natgillin/translations-raw huggingface dataset:
There is no clinical experience with riociguat in patients with elevated liver aminotransferases (> 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin (> 2 x ULN) prior to initiation of treatment; riociguat is not recommended in these patients.
Ker ni kliničnih izkušenj z riociguatom pri bolnikih s povečanimi vrednostmi jetrnih aminotransferaz (> 3-kratna zgornja meja normalne vrednosti (ULN - Upper Limit of Normal)) ali s povečanimi vrednostmi direktnega bilirubina (> 2 x ULN) pred začetkom zdravljenja, se uporaba riociguata pri teh bolnikih ne priporoča.
Therefore, administration of riociguat to such patients is not recommended.
Zato se uporabe riociguata ne priporoča pri teh bolnikih.
In the long term extension part of this study (non controlled) the concomitant use of sildenafil and riociguat resulted in a high rate of discontinuation, predominately due to hypotension.
V dolgotrajnem podaljšanju študije (brez primerjalne skupine) je sočasna uporaba sildenafila in riociguata povzročila pogostejše prekinitve zdravljenja, predvsem zaradi hipotenzije.
Other medicines for high blood pressure in the lung vessels (PAH), such as bosentan and iloprost, can be used with Adempas, but you should still tell your doctor.
Sočasno lahko uporabljate druga zdravila za zdravljenje visokega krvnega tlaka v pljučnih žilah (PAH), npr. bosentan in iloprost, vendar morate o tem obvestiti zdravnika.
Transitioning between phosphodiesterase-5 (PDE5) inhibitors and riociguat Sildenafil must be discontinued at least 24 hours prior to administration of riociguat.
Prehod med zaviralci fosfodiesteraze-5 (PDE5) in riociguatom Z uporabo sildenafila je treba prenehati vsaj 24 ur pred uporabo riociguata.
Your doctor will increase the dose every 2 weeks to a maximum of 2.5 mg 3 times a day (maximum daily dose of 7.5 mg) unless you experience any side effects or very low blood pressure.
Zdravnik bo povečal odmerek vsaka 2 tedna do največ 2,5 mg, trikrat na dan (največji dnevni odmerek 7,5 mg), razen če se vam bo pojavil kakšen neželeni učinek ali zelo nizek krvni tlak.
Improvement in exercise capacity was accompanied by consistent improvement in multiple clinicallyrelevant secondary endpoints.
Izboljšanje telesne zmogljivosti je spremljalo dosledno izboljšanje številnih klinično pomembnih sekundarnih opazovanih ciljev.
According to standard medical practice, expert assessment of operability should be done prior to treatment with riociguat.
Glede na običajno klinično prakso, je treba strokovno oceno o primernosti kirurškega posega pri bolniku opraviti pred zdravljenjem z riociguatom.
The most commonly reported adverse reactions, occurring in ≥10% of patients under Adempas treatment (up to 2.5 mg three times daily), were headache, dizziness, dyspepsia, peripheral oedema, nausea, diarrhoea and vomiting.
Neželeni učinki, o katerih so poročali najpogosteje in so se pojavili pri ≥ 10 % bolnikov, zdravljenih z zdravilom Adempas (do 2,5 mg trikrat na dan), so bili glavobol, omotica, dispepsija, periferni edem, navzea, driska in bruhanje.
42 film-coated tablets 84 film-coated tablets 90 film-coated tablets 294 film-coated tablets
42 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 294 filmsko obloženih tablet
The safety profile of Adempas in patients with CTEPH and PAH appeared to be similar, therefore adverse reactions identified from placebo controlled 12 and 16 weeks clinical studies are presented as pooled frequency in the table listed below (see table 1).
Profil varnosti za zdravilo Adempas pri bolnikih s CTEPH in PAH je podoben, zato so neželeni učinki, ki so jih ugotovili v s placebom nadzorovanih 12- in 16-tedenskih kliničnih študijah, predstavljeni združeno v spodnji preglednici pogostnosti (glejte preglednico 1).
Overall, the safety profile observed in the study was comparable with that observed in the pivotal trials, with no serious adverse events reported during the transition period.
Na splošno je varnostni profil, ki so ga opazili v študiji, primerljiv s tistim, ki so ga opazili v ključnih preskušanjih.
