FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Ilumetri?
Maltese: X'inhuma r-riskji assoċjati ma' Ilumetri?
English: As for all medicines, data on the use of Ilumetri are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Ilumetri hija ssorveljata kontinwament.
English: The first study involving 771 patients compared Ilumetri with placebo (a dummy treatment).
Maltese: L-ewwel studju, li involva 771 pazjent, qabbel Ilumetri ma' plaċebo (kura finta).
English: Headache, gastroenteritis (diarrhoea and vomiting), nausea (feeling sick), diarrhoea, pain at the site of the injection and back pain may affect up to 1 in 10 people.
Maltese: Uġigħ ta' ras, gastroenterite (dijarea u rimettar), nawsja (tħossok ma tiflaħx), dijarea, uġigħ fis-sit tal-injezzjoni u uġigħ fid-dahar jistgħu jaffettwaw sa persuna 1 minn kull 10.
English: Of those given Ilumetri, 55% (for 100 mg) and 59% (for 200 mg) had almost complete skin clearance compared with 48% given etanercept and 5% given placebo.
Maltese: Minn dawk li ngħataw Ilumetri, 55 % (għal 100 mg) u 59 % (għal 200 mg) kellhom tneħħija kważi sħiħa mill-ġilda meta mqabbel ma' 48 % ta' dawk li ngħataw etanercept u 5 % ta' dawk li ngħataw plaċebo.
English: After 12 weeks, 61% and 66% of patients given 100 mg and 200 mg Ilumetri respectively had at least 75% improvement in severity compared with 48% of those given etanercept and 6% given placebo.
Maltese: Wara 12-il ġimgħa, 61 % u 66 % tal-pazjenti li ngħataw 100 mg u 200 mg Ilumetri rispettivament kellhom tal-inqas titjib ta' 75 % fis-severità tal-marda meta mqabbel ma' 48 % ta' dawk li ngħataw etanercept u 6 % ta' li ngħataw plaċebo.
English: The most common side effects with Ilumetri are upper respiratory tract (nose and throat) infections (which may affect more than 1 in 10 people).
Maltese: L-effetti sekondarji l-aktar komuni b'Ilumetri huma infezzjonijiet fl-apparat respiratorju ta' fuq (imnieħer u griżmejn)(li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10).
English: After 12 weeks, 64% and 62% of patients given 100 mg and 200 mg Ilumetri respectively had at least a 75% improvement in disease severity compared with 6% of those given placebo.
Maltese: Wara 12-il ġimgħa, 64 % u 62 % tal-pazjenti li ngħataw 100 mg u 200 mg Ilumetri rispettivament kellhom tal-inqas titjib ta' 75 % fis-severità tal-marda meta mqabbel ma' 6 % ta' dawk li ngħataw plaċebo.
English: For the full list of side effects and restrictions with Ilumetri, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Ilumetri, ara l-fuljett ta' tagħrif.
English: By blocking the action of interleukin 23, Ilumetri reduces inflammation and symptoms associated with the disease.
Maltese: Billi jimblokka l-azzjoni ta' interleukin 23, Ilumetri jnaqqas linfjammazzjoni u s-sintomi assoċjati mal-marda.
English: Additionally, 58% of those given 100 mg and 59% of those given 200 mg had almost complete skin clearance compared with 7% given placebo.
Maltese: Barra minn hekk, 58 % ta' dawk li ngħataw 100 mg u 59 % ta' dawk li ngħataw 200 mg kellhom tneħħija kważi sħiħa mill-ġilda meta mqabbel ma' 7 % ta' dawk li ngħataw plaċebo.
English: Ilumetri is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Maltese: Ilumetri huwa mediċina li taġixxi fuq is-sistema immunitarja u li tintuża biex tikkura psorjasi bil-qoxra, marda li tikkawża rqajja' ħomor bil-qoxra fuq il-ġilda.
English: What measures are being taken to ensure the safe and effective use of Ilumetri?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Ilumetri?
English: Two main studies involving adults found Ilumetri effective for treating moderate to severe plaque psoriasis in patients for whom treatments applied to the skin did not work well enough.
Maltese: Żewġ studji ewlenin li involvew l-adulti sabu li Ilumetri huwa effettiv biex jikkura psorjasi bil-qoxra moderata sa severa f'pazjenti li għalihom kuri li jiġu applikati fuq il-ġilda ma ħadmux tajjeb biżżejjed.
