FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: 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.
English: figure 4
Danish: Figur 4
English: At single oral doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased.
Danish: Ved oralt administrerede enkeltdoser på 200 mg ses øget incidens af bivirkninger (hovedpine, ansigtsrødme, svimmelhed, dyspepsi, tilstopning af næsen og synsforstyrrelser).
English: Co-administration of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g) did not affect the oral pharmacokinetics of sildenafil.
Danish: Samtidig administration af orale antikonceptiva (30 g ethinylestradiol og 150 g levonorgestrel) påvirker ikke sildenafils orale farmakokinetik.
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 fæces (ca. 80% af indgivet oral dosis) og i mindre grad i urinen (ca. 13% af indgivet oral dosis).
English: Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Danish: Efter opblanding må den orale suspension kun tages ved hjælp af den vedlagte doseringssprøjte.
English: figure 6
Danish: Figur 6
English: However tell your doctor or pharmacist if you think that a dose has been forgotten.
Danish: Men spørg lægen eller sundhedspersonalet, hvis De tror, at De ikke har fået Revatio.
English: 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.
Danish: Bemærk: Der skal anvendes 90 ml (3 x 30 ml) vand til rekonstituering af indholdet i flasken, uanset hvilken dosis De skal tage.
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: Do not store above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30
English: figure 3
Danish: Figur 3
English: (p<0.0001) for sildenafil 20 mg, 40 mg and
Danish: (p<0,0001) for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt.
English: The Marketing Authorisation Holder shall agree the Information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country.
Danish: Indehaveren af markedsføringstilladelsen skal inden markedsføring af 20 ml hætteglas Revatio 0,8 mg/ml injektionsvæske i det pågældende medlemsland i samarbejde med de nationale myndigheder i de enkelte medlemslande blive enige om indholdet af informationen til sundhedspersonalet samt hvilken gruppe af sundhedspersonale der er relevant.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Lægemidlet bør derfor ikke anvendes til patienter med hereditær fructoseintolerans.
English: 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).
Danish: 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.
English: Revatio 20 mg film-coated tablets
Danish: Revatio 20 mg filmovertrukne tabletter
English: In clinical trials the side effects reported commonly (may affect up to 1 in 10 people) were facial flushing, headache, low blood pressure and nausea.
Danish: I de kliniske forsøg var de almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter): rødmen i ansigtet, hovedpine, lavt blodtryk og kvalme.
English: Placebo corrected increases in 6MWD were 45 metres (p < 0.0001), 46 metres (p < 0.0001) and 50 metres (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID, respectively.
Danish: Placebo-korrigeret stigning i 6MWD var 45 meter (p<0,0001), 46 meter (p<0,0001) og 50 meter (p<0,0001) for hhv. sildenafil 20 mg, 40 mg og 80 mg. Der var ingen signifikant forskel i effekten mellem sildenafildoserne.
English: *These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig pyreksi *Disse bivirkninger/hændelser er rapporteret hos patienter, der tager sildenafil til behandling af erektil dysfunktion (MED).
English: Patients enrolled into the pivotal oral route study were eligible to enter a long term open label extension study.
Danish: De patienter, der blev inkluderet i det pivotale studie (oralt administreret), var egnede til at indgå i et langvarigt, åbent, studie, der blev forlænget.
English: A 10 mg dose of Revatio solution for injection is predicted to provide exposure of sildenafil and its N-desmethyl metabolite and pharmacological effects comparable to those of a 20 mg oral dose.
Danish: En dosis på 10 mg Revatio injektionsvæske giver samme eksponering for sildenafil samt Ndesmethylmetabolitten og udviser sammenlignelig farmakologisk effekt som en oral dosis på 20 mg.
English: For patients with a baseline walking distance ≥ 325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance < 325 metres, the treatment effect was 2.3 metres in favour of placebo.
Danish: Hos patienter med en gangdistance på <325 m var behandlingseffekten 2,3 m til placebos fordel.
English: The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.
