FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Oxidative metabolism catalysed mainly by CYP2C8 and to a smaller extent by CYP3A4 leads to the formation of hydroxylated and dealkylated products.
Maltese: Metaboliżmu ossidattiv ikkatalizzat fil-biċċa l-kbira minn CYP2C8 u b'mod inqas permezz ta' CYP3A4 iwassal għall-formazzjoni ta' prodotti hydroxylated u dealkylated.
English: Dosage Adjustment with Co-administration of Moderate CYP2C8 Inhibitors
Maltese: Aġġustament fid-Dożaġġ mal-Għoti Flimkien ta' Inibituri Moderati ta' CYP2C8
English: Uptravi 400 microgram, 600 microgram, 800 microgram, 1,000 microgram, 1,200 microgram, 1,400 microgram, and 1,600 microgram film-coated tablets are supplied in blister packs of 60 tablets.
Maltese: Uptravi 400 mikrogramma, 600 mikrogramma, 800 mikrogramma, 1,000 mikrogramma, 1,200 mikrogramma, 1,400 mikrogramma, u 1,600 mikrogramma pilloli miksija b'rita huma fornuti f'pakketti b'folji ta' 60 pillola.
English: Uptravi is a medicine that contains the active substance selexipag.
Maltese: Uptravi huwa mediċina li fih is-sustanza attiva selexipag.
English: In the Phase 3 placebo-controlled study in patients with PAH, a transient increase in mean heart rate of 3-4 bpm at 2-4 hours post-dose was observed.
Maltese: Fl-istudju ta' Fażi 3 ikkontrollat bil-plaċebo f'pazjenti b'PAH, kienet osservata żieda temporanja firrata medja tal-qalb ta' 3-4 bpm, 2-4 sigħat wara d-doża.
English: Uptravi 200 microgram tablets Uptravi 400 microgram tablets Uptravi 600 microgram tablets Uptravi 800 microgram tablets Uptravi 1,000 microgram tablets Uptravi 1,200 microgram tablets Uptravi 1,400 microgram tablets Uptravi 1,600 microgram tablets selexipag
Maltese: Uptravi 200 mikrogramma pilloli Uptravi 400 mikrogramma pilloli Uptravi 600 mikrogramma pilloli Uptravi 800 mikrogramma pilloli Uptravi 1,000 mikrogramma pilloli Uptravi 1,200 mikrogramma pilloli Uptravi 1,400 mikrogramma pilloli Uptravi 1,600 mikrogramma pilloli selexipag
English: Fertility
Maltese: Belġju
English: Stimulation of the IP receptor by selexipag and the active metabolite leads to vasodilatory as well as anti-proliferative and anti-fibrotic effects.
Maltese: L-istimulazzjoni tar-riċettur IP minn selexipag u mill-metabolit attiv twassal għal vażodilatazzjoni kif ukoll għal effetti anti-proliferattivi u anti-fibrotiċi.
English: There is limited experience with Uptravi in patients older than 75 years.
Maltese: Hemm esperjenza limitata b'Uptravi f'pazjenti ta' aktar minn 75 sena.
