FrancophonIA/ELRC3.0 huggingface dataset:
English: Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).
Danish: Vedvarende og til tider smertefuld erektion er set hos mænd efter indtagelse af sildenafil (hyppighed er ukendt).
English: Time to clinical worsening was a secondary endpoint as defined as the time from randomisation to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy).
Danish: Et sekundært endepunkt var tid indtil klinisk forværring og var defineret som tiden fra randomisering til første forekomst af symptom på klinisk forværring (død, lungetransplantation, opstart af bosentan-behandling eller klinisk forværring, der krævede ændring i epoprostenol-behandling).
English: Anhydrous calcium hydrogen phosphate
Danish: Vandfrit calciumhydrogenphosphat
English: In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease.
Danish: Hos patienter med pulmonal arteriel hypertension kan der være en potentiel øget risiko for blødning, når sildenafil initieres hos patienter, der allerede anvender en vitamin-K-antagonist, især hos patienter med pulmonal arteriel hypertension sekundært til bindevævssygdom.
English: • lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids.
Danish: • har mistet store mængder væske (dehydrering), dette kan ske, hvis De sveder meget, eller hvis
English: • Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.
Danish: • medicin, der indeholder erythromycin, clarithromycin, telithromycin (antibiotika til at behandle visse typer bakterieinfektioner), saquinavir (mod hiv) eller nefazodon (mod depression), da dosis måske skal justeres.
English: A total of 234 subjects aged 1 to 17 years were treated in a randomised, double-blind, multi-centre, placebo controlled parallel group, dose ranging study.
Danish: I alt 234 forsøgspersoner i alderen 1-17 år blev behandlet i et randomiseret, dobbelt-blindt, multicenter, placebokontrolleret klinisk studie med parallelle grupper.
English: Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast-fed child.
Danish: Ordinerende læge bør nøje vurdere moderens kliniske behov for sildenafil op mod risikoen for bivirkninger hos det ammede barn.
English: When sildenafil and doxazosin were administered simultaneously to patients stabilised on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension.
Danish: Når sildenafil og doxazosin gives samtidigt til patienter, der er stabiliseret på doxazosinbehandling, ses af og til rapporter, hvor patienter oplever symptomatisk ortostatisk hypotension.
English: The overall frequency of discontinuations in sildenafil/epoprostenol treated patients due to adverse events was 5.2% compared to 10.7% in the placebo/epoprostenol treated patients.
Danish: For sildenafil/epoprostenol-behandlede patienter var den samlede hyppighed for ophør med behandling pga. bivirkninger 5,2% sammenlignet med 10,7% hos de placebo/epoprostenol-behandlede patienter.
English: Sildenafil (100 mg single dose) did not affect the steady state pharmacokinetics of the HIV protease inhibitor saquinavir, which is a CYP3A4 substrate/inhibitor.
Danish: Sildenafil (100 mg enkeltdosis) påvirker ikke steady-state farmakokinetikken af HIV-proteasehæmmeren saquinavir, som er et CYP3A4-substrat/hæmmer.
English: Patients were randomised to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day).
Danish: Patienterne blev randomiseret til placebo eller sildenafil (20 mg 3 gange om dagen) i kombination med bosentan (62,5-125 mg 2 gange dagligt).
English: Women of childbearing potential and contraception in males and females Due to lack of data on effects of sildenafil in pregnant women, Mysildecard is not recommended for women of childbearing potential unless also using appropriate contraceptive measures.
Danish: Kvinder i den fertile alder og prævention hos mænd og kvinder På grund af manglende data om virkningen af sildenafil hos gravide kvinder bør Mysildecard ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: Mysildecard contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Mysildecard indeholder sildenafil, der hører til en gruppe af lægemidler, som kaldes fosfodiesterase-type 5- (PDE5)-hæmmere.
English: • have a problem with the pumping chambers of your heart.
Danish: • har problemer med, at hjertekamrene ikke pumper normalt.
English: Do not stop taking Mysildecard unless your doctor tells you to.
Danish: Stop ikke med at tage Mysildecard, medmindre det sker i samråd med lægen.
