natgillin/translations-raw huggingface dataset:
Women of childbearing potential and contraception in males and females Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless also using appropriate contraceptive measures.
Ženske v rodni dobi in kontracepcija pri moških in ženskah Zaradi nezadostnih podatkov o učinkih zdravila Revatio pri nosečnicah, uporaba zdravila Revatio ni priporočljiva pri ženskah v rodni dobi, razen v primeru, da uporabljajo tudi ustrezne ukrepe za preprečevanje nosečnosti.
The adaptor is provided so that you can fill the oral dosing syringe with medicine from the bottle.
Nastavek je priložen zato, da lahko napolnite peroralno odmerno brizgo z zdravilom iz steklenice.
The usual dose is 10 mg (corresponding to 12.5 ml) three times a day.
Običajni odmerek je 10 mg (kar ustreza 12,5 ml) trikrat na dan.
One 125 ml amber glass bottle (with a polypropylene screw cap) contains 32.27 g of powder for oral suspension.
Ena 125 ml steklenica rjave barve (s polipropilensko navojno zaporko) vsebuje 32,27 g praška za peroralno suspenzijo.
A Revatio intravenous injection will be given to you instead of your Revatio tablets.
Zdravilo Revatio za intravensko injiciranje boste dobili namesto tablet zdravila Revatio.
If large bubbles can be seen, slowly push the plunger back into the syringe.
Če so opazni veliki mehurčki, počasi potisnite bat nazaj v brizgo.
Revatio solution for injection is for intravenous use as a bolus injection.
Revatio raztopina za injiciranje je namenjena za intravensko uporabo v bolusni injekciji.
Refer to the patient leaflet for more detailed instructions for use.
Za podrobnejša navodila za uporabo glejte navodila za bolnika.
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 %).
Če sildenafil zaužijemo s hrano, se hitrost absorpcije zmanjša s povprečno zakasnitvijo tmax 60 minut in povprečnim zmanjšanjem Cmax za 29 %, delež absorpcije pa se pomembneje ne zmanjša (zmanjšanje AUC za 11 %).
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 %).
Delež preiskovancev, ki so na začetku prejemali podporno zdravljenje (antikoagulante, digoksin, zaviralce kalcijevih kanalčkov, diuretike in/ali kisik), je bil podoben v združeni skupini, ki je prejemala sildenafil (47,7 %) in v skupini, ki je prejemala placebo (41,7 %).
Any unused oral suspension should be discarded or returned to your pharmacist after this date.
Po tem datumu neuporabljeno peroralno suspenzijo zavrzite ali jo vrnite vašemu farmacevtu.
If reconstituted, the oral suspension is in a liquid form.
Če je rekonstituirana, je peroralna suspenzija v tekoči obliki.
Unless otherwise specified, drug interaction studies have been performed in healthy adult male subjects using oral sildenafil.
Če ni navedeno drugače, so bile študije medsebojnega delovanja opravljene pri zdravih odraslih moških, ki so uporabljali peroralni sildenafil.
In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered.
Če se klinično stanje kljub zdravljenju z Revatiom poslabša, je treba pretehtati druge možnosti zdravljenja.
Revatio should not be given to women of child bearing potential unless using appropriate contraceptive methods.
Ženske v rodni dobi ne smejo uporabljati zdravila Revatio, razen če uporabljajo ustrezno kontracepcijsko metodo.
The European Medicines Agency has deferred the obligation to submit the results of studies with Revatio in newborns with pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Revatio pri novorojenčkih s pljučno arterijsko hipertenzijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Push the plunger back in to the syringe.
Potisnite bat nazaj v brizgo.
- The other ingredients are glucose and water for injections.
- Druge sestavine zdravila so: glukoza in voda za injekcije.
Safety and effectiveness of doses higher than 12.5 ml (10 mg) TID have not been established.
Varnost in učinkovitost odmerkov, večjih od 12,5 ml (10 mg) trikrat na dan, nista bili dokazani.
In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving Revatio than those receiving placebo leading to the premature termination of this study.
V klinični študiji so pri bolnikih, ki so prejemali zdravilo Revatio, v primerjavi z bolniki, ki so prejemali placebo, pogosteje poročali o primerih vazookluzivnih kriz, ki so zahtevale hospitalizacijo in, ki so vodile v predčasni zaključek študije.
There was one serious adverse reaction in a subject with severe ischaemic cardiomyopathy who experienced ventricular fibrillation and death 6 days post study.
Zabeležen je bil en resen neželen učinek pri preiskovancu s hudo ishemično kardiomiopatijo, ki je doživel fibrilacijo prekatov in smrt 6 dni po študijskem zdravilu.
Revatio solution for injection is for the treatment of adult patients (≥ 18 years) with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.