English: Uptravi 200 microgram film-coated tablets selexipag
Maltese: Uptravi 200 mikrogramma pilloli miksija b'rita selexipag
English: The primary study endpoint was the time to first occurrence of a morbidity or mortality event up to end of treatment, defined as a composite of death (all causes); or hospitalisation for PAH; or progression of PAH resulting in need for lung transplantation or balloon atrial septostomy; or initiation of parenteral prostanoid therapy or chronic oxygen therapy; or other disease-progression events (patients in WHO FC II or III at baseline) confirmed by a decrease in 6-minute walk distance (6MWD) from baseline (≥ 15%) and worsening of WHO FC or (patients in WHO FC III or IV at baseline) confirmed by a decrease in 6MWD from baseline (≥ 15%) and need for additional
Maltese: Il-punt finali primarju tal-istudju kien iż-żmien sal-ewwel okkorrenza ta' avveniment ta' morbidità jew mortalità sat-tmiem tat-trattament, definit bħala kompost ta' mewt (il-kawżi kollha); jew dħul l-isptar minħabba PAH; jew progressjoni ta' PAH li twassal għall-ħtieġa ta' trapjant tal-pulmun jew septostomija tal-atriju b'bużżieqa; jew bidu ta' terapija bi prostanoid parenterali jew terapija kronika b'ossiġnu; jew avvenimenti oħra ta' progressjoni tal-marda (pazjenti f'WHO FC II jew III fil-linja bażi) ikkonfermati minn tnaqqis fid-distanza ta' mixja ta' 6 minuti (6MWD - 6-minute walk distance)
English: The dose was increased at weekly intervals by increments of 200 micrograms given twice daily to determine the individualised maintenance dose (200-1,600 micrograms twice daily).
Maltese: Id-doża kienet miżjuda f'intervalli ta' kull ġimgħa b'inkrementi ta' 200 mikrogramma mogħtija darbtejn kuljum biex tiġi determinata d-doża ta' manteniment individwalizzata (200-1,600 mikrogramma darbtejn kuljum).
English: Selexipag and its active metabolite are highly bound to plasma proteins (approximately 99% in total and to the same extent to albumin and alpha1-acid glycoprotein).
Maltese: b'kollox u bl-istess mod mal-albumina u alpha1-acid glycoprotein).
English: Rash Urticaria Erythema
Maltese: Tnaqqis assolut tarriskju
English: A 1.4- to 1.7-fold increase in exposure (maximum plasma concentration and area under the plasma concentration-time curve) to selexipag and its active metabolite was observed in subjects with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
Maltese: 1.4 sa 1.7 darbiet fl-esponiment (konċentrazzjoni massima fil-plażma u erja taħt il-kurva talkonċentrazzjoni fil-plażma-ħin) għal selexipag u għall-metabolit attiv tiegħu.
English: Selexipag and its main metabolite showed 20- to 80-times lower prostacyclin (IP) receptor potency in vitro for animal species used in reproductive toxicity testing compared to humans.
Maltese: Selexipag u l-metabolit prinċipali tiegħu wrew effikaċja tar-ricettur ta' prostacyclin (IP) in vitro 20 sa 80 darba inqas għal speċi ta' annimali wżati fl-ittestjar tat-tossiċità riproduttiva meta mqabbla mal-bnedmin.
English: The approximate rate of adverse reactions that were serious was 2.3% in the selexipag group and 0.5% in the placebo group.
Maltese: Ir-rata approssimattiva ta' reazzjonijiet avversi li kienu serji kienet ta' 2.3% fil-grupp ta' selexipag u ta' 0.5% fil-grupp tal-plaċebo.
English: Uptravi 400 microgram, 600 microgram, 800 microgram, 1,000 microgram, 1,200 microgram, 1,400 microgram, and 1,600 microgram film-coated tablets Cartons of 60 film-coated tablets.
Maltese: Uptravi 400 mikrogramma, 600 mikrogramma, 800 mikrogramma, 1,000 mikrogramma, 1,200 mikrogramma, 1,400 mikrogramma, u 1,600 mikrogramma pilloli miksija b'rita Kaxxi tal-kartun ta' 60 pillola miksija b'rita.
English: In a Phase 3 placebo-controlled study in patients with PAH, hyperthyroidism was reported for 1.6% of patients in the selexipag group, compared to no case in the placebo group (see section 4.4).
Maltese: 1.6% tal-pazjenti fil-grupp ta' selexipag, meta mqabbel mal-ebda każ fil-grupp tal-plaċebo (ara sezzjoni 4.4).
English: In healthy subjects, inter-subject variability in exposure (area under the curve over a dosing interval) at steady state was 43% and 39% for selexipag and the active metabolite, respectively.
