FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains 3.7 mg of aspartame in each dispersible tablet.
Maltese: Din il-mediċina fiha 3.7 mg ta' aspartame f'kull pillola li tixtered.
English: In a pharmacokinetic crossover study (AC-052-116), 16 healthy adult subjects received 62.5 mg bosentan using the 62.5 mg film-coated tablet formulation or 64 mg bosentan using the 32 mg dispersible tablet formulation.
Maltese: Fi studju crossover dwar il-farmakokinetika (AC-052-116), 16-il individwu adult f'saħħithom irċevew 62.5 mg ta' bosentan fejn intużat il-formulazzjoni ta' pillola miksija b'rita ta' 62.5 mg jew 64 mg ta' bosentan fejn intużat il-formulazzjoni ta' pillola li tinxtered ta' 32 mg.
English: Simvastatin: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate) and its active β-hydroxy acid metabolite by 34% and 46%, respectively.
Maltese: L-għoti flimkien ta' 125 mg ta' bosentan darbtejn kuljum għal 5 ijiem naqqas ilkonċentrazzjonijiet ta' simvastatin fil-plażma (sottostrat ta' CYP3A4) u l-metabolit attiv tiegħu βhydroxy acid b'34% u 46% rispettivament.
English: ALT/AST levels
Maltese: Il-livelli ta'
English: In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients were treated with placebo.
Maltese: F'20 studju kkontrollat bil-plaċebo, imwettqa f'varjetà ta' indikazzjonijiet terapewtiċi, total ta' 2,486 pazjent kienu kkurati b'bosentan b'dożi ta' kuljum li varjaw minn 100 mg sa 2000 mg u 1,838 pazjent kienu kkurati bil-plaċebo.
English: Tmax and t1/2 of bosentan were not significantly affected by the formulation.
Maltese: Tmax u t1/2 ta' bosentan ma kinux affettwati b'mod sinifikanti mill-formulazzjoni.
English: The impact of moderately impaired liver function (Child-Pugh class B) on the pharmacokinetics of bosentan and its primary metabolite Ro 48-5033 was investigated in a study including 5 patients with pulmonary hypertension associated with portal hypertension and Child-Pugh class B hepatic impairment, and 3 patients with PAH from other causes and normal liver function.
Maltese: L-impatt ta' indeboliment moderat fil-funzjoni tal-fwied (Child-Pugh klassi B) fuq il-farmakokinetika ta' bosentan u l-metabolit primarju tiegħu Ro 48-5033 kien investigat fi studju li kien jinkludi 5 pazjenti bi pressjoni pulmonari għolja assoċjata ma' pressjoni portali għolja u indeboliment tal-fwied Child-Pugh Klassi B, u 3 pazjenti b'PAH minn kawżi oħra u funzjoni tal-fwied normali.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 5.2)
Maltese: • Indeboliment tal-fwied minn moderat sa sever, i.e. Child-Pugh klassi B jew Ċ (ara sezzjoni 5.2)
English: Tracleer is contraindicated in pregnancy (see section 4.3).
Maltese: Tracleer hu kontraindikat waqt it-tqala (ara sezzjoni 4.3).
English: • hormonal contraceptives, which are not effective as the sole method of contraception when you take Tracleer.
Maltese: • kontraċettivi ormonali, li mhumiex effettivi bħala metodu uniku ta' kontraċezzjoni meta inti tieħu Tracleer.
English: Lopinavir+ritonavir (and other ritonavir-boosted protease inhibitors): Co-administration of bosentan 125 mg twice daily and lopinavir+ritonavir 400+100 mg twice daily for 9.5 days in healthy volunteers resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after bosentan administered alone.
Maltese: Lopinavir+ritonavir (u inibituri ta' protease msaħħa b'ritonavir oħrajn): L-għoti ta' bosentan 125 mg darbtejn kuljum flimkien ma' lopinavir+ritonavir 400+100 mg darbtejn kuljum għal 9.5 ijiem f'voluntiera f'saħħithom, irriżulta f'konċentazzjonijiet tal-bidu l-aktar baxxi fil-plażma ta' bosentan li kienu madwar 48 darba ogħla minn dawk imkejla wara li bosentan kien mogħti waħdu.
