FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of serious and fatal respiratory tract bleeding may be further increased under treatment with riociguat, especially in the presence of risk factors, such as recent episodes of serious haemoptysis including those managed by bronchial arterial embolisation.
Slovenian: Tveganje za resne in smrtne krvavitve v dihalih se lahko med zdravljenjem z riociguatom še poveča, predvsem ob prisotnosti dejavnikov tveganja, kot so nedavne resne hemoptize, vključno s tistimi po embolizaciji bronhialnih arterij.
English: Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems.
Slovenian: Posebna navodila za bolnike, ki imajo težave z ledvicami ali jetri Obvestite zdravnika, če imate težave z ledvicami ali jetri.
English: Riociguat also directly stimulates sGC independently of NO.
Slovenian: Riociguat spodbuja sGC tudi neposredno, neodvisno od NO.
English: Your doctor will monitor your health status and should consider a reduced starting dose for Adempas.
Slovenian: Zdravnik bo spremljal vaše zdravstveno stanje in razmislil o zmanjšanju začetnega odmerka zdravila Adempas.
English: 95% CI, [p-value]
Slovenian: 95 % CI, [vrednost p]
English: The tablets should be taken 3 times a day, approximately 6 to 8 hours apart.
Slovenian: Tablete se jemlje trikrat na dan, približno vsakih 6 do 8 ur.
English: The safety profile observed in HIV patients taking a single dose of 0.5 mg riociguat together with different combinations of HIV drugs used in HAART was generally comparable to other patient populations.
Slovenian: Varnostni profil, ki so ga opazili pri bolnikih, okuženih z virusom HIV, ki so jemali enkratni odmerek 0,5 mg riociguata hkrati z različnimi kombinacijami zdravil proti virusu HIV, uporabljenih v HAART, je bil na splošno primerljiv z varnostnim profilom pri drugih populacijah bolnikov.
English: An open-label extension study (CHEST-2) included 237 patients who had completed CHEST-1.
Slovenian: V odprto podaljšanje študije (CHEST-2) je bilo vključenih 237 bolnikov, ki so zaključili študijo CHEST-1.
English: In cigarette smokers riociguat exposure is reduced by 50-60% (see section 5.2).
Slovenian: Pri kadilcih cigaret se izpostavljenost riociguatu zmanjša za 50 - 60 % (glejte poglavje 5.2).
English: Inadvertent overdosing with total daily doses of 9 to 25 mg riociguat between 2 to 32 days was reported.
Slovenian: Poročali so o nenamernih prevelikih dnevnih odmerkih od 9 do 25 mg riociguata med 2. do 32. dnem.
English: Patients should be aware of how they react to this medicinal product, before driving or using machines.
Slovenian: Bolniki morajo pred vožnjo ali upravljanjem strojev vedeti, kako se odzivajo na to zdravilo.
English: 15 to 56
Slovenian: 15 do 56
English: Tablets should be taken three times daily approximately 6 to 8 hours apart (see section 5.2).
Slovenian: Tablete je treba vzeti trikrat na dan, približno vsakih 6 do 8 ur (glejte poglavje 5.2).
English: In growing, juvenile and adolescent rats, effects on bone formation were seen.
Slovenian: Pri rastočih, mladih in adolescentnih podganah so opazili učinke na rast in razvoj kosti.
English: Current smokers should be advised to stop smoking due to a risk of a lower response.
Slovenian: Kadilcem je treba svetovati, da prenehajo s kajenjem, ker obstaja tveganje za slabši odziv na zdravljenje.
English: - if you have low blood pressure (systolic blood pressure less than 95 mmHg) before starting first treatment with this medicine.
Slovenian: - če imate nizek krvni tlak (sistolični krvni tlak manj kot 95 mm Hg) pred začetkom prvega zdravljenja s tem zdravilom).
English: Blood pressure should be monitored and dose reduction of riociguat be considered.
Slovenian: Spremljati je treba krvni tlak in razmisliti o zmanjšanju odmerka riociguata.
English: Adverse reactions were similar to those seen at lower doses (see section 4.8).
Slovenian: Neželeni učinki so bili podobni tistim, ki so jih opazili pri manjših odmerkih (glejte poglavje 4.8).
