FrancophonIA/ELRC3.0 huggingface dataset:
English: • The median time to complete weaning from mechanical ventilation was 10.8 days (95% CLs 3.21, 12.21 days) on bosentan and 8.6 days (95% CLs 3.71, 9.66 days) on placebo (p = 0.24).
Maltese: (CLs ta' 95% 3.21, 12.21 ijiem) fuq bosentan u 8.6 ijiem (CLs ta' 95% 3.71, 9.66 ijiem) fuq il plaċebo (p = 0.24).
English: Marketing authorisation holder:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: The study was primarily designed as a pharmacokinetic study (see section 5.2), and efficacy endpoints were only exploratory.
Maltese: L-istudju kien iddisinjat primarjament bħala studju farmakokinetiku (ara sezzjoni 5.2), u l-punti finali tal-effikaċja kienu esploratorji biss.
English: Blurred vision1
Maltese: Vista mċajpra1
English: Nasal congestion1
Maltese: Tromboċitopenija1
English: Uncommon (may affect up to one in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: After 16 weeks, the mean placebo-corrected increase in 6-minute walk distance was 53 metres (p = 0.0079), reflecting improvement in exercise capacity.
Maltese: Wara 16-il ġimgħa, il-medja taż-żieda fid-distanza tal-mixja ta' 6 minuti, ikkoreġuta għall-plaċebo, kienet ta' 53 metru (p = 0.0079), li tirrifletti t-tijib fil-kapaċità tal-eżerċizzju.
English: A pooled analysis of uncontrolled paediatric studies conducted in PAH with the bosentan 32 mg dispersible tablet formulation (FUTURE 1/2, FUTURE 3/Extension) included a total of 100 children treated with bosentan 2 mg/kg twice daily (n = 33), 2 mg/kg three times daily (n = 31), or 4 mg/kg twice daily (n = 36).
Maltese: Analiżi miġbura ta' studji pedjatriċi mhux ikkontrollati li saru f'PAH bil-formulazzjoni tal-pillola li tinxtered ta' bosentan 32 mg (FUTURE 1/2, FUTURE 3/Estensjoni) kienet tinkludi total ta' 100 tifel/tifla ikkurati b'bosentan 2 mg/kg darbtejn kuljum (n = 33), 2 mg/kg tliet darbiet kuljum (n = 31),
English: Liver dysfunction risk may also be increased when medicinal products that are inhibitors of the bile salt export pump, e.g., rifampicin, glibenclamide and cyclosporine A (see sections 4.3 and 4.5), are co-administered with bosentan, but limited data are available.
Maltese: Ir-riskju ta' funzjoni ħażina fil-fwied jista' jiżdied ukoll meta prodotti mediċinali oħra li huma impedituri tal-bile salt export pump, eż. rifampiċin, glibenclamide u cyclosporine A (ara sezzjonijiet 4.3 u 4.5), jittieħdu flimkien ma' bosentan.
English: STAYVEER is contraindicated in patients with moderate to severe liver dysfunction (see sections 4.3, 4.4 and 5.2).
Maltese: Indeboliment tal-fwied STAYVEER huwa kontraindikat f'pazjenti b'funzjoni ħażina tal-fwied li tkun minn moderata sa severa (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: STAYVEER tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Maltese: Pilloli STAYVEER fihom bosentan, li jimblokka ormon li jseħħ fin-natura msejjaħ endothelin-1 (ET1), li jġiegħel lill-kanali tad-demm jidjiequ.
English: In patients with severe renal impairment (creatinine clearance 15-30 mL/min), plasma concentrations of bosentan decreased by approximately 10%.
Maltese: Indeboliment tal-kliewi F'pazjenti b'indeboliment serju tal-kliewi (tneħħija tal-krejatinina 15-30 mL/min), il konċentrazzjonijiet ta' bosentan fil-plażma naqsu b'madwar 10%.
English: Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.
Maltese: Tadalafil ma affettwax l-esponiment (AUC u Cmax) ta' bosentan jew il-metaboliti tiegħu.
English: • flu-like syndrome (joint and muscle pain with fever)
Maltese: • sindrome tixbah lill-influwenza (uġigħ fil-ġogi u fil-muskoli flimkien ma' deni)
English: In the event of associated clinical symptoms of liver injury, i.e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of STAYVEER is not to be considered.
