natgillin/translations-raw huggingface dataset:
The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients. 
Tableta od 20 mg se ne smije koristiti u slučajevima kada treba primijeniti 10 mg tri puta na dan u mlađih bolesnika.
Prolonged and sometimes painful erections have been reported in men after taking sildenafil. 
Produljene i ponekad bolne erekcije zabilježene su u muškaraca nakon uzimanja sildenafila.
Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30 ml/min). 
Nije potrebno prilagođavati početnu dozu u bolesnika s oštećenjem funkcije bubrega, uključujući i teško oštećenje funkcije bubrega (klirens kreatinina < 30 ml/min).
At the recommended dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen. 
Pri preporučenoj dozi od 20 mg tri puta na dan nije zabilježeno sniženje sistoličkog ni dijastoličkog tlaka.
For dose recommendations, see section 4.2. 
Za preporuke o doziranju vidjeti dio 4.2.
PVC/Alu blisters of 90 tablets. 
PVC/alu blisteri sa 90 tableta.
The primary objective of the study was to assess the efficacy of 16 weeks of chronic treatment with oral sildenafil in paediatric subjects to improve exercise capacity as measured by the Cardiopulmonary Exercise Test (CPET) in subjects who were developmentally able to perform the test, n = 115). 
Primarni cilj istraživanja bio je procijeniti djelotvornost 16-tjednog kroničnog peroralnog liječenja sildenafilom u pedijatrijskih ispitanika na poboljšanje tjelesne sposobnosti, mjereno testom srčano plućnog opterećenja (CPET test) u ispitanika koji su s obzirom na stupanj razvoja bili sposobni izvestitaj test (n = 115).
Sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 µg and levonorgestrel 150 µg). 
Sildenafil nije imao klinički značajan utjecaj na koncentracije oralnih kontraceptiva u plazmi (etinilestradiol 30 µg i levonorgestrel 150 µg).
If you have an erection, which lasts continuously for more than 4 hours, stop taking Granpidam and contact your doctor immediately (see also section 4). 
Ako imate erekciju, koja neprekidno traje dulje od 4 sata, prestanite uzimati Granpidam i odmah se javite liječniku (pogledajte i dio 4).
Granpidam should not be given to women of child bearing potential unless using appropriate contraceptive methods. 
Granpidam se ne smije davati ženama reproduktivne dobi ako ne koriste odgovarajuće metode kontracepcije.
Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil. 
Pojedinačne doze antacida (magnezijev hidroksid/aluminijev hidroksid) nisu utjecale na bioraspoloživost sildenafila.
After chronic dosing of 80 mg three times a day to patients with pulmonary arterial hypertension no clinically relevant effects on the ECG were reported. 
Nakon dugotrajne primjene doze od 80 mg tri puta na dan u bolesnika s plućnom arterijskom hipertenzijom nisu prijavljeni klinički značajni učinci na EKG.
If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result (see section 4.8). 
Ako se prijapizam na liječi odmah, može doći do oštećenja tkiva penisa i trajnog gubitka potencije (vidjeti dio 4.8).
The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. 
Pretpostavlja se da je mehanizam ove promjene u razlikovanju boja povezan s inhibicijom enzima PDE6, koji je uključen u fototransdukcijsku kaskadu u mrežnici.
Patients enrolled into the pivotal study were eligible to enter a long term open label extension study. 
Bolesnici uključeni u pivotalno ispitivanje bili su pogodni za ulazak u dugotrajan produžetak otvorenog ispitivanja.
Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, change in background treatment, and quality of life measurements. 
Sekundarne ishodi obuhvaćali su praćenje hemodinamičkog statusa, procjenu simptoma, SZO funkcionalni stupanj, promjene osnovne terapije i mjerila kvalitete života.
Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg). 
Sildenafil (50 mg) nije potencirao produljenje vremena krvarenja uzrokovano acetilsalicilatnom kiselinom (150 mg).
Of the 234 paediatric subjects treated in the short-term, placebo-controlled study, 220 subjects entered the long-term extension study. 
