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).
Maltese: Analiżi esploratorja addizzjonali ta' sottogrupp żvelat effett tal-kura ta' 26 m, (CI ta' 95%: 5 m sa 46 m) f'pazjenti kkurati minn qabel b'ERAs (n=167) u effett tal-kura ta' 101 m (CI ta' 95%: 27 m sa 176 m) f'pazjenti kkurati minn qabel b'analogi ta' prostacyclin (n=27).
English: Transitioning between phosphodiesterase-5 (PDE5) inhibitors and riociguat Sildenafil must be discontinued at least 24 hours prior to administration of riociguat.
Maltese: Bidla bejn inibituri ta' phosphodiesterase-5 (PDE5) u riociguat Sildenafil għandu jitwaqqaf mill-inqas 24 siegħa qabel l-għoti ta' riociguat.
English: Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of NO and insufficient stimulation of the NO-sGC-cGMP pathway.
Maltese: Pressjoni pulmonari għolja hi assoċjata ma' disfunzjoni tal-endotelju, sintesi indebolita ta' NO u stimulazzjoni insuffiċjenti tal-passaġġ NO-sGC-cGMP.
English: • chronic thromboembolic pulmonary hypertension (CTEPH).
Maltese: • pressjoni għolja pulmonari tromboembolika kronika (CTEPH - chronic thromboembolic pulmonary hypertension).
English: Treatment-naïve patients (n=189) improved by 38 m, and pre-treated patients (n=191) by 36 m (ITT analysis, see table 4).
Maltese: Pazjenti li fil-passat qatt ma kienu kkurati (n=189) tjiebu bi 38 m, u pazjenti kkurati minn qabel (n=191) tjiebu b'36 m (analiżi ITT, ara tabella 4).
English: - Severe hepatic impairment (Child Pugh C).
Maltese: - Indeboliment sever tal-fwied (Child Pugh Ċ).
English: • 90 tablets: five transparent blisters of 18 tablets each.
Maltese: • 90 pillola: ħames folji transparenti ta' 18-il pillola kull waħda.
English: How to store Adempas 6.
Maltese: Kif taħżen Adempas 6.
English: Riociguat (2.5 mg three times per day) did not have a clinically meaningful effect on the plasma levels of combined oral contraceptives containing levonorgestrel and ethinyl estradiol when concomitantly administered to healthy female subjects.
Maltese: Riociguat (2.5 mg tliet darbiet kuljum) ma kellux effett klinikament sinifikanti fuq il-livelli fil-plażma ta' kontraċettivi orali kkombinati li fihom levonorgestrel u ethinyl estradiol meta ngħata flimkien magħhom lillindividwi nisa f'saħħithom.
English: Table 1: Adverse reactions reported with Adempas in the phase III studies MedDRA
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati b'Adempas fl-istudji ta' fażi III Klassi tas-Sistemi u tal-Organi
English: More patients taking riociguat died (11% vs. 4%) and had serious adverse events (37% vs. 23%) during the main phase.
Maltese: Aktar pazjenti li kienu qed jieħdu riociguat mietu (11% kontra 4%) u kellhom avvenimenti avversi serji (37% kontra 23%) matul il-fażi prinċipali.
English: Bosentan, reported to be a moderate inducer of CYP3A4, led to a decrease of riociguat steady-state plasma concentrations in PAH patients by 27% (see sections 4.1 and 5.1).
Maltese: Bosentan, irrappurtat li hu induttur moderat ta' CYP3A4, wassal għal tnaqqis ta' 27% filkonċentrazzjonijiet ta' riociguat fil-plażma fi stat fiss f'pazjenti b'PAH (ara sezzjonijiet 4.1 u 5.1).
