FrancophonIA/ELRC3.0 huggingface dataset:
English: Two main studies in over 5,100 adults with symptoms of DVT or PE, and who were initially treated with an injectable anticoagulant, compared Pradaxa with warfarin.
Maltese: Żewġ studji ewlenin f'aktar minn 5,100 adult b'sintomi ta' DVT jew PE, u li inizjalment ġew ikkurati b'antikoagulant injettabbli, meta mqabbla ma' Pradaxa b'warfarin.
English: In the second study, blood clots or blood-clot-related death occurred in 0.4% (3 out of 681) of patients treated with Pradaxa, compared with 5.6% (37 out of 662) of patients treated with placebo.
Maltese: Fit-tieni studju, l-emboli tad-demm jew il-mewt relatata mal-koagulazzjoni tad-demm seħħew f'0.4 % (3 minn 681) tal-pazjenti kkurati bi Pradaxa, meta mqabbel ma' 5.6 % (37 minn 662) tal-pazjenti kkurati bilplaċebo.
English: Another two studies looked at the prevention of VTE or PE in around 4,200 adults with symptoms of recurring blood clots and who were on long-term treatment with anticoagulants.
Maltese: Żewġ studji oħra taw ħarsa lejn il-prevenzjoni ta' VTE jew PE f'madwar 4,200 adult b'sintomi ta' emboli tad-demm rikorrenti u li kienu fuq kura fit-tul bl-antikoagulanti.
English: Treatment and prevention of DVT and PE
Maltese: Kura u prevenzjoni ta' DVT u PE
English: Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating (clotting).
Maltese: Dabigatran huwa antikoagulant, u dan ifisser li jipprevjeni d-demm milli jagħqad (koagulazzjoni).
English: In the study, around 18,000 adults were treated for one to three years.
Maltese: Fl-istudju, madwar 18,000 adult ġew ikkurati għal bejn sena u tliet snin.
English: Pradaxa compared well with warfarin in reducing the risk of strokes in patients with atrial fibrillation without increasing the risk of major bleeding.
Maltese: Pradaxa tqabbel sew ma' warfarin fit-tnaqqis tar-riskju ta' puplesiji f'pazjenti b'fibrillazzjoni atrijali mingħajr ma jiżdied ir-riskju ta' fsada kbira.
English: In addition, the overall benefit of Pradaxa in the treatment and prevention of DVT and PE is comparable to that of warfarin.
Maltese: Barra minn hekk, il-benefiċċju globali ta' Pradaxa fil-kura u fil-prevenzjoni ta' DVT u PE huwa komparabbli ma' dak ta' warfarin.
English: Since certain patients who take Pradaxa are at increased risk of bleeding, a number of precautions were included in the prescribing information.
Maltese: Peress li ċerti pazjenti li jieħdu Pradaxa huma f'riskju akbar ta' fsada, ġew inklużi għadd ta' prekawzjonijiet fl-informazzjoni ta' preskrizzjoni.
English: Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in their leg veins.
Maltese: Il-pazjenti li ssirilhom kirurġija ta' sostituzzjoni tal-ġenb jew tal-irkoppa jinsabu f'riskju għoli ta' emboli tad-demm fil-vini ta' riġlejhom.
English: What measures are being taken to ensure the safe and effective use of Pradaxa?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Pradaxa?
English: Pradaxa was as effective as warfarin in reducing formation of blood clots in the veins (DVT) or lungs (PE), or blood-clot-related death during treatment.
Maltese: Pradaxa kien effettiv daqs warfarin biex inaqqas il-formazzjoni ta' emboli tad-demm fil-vini (DVT) jew fil-pulmun (PE), jew il-mewt relatata mal-koagulazzjoni tad-demm waqt il-kura.
English: The company that makes Pradaxa will provide an educational pack for all doctors who are expected to prescribe the medicine, to increase awareness of the risk of bleeding and provide guidance on how to manage it.
