FrancophonIA/ELRC3.0 huggingface dataset:
English: In healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
Slovenian: Pri zdravih moških prostovoljcih ni bilo opaziti učinkov azitromicina (3 dni po 500 mg na dan) na AUC, Cmax, tmax, konstanto hitrosti eliminacije ali na poznejši razpolovni čas sildenafila oz.
English: Therefore, caution is recommended in case of co-administration.
Slovenian: Zato je v primeru sočasne uporabe potrebna previdnost.
English: Limited data suggest that the abrupt discontinuation of sildenafil is not associated with rebound worsening of pulmonary arterial hypertension.
Slovenian: Omejeni podatki kažejo, da nenadne prekinitve uporabe zdravila sildenafil spremlja povratno poslabšanje pljučne arterijske hipertenzije.
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.
Slovenian: Sildenafil (50 mg) ni stopnjeval hipotenzivnih učinkov alkohola pri zdravih prostovoljcih, ki so imeli povprečno največjo koncentracijo alkohola v krvi 80 mg/dl.
English: In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Slovenian: V majhni, s placebom nadzorovani študiji pri bolnikih s potrjeno zgodnjo starostno degeneracijo makule (n = 9) sildenafil v enkratnem 100 mg odmerku ni povzročil pomembnih sprememb na opravljenih preiskavah vida (ostrina vida, Amslerjeva mrežica, ločevanje barv na simuliranem semaforju, Humphreyev perimeter in fotostres).
English: Granpidam should not be given to women of child bearing potential unless using appropriate contraceptive methods.
Slovenian: Ženske v rodni dobi ne smejo uporabljati zdravila Granpidam, razen če uporabljajo ustrezno kontracepcijsko metodo.
English: Overall, the adverse events were generally similar between the two treatment groups (sildenafil plus bosentan vs. bosentan alone), and consistent with the known safety profile of sildenafil when used as monotherapy (see sections 4.4 and 4.5).
Slovenian: Na splošno so bili neželeni učinki med skupinama (sildenafil in bosentan v primerjavi s samim bosentanom) podobni in skladni z znanim varnostnim profilom sildenafila, kadar se uporablja kot samostojno zdravljenje (glejte poglavji 4.4 in 4.5).
English: - Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.
Slovenian: - zdravila, ki vsebujejo eritromicin, klaritromicin, telitromicin (antibiotiki za zdravljenje določenih bakterijskih okužb), sakvinavir (za HIV) ali nefazodon (za depresijo), kajti morda bo treba prilagoditi odmerek.
English: In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease.
Slovenian: Pri bolnikih s pljučno arterijsko hipertenzijo lahko obstaja večje tveganje za krvavitev v primeru uvedbe zdravljenja s sildenafilom pri bolnikih, ki že uporabljajo antagonist vitamina K; to še zlasti velja za bolnike s pljučno arterijsko hipertenzijo, ki je posledica bolezni vezivnega tkiva.
English: The efficacy of sildenafil has not been established in patients with severe pulmonary arterial hypertension (functional class IV).
Slovenian: Učinkovitost zdravila sildenafil ni ugotovljena pri bolnikih s hudo pljučno arterijsko hipertenzijo (funkcijski razred IV).
English: Of the subjects who completed the initial study, 242 entered a long-term extension study.
Slovenian: Od preiskovancev, ki so dokončali začetno študijo, so jih 242 vključili v dolgoročno podaljšano študijo.
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.
Slovenian: Pri bolnikih z izhodiščno prehojeno razdaljo ≥ 325 metrov je bil učinek zdravljenja 38,4 metra v korist sildenafila; pri bolnikih z izhodiščno prehojeno razdaljo < 325 metrov je bil učinek zdravljenja 2,3 metra v korist placeba.
English: These were the only factors with a statistically significant impact on sildenafil pharmacokinetics in patients with pulmonary arterial hypertension.
Slovenian: To so bili edini dejavniki, ki so pri bolnikih s pljučno arterijsko hipertenzijo statistično značilno vplivali na farmakokinetiko sildenafila.
English: The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as add-on therapy, and neither was arginine supplementation.
Slovenian: Uporaba prostaciklina, prostaciklinskih analogov in antagonistov endotelinskih receptorjev kot dodatno zdravljenje ni bilo dovoljeno, prav tako ne dodajanje arginina.
