FrancophonIA/ELRC3.0 huggingface dataset:
English: The two studies included approximately 20% of patients who used the AeroChamber Plus spacer.
Maltese: Iż-żewġ studji inkludew madwar 20% tal-pazjenti li wżaw l-ispacer AeroChamber Plus.
English: Study TRILOGY compared Riarify with a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily (1,368 randomised patients).
Maltese: Studju TRILOGY qabbel Riarify ma' kombinazzjoni fissa ta' beclometasone dipropionate u formoterol 100/6 mikrogrammi żewġ inalazzjonijiet darbtejn kuljum (1,368 pazjent li ntgħażlu b'mod każwali).
English: Glycopyrronium bromide is a high affinity muscarinic receptor antagonist with a greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor as it has been demonstrated.
Maltese: Glycopyrronium bromide hu antagonist tar-riċetturi muskariniċi b'affinità għolja b'selettività ta' aktar minn 4 darbiet għar-riċetturi M3 umani milli għar-riċetturi M2 umani, kif muri.
English: Tabulated summary of adverse reactions
Maltese: Sommarju f'tabella ta' reazzjonijiet avversi
English: The bronchodilating effect sets in rapidly, within 1-3 minutes after inhalation, and has a duration of 12 hours after a single dose.
Maltese: bronkodilatazzjoni jibda' jaħdem malajr, fi żmien 1-3 minuti wara l-inalazzjoni, u għandu tul ta' azzjoni ta' 12-il siegħa wara doża waħda.
English: Compared with a fixed combination of indacaterol and glycopyrronium, Riarify improved average pre-dose FEV1 over the 52-week treatment period by 22 mL (p=0.018).
Maltese: Meta mqabbel ma' kombinazzjoni fissa ta' indacaterol u glycopyrronium, Riarify tejjeb ilmedja ta' FEV1 ta' qabel id-doża matul il-perjodu ta' trattament ta' 52 ġimgħa bi 22 mL (p=0.018).
English: Riarify 87/5/9 micrograms pressurised inhalation beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium Inhalation use
Maltese: Riarify 87/5/9 mikrogrammi sustanza taħt pressjoni għolja li tittieħed man-nifs beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
English: TRIBUTE was a 52-week activecontrolled study comparing Riarify with a fixed combination of indacaterol/glycopyrronium 85/43 micrograms inhalation powder, hard capsule, one inhalation once daily (1,532 randomised patients).
Maltese: TRIBUTE kien studju kkontrollat b'mod attiv ta' 52 ġimgħa li qabbel Riarify ma' taħlita fissa ta' trab li jittieħed man-nifs ta' indacaterol/glycopyrronium 85/43 mikrogramma, kapsula iebsa, inalazzjoni waħda darba kuljum (1,532 pazjent randomised).
English: For the second puff, keep the inhaler in the upright position for about half a minute, then repeat steps 2 to 5.
Maltese: Għat-tieni nefħa, żomm l-inalatur f'pożizzjoni wieqfa għal madwar nofs minuta, imbagħad irrepeti passi 2 sa 5.
English: Pneumonia (in COPD patients), pharyngitis, oral candidiasis, urinary tract infection1, nasopharyngitis1
Maltese: Pulmonite (f'pazjenti b'COPD), farinġite, kandidjasi tal ħalq, infezzjoni fil-passaġġ urinarju1, nażofarinġite1
English: This has the potential to produce adverse cardiovascular effects.
Maltese: Dan għandu l-potenzjal li jikkawża effetti kardjovaskulari avversi.
English: For in-use storage conditions, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna waqt l-użu, ara sezzjoni 6.3.
English: Following glycopyrronium inhalation, the lung bioavailability was 10.5% (with activated charcoal ingestion) while the absolute bioavailability was 12.8% (without activated charcoal ingestion) confirming the limited gastrointestinal absorption and indicating that more than 80% of glycopyrronium systemic exposure was from lung absorption.
