FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with combination therapy resulted in a 50% risk reduction (hazard ratio [HR] 0.502; 95% CI: 0.348 to 0.724; p=0.0002) of the composite clinical failure endpoint up to final assessment visit when compared to the pooled monotherapy group [Figure 1 and Table 1].
Maltese: It-trattament b'terapija kombinata rriżulta f'tnaqqis tar-riskju ta' 50% (proporzjon tal-periklu [HR] 0.502; 95% CI: 0.348 sa 0.724; p=0.0002) tal-punti ta' tmiem tal-insuffiċjenza klinika tal-komposti saż-żjara tal-valutazzjoni finali meta mqabbel mal-grupp miġbur ta' monoterapija [Figura 1 u Tabella 1].
English: Exposures of ambrisentan as measured by AUC(0-inf) and Cmax were increased by 35% and 20%, respectively.
Maltese: Esponimenti għal ambrisentan kif imkejjel fl-AUC(0-inf) u Cmax ġew miżjuda b'35% u 20% rispettivament.
English: Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT))>3xULN (see sections 4.2 and 4.4).
Maltese: Indeboliment serju tal-fwied (bi jew mingħajr ċirrożi) (ara s-sezzjoni 4.2) Valuri bażi ta' aminotransferases tal-fwied (aspartate aminotransferases (AST)) u/jew alanine aminotransferases (ALT)) >3xULN (ara s-sezzjonijiet 4.2 u 4.4).
English: No clinical data are available (see section 5.3 regarding data available in juvenile animals).
Maltese: M'hemm l-ebda data klinika disponibbli (ara sezzjoni 5.3 dwar data disponibbli f'annimali żgħar).
English: Patients with WHO FC II and III had a mean baseline 6MWD of 353 metres.
Maltese: Il-pazjenti b'WHO FC II u III kellhom 6MWD medja fil-linja bażi ta' 353 metri.
English: The Cmax and AUC(0-∞) were slightly decreased for ethinyl estradiol (8% and 4%, respectively), and slightly increased for norethindrone (13% and 14 %, respectively).
Maltese: AU għal ethinyl estradiol (8% u 4% rispettivament), u żieda żgħira għal norethindrone (13% u 14%, rispettivament).
English: Patients started on ambrisentan 5 mg and tadalafil 20 mg, and were titrated to 40 mg tadalafil at week 4 and 10 mg ambrisentan at week 8, unless there were tolerability issues.
Maltese: Il-pazjenti nbdew fuq ambrisentan 5 mg u tadalafil 20 mg, u kienu titrati sa 40 mg tadalafil fil-ġimgħa 4 u10 mg ambrisentan fil-ġimgħa 8, sakemm ma kienx hemm kwistjonijiet ta' tollerabilità.
English: The incidence of peripheral oedema was increased when ambrisentan was dosed in combination with tadalafil (45% adverse event frequency), compared to the incidence of peripheral oedema when ambrisentan and tadalafil were given as monotherapy (38% and 28%, respectively).
Maltese: L-inċidenza ta' edima periferali żdiedet meta ambrisentan ġie ddożat f'kombinazzjoni ma' tadalafil (frekwenza ta' avveniment avvers ta' 45%), meta mqabbel malinċidenza ta' edima periferali meta ambrisentan u tadalafil ingħataw bħala monoterapija (38% u 28%, rispettivament).
English: Monotherapy Pooled (N=247)
Maltese: Monoterapija Miġbura (N=247)
English: The magnitude of the decrease in oral clearance is modest (20-40%) in patients with moderate renal impairment and therefore is unlikely to be of any clinical relevance.
Maltese: Id-daqs tat-tnaqqis tal-eliminazzjoni mill-ħalq hu ta' daqs modest (20-40% f'pazjenti b'indeboliment moderat tal-kliewi u għalhekk mhux probabbli li jkollu xi rilevanza klinika.
English: Treatment with ambrisentan led to a statistically significant improvement in Borg Dyspnea Index (BDI) at week 12 (placebo-adjusted BDI of -1.1 (95% CI: -1.8 to -0.4; p=0.019; combined dose group)).
Maltese: Trattament b'ambrisentan wassal għal titjib statistikament sinifikanti fl-Indiċi tadDispnea Borg (BDI) f'ġimgħa 12 (BDI aġġustat bil-plaċebo ta' -1.1 (95% CI: minn -1.8 sa -0.4; p=0.019; grupp tad-doża kombinata)).