Maltese: Il-kumpanija li tipproduċi Pradaxa ser tqassam pakkett edukattiv lit-tobba kollha li mistennija jippreskrivu l-mediċina, biex iżżid is-sensibilizzazzjoni dwar ir-riskju ta' fsada u tipprovdi gwida dwar kif din għandha tiġi mmaniġġjata.
English: How does Pradaxa work?
Maltese: Kif jaħdem Pradaxa?
English: For the full list of all side effects reported with Pradaxa, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Pradaxa, ara l-fuljett ta' tagħrif.
English: Three patients in the Pradaxa group died (less than 1%), but two of these deaths were unrelated to blood clots.
Maltese: Tliet pazjenti fil-grupp ta' Pradaxa mietu (inqas minn 1 %), iżda tnejn minn dawn l-imwiet ma kinux relatati ma' emboli tad-demm.
English: The dose and duration of treatment depend on the condition Pradaxa is being used to treat, the patient's age and kidney function, and other medicines the patient is taking.
Maltese: Id-doża u t-tul tat-trattament jiddependu fuq il-kondizzjoni li Pradaxa qed jintuża biex jikkura, l-età tal-pazjent u lfunzjoni tal-kliewi, u mediċini oħra li l-pazjent ikun qed jieħu.
English: Prevention of blood clots after hip or knee replacement
Maltese: Prevenzjoni ta' emboli tad-demm wara sostituzzjoni tal-ġenb jew tal-irkoppa
English: • evaluation of the left-ventricular ejection fraction (LVEF)
Maltese: • evalwazzjoni tat-tfigħ ‘il barra ventrikolari tax-xellug (LVEF)
English: • life-time maximum dose
Maltese: • doża massima tul il-ħajja
English: • signs and symptoms of cardiotoxicity and haematotoxicity
Maltese: • sinjali u sintomi ta' kardjotossiċità u tossiċità fil-fwied
English: • Novantrone could cause cardiotoxicity o need for echocardiogram or multiple-gated acquisition (MUGA) evaluation of the left-ventricular ejection fraction (LVEF) prior to administration of each dose and yearly for up to 5 years after the end of therapy.
Maltese: • Novantrone jista' jikkawża kardjotossiċità o sinjali u sintomi o ħtieġa għal ekokardjogramma jew evalwazzjoni talakkwist multiple-gated (MUGA) tat-tfigħ ‘il barra ventrikolari tax-xellug (LVEF) qabel l-għoti ta' kull doża u kull sena sa 5 snin wara t-tmiem tat-terapija.
English: • Novantrone could cause haematotoxicity, including secondary acute myeloid leukaemia and myelodysplastic syndrome o the need for monitoring at the start and prior to each treatment administration
Maltese: • Novantrone jista' jikkawża tossiċità fil-fwied, inkluż lewkimja majelojde akuta sekondarja u sindrome majelodisplastiku o sinjali u sintomi o il-ħtieġa għall-monitoraġġ fil-bidu u qabel kull għoti tal-kura Lista ta' kontroll tal-HCP li tinkludi l-elementi ewlenin li ġejjin:
English: The Marketing Authorisation Holders of Novantrone and associated names shall submit for assessment to the Reference Member State a Risk Management Plan containing key elements as described in the CHMP assessment report.
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta' Novantrone u ismijiet assoċjati għandhom jippreżentaw għall-valutazzjoni Pjan ta' Ġestjoni tar-Riskju li fih elementi ewlenin kif deskritti fir-rapport ta' valutazzjoni tas-CHMP lill-Istat Membru ta' Referenza.