Od 234 pedijatrijskih ispitanika liječenih u kratkotrajnom, placebom kontroliranom kliničkom ispitivanju, 220 ispitanika ušlo je u dugotrajan produžetak ispitivanja.
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). 
Zdravi stariji dobrovoljci (65 ili više godina) su imali smanjen klirens sildenafila, što je rezultiralo približno 90% višim plazmatskim koncentracijama sildenafila i aktivnog N-dezmetil metabolita u odnosu na one u zdravih mlađih dobrovoljaca (18-45 godina).
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. 
U dobrovoljaca s blagim do umjerenim oštećenjem funkcije bubrega (klirens kreatinina = 30-80 ml/min) farmakokinetika sildenafila nije se promijenila nakon jedne peroralne doze od 50 mg.
Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. 
Sildenafil, stoga, povećava cGMP-a u glatkim mišićnim stanicama krvnih žila u plućima, što dovodi do njihova opuštanja.
This medicine should be used only in case of administration of 20 mg three times a day. 
Ovaj lijek treba uzimati samo kada se radi o primjeni 20 mg tri puta na dan.
Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. 
Ispitivanja na ljudskim trombocitima pokazuju da sildenafil pojačava antiagregacijski učinak natrijevog nitroprusida in vitro.
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). 
U malom, placebom kontroliranom ispitivanju u bolesnika s dokumentiranom, ranom, dobno uvjetovanom degeneracijom makule (n = 9), sildenafil (jedna doza od 100 mg) nije pokazao značajne promjene u provedenim testovima vida (oštrina vida, Amslerova mreža, razlikovanje boja simulacijom semafora, Humphreyev perimetar i fotostres test).
Other pharmaceutical forms may be more appropriate for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets. 
Drugi farmaceutski oblici mogu biti primjereniji za primjenu kod bolesnika koji imaju 20 kg ili manje i kod drugih mlađih bolesnika koji ne mogu progutati tablete.
However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients. 
Međutim, prijavljeni su slučajevi po život opasnog plućnog edema kod primjene vazodilatatora (uglavnom prostaciklina) u tih bolesnika.
Patients with left ventricular ejection fraction <45% or left ventricular shortening fraction <0.2 were not studied. 
Bolesnici s istisnom frakcijom lijeve klijetke od < 45% ili frakcijom skraćenja lijeve klijetke od < 0,2 nisu ispitivani.
Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with pulmonary arterial hypertension compared to healthy volunteers. 
Oba nalaza upućuju na manji klirens i/ili veću bioraspoloživost sildenafila nakon peroralne primjene u bolesnika s plućnom arterijskom hipertenzijom u odnosu na zdrave dobrovoljce.
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. 
U specifičnom ispitivanju interakcije, u kojemu se sildenafil (100 mg) primjenjivao zajedno s amlodipinom u hipertenzivnih bolesnika, zabilježeno je dodatno sniženje sistoličkog krvnog tlaka u ležećem položaju od 8 mmHg.
Co-administration of oral contraceptives (ethinyloestradiol 30 µg and levonorgestrel 150 µg) did not affect the pharmacokinetics of sildenafil. 
Istovremena primjena oralnih kontraceptiva (etinilestradiol 30 µg i levonorgestrel 150 µg) nije utjecala na farmakokinetiku sildenafila.
Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B). 
Nije potrebno prilagođavati početnu dozu u bolesnika s oštećenjem funkcije jetre (Child-Pugh stadij A i B).
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. 
Granpidam 20 mg filmom obložene tablete isporučuju se u PVC/Alu blister pakiranjima koja sadrže 90 tableta i PVC/Alu blister pakiranjima koja sadrže 300 tableta.
Of the 94 subjects reporting a serious adverse event, 14/55 (25.5%) subjects were in the low dose group, 35/74 (47.3%) in the medium dose group, and 45/100 (45%) in the high dose group. 
Od 94 ispitanika koja su prijavila ozbiljnu nuspojavu, 14/55 (25,5%) ispitanika bili su u skupini s niskom dozom, 35/74 (47,3%) u skupini sa srednjom dozom, i 45/100 (45%) u skupini s visokom dozom.