English: Patients should not take a double dose to compensate for the missed dose.
Slovenian: Bolniki naj v primeru pozabljenega odmerka ne vzamejo dvojnega odmerka.
English: Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated (see sections 4.8 and 5.1).
Slovenian: Ocenjena je bila sočasna uporaba peroralnega sildenafila in intravenskega epoprostenola (glejte poglavji 4.8 in 5.1).
English: No interactions were observed between sildenafil (100 mg single dose) and acenocoumarol.
Slovenian: Med sildenafilom (posamičen odmerek 100 mg) in acenokumarolom niso opazili nobenih interakcij.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Granpidam, before driving or using machines.
Slovenian: V kliničnih preskušanjih s sildenafilom so poročali o omotici in spremembah vida, zato morajo biti bolniki pred vožnjo ali upravljanjem s stroji seznanjeni, kako lahko zdravilo Granpidam nanje vpliva.
English: Granpidam is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Slovenian: Zdravilo Granpidam je kontraindicirano pri bolnikih s hudo okvaro jeter (razred C po ChildPughu) (glejte poglavje 4.3).
English: Granpidam 20 mg film-coated tablets are provided in PVC/Alu blister packs containing 90 tablets and in PVC/Alu blister packs containing 300 tablets.
Slovenian: Granpidam 20 mg filmsko-obložene tablete so na voljo v pretisnih omotih iz PVC/Alu, ki vsebujejo 90 tablet in pretisnih omotih iz PVC/Alu, ki vsebujejo 300 tablet.
English: Of those sildenafil treated subjects developmentally able to perform the CPET 59/114 subjects (52%) had not shown any deterioration in Peak VO2 from start of sildenafil.
Slovenian: Izmed tistih preiskovancev, zdravljenih s sildenafilom, ki so bili glede na razvoj sposobni opraviti CPET, pri 59 izmed 114 preiskovancev (52 %) niso ugotovili nobenih odstopanj pri največji vrednosti VO2 od začetka uporabe sildenafila.
English: For dose recommendations, see section 4.2.
Slovenian: Za priporočila o odmerjanju glejte poglavje 4.2.
English: Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
Slovenian: Posamičen peroralni odmerek sildenafila do 100 mg pri zdravih prostovoljcih ni povzročil klinično pomembnih sprememb EKG-ja.
English: Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension.
Slovenian: Zdravljenje pediatričnih bolnikov s pljučno arterijsko hipertenzijo, starih od 1 leta do 17 let.
English: When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.
Slovenian: Med uporabo za zdravljenje erektilne disfunkcije (ED) pri moških so v povezavi z inhibitorji PDE5, vključno s sildenafilom, poročali o naslednjih neželenih učinkih na vid, ki so se pojavili z neznano pogostnostjo: delno, nenadno, začasno ali trajno poslabšanje ali izguba vida na enem ali obeh očesih.
English: A total of 207 patients were treated with sildenafil in the pivotal study, and their long term survival status was assessed for a minimum of 3 years.
Slovenian: V ključni študiji je skupno 207 bolnikov dobivalo sildenafil, njihovo dolgoročno preživetje pa je bilo ocenjeno na minimalno 3 leta.
English: In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Slovenian: Pri prostovoljcih z blago do zmerno okvaro ledvic (očistek kreatinina = 30 do 80 ml/min) se farmakokinetika sildenafila po enem posamičnem 50 mg peroralnem odmerku ni spremenila.
English: Of the 277 subjects treated in the pivotal study, 259 entered a long-term extension study.
Slovenian: Od 277 preiskovancev, ki so bili vključeni v ključno študijo, jih je bilo 259 vključenih v dolgoročno podaljšano študijo.
English: In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Slovenian: Selektivnost sildenafila je za PDE5 več kot 4.000-krat večja kakor za PDE3 - za cAMP specifično izoobliko fosfodiesteraze, ki sodeluje pri nadzoru krčljivosti srca.
English: If you are not certain, ask your doctor or pharmacist.
Slovenian: Če niste prepričani, vprašajte zdravnika ali farmacevta.
English: 175 patients (63%) included were diagnosed with primary pulmonary hypertension, 84 (30%) were diagnosed with PAH associated with connective tissue disease and 18 (7%) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions.
