktion blev der ikke påvist forandringer i ventrikel-remodellering, vurderet ved det systoliske slutvolumen i venstre ventrikel, med aliskiren sammenlignet med placebo som tillægsbehandling.
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters:
Danish: PVC/polychlortrifluorethylen (PCTFE) - Alu-blister:
English: The combined rates of cardiovascular death, hospitalisation for heart failure, recurrent heart attack, stroke and resuscitated sudden death were similar in the aliskiren group and the placebo group.
Danish: De kombinerede hyppigheder af kardiovaskulær død, hospitalisering pga. hjertesvigt, tilbagevendende hjerteanfald, apopleksi og genoplivning efter pludselig død var sammenlignelig i aliskiren- og placebogruppen.
English: The recommended dose of Sprimeo is 150 mg once daily.
Danish: Den anbefalede dosis af Sprimeo er 150 mg én gang dagligt.
English: Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion.
Danish: Prækliniske studier tyder på, at samtidig administration af aliskiren og ketoconazol øger aliskirens gastrointestinale absorption og mindsker den biliære udskillelse.
English: Safety pharmacology studies did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Danish: Sikkerhedsfarmakologistudier afslørede ingen bivirkninger på funktionen af centralnervesystemet og respiratorisk eller kardiovaskulær funktion.
English: No controlled clinical data are available on the use of Sprimeo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Danish: Der er ingen tilgængelige kontrollerede kliniske data om brug af Sprimeo til patienter med unilateral eller bilateral nyrearteriestenose eller brug af Sprimeo til patienter med stenose i en enkelt nyre.
English: Angioedema and hypersensitivity reactions have occurred during treatment with aliskiren.
Danish: Angioødem og overfølsomhedsreaktioner er forekommet under behandling med aliskiren.
English: The blood-pressure-lowering effect was sustained during long-term treatment, and was independent of age, gender, body mass index and ethnicity.
Danish: Den blodtryksnedsættende effekt blev opretholdt under langtidsbehandling og var uafhængig af alder, køn, BMI og etnicitet.
English: In some patients with compromised renal function (dehydrated patients or elderly patients) aliskiren given concomitantly with NSAIDs may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Danish: Hos visse patienter med påvirket nyrefunktion (dehydrerede patienter eller ældre patienter) kan samtidig administration af aliskiren og NSAID medføre en yderligere forværring af nyrefunktionen, inklusive risiko for akut nyresvigt, som sædvanligvis er reversibel.
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see P-glycoprotein interactions below).
Danish: Øget aliskiren-eksponering ved samtidig administration af CYP3A4-hæmmere, som også hæmmer P-gp, kan derfor forventes (se også P-glykoprotein interaktioner herunder).
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelopvervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen (ifølge aftalen i RMP, Modul 1.8.2 i markedsføringstilladelsen), og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
English: No patients discontinued therapy due to anaemia.
Danish: Ingen patienter fik seponeret behandlingen på grund af anæmi.
English: Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Danish: Stoffer, som er undersøgt i kliniske farmakokinetiske studier inkluderer acenocoumarol, atenolol, celecoxib, pioglitazon, allopurinol, isosorbid-5-mononitrat og hydrochlortiazid.
English: Sprimeo should be taken with a light meal once a day, preferably at the same time each day.
Danish: Sprimeo bør tages med et let måltid mad én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: By inhibiting the enzyme renin, aliskiren inhibits the RAAS at the point of activation, blocking the conversion of angiotensinogen to angiotensin I and decreasing levels of angiotensin I and angiotensin II.
Danish: Ved at hæmme enzymet renin hæmmer aliskiren RAAS-systemets aktiveringspunkt og blokerer konverteringen af angiotensinogen til angiotensin I og mindsker niveauet af angiotensin I og angiotensin II.
English: Therefore, the potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly (see interaction with Grapefruit juice).
Danish: Der er derfor risiko for interaktion mellem hæmmere af OATP og aliskiren, hvis de administreres samtidigt (se interaktion med grapefrugtjuice).