The recommended dose is 20 mg three times a day (TID). 
Preporučena doza je 20 mg tri puta na dan.
If you forget to take Granpidam 
Ako ste zaboravili uzeti Granpidam
Granpidam is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3). 
Granpidam je kontraindiciran u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) (vidjeti dio 4.3).
The primary endpoint was the placebo-corrected percentage change in peak VO2 from baseline to week 16 assessed by CPET testing in the combined dose groups (Table 2). 
Primarni ishod bila je za placebo korigirana postotna promjena vršne vrijednosti VO2 od početka ispitivanja do 16. tjedna, procijenjena CPET testom u skupinama koje su primale kombinirane doze (Tablica 2).
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. 
175 uključenih bolesnika (63%) imalo je dijagnozu primarne plućne hipertenzije, 84 (30%) dijagnozu PAH-a povezanog s bolešću vezivnog tkiva, a 18 (7%) dijagnozu PAH-a nastalog nakon kirurškog popravka urođenih srčanih lezija.
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. 
U tri specifična ispitivanja interakcija, lijekovi alfa-blokator doksazosin (4 mg i 8 mg) i sildenafil (25 mg, 50 mg ili 100 mg) su istovremeno primijenjeni bolesnicima s benignom hiperplazijom prostate (BHP), stabiliziranima na terapiji doksazosinom.
This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). 
Ovaj lijek se koristi u liječenju plućne arterijske hipertenzije (kod visokog krvnog tlaka u plućima) i kronične tromboembolijske plućne hipertenzije (kod visokog krvnog tlaka u plućima kao posljedica stvaranja krvnih ugrušaka).
White to off white, round shaped, approximately 6.6 mm in diameter, biconvex, film-coated tablets, debossed with ‘20' on one side and plain on other side. 
Bijele do gotovo bijele, okrugle, bikonveksne, filmom obložene tablete promjera od približno 6,6 mm s utisnutom oznakom „20“ na jednoj strani i bez oznake na drugoj strani.
The efficacy of sildenafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.5 and 5.1). 
Djelotvornost sildenafila u bolesnika već liječenih bosentanom još nije sa sigurnošću dokazana (vidjeti dijelove 4.5 i 5.1).
Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day). 
Bolesnici su randomizirani u skupine sa placebom ili sa sildenafilom (20 mg tri puta na dan) u kombinaciji s bosentanom (62,5-125 mg dva puta na dan).
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). 
U tom ispitivanju, 63 od 234 (27%) bolesnika bila su mlađa od 7 godina (niska doza sildenafila = 2; srednja doza = 17; visoka doza = 28; placebo = 16), dok je 171 od 234 (73%) bolesnika imao 7 ili više godina (niska doza sildenafila = 40; srednja doza = 38, visoka doza = 49; placebo = 44).
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. 
Cimetidin (800 mg), inhibitor citokroma P450 i nespecifični inhibitor CYP3A4, izazvao je povećanje koncentracije sildenafila u plazmi od 56% kada je primijenjen istovremeno sa sildenafilom (50 mg) u zdravih dobrovoljaca.
The study population consisted of 68 (25%) men and 209 (75%) women with a mean age of 49 years (range: 18-81 years) and baseline 6-minute walk test distance between 100 and 450 metres inclusive (mean: 344 metres). 
Populaciju uključenu u ispitivanje činilo je 68 (25%) muškaraca i 209 (75%) žena, prosječne dobi od 49 godina (raspon: 18 do 81 godine), a početna 6-minutna postignuta udaljenost hodom bila je između 100 i 450 metara (prosječno: 344 metra).
The following serious adverse events were considered to be treatment related, enterocolitis, convulsion, hypersensitivity, stridor, hypoxia, neurosensory deafness and ventricular arrhythmia. 
Sljedeće ozbiljne nuspojave, za koje se smatra da su povezane s terapijom su enterokolitis, konvulzije, preosjetljivost, stridor, hipoksija, neurosenzorna gluhoća i ventrikularna aritmija.
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%]. 
