FrancophonIA/ELRC3.0 huggingface dataset:
English: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.
Maltese: Is-sindrome ta' differenzazzjoni huwa assoċjat ma' proliferazzjoni u differenzazzjoni rapida ta' ċelluli tal-mijelojde u jista' jkun ta' theddida għall-ħajja jew fatali jekk ma jiġix trattat.
English: If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm.
Maltese: Jekk inti tuża kontraċettiv ormonali, għandek tuża wkoll metodu barriera, bħal kondom jew dijaframma.
English: Adverse reactions observed during clinical studies are listed below by frequency category.
Maltese: Ir-reazzjonijiet avversi osservati waqt l-istudji kliniċi huma elenkati hawn taħt skont il-kategorija ta' frekwenza.
English: Do not give Xospata to children and adolescents under 18 years because it is not known whether it is safe and effective in this age group.
Maltese: Tagħtix Xospata lil tfal u adolexxenti li għandhom inqas minn 18-il sena għax mhuwiex magħruf jekk hux sigur u effettiv f'dan il-grupp ta' età.
English: In situations where satisfactory therapeutic alternatives do not exist, patients should be closely monitored for toxicities during administration of gilteritinib (see section 4.5).
Maltese: F'sitwazzjonijiet fejn ma jeżistux alternattivi terapewtiċi sodisfaċenti, ilpazjenti għandhom jiġu mmonitorjati mill-qrib għal tossiċitajiet waqt l-għoti ta' gilteritinib (ara sezzjoni 4.5).
English: CRa (95% CIb) CRhc (95% CIb) CR/CRh (95% CIb) CI: confidence interval a. CR was defined as an absolute neutrophil count ≥1.0 x 109/L, platelets ≥100 x 109/L, normal marrow differential with <5% blasts, must have been red blood cells, platelet transfusion independent and no evidence of extramedullary leukemia.
Maltese: differenzjal tal-mudullun normali b'<5% blasts, jeħtieġ li kienu ċelluli tad-demm ħomor, indipendenti mit-trasfużjoni tal-plejtlits u ebda evidenza ta' lewkimja 'l barra mill-mudullun.
English: Posterior reversible encephalopathy syndrome
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: 20.4 0.3 Very common
Maltese: 0.3 Komuni ħafna
English: Xospata should be interrupted and can be resumed at a reduced dose when the signs and symptoms of pancreatitis have resolved (see section 4.2).
Maltese: Xospata għandu jiġi interrott u jista' jitkompla b'doża mnaqqsa meta s-sinjali u sintomi ta' pankreatite jkunu għaddew (ara sezzjoni 4.2).
English: In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: - medicines used to treat tuberculosis, such as rifampicin; - medicines used to treat epilepsy, such as phenytoin; - medicines used to treat fungal infections such as voriconazole, posaconazole or itraconazole; - medicines used to treat bacterial infections such as erythromycin, clarithromycin or azithromycin; - medicines used to treat high blood pressure (hypertension) such as captopril or carvedilol; - medicines used to treat infections with the human immunodeficiency virus (HIV) such as ritonavir; - medicines used to treat depression such as escitalopram, fluoxetine or sertraline; - St. John's wort (also known as Hypericum perforatum), a herbal medicine used to treat depression.
Maltese: B'mod partikulari, għid lit-tabib, lill-ispiżjar jew lill-infermier tiegħek jekk qed tieħu xi waħda minn dawn il-mediċini li ġejjin: - mediċini li jintużaw għall-kura tat-tuberkulożi - bħal rifampicin; - mediċini li jintużaw għall-kura tal-epilessija, bħal phenytoin; - mediċini li jintużaw għall-kura ta' nfezzjonijiet fungali bhal voriconazole, posaconazole jew itraconazole; - mediċini li jintużaw għall-kura ta' infezzjonijiet batterjali bħal erythromycin, clarithromycin jew azithromycin; - mediċini li jintużaw għall-kura ta' pressjoni tad-demm għolja (ipertensjoni) bħal captopril jew carvedilol; - mediċini li jintużaw għall-kura ta' infezzjonijiet bil-virus tal-immunodefiċjenza umana (HIV)
English: • Interrupt gilteritinib if severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids.
