FrancophonIA/ELRC3.0 huggingface dataset:
English: In placebo-controlled studies, marked decreases in haemoglobin (> 15% decrease from baseline with value < lower limit of normal) were observed in 7% of patients treated with Thelin (N = 149) and 3% of placebo-treated patients (N = 155).
Maltese: Fi studji kkontrollati bil-plaċebo, tnaqqis sostanzjali fl-emoglobina (tnaqqis ta' >15% mill-linja bażi b'valur <limitu t'isfel tan-normal) kien osservat f'7% tal-pazjenti ttrattati b'Thelin (N = 149) u fi 3% ta' pazjenti ttrattati bil-plaċebo (N = 155).
English: Omeprazole (substrate of CYP2C19): Concomitant administration of Thelin with omeprazole increased the omeprazole AUC0-24 by 30%; Cmax was unchanged.
Maltese: Omeprazole (sottostrat ta' CYP2C19): Meta Thelin ingħata flimkien ma' omeprazole kien hemm żiedet fl-AUC0-24 ta' omeprazole bi 30%; Cmax ma nbidilx.
English: Thelin is a potent (Ki 0.43 nM) and highly selective ETA antagonist (approximately 6,500-fold more selective for ETA as compared to ETB).
Maltese: Thelin huwa antagonist qawwi ta' l-ETA (Ki 0.43 nM) u selettiv ħafna (bejn wieħed u ieħor 6,500 aktar selettiv għall-ETA meta mqabbel ma' ETB).
English: Sitaxentan sodium is more than 99% protein bound to plasma proteins, predominantly albumin.
Maltese: Sitaxentan sodium huwa aktar minn 99% mwaħħal mal-proteini tal-plażma, l-biċċa l-kbira albumina.
English: Thelin tablets contain lactose monohydrate.
Maltese: Il-pilloli Thelin fihom lattosju monohydrate.
English: Use in children and adolescents (< 18 years).
Maltese: Użu fit-tfal u l-adoloxxenti (< 18 years).
English: • The tablet core contains cellulose, microcrystalline (E460), lactose monohydrate, hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), anhydrous disodium phosphate (E339), ascorbyl palmitate (E304), disodium edetate and monobasic sodium phosphate (E339).
Maltese: • Il-qalba tal-pillola tikkonsisti minn cellulose, microcrystalline (E460), lactose monohydrate, hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), anhydrous disodium phosphate (E339), ascorbyl palmitate (E304), disodium edetate u monobasic sodium phosphate (E339).
English: Haemoglobin concentration
Maltese: Konċentrazzjoni ta' l-emoglobina
English: The placebo-corrected increases in walk distance in the whole cohort compared to baseline were 35 metres (p = 0.006; ANCOVA) and 31 metres (p < 0.05; ANCOVA), respectively.
Maltese: Iż-żidiet fid-distanza li l-pazjent mexa (ikkoreġuta għallplaċebo) f'dan l-istudju kollu, meta mqabbla mal-linja bażi kienet ta' 35 metru (p=0.006, ANCOVA) u 31 metru (p<0.05, ANCOVA), rispettivament.
English: Effects of other medicinal products on Thelin
Maltese: Effetti ta' prodotti mediċinali oħrajn fuq Thelin
English: During clinical trials, Thelin was given as a daily oral dose of 1000 mg/day for 7 days to healthy volunteers.
Maltese: Waqt provi kliniċi, Thelin kien qed jingħata bħala doża orali ta' 1000 mg/kuljum għal 7 ijiem lil voluntieri b'saħħithom.
English: V.J.
Maltese: A-Ċ).
English: Approximately 50-60% of an oral dose is excreted in the urine with the remainder eliminated in the faeces.
Maltese: Madwar 50-60% tad-doża orali hi eliminata fl-awrina bil-bqija tiġi eliminata ma' l-ippurgar.
English: Rash (various types and presentations)
Maltese: Raxx (tipi u preżentazzjonijiet varji)
English: Thelin increases the plasma levels of Vitamin K antagonists such as warfarin, acenocoumarol and fenprocoumon (see section 4.5).
Maltese: Thelin iżid il-livelli tal-plażma ta' l-antagonisti tal-Vitamina K bħal warfarin, acenocoumarol u fenprocoumon (ara taqsima 4.5).
English: Decreased Haemoglobin (see section 4.4)
Maltese: Tnaqqis fl-Emoglobina (ara taqsima 4.4)
English: Predominant actions of ET-1 binding to ETA are vasoconstriction and vascular remodelling, while binding to ETB results in ET-1 clearance, and vasodilatory/ antiproliferative effects due in part to nitric oxide and prostacyclin release.