English: Infections and infestations Common cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Danish: Infektioner og parasitære sygdomme Almindelig cellulitis, influenza, bronkitis, sinuitis, rinitis, gastroenteritis
English: In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Danish: I et klinisk studie af de hæmodynamiske virkninger efter en enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) (>70% stenoser i mindst 1 koronararterie) faldt det gennemsnitlige systoliske og diastoliske blodtryk i hvile med hhv. 7% og 6% sammenlignet med baseline.
English: If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager Mysildecard.
English: Common pyrexia *These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
Danish: *Disse bivirkninger/hændelser er rapporteret hos patienter, der tager sildenafil til behandling af erektil dysfunktion (MED).
English: This concentration range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors (except with the most potent of the CYP3A4 inhibitors e.g. ketoconazole, itraconazole, ritonavir).
Danish: Dette koncentrationsinterval dækker stigningen i sildenafils eksponering set i specielt designede lægemiddelinteraktionsstudier med CYP3A4-hæmmere (undtagen med de mest potente af CYP3A4-hæmmerne som f.eks. ketoconazol, itraconazol, ritonavir).
English: Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, St John's wort and rifampicine.
Danish: Effekten af sildenafil bør overvåges nøje hos patienter, der samtidigt anvender potente CYP3A4-induktorer som carbamazepin, phenytoin, phenobarbital, perikon og rifampicin.
English: Table 2: Placebo Corrected % Change from Baseline in Peak VO2 by Active Treatment Group Treatment group
Danish: Tabel 2: Procentvis ændring i maksimal VO2 fra baseline i sildenafilgrupperne korrigeret for placebo Behandlingsgruppe
English: In patients with pulmonary arterial hypertension, the average steady state concentrations were 20-50% higher over the investigated dose range of 20-80 mg three times a day compared to healthy volunteers.
Danish: Hos patienter med pulmonal arteriel hypertension er de gennemsnitlige steady-state koncentrationer 20-50% højere end de undersøgte doser på 20-80 mg 3 gange dagligt sammenlignet med raske frivillige forsøgspersoner.
English: In pulmonary arterial hypertension patients, the oral bioavailability of sildenafil after 80 mg three times a day was on average 43% (90% CI: 27% - 60%) higher compared to the lower doses.
Danish: Hos patienter med pulmonal arteriel hypertension er den gennemsnitlige orale biotilgængelighed for sildenafil efter 80 mg 3 gange dagligt 43% (90% CI: 27-60%) højere sammenlignet med de lavere doser.
English: In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered (see section
Danish: Hvis der pludseligt opstår synsdefekt, skal behandlingen straks seponeres, og alternativ behandling bør overvejes.
English: For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤ 20 kg is 10 mg three times a day and for patients > 20 kg is 20 mg three times a day.
Danish: Hos pædiatriske patienter i alderen 1-17 år er den anbefalede dosis til patienter ≤20 kg 10 mg 3 gange dagligt, og til patienter >20 kg er dosis 20 mg 3 gange dagligt.
English: In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilised on doxazosin therapy.
Danish: I 3 specifikke lægemiddel-interaktionsstudier blev alfa-blokkeren doxazosin (4 mg og 8 mg) og sildenafil (25 mg, 50 mg eller 100 mg) anvendt samtidigt hos patienter med benign prostatahyperplasi (BPH) stabiliseret på doxazosinbehandling.
English: Mylan Italia S.r.l.
Danish: Italia Mylan Italia S.r.l
English: • Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).
Danish: • alfa-blokker (f.eks. doxazosin) til behandling af for højt blodtryk eller vandladningsbesvær ved forstørret blærehalskirtel (prostata), da kombination af disse to lægemidler kan give symptomer på grund af blodtryksnedsættelse (f.eks. svimmelhed).
English: • have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia),
Danish: • har unormale røde blodlegemer (seglcelleanæmi), blodkræft (leukæmi), knoglemarvskræft
English: there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
Danish: Hos raske mandlige frivillige forsøgspersoner ses for azithromycin (500 mg daglig i 3 dage) ingen tegn på ændringer af AUC, Cmax, Tmax, eliminationshastigheds-konstanten eller efterfølgende halveringstid for sildenafil eller dets væsentligste cirkulerende metabolit.
