FrancophonIA/ELRC3.0 huggingface dataset:
English: Teratogenicity is a suspected class effect of ERAs.
Maltese: Teratoġeniċità hija effett suspettat ta' klassi ta' ERAs.
English: How to store Ambrisentan Mylan
Maltese: X'fih Ambrisentan Mylan
English: Palpitation
Maltese: Palpitazzjoni
English: If you take cyclosporine A, do not take more than one 5 mg tablet of Ambrisentan Mylan once a day.
Maltese: Jekk tieħu cyclosporine A, tieħux aktar minn pillola ta' 5 mg ta' Ambrisentan Mylan darba kuljum.
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 filbili, tistenna li indeboliment tal-fwied jista' jżid l-espożizzjoni (Cmax u l-AUC) ta' ambrisentan.
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: Ambrisentan Mylan is not recommended for children and adolescents aged under 18 years as the safety and effectiveness is not known in this age group.
Maltese: Ambrisentan Mylan mhux irrakkomandat għal tfal u adolexxenti b'età inqas minn 18-il sena peress li s-sigurtà u l-effettività mhux magħrufa f'dan il-grupp ta' età.
English: Each tablet contains approximately 52 mg of lactose and 20 micrograms of Allura red AC Aluminium lake
Maltese: Kull pillola fiha madwar 52 mg ta' lactose u 20 mikrogrammi ta' Allura red AC Aluminium Lake Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics and pharmacodynamics of a single dose of warfarin (25 mg), as measured by PT and INR, were investigated in 20 healthy volunteers.
Maltese: L-effetti ta' ambrisentan fi stat fiss (10 mg darba kuljum) fuq il-farmakokinetika u l-farmakodinamika ta' doża waħda ta' warfarin (25 mg) kif imkejla b'PT u INR ġew investigati fuq 20 voluntier b'saħħtu.
English: PVC/PVdC blisters
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Pharmacotherapeutic group: Anti-hypertensives, other anti-hypertensives, ATC code: C02KX02
Maltese: Mediċini li jbaxxu l-pressjoni, mediċini oħra li jbaxxu l-pressjoni, Kodiċi ATC:
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' >3× ULN f'pazjenti kkurati b'ambrisentan kien ta' 3.9%.
English: The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of tadalafil, and the effects of steady-state tadalafil (40 mg once daily) on the pharmacokinetics of a single dose of ambrisentan were studied in 23 healthy volunteers.
Maltese: L-effetti ta' ambrisentan meta jingħata fi stat fiss (10 mg darba kuljum) fuq il-farmakokinetika ta' doża waħda ta' tadalafil, u l-effetti ta' tadalafil fi stat fiss (40mg darba kuljum) fuq il-farmakokinetika ta' doża waħda ta' ambrisentan ġew studjati fi 23 voluntier b'saħħtu.
English: The cumulative incidence of serum aminotransferase abnormalities >3xULN in all Phase 2 and 3 studies (including respective open label extensions) was 17 of 483 subjects over a mean exposure duration of 79.5 weeks.
Maltese: L-inċidenza kumulattiva ta' anormalitajiet ta' aminotransferase fis-serum >3× ULN fl-istudji kollha f'Fażi 2 u 3 (li jinkludu estensjonijiet open label rispettivi) kienu 17 minn 483 individwu matul medja ta' espożizzjoni ta' 79.5 ġimgħa.
English: Ambrisentan Mylan is indicated for the 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 f'kura ta' kombinazzjoni (ara sezzjoni 5.1).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
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 biex jiġu ppreżentati 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 kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Ambrisentan monotherapy
Maltese: Monoterapija ta' Ambrisentan
English: The higher dose (10 mg) was associated with a higher incidence of these adverse reactions, and peripheral oedema tended to be more severe in patients ≥65 years in short-term clinical studies (see section 4.4).
Maltese: L-aktar doża għolja (10 mg) kienet assoċjata ma' inċidenza ogħla ta' dawn ir-reazzjonijiet avversi, u edima periferali kellha tendenza li tkun aktar severa f'pazjenti ta' ≥65 sena fi studji kliniċi fuq perjodu ta' żmien qasir (ara sezzjoni 4.4).
English: The effects of acute and repeat dosing of rifampicin (600 mg once daily) on the steady-state pharmacokinetics of ambrisentan (10 mg once daily) were studied in healthy volunteers.