English: What Adempas is and what it is used for 2.
Slovenian: Kaj je zdravilo Adempas in za kaj ga uporabljamo 2.
English: Highly active antiretroviral therapy (HAART)
Slovenian: Visokoaktivno protiretrovirusno zdravljenje (HAART - highly active antiretroviral therapy)
English: - if you are allergic to riociguat or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na riociguat ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste noseči.
English: What you need to know before you take Adempas 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Adempas 3.
English: Adempas can be used for patients with CTEPH who cannot be operated on, or after surgery for patients in whom increased blood pressure in the lungs remains or returns.
Slovenian: Zdravilo Adempas se lahko uporablja pri bolnikih s CTEPH, ki jih ni mogoče operirati, ali pri bolnikih, ki so bili operirani, a je zvišan krvni tlak v pljučih ostal visok ali pa se je ponovno zvišal.
English: Efficacy in patients with CTEPH
Slovenian: Učinkovitost pri bolnikih s CTEPH
English: A careful monitoring of patients taking anticoagulants according to common medical practice is recommended.
Slovenian: Pri bolnikih, ki jemljejo antikoagulante, se priporoča skrbno spremljanje v skladu z običajno klinično prakso.
English: In addition, ritonavir showed inhibition of P-gp.
Slovenian: Poleg tega je ritonavir zaviral P-gp.
English: If you are 65 years or older your doctor will take extra care in adjusting your dose of Adempas, because you may be at greater risk of low blood pressure.
Slovenian: Če ste stari 65 let ali več, vam bo zdravnik posebno previdno določil odmerek zdravila Adempas, saj pri vas obstaja večje tveganje za nizek krvni tlak.
English: The safety of Adempas has been evaluated in phase III studies of 681 patients with CTEPH and PAH receiving at least one dose of riociguat (see section 5.1).
Slovenian: Varnost zdravila Adempas so ocenjevali v študijah faze III, v katere je bilo vključenih 681 bolnikov s CTEPH in PAH, ki so prejeli vsaj en odmerek riociguata (glejte poglavje 5.1).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bayer (Logo)
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer (logotip)
English: Developmental toxicity studies in rats and rabbits have shown reproductive toxicity of riociguat.
Slovenian: Študije razvojne toksičnosti pri podganah in kuncih so pokazale toksičnost riociguata na sposobnost razmnoževanja.
English: Intra-cellular cGMP plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis, and inflammation.
Slovenian: Znotrajcelični cGMP ima pomembno vlogo pri uravnavanju žilnega tonusa, proliferacije, fibroze in vnetja.
English: Dizziness has been reported and may affect the ability to drive and use machines (see section 4.8).
Slovenian: Poročali so o omotici, ki lahko vpliva na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
English: Results were consistent in the main sub-groups evaluated (ITT analysis, see table 2).
Slovenian: Izsledki so bili skladni v vseh glavnih ovrednotenih podskupinah (analiza glede na namero zdravljenja (ITT - intention-to-treat, glejte preglednico 2).
English: It may cause side effects such as dizziness.
Slovenian: Zdravilo lahko povzroči neželene učinke, kot je omotičnost.
English: These findings were in accordance with improvements in additional haemodynamic parameters.
Slovenian: Ti izsledki so bili v skladu z izboljšanji drugih hemodinamskih parametrov.
English: Hospitalisations due to PH Decrease in 6MWD due to PH Persistent worsening of Functional Class due to PH
Slovenian: bolniki s kakršnim koli kliničnim poslabšanjem smrt hospitalizacija zaradi PH skrajšanje 6MWD zaradi PH vztrajno poslabševanje funkcijskega razreda zaradi PH uvedba novega zdravljenja PH
English: Bayer (logo)
Slovenian: Bayer (logotip)
English: The use of riociguat in other forms of PAH not studied is not recommended (see section 5.1).
Slovenian: Uporabe riociguata se ne priporoča pri drugih, neraziskanih oblikah PAH (glejte poglavje 5.1).
English: Treatment should only be started and monitored by a doctor experienced in the treatment of CTEPH or PAH.
