FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with severe hepatic impairment (Child Pugh C) have not been studied and therefore use of Adempas is contraindicated in these patients (see section 4.3).
Croatian: Bolesnici s teškim oštećenjem funkcije jetre (Child-Pugh C) nisu ispitani i stoga je primjena lijeka Adempas u ovih bolesnika kontraindicirana (vidjeti dio 4.3).
English: A 12 week combination study in 18 patients with PAH on stable sildenafil treatment (20 mg three times daily) and riociguat (1.0 mg to 2.5 mg three times daily) compared to sildenafil alone was performed.
Croatian: Provedeno je 12-tjedno kombinirano ispitivanje u 18 bolesnika s PAH-om na stabilnom liječenju sildenafilom (20 mg tri puta na dan) i riocigvatom (1,0 mg do 2,5 mg tri puta na dan) u usporedbi sa samo sildenafilom.
English: In PATENT-2, all patients received an individualised riociguat dose up to 2.5 mg three times daily.
Croatian: U ispitivanju PATENT-2, svi su bolesnici primali individualiziranu dozu riocigvata do 2,5 mg tri puta na dan.
English: Table 3: Effects of riociguat in CHEST-1 on PVR, NT-proBNP and WHO functional class at last visit PVR
Croatian: Tablica 3: Učinci riocigvata u ispitivanju CHEST-1 na PVR, NT-proBNP i funkcionalni razred prema SZO-u na posljednjem posjetu
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.
Croatian: Riocigvat se uglavnom uklanja putem oksidativnog metabolizma posredovanog citokromom P450 (CYP1A1, CYP3A4, CYP3A5, CYP2J2), izravnim izlučivanjem riocigvata u neizmijenjenom obliku putem žuči/stolice i izlučivanjem riocigvata u neizmijenjenom obliku preko bubrega putem glomerularne filtracije.
English: Bioavailability (AUC and Cmax) is comparable for Adempas administered orally as a crushed tablet suspended in apple sauce or in water compared to a whole tablet (see section 4.2).
Croatian: Bioraspoloživost (AUC i Cmax) za Adempas primijenjen peroralno u obliku zdrobljene tablete pomiješane s kašom od jabuka ili vodom usporediva je s bioraspoloživosti pri primjeni cijele tablete (vidjeti dio 4.2).
English: Adverse Events leading to discontinuation occurred at a similar frequency in both treatment groups (riociguat individual dose titration (IDT) 1.0-2.5 mg, 2.9%; placebo, 2.3%).
Croatian: Učestalost nuspojava koje su dovele do prekida liječenja bila je slična u obje terapijske skupine (riocigvat individualna titracija doze (IDT) 1,0-2,5 mg, 2,9%; placebo, 2,3%).
English: - Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see sections 4.2 and 4.5).
Croatian: - Istodobna primjena s inhibitorima PDE-5 (kao što su sildenafil, tadalafil, vardenafil) (vidjeti dijelove 4.2 i 4.5).
English: Gastrointestinal disorders Dyspepsia, Diarrhoea,
Croatian: Gastroezofagealna refluksna bolest, Disfagija,
English: : + 359 2 819 37 37 info-msdbg@merck.com
Croatian: Teл.: + 359 2 819 37 37 info-msdbg@merck.com
English: hydroxypropylcellulose hypromellose 3 cP propylene glycol (E 1520) titanium dioxide (E 171) iron oxide yellow (E 172)
Croatian: hidroksipropilceluloza hipromeloza 3 cP propilenglikol (E 1520) titanijev dioksid (E 171) željezov oksid, žuti (E 172)
English: Luxembourg / Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Croatian: Luxembourg / Luxemburg MSD Belgium BVBA/SPRL Tel/Tél: +32(0)27766211 dpoc_belux@merck.com
English: Overall, mean dose- and weight- normalised exposure values for riociguat were higher in subjects with renal impairment compared to subjects with normal renal function.
Croatian: Općenito su srednje vrijednosti izloženosti riocigvatu normalizirane prema dozi i tjelesnoj težini bile veće u ispitanika s oštećenjem funkcije bubrega u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: Particular care should be exercised during individual dose titration.
Croatian: Potreban je poseban oprez tijekom titracije doze u pojedinog bolesnika.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 0.5 mg, 1 mg, 1.5 mg, 2 mg or 2.5 mg riociguat.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 0,5 mg, 1 mg, 1,5 mg, 2 mg ili 2,5 mg riocigvata.
