FrancophonIA/ELRC3.0 huggingface dataset:
English: Ultibro Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Ultibro Breezhaler belong (see section 4.5).
Maltese: Ultibro Breezhaler m'għandux jingħata flimkien ma' prodotti mediċinali li fihom agonisti betaadrenerġiċi oħrajn b'azzjoni fit-tul jew antagonisti muskariniċi b'azzjoni fit-tul, il-gruppi farmakoterapewtiċi li jagħmlu parti minnhom il-komponenti ta' Ultibro Breezhaler (ara sezzjoni 4.5).
English: Active tubular secretion contributes to the renal elimination of glycopyrronium.
Maltese: Is-sekrezzjoni tubulari attiva tikkontribwixxi għall-eliminazzjoni mill-kliewi ta' glycopyrronium.
English: The largest time-matched heart rate increase compared to placebo was +5.69 bpm (90% CI [2.71, 8.66]), the largest decrease was -2.51 bpm (90% CI [-5.48, 0.47]).
Maltese: L-akbar żieda skont il-ħin tar-rata tal-qalb imqabbla mal-plaċebo kienet ta' +5.69 bpm (90% CI [2.71, 8.66]), l-akbar tnaqqis kien ta' -2.51 bpm (90% CI
English: When to inhale Ultibro Breezhaler
Maltese: • Inhaler wieħed Ultibro Breezhaler
English: At 52 weeks, the reduction compared to fluticasone/salmeterol was statistically significant (LS mean treatment difference -1.3, p=0.003).
Maltese: Mat-52 ġimgħa, it-tnaqqis meta mqabbel ma' fluticasone/salmeterol kien statistikament sinifikanti (differenza fil-medja tal-kura ta' LS ta' -1.3, p=0.003).
English: The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 85 micrograms of indacaterol (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms of glycopyrronium (equivalent to 54 micrograms of glycopyrronium bromide).
Maltese: Id-doża li tittieħed (id-doża li tħalli l-bokkin tal-inhaler) hija ekwivalenti għal 85 mikrogramma ta' indacaterol (ekwivalenti għal 110 mikrogrammi ta' indacaterol maleate) u 43 mikrogramma ta' glycopyrronium (ekwivalenti għal 54 mikrogramma ta' glycopyrronium bromide).
English: The mean bronchodilator effect derived from serial FEV1 measurements over 24 h was 320 ml after 26 weeks of treatment.
Maltese: L-effett medju fuq il-bronkodilatatur minn sensiela ta' kejl tal-FEV1 tul 24 siegħa kien ta' 320 ml wara 26 ġimgħa ta' trattament.
English: Mild irritancy of the nasal cavity and larynx were seen in rodents.
Maltese: Fil-rodenti dehret irritazzjoni ħafifa fil-kavità nażali u fil-larinġi.
English: Renal elimination of parent drug accounts for about 60 to 70% of total clearance of systemically available glycopyrronium whereas non-renal clearance accounts for about 30 to 40%.
Maltese: L-eliminazzjoni tal-mediċina ewlenija mill-kliewi kien ta' madwar 60 u 70% tat-tneħħija totali ta' glycopyrronium disponibbli sistemikament filwaqt li l-proċessi tat-tneħħija mhux mill-kliewi kienu ta' madwar 30 sa 40%.
English: Ultibro Breezhaler also statistically significantly reduced the annualised rate of all COPD exacerbations (mild, moderate or severe) by 15% as compared to glycopyrronium (p=0.001) and 14% as compared to tiotropium (p=0.002).
Maltese: Ultibro Breezhaler naqqas ukoll b'mod statistikament sinifikanti ir-rata anwalizzata ta' kull taħrix ta' COPD (ħafif, moderat jew sever) b'15% meta mqabbel ma' glycopyrronium (p=0.001) u b'14% meta mqabbel ma' tiotropium (p=0.002).
English: Infections and infestations Upper respiratory tract infection
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni fin-naħa ta' fuq tal-passaġġ respiratorju
English: Impairment of the hepatic metabolism of glycopyrronium is not thought to result in a clinically relevant increase of systemic exposure.
Maltese: Mhux maħsub li indeboliment filmetaboliżmu epatiku ta' glycopyrronium iwassal għal żieda relevanti klinikament fl-espożizzjoni sistemika.
