FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients originally assigned to entecavir treatment, the reduction in HBV DNA at 48 weeks was -4.20 log10 copies/ml, ALT normalisation had occurred in 37% of patients with abnormal baseline ALT and none achieved HBeAg seroconversion.
Maltese: Għal pazjenti li oriġinarjament ġew assenjati għal trattament b'entecavir, it-tnaqqis fid-DNA ta' HBV wara 48 ġimgħa kien -4.20 log10 kopji/mL, normalizzazzjoni tal-ALT seħħet f'37% tal-pazjenti b'ALT ta' linja bażi anormali u ħadd minnhom ma' laħaq serokonversjoni ta' HBeAg.
English: • In HBeAg positive adult patients, treatment should be administered at least until 12 months after achieving HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Maltese: • F'pazjenti adulti li huma pożittivi għal HBeAg, it-trattament irid jingħata ta' l-inqas sa 12il xahar wara li tinkiseb serokonverżjoni ta' HBe (telf ta' HBeAg u DNA ta' HBV bi kxif ta' anti- HBe f'żewġ kampjuni tas-serum li jkunu ttieħdu konsekuttivament u ta' l-inqas 36 xhur minn xulxin) jew sakemm ikun hemm serokonverżjoni ta' HBs jew sakemm ikun hemm evidenza ta' nuqqas fl-effikaċja (ara sezzjoni 4.4).
English: Breast-feeding should be discontinued during treatment with Entecavir Mylan.
Maltese: It-treddigħ għandu jitwaqqaf waqt it-trattament b'Entecavir Mylan.
English: Your doctor will monitor you regularly while you are receiving Entecavir Mylan.
Maltese: It-tabib tiegħek sejjer jimmonitorjak regolarment meta tkun qed tirċievi Entecavir Mylan.
English: Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy (see section 4.2).
Maltese: Huwa rrakkomandat aġġustament fid-doża għal pazjenti b'indeboliment renali (ara sezzjoni 4.2).
English: HIV/HBV co-infected patients receiving concomitant HAART
Maltese: Pazjenti ko-infettati bl-HIV/HBV li ma jkunux qed jingħataw HAART fl-istess ħin
English: Occurrences of lactic acidosis (in the absence of hypoxaemia), sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues.
Maltese: Okkorrenzi ta' aċidożi lattika (mingħajr hypoxaemia), xi kultant fatali, li s-soltu huma assoċjati ma' epatomegalija gravi u ma' stenożi epatika, ġew irrapportati bl-użu ta' nucleoside analogues.
English: At study entry, the mean HBV DNA was 8.1 log10 IU/ml and mean ALT was 103 U/l across the study population.
Maltese: IU/mL u l-ALT medju kien 103 U/L fost il-popolazzjoni tal-istudju.
English: The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus.
Maltese: Il-benefiċċji ta' suppressjoni viroloġika fit-tul b'terapija kontinwata għandhom jitqabblu mar-riskju ta' kura mtawwla, inkluż it-tfaċċar ta' virus reżistenti talepatite B.
English: c Patients also have LVDr substitutions.
Maltese: c Il-pazjenti għandhom ukoll sostituzzjonijiet LVDr.
English: Exacerbations of hepatitis during and after discontinuation of entecavir therapy have also been reported (see section 4.4 and Description of selected adverse reactions).
Maltese: Aggravamenti tal-epatite waqt u wara it-twaqqif tatterapija b'entecavir ġew irrappurtati wkoll (ara sezzjonijiet 4.4 u Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: The entecavir-TP Ki for HBV DNA polymerase is 0.0012 μM.
Maltese: Entecavir Mylan hu disponibbli biss bħala pilloli miksija b'rita ta' 0.5 u 1 mg.
English: Dosage adjustment is recommended for patients with renal impairment (see section 4.2).
Maltese: Taħrix akut ta' l-epatite ġie rrappurtat ukoll f'pazjenti li waqqfu t-terapija għal epatite B (ara sezzjoni 4.2).
