FrancophonIA/ELRC3.0 huggingface dataset:
English: In 2008, key cooperation activities with international partners included:
Maltese: Fl-2008, l-attivitajiet ewlenin ta' kooperazzjoni ma' msieħba internazzjonali kienu jinkludu:
English: over 100 were type-II variation procedures that resulted in new information, including safety warnings or precautions, being added to the prescribing information for authorised medicines, thereby helping to reduce the risk of misuse or unwanted side-effects associated with the use of these medicines;
Maltese: aktar minn 100 kienu proċeduri ta' varjazzjoni tat-tip II li rriżultaw fiż-żieda ta' informazzjoni ġdida, inklużi twissijiet dwar is-sigurtà jew prekawzjonijiet, mal-informazzjoni tal-preskrizzjoni għal mediċini awtorizzati, biex b'hekk tgħin tnaqqas ir-riskju ta' użu ħażin jew effetti sekondarji mhux mixtieqa assoċjati mal-użu ta' dawn il-mediċini;
English: an ongoing programme of activities designed to help the regulatory authorities of Croatia, Turkey and the former Yugoslav Republic of Macedonia prepare for integration into the European medicines network upon the eventual accession of these countries to the EU;
Maltese: programm kontinwu ta' attivitajiet imfassla sabiex jgħinu lill-awtoritajiet regolatorji tal-Kroazja, litTurkija u lill-ex Repubblika Jugożlava tal-Maċedonja jħejju għall-integrazzjoni fin-netwerk Ewropew tal-mediċini malli dawn il-pajjiżi eventwalment jissieħbu fl-UE;
English: A special form of scientific advice, called protocol assistance, can be provided to help developers of orphan-designated medicines demonstrate that their medicine offers a significant benefit over other available treatments, which is a necessary condition for receiving a marketing authorisation for an orphan medicine.
Maltese: Tista' tingħata forma speċjali ta' parir xjentifiku, msejħa assistenza għall-protokoll sabiex tgħin lilliżviluppaturi ta' mediċini nnominati orfni juru li l-mediċina tagħhom toffri benefiċċju sinjifikanti fuq kuri oħrajn disponibbli, li hija kundizzjoni essenzjali sabiex wieħed jirċievi awtorizzazzjoni għattqegħid fis-suq għal mediċina orfni.
English: As a result, 66 new medicines - including ones for the prevention or treatment of serious and debilitating conditions such as bone cancer in children, immune-system diseases, HIV and rheumatoid arthritis - will become available to European citizens.
Maltese: B'riżultat ta' dan, 66 mediċina ġdida - inklużi xi wħud għall-prevenzjoni jew il-kura ta' kundizzjonijiet serji jew li jdgħajjfu s-saħħa bħall-kanċer tal-għadam fit-tfal, mard tas-sistema immunitarja, l-HIV u l-artrite rewmatika - sejrin ikunu disponibbli għaċ-ċittadini Ewropej.
English: The year 2008 was one of consolidation and steady progress for the European Medicines Agency (EMEA), rather than one of major leaps and bounds.
Maltese: Is-sena 2008 kienet waħda ta' konsolidazzjoni u ta' progress kostanti għall-Aġenzija Ewropea għallMediċini (European Medicines Agency - EMEA), aktar milli waħda ta' bidliet u qabżiet kbar.
English: 1.0 unit
Maltese: 1.0 unità
English: 30 doses 60 doses
Maltese: 30 doża 60 doża
English: Dose indicator moves slowly from 60 to 0: 60, 50, 40, 30, 20, 10, 0.
Maltese: L-indikatur tad-doża jiċċaqlaq bil-mod minn 60 għal 0: 60, 50, 40, 30, 20, 10, 0.
English: - 4.6 units a Minimum clinically important difference (MCID) of at least 1 unit change in TDI.
Maltese: -4.6 unitajiet a Differenza klinikament importanti minima (MCID) ta' mill-inqas bidla 1 fl-unità fit-TDI.
English: Paradoxical bronchospasm:
Maltese: Bronkospażmi paradossiċi:
English: Protective Cap
Maltese: Għatu Protettiv
English: The inhaler device is a multicomponent device made of polycarbonate, acrylonitrile-butadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene and stainless steel.