English: One colonic adenoma and one caecal adenocarcinoma recorded in rats at the dose of 1,500 mg/kg/day were not statistically significant.
Danish: Der er registreret et tilfælde af adenom i kolon og et tilfælde af adenocarcinom i coecum hos rotter ved dosen 1.500 mg/kg/dag, hvilket ikke var statistisk signifikant.
English: Although aliskiren has known irritation potential, safety margins obtained in humans at the dose of 300 mg during a study in healthy volunteers were considered to be appropriate at 9-11-fold based on faecal concentrations or 6-fold based on mucosa concentrations in comparison with 250 mg/kg/day in the rat carcinogenicity study.
Danish: Selvom aliskiren har et kendt irritationspotentiale blev de opnåede sikkerhedsmargener i et studie på raske frivillige forsøgspersoner hos mennesker ved en dosis på 300 mg anset for at være passende ved 9-11 gange baseret på fækale koncentrationer eller 6 gange baseret på koncentrationerne i mucosa, sammenlignet med 250 mg/kg/dag i karcinogenitetsstudiet hos rotter.
English: However, in patients receiving aliskiren there was a significantly higher rate of hyperkalaemia, hypotension and kidney dysfunction when compared to the placebo group.
Danish: Hos patienter, der fik aliskiren, var der dog en signifikant større hyppighed af hyperkaliæmi, hypotension og nedsat nyrefunktion sammenlignet med placebogruppen.
English: Aliskiren is metabolised minimally by the cytochrome P450 enzymes.
Danish: Aliskiren metaboliseres minimalt af cytokrom P450-enzymer.
English: In addition, an increased incidence of serious adverse outcomes was observed with aliskiren compared to placebo for renal complications (4.7% versus 3.3%), hyperkalaemia (36.9% versus 27.1%), hypotension (18.4% versus 14.6%) and stroke (2.7% versus 2.0%).
Danish: Desuden blev der observeret en øget forekomst af alvorlige hændelser ved aliskiren sammenlignet med placebo; nyrekomplikationer (4,7% vs. 3,3%), hyperkaliæmi (36,9% vs. 27,1%), hypotension (18,4% vs. 14,6%) og apopleksi (2,7% vs. 2,0%).
English: If pregnancy is detected during therapy, Sprimeo should be discontinued accordingly.
Danish: Hvis der opstår graviditet under behandlingen, skal Sprimeo seponeres som konsekvens heraf.
English: Therefore, P-gp inhibitors may increase tissue levels more than plasma levels.
Danish: Derfor kan kan P-gp-induktorer øge vævskoncentrationen mere end plasmakoncentrationen.
English: Administration of a single oral dose of 300 mg aliskiren was associated with very minor changes in the pharmacokinetics of aliskiren (change in Cmax of less than 1.2 fold; increase in AUC of up to 1.6 fold) compared to matched healthy subjects.
Danish: Administration af en enkelt oral dosis på 300 mg aliskiren viste meget minimale ændringer i aliskirens farmakokinetik (ændring i Cmax på mindre end 1,2 gange; AUC forøget op til 1,6 gange) sammenlignet med tilsvarende raske personer.
English: Caution should therefore be exercised when prescribing aliskiren to patients with a history of angioedema, and such patients should be closely monitored during treatment (see section 4.8) especially at the beginning of the treatment.
Danish: Der skal derfor udvises forsigtighed, når aliskiren udskrives til patienter med angioødem i anamnesen, og disse patienter skal følges tæt under behandlingen, især i begyndelsen af behandlingen (se pkt.
English: Relative AUC and Cmax of aliskiren in subjects with renal impairment ranged between 0.8 to 2 times the levels in healthy subjects following single dose administration and at steady state.
Danish: Den relative AUC og Cmax for aliskiren hos personer med nedsat nyrefunktion lå på mellem 0,8 og 2 gange niveauet hos raske personer efter administration af en enkelt dosis og ved steady state.