English: Steady-state exposure to glycopyrronium (AUC over the 24-hour dosing interval) was about 1.4- to 1.7-fold higher than after the first dose.
Maltese: L-espożizzjoni għal glycopyrronium fi stat fiss (l-AUC wara intervall mill-aħħar doża ta' 24 siegħa) kien ta' madwar 1.4 sa 1.7 drabi ogħla minn dik ta' wara l-ewwel doża.
English: The incidence of pneumonia was 3.2% in the Ultibro 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' Ultibro Breezhaler meta mqabbel ma' 4.8% fil-fergħa ta' fluticasone/salmeterol (p = 0.017).
English: At 64 weeks, the reduction compared to tiotropium was statistically significant (LS mean treatment difference -2.69, p<0.001).
Maltese: Mal-64 ġimgħa, it-tnaqqis imqabbel ma' tiotropium kien sinjifikanti statistikament (differenza fil-medja tal-kura ta' LS -2.69, p<0.001).
English: • palpitations - signs of abnormal heart beat.
Maltese: • palpitazzjonijiet - sinjali ta' taħbit tal-qalb mhux normali.
English: Cimetidine or other inhibitors of organic cation transport In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%.
Maltese: Cimetidine jew inibituri oħrajn tat-trasport ta' cation organiku Fi studju klinku fost voluntiera b'saħħithom, cimetidine, inibitur tat-trasport ta' cations organiċi li hu maħsub li għandhom sehem fl-eskrezzjoni ta' glycopyrronium mill-kliewi, żied l-espożizzjoni totali (AUC) għal glycopyrronium bi 22% u naqqas it-tneħħija tiegħu mill-kliewi bi 23%.
English: Respiratory, thoracic and mediastinal disorders Cough
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Sogħla
English: 30 capsules + 1 inhaler
Maltese: 30 kapsula + inhaler wieħed
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara “EXP”/“JIS”.
English: The capsules must be administered only using the Ultibro Breezhaler inhaler (see section 6.6).
Maltese: Il-kapsuli għandhom jittieħdu biss billi jintuża l-inhaler Ultibro Breezhaler (ara sezzjoni 6.6).
English: Indacaterol is a long-acting beta2-adrenergic agonist for once-daily administration.
Maltese: Indacaterol hu beta2-adrenerġiku b'azzjoni fit-tul biex jingħata darba kuljum.
English: Compared to fluticasone/salmeterol, Ultibro Breezhaler reduced the annualised rate of both moderate or severe exacerbations by 17% (p<0.001), and of severe exacerbations (requiring hospitalisation) by 13% (not statistically significant, p=0.231).
Maltese: Meta mqabbel ma' fluticasone/salmeterol, Ultibro Breezhaler naqqas ir-rata anwalizzata kemm tattaħrix moderat kif ukoll dak sever bi 17% (p<0.001), u ta' taħrix sever (li jeħtieġ rikoveru l-isptar) bi 13% (mhux statistikament sinifikanti, p=0.231).
English: Multipack comprising 4 packs (24 capsules + 1 inhaler)
Maltese: Pakkett b'ħafna li jinkludi 4 pakketti (24 kapsula + inhaler wieħed)
English: Tabulated summary of adverse reactions
Maltese: Sommarju ttabulat ta' reazzjonijiet avversi
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ultibro Breezhaler contains lactose”).
Maltese: - Is-sustanzi l-oħra tat-trab li jittieħed man-nifs huma l-lactose monohydrate u magnesium stearate (ara sezzjoni 2 taħt “Ultibro Breezhaler fih il-lactose”).
English: No specific interaction studies were conducted with Ultibro Breezhaler.
Maltese: Ma sarux studji speċifiċi interattivi b'Ultibro Breezhaler.
English: Reports received from post-marketing experience; frequencies calculated, however, on the basis of clinical trial data.
Maltese: Rapporti riċevuti minn esperjenza ta' wara t-tqegħid fis-suq; madankollu, il-frekwenzi huma ikkalkulati abażi ta' dejta minn provi kliniċi.
English: The amount of indacaterol and glycopyrronium inhaled is 85 micrograms (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms (equivalent to 54 micrograms of glycopyrronium bromide), respectively.