Revatio raztopina za injiciranje je namenjena za zdravljenje odraslih bolnikov (≥ 18 let) s pljučno arterijsko hipertenzijo, ki imajo trenutno predpisano peroralno obliko zdravila Revatio, vendar peroralnega zdravljenja začasno ne morejo prejemati, a so sicer klinično in hemodinamsko stabilni.
PDE5 inhibitors, such as Revatio have been shown to increase the hypotensive effects of this medicine.
Zaviralci PDE5, kot je zdravilo Revatio, dokazano povečujejo hipotenzivne učinke tega zdravila.
Excipient(s) with known effect Each tablet also contains 0.7 mg of lactose.
Pomožna snov z znanim učinkom: Ena tableta vsebuje tudi 0,7 mg laktoze.
A total of 134 patients were treated with Revatio in the initial study, and their long term survival status was assessed for a minimum of 3 years.
V ključni študiji je skupno 134 bolnikov dobivalo zdravilo Revatio, njihovo dolgoročno preživetje pa je bilo ocenjeno na minimalno 3 leta.
5 How to store Revatio Contents of the pack and other information
5 Shranjevanje zdravila Revatio Vsebina pakiranja in dodatne informacije
Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse.
Če zdravilo Revatio nehate jemati nenadoma, se vam simptomi lahko poslabšajo.
For instructions on constitution of the medicinal product before administration, see section 6.6.
Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
23 subjects experienced clinical worsening events in the placebo group (17.6 %) compared with 8 subjects in the sildenafil group (6.0 %).
V skupini s placebom je 23 preiskovancev (17,6 %) doživelo klinično poslabšanje v primerjavi z 8 preiskovanci v skupini s sildenafilom (6,0 %).
The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension (functional class IV).
Učinkovitost zdravila Revatio ni ugotovljena pri bolnikih s hudo pljučno arterijsko hipertenzijo (funkcijski razred IV).
You should always add a total of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking (figure 3).
Vedno dodajte skupno 90 ml (3 x 30 ml) vode, ne glede na odmerek, ki ga jemljete (slika 3).
The PAH patients included those with Primary Pulmonary Arterial Hypertension (212/267, 79 %) and PAH associated with connective tissue disease (55/267, 21 %).
Med bolniki s PAH so bili takšni s primarno pljučno arterijsko hipertenzijo (212/267, 79 %) in takšni s PAH, povezano z boleznimi vezivnega tkiva (55/267, 21 %).
The recommended dose of 10 mg requires a volume of 12.5 ml, to be administered as an intravenous bolus injection.
Za priporočeni odmerek 10 mg je potrebno odmeriti volumen 12,5 ml in ga injicirati kot intravensko bolusno injekcijo.
• Therapies for pulmonary hypertension (e.g. bosentan, iloprost).
• zdravila za zdravljenje pljučne hipertenzije (npr. bosentan, iloprost).
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 M).
Sildenafil je šibek zaviralec izoencimov 1A2, 2C9, 2C19, 2D6, 2E1 in 3A4 citokroma P450 (IC50 > 150 M).
Excipient(s) with known effect Each ml of oral suspension contains 250 mg sorbitol.
Pomožna snov z znanim učinkom: En ml peroralne suspenzije vsebuje 250 mg sorbitola.
The consequences of the subsequent lower exposure to the active Ndesmethyl metabolite observed after repeated IV administration of Revatio have not been documented.
Posledice nadaljnje manjše izpostavljenosti aktivnemu N-dezmetilnemu presnovku, opažene po ponavljajoči se intravenski uporabi zdravila Revatio, niso bile dokumentirane.
Remove the oral dosing syringe from the bottle.
Odstranite peroralno odmerno brizgo s steklenice.
Other pharmaceutical forms are available for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets.
Za uporabo pri bolnikih s telesno maso ≤ 20 kg in pri drugih mlajših bolnikih, ki ne morejo pogoltniti tablet, so na voljo druge farmacevtske oblike.
1 press-in bottle adapter, 1 measuring cup and 1 oral dosing syringe
1 nastavek za steklenico, 1 merica in 1 peroralna odmerna brizga
The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided with the following:
Imetnik dovoljenja za promet z zdravilom mora podrobnosti sistema nadzorovane distribucije za 20 ml vialo zdravila Revatio 0,8 mg/ml raztopina za injiciranje uskladti s pristojnimi nacionalnimi organi in tak program izvajati na nacionalni ravni tako, da bodo pred predpisovanjem zdravila vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali in/ali izdajali zdravilo Revatio 0,8 mg/ml raztopina za injiciranje, prejeli:
In study A1481262 Cmax, CL and AUC (0-8) of 248 ng/ml, 30.3 l/h and 330 ng h/ml, were observed respectively.