Ispitanici (38% muškog i 62% ženskog spola) su imali tjelesnu težinu ≥8 kg, a imali su primarnu plućnu hipertenziju (PPH) [33%] ili PAH kao posljedicu urođene bolesti srca [sistemsko-plućni spoj u 37%, a kirurški zahvat u 30% slučajeva].
In pups of rats which were pre- and postnatally treated with 60 mg/kg sildenafil, a decreased litter size, a lower pup weight on day 1 and a decreased 4-day survival were seen at exposures which were approximately fifty times the expected human exposure at 20 mg three times a day. 
U mladunčadi štakora koji su prije i nakon okota primali 60 mg/kg sildenafila opaženi su smanjena veličina legla, manja težina mladunaca 1. dana te smanjeno 4-dnevno preživljenje, pri razinama izloženosti koje su bile približno 50 puta veće od očekivane izloženosti u ljudi pri dozi od 20 mg tri puta na dan.
Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. 
Liječenje odraslih bolesnika s plućnom arterijskom hipertenzijom (PAH) funkcionalnog stupnja II i III prema klasifikaciji Svjetske zdravstvene organizacije (SZO), a u cilju poboljšanja tjelesne sposobnosti.
23 subjects experienced clinical worsening events in the placebo group (17.6%) compared with 8 subjects in the sildenafil group (6.0%). 
U skupini koja je primala placebo epizode kliničkog pogoršanja doživjela su 23 ispitanika (17,6%), u usporedbi s 8 ispitanika u skupini liječenoj sildenafilom (6,0%).
Wessling Hungary Kft. Foti ut 56 
Wessling Hungary Kft.
Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. 
Sok od grejpa je slab inhibitor CYP3A4 u stijenci crijeva i može izazvati malo povećanje plazmatskih koncentracija sildenafila.
These medicines are often given for relief of angina pectoris or “chest pain” (see section 2. 
Ti se lijekovi često daju za ublažavanje angine pectoris, odnosno "boli u prsima" (vidjeti dio 2.
Table 2: Placebo Corrected % Change from Baseline in Peak VO2 by Active Treatment Group 
Tablica 2: Za placebo korigirana postotna (%) promjena vršnog VO2 u odnosu na početne vrijednosti po aktivno liječenim skupinama
The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. 
Odgovarajuće dodatno sniženje dijastoličkog krvnog tlaka u ležećem položaju iznosilo je 7 mmHg.
- 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). 
- ako ste ikada doživjeli gubitak vida zbog problema s dotokom krvi u očni živac - stanja koje se zove nearterijska prednja ishemijska neuropatija vidnog živca.
Due to lack of data, Granpidam should not be used in pregnant women unless strictly necessary. 
Zbog nedostatnih podataka Granpidam se ne smije primjenjivati u trudnica, osim ako to nije izričito potrebno.
Doses up to 80 mg three times a day (4 times the recommended dose of 20 mg three times a day) were administered and after 3 years 87% of 183 patients on study treatment were receiving sildenafil 80 mg TID. 
Primjenjivale su se doze do 80 mg tri puta na dan (4 puta više od preporučene doze od 20 mg tri puta na dan), a nakon 3 godine je 87% od 183 bolesnika liječenih ispitivanim lijekom primalo sildenafil u dozi od 80 mg TID.
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. 
Očekuje se da će učinak inhibitora CYP3A4 kao što su klaritromicin, telitromicin i nefazodon biti između učinka ritonavira i učinka inhibitora CYP3A4 poput sakvinavira ili eritromicina; pretpostavlja se da će izloženost sedmerostruko porasti.
At single doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased. 
Kod primjene pojedinačnih doza od 200 mg povećala se incidencija nuspojava (glavobolja, navale crvenila, omaglica, dispepsija, kongestija nosa i promjene vida).
Bleeding disorders 
Poremećaji krvarenja
In patients with pulmonary arterial hypertension this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation. 
U bolesnika s plućnom arterijskom hipertenzijom to može dovesti do vazodilatacije plućnih krvnih žila te, u manjoj mjeri, do vazodilatacije u sistemskom krvotoku.
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. 
