natgillin/translations-raw huggingface dataset:
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. 
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.
Revatio pulver til oral suspension er hvidt til råhvidt pulver, der ved opblanding med vand giver en hvid suspension med druesmag. 
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.
Figur 5 
figure 5
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). 
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).
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. 
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.
Der er spontant rapporteret synsdefekter og i forbindelse med indtagelse af sildenafil og andre PDE5hæmmere (se pkt. 
Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors.
Der bør ikke anvendes højere doser end de anbefalede til pædiatriske patienter med PAH (se også pkt. 
Therefore, doses higher than the recommended doses should not be used in paediatric patients with PAH (see also sections 4.2 and
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 
Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
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. 
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.
Kliniske data for intravenøs sildenafil-behandling af patienter, der er klinisk eller hæmodynamisk ustabile er ikke tilgængelige. 
No clinical data is available for sildenafil IV administration in patients who are clinically or haemodynamically unstable.
Figur 2 
figure 2
Figur 9 
figure 9
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGE/KARTON 
OUTER PACKAGING/CARTON
PAHpatienterne 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.
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). 
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).
Grapefrugtjuice er en svag CYP3A4-hæmmer af tarmvæggens metabolisme, og kan give en mindre stigning i plasmakoncentrationen af oralt administreret sildenafil. 
Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of oral sildenafil.
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. 
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.
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. 
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.
Al resterende suspension skal bortskaffes 30 dage efter opblanding. 
Any remaining oral suspension should be discarded 30 days after constitution.
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. 
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.
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. 
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.
For N-desmethylmetabolitten var Cmax= 30,8 ng/ml og AUC (08) = 147 ng·time/ml. 
The Cmax and AUC (0-8) of the N-desmethyl metabolite were 30.8 ng/ml and 147 ng h/ml, respectively.
Placebokorrigeret behandlingseffekt af PVR var -178 dyn.sek/cm 
Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051),
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. 
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).
Virkninger af oralt administreret sildenafil på andre lægemidler 
Effects of oral sildenafil on other medicinal products
Øre og labyrint Almindelig Ikke kendt vertigo pludseligthøre tab 
Ear and labyrinth disorders Common vertigo
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. 
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).
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%). 
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 %).
Tabletkerne: Mikrokrystallinsk cellulose, calciumhydrogenfosfat (vandfrit), croscarmellosenatrium, magnesiumstearat. 
- The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
Maltodextrin Druesaft koncentrat Akaciegummi Ananasjuice koncentrat Citronsyre, vandfri Naturlige smagsstoffer 
Pineapple juice concentrate Citric acid anhydrous Natural flavouring
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. 
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.
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. 
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.
Ved den anbefalede dosis på 20 mg oralt administreret 3 gange dagligt ses ingen reduktion i det systoliske eller diastoliske tryk. 
At the recommended oral dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen.
To patienter fik alt 3 bivirkninger (ansigtsrødme, flatulens og hedestigninger). 
Two subjects experienced a total of 3 adverse reactions (flushing, flatulence and hot flush).
- Aktivt stof: sildenafil. 
What Revatio contains - The active substance is sildenafil.
Danmark Pfizer ApS 
Pfizer ApS
Efter opblanding er der fremkommet en hvid oral suspension med druesmag. 
When constituted the powder provides a white grape flavoured oral suspension.
Revatio 20 mg tabletter Sildenafil 
Revatio 20 mg tablets Sildenafil
- har unormale røde blodlegemer (seglcelleanæmi), blodkræft (leukæmi), knoglemarvskræft 
- 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.
Oralt administreret sildenafil har ingen klinisk betydende indvirkning på plasmaniveauerne af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel). 
Oral sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g).
Risk/benefit-ratio for sildenafil er ikke fastslået hos patienter med pulmonal arteriel hypertension WHO-funktionsklasse I. 
The benefit-risk balance of sildenafil has not been established in patients assessed to be at WHO functional class I pulmonary arterial hypertension.
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. 
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).
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. 
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.
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). 
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).
