FrancophonIA/ELRC3.0 huggingface dataset:
English: Further exploratory subgroup analysis revealed a treatment effect of 26 m, (95% CI: 5 m to 46 m) in patients pre-treated with ERAs (n=167) and a treatment effect of 101 m (95% CI: 27 m to 176 m) in patients pre-treated with prostacyclin analogues (n=27).
Slovenian: V nadaljnji analizi preučevanih podskupin so ugotovili podaljšanje prehojene razdalje v dolžini 26 m, (95-odstotni IZ: 5 m do 46 m) pri bolnikih, predhodno zdravljenih z ERA (n = 167) in 101 m (95-odstotni IZ: 27 m do 176 m) pri bolnikih, predhodno zdravljenih z analogi prostaciklina (n = 27).
English: Riociguat-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0046; Stratified log-rank test) (see table 6).
Slovenian: Pri bolnikih, zdravljenih z riociguatom, se je čas do kliničnega poslabšanja značilno podaljšal v primerjavi z bolniki, ki so prejemali placebo (p = 0,0046; stratificirani test log-rank) (glejte preglednico
English: Adempas is used in either of two types of pulmonary hypertension:
Slovenian: Zdravilo Adempas se uporablja za zdravljenje dveh oblik pljučne hipertenzije.
English: Non-clinical data show undesirable effects on growing bone (see section 5.3).
Slovenian: Predklinični podatki kažejo neželene učinke na rast in razvoj kosti (glejte poglavje 5.3).
English: Co-administration of the antacid aluminium hydroxide / magnesium hydroxide reduced riociguat mean AUC by 34% and mean Cmax by 56% (see section 4.2).
Slovenian: Sočasna uporaba antacida aluminijevega hidroksida/magnezijevega hidroksida zmanjša povprečno AUC riociguata za 34 % in povprečno Cmax riociguata za 56 % (glejte poglavje 4.2).
English: Table 1: Adverse reactions reported with Adempas in the phase III studies MedDRA
Slovenian: Preglednica 1: Neželeni učinki zdravila Adempas, o katerih so poročali v študijah faze III
English: Table 5: Effects of riociguat in PATENT-1 on PVR and NT-proBNP at last visit PVR
Slovenian: Preglednica 5: Učinki riociguata v študiji PATENT-1 na PVR in NT-proBNP pri zadnjem obisku
English: The concomitant use of riociguat with other cumarin-derivatives (e.g. phenprocoumon) is also not expected to alter prothrombin time.
Slovenian: Ni pričakovati, da bi sočasna uporaba riociguata z drugimi derivati kumarina (npr. fenprokumon) vplivala na protrombinski čas.
English: Patients treated with riociguat showed significant improvement in Borg CR 10 dyspnoea score (mean change from baseline (SD): riociguat -0.4 (2), placebo 0.1 (2); p = 0.0022).
Slovenian: Pri bolnikih, zdravljenih z riociguatom, so opazili značilno izboljšanje glede na oceno dispneje CR10 po Borgovi lestvici (povprečna sprememba od izhodiščne vrednosti (SD): riociguat -0,4 (2), placebo 0,1 (2); p = 0,0022).
English: In the longterm extension, more patients who switched from the placebo group to riociguat (21%) died than those who continued in the riociguat group (3%).
Slovenian: Pri dolgoročnem podaljšanju je umrlo več bolnikov, ki so najprej prejemali placebo in nato prešli na zdravljenje z riociguatom (21 %) v primerjavi s tistimi, ki so začeli in nadaljevali zdravljenje z riociguatom (3 %).
English: Tadalafil must be discontinued at least 48 hours prior to administration of riociguat.
Slovenian: Z uporabo tadalafila je treba prenehati vsaj 48 ur pred uporabo riociguata.
English: Riociguat restores the NO-sGC-cGMP pathway resulting in a significant improvement of pulmonary vascular haemodynamics and an increase in exercise ability.
Slovenian: Riociguat ponovno vzpostavi pot NO-sGC-cGMP, kar pomembno izboljša pljučno-žilno hemodinamiko in poveča telesno zmogljivost.
English: There is a direct relationship between riociguat plasma concentration and haemodynamic parameters such as systemic and pulmonary vascular resistance, systolic blood pressure and cardiac output.
Slovenian: Med koncentracijami riociguata v plazmi in hemodinamskimi parametri, kot so sistemski žilni upor in upor v pljučnem žilju, sistolični krvni tlak in iztis srca, obstaja neposredna povezava.
English: Moderate passage across the placental barrier was observed.
