FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Opsumit:
Maltese: Twissijiet u prekawzjonijiet:
English: Opsumit® 10 mg macitentan film-coated tablets
Maltese: Opsumit 10 mg pilloli macitentan
English: Macitentan and its active metabolite are not inhibitors of hepatic or renal uptake transporters at clinically relevant concentrations, including the organic anion transporting polypeptides (OATP1B1 and OATP1B3).
Maltese: F'konċentrazzjonijiet klinikament rilevanti Macitentan u l-metabolit attiv tiegħu mhumiex inibituri tattrasportaturi tat-teħid tal-fwied jew tal-kliewi, inkluż polipeptidi organiċi li jġorru l-anjoni (OATP1B1 u OATP1B3).
English: Concomitant use with strong CYP3A4 inducers
Maltese: Indutturi qawwija ta'CYP3A4:
English: Idiopathic or heritable PAH was the most common aetiology in the study population (57%), followed by PAH due to connective tissue disorders (31%), PAH associated with corrected simple congenital heart disease (8%), and PAH associated with other aetiologies (medicinal products and toxins [3%] and HIV [1%]).
Maltese: segwita minn PAH ikkawżata minn disturbi tat-tessut konnettiv (31%), PAH assoċjata ma' mard tal qalb konġenitali sempliċi kkoreġut (8%), u PAH assoċjata ma' etjoloġiji oħra (prodotti mediċinali u tossini [3%] u HIV [1%]).
English: Elevations of liver aminotransferases (AST, ALT) have been associated with PAH and with endothelin receptor antagonists (ERAs).
Maltese: antagonisti tar-riċettur ta' endothelin (ERAs - endothelin receptor antagonists).
English: Xanthan gum (E415)
Maltese: Lecithin derivat mill-fażola tas-sojja (E322) Xanthan gum (E415)
English: Sildenafil, a CYP3A4 substrate, did not affect the pharmacokinetics of macitentan, while there was a 15% reduction in the exposure to the active metabolite of macitentan.
Maltese: Sildenafil, sottostrat ta' CYP3A4, ma affettwax ilfarmakokinetika ta' macitentan, filwaqt li kien hemm tnaqqis ta' 15% fl-esponiment għall-metabolit attiv ta' macitentan.
English: Oxidative depropylation of the sulfamide yields a pharmacologically active metabolite.
Maltese: Tneħħija ossidattiva ta' propyl minn sulfamide tagħti metabolit attiv farmakoloġikament.
English: • Hypersensitivity to the active substance, soya or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva, għas-sojja jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: The majority of adverse reactions are mild to moderate in intensity.
Maltese: intensità ħafifa sa moderata.
English: Macitentan and its active metabolite do not have clinically relevant inhibitory or inducing effects on cytochrome P450 enzymes.
Maltese: Macitentan u l-metabolit attiv tiegħu m'għandhomx effetti ta' inibizzjoni jew ta' induzzjoni klinikament rilevanti fuq l-enzimi taċ-ċitokromu P450.
English: The incidence of aminotransferase elevations (ALT/AST) > 3 × ULN was 3.4% on macitentan 10 mg and 4.5% on placebo in a double-blind study in patients with PAH.
Maltese: 10 mg u 4.5% fuq plaċebo fi studju double-blind f'pazjenti b'PAH.
English: • flu-like syndrome (joint and muscle pain with fever)
Maltese: • sindrome tixbaħ lill-influwenza (uġigħ fil-ġogi u fil-muskoli bid-deni)
English: Opsumit contains lecithin derived from soya.
Maltese: Opsumit fih lecithin derivat mis-sojja.
English: Testicular tubular atrophy, and minimal effects on reproductive variables and sperm morphology were recorded at exposures 3.8-fold the human exposure.
Maltese: Atrofija tat-tubuli tat-testikoli, u effetti minimi fuq il-varjabbli riproduttivi u l-morfoloġija tal-isperma kienu rreġistrati b'esponimenti
English: Other worsening of PAH was defined as the presence of all of the three following components: a sustained decrease in 6-minute walk distance (6MWD) of at least 15% from baseline; worsening of PAH symptoms (worsening of WHO FC or right heart failure); and need for new treatment for PAH.