In nonsmoking individuals with mild (creatinine clearance 80-50 mL/min), moderate (creatinine clearance <50-30 mL/min) or severe (creatinine clearance <30 mL/min) renal impairment, riociguat plasma concentrations (AUC) were increased by 53%, 139% or 54%, respectively.
Pri nekadilcih z blago (očistek kreatinina 80 - 50 ml/min), zmerno (očistek kreatinina < 50 - 30 ml/min) ali hudo (očistek kreatinina < 30 ml/min) ledvično okvaro so se koncentracije riociguata v plazmi (AUC) povečale za 53 %, 139 % oz. 54 %.
Total riociguat (parent compound and metabolites) is excreted via both renal (33-45%) and biliary/faecal routes (48-59%).
Celokupni riociguat (izhodna spojina in presnovki) se izloča skozi ledvice (33 - 45 %) in z blatom/žolčem (48 - 59 %).
Preclinical studies in animal models showed additive systemic blood pressure lowering effect when riociguat was combined with either sildenafil or vardenafil.
Zaviralci PDE5 Predklinične študije na živalskih modelih so pokazale aditiven učinek na znižanje sistemskega krvnega tlaka, pri uporabi riociguata v kombinaciji s sildenafilom ali vardenafilom.
Serious bleeding occurred in 2.4% (12/490) of patients taking riociguat compared to 0/214 of placebo patients.
Resne krvavitve so se pojavile pri 2,4 % (12/490) bolnikov, ki so jemali riociguat, v primerjavi z 0/214 bolnikov, ki so jemali placebo.
The established individual dose should be maintained unless signs and symptoms of hypotension occur.
S titriranjem ugotovljeni odmerek za posameznega bolnika je treba vzdrževati, razen če se pojavijo znaki in simptomi hipotenzije.
More patients taking riociguat died (11% vs. 4%) and had serious adverse events (37% vs. 23%) during the main phase.
Med osnovno fazo je več bolnikov, ki so jemali riociguat, umrlo (11 % v primerjavi s 4 %) in imelo resne neželene učinke (37 % v primerjavi s 23 %).
Breast-feeding should be discontinued during treatment with this medicinal product.
Med zdravljenjem s tem zdravilom je treba prenehati z dojenjem.
Paediatric population No studies have been conducted to investigate the pharmacokinetics of riociguat in paediatric patients.
Pediatrična populacija Študij farmakokinetike riociguata pri pediatričnih bolnikih niso izvedli.
Improvement in exercise capacity was accompanied by improvement in multiple clinically relevant secondary endpoints.
Izboljšanje telesne zmogljivosti je spremljalo izboljšanje številnih klinično pomembnih sekundarnih opazovanih ciljev.
In some PAH patients, an adequate response on the 6-minute walk distance (6MWD) may be reached at a dose of 1.5 mg three times a day (see section 5.1).
Pri nekaterih bolnikih s PAH se lahko doseže ustrezni odziv pri merjenju prehojene razdalje v testu šestminutne hoje (6MWD - 6-minute walk distance) že z odmerkom 1,5 mg trikrat na dan (glejte poglavje 5.1).
Therefore, female patients at potential risk of pregnancy must use an effective method of contraception.
Ženske, pri katerih obstaja možnost, da zanosijo, morajo uporabljati učinkovito metodo kontracepcije.
However, if you are prone to having low blood pressure (hypotension), you should not switch from taking Adempas with food to taking Adempas without food because it may affect how you react to this medicine.
Če ste nagnjeni k nizkemu krvnemu tlaku (hipotenzija), ne spreminjajte načina jemanja zdravila Adempas, tako da ga enkrat vzamete s hrano, drugič brez nje, saj to lahko vpliva na vaš odziv na zdravljenje z zdravilom Adempas.
Dose should be increased by 0.5 mg three times daily every two weeks to a maximum of 2.5 mg three times daily, if systolic blood pressure is ≥95 mmHg and the patient has no signs or symptoms of hypotension.
Odmerek je treba povečevati vsaka dva tedna za 0,5 mg trikrat na dan do največ 2,5 mg trikrat na dan, če je sistolični krvni tlak ≥ 95 mm Hg in če bolnik nima znakov ali simptomov hipotenzije.
