FrancophonIA/ELRC3.0 huggingface dataset:
English: • Digital ulcers: (sores on the fingers and toes) in adult patients with a condition called scleroderma.
Maltese: • Ulċeri fis-swaba': (feriti fis-swaba' tal-idejn u tas-saqajn) f'pazjenti adulti b'kondizzjoni msejħa skleroderma.
English: Each tablet contains 125 mg of bosentan (as monohydrate).
Maltese: Kull pillola fiha 125 mg ta' bosentan (bħala monohydrate).
English: STAYVEER 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Maltese: STAYVEER 62.5 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 62.5 mg ta' bosentan (bħala monohydrate).
English: In the post-marketing period rare cases of unexplained hepatic cirrhosis were reported after prolonged therapy with STAYVEER in patients with multiple co-morbidities and therapies with medicinal products.
Maltese: Fil-perjodu ta' wara t-tqegħid fis-suq kienu rrappurtati każijiet rari ta' ċirrożi tal-fwied mhux spjegati wara terapija fit-tul b'STAYVEER f'pazjenti b'ko-morbiditajiet multipli u terapiji bi prodotti mediċinali.
English: Slightly increased incidence of testicular tubular atrophy was observed in rats given bosentan orally at doses as low as 125 mg/kg/day (about 4 times the maximum recommended human dose [MRHD] and the lowest doses tested) for two years but not at doses as high as 1,500 mg/kg/day (about 50 times the MRHD) for 6 months.
Maltese: Inċidenza kemmxejn miżjuda ta' atrofija tubulari tat-testikoli kienet osservata f'firien mogħtija bosentan mill-ħalq f'dożi baxxi ta' 125 mg/kg/jum (madwar 4 darbiet id-doża massima rakkomandata għall-bniedem [MRHD - maximum recommended human dose] u l-anqas dożi ttestjati) għal sentejn imma mhux f'dożi għolja sa 1,500 mg/kg/jum (madwar 50 darba l-MRHD) għal 6 xhur.
English: Patients had primary pulmonary hypertension (10 patients) or PAH related to congenital heart diseases (9 patients) and were in WHO functional class II (n = 15, 79%) or class III (n = 4, 21%) at baseline.
Maltese: II tad-WHO (n = 15, 79%) jew fi klassi III (n = 4, 21%) fil-linja bażi.
English: The possibility of altered efficacy of medicinal products metabolised by these isoenzymes should be considered.
Maltese: Għandha tkun ikkunsidrata l-possibbiltà li l-effikaċja ta' prodotti mediċinali metabolizzati minn dawn l-isoenzimi tinbidel.
English: The mean pulmonary vascular resistance was significantly reduced in the bosentan group (with a predominant effect observed in the subgroup of patients with bidirectional intracardiac shunt).
Maltese: Il-medja tar-reżistenza vaskulari pulmonari kienet imnaqqsa b'mod sinifikattiv fil grupp ta' bosentan (b'effett predominanti osservat fis-sottogrupp ta' pazjenti b'shunt intrakardijaku bi-direzzjonali).
English: In the post-marketing period there was one reported overdose of 10,000 mg of bosentan taken by an adolescent male patient.
Maltese: Fil-perjodu ta' wara t-tqegħid fis-suq, kienet irrapportata doża eċċessiva waħda ta' 10,000 mg ta' bosentan li ttieħdet minn pazjent maskili adolexxenti.
English: No clinically relevant differences in adverse reactions were observed between the overall dataset and the approved indications.
Maltese: Ma kienet osservata l-ebda differenza ta' rilevanza klinika fir-reazzjonijiet avversi bejn id-dejtaset globali u l-indikazzjonijiet approvati.
English: In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, a decrease in haemoglobin concentration from baseline to below 10 g/dL was reported in 10.0% of patients.
Maltese: FUTURE 3/Estensjoni, tnaqqis fil-konċentrazzjoni tal-emoglobina mil-linja bażi għal inqas minn 10 g/dL kien irrappurtat f'10.0% tal-pazjenti.
English: Enrolled patients were PAH-treatment-naïve (n = 156) or on a stable dose of sildenafil (n = 29).
Maltese: Pazjenti li daħlu fl-istudju jew qatt ma kienu ħadu kura qabel għal PAH (n = 156) jew kienu fuq doża stabbli ta' sildenafil (n = 29).