Za preporuke o doziranju vidjeti dio 4.2. U zdravih muških dobrovoljaca nije bilo dokaza o utjecaju azitromicina (500 mg na dan tijekom 3 dana) na AUC, Cmax, Tmax, konstantu brzine eliminacije niti kasniji poluvijek sildenafila ili njegovog glavnog metabolita u cirkulaciji.
Suddenly stopping your treatment with Granpidam may lead to your symptoms getting worse. 
Nagli prekid liječenja lijekom Granpidam može dovesti do pogoršanja simptoma.
Combined dose groups (n=77) 
Skupine s kombiniranim dozama (n = 77)
Combination with the most potent of the CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) (see section 4.5). 
Kombinacija s najsnažnijim inhibitorima CYP3A4 (npr. ketokonazolom, itrakonazolom, ritonavirom) (vidjeti dio 4.5).
The estimated difference between the medium sildenafil dose and placebo was 11.33% (95% CI: 1.72 to 20.94) (see Table 2). 
Procijenjena razlika između srednje doze sildenafila i placeba iznosila je 11,33% (95% CI: 1,72 do 20,94) (vidjeti Tablicu 2).
Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated (see sections 4.8 and 5.1). 
Procijenjeno je istovremeno liječenje peroralnim sildenafilom i intravenski primijenjenim epoprostenolom (vidjeti dijelove 4.8 i 5.1).
Psychiatric disorders Common insomnia, anxiety 
Psihijatrijski poremećaji često nesanica, anksioznost
A downward dose adjustment to 20 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. 
Treba se razmotriti snižavanje doze na 20 mg dva puta na dan kada se sildenafil istovremeno primjenjuje u bolesnika koji već primaju inhibitore CYP3A4 poput eritromicina ili sakvinavira.
How to take Granpidam 
Kako uzimati Granpidam
Pack size of 300 tablets in a carton. 
Veličina pakiranja: 300 tableta u kutiji.
In pulmonary arterial hypertension patients, the oral bioavailability of sildenafil after 80 mg three times a day was on average 43% (90% CI: 27%-60%) higher compared to the lower doses. 
U bolesnika s plućnom arterijskom hipertenzijom je bioraspoloživost sildenafila nakon peroralne primjene doze od 80 mg tri puta na dan bila u prosjeku 43% (90% CI: 27% - 60%) veća u usporedbi s nižim dozama.
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). 
Nuspojave prijavljene u >10% od 229 ispitanika liječenih sildenafilom (skupina koja je primala kombiniranu dozu, uključujući 9 bolesnika koji nisu nastavili u dugotrajnom ispitivanju) bile su infekcija gornjih dišnih puteva (31%), glavobolja (26%), povraćanje (22%), bronhitis (20%), faringitis (18%), pireksija (17%), proljev (15%) te gripa i epistaksa (12% svaka).
For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4.3. 
Za informacije o primjeni sildenafila s najsnažnijim inhibitorima CYP3A4, vidjeti dio 4.3.
A statistically significant increase in 6MWD was observed in all 3 sildenafil dose groups compared to those on placebo. 
Statistički značajno povećanje 6MWD-a zabilježeno je u svim trima skupinama koje su primale različite doze sildenafila u odnosu na skupinu koja je primala placebo.
The difference in results between these randomisation subgroups may have arisen by chance in view of their limited sample size. 
S obzirom na mali uzorak, razlika u rezultatima između ovih randomizacijskih podskupina mogla je nastati slučajno.
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. 
Pri klinički relevantnim razinama izloženosti, u životinja nisu zabilježene nuspojave koje bi mogle biti značajne za kliničku primjenu, a koje nisu opažene i u kliničkim ispitivanjima.
The overall frequency of discontinuations in sildenafil/epoprostenol treated patients due to adverse events was 5.2% compared to 10.7% in the placebo/epoprostenol treated patients. 
Ukupna učestalost prekida liječenja zbog nuspojava iznosila je 5,2% u bolesnika liječenih sildenafilom/epoprostenolom, u odnosu na 10,7% u bolesnika koji su primali placebo/epoprostenol.