natgillin/translations-raw huggingface dataset:
Transitioning between phosphodiesterase-5 (PDE5) inhibitors and riociguat Sildenafil must be discontinued at least 24 hours prior to administration of riociguat.
Prelazak između inhibitora fosfodiesteraze tipa 5 (PDE5) i riocigvata Najmanje 24 sata prije primjene riocigvata mora se prekinuti s primjenom sildenafila.
There is increased riociguat exposure in these patients (see section 5.2).
U tih je bolesnika povećana izloženost riocigvatu (vidjeti dio 5.2).
Effects of riociguat on other substances
Učinci riocigvata na druge lijekove
The primary endpoint of the study was placebo-adjusted change from baseline in 6MWD at the last visit (week 12).
Primarna mjera ishoda ispitivanja bila je placebom prilagođena promjena od početne vrijednosti u 6MWD na posljednjem posjetu (12. tjedan).
Riociguat exhibits a reduced solubility at neutral pH vs. acidic medium.
Riocigvat pokazuje smanjenu topljivost u neutralnom pH naspram kiselog medija.
20 to 52 [<0.0001]
20 do 52 [< 0,0001]
Dose adjustment may be necessary in patients who start or stop smoking during treatment with riociguat (see sections 4.2 and 5.2).
U bolesnika koji puše ili počnu pušiti tijekom liječenja može biti potrebna prilagodba doze tijekom liječenja riocigvatom (vidjeti dijelove 4.2 i 5.2).
Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 98%, 96% and 93% respectively, and for patients of WHO functional class III at baseline was 96%, 91% and 84% respectively.
Preživljenje u bolesnika funkcionalnog razreda II prema SZO na početku liječenja, nakon 1, 2 i 3 godine, bilo je 98%, 96% odnosno 93%, a za bolesnike funkcionalnog razreda III prema SZO na početku liječenja bilo je 96%, 91% odnosno 84%.
Table 2: Effects of riociguat on 6MWD in CHEST-1 at last visit Entire patient population
Tablica 2: Učinci riocigvata na 6MWD u ispitivanju CHEST-1 na posljednjem posjetu Cijela populacija bolesnika
Efficacy in patients with CTEPH
Djelotvornost u bolesnika s KTEPH-om
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.
Na posljednjem posjetu, povećanje 6MWD uz individualnu titraciju doze riocigvata (IDT) bilo je 36 m (95% CI: 20 m do 52 m; p  0,0001) u usporedbi s placebom.
Improvement in exercise capacity was accompanied by consistent improvement in multiple clinicallyrelevant secondary endpoints.
Poboljšanje kapaciteta podnošenja fizičkog napora bilo je popraćeno dosljednim poboljšanjem većeg broja klinički važnih sekundarnih mjera ishoda.
N-demethylation, catalysed by CYP1A1, CYP3A4, CYP3A5 and CYP2J2 is the major biotransformation pathway of riociguat leading to its major circulating active metabolite M-1 (pharmacological activity: 1/10th to 1/3rd of riociguat) which is further metabolised to the pharmacologically inactive N-glucuronide.
N-demetilacija, koju kataliziraju CYP1A1, CYP3A4, CYP3A5 i CYP2J2, glavni je put biotransformacije riocigvata kojim nastaje njegov glavni aktivni metabolit u cirkulaciji, M-1 (farmakološka aktivnost: 1/10 do 1/3 od riocigvata), koji se dalje metabolizira do farmakološki neaktivnog N-glukuronida.
Efficacy in patients with PAH
Djelotvornost u bolesnika s PAH-om
Table 5: Effects of riociguat in PATENT-1 on PVR and NT-proBNP at last visit PVR
Tablica 5: Učinci riocigvata u ispitivanju PATENT-1 na PVR i NT-proBNP na posljednjem posjetu
Data from animals indicate that riociguat is excreted into milk.
Podaci pokazuju da se riocigvat izlučuje u majčino mlijeko kod životinja.
Tablet core: cellulose microcrystalline, crospovidone (type B), hypromellose 5 cP, lactose monohydrate, magnesium stearate and sodium laurilsulfate (see end of section 2 for further information on lactose).
Jezgra tablete: mikrokristalična celuloza, krospovidon (tip B), hipromeloza 5cP, laktoza hidrat, magnezijev stearat i natrijev laurilsulfat (vidjeti kraj dijela 2 za dodatne informacije o laktozi).