Slovenian: 175 vključenih bolnikov (63 %) je imelo diagnosticirano primarno pljučno hipertenzijo, 84 (30 %) PAH, povezano z boleznimi vezivnega tkiva, in 18 (7 %) PAH po kirurški popravi prirojenih srčnih hib.
English: There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Slovenian: O interakcijah sildenafila z nespecifičnimi zaviralci fosfodiesteraze, kakršna sta teofilin ali dipiridamol, ni podatkov.
English: The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (e.g. ambrisentan, iloprost) has not been studied in controlled clinical trials.
Slovenian: Učinkovitost in varnost sočasne uporabe sildenafila in drugih zdravil za pljučno arterijsko hipertenzijo (npr. ambrisentana, iloprosta) nista bili raziskani v nadzorovanih kliničnih preskušanjih.
English: Subjects on active sildenafil therapy continued on the same treatment regimen, while those in the placebo group in the short-term study were randomly reassigned to sildenafil treatment.
Slovenian: Preiskovanci, ki so se zdravili z zdravilno učinkovino sildenafil, so nadaljevali z enakim režimom zdravljenja, medtem ko so bili preiskovanci, ki so v kratkoročni študiji prejemali placebo, randomizirani v skupine, ki so se zdravile s sildenafilom.
English: For patients with primary PAH, the treatment effect was 31.1 metres compared to 7.7 metres for patients with PAH associated with connective tissue disease.
Slovenian: Za bolnike s primarno PAH je bil učinek zdravljenja 31,1 metra, za bolnike s PAH, povezano z boleznimi vezivnega tkiva, pa 7,7 metra.
English: Effects of sildenafil on other medicinal products
Slovenian: Učinki sildenafila na druga zdravila
English: Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.
Slovenian: Zato lahko zaviralci teh izoencimov očistek sildenafila zmanjšajo, njihovi induktorji pa ga lahko povečajo.
English: Subjects (38% male and 62% female) had a body weight ≥8 kg, and had primary pulmonary hypertension (PPH) [33%], or PAH secondary to congenital heart disease [systemic-to-pulmonary shunt 37%, surgical repair 30%].
Slovenian: Preiskovanci (38 % moških in 62 % žensk) so imeli telesno maso ≥8 kg, in so imeli primarno pljučno hipertenzijo (PPH) [33 %] ali PAH kot posledico prirojenega srčnega obolenja [sistemsko-pljučni spoj 37 %, odprava težave s kirurškim posegom 30 %].
English: Bleeding disorders
Slovenian: Motnje strjevanja krvi
English: CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone are expected to have an effect in between that of ritonavir and CYP3A4 inhibitors like saquinavir or erythromycin, a seven-fold increase in exposure is assumed.
Slovenian: Pričakovati je, da imajo zaviralci CYP3A4, kot so klaritromicin, telitromicin in nefazodon, učinek, ki je med učinkom ritonavirja in učinkom zaviralcev CYP3A4, kot so sakvinavir ali eritromicin; predpostavljajo sedemkratno povečanje izpostavljenosti.
English: In this trial, 63 of 234 (27%) patients were <7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73%) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
Slovenian: V tem preskušanju je bilo 63 od 234 (27 %) bolnikov starih < 7 let (majhen odmerek sildenafila = 2; srednji odmerek = 17; velik odmerek = 28; placebo = 16), 171 od 234 (73 %) bolnikov pa je bilo starih 7 let ali več (majhen odmerek sildenafila = 40; srednji odmerek = 38; in velik odmerek = 49; placebo = 44).
English: Granpidam contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Slovenian: Zdravilo Granpidam vsebuje zdravilno učinkovino sildenafil, ki sodi med zdravila, ki jih imenujemo zaviralci fosfodiesteraze tipa 5 (PDE5).
English: - if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).
Slovenian: - če ste kadarkoli izgubili vid zaradi motene prekrvavitve očesnega živca; to motnjo imenujemo nearteritična anteriorna ishemična optična nevropatija (NAION).
English: Significant improvements in functional class were demonstrated only in subjects on sildenafil high dose compared to placebo.
