FrancophonIA/ELRC3.0 huggingface dataset:
English: Ultibro Breezhaler increased post-dose FEV1 AUC0-12 (primary endpoint) by 140 ml at 26 weeks (p<0.001) compared to fluticasone/salmeterol.
Maltese: Ultibro 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: The number of moderate or severe COPD exacerbations/patient-years was 0.98 for Ultibro 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 Ultibro Breezhaler (1,265 avveniment) u 1.19 għal fluticasone/salmeterol (1,452 avveniment).
English: Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Ultibro Breezhaler hu indikat bħala trattament bronkodilatatur ta' manutenzjoni biex iserraħ lil pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD) mis-sintomi.
English: In a 64-week study comparing Ultibro Breezhaler (n=729), glycopyrronium (n=739) and tiotropium (n=737), Ultibro 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 Ultibro Breezhaler (n=729), glycopyrronium (n=739) u tiotropium (n=737), Ultibro 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: Ultibro Breezhaler 85 mcg/43 mcg inhalation powder indacaterol/glycopyrronium
Maltese: Ultibro Breezhaler 85 mkg/43 mkg trab li jittieħed man-nifs indacaterol/glycopyrronium
English: Glycopyrronium bromide is a high affinity muscarinic receptor antagonist.
Maltese: Glycopyrronium bromide hu antagonist tar-riċettur muskariniku b'affinità għolja.
English: A higher proportion of patients demonstrated clinically meaningful response at week 26 on Ultibro Breezhaler as compared to tiotropium (68.1% Ultibro Breezhaler versus 59.2% tiotropium, p=0.016) and fluticasone/salmeterol (65.1% Ultibro Breezhaler versus 55.5% fluticasone/salmeterol, p=0.088).
Maltese: Proporzjon akbar ta' pazjenti wrew rispons sinjifikanti klinikament fis-26 ġimgħa b'Ultibro Breezhaler imqabbel ma' tiotropium (68.1% Ultibro Breezhaler kontra 59.2% tiotropium, p=0.016) u fluticasone/salmeterol (65.1% Ultibro Breezhaler kontra 55.5% fluticasone/salmeterol, p=0.088).
English: Paraesthesia
Maltese: Paraesteżija
English: Metabolism and nutrition disorders Hyperglycaemia and diabetes mellitus
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Ipergliċemija u dijabete mellitus
English: • muscle spasm.
Maltese: • spażmi fil-muskoli.
English: In COPD patients, supratherapeutic doses between 116 micrograms/86 micrograms and 464 micrograms/86 micrograms of Ultibro 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' Ultibro 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: In vitro enzyme induction studies did not indicate a clinically relevant induction by glycopyrronium bromide for any of the cytochrome P450 isoenzymes tested or for UGT1A1 and the transporters MDR1 and MRP2.
Maltese: Studji in vitro dwar l-induzzjoni tal-enzimi ma indikawx induzzjoni klinikament relevanti bi glycopyrronium bromide għaċ-ċitokromu tal-iżoenzimi P450 ttestjati jew għal UGT1A1 u t-trasportaturi MDR1 u MRP2.
English: Paradoxical bronchospasm
Maltese: Spażmi paradossali tal-bronki
English: A diastereomer of the hydroxylated derivative, a N-glucuronide of indacaterol, and C- and N-dealkylated products were further metabolites identified.
Maltese: Metaboliti oħrajn identifikati kienu d-diastereomer tad-derivattiv idrosillat, l-N-glukuronid tal-indacaterol, u l-prodotti C- u N-dealkilati.
English: Close the inhaler and repeat steps 3a to 3c.
Maltese: Agħlaq l-inhaler u rrepeti stadji 3a sa 3ċ.
English: A population pharmacokinetic analysis showed that there is no clinically relevant effect of age (adults up to 88 years), sex, weight (32-168 kg) or race on the pharmacokinetics of indacaterol.