Maltese: L-effetti ta' dożaġġ akut u ripetut ta' rifampicin (600 mg darba kuljun) fuq il-farmakokinetika fi stat fiss ta' ambrisentan (10 mg darba kuljum) ġew studjati f'voluntiera b'saħħithom.
English: The main primary endpoints of this study were the incidence and severity of adverse events associated with long-term exposure to ambrisentan, including serum LFTs.
Maltese: Ir-riżultati finali primarji ewlenin ta' dan l-istudju kienu l-inċidenza u s-severità ta' avvenimenti avversi assoċjati ma' esponiment fit-tul għal ambrisentan inkluż LFTs tas-serum.
English: Efficacy of combination therapy on the primary endpoint was consistent on the comparison to individual monotherapy and across the subgroups of age, ethnic origin, geographical region, aetiology (iPAH/hPAH and PAH-CTD).
Maltese: L-effikaċja tat-terapija kombinata fuq il-punt ta' tmiem primarju kienet konsistenti fit-tqabbil għall-monoterapija individwali u fis-sottogruppi ta' etajiet, oriġini etnika, reġjun ġeografiku, etjoloġija (iPAH/hPAH u PAH-CTD). L-effett kien sinifikanti kemm għall-pazjenti FC II kif ukoll dawk FC III.
English: The treatment effect was driven by a 63% reduction in hospitalisations on combination therapy, was established early and was sustained.
Maltese: L-effett tat-terapija kien immexxi minn tnaqqis ta' 63% f'rikoveri l-isptar fuq terapija kombinata, kien stabbilit fi stadju bikri u nżamm.
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' kura oħra 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: When used in combination with tadalafil, patients were initiated with 5 mg ambrisentan and 20 mg tadalafil.
Maltese: Meta użat f'kombinazzjoni ma' tadalafil, il-pazjenti nbdew b'5 mg ambrisentan u b'20 mg tadalafil.
English: Steady-state administration of ketoconazole (a strong inhibitor of CYP3A4) did not result in a clinically significant increase in exposure to ambrisentan (see section 5.2).
Maltese: L-għoti ta' ketoconazole (inibitur qawwi ta' CYP3A4) fi stat fiss ma rriżultax f'żieda klinikament sinifikanti fl-esponiment għal ambrisentan (ara sezzjoni 5.2).
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 il-produzzjoni ta' vażodilataturi bħal nitric oxide u prostacyclin li tiġi medjata minn ETB.
English: Two randomised, double-blind, multi-centre, placebo controlled, Phase 3 pivotal studies were conducted (ARIES-1 and 2).
Maltese: Saru żewġ studji pivitali (ARIES 1 u 2), ta' Fażi 3, ikkontrollati bil-plaċebo, f'ħafna ċentri, double blind u randomised.
English: No specific antidote is available.
Maltese: Ma hemmx antidot speċifiku disponibbli.
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: Co-administration of ambrisentan with a phosphodiesterase inhibitor, either sildenafil or tadalafil (both substrates of CYP3A4) in healthy volunteers did not significantly affect the pharmacokinetics of the phosphodiesterase inhibitor or ambrisentan (see section 5.2).
Maltese: It-teħid flimkien ta' ambrisentan ma' inibitur ta' phosphodiesterase, jew sildenafil jew tadalafil (ittnejn substrati ta' CYP3A4) f'voluntiera b'saħħithom m'affettwatx b'mod sinifikattiv ilfarmakokinetika tal-inibitur ta' phosphodiesterase jew ambrisentan (ara sezzjoni 5.2).
English: Each tablet contains 5 mg of ambrisentan.
Maltese: Kull pillola fiha 5 mg 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: Each tablet contains 10 mg ambrisentan
Maltese: Kull pillola fiha 10 mg ta' ambrisentan
English: Ambrisentan Mylan 10 mg film-coated tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Maltese: Il-pilloli miksija b'rita ta' 10 mg ta' Ambrisentan Mylan fihom anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Ambrisentan Mylan 5 mg film-coated tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Maltese: Il-pilloli miksija b'rita ta' 5 mg ta' Ambrisentan Mylan fihom anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: These effects occurred at exposures approximately 1.8 to 7 times human paediatric exposures at 10 mg (age 9 to 15 years), based on AUC.
