FrancophonIA/ELRC3.0 huggingface dataset:
English: Aerivio Spiromax 50 micrograms/500 micrograms inhalation powder salmeterol/fluticasone propionate
Maltese: Aerivio Spiromax 50 mikrogrammi/500 mikrogrammi trab li jittieħed man-nifs salmeterol/fluticasone propionate
English: There was an increased reporting of lower respiratory tract infections (particularly pneumonia and bronchitis) in the TORCH study in patients with COPD receiving salmeterol/fluticasone propionate 50/500 micrograms twice daily compared with placebo as well as in studies SCO40043 and SCO100250 comparing a lower dose of salmeterol/fluticasone propionate 50/250 micrograms twice daily, (a dose not authorised for use in COPD) with salmeterol 50 micrograms twice daily only (see section 4.8 and section 5.1).
Maltese: Kien hemm rappurtar akbar ta' infezzjonijiet fl-apparat respiratorju ta' isfel (speċjalment pulmonite u bronkite) fl-istudju TORCH f'pazjenti b'COPD li kienu qed jirċievu salmeterol/fluticasone propionate 50/500 mikrogramma darbtejn kuljum meta mqabbel mal-plaċebo kif ukoll fl-istudji SCO40043 u SCO100250 li qabblu doża aktar baxxa ta' salmeterol/fluticasone propionate 50/250 mikrogramma darbtejn kuljum (doża mhux awtorizzata biex tintuża f'COPD), ma' salmeterol 50 mikrogramma darbtejn kuljum biss (ara sezzjoni 4.8 u sezzjoni 5.1).
English: Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, acute adrenal crisis and growth retardation in children and adolescents and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression.
Maltese: Effetti sistemiċi possibbli jinkludu s-sindrome ta' Cushing, karatteristiċi Cushingoid, soppressjoni adrenali, kriżi adrenali akuta u ttardjar tat-tkabbir fi tfal u adolexxenti u aktar rari, firxa ta' effetti psikoloġiċi jew ta' mġiba li jinkludu attività psikomotorja eċċessiva, disturbi fl-irqad, ansjetà, depressjoni jew aggressjoni.
English: Pooled results across the 3 treatment levels *Well controlled asthma - less than or equal to 2 days with symptom score greater than 1 (symptom score 1 defined as ‘symptoms for one short period during the day'), SABA use on less than or equal to 2 days and less than or equal to 4 occasions/week, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy **Total control of asthma - no symptoms, no SABA use, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in
Maltese: Riżultati tat-3 livelli ta' trattament miġbura f'daqqa *Ażżma ikkontrollata tajjeb - jumejn jew inqas b'punteġġ ta' sintomi akbar minn 1 (punteġġ ta' sintomi 1 definit bħala ‘sintomi għal perjodu qasir wieħed matul il-ġurnata'), użu ta' SABA għal jumejn jew inqas u 4 okkażjonijiet/ġimgħa jew inqas, 80% jew aktar tal-fluss ta' espirazzjoni massimu mbassar ta' filgħodu, lebda qawmien matul il-lejl, l-ebda rkadar u l-ebda effetti sekondarji li jimponu bidla fit-terapija **Kontroll totali tal-ażżma - l-ebda sintomi, l-ebda użu ta' SADA, 80% jew aktar tal-fluss ta' espirazzjoni massimu mbassar ta' filgħodu, l-ebda qawmien matul il-lejl, l-ebda rkadar u l-ebda effetti sekondarji li jimponu bidla fit-terapija
English: Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection or any rapid reduction in dosage.
Maltese: Sitwazzjonijiet, li potenzjalment jistgħu jwasslu għal kriżi adrenali akuta jinkludu trawma, kirurġija, infezzjoni jew kwalunkwe tnaqqis rapidu fid-dożaġġ.
English: Some medicines may increase the effects of Aerivio Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Maltese: Xi mediċini jistgħu jżidu l-effetti ta Aerivio Spiromax u t-tabib tiegħek għandu mnejn ikun irid jissorveljak b'attenzjoni jekk qed tieħu dawn il-mediċini (inklużi xi mediċini għall-HIV: ritonavir, cobicistat).
