FrancophonIA/ELRC3.0 huggingface dataset:
English: A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favour of sildenafil (95% CI: -5.7, -2.1) (p = 0.00003).
Danish: Der blev set en gennemsnitlig placebo-korrigeret behandlingseffekt på -3,9 mmHg til fordel for sildenafil (95% CI: -5,7, -2,1) (p=0,00003).
English: Population pharmacokinetic analysis of pulmonary arterial hypertension clinical trial data indicated a reduction in sildenafil clearance and/or an increase of oral bioavailability when co-administered with CYP3A4 substrates and the combination of CYP3A4 substrates and beta-blockers.
Danish: Populationsfarmakokinetiske analyser af kliniske undersøgelsesdata af pulmonal arteriel hypertension tyder på en reduktion af sildenafils clearance og/eller en stigning i oral biotilgængelighed, ved administration sammen med CYP3A4-substrater og kombinationen af CYP3A4-substrater og betablokkere.
English: Effects of sildenafil on other medicinal products
Danish: Virkninger af sildenafil på andre lægemidler In vitro studier
English: Most patients were WHO Functional Class II (107/277, 39%) or III (160/277, 58%) with a mean baseline 6 minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4%) or IV (9/277, 3%) at baseline.
Danish: De fleste patienter var ved baseline klassificeret i WHO-funktionsklasse II (107/277, 39%) eller III (160/277, 58%) med en gennemsnitlig 6 minutters gangdistance på hhv. 378 meter og 326 meter ved baseline; færre patienter var i klasse I (1/277, 0,4%) eller IV (9/277, 3%) ved baseline.
English: For dose recommendations, see sections 4.2 and 4.3.
Danish: 4.2 og 4.4).
English: The most common serious adverse events that occurred with a frequency ≥1% in sildenafil patients (combined doses) were pneumonia (7.4%), cardiac failure, pulmonary hypertension (each 5.2%), upper respiratory tract infection (3.1%), right ventricular failure, gastroenteritis (each 2.6%), syncope, bronchitis, bronchopneumonia, pulmonary arterial hypertension (each 2.2%), chest pain, dental caries (each 1.7%), and cardiogenic shock, gastroenteritis viral, urinary tract infection (each 1.3%).
Danish: De hyppigste alvorlige bivirkninger, som forekom med en frekvens ≥1% hos sildenafilpatienter (alle doser), var pneumoni (7,4%), hjertesvigt og pulmonal hypertension (hver 5,2%), infektion i øvre luftveje, (3,1%), svigt af højre ventrikel og gastroenteritis (hver 2,6%), synkope, bronkitis, bronkopneumoni og pulmonal arteriel hypertension (hver 2,2%), brystsmerter og dental caries (hver 1,7%) samt kardiogent shock, viral gastroenteritis og urinvejsinfektion (hver 1,3%).
English: In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) sildenafil clearance was reduced, resulting in increases in AUC (85%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
Danish: Hos frivillige forsøgspersoner med let til moderat levercirrhose (Child-Pugh klasse A og B) reduceres sildenafils clearance, hvilket giver stigninger i AUC (85%) og Cmax (47%) sammenlignet med frivillige forsøgspersoner i samme alderskategori uden nedsat leverfunktion.
English: Differences in 6MWD were observed between patients with primary PAH and PAH associated with connective tissue disease.
Danish: Der blev set forskelle i 6MWD hos patienter med primær PAH og patienter med PAH forbundet med bindevævssygdom.
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: Subjects were allocated to one of three sildenafil treatment groups, low (10 mg), medium (10-40 mg) or high dose (20-80 mg) regimens of sildenafil given three times a day, or placebo.
Danish: Forsøgspersonerne blev allokeret til en af tre sildenafil-behandlingsgrupper: lav- (10 mg), middel- (1040 mg) eller højdosis (20-80 mg) regimer med sildenafil administreret 3 gange dagligt eller placebo.
English: Mean baseline peak volume of oxygen consumed (VO2) values were comparable across the sildenafil treatment groups (17.37 to 18.03 ml/kg/min), and slightly higher for the placebo treatment group (20.02 ml/kg/min).
Danish: Det gennemsnitlige maksimale iltforbrug (VO2) ved baseline var sammenligneligt i de 3 sildenafilgrupper (17,37-18,03 ml/kg/minut) og lidt højere i placebogruppen (20,02 ml/kg/minut).
English: For adults, the recommended dose is 20 mg three times a day (taken 6 to 8 hours apart) taken with or without food.
Danish: Til voksne er den sædvanlige dosis 20 mg 3 gange dagligt (taget med 6-8 timers mellemrum).
English: At single doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased.
Danish: Ved enkeltdoser på 200 mg ses øget incidens af bivirkninger (hovedpine, ansigtsrødme, svimmelhed, dyspepsi, tilstopning af næsen og synsforstyrrelser).
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200% and 79% respectively in subjects with severe renal impairment compared to subjects with normal renal function.