Maltese: Dawn l-effetti seħħew f'esponimenti ta' madwar 1.8 sa 7 darbiet l-esponimenti pedjatriċi fil-bniedem b'10 mg (età 9 sa 15-il sena), abbażi tal-AUC.
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 it-tibdil flespożizzjoni ta' ethinyl estradiol u norethindrone kien wieħed żgħir u għalhekk probabbilment mhux ta' rilevanza klinika (ara sezzjoni 4.5).
English: • dizziness
Maltese: • flissjoni
English: The effects of repeat dosing of ambrisentan (10 mg) on the pharmacokinetics of single dose digoxin were studied in 15 healthy volunteers.
Maltese: L-effetti ta' dożi ripetuti ta' ambrisentan (10 mg) fuq il-farmakokinetika ta' doża waħda ta' digoxin ġew studjati fuq 15-il voluntier b'saħħtu.
English: Ambrisentan Mylan 10 mg film-coated tablets contain the azo-colouring agent Allura red AC Aluminium Lake (E129), which may cause allergic reactions.
Maltese: Il-pilloli miksija b'rita ta' 10 mg ta' Ambrisentan Mylan fihom is-sustanza azo li tagħti l-kulur Allura red AC Aluminium Lake (E129), li tista' tikkawża reazzjonijiet allerġiċi.
English: Dizziness
Maltese: Nasofarinġite
English: In male rats, there were no effects of ambrisentan on sperm motility at all doses tested (up to 300 mg/kg/day).
Maltese: Fil-firien irġiel, ambrisentan ma kellu l-ebda effetti fuq il-motilità talisperma f'kull doża ttestjata (sa 300 mg/kg/jum).
English: Ambrisentan Mylan 5 mg film-coated tablets contain the azo-colouring agent Allura red AC Aluminium Lake (E129), which may cause allergic reactions.
Maltese: Il-pilloli miksija b'rita ta' 5 mg ta' Ambrisentan Mylan fihom is-sustanza azo li tagħti l-kulur Allura red AC Aluminium Lake (E129), li tista' tikkawża reazzjonijiet allerġiċi.
English: Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor.
Maltese: Ambrisentan huwa attiv meta jittieħed mill-ħalq, tal-klassi ta' aċidi propanoiċi u ERA selettiv għarriċettur ta' endotelina A (ETA).
English: • flushing (redness of the skin)
Maltese: • tirremetti (rimettar)
English: The primary analysis was combination group vs. pooled monotherapy groups.
Maltese: L-analiżi primarja kienet tal-grupp ta' kombinazzjoni kontra l-gruppi ta' monoterapija miġbura.
English: Ambrisentan Mylan 5 mg film-coated tablets ambrisentan
Maltese: Ambrisentan Mylan 5 mg pilloli miksija b'rita ambrisentan
English: Women receiving ambrisentan must be advised of the risk of foetal harm and alternative therapy initiated if pregnancy occurs (see sections 4.3, 4.4 and 5.3).
Maltese: Nisa li jkunu fuq ambrisentan għandhom jingħataw parir fuq ir-riskju ta' ħsara lil fetu u jekk ikun hemm tqala għandha tinbeda kura oħra (ara s-sezzjonijiet 4.3, 4.4 u 5.3).
English: Pack sizes of 30 film-coated tablets and unit dose blisters of 30x1 film-coated tablets Not all pack sizes may be marketed.
Maltese: Daqs tal-pakkett ta' 30 pillola miksija b'rita u b'folji ta' doża waħda ta' 30x1 pillola miksija b'rita Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Eye disorders Blurred vision, visual impairment
Maltese: Disturbi fl-għajnejn Vista mċajpra, indeboliment viżiv Mhux magħruf
English: NR - not reported
Maltese: NR - mhux rapportata
English: The MAH will agree the distribution plan with the National Competent Authorities before the product launch in each territory and will ensure that all patients taking Ambrisentan Mylan have been provided with the relevant educational materials.
Maltese: L-MAH se jiftiehem il-pjan ta' distribuzzjoni mal-Awtoritajiet Kompetenti Nazzjonali qabel it-tnedija tal-prodott f'kull territorju u se jiżgura li l-pazjenti kollha li jieħdu Ambrisentan Mylan ikunu ġew ipprovduti bil-materjali edukattivi rilevanti:
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: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu 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: The distribution of ambrisentan into red blood cells is low, with a mean blood: plasma ratio of 0.57 and 0.61 in males and females, respectively.