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. 
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.
Figur 7 
figure 7
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 ‰). 
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.
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. 
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.
Oralt administreret sildenafil (50 mg) øger ikke den af acetylsalicylsyre (150 mg) forlængede blødningstid. 
Oral sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
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. 
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.
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). 
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).
Vend flasken på hovedet medens sprøjten holdes på plads. 
Turn the bottle upside down while holding the oral dosing syringe in place.
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. 
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.
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. 
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.
Sæt låget på flasken igen og lad adaptoren blive siddende i flasken. 
Replace the cap on the bottle, leaving the bottle adaptor in place.
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. 
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.
Dosisjustering til 10 mg 1 gang dagligt anbefales ved samtidig behandling med mere potente CYP3A4-hæmmere som clarithromycin, telithromycin og nefazodon. 
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.
Bemærk: Der skal anvendes 90 ml (3 x 30 ml) vand til rekonstituering af indholdet i flasken, uanset hvilken dosis der skal tages. 
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
Apotekspersonalet kan vise Dem, hvordan De skal bruge den vedlagte doseringssprøjte. 
Your pharmacist should advise you how to measure the medicine using the oral dosing syringe provided in the pack.
Vejledning 
Posology
Isæt flaskeadaptoren som vist på figure 5. 
Press the bottle adaptor into the neck of the bottle (as shown on figure 5 below).
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). 
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).
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. 
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.
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. 
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.
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. 
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.
Hver ml rekonstitueret suspension indeholder 10 mg sildenafil (som citrat). 
Each ml of reconstituted suspension contains 10 mg of sildenafil (as citrate).
Samtidig administration af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel) påvirker ikke sildenafils farmakokinetik. 
Co-administration of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g) did not affect the pharmacokinetics of sildenafil.
For at afmåle dosis så præcist som muligt, skal det øverste del af stemplet være lige ud for mærket på den dosis der skal anvendes. 
To measure the dose accurately, the top edge of the plunger should be lined up with the appropriate graduated mark on the oral dosing syringe (figure 8).
Figur 4 
figure 4
Ved oralt administrerede enkeltdoser på 200 mg ses øget incidens af bivirkninger (hovedpine, ansigtsrødme, svimmelhed, dyspepsi, tilstopning af næsen og synsforstyrrelser). 
At single oral doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased.
Samtidig administration af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel) påvirker ikke sildenafils orale farmakokinetik. 
Co-administration of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g) did not affect the oral pharmacokinetics of sildenafil.
Efter enten oral eller intravenøs indgift udskilles sildenafil som metabolitter hovedsageligt i fæces (ca. 80% af indgivet oral dosis) og i mindre grad i urinen (ca. 13% af indgivet oral dosis). 
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).
Efter opblanding må den orale suspension kun tages ved hjælp af den vedlagte doseringssprøjte. 
Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Figur 6 
figure 6
Men spørg lægen eller sundhedspersonalet, hvis De tror, at De ikke har fået Revatio. 
However tell your doctor or pharmacist if you think that a dose has been forgotten.
Bemærk: Der skal anvendes 90 ml (3 x 30 ml) vand til rekonstituering af indholdet i flasken, uanset hvilken dosis De skal tage. 
Note: A total volume of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking should be used to reconstitute the contents of the bottle.
Ved ordination af sildenafil skal lægen omhyggeligt overveje, om patienter med visse underliggende tilstande vil kunne blive påvirket af sildenafils milde til moderate vasodilaterende effekt, f.eks. patienter med hypotension, patienter med dehydrering, svært venstre ventrikel udløbsobstruktion eller autonom dysfunktion (se pkt. 
When prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by sildenafil's mild to moderate vasodilatory effects, for example patients with hypotension, patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction (see section 4.4).
Effekt 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. 
Efficacy 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.
Må ikke opbevares ved temperaturer over 30 
Do not store above 30°C.
Figur 3 
figure 3
(p<0,0001) for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt. 
(p<0.0001) for sildenafil 20 mg, 40 mg and