natgillin/translations-raw huggingface dataset:
Time to clinical worsening was a secondary endpoint as defined as the time from randomisation to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy). 
Sekundarni opazovani dogodek je bil čas do kliničnega poslabšanja, ki je definiran kot čas od randomizacije do prvega pojava kliničnega poslabšanja (smrt, presaditev pljuč, začetek zdravljenja z bosentanom, ali klinično poslabšanje, ki zahteva spremembo pri zdravljenju z epoprostenolom).
Women of childbearing potential and contraception in males and females Due to lack of data on effects of sildenafil in pregnant women, Granpidam 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 sildenafila pri nosečnicah, uporaba zdravila Granpidam ni priporočljiva pri ženskah v rodni dobi, razen v primeru, da uporabljajo tudi ustrezne ukrepe za preprečevanje nosečnosti.
Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. 
Ni pričakovati, da bi hemodializa pospešila očistek, ker je sildenafil v veliki meri vezan na beljakovine v plazmi in se ne izloča v urinu.
cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis. 
raka kostnega mozga (multipli mielom) ali kakršnokoli bolezen ali deformacijo spolnega uda.
Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. 
Največjo koncentracijo v plazmi doseže v 30 do 120 minutah (mediana 60 minut) po peroralni uporabi na prazen želodec.
There are no data from the use of sildenafil in pregnant women. 
O uporabi sildenafila pri nosečnicah ni podatkov.
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 %).
Estimates based on ANCOVA with adjustments for the covariates baseline peak VO2, etiology and weight group 
Ocene, temelječe na ANCOVA, s prilagoditvami za kovariate izhodiščne največje vrednosti VO2, etiologijo in skupino z določeno telesno maso
Blood and lymphatic system disorders Common anaemia 
Bolezni krvi in limfatičnega sistema pogosti anemija
At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ml, compared to approximately 5 ng/ml when sildenafil was administered alone. 
Po 24 urah je bila koncentracija sildenafila v plazmi še vedno približno 200 ng/ml v primerjavi s približno 5 ng/ml v primeru, ko je bil sildenafil uporabljen sam.
When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. 
Ko so sildenafil in doksazosin sočasno uporabili pri bolnikih, stabiliziranih na zdravljenju z doksazosinom, so poročali o redkih primerih simptomatske posturalne hipotenzije.
Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE03 
Farmakoterapevtska skupina: zdravila za bolezni sečil, zdravila za zdravljenje erektilne disfunkcije Oznaka ATC: G04BE03
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). 
To zdravilo se uporablja za zdravljenje pljučne arterijske hipertenzije (tj. visokega krvnega tlaka v pljučih) in kronične trombembolične pljučne hipertenzije (tj. visokega krvnega tlaka v pljučih, ki nastane zaradi krvnih strdkov).
The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. 
Ustrezno dodatno znižanje diastoličnega krvnega tlaka v ležečem položaju je bilo 7 mmHg.
Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, change in background treatment, and quality of life measurements. 
Sekundarni opazovani dogodki so obsegali hemodinamsko spremljanje, ocenjevanje simptomov, funkcijski razred po SZO, spremembe osnovnega zdravljenja in meritve, povezane s kakovostjo življenja.
Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. 
Zato smejo takšni bolniki sildenafil dobiti le po natančnem pretehtanju koristi in tveganj.
Efficacy and safety in adult patients with PAH (when used in combination with bosentan) A randomized, double-blind, placebo controlled study was conducted in 103 clinically stable subjects with PAH (WHO FC II and III) who were on bosentan therapy for a minimum of three months. 
Učinkovitost in varnost pri odraslih bolnikih s PAH (uporabljen v kombinaciji z bosentanom) Randomizirana, dvojno slepa, s placebom nadzorovana študija je bila narejena pri 103 klinično stabilnih preiskovancih s PAH (funkcijskega razreda II in III po SZO), ki so se z bosentanom zdravili najmanj tri mesece.
Sildenafil causes mild and transient decreases in systemic blood pressure which, in the majority of cases, do not translate into clinical effects. 
Sildenafil blago in prehodno zniža sistemski krvni tlak, kar večinoma nima kliničnih posledic.
Long term extension data 
Razširjeni podatki, pridobljeni v daljšem obdobju
If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result (see section 4.8). 
Če priapizma ne zdravimo takoj, lahko pride do poškodbe tkiva penisa in stalne izgube spolne potence (glejte poglavje 4.8).
Nicorandil is a hybrid of potassium channel activator and nitrate. 
Nikorandil je hibrid aktivatorja kalijevih kanalčkov in nitrata.
Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 
Zaradi starostnih razlik v vezavi na beljakovine v plazmi so se ustrezne plazemske koncentracije prostega sildenafila povečale za približno 40 %.
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). 
Sočasna uporaba z donorji dušikovega oksida (npr. z amilnitritom) ali nitrati v kakršnikoli obliki zaradi hipotenzivnih učinkov nitratov (glejte poglavje 5.1).