Slovenian: Opazili so zmerno prehajanje skozi posteljico.
English: Based on in vitro data riociguat and its main metabolite are substrates of the transporter proteins P-gp (P-glycoprotein) and BCRP (breast cancer resistance protein).
Slovenian: Glede na podatke in vitro je znano, da sta riociguat in njegov glavni presnovek substrata prenašalnih proteinov P-gp (P-glikoprotein) in BCRP (protein odpornosti na raka dojke).
English: You should be aware of the side effects of this medicine before driving or using machines (see section 4).
Slovenian: Preden začnete voziti ali uporabljati stroje, morate poznati neželene učinke tega zdravila (glejte poglavje 4).
English: When NO binds to sGC, the enzyme catalyses synthesis of the signalling molecule cyclic guanosine monophosphate (cGMP).
Slovenian: Ko se dušikov oksid veže na sGC, encim katalizira sintezo signalne molekule ciklični gvanozin monofosfat (cGMP - cyclic guanosine monophosphate).
English: - if you have severe liver problems (severe hepatic impairment, Child Pugh C).
Slovenian: - če imate hude težave z jetri (hudo jetrno okvaro, Child Pugh C).
English: If not tolerated, dose reduction should be considered at any time.
Slovenian: Če bolnik zdravila ne prenaša, se lahko odmerek kadar koli zmanjša.
English: A dose decrease may be required in patients who stop smoking.
Slovenian: Pri bolnikih, ki prenehajo kaditi, bo morda treba odmerek zmanjšati.
English: Non-clinical data revealed no specific hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, phototoxicity, genotoxicity and carcinogenicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti po enkratnem odmerku, fototoksičnosti, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za ljudi.
English: In vitro, abacavir, rilpivirine, efavirenz, ritonavir, cobicistat and elvitegravir inhibited CYP1A1 and the metabolism of riociguat in the order listed with abacavir as the strongest inhibitor.
Slovenian: In vitro, abakavir, rilpivirin, efavirenz, ritonavir, kobicistat in elvitegravir so zavrli CYP1A1 in presnovo riociguata v navedenem vrstnem redu; abakavir je bil najmočnejši zaviralec.
English: - nausea, vomiting (feeling or being sick) (such as granisetron).
Slovenian: - lajšanju navzee (občutek siljenja na bruhanje), bruhanja (npr. granisetron).
English: 20 to 52 [<0.0001]
Slovenian: 20 do 52 [< 0,0001]
English: There is increased riociguat exposure in these patients (see section 5.2).
Slovenian: Pri teh bolnikih je izpostavljenost riociguatu večja (glejte poglavje 5.2).
English: In CTEPH, the blood vessels of the lung are blocked or narrowed with blood clots.
Slovenian: Pri CTEPH so krvne žile v pljučih zamašene ali zožene zaradi krvnih strdkov.
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.
Slovenian: Na splošno so bile povprečne vrednosti izpostavljenosti riociguatu, normalizirane glede na odmerek in telesno maso, večje pri osebah z ledvično okvaro v primerjavi z osebami z normalnim delovanjem ledvic.
English: If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine because it might harm your baby.
Slovenian: Če dojite ali nameravate dojiti, se pred uporabo tega zdravila posvetujte z zdravnikom ali farmacevtom, saj lahko to zdravilo škoduje vašemu otroku.
English: 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.
Slovenian: N-demetilacija, ki jo katalizirajo CYP1A1, CYP3A4, CYP3A5 in CYP2J2, je glavna pot biotransformacije riociguata, ki privede do nastanka glavnega aktivnega presnovka M-1 v krvnem obtoku (farmakološka aktivnost: 1/10 do 1/3 aktivnosti riociguata) in nadalje do farmakološko neaktivnega N-glukuronida.
English: Change in WHO Functional Class
Slovenian: Sprememba funkcijskega razreda po klasifikaciji SZO
English: In a clinical study the highest dose of Adempas (2.5 mg tablets three times daily) potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) taken 4 and 8 hours after intake.
Slovenian: V klinični študiji je največji odmerek zdravila Adempas (2,5 mg tablete trikrat na dan) povečal hipotenzivni učinek nitroglicerina (0,4 mg), vzetega sublingvalno, 4 do 8 ur po zaužitju zdravila Adempas.
English: How to store Adempas 6.
Slovenian: Shranjevanje zdravila Adempas 6.
English: Approximately 4-19% of the administered dose was excreted as unchanged riociguat via the kidneys.
Slovenian: Približno 4 - 19 % uporabljenega odmerka riociguata se je v nespremenjeni obliki izločilo skozi ledvice.