Maltese: Fil-każ ta' sintomi kliniċi assoċjati ma' ħsara tal-fwied, i.e. dardir, rimettar, deni, uġigħ addominali, suffejra, telqa u għeja mhux tas-soltu, sindrome bħall-influwenza (uġigħ fil-ġogi, uġigħ fil-muskoli, deni), il-kura għandha titwaqqaf u m'għandux jiġi kkunsidrat li l-kura bi STAYVEER terġa' tinbeda.
English: Jun ______
Maltese: Ismek: ____________________________________
English: Elevations in aminotransferases were associated with elevated bilirubin (≥ 2 × ULN) without evidence of biliary obstruction in 0.2% (5 patients) on bosentan and 0.3% (6 patients) on placebo.
Maltese: (≥ 2 × ULN) mingħajr evidenza ta' ostruzzjoni tal-bili f'0.2% (5 pazjenti) fuq bosentan u f'0.3% (6
English: ‘Class II' involves slight limitation of physical activity.
Maltese: II' tinvolvi limitazzjoni ħafifa ta' attività fiżika.
English: The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 24 weeks was 96.9% and 96.7% in the twice daily and three times daily groups, respectively.
Maltese: L-istima Kaplan-Meier mingħajr avveniment għall-irkadar ta' PAH (mewt, trapjant tal-pulmun, jew dħul l-isptar minħabba rkadar ta' PAH) wara 24 ġimgħa kienet ta' 96.9% u 96.7% fil-gruppi ta' darbtejn kuljum u tliet darbiet kuljum, rispettivament.
English: An open-label, non-comparative study (AC-052-362 [BREATHE-4]) was performed in 16 patients with WHO functional class III PAH associated with HIV infection.
Maltese: Studju open-label, mhux komparattiv (AC-052-362 [BREATHE-4]) twettaq fuq 16-il pazjent bil-PAH ta' klassi funzjonali
English: • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
Maltese: • ikkawżata minn skleroderma (imsejħa wkoll sklerosi sistemika, marda fejn ikun hemm tkabbir mhux normali tat-tessut konnettiv li jissapportja l-ġilda u organi oħra);
English: STAYVEER 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Maltese: STAYVEER 125 mg pilloli miksija b'rita Pilloli miksija b'rita, bojod fl-oranġjo, ovali, konvessi miż-żewġ naħat, bil-kitba “125” imnaqqxa fuq naħa waħda.
English: At baseline, patients had idiopathic (31 patients [86%]) or familial (5 patients [14%]) PAH, and were in WHO functional class II (n = 23, 64%) or class III (n = 13, 36%).
Maltese: Fil-linja bażi, il-pazjenti kellhom PAH idjopatika (31 pazjent [86%]) jew familjali (5 pazjenti [14%]), u kienu fi klassi funzjonali
English: • Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function)
Maltese: • Ċirrożi (ċikatriċi) tal-fwied, insuffiċjenza tal-fwied (disturb serju fil-funzjoni tal-fwied)
English: Abnormal liver function test (see section 4.4)
Maltese: Test tal-funzjoni tal-fwied mhux normali (ara sezzjoni 4.4)
English: Hormonal contraceptives: Co-administration of bosentan 125 mg twice daily for 7 days with a single dose of oral contraceptive containing norethisterone 1 mg + ethinyl estradiol 35 mcg decreased the AUC of norethisterone and ethinyl estradiol by 14% and 31%, respectively.
Maltese: L-għoti flimkien ta' bosentan 125 mg darbtejn kuljum għal 7 ijiem ma' doża waħda ta' kontraċettiv orali li fih norethisterone 1 mg + ethinyl estradiol 35 mcg naqqas l-AUC ta'
English: In the AC-052-352 study, 92% of the 213 patients were classified at baseline as WHO functional class III and 8% as class IV.
Maltese: Fl-istudju AC-052-352, 92% mill-213-il pazjent kienu kklassifikati fil-linja bażi bħala Klassi Funzjonali
English: An increased long-term risk of hepatic toxicity and haematological adverse events cannot be excluded when bosentan is used in combination with antiretroviral medicinal products.
Maltese: Meta bosentan jintuża flimkien ma' prodotti mediċinali antiretrovirali ma jistax jiġi eskluż riskju miżjud fuq tul ta' żmien ta' tossiċità tal-fwied u ta' avvenimenti ematoloġiċi avversi.
