FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Myozyme, alglucosidase alfa, is a copy of human alpha-glucosidase, which is produced by a method known as ‘recombinant DNA technology': the enzyme is made by a cell that has received a gene (DNA) that makes it able to produce the enzyme.
Maltese: Is-sustanza attiva f'Myozyme, alglucosidase alfa, hija kopja tal-alglucosidase alfa uman, prodotta b'metodu magħruf bħala “teknoloġija tad-DNA rikombinant”: l-enzima ssir minn ċellola li jkun irċieva ġene (DNA) li jagħmlu possibbli li jipproduċi lenzima.
English: The full EPAR for Myozyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Myozyme jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: During the studies in patients with infantile-onset Pompe disease, the most common side effects with Myozyme (seen in more than 1 patient in 10) were tachycardia (rapid heartbeat), flushing (redness), cough, tachypnoea (rapid breathing), vomiting, urticaria (itchy rash), rash, pyrexia (fever) and decreased oxygen saturation (low oxygen levels in the blood).
Maltese: Matul l-istudji f'pazjenti bil-forma infantili tal-marda ta' Pompe, l-iktar effetti sekondarji komuni b'Myozyme (li dehru f'iktar minn pazjent 1 minn kull 10) kienu takikardja (taħbit il-qalb mgħaġġel), ħmura fil-wiċċ, tqaħqiħ, takipnoea (nifs mgħaġġel), remettar, urtikarja, raxx, pireksja (deni) u inqas saturatzzjoni tal-ossiġnu (livelli baxxi ta' ossiġnu fid-demm).
English: This is a summary of the European public assessment report (EPAR) for Myozyme.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Myozyme.
English: Why has Myozyme been approved?
Maltese: Għaliex ġie approvat Myozyme?
English: Myozyme has been studied in two main studies involving a total of 39 babies and children up to the age of three and a half years with infantile-onset Pompe disease.
Maltese: Myozyme ġie studjat f'żewġ studji ewlenin li involvew 39 tarbija u tfal sal-età ta' tliet snin u nofs li jbatu mill-marda ta' Pampe bil-forma infantili.
English: Myozyme has also been compared with placebo (a dummy treatment) in one main study involving 90 patients with late-onset disease.
Maltese: Myozyme tqabbel ukoll ma' plaċebo (trattament finta) fi studju wieħed ewlieni li involva 90 pazjent bilforma tardiva tal-marda.
English: Because the number of patients with Pompe disease is low, the disease is considered ‘rare', and Myozyme was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 14 February
Maltese: Peress li n-numru ta' pazjenti li jbatu mill-marda ta' Pompe huwa wieħed baxx, il-marda hi kkunsidrata bħala ‘rari', u, fl-14 ta' Frar 2001, Myozyme ġie kklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari).
English: What is the risk associated with Myozyme?
Maltese: X'inhu r-riskju assoċjat ma' Myozyme?
English: The company that makes Myozyme is putting a plan in place to ensure that Myozyme is used safely, mainly by monitoring how patients who receive Myozyme develop antibodies, by setting up a register open to all patients with Pompe disease, and by ensuring that doctors know about the reactions that patients may have to the infusion.
Maltese: Il-kumpanija li timmanifattura Myozyme qed tħejji pjan biex tassigura li Myozyme jintuża b'mod sigur, l-aktar billi l-pazjenti li ngħataw Myozyme jiġu moniterjati sabiex ikun magħruf jekk żviluppawx antikorpi, permezz ta' twaqqif ta' reġistru miftuħ għal pazjenti kollha bil-marda ta' Pompe, u fl-istess ħin jassiguraw li t-tobba jkunu jafu fuq ir-reazzjonijiet li l-pazjenti jista' jkollhom għall-infużjoni.
English: How does Myozyme work?
Maltese: X'inhi Myozyme?
English: In contrast, only one of the 42 patients in the historical comparison group was alive at 18 months of age.