English: 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.
Slovenian: funkcijski razred po klasifikaciji SZO, je bilo po enem, dveh in treh letih zdravljenja 98 %, 96 % in 93 %, medtem ko je bilo preživetje bolnikov, ki so bili na začetku zdravljenja razvrščeni v III. funkcijski razred, 96 %, 91 % in 84 %.
English: Adempas 2 mg and 2.5 mg tablets also contains iron oxide yellow (E172) and iron oxide red (E 172).
Slovenian: Tablete Adempas 2 mg in 2,5 mg vsebujejo rumeni železov oksid (E 172) in rdeči železov oksid (E 172).
English: To mitigate the risk of hypotension, consider dose reduction and monitoring for signs and symptoms of hypotension (see sections 4.2 and 4.5).
Slovenian: Za zmanjšanje tveganja za hipotenzijo mora razmisliti o zmanjšanju odmerka in spremljati znake in simptome hipotenzije (glejte poglavji 4.2 in 4.5).
English: Treatment-naïve patients (n=189) improved by 38 m, and pre-treated patients (n=191) by 36 m (ITT analysis, see table 4).
Slovenian: Podaljšanje prehojene razdalje pri predhodno nezdravljenih bolnikih (n = 189) je bilo 38 m, pri predhodno zdravljenih bolnikih (n = 191) pa 36 m (analiza glede na namero zdravljenja (ITT), glejte preglednico 4).
English: Lack of pharmacokinetic interactions between riociguat and the CYP2C9 substrate warfarin was demonstrated in vivo.
Slovenian: In vivo je dokazano, da ni farmakokinetičnih interakcij med riociguatom in varfarinom, ki je substrat CYP2C9.
English: Table 4: Effects of riociguat on 6MWD in PATENT-1 at last visit Entire patient population Riociguat IDT (n=254)
Slovenian: Preglednica 4: Učinki riociguata na 6MWD v študiji PATENT-1 pri zadnjem obisku Celotna populacija bolnikov riociguat IDT (n = 254)
English: 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.
Slovenian: Pri bolnikih s cirozo (nekadilcih) z blago jetrno okvaro (Child Pugh A) se je povprečni AUC za riociguat povečal za 35 % v primerjavi z zdravimi osebami v primerjalni skupini, kar je znotraj interindividualne variabilnosti.
English: 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).
Slovenian: Jedro tablete: mikrokristalna celuloza, krospovidon (tip B), hipromeloza 5 cP, laktoza monohidrat, magnezijev stearat in natrijev lavrilsulfat (glejte zadnji odstavek v poglavju 2 za dodatne informacije o laktozi).
English: PVR= pulmonary vascular resistance
Slovenian: PVR (pulmonary vascular resistance)- upor v pljučnem žilju
English: • Periodic safety update reports
Slovenian: - Redno posodobljena poročila o varnosti zdravila (PSUR)
English: Concomitant use with medicinal products increasing gastric pH
Slovenian: Sočasna uporaba z zdravili, ki povečajo pH v želodcu
English: The recommended starting dose is a 1-mg tablet taken 3 times a day for 2 weeks.
Slovenian: Priporočeni začetni odmerek je 1 tableta po 1 mg, trikrat na dan v obdobju 2 tednov.
English: 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).
Slovenian: Pri celotni populaciji (n = 237) je bila povprečna sprememba od izhodiščne vrednosti do 6. meseca 57 m (n = 218), do 9. meseca 51 m (n = 219), do 12. meseca 52 m (n = 209) in do 24. meseca 48 m (n = 193).
English: These antacid medicines should be taken at least two hours before or one hour after taking
Slovenian: Te antacide morate vzeti vsaj dve uri pred ali eno uro po zaužitju zdravila Adempas.
English: Riociguat must be discontinued at least 24 hours prior to administration of a PDE5 inhibitor.
Slovenian: Z uporabo riociguata je treba prenehati vsaj 24 ur pred uporabo zaviralcev PDE5.
English: Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is contraindicated (see sections 4.2 and 4.3).
Slovenian: Sočasna uporaba riociguata z zaviralci PDE5 (kot so sildenafil, tadalafil, vardenafil) je kontraindicirana (glejte poglavji 4.2 in 4.3).
English: From the recombinant CYP isoforms investigated in vitro CYP1A1 catalysed formation of riociguat's main metabolite most effectively.
Slovenian: Med in vitro preučevanimi rekombinantnimi izooblikami CYP, je CYP1A1 najbolj učinkovito kataliziral nastajanje glavnega presnovka riociguata.