Maltese: Wara inalazzjoni ta' glycopyrronium, il-bijodisponibilità fil-pulmun kienet ta' 10.5% (ma' inġestjoni ta' faħam attivat) filwaqt li l-bijodisponibilità assoluta kienet ta' 12.8% (mingħajr inġestjoni ta' faħam attivat) li tikkonferma assorbiment gastrointestinali limitat u tindika li aktar minn 80% tal-esponiment sistemiku għal glycopyrronium kien minn assorbiment mill-pulmun.
English: Atrial fibrillation, electrocardiogram QT prolonged, tachycardia, tachyarrhythmia1, palpitations
Maltese: Fibrillazzjoni tal-atriju, titwil tal-QT fuq lelettrokardjogramm, takikardija, takiarritmija1, palpitazzjonijiet
English: After repeated inhalation of twice daily doses ranging from 12.5 to 50 micrograms via pressurised metered dose inhaler in COPD patients, glycopyrronium showed linear pharmacokinetics with little systemic accumulation at steady state (median accumulation ratio
Maltese: Wara inalazzjoni ripetuta ta' dożi darbtejn kuljum li jvarjaw minn 12.5 sa 50 mikrogramma permezz ta' inalatur ta' dożi mkejla taħt pressjoni għolja f'pazjenti b'COPD, glycopyrronium wera farmakokinetika lineari b'akkumulazzjoni sistemika żgħira fi stat fiss (proporzjon mejdan ta' akkumulazzjoni ta' 2.2-2.5).
English: Riarify 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Maltese: Riarify 87/5/9 mikrogrammi sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
English: Potentially serious hypokalaemia may result from beta2-agonist therapy.
Maltese: Ipokalemija potenzjalment serja tista' tirriżulta minn terapija b'agonist tar-riċetturi beta2.
English: Riarify significantly improved dyspnoea (measured as the Transition Dyspnoea Index - TDI - focal score) after 26 weeks of treatment compared with baseline (by 1.71 units; p < 0.001), but the adjusted mean difference versus a fixed combination of beclometasone dipropionate and formoterol was not statistically significant (0.21 units; p = 0.160).
Maltese: Riarify tejjeb il-qtugħ ta' nifs (imkejjel bħala punteġġ fokali tal-Indiċi ta' Transizzjoni ta' Qtugħ ta' Nifs - TDI [Transition Dyspnoea Index]) b'mod sinifikanti wara 26 ġimgħa ta' trattament meta mqabbel mal-linja bażi (b'1.71 unità; p < 0.001), iżda d-differenza medja aġġustata kontra kombinazzjoni fissa ta' beclometasone dipropionate u formoterol ma kinitx statistikament sinifikanti
English: 60 actuation pressurised container:
Maltese: Kontenitur għal kontenut taħt pressjoni għolja ta' 60 attwazzjoni:
English: Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms glycopyrronium bromide).
Maltese: Kull doża mkejla (id-doża li toħroġ mill-valv) fiha 100 mikrogramma ta' beclometasone dipropionate, 6 mikrogrammi ta' formoterol fumarate dihydrate u 10 mikrogrammi ta' glycopyrronium (bħala 12.5 mikrogrammi ta' glycopyrronium bromide).
English: Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics (see section 4.5).
Maltese: Ipokalemija tista' titqawwa wkoll permezz ta' trattament flimkien ma' prodotti mediċinali oħra li jistgħu jikkawżaw ipokalemija, bħal derivattivi ta' xanthine, sterojdi u dijuretiċi (ara sezzjoni 4.5).
English: TRISTAR was a 26-week active-controlled open label study comparing Riarify with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Maltese: fluticasone/vilanterol 92/22 mikrogramma, inalazzjoni waħda darba kuljum flimkien ma' trab li jittieħed man-nifs ta' tiotropium 18-il mikrogramma, kapsula iebsa, inalazzjoni waħda darba kuljum (1,157 pazjent randomised).
English: Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Riarify with the AeroChamber Plus spacer device increased the total systemic exposure (AUC0-t) to glycopyrronium.
Maltese: Data farmakokinetika b'doża waħda (ara sezzjoni 5.2) uriet li meta mqabbel ma' użu ta' rutina mingħajr apparat spacer, l-użu ta' Riarify flimkien mal-apparat spacer AeroChamber Plus, żied lesponiment sistemiku totali (AUC0-t) għal glycopyrronium.