English: In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with Tracleer who had a suspected diagnosis of pulmonary veno-occlusive disease.
Maltese: Fil-perjodu ta' wara t-tqegħid fis-suq, kien hemm rapporti rari ta' edima pulmonari f'pazjenti kkurati bi Tracleer li kellhom dijanjosi suspetta ta' mard veno-okklussiv pulmonari.
English: Sildenafil: Co-administration of bosentan 125 mg twice daily (steady state) with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease in the sildenafil AUC and a 50% increase in the bosentan AUC.
Maltese: Sildenafil: L-għoti flimkien ta' 125 mg ta' bosentan darbtejn kuljum (stat fiss) ma' 80 mg ta' sildenafil tliet darbiet kuljum (fl-istat fiss) mogħtija flimkien fuq medda ta' 6 ijiem f'voluntiera f'saħħithom, irriżulta fi tnaqqis ta' 63% fl-AUC ta' sildenafil u żieda ta' 50% fl-AUC ta' bosentan.
English: Aspartame (E951), see the package leaflet for further information Aspartame (E951) may be harmful for people with phenylketonuria
Maltese: Aspartame (E951), ara l-fuljett ta' tagħrif għall-aktar informazzjoni Aspartame (E951) jista' jkun ta' ħsara għall-persuni b'phenylketonuria
English: Tracleer 32 mg dispersible tablets are pale yellow to off-white, clover-shape dispersible tablets, quadrisected on one side and debossed with “32” on the other side.
Maltese: Tracleer 32 mg, pilloli li jinxterdu huma pilloli li jinxterdu sofor ċari sa off-white, forma ta' silla, b'sinjali biex jinqasmu f'erbgħa fuq naħa waħda u b'“32” imnaqqax fuq in-naħa l-oħra.
English: 5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo.
Maltese: Edima jew żamma ta' fluwidu kienet irrapportata fi 13.2% tal-pazjenti fuq bosentan u f'10.9% tal-pazjenti fuq il-plaċebo.
English: FUTURE 1 was an open-label, uncontrolled study that was conducted with the dispersible tablet formulation of bosentan administered at a maintenance dose of 4 mg/kg twice daily to 36 patients from 2 to 11 years of age.
Maltese: FUTURE 1 kien studju open-label, mhux ikkontrollat li twettaq bil-formulazzjoni tal-pillola li tinxtered ta' bosentan mogħti b'doża ta' manteniment ta' 4 mg/kg darbtejn kuljum lil 36 pazjent b'età minn sentejn sa 11-il sena.
English: Aspartame is a source of phenylalanine.
Maltese: phenylalanine.
English: In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, elevations in liver aminotransferases ≥ 3 × ULN were observed in 2% of patients.
Maltese: FUTURE 1/2 u FUTURE 3/Estensjoni, elevazzjonijiet fl-aminotransferases tal-fwied ta' ≥ 3 × ULN kienu osservati f'2% tal-pazjenti.
English: - The other ingredients are cellulose microcrystalline, calcium hydrogen phosphate anhydrous, croscarmellose sodium, silica colloidal anhydrous, tartaric acid, tutti frutti flavour, aspartame (E951, please read further information at the end of section 2), acesulfame potassium, magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, croscarmellose sodium, silica colloidal anhydrous, tartaric acid, benna ta' tutti frutti, aspartame
English: Tracleer 62.5 mg film-coated tablets Tracleer 125 mg film-coated tablets
Maltese: Tracleer 62.5 mg, pilloli miksija b'rita Tracleer 125 mg pilloli miksija b'rita
English: Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1).
Maltese: Tracleer huwa indikat ukoll biex inaqqas in-numru ta' ulċeri ġodda fis-swaba' f'pazjenti bi sklerosi sistemika u l-preżenza tal-marda tal-ulċeri fis-swaba' (ara sezzjoni 5.1).
English: In the post-marketing period there was one reported overdose of 10,000 mg of Tracleer taken by an adolescent male patient.
Maltese: Fil-perjodu ta' wara t-tqegħid fis-suq, kienet irrapportata doża eċċessiva waħda ta' 10,000 mg ta' Tracleer li ttieħdet minn pazjent maskili adolexxenti.