Maltese: L-ammont ta' indacaterol u glycopyrronium li jittieħed man-nifs huwa ta' 85 mikrogramma (ekwivalenti għal 110 mikrogramma ta' indacaterol maleate) u 43 mikrogramma (ekwivalenti għal 54 mikrogramma ta' glycopyrronium bromide), rispettivament.
English: 6 capsules + 1 inhaler
Maltese: 6 kapsuli + inhaler wieħed
English: The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h dosing interval on day 14 or day 15 compared to day 1, was in the range of 2.9 to 3.8 for once-daily inhaled doses between 60 micrograms and 480 micrograms (delivered dose).
Maltese: Il-proporzjon medju tal-akkumulazzjoni ta' indacaterol, jiġifieri l-AUC wara intervall fl-għoti tad-doża ta' 24 siegħa fl-14-jew il-15-il ġurnata meta mqabbel mal-ewwel ġurnata, kien ta' bejn 2.9 u 3.8 għal dożi ta' bejn 150 mikrogramma u ta' 60 mikrogramma and 480 mikrogramma (doża meħuda).
English: A thorough QT (TQT) study in healthy volunteers with high doses of inhaled indacaterol (up to twice the maximum recommended therapeutic dose) did not demonstrate a clinically relevant effect on the QT interval.
Maltese: Studju mirqum tal-QT (TQT) f'voluntiera b'saħħithom b'dożi għoljin ta' indacaterol meħud man-nifs (sa darbtejn id-doża terapewtika massima rrakkomandata) ma wrietx effett relevanti klinikament fuq l-intervall tal-QT.
English: For instructions on use of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq l-użu tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium.
Maltese: Kull doża meħuda (id-doża li tħalli l-bokkin tal-inhaler) fiha 110 mikrogrammi ta' indacaterol maleate ekwivalenti għal 85 mikrogramma ta' indacaterol u 54 mikrogramma ta' glycopyrronium bromide ekwivalenti għal 43 mikrogramma ta' glycopyrronium.
English: Due to the differential density of beta2-adrenoceptors and M3-receptors in central versus peripheral airways, beta2-agonists should be more effective in relaxing peripheral airways, whilst an anticholinergic compound may be more effective in central airways.
Maltese: Minħabba d-differenza fid-densità ta' beta2-adrenoċetturi u M3-riċetturi fil-passaġġi tal-arja ċentrali kontra dawk periferali, il-beta2-agonisti għandhom ikunu aktar effettivi biex jirrilassaw il-passaġġi tal-arja periferali, filwaqt li kompost antikolinerġiku jista' jkun aktar effettiv fil-passaġġi tal-arja ċentrali.
English: Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged (>450 ms) were excluded from the clinical trials, and therefore there is no experience in these patient groups.
Maltese: Pazjenti b'mard tal-qalb iskemiku instabbli, insuffiċjenza tal-ventrikolu tax-xellug, storja ta' infart mijokardijaku, arritmija (mhux inkluża fibrillazzjoni atrijali kronika stabbli), storja ta' QT twil jew li lQTc tagħhom (metodu ta' Fridericia) kien imtawwal (>450 ms) kienu esklużi mill-provi kliniċi, u għalhekk m'hemmx esperjenza f'dawn il-gruppi ta' pazjenti.
English: • muscle pain, aches or tenderness.
Maltese: • uġigħ, weġgħat jew tenerezza fil-muskoli.
English: The effects of Ultibro Breezhaler on QTc interval were investigated in healthy volunteers after inhalation of Ultibro Breezhaler up to 4 times the recommended therapeutic dose in four dose steps each separated by one hour.
Maltese: L-effetti ta' Ultibro Breezhaler fuq l-intervall tal-QTc kien mistħarreġ fost voluntiera b'saħħithom wara li ħadu man-nifs Ultibro Breezhaler sa 4 darbiet aktar id-doża terapewtika rrakkomandata mqassma f'4 stadji kull wieħed imbiegħed mill-ieħor b'siegħa.