Maltese: L-istrument inalatur huwa strument b'diversi komponenti magħmul minn polycarbonate, acrylonitrilebutadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene u stainless steel.
English: Anticholinergic activity:
Maltese: Attività antikolinerġika:
English: 08740 Sant Andreu de la Barca, Barcelona Spain
Maltese: Sant Andreu de la Barca, Barcelona Spanja
English: - The other ingredient is lactose monohydrate (refer to Section 2 “Bretaris Genuair contains lactose”).
Maltese: - Is-sustanza l-oħra hija lactose monohydrate (irreferi għal Sezzjoni 2 “Bretaris Genuair fih lactose”).
English: Date of first authorisation: 20 July 2012 Date of last renewal: 20 April 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Lulju 2012 Data tal-ewwel tiġdid: 20' ta' April 2017
English: Cardiovascular effects:
Maltese: Effetti kardjovaskulari:
English: Up to 65% of the dose was eliminated as metabolites in the urine and up to 33% as metabolites in the faeces.
Maltese: Sa 65% taddoża ġiet eliminata bħala metaboliti fl-awrina u sa 33% bħala metaboliti fl-ippurgar.
English: Bronchodilation
Maltese: Bronkodilatazzjoni
English: Bretaris Genuair statistically significantly reduced lung hyperinflation at rest (functional residual capacity [FRC]=0.197 L [95% CI=0.321, 0.072; p=0.002]; residual volume [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) and also improved trough inspiratory capacity (by 0.078 L; 95% CI=0.01, 0.145; p=0.025) and reduced dyspnoea during exercise (Borg scale) (by 0.63 Borg units; 95% CI=1.11, 0.14; p=0.012).
Maltese: [FRC]=0.197 L [95% CI=0.321, 0.072; p=0.002]; volum residwu [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) u tejjeb ukoll il- kapaċità minima ta' teħid 'il ġewwa tan-nifs (b'0.078 L; 95% CI=0.01, 0.145; p=0.025) u naqqas id-dispnea matul eżerċizzju (skala ta' Borg) (b'0.63 unitajiet Borg; 95% CI=1.11, 0.14; p=0.012).
English: (Figure N), or
Maltese: (Figura N), jew
English: Read steps 2.1 to 2.7 fully before use.
Maltese: Aqra l-passi 2.1 sa 2.7 kompletament qabel l-użu.
English: Go back to ‘STEP 1 Prepare your dose' and repeat steps 1.1 to 1.6.
Maltese: Mur lura għal “PASS 1 Ipprepara d-doża tiegħek” u rrepeti lpassi 1.1 sa 1.6.
English: The frequency of patients with at least one MACE was 3.85% vs. 4.23% patients in the aclidinium and placebo groups, respectively.
Maltese: Il-frekwenza tal-pazjenti b'tal-inqas MACE wieħed kienet 3.85% vs. 4.23% pazjenti fil-gruppi ta' aclidinium u plaċebo, rispettivament.
English: Approximately 48% of enrolled patients had a prior history of at least 1 documented previous cardiovascular event; cerebrovascular disease (13.1%), coronary artery disease (35.4%), peripheral vascular disease or history of claudication (13.6%).
Maltese: Madwar 48 % tal-pazjenti rreġistrati kellhom storja preċedenti ta' mill-inqas avveniment kardjovaskulari preċedenti 1 dokumentat; marda ċerebrovaskulari (13.1%), marda tal-arterja koronarja (35.4%), marda vaskulari periferali jew storja ta' klawdikazzjoni (13.6%).
English: Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Maltese: Bretaris Genuair huwa indikat bħala trattament ta' manutenzjoni bi bronkodilatatur sabiex itaffi ssintomi fil-pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD) (ara sezzjoni 5.1).
English: 1.68-fold c increase in likelihood
Maltese: żieda ta' 1.68 drabi fil-probabbiltà
English: This corresponds to a metered dose of 400 µg aclidinium bromide equivalent to 343 µg aclidinium.
Maltese: Din tikkorrispondi għal doża mkejla ta' 400 µg ta' aclidinium bromide ekwivalenti għal 343 µg ta' aclidinium.