English: Of the 94 subjects reporting a serious adverse event, 14/55 (25.5%) subjects were in the low dose group, 35/74 (47.3%) in the medium dose group, and 45/100 (45%) in the high dose group.
Danish: Ud af de 94 forsøgspersoner, som rapporterede en alvorlig bivirkning, var 14/55 (25,5%) forsøgspersoner i lavdosis-gruppen, 35/74 (47%) i middeldosis-gruppen og 45/100 (45%) i højdosis-gruppen.
English: If you have an erection, which lasts continuously for more than 4 hours, stop taking Mysildecard and contact your doctor immediately (see also section 4).
Danish: Hvis De får erektion, som varer længere end 4 timer, skal De stoppe med at tage Mysildecard og straks kontakte Deres læge (se også afsnit 4).
English: Each tablet contains 20 mg of sildenafil (as the citrate).
Danish: Hver tablet indeholder 20 mg sildenafil (som citrat).
English: Of the 277 subjects treated in the pivotal study, 259 entered a long-term extension study.
Danish: Af de 277 forsøgspersoner, som deltog i pivotal-studiet, indgik 259 i det langvarige forlængelsesstudie.
English: Sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 µg and levonorgestrel 150 µg).
Danish: Sildenafil har ingen klinisk betydende indvirkning på plasmaniveauerne af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel).
English: Population pharmacokinetic analysis of pulmonary arterial hypertension clinical trial data indicated a reduction in sildenafil clearance and/or an increase of oral bioavailability when co-administered with CYP3A4 substrates and the combination of CYP3A4 substrates and beta-blockers.
Danish: Populationsfarmakokinetiske analyser af kliniske undersøgelsesdata af pulmonal arteriel hypertension tyder på en reduktion af sildenafils clearance og/eller en stigning i oral biotilgængelighed, ved administration sammen med CYP3A4-substrater og kombinationen af CYP3A4-substrater og beta-blokkere.
English: - The other ingredients are: Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate anhydrous, croscarmellose sodium and magnesium stearate.
Danish: Tabletkerne: Mikrokrystallinsk cellulose (PH 102), vandfrit calciumhydrogenfosfat, croscarmellosenatrium og magnesiumstearat.
English: The estimated difference between the medium sildenafil dose and placebo was 11.33% (95% CI: 1.72 to 20.94) (see Table 2).
Danish: Den estimerede forskel mellem den gennemsnitslige sildenafildosis og placebo var 11,33% (95% CI: 1,72-20,94) (se tabel 2).
English: • Therapies for pulmonary hypertension (e.g. bosentan, iloprost)
Danish: • behandling af pulmonal hypertension (f.eks. bosentan eller iloprost).
English: If you experience sudden decrease or loss of vision, stop taking Mysildecard and contact your doctor immediately (see also section 4).
Danish: Hvis De oplever pludseligt nedsat syn eller synstab, skal De stoppe med at tage Mysildecard og straks kontakte Deres læge (se også afsnit 4).
English: Marketing Authorisation Holder: Mylan S.A.S
Danish: Indehaver af markedsføringstilladelsen: Mylan S.A.S
English: • Medicines containing St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)
Danish: • medicin, der indeholder perikon (naturmedicin), rifampicin (mod tuberkulose), carbamazepin, phenytoin og phenobarbital (bruges bl.a. til behandling af epilepsi).
English: • currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
Danish: • for tiden har mavesår eller har blødningsforstyrrelse (som f.eks. hæmofili) eller hyppigt får næseblod.
English: In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96%, 91% and 82%, respectively.
Danish: I denne population var Kaplan-Meier-estimater for 1, 2 og 3 års overlevelse hhv. 96%, 91% og 82%.
English: • Tell your doctor or pharmacist if you are already taking riociguat (see section 2).
Danish: • Fortæl det altid til lægen eller apotekspersonalet, hvis du allerede tager medicin der indeholder riociguat.
English: Efficacy and safety in adult patients with PAH (when used in combination with bosentan) A randomised, double-blind, placebo controlled study was conducted in 103 clinically stable subjects with PAH (WHO FC II and III) who were on bosentan therapy for a minimum of three months.