Maltese: Analiżi farmakokinetika tal-popolazzjoni wriet li l-età (adulti sa 88 sena), is-sess, il-piż (32-168 kg) jew ir-razza m'għandhomx effett relevanti klinikament fuq il-farmakokinetiċi tal-indacaterol.
English: There is no information on clinically relevant overdosing with Ultibro Breezhaler.
Maltese: M'hemm l-ebda informazzjoni dwar doża eċċessiva klinikament rilevanti b'Ultibro Breezhaler.
English: 24 x 1 capsules + 1 inhaler.
Maltese: 24 x 1 kapsula + inhaler wieħed.
English: The number of moderate or severe COPD exacerbations/patient-years was 0.94 for Ultibro 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 Ultibro Breezhaler (812 ilavveniment), 1.07 għal glycopyrronium (900 avveniment) u 1.06 għal tiotropium (898 avveniment).
English: The number of all COPD exacerbations/patient-years was 3.59 for Ultibro 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 Ultibro Breezhaler (4,531 avveniment) u 4.03 għal fluticasone/salmeterol (4,969 avveniment).
English: Hydroxylation resulting in a variety of mono- and bis-hydroxylated metabolites and direct hydrolysis resulting in the formation of a carboxylic acid derivative (M9) were seen.
Maltese: Kien hemm idroksillazzjoni li wasslet għal varjetà ta' metaboliti mono u bisidroksillati u idrolisi diretta li wasslet biex jiffurmaw derivattivi ta' aċdi karboksilliċi (M9).
English: Indacaterol serum concentrations declined in a multi-phasic manner with an average terminal half-life ranging from 45.5 to 126 hours.
Maltese: Il-konċentrazzjonijiet tas-serum tal-indacaterol battew f'fażijiet differenti b'medja tal-half-life terminali ta' bejn 45.5 u 126 siegħa.
English: Ultibro Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Maltese: Ultibro Breezhaler għandu jintuża b'kawtela f'pazjenti b'disturbi kardjovaskulari (mard tal-arterja koronarja, infart mijokardijaku akut, arritmija kardijaka, pressjoni għolja).
English: Clinically relevant effects of hypokalaemia have not been observed in clinical studies of Ultibro Breezhaler at the recommended therapeutic dose (see section 5.1).
Maltese: Fi studji kliniċi dwar Ultibro Breezhaler ma dehrux effetti relevanti klinikament ta' ipokalimja meta mogħti skont id-doża terapewtika rrakkomandata (ara sezzjoni 5.1).
English: Systemic exposure to indacaterol increased with increasing (delivered) dose (120 micrograms to 480 micrograms) in a dose proportional manner.
Maltese: L-espożizzjoni sistemika għal indacaterol żdiedet hekk kif id-doża (meħuda) żdiedet (120 mikrogramma sa 480 mikrogramma) u dan proporzjonalment skont id-doża.
English: 6 or 10 Ultibro Breezhaler capsules to be used in the inhaler
Maltese: 10 kapsuli Ultibro Breezhaler biex jintużaw mal inhaler
English: In vitro the UGT1A1 isoform is a major contributor to the metabolic clearance of indacaterol.
Maltese: In vitro l-isoform UGT1A1 hu kontributur ewlieni għat-tneħħija metabolika ta' indacaterol.
English: At week 64, Ultibro 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, Ultibro 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: It did not suggest any difference between ethnic subgroups in this population.
Maltese: Ma wrietx li jista' jkun hemm differenzi bejn sottogruppi etniċi f'din il-popolazzjoni.
English: Step 1e: Close inhaler
Maltese: Stadju 1e: Agħlaq l-inhaler
English: (same class) to those in Ultibro Breezhaler (see section “Other medicines and Ultibro
Maltese: (l-istess klassi) lil dawk ta' Ultibro Breezhaler (ara t-taqsima “Mediċini oħra u Ultibro
English: In the 52-week study comparing Ultibro Breezhaler (n=1,675) and fluticasone/salmeterol (n=1,679), Ultibro 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 Ultibro Breezhaler (n=1,675) u fluticasone/salmeterol (n=1,679), Ultibro 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: In vivo, M9 is formed from the swallowed dose fraction of inhaled glycopyrronium bromide.