English: Adverse event profiles were similar with the exception of a higher incidence of pneumonias and known local side effects (candidiasis and dysphonia) in the salmeterol/fluticasone propionate 50/250 micrograms twice daily group compared with salmeterol.
Maltese: Il-profili ta' avvenimenti avversi kienu simili bl-eċċezzjoni ta' inċidenza ogħla ta' pulmonite u effetti sekondarji lokali magħrufa (kandidjasi u disfonja) fil-grupp ta' salmeterol/fluticasone propionate 50/250 mikrogramma darbtejn kuljum meta mqabbel ma' salmeterol.
English: Endocrine disorders Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density
Maltese: Sindrome ta' Cushing, karatteristiċi Cushingoid, Soppressjoni adrenali, Ittardjar fit-tkabbir fit-tfal u fladolexxenti, Tnaqqis fid-densità minerali tal-għadam
English: Anaphylactic reactions including anaphylactic shock
Maltese: Reazzjonijiet anafilattiċi inklużi xokk anafilattiku
English: Severe asthma in adults 18 years of age and older
Maltese: Ażżma severa f'adulti ta' età minn 18-il sena 'l fuq
English: • Cataract (cloudy lens in the eye).
Maltese: • Katarretti (lenti imċajpra fl-għajn).
English: Salmeterol/fluticasone propionate COPD - clinical trials TORCH was a 3-year study to assess the effect of treatment with salmeterol/fluticasone propionate inhalation powder 50/500 micrograms twice daily, salmeterol inhalation powder 50 micrograms twice daily, fluticasone propionate (FP) inhalation powder 500 micrograms twice daily or placebo on all-cause mortality in patients with COPD.
Maltese: Provi kliniċi dwar Salmeterol/fluticasone propionate f'COPD TORCH kien studju ta' 3 snin biex jevalwa l-effett ta' trattament b'salmeterol/fluticasone propionate trab li jittieħed man-nifs 50/500 mikrogramma darbtejn kuljum, salmeterol trab li jittieħed man-nifs 50 mikrogramma darbtejn kuljum, fluticasone propionate (FP) trab li jittieħed man-nifs 500 mikrogramma darbtejn kuljum jew plaċebo fuq il-mortalità minn kull kawża f'pazjenti b'COPD.
English: Animal studies have shown reproductive toxicity after administration of β2 adrenoreceptor agonists and glucocorticosteroids (see section
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva wara l-għoti ta' agonisti tar-riċetturi β2 adrenerġiċi u glukokortikosterojdi (ara sezzjoni 5.3).
English: The results of both studies showed that treatment with salmeterol/fluticasone propionate 50/250 resulted in a significantly lower annual rate of moderate/severe COPD exacerbations compared with salmeterol (SCO40043: 1.06 and 1.53 per subject per year, respectively, rate ratio of 0.70, 95% CI: 0.58 to 0.83, p<0.001; SCO100250: 1.10 and 1.59 per subject per year, respectively, rate ratio of 0.70, 95% CI: 0.58 to 0.83, p<0.001).
Maltese: Ir-riżultati taż-żewġ studji wrew li trattament b'salmeterol/fluticasone propionate 50/250 wassal għal rata annwali aktar aktar baxxa b'mod sinifikanti ta' episodji ta' rkadar moderat/sever ta' COPD meta mqabbel ma' salmeterol (SCO40043: 1.06 u 1.53 għal kull individwu fis-sena, rispettivament, proporzjon ta' rata ta' 0.70, CI ta' 95%: 0.58 sa 0.83, p<0.001; SCO100250: 1.10 u 1.59 għal kull individwu kull sena, rispettivament, proporzjon ta' rata ta' 0.70, CI ta' 95%: 0.58 sa 0.83, p<0.001). Sejbiet għall-kejl sekondarju tal-effikaċja (żmien sal-ewwel episodju ta' rkadar moderat/sever, ir-rata annwali ta' episodji ta' rkadar li jeħtieġu kortikosterojdi orali, u FEV1 ta' filgħodu (AM - morning) qabel id-doża) iffavorixxa b'mod sinifikanti salmeterol/fluticasone propionate 50/250 mikrogramma darbtejn kuljum fuq salmeterol.
