FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, a higher percentage of patients receiving Brimica Genuair responded with a clinically meaningful improvement in TDI focal score compared to either aclidinium or formoterol (61.9% compared to 55.7% and 57.0%, respectively; p=0.056 and p=0.100, respectively).
Maltese: Barra minn hekk, perċentwal ogħla ta' pazjenti li jingħataw Brimica Genuair irrispondew b'titjib klinikament sinifikanti fil-punteġġ fokali TDI meta mqabbel ma' aclidinium jew formoterol (61.9% meta mqabbel ma' 55.7% u 57.0%, rispettivament; p=0.056 u p=0.100, rispettivament).
English: In Phase III clinical studies, the frequency of notable increases in blood glucose with Brimica Genuair was low (0.1%) and similar to placebo.
Maltese: III, il-frekwenza ta' żidiet notevoli fil-glukożju fid-demm b'Brimica Genuair kienet baxxa (0.1%) u simili għal plaċebo.
English: These include medicines for the treatment of: o depression (such as monoamine oxidase inhibitors or tricyclic antidepressants), o bacterial infections (such as erythromycin, clarithromycin, telithromycin), o allergic reactions (anti-histamines).
Maltese: Dawn jinkludu mediċini għall-kura ta': o depressjoni (bħal inibituri ta' monoamine oxidase jew antidepressanti triċikliċi), o infezzjonijiet batteriċi (bħal erythromycin, clarithromycin, telithromycin), o reazzjonijiet allerġiċi (antiistaminiċi).
English: Hypersensitivity to the active substances or to the excipient listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: [arrow] Tear here
Maltese: [vleġġa] Qatta' hawn
English: Following inhalation of Brimica Genuair 340/12 micrograms, with plasma sampling up to 24 hours post-dose, the terminal elimination half-life observed for aclidinium bromide ranged from 11-33 hours and for formoterol from 12-18 hours.
Maltese: Wara t-teħid man-nifs ta' Brimica Genuair 340/12-il mikrogramma, b'kampjun tal-plażma sa 24 siegħa wara d-doża, il-half life ta' eliminazzjoni terminali osservata għal aclidinium bromide varjat minn 11-il siegħa sa 33 siegħa u għal formoterol minn 12-il siegħa sa 18-il siegħa.
English: Brimica Genuair reduced the use of rescue medication over 6 months compared to placebo (by 0.9 puffs per day [p<0.0001]), aclidinium (by 0.4 puffs/day [p<0.001]) and formoterol (by 0.2 puffs/day [p=0.062]).
Maltese: Brimica Genuair naqqas l-użu ta' medikazzjoni ta' salvataġġ matul 6 xhur meta mqabbel ma' plaċebo (b'0.9 għafsiet kuljum [p<0.0001]), aclidinium (b'0.4 għafsiet/kuljum [p<0.001]) u formoterol (b'0.2 għafsiet/kuljum [p=0.062]).
English: The plasma protein binding of aclidinium determined in vitro most likely corresponded to the protein binding of the metabolites due to the rapid hydrolysis of aclidinium in plasma; plasma protein binding was 87% for the carboxylic acid metabolite and 15% for the alcohol metabolite.
Maltese: B'mod mill-aktar probabbli, it-twaħħil tal-proteina tal-plażma ta' aclidinium determinat in vitro aktarx li kkorrisponda għat-twaħħil tal-proteina tal-metaboliti minħabba l-idroliżi mgħaġġla ta' aclidinium fil-plażma; it-twaħħil tal-proteina tal-plażma kien ta' 87% għall-metabolit tal-carboxylic acid u 15% għall-metabolit tal-alkoħol.
English: Both belong to a group of medicines called bronchodilators.
Maltese: It-tnejn jagħmlu parti minn grupp ta' mediċini msejħin bronkodilaturi.
English: The peak plasma concentrations at steady state of aclidinium and formoterol observed in patients with COPD treated with Brimica Genuair twice daily for 5 days were reached within 5 minutes post-inhalation and were 128 pg/ml and 17 pg/ml, respectively.