Maltese: L-effetti predominanti tat-twaħħil ta' ET-1 ma' ETA huma, vasorestrizzjoni u mmudellar vaskulari mill-ġdid, filwaqt li t-twaħħil ma' ETB jirriżulta fl-eliminazzjoni ta' ET-1, u f'effetti vasodilatorji/antiproliferattivi li parti minnhom huma effetti tal-liberazzjoni ta' nitric oxide u prostacyclin.
English: Two randomized, double-blind, multi-centre, placebo-controlled trials were conducted to demonstrate efficacy.
Maltese: Żewġ provi randomized, double-blind, multi-centre, ikkontrollati bil-plaċebo twettqu biex juru leffikaċja.
English: Thelin 100 mg film-coated tablets Sitaxentan sodium
Maltese: Thelin 100 mg pilloli miksija b'rita Sitaxentan sodium
English: The mechanism of liver toxicity is not fully documented and it might vary between endothelin receptor antagonists.
Maltese: Il-mekkaniżmu ta' tossiċita' tal-fwied mhix dokumentata kompletament u tista' tvarja bejn antagonisti tar-riċettur endothelin.
English: Blood and lymphatic system disorders Haemoglobin decrease (rarely resulting in anaemia), haematocrit decrease
Maltese: Disturbi tad-demm u tas-sistema limfatika Tnaqqis fl-emoglobina (li rarament tirriżulta f'anemija), tnaqqis flematokrita
English: Sildenafil (substrate of CYP3A4): A single dose of sildenafil 100 mg coadministered with Thelin increased Cmax and AUC∞ of sildenafil by 18% and 28%, respectively.
Maltese: Doża waħda ta' sildenafil 100 mg mogħtija ma' Thelin żiedet Cmax and AUC∞ ta' sildenafil bi 18% u 28% rispettivament.
English: STRIDE-4 included 98 patients randomised to sitaxentan sodium 50 mg, 100 mg, and placebo once daily for 18 weeks.
Maltese: STRIDE-4 inkludiet 98 pazjent li ġew mogħtija b'ordni addoċċ sitaxetan sodium 50mg, 100mg, u plaċebo darba kuljum għal tmintax-il gimgħa.
English: A NOAEL has not been established.
Maltese: NOAEL ma ġiex stabbilit.
English: Liver aminotransferases increase, bilirubin increase (associated with liver aminotransferase increase)
Maltese: Żieda fl-aminotransferases tal-fwied, żieda fil-bilirubin (assoċċjata ma' żieda tal-aminotransferase tal-fwied)
English: • Effect of Thelin on bleeding o Interaction with warfarin and vitamin K antagonists leading to an increased INR o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium o Need for regular monitoring of INR o Be aware of the potential for haemorrhage and investigate as appropriate o Increased risk of epistaxis and gingival bleeding
Maltese: • L-effett ta' Thelin fuq il-ħruġ tad-demm o Interazzjoni ma' warfarin u antagonisti ta' vitamina K li jwasslu għal żieda fl-INR o Il-ħtieġa li tnaqqas id-doża stabbilita ta' l-antagonisti ta' vitamina K meta tibda t terapija b'sitaxentan o Ibda l-kura bl-antagonisti ta' vitamina K b'doża mnaqqsa jekk diġà qed jingħata sitaxentan sodium o Il-ħtieġa ta' monitoraġġ regolari ta' l-INR o Kun af dwar il-potenzjal ta' emorraġija u investiga kif suppost o Żieda fir-riskju li tinfaraġ u ħruġ ta' demm ġinġivali
English: • If you are taking a statin (e.g. pravastatin or simvastatin).
Maltese: • Jekk qed tieħu xi statin (eż. pravastatin jew simvastatin).
English: The most common metabolic products are at least 10 times less potent as ETA antagonists than sitaxentan sodium in a standard in vitro test of activity.
Maltese: L-aktar prodotti metaboliċi komuni huma mill-inqas 10 darbiet inqas qawwija minn sitaxentan sodium bħala antagonisti ta' ET A f'test ta' attività in vitro standard.
English: In vitro, sitaxentan sodium is metabolized by CYP2C9 and CYP3A4/5.
Maltese: In vitro, sitaxentan sodium huwa metabolizzat minn CYP2C9 u CYP3A4.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini http://www.ema.europa.eu/.