Maltese: Id-distribuzzjoni ta' ambrisentan f'ċambriseħomor tad-demm hi baxxa, b'medja proporzjonali demm: plażma ta' 0.57 u 0.61 fi rġielu nisa rispettivament.
English: Ambrisentan did not have any clinically relevant effects on the pharmacokinetics or pharmacodynamics of warfarin.
Maltese: Ambrisentan ma kellu l-ebda effetti ta' rilevanza klinika fuq il-farmakokinetika jew ilfarmakodinamika ta' warfarin.
English: Routine pharmacovigilance data are also presented.
Maltese: Dejta ta' farmakoviġilanza ta' rutina hija ppreżentata wkoll.
English: The frequency of decreased haemoglobin (anaemia) was higher with 10 mg ambrisentan.
Maltese: Il-frekwenza ta' nuqqas fl-emoglobina (anemija) dehret aktar b'10 mg ta' ambrisentan.
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 (>3× ULN); (ara s-sezzjonijiet 4.3 u 4.4).
English: Ambrisentan Mylan 10 mg film-coated tablets ambrisentan
Maltese: Ambrisentan Mylan 10 mg pilloli miksija b'rita ambrisentan
English: Secondary endpoints were tested:
Maltese: Il-punti ta' tmiem sekondarji kienu ttestjati:
English: Co-administration of rifampicin (an inhibitor of Organic Anion Transporting Polypeptide [OATP], a strong inducer of CYP3A and 2C19, and inducer of P-gp and uridine-diphosphoglucuronosyltransferases [UGTs]) was associated with a transient (approximately 2-fold) increase in ambrisentan exposure following initial doses in healthy volunteers.
Maltese: L-għoti flimkien ta' rifampicin (inibitur tal-Polipeptida tat-Trasport tal-Anjoni Organiċi [OATP], induttur qawwi ta' CYP3A u 2C19, u induttur ta' P-gp u ta' uridine-diphosphoglucuronosyltransferases [UGTs]) kien assoċjat ma' żieda (bejn wieħed u ieħor ta' darbtejn aktar) temporanja fl-esponiment għal ambrisentan wara dożi inizjali f'voluntiera f'saħħithom.
English: Clinical efficacy in combination with tadalafil
Maltese: Effikaċja klinika f'kombinazzjoni ma' tadalafil
English: Supportive comparisons of combination therapy group vs. the individual monotherapy groups were also made.
Maltese: Twettqu wkoll paraguni ta' appoġġ tal-grupp ta' terapija ta' kombinazzjoni meta mqabbel mal-gruppi ta' monoterapija individwali.
English: • dark-coloured urine
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: Patients with pre-existent hepatic disease (cirrhosis or clinically significantly elevated aminotransferases) and patients using other targeted therapy for PAH (e.g. prostanoids) were excluded.
Maltese: Kienu esklużi pazjenti li diġà jbatu minn mard tal-fwied (ċirrożi jew żieda klinikament sinifikanti ta' aminotransferases) u pazjenti li jużaw terapija immirata oħra għal PAH (e.ż. prostanoids).
English: It is used to treat pulmonary arterial hypertension (PAH) in adults.
Maltese: Huwa jintuża biex jikkura pazjenti b'ipertensjoni arterjali tal-pulmun (PAH) fl-adulti.
English: The effect of ambrisentan on male human fertility is not known.
Maltese: Mhux magħruf l-effett ta' ambrisentan fuq il-fertilità tal-uman maskil.
English: Tadalafil monotherapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: In dogs, slight inflammatory responses were observed following chronic high dose administration of ambrisentan at exposures greater than 20-fold that observed in patients.
Maltese: Fil-klieb, ġew osservati risponsi infjammatorji minimi wara teħid kroniku ta' doża għolja ta' ambrisentan f'esponimenti ta' aktar minn 20 darba osservati fil-pazjenti.
English: However, the magnitude of effect of bilirubin is modest (compared to the typical patient with a bilirubin of 0.6 mg/dl, a patient with an elevated bilirubin of 4.5 mg/dl would have approximately 30% lower oral clearance of ambrisentan).