Maltese: F'individwi f'saħħithom, varjabilità bejn individwu u ieħor fl-esponiment (erja taħt il-kurva fuq intervall ta' dożaġġ) fi stat fiss kienet ta' 43% u 39% għal selexipag u l-metabolit attiv, rispettivament.
English: Talk to your PAH doctor or nurse if you are taking any of the following medicines: - Gemfibrozil (medicine used to lower the level of fats [lipids] in the blood) - Clopidogrel (medicine used to inhibit blood clots in coronary artery disease) - Deferasirox (medicine used to remove iron from the blood stream) - Teriflunomide (medicine used to treat relapsing-remitting multiple sclerosis) - Carbamazepine (medicine used to treat some forms of epilepsy, nerve pain or to help control serious mood disorders when some other medicines do not work) - Phenytoin (medicine used to treat epilepsy) - Valproic acid (medicine used to treat epilepsy) - Probenecid (medicine used to treat gout) - Fluconazole, rifampicin or rifapentine (antibiotics used to treat infections)
Maltese: Uptravi jintuża għal trattament fit-tul ta' pressjoni għolja fl-arterja tal-pulmun (PAH - pulmonary arterial hypertension) f'pazjenti adulti li ma jkunux ikkontrollati b'mod suffiċjenti b'tipi oħra ta' mediċini għal PAH magħrufa bħala antagonisti tar-riċettur ta' endothelin u inibituri ta'
English: Selexipag and its active metabolite do not inhibit or induce cytochrome P450 enzymes and transport proteins at clinically relevant concentrations.
Maltese: F'konċentrazzjonijiet klinikament rilevanti Selexipag u l-metabolit attiv tiegħu ma jinibixxux jew ma jinduċux enzimi taċ-ċitokromu P450 u proteini tat-trasport.
English: • Myocardial infarction within the last 6 months.
Maltese: • Infart mijokardijaku fl-aħħar 6 xhur.
English: Selexipag is hydrolysed to its active metabolite in the liver and in the intestine by carboxylesterases.
Maltese: Selexipag huwa idrolizzat għall-metabolit attiv tiegħu fil-fwied u fl-imsaren permezz ta' carboxylesterases.
English: Jaw pain* Myalgia* Arthralgia* Pain in extremity*
Maltese: Uġigħ fix-xedaq* Majalġja* Artralġja* Uġigħ fl estremitajiet*
English: Safety margins for potential IP receptor-related effects on reproduction were 20 for fertility and 5 and 1 (based on free exposure) for embryo-foetal development in rats and rabbits, respectively, when adapted for differences in receptor potency.
Maltese: Marġini ta' sigurtà għal effetti potenzjali relatati mar-ricettur IP fuq ir-riproduzzjoni kienu 20 għall-fertilità u 5 u 1 (ibbażat fuq esponiment ħieles) għall-iżvilupp tal-embrju u l-fetu fil-firien u lfniek, rispettivament, meta adattati għal differenzi fl-effikaċja tar-riċettur.
English: Pain in jaw Myalgia
Maltese: OĦRA, JEKK MEĦTIEĠA
English: If confirmed, treatment with Uptravi should be discontinued.
Maltese: Jekk ikkonfermata, it-trattament b'Uptravi għandu jitwaqqaf.
English: In patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2), caution should be exercised during dose titration.
Maltese: Indeboliment tal-kliewi F'pazjenti b'indeboliment sever tal-kliewi (eGFR < 30 mL/min/1.73 m2), għandu jkun hemm attenzjoni waqt titrazzjoni tad-doża.
English: A Phase 2 double-blind, placebo-controlled clinical study assessed haemodynamic variables after 17 weeks of treatment in patients with PAH WHO FC II-III and concomitantly receiving ERAs and/or PDE-5 inhibitors.