English: Warfarin (vitamin K antagonist, substrate of CYP2C9): Concomitant treatment with sitaxentan sodium resulted in a 2.4 fold increase in S-warfarin exposure.
Maltese: Warfarin (antagonista tal-vitamina K, sottostrat ta' CYP2C9):
English: In the 26-week study, moderate to marked diffuse seminiferous tubular atrophy was present at a very low incidence, whereas in the 99-week study there was a dose-related, slightly increased incidence of minimal to mild focal atrophy at doses providing 29 to 94 times the human exposure.
Maltese: Fl-istudju ta' 26 ġimgħa, atropija tubulari seminiferuża mifruxa minn moderata sa severa kienet preżenti f'inċidenza baxxa ħafna, filwaqt li fl-istudju ta' 99 ġimgħa kien hemm inċidenza kemmxejn ogħla ta' atropija fokali minn minima sa ħafifa f'dożi li jipprovdu minn 29 sa 94 darba aktar mill-espożizzjoni fil-bniedem.
English: Thelin did not affect fertility in males and females.
Maltese: Thelin ma affettwax il-fertilità fl-irġiel u fin-nisa.
English: No evidence for acute rebound has been observed.
Maltese: L-ebda evidenza ta' rebound akuta ma ġiet osservata.
English: In STRIDE-4, a statistically non-significant placebo-corrected mean improvement of 24.3 metres (p = 0.2078) was observed in the whole cohort.
Maltese: Fil-pazjenti kollha ta' STRIDE-4 ġie osservat ameljorament medju irranġat bi plaċebo u li mhux statistikament sinifikanti, ta' 24.3 metri (p = 0.2078).
English: In this total population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96%, 85% and 78% respectively.
Maltese: F'din il-popolazzjoni totali, stimi ta' sopravivenza Kaplan-Meier kienu ta' 96%, 85% u 78% għall-pazjenti wara terapija ta' sena, sentejn u tlett snin b'sitaxentan sodium rispettivament.
English: • The film-coat contains stearic acid (E570b), hypromellose (E464), microcrystalline cellulose (E460), titanium dioxide (E171), yellow iron oxide dehydrate (E172), red iron oxide dehydrate (E172) and talc (E553b).
Maltese: • Il-kisi tar-rita jikkonsisti minn stearic acid (E570b), hypromellose (E464), microcrystalline cellulose (E460), titanium dioxide (E171), yellow iron oxide dihydrate (E172), red iron oxide dihydrate (E172) u talc (E553b).
English: • That Thelin is hepatotoxic o Need for liver function tests prior to and during treatment o Contraindication in patients with pre-existing hepatic impairment (Child-Pugh Class A-C).
Maltese: • Li Thelin hu epatotossiku o Il-ħtieġa ta' testijiet tal-funzjoni tal-fwied qabel u waqt il-kura o Kontra-indikazzjoni f'pazjenti li kellhom indeboliment tal-fwied li kien jeżisti minn qabel (Child-Pugh Class A-C).
English: Increased Liver Aminotransferases (see section 4.4) Elevations of AST and/or ALT are associated with sitaxentan sodium.
Maltese: Żieda fl-Aminotransferases tal-Fwied (ara taqsima 4.4) Żidiet ta' l-AST u/jew ALT huma assoċjati ma' sitaxentan sodium.
English: Subjects receiving warfarin achieve therapeutic anticoagulation (International Normalised Ratio [INR] target) with lower doses of the anticoagulant in the presence of sitaxentan sodium.
Maltese: Individwi li jieħdu warfarin jilħqu livelli terapewtiċi ta' antikoagulazzjoni (International Normalised Ratio (INR) target) b'dożi aktar baxxi ta' antikoagulant fil-preżenza ta' sitaxentan sodium.
English: Patients had moderate to severe (NYHA/WHO functional class II-IV) PAH resulting from idiopathic pulmonary arterial hypertension (IPAH, also known as primary pulmonary hypertension), connective tissue disease (CTD), or congenital heart disease (CHD).
Maltese: II-IV NYHA/WHO) li tirriżulta minn pressjoni għolja idjopatika fl-arterji tal-pulmun (IPAH, magħrufa ukoll bħala pressjoni pulmonari għolja primarja), mard tat-tessut konnettiv (CTD), jew mard tal-qalb konġenitali (CHD).
English: Sitaxentan sodium does not penetrate into erythrocytes and does not appear to cross the blood-brain barrier.