Maltese: Aggravar ieħor ta' PAH kien definit bħala l-preżenza tat-tliet komponenti kollha li ġejjin: tnaqqis sostnut fid-distanza koperta f'mixja ta' 6 minuti (6MWD - 6-minute walk distance) ta' mill-inqas 15% mil-linja bażi; aggravar tas-sintomi ta' PAH (aggravar ta' WHO FC jew insuffiċjenza tan-naħa tal-lemin tal-qalb); u l-ħtieġa ta' kura ġdida għal PAH.
English: • Pharyngitis (inflammation of the throat)
Maltese: • Farinġite (infjammazzjoni tal-gerżuma)
English: Exercise capacity was evaluated as a secondary endpoint.
Maltese: Il-kapaċità ta' eżerċizzju kienet evalwata bħala punt finali sekondarju.
English: Macitentan was not genotoxic in a standard battery of in vitro and in vivo assays.
Maltese: Macitentan ma kellux effett tossiku fuq il-ġeni f'sensiela standard ta' analiżi in vitro u in vivo.
English: If you stop taking Opsumit
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: Intimal thickening of coronary arteries was observed at 17-fold the human exposure after 4 to 39 weeks of treatment.
Maltese: Tħaxxin intimali tal-arterji koronarji ġie osservat b'esponiment ta' 17-il darba dak filbniedem wara 4 sa 39 ġimgħat ta' kura.
English: At clinically relevant concentrations, macitentan and its active metabolite do not interact with proteins involved in hepatic bile salt transport, i.e., the bile salt export pump (BSEP) and the sodium-dependent taurocholate co-transporting polypeptide (NTCP).
Maltese: (BSEP - bile salt export pump) u l-polipeptid dipendenti mis-sodium li wkoll iġorr taurocholate (NTCP - sodium-dependent taurocholate co-transporting polypeptide).
English: while you are taking Opsumit.
Maltese: waqt li tkun qed tieħu Opsumit.
English: A decrease from baseline in haemoglobin concentration to below 10 g/dL was reported in 8.7% of patients treated with macitentan 10 mg and 3.4% of placebo-treated patients.
Maltese: Tnaqqis fil-konċentrazzjoni tal-emoglobina mil-linja bażi għal inqas minn 10 g/dL kien irrappurtat fi 8.7% tal-pazjenti kkurati b'macitentan 10 mg u fi 3.4% talpazjenti kkurati bil-plaċebo.
English: Macitentan is only excreted after extensive metabolism.
Maltese: Macitentan jitneħħa biss wara metaboliżmu estensiv.
English: There is no clinically relevant effect of age, sex or ethnic origin on the pharmacokinetics of macitentan and its active metabolite.
Maltese: M'hemm l-ebda effett klinikament rilevanti tal-età, sess jew oriġini etnika fuq il-farmakokinetika ta' macitentan u tal-metabolit attiv tiegħu.
English: Microcrystalline cellulose (E460i)
Maltese: Lactose monohydrate Microcrystalline cellulose (E460i) Sodium starch glycolate Tip A Povidone K-30
English: Thrombocytopenia7
Maltese: Qalba tal-pillola
English: The pharmacokinetics of macitentan and its active metabolite were not affected by warfarin.
Maltese: Il-farmakokinetika ta' macitentan u tal-metabolit attiv tiegħu ma ġietx affettwata minn warfarin.
English: There is limited experience with Opsumit in patients older than 75 years.
Maltese: Hemm esperjenza limitata b'Opsumit f'pazjenti b'età 'l fuq minn 75 sena.
English: Strong CYP3A4 inducers: Concomitant treatment with rifampicin 600 mg daily, a potent inducer of CYP3A4, reduced the steady-state exposure to macitentan by 79% but did not affect the exposure to the active metabolite.
Maltese: CYP3A4 , naqqas l-esponiment fi stat fiss għal macitentan b'79% iżda m'affettwax l-esponiment għall-metabolit attiv.
English: The combination of macitentan with strong CYP3A4 inducers (e.g., rifampicin, St. John's wort, carbamazepine, and phenytoin) should be avoided (see section 4.5).
Maltese: John's wort, carbamazepine, u phenytoin) għandha tiġi evitata (ara sezzjoni 4.5).
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a mean decrease in haemoglobin versus placebo of 1 g/dL.
Maltese: Fi studju double-blind f'pazjenti b'PAH, macitentan 10 mg kien assoċjat ma' tnaqqis medju fl emoglobina kontra plaċebo ta' 1 g/dL.
English: Opsumit is supplied as 10 mg film-coated tablets in blister packs of 15 or 30 tablets, or in bottles of 30 tablets.