English: The doctor may decide to stop treatment if the condition does not improve after 28 weeks.
Maltese: It-tabib jista' jiddeċiedi li jwaqqaf il-kura jekk il-kondizzjoni ma titjiebx wara 28 ġimgħa.
English: The recommended dose is one 100 mg injection, followed by a further dose after 4 weeks and then an injection every 12 weeks.
Maltese: Id-doża rakkomandata hija ta' injezzjoni waħda ta' 100 mg, segwita minn doża oħra wara 4 ġimgħat imbagħad injezzjoni kull 12-il ġimgħa.
English: Side effects reported with Ilumetri are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Ilumetri huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The dose may be increased to 200 mg in certain patients, for example patients badly affected by the disease or with bodyweight over 90 kg.
Maltese: Id-doża tista' tiżdied għal 200 mg f'ċerti pazjenti, pereżempju, f'pazjenti affettwati severament mill-marda jew b'piż tal-ġisem ta' aktar minn 90 kg.
English: How does Ilumetri work?
Maltese: Kif jaħdem Ilumetri?
English: Treatment centre: ____________________________________ Name of prescribing doctor: ___________________________ Phone number of prescribing doctor: _____________________
Maltese: Ċentru tal-kura: ____________________________________ Isem it-tabib li qed jippreskrivi: ___________________________ Numru tat-telefon tat-tabib li qed jippreskrivi: _____________________
English: ATC code: C02KX04.
Maltese: Kodiċi ATC: C02KX04.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Kienu osservati reazzjonijiet avversi ta' uġigħ ta' ras, dardir, u rimettar.
English: • Influenza (flu)
Maltese: • Influwenza (flu)
English: Table 1 Summary of outcome events
Maltese: Tabella 1 Sommarju ta' avvenimenti finali
English: INFORMATION IN BRAILLE Opsumit 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Opsumit 10 mg
English: Morbiditymortality event b
Maltese: Avveniment ta' mobiditàmortalità b
English: EXPIRY DATE EXP
Maltese: DATA TA' SKADENZA EXP
English: Leukopenia6
Maltese: Lewkopenija6
English: Symptomatic endpoints
Maltese: Punti finali sintomatiċi
English: Worsening of PAH n (%) i.v./s.c.
Maltese: Irkadar ta' PAH n (%) Bidu ta' prostanoid i.v./s.c.
English: Opsumit contains lactose.
Maltese: Opsumit fih lactose.
English: Approximately 52%, 46%, and 2% of patients were in WHO FC II, III, and IV, respectively.
Maltese: Madwar 52%, 46%, u 2% tal-pazjenti kienu f'WHO FC II, III, u IV, rispettivament.
English: • rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
Maltese: • rifampicin, clarithromycin, telithromycin (antibijotiċi użati biex jikkuraw infezzjonijiet),
English: In vitro studies
Maltese: in vitro.
English: Date of latest renewal: 23 August 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Diċembru 2013 Data tal-aħħar tiġdid: 23 Awissu 2018
English: Hormonal contraceptives: Macitentan 10 mg once daily did not affect the pharmacokinetics of an oral contraceptive (norethisterone 1 mg and ethinyl estradiol 35 µg).
Maltese: Macitentan 10 mg darba kuljum ma affettwax il-farmakokinetika ta' kontraċettiv orali (norethisterone 1 mg u ethinyl estradiol 35 µg).
English: Figure 1 Kaplan-Meier estimates of the first morbidity-mortality event in SERAPHIN
Maltese: Figura 1 Stimi Kaplan-Meier tal-ewwel avveniment ta' morbidità-mortalità f'SERAPHIN
English: • Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 × ULN) (see sections 4.2 and 4.4).
Maltese: • Valuri fil-linja bażi ta' aminotransferases tal-fwied (aspartate aminotransferases (AST) u/jew alanine aminotransferases (ALT) > 3 × ULN) (ara sezzjonijiet 4.2 u 4.4).
English: - The other ingredients are lactose monohydrate (see section 2 “Opsumit contains lactose, lecithin from soya and sodium"), microcrystalline cellulose (E460i), povidone, sodium starch glycolate Type A (see section 2 “Opsumit contains lactose, lecithin from soya and sodium”), magnesium stearate (E572), polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soya bean lecithin (E322) (see section 2 “Opsumit contains lactose, lecithin from soya and sodium") and xanthan gum (E415).