Maltese: Sitaxentan sodium ma jippenetrax fiċ-ċelluli tad-demm il-ħomor u ma jidhirx li jaqsam il-blood brain barrier.
English: Each tablet contains 100 mg of sitaxentan sodium
Maltese: Kull pillola fiha 100 mg of sitaxentan sodium
English: Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000
Maltese: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
English: In phase 2 and 3 oral studies in patients with PAH, elevations in ALT and/or AST > 3 ULN were observed in 5% of placebo-treated patients (N = 155) and 7% of Thelin 100 mg-treated patients (N = 887).
Maltese: F'fażi 2 u 3 ta' studji orali f'pazjenti bil-PAH, livelli ogħla fl-ALT u/jew AST > 3 ULN kienu osservati f'5% ta' pazjenti ttrattati bil-plaċebo (N = 155) u f'7% tal-pazjenti ttrattati b' Thelin 100 mg.
English: A decrease in haemoglobin concentration by at least 1 g/dl was observed in 60% of patients treated with Thelin as compared to 32% of placebo-treated patients.
Maltese: Tnaqqis filkonċentrazzjoni ta' l-emoglobina b'ta' mill-inqas 1 g/dl kien osservat f'60% tal-pazjenti ttrattati b'Thelin meta mqabbel ma' 32% ta' pazjenti ttrattati bil-plaċebo.
English: No unexpected accumulation in the plasma was observed after multiple dosing at the recommended dose of 100 mg once daily.
Maltese: L-ebda akkummulazzjoni mhux mistennija fil-plażma ma ġiet osservata wara dożaġġ ripetut bid-doża rrakkomandata ta' 100 mg kuljum.
English: There is limited experience with abrupt discontinuation of sitaxentan sodium.
Maltese: Hemm esperjenza limitata dwar il-waqfien f'daqqa ta' sitaxentan sodium.
English: In vitro studies using human liver microsomes or primary hepatocytes show that sitaxentan sodium inhibits CYP2C9, and, to a lesser extent, CYP 2C8, CYP2C19 and CYP3A4/5.
Maltese: Studji in vitro bl-użu ta' mikrosomi tal-fwied tal-bniedem jew epatoċiti primarji juru li sitaxentan sodium jimpedixxi CYP2C9, u, bi ftit inqas, lil CYP 2C8, CYP2C19 u CYP3A4/5.
English: STRIDE-1, which included 178 patients, compared 2 oral doses of Thelin (100 mg once daily and 300 mg once daily) with placebo during 12 weeks of treatment.
Maltese: STRIDE-1, li kien jinkludi 178 pazjent, qabbel 2 dożi orali ta' Thelin (100 mg darba kuljum u 300 mg darba kuljum) mal-plaċebo waqt 12-il ġimgħa ta' kura.
English: PVC/ACLAR/paper-backed aluminium blisters containing 14 tablets.
Maltese: PVC/ACLAR/folji ta' l-aluminju b'dahar tal-karta li fihom 14-il pillola.
English: ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension (PAH), as well as other cardiovascular disorders and connective tissue diseases, including scleroderma, acute and chronic heart failure, myocardial ischaemia, systemic hypertension, and atherosclerosis, suggesting a pathogenic role of ET-1 in these diseases.
Maltese: Il-konċentrazzjonijiet ta' ET-1 huma għoljin fil-plażma u fittessut tal-pulmun ta' pazjenti bi pressjoni għolja fl-arterji pulmonari (PAH), kif ukoll f'każijiet ta' mard kardjovaskulari u mard tat-tessut konnettiv, inkluża l-iskleroderma, insuffiċjenza tal-qalb akuta u kronika, iskemija mijokardijaka, pressjoni għolja sistemika, u aterosklerożi; dan jissuġġerixxi rwol patoġeniku ta' ET-1 f'dan il-mard.
English: General disorders and administration site conditions Fatigue, oedema (most commonly peripheral)
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Għejja, edema (l-aktar komuni dik periferali)
English: In an open-label PAH study, one fatal case of hepatic failure has been reported after chronic dosing of sitaxentan at 600 mg/day administered as 300 mg bid.
Maltese: Fi studju open-label dwar PAH, kien hemm każ waħdieni ta' falliment tal-fwied fatali, li kien irrappurtat wara dużaġġ kroniku ta' sitaxentan 600mg/kuljum, mogħti f'żewġ dożi ta' 300mg darbtejn kuljum.
