FrancophonIA/ELRC3.0 huggingface dataset:
English: Sildenafil potentiates the hypotensive effect of nitrates (see section 4.3).
Danish: Sildenafil forstærker nitraters hypotensive effekt (se pkt.
English: Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries.
Danish: Sildenafil havde ingen virkning på slagvolumen og nedsatte ikke blodcirkulationen gennem de forsnævrede koronararterier.
English: If sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Danish: Hvis sildenafil indtages sammen med føde, kan virkningens indtræden forsinkes i forhold til indtagelse under fastende forhold (se pkt.
English: - if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called “poppers”).
Danish: - hvis du tager medicin, som indeholder nitrater (f.eks. glyceryltrinitrat) eller nitrogenoxiddonorer (f.eks. amylnitrit, også kaldet “poppers”).
English: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Danish: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Tyskland
English: Sudden cardiac death*, Myocardial infarction, Ventricular arrhythmia*, Atrial fibrillation, Unstable angina
Danish: Pludselig hjertedød*, myokardieinfarkt, ventrikulær arytmi*,atrieflimren, ustabil angina
English: Healthy, elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Danish: Hos raske ældre frivillige forsøgspersoner (65 år og derover) ses en reduceret clearance af sildenafil, som medfører ca. 90% højere plasmakoncentration af sildenafil og den aktive N-desmethylmetabolit, sammenlignet med yngre frivillige forsøgspersoner (18-45 år).
English: The corresponding change in supine diastolic blood pressure was 5.5 mmHg.
Danish: Den tilsvarende forandring i diastolisk blodtryk i liggende stilling var 5,5 mmHg.
English: The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
Danish: Den tilsvarende reduktion i diastolisk blodtryk i liggende stilling var 7 mmHg.
English: What you need to know before you take Sildenafil ratiopharm
Danish: Det skal du vide, før du begynder at tage Sildenafil ratiopharm
English: Chest pain, Fatigue, Feeling hot
Danish: Brystsmerter, træthed, varmefølelse
English: *Reported during post-marketing surveillance only **Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia ***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased
Danish: *Udelukkende set efter markedsføringen ** Synsfarveforvrængning: chloropsi, kromatopsi, cyanopsi, erythropsi og xanthopsi *** Forstyrrelser i tåredannelsen: tørre øjne, forstyrrelser i tåreproduktionen og tåreflåd
English: HBM Pharma s.r.o.
Danish: HBM Pharma s.r.o Sklabinská 30
English: There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina.
Danish: Selektiviteten er 10 gange højere end for PDE6, som er involveret i lysoverførelsen i retina.
English: Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Danish: Sildenafil (50 mg) forstærker ikke den hypotensive effekt af alkohol hos raske frivillige forsøgspersoner med gennemsnitlig Cmax af alkohol i blodet på 80 mg/dl.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Danish: Skønt der ikke er foretaget specifikke interaktionsundersøgelser for alle lægemidler, viste populationsfarmakokinetiske analyser, at sildenafils farmakokinetik ikke blev påvirket ved samtidig indgift med CYP2C9-hæmmere (som tolbutamid, warfarin, phenytoin), CYP2D6-hæmmere (som selektive serotoningenoptagshæmmere, tricykliske antidepressiva), thiazider og beslægtede diuretika, loop- og kaliumbesparende diuretika, ACE-hæmmere, calciumblokkere, beta-adrenerge receptorantagonister eller stoffer, som inducerer CYP-metabolisme (som rifampicin, barbiturater).
English: Patients should be advised that in the event of any sudden visual defect, they should stop taking sildenafil and consult a physician immediately (see section 4.3).
Danish: Patienten skal informeres om at stoppe med at tage sildenafil og omgående konsultere en læge, hvis der pludseligt opstår synsdefekt (se pkt.
English: Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
Danish: Symptomerne omfatter pludselig hvæsende vejrtrækning, vejrtrækningsbesvær eller svimmelhed, hævelser af øjenlåg, ansigt, læber eller hals.
English: No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
Danish: I reproduktionsstudier med rotter og kaniner sås ingen relevante ugunstige virkninger efter oral indgift af
English: There are no adequate and well-controlled studies in pregnant or breast-feeding women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af sildenafil til gravide eller ammende kvinder.
English: PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effects of this medicine.
Danish: PDE5-hæmmere, så som sildenafil, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
English: This is most likely to occur within 4 hours post sildenafil dosing.
Danish: Det er mest sandsynligt, at dette indtræder inden for 4 timer efter indtagelse af sildenafildosen.
English: Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis), a 25 mg dose should be considered.
Danish: Da sildenafil-clearance er nedsat hos patienter med leverinsufficiens (f.eks. cirrose) skal en 25 mg dosis overvejes.