Maltese: Interrompi t-trattament b'gilteritinib jekk sinjali u/jew sintomi severi jippersistu għal aktar minn 48 siegħa wara l-bidu ta' kortikosterojdi.
English: Symptoms and clinical findings of differentiation syndrome in patients treated with Xospata included fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Maltese: Issintomi u s-sejbiet kliniċi ta' sindrome ta' differenzazzjoni f'pazjenti ttrattati b'Xospata inkludew deni, qtugħ ta' nifs, effużjoni mill-plewra, effużjoni mill-perikardju, edema pulmonari, pressjoni baxxa, żieda rapida fil-piż, edema periferali, raxx, u funzjoni ħażina tal-kliewi.
English: Taking Xospata
Maltese: Dożaġġ ta' Xospata
English: Pericardial effusion
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: The patient information pack:
Maltese: Il-pakkett tal-informazzjoni tal-pazjent:
English: For patients who achieved a CR/CRh, the median time to first response was 3.7 months (range, 0.9 to 10.6 months) in the gilteritinib arm and 1.2 months (range: 1 to 2.6 months) in the salvage chemotherapy arm.
Maltese: Għal pazjenti li kisbu CR/CRh, iż-żmien medjan għall-ewwel rispons kien 3.7 xhur (medda, 0.9 sa 10.6 xhur) fil-grupp ta' gilteritinib u 1.2 xhur (medda: 1 sa 2.6 xhur) fil-grupp ta' kimoterapija ta' salvataġġ.
English: Gilteritinib may reduce the effects of medicinal products that target 5HT2B receptor or sigma nonspecific receptors.
Maltese: Gilteritinib jista' jnaqqas l-effeti ta' prodotti mediċinali li huma mmirati fuq riċettur ta' 5HT2B jew riċetturi sigma mhux speċifiċi.
English: Fertility There are no data on the effect of gilterinitib on human fertility.
Maltese: Fertilità M'hemm l-ebda data dwar l-effett ta' gilterinitib fuq il-fertilità tal-bniedem.
English: Caution is required when concomitantly prescribing gilteritinib with medicinal products that are strong inhibitors of CYP3A and/or P-gp (such as, but not limited to, voriconazole, itraconazole, posaconazole and clarithromycin ) because they can increase gilteritinib exposure.
Maltese: Jeħtieġ li wieħed joqgħod attent meta jippreskrivi gilteritinib fl-istess ħin ma' prodotti mediċinali li huma inibituri qawwija ta' CYP3A u/jew P-gp (bħal, iżda mhux limitati għal, voriconazole, itraconazole, posaconazole u clarithromycin) għax dawn jistgħu jżidu l-esponiment għal gilteritinib.
English: Xospata 40 mg film-coated tablets are round, light yellow film-coated tablets with the company logo and ‘235' debossed on one side of the tablet.
Maltese: Xospata 40 mg pilloli miksija b'rita huma pilloli miksija b'rita tondi ta' lewn isfar ċar, bil-logo talkumpanija u ‘235' imnaqqxin fuq naħa waħda tal-pillola.
English: Blood alkaline phosphatase increased* 68.7 1.6 Very common Pain in extremity
Maltese: 6%), żieda fl-alkaline phosphatase fid-demm (68.7%), dijarea (35.
English: In the study 42% of patients were 65 years or older and 12% were 75 years or older.
Maltese: Fl-istudju, 42% tal-pazjenti kellhom 65 sena jew aktar u 12% kellhom 75 sena jew aktar.
English: Xospata dose interruption, reduction and discontinuation recommendations in patients with relapsed or refractory AML
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: There is no clinical experience in patients with severe renal impairment (see section 5.2).
Maltese: M'hemm l-ebda esperjenza klinika f'pazjenti b'indeboliment tal-kliewi sever (ara sezzjoni 5.2).
English: Women using hormonal contraceptives should add a barrier method of contraception.
Maltese: Nisa li jkunu qed jużaw kontraċettivi ormonali għandhom iżidu metodu barriera tal-kontraċezzjoni.
English: The effect of mild hepatic impairment [as defined by NCI-ODWG] on gilteritinib exposure was also assessed using the population PK model and the results demonstrate little difference in predicted steady-state gilteritinib exposure relative to a typical patient with relapsed or refractory AML and normal liver function.