English: Tracleer 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Maltese: Tracleer 125 mg pilloli miksija b'rita Pilloli miksija b'rita, bojod fl-oranġjo, ovali, konvessi miż-żewġ naħat, bil-kitba “125” imnaqqxa fuq naħa waħda.
English: Sep _____
Maltese: Set _____
English: In the event of late clinical deterioration despite treatment with Tracleer (i.e., after several months of treatment), the treatment should be re-assessed.
Maltese: Fil-każ ta' deterjorament kliniku tard minkejja kura bi Tracleer (i.e. wara ħafna xhur ta' kura), il-kura għandha terġa' tkun evalwata mill-ġdid.
English: In the post-marketing period rare cases of unexplained hepatic cirrhosis were reported after prolonged therapy with Tracleer in patients with multiple co-morbidities and therapies with medicinal products.
Maltese: Fil-perjodu ta' wara t-tqegħid fis-suq kienu rrappurtati każijiet rari ta' ċirrożi tal-fwied mhux spjegati wara terapija fit-tul b'Tracleer f'pazjenti b'ko-morbiditajiet multipli u terapiji bi prodotti mediċinali.
English: At study entry, patients were treated with PAH medications (most frequently phosphodiesterase type-5 inhibitor [sildenafil] alone [35.9%], bosentan alone [10.9%], and a combination of bosentan, iloprost, and sildenafil [10.9%]) and continued their PAH treatment during the study.
Maltese: Meta daħlu fl-istudju, il-pazjenti kienu kkurati b'medikazzjoni għall-PAH (l-aktar frekwenti, inibitur ta' phosphodiesterase tat-tip 5 [sildenafil] waħdu [35.9%], bosentan waħdu [10.9%], u kombinazzjoni ta' bosentan, iloprost, u sildenafil [10.9%]) u komplew il-kura tagħhom għal PAH matul l-istudju.
English: Aluminium/Aluminium peel-push blisters containing 14 dispersible tablets.
Maltese: Folji ‘peel-push' ta' Aluminju/Aluminju li fihom 14-il pillola li tinxtered.
English: In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
Maltese: Fi studju randomised u kkontrollat bil-plaċebo, li sar f'pazjenti b'PPHN (FUTURE-4), total ta' 13-il tarbija tat-twelid kienu kkurati bil-formulazzjoni tal-pillola li tinxtered ta' bosentan b'doża ta' 2 mg/kg darbtejn kuljum (8 pazjenti kienu fuq plaċebo).
English: In the overall population (n = 31), 2 mg/kg twice daily resulted in a daily exposure of 8,535 ng·h/mL; AUCτ was 4,268 ng·h/mL (CV: 61%).
Maltese: 8,535 ng·siegħa/mL; AUCt kien ta' 4,268 ng·siegħa/mL (CV: 61%).
English: The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%.
Maltese: Il konċentrazzjonijiet ta' cyclosporine A (sottostrat ta' CYP3A4) fid-demm naqset b'madwar 50%.
English: Cartons contain 14, 56 or 112 film-coated tablets.
Maltese: Il-kartun fihom 14, 56 jew 112-il pillola miksija b'rita.
English: Following treatment with the dispersible tablet, exposure to bosentan was lower than with the film-coated tablet (ratio of geometric means for AUC0-∞ 0.87 [90% CI: 0.78, 0.97]).
Maltese: Wara l-kura bil-pillola li tinxtered, l-esponiment għal bosentan kien inqas minn dak bil-pillola miksija b'rita (proporzjon ta' medji ġeometriċi għal AUC0-∞ 0.87 [90% CI: 0.78, 0.97]).
English: • Anaphylaxis (general allergic reaction), angioedema (swelling, most commonly around the eyes, lips, tongue or throat)
Maltese: • Anafilassi (reazzjoni allerġika ġenerali), anġjoedima (nefħa, l-aktar komuni madwar l-għajnejn, xofftejn, ilsien jew griżmejn)
English: In a juvenile rat toxicity study, where rats were treated from Day 4 post partum up to adulthood, decreased absolute weights of testes and epididymides, and reduced number of sperm in epididymides were observed after weaning.