English: Digoxin and verapamil bioavailability may be slightly decreased by Sprimeo.
Danish: Biotilgængeligheden af digoxin og verapamil kan blive lettere nedsat af Sprimeo.
English: In a 8-week study in 754 hypertensive elderly (≥ 65 years) and very elderly patients (30% ≥ 75 years) aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo.
Danish: I et 8-ugers studie med 754 hypertensive ældre patienter (≥ 65 år) og gamle patienter (30 % ≥ 75 år) gav aliskiren i doser på 75 mg, 150 mg og 300 mg statistisk signifikant større blodtryksreduktioner (både systolisk og diastolisk) sammenlignet med placebo.
English: The usual starting dose is one 150 mg tablet once daily.
Danish: Startdosis er normalt en tablet på 150 mg én gang daglig.
English: Aliskiren was devoid of any mutagenic potential in the in vitro and in vivo mutagenicity studies.
Danish: Aliskiren havde ikke noget mutagent potentiale i in vitro- og in vivo-mutagenicitetsstudierne.
English: • When new information is received that may impact on the current Safety Specification,
Danish: • når der modtages nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter.
English: Acute renal failure, reversible upon discontinuation of treatment, has been reported in at-risk patients receiving aliskiren in post-marketing experience.
Danish: Akut nyresvigt, som var reversibel ved seponering af behandlingen, er rapporteret efter markedsføring hos risikopatienter, som fik aliskiren.
English: MDR1/Mdr1a/1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in preclinical studies.
Danish: I prækliniske forsøg er det vist, at MDR1/Mdr1a/1b (P-gp) er det vigtigste efflukssystem involveret i aliskirens intestinale absorption og galdeudskillelse.
English: The assays included in vitro assays in bacterial and mammalian cells and in vivo assessments in rats.
Danish: Analyserne omfattede in vitro-analyser af bakterie- og pattedyrsceller og in vivo-vurderinger hos rotter.
English: hereditary angioedema.
Danish: arveligt angioødem.
English: Aliskiren 150 mg or 300 mg per day or ramipril 5 mg or 10 mg per day were administered for 36 weeks with optional add-on therapy of hydrochlorothiazide (12.5 mg or 25 mg) at week 12, and amlodipine (5 mg or 10 mg) at week 22.
Danish: Aliskiren 150 mg eller 300 mg pr. dag eller ramipril 5 mg eller 10 mg pr. dag blev administreret i 36 uger med mulighed for tillæg af hydrochlorthiazid (12,5 mg eller 25 mg) ved uge 12 og amlodipin (5 mg eller 10 mg) ved uge 22.
English: In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (< 2% of oral clearance).
Danish: I et studie udført hos hæmodialyse-patienter med nyresygdom i slutstadie (end stage renal disease, ESRD), var clearencedialyse af aliskiren lav (< 2 % oral clearence).
English: Furosemide
Danish: Furosemid
English: Its use is therefore not recommended in women who are breast-feeding.
Danish: Det anbefales derfor ikke til kvinder, der ammer.
English: You should take Sprimeo with a light meal once a day, preferably at the same time each day.
Danish: Du bør tage Sprimeo sammen med et let måltid mad, én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: Angiotensin II causes blood vessels to tighten, which increases the blood pressure.
Danish: Angiotensin-II får blodkarrene til at trække sig sammen, hvilket øger blodtrykket.
English: or an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc. - if you have impaired kidney function, your doctor will carefully consider whether Sprimeo is suitable for you and may wish to monitor you carefully.
Danish: eller en ”angiotensin-II receptorblokker”, som fx valsartan, telmisartan, irbesartan osv. - hvis du har nedsat nyrefunktion, vil din læge nøje overveje, om Sprimeo er egnet til dig, og kan vælge at følge dig nøje.
English: Sprimeo has negligible influence on the ability to drive and use machines.
Danish: Sprimeo påvirker i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: In this study, aliskiren 300 mg was compared to placebo when added to standard of care which included either an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker.