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.
Croatian: Preživljenje u bolesnika funkcionalnog razreda II prema SZO na početku liječenja, nakon 1, 2 i 3 godine, bilo je 97%, 94% odnosno 90%, a za bolesnike funkcionalnog razreda III prema SZO na početku liječenja bilo je 97%, 93% odnosno 88%.
English: By widening the narrowed arteries, Adempas leads to an improvement in your ability to carry out physical activity.
Croatian: Širenjem suženih arterija, Adempas dovodi do poboljšanja
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.
Croatian: Na posljednjem posjetu, 6MWD u bolesnika liječenih riocigvatom povećao se za 46 m (95% interval pouzdanosti (CI): 25 m do 67 m; p < 0,0001) u usporedbi s placebom.
English: Mean change from baseline for the overall population (N=396) was 53 m at 6 months (n=366), 52 m at 9 months (n=354), 50 m at 12 months (n=351) and 46 m at 24 months (n=316).
Croatian: Srednja vrijednost promjene od početne vrijednosti za sveukupnu populaciju (N=396) bila je 53 m nakon 6 mjeseci (n=366), 52 m nakon 9 mjeseci (N=354), 50 m nakon 12 mjeseci (n=351) te 46 m nakon 24 mjeseca (n=316).
English: -843.0 to -45.0 [<0.0001]
Croatian: -843,0 do -45,0 [< 0,0001]
English: Patient population with CTEPH post-PEA
Croatian: Populacija bolesnika s KTEPH-om nakon-PEA
English: Crushed tablets:
Croatian: Zdrobljene tablete:
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).
Croatian: - uzimate lijekove za liječenje gljivičnih infekcija (npr. ketokonazol, posakonazol, itrakonazol) ili lijekove za liječenje infekcije HIV-om (npr. abakavir, atazanavir, kobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabin, lamivudin, rilpivirin, ritonavir i tenofovir).
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 8 weeks.
Croatian: Tijekom prvih 8 tjedana riocigvat je bio titriran svaka 2 tjedna na temelju bolesnikovog sistoličkog krvnog tlaka i znakova ili simptoma hipotenzije do optimalne individualne doze (raspon od 0,5 mg do 2,5 mg tri puta na dan) koja se onda održavala tijekom daljnjih 8 tjedana.
English: Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is contraindicated (see sections 4.2 and 4.3).
Croatian: Istodobna primjena riocigvata s inhibitorima PDE-5 (kao što su sildenafil, tadalafil i vardenafil) je kontraindicirana (vidjeti dijelove 4.2 i 4.3).
English: Baseline (ng/L) [SD]
Croatian: Početna vrijednost (ng/l) [SD]
English: Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
Croatian: Bolesnici s plućnom hipertenzijom povezanom s idiopatskim intersticijskim pneumonijama (PH-IIP)
English: Co-treatment of medicinal products increasing the upper gastro intestinal pH may lead to lower oral bioavailability.
Croatian: Istodobno liječenje lijekovima koji povećavaju pH u gornjem dijelu gastrointestinalnog sustava mogu dovesti do smanjene bioraspoloživosti riocigvata nakon peroralne primjene.
English: -303.3 to -189.5 [<0.0001]
Croatian: -303,3 do -189,5 [< 0,0001]
English: Baseline (m) [SD]
Croatian: Početna vrijednost (m) [SD]
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.
Croatian: Tijekom prvih 8 tjedana riocigvat je bio titriran svaka 2 tjedna prema bolesnikovom sistoličkom krvnom tlaku i znakovima ili simptomima hipotenzije do optimalne pojedinačne doze (raspon od 0,5 mg do 2,5 mg tri puta na dan), koja se onda održavala tijekom sljedeća 4 tjedna.
English: In CHEST-2, all patients received an individualised riociguat dose up to 2.5 mg three times daily.
Croatian: U ispitivanju CHEST-2, svi su bolesnici primili riocigvat u pojedinačnoj dozi do 2,5 mg tri puta na dan.
English: How to store Adempas
Croatian: Kako čuvati Adempas
English: -281.4 to -170.1[<0.0001]
Croatian: -281,4 do -170,1[< 0,0001]
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.