Slovenian: Zdravljenje mora uvesti in nadzirati zdravnik, ki ima izkušnje z zdravljenjem CTEPH ali PAH.
English: Your doctor will decide with you if you either should stop breast-feeding or stop treatment with Adempas.
Slovenian: Zdravnik se bo skupaj z vami odločil, ali boste prenehali dojiti ali pa se boste prenehali zdraviti z zdravilom Adempas.
English: All patients were WHO Functional Class III and 82% received background therapy with an endothelin receptor antagonist (ERA).
Slovenian: Vsi bolniki so spadali v III. funkcijski razred po klasifikaciji SZO in 82 % jih je prejemalo osnovno zdravljenje z antagonisti endotelinskih receptorjev (ERA - endothelin receptor antagonist).
English: If you have taken more tablets than you should and experience any side effects (see section 4), please contact your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila Adempas, kot bi smeli Če ste vzeli več tablet, kot bi smeli, in imate kakršne koli neželene učinke (glejte poglavje 4), se posvetujte z zdravnikom.
English: Riociguat has vasodilatory properties which may result in lowering of blood pressure.
Slovenian: Riociguat deluje vazodilatacijsko, kar ima lahko za posledico znižanje krvnega tlaka.
English: Please tell your doctor if you smoke or if you stop smoking during treatment.
Slovenian: Zdravnika obvestite, če kadite ali če med zdravljenjem prenehate kaditi.
English: You will receive Adempas only for special types of pulmonary arterial hypertension (PAH), see section 1.
Slovenian: Zdravilo Adempas boste prejeli le za določeno obliko pljučne arterijske hipertenzije (PAH), glejte poglavje 1.
English: An open-label extension study (PATENT-2) included 396 patients who had completed PATENT-1 at the cut-off-date.
Slovenian: V odprto podaljšanje študije (PATENT-2) je bilo vključenih 396 bolnikov, ki so zaključili študijo PATENT-1 na presečni dan zbiranja podatkov.
English: Due to the potential for serious adverse reactions in breast-fed infants Adempas should not be used during breast-feeding.
Slovenian: Zaradi možnih resnih neželenih učinkov pri dojenčkih, se zdravila Adempas ne sme uporabljati med dojenjem.
English: you have any symptoms of low blood pressure (hypotension) such as dizziness, lightheadedness, or fainting or if you are taking medicines to lower your blood pressure or medicines that cause an increase in urination or if you have problems with your heart or circulation.
Slovenian: - če imate simptome nizkega krvnega tlaka (hipotenzija), kot so omotica, vrtoglavica ali omedlevica, ali če jemljete zdravila za zniževanje krvnega tlaka ali zdravila, ki povečajo pogostnost uriniranja, ali če imate težave s srcem ali krvnim obtokom.
English: If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Adempas.
Slovenian: Če ne morete požirati celih tablet, se z zdravnikom pogovorite o drugih načinih jemanja zdravila Adempas.
English: The maximum total daily dose is 7.5 mg i.e., 2.5 mg 3 times daily.
Slovenian: Največji dnevni odmerek je 7,5 mg, tj. 2,5 mg trikrat na dan.
English: Concomitant treatment of riociguat and warfarin did not alter prothrombin time induced by the anticoagulant.
Slovenian: Sočasno zdravljenje z riociguatom in varfarinom ni vplivalo na spremembo protrombinskega časa, doseženega z antikoagulantom.
English: - if you have increased pressure in your pulmonary circulation associated with scarring of the lungs, of unknown cause (idiopathic pulmonary pneumonia).
Slovenian: - če imate zvišan tlak v pljučnem krvnem obtoku, povezan z brazgotinjenjem pljuč neznanega vzroka (idiopatsko pljučnico).
English: In chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy is the treatment of choice as it is a potentially curative option.
Slovenian: Pri kronični trombembolični pljučni hipertenziji je pljučna endarteriektomija metoda izbora za zdravljenje, saj je potencialno kurativna.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Therefore, patients are advised to stop smoking (see section 4.2).
Slovenian: Zato je treba bolnikom svetovati, da prenehajo kaditi (glejte poglavje 4.2).
English: Cobicistat, ritonavir, atazanavir and darunavir are additionally classified as CYP3A inhibitors.
