FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose adjustment may be necessary in patients who start or stop smoking during treatment with riociguat (see sections 4.2 and 5.2).
Slovenian: Bolnikom, ki med zdravljenjem začnejo ali prenehajo kaditi, bo morda treba odmerek prilagoditi (glejte poglavji 4.2 in 5.2).
English: Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 97%, 94% and 90% respectively, and for patients of WHO functional class III at baseline was 97%, 93% and 88% respectively.
Slovenian: funkcijski razred po klasifikaciji SZO, je bilo po enem, dveh in treh letih zdravljenja 97 %, 94 % in 90 %, medtem ko je bilo preživetje bolnikov, ki so bili na začetku zdravljenja razvrščeni v III. funkcijski razred, 97 %, 93 % in 88 %.
English: -303.3 to -189.5 [<0.0001]
Slovenian: -303,3 do -189,5 [< 0,0001]
English: Gender Pharmacokinetic data reveal no relevant differences due to gender in the exposure to riociguat.
Slovenian: Spol Farmakokinetični podatki niso pokazali razlik v izpostavljenosti riociguatu glede na spol.
English: Riociguat is cleared mainly via cytochrome P450-mediated (CYP1A1, CYP3A4, CYP3A5, CYP2J2) oxidative metabolism, direct biliary/faecal excretion of unchanged riociguat and renal excretion of unchanged riociguat via glomerular filtration.
Slovenian: Riociguat se odstranjuje iz telesa z oksidativno presnovo, v glavnem preko citokroma P450 (CYP1A1, CYP3A4, CYP3A5, CYP2J2), v nespremenjeni obliki pa z žolčem/blatom in glomerulno filtracijo skozi ledvice.
English: Talk to your doctor or pharmacist before taking Adempas if: you have recently experienced serious bleeding from the lung, or if you have undergone treatment to stop coughing up blood (bronchial arterial embolisation).
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Adempas se posvetujte z zdravnikom ali farmacevtom: - če ste imeli pred kratkim hudo krvavitev v pljučih ali ste se zdravili zaradi izkašljevanja krvi (embolizacija bronhialnih arterij), - če jemljete zdravila za redčenje krvi (antikoagulante), saj lahko to povzroči krvavitev v pljučih.
English: For co-administration with bosentan follow the recommendation on dose titration (see section 4.2).
Slovenian: Pri sočasni uporabi z bosentanom upoštevajte priporočila glede titriranja odmerka (glejte poglavje 4.2).
English: you take medicines used to treat fungal infections (e.g. ketoconazole, posaconazole, itraconazole) or medicines for the treatment of HIV infection (e.g. abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, lamivudine, rilpivirine, ritonavir, and tenofovir).
Slovenian: - če jemljete zdravila za zdravljenje glivičnih okužb (npr. ketokonazol, posakonazol, itrakonazol) ali zdravil za zdravljenje okužb z virusom HIV(npr. abakavir, atazanavir, kobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabin, lamivudin, rilpivirin, ritonavir in tenofovir).
English: Data in patients with severe renal impairment (creatinine clearance < 30 mL/min) are limited and there are no data for patients on dialysis, therefore riociguat is not recommended in these patients.
Slovenian: Podatki o bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) so omejeni in na voljo ni podatkov o bolnikih na dializi, zato se uporaba riociguata ne priporoča pri teh bolnikih.
English: -281.4 to -170.1[<0.0001]
Slovenian: -281,4 do -170,1[< 0,0001]
English: Most of the adverse reactions are caused by relaxation of smooth muscle cells in vasculature or the gastrointestinal tract.
Slovenian: Večina neželenih učinkov je bila posledica sprostitve gladkih mišic v žilju ali prebavilih.
English: Studies in animals have shown reproductive toxicity and placental transfer (see section 5.3).
Slovenian: Študije na živalih so pokazale škodljiv vpliv na sposobnost razmnoževanja in prehajanje skozi posteljico (glejte poglavje 5.3).
English: In rabbits, starting at systemic exposure of about 3-fold of human exposure (2.5 mg three times daily) abortion and foetal toxicity were seen.
Slovenian: Pri kuncih so pri sistemski izpostavljenosti, ki je bila približno 3-krat večja od izpostavljenosti pri ljudeh (2,5 mg trikrat na dan), opazili splavnost in toksičnost za zarodek.