Common: may affect up to 1 in 10 people - inflammation of the stomach (gastritis) - inflammation in the digestive system (gastroenteritis) - reduction of red blood cells (anaemia) seen as pale skin, weakness or breathlessness - awareness of an irregular, hard, or rapid heartbeat (palpitation) - low blood pressure (hypotension) - nose bleed (epistaxis) - difficulty breathing through your nose (nasal congestion) - pain in the stomach, intestine or abdomen (gastrointestinal and abdominal pain) - heartburn (gastro-oesophageal reflux disease) - difficulty in swallowing (dysphagia) - constipation - bloating (abdominal distension)
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - vnetje v želodcu (gastritis) - vnetje v prebavilih (gastrenteritis) - zmanjšanje števila rdečih krvnih celic (anemija), kar se kaže kot bleda koža, šibkost ali zasoplost - občutek nerednega, močnega ali hitrega srčnega utripa (palpitacije) - nizek krvni tlak (hipotenzija) - krvavitev iz nosu (epistaksa) - oteženo dihanje skozi nos (kongestija nosne sluznice) - bolečine v želodcu, prebavilih ali trebuhu (gastrointestinalne in abdominalne bolečine) - zgaga (gastroezofagealna refluksna bolezen) - težave pri požiranju (disfagija) - zaprtost - napenjanje (abdominalna distenzija)
For patients who are unable to swallow whole tablets, Adempas tablets may be crushed and mixed with water or soft foods, such as apple sauce, immediately prior to use and administered orally (see section 5.2).
Za bolnike, ki ne morejo požirati celih tablet, se lahko tablete zdravila Adempas tik pred uporabo zdrobijo in zmešajo z vodo ali mehko hrano, kot je na primer jabolčna čežana, ter dajo peroralno (glejte poglavje 5.2).
If you have severe liver problems (Child Pugh C), do not take Adempas.
Če imate hudo jetrno okvaro (Child Pugh C), ne jemljite zdravila Adempas.
Riociguat restores the NO-sGC-cGMP pathway and leads to increased generation of cGMP.
Riociguat ponovno vzpostavi pot NO-sGC-cGMP in poveča nastajanje cGMP.
Serious haemoptysis occurred in 1% (5/490) patients taking riociguat compared to 0/214 patients taking placebo, including one event with fatal outcome.
Resna hemoptiza se je pojavila pri 1 % (5/490) bolnikov, ki so jemali riociguat, v primerjavi z 0/214 bolnikov, ki so jemali placebo, vključno z enim smrtnim izidom.
Antacids should be taken at least 2 hours before, or 1 hour after riociguat.
Antacide je treba vzeti najmanj 2 uri pred oziroma 1 uro po zaužitju riociguata.
Bosentan, reported to be a moderate inducer of CYP3A4, led to a decrease of riociguat steady-state plasma concentrations in PAH patients by 27% (see sections 4.1 and 5.1).
Bosentan, za katerega poročajo, da je zmerni induktor CYP3A4, je v stanju dinamičnega ravnovesja pri bolnikih s PAH zmanjšal koncentracijo riociguata v plazmi za 27 % (glejte poglavji 4.1 in 5.1).
RESPITE was a 24-week, uncontrolled study to investigate switching from PDE5 inhibitors to riociguat, in 61 adult PAH patients on stable PDE5 inhibitors.
V nenadzorovani, 24-tedenski študiji RESPITE so preučevali prehod z zaviralcev PDE5 na riociguat pri 61 odraslih bolnikih s PAH, ki so bili stabilni na zdravljenju z zaviralci PDE5.
Medicinal products strongly inhibiting P-gp/BCRP such as the immuno-suppressive cyclosporine A, should be used with caution (see sections 4.4 and 5.2).
Zdravila, ki močno zavirajo P-gp/BCRP, kot je imunosupresiv ciklosporin A, je treba uporabljati previdno (glejte poglavji 4.4 in 5.2).
Patients with mild and moderate renal impairment (creatinine clearance <80 - 30 mL/min) showed a higher exposure to this medicinal product (see section 5.2).
Pri bolnikih z blago in zmerno ledvično okvaro (očistek kreatinina < 80 - 30 ml/min) je bila izpostavljenost temu zdravilu večja (glejte poglavje 5.2).
Co-treatment of medicinal products increasing the upper gastro intestinal pH may lead to lower oral bioavailability.
