FrancophonIA/ELRC3.0 huggingface dataset:
English: In the two-placebo controlled studies adverse events were generally mild to moderate in severity.
Danish: I to placebo-kontrollerede studier er bivirkningerne generelt milde til moderate.
English: The percent reduction at 12 weeks for sildenafil 20 mg, 40 mg and 80 mg TID in PVR (11.2 %, 12.9 %, 23.3 %) was proportionally greater than the reduction in systemic vascular resistance (SVR) (7.2 %, 5.9 %, 14.4 %).
Danish: Den procentvise reduktion i PVR (11,2%, 12,9%, 23,3%) efter 12 uger for sildenafil 20 mg, 40 mg og 80 mg 3 gange dagligt var proportionelt større end reduktionen i systemisk vaskulær modstand (SVR) (7,2%, 5,9%, 14,4%).
English: Titanium dioxide (E171) Sodium benzoate (E211) Silica, colloidal anhydrous
Danish: Xanthangummi Titandioxid (E171) Natriumbenzoat (E211) Silica, kolloid vandfri
English: Using the cup measure another 30 ml of water and add this to the bottle.
Danish: Brug målebægeret til at afmåle 30 ml vand og overfør det til flasken.
English: In clinical trials side effects reported commonly (may affect up to 1 in 10 people) by patients with pulmonary arterial hypertension were facial flushing and nausea.
Danish: I de kliniske forsøg var de almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter) hos patienter med pulmonal arteriel hypotension: rødmen i ansigtet og kvalme.
English: Measure 30 ml of water by filling the measuring cup (included in the carton) to the marked line then pour the water into the bottle.
Danish: Afmål 30 ml vand ved at hælde vand op til stregen på målebægeret (ligger i pakningen) og overfør vandet til flasken.
English: Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate, glycerol triacetate
Danish: Filmovertræk: Hypromellose, titandioxid (E171), lactosemonohydrat, glyceroltriacetat.
English: Medium dose (n=26)
Danish: Lavdosis (n=24) Middeldosis (n=26) Højdosis (n=27) Total (n=77)
English: Once reconstituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Danish: Efter rekonstituering må den orale suspension kun administreres med den vedlagte sprøjte.
English: Each pack contains one 20 ml clear, type I glass vial with a chlorobutyl rubber stopper and an aluminium overseal.
Danish: Hver pakning indeholder et 20 ml hætteglas (klart type I) med en chlorbutyl-gummiprop og aluminiumsforsegling.
English: Sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g).
Danish: Sildenafil har ingen klinisk betydende indvirkning på plasmaniveauerne af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel).
English: Do not store above 30OC.
Danish: Må ikke opbevares ved temperaturer over 30 oC.
English: Efficacy in adult patients with PAH (when used in combination with epoprostenol) A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol.
Danish: Effekt hos voksne patienter med PAH (ved anvendelse sammen med epoprostenol) Der blev udført et randomiseret, dobbelt-blindt, placebo-kontrolleret studie med 267 patienter med PAH, som var stabiliseret på intravenøs epoprostenol.
English: What Revatio looks like and contents of the pack Revatio is supplied as a white to off-white powder for oral suspension providing a white, grape flavoured oral suspension when constituted with water.
Danish: Revatio pulver til oral suspension er hvidt til råhvidt pulver, der ved opblanding med vand giver en hvid suspension med druesmag.
English: figure 5
Danish: Figur 5
English: Subjects who had been in the placebo group in the shortterm study were randomly reassigned to sildenafil treatment; subjects weighing ≤ 20 kg entered the medium or high dose groups (1:1), while subjects weighing > 20 kg entered the low, medium or high dose groups (1:1:1).
Danish: Forsøgspersoner, der vejede ≤ 20 kg, blev inkluderet i middel- eller højdosisgruppen (1:1), mens forsøgspersoner, der vejede > 20 kg, blev inkluderet i lav-, middel- eller højdosisgruppen (1:1:1).
English: Warnings and precautions Talk to your doctor before taking Revatio if you: - have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
Danish: Kontakt lægen, før De tager Revatio, hvis De - har sygdom forårsaget af blokeret eller forsnævret vene i lungerne og ikke en blokeret eller forsnævret arterie.
English: Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors.
Danish: Der er spontant rapporteret synsdefekter og i forbindelse med indtagelse af sildenafil og andre PDE5hæmmere (se pkt.