Danish: Herudover er AUC og Cmax- værdierne for N-desmethylmetabolitten signifikant forhøjede, med hhv. 200% og 79% hos forsøgspersoner med svært nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
English: No data are available with sildenafil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
Danish: Der er ikke tilgængelige data vedrørende sildenafil til patienter med pulmonal hypertension i forbindelse med pulmonal veneokklusiv sygdom.
English: Newly reported adverse reactions, which occurred more frequently in the sildenafil/ epoprostenol group, were ocular hyperaemia, vision blurred, nasal congestion, night sweats, back pain and dry mouth.
Danish: De senest rapporterede bivirkninger, som forekommer hyppigere i sildenafil/epoprostenolgruppen, er okulær hyperæmi, sløret syn, tilstopning af næsen, svedtendens om natten, rygsmerter og mundtørhed.
English: Granpidam should not be given to women of child bearing potential unless using appropriate contraceptive methods.
Danish: Granpidam må ikke gives til kvinder i den fødedygtige alder, medmindre der anvendes sikker prævention.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PRIMÆR EMBALLAGE/BLISTER
English: After chronic 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 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: A mean placebo corrected increase in walk distance of 26 metres was observed in favour of sildenafil (95% CI: 10.8, 41.2) (p = 0.0009).
Danish: Der blev set en gennemsnitlig placebo-korrigeret øgning i gangdistancen på 26 meter til fordel for sildenafil (95% CI: 10,8, 41,2) (p=0,0009).
English: Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Danish: Sildenafil metaboliseres hovedsageligt af CYP3A4 (primær vej) og CYP2C9 (sekundær vej) mikrosomale leverisoenzymer.
English: Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated (see section 4.3).
Danish: Samtidig brug af riociguat med PDE5-hæmmere, inklusive sildenafil, er kontraindikeret (se pkt.
English: Prolonged erections and priapism have been reported with sildenafil in post-marketing experience.
Danish: Efter markedsføringen er der rapporteret forlænget erektion og priapisme ved brug af sildenafil.
English: Significant improvements in functional class were demonstrated only in subjects on sildenafil high dose compared to placebo.
Danish: Signifikant forbedring i funktionsklasse sås kun hos forsøgspersonerne i højdosis-gruppen sammenlignet med placebo.
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: Combination with the most potent of the CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) (see section 4.5).
Danish: Kombination med de mest potente af CYP3A4-hæmmerne (f.eks. ketoconazol, itraconazol, ritonavir) (se pkt.
English: There were no adverse reactions, with possible relevance to clinical use, seen in animals at clinically relevant exposure levels which were not also observed in clinical studies.
Danish: Efter eksponering, der svarer til human-terapeutiske doser, blev der i dyreforsøg ikke set bivirkninger, der anses for relevante for den kliniske anvendelse, som ikke også var set i kliniske forsøg.
English: Odds ratios for the sildenafil low, medium and high dose groups compared to placebo were 0.6 (95% CI: 0.18, 2.01), 2.25 (95% CI: 0.75, 6.69) and 4.52 (95% CI: 1.56, 13.10), respectively.
Danish: Odds ratio for lav-, middel- og højdosis-grupperne sammenlignet med placebo var hhv. 0,6 (95% CI: 0,18 2,01), 2,25 (95% CI: 0,75 6,69), og 4,52 (95% CI: 1,56 13,10).
English: Co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form due to the hypotensive effects of nitrates (see section 5.1).
Danish: Samtidig behandling med nitrogenoxiddonorer (som amylnitrit) eller enhver form for nitrater pga. nitraters hypotensive virkning (se pkt.
English: Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Danish: Virkningen er set ved primær pulmonal hypertension og ved pulmonal hypertension i forbindelse med bindevævssygdom.
English: At 3 years 87% of the patients were receiving a dose of 80 mg TID.
Danish: Efter 3 år fik 87% af patienterne en dosis på 80 mg 3 gange dagligt.
English: Common gastritis, gastrooesophageal reflux disease, haemorrhoids, abdominal distension, dry mouth
Danish: Almindelig gastritis, gastroøsofageal reflukssygdom, hæmorroider, oppustet abdomen, mundtørhed
English: Patients using other medicinal products
Danish: Patienter, som får anden medicin
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 samt forstørrelse af brysterne hos mænd.
English: Special populations
Danish: Særlige patientpopulationer
English: Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients (see section 4.3).
Danish: På baggrund af resultaterne af disse farmakokinetiske studier er samtidig indgift af sildenafil og ritonavir kontraindiceret hos patienter med pulmonal arteriel hypertension (se pkt.
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. Granpidam kan tages sammen med eller uden mad.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Granpidam nøjagtigt efter lægens anvisning.
English: In a placebo-controlled study of sildenafil as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with sildenafil (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 sildenafil som tillæg til intravenøs epoprostenol ved pulmonal arteriel hypertension blev i alt 134 patienter behandlet med sildenafil (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: Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers (see section 4.5).
Danish: Dosisjustering af sildenafil kan være påkrævet ved samtidig anvendelse af CYP3A4-induktorer (se pkt.
English: There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration.