Maltese: Studju kliniku ta' Fażi 2, double-blind u kkontrollat bil-plaċebo evalwa l-varjabbli emodinamiċi wara 17-il ġimgħa ta' trattament f'pazjenti b'PAH WHO FC II-III li kienu qed jirċievu wkoll ERAs u/jew inibituri ta' PDE-5.
English: Isolated cases of overdose up to 3,200 micrograms were reported.
Maltese: Kienu rrappurtati każijiet iżolati ta' doża eċċessiva sa 3,200 mikrogramma.
English: Uptravi 200 microgram film-coated tablets Each film-coated tablet contains 200 micrograms of selexipag.
Maltese: Din hija pillola waħda ta' 200 mikrogramma filgħodu u pillola oħra ta' 200 mikrogramma filgħaxija.
English: No clinically relevant effects of sex, race, age, or body weight on the pharmacokinetics of selexipag and its active metabolite have been observed in healthy subjects or PAH patients.
Maltese: Ma kinux osservati effetti klinikament rilevanti tas-sess, razza, età, jew piż tal-ġisem fuq il farmakokinetika ta' selexipag u tal-metabolit attiv tiegħu f'individwi f'saħħithom jew pazjenti b'PAH.
English: Maximum observed plasma concentrations of selexipag and its active metabolite after oral administration are reached within 1-3 h and 3-4 h, respectively.
Maltese: Konċentrazzjonijiet massimi osservati fil-plażma ta' selexipag u tal-metabolit attiv tiegħu wara għoti mill-ħalq jintlaħqu fi żmien 1-3 sigħat u 3-4 sigħat, rispettivament.
English: There is limited clinical experience with selexipag in patients over the age of 75 years, therefore Uptravi should be used with caution in this population (see section 4.2).
Maltese: Hemm esperjenza klinika limitata b'selexipag f'pazjenti ta' età 'l fuq minn 75 sena, għalhekk Uptravi għandu jintuża b'attenzjoni f'din il-popolazzjoni (ara sezzjoni 4.2).
English: No change in starting dose is required in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2); dose titration should be done with caution in these patients (see section 4.4).
Maltese: Mhux meħtieġa bidla fid-doża tal-bidu f'pazjenti b'indeboliment sever tal-kliewi (rata stmata ta' filtrazzjoni mill-glomeruli [eGFR - estimated glomerular filtration rate] ta' < 30 mL/min/1.73 m2); titrazzjoni tad-doża għandha ssir b'attenzjoni f'dawn il-pazjenti (ara sezzjoni 4.4).
English: Selexipag is a weak substrate of the P-gp efflux pump.
Maltese: Selexipag huwa sottostrat dgħajjef tal-pompa P-gp tal-effluss.
English: In a thorough QT study in healthy subjects, repeated doses of 800 and 1,600 micrograms of selexipag twice daily did not show an effect on cardiac repolarisation (QTc interval) or conduction (PR and QRS intervals) and had a mild accelerating effect on heart rate (the placebo-corrected, baseline-adjusted increase in heart rate reached 6-7 bpm at 1.5 to 3 h after dosing with 800 micrograms selexipag and 9-10 bpm at the same timepoints after 1,600 micrograms selexipag).
Maltese: selexipag darbtejn kuljum ma wrew l-ebda effett fuq ir-ripolarizzazzjoni kardijaka (intervall QT c) jew fuq il-konduzzjoni (intervalli PR u QRS) u kellhom effett ta' aċċellerazzjoni ħafifa fuq ir-rata tal-qalb (iż-żieda ikkoreġuta bi plaċebo u aġġustata għal-linja bażi fir-rata tal-qalb laħqet 6-7 bpm wara 1.5 sa 3 sigħat wara dożaġġ bi 800 mikrogramma ta' selexipag u 9-10 bpm fl-istess punti ta' ħin wara
English: Elimination of selexipag is predominantly via metabolism with a mean terminal half-life of 0.8-2.5 h. The active metabolite has a half-life of 6.2-13.5 h. The total body clearance of selexipag is 17.9 L/h.