Croatian: Srednja vrijednost promjene od početne vrijednosti 6MWD-a do 12. tjedna (zadnje opažanje do 12. tjedna) u PATENT-2 (24 tjedna u ispitivanju za PATENT-1 + PATENT-2) iznosila je 52 m u skupini koja je prethodno primala 1,0-2,5 mg riocigvata, 45 m u skupini koja je prethodno primala placebo i 52 m u skupini koja je prethodno primala 1,0-1,5 mg riocigvata.
English: 51368 Leverkusen Germany
Croatian: 51368 Leverkusen
English: Gender Pharmacokinetic data reveal no relevant differences due to gender in the exposure to riociguat.
Croatian: Spol Farmakokinetički podaci ne pokazuju važne razlike između spolova u izloženosti riocigvatu.
English: (in 1 mg, 1.5 mg, 2 mg and 2.5 mg tablets only)
Croatian: (samo u tabletama od 1 mg, 1,5 mg, 2 mg i 2,5 mg)
English: Adempas is contraindicated during pregnancy (see section 4.3).
Croatian: Adempas je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: Adempas 2 mg and 2.5 mg tablets also contains iron oxide yellow (E172) and iron oxide red (E 172).
Croatian: Adempas tablete od 1 mg, 1,5 mg također sadrže: željezov oksid, žuti (E 172) Adempas tablete od 2 mg i 2,5 mg također sadrže: željezov oksid, žuti (E 172) i željezov oksid, crveni (E 172).
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.
Croatian: Kada se započinje terapija lijekom Adempas u bolesnika na stabilnim dozama jakih inhibitora više puteva CYP-a i P-gp-a/BCRP-a, poput azolnih antimikotika (npr. ketokonazol, posakonazol, itrakonazol) ili inhibitora HIV proteaze (npr. ritonavir), razmotrite početnu dozu od 0,5 mg, tri puta na dan, kako bi se smanjio rizik od hipotenzije.
English: Riociguat pharmacokinetics are linear from 0.5 to 2.5 mg. Inter-individual variability (CV) of riociguat exposure (AUC) across all doses is approximately 60%.
Croatian: Interindividualna varijabilnost (CV) izloženosti riocigvatu (AUC) kod svih doza je približno 60%.
English: For coadministration with strong CYP3A4 inducers follow the recommendation on dose titration (see section
Croatian: Kod istodobne primjene s jakim induktorima CYP3A4 slijedite preporuke o titraciji doze (vidjeti dio 4.2).
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.
Croatian: Srednja vrijednost promjene od početne vrijednosti 6MWD-a do 12. tjedna (zadnje zapažanje do 12. tjedna) u CHEST-2 (28 tjedana u ispitivanju za CHEST-1 + CHEST-2) bila je 57 m u skupini koja je prethodno primala riocigvat u dozi od 1,0 do 2,5 mg i 43 m u skupini koja je prethodno primala placebo.
English: These antacid medicines should be taken at least two hours before or one hour after taking
Croatian: Ove lijekove protiv kiseline treba uzeti najmanje dva sata prije ili jedan sat nakon uzimanja lijeka Adempas. - mučnine, povraćanja (kao što je granizetron).
English: -781.5 to -82.1 [<0.0001]
Croatian: -781,5 do -82,1 [< 0,0001]
English: Concomitant use with other CYP and P-gp/BCRP inhibitors
Croatian: Istodobna primjena s drugim inhibitorima CYP-a i P-gp-a/BCRP-a
English: Change in WHO Functional Class
Croatian: Promjena u funkcionalnom razredu prema SZO-u
English: Plasma concentrations of riociguat in smokers are reduced compared to non-smokers.
Croatian: U usporedbi s nepušačima, pušači imaju smanjene koncentracije riocigvata u plazmi.
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.
Croatian: Podaci za bolesnike s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) su ograničeni, a podataka za bolesnike na dijalizi nema, pa se stoga riocigvat ne preporučuje u tih bolesnika.
English: MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bayer AG 51368 Leverkusen Njemačka
English: - Severe hepatic impairment (Child Pugh C).
Croatian: - Teško oštećenje funkcije jetre (Child-Pugh C).
English: Data in patients with creatinine clearance <30 mL/min are limited and there are no data for patients on dialysis.
Croatian: Podaci za bolesnike s klirensom kreatinina < 30 ml/min su ograničeni, dok podataka za bolesnike na dijalizi nema.