English: Background treatments for systemic sclerosis and digital ulcers were permitted if they remained constant for at least 1 month prior to the start of treatment and during the double-blind study period.
Maltese: Kura oħra li kienet qed tittieħed għal sklerosi sistemika u l-ulċeri fis-swaba' kienet permessa jekk baqgħet konstanti mill-anqas xahar qabel il-bidu tal-kura u waqt il-perjodu tal-istudju double-blind.
English: Bosentan was added to patients' current therapy, which could include a combination of anticoagulants, vasodilators (e.g., calcium channel blockers), diuretics, oxygen and digoxin, but not epoprostenol.
Maltese: Bosentan żdied mat-terapija kurrenti tal-pazjenti, li setgħet tinkludi kombinazzjoni ta' sustanzi kontra l-koagulazzjoni, sustanzi li jwessgħu l-vini u l-arterji (eż. imblokkaturi tal-kanali tal-calcium),
English: There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years; however, this is based on only 21 children less than 2 years, including 6 patients between 3 months to 1 year of age.
Maltese: avvenimenti avversi bejn pazjenti b'età ta' aktar jew inqas minn sentejn (2); iżda, dan huwa bbażat biss fuq 21 tifel/tifla ta' anqas minn sentejn, inklużi 6 pazjenti ta' età bejn 3 xhur sa sena.
English: Cartons contain 56 film-coated tablets (STAYVEER 125 mg film-coated tablets).
Maltese: Kaxxi tal-kartun fihom 56 pillola miksija b'rita (STAYVEER 125 mg pillola miksija b'rita).
English: In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and
Maltese: Fl-analiżi miġbura ta' 100 tifel/tifla b'PAH mill-istudji pedjatriċi mhux ikkontrollati FUTURE 1/2 u
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance dose studied in both these studies was 125 mg twice daily.
Maltese: Wara 4 ġimgħat b'bosentan 62.5 mg darbtejn kuljum, id-doża ta' manteniment studjata fiż żewġ studji kienu ta' 125 mg darbtejn kuljum.
English: Adverse reactions were defined as events occurring in at least 1% of patients on bosentan and at a frequency at least 0.5% more than on placebo.
Maltese: Ir-reazzjonijiet avversi kienu definiti bħala avvenimenti li jseħħu f'mill-inqas 1% tal-pazjenti kkurati b'bosentan u bi frekwenza ta'
English: In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with STAYVEER who had a suspected diagnosis of pulmonary veno-occlusive disease.
Maltese: Fil-perjodu ta' wara t-tqegħid fis-suq, kien hemm rapporti rari ta' edima pulmonari f'pazjenti kkurati bi STAYVEER li kellhom dijanjosi suspetta ta' mard veno-okklussiv pulmonari.
English: Common (may affect up to one in 10 people):
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10):
English: Based on the investigated range of each variable, it is not expected that the pharmacokinetics of bosentan will be influenced by gender, body weight, race, or age in the adult population to any relevant extent.
Maltese: Ibbażat fuq il-medda investigata ta' kull varjant, mhux mistenni li l-farmakokinetiċi ta' bosentan se jiġu influwenzati mis-sess, il-piż korporju, ir-razza, jew l-età fil-popolazzjoni adulta sa punt li hu rilevanti.
English: He had symptoms of nausea, vomiting, hypotension, dizziness, sweating and blurred vision.
Maltese: Huwa kellu sintomi ta' tqalligħ, rimettar, pressjoni baxxa, sturdament, għaraq u vista mċajpra.
English: STAYVEER reduces the number of new finger and toe ulcers that appear.
Maltese: STAYVEER inaqqas in-numru ta' ulċeri ġodda fis-swaba' tal-idejn u tassaqajn.
English: Laboratory abnormalities
Maltese: Informazzjoni għall-utent
English: The most serious side effects with STAYVEER are
Maltese: L-aktar effetti sekondarji serji b'STAYVEER huma
English: The majority of patients were diagnosed with idiopathic or heritable PAH (61%).
Maltese: idjopatika jew li tintiret (61%).
English: However, 1,611 patients (804 bosentan- and 807 placebo-treated patients) with severe chronic heart failure (CHF) were treated for a mean duration of 1.5 years in a placebo controlled study (study AC-052-301/302 [ENABLE 1 & 2]).