English: hydroxypropylcellulose hypromellose 3 cP propylene glycol (E 1520) titanium dioxide (E 171) iron oxide yellow (E 172)
Maltese: hydroxypropylcellulose hypromellose 3 cP propylene glycol (E 1520) titanium dioxide (E 171) iron oxide isfar (E 172) (f'pilloli ta' 1 mg, 1.5 mg, 2 mg u 2.5 mg biss) iron oxide aħmar (E 172)
English: Placebo-adjusted difference (m) 95% CI, [p-value]
Maltese: Differenza aġġustata għall-plaċebo (m) CI ta' 95%, [valur p]
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.
Maltese: Hemm relazzjoni diretta bejn il-konċentrazzjoni ta' riociguat fil-plażma u l-parametri emodinamiċi bħal reżistenza vaskulari sistemika u pulmonari, pressjoni sistolika u output kardijaku.
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
Maltese: Adempas 0.5 mg pilloli Adempas 1 mg pilloli Adempas 1.5 mg pilloli Adempas 2 mg pilloli Adempas 2.5 mg pilloli riociguat
English: A randomised, double-blind, multi-national, placebo controlled, phase III study (CHEST-1) was conducted in 261 adult patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) (72%) or persistent or recurrent CTEPH after pulmonary endarterectomy (PEA; 28%).
Maltese: III, randomised, double-blind, multinazzjonali, ikkontrollat bi plaċebo, (CHEST-1), twettaq f'261 pazjent adult bi pressjoni għolja pulmonari tromboembolika kronika (CTEPH) li ma tistax tiġi operata (72%) jew CTEPH persistenti jew rikorrenti wara endarterektomija pulmonari (PEA; 28%).
English: -781.5 to -82.1 [<0.0001]
Maltese: sa -82.1 [<0.
English: Patients were either treatment-naïve (50%) or pre-treated with ERA (43%) or a prostacyclin analogue (inhaled (iloprost), oral (beraprost) or subcutaneous (treprostinil); 7%) and had been diagnosed with idiopathic or heritable PAH (63.4%), PAH associated with connective tissue disease (25.1%) and congenital heart disease (7.9%).
Maltese: Il-pazjenti kienu jew li fil-passat qatt ma ġew ikkurati (50%) jew inkella kienu rċivew kura minn qabel b'ERA (43%) jew analogu ta' prostacyclin (miġbud man-nifs (iloprost), orali (beraprost) jew taħt il-ġilda (treprostinil); 7%) u kienu ġew iddijanjostikati b'PAH idjopatika jew li tintiret (63.4%), PAH assoċjata ma' mard tat-tessut konnettiv (25.1%) u mard konġenitali tal-qalb (7.9%).
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).
Maltese: Ilbidla medja mil-linja bażi għall-popolazzjoni totali (N=396) kienet ta' 53 m wara 6 xhur (n=366), 52 m wara 9 xhur (n=354), 50 m wara 12-il xahar (n=351) u 46 m wara 24 xahar (n=316).
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).
Maltese: Il-bidla medja mil-linja bażi għall-popolazzjoni totali (N=237) kienet ta' 57 m wara 6 xhur (n=218), 51 m wara 9 xhur (n=219), 52 m wara 12-il xahar (n=209) u 48 m wara 24 xahar (n=193).
English: Chronic thromboembolic pulmonary hypertension (CTEPH)
Maltese: Pressjoni għolja pulmonari tromboembolika kronika (CTEPH - Chronic thromboembolic pulmonary hypertension)
English: Common: may affect up to 1 in 10 people - inflammation of the stomach (gastritis) - inflammation in the digestive system (gastroenteritis) - reduction of red blood cells (anaemia) seen as pale skin, weakness or breathlessness - awareness of an irregular, hard, or rapid heartbeat (palpitation) - low blood pressure (hypotension) - nose bleed (epistaxis) - difficulty breathing through your nose (nasal congestion) - pain in the stomach, intestine or abdomen (gastrointestinal and abdominal pain) - heartburn (gastro-oesophageal reflux disease) - difficulty in swallowing (dysphagia) - constipation - bloating (abdominal distension)
Maltese: Komuni: jistgħu jaffettwaw sa persuna waħda minn kull 10 - infjammazzjoni tal-istonku (gastrite) - infjammazzjoni fis-sistema diġestiva (gastroenterite) - tnaqqis ta' ċelluli ħomor tad-demm (anemija) li huwa osservat bħala ġilda pallida, dgħufija jew qtugħ ta' nifs - tħoss qalbek tħabbat b'mod irregolari, bil-qawwi jew b'mod mgħaġġel (palpitazzjoni) - pressjoni baxxa - tinfaraġ (epistassi) - diffikultà biex tieħu nifs minn imnieħrek (konġestjoni fl-imnieħer) - uġigħ fl-istonku, fl-imsaren jew fiż-żaqq (uġigħ gastrointestinali u addominali) - ħruq ta' stonku (marda ta' rifluss gastro-esofagali) - diffikultà biex tibla' (disfaġja) - stitikezza - gass żejjed (nefħa fl-addome)
English: Adempas 2 mg and 2.5 mg tablets also contains iron oxide yellow (E172) and iron oxide red (E 172).