English: NT-proBNP (% reduction)
Maltese: NT-proBNP (tnaqqis %) -67.2
English: Contains lactose, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).
Maltese: Fih lactose, lecithin (sojja) (E322) u Allura red AC Aluminium Lake (E129).
English: Autoimmune hepatitis (see section
Maltese: Epatite awtoimmuni (ara sezzjoni
English: • ringing in the ears (tinnitus) only when taking the combination treatment.
Maltese: • tisfir fil-widnejn (tinnitus) meta tieħu t-trattament kombinat.
English: Co. Durham DL12 8DT United Kingdom
Maltese: Durham DL12 8DT Ir-Renju Unit
English: Data derived from routine pharmacovigilance surveillance, frequencies based on statistical modelling of placebocontrolled clinical trial data.
Maltese: Dejta derivata minn sorveljanza ta' farmakoviġilanza ta' rutina, frekwenzi ibbażati fuq immudellar statistiku ta' data minn prova klinika kkontrollata bil-plaċebo.
English: INFORMATION IN BRAILLE volibris 10 mg
Maltese: volibris 10 mg
English: Following initial doses of rifampicin, a transient increase in ambrisentan AUC(0-τ) (121% and 116% after first and second doses of rifampicin, respectively) was observed, presumably due to a rifampicin-mediated OATP inhibition.
Maltese: Wara dożi inizjali ta' rifampicin, kienet osservata żieda temporanja fl-AUC ta' ambrisentan (0-T) (121% u 116% wara lewwel u t-tieni doża ta' rifampicin, rispettivament, probabbilment minħabba inibizzjoni ta' OATP minħabba rifampicin.
English: 30x1 film-coated tablets.
Maltese: 30x1 pillola miksija b'rita.
English: Please read the information under ‘Pregnancy'
Maltese: Aqra l-informazzjoni taħt ‘Treddigħ'
English: Patients enrolled into ARIES-1 and 2 were eligible to enter a long term open label extension study ARIES-E (n=383).
Maltese: Pazjenti irreġistrati f'ARIES 1 u 2 kienu eliġibbli li jidħlu fi studju ta' estensjoni open label fuq tul ta' żmien ARIES E (n=383).
English: Ninety events (27%) of IPF progression (including respiratory hospitalisations) or death were observed in the ambrisentan group compared to 28 events (17%) in the placebo group.
Maltese: Disgħin avveniment (27%) ta' progressjoni ta' IPF (inkluż dħul l-isptar minħabba avvenimenti respiratorji) jew mewt kienu osservati fil-grupp ta' ambrisentan meta mqabbel ma' 28 avveniment (17%) fil-grupp tal-plaċebo.
English: This is an event rate of 2.3 events per 100 patient years of exposure for ambrisentan.
Maltese: Din hija rata ta' avvenimentita' 2.3 avvenimenti kull 100 sena ta' pazjent ta' espożizzjoni għal ambrisentan.
English: Ambrisentan has not been studied in a sufficient number of patients to establish the benefit/risk balance in WHO functional class I PAH.
Maltese: Ambrisentan ma ġiex studjat f'numru suffiċjenti ta' pazjenti biex jiġi stabbilit il-bilanċ ta' benefiċċju/riskju fil-klassi funzjonali I ta' PAH skont WHO.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma mfissra bħala komuni ħafna (>1/10), komuni (>1/100, <1/10), mhux komuni(>1/1,000, <1/100), rari (>1/10,000, <1/1,000) rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: ARIES-1 included 201 patients and compared ambrisentan 5 mg and 10 mg with placebo.
Maltese: ARIES 1 kien jinkludi 201 pazjenti u pparaguna ambrisentan 5 mg u 10 mg ma' plaċebo.
English: In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including the P-glycoprotein (Pgp), breast cancer resistance protein (BCRP), multidrug resistance related protein 2 (MRP2), bile salt export pump (BSEP), organic anion transporting polypeptides (OATP1B1 and OATP1B3) and the sodium-dependent taurocholate co-transporting polypeptide (NTCP).