Maltese: Madankollu, 1,611-il pazjent (804 li kienu qed jieħdu bosentan u 807 li kienu qed jieħdu l-plaċebo) b'insuffiċjenza kronika severa tal-qalb (CHF - chronic heart failure) kienu kkurati għal tul ta' żmien medju ta' sena u nofs fl-istudju kkontrollat bil-plaċebo (studju numru AC
English: Efficacy in adult patients with pulmonary arterial hypertension Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 32 (study AC-052-351) and 213 (study AC-052-352 [BREATHE-1]) adult patients with WHO functional class III-IV PAH (primary pulmonary hypertension or pulmonary hypertension secondary mainly to scleroderma).
Maltese: 052-351) u 213 (studju AC-052-352, [BREATHE-1]) pazjent adult b'PAH tal-Klassi Funzjonali
English: Long-term data were generated from all 173 patients who were treated with bosentan in the controlled phase and/or were switched from placebo to bosentan in the open-label extension phase of the EARLY study.
Maltese: Dejta fit-tul inkisbet mill-173 pazjent kollha li kienu kkurati b'bosentan fil-fażi kkontrollata u/jew li nqalbu mill-plaċebo għal bosentan fil-fażi open-label ta' estensjoni tal-istudju EARLY.
English: • Syncope (fainting)
Maltese: • tqalligħ (tħossok se tirremetti)
English: • Anaphylaxis (general allergic reaction), angioedema (swelling, most commonly around the eyes,
Maltese: • Anafilassi (reazzjoni allerġika ġenerali), anġjoedima (nefħa, l-aktar komuni madwar l-għajnejn, xofftejn, ilsien jew griżmejn)
English: • a pregnancy test if you are a woman of childbearing potential Some patients taking STAYVEER have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Maltese: • test tat-tqala jekk inti mara li tista' toħroġ tqila • Xi pazjenti li jieħdu STAYVEER instabu li għandhom testijiet tal-funzjoni tal-fwied mhux nomali u anemija (emoglobina baxxa).
English: Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)
Maltese: Kull pillola miksija b'rita fiha 62.5 mg bosentan (bħala monohydrate)
English: In animal models of pulmonary hypertension, chronic oral administration of bosentan reduced pulmonary vascular resistance and reversed pulmonary vascular and right ventricular hypertrophy.
Maltese: F'mudelli ta' annimali bi pressjoni għolja fl-arterji tal-pulmun, għoti kroniku mill-ħalq ta' bosentan naqqas ir-reżistenza vaskulari pulmonari u reġġa' lura l-ipertrofija vaskulari pulmonari u dik tal ventrikolu tal-lemin.
English: In healthy subjects, bosentan displays dose- and time-dependent pharmacokinetics.
Maltese: epoprostenol fil-vini ma kellhom l-ebda effett sinifikanti fuq il-farmakokinetika ta' bosentan.
English: • if you are pregnant, or could get pregnant because you are not using reliable contraceptive methods.
Maltese: • jekk int tqila, jew tista' toħroġ tqila minħabba li m'intix qed tuża metodu ta' kontraċezzjoni affidabbli.
English: Concomitant use of STAYVEER and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Maltese: L-użu ta' STAYVEER flimkien ma' cyclosporine A huwa kontraindikat (ara sezzjonijiet 4.3 u 4.5).
English: No dose proportionality was observed, as steady-state bosentan plasma concentrations and AUCs were similar at oral doses of 2 and 4 mg/kg (AUCτ: 3,577 ng·h/mL and 3,371 ng·h/mL for 2 mg/kg twice daily and 4 mg/kg twice daily, respectively).
Maltese: 3,577 ng·siegħa/mL u 3,371 ng·siegħa/mL għal 2 mg/kg darbtejn kuljum u 4 mg/kg darbtejn kuljum,
English: Film coat:
Maltese: Tadalafil:
English: The benefit/risk balance of bosentan has not been established in patients with WHO class I functional status of PAH.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju ta' bosentan ma ġiex stabbilit f'pazjenti bi Klassi I tal-istat funzjonali tal-WHO tal-PAH.
English: The analysis on the global population included (64 patients) showed that the majority had remained at least stable (i.e., without deterioration) based on non-paediatric-specific WHO functional class assessment (97% twice daily, 100% three times daily) and physician's global clinical impression (94% twice daily, 93% three times daily) during the treatment period.