English: The Marketing Authorisation Holder(s) shall ensure that in each Member State where Novantrone and associated names are marketed, all healthcare professional (HCP) and patients/carers who are expected to prescribe and dispense or use Novantrone in treatment of multiple sclerosis have access to/are provided with the following educational package:
Maltese: Id-Detentur(i) tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu/għandhom jiżgura/jiżguraw li f'kull Stat Membru fejn Novantrone u ismijiet assoċjati huma mqiegħda fis-suq, ilprofessjonisti tal-kura tas-saħħa (HCP) u l-pazjenti/dawk li jikkurawhom li huma mistennija jagħtu Novantrone b'riċetta u jqassmu jew jużaw Novantrone għall-kura ta' sklerożi multipla jkollhom aċċess għal/huma pprovduti bil-pakkett edukattiv li ġej: Fuljett tal-HCP li jinkludi l-elementi ewlenin li ġejjin:
English: HCP checklist including the following key-elements:
Maltese: • għadd tad-demm sħiħ inkluż il-pjastrini Dokument bl-informazzjoni dwar il-pazjent inkluż l-elementi ewlenin li ġejjin:
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istat(i) Membru(i) jew l-Istat(i) Membru(i) ta' Referenza jekk applikabbli, għandhom jiżguraw li l-kondizzjonijiet li ġejjin ikunu ssodisfati mill-MAH(s):
English: 6 x 1 capsules + 1 inhaler 10 x 1 capsules + 1 inhaler 12 x 1 capsules + 1 inhaler 30 x 1 capsules + 1 inhaler 90 x 1 capsules + 1 inhaler
Maltese: 6 x1 kapsuli + inhaler wieħed 10 x 1 kapsuli + inhaler wieħed 12 x1 kapsula + inhaler wieħed 30 x1 kapsula + inhaler wieħed 90 x 1 kapsula + inhaler wieħed
English: Xoterna Breezhaler showed similar adverse reactions to the individual components.
Maltese: Xoterna Breezhaler wera reazzjonijiet avversi simili għall-komponenti individwali.
English: Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Xoterna Breezhaler hu indikat bħala trattament bronkodilatatur ta' manutenzjoni biex iserraħ lil pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD) mis-sintomi.
English: The number of all COPD exacerbations/patient-years was 3.34 for Xoterna Breezhaler (2,893 events), 3.92 for glycopyrronium (3,294 events) and 3.89 for tiotropium (3,301 events).
Maltese: In-numru ta' kull taħrix ta' COPD/snin ta' pazjent kien ta' 3.34 għal Xoterna Breezhaler (2,893 avveniment), 3.92 għal glycopyrronium (3,294 avveniment) u 3.89 għal tiotropium (3,301 avveniment).
English: The Xoterna Breezhaler clinical Phase III development programme included six studies in which over 8,000 patients were enrolled: 1) a 26-week placebo- and active-controlled (indacaterol once daily, glycopyrronium once daily, open-label tiotropium once daily) study; 2) a 26-week active-controlled (fluticasone/salmeterol twice daily) study; 3) a 64-week active-controlled (glycopyrronium once daily, open-label tiotropium once daily) study; 4) a 52-week placebo-controlled study; 5) a 3-week placeboand active-controlled (tiotropium once daily) exercise tolerance study; and 6) a 52-week activecontrolled (fluticasone/salmeterol twice daily) study.
Maltese: Il-programm ta' żvilupp ta' Xoterna Breezhaler f'Fażi III kien jinkludi sitt studji li matulhom issieħbu aktar minn 8,000 pazjent: 1) studju ta' 26 ġimgħa kkontrollat bil-plaċebo u bl-attiv (indacaterol darba kuljum, glycopyrronium darba kuljum, tiotropium open-label darba kuljum); 2) studju ta' 26 ġimgħa kkontrollat bl-attiv (fluticasone/salmeterol darbtejn kuljum); 3) studju ta' 64 ġimgħa kkontrollat blattiv (glycopyrronium darba kuljum, tiotropium open-label darba kuljum); 4) studju ta' 52 ġimgħa kkontrollat bi plaċebo; 5) studju ta' 3 ġimgħat dwar it-tolleranza għall-eżerċizzju ikkontrollat bi plaċebo u b'attiv (tiotropium darba kuljum); u 6) studju ta' 52 ġimgħa kkontrollat bl-attiv (fluticasone/salmeterol darbtejn kuljum).