V študiji A1481262 so ugotovili naslednje vrednosti: Cmax 248 ng/ml, CL 30,3 l/h in AUC (0-8) 330 ng h/ml.
Revatio should not be used during pregnancy unless strictly necessary.
Zdravila Revatio ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
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 eg, ketoconazole, itraconazole, ritonavir).
Ta razpon koncentracij zajema povečanje izpostavljenosti sildenafilu, ki so jo opazili v specifično zasnovanih študijah interakcij z zaviralci CYP3A4 (razen najmočnejših zaviralcev CYP3A4, kot so ketokonazol, itrakonazol, ritonavir).
Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Učinkovitost je dokazana pri primarni pljučni hipertenziji in pljučni hipertenziji, ki spremlja bolezni vezivnega tkiva.
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).
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).
The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as addon therapy, and neither was arginine supplementation.
Uporaba prostaciklina, prostaciklinskih analogov in antagonistov endotelinskih receptorjev kot dodatno zdravljenje ni bilo dovoljeno, prav tako ne dodajanje arginina.
Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.
Revatio raztopina za injiciranje je druga možna oblika zdravila Revatio za bolnike, ki začasno ne morejo jemati tablet zdravila Revatio.
If you have an erection, which lasts continuously for more than 4 hours, stop taking Revatio and contact your doctor immediately (see also section 4).
Če imate erekcijo, ki nepretrgano traja dlje kot 4 ure, prenehajte jemati zdravilo Revatio in nemudoma obvestite zdravnika (glejte tudi poglavje 4).
See section 6.6 for instructions of use.
Za navodila za uporabo glejte poglavje 6.6.
• Blood thinning medicines (for example warfarin) although these did not result in any side effects.
• zdravila proti strjevanju krvi (npr. varfarin), čeprav ta niso povzročila nobenih neželenih učinkov.
Since there are limited data for intravenous Revatio use and since pharmacokinetic models predict that 20 mg oral and 10 mg intravenous formulations will yield similar plasma exposures, the safety information for intravenous Revatio is supported by that of oral Revatio.
Ker ni zadosti podatkov o intravenski uporabi zdravila Revatio, in ker farmakokinetični model predvideva, da povzročita odmerka 20 mg peroralno in 10 mg intravensko podobno plazemsko izpostavljenost, so varnostne informacije o peroralni obliki v podporo varnostnim informacijam o intravenski obliki zdravila Revatio.
No clinical studies have been performed to demonstrate that these formulations have comparable efficacy
Klinične študije za potrditev primerljive učinkovitosti teh oblik niso bile izvedene.
The magnitude of the interaction is expected to be reduced for intravenous sildenafil, as interactions for oral sildenafil are due, at least in part, to effects on oral first pass metabolism.
Obseg medsebojnega delovanja naj bi bil pri intravenskem sildenafilu po pričakovanjih manjši, ker so medsebojna delovanja pri peroralnem sildenafilu vsaj deloma posledica presnove prvega prehoda po peroralni uporabi.
It is recommended that a pharmacist constitutes Revatio oral suspension prior to its dispensing to the patient.
Priporočljivo je, da farmacevt peroralno suspenzijo zdravila Revatio pripravi pred izdajo bolniku.
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Revatio, before driving or using machines.
V kliničnih preskušanjih s sildenafilom so poročali o omotici in spremembah vida, zato morajo biti bolniki pred vožnjo ali upravljanjem strojev seznanjeni, kako lahko zdravilo Revatio nanje vpliva.
Instructions to reconstitute the oral suspension It is recommended that your pharmacist reconstitutes (makes up) the oral suspension before giving it to you.
Priporočljivo je, da vaš farmacevt rekonstituira (pripravi) peroralno suspenzijo, preden vam jo izroči.
• 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.
• 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.
A total of 207 patients were treated with Revatio in the pivotal study, and their long term survival status was assessed for a minimum of 3 years.
V ključni študiji je skupno 207 bolnikov dobivalo zdravilo Revatio, njihovo dolgoročno preživetje pa je bilo ocenjeno na minimalno 3 leta.
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.
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.
The oral suspension must be shaken vigorously for a minimum of 10 seconds before use.
Pred uporabo je treba peroralno suspenzijo dobro pretresati najmanj 10 sekund.
These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
Ta zdravila se pogosto uporabljajo za olajšanje pri angini pektoris ali bolečini v prsnem košu (glejte poglavje
While the bottle is upright, on a flat surface, insert the tip of the oral dosing syringe into the adaptor (figure 7).
Medtem, ko steklenica pokončno stoji na ravni podlagi, vstavite konico peroralne odmerne brizge v nastavek (slika 7).