Maltese: Is-sustanzi l-oħra huma lactose monohydrate (ara sezzjoni 2 “Opsumit fih lactose, lecithin derivat mis-sojja u sodium”), microcrystalline cellulose (E460i), povidone, sodium starch glycolate Tip A (ara sezzjoni 2 “Opsumit fih lactose, lecithin derivat mis-sojja u sodium”), magnesium stearate (E572), polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talkum (E553b), lecithin derivat mill-fażola tas-sojja (E322) (ara sezzjoni 2 “Opsumit fih lactose, lecithin derivat mis-sojja u sodium”), u xanthan gum (E415).
English: Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of effects such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation.
Maltese: Endothelin (ET)-1 u r-riċetturi tiegħu (ETA u ETB) jimmedjaw varjetà ta' effetti bħal vażokostrizzjoni, fibrożi, proliferazzjoni, ipertrofija, u infjammazzjoni.
English: Death c n (%)
Maltese: n (%)
English: After repeated administration, the pharmacokinetics of macitentan are dose-proportional up to and including 30 mg.
Maltese: Wara għoti ripetut, il-farmakokinetika ta' macitentan hija proporzjonali mad-doża sa u inkluż 30 mg.
English: Placebo (N = 250)
Maltese: (N = 250)
English: Logrank p-value
Maltese: Valur p logrank
English: Polysorbate 80 (E433)
Maltese: Magnesium stearate (E572) Polysorbate 80 (E433)
English: Pulmonary veno-occlusive disease
Maltese: marda veno-okklussiva tal-pulmun.
English: • carbamazepine (used to treat depression and epilepsy),
Maltese: • carbamazepine (użat biex jikkura depressjoni u epilessija),
English: The most commonly reported adverse reactions are nasopharyngitis (14%), headache (13.6%) and anaemia (13.2%, see section 4.4).
Maltese: ras (13.6%) u anemija (13.2%, ara sezzjoni 4.4).
English: Treatment comparison: macitentan 10 mg vs placebo
Maltese: Paragun tal-kura: macitentan 10 mg kontra plaċebo
English: Tubular dilatation was fully reversible.
Maltese: Twessigħ tat-tubuli kien kompletament riversibbli.
English: Exposure to the active metabolite of macitentan was reduced by 26%.
Maltese: Esponiment għall-metabolit attiv ta' macitentan naqas b'26%.
English: Anaemia, haemoglobin decrease5
Maltese: Anemija, tnaqqis fl-emoglobina5
English: OUTER CARTON/BOTTLE
Maltese: KARTUNA TA' BARRA/FLIXKUN
English: • St. John's Wort (an herbal preparation used to treat depression),
Maltese: John's wort (preparazzjoni mill-ħxejjex użata biex tikkura depressjoni),
English: Testicular tubular dilatation was observed in chronic toxicity studies with male rats and dogs with safety margins of 11.6 and 5.8, respectively.
Maltese: Twessigħ tat-tubuli tat-testikoli kien osservat fi studji dwar it-tossiċità kronika b'firien u klieb maskili b'marġini ta' sigurtà ta' 11.6 u 5.8, rispettivament.
English: Opsumit is a registered trademark of Actelion Pharmaceuticals Ltd
Maltese: Opsumit huwa trejdmark reġistrat ta' Actelion Pharmaceuticals Ltd
English: - The active substance is macitentan.
Maltese: X'fih Opsumit Is-sustanza attiva hi macitentan.
English: No data are available.
Maltese: L-ebda dejta mhi disponibbli.
English: Several members of the CYP2C family, namely CYP2C8, CYP2C9 and CYP2C19, as well as CYP3A4, are involved in the formation of these metabolites.
Maltese: Diversi membri tal-familja CYP2C, jiġifieri CYP2C8, CYP2C9 u CYP2C19, kif ukoll CYP3A4, huma nvoluti fil formazzjoni ta' dawn il-metaboliti.
English: Oedema, fluid retention3
Maltese: Edima, żamma ta' fluwidi3
English: • ketoconazole (except shampoo), itraconazole, voriconazole (medicines used against fungal infections)
Maltese: • nefazodone (użat biex jikkura depressjoni), • ketoconazole (minbarra xampù), itraconazole, voriconazole (mediċini użati kontra infezzjonijiet fungali)
English: In two double-blind clinical studies in patients with digital ulcers associated with systemic sclerosis, the incidences of peripheral oedema AEs ranged from 13.4% to 16.1% in the macitentan 10 mg groups and from 6.2% to 4.5% in the placebo groups.