English: Pulmonary arterial hypertension (PAH)
Slovenian: Pljučna arterijska hipertenzija (PAH - pulmonary arterial hypertension)
English: Changes from baseline suggested beneficial effects in selected patients, e.g. improvement in 6MWD (+31m), N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels (-347 pg/mL) and WHO FC I/II/III/IV,% (2/52/46/0), cardiac index (+0.3 L/min/m2).
Slovenian: Spremembe od izhodiščnega stanja kažejo na ugodne učinke pri izbranih bolnikih, tj. izboljšanje glede prehojene razdalje v testu šestminutne hoje (+ 31 m), ravni Nterminalnega natriuretičnega propeptida tipa B (NT-proBNP) (-347 pg/ml) in razvstitve v I./II./III./IV.
English: Data in patients with severe renal impairment (creatinine clearance <30 mL/min) are limited and there are no data for patients on dialysis.
Slovenian: Podatki o bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) so omejeni in na voljo ni podatkov o bolnikih na dializi.
English: In PATENT-2, all patients received an individualised riociguat dose up to 2.5 mg three times daily.
Slovenian: V študiji PATENT-2 so vsi bolniki prejemali bolniku prilagojen odmerek riociguata (do največ 2,5 mg trikrat na dan).
English: -781.5 to -82.1 [<0.0001]
Slovenian: -781,5 do -82,1 [< 0,0001]
English: For co-administration with these substances follow the recommendation on dose titration (see section 4.2).
Slovenian: Pri sočasni uporabi s temi zdravili upoštevajte priporočila glede titriranja odmerka (glejte poglavje 4.2).
English: Patients with moderate hepatic impairment (Child Pugh B) showed a higher exposure to this medicinal product (see section 5.2).
Slovenian: Pri bolnikih z zmerno okvaro jeter (Child Pugh B) je bila izpostavljenost temu zdravilu večja (glejte poglavje 5.2).
English: Concomitant use with strong multi pathway CYP and P-gp/BCRP inhibitors
Slovenian: Sočasna uporaba močnih zaviralcev več presnovnih poti CYP in P-gp/BCRP
English: Improvements in 6MWD persisted at 2 years in PATENT-2.
Slovenian: V študiji PATENT-2 so izboljšanja prehojene razdalje v testu šestminutne hoje trajala 2 leti.
English: FC II patient population
Slovenian: Populacija bolnikov II.
English: Talk to your doctor if this happens.
Slovenian: V tem primeru se posvetujte z zdravnikom.
English: At the last visit the increase in 6MWD with riociguat individual dose titration (IDT) was 36 m (95% CI: 20 m to 52 m; p0.0001) compared to placebo.
Slovenian: Pri zadnjem obisku je bilo podaljšanje prehojene razdalje v testu šestminutne hoje pri titriranju odmerka riociguata za posameznega bolnika (IDT - individual dose titration) 36 m (95-odstotni IZ: 20 m do 52 m; p < 0,0001) v primerjavi s placebom.
English: How to store Adempas
Slovenian: Kako jemati zdravilo Adempas
English: The mean change in 6MWD from baseline to week 12 (last observation until week 12) in CHEST-2 (28 weeks on-study for CHEST-1 + CHEST-2) was 57 m in the former 1.0-2.5 mg riociguat group and 43 m in the former placebo group.
Slovenian: Pri merjenju prehojene razdalje v testu šestminutne hoje je bila povprečna sprememba od izhodiščne vrednosti do 12. tedna (zadnje opazovanje do 12. tedna) v študiji CHEST-2 (28 tednov študije CHEST-1 + CHEST-2) 57 m v skupini, ki je predhodno prejemala 1,0 - 2,5 mg riociguata, in 43 m v skupini, ki je predhodno prejemala placebo.
English: During the first 8 weeks riociguat was titrated every 2-weeks based on the patient's systolic blood pressure and signs or symptoms of hypotension to the optimal individual dose (range 0.5 mg to 2.5 mg three times daily), which was then maintained for a further 4 weeks.
Slovenian: V prvih 8 tednih so riociguat titrirali vsaka 2 tedna glede na bolnikov sistolični krvni tlak in znake ter simptome hipotenzije in sicer do odmerka, ki je bil najbolj primeren za posameznega bolnika (razpon od 0,5 mg do 2,5 mg trikrat na dan).
English: The mean change in 6MWD from baseline to week 12 (last observation until week 12) in PATENT-2 (24 weeks on-study for PATENT-1 + PATENT-2) was 52 m in the former 1.0-2.5 mg riociguat group,45 m in the former placebo group and 52 m in the former 1.0-1.5 mg riociguat group.