Slovenian: Kobicistat, ritonavir, atazanavir in darunavir so dodatno opredeljeni kot zaviralci CYP3A.
English: -11 to 31
Slovenian: -11 do 31
English: Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of riociguat (haemodynamic and smooth muscle relaxing effects).
Slovenian: Učinki, ki so jih opazili v študijah ponavljajočih odmerkov, so bili posledica predvsem poudarjene farmakodinamične aktivnosti riociguata (hemodinamski učinki in sprostitev gladkih mišic).
English: Corresponding values for the main metabolite were higher in subjects with renal impairment compared to healthy subjects.
Slovenian: Ustrezne vrednosti za glavni presnovek so bile večje pri osebah z ledvično okvaro v primerjavi z zdravimi osebami.
English: Should signs of pulmonary oedema occur, the possibility of associated PVOD should be considered and treatment with riociguat should be discontinued.
Slovenian: Če se pojavijo znaki pljučnega edema, je treba pomisliti na možnost pridružene pljučne venookluzivne bolezni in zdravljenje z riociguatom prekiniti.
English: What you need to know before you take Adempas
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Adempas
English: What Adempas is and what it is used for
Slovenian: Kaj je zdravilo Adempas in za kaj ga uporabljamo
English: These findings were in accordance with improvements in additional haemodynamic parameters (see table 5).
Slovenian: Ti izsledki so bili v skladu z izboljšanjem drugih hemodinamskih parametrov (glejte preglednico 5).
English: In elderly patients (65 years or older) there is a higher risk of hypotension and therefore particular care should be exercised during individual dose titration (see section 5.2).
Slovenian: Pri starejših bolnikih (starih 65 let ali več) obstaja večje tveganje za hipotenzijo, zato je pri titriranju odmerka potrebna posebna previdnost (glejte poglavje 5.2).
English: Riociguat must not be used in patients with a systolic blood pressure below 95 mmHg (see section 4.3).
Slovenian: Riociguata se ne sme uporabljati pri bolnikih s sistoličnim krvnim tlakom nižjim od 95 mm Hg (glejte poglavje 4.3).
English: There was no evidence of a favourable clinical effect of the combination in the population studied.
Slovenian: Koristni klinični učinki omenjene kombinacije zdravil v preučevani populaciji niso bili ugotovljeni.
English: Adempas is available in different strengths and by checking your blood pressure regularly at the beginning of your treatment, your doctor will ensure that you are taking the appropriate dose.
Slovenian: Zdravilo Adempas je na voljo v različnih jakostih, zato bo zdravnik z rednim merjenjem vašega krvnega tlaka na začetku zdravljenja določil ustrezen odmerek.
English: If you forget to take Adempas
Slovenian: Če ste pozabili vzeti zdravilo Adempas
English: Adempas is a film-coated tablet:
Slovenian: Zdravilo Adempas je filmsko obložena tableta:
English: • acute bleeding from the lungs (pulmonary haemorrhage) may result in coughing up blood, cases with fatal outcomes were observed (uncommon side effect, may affect up to 1 in 100 people).
Slovenian: • akutna krvavitev v pljučih (pulmonalna krvavitev) lahko povzroči izkašljevanje krvi, opazili so primere s smrtnim izidom (občasni neželeni učinek, ki se lahko pojavi pri največ 1 od
English: Intake with food reduced riociguat AUC slightly, Cmax was reduced by 35%.
Slovenian: Jemanje s hrano blago zmanjša AUC riociguata; Cmax se je zmanjšal za 35 %.
English: 29 to 79
Slovenian: 29 do 79
English: • In patients on stable doses of Adempas, the initiation of strong multi pathway CYP and P-gp/BCRP inhibitors is not recommended as no dosage recommendation can be given due to limited data.
Slovenian: • Pri bolnikih na stabilnih odmerkih zdravila Adempas se ne priporoča uvedba močnih zaviralcev več presnovnih poti CYP in P-gp/BCRP, ker zaradi omejenih podatkov ni mogoče dati nobenega priporočila.