Maltese: Il-pilloli Adempas 2 mg u 2.5 mg fihom ukoll iron oxide isfar (E172) u iron oxide aħmar (E 172).
English: In elderly patients (65 years or older) there is a higher risk of hypotension and therefore particular care should be exercised during individual dose titration (see section 5.2).
Maltese: F'pazjenti anzjani (65 sena jew aktar) hemm riskju ogħla ta' pressjoni baxxa u għandu jkun hemm attenzjoni partikulari waqt it-titrazzjoni tad-doża individwali (ara sezzjoni 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).
Maltese: In vitro, ketoconazole, ikklassifikat bħala inibitur qawwi ta' CYP3A4 u tal-glikoproteina P (P-gp - Pglycoprotein), intwera li hu inibitur ta' passaġġi multipli ta' CYP u P-gp/proteina ta' reżistenza għallkanċer tas-sider (BCRP - breast cancer resistance protein) għall-metaboliżmu u t-tneħħija ta' riociguat (ara sezzjoni 5.2).
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.
Maltese: Riociguat fil-biċċa l-kbira jitneħħa permezz ta' metaboliżmu ossidattiv medjat miċ-ċitokrom P450 (CYP1A1, CYP3A4, CYP3A5, CYP2J2), tneħħija diretta biljari/fl-ippurgar ta' riociguat mhux mibdul u tneħħija mill-kliewi ta' riociguat mhux mibdul permezz ta' filtrazzjoni mill-glomeruli.
English: MON TUE WED THU FRI SAT SUN
Maltese: Popolazzjoni ta' pazjenti li qatt ma ngħataw kura filpassat
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: From the recombinant CYP isoforms investigated in vitro CYP1A1 catalysed formation of riociguat's main metabolite most effectively.
Maltese: Mill-isoformi CYP rikombinanti investigati in vitro CYP1A1 ikkatalizza l-formazzjoni tal-metabolit ewlieni ta' riociguat bl-iktar mod effettiv.
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).
Maltese: • L-użu ta' riociguat flimkien ma' inibituri qawwija ta' passaġġi multipli taċ-ċitokrom P450 (CYP - cytochrome P450) u ta' glikoproteina P (P-gp) / proteina tar-reżistenza tal-kanċer tas sider (BCRP - breast cancer resistance protein) bħal antimikotiċi azole (eż. ketoconazole,posaconazole, itraconazole) jew inibituri tal-protease tal-HIV (eż. ritonavir) iwassal għal żieda qawwija fl-esponiment għal riociguat (ara sezzjonijiet 4.5 u 5.2).
English: Placebo-adjusted difference (dyn·s·cm-5)
Maltese: Differenza aġġustata għall-plaċebo (dyn·s·cm-5)
English: Adempas 1 mg, 1.5 mg tablets also contains iron oxide yellow (E 172).
Maltese: Il-pilloli Adempas 1 mg u 1.5 mg fihom ukoll iron oxide isfar (E 172).
English: - Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see sections 4.2 and 4.5).