English: Glaucoma
Maltese: Hrvatska
English: Salmeterol/Fluticasone propionate - Asthma clinical trials A twelve month study (Gaining Optimal Asthma ControL, GOAL), in 3416 adult and adolescent patients with persistent asthma, compared the safety and efficacy of salmeterol/fluticasone propionate versus inhaled corticosteroid (fluticasone propionate) alone to determine whether the goals of asthma management were achievable.
Maltese: Salmeterol/Fluticasone propionate - Provi kliniċi dwar l-ażżma Studju ta' tnax-il xahar (Biex Jinkiseb l-Aħjar Kontroll tal-Ażżma, GOAL - Gaining Optimal Asthma ControL), fuq 3416-il pazjent adulti u adolexxenti b'ażżma persistenti, qabbel is-sigurtà u l-effikaċja ta' salmeterol/fluticasone propionate ma' kortikosterojd meħud man-nifs (fluticasone propionate) waħdu sabiex jiġi determinat jekk l-għanijiet tal-immaniġġjar tal-ażżma setgħux jintlaħqu.
English: A similar incidence of pneumonia in the salmeterol/fluticasone propionate group was seen across all studies.
Maltese: Inċidenza simili ta' pulmonite fil-grupp ta' salmeterol/fluticasone propionate kienet osservata fl-istudji kollha.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics, ATC code: R03AK06
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tan-nifs, adrenerġiċi flimkien ma' kortikosterojdi jew mediċini oħra, minbarra antikolinerġiċi, Kodiċi ATC:
English: There were no other differences in safety profile between the treatment arms.
Maltese: Ma kien hemm l-ebda differenza oħra fil-profil tas-sigurtà bejn il-gruppi ta' trattament.
English: • A fungal infection in the oesophagus (food canal), which might cause difficulties in swallowing.
Maltese: • Infezzjoni kkawżata minn fungi fl-esofagu (kanal tal-ikel), li tista' tikkawża diffikultajiet biex tibla'.
English: Aerivio Spiromax should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway.
Maltese: Aerivio Spiromax għandu jingħata b'kawtela f'pazjenti b'tuberkulosi pulmonari attiva jew passiva u infezzjonijiet fungali, virali jew infezzjonijiet oħra tal-passaġġ tan-nifs.
English: Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Maltese: Marda Kronika Ostruttiva tal-Pulmun (COPD - Chronic Obstructive Pulmonary Disease) Aerivio Spiromax huwa indikat għat-trattament sintomatiku ta' pazjenti b'COPD, b'FEV1 <60% tan-normal imbassar (qabel teħid ta' bronkodilatur) u storja ta' aggravar tal-kundizzjoni b'mod ripetut, li għandhom sintomi sinifikanti minkejja terapija regolari bi bronkodilatur.
English: Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000 micrograms.
Maltese: Każijiet rari ħafna ta' soppressjoni adrenali u kriżi adrenali akuta kienu deskritti wkoll b'dożi ta' fluticasone propionate bejn 500 u inqas minn 1000 mikrogramma.
English: The remainder of the inhaled dose of fluticasone propionate may be swallowed but contributes minimally to systemic exposure due to the low aqueous solubility and presystemic metabolism, resulting in oral availability of less than 1%.
Maltese: Il-bqija tad-doża meħuda man-nifs ta' fluticasone propionate tista' tinbela' iżda tikkontribwixxi minimament għall-esponiment sistemiku minħabba solubilità baxxa fl-ilma u metaboliżmu presistemiku, li jwassal għal disponibiltà orali ta' inqas minn 1%.
English: Aerivio Spiromax is indicated for use in adults aged 18 years and older only.
Maltese: Aerivio Spiromax huwa indikat għal użu f'adulti ta' eta' minn 18-il sena 'l fuq biss.
English: Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4fold Cmax and 15-fold AUC).
Maltese: Għoti flimkien ta' ketoconazole (400 mg mill-ħalq darba kuljum) u salmeterol (50 mikrogramma meħuda man-nifs darbtejn kuljum) fi 15-il individwu f'saħħithom għal 7 ijiem wassal għal żieda sinifikanti flesponiment għal salmeterol fil-plażma (Cmax ta' 1.4 darbiet u AUC ta' 15-il darba).