English: The highest dose level of 464 micrograms/86 micrograms Xoterna Breezhaler also showed a higher proportion of absolute QTcF values >450 ms (12.2% vs. 5.7% for placebo).
Maltese: L-ogħla livell ta' doża ta' 464 mikrogramma/86 mikrogramma Xoterna Breezhaler wera wkoll proporzjon ogħla talvaluri assoluti tal-QTcF ta' >450 ms (12.2% kontra 5.7% għall-plaċebo).
English: Xoterna Breezhaler increased post-dose FEV1 AUC0-12 (primary endpoint) by 140 ml at 26 weeks (p<0.001) compared to fluticasone/salmeterol.
Maltese: Xoterna Breezhaler żied il-FEV1 u l-AUC0-12 (endpoint primarju) wara l-għoti tad-doża b'140 ml wara 26 ġimgħa (p<0.001) imqabbel ma' fluticasone/salmeterol.
English: A higher percentage of patients receiving Xoterna Breezhaler responded with a clinically meaningful improvement in SGRQ score (defined as a decrease of at least 4 units from baseline) at week 26 compared to placebo (63.7% and 56.6% respectively, p=0.088) and tiotropium (63.7% Xoterna Breezhaler vs. 56.4% tiotropium, p=0.047), at week 64 compared to glycopyrronium and tiotropium (57.3% Xoterna Breezhaler versus 51.8% glycopyrronium, p=0.055; versus 50.8% tiotropium, p=0.051, respectively) and at week 52 compared to fluticasone/salmeterol (49.2% Xoterna Breezhaler vs. 43.7% fluticasone/salmeterol, odds ratio: 1.30, p<0.001).
Maltese: Persentaġġ ogħla ta' pazjenti mogħtija Xoterna Breezhaler irrispondew b'titjib sinjifikanti klinikament fl-iskor tal-SGRQ (iddefinit bħala tnaqqis ta' mill-inqas 4 unitajiet mil-linjabażi) fis-26 ġimgħa mqabbel mal-plaċebo (63.7% u 56.6% rispettivament, p=0.088) u tiotropium (63.7% Xoterna Breezhaler kontra 56.4% tiotropium, p=0.047), fl-64 ġimgħa mqabbel ma' glycopyrronium u tiotropium (57.3% Xoterna Breezhaler kontra 51.8% glycopyrronium, p=0.055; kontra 50.8% tiotropium, p=0.051, rispettivament), u mat-52 ġimgħa meta mqabbel ma' fluticasone/salmeterol (49.2% Xoterna Breezhaler vs. 43.7% fluticasone/salmeterol, proporzjon ta' probabbiltà:
English: In a 64-week study comparing Xoterna Breezhaler (n=729), glycopyrronium (n=739) and tiotropium (n=737), Xoterna Breezhaler reduced the annualised rate of moderate or severe COPD exacerbations by 12% compared to glycopyrronium (p=0.038) and by 10% compared to tiotropium (p=0.096).
Maltese: Fi studju ta' 64 ġimgħa li qabbel Xoterna Breezhaler (n=729), glycopyrronium (n=739) u tiotropium (n=737), Xoterna Breezhaler naqqas ir-rata anwalizzata ta' taħrix moderat jew serju tas-COPD bi 12% mqabbel ma' glycopyrronium (p=0.038) u b'10% mqabbel ma' tiotropium (p=0.096).
English: A higher proportion of patients demonstrated clinically meaningful response at week 26 on Xoterna Breezhaler as compared to tiotropium (68.1% Xoterna Breezhaler versus 59.2% tiotropium, p=0.016) and fluticasone/salmeterol (65.1% Xoterna Breezhaler versus 55.5% fluticasone/salmeterol, p=0.088).