Slovenian: Pri merjenju prehojene razdalje v testu šestminutne hoje je bila povprečna sprememba od izhodiščne vrednosti do 12. tedna (zadnje opazovanje do 12. tedna) v študiji PATENT-2 (24 tednov študije PATENT-1 + PATENT-2) 52 m v skupini, ki je predhodno prejemala 1,0 - 2,5 mg riociguata, 45 m v skupini, ki je predhodno prejemala placebo, in 52 m v skupini, ki je predhodno prejemala 1,0 - 1,5 mg riociguata.
English: At the last visit, the increase in 6MWD in patients treated with riociguat was 46 m (95% confidence interval (CI): 25 m to 67 m; p<0.0001), compared to placebo.
Slovenian: Pri zadnjem obisku je bilo podaljšanje prehojene razdalje v testu šestminutne hoje pri bolnikih, zdravljenih z riociguatom, 46 m (95-odstotni interval zaupanja (IZ): 25 m do 67 m; p < 0,0001) v primerjavi s placebom.
English: • chronic thromboembolic pulmonary hypertension (CTEPH).
Slovenian: • kronična trombembolična pljučna hipertenzija (CTEPH - chronic thromboembolic pulmonary hypertension)
English: Data in patients with creatinine clearance <30 mL/min are limited and there are no data for patients on dialysis.
Slovenian: Podatki o bolnikih z očistkom kreatinina < 30 ml/min so omejeni, podatkov o bolnikih na dializi pa ni na voljo.
English: • The concomitant use of riociguat with strong CYP1A1 inhibitors, such as the tyrosine kinase inhibitor erlotinib, and strong P-glycoprotein (P-gp) / breast cancer resistance protein (BCRP) inhibitors, such as the immuno-suppressive agent cyclosporine A, may increase riociguat exposure (see sections 4.5 and 5.2).
Slovenian: • Sočasna uporaba riociguata z močnimi zaviralci CYP1A1, kot je zaviralec tirozin-kinaze erlotinib in močnimi zaviralci P-glikoproteina (P-gp) / proteina odpornosti za raka dojke (BCRP), kot je imunosupresiv ciklosporin A, lahko poveča izpostavljenost riociguatu (glejte poglavji 4.5 in 5.2).
English: It sensitises sGC to endogenous NO by stabilising the NO-sGC binding.
Slovenian: Riociguat poveča občutljivost sGC za endogeni dušikov oksid tako, da stabilizira vezavo NO-sGC.
English: Serious haemorrhagic events also included 2 patients with vaginal haemorrhage, 2 with catheter site haemorrhage, and 1 each with subdural haematoma, haematemesis, and intra-abdominal haemorrhage.
Slovenian: Med resne krvavitve so bili prav tako vključeni dve bolnici s krvavitvijo iz nožnice, dva bolnika s krvavitvijo iz mesta vstavitve katetra, in po en bolnik s subduralnim hematomom, hematemezo in krvavitvijo v trebušno votlino.
English: If a dose is missed, treatment should be continued with the next dose as planned.
Slovenian: Če bolnik pozabi vzeti odmerek, mora zdravljenje nadaljevati z naslednjim odmerkom ob običajnem času.
English: - fungal infections (such as ketoconazole, posaconazole, itraconazole) or HIV infection (such as abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine or ritonavir) because alternative treatment options may be considered.
Slovenian: - erektilni disfunkciji (npr. sildenafil, tadalafil, vardenafil), saj teh zdravil ne smete jemati sočasno z zdravilom Adempas, - glivičnih okužbah (npr. ketokonazol, posakonazol, itrakonazol) ali okužbi z virusom HIV (npr. abakavir, atazanavir, kobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabin, rilpivirin ali ritonavir), ker bo morda potrebno razmisliti o alternativnih možnostih zdravljenja.
English: The primary endpoint of the study was placebo-adjusted change from baseline in 6MWD at the last visit (week 12).
Slovenian: Primarni opazovani cilj študije je bila glede na placebo prilagojena sprememba prehojene razdalje v testu šestminutne hoje od izhodiščne vrednosti do vrednosti pri zadnjem obisku (12. teden).
English: A dose increase to the maximum daily dose of 2.5 mg three times daily may be required in patients who are smoking or start smoking during treatment (see sections 4.5 and 5.2).
Slovenian: Bolnikom, ki kadijo ali med zdravljenjem začnejo kaditi, bo morda treba odmerek povečati do največjega dnevnega odmerka 2,5 mg trikrat na dan (glejte poglavji 4.5 in 5.2).