Patients enrolled into the pivotal study were eligible to enter a long term open label extension study. 
Bolniki, vključeni v ključno študijo, so bili primerni za dolgoročno odprto podaljšano študijo.
If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (e.g. 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).
- 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). 
- zaviralce alfa (npr. doksazosin) za zdravljenje visokega krvnega tlaka ali težav s prostato, saj lahko kombinacija teh dveh zdravil povzroči simptome znižanega krvnega tlaka (npr. omotica, vrtoglavica).
Non-clinical data revealed no special hazard for humans based on conventional studies of fertility (see section 5.3). 
Neklinični podatki na podlagi običajnih študij plodnosti niso razkrili nobenih posebnih tveganj za ljudi (glejte poglavje 5.3).
Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. 
Podatki, pridobljeni pri eni doječi materi, kažejo, da se sildenafil in njegov aktivni presnovek N-dezmetil-sildenafil izločata v materino mleko v zelo nizkih koncentracijah.
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 %).
Of the 234 paediatric subjects treated in the short-term, placebo-controlled study, 220 subjects entered the long-term extension study. 
Od 234 pediatričnih preiskovancev, ki so se zdravili v kratkoročni, s placebom nadzorovani študiji, jih je bilo 220 vključenih v dolgoročno podaljšano študijo.
Due to the nitrate component it has the potential to have serious interaction with sildenafil (see section 4.3). 
Zaradi njegove nitratne komponente obstaja možnost za močnejše interakcije s sildenafilom (glejte poglavje 4.3).
Common pyrexia *These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED). 
* O teh neželenih učinkih/reakcijah so poročali pri bolnikih, ki so sildenafil jemali za zdravljenje moške erektilne disfunkcije (MED).
For adults, the recommended dose is 20 mg three times a day (taken 6 to 8 hours apart) taken with or without food. 
Priporočeni odmerek za odrasle je 20 mg trikrat na dan (v presledkih od 6 do 8 ur), s hrano ali brez nje.
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 je treba previdno uporabljati pri bolnikih z anatomskimi deformacijami penisa (npr. z angulacijo, kavernozno fibrozo ali Peyronijevo boleznijo) in pri bolnikih z določenimi boleznimi, ki povzročajo nagnjenost k priapizmu (npr. s srpastocelično anemijo, multiplim mielomom ali levkemijo).
Effects in non-clinical studies were observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. 
Učinke v predkliničnih študijah so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. 
Riociguat: Predklinične študije so pokazale dodaten učinek na sistemsko zniževanje krvnega tlaka ob kombiniranju zaviralcev PDE5 z riociguatom.
Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. 
Študije s humanimi trombociti kažejo, da sildenafil stopnjuje antiagregacijski učinek natrijevega nitroprusida in vitro.
Granpidam 20 mg film-coated tablets are also provided in PVC/Alu perforated unit dose blister packs containing 15x1, 90x1 and 300x1 tablets. 
Granpidam 20 mg filmsko obložene tablete so na voljo tudi v PVC / Alu perforiran enoodmernih pretisnih omotih, ki vsebujejo 15x1, 90x1 in 300x1 tablet.
The mean steady state volume of distribution (Vss) for sildenafil is 105 l, indicating distribution into the tissues. 
Povprečni volumen porazdelitve (Vss) sildenafila v stanju dinamičnega ravnovesja je 105 l, kar kaže, da se sildenafil porazdeli v tkiva.
Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day). 
Bolnike so randomizirali na placebo ali sildenafil (20 mg trikrat na dan) v kombinaciji z bosentanom (62,5-125 mg dvakrat na dan).
In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving sildenafil than those receiving placebo leading to the premature termination of this study. 
V klinični študiji so pri bolnikih, ki so prejemali sildenafil, 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.
Actual doses administered within a group were dependent on body weight (see Section 4.8). 
Dejanski odmerki, ki so jih bolniki znotraj skupin prejemali, so bili odvisni od telesne mase (glejte poglavje 4.8).
A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol. 
Randomizirana, dvojno slepa, s placebom nadzorovana študija je bila narejena pri 267 bolnikih s PAH, stabiliziranih na intravenskem epoprostenolu.
A total of 234 subjects aged 1 to 17 years were treated in a randomized, double-blind, multi-centre, placebo controlled parallel group, dose ranging study. 
Skupno 234 preiskovancev, starih od 1 leta do 17 let, je sodelovalo v randomizirani, dvojno slepi, multicentrični, s placebom nadzorovani študiji z vzporednima skupinama, v kateri je bil uporabljen niz odmerkov.
At the recommended dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen. 
Ob priporočenem odmerku 20 mg trikrat na dan niso opazili znižanja sistoličnega ali diastoličnega tlaka.
In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively were observed. 
V teh študijskih populacijah so opazili povprečno dodatno znižanje krvnega tlaka v ležečem položaju za 7/7 mmHg, 9/5 mmHg oz. 8/4 mmHg ter dodatno znižanje krvnega tlaka v stoječem položaju za 6/6 mmHg, 11/4 mmHg in 4/5 mmHg.