Danish: Effekt og sikkerhed hos voksne patienter med PAH (ved samtidig administration af bosentan) Et randomiseret dobbelt-blindt, placebo-kontrolleret studie blev udført hos 103 klinisk stabile patienter med PAH (WHO FC II og III), som havde fået behandling med bosentan i mindst 3 måneder.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 20 mg sildenafil (som citrat).
English: In the placebo-controlled study of sildenafil in patients 1 to 17 years of age with pulmonary arterial hypertension, a total of 174 patients were treated three times a day with either low (10 mg in patients > 20 kg; no patients ≤ 20 kg received the low dose), medium (10 mg in patients ≥ 8-20 kg; 20 mg in patients ≥ 20-45 kg; 40 mg in patients > 45 kg) or high dose (20 mg in patients ≥ 8-20 kg; 40 mg in patients ≥ 20-45 kg; 80 mg in patients > 45 kg) regimens of sildenafil and 60 were treated with placebo.
Danish: I et placebo-kontrolleret studie med sildenafil til patienter i alderen 1-17 år med pulmonal arteriel hypertension blev i alt 174 patienter behandlet med enten lavdosis (10 mg til patienter >20 kg, ingen patienter ≤20 kg fik lavdosis), middeldosis (10 mg til patienter ≥8-20 kg, 20 mg til patienter ≥20-45 kg, 40 mg til patienter >45 kg) eller højdosis (20 mg til patienter ≥8-20 kg, 40 mg til patienter ≥20-45 kg, 80 mg til patienter >45 kg) sildenafil og 60 blev behandlet med placebo.
English: Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 99%, 91%, and 84% respectively, and for patients of WHO functional class III at baseline was 94%, 90%, and 81%, respectively.
Danish: Ved baseline var overlevelse for patienter i WHO-funktionsklasse II efter 1, 2 og 3 år hhv. 99%, 91% og 84%, og for patienter i WHO-funktionsklasse III hhv. 94%, 90% og 81%.
English: Sildenafil is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Danish: Sildenafil er kontraindiceret hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) (se pkt.
English: These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
Danish: Denne type medicin bruges ofte til lindring af angina pectoris eller “brystsmerter” (se afsnit 2 Før De tager Mysildecard).
English: For patients with a baseline 6MWD < 325 m improved efficacy was observed with higher doses (placebo-corrected improvements of 58 metres, 65 metres and 87 metres for 20 mg, 40 mg and 80 mg doses TID, respectively).
Danish: For patienter med 6MWD < 325 meter ved baseline blev der set bedre effekt ved højere doser (placebo-korrigeret stigning på 58 meter, 65 meter og 87 meter for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt).
English: Co-administration of oral contraceptives (ethinyloestradiol 30 μg and levonorgestrel 150 μg) did not affect the pharmacokinetics of sildenafil.
Danish: Samtidig administration af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel) påvirker ikke sildenafils farmakokinetik.
English: In this trial, 63 of 234 (27%) patients were < 7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73%) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
Danish: I dette studie var 63 af 234 (27%) af patienterne <7 år (sildenafil lavdosis=2, middeldosis=17, højdosis=28, placebo=16), og 171 af 234 (73%) af patienterne var >7 år (sildenafil lavdosis=40, middeldosis=37, højdosis=49, placebo=44 se nedenfor).
English: Mysildecard should not be used during pregnancy unless strictly necessary.
Danish: Mysildecard må kun anvendes under graviditet, hvis det er strengt nødvendigt.
English: • if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
Danish: • hvis De tager medicin, som indeholder nitrater eller nitrogenoxiddonorer som amylnitrit (“poppers”).
English: Due to lack of data, Mysildecard should not be used in pregnant women unless strictly necessary.
Danish: Mysildecard bør pga. manglende data ikke anvendes til gravide, medmindre det er strengt nødvendigt.
English: • Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
Danish: • medicin der indeholder nitrater eller såkaldte nitrogenoxiddonorer som f.eks. amylnitrit (“poppers”).