Maltese: Eliminazzjoni Eliminazzjoni ta' selexipag fil-biċċa l-kbira ssir permeżż ta' metaboliżmu b'half-life terminali medja ta' 0.8-2.5 sigħat.
English: When co-administered with moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide), reduce the dosing of Uptravi to once daily.
Maltese: Meta jingħata flimkien ma' inibituri moderati ta' CYP2C8 (eż., clopidogrel, deferasirox u teriflunomide), wieħed għandu jnaqqas id-dożaġġ ta' Uptavi għal darba kuljum.
English: Uptravi 1,600 microgram film-coated tablets contain iron oxide black, iron oxide red and iron oxide yellow (E172).
Maltese: Uptravi 1,600 mikrogramma pilloli miksija b'rita fihom iron oxide iswed, iron oxide aħmar u iron oxide isfar (E172).
English: Other medicines and Uptravi
Maltese: Mediċini oħra u Uptravi
English: Selexipag and its active metabolite both undergo oxidative metabolism mainly by CYP2C8 and to a smaller extent by CYP3A4.
Maltese: Selexipag u l-metabolit attiv tiegħu t-tnejn jgħaddu minn metaboliżmu ossidattiv fil-biċċa l-kbira permezz ta' CYP2C8 u b'mod inqas permezz ta' CYP3A4.
English: Nasopharyngitis (of non-infectious origin)
Maltese: Nażofarinġite (ta' oriġini mhux infettiva)
English: The number of deaths due to PAH up to study closure was 70 (12.2%) for the selexipag group and 83 (14.3%) for the placebo group.
Maltese: In-numru ta' mwiet minħabba PAH sal-għeluq tal-istudju kien 70 (12.2%) għall-grupp ta' selexipag u 83 (14.3%) għall-grupp tal-plaċebo.
English: Uptravi 800 microgram film-coated tablet
Maltese: Uptravi 800 mikrogramma pillola miksija b'rita
English: At baseline, the majority of enrolled patients (80%) were being treated with a stable dose of a specific therapy for PAH, either an ERA (15%) or a PDE-5 inhibitor (32%) or both an ERA and a PDE-5 inhibitor (33%).
Maltese: Fil-linja bażi, il-maġġoranza tal-pazjenti irreġistrati (80%) kienu qed jiġu ttrattati b'doża stabbli ta' terapija speċifika għal PAH, ERA (15%) jew inibitur ta' PDE-5 (32%) jew ERA kif ukoll inibitur ta'
English: Uptravi 800 microgram film-coated tablets.
Maltese: Uptravi 800 mikrogramma pilloli miksija b'rita.
English: Effect of other medicinal products on selexipag
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Effett ta' prodotti mediċinali oħra fuq selexipag
English: Thyroid function tests are recommended as clinically indicated in the presence of signs or symptoms of hyperthyroidism.
Maltese: Huma rakkomandati testijiet tal-funzjoni tat-tirojde kif indikat klinikament fil-preżenza ta' sinjali jew sintomi ta' ipertirojdiżmu.
English: Exposure to selexipag and its active metabolite in these two subjects was similar to that in subjects with moderate (Child-Pugh class B) hepatic impairment.
Maltese: Esponiment għal selexipag u għal metabolit attiv tiegħu f'dawn iż-żewġ individwi kien simili għal dak f'individwi b'indeboliment moderat tal-fwied (Child-Pugh klassi B).
English: Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.
Maltese: pulmonary arterial hypertension) f'pazjenti adulti bi klassi funzjonali (FC - functional class) tadWHO II-III, bħala terapija kombinata f'pazjenti li ma jkunux ikkontrollati b'mod suffiċjenti b'antagonist tar-riċettur ta' endothelin (ERA - endothelin receptor antagonist) u/jew inibitur ta'
English: Treatment with selexipag resulted in a placebo-corrected median effect on 6MWD measured at trough (i.e., approximately 12 h post-dose) of 12 m at Week 26 (99% CI: 1, 24 m;
Maltese: Trattament b'selexipag wassal għal effett medjan ikkoreġut bi plaċebo fuq 6MWD imkejla fl-aktar punt baxx (jiġifieri, madwar 12-il siegħa wara d-doża) ta' 12 m f'Ġimgħa 26 (CI ta' 99%: 1, 24 m; valur p ta' naħa waħda = 0.0027).