Danish: I dette studie blev tillæg af 300 mg aliskiren sammenlignet med tillæg af placebo til standardbehandling, som inkluderede enten en angiotensin-konverteringshæmmer eller en angiotensin-receptorblokker.
English: Administration of grapefruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren.
Danish: Indtagelse af grapefrugtjuice sammen med aliskiren resulterede i en reduktion i AUC og Cmax for aliskiren.
English: Therefore, caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors (clarithromycin, telithromycin, erythromycin, amiodarone).
Danish: Der skal derfor udvises forsigtighed, hvis aliskiren gives sammen ketoconazol, verapamil eller andre moderate P-gp-hæmmere (clarithromycin, telithromycin, erythromycin, amiodaron).
English: After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6fold increase in AUC and Cmax, respectively.
Danish: Efter administration af en enkelt dosis i intervallet 75 til 600 mg, resulterede en fordobling i dosis i en ~2,3 og 2,6 fold stigning i respektivt AUC og Cmax.
English: When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49% respectively.
Danish: Når aliskiren blev administreret sammen med furosemid, faldt AUC og Cmax for furosemid med henholdsvis 28 % og 49 %.
English: Laboratory findings
Danish: Laboratoriefund
English: The enzyme responsible for this metabolism is CYP3A4.
Danish: Denne metabolisering skyldes enzymet CYP3A4.
English: In controlled clinical trials, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators.
Danish: I kontrollerede kliniske studier forekom angioødem og overfølsomhedsreaktioner sjældent under behandling med aliskiren og med tilsvarende hyppighed som placebo eller komparator.
English: If renal failure occurs, treatment should be discontinued.
Danish: Hvis der opstår nyresvigt, skal behandlingen afbrydes.
English: In clinical studies in hypertensive patients, Sprimeo had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Danish: I kliniske studier af hypertensive patienter havde Sprimeo ingen klinisk signifikant virkning på total kolesterol, HDL-kolesterol, fastende triglycerider, fastende glukose eller urinsyre.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl så spørg lægen eller på apoteket.
English: However, as with other agents acting on the renin-angiotensin system, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Danish: Der er dog, ligesom for andre stoffer, der virker på renin-angiotensin-systemet, en øget risiko for nyreinsufficiens, inklusive akut nyresvigt, når patienter med nyrearteriestenose behandles med aliskiren.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Danish: Hver filmovertrukken tablet indeholder 300 mg aliskiren (som hemifumarat).
English: In post-marketing experience, renal dysfunction and cases of acute renal failure have been reported in patients at risk (see section 4.4).
Danish: Efter markedsføring er der rapporteret om renal dysfunktion og tilfælde af akut nyresvigt hos risikopatienter (se pkt.
English: This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren by grapefruit juice in the gastrointestinal tract.
Danish: Det er sandsynligt, at denne reduktion skyldes en hæmning af organisk anion-transportpolypeptid-medieret optagelse af aliskiren, forårsaget af grapefrugtjuice i mave-tarm-kanalen.
English: In clinical studies Sprimeo has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR < 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Danish: Sprimeo er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/l eller 1,70 mg/dl hos kvinder og ≥ 177 μmol/l eller 2,00 mg/dl hos mænd og/eller estimeret GFR < 30 ml/min./1,73 m2), tidligere dialyse, nefrotisk syndrom eller renovaskulær hypertension.
English: Reducing the amount of angiotensin II allows the blood vessels to relax, which lowers blood pressure.
Danish: Når mængden af angiotensin-II mindskes, kan blodkarrene slappe af, og det sænker blodtrykket.
English: Compared to a diuretic (hydrochlorothiazideHCTZ), Sprimeo 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Danish: Sammenlignet med et diuretikum (hydrochlortiazid - HCTZ) sænkede Sprimeo 300 mg det systoliske/diastoliske blodtryk med 17,0/12,3 mmHg sammenlignet med 14,4/10,5 mmHg for HCTZ 25 mg efter 12 ugers behandling.