English: There are no data in patients with severe hepatic impairment (classified as Child Pugh C).
Slovenian: Podatkov o bolnikih s hudo jetrno okvaro (Child Pugh C) ni na voljo.
English: Table 3: Effects of riociguat in CHEST-1 on PVR, NT-proBNP and WHO functional class at last visit PVR
Slovenian: Preglednica 3: Učinki riociguata v študiji CHEST-1 na upor v pljučnem žilju (PVR), N-terminalni natriuretični propeptid tipa B (NT-proBNP) in funkcijski razred po klasifikaciji SZO pri zadnjem obisku
English: In CHEST-2, all patients received an individualised riociguat dose up to 2.5 mg three times daily.
Slovenian: V študiji CHEST-2 so vsi bolniki prejemali bolniku prilagojen odmerek riociguata (do največ 2,5 mg trikrat na dan).
English: • 42 tablets: two transparent calendar blisters of 21 tablets each.
Slovenian: • 42 tablet: dva prozorna, z dnevi označena pretisna omota po 21 tablet
English: Improvements in 6MWD persisted at 2 years in CHEST-2.
Slovenian: V študiji CHEST-2 so izboljšanja prehojene razdalje v testu šestminutne hoje trajala 2 leti.
English: Serious haemoptysis and pulmonary haemorrhage, including cases with fatal outcome have been observed in patients with CTEPH or PAH treated with Adempas (see section 4.4).
Slovenian: Pri bolnikih s CTEPH ali PAH, zdravljenih z zdravilom Adempas, so poročali o resni hemoptizi in krvavitvi v pljučih, vključno s smrtnimi primeri (glejte poglavje 4.4).
English: Therefore, Adempas is contraindicated during pregnancy (see section 4.3).
Slovenian: Zato je uporaba zdravila Adempas med nosečnostjo kontraindicirana (glejte poglavje 4.3).
English: In vitro, ketoconazole, classified as a strong CYP3A4 and P-glycoprotein (P-gp) inhibitor, has been shown to be a multi-pathway CYP and P-gp/breast cancer resistance protein (BCRP) inhibitor for riociguat metabolism and excretion (see section 5.2).
Slovenian: In vitro je ketokonazol, močan zaviralec CYP3A4 in glikoproteina-P (P-gp), zaviral več presnovnih poti ali izločanja riociguata preko CYP in P-gp/protein odpornosti pri raku dojke (BCRP - breast cancer resistance protein) (glejte poglavje 5.2).
English: Table 2: Effects of riociguat on 6MWD in CHEST-1 at last visit Entire patient population
Slovenian: Preglednica 2: Učinki riociguata na 6MWD v študiji CHEST-1 pri zadnjem obisku Celotna populacija bolnikov riociguat (n = 173)
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Adempas ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: - Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see sections 4.2 and 4.5).
Slovenian: - sočasna uporaba z zaviralci PDE5 (npr. sildenafil, tadalafil, vardenafil) (glejte poglavji 4.2 in
English: Particular care should be exercised during individual dose titration.
Slovenian: Pri titriranju odmerka je potrebna posebna previdnost.
English: Chronic thromboembolic pulmonary hypertension (CTEPH)
Slovenian: Kronična trombembolična pljučna hipertenzija (CTEPH - chronic thromboembolic pulmonary hypertension)
English: There is a higher risk of hypotension in patients with renal impairment, therefore particular care should be exercised during individual dose titration.
Slovenian: Pri bolnikih z ledvično okvaro je tveganje za hipotenzijo večje, zato je pri teh bolnikih pri titriranju odmerka potrebna posebna previdnost.
English: • Assess the benefit-risk for each patient individually before prescribing Adempas in patients on stable doses of strong multi pathway CYP and P-gp/BCRP inhibitors.
Slovenian: • Preden zdravnik predpiše zdravilo Adempas bolnikom na stabilnih odmerkih močnih zaviralcev več presnovnih poti CYP in P-gp/BCRP, mora oceniti koristi in tveganja za vsakega posameznega bolnika.
English: Plasma protein binding in humans is high at approximately 95%, with serum albumin and alpha 1-acidic glycoprotein being the main binding components.
Slovenian: Glavni komponenti za vezavo sta serumski albumin in alfa -1 kisli glikoprotein.