Maltese: B'kuntrast ma' dan, 42 pazjent biss fil-grupp storiku ta' tqabbil kienu ħajjin fl-età ta' 18-il xahar.
English: Myozyme is a powder that is made up into a solution for infusion (drip into a vein).
Maltese: Myozyme huwa trab li jsir soluzzjoni għall-infużjoni (dripp fil-vina).
English: Patients who receive Myozyme may develop antibodies (proteins that are produced in response to Myozyme).
Maltese: Il-pazjenti li ngħataw Myozyme jistgħu jiżviluppaw antikorpi (proteini prodotti b'rispons għal Myozyme).
English: Enzyme replacement therapy provides patients with the enzyme they are lacking; in this case, alpha-glucosidase.
Maltese: Terapija enzimatika sostituttiva tipprovdi lill-pazjenti blenzima li ma għandhomx; f'dan il-każ, alglucosidase alfa.
English: Myozyme is given as an infusion of 20 mg per kilogram body weight given once every two weeks.
Maltese: Myozyme jingħata bħala infużjoni fil-vina ta' 20 mg għal kull kg piż tal-ġisem mogħti darba kull ġimagħtejn.
English: For the full list of all side effects reported with Myozyme, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Myozyme, ara l-Fuljett ta' Tagħrif.
English: The disease can appear at birth (the ‘infantile-onset' form) but also later in life (the ‘late-onset' form).
Maltese: Il-marda tista' titfaċċa fit-twelid (il-‘forma infantili') kif ukoll iktar tard fil-ħajja (il-‘forma tardiva').
English: What is Myozyme?
Maltese: Għal xiex jintuża Myozyme?
English: What benefit has Myozyme shown during the studies?
Maltese: Liema benefiċċju wera Myozyme waqt l-istudji mwettqa?
English: The progressive build-up of glycogen causes a wide range of symptoms, including an enlarged heart, breathing difficulties and muscle weakness.
Maltese: L-akkumulazzjoni prgressiva ta' glisoġin tikkawża firxa wiesa' ta' sintomi, fosthom tkabbir fil-qalb, diffikultajiet fit-teħid tan-nifs u dgħjufija fil-muskoli.
English: If the enzyme is not present, glycogen builds up in certain tissues, particularly the muscles, including the heart and diaphragm (the main breathing muscle under the lungs).
Maltese: Jekk l-enzima ma tkunx preżenti, il-glisoġin jakkumula f'ċerti tessuti, partikolarment il-muskoli, fosthom il-qalb u d-dijaframma (il-muskoli ewlieni li permezz tiegħu nieħdu n-nifs li jinstab taħt il-pulmuni).
English: In the study of late-onset disease, patients had many of the same side effects, but they were seen less often than in studies of infantileonset disease.
Maltese: Fl-istudju tal-forma tardiva, il-pazjenti kellhom ħafna mill-istess effetti sekondarji, iżda dehru inqas spissi milli fl-istudji fil-forma infantili talmarda.
English: Very common (may effect more than 1 in 10 people) - Numbness, tingling or weakness in arms and legs (all symptoms of peripheral neuropathy)* *Can persist beyond 6 months of paclitaxel discontinuation Frequency not known (cannot be estimated from the available data): - redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 persuni) - Tnemnim, tagħrix jew dgħufija fir-riġlejn u fis-saqajn (kollha sintomi ta' newropatija periferali)* *Tista' tippersisti għal aktar minn 6 xhur minn meta jitwaqqaf paclitaxel Frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli): - ħmura u nefħa tal-wiċċ ta' idejk jew tal-qiegħ ta' saqajk li jistgħu jwasslu sabiex il-ġilda tiegħek titqaxxar
English: In addition, the introductory sentence to the table listing adverse reactions is to be amended to reflect that it includes adverse reactions from post marketing experience, as appropriate: Table X lists adverse reactions (…) observed in (a) clinical study(ies) and adverse reactions from post-marketing experience.