English: The pharmacokinetics of selexipag and the active metabolite, both after single- and multiple-dose administration, were dose-proportional up to a single dose of 800 micrograms and multiple doses of up to 1,800 micrograms twice daily.
Maltese: Il-farmakokinetika ta' selexipag u tal-metabolit attiv, kemm wara għoti ta' doża waħda kif ukoll wara għoti ta' dożi multipli kienet proporzjonali mad-doża sa doża waħda ta' 800 mikrogramma u dożi multipli sa 1,800 mikrogramma darbtejn kuljum.
English: In the presence of 400/100 mg lopinavir/ritonavir twice daily, a strong OATP (OATP1B1 and OATP1B3) and P-gp inhibitor, exposure to selexipag increased approximately 2-fold, whereas the exposure to the active metabolite of selexipag did not change.
Maltese: u OATP1B3) u ta' P-gp, l-esponiment għal selexipag żdied b'madwar darbtejn, filwaqt li l-esponiment għall-metabolit attiv ta' selexipag ma nbidilx.
English: Selexipag is rapidly absorbed and is hydrolysed by carboxylesterases to its active metabolite.
Maltese: Selexipag jiġi assorbit malajr u huwa idrolizzat permezz ta' carboxylesterases għall-metabolit attiv tiegħu.
English: Exercise capacity was evaluated as a secondary endpoint.
Maltese: Punti finali sintomatiċi Il-kapaċità ta' eżerċizzju kienet evalwata bħala punt finali sekondarju.
English: Except for the active metabolite, none of the circulating metabolites in human plasma exceed 3% of the total drug-related material.
Maltese: Minbarra l-metabolit attiv, l-ebda wieħed mill-metaboliti li jiċċirkolaw fil-plażma umana ma jkun aktar minn 3% tal-materjal totali relatat mal-mediċina.
English: • Severe coronary heart disease or unstable angina.
Maltese: • Marda severa tal-koronarja tal-qalb jew anġina instabbli.
English: The numerical increase in deaths up to end of treatment + 7 days but not up to study closure was further investigated by mathematical modelling, showing that the imbalance in deaths is consistent with the assumption of a neutral effect on PAH mortality and reduction of non-fatal events.
Maltese: Iż-żieda numerika fl-imwiet sa tmiem it-trattament + 7 ijiem iżda mhux sal-għeluq tal-istudju ġiet investigata aktar permezz ta' mudellar matematiku, li juri li l-iżbilanċ fl-imwiet huwa konsistenti malipotesi ta' effett newtrali fuq mortalità minħabba PAH u tnaqqis ta' avvenimenti mhux fatali.
English: Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease (see section 5.1).
Maltese: Effikaċja intweriet f'popolazzjoni b'PAH inkluż PAH idjopatika u li tintiret, PAH assoċjata ma' disturbi fit-tessut konnettiv, u PAH assoċjata ma' mard konġenitali sempliċi kkoreġut tal-qalb (ara sezzjoni 5.1).
English: Uptravi 800 microgram film-coated tablets Each film-coated tablet contains 800 micrograms of selexipag.
Maltese: Uptravi 800 mikrogramma pilloli miksija b'rita Kull pillola miksija b'rita fiha 800 mikrogramma ta' selexipag.
English: Each film-coated tablet contains 200 micrograms of selexipag
Maltese: Kull pillola miksija b'rita fiha 200 mikrogramma ta' selexipag
English: Selexipag does not cause IP receptor desensitisation in vitro nor tachyphylaxis in a rat model.