Maltese: Proporzjon akbar ta' pazjenti wrew rispons sinjifikanti klinikament fis-26 ġimgħa b'Xoterna Breezhaler imqabbel ma' tiotropium (68.1% Xoterna Breezhaler kontra 59.2% tiotropium, p=0.016) u fluticasone/salmeterol (65.1% Xoterna Breezhaler kontra 55.5% fluticasone/salmeterol, p=0.088).
English: The number of moderate or severe COPD exacerbations/patient-years was 0.98 for Xoterna Breezhaler (1,265 events) and 1.19 for fluticasone/salmeterol (1,452 events).
Maltese: In-numru ta' taħrix moderat jew sever ta' COPD/snin ta' pazjent kien ta' 0.98 għal Xoterna Breezhaler (1,265 avveniment) u 1.19 għal fluticasone/salmeterol (1,452 avveniment).
English: Xoterna Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Maltese: Xoterna Breezhaler għandu jintuża b'kawtela f'pazjenti b'disturbi kardjovaskulari (mard tal-arterja koronarja, infart mijokardijaku akut, arritmija kardijaka, pressjoni għolja).
English: In COPD patients, supratherapeutic doses between 116 micrograms/86 micrograms and 464 micrograms/86 micrograms of Xoterna Breezhaler showed a higher proportion of patients with QTcF increases vs. baseline between 30 ms and 60 ms (ranging from 16.0% to 21.6% vs. 1.9% for placebo), but there were no QTcF increases >60 ms from baseline.
Maltese: Fost pazjenti b'COPD, dożi supraterapewtiċi ta' bejn 116-il mikrogramma/86 mikrogramma u 464 mikrogramma/86 mikrogramma ta' Xoterna Breezhaler urew proporzjon ogħla ta' pazjenti b'żidiet fil-QTcF imqabbel mal-linja bażi ta' bejn 30 ms u 60 ms (fuq medda ta' bejn 16.0% u 21.6% kontra 1.9% għall-plaċebo), imma ma kienx hemm żidiet fil-QTcF ta' >60 ms mil-linja bażi.
English: The number of all COPD exacerbations/patient-years was 3.59 for Xoterna Breezhaler (4,531 events) and 4.03 for fluticasone/salmeterol (4,969 events).
Maltese: In-numru ta' kull taħrix ta' COPD/snin ta' pazjent kien ta' 3.59 għal Xoterna Breezhaler (4,531 avveniment) u 4.03 għal fluticasone/salmeterol (4,969 avveniment).
English: What Xoterna Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Maltese: X'fih Xoterna Breezhaler - Is-sustanzi attivi huma indacaterol (bħala maleate) u glycopyrronium bromide.
English: At week 64, Xoterna Breezhaler showed numerical improvement over glycopyrronium (LS mean treatment difference 1.95%; p=0.175) and statistical improvement over tiotropium (LS mean treatment difference 4.96%; p=0.001).
Maltese: Fl-64 ġimgħa, Xoterna Breezhaler wera titjib numeriku fuq glycopyrronium (differenza fil-medja tal-kura ta' LS ta' 1.95%, p=0.175) u titjib statistikament fuq tiotropium (differenza fil-medja tal-kura ta' LS ta' 4.96%; p=0.001).
English: Xoterna Breezhaler further showed superiority in reducing the annualised rate of all exacerbations by 11% versus fluticasone/salmeterol (p=0.003).
Maltese: Xoterna Breezhaler wera wkoll superjorità fit-tnaqqis tarrata anwalizzata ta' kull taħrix bi 11% meta mqabbel ma' fluticasone/salmeterol (p=0.003).
English: The number of moderate or severe COPD exacerbations/patient-years was 0.94 for Xoterna Breezhaler (812 events), 1.07 for glycopyrronium (900 events) and 1.06 for tiotropium (898 events).
Maltese: In-numru ta' taħrix moderat jew sever ta' COPD/snin ta' pazjent kien ta' 0.94 għal Xoterna Breezhaler (812 ilavveniment), 1.07 għal glycopyrronium (900 avveniment) u 1.06 għal tiotropium (898 avveniment).