Maltese: L-ogħla konċetrazzjonijiet fil-plażma fi stat fiss ta' aclidinium u formoterol osservati fil-pazjenti b'COPD ikkurati b'Brimica Genuair darbtejn kuljum għal 5 ijiem intlaħqu fi żmien 5 minuti wara l-inalazzjoni u kienu 128 pg/ml u 17 pg/ml, rispettivament.
English: Metabolic effects of hyperglycaemia and hypokalaemia may be observed with high doses of β2-adrenergic agonists.
Maltese: Jistgħu jiġi osservati effetti metaboliċi ta' ipergliċemija u ipokalemija b'dożi għoljin ta' agonisti adrenerġiċi β2.
English: These effects are known exaggerated pharmacological responses observed with β2-agonists.
Maltese: Dawn l-effetti huma risponsi farmakoloġiċi esaġerati magħrufin li huma osservati b'agonisti β2.
English: However, paradoxical bronchospasm has been observed with other inhalation therapies.
Maltese: Madankollu ġie osservat bronkospażmu paradossali b'terapiji ta' inalazzjoni oħra.
English: In study ACLIFORM-COPD, Brimica Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 299 ml and 125 ml, respectively (both p<0.0001) and improvements in trough FEV1 relative to placebo and formoterol of 143 ml and 85 ml, respectively (both p<0.0001).
Maltese: Fi studju ACLIFORM-COPD, Brimica Genuair wera titjib f'FEV1 f'siegħa wara d-doża meta mqabbel ma' plaċebo u aclidinium ta' 299 ml u 125 ml, rispettivament (it-tnejn p<0.0001) u titjib fl-FEV1 l-aktar baxx meta mqabbel ma' plaċebo u formoterol ta' 143 ml u 85 ml, rispettivament (it-tnejn p<0.0001).
English: Insomnia Anxiety
Maltese: Insomnja Ansjetà
English: *As the primary endpoint did not achieve statistical significance, all p-values for secondary endpoints are tested at a nominal significance level of 0.05, and no formal statistical inference can be drawn.
Maltese: *Peress li l-punt ta' tmiem primarju ma kisibx sinifikat statistiku, il-valuri-p kollha għall-punti ta' tmiem sekondarji jiġu ttestjati f'livell ta' sinifikanza nominali ta' 0.05, u ma tista' tinstilet l-ebda inferenza statistika formali.
English: Brimica Genuair also showed improvements in exercise endurance time compared to placebo after 8 weeks of treatment (55 seconds [95% CI=5.6, 104.8; p=0.0292]; baseline value: 456 seconds).
Maltese: Brimica Genuair wera wkoll titjib fil-ħin tar-reżistenza għall-eżerċizzju meta mqabbel mal-plaċebo wara 8 ġimgħat ta' kura (55 sekonda [95% CI=5.6, 104.8; p=0.0292]; valur bażali: 456 sekonda).
English: Brimica Genuair improved daily symptoms of COPD such as ‘breathlessness', ‘chest symptoms', ‘cough and sputum' (assessed by E-RS total score) as well as overall night-time symptoms, overall early morning symptoms and symptoms limiting early morning activities compared to placebo, aclidinium and formoterol but the improvements were not always statistically significant.
Maltese: Brimica Genuair tejjeb is-sintomi ta' kuljum ta' COPD bħal ‘qtugħ ta' nifs', ‘sintomi tas-sider', ‘sogħla u sputum' (ivvalutati bil-punteġġ totali ta' E-RS) kif ukoll sintomi ġenerali ta' matul il-lejl, is-sintomi ġenerali ta' kmieni filgħodu u sintomi li jillimitaw l-attivitajiet ta' filgħodu kmieni meta mqabbel ma' plaċebo, aclidinium u formoterol, iżda t-titjib ma kienx dejjem statistikament sinifikanti.