Maltese: Madankollu, l-effett ta' bilirubin kien ta' kobor modest (meta mqabbel ma' pazjent tipiku b'bilirubin ta' 0.6 mg/dl, pazjent b'bilirubin għoli ta' 4.5mg/dl kien ikollu tneħħija ta' madwar 30% inqas ta' ambrisentan).
English: Blood and lymphatic system disorders Anaemia (decreased haemoglobin, decreased haematocrit)
Maltese: Disturbi tad-demm u tas-sistema limfatika Anemija (nuqqas fl-emoglobina, nuqqas fil-ematokrit)
English: Liver function abnormalities have been associated with PAH.
Maltese: Anormalitajiet tal-funzjoni tal-fwied ġew assoċjati ma' PAH.
English: In healthy volunteers, single doses of 50 and 100 mg (5 to 10 times the maximum recommended dose) were associated with headache, flushing, dizziness, nausea and nasal congestion.
Maltese: F'voluntiera b'saħħithom, dożi waħedhom ta' 50 u 100 mg (5 sa 10 darbiet id-doża massima rakkommandata) kienu assoċjati ma' wġigħ ta' ras, fawra, sturdament, dardir u sadda fl-imnieħer.
English: Each tablet contains approximately 26 mg of lactose and 10 micrograms of Allura red AC Aluminium lake
Maltese: Kull pillola fiha madwar 26 mg ta' lactose u 10 mikrogrammi ta' Allura red AC Aluminium Lake Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: The combined mean exposure was approximately 145 ± 80 weeks, and the maximum exposure was approximately 295 weeks.
Maltese: L-esponiment medju kkombinat kien madwar 145 ±80 ġimgħat, u l-esponiment massimu kien madwar 295 ġimgħa.
English: • ringing in the ears (tinnitus) only when taking the combination treatment.
Maltese: • tisfir fil-widnejn (tinnitus) meta tieħu l-kura kombinata.
English: CI: 1.05, 2.32
Maltese: HR: 0.502
English: No dose adjustment is required in patients over the age of 65 (see section 5.2).
Maltese: Ma hemmx għalfejn aġġustament fid-doża f'pazjenti ‘il fuq minn 65 sena (ara s-sezzjoni 5.2).
English: Administration of ambrisentan to female rats from late-pregnancy through lactation caused adverse events on maternal behaviour, reduced pup survival and impairment of the reproductive capability of the offspring (with observation of small testes at necropsy), at exposure 3-fold the AUC at the maximum recommended human dose.
Maltese: L-għoti ta' ambrisentan lil firien nisa mill-aħħar tat-tqala sa kemm jibdew ireddgħu ikkaġuna diversi effetti mhux mixtieqa fuq l-imġieba materna, tnaqqis fin-numru ta' żgħar li baqgħu ħajjin u kkawża indeboliment tal-kapaċità riproddutiva fil-frieħ (bl-osservazzjoni ta' testikoli żgħar f'nekroskopija), b'esponiment ta' 3-darbiet aktar mill-AUC bl-akbar doża rrakkomandata għall-bniedem.
English: In a population pharmacokinetic analysis, creatinine clearance was found to be a statistically significant covariate affecting the oral clearance of ambrisentan.
Maltese: F'analiżi farmakokinetika ta' popolazzjoni, it-tneħħija tal-kreatinina instabet li kienet covariate statistikament sinifikanti li taffettwa it-tneħħija mill-ħalq ta' ambrisentan.
English: Each tablet contains 5 mg ambrisentan
Maltese: Kull pillola fiha 5 mg ta' ambrisentan
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' kura b'ambrisentan fl-istudju open-label fit-tul, ARIES-E.
English: • nose bleed
Maltese: • tħossok debboli
English: Based on the results of a population pharmacokinetic analysis in healthy volunteers and patients with PAH, the pharmacokinetics of ambrisentan were not significantly influenced by gender or age (see section 4.2).
Maltese: Fuq bażi tar-riżultati minn analiżi farmakokinetika ta' popolazzjoni fuq voluntieri b'saħħithom u pazjenti b'PAH, il-farmakokinetika ta' ambrisentan ma ġietx influwenzata sostanzjalment mis-sess jew mill-età (ara sezzjoni 4.2).