Maltese: Fi studju dwar l-effett tossiku f'firien żgħażagħ, fejn firien kienu kkurati minn Jum 4 post partum sa meta jsiru adulti, kien osservat tnaqqis fil-piż assolut tal-testikoli u tal-epididimi, u numru mnaqqas ta' sperma flepididimi wara li nfatmu.
English: In the event of associated clinical symptoms of liver injury, i.e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of Tracleer is not to be considered.
Maltese: Fil-każ ta' sintomi kliniċi assoċjati ma' ħsara tal-fwied, i.e. dardir, rimettar, deni, uġigħ addominali, suffejra, telqa u għeja mhux tas-soltu, sindrome bħall-influwenza (uġigħ fil-ġogi, uġigħ fil-muskoli, deni), il-kura għandha titwaqqaf u m'għandux jiġi kkunsidrat li l-kura bi Tracleer terġa' tinbeda.
English: Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with Tracleer should be avoided (see section 4.5).
Maltese: L-għoti flimkien kemm ta' impeditur ta' CYP3A4 kif ukoll ta' impeditur ta' CYP2C9 ma' Tracleer għandu jiġi evitat (ara sezzjoni 4.5).
English: The co-primary endpoints were percentage change from baseline in pulmonary vascular resistance (PVR) and change from baseline in 6-minute walk distance to Month 6 versus placebo.
Maltese: endpoints ko-primarji kienu l-persentaġġ ta' bidla mil-linja bażi fir-reżistenza vaskulari fil-pulmun (PVR) u bidla mil-linja bażi fid-distanza ta' mixja f'6 minuti sa Xahar 6 kontra l-plaċebo.
English: Tracleer therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
Maltese: Għalhekk Tracleer iġiegħel lill-kanali tad-demm biex jespandu u jagħmel parti mill-klassi ta' mediċini msejħa “antagonisti tar-riċettur ta' endothelin”.
English: Tracleer 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
Maltese: Tracleer 62.5 mg, pilloli miksija b'rita huma pilloli, oranġjo-bojod, tondi, miksija b'rita, b'“62.5” fuq naħa minnhom.
English: Bosentan was added to patients' current therapy, which could include a combination of anticoagulants, vasodilators (e.g., calcium channel blockers), diuretics, oxygen and digoxin, but not epoprostenol.
Maltese: Bosentan żdied mat-terapija kurrenti tal-pazjenti, li setgħet tinkludi kombinazzjoni ta' sustanzi kontra l-koagulazzjoni, sustanzi li jwessgħu l-vini u l-arterji (eż. imblokkaturi tal-kanali tal-calcium), dijuretiċi, ossiġnu, u digoxin, imma mhux epoprostenol.
English: Though the number of patients included was limited and with high variability, these data indicate a marked increase in the exposure to bosentan and its primary metabolite Ro 485033 in patients with moderate liver function impairment (Child-Pugh class B).
Maltese: Għalkemm in-numru ta' pazjenti inklużi kien limitat u b'varjabilità għolja, din id-dejta tindika żieda notevoli fl-esponiment għal bosentan u għall-metabolit primarju tiegħu Ro 48-5033 f'pazjenti b'indeboliment moderat fil-funzjoni tal-fwied (Child-Pugh klassi B).
English: You need to use a barrier form of birth control - like a condom, diaphragm or vaginal sponge - in addition to any of these kinds of hormonal birth control.
Maltese: Trid tuża forma ta' barriera għall-kontroll tattwelid - bħal kondom, dijaframma jew sponża vaġinali - barra kull tip ta' kontroll tattwelid ormonali.
English: Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and Tracleer has not been studied in man but co-administration of tacrolimus or sirolimus and Tracleer may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant Tracleer may reduce the plasma concentrations of tacrolimus and sirolimus.
Maltese: L-għoti flimkien ta' tacrolimus jew sirolimus u Tracleer ma kienx studjat filbniedem, imma l-għoti flimkien ta' tacrolimus jew sirolimus u Tracleer jista' jirriżulta f'konċentrazzjonijiet miżjuda ta' bosentan fil-plażma, bħal fil-każ tal-għoti flimkien ma' cyclosporine A.