Maltese: L-analiżi tal-popolazzjoni globali inkluża (64 pazjent) uriet li l-maġġoranza kienu baqgħu għall-inqas stabbli (jiġifieri mingħajr irkadar) ibbażat fuq valutazzjoni tal-klassi funzjonali tad-WHO mhux speċifika għat-tfal (97% darbtejn kuljum, 100% tliet darbiet kuljum) u l-impressjoni klinika globali tat-tabib (94% darbtejn kuljum, 93% tliet darbiet kuljum) matul il-perjodu ta' kura.
English: Patients in need of the combination should be closely monitored for adverse events related to STAYVEER and for tacrolimus and sirolimus blood concentrations.
Maltese: Avvenimenti avversi ta' anormalitajiet fil-fwied u anemija\
English: Survival estimates were lower in the subgroup of patients with PAH secondary to systemic sclerosis.
Maltese: L-istimi tas-sopravivenza kienu iktar baxxi fis-sottogrupp ta' pazjenti b'PAH sekondarja għal sklerożi sistemika.
English: Bosentan forms three metabolites and only one of these is pharmacologically active.
Maltese: Bosentan jifforma tliet metaboliti u wieħed biss minn dawn hu attiv farmakoloġikament.
English: Fluconazole and other inhibitors of both CYP2C9 and CYP3A4: Co-administration with fluconazole, which inhibits mainly CYP2C9, but to some extent also CYP3A4, could lead to large increases in plasma concentrations of bosentan.
Maltese: L-għoti flimkien ma' fluconazole, li prinċipalment jimpedixxi CYP2C9, iżda anki xi ftit lil CYP3A4, jista' jwassal għal żidiet kbar fil-konċentrazzjoni ta' bosentan fil-plażma.
English: OUTER CARTON & BOTTLE LABEL/ BOTTLES
Maltese: KARTUNA TA' BARRA &
English: INSTRUCTIONS ON USE
Maltese: Doża rakkomandata
English: Uncontrolled clinical studies in paediatric patients
Maltese: Studji kliniċi mhux ikkontrollati f'pazjenti pedjatriċi
English: STAYVEER 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 125 mg ta' bosentan (bħala monohydrate).
English: Lopinavir+ritonavir (and other ritonavir-boosted protease inhibitors): Co-administration of bosentan 125 mg twice daily and lopinavir+ritonavir 400+100 mg twice daily for 9.5 days in healthy volunteers resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after bosentan administered alone.
Maltese: 125 mg darbtejn kuljum flimkien ma' lopinavir+ritonavir 400+100 mg darbtejn kuljum għal 9.5 ijiem f'voluntiera f'saħħithom, irriżulta f'konċentazzjonijiet tal-bidu l-aktar baxxi fil-plażma ta' bosentan li kienu madwar 48 darba ogħla minn dawk imkejla wara li bosentan kien mogħti waħdu.
English: STAYVEER 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Maltese: STAYVEER 125 mg, pilloli miksija b'rita huma pilloli, oranġjo-bojod, ovali, miksija b'rita, b'“125”
English: Treatment with bosentan has been associated with dose-related decreases in haemoglobin concentration (see section 4.8).
Maltese: Konċentrazzjoni tal-emoglobina Il-kura b'bosentan ġiet assoċjata ma' tnaqqis relatat mad-doża fil-konċentrazzjoni tal-emoglobina (ara sezzjoni 4.8).
English: Each film-coated tablet contains 125 mg bosentan (as monohydrate)
Maltese: Kull pillola miksija b'rita fiha 125 mg bosentan (bħala monohydrate)
English: No formal conclusion can be drawn regarding the effects of bosentan on antiretroviral drug efficacy (see also section 4.4).
Maltese: Ma tistax tintlaħaq konklużjoni formali dwar l-effetti ta' bosentan fuq l-effikaċja tal-mediċina antiretrovirali (ara wkoll sezzjoni 4.4).
English: Blood tests for anaemia
Maltese: Testijiet tad-demm għall-anemija
English: Inhibition by ritonavir of transport protein-mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction.
Maltese: Din x'aktarx hija minħabba induzzjoni ta' CYP3A4 minn bosentan.
English: How to store STAYVEER
Maltese: X'fih STAYVEER
English: Pregnancy tests
Maltese: TAL-PRODOTT MEDIĊINALI
English: • dark-coloured urine
Maltese: Indeboliment tal-fwied
English: • Monthly pregnancy tests are recommended during treatment to allow early detection of pregnancy
Maltese: • Testijiet tat-tqala kull xahar huma rakkomandati waqt il-kura biex jippermettu sejba bikrija tat tqala
English: Overall, 78% of patients remained in WHO functional class II.