Slovenian: Pomembna izboljšanja pri funkcijskem razredu so ugotovili le pri preiskovancih, ki so prejemali velik odmerek sildenafila v primerjavi s placebom.
English: If you forget to take Granpidam
Slovenian: Če ste pozabili vzeti zdravilo Granpidam
English: Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Slovenian: Zdravi starejši prostovoljci (stari 65 let ali več) so imeli manjši očistek sildenafila, zato je bila koncentracija sildenafila in aktivnega N-dezmetilnega presnovka v plazmi pri njih približno 90 % večja kot pri mlajših zdravih prostovoljcih (starih od 18 do 45 let).
English: In the placebo-controlled study of sildenafil in patients 1 to 17 years of age with pulmonary arterial hypertension, a total of 174 patients were treated three times a day with either low (10 mg in patients >20 kg; no patients ≤20 kg received the low dose), medium (10 mg in patients ≥8-20 kg; 20 mg in patients ≥20-45 kg; 40 mg in patients >45 kg) or high dose (20 mg in patients ≥8-20 kg; 40 mg in patients ≥20-45 kg; 80 mg in patients >45 kg) regimens of sildenafil and 60 were treated with placebo.
Slovenian: V s placebom nadzorovani študiji sildenafila pri bolnikih, starih od 1 leta do 17 let, s pljučno arterijsko hipertenzijo, je skupno 174 bolnikov trikrat na dan prejemalo bodisi majhen odmerek (10 mg pri bolnikih s telesno maso > 20 kg; noben bolnik s telesno maso ≤20 kg ni prejemal majhnega odmerka), ali srednji odmerek (10 mg pri bolnikih s telesno maso ≥8-20 kg; 20 mg pri bolnikih s telesno maso ≥ 20-45 kg; 40 mg pri bolnikih s telesno maso > 45 kg), bodisi velik odmerek (20 mg pri bolnikih s telesno maso ≥ 8-20 kg; 40 mg pri bolnikih s telesno maso ≥20-45 kg; 80 mg pri bolnikih s telesno maso > 45 kg) sildenafila, 60 bolnikov pa je prejemalo placebo.
English: Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Slovenian: Pri bolnikih, ki so izgubili vid na enem očesu zaradi nearteritične anteriorne ishemične optične nevropatije (NAION), ne glede na to ali je ta dogodek bil povezan s predhodnim jemanjem zaviralcev PDE5 ali ne (glejte poglavje 4.4).
English: Vaso-occlusive crises in patients with sickle cell anaemia Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia.
Slovenian: Vazookluzivne krize pri bolnikih z anemijo srpastih celic Sildenafila se ne sme uporabljati pri bolnikih s pulmonarno hipertenzijo in spremljajočo anemijo srpastih celic.
English: Patients were naïve for specific PAH therapy and the use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted in the study, and neither was arginine supplementation, nitrates, alpha-blockers and potent CYP450 3A4 inhibitors.
Slovenian: Bolniki pred tem niso bili deležni nikakršnega posebnega zdravljenja PAH, uporaba prostaciklina, prostaciklinskih analogov in antagonistov endotelinskih receptorjev med študijo ni bila dovoljena, prav tako pa ni bila dovoljena sočasna uporaba arginina, nitratov, antagonistov adrenergičnih receptorjev alfa in močnih zaviralcev CYP450 3A4.
English: The recommended dose is 20 mg three times a day (TID).
Slovenian: Priporočeni odmerek je 20 mg trikrat na dan.
English: Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, St John's wort and rifampicine.
Slovenian: Učinkovitost sildenafila je treba natančno nadzirati pri bolnikih, ki sočasno uporabljajo močne induktorje CYP3A4, npr. karbamazepin, fenitoin, fenobarbital, šentjanževko ali rifampicin.
English: There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance.
Slovenian: Sildenafil je v primerjavi s placebom statistično pomembno koristil, kar zadeva razdaljo, prehojeno v 6 minutah.
English: Studies with sildenafil have been performed in forms of pulmonary arterial hypertension related to primary (idiopathic), connective tissue disease associated or congenital heart disease associated forms of PAH (see section 5.1).
Slovenian: Študije s sildenafilom so izvedli pri oblikah pljučne arterijske hipertenzije, ki je bila sorodna primarni (idiopatski), povezana z boleznimi vezivnega tkiva ali sorodna oblikam PAH, povezanim s prirojenim srčnim obolenjem (glejte poglavje 5.1).