English: Studies SCO40043 and SCO100250 were randomised, double-blind, parallel-group, replicate studies comparing the effect of salmeterol/fluticasone propionate 50/250 micrograms twice daily (a dose not licensed for COPD treatment in the European Union) with salmeterol 50 micrograms twice daily, on the annual rate of moderate/severe exacerbations in subjects with COPD with FEV1 less than 50% predicted and a history of exacerbations.
Maltese: Studji SCO40043 u SCO100250 kienu studji b'replika, randomised, double-blind u bi grupp parallel li qabblu l-effett ta' salmeterol/fluticasone propionate 50/250 mikrogramma darbtejn kuljum (doża mhux liċenzjata għat-trattament ta' COPD fl-Unjoni Ewropea) ma' salmeterol 50 mikrogramma darbtejn kuljum fuq ir-rata annwali ta' episodji ta' rkadar moderat/sever f'individwi b'COPD b'FEV1 ta' inqas minn 50% ta' dak imbassar u passat ta' episodji ta' rkadar.
English: Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures.
Maltese: Sintomi ta' indikazzjoni tipikament huma vagi u jistgħu jinkludu anoreksja, uġigħ addominali, telf ta' piż, għeja, uġigħ ta' ras, dardir, rimettar, pressjoni baxxa, tnaqqis fil-livell ta' koxjenza, ipogliċemija, u aċċessjonijiet.
English: In a 12-week trial of children aged 4 to 11 years [n=257] treated with either salmeterol/fluticasone propionate 50/100 or salmeterol 50 micrograms + fluticasone propionate 100 micrograms both twice daily, both treatment arms experienced a 14% increase in peak expiratory flow rate as well as improvements in symptom score and rescue salbutamol use.
Maltese: Fi prova ta' 12-il ġimgħa ta' tfal ta' età minn 4 snin sa 11-il sena [n=257] ittrattati b'salmeterol/fluticasone propionate 50/100 jew salmeterol 50 mikrogramma + fluticasone propionate 100 mikrogramma it-tnejn darbtejn kuljum, iż-żewġ gruppi ta' trattament kellhom żieda ta' 14% fir-rata massima ta' fluss espiratorju kif ukoll titjib fil-punteġġ tas-sintomi u l-użu ta' salbutamol bħala salvataġġ.
English: Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:
Maltese: Aerivio Spiromax huwa indikat għat-trattament regolari ta' pazjenti b'ażżma severa fejn l-użu ta' prodott ikkombinat (kortikosterojd li jittieħed man-nifs u agonist tar-riċetturi β2 li jaħdem fit-tul) huwa xieraq:
English: • Thrush (sore, creamy-yellow, raised patches) in the mouth and throat.
Maltese: • Traxx (irqajja mqabżin, juġgħu, sofor lewn il-krema) fil-ħalq u l-gerżuma.
English: • Blurred vision
Maltese: • Vista mċajpra.
English: Aerivio Spiromax is indicated in adults 18 years of age and older only.
Maltese: Aerivio Spiromax huwa indikat f'adulti ta' eta' minn 18-il sena 'l fuq biss.
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index
Maltese: Fatturi ta' riskju għall-pulmonite f'pazjenti b'COPD jinkludu tipjip attwali, età akbar, indiċi tal-massa talġisem (BMI - body mass index) baxx u COPD severa.
English: Asthma
Maltese: Ipokalimja
English: This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see section 4.4).
Maltese: Dan jista' jwassal għal żieda fl-inċidenza ta' effetti sistemiċi oħra ta' trattament b'salmeterol (eż. titwil tal-intervall QTc u palpitazzjonijiet) meta mqabbel ma' trattament ta' salmeterol jew ketoconazole waħedhom (ara sezzjoni 4.4).
English: As Aerivio Spiromax contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected.
Maltese: Peress li Aerivio Spiromax fih salmeterol u fluticasone propionate, jistgħu jkunu mistennija it-tip u s-severità ta' reazzjonijiet avversi assoċjati ma' kull wieħed mis-sustanzi attivi.