English: Not applicable
Danish: Ikke relevant
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Sprimeo.
Danish: Inducere af P-gp (perikon, rifampicin) kan derfor nedsætte biotilgængeligheden af Sprimeo.
English: The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Danish: Brug af aliskiren sammen med ciclosporin eller itraconazol, to yderst potente P-glykoprotein- (P-gp)hæmmere, eller andre potente P-gp-hæmmere (f.eks. quinidin) er kontraindiceret (se pkt.
English: P-gp substrates or weak inhibitors
Danish: P-gp-substrater og svage P-gp-hæmmere
English: The incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity.
Danish: Incidensen af bivirkninger viste ingen forbindelse med køn, alder, BMI, race eller etnicitet.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system (see section 5.1).
Danish: Dobbelt hæmning af renin-angiotensin-aldosteronsystemet (RAAS) Der er rapporteret hypotension, syncope, apopleksi, hyperkaliæmi og ændringer i nyrefunktionen (herunder akut nyresvigt) hos følsomme patienter, specielt ved anvendelse af flere lægemidler, der påvirker dette system (se pkt.
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Danish: Hver filmovertrukken tablet indeholder 150 mg aliskiren (som hemifumarat).
English: Dual blockade of the renin-angiotensin-aldosterone system by combining aliskiren with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) is therefore not recommended.
Danish: Dobbelt hæmning af renin-angiotensin-aldosteronsystemet ved kombination af aliskiren med en angiotensin-konverteringsenzym (ACE)-hæmmer eller en angiotensin-II receptorblokker (ARB) frarådes.
English: There have also been reports of peripheral oedema, increase in blood creatinine and severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions.
Danish: Der har også været rapportering af perifert ødem, stigning i blodkreatinin og svære kutane bivirkninger inklusive toksisk epidermal nekrolyse (TEN) og bivirkninger fra mundslimhinden.
English: Timing of haemodialysis did not significantly alter the pharmacokinetics of aliskiren in ESRD patients.
Danish: Tidspunktet for hæmodialyse ændrede ikke signifikant aliskirens farmakokinetik hos ESRD-patienter.
English: In hypertensive patients, once-daily administration of Sprimeo at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Danish: Hos hypertensive patienter gav administration af Sprimeo en gang dagligt i doser på 150 mg og 300 mg dosisafhængige reduktioner i både det systoliske og det diastoliske blodtryk, som blev opretholdt over hele dosisintervallet på 24 timer (med vedvarende gavnlig virkning tidligt om morgenen) med en gennemsnitlig peak/trough ratio for diastolisk respons på op til 98 % for 300-mgdosen.
English: As with other agents acting on the renin-angiotensin system, angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.
Danish: Som ved andre stoffer, der virker på renin-angiotensin-systemet, er angioødem eller symptomer, som tyder på angioødem (hævet ansigt, læber, svælg og/eller tunge) blevet rapporteret hos patienter, som behandles med aliskiren.
English: Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Sprimeo.
Danish: Samtidig administration af aliskiren med enten metformin (↓28 %), amlodipin (↑29 %) eller cimetidin (↑19 %) resulterede i en ændring af Cmax eller AUC for Sprimeo på mellem 20 % og 30 %.
English: 98 film-coated tablets (2x49) (perforated unit-dose blister)
Danish: 98 filmovertrukne tabletter (2x49) (perforeret enkeltdosisblister)
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Sprimeo 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Danish: Hos patienter, som ikke responderede tilstrækkeligt på 5 mg af calciumantagonisten amlodipin, havde kombinationen med Sprimeo 150 mg en blodtrykssænkende virkning, som svarede til den opnåede virkning ved at amlodipindosen blev øget til 10 mg, men med en lavere incidens af ødem (aliskiren 150 mg/amlodipin 5 mg 2,1 % kontra amlodipin 10 mg 11,2 %).