Maltese: In vivo, M9 hu ffurmat mill-frazzjoni ta' doża miblugħa ta' glycopyrronium bromide meħud man-nifs.
English: Renal impairment has an impact on the systemic exposure to glycopyrronium bromide.
Maltese: Indeboliment tal-kliewi għandu impatt fuq l-espożizzjoni sistemika ta' glycopyrronium bromide.
English: Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.
Maltese: Pakkett ta' b'wieħed li fih 6x1, 10x1, 12x1, 30x1 jew 90x1 kapsula iebsa, flimkien ma' inhaler wieħed.
English: Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium.
Maltese: Kull kapsula fiha 143 mikrogramma ta' indacaterol maleate ekwivalenti għal 110 mikrogrammi ta' indacaterol u 63 mikrogramma ta' glycopyrronium bromide ekwivalenti għal 50 mikrogramma ta' glycopyrronium.
English: Dysphonia
Maltese: Disfonja
English: Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-glycoprotein (P-gp), raises the systemic exposure of indacaterol up to two-fold.
Maltese: L-inibizzjoni tal-kontributuri ewlenin fit-tneħħija tal-indacaterol, is-CYP3A4 u l-P-glikoproteina (Pgp) tgħolli sa darbtejn l-espożizzjoni sistemika tal-indacaterol.
English: Ultibro Breezhaler - placebo
Maltese: Ultibro Breezhaler - plaċebo
English: Inhibition or induction of the metabolism of glycopyrronium is unlikely to result in a relevant change of systemic exposure to the active substance.
Maltese: M'hemmx il-probabbiltà li inibizzjoni jew induzzjoni tal-metaboliżmu ta' glycopyrronium iwasslu għal bidla relevanti fl-espożizzjoni sistemika tas-sustanza attiva.
English: Available pharmacokinetic/toxicological data have shown excretion of indacaterol, glycopyrronium and their metabolites in the milk of lactating rats.
Maltese: Dejta farmakokinetika/tossikoloġika wriet l-eliminazzjoni ta' indacaterol, glycopyrronium u l-metaboliti tagħhom tal-ħalib ta' firien ireddgħu.
English: Post-dose trough FEV1 (least squares mean) at day 1 and week 26 (primary endpoint)
Maltese: L-anqas FEV1 wara l-għoti tad-doża (medja tal-anqas kwadri) fl-1 ġurnata u fis-26 ġimgħa (endpoint primarju)
English: Mean renal clearance of glycopyrronium following inhalation was in the range of 17.4 and 24.4 litres/h.
Maltese: It-tneħħija medja ta' glycopyrronium mill-kliewi wara t-teħid tal-mediċina man-nifs kienet ta' bejn 17.4 u 24.4 litri/siegħa.
English: At 26 weeks (primary endpoint), Ultibro Breezhaler increased trough FEV1 by 80 ml in patients (Ultibro Breezhaler n=82; placebo n=42) with the lowest degree of reversibility (<5%) (p=0.053) and by 220 ml in those patients (Ultibro 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), Ultibro Breezhaler żied l-anqas FEV1 bi 80 ml f'pazjenti (Ultibro Breezhaler n=82; plaċebo n=42) bl-anqas grad ta' riversibbiltà (<5%) (p=0.053) u b'220 ml f'dawk il-pazjenti (Ultibro Breezhaler n=392, plaċebo n=190) b'livell ogħla ta' riversibbiltà fil-linja bażi (≥5%) imqabbel mal-plaċebo (p<0.
English: Ultibro 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: Ultibro 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: In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Barra minn hekk, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa tissejjes fuq il-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: Ultibro 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: Ultibro 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: Beta-adrenergic blockers
Maltese: Imblukkaturi beta-adrenerġiċi
English: A greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor has been demonstrated using radioligand binding studies.