English: No clinically significant effects of Brimica Genuair on cardiac rhythm were observed on 24-hour Holter monitoring in a subset of 551 patients, of whom 114 received Brimica Genuair twice daily.
Maltese: Ma ġie osservat l-ebda effett klinikament sinifikanti ta' Brimica Genuair fuq ir-ritmu kardijaku matul monitoraġġ Holter ta' 24 siegħa f'sottosett ta' 551 pazjent, li 114 minnhom ingħataw Brimica Genuair darbtejn kuljum.
English: - The other ingredient is lactose monohydrate (see end of section 2 under ‘Brimica Genuair contains lactose' for more information).
Maltese: - Is-sustanza l-oħra hija lactose monohydrate (ara t-tmiem ta' sezzjoni 2 taħt “Brimica Genuair fih lactose” għal aktar informazzjoni).
English: In vitro studies have shown that aclidinium at the therapeutic dose or its metabolites do not inhibit or induce any of the cytochrome P450 (CYP450) enzymes and do not inhibit esterases (carboxylesterase, acetylcholinesterase and butyrylcholinesterase).
Maltese: L-istudji in vitro wrew li aclidinium fid-doża terapewtika tiegħu jew il-metaboliti tiegħu ma jinibixxux u lanqas ma jinduċu xi wieħed mill-enzimi taċ-ċitokromu P450 (CYP450) u ma jinibixxux esterases (carboxylesterase, acetylcholinesterase u butyrylcholinesterase).
English: Brimica Genuair should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval such as monoamine oxidase inhibitors, tricyclic antidepressants, antihistamines or macrolides because the action of formoterol, a component of Brimica Genuair, on the cardiovascular system may be potentiated by these medicinal products.
Maltese: Brimica Genuair għandu jingħata b'kawtela lil pazjenti kkurati bi prodotti mediċinali magħrufin li jtawlu l-intervall QTc bħall-inibituri monoamine oxidase, l-antidepressanti triċikliċi, l-antistamini jew il-makrolidi peress li l-azzjoni ta' formoterol, komponent ta' Brimica Genuair, fuq is-sistema kardjovaskulari tista' titqawwa minn dawn il-prodotti mediċinali.
English: ALUMINIUM BAG
Maltese: BORŻA TAL-ALUMINJU
English: Brimica Genuair 340/12 micrograms twice daily consistently provided clinically meaningful improvements in lung function (as assessed by FEV1, forced vital capacity and inspiratory capacity) compared with placebo.
Maltese: Brimica Genuair 340/12-il mikrogramma darbtejn kuljum ipprovda b'mod konsistenti titjib sinifikanti fil-funzjoni tal-pulmuni (kif ivvalutat minn FEV1, kapaċità vitali sfurzata u kapaċità ispiratorja) meta mqabbel ma' plaċebo.
English: Submission of the results of the agreed post-authorisation safety study (PASS) for aclidinium bromide to evaluate the overall mortality and the proposed cardiovascular safety endpoints (with an additional endpoint of cardiac arrhythmia) among patients with COPD using aclidinium/formoterol, according to a protocol agreed by the PRAC.
Maltese: Is-sottomissjoni tar-riżultati tal-istudju maqbul dwar is-sigurtà wara t-tqegħid fis-suq (PASS) għal aclidinium bromide biex tiġi evalwata l-mortalità globali u l-punti aħħarin tas-sigurtà kardjovaskulari proposti (b'punt aħħari addizzjonali ta' arritmija kardijaka) fost pazjenti b'COPD li jużaw aclidinium/formoterol, skont protokoll maqbul millPRAC.
English: Brimica Genuair 340 micrograms /12 micrograms inhalation powder aclidinium/formoterol fumarate dihydrate
Maltese: Brimica Genuair 340 mikrogramma/12-il mikrogramma trab li jittieħed man-nifs aclidinium/formoterol fumarate dihydrate
English: Longacting β2-adrenergic agonists should be used with caution in patients with history of or known prolongation of the QTc-interval or treated with medicinal products affecting the QTc interval (see section 4.5).