English: - when using the container providing 120 puffs
Maltese: - meta tuża l-kontenitur li jipprovdi 120 nefħa
English: The pressurised container is inserted in a plastic inhaler.
Maltese: Il-kontenitur għal kontenut taħt pressjoni għolja huwa mpoġġi f'inalatur tal-plastik.
English: Beclometasone dipropionate/beclometasone-17-monopropionate was considered responsible for reproductive toxicity effects in rats such as reduction of the conception rate, fertility index, early embryonic development parameters (implantation loss), delay in ossification and increased incidence of visceral variations; while tocolytic and anti-muscarinic effects, attributed to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium, affected pregnant rats in the late phase of gestation and/or early phase of lactation, leading to loss of pups.
Maltese: Beclometasone dipropionate/beclometasone-17-monopropionate kien ikkunsidrat responsabbli għall-effetti ta' effett tossiku fuq is-sistema riproduttiva fil-firien bħal tnaqqis fir-rata ta' konċepiment, fl-indiċi tal-fertilità, fil-parametri tal-iżvilupp bikri tal-embrijun (telf tal-implantazzjoni), dewmien fl-ossifikazzjoni u żieda fl-inċidenza ta' varjazzjonijiet tal-vixxri; waqt li l-effetti kontra l-kontrazzjonijiet u anti-muskariniċi, attribwiti għall-attività beta2 adrenerġika ta' formoterol u l-attività anti-muskarinika ta' glycopyrronium, kellhom effett fuq firien tqal fil-fażi mwaħħra tal-ġestazzjoni u/jew fil-fażi bikrija tat-treddigħ, li wasslu għal telf tal-frieħ.
English: Rash1, urticaria1, pruritus, hyperhidrosis1
Maltese: Raxx1, urtikarja1, ħakk, għaraq eċċessiv1
English: The following side effects can also occur with high-dose inhaled corticosteroids used over a long time, but the frequency is not known (frequency cannot be estimated from the available data) at present:
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mill-informazzjoni disponibbli):
English: The maximum plasma concentration and systemic exposure of beclometasone dipropionate main active metabolite (beclometasone 17-monopropionate) and formoterol were similar after administration of the fixed or extemporary combination.
Maltese: Il-konċentrazzjoni massima fil-plażma u l-esponiment sistemiku għall-metabolit attiv ewlieni ta' beclometasone dipropionate (beclometasone 17-monopropionate) u formoterol kienu simili wara l-għoti tal-kombinazzjoni fissa jew dik estemporanja.
English: - when using the container providing 60 puffs
Maltese: - meta tuża l-kontenitur li jipprovdi 60 nefħa
English: Both studies were conducted in patients with a clinical diagnosis of COPD with severe to very severe airflow limitation (FEV1 less than 50% predicted), with symptoms assessed as a COPD Assessment Test (CAT) score of 10 or above, and with at least one COPD exacerbation in the previous year.
Maltese: Iż-żewġ studji twettqu f'pazjenti b'dijanjosi klinika ta' COPD b'limitazzjoni tal-fluss tal-arja severa sa severa ħafna (FEV1 inqas minn 50% ta' dak imbassar), b'sintomi evalwati bħala punteġġ fit-Test ta' Evalwazzjoni ta' COPD (CAT - COPD
English: • changes in the electrocardiogram (heart trace)
Maltese: • bidliet fil-elettrokardjogramm (traċċa tal qalb)
English: Similar improvements, although not statistically significant, were observed at weeks 26 and 52.
Maltese: F'ġimgħat 26 u 52 kien osservat titjib simili, għalkemm mhux statistikament sinifikanti.
English: If your COPD gets worse:
Maltese: Tnaqqis ta' aggravar ta' COPD
English: Study TRINITY compared Riarify with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients).