English: Treatment with bosentan has been associated with dose-dependent elevations in liver aminotransferases and decreases in haemoglobin concentration (see section 4.4).
Maltese: Kura b'bosentan kienet assoċjata ma' elevazzjonijiet dipendenti mid-doża fl-aminotransferases tal fwied u tnaqqis fil-konċentrazzjoni tal-emoglobina (ara sezzjoni 4.4).
English: Each tablet contains 62.5 mg of bosentan (as monohydrate).
Maltese: Kull pillola fiha 62.5 mg ta' bosentan (bħala monohydrate).
English: The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%.
Maltese: Ilkonċentrazzjonijiet ta' cyclosporine A (sottostrat ta' CYP3A4) fid-demm naqset b'madwar 50%.
English: In study AC-052-365 (FUTURE 1), dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
Maltese: Fl-istudju AC-052-365 (FUTURE 1), pilloli li jinxterdu ngħataw lil 36 tifel/tifla b'PAH b'età minn 2
English: • One patient in the bosentan group had treatment failure (need for ECMO as per protocol definition), which was declared based on increasing Oxygenation Index values within 8 h after the first study drug dose.
Maltese: • Pazjent wieħed fil-grupp ta' bosentan kellu falliment tal-kura (ħtieġa ta' ECMO skont iddefinizzjoni tal-Protokoll), li kien iddikjarat ibbażat fuq żieda fil-valuri tal-Indiċi ta' Ossiġenazzjoni 8 sigħat wara l-ewwel doża tal-mediċina tal-istudju.
English: Headache3
Maltese: Treddigħ
English: For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with STAYVEER is not recommended.
Maltese: (bħal ketoconazole, itraconazole jew ritonavir) u ta' impeditur ta' CYP2C9 (bħal voriconazole) flimkien ma' STAYVEER
English: At steady state, AUCτ was 6,165 ng·h/mL (CV: 133%, n = 7), which is similar to the exposure observed in adult PAH patients receiving 125 mg twice daily and taking into account a blood/plasma distribution ratio of 0.6.
Maltese: (CV: 133%, n = 7), li huwa simili għall-esponiment osservat f'pazjenti adulti b'PAH li kienu qed jirċievu 125 mg darbtejn kuljum u b'kunsiderazzjoni tal-proporzjon ta' distribuzzjoni fid demm/plażma ta' 0.6.
English: Appropriate precautions must be taken for women of childbearing potential (see sections 4.3, 4.4 and 4.6).
Maltese: Għandhom jittieħdu prekawzjonijiet adattati f'nisa li jistgħu joħorġu tqal (ara sezzjoni 4.3, 4.4 u 4.6).
English: The requirements for submission of periodic safety update reports including liver reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà inklużi rapporti dwar il fwied għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: STAYVEER 62.5 mg film-coated tablets STAYVEER 125 mg film-coated tablets
Maltese: STAYVEER 62.5 mg, pilloli miksija b'rita STAYVEER 125 mg pilloli miksija b'rita
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance doses studied in these studies were 125 mg twice daily in AC-052-351, and 125 mg twice daily and 250 mg twice daily in AC-052-352.
Maltese: Wara 4 ġimgħat ta' kura b'bosentan b'doża ta' 62.5 mg darbtejn kuljum, id-dożi tal-manteniment studjati f'dawn l-istudji kienu ta' 125 mg darbtejn kuljum f'AC-052-351, u 125 mg darbtejn kuljum u 250 mg darbtejn kuljum f'AC-052-352.
English: The pharmacokinetics of bosentan have mainly been documented in healthy subjects.
Maltese: Il-farmakokinetika ta' bosentan kienet dokumentata l-aktar f'pazjenti f'saħħithom.
English: In a juvenile rat toxicity study, where rats were treated from Day 4 post partum up to adulthood, decreased absolute weights of testes and epididymides, and reduced number of sperm in epididymides were observed after weaning.
Maltese: Fi studju dwar l-effett tossiku f'firien żgħażagħ, fejn firien kienu kkurati minn Jum 4 post partum sa meta jsiru adulti, kien osservat tnaqqis fil-piż assolut tal-testikoli u tal-epididimi, u numru mnaqqas ta' sperma fl-epididimi wara li nfatmu.