English: The most common adverse reactions that occurred (with a frequency ≥ 1%) in sildenafil patients (combined doses) and with a frequency > 1% over placebo patients were pyrexia, upper respiratory tract infection (each 11.5%), vomiting (10.9%), erection increased (including spontaneous penile erections in male subjects) (9.0%), nausea, bronchitis (each 4.6%), pharyngitis (4.0%), rhinorrhoea (3.4%), and pneumonia, rhinitis (each 2.9%).
Danish: De hyppigste bivirkninger (med en frekvens ≥ 1%) hos sildenafil-patienter (kombinerede doser) og med en frekvens på > 1% i forhold til placebo-patienter var pyreksi, øvre luftvejsinfektioner (hver 11,5%), opkastning (10,9%), kraftigere erektion (herunder spontane erektioner hos drenge) (9,0%), kvalme, bronkitis (hver 4,6%), pharyngitis (4,0%), næseflåd (3,4%) samt pneumoni og rhinitis (hver 2,9%).
English: For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4.3.
Danish: For samtidig behandling med sildenafil og de mest potente CYP3A4-hæmmere, se pkt.
English: Most patients were WHO Functional Class II (107/277, 39%) or III (160/277, 58%) with a mean baseline 6-minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4%) or IV (9/277, 3%) at baseline.
Danish: De fleste patienter var ved baseline klassificeret i WHO-funktionsklasse II (107/277, 39%) eller III (160/277, 58%) med en gennemsnitlig 6 minutters gangdistance på hhv. 378 meter og 326 meter ved baseline; færre patienter var i klasse I (1/277, 0,4%) eller IV (9/277, 3%) ved baseline.
English: The most common serious adverse events that occurred with a frequency ≥ 1% in sildenafil patients (combined doses) were pneumonia (7.4%), cardiac failure, pulmonary hypertension (each 5.2%), upper respiratory tract infection (3.1%), right ventricular failure, gastroenteritis (each 2.6%), syncope, bronchitis, bronchopneumonia, pulmonary arterial hypertension (each 2.2%), chest pain, dental caries (each 1.7%), and cardiogenic shock, gastroenteritis viral, urinary tract infection (each 1.3%).
Danish: De hyppigste alvorlige bivirkninger, som forekom med en frekvens ≥1% hos sildenafilpatienter (alle doser), var pneumoni (7,4%), hjertesvigt og pulmonal hypertension (hver 5,2%), infektion i øvre luftveje, (3,1%), svigt af højre ventrikel og gastroenteritis (hver 2,6%), synkope, bronkitis, bronkopneumoni og pulmonal arteriel hypertension (hver 2,2%), brystsmerter og dental caries (hver 1,7%) samt kardiogent shock, viral gastroenteritis og urinvejsinfektion (hver 1,3%).
English: Other medicines and Mysildecard
Danish: Brug af anden medicin sammen med Mysildecard
English: In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
Danish: Patienter, som får anden medicin Generelt bør enhver dosisjustering kun foretages efter en omhyggelig vurdering af risk/benefit.
English: The PAH patients included those with primary PAH, and PAH associated with connective tissue disease.
Danish: PAH-patienterne omfattede patienter med primær PAH og PAH forbundet med bindevævssygdom.
English: Subjects were allocated to one of three sildenafil treatment groups, low (10 mg), medium (10-40 mg) or high dose (20-80 mg) regimens of sildenafil given three times a day, or placebo.
Danish: Forsøgspersonerne blev allokeret til en af tre sildenafil-behandlingsgrupper: lav- (10 mg), middel- (10-40 mg) eller højdosis (20-80 mg) regimer med sildenafil administreret 3 gange dagligt eller placebo.
English: What you need to know before you take Mysildecard
Danish: Det skal De vide, før De begynder at tage Mysildecard
English: Do not take Mysildecard: • if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Danish: • hvis De er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i Mysildecard (angivet i afsnit 6).
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 200% and 79% respectively in subjects with severe renal impairment compared to subjects with normal renal function.
Danish: Herudover er AUC og Cmax- værdierne for N-desmethylmetabolitten signifikant forhøjede, hhv. 200% og 79% hos forsøgspersoner med svært nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.