Maltese: III tal-WHO u 8% bħala Klassi
English: Gastrooesophageal reflux disease Diarrhoea
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Tablet core:
Maltese: Data meta nfetaħ:
English: The mean increase from baseline in cardiac index was 0.5 L/min/m2, the mean decrease in mean pulmonary arterial pressure was 8 mmHg, and the mean decrease in PVR was 389 dyn·sec·cm-5.
Maltese: L/min/m2, it-tnaqqis medju fil-pressjoni fl-arterji tal-pulmun kien ta' 8 mmHg, u t-tnaqqis medju f'PVR kien ta' 389 dyn·sek·ċm-5.
English: In adult patients, the exposure to the active metabolite is greater than in healthy subjects.
Maltese: F'pazjenti adulti, l-espożizzjoni għal metabolit attiv hi akbar milli fil-pazjenti f'saħħithom.
English: STAYVEER therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
Maltese: Għalhekk STAYVEER iġiegħel lill-kanali tad-demm biex jespandu u jagħmel parti mill-klassi ta' mediċini msejħa “antagonisti tar-riċettur ta' endothelin”.
English: Because STAYVEER may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable.
Maltese: Peress li STAYVEER jista' jirrendi lkontraċezzjoni ormonali (eż. orali, injezzjoni, impjant jew gareż li jipprovdu mediċina li tgħaddi minn ġol-ġilda) mhux effettiva, dan il-metodu waħdu mhux affidabbli.
English: Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and STAYVEER has not been studied in man but co-administration of tacrolimus or sirolimus and STAYVEER may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant STAYVEER may reduce the plasma concentrations of tacrolimus and sirolimus.
Maltese: L-għoti flimkien ta' tacrolimus jew sirolimus u STAYVEER ma kienx studjat fil-bniedem, imma l-għoti flimkien ta' tacrolimus jew sirolimus u STAYVEER jista' jirriżulta f'konċentrazzjonijiet miżjuda ta' bosentan fil-plażma, bħal fil-każ tal-għoti flimkien ma' cyclosporine A.
English: Twenty-six patients continued to receive bosentan in the 24-week open-label extension phase (AC-052-409) of the BREATHE-5 study (mean duration of treatment = 24.4 ± 2.0 weeks) and, in general, efficacy was maintained.
Maltese: 409) tal-istudju BREATHE-5 (tul medju tal-kura = 24.4 ± 2.0 ġimgħat) u, b'mod ġenerali l-effikaċja kienet miżmuma.
English: After 16 weeks' treatment, there were significant improvements from baseline in exercise capacity: the mean increase in 6-minute walk distance was 91.4 metres from 332.6 metres on average at baseline (p < 0.001).
Maltese: Wara 16-il ġimgħa ta' kura, kien hemm titjib sinifikanti mil-linja bażi fil-kapaċità tal-eżerċizzju: iż-żieda medja fid-distanza ta' mixi f'6 minuti kienet 91.4 metri minn 332.6
English: There have also been rare reports of liver failure.
Maltese: Kien hemm ukoll rapporti rari ta' insuffiċjenza tal-fwied.
English: STAYVEER may harm the development of the foetus.
Maltese: STAYVEER jista' jkollhom anemija.
English: Clinical experience with concomitant administration of bosentan with warfarin in patients with PAH did not result in clinically relevant changes in International Normalized Ratio (INR) or warfarin dose (baseline versus end of the clinical studies).
Maltese: Fil-każ ta' deterjorament kliniku tard minkejja kura bi STAYVEER (i.e. wara ħafna xhur ta' kura), ilkura għandha terġa' tkun evalwata mill-ġdid.
English: STAYVEER is contraindicated in patients with moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 4.3).
Maltese: Child-Pugh klassi B jew Ċ (ara sezzjoni 4.3).
English: At enrolment, six patients were between 3 months and 1 year old, 15 children were between 1 and less than 2 years old, and 79 were between 2 and 12 years old.
Maltese: Meta ġew irreġistrati, sitt pazjenti kellhom età bejn 3 xhur u sena, 15-il tifel/tifla kellhom età bejn sena u inqas minn sentejn, u 79 kellhom età bejn sentejn u 12-il sena.