English: Xoterna Breezhaler 85 mcg/43 mcg inhalation powder indacaterol/glycopyrronium
Maltese: Xoterna Breezhaler 85 mkg/43 mkg trab li jittieħed man-nifs indacaterol/glycopyrronium
English: In the 52-week study comparing Xoterna Breezhaler (n=1,675) and fluticasone/salmeterol (n=1,679), Xoterna Breezhaler met the primary study objective of non-inferiority in rate of all COPD exacerbations (mild, moderate or severe) compared to fluticasone/salmeterol.
Maltese: Fl-istudju ta' 52 ġimgħa li qabbel Xoterna Breezhaler (n=1,675) u fluticasone/salmeterol (n=1,679), Xoterna Breezhaler laħaq l-objettiv primarju tal-istudju ta' non-inferjorità fir-rata ta' kull taħrix ta' COPD (ħafif, moderat jew sever) meta mqabbel ma' fluticasone/salmeterol.
English: 6 or 10 Xoterna Breezhaler capsules to be used in the inhaler
Maltese: 10 kapsuli Xoterna Breezhaler biex jintużaw mal inhaler
English: At 26 weeks (primary endpoint), Xoterna Breezhaler increased trough FEV1 by 80 ml in patients (Xoterna Breezhaler n=82; placebo n=42) with the lowest degree of reversibility (<5%) (p=0.053) and by 220 ml in those patients (Xoterna Breezhaler n=392, placebo n=190) with a higher degree of reversibility at baseline (≥5%) compared to placebo (p<0.001).
Maltese: Fis-26 ġimgħa (endpoint primarju), Xoterna Breezhaler żied l-anqas FEV1 bi 80 ml f'pazjenti (Xoterna Breezhaler n=82; plaċebo n=42) bl-anqas grad ta' riversibbiltà (<5%) (p=0.053) u b'220 ml f'dawk il-pazjenti (Xoterna Breezhaler n=392, plaċebo n=190) b'livell ogħla ta' riversibbiltà fil-linja bażi (≥5%) imqabbel mal-plaċebo (p<0.
English: There were no relevant effects of Xoterna Breezhaler on mean heart rate over 24 h and heart rate assessed after 30 minutes, 4 h and 24 h.
Maltese: Ma kienx hemm effetti relevanti ta' Xoterna Breezhaler fuq il-medja tar-rata tal-qalb fuq medda ta' 24 siegħa u r-rata tal-qalb evalwata wara 30 minuta, 4 sigħat u 24 siegħa.
English: Xoterna Breezhaler - placebo
Maltese: Xoterna Breezhaler - plaċebo
English: Xoterna Breezhaler statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI); it demonstrated a statistically significant improvement in the TDI focal score at week 26 compared to placebo (LS mean treatment difference 1.09, p<0.001), tiotropium (LS mean treatment difference 0.51, p=0.007) and fluticasone/salmeterol (LS mean treatment difference 0.76, p=0.003).
Maltese: Xoterna Breezhaler naqqas b'mod sinjifikanti statistikament il-qtugħ ta' nifs kif evalwat skont itTransitional Dyspnoea Index (TDI); dan wera titjib sinjifikanti statistikament fl-iskor fokali TDI mas26 ġimgħa mqabbel ma' plaċebo (differenza medja fil-kura ta' LS ta' 1.09, p<0.001), tiotropium (differenza medja fil-kura ta' LS ta' 0.51, p=0.007) u fluticasone/salmeterol (differenza medja fil-kura ta' LS ta' 0.76, p=0.003).
English: Clinically relevant effects of hypokalaemia have not been observed in clinical studies of Xoterna Breezhaler at the recommended therapeutic dose (see section 5.1).
Maltese: Fi studji kliniċi dwar Xoterna Breezhaler ma dehrux effetti relevanti klinikament ta' ipokalimja meta mogħti skont id-doża terapewtika rrakkomandata (ara sezzjoni 5.1).