Maltese: Tabella X telenka r-reazzjonijiet avversi (…) osservati fi (a) studju(i) kliniċi u reazzjonijiet avversi minn esperjenza ta' wara t-tqegħid fis-suq.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for paclitaxel, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal paclitaxel, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Therefore, the SmPC of paclitaxel should be updated with the inclusion of palmar-plantar erythrodysesthesia syndrome as an ADR in section 4.8 under SOC Skin and subcutaneous tissue disorders.
Maltese: Għaldaqstant, is-SmPC ta' paclitaxel għandu jiġi aġġornat bl-inklużjoni tas-sindrome ta' ertrodisestezija ta' palmar-plantar bħala ADR fis-sezzjoni 4.8 taħt l-SOC Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda. Frekwenza ta' "mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)" hija meqjusa xierqa.
English: Based on a cumulative review of data from all the MAHs, the causal role of paclitaxel for palmarplantar erythrodysesthesia syndrome is at least a reasonable possibility.
Maltese: Abbażi ta' reviżjoni kumulattiva tad-data mill-MAHs kollha, ir-rwol kawżali ta' paclitaxel għas-sindrome ta' ertrodisestezija ta' palmar-plantar huwa għallinqas possibilità raġjonevoli.
English: Neuropathy is a known ADR with the use of paclitaxel.
Maltese: In-newropatija hija ADR magħrufa bl-użu ta' paclitaxel.
English: The following adverse reaction should be added under the SOC Skin and subcutaneous tissue disorders with a frequency “not known” (cannot be estimated from available data): “Palmar-plantar erythrodysesthesia syndrome*” *As reported in the post marketing surveillance of paclitaxel.
Maltese: Abbażi tad-data pprovduta, huwa rrakkomandat li l-informazzjoni attwali dwar in-newropatija fl-SmPC tiġi aġġornata, billi tiżdied informazzjoni li tikkonċerna newropatija persistenti wara l-waqfien ta' paclitaxel.
English: Data from published literature and administrative claims databases confirmed the persistence of neuropathy with paclitaxel exposure beyond 12 months.
Maltese: Data minn riċensjoniijet ippubblikati u minn bażijiet ta' data ta' pretensjonijiet amministrattivi kkonfermat il-persistenza ta' newropatija b'esponiment għal paclitaxel lil hinn minn 12-il xahar.
English: From the cases of palmarplantar erythrodysesthesia syndrome and symptoms received by the MAHs, there were several cases with a positive dechallenge and with a positive rechallenge.
Maltese: Mill-każijiet tas-sindrome ta' ertrodisestezija ta' palmar-plantar u sintomi rċevuti mill-MAHs, kien hemm bosta każijiet b'"dechallenge" pożittiv u b'"rechallenge" pożittiv.
English: In addition, palmar-plantar erythrodysesthesia syndrome associated with paclitaxel treatment has been reported in clinical trials and in the published literature.
Maltese: “Sindrome ta' ertrodisestezija palmar-plantar*”
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for paclitaxel the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing paclitaxel is unchanged subject to the proposed changes to the product information.
Maltese: Barra minn hekk, is-sentenza introduttorja għat-tabella li telenka r-reazzjonijiet avversi għandha tiġi emendata biex tirrifletti li tinkludi reazzjonijiet avversi minn esperjenza ta' wara t-tqegħid fis-suq, kif xieraq:
English: Further, it has been demonstrated that peripheral neuropathies can persist beyond 6 months of paclitaxel discontinuation.
Maltese: Barra minn hekk, intwera li newropatiji periferali jistgħu jippersistu għal aktar minn 6 xhur minn meta jitwaqqaf paclitaxel.
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Maltese: Is-CHMP jaqbel mal-konklużjonijiet xjentifiċi magħmula mill-PRAC.