Maltese: Studju TRINITY qabbel Riarify ma' tiotropium 18-il mikrogramma trab li jittieħed man-nifs, kapsula iebsa, inalazzjoni waħda darba kuljum; barra dan, l-effetti tqabblu ma' kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol 100/6 mikrogrammi żewġ inalazzjonijiet darbtejn kuljum flimkien ma'
English: Bronchospasm paradoxical1, oropharyngeal pain, pharyngeal erythema, pharyngeal inflammation, dry throat
Maltese: Bronkospażmu paradossali1, uġigħ fil-ħalq u fil-farinġi, eritema fil-farinġi, infjammazzjoni fil-farinġi, griżmejn xotti
English: • medicines for treating Parkinson's disease (levodopa), to treat an underactive thyroid gland (levothyroxine), medicines containing oxytocin (which causes uterine contraction) and alcohol can increase the chances of formoterol side effects on the heart.
Maltese: • mediċini għat-trattament tal-marda ta' Parkinson (levodopa), biex jittrattaw glandola tat-tirojde li ma tkunx attiva biżżejjed (levothyroxine), mediċini li fihom oxytocin (li jikkawża kontrazzjoni tal-utru) u l-alkoħol, jistgħu jżidu ċ-ċans ta' effetti sekondarji ta' formoterol fuq il qalb.
English: Muscle spasms, myalgia, pain in extremity1, musculoskeletal chest pain1
Maltese: Spażmi fil-muskoli, uġigħ fil-muskoli, uġigħ flestremitajiet1, uġigħ muskoluskeletali fis-sider1
English: The most frequently reported adverse reactions with Riarify were oral candidiasis (which occurred in 0.8% of the exposed subjects), which is normally associated with inhaled corticosteroids; muscle spasms (0.4%), which can be attributed to the long-acting beta2-agonist component; dry mouth (0.4%), which is a typical anticholinergic effect.
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjonijiet avversi rrappurtati l-aktar frekwenti b‘Riarify kienu kandidjasi tal-ħalq (li seħħet f'0.8% tal-individwi esposti), li normalment hija assoċjata ma' kortikosterojdi li jittieħdu man-nifs; spażmi fil-muskoli (0.4%), li jistgħu jiġu attribwiti għall-komponent agonist tar-riċetturi beta2 li jaħdem fit-tul; ħalq xott (0.4%), li huwa effett antikolinerġiku tipiku.
English: 1 pressurised container of 120 actuations.
Maltese: Kontenitur wieħed għal kontenut taħt pressjoni għolja ta' 120 attwazzjoni.
English: The bioavailability of swallowed beclometasone dipropionate is negligible; however, pre-systemic conversion to beclometasone 17-monopropionate results in 41% of the dose being absorbed as the active metabolite.
Maltese: beclometasone dipropionate li jinbela' hija negliġibbli; madankollu, il-bidla pre-sistemika għal beclometasone 17-monopropionate twassal għall-assorbiment ta' 41% tad-doża bħala l-metabolit attiv.
English: The study compared data obtained after treatment with a single dose of Riarify (4 inhalations of 100/6/25 micrograms, a non-marketed formulation containing twice the approved strength of glycopyrronium) or a single dose of the extemporary combination of beclometasone dipropionate/formoterol (4 inhalations of 100/6 micrograms) plus glycopyrronium (4 inhalations of 25 micrograms).
Maltese: L-istudju qabbel data miksuba wara trattament b'doża waħda ta' Riarify (4 inalazzjonijiet ta' 100/6/25 mikrogramma, formulazzjoni li ma tqegħditx fis-suq li fiha qawwa ta' glycopyrronium id-doppju ta' dak approvat) jew doża waħda tal kombinazzjoni estemporanja ta' beclometasone dipropionate/formoterol (4 inalazzjonijiet ta' 100/6 mikrogrammi) flimkien ma' glycopyrronium (4 inalazzjonijiet ta' 25 mikrogramma).
English: Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium.
Maltese: Kull doża mkejla (id-doża li toħroġ mill-valv) fiha 100 mikrogramma ta' beclometasone dipropionate, 6 mikrogrammi ta' formoterol fumarate dihydrate u 10 mikrogrammi ta' glycopyrronium.
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Maltese: M'hemm l-ebda evidenza klinika konklużiva għal differenzi fil-klassi nfisha fil-kobor tar-riskju ta' pulmonite fost prodotti kortikosterojdi li jittieħdu man-nifs.