Maltese: Selexipag ma jikkawżax desensittizzazzjoni tar-riċettur IP in vitro u lanqas takifilassi fil-far bħala mudell.
English: In juvenile dogs, intussusception due to prostacyclin-related effects on intestinal motility was observed sporadically.
Maltese: Fi klieb frieħ, intussussezzjoni minħabba effetti relatati ma' prostacyclin fuq il-motilità intestinali kienet osservata b'mod sporadiku.
English: i.v./s.c.
Maltese: L/siegħa.
English: Selectivity against EP2, EP4, and DP1 is important because these receptors mediate immune depressive effects.
Maltese: u DP1 hija importanti għaliex dawn ir-riċetturi jimmedjaw effetti immuni depressivi.
English: Exposure to selexipag and the active metabolite at steady state in PAH patients and healthy subjects was similar.
Maltese: Esponiment għal selexipag u l-metabolit attiv fi stat fiss f'pazjenti b'PAH u f'individwi f'saħħithom kien simili.
English: Uptravi 1,200 microgram film-coated tablets.
Maltese: Uptravi 1,200 mikrogramma pilloli miksija b'rita.
English: Every patient with PAH is different.
Maltese: Kull pazjent b'PAH huwa differenti.
English: In a Phase 3 placebo-controlled study in patients with PAH, mean absolute changes in haemoglobin at regular visits compared to baseline ranged from −0.34 to −0.02 g/dL in the selexipag group compared to −0.05 to 0.25 g/dL in the placebo group.
Maltese: 02 g/dL fil-grupp ta' selexipag meta mqabbla ma' −0.05 sa 0.25 g/dL fil-grupp tal-plaċebo.
English: The mean treatment duration was 76.4 weeks (median 70.7 weeks) for patients receiving selexipag versus 71.2 weeks (median 63.7 weeks) for patients on placebo.
Maltese: 70.7 ġimgħat) għall-pazjenti li kienu qed jirċievu selexipag kontra 71.2 ġimgħat (medjan 63.7 ġimgħat) għall-pazjenti fuq plaċebo.
English: The most common side effects (may affect more than 1 in 10 people) you may experience while taking Uptravi are:
Maltese: L-effetti sekondarji l-aktar komuni (jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) li jista' jkollok waqt li tkun qed tieħu Uptravi huma:
English: Uptravi 1,200 microgram film-coated tablet
Maltese: Uptravi 1,200 mikrogramma pillola miksija b'rita
English: The maximum dose of Uptravi is 1,600 micrograms in the morning and 1,600 micrograms in the evening.
Maltese: Id-doża massima ta' Uptravi hija 1,600 mikrogramma filgħodu u 1,600 mikrogramma filgħaxija.
English: Idiopathic or heritable PAH was the most common aetiology in the study population (58%) followed by PAH due to connective tissue disorders (29%), PAH associated with simple corrected congenital heart disease (10%), and PAH associated with other aetiologies (drugs and toxins [2%] and HIV
Maltese: segwita minn PAH ikkawżata minn disturbi fit-tessut konnettiv (29%), PAH assoċjata ma' mard konġentali tal-qalb sempliċi kkoreġut (10%), u PAH assoċjata ma' etjoloġiji oħrajn (mediċini u tossini
English: Uptravi 1,400 microgram film-coated tablet
Maltese: Uptravi 1,400 mikrogramma pillola miksija b'rita
English: Dosing frequency of Uptravi should be reverted to twice daily when co-administration of moderate CYP2C8 inhibitor is stopped (see section 4.2).
Maltese: Il-frekwenza tad-dożaġġ ta' Uptravi għandha tmur lura għal darbtejn kuljum meta jitwaqqaf l-għoti flimkien ma' inibitur moderat ta' CYP2C8 (ara sezzjoni 4.2).
English: Hyperthyroidism
Maltese: Artralġja