Maltese: Opsumit huwa fornut bħala pilloli miksija b'rita ta' 10 mg f'pakketti bil-folji ta' 15 jew 30 pillola, jew fi fliexken ta' 30 pillola.
English: At 36 months, 44.6% of patients on placebo and 29.4% of patients on macitentan 10 mg (Absolute Risk Reduction = 15.2%) had been hospitalised for PAH or died from a PAH-related cause.
Maltese: Wara 36 xahar, 44.6% tal-pazjenti fuq plaċebo u 29.4% tal-pazjenti fuq macitentan 10 mg (Tnaqqis Assolut tar-Riskju = 15.
English: 2 Hypotension has been associated with the use of ERAs including macitentan.
Maltese: 2Pressjoni baxxa ġiet assoċjata mal-użu ta' ERAs inkluż macitentan.
English: LIST OF EXCIPIENTS Also contains lactose and soya bean lecithin (E322).
Maltese: Fiha wkoll lactose u lecithin derivat mill-fażola tas-sojja (E322).
English: Each tablet contains 10 mg macitentan.
Maltese: Kull pillola fiha 10 mg ta' macitentan.
English: A multicenter, double-blind, placebo-controlled, parallel-group, event-driven, Phase 3 outcome study (AC-055-302/SERAPHIN) was conducted in 742 patients with symptomatic PAH, who were randomised to three treatment groups (placebo [N = 250], 3 mg [N = 250] or 10 mg [N = 242] of macitentan once daily), to assess the long-term effect on morbidity or mortality.
Maltese: Effikaċja f'pazjenti bi pressjoni arterjali pulmonari għolja Twettaq studju ta' Fażi 3 dwar ir-riżultat, b'aktar minn ċentru wieħed, double-blind, ikkontrollat bilplaċebo, bi grupp parallel, immexxi minn avvenimenti (AC-055-302/SERAPHIN) f'742 pazjent b'PAH sintomatika, li kienu randomised għal tliet gruppi ta' kura (plaċebo [N = 250], 3 mg [N = 250]
English: Pharmacotherapeutic group: anti-hypertensives, anti-hypertensives for pulmonary arterial hypertension.
Maltese: Kategorija farmakoterapewtika: mediċini kontra l-pressjoni għolja, mediċini konta l-pressjoni għolja għall-pressjoni arterjali pulmonari għolja.
English: Use in women of childbearing potential/Contraception in males and females Opsumit treatment should only be initiated in women of childbearing potential when the absence of pregnancy has been verified, appropriate advice on contraception provided, and reliable contraception is practised (see sections 4.3 and 4.4).
Maltese: F'nisa li jistgħu joħorġu tqal kura b'Opsumit għandha tinbeda biss meta n-nuqqas tat-tqala ikun ġie verifikat, ikun ingħata parir xieraq dwar kontraċezzjoni, u tkun qed tiġi pprattikata kontraċezzjoni affidabbli (ara sezzjonijiet 4.3 u 4.4).
English: The risk of PAH related death or hospitalisation for PAH up to EOT was reduced by 50% (HR 0.50; 97.5% CI: 0.34 to 0.75; logrank p < 0.0001) in patients receiving macitentan 10 mg (50 events) compared to placebo (84 events).
Maltese: Ir-riskju ta' mewt ralatat ma' PAH jew dħul l-isptar minħabba PAH sa EOT naqsu b'50% (HR 0.50; CI ta' 97.5%: 0.34 sa 0.75; logrank p < 0.0001) f'pazjenti li kienu qed jirċievu macitentan 10 mg
English: Treatment with macitentan 10 mg at Month 6 led to a 74% higher chance of WHO FC improvement relative to placebo (risk ratio 1.74; 97.5% CI: 1.10 to 2.74; p = 0.0063).
Maltese: Il-kura b'macitentan 10 mg f'Xahar 6 wasslet għal opportunità ogħla b'74% ta' titjib f'WHO FC meta mqabbel mal-plaċebo (proporzjon ta' riskju 1.74; CI ta' 97.5%: 1.10 sa 2.74; p = 0.0063). Macitentan 10 mg tejjeb il-kwalità tal-ħajja evalwata mill-kwestjonarju SF-36.
English: Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells.
Maltese: Macitentan juri affinità għolja u okkupazzjoni sostnuta tar-riċetturi ta' ET fiċ-ċelluli tal muskoli lixxi tal-arterja pulmonari umana.