English: Simulations performed with a pharmacokinetic model showed that even when covariates had extreme values (body weight less than 40 kg and concomitant glomerular filtration rate below 27 mL/min/1.73 m²), exposure to Riarify active substances remains in approximately a 2.5-fold range compared to the exposure in a typical patient with median covariate values.
Maltese: Simulazzjonijiet imwettqa b'mudell farmakokinetiku wrew li anke meta kovarjabbli kellhom valuri estremi (piż tal-ġisem inqas minn 40 kg u rata ta' filtrazzjoni glomerulari taħt 27 mL/min/1.73 m² fl-istess waqt), esponiment għas sustanzi attivi ta' Riarify jibqa' fil-firxa ta' madwar 2.5 darbiet meta mqabbel mal-esponiment f'pazjent tipiku b'valuri medjana ta' kovarjabbli.
English: Chemical and physical in-use stability has been demonstrated for 4 months at 25°C.
Maltese: Stabbiltà kimika u fiżika waqt l-użu ntweriet għal 4 xhur f'temperatura ta' 25°C.
English: Related to glycopyrronium
Maltese: Relatat ma' glycopyrronium
English: • if you experience any allergic reactions like skin allergies, hives, skin itching, skin rash (may affect up to 1 in 100 people), reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat (may affect up to 1 in 1,000 people).
Maltese: • jekk ikollok xi reazzjonijiet allergiċi bħal allerġiji fil-ġilda, ħorriqija, ħakk tal-ġilda, raxx talġilda (jistgħu jaffettwaw sa persuna waħda minn kull 100 persuna), ħmura tal-ġilda, nefħa talġilda jew tal-membrani mukużi speċjalment tal-għajnejn, wiċċ, xufftejn u gerżuma (jistgħu jaffettwaw sa persuna waħda minn kull 1,000 persuna).
English: Pre-dose FEV1
Maltese: FEV1 sagħtejn wara d-doża
English: Elderly No dosage adjustment is required in elderly patients (65 years of age and older).
Maltese: Anzjani Mhux meħtieġ aġġustament fid-doża f'pazjenti anzjani (65 sena u aktar).
English: Systemic exposure (AUC0-t) to beclometasone dipropionate, to its metabolite beclometasone 17-monopropionate and to formoterol was not affected by mild to severe renal impairment.
Maltese: L-esponiment sistemiku (AUC0-t) għal beclometasone dipropionate, għall-metabolit tiegħu beclometasone 17-monopropionate u għal formoterol, ma kienx affettwat minn indeboliment ħafif sa sever tal-kliewi.
English: Animal studies have shown impairment of fertility (see section 5.3).
Maltese: Studji fuq l-annimali wrew indeboliment tal-fertilità (ara sezzjoni 5.3).
English: Diarrhoea1, dry mouth, dysphagia1, nausea, dyspepsia1, burning sensation of the lips1, dental caries1, (aphthous) stomatitis
Maltese: Attività psikomotorja eċċessiva1, disturbi fl-irqad1, ansjetà, depressjoni1, aggressjoni1, tibdil fl-imġiba (laktar fit-tfal)1
English: In repeat dose inhalation studies with Riarify in rats and dogs of up to 13 weeks duration, the main observed alterations were related to effects on the immune system (probably due to systemic corticosteroid effects of beclometasone dipropionate and its active metabolite beclometasone17-monopropionate) and on the cardiovascular system (probably related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium).
Maltese: Fi studji b‘Riarify dwar dożi ripetuti li jittieħdu man-nifs fil-firien u l-klieb li damu sa 13-il ġimgħa, ilbidliet ewlenin osservati kienu relatati ma' effetti fuq is-sistema immuni (probabbilment minħabba leffetti sistemiċi tal-kortikosterojdi ta' beclometasone dipropionate u l-metabolit attiv tiegħu beclometasone-17-monopropionate) u fuq is-sistema kardjovaskulari (probabbilment relatati malattività beta2-adrenerġika ta' formoterol u l-attività anti-muskarinika ta' glycopyrronium).