Maltese: Agonisti adrenerġiċi β2 li jaġixxu fit-tul għandhom jintużaw b'attenzjoni f'pazjenti bi storja ta' jew titwil magħruf tal-intervall QTc jew li huma kkurati bi prodotti mediċinali li jaffettwaw l-intervall QTc (ara sezzjoni 4.5).
English: Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Maltese: Il-prodotti mediċinali li huma magħrufin li jtawlu l-intervall QTc huma assoċjati ma' żieda fir-riskju ta' arritmija ventrikulari.
English: Brimica Genuair demonstrated a rapid onset of action within 5 minutes of the first inhalation relative to placebo (p<0.0001).
Maltese: Brimica Genuair wera bidu ta' azzjoni rapida fi żmien 5 minuti mill-ewwel teħid tan-nifs relattiv għal plaċebo (p<0.
English: This corresponds to a metered dose of 400 micrograms of aclidinium bromide (equivalent to 343 micrograms of aclidinium) and a metered dose of 12 micrograms of formoterol fumarate dihydrate.
Maltese: Dan jikkorrispondi għal doża mkejla ta' 400 mikrogramma ta' aclidinium bromide (ekwivalenti għal 343 mikrogramma ta' aclidinium) u 12-il mikrogramma ta' formoterol fumarate dihydrate.
English: During the reporting period of the PSUR, study D6560C00002 was completed and showed that the proportion of patients with an adverse event of ‘peripheral oedema' was numerically lower in the aclidinium group than in the placebo group.
Maltese: Waqt il-perjodu ta' rappurtar tal-PSUR, intemm l-istudju D6560C00002 u wera li l-proporzjon ta' pazjenti b'avveniment avvers ta' “edema periferali” kien numerikament akbar baxx fil-grupp ta' aclidinium milli fil-grupp tal-plaċebo.
English: The percentage of patients in AUGMENT who achieved a clinically meaningful improvement from baseline in SGRQ total score (defined as a decrease of at least 4 units) was higher with Brimica Genuair than with placebo (58.2% compared to 38.7%, respectively; p<0.001).
Maltese: Il-perċentwal ta' pazjenti f'AUGMENT li kisbu titjib klinikament sinifikanti mil-linja bażi fil-punteġġ totali ta' SGRQ (definit bħala tnaqqis ta' mill-inqas 4 unitajiet) kien ogħla b'Brimica Genuair milli bi plaċebo (58.2% meta mqabbel ma' 38.7%, rispettivament; p<0.001).
English: Lung volumes, exercise endurance and physical activity The effect of Brimica Genuair on lung volumes, exercise endurance and physical activity was investigated in an 8-week parallel, randomised, placebo-controlled clinical study in COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Maltese: Volumi fil-pulmun, felħan għall-eżerċizzju u għall-attività fiżika L-effett ta' Brimica Genuair fuq il-volumi fil-pulmun, felħan għall-eżerċizzju u għall-attività fiżika ġie investigat fi studju kliniku ta' 8 ġimgħat, parallel, randomizzat, ikkontrollat bi plaċebo f'pazjenti COPD b'iperinflazzjoni (kapaċità residwali funzjonali
English: Similarly, in pooled clinical studies with Duaklir Genuair/Brimica Genuair and its mono-component, ‘peripheral oedema' was numerically less common on the active treatment than on placebo.
Maltese: B'mod simili, fi studji kliniċi miġbura b'Duaklir Genuair/Brimica Genuair u l-monokomponent tiegħu, “edema periferali” kienet numerikament inqas komuni fuq il-kura attiva milli fuq il-plaċebo.
English: Electrocardiogram QTc prolonged Palpitations
Maltese: QTc ta' elettrokardjogramma mtawwal Palpitazzjonijiet
English: The percentages of patients with clinically meaningful improvements in TDI focal score (defined as an increase of at least 1 unit) were higher with Brimica Genuair than with placebo in ACLIFORM-COPD (64.8% compared to 45.5%; p<0.001) and AUGMENT (58.1% compared to 36.6%; p<0.0001).