Maltese: L-effett ta' ambrisentan fuq trasportaturi xenobijotiċi Ambrisentan m'għandu l-ebda effett inbitorju fuq trasportaturi umani f'konċentrazzjonijiet relevanti kliniċi, inkluż glikoproteina-P (Pgp), proteina ta' reżistenza għal kanċer tas-sider (BCRP), proteina 2 relatata mar-reżistenza għal aktar minn mediċina waħda (MRP2), pompa ta' esportazzjoni tal-melħ biljari (BSEP), polipeptidi ta' trasport tal-anjoni organiċi (OATP1B1 u OATP1B3) u polipeptid kotrasportatur ta' taurocholate dipendenti fuq is-sodium (NTCP).
English: Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).
Maltese: WHO (FC - Functional Class) II sa III, inkluż l-użu fi trattament ta' kombinazzjoni (ara sezzjoni 5.1).
English: That Volibris is teratogenic in animals;
Maltese: − Li Volibris huwa teratoġeniku fl-annimali;
English: A statistically significant increase (3.41 ± 6.96) was observed for the combined dose group in the physical functioning scale of the SF-36 Health Survey compared with placebo (-0.20 ± 8.14, p=0.005).
Maltese: Kienet osservata żieda statistikament sinifikanti (3.41 ± 6.96) għal grupp tad-doża kombinata fl-iskala ta' funzjoni fiżika tal-Istħarriġ tas-Saħħa SF 36 meta mqabbla ma' plaċebo (0.20 ± 8.14; p=0.005).
English: The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p<0.001) for the 5 mg group, in
Maltese: It-titjib aġġustat skont il-plaċebo fil-medja ta' 6MWD f'ġimgħa 12 meta mqabbla mal-linja bażi kien ta' 30.6 m (95% CI: 2.9 sa 58.3; p=0.008) u 59.4 m (95%CI: minn 29.6 sa 89.3; p<0.001) għall-grupp ta' 5 mg, f'ARIES 1 u 2 rispettivament.
English: Taken together, the in vitro data suggest ambrisentan at clinically relevant concentrations (plasma Cmax up to 3.2 μM) would not be expected to have an effect on UGT1A1, UGT1A6, UGT1A9, UGT2B7 or cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 or transport via BSEP, BCRP, Pgp, MRP2, OATP1B1/3, or NTCP.
Maltese: Meqjusa flimkien, id-data in vitro tissuġġerixxi li ambrisentan f'konċentrazzjonijiet klinikament relevanti (Cmax fil-plasma sa 3.2 μM) mhuwiex mistenni li jkollu effett fuq UGT1A1, UGT1A6, UGT1A9, UGT2B7 jew enzimi ta' cytochrome P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 jew trasport permezz ta' BSEP, BCRP, Pgp, MRP2, OATP1B1/3, jew NTCP.
English: A multicenter, double-blind, active comparator, event-driven, Phase 3 outcome study (AMB112565/AMBITION) was conducted to assess the efficacy of initial combination of ambrisentan and tadalafil vs. monotherapy of either ambrisentan or tadalafil alone, in 500 treatment naive PAH patients, randomised 2:1:1, respectively.
Maltese: Twettaq studju tar-riżultati, ta' Fażi 3, immexxi mill-avvenimenti, b'komparatur attiv, double-blind, multiċentriku (AMB112565/AMBITION) biex tiġi vvalutata l-effikaċja tal-kombinazzjoni inizjali ta' ambrisentan u tadalafil meta mqabbel ma' monoterapija ta' ambrisentan jew tadalafil waħdu, f'500 pazjent PAH li qatt ma ġew ittrattati qabel, randomizzati 2:1:1, rispettivament.
English: Volibris is supplied as 5 mg and 10 mg film-coated tablets in unit dose blister packs of 10x1 or 30x1 tablets.
Maltese: Volibris issibu bħala pilloli ta' 5 mg u 10 mg f'pakketti ta' folji b'doża waħda ta' 10x1 jew 30x1 pillola miksija b'rita.
English: INFORMATION IN BRAILLE volibris 5 mg
Maltese: volibris 5 mg
English: Monthly pregnancy tests during treatment with ambrisentan are recommended (see sections 4.3 and 4.6).
Maltese: Huma rakkommandati testijiet tat-tqala kull xahar waqt trattament b'ambrisentan (ara sezzjonijiet 4.3 u 4.6).
English: Volibris contains lactose, lecithin (soya), Allura red AC Aluminium Lake (E129) and sodium Volibris tablets contain small amounts of a sugar called lactose.
Maltese: Volibris fih lactose, lecithin (sojja), Allura red AC Aluminium Lake (E129) u sodium Il-pilloli ta' Volibris fihom ammonti żgħar ta' zokkor li jissejjaħ lactose.