English: Digoxin (substrate of p-Glycoprotein): Concomitant administration of Thelin did not alter the pharmacokinetics of digoxin indicating no effect on the p-glycoprotein transporter
Maltese: Digoxin (Sottostrat ta' p-Glycoprotein):
English: o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN):
Maltese: o Il-ħtieġa ta' monitoraġġ mill-qrib jekk il-kejl ta' l-enzimi tal-fwied ikun > 3 x il-limitu normali ta' fuq (ULN):
English: Less than 1% of the dose is excreted as unchanged active ingredient.
Maltese: Inqas minn 1% tad-doża hi eliminata bħala ingredjent attiv mhux mibdul.
English: Functional Class: A reduction in symptoms of PAH were observed with sitaxentan sodium 100 mg treatment.
Maltese: Ġie osservat tnaqqis fis-sintomi ta PAH fil-pazjenti li kienu qegħdin jieħdu ittrattament ta' sitaxetan sodium 100mg.
English: Sitaxentan sodium is metabolised in the liver by cytochrome P450 CYP2C9 and CYP3A4/5 isoenzymes.
Maltese: Sitaxentan sodium huwa metabolizzat fil-fwied miċ-ċitokromu P450 u isoenżimi CYP2C9 u CYP3A4/5.
English: The clearance of nelfinavir was not clinically significantly changed in one subject that was classified as a CYP2C19 poor metaboliser.
Maltese: Leliminazzjoni ta' nelfinavir ma kellix bdil klinikament sinifikanti f'suġġett wieħed partikulari li kien klassifikat bħala metabolizzatur batut ta' CYP2C19.
English: The influence of liver impairment on the pharmacokinetics of sitaxentan sodium has not been evaluated.
Maltese: L-influwenza ta' indeboliment tal-fwied fuq il-farmakokinetiċi ta' sitaxentan sodium ma ġietx evalwata.
English: Organic Anion Transporting Polypeptides (OATP) Inhibitors: Co-administration with ciclosporin A, a potent OATP inhibitor, resulted in a 6-fold increase in Cmin and a 67% increase in AUC of sitaxentan therefore the use of Thelin in patients receiving systemic ciclosporin A is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ma' ciclosporin A, inibitur qawwi ta' OATP irriżulta f'żieda ta' 6 darbiet iktar filCmin u żieda ta' 67% fl-AUC ta' sitaxentan, u għalhekk l-użu ta' Thelin f'pazjenti li qegħdin jieħdu ciclosporin A huwa kontra-indikat (ara taqsima 4.3).
English: (16%)) was improved after 12 weeks of treatment.
Maltese: (16%)), wara 12-il ġimgħa ta' trattament.
English: Endothelin receptor antagonists, as a class, have been associated with liver function abnormalities.
Maltese: Bħala kategorija, antagonisti tar-riċettur endothelin, ġew assoċjati ma' anormalitajiet tal-funzjoni tal-fwied.
English: Rare side effects (likely to affect less than 1 in 1000 people):
Maltese: Effetti sekondarji rari (li x'aktarx jaffettwaw inqas minn persuna 1 minn kull 1000 ruħ):
English: Liver aminotransferase elevations may reverse spontaneously while continuing treatment with sitaxentan sodium.
Maltese: Elevazzjonijiet ta' aminotransferases tal-fwied jistgħu jitranġaw spontanjament waqt ilkontinwazzjoni tal-kura b'sitaxentan sodium.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galattosju, id-defiċjenza ta' Lapp lactase, jew assorbiment difettuż ta' glukosju-galattosju m'għandomx jieħdu din il-mediċina.
English: Co-administration with drugs metabolized by CYP2C19 or CYP3A4/5 is not expected to result in clinically significant drug interactions.
Maltese: Meta jingħata ma' mediċini metabolizzati minn CYP2C19 jew CYP3A4/5 mhix mistennija li tirriżulta f'interazzjonijiet mediċinali klinikament sinifikanti.
English: Sitaxentan sodium is an inhibitor of CYP2C9 and, to a lesser extent, CYP2C19, CYP3A4/5 and CYP2C8.
Maltese: Sitaxentan sodium huwa inibitur ta' CYP2C9 u, sa ċertu punt, inibitur iktar dgħajjef ta' CYP2C19, CYP3A4/5 u CYP2C8.
English: A total of 145 patients were treated with sitaxentan sodium 100 mg and their long term survival status was assessed for a minimum of 3 years.
Maltese: Total ta' 145 pazjent ġew ikkurati b'100 mg ta' sitaxetan sodium u is-sopravivenza fuq perijodu twil ta' żmien kien assessjat għal mhux inqas minn 3 snin.