English: Strength Pharmaceutical Form
Maltese: Numru tal-EMA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: % difference
Maltese: % differenza
English: Ambrisentan (AMBITION and ARIES-E)
Maltese: Ambrisentan (AMBITION u ARIES-E)
English: Odds ratio 1.56; 95% CI: 1.05,
Maltese: Proporzjon ta' probabbiltà 1.56; 95% CI: 1.05,
English: P-value, Log-rank test
Maltese: Valur p, Test log-rank
English: Microcrystalline cellulose (E460i) Croscarmellose sodium Magnesium stearate (E570)
Maltese: Microcrystalline cellulose (E460) Croscarmellose sodium Magnesium stearate (E570)
English: Mylan Hungary Kft, Mylan utca 1, 2900 Komárom,
Maltese: Mylan Hungary Kft, Mylan utca 1, 2900
English: McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Maltese: McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, L-Irlanda
English: Ambrisentan is a non-sulphonamide (propanoic acid) ERA.
Maltese: Ambrisentan hu ERA mhux sulphonamide (propanoic acid).
English: Poly(vinyl alcohol)(partly hydrolysed) Titanium dioxide (E171) Macrogol
Maltese: Polyvinyl alcohol (parzjalment idroliżżat) Titanium dioxide (E171) Macrogol
English: Difference and Confidence Interval p-value
Maltese: Differenza u Intervall ta' Kunfidenza valur p
English: Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Maltese: Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL, Ir-Renju Unit
English: Combination with tadalafil (AMBITION)
Maltese: Kombinazzjoni ma' tadalafil (AMBITION)
English: The mean age of all patients was 54 years (SD 15; range 18-75 years of age).
Maltese: L-età medja tal-pazjenti kollha kienet ta' 54 sena (SD 15; medda ta' 18 - 75 sena).
English: 6MWD (metres, median change)
Maltese: 6MWD (metri, bidla medjana)
English: The active substance is ambrisentan.
Maltese: Is-sustanza attiva hija ambrisentan.
English: Hazard ratio (95% CI)
Maltese: Proporzjon tal-periklu (95% CI)
English: The other ingredients are lactose, see section 2, ‘Ambrisentan Mylan contains lactose', microcrystalline cellulose (E460i), sodium croscarmellose, magnesium stearate (E570), polyvinyl alcohol part hydrolysed, titanium dioxide (E171), macrogol/PEG, talc (E553b), Allura red (E129), see section 2 ‘Ambrisentan Mylan contains Allura red (E129)', Indigo carmine (E132)
Maltese: Is-sustanzi mhux attivi l-oħra huma lactose, ara sezzjoni 2, ‘Ambrisentan Mylan fih lactose', microcrystalline cellulose (E460i), sodium croscarmellose, magnesium stearate (E570), polyvinyl alcohol parzjalment idrolizzat, titanium dioxide (E171), macrogol/PEG, talc (E553b), Allura red (E129), ara sezzjoni 2 ‘Ambrisentan Mylan fih Allura red (E129)', Indigo carmine (E132)
English: Sinusitis, rhinitis
Maltese: Sinużite, rinite
English: Ambrisentan is a potent (Ki 0.016 nM) and highly selective ETA antagonist (approximately 4000-fold more selective for ETA as compared to ETB).
Maltese: Ambrisentan huwa antagonist ETA potenti (Ki 0.016 nM) u selettiv ħafna (bejn wieħed u ieħor 4000 darba aktar selettiv għal ETA meta mqabbel ma' ETB).
English: • high temperature (fever)
Maltese: • temperatura għolja (deni)
English: Patients WHO FC at baseline was II (31%) and FC III (69%).
Maltese: Il-WHO FC talpazjenti fil-linja bażi kienet FC II (31%) u FC III (69%).
English: Contains lactose and Allura red AC Aluminium Lake (E129).