English: Hepatic transaminases increased Common3
Maltese: Żieda fit-transaminases tal-fwied Komuni
English: A study of 492 patients (ambrisentan N=329, placebo N=163) with idiopathic pulmonary fibrosis (IPF), 11% of which had secondary pulmonary hypertension (WHO group 3), has been conducted, but was terminated early when it was determined that the primary efficacy endpoint could not be met (ARTEMIS-IPF study).
Maltese: Twettaq studju fuq 492 pazjent (ambrisentan N = 329, plaċebo N = 163) b'fibrożi idjopatika talpulmun (IPF), li 11% minnhom kellhom pressjoni sekondarja għolja tal-pulmun (WHO grupp 3), iżda dan kien imwaqqaf kmieni meta kien determinat li r-riżultat finali primarju tal-effikaċja ma setgħax jiġi sodisfatt (studju ARTEMIS-IPF).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/451/001 10 film-coated tablets EU/1/08/451/002 30 film-coated tablets 13.
Maltese: EU/1/08/451/001 10 pilloli miksija b'rita EU/1/08/451/002 30 pillola miksija b'rita
English: The placebo-adjusted improvement in mean 6MWD at week 12 in patients in the 10 mg group in ARIES-1 was 51.4 m (95% CI: 26.6 to 76.2; p <0.001).
Maltese: It-titjib aġġustat skont il-plaċebo fil-medja ta' 6MWD f'ġimgħa 12 f'pazjenti fil-grupp ta' 10 mg f'ARIES 1 kien ta' 51.4 m (95% CI: minn 26.6 sa 76.2; p<0.001).
English: Idiopathic or heritable PAH was the most common aetiology in the study population (56%), followed by PAH due to connective tissue disorders (37%), PAH associated with drugs and toxins (3%), corrected simple congenital heart disease (2%), and HIV (2%).
Maltese: PAH idjopatika jew li tista' tintiret kienet letjoloġija l-aktar komuni fil-popolazzjoni tal-istudju (56%), segwita minn PAH minħabba disturbi fittessut konnettiv (37%), PAH assoċjata ma' mediċini u tossini (3%), mard konġenitali sempliċi korrett (2%), u HIV (2%).
English: The effects of 12 days dosing with ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of oral contraceptive containing ethinyl estradiol (35 μg) and norethindrone (1 mg) were studied in healthy female volunteers.
Maltese: L-effetti ta' dożaġġ ta' 12-il ġurnata b'ambrisentan (10 mg darba kuljum) fuq il-farmakokinetika ta' doża waħda ta' kontraċettiv orali li fih ethinyl estradiol (35μg) u norethindrone (1 mg) ġew studjati f'voluntiera b'saħħithom nisa.
English: Hypersensitivity to the active substance, to soya, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għas-sojja jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: The Cmax and AUC(0-τ) of ambrisentan increased (48% and 121%, respectively) in the presence of multiple doses of cyclosporine A. Based on these changes, the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Maltese: Is-Cmax u AUC(0-t) ta' ambrisentan żdiedu (b'48% u 121% rispettivament) fil-preżenza ta' dożi multipli ta' cyclosporine A.
English: Uncommon3
Maltese: ANNESS III
English: The requirements for submission of periodic safety update 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: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà 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 kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini..
English: Multiple doses of ambrisentan resulted in slight increases in digoxin AUC0-last and trough concentrations, and a 29% increase in digoxin Cmax.
Maltese: Dożi ripetuti ta' ambrisentan wasslu għal żidiet żgħar flAUC0-last ta'digoxin u konċentrazzjonijiet baxxi, u żieda ta' 29% ta' digoxin Cmax.
English: 3 Data derived from routine pharmacovigilance surveillance and frequencies based on placebocontrolled clinical trial experience.
Maltese: Dejta derivata minn farmakoviġilanza ta' rutina u frekwenzi bbażati fuq esperjenza minn prova klinika kkontrollata bil-plaċebo.
English: The primary endpoint defined for the Phase 3 studies was improvement in exercise capacity assessed by change from baseline in 6 minute walk distance (6MWD) at 12 weeks.
Maltese: L-endpoint primarju definit fl-istudji Fażi 3 kien titjib fil-kapaċità ta' eżerċizzju assessjata permezz ta' bidla mil-linja bażi f'mixjiet ta' 6 minuti (6MWD) fi 12-il ġimgħa.