Maltese: - Għoti flimkien ma' inibituri ta' PDE 5 (bħal sildenafil, tadalafil, vardenafil) (ara sezzjonijiet 4.2
English: Inter-ethnic differences Pharmacokinetic data reveal no relevant inter-ethnic differences.
Maltese: Differenzi bejn razza u oħra Data farmakokinetika ma tiżvela l-ebda differenza rilevanti bejn razza u oħra.
English: Riociguat is rapidly absorbed with maximum concentrations (Cmax) appearing 1-1.5 hours after tablet intake.
Maltese: Riociguat jiġi assorbit malajr b'konċentrazzjonijiet massimi (Cmax) osservati 1-1.5 sigħat wara li tittieħed il-pillola.
English: Placebo-adjusted difference (m) 95% CI
Maltese: Differenza aġġustata għall-plaċebo (m) CI ta' 95%
English: How to take Adempas
Maltese: X'fih Adempas
English: 42 film-coated tablets 84 film-coated tablets 90 film-coated tablets 294 film-coated tablets
Maltese: 42 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 294 pillola miksija b'rita
English: Patients on stable doses of strong multi pathway CYP / P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) inhibitors
Maltese: Pazjenti fuq dożi stabbli ta' inibituri qawwija ta' passaġġi multipli ta' CYP / glikoproteina p (P-gpP-glycoprotein) u tal-proteini ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein)
English: - Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form including recreational drugs called ‘poppers' (see section 4.5).
Maltese: - Għoti flimkien ma' nitrates jew donaturi ta' nitric oxide (bħal amyl nitrite) fi kwalunkwe forma inkluż drogi għar-rikreazzjoni msejħa ‘poppers' (ara sezzjoni 4.5).
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
Maltese: Adempas 1.5 mg - pakkett ta' 294 pillola miksija b'rita - EU/1/13/907/018 Adempas 2 mg - pakkett ta' 42 pillola miksija b'rita - EU/1/13/907/010
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.
Maltese: Fl-aħħar vista, iż-żieda fis-6MWD f'pazjenti kkurati b'riociguat kienet ta' 46 m (intervall ta' kunfidenza (CI - confidence interval) ta' 95%: 25 m sa 67 m; p<0.0001), meta mqabbla ma' plaċebo.
English: Cobicistat, ritonavir, atazanavir and darunavir are additionally classified as CYP3A inhibitors.
Maltese: Cobicistat, ritonavir, atazanavir u darunavir huma kklassifikati wkoll bħala inibituri ta' CYP3A.
English: The class of tyrosine kinase inhibitors was identified as potent inhibitors of CYP1A1, with erlotinib and gefitinib exhibiting the highest inhibitory potency in vitro.
Maltese: Il-klassi ta' inibituri ta' tyrosine kinase ġiet identifikata bħala inibituri qawwija ta' CYP1A1, b'erlotinib u gefitinib li wrew l-ogħla qawwa inibitorja in vitro.
English: Placebo (n = 125)
Maltese: Plaċebo (n=125)
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
Maltese: Adempas 0.5 mg - pakkett ta' 294 pillola miksija b'rita - EU/1/13/907/016 Adempas 1 mg - pakkett ta' 42 pillola miksija b'rita - EU/1/13/907/004
English: Do not take Adempas: - if you are taking certain medicines called PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil).
Maltese: Tiħux Adempas: - jekk qed tieħu ċerti mediċini li jissejħu inibituri ta' PDE5 (eż. sildenafil, tadalafil, vardenafil).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment “ħielsa mis-sodium”.
English: The adverse reactions reported with Adempas are listed in the table below by MedDRA system organ class and by frequency.
Maltese: Ir-reazzjonijiet avversi rrappurtati b'Adempas huma elenkati fit-tabella hawn taħt skont il-klassi tassistemi u tal-organi MedDRA u skont il-frekwenza.
English: • 42 tablets: two transparent calendar blisters of 21 tablets each.
Maltese: • 42 pillola: żewġ folji transparenti b'kalendarju ta' 21 pillola kull waħda.