English: In BREATHE-3, the most frequent adverse reactions were flushing (21%), headache, and abnormal liver function test (each 16%).
Maltese: Fi BREATHE-3, l-aktar reazzjonijiet avversi frekwenti kienu fwawar (21%), uġigħ ta' ras, u test tal-funzjoni tal-fwied mhux normali (kull wieħed 16%).
English: The treatment effect was driven by improvement in the component symptomatic progression.
Maltese: L-effett tal-kura kien immexxi minn titjib fil-komponent ta' progressjoni sintomatika.
English: In this total population, Kaplan-Meier estimates of survival were 93% and 84% 1 and 2 years after the start of treatment with bosentan, respectively.
Maltese: F'din il-popolazzjoni totali, l-istimi ta' Kaplan-Meier tas-sopravivenza kienu ta' 93% u 84% sena u sentejn wara l-bidu talkura b'bosentan, rispettivament.
English: Liver cirrhosis, liver failure1
Maltese: Ċirrożi tal-fwied, insuffiċjenza tal-fwied1
English: • a blood test to check for anaemia (low haemoglobin)
Maltese: • test tad-demm biex jiċċekkja għall-anemija (emoglobina baxxa)
English: Cartons contain 56 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).
Maltese: Kaxxi tal-kartun fihom 56 pillola miksija b'rita (STAYVEER 62.5 mg pillola miksija b'rita).
English: In study AC-052-331, during 24 weeks of double-blind therapy, the corresponding figures were 1.9 vs 2.7 new digital ulcers, respectively (p = 0.0351).
Maltese: Fl-istudju AC-052-331, waqt 24 ġimgħa ta' terapija double-blind, il-figuri korrispondenti kienu ta' 1.9 vs.
English: There was no decrease to below 8 g/dL.
Maltese: Ma kien hemm l-ebda tnaqqis għal inqas minn 8 g/dL.
English: In vitro, bosentan inhibits the bile salt export pump in hepatocyte cultures.
Maltese: bosentan jimpedixxi l-bile salt export pump f'kultivazzjoni taċ-ċelluli tal-fwied.
English: The differences between the two groups, 125 mg twice daily and 250 mg twice daily, were not statistically significant but there was a trend towards improved exercise capacity in the group treated with 250 mg twice daily.
Maltese: Id-differenzi bejn iż żewġ gruppi, fejn grupp ingħata 125 mg darbtejn kuljum u grupp ieħor ingħata 250 mg darbtejn kuljum, ma kinux statistikament sinifikanti imma kien hemm tendenza lejn titjib fil-kapaċità tależerċizzju fiżiku fil-grupp ikkurat bil-250 mg darbtejn kuljum.
English: System organ class
Maltese: II. ‘Klassi
English: Bosentan film-coated tablets were evaluated in an open-label uncontrolled study in 19 paediatric patients with PAH aged 3 to 15 years.
Maltese: Bosentan pilloli miksija b'rita kienu evalwati fi studju open-label, mhux ikkontrollat f'19-il pazjent pedjatriku b'PAH b'età minn 3 snin sa 15-il sena.
English: Though the number of patients included was limited and with high variability, these data indicate a marked increase in the exposure to bosentan and its primary metabolite Ro 485033 in patients with moderate liver function impairment (Child-Pugh class B).
Maltese: Għalkemm in-numru ta' pazjenti inklużi kien limitat u b'varjabilità għolja, din id-dejta tindika żieda notevoli fl-esponiment għal bosentan u għall-metabolit primarju tiegħu Ro 48-5033 f'pazjenti b'indeboliment moderat filfunzjoni tal-fwied (Child-Pugh klassi B).
English: • other medications for the treatment of pulmonary hypertension: sildenafil and tadalafil;
Maltese: • mediċini oħra għat-trattament ta' pressjoni fil-pulmun: sildenafil u tadalafil; • warfarina (sustanza antikoagulanti);
English: In study AC-052-373 (FUTURE 3), using dispersible tablets, the exposure to bosentan in the patients treated with 2 mg/kg twice daily was comparable to that in the FUTURE 1 study.