English: Administration of Bretaris Genuair may cause paradoxical bronchospasm.
Maltese: L-għoti ta' Bretaris Genuair jista' jikkawża bronkospażmi paradossiċi.
English: Patients in the aclidinium bromide group had a 18% relative reduction of the risk of an exacerbation (HR 0.82; 95% CI [0.73, 0.92], p<0.001).
Maltese: Il-pazjenti fil-grupp ta' aclidinium bromide kellhom tnaqqis relattiv ta' 18 % fir-riskju ta' aggravar (HR 0.82; 95% CI [0.73, 0.92], p<0.001).
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita billi tintuża l-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 70.7% of patients completed the study per investigator assessment.
Maltese: 70.7 % talpazjenti temmew l-istudju skont il-valutazzjoni tal-investigatur.
English: The study had an event-driven design and was terminated once sufficient MACE events for the primary safety analysis were observed.
Maltese: L-istudju kellu tfassil xprunat mill-avvenimenti u ntemm ladarba ġew osservati avvenimenti MACE suffiċjenti għall-analiżi tas-sigurtà primarja.
English: The upper bound of the confidence interval excluded a pre-defined risk margin of 1.8.
Maltese: Il-valur ta' fuq tal-intervall ta' kunfidenza eskluda marġini ta' riskju definit minn qabel ta' 1.8.
English: Pack sizes supplied:
Maltese: Daqsijiet tal-pakketti pprovduti:
English: Aclidinium bromide is a competitive, selective muscarinic receptor antagonist (also known as an anticholinergic), with a longer residence time at the M3 receptors than the M2 receptors.
Maltese: Aclidinium bromide huwa antagonista tar-riċettur muskariniku kompetittiv u selettiv (magħruf ukoll bħala antikolinerġiku), bi żmien ta' residenza akbar fir-riċetturi M3 mir-riċetturi M2.
English: The most frequently reported adverse reactions with Bretaris Genuair were headache (6.6%) and nasopharyngitis (5.5%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni b'Bretaris Genuair kienu l-uġigħ ta' ras (6.6%) u nasofarinġite (5.5%).
English: In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide at the therapeutic dose are not expected to cause interactions with active substances that are substrates of Pglycoprotein (P-gp) or active substances metabolised by cytochrome P450 (CYP450) enzymes and esterases (see section 5.2).
Maltese: Studji in vitro wrew li aclidinium bromide jew il-metaboliti ta' aclidinium bromide fid-doża terapewtika mhumiex mistennija li jikkawżaw interazzjonijiet ma' sustanzi attivi li huma substrati ta' glikoproteina (P-gp), jew sustanzi attivi metabolizzati minn enzimi taċ-ċitokrom P450 (CYP450) u esterases (ara sezzjoni 5.2).
English: For Instructions for Use, see section 6.6.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Long Term Safety and Efficacy Trial up to 3 years
Maltese: Prova ta' Sigurtà u Effikaċja Fit-Tul sa 3 snin
English: The pharmacokinetic properties of aclidinium bromide in patients with moderate to severe COPD appear to be similar in patients aged 40-59 years and in patients aged ≥70 years.
Maltese: Il-proprjetajiet farmakokinetiċi ta' aclidinium bromide f'pazjenti b'COPD moderata sa severa jidhru simili f'pazjenti ta' 40-59 sena u f'pazjenti ta' ≥70 sena.
English: Experience in patients with cardiovascular comorbidities in clinical trials is limited (see section 5.1).
Maltese: Esperjenza f'pazjenti b'komorbiditajiet kardjovaskulari fi provi kliniċi hija limitata (ara sezzjoni 5.1).
English: EU/1/12/781/001 30 doses
Maltese: EU/1/12/781/001 30 doża
English: Also contains: Lactose
Maltese: Fih ukoll: Lactose
English: Aclidinium bromide is rapidly and extensively hydrolysed to its pharmacologically inactive alcoholand carboxylic acid-derivatives.
Maltese: Aclidinium bromide huwa idrolizzat malajr u b'mod estensiv għad-derivati farmakoloġikament inattivi tiegħu tal-alkoħol u tal-carboxylic acid.
English: Bretaris Genuair contains lactose
Maltese: Bretaris Genuair fih lactose
English: Do not tilt.