Maltese: L-effett ta' indeboliment tal-fwied ħafif [kif definit minn NCI-ODWG] fuq l-esponiment għal gilteritinib kien ivvalutat ukoll bil-mudell farmakokinetiku tal-popolazzjoni u r-riżultati juru ftit li xejn differenza flesponiment imbassar għal gilteritinib fl-istat fiss relattiv għal pazjent tipiku b'AML li rkadiet jew refrattorja u funzjoni tal-fwied normali.
English: PRES is a rare, reversible, neurological disorder which can present with rapidly evolving symptoms including seizure, headache, confusion, visual and neurological disturbances, with or without associated hypertension and altered mental status.
Maltese: PRES huwa disturb newroloġiku riversibbli rari, li jista' jippreżenta sintomi li jevolvu malajr inkluż aċċessjoni, uġigħ ta' ras, konfużjoni, disturbi viżwali u newroloġiċi, bi jew mingħajr pressjoni għolja assoċjati.
English: Fifty-four percent of the patients were female.
Maltese: 6% kellhom ċitoġenetika mhux klassifikata.
English: The primary efficacy endpoint for the final analysis was OS in the intent-to-treat (ITT) population, measured from the date of randomisation until death by any cause (number of events analysed was 261).
Maltese: Il-punt tat-tmiem primarju tal-effikaċja għall-analiżi finali kien OS fil-popolazzjoni b'intenzjoni li tiġi trattata, imkejjel mid-data tal-għażla każwali sal-mewt minn kwalunkwe kawża (l-għadd ta' avvenimenti analizzati kien 261).
English: Placental transfer of gilteritinib was shown in the rat resulting in transfer of radioactivity to the foetus similar to that observed in maternal plasma.
Maltese: It-trasferiment mill-plaċenta ta' gilteritinib intwera fil-far li jirriżulta fi trasferiment tarradjoattività lill-fetu simili għal dak osservat fil-plażma tal-omm.
English: No dose adjustment is required in patients ≥65 years of age (see section 5.2).
Maltese: Anzjani L-ebda aġġustament fid-doża mhu meħtieġ f'pazjenti f'età ta' ≥ 65 sena (ara sezzjoni 5.2).
English: • If differentiation syndrome is suspected, administer corticosteroids and initiate hemodynamic monitoring (see section 4.4).
Maltese: agħti l-kortikosterojdi u ibda l-monitoraġġ emodinamiku (ara sezzjoni 4.4).
English: If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, Xospata should be interrupted until signs and symptoms are no longer severe (see sections 4.2 and 4.8).
Maltese: Jekk is-sinjali u/jew sintomi severi jippersistu għal aktar minn 48 siegħa wara l-bidu tal-kortikosterojdi, Xospata għandu jiġi interrott sakemm is-sinjali u s-sintomi ma jibqgħux severi (ara sezzjonijiet 4.2 u 4.8).
English: Hypokalaemia or hypomagnesaemia may increase the QT prolongation risk.
Maltese: Rilevanza klinika possibbli ta' dawn is-sejbiet mhijiex magħrufa.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Sogħla
English: GENERAL CLASSIFICATION FOR SUPPLY 15.
Maltese: GĦALL-FORNITURI
English: The safety of Xospata was evaluated in 319 patients with relapsed or refractory AML who have received at least one dose of 120 mg gilteritinib.
Maltese: Is-sigurtà ta' Xospata ġiet evalwata fi 319-il pazjent b'AML li rkadiet jew refrattorja li rċivew millinqas doża waħda ta' 120 mg gilteritinib.
English: Package leaflet: Information for the patient Xospata 40 mg film-coated tablets gilteritinib This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: QT prolongation can be observed in the first two months of treatment with gilteritinib.
Maltese: It-titwil tal-QT jista' jiġi osservat fl-ewwel xahrejn tat-trattament b'gilteritinib.
English: Additionally, the pharmacokinetics of cephalexin (a sensitive MATE1 substrate) were not significantly (Cmax and AUC decreased by less than 10%) affected after once daily administration of gilteritinib (200 mg) for 15 days in patients with FLT3-mutated relapsed or refractory AML.