Sočasno zdravljenje z zdravili, ki zvišujejo pH vrednost v zgornjih prebavilih, lahko povzroči manjšo peroralno biološko uporabnost.
If you stop taking Adempas
Če ste prenehali jemati zdravilo Adempas
Concomitant administration of 400 mg once daily ketoconazole led to a 150% (range up to 370%) increase in riociguat mean AUC and a 46% increase in mean Cmax.
Sočasna uporaba s 400 mg ketokonazola enkrat na dan je povzročila 150 % (razpon do 370 %) povečanje povprečne AUC in 46 % povečanje povprečne Cmax riociguata.
Therefore, clinically relevant drug-drug interactions with co-treatment which are significantly cleared by CYP1A1-mediated biotransformation, such as erlotinib or granisetron cannot be ruled out.
Zato klinično pomembnega medsebojnega delovanja s sočasnim zdravljenjem z zdravili, ki se izločajo predvsem preko presnove s CYP1A1, kot sta erlotinib ali granisetron, ni mogoče izključiti.
If systolic blood pressure falls below 95 mmHg, the dose should be maintained provided the patient does not show any signs or symptoms of hypotension.
Če se sistolični krvni tlak zniža pod 95 mm Hg, je treba odmerek vzdrževati, če bolnik nima znakov ali simptomov hipotenzije.
Concomitant administration of HAART combinations led to an increase in riociguat mean AUC of up to about 160% and to an approximate 20% increase in mean Cmax.
Sočasna uporaba s HAART kombinacijami je povzročila do 160 % povečanje povprečne AUC in približno 20 % povečanje povprečne Cmax riociguata.
cellulose microcrystalline crospovidone (type B) hypromellose 5 cP magnesium stearate lactose monohydrate sodium laurilsulfate
mikrokristalna celuloza krospovidon (tip B) hipromeloza 5 cP magnezijev stearat laktoza monohidrat natrijev lavrilsulfat
Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of NO and insufficient stimulation of the NO-sGC-cGMP pathway.
Pljučna hipertenzija je povezana s poškodbo endotelija, moteno sintezo dušikovega oksida in nezadostnim spodbujanjem poti NO-sGC-cGMP.
Women of childbearing potential / Contraception
Ženske v rodni dobi/ kontracepcija
You should tell your doctor if you start or stop smoking during treatment with this medicine.
Obvestite zdravnika, če med zdravljenjem s tem zdravilom začnete ali prenehate kaditi.
Therefore use of Adempas is not recommended in these patients (see section 4.4).
Zato se uporaba zdravila Adempas pri teh bolnikih ne priporoča (glejte poglavje 4.4).
Before prescribing riociguat, physicians should carefully consider whether patients with certain underlying conditions, could be adversely affected by vasodilatory effects (e.g. patients on antihypertensive therapy or with resting hypotension, hypovolaemia, severe left ventricular outflow obstruction or autonomic dysfunction).
Preden zdravnik predpiše riociguat, mora skrbno oceniti, ali bi lahko vazodilatacijski učinki riociguata vplivali na nekatera obstoječa stanja bolnika (npr. bolniki, ki uporabljajo antihipertenzivna zdravila ali hipotenzija med mirovanjem, hipovolemija, huda obstrukcija izstisa iz levega prekata ali avtonomna okvara).
In case of respiratory tract bleeding, the prescriber should regularly assess the benefitrisk of treatment continuation.
V primeru krvavitve v dihalih mora zdravnik redno ocenjevati korist nadaljevanja zdravljenja v primerjavi s tveganjem.
What Adempas looks like and contents of the pack
Izgled zdravila Adempas in vsebina pakiranja
In pulmonary arterial hypertension, studies with riociguat have been mainly performed in forms related to idiopathic or heritable PAH and PAH associated with connective tissue disease.
Pri bolnikih s pljučno arterijsko hipertenzijo so študije z riociguatom izvedli predvsem pri idiopatski ali dedni PAH in PAH, povezani z boleznijo veziva.
In rats, an increased rate of cardiac malformation was observed as well as a reduced gestation rate due to early resorption at maternal systemic exposure of about 7-fold of human exposure (2.5 mg three times daily).