English: Each dispersible tablet contains 32 mg bosentan (as monohydrate)
Maltese: Kull pillola li tinxtered fiha 32 mg bosentan (bħala monohydrate)
English: Dec _____
Maltese: Diċ _____
English: Cartons contain 56 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
Maltese: Kaxxi tal-kartun fihom 56 pillola miksija b'rita (Tracleer 62.5 mg pilloli miksija b'rita).
English: Study performed in neonates with persistent pulmonary hypertension of the newborn (PPHN):
Maltese: Studju mwettaq fi trabi tat-twelid bi pressjoni pulmonari għolja b'mod persistenti tat-trabi tat-twelid (PPHN - persistent pulmonary hypertension of the newborn):
English: Tracleer 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Maltese: Folji magħmula minn PVC/PE/PVDC/aluminju li fihom 14-il pillola miksija b'rita.
English: • a pregnancy test if you are a woman of childbearing potential Some patients taking Tracleer have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Maltese: • test tat-tqala jekk inti mara li tista' toħroġ tqila Xi pazjenti li jieħdu Tracleer instabu li għandhom testijiet tal-funzjoni tal-fwied mhux nomali u anemija (emoglobina baxxa).
English: Tracleer 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Maltese: Tracleer 62.5 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 62.5 mg ta' bosentan (bħala monohydrate).
English: 112 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
Maltese: 56 jew 112-il pillola miksija b'rita (Tracleer 62.5 mg pilloli miksija b'rita).
English: Due to the potential for interactions related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection.
Maltese: Minħabba l-potenzjal ta' interazzjonijiet marbuta mal-effett inducing ta' bosentan fuq CYP450 (ara sezzjoni 4.5), li jista' jaffettwa l-effikaċja tat-terapija antiretrovirali, dawn il-pazjenti għandhom jiġu wkoll immonitorjati bl-attenzjoni dwar l infezzjoni tagħhom bl-HIV.
English: Inside your pack of Tracleer tablets you will find a Patient Alert Card which you should read carefully.
Maltese: Fil-pakkett tiegħek tal-pilloli Tracleer se ssib Kartuna ta' Twissija tal-Pazjent li inti għandek taqra b'attenzjoni.
English: Tracleer may harm the development of the foetus.
Maltese: Tracleer jista' jkollhom anemija.
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance doses studied in these studies were 125 mg twice daily in AC-052-351, and 125 mg twice daily and 250 mg twice daily in AC-052-352.
Maltese: Wara 4 ġimgħat ta' kura b'bosentan b'doża ta' 62.5 mg darbtejn kuljum, id-dożi tal manteniment studjati f'dawn l-istudji kienu ta' 125 mg darbtejn kuljum f'AC-052-351, u 125 mg darbtejn kuljum u 250 mg darbtejn kuljum f'AC-052-352.
English: Dispersible tablet:
Maltese: Kontraċettivi ormonali:
English: However, no effects on general development, growth, sensory, cognitive function and reproductive performance were detected at 7 (males) and 19 (females) times the human therapeutic exposure at Day 21 post partum.
Maltese: Madankollu, ma kienu osservati l-ebda effetti fuq l-iżvilupp ġenerali, tkabbir, funzjoni sensorjali, funzjoni konoxxittiva u l-prestazzjoni riproduttiva b'7 darbiet (irġiel) u 19-il darba (nisa) l-esponiment terapewtiku fil-bniedem f'Jum 21 post partum.
English: Cartons contain 56 dispersible tablets.
Maltese: Il-kartun fihom 56 pillola li tinxtered.
English: Tracleer tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Maltese: Pilloli Tracleer fihom bosentan, li jimblokka ormon li jseħħ fin-natura msejjaħ endothelin-1 (ET-1), li jġiegħel lill-kanali tad-demm jidjiequ.
English: Tracleer 32 mg dispersible tablets bosentan
Maltese: Tracleer 32 mg, pilloli li jinxterdu bosentan
English: This difference in infection frequency may in part be due to the longer median treatment exposure in the paediatric set (median 71.8 weeks) compared with the adult set (median 17.4 weeks).
Maltese: Din id-differenza fil-frekwenza ta' infezzjoni tista' tkun parzjalment minħabba esponiment medjan għall-kura itwal fil-grupp pedjatriku (medjan 71.8 ġimgħat) meta mqabbel mal-grupp ta' adulti (medjan 17.4 ġimgħat).