English: Dysphagia,
Maltese: Epistassi,
English: The probability of survival at 1 year was 97%, at 2 years 93% and at 3 years 88%.
Maltese: Il-probabbiltà ta' sopravivenza wara sena kienet ta' 97%, wara sentejn 93% u wara 3 snin 88%.
English: • 84 tablets: four transparent calendar blisters of 21 tablets each.
Maltese: • 84 pillola: erba' folji transparenti b'kalendarju ta' 21 pillola kull waħda.
English: - preventing rejection of transplanted organs (ciclosporin).
Maltese: - prevenzjoni ta' rifjut ta' organi trapjantati (ciclosporin). - uġigħ fil-ġogi u l-muskoli (niflumic acid).
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.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola miksija b'rita fiha 0.5 mg, 1 mg, 1.5 mg, 2 mg jew 2.5 mg ta' riociguat.
English: FC III patients
Maltese: Pazjenti b'FC III
English: Placebo (n=25)
Maltese: Plaċebo (n=25)
English: The probability of survival at 1 year was 97%, at 2 years 93% and at 3 years 89%.
Maltese: Il-probabbiltà ta' sopravivenza wara sena kienet ta' 97%, wara sentejn 93% u wara 3 snin 89%.
English: The use of Adempas in children and adolescents (under 18 years of age) should be avoided because efficacy and safety have not been established for this age group.
Maltese: L-użu ta' Adempas fi tfal u adolexxenti (inqas minn 18-il sena) għandu jiġi evitat peress li s-sigurtà u l-effikaċja ma ġewx determinati għal dan il-grupp ta' età.
English: Concomitant administration of 400 mg once daily ketoconazole led to a 150% (range up to 370%) increase in riociguat mean AUC and a 46% increase in mean Cmax.
Maltese: L-għoti fl-istess waqt ta' ketoconazole 400 mg darba kuljum wassal għal żieda ta' 150% (firxa sa 370%) fl-AUC medja ta' riociguat u żieda ta' 46% f'Cmax medja.
English: Serious bleeding occurred in 2.4% (12/490) of patients taking riociguat compared to 0/214 of placebo patients.
Maltese: Seħħ ħruġ ta' demm serju fi 2.4% (12/490) tal-pazjenti li kienu qed jieħdu riociguat meta mqabbla ma' 0/214 tal-pazjenti li kienu qed jieħdu plaċebo.
English: Placebo (n=66)
Maltese: Plaċebo (n=66)
English: The maximum total daily dose is 7.5 mg i.e., 2.5 mg 3 times daily.
Maltese: Id-doża massima totali ta' kuljum hi ta' 7.5 mg jiġifieri, 2.5 mg 3 darbiet kuljum.
English: Concomitant use with strong multi pathway CYP and P-gp/BCRP inhibitors
Maltese: Użu flimkien ma' inibituri oħra ta' CYP u P-gp/BCRP
English: • In patients on stable doses of Adempas, the initiation of strong multi pathway CYP and P-gp/BCRP inhibitors is not recommended as no dosage recommendation can be given due to limited data.
Maltese: • F'pazjenti fuq dożi stabbli ta' Adempas, il-bidu ta' inibituri qawwija ta' passaġġi multipli ta' CYP u P-gp/BCRP mhux rakkomandat għax ma tistax tingħata rakkomandazzjoni ta' dożaġġ minħabba data limitata.
English: If you are older than 65 years, you have an increased risk of developing low blood pressure.
Maltese: Pazjenti li għandhom iktar minn 65 sena huma f'riskju miżjud ta' pressjoni baxxa.
English: Riociguat must not be used in patients with a systolic blood pressure below 95 mmHg (see section 4.3).
Maltese: Riociguat m'għandux jintuża f'pazjenti bi pressjoni sistolika taħt 95 mmHg (ara sezzjoni 4.3).
English: The volume of distribution is moderate with volume of distribution at steady state being approximately 30 L.