Danish: Følgende alvorlige bivirkninger betragtes som forbundet med behandlingen og er ikke almindelige (det sker hos mellem 1 og 10 ud af 100 patienter): allergisk reaktion (såsom hududslæt, hævelser i ansigt, læber og tunge, hvæsende vejrtrækning, åndedrætsbesvær og synkebesvær), kramper, uregelmæssig puls, nedsat hørelse, åndenød, betændelseslignende reaktion i mave-tarmkanalen og hvæsende vejrtrækning pga. blokering af luftvejene.
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72 % those of sildenafil after 20 mg three times a day dosing (translating into a 36 % contribution to sildenafil's pharmacological effects).
Danish: Hos patienter med pulmonal arteriel hypertension er plasmakoncentrationerne af N-desmethylmetabolitten ca. 72% af sildenafils efter 20 mg 3 gange dagligt (overført til et 36% bidrag til sildenafils farmakologiske effekt).
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with oral sildenafil (50 mg) to healthy volunteers.
Danish: Hos raske frivillige forsøgspersoner gav cimetidin (800 mg), en CYP450-hæmmer og ikke specifik CYP3A4-hæmmer, en 56% stigning i plasmakoncentrationer af sildenafil ved oralt administreret indgift sammen med sildenafil (50 mg).
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 daglig i 5 dage) ses en 182% stigning i optagelsen af sildenafil (AUC).
English: A downward dose adjustment to 10 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir.
Danish: Dosisjustering af sildenafil til 10 mg 2 gange dagligt bør overvejes til patienter i behandling med CYP3A4-hæmmere som erythromycin eller saquinavir.
English: When a single 100 mg dose of oral 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 oral indgift af en enkeltdosis sildenafil 100 mg sammen med erythromycin, en moderat CYP3A4hæmmer, i steady-state (500 mg 2 gange daglig i 5 dage) ses en 182% stigning i optagelsen af sildenafil (AUC).
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72 % those of sildenafil after 20 mg three times a day oral dosing (translating into a 36 % contribution to sildenafil's pharmacological effects).
Danish: Hos patienter med pulmonal arteriel hypertension er plasmakoncentrationerne af N-desmethylmetabolitten ca. 72% af sildenafils efter 20 mg administreret oralt 3 gange dagligt (overført til et 36% bidrag til sildenafils farmakologiske effekt).
English: Shake the closed bottle of constituted oral suspension vigorously for a minimum of 10 seconds before use.
Danish: Flasken med oral suspension omrystes grundigt i mindst 10 sekunder, før den angivne dosis udtages.
English: For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food.
Danish: Den sædvanlige dosis til børn og unge i alderen 1-17 år er 10 mg 3 gange dagligt ved legemsvægt 20 kg eller derunder og 20 mg 3 gange dagligt ved legemsvægt over 20 kg. Revatio kan tages sammen med eller uden mad.
English: - have a problem with the pumping chambers of your heart - have high blood pressure in the blood vessels in the lungs.
Danish: - har for højt blodtryk i blodkarrene i lungerne.
English: After chronic oral dosing of 80 mg three times a day to patients with pulmonary arterial hypertension lesser effects in blood pressure reduction were observed (a reduction in both systolic and diastolic pressure of 2 mmHg).
Danish: Efter kronisk oral dosering på 80 mg 3 gange dagligt til patienter med pulmonal arteriel hypertension ses en mindre effekt i blodtryksreduktionen (en reduktion i både systolisk og diastolisk tryk på 2 mmHg).
English: Revatio 20 mg film-coated tablets Sildenafil
Danish: Revatio 20 mg filmovertrukne tabletter Sildenafil
English: 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: 10 mg Revatio injektionsvæske giver samme eksponering for sildenafil og dets N-desmethylmetabolit og den kombinerede farmakologiske effekt er sammenlignelig med den for en oralt administreret dosis på 20 mg.
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and a 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 CYP450-hæmmer og ikke specifik CYP3A4-hæmmer, en 56% stigning i plasmakoncentrationer af sildenafil ved indgift sammen med sildenafil (50 mg).
English: Point the tip of the oral dosing syringe towards the inside of the cheek.