English: Cartons contain 56 film-coated tablets (Tracleer 125 mg film-coated tablets).
Maltese: Kaxxi tal-kartun fihom 56 pillola miksija b'rita (Tracleer 125 mg pilloli miksija b'rita).
English: • Hormonal contraceptives cannot be the sole method of contraception during treatment with Tracleer
Maltese: • Kontraċettivi ormonali ma jistgħux ikunu l-uniku metodu ta' kontraċezzjoni waqt il-kura bi
English: Feb ______
Maltese: Frar ______
English: Tutti frutti flavour
Maltese: Indeboliment tal-fwied
English: For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with Tracleer is not recommended.
Maltese: (bħal ketoconazole, itraconazole jew ritonavir) u ta' impeditur ta' CYP2C9 (bħal voriconazole) flimkien ma' Tracleer mhuwiex rakkomandat.
English: Тел.
Maltese: dijalisi.
English: How to store Tracleer
Maltese: Tiħux Tracleer:
English: Each dispersible tablet contains 32 mg bosentan (as monohydrate).
Maltese: Kull pillola li tinxtered fiha 32 mg ta' bosentan (bħala monohydrate).
English: Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about Tracleer ask your doctor.
Maltese: It-tabib li kiteb ir-riċetta: ______________________________ Jekk għandek xi mistoqsijiet dwar Tracleer staqsi lit-tabib tiegħek.
English: Tracleer 32 mg dispersible tablets
Maltese: Tracleer 32 mg, pilloli li jinxterdu
English: Leave for about one minute, until the tablet has fully dissolved, and then swallow all of the liquid.
Maltese: Ħalliha għal madwar minuta sakemm il-pillola tinħall kompletament, u wara ibla' l-likwidu kollu.
English: Pale yellow to off-white, clover-shape tablets, quadrisected on one side and debossed with “32” on the other side.
Maltese: Pilloli sofor ċari sa off-white, forma ta' silla, b'sinjali biex jinqasmu f'erbgħa fuq naħa waħda u b'“32”
English: ng·h/mL; AUCτ was 3,939 ng·h/mL (CV: 72%).
Maltese: 4,410 ng·siegħa/mL (CV: 58%).
English: 14 film-coated tablets 56 film-coated tablets 112 film-coated tablets
Maltese: 14-il pillola miksija b'rita 56 pillola miksija b'rita 112-il pillola miksija b'rita
English: Tracleer reduces the number of new finger and toe ulcers that appear.
Maltese: Tracleer inaqqas in-numru ta' ulċeri ġodda fis-swaba' tal-idejn u tassaqajn.
English: • Syncope (fainting)
Maltese: Tracleer (bosentan)
English: Therefore, concomitant use of Tracleer and tacrolimus or sirolimus is not advisable.
Maltese: Tacrolimus, sirolimus:
English: In the FUTURE-4 study including 13 neonates with PPHN treated with bosentan 2 mg/kg twice daily for less than 10 days (range 0.5-10.0 days), there were no cases of liver aminotransferases ≥ 3 × ULN during treatment, but one case of hepatitis occurred 3 days after the end of bosentan treatment.
Maltese: Fl-istudju FUTURE-4 li kien jinkludi 13-il tarbija tat-twelid b'PPHN ikkurati b'bosentan 2 mg/kg darbtejn kuljum għal inqas minn 10 ijiem (firxa 0.5-10.0 ijiem), ma kien hemm l-ebda każ ta' aminotransferases tal-fwied ta' ≥ 3 x ULN waqt il-kura, iżda seħħ każ wieħed ta' epatite 3 ijiem wara t-tmiem tal-kura b'bosentan.
English: In neonates with persistent pulmonary hypertension of the newborn (PPHN), the benefit of bosentan has not been shown in the standard-of-care treatment.
Maltese: Fi trabi tat-twelid bi pressjoni pulmonari għolja b'mod persistenti (PPHN - persistent pulmonary hypertension of the newborn), il-benefiċċju ta' bosentan ma ntweriex b'kura standard.
English: Tracleer 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Maltese: Tracleer 125 mg, pilloli miksija b'rita huma pilloli, oranġjo-bojod, ovali, miksija b'rita, b'“125” fuq naħa minnhom.