Maltese: F'żewġ studji kliniċi double-blind f'pazjenti b'ulċeri fisswaba assoċjati ma' sklerożi sistemika, l-inċidenzi ta' AEs ta' edima periferali varjat minn 13.4% sa 16.1% fil-gruppi ta' macitentan 10 mg u minn 6.2% sa 4.5% fil-gruppi tal-plaċebo.
English: The combination of macitentan with strong CYP3A4 inducers should be avoided (see section 4.4).
Maltese: Il-kombinazzjoni ta' macitentan ma' indutturi qawwija ta' CYP3A4 għandha tkun evitata (ara sezzjoni 4.4).
English: Macitentan and its active metabolite ACT-132577 are well distributed into tissues as indicated by an apparent volume of distribution (Vss/F) of approximately 50 L and 40 L for macitentan and ACT-132577, respectively.
Maltese: Macitentan u l-metabolit attiv tiegħu ACT-132577 huma distribwiti sew fit-tessuti kif indikat minn volum ta' distribuzzjoni (Vss/F) apparenti ta' madwar 50 L u 40 L għal macitentan u ACT-132577, rispettivament.
English: Other metabolic pathways yield products without pharmacological activity.
Maltese: Rotot metaboliċi oħra tagħtu prodotti mingħajr attività farmakoloġika.
English: The cytochrome P450 enzymes CYP3A4, CYP2C8, CYP2C9, and CYP2C19 are involved in the metabolism of macitentan and formation of its metabolites (see section 5.2).
Maltese: L-enzimi taċ-ċitokromu P450 CYP3A4, CYP2C8, CYP2C9, u CYP2C19 huma involuti fil metaboliżmu ta' macitentan u fil-formazzjoni tal-metaboliti tiegħu (ara sezzjoni 5.2).
English: There is limited clinical experience in patients over the age of 75 years.
Maltese: Hemm esperjenza klinika limitata f'pazjenti b'età 'l fuq minn 75 sena.
English: • regular monitoring of haemoglobin levels;
Maltese: • b'mod regolari ta' monitoraġġ tal-livelli tal-emoglobina;
English: The safety of macitentan has been evaluated in a long-term placebo-controlled trial of 742 patients with symptomatic PAH.
Maltese: Is-sigurtà ta' macitentan ġiet evalwata fi prova fit-tul ikkontrollata bil-plaċebo ta' 742 pazjent b'PAH
English: • phenytoin (a medicine used to treat seizures),
Maltese: • phenytoin (mediċina użata biex tikkura aċċessjonijiet),
English: Poly(vinyl-alcohol) (E1203)
Maltese: Poly(vinyl-alcohol) (E1203) Titanium dioxide (E171) Talkum (E553b)
English: Warfarin: Macitentan given as multiple doses of 10 mg once daily had no effect on exposure to S-warfarin (CYP2C9 substrate) or R-warfarin (CYP3A4 substrate) after a single dose of 25 mg warfarin.
Maltese: Warfarin: Macitentan mogħti bħala dożi multipli ta' 10 mg darba kuljum ma kellu l-ebda effett fuq l-esponiment għal S-warfarin (sottostrat ta' CYP2C9) jew R-warfarin (sottostrat ta' CYP3A4) wara doża waħda ta' 25 mg warfarin.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 4.6 Fertility, pregnancy, and lactation
Maltese: .6 Fertilità, tqala u treddigħ
English: Macitentan is not a substrate for Pgp/MDR-1.
Maltese: P-gp/MDR-1.
English: The safety margins for fertility were 18 for male and 44 for female rats.
Maltese: Il-marġini tas-sigurtà għall-fertilità kienu ta' 18 għall-firien maskili u 44 għal dawk femminili.
English: Macitentan has four primary metabolic pathways.
Maltese: Macitentan għandu erba' rotot metaboliċi primarji.
English: • Breastfeeding (see section 4.6).
Maltese: • Treddigħ (ara sezzjoni 4.6).
English: EU/1/13/893/002
Maltese: EU/1/13/893/001 EU/1/13/893/002
English: • If it is possible you could become pregnant, use a reliable form of birth control (contraception)
Maltese: • Jekk huwa possibbli li toħroġ tqila, uża forma affidabbli ta' kontroll tat-twelid (kontraċezzjoni)
English: At baseline, the majority of enrolled patients (64%) were treated with a stable dose of specific therapy for PAH, either oral phosphodiesterase inhibitors (61%) and/or inhaled/oral prostanoids (6%).