English: Pack sizes: 42, 84, 90 or 294 film-coated tablets.
Slovenian: PRETISNI OMOT - PAKIRANJA Z 42, 84, 90, 294 FILMSKO OBLOŽENIMI TABLETAMI
English: Placebo-adjusted difference (dyn·s·cm-5)
Slovenian: glede na placebo prilagojena razlika (dyn·s·cm-5)
English: Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1).
Slovenian: Učinkovitost zdravila je bila dokazana pri bolnikih s PAH, tudi pri bolnikih z etiologijo idiopatske ali dedne PAH ali PAH, povezane z boleznijo veziva (glejte poglavje 5.1).
English: 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.
Slovenian: Tudi sočasna uporaba riociguata z močnimi induktorji CYP3A4 (npr. fenitoin, karbamazepin, fenobarbiton ali šentjanževka) lahko povzroči zmanjšanje koncentracije riociguata v plazmi.
English: Riociguat did not potentiate the bleeding time caused by acetyl-salicylic acid or affect the platelet aggregation in humans.
Slovenian: Riociguat pri ljudeh ni dodatno podaljšal časa krvavitve po uporabi acetilsalicilne kisline, ali vplival na agregacijo trombocitov.
English: 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.
Slovenian: Vpliv HAART (vključno z različnimi kombinacijami abakavirja, atazanavirja, kobicistata, darunavirja, dolutegravirja, efavirenza, elvitegravirja, emtricitabina, lamivudina, rilpivirina, ritonavirja in tenofovirja) na izpostavljenost riociguatu so preučevali v posebni študiji pri bolnikih, okuženih z virusom HIV.
English: Adempas 1 mg, 1.5 mg tablets also contains iron oxide yellow (E 172).
Slovenian: Tablete Adempas 1 mg, 1,5 mg vsebujejo tudi rumeni železov oksid (E 172).
English: 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.
Slovenian: V študiji medsebojnega delovanja, v katero je bilo vključenih 7 bolnikov s PAH, ki so bili stabilni na zdravljenju s sildenafilom (20 mg trikrat na dan), so enkratni odmerki riociguata (0,5 mg in nato 1 mg) pokazali aditivne hemodinamske učinke.
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).
Slovenian: Bolnikov s hudo jetrno okvaro (Child Pugh C) niso preučevali, zato je pri teh bolnikih uporaba zdravila Adempas kontraindicirana (glejte poglavje 4.3).
English: Adempas has moderate influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Adempas ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: These are medicines used for the treatment of high blood pressure in the arteries of the lungs (PAH) or erectile dysfunction.
Slovenian: Ta zdravila se uporabljajo za zdravljenje visokega krvnega tlaka v pljučnih arterijah (PAH
English: PP/Aluminium foil blister.
Slovenian: Pretisni omot iz PP/aluminijaste folije.
English: Elderly patients (65 years or older) exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 40% higher in elderly, mainly due to reduced (apparent) total and renal clearance.
Slovenian: Povprečne vrednosti AUC so bile približno 40 % večje pri starejših bolnikih, predvsem zaradi zmanjšanega (navideznega) celokupnega in ledvičnega očistka.
English: • coughing up blood (haemoptysis) (common side effect, may affect up to 1 in 10 people),
Slovenian: • izkašljevanje krvi (hemoptiza) (pogosti neželeni učinek, ki se lahko pojavi pri največ 1 od
English: Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
Slovenian: Bolniki s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP)
English: Patient population with CTEPH post-PEA
Slovenian: Populacija bolnikov s CTEPH po PEA
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).
Slovenian: Pri celotni populaciji (n = 396) je bila povprečna sprememba od izhodiščne vrednosti do 6. meseca 53 m (n = 366), do 9. meseca 52 m (n = 354), do 12. meseca 50 m (n = 351) in do 24. meseca 46 m (n = 316).
English: 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%).
Slovenian: Neželeni učinki, ki so privedli do prenehanja zdravljenja, so se manj pogosto pojavljali v skupinah bolnikov, zdravljenih z riociguatom kot v skupini, ki je prejemala placebo (riociguat IDT 1,0 - 2,5 mg, 3,1 %; riociguat CT 1,6 %; placebo 7,1 %).
English: Riociguat and its main metabolite are not inhibitors or inducers of major CYP isoforms (including CYP 3A4) or transporters (e.g. P-gp/BCRP) in vitro at therapeutic plasma concentrations.