English: Therefore, doses higher than the recommended doses should not be used in paediatric patients with PAH (see also sections 4.2 and
Danish: Der bør ikke anvendes højere doser end de anbefalede til pædiatriske patienter med PAH (se også pkt.
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 gennemsnitlige maksimale koncentrationer af alkohol i blodet på 80 mg/dl
English: CYP3A4 inducers seemed to have a substantial impact on the oral pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in-vivo interaction study with CYP3A4 inducer bosentan.
Danish: CYP3A4-induktorer ser ud til at have en betydelig indvirkning på farmakokinetikken af oralt administreret sildenafil hos patienter med pulmonal arteriel hypertension, hvilket er bekræftet i et invivo interaktionsstudie med CYP3A4-induktoren bosentan.
English: No clinical data is available for sildenafil IV administration in patients who are clinically or haemodynamically unstable.
Danish: Kliniske data for intravenøs sildenafil-behandling af patienter, der er klinisk eller hæmodynamisk ustabile er ikke tilgængelige.
English: figure 2
Danish: Figur 2
English: figure 9
Danish: Figur 9
English: OUTER PACKAGING/CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGE/KARTON
English: The PAH patients included those with Primary PAH, and PAH associated with connective tissue disease.
Danish: PAHpatienterne omfattede patienter med primær PAH og PAH forbundet med bindevævssygdom.
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 en forbedret effekt med højere dosis (placebo-korrigeret stigning på 58 meter, 65 meter, 87 meter for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt).
English: Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of oral sildenafil.
Danish: Grapefrugtjuice er en svag CYP3A4-hæmmer af tarmvæggens metabolisme, og kan give en mindre stigning i plasmakoncentrationen af oralt administreret sildenafil.
English: Warnings and Precautions Talk to your doctor before taking Revatio if you: - have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
Danish: Kontakt lægen, før De får Revatio, hvis De - har sygdom forårsaget af blokeret eller forsnævret vene i lungerne og ikke en blokeret eller forsnævret arterie.
English: For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤ 20 kg is 10 mg (1 ml of reconstituted suspension) three times a day and for patients > 20 kg is 20 mg (2 ml of reconstituted suspension) three times a day.
Danish: Hos pædiatriske patienter i alderen 1-17 år er den anbefalede dosis til patienter ≤20 kg 10 mg (1 ml rekonstitueret suspension) 3 gange dagligt, og til patienter ≥20 kg er dosis 20 mg (2 ml rekonstitueret suspension eller 1 tablet) 3 gange dagligt.
English: Any remaining oral suspension should be discarded 30 days after constitution.
Danish: Al resterende suspension skal bortskaffes 30 dage efter opblanding.
English: Placebo-corrected treatment effects with mPAP were -2.7 mmHg (p = 0.04), -3.0 mm Hg (p = 0.01) and -5.1 mm Hg (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Danish: Placebokorrigeret behandlingseffekt af mPAP var -2,7 mmHg (p=0,04), -3,0 mmHg (p=0,01) og -5,1 mmHg (p<0,0001) for hhv. sildenafil 20 mg, 40 mg og 80 mg 3 gange dagligt.
English: In patients with pulmonary arterial hypertension, the average steady state concentrations were 20-50 % higher over the investigated oral 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 administreret oralt 3 gange dagligt sammenlignet med raske frivillige forsøgspersoner.
English: The Cmax and AUC (0-8) of the N-desmethyl metabolite were 30.8 ng/ml and 147 ng h/ml, respectively.
Danish: For N-desmethylmetabolitten var Cmax= 30,8 ng/ml og AUC (08) = 147 ng·time/ml.
English: Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051),
Danish: Placebokorrigeret behandlingseffekt af PVR var -178 dyn.sek/cm
English: A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy (62.5 mg - 125 mg twice a day) indicated an increase (20% (95% CI: 9.8 - 30.8)) of bosentan AUC with co-administration of steady-state sildenafil (20 mg three times a day) of a smaller magnitude than seen in healthy volunteers when co-administered with 80 mg sildenafil three times a day (see sections 4.4 and 5.1).
Danish: En populationsfarmakokinetisk analyse af data fra et studie med voksne PAH-patienter, som fik baggrundsbehandling med bosentan (62,5 - 125 mg 2 gange dagligt), indikerede en stigning i AUC (20% (95% CI: 9,8-30,8) for bosentan ved samtidig administration af steady-state sildenafil (20 mg 3 gange dagligt), som er mindre end den, der ses hos raske frivillige forsøgspersoner ved samtidig administration af 80 mg sildenafil 3 gange dagligt (se pkt.