Maltese: Fil-linja bażi, il-maġġoranza tal-pazjenti rreġistrati (64%) kienu kkurati b'doża stabbli ta' terapija speċifika għal PAH, inibituri orali ta' phosphodiesterase (61%) u/jew prostanoids meħuda man nifs/orali (6%).
English: Treatment with macitentan 10 mg resulted in a 45% risk reduction (hazard ratio [HR] 0.55; 97.5% CI: 0.39 to 0.76; logrank p < 0.0001) of the composite morbidity-mortality endpoint up to EOT when compared to placebo [Figure 1 and Table 1].
Maltese: Kura b'macitentan 10 mg wasslet għal tnaqqis fir-riskju ta' 45% (proporzjon ta' periklu [HR - hazard ratio] 0.55; CI ta' 97.5% 0.39 sa 0.76; logrank p < 0.0001) tal-punt finali kompost ta' morbiditàmortalità sa EOT meta mqabbel mal-plaċebo [Figura 1 u Tabella 1].
English: • regular monitoring of liver function;
Maltese: • b'mod regolari ta' monitoraġġ tal-funzjoni tal-fwied;
English: Macitentan and its active metabolite are not relevant substrates of OATP1B1 and OATP1B3, but enter the liver by passive diffusion.
Maltese: Macitentan u l-metabolit attiv tiegħu mhumiex sottostrati rilevanti ta' OATP1B1 u OATP1B3, iżda jidħlu fil-fwied permezz ta' diffużjoni passiva.
English: This corresponded to 3.5 events / 100 patient-years on macitentan 10 mg compared to 2.7 events / 100 patient-years on placebo.
Maltese: Dan jikkorrispondi għal 3.5 avvenimenti/100 sena ta' pazjent fuq macitentan 10 mg imqabbel ma' 2.7 avvenimenti/100 sena ta' pazjent fuq il-plaċebo.
English: The number of deaths of all causes up to EOS on macitentan 10 mg was 35 versus 44 on placebo (HR 0.77; 97.5% CI: 0.46 to 1.28).
Maltese: In-numru ta' mwiet minn kull kawża sa EOS fuq macitentan 10 mg kien ta' 35 kontra 44 fuq plaċebo (HR 0.77; CI ta' 97.5%: 0.46 sa 1.28).
English: Nasal congestion1
Maltese: Konġestjoni fl-imnieħer1
English: In a long-term doubleblind study in patients with PAH, hypotension was reported for 7.0% and 4.4% of patients on macitentan 10 mg and placebo, respectively.
Maltese: Fi studju double-blind fit-tul f'pazjenti b'PAH, pressjoni baxxa kienet irrappurtata f'7.0% u 4.4% tal-pazjenti fuq macitentan 10 mg u plaċebo, rispettivament.
English: How to store Opsumit 6.
Maltese: Kif taħżen Opsumit 6.
English: Aminotransferase elevations4
Maltese: Żidiet fl-aminotransferase4
English: Caution should be exercised when macitentan is administered concomitantly with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir) (see section 4.5).
Maltese: (eż., itraconazole, ketoconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, u saquinavir) (ara sezzjoni 4.5).
English: • The risk of anaemia, hepatotoxicity and teratogenicity and the need for reliable contraception;
Maltese: • Ir-riskju ta' anemija, epatotossiċità u teratoġeniċità u l-ħtieġa ta' kontraċezzjoni affidabbli;
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, nuqqas totali ta' lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Macitentan and its active metabolite are not inhibitors of hepatic or renal efflux pumps at clinically relevant concentrations, including the multi-drug resistance protein (P-gp, MDR-1) and multidrug and toxin extrusion transporters (MATE1 and MATE2-K).
Maltese: F'konċentrazzjonijiet klinikament rilevanti Macitentan u l-metabolit attiv tiegħu mhumiex inibituri talpompi tal-effluss tal-fwied jew tal-kliewi, inkluż il-proteina ta' reżistenza għal ħafna mediċini (P-gp, MDR-1) u trasportaturi ta' ħafna mediċini u ta' tneħħija ta' tossina (MATE1 u MATE2-K).
English: This increase is not considered clinically relevant (see sections 4.2 and 4.4).
Maltese: Dan it-tnaqqis mhux ikkunsidrat klinikament rilevanti (ara sezzjonijiet 4.2 u 4.4).
