natgillin/translations-raw huggingface dataset:
When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29% however, the extent of absorption was not significantly affected (AUC decreased by 11%).
Kada se sildenafil uzima s hranom, brzina apsorpcije se smanjuje, uz srednju vrijednost odgode Tmax za 60 minuta i prosječno smanjenje Cmax za 29%; međutim, nema značajnog utjecaja na stupanj apsorpcije (AUC smanjen za 11%).
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.
U bolesnika s plućnom arterijskom hipertenzijom postoji mogućnost povećanog rizika od krvarenja kada se započinje liječenje sildenafilom u bolesnika koji već uzimaju antagonist vitamina K, osobito u onih bolesnika u kojih je plućna arterijska hipertenzija posljedica bolesti vezivnog tkiva.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 20 mg sildenafila (u obliku sildenafilcitrata).
There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance.
Ustanovljena je statistički značajna korist primjene sildenafila u usporedbi s placebom u 6minutnoj postignutoj udaljenosti hodom.
In the long term paediatric extension study, an increase in deaths was observed in patients administered doses higher than the recommended dose.
U dugoročnom produljenju ispitivanja u pedijatrijskih bolesnika opažena je povećana smrtnost u bolesnika koji su primali veće doze od preporučenih.
The major circulating metabolite results from N-demethylation of sildenafil.
Glavni metabolit u cirkulaciji nastaje N-demetilacijom sildenafila.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Učinci drugih lijekova na sildenafil
Galactose intolerance
Nepodnošenje galaktoze
Granpidam with food and drink You should not drink grapefruit juice while you are being treated with Granpidam.
Ne smijete piti sok od grejpa dok se liječite lijekom Granpidam.
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.
Djelotvornost i sigurnost sildenafila primijenjenog istovremeno s drugim lijekovima za plućnu arterijsku hipertenziju (npr. ambrisentan, iloprost) nije ispitana u kontroliranim kliničkim ispitivanjima.
Similarly 191 of 229 subjects (83%) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment.
Slično tomu, u 191 od 229 ispitanika (83%) koji su primali sildenafil, funkcionalni stupanj bolesti po SZO-u procijenjen nakon godine dana održao se ili poboljšao.
Of the subjects who completed the initial study, 242 entered a long-term extension study.
Od ispitanika koji su završili prvobitno ispitivanje, 242 su ušla u dugoročno produljeno ispitivanje.
Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries.
Sildenafil nije pokazao učinak na minutni volumen srca i nije ometao protok krvi kroz stenozirane koronarne arterije.
Patients using other medicinal products
Bolesnici koji uzimaju druge lijekove
Efficacy in adult patients with PAH (when used in combination with epoprostenol)
Djelotvornost u odraslih bolesnika sPAH-om (kada se primjenjuje u kombinaciji s epoprostenolom)
In case of clinical deterioration in spite of Granpidam treatment, alternative therapies should be considered.
U slučaju kliničkog pogoršanja unatoč liječenju lijekom Granpidam, treba razmotriti druge mogućnosti liječenja.
The European Medicines Agency has deferred the obligation to submit the results of studies with sildenafil in newborns with pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja sildenafila u novorođenčadi s plućnom arterijskom hipertenzijom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
- Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).
- alfa-blokatore (npr. doksazosin) za liječenje visokog krvnog tlaka ili tegoba s prostatom, jer kombinacija ovih dvaju lijekova može izazvati simptome niskog krvnog tlaka (npr. omaglicu, ošamućenost).
Veno-occlusive disease
Venske okluzivne bolesti
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).
Istovremena rimjena s donorima dušikova oksida (poput amil nitrita) ili nitratima u bilo kojem obliku, zbog hipotenzivnih učinaka nitrata (vidjeti dio 5.1).
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.
U bolesnika s primarnim PAH-om je učinak liječena bio 31,1 metar, u usporedbi sa 7,7 metara u bolesnika s PAH-om povezanim s bolešću vezivnog tkiva.
This concentration range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors (except with the most potent of the CYP3A4 inhibitors e.g. ketoconazole, itraconazole, ritonavir).
Ovaj raspon koncentracija obuhvaća povećanje izloženosti sildenafila opaženo u posebno dizajniranim ispitivanjima interakcija s inhibitorima CYP3A4 (osim s najsnažnijim CYP3A4 inhibitorima, primjerice ketokonazolom, itrakonazolom, ritonavirom).
Granpidam should not be used during pregnancy unless strictly necessary.
Granpidam se ne smije primjenjivati u trudnoći, osim ako to nije izričito nužno.
The proportion of subjects receiving supportive medicinal products at baseline (anticoagulants, digoxin, calcium channel blockers, diuretics and/or oxygen) was similar in the combined sildenafil treatment group (47.7%) and the placebo treatment group (41.7%).
Udio ispitanika koji su na početku liječenja primali potpornu terapiju (antikoagulanse, digoksin, blokatore kalcijevih kanala, diuretike i/ili kisik) bio je podjednak u kombiniranoj skupini liječenoj sildenafilom (47,7%) i skupini koja je primala placebo (41,7%).
The PAH patients included those with Primary Pulmonary Arterial Hypertension (212/267, 79%) and PAH associated with connective tissue disease (55/267, 21%).
Obuhvaćeni su bili bolesnici s primarnom plućnom arterijskom hipertenzijom (212/267, 79%) i PAH-om povezanim s bolešću vezivnog tkiva (55/267, 21%).
Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Sildenafil se treba primjenjivati uz oprez u bolesnika s anatomskim deformitetima penisa (poput angulacije, kavernozne fibroze ili Peyronijeve bolesti) i u bolesnika koji pate od nekih stanja koja mogu biti predispozicija za prijapizam (poput anemije srpastih stanica, multiplog mijeloma ili leukemije).
Other pharmaceutical forms are available for administration to patients ≤20 kg and other younger patients who are not able to swallow tablets.
Drugi farmaceutski oblici su dostupni za primjenu u bolesnika tjelesne težine ≤ 20 kg i drugih mlađih bolesnika koji ne mogu progutati tablete.
PVC/Alu blisters of 300 tablets.
PVC/alu blisteri sa 300 tableta.
Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature.
Osim u kavernoznom tijelu penisa, enzim PDE5 se nalazi i u plućnim krvnim žilama.
Estimates based on ANCOVA with adjustments for the covariates baseline peak VO2, etiology and weight group
Procjene se temelje na metodi ANCOVA, uz prilagodbe za kovarijante: vršni VO2 na početku ispitivanja, etiologija i težinska skupina
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 >150 µM).
Sildenafil je slab inhibitor izoformi 1A2, 2C9, 2C19, 2D6, 2E1 i 3A4 citokroma P450 (IC50 > 150 µm).
Infections and infestations Common cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Infekcije i infestacije često celulitis, gripa, bronhitis, sinusitis, rinitis,
Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Djelotvornost je dokazana u primarnoj plućnoj hipertenziji i plućnoj hipertenziji povezanoj s bolešću vezivnog tkiva.
Effects in non-clinical studies were observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
U nekliničkim ispitivanjima učinci su zapaženi pri razinama izloženosti koje se smatraju dovoljno većima od maksimalne izloženosti lijeku u ljudi, što ukazuje na mali značaj za kliničku primjenu.
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].