natgillin/translations-raw huggingface dataset:
• 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. 
• 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.
I alt 234 forsøgspersoner i alderen 1-17 år blev behandlet i et randomiseret, dobbelt-blindt, multicenter, placebokontrolleret klinisk studie med parallelle grupper. 
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.
Ordinerende læge bør nøje vurdere moderens kliniske behov for sildenafil op mod risikoen for bivirkninger hos det ammede barn. 
Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast-fed child.
Når sildenafil og doxazosin gives samtidigt til patienter, der er stabiliseret på doxazosinbehandling, ses af og til rapporter, hvor patienter oplever symptomatisk ortostatisk hypotension. 
When sildenafil and doxazosin were administered simultaneously to patients stabilised on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension.
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. 
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.
Sildenafil (100 mg enkeltdosis) påvirker ikke steady-state farmakokinetikken af HIV-proteasehæmmeren saquinavir, som er et CYP3A4-substrat/hæmmer. 
Sildenafil (100 mg single dose) did not affect the steady state pharmacokinetics of the HIV protease inhibitor saquinavir, which is a CYP3A4 substrate/inhibitor.
Patienterne blev randomiseret til placebo eller sildenafil (20 mg 3 gange om dagen) i kombination med bosentan (62,5-125 mg 2 gange dagligt). 
Patients were randomised to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day).
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. 
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.
Mysildecard indeholder sildenafil, der hører til en gruppe af lægemidler, som kaldes fosfodiesterase-type 5- (PDE5)-hæmmere. 
Mysildecard contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
• har problemer med, at hjertekamrene ikke pumper normalt. 
• have a problem with the pumping chambers of your heart.
Stop ikke med at tage Mysildecard, medmindre det sker i samråd med lægen. 
Do not stop taking Mysildecard unless your doctor tells you to.
Infektioner og parasitære sygdomme Almindelig cellulitis, influenza, bronkitis, sinuitis, rinitis, gastroenteritis 
Infections and infestations Common cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
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. 
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.
Hvis De er gravid eller ammer, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager Mysildecard. 
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.
*Disse bivirkninger/hændelser er rapporteret hos patienter, der tager sildenafil til behandling af erektil dysfunktion (MED). 
Common pyrexia *These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
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). 
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).
Effekten af sildenafil bør overvåges nøje hos patienter, der samtidigt anvender potente CYP3A4-induktorer som carbamazepin, phenytoin, phenobarbital, perikon og rifampicin. 
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.
Tabel 2: Procentvis ændring i maksimal VO2 fra baseline i sildenafilgrupperne korrigeret for placebo Behandlingsgruppe 
Table 2: Placebo Corrected % Change from Baseline in Peak VO2 by Active Treatment Group Treatment group
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. 
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.
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. 
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.
Hvis der pludseligt opstår synsdefekt, skal behandlingen straks seponeres, og alternativ behandling bør overvejes. 
In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered (see section
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. 
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.
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. 
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.
Italia Mylan Italia S.r.l 
Mylan Italia S.r.l.
• 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). 
• 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).
• har unormale røde blodlegemer (seglcelleanæmi), blodkræft (leukæmi), knoglemarvskræft 
• have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia),
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. 
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.
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. 
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.
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). 
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).
Hver tablet indeholder 20 mg sildenafil (som citrat). 
Each tablet contains 20 mg of sildenafil (as the citrate).
Af de 277 forsøgspersoner, som deltog i pivotal-studiet, indgik 259 i det langvarige forlængelsesstudie. 
Of the 277 subjects treated in the pivotal study, 259 entered a long-term extension study.
Sildenafil har ingen klinisk betydende indvirkning på plasmaniveauerne af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel). 
Sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 µg and levonorgestrel 150 µg).
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. 
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.
Tabletkerne: Mikrokrystallinsk cellulose (PH 102), vandfrit calciumhydrogenfosfat, croscarmellosenatrium og magnesiumstearat. 
- The other ingredients are: Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate anhydrous, croscarmellose sodium and magnesium stearate.
Den estimerede forskel mellem den gennemsnitslige sildenafildosis og placebo var 11,33% (95% CI: 1,72-20,94) (se tabel 2). 
The estimated difference between the medium sildenafil dose and placebo was 11.33% (95% CI: 1.72 to 20.94) (see Table 2).
• behandling af pulmonal hypertension (f.eks. bosentan eller iloprost). 
• Therapies for pulmonary hypertension (e.g. bosentan, iloprost)
Hvis De oplever pludseligt nedsat syn eller synstab, skal De stoppe med at tage Mysildecard og straks kontakte Deres læge (se også afsnit 4). 
If you experience sudden decrease or loss of vision, stop taking Mysildecard and contact your doctor immediately (see also section 4).