English: • The concomitant use of riociguat with strong multi pathway cytochrome P450 (CYP) and Pglycoprotein (P-gp) / breast cancer resistance protein (BCRP) inhibitors such as azole antimycotics (e.g. ketoconazole, posaconazole, itraconazole) or HIV protease inhibitors (e.g. ritonavir) results in a pronounced increase in riociguat exposure (see sections 4.5 and 5.2).
Slovenian: • Sočasna uporaba riociguata z močnimi zaviralci več presnovnih poti citokroma P450 (CYP) in P-glikoproteina (P-gp) / proteina odpornosti pri raku dojke (BCRP - breast cancer resistance protein), kot so azolni antimikotiki (npr. ketokonazol, posakonazol, itrakonazol) ali zaviralci proteaze HIV (npr. ritonavir), se kaže kot izrazito povečanje izpostavljenosti riociguatu (glejte poglavji 4.5 in 5.2).
English: For patients prone to hypotension, as a precautionary measure, switches between fed and fasted Adempas intake are not recommended because of increased peak plasma levels of riociguat in the fasting compared to the fed state (see section 5.2).
Slovenian: Ker je povečanje koncentracije riociguata v plazmi vzetega na tešče večje od koncentracije riociguata vzetega po obroku, se pri bolnikih, ki so nagnjeni k hipotenziji, iz previdnostnih razlogov ne priporoča spreminjanje načina jemanja zdravila Adempas tako, da je enkrat vzet na tešče drugič pa s hrano ali obratno (glejte poglavje 5.2).
English: Each film-coated tablet contains 0.5 mg of riociguat.
Slovenian: Ena filmsko obložena tableta vsebuje 0,5 mg riociguata.
English: Riociguat should be avoided in patients with a history of serious haemoptysis or who have previously undergone bronchial arterial embolisation.
Slovenian: Pri bolnikih z resno hemoptizo v anamnezi ali predhodno embolizacijo bronhialnih arterij, se je treba uporabi riociguata izogibati.
English: Riociguat exhibits a reduced solubility at neutral pH vs. acidic medium.
Slovenian: Riociguat je v mediju z nevtralno pH vrednostjo manj topen kot v kislem mediju.
English: Different weight categories Pharmacokinetic data reveal no relevant differences due to weight in the exposure to riociguat.
Slovenian: Razlike glede na telesno maso Farmakokinetični podatki niso pokazali razlik v izpostavljenosti riociguatu glede na telesno maso.
English: Respiratory tract bleeding
Slovenian: Krvavitev v dihalih
English: There is a higher risk of hypotension in these patients, particular care should be exercised during individual dose titration.
Slovenian: Ker je pri teh bolnikih tveganje za hipotenzijo večje, je pri titriranju odmerka potrebna posebna previdnost.
English: Consider a dose reduction for patients on Adempas doses higher than or equal to 1.0 mg if the patient develops signs or symptoms of hypotension (see sections 4.4 and 4.5).
Slovenian: Pri bolnikih, pri katerih se razvijejo znaki in simptomi hipotenzije in imajo odmerek zdravila Adempas večji ali enak 1,0 mg, je treba razmisliti o zmanjšanju odmerka (glejte poglavji 4.4 in 4.5).
English: To mitigate the risk of hypotension when Adempas is initiated in patients on stable doses of strong multi pathway CYP (especially CYP1A1 and CYP3A4) and P-gp/BCRP inhibitors, e.g. as contained in HAART, consider a reduced starting dose.
Slovenian: Kadar se zdravilo Adempas uvede bolnikom na stabilnih odmerkih močnih zaviralcev več presnovnih poti CYP (predvsem CYPA1 in CYP3A4) in P-gp/BCRP, npr. zdravil, ki so v HAART, je treba za zmanjšanje tveganja za hipotenzijo razmisliti o zmanjšanju začetnega odmerka.
English: • 84 tablets: four transparent calendar blisters of 21 tablets each.
Slovenian: • 84 tablet: štirje prozorni, z dnevi označeni pretisni omoti po 21 tablet
English: Table 6: Effects of riociguat in PATENT-1 on events of clinical worsening Clinical Worsening Events
Slovenian: Preglednica 6: Učinki riociguata v študiji PATENT-1 na klinično poslabšanje Klinično poslabšanje riociguat IDT (n = 254)
English: • 294 tablets: fourteen transparent calendar blisters of 21 tablets each.
Slovenian: • 294 tablet: štirinajst prozornih, z dnevi označenimi pretisnimi omoti po 21 tablet Na trgu morda ni vseh navedenih pakiranj.