English: Somnolence, Hypoaesthesia
Danish: Søvnighed, hypæstesi
English: Tell your doctor or pharmacist if you are already taking riociguat.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du tager medicin der indeholder riociguat.
English: If you are not certain, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%),
Danish: Baseret på alle studier har følgende procentdele af patienterne rapporteret om forbedring efter behandling med sildenafil: Psykogen erektil dysfunktion (84%), blandet erektil dysfunktion (77%), organisk erektil dysfunktion (68%), ældre (67%), diabetes mellitus (59%), iskæmisk hjertesygdom (69%), hypertension (68%), TURP (61%), radikal prostatektomi (43%), rygmarvsskade (83%), depression (75%).
English: Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the co-administration may lead to symptomatic hypotension in a few susceptible individuals (see section 4.5).
Danish: Forsigtighed tilrådes, når sildenafil gives til patienter, der tager alfa-blokkere, da samtidig administration hos få følsomme individer kan føre til symptomatisk hypotension (se pkt.
English: In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment.
Danish: For at nedsætte risikoen for udvikling af postural hypotension hos patienter, der er i behandling med alfa-blokker, bør patienterne være stabile på alfa-blokker, før sildenafilbehandling initieres.
English: Sildenafil had no effect on saquinavir pharmacokinetics (see section 4.2).
Danish: Sildenafil har ingen virkning på saquinavirs farmakokinetik (se pkt.
English: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
Danish: Merckle GmbH Ludvig-Merckle-Strasse 3 89143 Blaubeuren Tyskland
English: The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied.
Danish: Sikkerhed og effekt er ikke undersøgt ved samtidig brug af sildenafil og andre PDE5-hæmmere eller andre behandlinger af erektil dysfunktion eller ved samtidig sildenafil-behandling af pulmonal arteriel hypertension (PAH).
English: In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
Danish: Hos frivillige forsøgspersoner med let til moderat levercirrhose (Child-Pugh A og B) reduceres sildenafils clearance, hvilket giver stigninger i AUC (84%) og Cmax (47%) sammenlignet med frivillige forsøgspersoner i samme alderskategori uden leverinsufficiens.
English: Take 1 film-coated tablet of Sildenafil ratiopharm about 1 hour before sexual activity.
Danish: Følg lægens ordination og tag 1 filmovertrukket tablet Sildenafil ratiopharm ca. 1 time før seksuel aktivitet.
English: Posology Use in adults
Danish: Dosering Voksne
English: Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals.
Danish: Samtidig administration af sildenafil hos patienter, der er i alfa-blokker-behandling, kan hos få følsomme individer føre til symptomatisk hypotension.
English: The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.
Danish: De hyppigst rapporterede bivirkninger i kliniske studier hos sildenafilbehandlede patienter var hovedpine, ansigtsrødme, dyspepsi, næsetilstopning, svimmelhed, kvalme, hedeture, synsforstyrrelser, cyanopsi (blåsyn) og sløret syn.
English: - Serious skin reactions - this occurs rarely.
Danish: Alvorlige hudreaktioner- dette ses sjældent.
English: Therefore, tell your doctor if you are taking any of the following medicines: - ritonavir or saquinavir (medicines for the treatment of HIV infections); - ketoconazole or itraconazole (medicines for the treatment of fungal infections); - erythromycin (an antibiotic); - cimetidine (medicine for the treatment of heartburn and peptic ulcers);
Danish: - ritonavir eller saquinavir (medicin til behandling af hiv-infektioner); - ketoconazol eller itraconazol (medicin til behandling af svampeinfektioner); - erythromycin (et antibiotikum); - cimetidin (medicin til behandling af halsbrand og mavesår);
English: Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis
Danish: Forstyrrelser i tåredannelsen***, øjensmerter, fotofobi, fotopsi, okulær hyperæmi, lysglimt, konjunktivitis
English: 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.
Danish: Hos frivillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) reduceres sildenafil-clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på henholdsvis 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
English: Manufacturer Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany
Danish: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Tyskland
English: There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Danish: Der var ingen effekt på spermiemotilitet eller -morfologi efter indgift af en enkelt oral dosis sildenafil 100 mg hos raske forsøgspersoner (se pkt.
English: Calcium hydrogen phosphate, anhydrous Talc
Danish: Croscarmellosenatrium Calciumhydrogenphosphat (vandfrit) Talcum
English: 8, 9, 10 and 11.
Danish: 4.4 og 4.5).
English: Iron oxide red
Danish: Jernoxid, rød
English: Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Danish: Der er spontane rapporter om synsdefekter i forbindelse med indtagelse af sildenafil og andre PDE5hæmmere (se pkt.