Maltese: Il-perċentwali tal-pazjent b'titjib klinikament li jagħmel sens fil-punteġġ fokali tat-TDI (definiti bħala żieda ta' mill-inqas unità waħda) kienu ogħla b'Brimica Genuair milli bi plaċebo ACLIFORM-COPD (64.8% meta mqabbel ma' 45.5%; p<0.001) u AUGMENT (58.1% meta mqabbel ma' 36.6%; p<0.0001).
English: Brimica Genuair provided a clinically meaningful improvement in breathlessness (assessed by the Transition Dyspnoea Index [TDI]) with an improvement in the TDI focal score at 6 months compared to placebo of 1.29 units in study ACLIFORM-COPD (p<0.0001) and 1.44 units in study AUGMENT (p<0.0001).
Maltese: [TDI]) b'titjib fil-punteġġ fokali ta' TDI wara 6 xhur meta mqabbel ma' plaċebo ta' 1.29 unità fl-istudju ACLIFORM-COPD (p<0.0001) u 1.44 unità fl-istudju AUGMENT (p<0.0001).
English: The number of steps/day in the Brimica Genuair treatment group was maintained resulting in a treatment effect compared to placebo of 510 steps/day (p=0.1588) and a reduction versus placebo in the percentage of inactive patients (<6000 steps per day) (41.5% compared to 50.4%; p=0.1134).
Maltese: Innumru ta' passi/jum fil-grupp ta' kura bi Brimica Genuair inżamm u rriżulta f'effett ta' kura meta mqabbel mal-plaċebo ta' 510 pass/jum (p=0.1588) u tnaqqis kontra l-plaċebo fil-perċentwali ta' pazjenti mhux attivi (<6000 pass kuljum) (41.5% meta mqabbel ma' 50.4%; p=0.1134).
English: In study ACLIFORM-COPD, only a small decrease in SGRQ total score compared to placebo was observed due to an unexpectedly large placebo response (p=0.598) and the percentages of patients who achieved clinically meaningful improvements from baseline were 55.3% with Brimica Genuair and 53.2% with placebo (p=0.669).
Maltese: Fl-istudju ACLIFORM-COPD, ġie osservat biss tnaqqis żgħir fil-punteġġ totali tal-SGRQ meta mqabbel ma' plaċebo minħabba rispons kbir mhux mistenni bi plaċebo (p=0.598) u l-perċentwali ta' pazjenti li kisbu titjib klinikament sinifikanti mil-linja bażi kienu 55.3% bi Brimica Genuair u 53.2% bi plaċebo (p=0.669)
English: - If you have thyroid gland problems (thyrotoxicosis).
Maltese: - Jekk għandek problemi fil-glandola tat-tirojde (tirotossikożi).
English: Each delivered dose contains 396 micrograms aclidinium bromide (equivalent to 340 micrograms of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate.
Maltese: Kull doża fornuta fiha 396 mikrogramma ta' aclidinium bromide (ekwivalenti għal 340 mikrogramma ta' aclidinium) u 11.8 mikrogramma ta' formoterol fumarate dihydrate.
English: Dysphonia Throat irritation
Maltese: Disfonja Irritazzjoni fil-griżmejn
English: In Phase III studies, clinically meaningful bronchodilator effects were seen within 5 minutes of the first dose and were maintained over the dosing interval.
Maltese: III, intwerew effetti ta' bronkodilatur klinikament sinifikanti fi żmien 5 minuti mill-ewwel doża u dawn inżammu tul l-intervall tad-dożaġġ kollu.
English: β2-adrenergic agonists may produce increases in pulse rate and blood pressure, electrocardiogram (ECG) changes such as T wave flattening, ST segment depression and prolongation of the QTcinterval in some patients.