Maltese: Fi studju AC-052-373 (FUTURE 3), bl-użu ta' pilloli li jinxterdu, l-esponiment għal bosentan f'pazjenti kkurati b'2 mg/kg darbtejn kuljum kien komparabbli ma' dak fi studju FUTURE 1.
English: The mean duration of exposure to bosentan treatment was 3.6 ± 1.8 years (up to 6.1 years), with 73% of patients treated for at least 3 years and 62% for at least 4 years.
Maltese: It-tul medju ta' espożizzjoni għall-kura b'bosentan kien ta' 3.6 ± 1.8 snin (sa 6.1 snin), bi 73% tal-pazjenti kkurati għal mill-inqas 3 snin u 62% għal mill-inqas 4 snin.
English: 2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo.
Maltese: 2 Reazzjonijiet ta' sensittività eċċessiva kienu rrappurtati f'9.9% tal-pazjenti fuq bosentan u f'9.1%
English: In vitro data also suggest an induction of CYP2C19.
Maltese: L-informazzjoni minn studji in vitro tindika li bosentan jinduċi wkoll CYP2C19.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq il-folja wara “EXP”.
English: Because of possible hormonal contraception failure during STAYVEER treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with STAYVEER are recommended to allow early detection of pregnancy.
Maltese: Minħabba l-possibbiltà ta' falliment ta' kontraċezzjoni ormonali waqt kura b'STAYVEER, kif ukoll b'konsiderazzjoni tar-riskju li pressjoni pulmonari għolja tista' tiddeterjora b'mod sever bit-tqala, hu rakkomandat li jsiru testijiet tat-tqala kull xahar matul il-kura bi STAYVEER biex tkun possibbli s-sejba bikrija tat-tqala.
English: STAYVEER 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
Maltese: STAYVEER 62.5 mg, pilloli miksija b'rita huma pilloli, oranġjo-bojod, tondi, miksija b'rita, b'“62.5”
English: Elevations in liver aminotransferases, i.e., aspartate and alanine aminotransferases (AST and/or ALT), associated with bosentan are dose dependent.
Maltese: Funzjoni tal-fwied Żieda ta' aminotransferases fil-fwied, i.e. ta' aspartate u ta' alanine aminotransferases (AST u/jew
English: In patients with mildly impaired liver function (Child-Pugh class A) no relevant changes in the pharmacokinetics have been observed.
Maltese: F'pazjenti b'indeboliment ħafif tal-fwied (Child-Pugh Klassi A) ma ġew osservati l-ebda bidliet farmakokinetiċi sinifikanti.
English: Mar ______
Maltese: Jan ______ Mej ______ Set _____ Frar ______ Ġun ______ Ott _____ Mar ______ Lul ______ Nov _____ Apr ______ Aww ______ Diċ _____
English: Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with STAYVEER should be avoided (see section 4.5).
Maltese: L-għoti flimkien kemm ta' impeditur ta' CYP3A4 kif ukoll ta' impeditur ta' CYP2C9 ma' STAYVEER għandu jiġi evitat (ara sezzjoni 4.5).
English: In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients were treated with placebo.
Maltese: pazjent kienu kkurati b'bosentan b'dożi ta' kuljum li varjaw minn 100 mg sa 2000 mg u 1,838 pazjent kienu kkurati bil-plaċebo.
English: It was primarily designed as a pharmacokinetic study (see section 5.2).
Maltese: Dan l-istudju kien primarjament maħsub bħala studju farmakokinetiku (ara sezzjoni 5.2).
English: The mechanism of this interaction is most likely inhibition of transport protein-mediated uptake of bosentan into hepatocytes by cyclosporine.
Maltese: Il-mekkaniżmu ta' din l-interazzjoni x'aktarx hija inibizzjoni ta' teħid medjat minn proteini tat-trasport ta' bosentan fl-epatoċiti minn cyclosporine.
English: • Neutropenia/leukopenia (low number of white blood cells)
Maltese: • Newtropenija/lewkopenija (għadd baxx ta' ċelluli bojod tad-demm)
English: OUTER CARTON/BLISTERS
Maltese: TIKKETTA TAL-FLIXKUN/ FLIEXKEN
English: However, there was no evidence of bosentan affecting thyroid function (thyroxine, TSH) in humans.
Maltese: Madankollu, m'hemm l-ebda evidenza li bosentan jaffettwa l-funzjoni tat-tirojde (thyroxine, TSH) fil-bnedmin.