English: In another study comparing Ultibro Breezhaler (n=258) and fluticasone/salmeterol (n=264), for 26 weeks, the number of moderate or severe COPD exacerbations/patient-years was 0.15 versus 0.18 (18 events versus 22 events), respectively (p=0.512), and the number of all COPD exacerbations/patients-years (mild, moderate or severe) was 0.72 versus 0.94 (86 events versus 113 events), respectively (p=0.098).
Maltese: Fi studju ieħor li qabbel Ultibro Breezhaler (n=258) u fluticasone/salmeterol (n=264) għal 26 ġimgħa, l-għadd ta' taħrixiet ta' COPD ħfief jew moderat/snin ta' pazjent kien ta' 0.15 kontra 0.18 (18il avveniment kontra 22 avveniment), rispettivament (p=0.512), u n-numru ta' kull taħrix tasCOPD/snin ta' pazjent (ħafif, moderat jew sever) kien ta' 0.
English: The mean pre-dose FEV1 (average of the values taken at -45 and -15 minutes prior to the morning dose of study medication) was statistically significant in favour of Ultibro Breezhaler at week 26 compared to fluticasone/salmeterol (least squares [LS] mean treatment difference 100 ml, p<0.001), at week 52 compared to placebo (LS mean treatment difference 189 ml, p<0.001) and at all visits up to week 64 compared to glycopyrronium (LS mean treatment difference 70-80 ml, p<0.001) and tiotropium (LS mean treatment difference 60-80 ml, p<0.001).
Maltese: Il-medja tal-FEV1 wara l-għoti tad-doża (il-medja tal-valuri ttieħdet -45 u -15-il minuta qabel ma ngħatat id-doża tal-mediċina mogħtija waqt l-istudju għal filgħodu) kienet sinjifikanti statistikament favur Ultibro Breezhaler fis-26 ġimgħa mqabbel ma' fluticasone/salmeterol (differenza fil-medja talkura tal-anqas kwadri [LS] 100 ml, p<0.001), fit-52 ġimgħa mqabbel ma' plaċebo (differenza filmedja tal-kura ta' LS ta' 189 ml, p<0.001) u waqt il-viżti kollha sal-64 ġimgħa mqabbel ma' glycopyrronium (differenza fil-medja tal-kura ta' LS ta' 70-80 ml, p <0.
English: • dizziness.
Maltese: Nażofarinġite
English: The magnitude of the effect was dependent on the degree of reversibility of airflow limitation at baseline (tested by administration of a short-acting muscarinic antagonist bronchodilator and a short-acting beta2-agonist bronchodilator): Patients with the lowest degree of reversibility at baseline (<5%) generally exhibited a lower bronchodilator response than patients with a higher degree of reversibility at baseline (≥5%).
Maltese: Pazjenti bl-anqas grad ta' riversibbiltà fil-linja bażi (<5%) normalment urew rispons bronkodilataturi aktar baxx minn pazjenti bi grad ogħla ta' riversabbiltà fil-linja bażi (≥5%).
English: 10 capsules + 1 inhaler
Maltese: 10 kapsuli + inhaler wieħed
English: Rare (may affect up to 1 in 1000 people) • tingling or numbness.
Maltese: Rare (jistgħu jaffettwaw sa persuna waħda minn kull 1000)
English: Effects on the cardiovascular system attributable to the beta2-agonistic properties of indacaterol included tachycardia, arrhythmias and myocardial lesions in dogs.
Maltese: Fost l-effetti fuq is-sistema kardjovaskulari fil-klieb attribwiti lill-proprjetajiet tal-beta2-agonisti talindacaterol kien hemm it-takikardija, l-arritmija u feriti mijokardijaċi.
English: Breezhaler inhaler).
Maltese: Agħlaq l-inhaler.
English: Ultibro Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).
Maltese: Ultibro Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti anzjani (minn 75 sena 'l fuq).
English: The co-administration of Ultibro Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' Ultibro Breezhaler ma' prodotti mediċinali oħrajn li fihom antikolinerġiċi ma ġiex studjat u għalhekk mhuwiex irrakkomandat (ara sezzjoni 4.4).
English: Based on the in vitro performance data, the dose of indacaterol delivered to the lung is expected to be similar for Ultibro Breezhaler and indacaterol monotherapy product.