English: • 294 tablets: fourteen transparent calendar blisters of 21 tablets each.
Croatian: • 294 tablete: četrnaest prozirnih kalendarskih blistera, svaki s 21 tabletom.
English: Adempas contains sodium
Croatian: Adempas sadrži natrij
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.
Croatian: Kako bi se smanjio rizik od hipotenzije kad se započinje terapija lijekom Adempas u bolesnika na stabilnim dozama jakih inhibitora više puteva CYP-a (osobito CYP1A1 i CYP3A4) i P-gp-a/BCRP-a, npr. onih u sklopu HAART-a, razmotrite primjenu smanjene početne doze.
English: • chronic thromboembolic pulmonary hypertension (CTEPH).
Croatian: • kronična tromboembolijska plućna hipertenzija (KTEPH).
English: Therefore, Adempas is contraindicated during pregnancy (see section 4.3).
Croatian: Stoga je Adempas kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
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).
Croatian: U bolesnika s KTEPH-om ili PAH-om liječenih lijekom Adempas opaženi su ozbiljna hemoptiza i krvarenje u pluća, uključujući slučajeve sa smrtnim ishodom (vidjeti dio 4.4).
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).
Croatian: N-terminal prohormone of brain natriuretic peptide, NT-proBNP) (-347 pg/ml), WHO funkcionalne klase I/II/III/IV,% (2/52/46/0) i srčanog indeksa (+0.3 l/min/m2).
English: Adempas contains lactose
Croatian: Adempas sadrži laktozu
English: In PAH, the wall of the blood vessels of the lungs are thickened and the vessels become narrowed.
Croatian: Kod PAH-a, stijenke krvnih žila pluća su zadebljane te žile postaju sužene.
English: For co-administration with these substances follow the recommendation on dose titration (see section 4.2).
Croatian: Kod istodobne primjene ovih tvari slijedite preporuke o titraciji doze (vidjeti dio 4.2).
English: Data in patients with severe renal impairment (creatinine clearance <30 mL/min) are limited and there are no data for patients on dialysis.
Croatian: Podaci za bolesnike s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) su ograničeni, a podataka za bolesnike na dijalizi nema.
English: Baseline (dyn·s·cm-5) [SD]
Croatian: Početna vrijednost (dyn·s·cm-5) [SD]
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).
Croatian: • Istodobna primjena riocigvata s jakim inhibitorima CYP1A1, kao što je inhibitor tirozin-kinaze erlotinib, i jakim inhibitorima P-glikoproteina (P-gp)/proteina rezistencije karcinoma dojke (BCRP), kao što je imunosupresiv ciklosporin A, može povećati izloženost riocigvatu (vidjeti dijelove 4.5 i 5.2).
English: 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).
Croatian: Pokazalo se da je izloženost ovom lijeku u bolesnika s blagim i umjerenim oštećenjem funkcije bubrega (klirens kreatinina od < 80-30 ml/min) povećana (vidjeti dio 5.2).
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).
Croatian: U in vitro ispitivanju, pokazalo se da ketokonazol, klasificiran kao jaki inhibitor CYP3A4 i Pglikoproteina (P-gp), inhibira više puteva CYP-a i P-gp-a/BCRP-a u metabolizmu i izlučivanju riocigvata (vidjeti dio 5.2).
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).
Croatian: U bolesnika koji puše ili počnu pušiti tijekom liječenja može biti potrebno povisiti dozu na najvišu dnevnu od 2,5 mg tri puta na dan (vidjeti dijelove 4.5 i 5.2).
English: Talk to your doctor if this happens.
Croatian: Ako se to dogodi, obratite se svom liječniku.
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).
Croatian: • Istodobna primjena riocigvata s jakim inhibitorima višestrukih puteva citokroma P450 (CYP) i P-glikoproteina (P-gp)/proteina rezistencije karcinoma dojke (BCRP) poput azolnih antimikotika (npr. ketokonazol, posakonazol, itrakonazol) ili inhibitora HIV proteaze (npr. ritonavir) dovodi do izrazitog povećanja izloženosti riocigvatu (vidjeti dijelove 4.5 i 5.2).
English: The primary endpoint of the study was the placebo adjusted change from baseline in 6-minute walk distance (6MWD) at the last visit (week 16).