Indehaver af markedsføringstilladelsen: Mylan S.A.S 
Marketing Authorisation Holder: Mylan S.A.S
• medicin, der indeholder perikon (naturmedicin), rifampicin (mod tuberkulose), carbamazepin, phenytoin og phenobarbital (bruges bl.a. til behandling af epilepsi). 
• 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)
• for tiden har mavesår eller har blødningsforstyrrelse (som f.eks. hæmofili) eller hyppigt får næseblod. 
• currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
I denne population var Kaplan-Meier-estimater for 1, 2 og 3 års overlevelse hhv. 96%, 91% og 82%. 
In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96%, 91% and 82%, respectively.
• Fortæl det altid til lægen eller apotekspersonalet, hvis du allerede tager medicin der indeholder riociguat. 
• Tell your doctor or pharmacist if you are already taking riociguat (see section 2).
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. 
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.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 20 mg sildenafil (som citrat). 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
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. 
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.
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%. 
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.
Sildenafil er kontraindiceret hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) (se pkt. 
Sildenafil is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Denne type medicin bruges ofte til lindring af angina pectoris eller “brystsmerter” (se afsnit 2 Før De tager Mysildecard). 
These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
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). 
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).
Samtidig administration af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel) påvirker ikke sildenafils farmakokinetik. 
Co-administration of oral contraceptives (ethinyloestradiol 30 μg and levonorgestrel 150 μg) did not affect the pharmacokinetics of sildenafil.
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). 
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).
Mysildecard må kun anvendes under graviditet, hvis det er strengt nødvendigt. 
Mysildecard should not be used during pregnancy unless strictly necessary.
• hvis De tager medicin, som indeholder nitrater eller nitrogenoxiddonorer som amylnitrit (“poppers”). 
• if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
Mysildecard bør pga. manglende data ikke anvendes til gravide, medmindre det er strengt nødvendigt. 
Due to lack of data, Mysildecard should not be used in pregnant women unless strictly necessary.
• medicin der indeholder nitrater eller såkaldte nitrogenoxiddonorer som f.eks. amylnitrit (“poppers”). 
• Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
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%). 
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%).
For samtidig behandling med sildenafil og de mest potente CYP3A4-hæmmere, se pkt. 
For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4.3.
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. 
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.
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%). 
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%).
Brug af anden medicin sammen med Mysildecard 
Other medicines and Mysildecard
Patienter, som får anden medicin Generelt bør enhver dosisjustering kun foretages efter en omhyggelig vurdering af risk/benefit. 
In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
PAH-patienterne omfattede patienter med primær PAH og PAH forbundet med bindevævssygdom. 
The PAH patients included those with primary PAH, and PAH associated with connective tissue disease.
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. 
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.
Det skal De vide, før De begynder at tage Mysildecard 
What you need to know before you take Mysildecard
• hvis De er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i Mysildecard (angivet i afsnit 6). 
Do not take Mysildecard: • if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
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. 
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.
Der er spontant rapporteret synsdefekter i forbindelse med indtagelse af sildenafil og andre PDE5-hæmmere (se pkt. 
Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors.
Mysildecard må ikke gives til kvinder i den fødedygtige alder, medmindre der anvendes sikker prævention. 
Mysildecard should not be given to women of child bearing potential unless using appropriate contraceptive methods.
AUC og Cmax-værdierne for N-desmethylmetabolitten er yderligere signifikant forhøjet med hhv. 154% og 87% hos cirrotiske forsøgspersoner sammenlignet med forsøgspersoner med normal leverfunktion. 
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154% and 87%, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Hvis De har glemt at tage Mysildecard 
If you forget to take Mysildecard
En populationsfarmakokinetisk analyse af data fra kliniske studier med sildenafil hos voksne PAH-patienter, herunder et 12-ugers studie, der vurderede effekten og sikkerheden af 20 mg sildenafil oralt 3 gange dagligt som tillæg til en stabil dosis bosentan (62,5-125 mg 2 gange dagligt), indikerede et fald i eksponeringen for sildenafil ved samtidig administration af bosentan, som svarede til det, der sås hos raske frivillige forsøgspersoner (se pkt. 
A population pharmacokinetic analysis of sildenafil data from adult PAH patients in clinical trials including a 12 week study to assess the efficacy and safety of oral sildenafil 20 mg three times a day when added to a stable dose of bosentan (62.5 mg - 125 mg twice a day) indicated a decrease in sildenafil exposure with bosentan co-administration, similar to that observed in healthy volunteers (see sections 4.4 and 5.1).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 20 mg sildenafil (som citrat). 
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Hos frivillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance <30 ml/min) reduceres sildenafils clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på hhv. 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion. 
In volunteers with severe renal impairment (creatinine clearance < 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.