Maltese: Intweriet selettività ta' aktar minn 4 darbiet għar-riċetturi umani
English: In COPD patients both systemic exposure and total urinary excretion of glycopyrronium at pharmacokinetic steady state increased about dose-proportionally over the (delivered) dose range of 44 to 176 micrograms.
Maltese: F'pazjenti b'COPD kemm l-espożizzjoni sistemika u l-eskrezzjoni totali mal-awrina ta' glycopyrronium fi stat farmakokinetiku fiss żdiedet proporzjonalment skont id-doża (meħuda) fuq ilmedda tad-dożi mogħtija minn 44 sa 176 mikrogramma.
English: Systemic exposures (AUC) at the no-observed-adverse-effect level (NOAEL) were 79- and 126-fold higher than in humans, for indacaterol and glycopyrronium respectively.
Maltese: L-espożizzjonijiet sistemiċi (AUC) fil-livell ta' effetti avversi mhux osservati (NOAEL) għal feriti mijokardijaċi kienu 79 u 126 darba aktar milli għall-bnedmin, għal indacaterol u glycopyrronium rispettivament.
English: 6 x 1 capsules + 1 inhaler.
Maltese: 6 x 1 kapsuli + inhaler wieħed.
English: Show the pack of Ultibro Breezhaler.
Maltese: Uri l-pakkett ta' Ultibro Breezhaler.
English: 90 capsules + 1 inhaler
Maltese: 90 kapsula + inhaler wieħed
English: Multipack: 150 (25 packs of 6 x 1) capsules + 25 inhalers.
Maltese: Pakkett b'ħafna: 150 (25 pakkett ta' 6 x 1) kapsuli + 25 inhaler.
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) glycopyrronium bromide can be used at the recommended dose.
Maltese: F'pazjenti b'COPD b'indeboliment tal-kliewi minn ħafif għal moderat (rata ta' filtrazzjoni glomerulari, eGFR taħt it-30 ml/min/1.73 m2) glycopyrronium bromide jista' jintuża skont id-doża rrakkomandata.
English: The steady-state mean peak and trough plasma concentrations of glycopyrronium at the recommended once-daily dosing regimen were 166 picograms/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: What Ultibro Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Maltese: X'fih Ultibro Breezhaler - Is-sustanzi attivi huma indacaterol (bħala maleate) u glycopyrronium bromide.
English: No difference between ethnic subgroups was identified.
Maltese: Ma kinitx identifikata differenza bejn sottogruppi etniċi.
English: An overdose could lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding.
Maltese: Doża eċċessiva tista' twassal sabiex l-effetti tipiċi tal-istimulanti beta2-adrenerġiċi jkunu esaġerati, jiġifieri takikardija, tregħid, palpitazzjonijiet, uġigħ ta' ras, dardir, rimettar, sturdament, arritmija ventrikulari, aċidożi metabolika, ipokalimja u ipergliċemija jew tista' tinduċi effetti antikolinerġiċi bħal żieda fil-pressjoni ta' ġewwa l-għajn (li tikkawża uġigħ, disturbi fil-vista jew ħmura fll-għajn), stitikezza jew diffikultajiet biex titbattal.
English: Systemic exposures (AUC) at the no-observed-adverse-effect level (NOAEL) for myocardial lesions were 64- and 59-fold higher than in humans, for each component respectively.
Maltese: L-espożizzjonijiet sistemiċi (AUC) fil-livell ta' effetti avversi mhux osservati (NOAEL) għal feriti mijokardijaċi kienu 64 u 59 darba aktar milli għall-bnedmin, għal kull komponenti rispettivament.
English: There were no relevant effects of Ultibro 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' Ultibro 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: After intravenous dosing, the steady-state volume of distribution of glycopyrronium was 83 litres and the volume of distribution in the terminal phase was 376 litres.
Maltese: Wara l-għoti tad-doża mill-vina, il-volum tad-distribuzzjoni ta' glycopyrronium fi stat fiss kien ta' 83 litru u l-volum tad-distribuzzjoni fil-fażi terminali kien ta' 376 litru.