Maltese: Il-volum ta' distribuzzjoni hu moderat b'volum ta' distribuzzjoni fi stat fiss ta' madwar 30 L.
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).
Maltese: Jekk għandek aktar minn 65 sena, għandek riskju akbar li tiżviluppa pressjoni baxxa inti tieħu mediċini użati biex jittrattaw infezzjonijiet ikkawżati minn fungu (eż. ketoconazole, posaconazole, itraconazole) jew mediċini għat-trattament ta' infezzjoni blHIV (eż. abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, lamivudine, rilpivirine, ritonavir, u tenofovir).
English: Intake with food reduced riociguat AUC slightly, Cmax was reduced by 35%.
Maltese: It-teħid mal-ikel naqqas kemmxejn l-AUC ta' riociguat, Cmax kienet imnaqqsa b'35%.
English: Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is contraindicated (see sections 4.2 and 4.3).
Maltese: L-użu ta' riociguat flimkien ma' inibituri ta' PDE 5 (bħal sildenafil, tadalafil, vardenafil) hu kontraindikat (ara sezzjonijiet 4.2 u 4.3).
English: • 294 tablets: fourteen transparent calendar blisters of 21 tablets each.
Maltese: • 294 pillola: erbatax-il folja transparenti b'kalendarju ta' 21 pillola kull waħda.
English: • inoperable CTEPH,
Maltese: • CTEPH li ma tistax tiġi operata,
English: Adempas is contraindicated during pregnancy (see section 4.3).
Maltese: Adempas huwa kontraindikat waqt it-tqala (ara sezzjoni 4.3).
English: Placebo (n=126)
Maltese: Plaċebo (n=126)
English: Placebo (n = 106)
Maltese: Plaċebo (n=106)
English: Placebo (n=58)
Maltese: Plaċebo (n=58)
English: Placebo (n=107)
Maltese: Plaċebo (n=107)
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).
Maltese: • L-użu ta' riociguat flimkien ma' inibituri qawwija ta' CYP1A1, bħall-inibitur ta' tyrosine kinase erlotinib, u inibituri qawwija ta' glikoproteina P (P-gp) / proteina tar-reżistenza talkanċer tas-sider (BCRP), bħas-sustanza immunosoppressiva cyclosporine A, jista' jżid lesponiment għal riociguat (ara sezzjoni 4.5 u 5.2).
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.
Maltese: F'pazjenti b'ċirrożi (li ma jpejpux) b'indeboliment moderat tal-fwied (ikklassifikat bħala Child Pugh B), l-AUC medja ta' riociguat żdiedet b'51% meta mqabbla ma' kontrolli f'saħħithom.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - PACKS OF 42, 84, 90, 294 FILM-COATED TABLETS
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI FOLJA - PAKKETTI TA' 42, 84, 90, 294 PILLOLA MIKSIJA B'RITA
English: Gastrointestinal disorders Dyspepsia, Diarrhoea,
Maltese: Uġigħ gastrointestinali u addominali,
English: Placebo (n=20)
Maltese: Plaċebo (n=20)
English: Placebo (n=60)
Maltese: Plaċebo (n=60)
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.
Maltese: Il-bidla medja f'6MWD mil-linja bażi sa ġimgħa 12 (l-aħħar osservazzjoni sa ġimgħa 12) f'PATENT-2 (24 ġimgħa waqt l-istudju għal PATENT-1 + PATENT-2) kienet ta' 52 m fil-grupp ta' qabel ta' 1.0-2.5 mg ta' riociguat, ta' 45 m fil-grupp ta' qabel tal-plaċebo u ta' 52 m filgrupp ta' qabel ta' 1.0-1.5 mg ta' riociguat.
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.
Maltese: Adempas, bħala monoterapija jew flimkien ma' antagonisti tar-riċettur ta' endothelin, huwa indikat għall-kura ta' pazjenti adulti bi pressjoni għolja fl-arterji tal-pulmun (PAH) bi klassi funzjonali (FCFunctional Class) WHO II sa III biex ittejjeb il-kapaċità tal-eżerċizzju.