English: To mitigate the risk of hypotension when Adempas is initiated in patients on stable doses of strong multi pathway CYP (especially CYP1A1 and CYP3A4) and P-gp/BCRP inhibitors, e.g. ketoconazole, posaconazole or itraconazole consider a reduced starting dose.
Slovenian: Kadar se zdravilo Adempas uvede bolnikom na stabilnih odmerkih močnih zaviralcev več presnovnih poti CYP (predvsem CYPA1 in CYP3A4) in P-gp/BCRP, npr. ketokonazol, posakonazol ali itrakonazol, je treba za zmanjšanje tveganja za hipotenzijo razmisliti o zmanjšanju začetnega odmerka.
English: Patients must not get pregnant during Adempas therapy (see section 4.3).
Slovenian: Med zdravljenjem z zdravilom Adempas bolnice ne smejo zanositi (glejte poglavje 4.3).
English: When initiating Adempas in patients on stable doses of strong multi pathway CYP and P-gp/BCRP inhibitors, such as azole antimycotics (e.g. ketoconazole, posaconazole, itraconazole) or HIV protease inhibitors (e.g. ritonavir), consider a starting dose of 0.5 mg, three times a day to mitigate the risk of hypotension.
Slovenian: Bolniki na stabilnih odmerkih močnih zaviralcev več presnovnih poti CYP / P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (BCRP - breast cancer resistance protein) Pri uvedbi zdravila Adempas bolnikom s stabilnimi odmerki močnih zaviralcev več presnovnih poti CYP in P-gp/BCRP), kot so azolni antimikotiki (npr. ketokonazol, posakonazol, itrakonazol) ali zaviralci proteaze HIV (npr. ritonavir), je treba razmisliti o začetnem odmerku 0,5 mg trikrat na dan, da se zmanjša tveganje za hipotenzijo.
English: Nausea,
Slovenian: Jetrna okvara
English: Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets riociguat
Slovenian: Adempas 2 mg filmsko obložene tablete Adempas 2,5 mg filmsko obložene tablete riociguat
English: It is recommended to monitor for signs and symptoms of hypotension after any transition (see sections 4.3, 4.5 and 5.1).
Slovenian: Po vsakem prehodu na drugo zdravilo je priporočljivo spremljati bolnika glede znakov in simptomov hipotenzije (glejte poglavja 4.3, 4.5 in 5.1).
English: Adempas 0.5 mg tablets Adempas 1 mg tablets Adempas 1.5 mg tablets Adempas 2 mg tablets Adempas 2.5 mg tablets riociguat
Slovenian: Adempas 0,5 mg tablete Adempas 1 mg tablete Adempas 1,5 mg tablete Adempas 2 mg tablete Adempas 2,5 mg tablete riociguat
English: Adempas 1.5 mg - pack of 294 film-coated tablets - EU/1/13/907/018 Adempas 2 mg - pack of 42 film-coated tablets - EU/1/13/907/010
Slovenian: Adempas 1,5 mg - pakiranje z 294 filmsko obloženimi tabletami - EU/1/13/907/018 Adempas 2 mg - pakiranje z 42 filmsko obloženimi tabletami - EU/1/13/907/010
English: Adempas can be used to treat adults with certain forms of pulmonary hypertension, a condition in which these blood vessels become narrowed, making it harder for the heart to pump blood through them and leading to high blood pressure in the vessels.
Slovenian: Zdravilo Adempas se lahko uporablja za zdravljenje odraslih bolnikov z določeno obliko pljučne hipertenzije, stanja pri katerem so te krvne žile zožene.
English: Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets
Slovenian: Adempas 1 mg filmsko obložene tablete Adempas 1,5 mg filmsko obložene tablete
English: Adempas 0.5 mg - pack of 294 film-coated tablets - EU/1/13/907/016 Adempas 1 mg - pack of 42 film-coated tablets - EU/1/13/907/004
Slovenian: Adempas 0,5 mg - pakiranje z 294 filmsko obloženimi tabletami - EU/1/13/907/016 Adempas 1 mg - pakiranje z 42 filmsko obloženimi tabletami - EU/1/13/907/004
English: Adempas contains lactose
Slovenian: Zdravilo Adempas vsebuje laktozo
English: Adempas contains sodium
Slovenian: Zdravilo Adempas vsebuje natrij.
English: Adempas 1 mg film-coated tablets
Slovenian: Adempas 1 mg filmsko obložene tablete