Maltese: Menarini Kft.
English: EU/1/12/781/002 60 doses
Maltese: EU/1/12/781/002 60 doża
English: Although no formal in vivo drug interaction studies have been performed, inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Maltese: Għad li ma sar l-ebda studju formali in vivo tal-interazzjoni tal-mediċina, aclidinium bromide meħud man-nifs intuża b'mod konkomitanti ma' prodotti mediċinali tas-COPD oħrajn inklużi bronkodilataturi simpatomimetiċi, methylxanthines, u sterojdi orali u li jittieħdu man-nifs mingħajr prova klinika ta' interazzjonijiet tal-mediċina.
English: Carton containing 1 inhaler with 30 doses.
Maltese: Kartuna li fiha inalatur 1 bi 30 doża.
English: 1 inhaler containing 30 doses 1 inhaler containing 60 doses 3 inhalers each containing 60 doses
Maltese: 1 inalatur li fih 30 doża 1 inalatur wieħed li fih 60 doża 3 inalaturi li kull wieħed fih 60 doża
English: The active ingredient of Bretaris Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators.
Maltese: Is-sustanza attiva ta' Bretaris Genuair hija aclidinium bromide, li tappartjeni għal grupp ta' mediċini msejħa bronkodilataturi.
English: Each delivered dose contains 375 micrograms aclidinium bromide equivalent to 322 micrograms of aclidinium.
Maltese: Kull doża fornuta fiha 375 mikrogramma ta' aclidinium bromide ekwivalenti għal 322 mikrogramma ta' aclidinium.
English: Uncommon: may affect up to 1 in 100 people - Dizziness - Dry mouth - Inflammation of the mouth (stomatitis) - Hoarseness (dysphonia) - Faster heart beat (tachycardia) - Sensation of heart beating (palpitations) - Difficulty passing urine (urinary retention) - Blurred vision - Rash - Itching of the skin
Maltese: Mhux komuni: jistgħu jaffettwaw sa 1 f'100 persuna - Sturdament - Ħalq niexef - Infjammazzjoni tal-ħalq (stomatite) - Ħanqa (disfonja) - Rata ta' taħbit tal-qalb mgħaġġla (takikardija) - Sensazzjoni tal-qalb tħabbat (palpitazzjonijiet) - Diffikultà biex tagħmel l-awrina (żamma tal-awrina) - Vista mċajpra - Raxx - Ħakk tal-ġilda
English: Aclidinium bromide demonstrated kinetic linearity and a time-independent pharmacokinetic behaviour in the therapeutic range.
Maltese: Aclidinium bromide wera linearità kinetika u mġiba farmakokinetika indipendenti mill-ħin fil-medda terapewtika.
English: Patients treated with Bretaris Genuair showed a statistically significant reduction of 22% compared to placebo (rate ratio [RR] 0.78; 95% CI 0.68 to 0.89; p<0.001).
Maltese: Il-pazjenti ttrattati b'Bretaris Genuair urew tnaqqis statistikament sinifikanti ta' 22 % meta mqabbel ma' plaċebo (proporzjon tar-rata [RR] 0.78; 95% CI 0.68 sa 0.89; p<0.001).
English: - Getting started - Step 1: Prepare your dose - Step 2: Inhale your medicine - Additional information
Maltese: - Biex tibda - Pass 1: Ipprepara d-doża tiegħek - Pass 2: Iġbed man-nifs il-mediċina tiegħek - Informazzjoni addizzjonali
English: Inhalation powder.
Maltese: Mhux applikabbli.
English: The median time on-treatment in the Bretaris Genuair and placebo groups was 1.1 and 1 year, respectively.
Maltese: Iż-żmien medjan fuq it-trattament filgruppi ta' Bretaris Genuair u tal-plaċebo kien 1.1 u sena, rispettivament.
English: Similar observations were made with Bretaris Genuair in the 3 month study.
Maltese: Kien hemm osservazzjonijiet simili b'Bretaris Genuair fl-istudju ta' 3 xhur.
English: In vitro studies have shown that aclidinium bromide 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 bromide 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: In the 6-month study, patients receiving Bretaris Genuair 322 µg twice daily experienced a clinically meaningful improvement in their lung function (as measured by FEV1).