English: Effects of oral sildenafil on other medicinal products
Danish: Virkninger af oralt administreret sildenafil på andre lægemidler
English: Ear and labyrinth disorders Common vertigo
Danish: Øre og labyrint Almindelig Ikke kendt vertigo pludseligthøre tab
English: The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including Viagra, has not been studied in PAH patients and such concomitant use is not recommended (see section 4.5).
Danish: Sildenafils sikkerhed og effekt ved samtidig anvendelse af andre PDE5-hæmmere, herunder Viagra, er ikke undersøgt hos patienter med pulmonal arteriel hypertension og samtidig anvendelse kan ikke anbefales (se pkt.
English: The sildenafil medium and high dose groups both showed PVRI reductions compared to placebo, of 18 % (95 %CI: 2 % to 32 %) and 27 % (95 %CI: 14 % to 39 %), respectively; whilst the low dose group showed no significant difference from placebo (difference of 2 %).
Danish: De grupper, der fik middel- eller højdosis sildenafil, udviste reduktion i PVRI sammenlignet med placebo på hhv. 18% (95% CI: 2%-32%) og 27% (95% CI: 14%-39%), mens der for lavdosis-gruppen ikke var signifikant forskel fra placebo (2%).
English: - The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
Danish: Tabletkerne: Mikrokrystallinsk cellulose, calciumhydrogenfosfat (vandfrit), croscarmellosenatrium, magnesiumstearat.
English: Pineapple juice concentrate Citric acid anhydrous Natural flavouring
Danish: Maltodextrin Druesaft koncentrat Akaciegummi Ananasjuice koncentrat Citronsyre, vandfri Naturlige smagsstoffer
English: Sildenafil exposure was 5-fold higher at an oral dose of 80 mg three times a day compared to the exposure at an oral dose of 20 mg three times a day.
Danish: Sildenafils eksponering var 5 gange højere ved oralt administreret dosis på 80 mg 3 gange dagligt sammenlignet med en eksponering med en oralt administreret dosis på 20 mg 3 gange dagligt.
English: The overall frequency of discontinuation in sildenafil treated patients at doses of 20 mg, 40 mg and 80 mg TID was 2.9 %, 3.0 % and 8.5 % respectively, compared to 2.9 % with placebo.
Danish: Totalt seponerede hhv. 2,9%, 3,0% og 8,5% af patienterne behandlingen med 20 mg, 40 mg og 80 mg sildenafil 3 gange dagligt sammenlignet med 2,9% i placebogruppen.
English: At the recommended oral dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen.
Danish: Ved den anbefalede dosis på 20 mg oralt administreret 3 gange dagligt ses ingen reduktion i det systoliske eller diastoliske tryk.
English: Two subjects experienced a total of 3 adverse reactions (flushing, flatulence and hot flush).
Danish: To patienter fik alt 3 bivirkninger (ansigtsrødme, flatulens og hedestigninger).
English: What Revatio contains - The active substance is sildenafil.
Danish: - Aktivt stof: sildenafil.
English: Pfizer ApS
Danish: Danmark Pfizer ApS
English: When constituted the powder provides a white grape flavoured oral suspension.
Danish: Efter opblanding er der fremkommet en hvid oral suspension med druesmag.
English: Revatio 20 mg tablets Sildenafil
Danish: Revatio 20 mg tabletter Sildenafil
English: - have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
Danish: - har unormale røde blodlegemer (seglcelleanæmi), blodkræft (leukæmi), knoglemarvskræft
English: Oral sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g).
Danish: Oralt administreret sildenafil har ingen klinisk betydende indvirkning på plasmaniveauerne af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel).
English: The benefit-risk balance of sildenafil has not been established in patients assessed to be at WHO functional class I pulmonary arterial hypertension.
Danish: Risk/benefit-ratio for sildenafil er ikke fastslået hos patienter med pulmonal arteriel hypertension WHO-funktionsklasse I.
English: Kaplan-Meier estimates of survival at 3 years in patients > 20 kg in weight at baseline were 94 %, 93 % and 85 % in the low, medium and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94 % and 93 % for subjects in the medium and high dose groups respectively (see sections 4.4 and 4.8).