Granpidam should not be used during pregnancy unless strictly necessary. 
Zdravila Granpidam ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
The efficacy of sildenafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.5 and 5.1). 
Učinkovitost sildenafila pri bolnikih, ki že prejemajo zdravljenje z bosentanom, ni bila zanesljivo dokazana (glejte poglavji 4.5 in 5.1).
The safety of sildenafil has not been studied in patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases) and therefore its use is not recommended. 
Varnost sildenafila ni raziskana pri bolnikih z znanimi dednimi degenerativnimi boleznimi mrežnice, npr. pri retinitis pigmentosa (manjši del teh bolnikov ima genetsko motnjo mrežničnih fosfodiesteraz), zato uporaba sildenafila pri njih ni priporočljiva.
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 je povezana z boleznijo vezivnega tkiva.
In case of clinical deterioration in spite of Granpidam treatment, alternative therapies should be considered. 
Če se klinično stanje kljub zdravljenju z zdravilom Granpidam poslabša, je treba pretehtati druge možnosti zdravljenja.
PDE5 inhibitors, such as sildenafil have been shown to increase the hypotensive effects of this medicine. 
Zaviralci PDE5, kot je sildenafil, dokazano povečujejo hipotenzivne učinke tega zdravila.
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. 
Po kroničnem odmerjanju 80 mg trikrat na dan pri bolnikih s pljučno arterijsko hipertenzijo niso poročali o klinično pomembnih učinkih na EKG.
Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. 
Sildenafil torej zvišuje raven cGMP v gladkih mišičnih celicah pljučnega ožilja in tako povzroči njihovo sprostitev.
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 %).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Bolniki z redkimi prirojenimi motnjami, kot so galaktozna intoleranca, laponska oblika zmanjšane aktivnosti laktaze ali malabsorbcija laktoze, ne smejo jemati tega zdravila.
Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil. 
Posamični odmerki antacida (magnezijev hidroksid/aluminijev hidroksid) niso vplivali na biološko uporabnost sildenafila.
Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries. 
Sildenafil ni vplival na minutni volumen srca in ni poslabšal pretoka krvi skozi stenotične koronarne arterije.
A statistically significant increase in 6MWD was observed in all 3 sildenafil dose groups compared to those on placebo. 
Statistično pomembno povečanje 6MWD so ugotovili v skupinah z vsemi 3 odmerki sildenafila v primerjavi s skupino, ki je prejemala placebo.
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. 
Domnevni mehanizem spremenjenega razločevanja barv je povezan z zavrtjem PDE6, ki sodeluje pri fototransdukcijski kaskadi v mrežnici.
In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. 
V študijah posamičnega odmerka pri zdravih prostovoljcih so bile neželene reakcije pri odmerkih do 800 mg podobne tistim pri nižjih odmerkih, bile pa so pogostejše in izrazitejše.
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). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s sildenafilom pri novorojenčkih s pljučno arterijsko hipertenzijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
A total of 134 patients were treated with sildenafil 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 sildenafil, njihovo dolgoročno preživetje pa je bilo ocenjeno na minimalno 3 leta.
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 >150 µM). 
Sildenafil je šibek zaviralec izoencimov 1A2, 2C9, 2C19, 2D6, 2E1 in 3A4 citokroma P450 (IC50 > 150 μM).
These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers. 
To dodatno znižanje krvnega tlaka je bilo po velikosti podobno kot pri dajanju sildenafila samega zdravim prostovoljcem.
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). 
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).
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.
Taking more Granpidam than you should may increase the risk of known side effects. 
Večji odmerek zdravila Granpidam, kot je dovoljen, lahko poveča tveganje znanih neželenih učinkov.
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. 
Pri bolnikih s pljučno arterijsko hipertenzijo lahko to povzroči vazodilatacijo v povirju pljučnih žil in v manjši meri vazodilatacijo v sistemskem obtoku.
Dose adjustments are not required in elderly patients. 
Pri starejših bolnikih odmerka ni treba prilagajati.
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. 
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.
Therefore, caution is recommended in case of co-administration. 
Zato je v primeru sočasne uporabe potrebna previdnost.
Limited data suggest that the abrupt discontinuation of sildenafil is not associated with rebound worsening of pulmonary arterial hypertension. 
Omejeni podatki kažejo, da nenadne prekinitve uporabe zdravila sildenafil spremlja povratno poslabšanje pljučne arterijske hipertenzije.
Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl. 
Sildenafil (50 mg) ni stopnjeval hipotenzivnih učinkov alkohola pri zdravih prostovoljcih, ki so imeli povprečno največjo koncentracijo alkohola v krvi 80 mg/dl.
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).
Granpidam should not be given to women of child bearing potential unless using appropriate contraceptive methods. 
Ženske v rodni dobi ne smejo uporabljati zdravila Granpidam, razen če uporabljajo ustrezno kontracepcijsko metodo.
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). 
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).
- 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.
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. 
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.