English: - Seizures or fits - this occurs rarely.
Danish: Kramper eller krampeanfald - dette ses sjældent.
English: In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg twice a day) with sildenafil at steady state (80 mg three times a day) resulted in 62.6% and 55.4% decrease in sildenafil AUC and Cmax, respectively.
Danish: I et studie med raske, frivillige mænd resulterede samtidig administration af endothelinantagonisten bosentan (en induktor af CYP3A4 (moderat), CYP2C9 og muligvis CYP2C19) ved steady state (125 mg 2 gange daglig) og sildenafil ved steady state (80 mg 3 gange daglig) i en reduktion i AUC og Cmax på henholdsvis 62,6% og 55,4%.
English: Initiation of sildenafil at a dose of 25 mg should be considered (see section 4.2).
Danish: Initiering af sildenafil i en dosis på 25 mg bør overvejes (se pkt.
English: In the natural setting, i.e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.
Danish: Sildenafil er en oral behandling af erektil dysfunktion, som genopretter nedsat erektil funktion ved at øge blodtilstrømningen til penis på en naturlig måde ved seksuel stimulation.
English: Penile haemorrhage, Priapism*, Haematospermia, Erection increased
Danish: Blødning fra penis, priapisme*, hæmatospermi, forlænget erektion
English: Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route).
Danish: Sildenafils metabolisme sker overvejende via CYP isoformer 3A4 (primær vej) og 2C9 (sekundær vej).
English: Myalgia, Pain in extremity
Danish: Myalgi, ekstremitetssmerter
English: Other medicines and Sildenafil ratiopharm
Danish: Brug af anden medicin sammen med Sildenafil ratiopharm
English: In order for sildenafil to be effective, sexual stimulation is required.
Danish: Seksuel stimulation er nødvendig, for at sildenafil kan virke.
English: Visual colour distortions**, Visual disturbance, Vision blurred
Danish: Synsfarveforvrængning**, synsforstyrrelser, sløret syn
English: (≥ 1/100 and
Danish: (≥ 1/100 og <1/10)
English: Co-administration of sildenafil with ritonavir is not advised (see section 4.5).
Danish: Samtidig indgift af sildenafil og ritonavir anbefales ikke (se pkt.
English: When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Danish: Ved indgift af en enkeltdosis sildenafil 100 mg sammen med erythromycin, en moderat CYP3A4hæmmer, i steady state (500 mg 2 gange dagligt i 5 dage) sås en 182% stigning i optagelsen af sildenafil (AUC).
English: Take ½ or 1 film-coated tablet of Sildenafil ratiopharm as prescribed by your doctor about 1 hour before sexual activity.
Danish: Følg lægens ordination og tag ½ eller 1 filmovertrukket tablet Sildenafil ratiopharm ca. 1 time før seksuel aktivitet.
English: EU/1/09/603/009 1 film-coated tablet EU/1/09/603/010 4 film-coated tablets EU/1/09/603/011 8 film-coated tablets EU/1/09/603/012 12 film-coated tablets EU/1/09/603/015 2 film-coated tablets EU/1/09/603/016 24 film-coated tablets EU/1/09/603/018 48 film-coated tablets
Danish: EU/1/09/603/009 1 filmovertrukket tablet EU/1/09/603/010 4 filmovertrukne tabletter EU/1/09/603/011 8 filmovertrukne tabletter EU/1/09/603/012 12 filmovertrukne tabletter EU/1/09/603/015 2 filmovertrukne tabletter EU/1/09/603/016 24 filmovertrukne tabletter EU/1/09/603/018 48 filmovertrukne tabletter
English: The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Danish: Efter enten oral eller intravenøs indgift udskilles sildenafil som metabolitter hovedsageligt i faeces (ca. 80% af indgivet oral dosis) og i mindre grad i urinen (ca. 13% af indgivet oral dosis).
English: Teva Nederland B.V. Tel: +31 (0) 800 0228 400
Danish: Tel: +31 (0) 800 0228 400
English: A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates).
Danish: I et dobbelt-blindt, placebo-kontrolleret motionsstressstudie, hvori 144 patienter med erektil dysfunktion og stabil angina tog deres sædvanlige medicin mod angina pectoris (undtaget nitrater), blev der ikke set klinisk relevante forskelle i tiden indtil angina blev en begrænsende faktor for sildenafil sammenlignet med placebo.
English: How to take Sildenafil ratiopharm
Danish: Sådan skal du tage Sildenafil ratiopharm
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 December 2009.
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Danish: Hos raske frivillige forsøgspersoner gav cimetidin (800 mg), en cytokrom P450-hæmmer og ikke specifik CYP3A4-hæmmer en 56% stigning i plasmakoncentrationer af sildenafil ved indgift sammen med sildenafil (50 mg).