Maltese: Fl-istudju ta' 6 xhur, il-pazjenti li rċivew Bretaris Genuair 322 µg darbtejn kuljum kellhom titjib klinikament sinifikanti fil-funzjoni tal-pulmun tagħhom (kif imkejjel mill-FEV1).
English: b MCID of at least - 4 units change in SGRQ.
Maltese: b MCID ta' mill-inqas bidla ta' - 4 unitajiet f'SGRQ.
English: Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of aclidinium bromide.
Maltese: Il-bijotrasformazzjoni permezz ta' enzimi CYP450 għandha rwol żgħir fit-tneħħija metabolika totali ta' aclidinium bromide.
English: EU/1/12/781/003 3 inhalers each containing 60 doses
Maltese: EU/1/12/781/003 3 inalaturi b'kull wieħed fih 60 doża
English: Aclidinium bromide is rapidly absorbed from the lung, achieving maximum plasma concentrations within 5 minutes of inhalation in healthy subjects, and normally within the first 15 minutes in COPD patients.
Maltese: Aclidinium bromide jiġi assorbit malajr mill-pulmun, u jikseb konċentrazzjonijiet massimi ta' plażma fi żmien 5 minuti minn meta jittieħed man-nifs f'individwi b'saħħithom, u normalment fi żmien lewwel 15-il minuta fil-pazjenti bis-COPD.
English: What Bretaris Genuair contains - The active substance is aclidinium bromide.
Maltese: - Is-sustanza attiva hi aclidinium bromide.
English: The inhaler is supplied in a plastic laminate pouch, placed in a cardboard carton.
Maltese: L-inalatur huwa fornut f'pawċ tal-plastik laminat, imqiegħda f'kartuna tal-kartonċin.
English: No significant pharmacokinetic differences were observed between subjects with normal renal function and subjects with renal impairment.
Maltese: Ma ġew osservati l-ebda differenzi farmakokinetiċi sinifikanti bejn l-individwi b'funzjoni renali normali u individwi b'indeboliment renali.
English: Go back to ‘STEP 2 Inhale your medicine' and repeat steps 2.1 to 2.7.
Maltese: Mur lura għal “PASS 2 Iġbed man-nifs il-mediċina tiegħek” u rrepeti l-passi 2.1 sa 2.7.
English: The plasma protein binding of aclidinium bromide determined in vitro most likely corresponded to the protein binding of the metabolites due to the rapid hydrolysis of aclidinium bromide 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 bromide determinat in vitro aktarx li kkorrisponda għat-twaħħil tal-proteina tal-metaboliti minħabba l-idroliżi mgħaġla ta' aclidinium bromide fil-plażma; it-twaħħil tal-proteina tal-plażma kien ta' 87% għall-metabolit talcarboxylic acid u 15% għall-metabolit tal-alkoħol.
English: The effect of aclidinium bromide on the occurrence of major adverse cardiovascular events (MACE) was assessed in a randomised, double-blind, placebo-controlled, parallel-group study in 3630 adult patients between 40 and 91 years of age with moderate to very severe COPD, treated for up to 36 months.
Maltese: L-effett ta' aclidinium bromide fuq l-okkorrenza ta' avvenimenti kardjovaskulari avversi maġġuri (MACE, major adverse cardiovascular events) ġie vvalutat fi studju randomizzat, double-blind, ikkontrollat bil-plaċebo u ta' grupp parallel fi 3,630 pazjent adult bejn l-età ta' 40 u 91 sena b'COPD moderata għal severa ħafna, ittrattati sa 36 xahar. 58.7 % kienu rġiel u 90.7 % kienu Bojod, b'FEV1 ta' wara l-bronkodilatur medju ta' 47.
English: Do not use this medicine after the expiry date which is stated on the inhaler label and carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-inalatur u l-kartuna wara “EXP”.
English: The median time on-study in the Bretaris Genuair and placebo groups was approximately 1.4 and 1.3 years, respectively.
Maltese: Iż-żmien medjan fuq l-istudju fil-gruppi ta' Bretaris Genuair u tal-plaċebo kien madwar 1.4 u 1.3 snin, rispettivament.