Maltese: Fih lactose u Allura red AC Aluminium Lake (E129).
English: Plasma elimination half-life in humans ranges from 13.6 to 16.5 hours.
Maltese: Il-half life tal-eliminazzjoni mill-plażma fil-bniedem tvarja minn 13.6 sa 16.5 sigħat.
English: % subjects achieving a satisfactory clinical response at week 24
Maltese: % tal-individwi li jilħqu rispons kliniku sodisfaċenti filġimgħa 24
English: Ambrisentan is primarily bound to albumin (96.5%) and to a lesser extent to alpha1-acid glycoprotein.
Maltese: Ambrisentan jintrabat primarjament mal-albumina (96.5%) u ftit anqas minn hekk mal-glikoproteina alpha 1-acid.
English: Summary of the safety profile
Maltese: Sommarju tal-profil tas- sigurtà
English: Peripheral oedema has been observed with ERAs including ambrisentan.
Maltese: Kienet osservata edima periferali b'ERAs inkluż ambrisentan.
English: Phosphodiesterase inhibitors
Maltese: Inibituri ta' phosphodiesterase
English: Ambrisentan is glucuronidated via several UGT isoenzymes (UGT1A9S, UGT2B7S and UGT1A3S) to form ambrisentan glucuronide (13%).
Maltese: Ambrisentan jiġi glukuronidat permezz ta' ħafna isoenżimi UGT (UGT1A9S, UGT2B7S u UGT1A3S) biex jifforma ambrisentan glucuronide (13%).
English: NT-proBNP (% reduction)
Maltese: Mingħajr Avveniment (%)
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: Kien hemm tnaqqis zgħir fis-Cmax u AUC(0-∞) għal ethinyl estradiol (8% u 4%, rispettivament), u żieda żgħira għal norethindrone (13% u 14%, rispettivament).
English: Idiopathic Pulmonary Fibrosis
Maltese: Fibrożi idjopatika tal-pulmun
English: ARIES-2 included 192 patients and compared ambrisentan 2.5 mg and 5 mg with placebo.
Maltese: ARIES-2 kien jinkludi 192 pazjent u pparaguna ambrisentan 2.5 mg u 5 mg ma' plaċebo.
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: Respiratory, thoracic and mediastinal disorders Epistaxis
Maltese: Disturbi respiratorji, toraċiċi, u medjastinali Epistassi
English: Ambrisentan did not have any clinically relevant effects on the pharmacokinetics of tadalafil.
Maltese: Ambrisentan ma kellux effetti klinikament rilevanti fuq il-farmakokinetika ta' tadalafil.
English: In vitro data indicate that ambrisentan at 300 μM resulted in less than 50% inhibition of UGT1A1, UGT1A6, UGT1A9, UGT2B7 (up to 30%) or of cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 (up to 25%).
Maltese: Dejta in vitro tindika li ambrisentan fi 300 μM irriżulta f'inqas minn inibizzjoni ta' 50% ta' UGT1A1, UGT1A6, UGT1A9, UGT2B7 (sa 30%) jew ta' enzimi ta' P450 ta' cytochrome 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A4 (sa 25%).
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: Il-kura b'terapija kombinata rriżultat 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: Hypersensitivity reactions (e.g. angioedema, rash, pruritus)
Maltese: Disturbi fis-sistema immuni Reazzjonijiet ta' sensittività eċċessiva (eż. anġjoedima, raxx, ħakk)
English: The majority of patients had WHO functional Class II (38.4%) or Class III (55.0%) symptoms.
Maltese: Klassi funzjonali WHO II (38.4%) jew Klassi
English: The effects of repeat dosing of cyclosporine A (100 - 150 mg twice daily) on the steady-state pharmacokinetics of ambrisentan (5 mg once daily), and the effects of repeat dosing of ambrisentan (5 mg once daily) on the steady-state pharmacokinetics of cyclosporine A (100 - 150 mg twice daily) were studied in healthy volunteers.