English: The co-primary endpoints were percentage change from baseline in pulmonary vascular resistance (PVR) and change from baseline in 6-minute walk distance to Month 6 versus placebo.
Maltese: L-endpoints ko-primarji kienu l-persentaġġ ta' bidla mil-linja bażi fir-reżistenza vaskulari fil-pulmun (PVR) u bidla mil-linja bażi fid-distanza ta' mixja f'6 minuti sa Xahar 6 kontra l-plaċebo.
English: Both glibenclamide and bosentan inhibit the bile salt export pump, which could explain the elevated aminotransferases.
Maltese: Kemm glibenclamide kif ukoll bosentan jimpedixxu l-bile salt export pump, u dan jista' jispjega għaliex il-livell ta' aminotranferases jiżdied.
English: STAYVEER is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1).
Maltese: STAYVEER huwa indikat ukoll biex inaqqas in-numru ta' ulċeri ġodda fis-swaba' f'pazjenti bi sklerosi sistemika u l-preżenza tal-marda tal-ulċeri fis-swaba' (ara sezzjoni 5.1).
English: STAYVEER 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Maltese: Folji magħmula minn PVC/PE/PVDC/aluminju li fihom 14-il pillola miksija b'rita.
English: Inhibition of these isoenzymes may increase the plasma concentration of bosentan (see ketoconazole).
Maltese: Inibizzjoni ta' dawn l-isoenzimi tista' żżid il konċentrazzjoni ta' bosentan fil-plażma (ara ketoconazole).
English: However, no effects on general development, growth, sensory, cognitive function and reproductive performance were detected at 7 (males) and 19 (females) times the human therapeutic exposure at Day 21 post partum.
Maltese: Madankollu, ma kienu osservati l-ebda effetti fuq l-iżvilupp ġenerali, tkabbir, funzjoni sensorjali, funzjoni konoxxittiva u l-prestazzjoni riproduttiva b'7 darbiet (irġiel) u 19-il darba (nisa) lesponiment terapewtiku fil-bniedem f'Jum 21 post partum.
English: Patients with suboptimal response to inhaled nitric oxide (iNO) despite at least 4 hours of continuous treatment were treated with bosentan dispersible tablets at 2 mg/kg twice daily (N = 13) or placebo (N = 8) via nasogastric tube as add-on therapy on top of iNO until complete weaning of iNO or until treatment failure (defined as need for extra-corporeal membrane oxygenation [ECMO] or initiation of alternative pulmonary vasodilator), and for a maximum of 14 days.
Maltese: Pazjenti b'rispons inqas minn ottimali għal nitric oxide meħud man-nifs (iNO - inhaled nitric oxide) minkejja mill-inqas 4 sigħat ta' kura kontinwa kienu kkurati b'pilloli li jinxterdu bosentan b'doża ta' 2 mg/kg darbtejn kuljum (N = 13) jew plaċebo (N = 8) permezz tat-tubu nażogastriku bħala terapija miżjuda ma' iNO sakemm iNO tnaqqas bil-mod għax-xejn jew sa falliment tal-kura (definit bħala l-ħtieġa ta'
English: Recommendations in the event of ALT/AST elevations ALT/AST levels
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI
English: Therefore, concomitant use of STAYVEER and tacrolimus or sirolimus is not advisable.
Maltese: Tacrolimus, sirolimus:
English: In this open-label randomised study with the bosentan 32 mg dispersible tablet formulation, 64 children with stable PAH from 3 months to 11 years of age were randomised to 24 weeks' bosentan treatment 2 mg/kg twice daily (n = 33) or 2 mg/kg three times daily (n = 31).
Maltese: F'dan l-istudju randomised u open-label bil-formulazzjoni ta' pillola li tinxtered ta' bosentan 32 mg, 64 tifel/tifla b'PAH stabbli b'età minn 3 xhur sa 11-il sena kienu randomised għal 24 ġimgħa ta' kura b'bosentan 2 mg/kg darbtejn kuljum (n = 33) jew 2 mg/kg tliet darbiet kuljum (n = 31). 43 (67.2%) kellhom età ta' ≥ sentejn sa 11-il sena, 15 (23.4%) kellhom età bejn 1 u sentejn, u 6 (9.4%) kellhom età bejn 3 xhur u sena.