Croatian: Primarna mjera ishoda ispitivanja bila je promjena prevaljenog puta tijekom 6-minutnog hoda (6MWD) kod posljednjeg posjeta (16. tjedan) u odnosu na početnu vrijednost, prilagođena za placebo.
English: Riociguat (n=107)
Croatian: Riocigvat (n=107)
English: There is a higher risk of hypotension in patients with renal impairment, therefore particular care should be exercised during individual dose titration.
Croatian: U bolesnika s oštećenjem funkcije bubrega postoji povećan rizik od hipotenzije pa je stoga potreban poseban oprez tijekom titracije doze u pojedinog bolesnika.
English: Concomitant use with medicinal products increasing gastric pH
Croatian: Istodobna primjena s lijekovima koji povisuju pH u želucu
English: There is a higher risk of hypotension in these patients, particular care should be exercised during individual dose titration.
Croatian: Postoji veći rizik od hipotenzije u ovih bolesnika pa je titraciji doze u pojedinog bolesnika potrebno pristupiti osobito pažljivo.
English: PK data show that higher riociguat exposure was observed in patients with moderate hepatic impairment (Child Pugh B) (see section 5.2).
Croatian: Farmakokinetički podaci pokazuju da je u bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh B) opažena povećana izloženost riocigvatu (vidjeti dio 5.2).
English: Riociguat (n=121)
Croatian: Riocigvat (n=121)
English: * fatal pulmonary haemorrhage was reported in uncontrolled long term extension studies
Croatian: * u dugotrajnim nekontroliranim nastavcima ispitivanja zabilježeno je plućno krvarenje sa smrtnim ishodom
English: Riociguat (n=173)
Croatian: Riocigvat (n=173)
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.
Croatian: Kako bi se smanjio rizik od hipotenzije kad se započinje liječenje lijekom Adempas u bolesnika na stabilnim dozama jakih inhibitora više puteva CYP-a (osobito CYP1A1 i CYP3A4) i P-gp-a/BCRP-a, poput ketokonazola, posakonazola ili itrakonazola, razmotrite primjenu smanjene početne doze.
English: - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH
Croatian: - Bolesnici s plućnom hipertenzijom povezanom s idiopatskim intersticijskim pneumonijama
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.
Croatian: - erektilne disfunkcije (kao što su sildenafil, tadalafil, vardenafil), jer ih ne smijete uzimati zajedno s lijekom Adempas. - gljivičnih infekcija (kao što su ketokonazol, posakonazol, itrakonazol) ili HIV-infekcije (kao što su abakavir, atazanavir, kobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabin, rilpivirin i ritonavir), s obzirom na to da mogu biti razmotrene druge terapijske opcije.
English: These are medicines used for the treatment of high blood pressure in the arteries of the lungs (PAH) or erectile dysfunction.
Croatian: Ti se lijekovi primjenjuju za liječenje visokog krvnog tlaka u plućnim arterijama
English: Tadalafil must be discontinued at least 48 hours prior to administration of riociguat.
Croatian: Najmanje 48 sati prije primjene riocigvata mora se prekinuti s primjenom tadalafila.
English: Riociguat must be discontinued at least 24 hours prior to administration of a PDE5 inhibitor.
Croatian: Najmanje 24 sata prije primjene inhibitora PDE5 mora se prekinuti s primjenom riocigvata.
English: Chronic thromboembolic pulmonary hypertension (CTEPH)
Croatian: Kronična tromboembolijska plućna hipertenzija (KTEPH)
English: • 84 tablets: four transparent calendar blisters of 21 tablets each.
Croatian: • 84 tablete: četiri prozirna kalendarska blistera, svaki s 21 tabletom.
English: • 42 tablets: two transparent calendar blisters of 21 tablets each.
Croatian: • 42 tablete: dva prozirna kalendarska blistera, svaki s 21 tabletom.
English: Riociguat (n=55)
Croatian: Riocigvat (n=55)
English: Riociguat (n=150)
Croatian: Riocigvat (n=150)
English: Riociguat (n=52)
Croatian: Riocigvat (n=52)
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
Croatian: Adempas 0,5 mg tablete Adempas 1 mg tablete Adempas 1,5 mg tablete Adempas 2 mg tablete Adempas 2,5 mg tablete riocigvat
English: Concomitant use with strong multi pathway CYP and P-gp/BCRP inhibitors
Croatian: Istodobna primjena s jakim inhibitorima više puteva CYP-a i P-gp/BCRP-a