English: Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean lecithin (E322).
Maltese: Kull pillola miksija b'rita fiha madwar 37 mg ta' lactose (bħala monohydrate) u madwar 0.06 mg ta' lecithin li huwa derivat mill-fażola tas-sojja (E322).
English: The predicted increase was approximately 3fold in the presence of ketoconazole 200 mg twice daily using physiologically based pharmacokinetic (PBPK) modelling.
Maltese: Iż-żieda mbassra kienet ta' madwar 3 darbiet fil-preżenza ta' ketoconazole 200 mg darbtejn kuljum bl-użu ta' immudellar farmakokinetiku bbażat fuq il-fiżjoloġija (PBPK - physiologically based pharmacokinetic).
English: The pharmacodynamic effect of warfarin on International Normalised Ratio (INR) was not affected by macitentan.
Maltese: Internazzjonali (INR - International Normalized Ratio) ma kienx affettwat minn macitentan.
English: Exposure to macitentan was decreased by 21%, 34%, and 6% and, for the active metabolite by 20%, 25%, and 25% in subjects with mild, moderate or severe hepatic impairment, respectively.
Maltese: L-esponiment għal macitentan kien imnaqqas b'21%, 34%, u 6% u, għall-metabolit attiv b'20%, 25%, u 25% f'individwi b'indeboliment tal-fwied ħafif, moderat jew sever, rispettivament.
English: The mean age of all patients was 46 years (range 12-85 years of age, including 20 patients below 18, 706 patients between 18-74 years, and 16 patients aged 75 and older) with the majority of subjects being Caucasian (55%) and female (77%).
Maltese: L-età medja tal-pazjenti kollha kienet ta' 46 sena (firxa ta' 12-85 sena, inkluż 20 pazjent taħt it-18, 706 pazjent bejn 18-74 sena, u 16-il pazjent b'età minn 75 'il fuq) bil-maġġoranza tal-individwi kienu Kawkasi (55% ) u nisa (77%).
English: • ritonavir, saquinavir (used to treat HIV infections),
Maltese: • ritonavir, saquinavir (użati biex jikkuraw infezzjonijiet tal-HIV),
English: In a double-blind study in patients with idiopathic pulmonary fibrosis, the incidence of peripheral oedema AEs in the macitentan and placebo treatment groups was 11.8% and 6.8%, respectively.
Maltese: Fi studju double-blind f'pazjenti b'fibrożi idjopatika tal-pulmun, l-inċidenza ta' AEs ta' edima periferali fil-gruppi ta' kura ta' macitentan u tal-plaċebo kienet ta' 11.8% u 6.8%, rispettivament.
English: Page 4 (inside centre)
Maltese: Paġna 4 (ġewwa ċentru)
English: Efficacy of macitentan 10 mg on the primary endpoint was consistent across subgroups of age, sex, ethnic origin, geographical region, aetiology, by monotherapy or in combination with another PAH therapy and by WHO FC (I/II and III/IV).
Maltese: età, sess, oriġini etnika, reġjun ġeografiku, etjoloġija, bħala monoterapija jew flimkien ma' terapija oħra għal PAH u skont WHO FC (I/II u III/IV).
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean platelet count of 17 × 109/L, versus a mean decrease of 11 × 109/L in placebo-treated patients.
Maltese: Fi studju double-blind f'pazjenti b'PAH, macitentan 10 mg kien assoċjat ma' tnaqqis fl-għadd medju ta' plejtlits ta' 17 × 109/L, kontra tnaqqis medju ta' 11 × 109/L f'pazjenti kkurati bil-plaċebo.
English: This reaction is dependent on the cytochrome P450 system, mainly CYP3A4 (approximately 99%) with minor contributions of CYP2C8, CYP2C9 and CYP2C19.
Maltese: Din ir-reazzjoni hija dipendenti fuq is-sistema taċ ċitokromju P450, l-aktar CYP3A4 (madwar 99%) b'kontribuzzjonijiet minuri ta' CYP2C8, CYP2C9
English: a = based on Cox's Proportional Hazards Model b = % of patients with an event at 36 months = 100 × (1 - KM estimate) c= all cause death up to EOT regardless of prior worsening
Maltese: a = ibbażat fuq Mudell ta' Perikli Proporzjonali ta' Cox b = % ta' pazjenti b'avveniment wara 36 xahar = 100 × (1 - Estimu ta' KM)