Maltese: L-effetti ta' dożi ripetuti ta' cyclosporine A (100 - 150 mg darbtejn kuljum) fuq il-farmakokinetika fi stat fiss ta' ambrisentan (5 mg darba kuljum), u l-effetti ta' dożi ripetuti ta' ambrisentan (5 mg darba kuljum) fuq il-farmakokinetiċi ta' cyclosporine A (100 - 150 mg darbtejn kuljum) ġew studjati f'voluntiera b'saħħithom.
English: Upper respiratory (e.g. nasal, sinus) congestion, sinusitis, nasopharyngitis, rhinitis
Maltese: Parti respiratorja ta' fuq (eż. nasali, sinus), konġestjoni, sinużite, nasofarinġite, rinite
English: The median double-blind treatment duration for combination therapy was greater than 1.5 years.
Maltese: It-tul medjan tal-kura double-blind għat-terapija ta' kombinazzjoni kien ta' aktar minn 1.5 snin.
English: No data are available (see section 5.3 regarding data available in juvenile animals).
Maltese: M'hemm l-ebda data 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 metru.
English: A slight (<10%) decrease in the percentage of morphologically normal sperms was noted at 300 mg/kg/day but not at 100 mg/kg/day (>9-fold clinical exposure at 10 mg/day).
Maltese: Tnaqqis żgħir (<10%) fil-perċentwal ta' spermi normali mill-punt morfoloġiku ġie nnutat b'doża ta' 300 mg/kg/jum iżda mhux b'doża ta' 100 mg/kg/jum (>9 darbiet l-esponiment kliniku ta' 10 mg/jum).
English: The number of patients who received concomitant ambrisentan and sildenafil in ARIES-E and AMB222 was 22 patients (5.7%) and 17 patients (47%), respectively.
Maltese: In-numru ta' pazjenti li rċevew ambrisentan u sildenafil flimkien f'ARIES E u AMB222 kien ta' 22 pazjent (5.7%) u 17-il pazjent 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)) >3× ULN (ara s-sezzjonijiet 4.2 u 4.4).
English: Ambrisentan Mylan is supplied as 5 mg and 10 mg film-coated tablets in packs of 30 tablets and unit dose blister packs of 30x1 tablets.
Maltese: Ambrisentan Mylan issibu bħala pilloli miksija b'rita ta' 5 mg u 10 mg f'pakketti ta' 30 pillola u pakketti ta' folji b'doża waħda ta' 30x1 pillola.
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: Kura b'ambrisentan wasslet għal titjib statistikament sinifikanti fl-Indiċi tad-Dispnea 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: 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: 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 u 10 mg ambrisentan fil-ġimgħa 8, sakemm ma kienx hemm kwistjonijiet ta' tollerabilità.
English: This may be due to the inhibition by cyclosporine A of transporters and metabolic enzymes involved in the pharmacokinetics of ambrisentan.
Maltese: Dan jista' jkun minħabba l-inibizzjoni kkawżata minn cyclosporine A ta' trasportaturi u ta' enzimi metaboliċi involuti fil-farmakokinetika ta' ambrisentan.
English: In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including Pgp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and NTCP.
Maltese: In vitro, ambrisentan ma għandu ebda effett inibitorju fuq ittrasportaturi umani f'konċentrazzjonijiet klinikament relevanti, inkluż Pgp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 u NTCP.
English: The potential for ambrisentan to induce CYP3A4 activity was explored in healthy volunteers with results suggesting a lack of inductive effect of ambrisentan on the CYP3A4 isoenzyme.
Maltese: Il-potenzjal li ambrisentan jinduċi attività f'CYP3A4 ġiet esplorata f'voluntieri b'saħħithom b'riżultati li jissuġġerixxu nuqqas ta' effett induttiv ta' ambrisentan fuq l-isoenzyme CYP3A4.
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.