English: No dose adjustment is required in patients over the age of 65 years (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'età 'l fuq minn 65 sena (ara sezzjoni 5.2).
English: Sildenafil: At steady-state, the exposure to sildenafil 20 mg three times a day was increased by 15% during concomitant administration of macitentan 10 mg once daily.
Maltese: Fi stat fiss, l-esponiment għal sildenafil 20 mg tliet darbiet kuljum żdied b'15% waqt l għoti flimkien ma' macitentan 10 mg darba kuljum.
English: In a longterm double-blind study in patients with PAH, the incidence of oedema AEs in the macitentan 10 mg and placebo treatment groups was 21.9% and 20.5%, respectively.
Maltese: Fi studju double-blind fit-tul f'pazjenti b'PAH, l-inċidenza ta' AEs ta' edima fil-gruppi ta' kura ta' macitentan 10 mg u talplaċebo kienet ta' 21.9% u 20.
English: Elevations > 5 × ULN occurred in 2.5% of patients on macitentan 10 mg versus 2% of patients on placebo.
Maltese: 2.5% tal-pazjenti fuq macitentan 10 mg kontra 2% tal-pazjenti fuq plaċebo. 5Emoglobina
English: Opsumit contains lactose, lecithin from soya and sodium Opsumit contains a sugar called lactose.
Maltese: Opsumit fih lactose, lecithin derivat mis-sojja u sodium
English: Haemodynamic parameters were assessed in a subset of patients (placebo [N = 67], macitentan 10 mg [N = 57]) after 6 months of treatment.
Maltese: Punti finali emodinamiċi Parametri emodinamiċi kienu evalwati f'sottogrupp ta' pazjenti (plaċebo [N = 67],
English: • Anaemia (low number of red blood cells) or reduced haemoglobin
Maltese: • Anemija (għadd baxx ta' ċelluli ħomor tad-demm) jew tnaqqis fl-emoglobina
English: • Bronchitis (inflammation of the airways)
Maltese: • Bronkite (infjammazzjoni tal-passaġġi tan-nifs)
English: Opsumit contains the active substance macitentan, which belongs to the class of medicines called “endothelin receptor antagonists”.
Maltese: Opsumit fih is-sustanza attiva macitentan, li tagħmel parti minn klassi ta' mediċini msejħa “antagonisti tar-riċettur ta' endothelin”.
English: The requirements for submission of periodic safety updated reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Macitentan was not phototoxic in vivo after single dose at exposures of up to 24-fold the human exposure.
Maltese: Macitentan ma kienx fototossiku in vivo wara doża waħda f'esponiment sa 24 darba l-esponiment filbniedem.
English: Haemodynamic endpoints
Maltese: Punti finali tar-riżultat
English: Macitentan inhibits the breast cancer resistance protein (BCRP) at clinically relevant intestinal concentrations.
Maltese: F'konċentrazzjonijiet intestinali klinikament rilevanti Macitentan jinibixxi l-proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein).
English: • unusual tiredness or exhaustion (lethargy or fatigue)
Maltese: • tħossok se tirremetti (dardir)
English: Ketoconazole: In the presence of ketoconazole 400 mg once daily, a strong CYP3A4 inhibitor, exposure to macitentan increased approximately 2-fold.
Maltese: Fil-preżenza ta' ketoconazole 400 mg darba kuljum, inibitur qawwi ta' CYP3A4,
English: 1Data derived from pooled placebo-controlled studies.
Maltese: 1Dejta miksuba minn studji kkontrollati bi plaċebo miġbura f'daqqa.
English: Opsumit 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 (> 3 × ULN); see sections 4.3 and
Maltese: Opsumit m'għandux jinbeda f'pazjenti b'indeboliment sever tal-fwied, jew b'aminotransferases tal-fwied għolja b'mod klinikament sinifikanti (aktar minn 3 darbiet il-Limitu ta' Fuq tan-Normal (> 3 × ULN - greater than 3 times the Upper Limit of Normal); ara sezzjonijiet 4.3 u 4.4).
English: Patients treated with macitentan 10 mg achieved a median reduction of 36.5% (97.5% CI: 21.7 to 49.2%) in pulmonary vascular resistance and an increase of 0.58 L/min/m2 (97.5% CI: 0.28 to 0.93 L/min/m2) in cardiac index compared to placebo.