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteket, hvis du er i tvivl.
English: Sildenafil ratiopharm 25 mg film-coated tablets White to off-white, oblong film-coated tablet with edge.
Danish: Sildenafil ratiopharm 25 mg filmovertrukne tabletter Hvid til off-white, aflang, filmovertrukket tablet med kant.
English: Heart rate increased
Danish: Øget hjerterytme
English: Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Danish: Almindelig (kan ses hos op til 1 ud af 10 personer): kvalme, ansigtsrødme, hedeture (symptomerne omfatter en pludselig varmefølelse i overkroppen), dårlig fordøjelse, farvesyn, sløret syn, synsforstyrrelser, tilstoppet næse og svimmelhed.
English: If you feel dizzy, or if your vision or hearing is affected after taking Sildenafil ratiopharm, do not drive or operate any tools or machines.
Danish: Lad være med at arbejde med værktøj eller maskiner, hvis du føler dig svimmel, eller dit syn eller din hørelse påvirkes efter indtagelse af Sildenafil ratiopharm.
English: Sildenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Danish: Sildenafil er kontraindiceret til patienter, som på grund af non-arteritis anterior iskæmisk opticusneuropati (NAION) har nedsættelse af synet på det ene øje.
English: Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
Danish: Sjælden (kan ses hos op til 1 ud af 1.000 personer): besvimelse, slagtilfælde, hjerteanfald, uregelmæssig hjerterytme, midlertidigt nedsat blodtilførsel til dele af hjernen, følelse af, at halsen snører sig sammen, følelsesløshed i munden, blødninger i den bagerste del af øjet, dobbeltsyn, nedsat synsskarphed, unormal følelse i øjet, hævede øjne eller øjenlåg, små partikler eller pletter i synsfeltet, se en farvet ring omkring lyskilder, forstørrede pupiller, misfarvning af det hvide i øjet, blødning fra penis, blod i sæden, næsetørhed, hævelse inde i næsen, følelse af irritation og pludselig hørenedsættelse eller høretab.
English: - Chest pains - this occurs uncommonly.
Danish: Smerter i brystet - dette ses ikke almindeligt.
English: Sildenafil ratiopharm 25 mg film-coated tablets EU/1/09/603/001
Danish: Sildenafil ratiopharm 25 mg filmovertrukne tabletter EU/1/09/603/001
English: The mean AUC and Cmax of the N-desmethyl metabolite increased up to 126% and up to 73% respectively,
Danish: Gennemsnitlig AUC og Cmax af N-desmethylmetabolitten øges med henholdsvis op til 126% og op til 73% sammenlignet med frivillige forsøgspersoner med samme alder uden nedsat nyrefunktion.
English: Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildenafil.
Danish: Efter markedsføringen er der i forbindelse med brugen af sildenafil rapporteret alvorlige kardiovaskulære hændelser, inklusiv myokardieinfarkt, ustabil angina pectoris, pludselig hjertedød, ventrikulær arytmi, cerebrovaskulær blødning, transitorisk cerebral iskæmi, hypertension og hypotension.
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets 48 film-coated tablets
Danish: 1 filmovertrukket tablet 2 filmovertrukne tabletter 4 filmovertrukne tabletter 8 filmovertrukne tabletter 12 filmovertrukne tabletter 24 filmovertrukne tabletter 48 filmovertrukne tabletter
English: Sildenafil ratiopharm 100 mg film-coated tablets EU/1/09/603/009
Danish: Sildenafil ratiopharm 100 mg filmovertrukne tabletter EU/1/09/603/009
English: EU/1/09/603/005 1 film-coated tablet EU/1/09/603/006 4 film-coated tablets EU/1/09/603/007 8 film-coated tablets EU/1/09/603/008 12 film-coated tablets EU/1/09/603/014 2 film-coated tablets EU/1/09/603/017 24 film-coated tablets
Danish: EU/1/09/603/005 1 filmovertrukket tablet EU/1/09/603/006 4 filmovertrukne tabletter EU/1/09/603/007 8 filmovertrukne tabletter EU/1/09/603/008 12 filmovertrukne tabletter EU/1/09/603/014 2 filmovertrukne tabletter EU/1/09/603/017 24 filmovertrukne tabletter
English: Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
Danish: Samtidig indgift af HIV-proteasehæmmeren ritonavir, som er en meget potent CYP-hæmmer, ved steady state (500 mg 2 gange dagligt) og enkeltdosis af sildenafil (100 mg) gav en stigning i sildenafils Cmax på 300% (4 gange) og en stigning i sildenafils plasma-AUC på 1.000% (11 gange).