Maltese: Barra minn hekk, ilfarmakokinetika ta' cephalexin (substrat sensittiv ta' MATE1) ma ġietx affettwata b'mod sinifikanti (Cmass u AUC naqsu b'anqas minn 10%) wara l-għoti ta' darba kuljum ta' gilteritinib (200 mg) għal 15-il jum f'pazjenti b'AML b'mutazzjoni FLT3 li rkadiet jew refrattorja.
English: These may be signs of a condition called PRES (see section 4.
Maltese: Dawn jistgħu jkunu sinjali ta' kundizzjoni magħrufa bħala PRES (ara sezzjoni 4 - Effetti sekondarji possibbli).
English: Electrocardiogram QT prolonged
Maltese: Disturbi fil-qalb Titwil tal-QT fl-elettrokardjogram
English: Blood creatine phosphokinase increased*
Maltese: Żieda fl-alkaline phosphatase fid-demm*
English: Transporter drug-drug interactions
Maltese: TAL-PRODOTT MEDIĊINALI
English: Gilteritinib plasma concentrations declined in a bi-exponential manner with a population mean estimated half-life of 113 hours.
Maltese: Il-konċentrazzjonijiet fil-plażma ta' gilteritinib naqsu b'mod bi-esponenzjali b'half-life stmata medja tal-popolazzjoni ta' 113-il siegħa.
English: 84 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 84 pillola miksija b'rita
English: Gilteritinib was excreted into the milk of lactating rats with milk concentrations being higher than in maternal plasma.
Maltese: Dawn il-bidliet ġew ossevati f'livelli ta' esponiment fil-plażma simili għal jew inqas mil-livelli ta' esponiment kliniku.
English: • If differentiation syndrome is suspected, corticosteroid therapy should be initiated along with hemodynamic monitoring until symptom resolution.
Maltese: • Jekk jiġi ssuspettat is-sindrome ta' differenzazzjoni, għandha tinbeda t-terapija bilkortikosterojdi flimkien ma' monitoraġġ emodinamiku sakemm ifiequ s-sintomi.
English: Concomitant use of Xospata with strong CYP3A/P-gp inducers (e.g., phenytoin, rifampin and St. John's Wort) should be avoided because they can decrease gilteritinib plasma concentrations.
Maltese: L-użu fl-istess ħin ta' Xospata ma' indutturi qawwija ta' CYP3A/P-gp (eż., phenytoin, rifampin u St.
English: These may be signs of a condition called differentiation syndrome (may affect up to 1 in 10 people).
Maltese: Dawn jistgħu jkunu sinjali ta' kundizzjoni magħrufa bħala sindrome ta' differenzazzjoni (tista' taffettwa sa 1 minn kull 10 persuni).
English: Atreiza Laboratorios S.L.U.
Maltese: Atreiza Laboratorios S.
English: EU/1/18/1274/001 EU/1/18/1274/002 EU/1/18/1274/003 EU/1/18/1274/004 EU/1/18/1274/005
Maltese: EU/1/18/1274/001 EU/1/18/1274/002 EU/1/18/1274/003 EU/1/18/1274/004
English: Cytochrome P450 isoenzymes CYP2D6, CYP2C19 and CYP2C9 are involved in the O-demethylation of formoterol.
Maltese: L-isoenzimi taċ ċitokroma P450 CYP2D6, CYP2C19 u CYP2C9 huma involuti fl-O-demethylation ta' formoterol.
English: EU/1/18/1274/004 EU/1/18/1274/005
Maltese: EU/1/18/1274/005
English: Date of first authorisation: 26 April 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 26 ta' April 2018
English: See section 4.4 and section 5.2.
Maltese: Ara sezzjoni 4.4 u sezzjoni 5
English: The renal clearance of formoterol is 150 mL/min.
Maltese: It-tneħħija ta' formoterol millkliewi hija ta' 150 mL/min.
English: Trydonis is available in three container sizes:
Maltese: Trydonis huwa disponibbli f'kontenituri ta' tliet daqsijiet:
English: Trydonis can reduce exacerbations (flare-ups) of COPD symptoms.
Maltese: Trydonis jista' jnaqqas aggravar (irkadar) tas-sintomi ta' COPD.
English: Similar effects were seen when comparing Trydonis with the extemporary triple combination.
Maltese: Trydonis kien imqabbel mal-kombinazzjoni tripla estemporanja.