Maltese: L-agonisti adrenerġiċi β2 jistgħu jipproduċu żidiet fir-rata tal-polz u fil-pressjoni tad-demm, bidliet fl-elettrokardjogramm (ECG) bħall-iċċattjar tal-mewġa T, depressjoni tas-segment ST u titwil tal-intervall QTc f'xi pazjenti.
English: Carton containing 3 inhalers each with 60 doses.
Maltese: Kartuna li fiha 3 inalaturi kull wieħed b'60 doża.
English: Adverse reactions associated with Brimica Genuair were similar to those of the individual components.
Maltese: Reazzjonijiet avversi assoċjati ma' Brimica Genuair kienu simili għal dawk tal-komponenti individwali.
English: The inhaler is supplied sealed in a protective aluminium laminate bag containing a silica gel desiccant sachet, placed in a cardboard carton.
Maltese: L-inalatur huwa fornut issiġillat f'borża protettiva tal-aluminju laminat, li fih qartas desikkant tas-silica gel, imqiegħed f'kartuna tal-kartonċin.
English: What Brimica Genuair contains - The active substances are aclidinium and formoterol fumarate dihydrate.
Maltese: X'fih Brimica Genuair - Is-sustanzi attivi huma aclidinium u formoterol fumarate dihydrate.
English: Other pharmacodynamic interactions
Maltese: Interazzjonijiet farmakodinamiċi oħra
English: It is white-coloured with an integral dose indicator and an orange dosage button.
Maltese: Huwa ta' kulur abjad b'indikatur tad-dożi integrali u buttuna oranġjo tad-dożaġġ.
English: Each delivered dose contains approximately 11 mg lactose (as monohydrate).
Maltese: Kull doża mogħtija fiha bejn wieħed u ieħor 11 mg ta' lactose (bħala monoidrat).
English: The pooled analysis of these two studies showed Brimica Genuair to be associated with statistically significantly greater improvements in TDI focal score compared to aclidinium (0.4 units, p=0.016) or formoterol (0.5 units, p=0.009).
Maltese: L-analiżi miġbura ta' dawn iż-żewġ studji uriet li Brimica Genuair huwa assoċjat ma' titjib statistikament sinifikanti ferm akbar fil-punteġġ fokali tat-TDI meta' mqabbel ma' aclidinium (0.4 unitajiet, p=0.016) jew formoterol (0.5 unitajiet, p=0.009).
English: Improvements in the PROactive total score were observed in patients treated with Brimica Genuair compared with placebo (p=0.0002).
Maltese: Ġie osservat titjib fil-punteġġ totali PROactive f'pazjenti kkurati bi Brimica Genuair meta mqabbel mal-plaċebo (p=0.0002).
English: The Phase III clinical development programme included approximately 4,000 patients with a clinical diagnosis of COPD and comprised two 6-month randomised, placebo- and active-controlled studies (ACLIFORM-COPD and AUGMENT), a 6-month extension of the AUGMENT study and a further 12-month randomised controlled study.
Maltese: III inkluda madwar 4,000 pazjent b'dijanjosi klinika ta' COPD u kien jinkludi żewġ studji ta' 6 xhur ikkontrollati bi plaċebo u b'mod attiv (ACLIFORM-COPD u AUGMENT), estensjoni ta' 6 xhur tal-istudju AUGMENT u studju kkontrollat li fih il-pazjenti ntgħażlu b'mod każwali ta' 12-il xahar addizzjonali.
English: Nevertheless, it is considered unlikely that Brimica Genuair administered at the recommended dose will affect fertility in humans.
Maltese: Madankollu, huwa kkunsidrat improbabbli li Brimica Genuair mogħti bid-doża rakkomandata jaffettwa l-fertilità fil-bnedmin.
English: Brimica Genuair provided a clinically meaningful improvement in disease-specific health status (as assessed by the St. George's Respiratory Questionnaire [SGRQ]) in study AUGMENT, with an improvement in the SGRQ total score compared to placebo of -4.35 units (p<0.0001).