English: At week 26, Ultibro 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, Ultibro 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: In vitro investigations further indicated that indacaterol is a low affinity substrate for the efflux pump P-gp.
Maltese: Investigazzjonijiet in vitro komplew juru li l-indacaterol huwa substrat b'affinità baxxa għall-pompa ta' effluss P-gp.
English: Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ultibro Breezhaler.
Maltese: Reazzjonijiet immedjati ta' sensittività eċċessiva ġew irrappurtati wara l-għoti ta' indacaterol jew glycopyrronium, li huma s-sustanzi attivi ta' Ultibro Breezhaler.
English: Adverse reactions detected during clinical trials and from post-marketing sources are listed by MedDRA system organ class (Table 1).
Maltese: Ir-reazzjonijiet avversi osservati matul il-provi kliniċi u minn sorsi ta' wara t-tqegħid fis-suq qed jitniżżlu skont is-sistema ta' klassifika tal-organi fid-databażi MedDRA (Tabella 1).
English: Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.
Maltese: Pakketti multipli li fihom 150 (25 pakkett ta' 6x1) kapsula iebsa u 25 inhaler.
English: Step 1b: Open inhaler
Maltese: Stadju 1b: Iftaħ l-inhaler
English: 10 x 1 capsules + 1 inhaler.
Maltese: 10 x 1 kapsuli + inhaler wieħed.
English: Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules indacaterol/glycopyrronium
Maltese: Ultibro Breezhaler 85 mikrogramma/43 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa indacaterol/glycopyrronium
English: • Do not use the Ultibro Breezhaler capsules with any other inhaler.
Maltese: • Tużax il-kapsuli Ultibro Breezhaler ma' xi inhaler ieħor.
English: Phenolic O-glucuronides of indacaterol and hydroxylated indacaterol were further prominent metabolites.
Maltese: Metaboliti prominenti oħrajn kienu l-O-glukuronidi fenoliċi tal-indacaterol u l-indacaterol idrosillat.
English: PA/Alu/PVC - Alu perforated unit-dose blister.
Maltese: Folja pperforata b'dożi waħdiena PA/Alu/PVC - Alu.
English: Multipack: 150 (15 packs of 10 x 1) capsules + 15 inhalers.
Maltese: Pakkett b'ħafna: 150 (15-il pakkett ta' 10 x 1) kapsuli + 15-il inhaler.
English: Increased incidences of benign ovarian leiomyoma and focal hyperplasia of ovarian smooth muscle in rats were consistent with similar findings reported for other beta2-adrenergic agonists.
Maltese: Iż-żieda fl-inċidenza tal-leiomyoma beninn tal-ovarji u iperplasja fokali tal-muskoli lixxi tal-ovarji fil-firien kienet konsistenti ma' sejbiet simili rrappurtati għal agonisti beta2-adrenerġiċi oħrajn.
English: Ultibro 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: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Maltese: L-agonisti beta2-adrenerġiċi jistgħu jżidu r-riskju ta' episodji avversi serji relatati mal-ażma, inkluż imwiet minħabba l-ażma, meta jintużaw għat-trattament tal-ażma.
English: Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules
Maltese: Ultibro Breezhaler 85 mikrogramma/43 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa
English: • cough.
Maltese: • sogħla.
English: The largest time-matched difference versus placebo was 4.62 ms (90% CI 0.40, 8.85 ms), the largest time-matched decrease was -2.71 ms (90% CI -6.97, 1.54 ms), indicating that Ultibro Breezhaler had no relevant impact on the QT interval, as was expected by the properties of its components.
Maltese: L-akbar differenza fil-ħin mqabbel malplaċebo kien ta' 4.62 ms (90% CO 0.40, 8.85 ms), l-akbar tnaqqis fil-ħin imqabbel kien ta' -2.71 ms (90% CI -6.97, 1.54 ms), li juri li Ultibro Breezhaler ma kellu l-ebda impatt relevanti fuq l-intervall tal-QT, kif kien mistenni minħabba l-proprjetajiet tal-komponenti tiegħu.