Use of Adempas in other types of PAH is therefore not recommended.
Primjena lijeka Adempas kod drugih tipova PAH-a se stoga ne preporučuje.
In cirrhotic patients (non-smokers) with moderate hepatic impairment (classified as Child Pugh B), riociguat mean AUC was increased by 51% compared to healthy controls.
U bolesnika s cirozom (nepušača) i umjerenim oštećenjem funkcije jetre (klasificiranog kao Child-Pugh B), srednja vrijednost AUC riocigvata bila je povećana za 51% u usporedbi sa zdravim kontrolnim ispitanicima.
In an exploratory interaction study in 7 patients with PAH on stable sildenafil treatment (20 mg three times daily) single doses of riociguat (0.5 mg and 1 mg sequentially) showed additive haemodynamic effects.
U jednom eksplorativnom ispitivanju interakcija u 7 bolesnika s PAH-om na stabilnom liječenju sildenafilom (20 mg tri puta na dan) pokazalo se da jednostruke doze riocigvata (0,5 mg i 1 mg uzastopno) imaju aditivne hemodinamske učinke.
In cirrhotic patients (non-smokers) with mild hepatic impairment (classified as Child Pugh A) riociguat mean AUC was increased by 35% compared to healthy controls, which is within normal intra-individual variability.
U bolesnika s cirozom (nepušača) i blagim oštećenjem funkcije jetre (klasificiranog kao Child-Pugh A) srednja vrijednost AUC riocigvata bila je povećana za 35% u usporedbi sa zdravim kontrolnim ispitanicima, što je unutar normalne intraindividualne varijabilnosti.
The probability of survival at 1 year was 97%, at 2 years 93% and at 3 years 88%.
Vjerojatnost jednogodišnjeg preživljenja bila je 97%, dvogodišnjeg 93%, a trogodišnjeg 88%.
The probability of survival at 1 year was 97%, at 2 years 93% and at 3 years 89%.
Vjerojatnost jednogodišnjeg preživljenja bila je 97%, dvogodišnjeg 93%, a trogodišnjeg 89%.
Due to the high plasma protein binding riociguat is not expected to be dialysable.
Zbog visokog postotka vezanja riocigvata za proteine plazme, ne očekuje se da ga se može ukloniti dijalizom.
INFORMATION IN BRAILLE Adempas 0.5 mg, 1 mg, 1.5 mg, 2 mg or 2.5 mg
16. PODACI NA BRAILLEOVOM PISMU Adempas 0,5 mg, 1 mg, 1,5 mg, 2 mg ili 2,5 mg
• certain types of pulmonary arterial hypertension (PAH).
• određeni oblici plućne arterijske hipertenzije (PAH).
• 90 tablets: five transparent blisters of 18 tablets each.
• 90 tableta: pet prozirnih blistera, svaki s 18 tableta.
For co-administration with bosentan follow the recommendation on dose titration (see section 4.2).
Kod istodobne primjene s bosentanom slijedite preporuke o titraciji doze (vidjeti dio 4.2).
Mean change from baseline for the overall population (N=237) was 57 m at 6 months (n=218), 51 m at 9 months (n=219), 52 m at 12 months (n=209) and 48 m at 24 months (n=193).
Srednja vrijednost promjene od početne vrijednosti za sveukupnu populaciju (N=237) bila je 57 m nakon 6 mjeseci (n=218), 51 m nakon 9 mjeseci (N=219), 52 m nakon 12 mjeseci (n=209) te 48 m nakon 24 mjeseca (n=193).
Adverse Events leading to discontinuation occurred less frequently in both riociguat treatment groups than in the placebo group (riociguat IDT 1.0-2.5 mg, 3.1%; riociguat CT 1.6%; placebo, 7.1%).
Učestalost nuspojava koje su dovele do prekida liječenja bila je manja u obje terapijske skupine koje su primale riocigvat nego u placebo skupini (riocigvat IDT 1,0-2,5 mg, 3,1%; riocigvat CT 1,6%; placebo, 7,1%).
The impact of HAART (including different combinations of abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, lamivudine, rilpivirine, ritonavir, and tenofovir) on riociguat exposure was investigated in a dedicated study in HIV patients.