English: In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Slovenian: V specifični interakcijski študiji, v kateri so hipertenzivni bolniki dobivali sildenafil (100 mg) sočasno z amlodipinom, se je sistolični krvni tlak v ležečem položaju dodatno znižal za 8 mmHg.
English: Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
Slovenian: Sildenafil (50 mg) ni dodatno podaljšal časa krvavitve, podaljšanega zaradi acetilsalicilne kisline (150 mg).
English: For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4.3.
Slovenian: Za uporabo sildenafila skupaj z najmočnejšimi zaviralci encima CYP3A4 glejte poglavje 4.3.
English: The difference in results between these randomisation subgroups may have arisen by chance in view of their limited sample size.
Slovenian: Glede na majhno velikost vzorca je razlika v rezultatih med tema randomiziranima podskupinama lahko nastala slučajno.
English: In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (>70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Slovenian: V študiji hemodinamskih učinkov posamičnega 100 mg peroralnega odmerka sildenafila pri 14 bolnikih s hudo boleznijo koronarnih arterij (> 70 % stenoza vsaj ene koronarne arterije) se je povprečni sistolični tlak v mirovanju v primerjavi z izhodiščem znižal za 7 %, povprečni diastolični v mirovanju pa za 6 %.
English: Adverse reactions reported in >10% of 229 subjects treated with sildenafil (combined dose group, including 9 patients that did not continue into the long-term study) were upper respiratory infection (31%), headache (26%), vomiting (22%), bronchitis (20%), pharyngitis (18%), pyrexia (17%), diarrhoea (15%), and influenza, epistaxis (12% each).
Slovenian: Neželeni učinki, o katerih so poročali pri > 10 % od 229 preiskovancev, zdravljenih s sildenafilom (skupina z vsemi odmerki, vključno z 9 bolniki, ki niso nadaljevali v dolgoročno študijo), so bili okužba zgornjih dihal (31 %), glavobol (26 %), bruhanje (22 %), bronhitis (20 %), faringitis (18 %), pireksija (17 %), diareja (15 %), gripa in epistaksa (oba 12 %).
English: The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied.
Slovenian: Farmakokinetika sildenafila pri bolnikih s hudo okvarjenim delovanjem ledvic ni raziskana.
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.
Slovenian: Pri klinično pomembnih ravneh izpostavljenosti na živalih ni bilo neželenih učinkov, ki bi lahko bili povezani s klinično uporabo, in ki ne bi bili opaženi tudi pri kliničnih študijah.
English: Adverse reactions which occurred in >1% of sildenafil-treated patients and were more frequent (>1% difference) on sildenafil in the pivotal study or in the sildenafil 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 (≥1/1,000 to ≤1/100) and not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki, ki so se pojavili pri > 1 % bolnikov, zdravljenih s sildenafilom, ter so bili v ključni študiji oziroma v združenih podatkih iz obeh s placebom nadzorovanih študij pljučne arterijske hipertenzije ob odmerkih 20, 40 ali 80 mg trikrat na dan pogostejši pri jemanju sildenafila (razlika > 1 %), so prikazani v spodnji preglednici po organskem sistemu in pogostnosti: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do ≤ 1/100) in neznana (ni mogoče oceniti iz podatkov, ki so na voljo).
English: Patients with left ventricular ejection fraction <45% or left ventricular shortening fraction <0.2 were not studied.
Slovenian: Študija ni proučevala bolnikov z iztisnim deležem levega prekata < 45 % ali skrčitvenim deležem levega prekata < 0,2.
English: The known adverse reactions headache, flushing, pain in extremity and oedema were noted in a higher frequency in sildenafil/epoprostenol treated patients compared to placebo/epoprostenol treated patients.
Slovenian: Znani neželeni učinki glavobol, zardevanje, bolečine v udih in edemi so bili pogostejši pri bolnikih, ki so dobivali sildenafil/epoprostenol, kot pri tistih, ki so dobivali placebo/epoprostenol.
English: Skin and subcutaneous tissue disorders Common alopecia, erythema, night sweats
Slovenian: Bolezni kože in podkožja pogosti alopecija, eritem, nočno znojenje