Maltese: George (Respiratory Questionnaire-[SGRQ]) fi studju AUGMENT, b'titjib fil-punteġġ totali tal-SGRQ meta mqabbel ma' plaċebo ta' -4.35 unità (p<0.
English: In clinical studies, paradoxical bronchospasm was not observed with Brimica Genuair at its recommended dose.
Maltese: Fi studji kliniċi ġie osservat bronkospażmu paradossali b'Brimica Genuair fid-doża rakkomandata tiegħu.
English: • Medicines which can cause a type of change in the electrical activity of the heart known as QT interval prolongation (observed in an electrocardiogram).
Maltese: • Mediċini li jistgħu jikkawżaw tip ta' bidla fl-attività elettrika tal-qalb magħrufa bħala titwil fl-intervall QT (osservata f'elettrokardjogramma).
English: *Half-life consistent with product accumulation based on a known dose regimen.
Maltese: *Half-life konsistenti mal-akkumulazzjoni tal-prodott ibbażata fuq kors ta' doża magħrufa.
English: Pooled efficacy analysis of the two 6-month Phase III studies demonstrated a statistically significant reduction of 29% in the rate of moderate or severe exacerbations (requiring treatment with antibiotics or corticosteroids or resulting in hospitalisations) with Brimica Genuair compared to placebo (rates per patient per year: 0.29 vs. 0.42, respectively; p=0.036).
Maltese: III uriet tnaqqis statistikament sinifikanti ta' 29% fir-rata ta' taħrix moderat jew sever tal-marda (li kien jeħtieġ kura b'antibijotiċi jew kortikosterojdi jew li rriżulta f'li l-pazjent kellu jiddaħħal l-isptar) b'Brimica Genuair meta mqabbel ma' plaċebo (rati għal kull pazjent kull sena: 0.29 vs. 0.42, rispettivament; p=0.036).
English: This medicine contains two active ingredients called aclidinium and formoterol fumarate dihydrate.
Maltese: Din hija mediċina li fiha żewġ sustanzi attivi msejħin aclidinium u formoterol fumarate dihydrate.
English: Inhalation powder 1 inhaler containing 30 doses 1 inhaler containing 60 doses 3 inhalers each containing 60 doses
Maltese: Trab li jittieħed man-nifs 1 inalatur wieħed li fih 30 doża 1 inalatur wieħed li fih 60 doża 3 inalaturi li kull wieħed fih 60 doża
English: Following intravenous administration of radiolabelled aclidinium 400 micrograms to healthy subjects, approximately 1% of the dose was excreted as unchanged aclidinium bromide in the urine.
Maltese: Wara għoti ġol-vini ta' 400 mikrogramma ta' aclidinium radjutikkettat lil individwi b'saħħithom, bejn wieħed u ieħor 1% tad-doża tneħħiet bħala aclidinium bromide mhux mibdul fl-awrina.
English: The frequencies assigned to the adverse reactions are based on crude incidence rates observed with Brimica Genuair 340 micrograms /12 micrograms in the pooled analysis of randomised, placebo-controlled Phase III clinical studies of at least six months duration, or on experience with individual components.
Maltese: Il-frekwenzi assenjati għar-reazzjonijiet avversi huma bbażati fuq rati ta' inċidenza approssimattivi osservati b'Brimica Genuair 340 mikrogramma /12-il mikrogramma fl-analiżi miġbura ta' studji kliniċi ta' Fażi
English: The prominent pathway involves direct glucuronidation, with O-demethylation followed by glucuronide conjugation being a further metabolic pathway.
Maltese: Il-mogħdija ewlenija tinvolvi glukoronidazzjoni diretta, b'demetilizzazzjoni-O segwita mill-konjugazzjoni ta' glucoronide li hija mogħdija metabolika oħra.
English: The mouthpiece is covered with a removable orange protective cap.
Maltese: Il-biċċa tal-ħalq hija miksija b'tapp protettiv oranġjo li jinqala'.