English: Less than 5% of the dose is excreted in urine, mainly as metabolites.
Maltese: Inqas minn 5% tad-doża tiġi mneħħija fl-awrina, il-biċċa l-kbira bħala metaboliti.
English: Children received either salmeterol/fluticasone propionate (50/100 micrograms) or fluticasone propionate (100 micrograms) alone twice daily.
Maltese: It-tfal irċevew salmeterol/fluticasone propionate (50/100 mikrogramma) jew fluticasone propionate (100 mikrogramma) waħdu darbtejn kuljum.
English: Each inhaler contains 60 doses and is foil-wrapped.
Maltese: 3 inalaturi li kull wieħed fih 60 doża.
English: In a study in 158 children aged 6 to 16 years with symptomatic asthma, the combination of salmeterol/ fluticasone propionate is as efficacious as doubling the dose of fluticasone propionate in respect of symptom control and lung function.
Maltese: Fi studju fuq 158 tifel u tifla ta' età minn 6 snin sa 16-il sena b'ażżma sintomatika, il-kombinazzjoni ta' salmeterol/ fluticasone propionate hija effikaċi daqs doża rduppjata ta' fluticasone propionate rigward ilkontroll tas-sintomi u l-funzjoni tal-pulmun.
English: Ritonavir can greatly increase the concentration of fluticasone propionate in plasma.
Maltese: Ritonavir jista' jżid b'ammont kbir il-konċentrazzjoni ta' fluticasone propionate fil-plażma.
English: Adverse reactions which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency.
Maltese: Reazzjonijiet avversi li kienu assoċjati ma' salmeterol/fluticasone propionate huma mogħtija hawn taħt, elenkati skont il-klassi tas-sistemi u tal-organi u l-frekwenza.
English: • Tiredness and loss of appetite, feeling sick
Maltese: • Għeja u telf ta' aptit, tħossok se tirremetti
English: Each metered dose contains 50 micrograms salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone propionate.
Maltese: Kull doża mkejla fiha 50 mikrogramma salmeterol (bħala salmeterol xinafoate) u 500 mikrogramma fluticasone propionate.
English: Teva Pharma - Produtos Farmacêuticos Lda Tel: +351 21 476 75 50
Maltese: Teva Pharmaceuticals Ireland Tel: +353 51 321 740
English: Very Common
Maltese: Nażofarinġite
English: A flow rate of greater than 60L/min is required for optimal delivery of drugs to the lungs through the multidose dry powder Spiromax inhaler.
Maltese: Rata ta' fluss ta' aktar minn 60L/min hija meħtieġa għall-aħjar twassil tal-mediċina lejn il-pulmuni permezz tal-inalatur b'dożi multipli ta' trab niexef Spiromax.
English: Pneumonia (in COPD patients)
Maltese: Pulmonite (f'pazjenti b'COPD)
English: • Muscle cramps.
Maltese: Angina pectoris
English: In a 12-week trial of children 4 to 11 years of age [n=203] randomized in a parallel-group study with persistent asthma and who were symptomatic on inhaled corticosteroid, safety was the primary objective.
Maltese: Fi prova ta' 12-il ġimgħa ta' tfal minn 4 snin sa 11-il sena [n=203] randomised fi studju bi grupp parallel b'ażżma persistenti u li kienu sintomatiċi fuq kortikosterojdi li jittieħdu man-nifs, is-sigurtà kienet l-oġġettiv primarju.
English: • Corticosteroids (by mouth or by injection).
Maltese: • Kortikosterojdi (mill-ħalq jew permezz ta' injezzjoni).
English: The primary endpoint was reduction in all-cause mortality at 3 years for salmeterol/fluticasone
Maltese: Il-punt tat-tmiem primarju kien tnaqqis fil-mortalità minn kull kawża wara 3 snin għal salmeterol/fluticasone propionate kontra plaċebo.
English: The studies described below (GOAL, TORCH and SMART) were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product; the studies described were not carried out with Aerivio Spiromax.