Utjecaj HAART-a (uključujući različite kombinacije abakavira, atazanavira, kobicistata, darunavira, dolutegravira, efavirenza, elvitegravira, emtricitabina, lamivudina, rilpivirina, ritonavira i tenofovira) na izloženost riocigvatu ispitivana je u posebnom ispitivanju u bolesnika s HIV infekcijom.
Patients on stable doses of strong multi pathway CYP / P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) inhibitors
Bolesnici na stabilnim dozama jakih inhibitora više puteva CYP-a / P-glikoproteina (P-gp) i proteina rezistencije karcinoma dojke (BCRP)
Patients must not get pregnant during Adempas therapy (see section 4.3).
Bolesnice ne smiju zatrudniti za vrijeme liječenja lijekom Adempas (vidjeti dio 4.3).
- Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form including recreational drugs called ‘poppers' (see section 4.5).
- Istodobna primjena s nitratima ili donorima dušičnog oksida (kao što je amilnitrit) u bilo kojem obliku, uključujući rekreacijske droge, tzv. „poppers“ (vidjeti dio 4.5).
The concomitant use of riociguat with strong CYP3A4 inducers (e.g. phenytoin, carbamazepine, phenobarbitone or St. John's Wort) may also lead to decreased riociguat plasma concentration.
Istodobna primjena riocigvata s jakim induktorima CYP3A4 (npr. fenitoinom, karbamazepinom, fenobarbitonom ili gospinom travom) također može dovesti do sniženja koncentracije riocigvata u plazmi.
From the recombinant CYP isoforms investigated in vitro CYP1A1 catalysed formation of riociguat's main metabolite most effectively.
Od rekombinantnih izooblika CYP ispitivanih in vitro, CYP1A1 najučinkovitije je katalizirao stvaranje glavnog metabolita riocigvata.
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).
Stoga je istodobna primjena lijeka Adempas s nitratima ili donorima dušičnog oksida (kao što je amilnitrit) u bilo kojem obliku, uključujući rekreacijske droge, tzv. „poppers“, kontraindicirana (vidjeti dio 4.3).
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).
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).
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.
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.
In PATENT-2, all patients received an individualised riociguat dose up to 2.5 mg three times daily.
U ispitivanju PATENT-2, svi su bolesnici primali individualiziranu dozu riocigvata do 2,5 mg tri puta na dan.
Table 3: Effects of riociguat in CHEST-1 on PVR, NT-proBNP and WHO functional class at last visit PVR
Tablica 3: Učinci riocigvata u ispitivanju CHEST-1 na PVR, NT-proBNP i funkcionalni razred prema SZO-u na posljednjem posjetu
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.
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.
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).
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).
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%).
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%).
- Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see sections 4.2 and 4.5).
- Istodobna primjena s inhibitorima PDE-5 (kao što su sildenafil, tadalafil, vardenafil) (vidjeti dijelove 4.2 i 4.5).
Gastrointestinal disorders Dyspepsia, Diarrhoea,
Gastroezofagealna refluksna bolest, Disfagija,
: + 359 2 819 37 37 info-msdbg@merck.com
Teл.: + 359 2 819 37 37 info-msdbg@merck.com
hydroxypropylcellulose hypromellose 3 cP propylene glycol (E 1520) titanium dioxide (E 171) iron oxide yellow (E 172)
hidroksipropilceluloza hipromeloza 3 cP propilenglikol (E 1520) titanijev dioksid (E 171) željezov oksid, žuti (E 172)
Overall, mean dose- and weight- normalised exposure values for riociguat were higher in subjects with renal impairment compared to subjects with normal renal function.
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.
Particular care should be exercised during individual dose titration.
Potreban je poseban oprez tijekom titracije doze u pojedinog bolesnika.
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 0.5 mg, 1 mg, 1.5 mg, 2 mg or 2.5 mg riociguat.
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 0,5 mg, 1 mg, 1,5 mg, 2 mg ili 2,5 mg riocigvata.
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.
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%.
By widening the narrowed arteries, Adempas leads to an improvement in your ability to carry out physical activity.
Širenjem suženih arterija, Adempas dovodi do poboljšanja
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.
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.
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).
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).
-843.0 to -45.0 [<0.0001]
-843,0 do -45,0 [< 0,0001]
Patient population with CTEPH post-PEA
Populacija bolesnika s KTEPH-om nakon-PEA
Crushed tablets:
Zdrobljene tablete:
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).
- 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).