Maltese: Pazjenti kkurati b'macitentan 10 mg kisbu tnaqqis medjan ta' 36.5% (CI ta' 97.5%: 21.7 sa 49.2%) fir-reżistenza vaskulari tal-pulmun u żieda ta' 0.58
English: Other medicines and Opsumit
Maltese: Mediċini oħra u Opsumit
English: Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Ibbażat fuq dejta farmakokinetika (PK - pharmakokinetic), mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment ħafif, moderat jew sever tal-fwied (ara sezzjonijiet 4.4 u 5.2).
English: Pharyngitis
Maltese: Plejtlits
English: Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Maltese: Opsumit, bħala monoterapija jew f'kombinazzjoni, hu indikat għall-kura fit-tul ta' pressjoni arterjali pulmonari għolja (PAH - pulmonary arterial hypertension) f'pazjenti adulti ta' Klassi Funzjonali
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean leucocyte count from baseline of 0.7 × 109/L versus no change in placebo-treated patients.
Maltese: Fi studju double-blind f'pazjenti b'PAH, macitentan 10 mg kien assoċjat ma' tnaqqis fl-għadd medju ta' lewkoċiti mil-linja bażi ta' 0.7 × 109/L kontra l-ebda bidla f'pazjenti kkurati bil-plaċebo.
English: Decrease in haemoglobin concentrations has been associated with endothelin receptor antagonists (ERAs) including macitentan (see section 4.8).
Maltese: (ERAs) inkluż macitentan (ara sezzjoni 4.8).
English: In patients with pulmonary veno-occlusive disease (obstruction of the lung veins), the use of medicines for treatment of PAH, including Opsumit, may lead to pulmonary oedema.
Maltese: F'pazjenti b'marda veno-okklussiva tal-pulmun (imblukkar tal-vini pulmonari), l-użu tal-mediċini għall-kura ta' PAH, inkluż Opsumit, jista' jwassal għal edima pulmonari.
English: This prevents endothelin-mediated activation of second messenger systems that result in vasoconstriction and smooth muscle cell proliferation.
Maltese: Dan jimpedixxi l-attivazzjoni medjata minn endothelin tas sistemi ta' messaġġiera sekondarji li jwassal għal vażokonstrizzjoni u proliferazzjoni taċ-ċelluli tal muskoli lixxi.
English: See section ‘Pregnancy and breastfeeding'.
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: Macitentan and its active metabolite are highly bound to plasma proteins (> 99%), primarily to albumin and to a lesser extent to alpha1-acid glycoprotein.
Maltese: Macitentan u l-metabolit attiv tiegħu huma marbuta ħafna mal-proteini fil-plażma (> 99%),
English: Hypersensitivity reactions (e.g., angioedema, pruritus, rash)1
Maltese: • Reazzjonijiet allerġiċi (nefħa madwar l-għajnejn, wiċċ, xufftejn, ilsien jew gerżuma, ħakk u/jew raxx)
English: The MAH shall agree the details of the Prescriber kit and a controlled distribution system with the National Competent Authority and implement it prior to launch in that Member State.
Maltese: L-MAH għandu jiftiehem dwar id-dettalji tal-kitt għal min Jippreskrivi u sistema ta' distribuzzjoni kkontrollata mal-Awtorità Kompetenti Nazzjonali u jimplimentha qabel jitqiegħed fis-suq f'dak l-Istat Membru.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag Int
Maltese: Janssen-Cilag Int
English: • The Summary of Product Characteristics for Opsumit;
Maltese: • Is-Sommarju tal-Karatteristiċi tal-Prodott ta' Opsumit;
English: • pallor
Maltese: • sturdament
English: Evaluation of 6MWD by functional class resulted in a placebo-corrected mean increase from baseline to Month 6 in FC III/IV patients of 37 meters (97.5% CI: 5 to 69) and in FC I/II of 12 meters (97.5% CI: −8 to 33).
Maltese: (CI ta' 97.5%: 5 sa 69) u ta' FC I/II ta' 12-il metru (CI ta' 97.5%: -8 sa 33). Iż-żieda f'6MWD
English: The pharmacokinetics of macitentan and its active metabolite have mainly been documented in healthy subjects.
Maltese: Il-farmakokinetika ta' macitentan u tal-metabolit attiv tiegħu ġew dokumentati primarjament f'individwi f'saħħithom.
English: In the period between end-of-treatment (EOT) and EOS, patients could receive open-label macitentan 10 mg or alternative PAH therapy.