Pri podganah so opazili pogostejše deformacije srca in manj pogoste gestacije zaradi hitre resorpcije pri sistemski izpostavljenosti matere, ki je bila približno 7-krat večja od izpostavljenosti pri ljudeh (2,5 mg trikrat na dan).
Nervous system disorders Dizziness, Headache
Bolezni živčevja omotica, glavobol
Therefore co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form, including recreational drugs called ‘poppers', is contraindicated (see section 4.3).
Zato je sočasna uporaba zdravila Adempas z nitrati ali donorji dušikovega oksida (npr. amilnitrit) v kakršni koli obliki, vključno z rekreacijskimi drogami, t. i. »poppers«, kontraindicirana (glejte poglavje 4.3).
There are no data from the use of riociguat in pregnant women.
Podatkov o uporabi riociguata pri nosečnicah ni na voljo.
Riociguat is a stimulator of soluble guanylate cyclase (sGC), an enzyme in the cardiopulmonary system and the receptor for nitric oxide (NO).
Riociguat je spodbujevalec topne gvanilat-ciklaze (sGC - soluble guanylate cyclase), encima v kardiopulmonarnem sistemu in receptorja za dušikov oksid (NO - nitric oxide).
Other medicines and Adempas Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular, medicines used for: - high blood pressure or heart disease (such as nitrates and amyl nitrite) in any form, as you must not take those medicines together with Adempas.
Druga zdravila in zdravilo Adempas Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, predvsem zdravila, ki se uporabljajo pri: - visokem krvnem tlaku ali boleznih srca (npr. nitrati in amilnitrit) v kakršni koli obliki, saj teh zdravil ne smete jemati sočasno z zdravilom Adempas, - visokem krvnem tlaku v pljučnih žilah (pljučnih arterijah), saj določenih zdravil (sildenafil in tadalafil) ne smete jemati sočasno z zdravilom Adempas.
you feel short of breath during treatment with this medicine, this can be caused by a build-up of fluid in the lungs.
- če ste zasopli med zdravljenjem s tem zdravilom, kar je lahko posledica kopičenja tekočine v pljučih.
In a reproduction toxicity study in rats, decreased testes weights were seen, but there were no effects on fertility (see section 5.3).
V študiji vpliva na sposobnost razmnoževanja pri podganah so opazili zmanjšano maso mod, vendar učinkov na plodnost niso opazili (glejte poglavje 5.3).
Approximately 9-44% of the administered dose was found as unchanged riociguat in faeces.
Približno 9 - 44 % uporabljenega odmerka riociguata se je v nespremenjeni obliki izločilo z blatom.
With a systemic clearance of about 3-6 L/h, riociguat can be classified as a low-clearance drug.
Sistemski očistek je približno 3 - 6 l/h, kar riociguat uvršča med zdravila z majhnim očistkom.
The adverse reactions reported with Adempas are listed in the table below by MedDRA system organ class and by frequency.
Neželeni učinki, o katerih so poročali pri zdravljenju z zdravilom Adempas, so navedeni v spodnji preglednici po organskih sistemih klasifikacije MedDRA in pogostnosti.
A randomised, double-blind, multi-national, placebo controlled, phase III study (PATENT-1) was conducted in 443 adult patients with PAH (riociguat individual dose titration up to 2.5 mg three times daily: n=254, placebo: n=126, riociguat “capped” dose titration (CT) up to 1.5 mg (exploratory dose arm, no statistical testing performed; n=63)).
V randomizirano, dvojno slepo, multinacionalno, s placebom nadzorovano študijo faze III (PATENT-1) je bilo vključenih 443 odraslih bolnikov s PAH (titriranje odmerka riociguata za posameznega bolnika do 2,5 mg trikrat na dan: n = 254, placebo: n = 126, navzgor omejeno titriranje odmerka riociguata (CT - ''capped'' dose titration) do 1,5 mg (skupina za določanje odmerka, statistična analiza ni bila izvedena; n = 63)).
Concomitant use with other CYP and P-gp/BCRP inhibitors
Sočasna uporaba z drugimi zaviralci CYP in P-gp/BCRP
If at any time during the up-titration phase systolic blood pressure decreases below 95 mmHg and the patient shows signs or symptoms of hypotension the current dose should be decreased by 0.5 mg three times daily.