Danish: Placér spidsen af sprøjten mod indersiden af kinden og tryk LANGSOMT stemplet i bund.
English: Revatio 0.8 mg/ml solution for injection Sildenafil
Danish: Revatio 0,8 mg/ml injektionsvæske, opløsning Sildenafil
English: (p=0.0017) and -320 dyne.sec/cm
Danish: (p=0,0051), -195 dyn.sek/cm
English: Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Danish: Hver filmovertrukken tablet indeholder 20 mg sildenafil (som citrat).
English: Instructions to reconstitute the oral suspension It is recommended that your pharmacist reconstitutes (makes up) the oral suspension before giving it to you.
Danish: Det anbefales, at en farmaceut blander Revatio oral suspension, inden den udleveres til Dem.
English: How to take Revatio
Danish: Sådan skal De tage Revatio
English: Most subjects were WHO Functional Class I (75/234, 32 %) or II (120/234, 51 %) at baseline; fewer patients were Class III (35/234, 15 %) or IV (1/234, 0.4 %); for a few patients (3/234, 1.3 %), the WHO Functional Class was unknown.
Danish: De fleste forsøgspersoner var WHOfunktionsklasse I (75/234, 32%) eller II (120/234, 51%) ved baseline.
English: After reconstitution, each ml of the oral suspension contains 10 mg of sildenafil (as citrate) One bottle of reconstituted oral suspension (112 ml) contains 1.12 g of sildenafil (as citrate)
Danish: 1 flaske med rekonstitueret oral suspension (112 ml) indeholder 1,12 g sildenafil (som citrat).
English: Effects of other medicinal products on oral sildenafil
Danish: Virkninger af andre præparater på oralt administreret sildenafil
English: Turn the bottle back upright with the oral dosing syringe still in place.
Danish: Vend flasken om igen stadig med sprøjten på plads og tag sprøjten ud af flasken.
English: Most patients were WHO Functional Class II (68/267, 26 %) or III (175/267, 66 %); fewer patients were Class I (3/267, 1 %) or IV (16/267, 6 %) at baseline; for a few patients (5/267, 2 %), the WHO Functional Class was unknown.
Danish: Få patienter var klasse I (3/267, 1%) eller IV (16/267, 6%) ved baseline.
English: Revatio 0.8 mg/ml solution for injection
Danish: Revatio 0,8 mg/ml injektionsvæske, opløsning
English: After chronic oral dosing of 80 mg three times a day to patients with systemic hypertension the mean change from baseline in systolic and diastolic blood pressure was a decrease of 9.4 mmHg and 9.1 mm Hg respectively.
Danish: Efter kronisk oral dosering af 80 mg 3 gange dagligt til patienter med systemisk hypertension ses et gennemsnitlig fald fra baseline i det systoliske og diastoliske blodtryk på hhv. 9,4 mmHg og 9,1 mmHg.
English: Replace the cap on the bottle.
Danish: Sæt låget på flasken igen.
English: Grape flavour:
Danish: Druesmag:
English: Each 20 ml vial contains 12.5 ml (10 mg sildenafil, as citrate).
Danish: Et 20 ml hætteglas indeholder 12,5 ml (10 mg sildenafil som citrat)
English: Each ml of solution contains 0.8 mg of sildenafil (as citrate).
Danish: 1 ml indeholder 0,8 mg sildenafil (som citrat).
English: In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with oral Revatio (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day as tolerated) and epoprostenol, and 131 patients were treated with placebo and epoprostenol.
Danish: I et placebo-kontrolleret studie af Revatio som tillæg til intravenøs epoprostenol ved pulmonal arteriel hypertension blev i alt 134 patienter behandlet med oralt administreret Revatio (i en fastsat dosistitrering, der startede fra 20 mg 3 gange dagligt til 40 mg og herefter 80 mg 3 gange dagligt alt efter hvor godt det blev tolereret) og epoprostenol; 131 patienter blev behandlet med placebo og epoprostenol.
English: In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with Revatio (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day as tolerated) and epoprostenol, and 131 patients were treated with placebo and epoprostenol.