English: Beclometasone dipropionate
Maltese: Relatat ma' beclometasone dipropionate
English: The use of Trydonis with the AeroChamber Plus spacer in COPD patients increased the lung delivery of beclometasone 17-monopropionate, formoterol and glycopyrronium (maximum plasma concentration increased by 15%, 58% and 60% respectively).
Maltese: L-użu ta' Trydonis bl-ispacer AeroChamber Plus f'pazjenti b'COPD żied it-twassil fil-pulmun ta' beclometasone 17-monopropionate, formoterol u glycopyrronium (il-konċentrazzjoni massima fil plażma żdiedet bi 15%, 58% u 60% rispettivament).
English: Trydonis contains beclometasone dipropionate, formoterol and glycopyrronium in a solution formulation resulting in an aerosol with extrafine particles with an average mass median aerodynamic diameter (MMAD) of around 1.1 micrometres and co-deposition of the three components.
Maltese: Trydonis fih beclometasone dipropionate, formoterol u glycopyrronium f'formulazzjoni ta' soluzzjoni li twassal għal aerosol b'partiċelli fini ħafna b'dijametru aerodinamiku medjan tal-massa (MMADmass median aerodynamic diameter) medju ta' madwar 1.1 mikrometri u ko-depożizzjoni tat-tliet komponenti.
English: Compared with tiotropium, Trydonis also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017).
Maltese: 043). Meta mqabbel ma' tiotropium, Trydonis naqqas ukoll ir-rata ta' episodji ta' aggravar sever (jiġifieri episodji ta' aggravar moderat kienu esklużi) bi 32% (rata: 0.067 kontra 0.098 avveniment għal kull pazjent/sena; p = 0.017).
English: After dispensing:
Maltese: 10 persuni):
English: Trydonis 87/5/9 micrograms pressurised inhalation beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium Inhalation use
Maltese: Trydonis 87/5/9 mikrogrammi sustanza taħt pressjoni għolja li tittieħed man-nifs beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
English: Both studies were conducted in patients with a clinical diagnosis of COPD with severe to very severe airflow limitation (FEV1 less than 50% predicted), with symptoms assessed as a COPD Assessment Test (CAT) score of 10 or above, and with at least one COPD exacerbation in the previous year.
Maltese: Iż-żewġ studji twettqu f'pazjenti b'dijanjosi klinika ta' COPD b'limitazzjoni tal-fluss tal-arja severa sa severa ħafna (FEV1 inqas minn 50% ta' dak imbassar), b'sintomi evalwati bħala punteġġ fit-Test ta' Evalwazzjoni ta' COPD (CAT - COPD Assessment Test) ta' 10 jew aktar, u b'mill-inqas episodju wieħed ta' aggravar ta' COPD fis-sena preċedenti.
English: Related to Trydonis
Maltese: Tużax Trydonis:
English: Study TRINITY compared Trydonis with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients).
Maltese: Studju TRINITY qabbel Trydonis ma' tiotropium 18-il mikrogramma trab li jittieħed man-nifs, kapsula iebsa, inalazzjoni waħda darba kuljum; barra dan, l-effetti tqabblu ma' kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol 100/6 mikrogrammi żewġ inalazzjonijiet darbtejn kuljum flimkien ma' tiotropium 18-il mikrogramma trab li jittieħed man-nifs, kapsula iebsa, inalazzjoni waħda darba kuljum (2,691 pazjent li ntgħażlu b'mod każwali).
English: Multipack: 360 actuations (3 pressurised containers of 120 actuations each).
Maltese: Pakkett b'ħafna: 360 attwazzjoni (3 kontenituri għal kontenut taħt pressjoni għolja ta'
English: There is a risk of worsening shortness of breath and wheezing immediately after using Trydonis and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people).
Maltese: Hemm riskju ta' aggravar tal-qtugħ ta' nifs u tħarħir immedjatament wara li tuża Trydonis u dan huwa magħruf bħala bronkospażmu paradossali (jista' jaffettwa sa persuna waħda minn kull 1,000 persuna).
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trydonis reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005).
Maltese: Meta mqabbel ma' kombinazzjoni fissa ta' beclometasone dipropionate u formoterol, Trydonis naqqas ir-rata ta' episodji ta' aggravar moderat/sever fuq medda ta' 52 ġimgħa bi 23% (rata: 0.41 kontra 0.53 avveniment għal kull pazjent/sena; p = 0.005).