English: No differences were observed when comparing Riarify and the extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol plus tiotropium (difference of 3 mL in pre-dose FEV1 after 52 weeks of treatment).
Maltese: Ma kienu osservati l-ebda differenzi meta Riarify kien imqabbel mal-kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol flimkien ma' tiotropium (differenza ta' 3 mL f'FEV1 qabel id-doża wara 52 ġimgħa ta' trattament).
English: Following intravenous dosing, the disposition of beclometasone dipropionate and its active metabolite is characterised by high plasma clearance (150 and 120 L/h respectively), with a small volume of distribution at steady state for beclometasone dipropionate (20 L) and larger tissue distribution for its active metabolite (424 L).
Maltese: L/siegħa rispettivament), b'volum żgħir ta' distribuzzjoni fi stat fiss għal beclometasone dipropionate (20 L) u distribuzzjoni akbar fit-tessuti għal metabolit attiv tiegħu (424 L).
English: Fatigue1
Maltese: Għeja1
English: Each delivered dose contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium.
Maltese: Kull doża mogħtija fiha 87 mikrogramma ta' beclometasone dipropionate, 5 mikrogrammi ta' formoterol fumarate dihydrate u 9 mikrogrammi ta' glycopyrronium.
English: Based on plasma concentrations measured following inhalation of a single 120 micrograms dose by 12 healthy subjects, the mean terminal elimination half-life was determined to be 10 hours.
Maltese: Ibbażat fuq konċentrazzjonijiet fil-plażma imkejla wara inalazzjoni ta' doża waħda ta' 120 mikrogramma minn 12-il individwu f'saħħtu, il-half-life medja tal-eliminazzjoni terminali kienet determinata li hija 10 sigħat.
English: The effect of organic cation transport inhibition (using cimetidine as a probe inhibitor of OCT2 and MATE1 transporters) in the kidneys on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 16% and a slight decrease in renal clearance by 20% due to co administration of cimetidine.
Maltese: L-effett ta' inibizzjoni tat-trasport ta' ketajins organiċi (bl-użu ta' cimetidine bħala probe inhibitor tat-trasportaturi OCT2 u MATE1) fil-kliewi fuq id-dispożizzjoni ta' glycopyrronium meħud man-nifs wera żieda limitata fuq l-esponiment sistemiku totali tiegħu (AUC0-t) ta' 16% u tnaqqis żgħir fit-tneħħija mill-kliewi b'20% minħabba l-għoti fl-istess waqt ta' cimetidine.
English: Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females), either congenital or induced by medicinal products as these patients were excluded from clinical trials with Riarify.
Maltese: Għandu jkun hemm kawtela wkoll meta jiġu ttrattati pazjenti b'titwil magħruf jew issuspettat tal intervall QTc (QTc > 450 millisekonda għall-irġiel, jew > 470 millisekonda għan-nisa), li jista' jkun konġenitali jew ikkaġunat minn prodotti mediċinali għax dawn il-pazjenti kienu esklużi minn provi kliniċi b‘Riarify.
English: • inflammation and redness of the pharynx
Maltese: • irritazzjoni fil-griżmejn
English: - when using the container providing 180 puffs
Maltese: - meta tuża l-kontenitur li jipprovdi 180 nefħa
English: Riarify was also statistically significantly superior to a fixed combination of beclometasone dipropionate and formoterol, to tiotropium and to a fixed combination of indacaterol and glycopyrronium in terms of improvement in quality of life (measured by the Saint George Respiratory Questionnaire - SGRQ - total score).
Maltese: Riarify kien ukoll superjuri b'mod statistikament sinifikanti għall-kombinazzjoni fissa ta' beclometasone dipropionate u formoterol, għal tiotropium u għall-kombinazzjoni fissa ta' indacaterol u glycopyrronium f'termini ta' titjib fil-kwalità tal-ħajja (imkejjel permezz tal-punteġġ totali tal
English: They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias).
Maltese: Dawn jistgħu wkoll iżidu r-riskju ta' disturbi fir-ritmu tal-qalb (arritmija ventrikulari).