English: The information collected should include: o Anonymised patient details - age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Elevated direct bilirubin > 2 ×ULN o Anaemia o Haemorrhage o Pregnancy and outcome o Pulmonary oedema (associated with veno-occlusive disease) o Suspected interactions o Unexpected ADRs according to the SPC.
Maltese: o Dettalji anonimi tal-pazjent - età, sess u etoloġija tal-PAH o Mediċini li jittieħdu fl-istess ħin o Raġuni dwar għaliex Thelin m'għadux jingħata o ADRs ○ L-ADRs serji kollha ○ Żieda fl-enzimi tal-fwied sa > 3 x ULN ○ Żieda fil-bilirubina tat-tip dirett ta' > 2x ULN ○ Anemija ○ Emorraġija ○ Tqala u r-riżultat ○ Edema pulmonari (assoċjata ma' mard okklużiv tal-vini)
English: Thelin increases oestrogen exposure when given concomitantly with oral contraceptive agents (see Section 4.5).
Maltese: Thelin iżid l-espożizzjoni għall-estroġeni meta jingħata flimkien ma' sustanzi kontraċettivi orali (ara Taqsima 4.5).
English: Pregnancy and breast-feeding
Maltese: Indeboliment pre-eżistenti tal-fwied
English: Given a theoretical higher risk for thromboembolism, traditional concomitant use of vitamin K antagonists should be considered.
Maltese: Minħabba r-riskju teoretiku ogħla għat-tromboemboliżmu, l-użu tradizzjonali konkomitanti ta' antagonisti tal-vitamina K għandu jkun ikkunsidrat.
English: Thelin 100 mg film-coated tablets
Maltese: Thelin 100 mg pilloli miksija b'rita
English: Liver Function Impairment
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI
English: However, at doses of 300 mg or higher, non-linear pharmacokinetics result in disproportionately higher plasma concentrations of sitaxentan sodium.
Maltese: Madankollu, f'dożi ta' 300 mg jew ogħla, farmakokinetiċi mhux lineari rriżultaw f'konċentrazzjonijiet sproporzjonalment ogħla ta' sitaxentan sodium fil-plażma.
English: The degree of binding is independent of concentration in the clinically relevant range.
Maltese: Il-grad ta' twaħħil huwa independenti mill-konċentrazzjoni fil-medda klinikament rilevanti.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Fi żmien 60 ġurnata ta' avveniment importanti (Farmakoviġilanza jew tnaqqis tar-riskju).
English: • cramp in muscles
Maltese: • bugħawwieġ fil-muskoli
English: Respiratory, thoracic, and mediastinal disorders Nasal congestion, epistaxis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Imnieħer misdud, friġ mill-imnieħer
English: • If you have raised levels of some liver enzymes (detected by blood tests);
Maltese: • Jekk għandek livelli għolja ta' xi enzimi tal-fwied (misjuba permezz ta' testijiet tad-demm);
English: Appropriate care should be exercised when initiating sitaxentan in patients who discontinued other endothelin receptor antagonists due to liver enzyme abnormalities (see section 4.8).
Maltese: Għandha tingħata attenzjoni meta, pazjenti li waqqfu antagonisti tar-riċettur endothelin oħrajn għaliex kien hemm annormalita' fl-enżimi tal-fwied, jingħataw sitaxetan (ara sezzjoni 4.8).
English: Testing for anaemia
Maltese: Ittestjar għall-anemija
English: Take special care with Thelin:
Maltese: Oqgħod attent ħafna b'Thelin:
English: Prothrombin time (PT) increase (with concomitant vitamin K antagonist therapy).
Maltese: Zieda fl-INR (b'terapija konkomittanti ta' antagonisti ta' vitamina K). Prothrombin (PT) imtawwal (b'terapija konkomittanti ta' antagonisti ta' vitamina K)
English: At high doses, dose-related increases in prothrombin time (PT) and activated partial thromboplastin time (APTT) were also seen, most prominently in rats, and coagulopathy (bleedings) in rats and dogs, but not mice.
Maltese: F'dożi għoljin, żidiet marbuta mad-doża fil-prothrombin time (PT) u fl-activated partial thromboplastin time (APTT), intwerew ukoll, bl-iktar mod prominenti fil-firien, u koagulopatija (ħruġ ta' demm) fil-firien u fil-klieb, imma mhux fil-ġrieden.
English: • feeling sick (nausea)
Maltese: • tkun marid (rimettar)