English: Trydonis contains a small amount of ethanol.
Maltese: Trydonis fih ammont żgħir ta' ethanol.
English: It is important to use Trydonis every day.
Maltese: Huwa importanti li tuża Trydonis kuljum.
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Maltese: Fatturi ta' riskju għall-pulmonite f'pazjenti b'COPD jinkludu tipjip attwali, età akbar, indiċi tal-massa tal-ġisem (BMI - body mass index) baxx u COPD severa.
English: Study TRILOGY compared Trydonis with a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily (1,368 randomised patients).
Maltese: Studju TRILOGY qabbel Trydonis ma' kombinazzjoni fissa ta' beclometasone dipropionate u formoterol 100/6 mikrogrammi żewġ inalazzjonijiet darbtejn kuljum (1,368 pazjent li ntgħażlu b'mod każwali).
English: TRIBUTE was a 52-week activecontrolled study comparing Trydonis with a fixed combination of indacaterol/glycopyrronium 85/43 micrograms inhalation powder, hard capsule, one inhalation once daily (1,532 randomised patients).
Maltese: TRIBUTE kien studju kkontrollat b'mod attiv ta' 52 ġimgħa li qabbel Trydonis ma' taħlita fissa ta' trab li jittieħed man-nifs ta' indacaterol/glycopyrronium 85/43 mikrogramma, kapsula iebsa, inalazzjoni waħda darba kuljum (1,532 pazjent randomised).
English: 1 Adverse reactions reported in the SmPC of at least one of the individual components, but not observed as adverse reactions in the clinical development of Trydonis
Maltese: 1 Reazzjonijiet avversi rrappurtati fl-SmPC ta' mill-inqas wieħed mill-komponenti ndividwali, iżda mhux osservati bħala reazzjonijiet avversi fl-iżvilupp kliniku ta' Trydonis
English: No differences were observed when comparing Trydonis with the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (moderate/severe exacerbation rate: 0.46 versus 0.45 events per patient/year).
Maltese: Ma kienu osservati l-ebda differenzi meta Trydonis kien imqabbel mal-kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol flimkien ma' tiotropium (rata ta' episjodi ta' aggravar moderat/sever: 0.46 kontra 0.45 avveniment għal kull pazjent/sena).
English: Compared with a fixed combination of indacaterol and glycopyrronium, Trydonis improved average pre-dose FEV1 over the 52-week treatment period by 22 mL (p=0.018).
Maltese: Meta mqabbel ma' kombinazzjoni fissa ta' indacaterol u glycopyrronium, Trydonis tejjeb il-medja ta' FEV1 ta' qabel id-doża matul il-perjodu ta' trattament ta' 52 ġimgħa bi 22 mL (p=0.018).
English: Trydonis significantly improved dyspnoea (measured as the Transition Dyspnoea Index - TDI - focal score) after 26 weeks of treatment compared with baseline (by 1.71 units; p < 0.001), but the adjusted mean difference versus a fixed combination of beclometasone dipropionate and formoterol was not statistically significant (0.21 units; p = 0.160).
Maltese: Trydonis tejjeb il-qtugħ ta' nifs (imkejjel bħala punteġġ fokali tal-Indiċi ta' Transizzjoni ta' Qtugħ ta' Nifs - TDI [Transition Dyspnoea Index]) b'mod sinifikanti wara 26 ġimgħa ta' trattament meta mqabbel mal-linja bażi (b'1.71 unità; p < 0.001), iżda d-differenza medja aġġustata kontra kombinazzjoni fissa ta' beclometasone dipropionate u formoterol ma kinitx statistikament sinifikanti
English: The bioavailability of swallowed beclometasone dipropionate is negligible; however, pre-systemic conversion to beclometasone 17-monopropionate results in 41% of the dose being absorbed as the active metabolite.
Maltese: Il-bijodisponibilità ta' beclometasone dipropionate li jinbela' hija negliġibbli; madankollu, il-bidla pre-sistemika għal beclometasone 17-monopropionate twassal għall-assorbiment ta' 41% tad-doża bħala l-metabolit attiv.