Če se kadar koli v obdobju titriranja odmerka sistolični krvni tlak zniža pod 95 mm Hg in ima bolnik znake ali simptome hipotenzije, je treba trenutni odmerek zdravila zmanjšati za 0,5 mg trikrat na dan.
Women of childbearing potential must use effective contraception during treatment with Adempas.
Ženske v rodni dobi morajo med zdravljenjem z zdravilom Adempas uporabljati učinkovito kontracepcijsko metodo.
Riociguat (2.5 mg three times per day) did not have a clinically meaningful effect on the plasma levels of combined oral contraceptives containing levonorgestrel and ethinyl estradiol when concomitantly administered to healthy female subjects.
Pri zdravih ženskah riociguat (2,5 mg trikrat na dan) ni klinično pomembno vplival na plazemske vrednosti kombiniranih peroralnih kontraceptivov, ki vsebujejo levonorgestrel in etinilestradiol, če je bil uporabljen sočasno.
It is recommended to monitor these patients for signs and symptoms of hypotension (see sections 4.2 and 4.4).
Priporočljivo je spremljanje teh bolnikov glede znakov in simptomov hipotenzije (glejte poglavji 4.2 in 4.4).
In a fertility study in rats, decreased testes weights occurred at systemic exposure of about 7-fold of human exposure, whereas no effects on male and female fertility were seen.
V študiji vpliva na plodnost pri podganah so opazili zmanjšano maso mod pri sistemski izpostavljenosti, ki je bila približno 7-krat večja od izpostavljenosti pri ljudeh, pri čemer pa učinkov na plodnost samcev ali samic niso opazili.
Patients were either treatment-naïve (50%) or pre-treated with ERA (43%) or a prostacyclin analogue (inhaled (iloprost), oral (beraprost) or subcutaneous (treprostinil); 7%) and had been diagnosed with idiopathic or heritable PAH (63.4%), PAH associated with connective tissue disease (25.1%) and congenital heart disease (7.9%).
Bolniki so bili predhodno nezdravljeni (50 %) ali pa so se predhodno zdravili z antagonisti endotelinskih receptorjev (43 %) ali z analogom prostaciklina (inhalacija (iloprost), peroralna uporaba (beraprost) ali subkutana uporaba (treprostinil); 7 %); PAH je bila opredeljena kot idiopatska ali dedna (63,4 %), PAH, povezana z boleznijo veziva (25,1 %) in prirojeno boleznijo srca (7,9 %).
A randomised, double blind, placebo-controlled phase II study (RISE-IIP) to evaluate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) was terminated early due to an increased risk of mortality and serious adverse events in patients treated with riociguat and a lack of efficacy.
faze (RISE-IIP), ki je vrednotila učinkovitost in varnost riociguata pri bolnikih s simptomatsko pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP), je bila predčasno zaključena zaradi povečanega tveganja za umrljivost in resne neželene učinke pri bolnikih, ki so se zdravili z riociguatom, in zaradi pomanjkanja učinkovitosti.
Adempas is only prescribed for certain forms of PAH, i.e. idiopathic PAH (the cause of PAH is unknown), heritable PAH and PAH caused by connective tissue disease.
Zdravilo Adempas se predpisuje samo za zdravljenje določenih oblik pljučne arterijske hipertenzije, tj. idiopatske PAH (vzrok bolezni je neznan), dedne PAH in PAH, ki jo je povzročila bolezen veziva.
A randomised, double-blind, multi-national, placebo controlled, phase III study (CHEST-1) was conducted in 261 adult patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) (72%) or persistent or recurrent CTEPH after pulmonary endarterectomy (PEA; 28%).
V randomizirano, dvojno slepo, multinacionalno, s placebom nadzorovano študijo faze III (CHEST-1), je bilo vključenih 261 odraslih bolnikov z neoperabilno kronično trombembolično pljučno hipertenzijo (CTEPH) (72 %) ali perzistentno ali ponovno CTEPH po pljučni endarteriektomiji (PEA; 28 %).
Riociguat is a type of medicine called a guanylate cyclase (sGC)-stimulator.
Riociguat je vrsta zdravila, ki se imenuje spodbujevalec topne gvanilat-ciklaze (sGC - soluble guanylate cyclase).
No specific studies with riociguat in humans have been conducted to evaluate effects on fertility.
Posebnih študij za oceno učinkov riociguata na plodnost pri ljudeh niso izvedli.