English: If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Slovenian: Pljučni vazodilatatorji lahko močno poslabšajo kardiovaskularno stanje bolnikov s pljučno venookluzivno boleznijo (PVOD - pulmonary veno-occlusive disease).
English: In pulmonary hypertension patients there is increased likelihood for respiratory tract bleeding, particularly among patients receiving anticoagulation therapy.
Slovenian: Pri bolnikih s pljučno hipertenzijo je večja verjetnost krvavitev v dihalih, predvsem pri bolnikih, ki se zdravijo z antikoagulanti.
English: Therefore, drug-drug interactions by inhibition of CYP1A1 could result in increased riociguat exposure, especially in smokers (see section 5.2).
Slovenian: Zato lahko medsebojno delovanje zdravil, ki zavirajo CYP1A1 poveča izpostavljenost riociguatu, predvsem pri kadilcih (glejte poglavje 5.1).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni »brez natrija«.
English: Do not take Adempas: - if you are taking certain medicines called PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil).
Slovenian: Ne jemljite zdravila Adempas: - če jemljete določena zdravila, imenovana zaviralci PDE-5 (npr. sildenafil, tadalafil, vardenafil).
English: Strong CYP1A1 inhibitors should be used with caution (see section 4.4).
Slovenian: Močne zaviralce CYP1A1 je treba uporabljati previdno (glejte poglavje 4.4).
English: For the transition from PDE5 inhibitors to riociguat, median treatment-free time for sildenafil was 1 day and for tadalafil 3 days.
Slovenian: Ob prehodu z zaviralcev PDE5 na riociguat je bil mediani čas brez zdravljenja 1 dan za sildenafil in 3 dni za tadalafil.
English: The recommended starting dose is 1 mg three times daily for 2 weeks.
Slovenian: Priporočeni začetni odmerek je 1 mg trikrat na dan 2 tedna.
English: 14 to 62
Slovenian: 14 do 62
English: 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.
Slovenian: 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.
English: Therefore, administration of riociguat to such patients is not recommended.
Slovenian: Zato se uporabe riociguata ne priporoča pri teh bolnikih.
English: 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.
Slovenian: V dolgotrajnem podaljšanju študije (brez primerjalne skupine) je sočasna uporaba sildenafila in riociguata povzročila pogostejše prekinitve zdravljenja, predvsem zaradi hipotenzije.
English: 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.
Slovenian: Sočasno lahko uporabljate druga zdravila za zdravljenje visokega krvnega tlaka v pljučnih žilah (PAH), npr. bosentan in iloprost, vendar morate o tem obvestiti zdravnika.
English: Transitioning between phosphodiesterase-5 (PDE5) inhibitors and riociguat Sildenafil must be discontinued at least 24 hours prior to administration of riociguat.
Slovenian: Prehod med zaviralci fosfodiesteraze-5 (PDE5) in riociguatom Z uporabo sildenafila je treba prenehati vsaj 24 ur pred uporabo riociguata.
English: 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.
Slovenian: 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.
English: Improvement in exercise capacity was accompanied by consistent improvement in multiple clinicallyrelevant secondary endpoints.
Slovenian: Izboljšanje telesne zmogljivosti je spremljalo dosledno izboljšanje številnih klinično pomembnih sekundarnih opazovanih ciljev.
English: According to standard medical practice, expert assessment of operability should be done prior to treatment with riociguat.
Slovenian: Glede na običajno klinično prakso, je treba strokovno oceno o primernosti kirurškega posega pri bolniku opraviti pred zdravljenjem z riociguatom.
English: 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.
Slovenian: 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.
English: 42 film-coated tablets 84 film-coated tablets 90 film-coated tablets 294 film-coated tablets
Slovenian: 42 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 294 filmsko obloženih tablet
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Na splošno je varnostni profil, ki so ga opazili v študiji, primerljiv s tistim, ki so ga opazili v ključnih preskušanjih.
English: 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.
Slovenian: 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 %.
English: Total riociguat (parent compound and metabolites) is excreted via both renal (33-45%) and biliary/faecal routes (48-59%).
Slovenian: Celokupni riociguat (izhodna spojina in presnovki) se izloča skozi ledvice (33 - 45 %) in z blatom/žolčem (48 - 59 %).