Danish: I et placebo-kontrolleret studie af Revatio som tillæg til intravenøs epoprostenol ved pulmonal arteriel hypertension blev i alt 134 patienter behandlet med Revatio (i en fast dosistitrering, der startede fra 20 mg 3 gange dagligt til 40 mg og herefter 80 mg 3 gange dagligt alt efter, hvor godt det blev tolereret) og epoprostenol; 131 patienter blev behandlet med placebo og epoprostenol.
English: One 20 ml vial contains 10 mg of sildenafil (as citrate).
Danish: Et 20 ml hætteglas indeholder 10 mg sildenafil (som citrat).
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 med HIV-proteasehæmmeren, ritonavir, som er en meget potent P450 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).
English: Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with oral 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 med HIV-proteasehæmmeren, ritonavir, som er en meget potent P450 hæmmer, ved steady-state (500 mg 2 gange dagligt) og enkeltdosis af oralt administreret 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).
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC.
Danish: Samtidig indgift med HIV-proteasehæmmeren saquinavir, en CYP3A4-hæmmer, ved steady-state (1200 mg 3 gange dagligt) og enkeltdosis sildenafil (100 mg) gav en stigning i sildenafils Cmax på 140% og en stigning i sildenafils plasma AUC på 210%.
English: Side effects reported uncommonly (may affect 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.
Danish: Ikke almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter) omfatter: nedsat skarpsyn, dobbeltsyn, unormal følelse i øjet, blødning fra penis, blod i sæden og/eller urinen og forstørrelse af brysterne hos mænd.
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with oral sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC.
Danish: Samtidig indgift med HIV-proteasehæmmeren saquinavir, en CYP3A4-hæmmer, ved steady-state (1.200 mg 3 gange dagligt) og oralt administreret enkeltdosis sildenafil (100 mg) gav en stigning i sildenafils Cmax på 140% og en stigning i sildenafils plasma AUC på 210%.
English: If you miss a dose of Revatio
Danish: Hvis De har fået for meget Revatio
English: Adverse reactions which occurred in > 1 % of Revatio-treated patients and were more frequent (> 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at oral doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1000 to ≤ 1/100) and not known (cannot be estimated from the available data).
Danish: Bivirkninger, der forekommer hos >1% af Revatio-behandlede patienter, og som er hyppigere (>1% forskel) for Revatio i pivotal-studiet eller i det Revatiokombinerede datasæt for begge placebokontrollerede studier med pulmonal arteriel hypertension i oralt administrerede doser på 20 mg, 40 mg eller 80 mg 3 gange dagligt, er anført i skemaet nedenfor.
English: Side effects reported uncommonly (may affect upto 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.
Danish: Ikke almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter) omfatter: nedsat skarpsyns, dobbeltsyn, unormal følelse i øjet, blødning fra penis, blod i sæden og/eller urinen og forstørrelse af brysterne hos mænd.
English: Each 20 ml vial contains 12.5 ml of solution (10 mg of sildenafil, as citrate).
Danish: Hvert 20 ml hætteglas indeholder 12,5 ml injektionsvæske (10 mg sildenafil som citrat).
English: After reconstitution: Store below 30°C or in refrigerator at 2°C to 8°C.
Danish: Efter rekonstituering: Opbevares ved temperaturer under 30
English: Store below 30°C or in refrigerator at 2ºC to 8°C.
Danish: oC eller i køleskab (2 oC-8
English: Each 20 ml vial contains 10 mg sildenafil (as citrate).
Danish: Hvert 20 ml hætteglas indeholder 10 mg sildenafil (som citrat).
English: Adverse reactions which occurred in > 1 % of Revatio-treated patients and were more frequent (> 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
Danish: Bivirkninger, der forekommer hos >1% af Revatio-behandlede patienter, og som er hyppigere (>1% forskel) for Revatio i pivotal-studiet eller i det Revatiokombinerede datasæt for begge placebokontrollerede studier med pulmonal arteriel hypertension i doser på 20 mg, 40 mg eller 80 mg 3 gange dagligt, er anført i skemaet nedenfor.