Danish: Kaplan-Meier-estimat af overlevelse efter 3 år for patienter >20 kg ved baseline var hhv. 94%, 93% og 85% for lav-, middel- og højdosis-grupperne.
English: Doses up to 80 mg TID were administered and after 3 years 68 % of 133 patients on study treatment were receiving Revatio 80 mg TID.
Danish: Patienterne fik doser på op til 80 mg 3 gange dagligt, og efter 3 år var 68% af 133 patienter i behandling med Revatio 80 mg 3 gange dagligt.
English: In a study of healthy volunteers sildenafil at steady state (80 mg three times a day) resulted in a 50 % increase in bosentan AUC (125 mg twice daily).
Danish: I et studie med raske frivillige forsøgspersoner gav sildenafil ved steady-state (80 mg 3 gange dagligt) en stigning i bosentans AUC på 50% (125 mg 2 gange dagligt).
English: In the pivotal placebo-controlled study of Revatio in pulmonary arterial hypertension, a total of 207 patients were randomized to and treated with 20 mg, 40 mg, or 80 mg TID doses of Revatio and 70 patients were randomized to placebo.
Danish: I det pivotale placebo-kontrollerede studie af Revatio ved pulmonal arteriel hypertension blev i alt 207 patienter randomiseret til behandling med 20 mg, 40 mg eller 80 mg Revatio 3 gange dagligt, og 70 patienter blev randomiseret til placebo.
English: figure 7
Danish: Figur 7
English: Oral 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: Oralt administreret sildenafil (50 mg) forstærker ikke den hypotensive effekt af alkohol hos raske frivillige forsøgspersoner med gennemsnitlige maksimale koncentrationer af alkohol i blodet på 80 mg/dl (0,8 ‰).
English: A total of 106 out of 234 (45 %) subjects were evaluable for CPET, which comprised those children ≥ 7 years old and developmentally able to perform the test. Children < 7 years (sildenafil combined dose = 47; placebo = 16) were evaluable only for the secondary endpoints.
Danish: I alt 106 ud af 234 (45%) forsøgspersoner kunne evalueres ved CPET, hvilket omfattede børn ≥7 år, som udviklingsmæssigt var i stand til at udføre testen.
English: Oral sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
Danish: Oralt administreret sildenafil (50 mg) øger ikke den af acetylsalicylsyre (150 mg) forlængede blødningstid.
English: For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg (1 ml of oral suspension) three times a day for children and adolescents weighing 20 kg or under, or 20 mg (2 ml of oral suspension) three times a day for children and adolescents weighing over 20 kg, taken with or without food.
Danish: Den sædvanlige dosis til børn og unge i alderen 1-17 år er 10 mg (1 ml oral suspension) 3 gange dagligt ved legemsvægt 20 kg eller derunder og 20 mg (2 ml oral suspension) 3 gange dagligt ved legemsvægt over 20 kg. Revatio kan tages sammen med eller uden mad.
English: The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of -3.5 mmHg (95 %CI: -8.9, 1.9) and -7.3 mmHg (95 %CI: -12.4, -2.1), respectively; whilst the low dose group showed little difference from placebo (difference of 1.6 mmHg).
Danish: Middelog højdosis-grupperne viste ændringer i mPAP fra baseline sammenlignet med placebo på hhv.3,5 mmHg (95% CI: -8,9; 1.9) og -7,3 mmHg (95% CI: -12,4; -2,1), mens lavdosis-gruppen viste en lille forskel fra placebo (1,6 mmHg).
English: Turn the bottle upside down while holding the oral dosing syringe in place.
Danish: Vend flasken på hovedet medens sprøjten holdes på plads.
English: PC:
Danish: EXP:
English: However, for subjects with PAH associated with connective tissue disease (36 subjects) mean changes from baseline were -18.32 m (95% CI:65.66 to 29.02) and 17.50 m (95% CI: -9.41 to 44.41) for the sildenafil and placebo groups, respectively.
Danish: Patienter med PAH forbundet med bindevævssygdom (36 personer) havde imidlertid en gennemsnitlig ændring fra baseline på -18,32 m (95% CI: -65,66 til 29,02) i sildenafilgruppen og 17,50 m (95% CI: -9,41 til 44,41) i placebogruppen.
English: Efficacy of oral sildenafil in adult patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 278 patients with primary pulmonary hypertension, PAH associated with connective tissue disease, and PAH following surgical repair of congenital heart lesions.