English: At week 26, Xoterna Breezhaler produced statistically significant improvement in peak FEV1 compared to placebo in the first 4 hours post dose (LS mean treatment difference 330 ml) (p<0.001).
Maltese: Mas-26 ġimgħa, Xoterna Breezhaler ipproduċa titjib sinjifikanti statistikament fl-ogħla FEV1 imqabbel mal-plaċebo fl-ewwel 4 sigħat wara l-għoti tad-doża (differenza fil-medja talkura ta' LS ta' 330 ml) (p<0.
English: There is no information on clinically relevant overdosing with Xoterna Breezhaler.
Maltese: M'hemm l-ebda informazzjoni dwar doża eċċessiva klinikament rilevanti b'Xoterna Breezhaler.
English: Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Xoterna Breezhaler.
Maltese: Reazzjonijiet immedjati ta' sensittività eċċessiva ġew irrappurtati wara l-għoti ta' indacaterol jew glycopyrronium, li huma s-sustanzi attivi ta' Xoterna Breezhaler.
English: The steady-state mean peak and trough plasma concentrations of glycopyrronium at the recommended once-daily dosing regimen were 166 picrograms/ml and 8 picograms/ml, respectively.
Maltese: Il-quċċata medja milħuqa waqt stat stabbli u permezz tal-konċentrazzjonijiet tal-plażma ta' glycopyrronium skont id-doża rrakkomandata ta' doża waħda kuljum kienet ta' 166 pikogramma/ml u 8 pikogrammi/ml rispettivament.
English: Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules indacaterol/glycopyrronium
Maltese: Xoterna Breezhaler 85 mikrogramma/43 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa indacaterol/glycopyrronium
English: Xoterna Breezhaler demonstrated a statistically superior improvement versus tiotropium in the percentage of “days able to perform usual daily activities” over 26 weeks (LS mean treatment difference 8.45%, p<0.001).
Maltese: Xoterna Breezhaler wera titjib superjuri statistikament kontra tiotropium fil-perċentwali ta' “jiem li fihom tkun kapaċi twettaq attivitajiet ta' kuljum” tul medda ta' 26 ġimgħa (differenza fil-medja talkura ta' LS ta' 8.45%, p<0.001).
English: Xoterna Breezhaler has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at 26 weeks compared to placebo (LS mean treatment difference -3.01, p=0.002) and tiotropium (LS mean treatment difference -2.13, p=0.009) and reductions versus indacaterol and glycopyrronium were -1.09 and -1.18, respectively.
Maltese: George's Respiratory Questionnaire (SGRQ) kif indikat bi tnaqqis fl-iskor totali ta' SGRQ mas-26 ġimgħa mqabbel mal-plaċebo (differenza fil-medja tal-kura ta' LS ta' -3.01, p=0.002) u tiotropium (differenza fil-medja tal-kura ta' LS ta' -2.13, p=0.009) u tnaqqis kontra indacaterol u glycopyrronium kienu ta' -1.09% u -1.18, rispettivament.
English: The incidence of pneumonia was 3.2% in the Xoterna Breezhaler arm compared to 4.8% in the fluticasone/salmeterol arm (p=0.017).
Maltese: L-inċidenza ta' pnewmonja kienet ta' 3.2% fil-fergħa ta' Xoterna Breezhaler meta mqabbel ma' 4.8% fil-fergħa ta' fluticasone/salmeterol (p = 0.017).
English: The capsules must be administered only using the Xoterna Breezhaler inhaler (see section 6.6).
Maltese: Il-kapsuli għandhom jittieħdu biss billi jintuża l-inhaler Xoterna Breezhaler (ara sezzjoni 6.6).
English: Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules
Maltese: Xoterna Breezhaler 85 mikrogramma/43 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa
English: When to inhale Xoterna Breezhaler
Maltese: • Inhaler wieħed Xoterna Breezhaler