Maltese: EOS kien iddikjarat meta ntlaħaq in-numru definit minn qabel ta' avvenimenti ta' punt finali primarju. Filperjodu bejn it-tmiem tal-kura (EOT - end-of-treatment) u EOS, il-pazjenti setgħu jirċievu open-label macitentan 10 mg jew terapija alternattiva għal PAH.
English: • dark-coloured urine
Maltese: 4. GĦAMLA
English: White, opaque PVC/PE/PVdC/Aluminium blisters in cartons containing 15 or 30 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji bojod, opaki magħmula minn PVC/PE/PVdC/Aluminju f'kartun li fihom 15 jew 30 pillola miksija b'rita.
English: The overall median double-blind treatment duration was 115 weeks (up to a maximum of 188 weeks on macitentan).
Maltese: It-tul medjan globali ta' kura double-blind kien ta' 115-il ġimgħa (sa massimu ta' 188 ġimgħa fuq macitentan).
English: Opsumit is contraindicated during pregnancy and in women of childbearing potential who are not using reliable contraception (see section 4.3).
Maltese: Opsumit huwa kontraindikat waqt it-tqala u f'nisa li jistgħu joħorġu tqal li mhumiex qed jużaw kontraċezzjoni affidabbli (ara sezzjoni 4.3).
English: Opsumit is contraindicated during breastfeeding (see section 4.3).
Maltese: Opsumit hu kontraindikat waqt it-treddigħ (ara 4.3).
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: Intweriet effikaċja f'popolazzjoni b'PAH inkluż PAH idjopatika u li tintiret, PAH assoċjata ma' disturbi tat-tessut konnettiv, u PAH assoċjata ma' mard tal-qalb konġenitali sempliċi kkoreġut (ara sezzjoni 5.1).
English: Macitentan induced minimal to slight mucosal hyperplasia and inflammatory infiltration in the submucosa of the nasal cavity in the mouse carcinogenicity study at all doses.
Maltese: Macitentan induċa iperplasija minima sa ħafifa tal-mukuża u infiltrazzjoni infjammatorja fissottomukuża tal-kavità tal-imnieħer fl-istudju dwar ir-riskju ta' kanċer fil-ġrieden fid-dożi kollha.
English: There is limited clinical experience with macitentan in patients over the age of 75 years, therefore Opsumit should be used with caution in this population (see section 4.2).
Maltese: Hemm esperjenza klinika limitata b'macitentan f'pazjenti b'età 'l fuq minn 75 sena, għalhekk Opsumit għandu jintuża b'attenzjoni f'din il-popolazzjoni (ara sezzjoni 4.2).
English: Tablet core
Maltese: sildenafil.
English: • fever
Maltese: • sfurija
English: In the presence of strong CYP3A4 inducers reduced efficacy of macitentan could occur.
Maltese: Fil-preżenza ta' indutturi qawwija ta' CYP3A4 jista' jkun hemm effikaċja mnaqqsa ta' macitentan.
English: • Urinary tract infection (bladder infection)
Maltese: • Infezzjoni fl-apparat tal-awrina (infezzjoni fil-bużżieqa tal-awrina)
English: Opsumit is not to be initiated in patients with severe hepatic impairment or elevated aminotransferases (> 3 × ULN) (see sections 4.2 and 4.3), and is not recommended in patients with moderate hepatic impairment.
Maltese: Opsumit m'għandux jinbeda f'pazjenti b'indeboliment sever tal-fwied jew b'aminotransferases elevati (> 3 × ULN) (ara sezzjonijiet 4.2 u 4.3), u mhux irrakkomandat f'pazjenti b'indeboliment moderat tal-fwied.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/893/001
Maltese: EU/1/13/893/001 EU/1/13/893/002 EU/1/13/893/003
English: Signs that your liver may not be working properly include: nausea (urge to vomit) vomiting fever (high temperature) pain in your stomach (abdomen) jaundice (yellowing of your skin or the whites of your eyes) dark-coloured urine itching of your skin lethargy or fatigue (unusual tiredness or exhaustion) flu-like syndrome (joint and muscle pain with fever)
Maltese: awrina ta' lewn skur ħakk fil-ġilda letarġija jew għeja (għeja mhux tas-soltu jew tħossok bla saħħa) sindrome tixbaħ lill-influwenza (uġigħ fil-ġogi u fil-muskoli bid-deni)