Danish: Der er ingen sikkerhedsinformation vedrørende anvendelsen af sildenafil til patienter med blødningslidelser eller aktive sår i mave-tarmkanalen.
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: In the pivotal placebo-controlled study of sildenafil 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 sildenafil and 70 patients were randomized to placebo.
Danish: I det pivotale placebo-kontrollerede studie af sildenafil ved pulmonal arteriel hypertension blev i alt 207 patienter randomiseret til behandling med 20 mg, 40 mg eller 80 mg sildenafil 3 gange dagligt, og 70 patienter blev randomiseret til placebo.
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: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154% and 87%, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Danish: N-desmethylmetabolitten er yderligere signifikant forhøjet med hhv. 154% og 87% hos cirrotiske forsøgspersoner sammenlignet med forsøgspersoner med normal leverfunktion.
English: Granpidam 20 mg film-coated tablets sildenafil
Danish: Granpidam 20 mg filmovertrukne tabletter Sildenafil
English: Long term extension data
Danish: Data fra langvarige studier, der blev forlænget
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 (62,5125 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: Actual doses administered within a group were dependent on body weight (see Section 4.8).
Danish: Dosis inden for hver gruppe afhang af legemsvægt (se pkt.
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 sildenafils clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på hhv. 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
English: Efficacy and safety in adult patients with PAH (when used in combination with bosentan) A randomized, double-blind, placebo controlled study was conducted in 103 clinically stable subjects with PAH (WHO FC II and III) who were on bosentan therapy for a minimum of three months.
Danish: Et randomiseret dobbelt-blindt, placebo-kontrolleret studie blev udført hos 103 klinisk stabile patienter med PAH (WHO FC II og III), som havde fået behandling med bosentan i mindst 3 måneder.
English: What Granpidam contains - The active substance is sildenafil.
Danish: Aktivt stof: sildenafil.
English: When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose group.
Danish: En statistisk signifikant stigning i 6MWD blev set i 20 mg dosisgruppe efter analyse i henhold til WHO-funktionsklasse.
English: At 3 years 68% of the patients were receiving a dose of 80 mg TID.
Danish: Efter 3 år fik 68% af patienterne en dosis på 80 mg 3 gange dagligt.
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 i forbindelse med indtagelse af sildenafil og andre PDE5hæmmere (se pkt.
English: Uncommon visual acuity reduced, diplopia, abnormal sensation in eye
Danish: Ikke almindelig uskarpt syn, dobbeltsyn, usædvanlig følelse i øjet
English: Doses up to 80 mg TID were administered and after 3 years 68% of 133 patients on study treatment were receiving sildenafil 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 sildenafil 80 mg 3 gange dagligt.
English: The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil (20 mg three times a day) and placebo (13.62 m (95% CI: -3.89 to 31.12) and 14.08 m (95% CI: -1.78 to 29.95), respectively).
Danish: Resultaterne indikerer, at der ingen signifikant forskel er i den gennemsnitlige ændring fra baseline i 6MWD med sildenafil (20 mg 3 gange dagligt) sammenlignet med placebo (hhv. 13,62 m (95% CI: -3,89 til 31,12) og 14,08 m (95% CI: -1,78 til 29,95).
English: Cmax after a single 20 mg sildenafil dose administered PO was estimated at 49, 104 and 165 ng/ml for 70, 20 and 10 kg patients, respectively.
Danish: Efter enkeltdosis på 20 mg oral sildenafil blev Cmax estimeret til hhv. 49, 104 og 165 ng/ml for patienter, der vejede 70, 20 og 10 kg.
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: 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: Middel- og 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: 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: 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 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: Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals (see section 4.4).
Danish: Samtidig administration af sildenafil hos patienter, der er i alfa-blokker-behandling, kan hos følsomme patienter føre til symptomatisk hypotension (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Granpidam 20 mg tablets sildenafil
Danish: LÆGEMIDLETS NAVN Granpidam 20 mg tabletter Sildenafil
English: High dose (n=27)
Danish: Lavdosis (n=24) Middeldosis (n=26) Højdosis (n=27) Total (n=77)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Lægemidlet bør derfor ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: If you are taking riociguat or are unsure tell your doctor.
Danish: Tal med Deres læge hvis De tager riociguat eller er usikker.
English: Population pharmacokinetics
Danish: Populationsfarmakokinetik
English: Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) and -320 dyne.sec/cm5 (p<0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID,
Danish: Placebokorrigeret behandlingseffekt af PVR var -178 dyn.sek/cm5 (p=0,0051), -195 dyn.sek/cm5 (p=0,0017) og -320 dyn.sek/cm5 (p<0,0001) for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt.
English: Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease (see section 5.1).
Danish: Virkning i form af forbedret fysisk funktionsniveau eller pulmonal hæmodynamik er set ved primær pulmonal hypertension og ved pulmonal hypertension i forbindelse med kongenit hjertesygdom (se pkt.
English: cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
Danish: har unormale røde blodlegemer (seglcelleanæmi), blodkræft (leukæmi), knoglemarvskræft (myelomatose/multipelt myelom) har en hvilken som helst sygdom eller deformitet af penis.