English: Systemic exposure to ambrisentan in male rats at this dose (based on steady-state AUC) was 6-fold that achieved at the 10 mg/day clinical dose.
Maltese: L-esponiment sistemiku għal ambrisentan fil-firien irġiel b'din id-doża (ibbażat fuq l-AUC fi stat fiss) kien ta' 6 darbiet dak miksub bid-doża klinika ta' 10 mg/kuljum.
English: Volibris tablets contain less than 1 mmol sodium (23 mg), which is essentially ‘sodium-free'.
Maltese: Il-pilloli ta' Volibris fihom inqas minn 1 mmol sodium (23 mg), jiġifieri essenzjalment huma “mingħajr sodium”.
English: The mean decreases in systolic and diastolic blood pressures persisted for up to 4 years of treatment with ambrisentan in the long term open label ARIES E study.
Maltese: It-tnaqqis medju filpressjoni sistolika u dijastolika ppersista sa 4 snin ta' trattament b'ambrisentan fl-istudju open-label fit-tul, ARIES E.
English: The median double-blind treatment duration for combination therapy was greater than 1.5 years.
Maltese: It-tul medjan tat-trattament double-blind għatterapija ta' kombinazzjoni kien ta' aktar minn 1.5 snin.
English: In the ARIES-E open label long term extension study, the 2 year risk of developing serum aminotransferase elevations >3xULN in patients treated with ambrisentan was 3.9%.
Maltese: Fl-istudju open-label ta' estensjoni fit-tul, ARIES E, irriskju ta' sentejn għall-iżvilupp ta' elevazzjonijiet ta' aminotransferase fis-serum ta' >3xULN f'pazjenti ttrattati b'ambrisentan kien ta' 3.9%.
English: 1 See section ‘Description of selected adverse reactions'.
Maltese: NR - mhux rapportata Ara sezzjoni ‘Deskrizzjoni ta' reazzjonijiet avversi magħżula'.
English: • The selectivity of ambrisentan for the ETA over the ETB receptor is expected to retain ETB receptor mediated production of the vasodilators nitric oxide and prostacyclin.
Maltese: • Is-selettività ta' ambrisentan għal ETA fuq ir-riċettur ETB hija mistennija li żżomm ilproduzzjoni ta' vażodilataturi bħal nitric oxide u prostacyclin li tiġi medjata minn ETB.
English: Combination with tadalafil
Maltese: Kombinazzjoni ma' tadalafil (AMBITION)
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 5.2).
Maltese: Pazjenti fuq terapija ta' ambrisentan għandhom jiġu ssorveljati mill-qrib meta jinbeda trattament b'rifampicin (ara sezzjonijiet 4.4 u 5.2).
English: Each tablet contains approximately 95 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.11 mg of Allura red AC Aluminium Lake (E129).
Maltese: Kull pillola fiha madwar 95 mg ta' lactose (bħala monohydrate), madwar 0.25 mg ta' lecithin (sojja) (E322) u madwar 0.11 mg ta' Allura red AC Aluminium Lake (E129).
English: The efficacy and safety of ambrisentan when co-administered with other treatments for PAH (e.g. prostanoids and soluble guanylate cyclase stimulators) has not been specifically studied in controlled clinical trials in PAH patients (see section 5.1).
Maltese: L-effikaċja u s-sigurtà ta' ambrisentan meta jingħata flimkien ma' trattament ieħor għall-PAH (eż. prostanoids u stimulaturi ta' guanylate cyclase li jdubu) ma ġewx studjati speċifikament fi provi kliniċi kkontrollati f'pazjenti b'PAH (ara sezzjoni 5.1).
English: → Contact your doctor before taking Volibris.
Maltese: Mediċini oħra u Volibris
English: Each tablet contains approximately 90 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.45 mg of Allura red AC Aluminium Lake (E129).
Maltese: Kull pillola fiha madwar 90 mg ta' lactose (bħala monohydrate), madwar 0.25 mg ta' lecithin (sojja) (E322) u madwar 0.45 mg ta' Allura red AC Aluminium Lake (E129).
English: Volibris 10 mg film-coated tablets
Maltese: Volibris 10 mg pilloli ambrisentan
English: Pale-pink, square, convex, film-coated tablet with “GS” debossed on one side and “K2C” on the other side.