If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (eg, epoprostenol) should be considered (see section 4.2).
Če se klinično stanje poslabša, je treba razmisliti o uporabi zdravil, ki pridejo v poštev v hudi fazi bolezni (npr. epoprostenol) (glejte poglavje 4.2).
Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse France
Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse Francija
Children and adolescents Revatio should not be given to children and adolescents under the age of 18.
Otroci in mladostniki, mlajši od 18 let, ne smejo jemati zdravila Revatio.
The recommended dose is 10 mg (corresponding to 12.5 ml) three times a day administered as an intravenous bolus injection (see section 6.6).
Priporočeni odmerek je 10 mg (kar ustreza 12,5 ml) trikrat na dan v intravenski bolusni injekciji (glejte poglavje 6.6).
Revatio contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Zdravilo Revatio vsebuje učinkovino sildenafil, ki sodi med zdravila, ki jih imenujemo zaviralci fosfodiesteraze tipa 5 (PDE5).
Your doctor may reduce the dose over a few days before stopping completely.
Zdravnik vam bo morda pred popolno opustitvijo zdravila odmerek nekaj dni postopoma zmanjševal.
The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (eg, ambrisentan, iloprost) has not been studied in controlled clinical trials.
Učinkovitost in varnost sočasne uporabe sildenafila in drugih zdravil za pljučno arterijsko hipertenzijo (npr. ambrisentana, iloprosta) nista bili raziskani v nadzorovanih kliničnih preskušanjih.
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.
Preiskovanci, ki so se zdravili z 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.
The tablets are provided in blister packs containing 90 tablets, 90 x 1 tablets as perforated unit dose blisters and in blister packs containing 300 tablets.
Tablete so na voljo v pretisnih omotih po 90 tablet, perforiranih enoodmernih pretisnih omotih po 90 x 1 tablet in v pretisnih omotih po 300 tablet.
Slowly pull back the plunger of the oral dosing syringe to the graduation mark that marks the dose for you (withdrawing 1 ml provides a 10 mg dose, withdrawing 2 ml provides a 20 mg dose).
Počasi izvlecite bat peroralne odmerne brizge do oznake, ki označuje vaš odmerek (odvzem 1 ml vsebuje 10 mg odmerek, odvzem 2 ml pa vsebuje 20 mg odmerek).
Measure 30 ml of water by filling the measuring cup (included in the carton) to the marked line then pour the water into the bottle.
Odmerite 30 ml vode tako, da napolnite merico (vključena v pakiranju) do označbe, nato vlijte vodo v steklenico.
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).
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).
This medicinal product does not require dilution or reconstitution before use.
Zdravila pred uporabo ni potrebno redčiti ali rekonstituirati.
White, round, biconvex film-coated tablets marked “PFIZER” on one side and “RVT 20”on the other.
filmsko obložena tableta bele, okrogle, na obeh straneh izbočene filmsko obložene tablete z oznako "PFIZER" na eni in "RVT 20" na drugi strani
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 %].
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 %].
To measure the dose accurately, the top edge of the plunger should be lined up with the appropriate graduated mark on the oral dosing syringe (figure 8).
Za natančno odmerjanje mora biti zgornji rob bata poravnan z ustrezno oznako na peroralni odmerni brizgi (slika 8).
If you experience sudden decrease or loss of vision, stop taking Revatio and contact your doctor immediately (see also section 4).
Če doživite nenadno poslabšanje ali izgubo vida, prenehajte jemati zdravilo Revatio in nemudoma obvestite zdravnika (glejte tudi poglavje 4).
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 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).
5 % glucose solution sodium chloride 9 mg/ml (0.9 %) solution Lactated Ringer's solution 5 % glucose/0.45 % sodium chloride solution 5 % glucose/lactated Ringer's solution 5 % glucose/20 mEq potassium chloride solution
9 mg/ml (0,9 %) raztopina natrijevega klorida Ringerjeva laktatna raztopina raztopina 5 % glukoze in 0,45 % natrijevega klorida raztopina 5 % glukoze in Ringerjevega laktata raztopina 5 % glukoze in 20 mEq kalijevega klorida
You should not take more medicine than your doctor tells you to.
Ne vzemite več zdravila, kot vam je naročil zdravnik.
Patients with left ventricular ejection fraction < 45 % or left ventricular shortening fraction < 0.2 were not studied.
Študija ni proučevala bolnikov z iztisnim deležem levega prekata < 45 % ali skrčitvenim deležem levega prekata < 0,2.
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 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.
Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets.
Neželeni učinki, opisani v kliničnih preskušanjih z intravenskim zdravilom Revatio, so bili podobni kot v kliničnih preskušanjih s tabletami zdravila Revatio.