English: System organ class
Maltese: Sistema tal-klassifika tal-organi Terminu ppreferut
English: The Bretaris Genuair Phase III clinical development programme included 269 patients treated with Bretaris Genuair 322 µg twice daily in one 6-month randomised, placebo-controlled study and 190 patients treated with Bretaris Genuair 322 µg twice daily in one 3-month randomised, placebocontrolled study.
Maltese: III ta' Bretaris Genuair inkluda 269 pazjent ittrattat b'Bretaris Genuair 322 µg darbtejn kuljum fi studju wieħed ta' sitt xhur li fih il-parteċipanti ntgħażlu b'mod każwali kkontrollat bi plaċebo u 190 pazjent ittrattat b'Bretaris Genuair 322 µg darbtejn kuljum fi studju wieħed li fih il-parteċipanti ntgħażlu b'mod każwali, li dam tliet xhur, ikkontrollat bi 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, according to a protocol agreed by the PRAC.
Maltese: Is-sottomissjoni tar-riżultati tal-istudju tas-sigurtà wara l-awtorizzazzjoni (PASS) maqbul għal aclidinium bromide biex jevalwa l-mortalità globali u l-punti tattmiem tas-sigurtà kardjovaskulari proposti (b'punt tat-tmiem addizzjonali ta' arritmija kardijaka) fost pazjenti b'COPD li jużaw aclidinium, skont protokoll maqbul mill-PRAC.
English: • The dose indicator shows the total number of doses left in the inhaler (Figure N).
Maltese: • L-indikatur tad-doża juri n-numru totali ta' dożi li għad fadal fl-inalatur (Figura N).
English: Bretaris Genuair did not increase the MACE risk in patients with COPD compared to placebo when added to current background therapy (hazard ratio (HR) 0.89; 95% CI: 0.64, 1.23).
Maltese: Bretaris Genuair ma żiedx ir-riskju ta' MACE f'pazjenti b'COPD meta mqabbel ma' plaċebo meta ġie miżjud ma' terapija ta' sfond attwali (proporzjon ta' riskju (HR) 0.89; 95% CI: 0.64, 1.23).
English: The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse reactions (i.e. events attributed to Bretaris Genuair) observed with Bretaris Genuair 322 µg (636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled clinical trials.
Maltese: Il-frekwenzi assenjati għall-effetti mhux mixtieqa ta' hawn taħt huma bbażati fuq rati ta' inċidenza mhux aġġustati ta' reazzjonijiet avversi (jiġifieri avvenimenti attribwiti lil Bretaris Genuair) osservati b'Bretaris Genuair 322 µg (636 pazjent) fl-analiżi miġbura ta' prova klinika waħda ta' 6 xhur u tnejn ta' 3 xhur fejn il-pazjenti ntgħażlu b'mod każwali, ikkontrollata bil-plaċebo.
English: Some patients may not hear the ‘click'.
Maltese: Xi pazjenti jaf ma jisimgħux il-‘klikk'.
English: Bretaris Genuair 322 mcg inhalation powder aclidinium (aclidinium bromide) Inhalation use
Maltese: Bretaris Genuair 322 mcg trab li jittieħed man-nifs aclidinium (aclidinium bromide) Użu b'teħid man-nifs
English: Patients treated with Bretaris Genuair required less rescue medication than patients treated with placebo (a reduction of 0.95 puffs per day at 6 months [p=0.005]).
Maltese: Pazjenti ttrattati b'Bretaris Genuair kienu jeħtieġu inqas mediċina ta' salvataġġ mill-pazjenti ttrattati bi plaċebo (tnaqqis ta' 0.95 għafsiet kuljum f'6 xhur [p=0.005]).
English: The low toxicity observed in nonclinical toxicity studies is in part due to rapid metabolism of aclidinium bromide in plasma and the lack of significant pharmacological activity of the major metabolites.
Maltese: It-tossiċità baxxa osservata fl-istudji mhux kliniċi tat-tossiċità kienet parzjalment dovuta għallmetaboliżmu mgħaġġel ta' aclidinium bromide fil-plażma u n-nuqqas ta' attività farmakoloġika importanti tal-metaboliti ewlenin.