Maltese: Pillola miksija b'rita, roża ċar, kwadra, konvessa, b'"GS" imnaqqxa fuq naħa waħda u "K2C" fuq innaħa l-oħra.
English: Volibris tablets contain a colouring called Allura red AC Aluminium Lake (E129) which can cause allergic reactions (see section 4).
Maltese: Il-pilloli ta' Volibris fihom is-sustanza li tagħti l-kulur Allura red AC Aluminium Lake (E129), li tista' tikkawża reazzjonijiet allerġiċi (ara sezzjoni 4).
English: Volibris 5 mg film-coated tablets
Maltese: Volibris 5 mg pilloli ambrisentan
English: Volibris 5 mg film-coated tablet (tablet) is a pale pink, square, convex tablet engraved with ‘GS' on one face and ‘K2C' on the other.
Maltese: Il-pillola miksija b'rita ta' Volibris 5 mg (pillola) hija roża ċar, kwadra, u konvessa b"GS' imnaqqxa fuq naħa waħda u ‘K2C' fuq in-naħa l-oħra.
English: The clinical status of the patient and the adverse reaction profile of ambrisentan (such as hypotension, dizziness, asthenia, fatigue) should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8).
Maltese: L-istat kliniku tal-pazjent u l-profil tar-reazzjonijiet avversi ta' ambrisentan (bħal pressjoni baxxa, sturdament, astenja, għeja) għandu jittieħed f'kunsiderazzjoni meta tiġi kkunsidrata l-ħila tal-pazjent li jwettaq kompiti li jeħtieġu ġudizzju u ħila motorja jew konjittiva (ara sezzjoni 4.8) .
English: The main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile and therefore hepatic impairment might be expected to increase exposure (Cmax and AUC) of ambrisentan.
Maltese: Billi ambrisentan jiġi metabolizzat primarjament b'glukoronidazzjoni u ossidazzjoni u wara jiġi eliminat fil-bili, tistenna li indeboliment tal-fwied jista' jżid l-espożizzjoni (Cmax u l-AUC) ta' ambrisentan.
English: Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension (see section
Maltese: Fibrożi idjopatika tal-pulmun (IPF), bi jew mingħajr pressjoni sekondarja pulmonari għolja (ara sezzjoni 5.1).
English: Therefore at concentrations observed in the plasma (approximately 4% relative to parent ambrisentan), 4-hydroxymethyl ambrisentan is not expected to contribute to pharmacological activity of ambrisentan.
Maltese: Għaldaqstant f'konċentrazzjonijiet osservati fil-plażma (madwar 4% relatati ma' ambrisentan mhux mibdul), 4-hydroxymethyl ambrisentan mhux mistenni li jikkontribwixxi għal attività farmakoloġika ta' ambrisentan.
English: In juvenile rats administered ambrisentan orally once daily during postnatal day 7 to 26, 36 or 62, a decrease in brain weight (−3% to -8%) with no morphologic or neurobehavioral changes occurred after breathing sounds, apnoea and hypoxia were observed.
Maltese: F'firien żgħar li ngħataw ambrisentan mill-ħalq darba kuljum waqt jum ta' wara t-twelid 7 sa 26, 36 jew 62, seħħ tnaqqis fil-piż tal-moħħ (−3% sa -8%) bl-ebda tibdil morfoloġiku jew fl-imġiba tal-moħħ wara li ġew osservati ħsejjes mat-teħid tan-nifs, apnea u ipoksja.
English: These changes in exposure to ethinyl estradiol or norethindrone were small and are unlikely to be clinically significant (see section 4.5).
Maltese: Dan ittibdil fl-espożizzjoni ta' ethinyl estradiol u norethindrone kien wieħed żgħir u għalhekk probabbilment mhux ta' rilevanza klinika (ara sezzjoni 4.5).
English: Marketing Authorisation Holder GlaxoSmithKline (Ireland) Limited 12 Riverwalk
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq GlaxoSmithKline (Ireland) Limited 12 Riverwalk
English: Therefore ambrisentan must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (>3xULN); see sections 4.3 and 4.4).
Maltese: Għalhekk ambrisentan m'għandux jinbeda f'pazjenti b'indeboliment sever tal-fwied, jew livell għoli b'mod sinifikattiv klinikament ta' aminotransferases tal-fwied (aktar minn 3 darbiet l-Għola Limitu tan-Normal (>3xULN); (ara s-sezzjonijiet 4.3 u 4.4).