English: • Headache • Oedema (swelling of the legs and ankles or other signs of fluid retention)
Maltese: • Uġigħ ta' ras • Edima (nefħa fis-saqajn u l-għekiesi jew sinjali oħra ta' żamma ta' fluwidu)
English: - STAYVEER 125 mg film-coated tablets: The active substance is bosentan as monohydrate.
Maltese: Is-sustanza attiva hi bosentan bħala monohydrate.
English: Do you currently use or take contraceptives?
Maltese: Bħalissa qed tuża jew tieħu kontraċettivi?
English: The plasma concentrations of bosentan were also decreased by 29%.
Maltese: Il-konċentrazzjoni ta' bosentan fil-plażma tnaqqset ukoll b'29%.
English: The improvement in walk distance was apparent after 4 weeks of treatment, was clearly evident after 8 weeks of treatment and was maintained for up to 28 weeks of double-blind treatment in a subset of the patient population.
Maltese: It-titjib fid-distanza tal-mixja deher wara 4 ġimgħat ta' kura, u kien evidenti wara 8 ġimgħat ta' kura u nżamm sa 28 ġimgħa ta' kura double-blind f'sottoset tal-populazzjoni tal-pazjenti.
English: Controlled clinical study experience in this indication is limited to 6 months (see section 5.1).
Maltese: Esperjenza minn studji kliniċi kkontrollati f'din l-indikazzjoni hija limitata għal 6 xhur (ara sezzjoni
English: Aminotransferase elevations associated with hepatitis (including possible exacerbation of underlying hepatitis) and/or jaundice1 (see section 4.4)
Maltese: Żidiet ta' aminotransferase assoċjati ma' epatite (inkluż il possibbiltà ta' aggravar ta'
English: At the same timepoints, 88% and 79% of patients remained free from PAH worsening (defined as all-cause death, lung transplantation, atrial septostomy or start of intravenous or subcutaneous prostanoid treatment).
Maltese: Fl-istess żmien, 88% u 79% tal-pazjenti baqgħu ħielsa minn irkadar ta' PAH (definita bħala mewt ta' kull kawża, trapjant tal-pulmun, septostomija atrijali jew bidu ta' kura bi prostanoid fil-vini jew taħt il-ġilda).
English: 56 film-coated tablets 112 film-coated tablets
Maltese: 56 pillola miksija b'rita 112-il pillola miksija b'rita
English: In study AC-052-401, during 16 weeks of double-blind therapy, patients in the bosentan group developed a mean of 1.4 new digital ulcers vs 2.7 new digital ulcers in the placebo group (p = 0.0042).
Maltese: Fl-istudju AC-052-401, waqt 16-il ġimgħa ta' terapija double-blind, il-pazjenti fil-grupp b'bosentan żviluppaw medja ta' 1.4 ulċeri fis-swaba' ġodda vs.
English: However, long-term vital status was recorded for all 235 patients who were treated with bosentan in the two pivotal placebo-controlled studies (AC-052-351 and AC-052-352) and/or their two uncontrolled, open-label extensions.
Maltese: Madankollu, l-istatus vitali għal tul ta' żmien kien irrekordjat għall-235 pazjent kollha li kienu kkurati b'bosentan f'żewġ studji importanti ħafna kkontrollati bil-plaċebo (AC-052-351 u AC-052-352) u/jew iż-żewġ estensjonijiet open-label tagħhom.
English: STAYVEER 125 mg film-coated tablets bosentan
Maltese: STAYVEER 125 mg pilloli miksija b'rita bosentan
English: The mean duration of exposure to bosentan was 1.9 years ± 0.7 years (min: 0.1 years; max: 3.3 years) and patients were observed for a mean of 2.0 ± 0.6 years.
Maltese: Il-medja tat-tul ta' żmien tal-espożizzjoni għal bosentan kienet ta' 1.9 snin ± 0.7 snin; (minimu: 0.1 snin; massimu: 3.3 snin) u l-pazjenti kienu osservati għal medja ta' 2.0 ± 0.6 snin.
English: After 16 weeks, the mean oxygen saturation was increased in the bosentan group by 1.0% (95% CI -0.7%-2.8%) as compared to the placebo group (n = 17), showing that bosentan did not worsen hypoxaemia.
Maltese: 7%-2.8%) meta mqabbla mal-grupp tal-plaċebo (n = 17), li turi li bosentan ma kompliex jiggrava l-livell baxx ta'