Danish: Effekt af oralt administreret sildenafil hos voksne patienter med pulmonal arteriel hypertension (PAH) Et randomiseret dobbelt-blindt, placebo-kontrolleret studie blev udført på 278 patienter med primær pulmonal hypertension, PAH forbundet med bindevævssygdom og PAH efterfulgt af kirurgisk intervention af medfødte hjertelidelser.
English: Replace the cap on the bottle, leaving the bottle adaptor in place.
Danish: Sæt låget på flasken igen og lad adaptoren blive siddende i flasken.
English: The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.
Danish: Følgende alvorlige bivirkninger er almindelige (det sker hos mellem 1 og 10 patienter): lungebetændelse, hjertesvigt, højresidigt hjertesvigt, shock pga. hjerteproblemer, høj blodtryk i lungerne, smerter i brystet, besvimelse, infektion i luftvejene, bronkitis, virusinfektion i maven og tarmen, urinvejsinfektion og huller i tænderne.
English: A downward dose adjustment to 10 mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone.
Danish: Dosisjustering til 10 mg 1 gang dagligt anbefales ved samtidig behandling med mere potente CYP3A4-hæmmere som clarithromycin, telithromycin og nefazodon.
English: Note: A total volume of 90 ml (3 x 30 ml) of water irrespective of the dose to be taken should be used to reconstitute the contents of the bottle
Danish: Bemærk: Der skal anvendes 90 ml (3 x 30 ml) vand til rekonstituering af indholdet i flasken, uanset hvilken dosis der skal tages.
English: Your pharmacist should advise you how to measure the medicine using the oral dosing syringe provided in the pack.
Danish: Apotekspersonalet kan vise Dem, hvordan De skal bruge den vedlagte doseringssprøjte.
English: Posology
Danish: Vejledning
English: Press the bottle adaptor into the neck of the bottle (as shown on figure 5 below).
Danish: Isæt flaskeadaptoren som vist på figure 5.
English: In a study of healthy volunteers oral sildenafil at steady state (80 mg three times a day) resulted in a 50 % increase in bosentan AUC (125 mg twice daily).
Danish: I et studie med raske frivillige forsøgspersoner gav oralt administreret sildenafil ved steady-state (80 mg 3 gange dagligt) en stigning i bosentans AUC på 50% (125 mg 2 gange dagligt).
English: The population pharmacokinetic analysis in pulmonary arterial hypertension patients receiving oral sildenafil suggested that co-administration of beta-blockers in combination with CYP3A4 substrates might result in an additional increase in sildenafil exposure compared with administration of CYP3A4 substrates alone.
Danish: Populationsfarmakokinetiske analyser hos patienter med pulmonal arteriel hypertension, der fik oralt administreret sildenafil, tyder på, at samtidig anvendelse af beta-blokkere i kombination med CYP3A4-substrater kan resultere i en øget sildenafil-eksponering sammenlignet med anvendelse af CYP3A4-substrater alene.
English: Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125 mg twice daily with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63 % decrease of sildenafil AUC.
Danish: Samtidig anvendelse af bosentan (en moderat induktor af CYP3A4, CYP2C9 og muligvis af CYP2C19) 125 mg 2 gange dagligt og oralt administreret sildenafil 80 mg 3 gange dagligt (ved steady-state) i 6 dage gav et fald i sildenafils AUC på 63% hos raske frivillige forsøgspersoner.
English: Efficacy of intravenous sildenafil in adult patients with pulmonary arterial hypertension (PAH) A 10 mg dose of Revatio solution for injection is predicted to provide total exposure of free sildenafil and its N-desmethyl metabolite and their combined pharmacological effects comparable to those of a 20 mg oral dose.
Danish: Effekt af intravenøst administreret sildenafil hos voksne patienter med pulmonal arteriel hypertension: 10 mg Revatio injektionsvæske forventes at give samme eksponering for sildenafil og dets Ndesmethylmetabolit, og den kombinerede farmakologiske effekt forventes at være sammenlignelig med den for en oralt administreret dosis på 20 mg.
English: Each ml of reconstituted suspension contains 10 mg of sildenafil (as citrate).
Danish: Hver ml rekonstitueret suspension indeholder 10 mg sildenafil (som citrat).
English: Co-administration of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g) did not affect the pharmacokinetics of sildenafil.
Danish: Samtidig administration af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel) påvirker ikke sildenafils farmakokinetik.