Maltese: Skont id-dejta ta' wirja in vitro, id-doża ta' indacaterol imwassla fil-pulmun hi mistennija li tkun tixbah lil dik ta' Ultibro Breezhaler u l-prodott monoterapewtiku b'indacaterol.
English: Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD.
Maltese: Glycopyrronium hu antagonist tar-riċettur muskariniku li jittieħed man-nifs u li jaħdem fit-tul (antikolinerġiku) għat-trattament bronkodilatatur ta' manutenzjoni ta' COPD li jintuża darba kuljum.
English: Mouthpiece
Maltese: Folja
English: Step 1c:
Maltese: Stadju 1a:
English: Genotoxicity studies did not reveal any mutagenic or clastogenic potential for glycopyrronium bromide.
Maltese: Studji ġenotossiċi ma wrew l-ebda potenzjal ta' mutaġeniċità jew klastoġeniċità minn glycopyrronium bromide.
English: The presentation of the safety profile is based on the experience with Ultibro Breezhaler and the individual active substances.
Maltese: Il-preżentazzjoni tal-profil ta' sigurtà tissejjes fuq l-esperjenza ta' Ultibro Breezhaler u s-sustanzi attivi individwali.
English: Check Check capsule is empty
Maltese: Taqqab il-kapsula darba biss.
English: • itching or rash.
Maltese: • ħakk jew raxx.
English: Step 2b: Release side buttons
Maltese: Stadju 2b: Erħi l-buttuni tal-ġenb
English: Ultibro Breezhaler prolonged time to first moderate or severe exacerbation with a 22% reduction in risk of an exacerbation (p<0.001) and prolonged time to first severe exacerbation with a 19% reduction in risk of an exacerbation (p=0.046).
Maltese: Ultibro Breezhaler tawwal il-ħin sal-ewwel taħrix moderat jew sever bi tnaqqis ta' 22% fir-riskju ta' taħrix (p<0.001) u tawwal il-ħin sal-ewwel taħrix sever bi tnaqqis ta' 19% firriskju ta' taħrix (p=0.046).
English: Based on the clinical pharmacokinetic characteristics of its monotherapy components, Ultibro Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Maltese: Skont karatteristiċi farmakokinetiċi kliniċi tal-komponenti monoterapewtiċi tiegħu, Ultibro Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti b'indeboliment tal-fwied minn ħafif sa moderat.
English: In the 52-week active-controlled study, the mean pre-dose FEV1 was statistically significant in favour of Ultibro Breezhaler at all visits up to week 52 compared to fluticasone/salmeterol (LS mean treatment difference 62-86 ml, p<0.001).
Maltese: Fl-istudju ta' 52 ġimgħa kkontrollat bl-attiv, il-medja tal-FEV1 ta' qabel id-doża kienet statistikament sinifikanti favur Ultibro Breezhaler waqt il-viżti kollha sat-52 ġimgħa, meta mqabbel ma' fluticasone/salmeterol (differenza fil-medja tal-kura ta' LS ta' 62-86 ml, p<0.001).
English: Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder.
Maltese: Ultibro Breezhaler 85 mikrogramma/43 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa trasparenti u sofor u fihom trab minn abjad għal kważi abjad.
English: Exercise tolerance
Maltese: Tolleranza ta' eżerċizzju
English: Although beta2-adrenergic receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenergic receptors are the predominant receptors in the human heart, there are also beta2-adrenergic receptors in the human heart comprising 10% to 50% of the total adrenergic receptors.
Maltese: Minkejja li r-riċetturi-beta2-adrenerġiċi huma r-riċetturi adrenerġiċi predominanti fil-muskolu lixx talbronki u r-riċetturi-beta1-adrenerġiċi huma r-riċetturi predominanti fil-qalb tal-bniedem, hemm ukoll riċetturi beta2-adrenerġiċi fil-qalb tal-bniedem li jiffurmaw bejn 10 u 50% tar-riċetturi adrenerġiċi kollha.
English: A statistically significantly higher percentage of patients receiving Ultibro Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (68.1% and 57.5% respectively, p=0.004).
Maltese: Persentaġġ ogħla u sinjifikanti statistikament ta' pazjenti mogħtija Ultibro Breezhaler irrispondew b'titjib ta' punt 1 jew akbar fl-iskor fokali tat-TDI fis-26 ġimgħa mqabbel mal-plaċebo (68.1% u 57.5% rispettivament, p=0.004).