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.
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.
Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is contraindicated (see sections 4.2 and 4.3).
Istodobna primjena riocigvata s inhibitorima PDE-5 (kao što su sildenafil, tadalafil i vardenafil) je kontraindicirana (vidjeti dijelove 4.2 i 4.3).
Baseline (ng/L) [SD]
Početna vrijednost (ng/l) [SD]
Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
Bolesnici s plućnom hipertenzijom povezanom s idiopatskim intersticijskim pneumonijama (PH-IIP)
Co-treatment of medicinal products increasing the upper gastro intestinal pH may lead to lower oral bioavailability.
Istodobno liječenje lijekovima koji povećavaju pH u gornjem dijelu gastrointestinalnog sustava mogu dovesti do smanjene bioraspoloživosti riocigvata nakon peroralne primjene.
-303.3 to -189.5 [<0.0001]
-303,3 do -189,5 [< 0,0001]
Baseline (m) [SD]
Početna vrijednost (m) [SD]
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.
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.
In CHEST-2, all patients received an individualised riociguat dose up to 2.5 mg three times daily.
U ispitivanju CHEST-2, svi su bolesnici primili riocigvat u pojedinačnoj dozi do 2,5 mg tri puta na dan.
How to store Adempas
Kako čuvati Adempas
-281.4 to -170.1[<0.0001]
-281,4 do -170,1[< 0,0001]
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.
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.
Gender Pharmacokinetic data reveal no relevant differences due to gender in the exposure to riociguat.
Spol Farmakokinetički podaci ne pokazuju važne razlike između spolova u izloženosti riocigvatu.
(in 1 mg, 1.5 mg, 2 mg and 2.5 mg tablets only)
(samo u tabletama od 1 mg, 1,5 mg, 2 mg i 2,5 mg)
Adempas is contraindicated during pregnancy (see section 4.3).
Adempas je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
Adempas 2 mg and 2.5 mg tablets also contains iron oxide yellow (E172) and iron oxide red (E 172).
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).
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.
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.
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%.
Interindividualna varijabilnost (CV) izloženosti riocigvatu (AUC) kod svih doza je približno 60%.
For coadministration with strong CYP3A4 inducers follow the recommendation on dose titration (see section
Kod istodobne primjene s jakim induktorima CYP3A4 slijedite preporuke o titraciji doze (vidjeti dio 4.2).
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.
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.
These antacid medicines should be taken at least two hours before or one hour after taking
Ove lijekove protiv kiseline treba uzeti najmanje dva sata prije ili jedan sat nakon uzimanja lijeka Adempas. - mučnine, povraćanja (kao što je granizetron).
-781.5 to -82.1 [<0.0001]
-781,5 do -82,1 [< 0,0001]
Concomitant use with other CYP and P-gp/BCRP inhibitors
Istodobna primjena s drugim inhibitorima CYP-a i P-gp-a/BCRP-a
Change in WHO Functional Class
Promjena u funkcionalnom razredu prema SZO-u
Plasma concentrations of riociguat in smokers are reduced compared to non-smokers.
U usporedbi s nepušačima, pušači imaju smanjene koncentracije riocigvata u plazmi.
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.
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.
MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bayer AG 51368 Leverkusen Njemačka
- Severe hepatic impairment (Child Pugh C).
- Teško oštećenje funkcije jetre (Child-Pugh C).
Data in patients with creatinine clearance <30 mL/min are limited and there are no data for patients on dialysis.
Podaci za bolesnike s klirensom kreatinina < 30 ml/min su ograničeni, dok podataka za bolesnike na dijalizi nema.
• 294 tablets: fourteen transparent calendar blisters of 21 tablets each.
• 294 tablete: četrnaest prozirnih kalendarskih blistera, svaki s 21 tabletom.
Adempas contains sodium
Adempas sadrži natrij
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.
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.
• chronic thromboembolic pulmonary hypertension (CTEPH).
• kronična tromboembolijska plućna hipertenzija (KTEPH).
Therefore, Adempas is contraindicated during pregnancy (see section 4.3).
Stoga je Adempas kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
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).
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).
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).
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).
Adempas contains lactose
Adempas sadrži laktozu
In PAH, the wall of the blood vessels of the lungs are thickened and the vessels become narrowed.
Kod PAH-a, stijenke krvnih žila pluća su zadebljane te žile postaju sužene.