Slovenian: Riociguat in njegov glavni presnovek v terapevtskih plazemskih koncentracijah in vitro ne zavirata ali inducirata glavnih izooblik CYP (vključno s CYP 3A4) ali prenašalcev (npr. P-gp/BCRP).
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.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 0,5 mg, 1 mg, 1,5 mg, 2 mg ali 2,5 mg riociguata.
English: Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.
Slovenian: Zdravilo Adempas, kot monoterapija ali v kombinaciji z antagonisti endotelinskih receptorjev, je indicirano za zdravljenje odraslih bolnikov s pljučno arterijsko hipertenzijo (PAH) II.
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%).
Slovenian: Neželeni učinki, ki so privedli do prenehanja zdravljenja, so se v obeh zdravljenih skupinah pojavljali s podobno pogostnostjo (titriranje odmerka riociguata za posameznega bolnika (IDT - individual dose titration) 1,0 - 2,5 mg, 2,9 %; placebo 2,3 %).
English: Riociguat and its main metabolite are strong inhibitors of CYP1A1 in vitro.
Slovenian: Riociguat in njegov glavni presnovek sta in vitro močna zaviralca CYP1A1.
English: 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.
Slovenian: Pri bolnikih s cirozo (nekadilcih) z zmerno jetrno okvaro (Child Pugh B) se je povprečni AUC za riociguat povečal za 51 % v primerjavi z zdravimi osebami v primerjalni skupini.
English: Effects of riociguat on other substances
Slovenian: Vpliv riociguata na druge učinkovine
English: Luxembourg / Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Slovenian: Luxembourg / Luxemburg MSD Belgium BVBA/SPRL Tel/Tél: +32(0)27766211 dpoc_belux@merck.com
English: Use of Adempas in other types of PAH is therefore not recommended.
Slovenian: Izkušenj z uporabo zdravila Adempas pri drugih oblikah PAH ni, zato se uporaba zdravila Adempas pri drugih oblikah PAH ne priporoča.
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).
Slovenian: Primarni opazovani cilj študije je bila glede na placebo prilagojena sprememba prehojene razdalje v testu šestminutne hoje (6MWD - 6-minute walk distance) od izhodiščne vrednosti do vrednosti pri zadnjem obisku (16. teden).
English: Inter-ethnic differences Pharmacokinetic data reveal no relevant inter-ethnic differences.
Slovenian: Medetnične razlike Farmakokinetični podatki niso pokazali pomembnih razlik glede na etično pripadnost.
English: No data on the use of riociguat in breast-feeding women are available.
Slovenian: Podatkov o uporabi riociguata pri doječih ženskah ni na voljo.
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.
Slovenian: V kombinirani 12-tedenski študiji, v katero je bilo vključenih 18 bolnikov s PAH, ki so bili stabilni na zdravljenju s sildenafilom (20 mg trikrat na dan) in riociguatom (1,0 mg do 2,5 mg trikrat na dan), so to zdravljenje primerjali z zdravljenjem samo s sildenafilom.
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).
Slovenian: Biološka uporabnost (AUC in Cmax) peroralno dane zdrobljene tablete zdravila Adempas, zmešane z jabolčno čežano ali vodo, je primerljiva z biološko uporabnostjo cele tablete (glejte poglavje 4.2).
English: -843.0 to -45.0 [<0.0001]
Slovenian: -843,0 do -45,0 [< 0,0001]
English: By widening the narrowed arteries, Adempas leads to an improvement in your ability to carry out physical activity.
Slovenian: Zdravilo Adempas razširi zožane arterije ter tako izboljša vašo telesno zmogljivost.
English: PK data show that higher riociguat exposure was observed in patients with moderate hepatic impairment (Child Pugh B) (see section 5.2).
Slovenian: Farmakokinetični podatki kažejo večjo izpostavljenost riociguatu pri bolnikih z zmerno jetrno okvaro (Child Pugh B) (glejte poglavje 5.2).
English: For coadministration with strong CYP3A4 inducers follow the recommendation on dose titration (see section
Slovenian: Pri sočasni uporabi z močnimi induktorji CYP3A4 upoštevajte priporočila glede titriranja odmerka (glejte poglavje 4.2).
English: Adempas is contraindicated during pregnancy (see section 4.3).
Slovenian: Zdravilo Adempas je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: There is no experience in patients with severe hepatic impairment (Child Pugh C); riociguat is contraindicated in these patients (see section 4.3).
Slovenian: Izkušenj pri bolnikih s hudo jetrno okvaro (Child Pugh C) ni; uporaba riociguata je pri teh bolnikih kontraindicirana (glejte poglavje 4.3).