English: Time to first pneumonia was prolonged with Ultibro Breezhaler compared to fluticasone/salmeterol (p=0.013).
Maltese: Il-ħin sal-ewwel avveniment ta' pnewmonja ttawwal b'Ultibro Breezhaler meta mqabbel ma' fluticasone/salmeterol (p=0.013).
English: Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.
Maltese: Pakketti multipli li fihom 150 (15-il pakkett ta' 10x1) kapsula iebsa u 15-il inhaler.
English: In addition, beta-adrenergic agonists have been reported to produce electrocardiographic (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Maltese: Barra minn hekk, kien irrappurtat li l-agonisti beta-adrenerġiċi jipproduċu tibdiliet elettrokardjografiċi (ECG), bħalma huma l-iċċattjar tal-mewġa T, it-titwil tal-intervall QT u ddepressjoni tas-segment ST, minkejja li l-effett kliniku ta' dawn l-osservazzjonijiet mhuwiex magħruf.
English: Glycopyrronium plasma concentrations declined in a multi-phasic manner.
Maltese: Il-konċentrazzjonijiet tal-plażma ta' glycopyrronium niżlu f'fażijiet differenti.
English: Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25ºC.
English: • irregular heartbeat.
Maltese: • diffikultà biex torqod.
English: • chest pain.
Maltese: • fsada mill-imnieħer.
English: A moderate mean increase in total system exposure (AUClast) to glycopyrronium of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease.
Maltese: Kien hemm żieda moderata fil-medja tal-espożizzjoni sistemika totali (AUClast) għal glcopyrronium sa 1.4 drabi f'suġġetti b'indeboliment tal-kliewi ħafif u moderat u sa 2.2 drabi f'suġġetti b'indeboliment tal-kliewi gravi u li jinsabu fl-aħħar stadju tal-mard tal-kliewi.
English: Insufficient pharmacokinetic data is available for other ethnicities or races.
Maltese: Ma teżistix biżżejjed dejta farmakokinetika dwar etniċitajiet jew razez oħrajn.
English: Urinary retention
Maltese: Retenzjoni tal-awrina
English: 12 capsules + 1 inhaler
Maltese: 12-il kapsula + inhaler wieħed
English: The maximal effect on blood glucose was 0.67 mmol/l.
Maltese: L-effett massimu fuq il-glukosju tad-demm kien ta' 0.67 mmol/l.
English: 3H]-labelled glycopyrronium bromide, the mean urinary excretion of radioactivity in 48 hours amounted to 85% of the dose.
Maltese: 3H], l-eskrezzjoni medja tarradjuattività mal-awrina fi żmien 48 siegħa kien ta' 85% tad-doża. 5% oħra tad-doża nstab mal-bajl.
English: The effect remains constant over the whole 24-h dosing interval.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: • difficulty breathing or swallowing, swelling of tongue, lips or face, urticaria, skin rash - these may be signs of an allergic reaction.
Maltese: • diffikultà biex tieħu n-nifs u biex tibla', nefħa tal-ilsien, xufftejn jew wiċċ, urtikarja, raxx talġilda - dawn jistgħu jkunu sinjali ta' reazzjoni allerġika.
English: In healthy volunteers, after the administration of 4 times the recommended therapeutic dose of Ultibro Breezhaler, the effect on serum potassium was very small (maximal difference -0.14 mmol/l when compared to placebo).
Maltese: L-effett fuq il-potassju fis-serum fost voluntiera b'saħħithom, wara l-għoti ta' 4 darbiet aktar mid-doża terapewtika rrakkomandata ta' Ultibro Breezhaler, kien żgħir ħafna (id-differenza massima ta'0.14 mmol/l meta mqabbel mal-plaċebo).
English: Glucuronide and/or sulfate conjugates of glycopyrronium were found in urine of humans after repeated inhalation, accounting for about 3% of the delivered dose.
Maltese: Instab li kien hemm glucuronide u/jew konjugati tas-sulfat ta' glycopyrronium fl-awrina tal-bnedmin wara teħid ripetut tal-mediċina man-nifs, li jammontaw għal madwar 3% tad-doża meħuda.