Maltese: L-istudji deskritti hawn taħt (GOAL, TORCH u SMART) twettqu bl-istess kombinazzjoni ta' doża fissa, salmeterol xinafoate u fluticasone propionate, iżda studjaw prodott awtorizzat qabel; l-istudji deskritti ma twettqux b'Aerivio Spiromax.
English: The results of this study suggest that salmeterol/fluticasone propionate 50/100 micrograms twice daily may be considered as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is deemed essential (see section 4.2).
Maltese: Ir-riżultati ta' dan l-istudju jissuġġerixxu li salmeterol/fluticasone propionate 50/100 mikrogramma darbtejn kuljum jista' jiġi kkunsidrat bħala terapija ta' manteniment inizjali f'pazjenti b'ażżma persistenti moderata li għalihom kontroll rapidu tal-ażżma huwa meqjus essenzjali (ara sezzjoni 4.2).
English: Oral corticosteroids and antibiotics were allowed for the acute treatment of COPD exacerbations with specific guidelines for use.
Maltese: Kortikosterojdi orali u antibijotiċi kienu permessi għat-trattament akut ta' episjodi ta' rkadar ta'
English: Co-administration of erythromycin (500 mg orally three times a day) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC).
Maltese: Għoti flimkien ta' erythromycin (500 mg mill-ħalq tliet darbiet kuljum) u salmeterol (50 mikrogramma meħuda man-nifs darbtejn kuljum) fi 15-il individwu f'saħħithom għal 6 ijiem wassal għal żieda żgħira iżda mhux statistikament sinifikanti fl-esponiment għal salmeterol (Cmax ta' 1.4 darbiet u AUC ta' 1.2 darbiet).
English: • Increases in the amount of sugar (glucose) in your blood (hyperglycaemia).
Maltese: • Żidiet fl-ammont ta' zokkor (glucose) fid-demm tiegħek (ipergliċemija).
English: The safety and efficacy of Aerivio Spiromax in children and adolescents aged less than 18 years of age has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Aerivio Spiromax fit-tfal u fl-adolexxenti ta' età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Non-significant p value after adjustment for 2 interim analyses on the primary efficacy comparison from a log-rank analysis stratified by smoking status
Maltese: Valur p mhux sinifikanti wara aġġustament għal 2 analiżi interim fuq il-paragun tal-effikaċja primarja minn analiżi log-rank stratifikata skont l-istat ta' tipjip
English: In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg twice daily increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations.
Maltese: Fi studju dwar interazzjoni f'individwi f'saħħithom b'fluticasone propionate mogħti fl-imnieħer, ritonavir (inibitur qawwi ħafna taċ-ċitokroma P450 3A4) 100 mg darbtejn kuljum żied il-konċentrazzjonijiet filplażma ta' fluticasone propionate b'diversi mijiet ta' drabi, li jwassal għall-konċentrazzjonijiet ta' cortisol fis-serum imnaqqsa sew.
English: Aerivio Spiromax is not recommended for use in either children aged 12 years of age and younger or in adolescents aged 13 to 17 years.
Maltese: Aerivio Spiromax mhux rakkomandat għal użu fi tfal ta' età ta' 12-il sena jew iżgħar jew f'adolexxenti ta' età minn 13 sa 17-il snin.
English: Aerivio Spiromax should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Maltese: Aerivio Spiromax għandu jitwaqqaf minnufih, il-pazjent evalwat u jekk ikun meħtieġ għandha tinbeda terapija alternattiva.
English: Acute: Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function.
Maltese: Teħid man-nifs akut ta' dożi ta' fluticasone propionate li jaqbżu dawk rakkomandati jista' jwassal għal soppressjoni temporanja tal-funzjoni adrenali.
English: Aerivio Spiromax 50 micrograms/500 micrograms inhalation powder
Maltese: Aerivio Spiromax 50 mikrogrammi/500 mikrogrammi trab li jittieħed man-nifs
English: • Do not stop taking Aerivio Spiromax or reduce the dose of Aerivio Spiromax without talking to your doctor first.
Maltese: • Tiqafx tieħu Aerivio Spiromax u tnaqqasx id-doża ta' Aerivio Spiromax qabel ma tkellem lit-tabib tiegħek.