English: GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus Dublin 24, Ireland
Maltese: GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus Dublin 24, L- Irlanda
English: **Growth retardation (see Clinical experience).
Maltese: **Ittardjar fit-tkabbir (ara Esperjenza klinika).
English: ATC code: R01AD12
Maltese: R01AD12
English: *Epistaxis
Maltese: *Epistassi
English: Sími: +354 535 7000
Maltese: Tel: +354 535 7000
English: Nasal spray, suspension.
Maltese: Sprej ta' l-imnieħer, suspensjoni.
English: Interaction with CYP3A inhibitors
Maltese: Interazzjoni ma' inibituri ta' CYP3A
English: • ketoconazole, used to treat fungal infections
Maltese: • ketoconazole, li jintuża għat-trattament ta' infezzjonijiet fungali
English: Avamys contains benzalkonium chloride
Maltese: Avamys fih benzalkonium chloride.
English: The mean treatment difference was -0.27 cm per year [95% CI -0.48 to -0.06].
Maltese: Id-differenza medja tal-kura kienet ta' -0.27 cm kull sena [95% CI -0.48 sa -0.06].
English: Taking Avamys:
Maltese: Tużax Avamys:
English: Avamys (fluticasone furoate) belongs to a group of medicines called glucocorticoids.
Maltese: Avamys (fluticasone furoate) jagħmel parti minn grupp ta' mediċini msejħa glucocorticoids.
English: The following convention has been used for the classification of frequencies: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10,000 to <1/1000; Very rare
Maltese: Mhux komuni >1/1000 sa <1/100; Rari >1/10,000 sa <1/1000; Rari ħafna<1/10,000.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Harmire Road
Maltese: Glaxo Operations UK Ltd (fil-kummerċ Glaxo Wellcome Operations) Harmire Road
English: Glaxo Operations UK, Ltd,(trading as Glaxo Wellcome Operations) Harmire Road
Maltese: Glaxo Operations UK, Ltd, (fil-kummerċ Glaxo Wellcome Operations) Harmire Road
English: Visual disturbance
Maltese: Disturbi fil-vista
English: Fluticasone furoate is widely distributed with volume of distribution at steady-state of, on average, 608 l.
Maltese: Fluticasone furoate jitferrex ħafna b'volum medju ta' distribuzzjoni steady-state ta' 608 l.
English: Benzalkonium chloride Disodium edetate Purified water
Maltese: Benzalkonium Chloride Disodium Edetate Ilma Purifikat
English: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Maltese: Reazzjonijiet ta' sensittività eċċesiva inkluż anafilassi, anġjoedima, raxx u urtikarja.
English: Seasonal Allergic Rhinitis in adults and adolescents
Maltese: Rinite Allerġika ta' l-Istaġun f'adulti u adolexxenti
English: 8 Repeat steps 4 to 7 to treat the other nostril.
Maltese: 8 Irrepeti passi 4 sa 7 biex tikkura l-imnifsejn l-ieħor.
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 17 December 2012
Maltese: Data tal-aħħar tiġdid: 17 ta' Diċembru 2012
English: Patients on ritonavir
Maltese: Pazjenti fuq ritonavir
English: Children (6 to 11 years of age)
Maltese: Tfal (6 snin sa 11-il sena)
English: Adults and adolescents (12 years and over)
Maltese: Adulti u adolexxenti (12-il sena u ikbar)
English: Avamys is available in pack sizes 30, 60 and 120 sprays.
Maltese: Avamys ikun f'pakketti ta' 30, 60 u 120 sprejjaturi.
English: The plasma protein binding of fluticasone furoate is greater than 99 %.
Maltese: Dak li jeħel mal-proteini tad-demm fi fluticasone furoate hu aktar minn 99 %.
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħrufa (frekwenza ma tistax tiġi stmata minn dejta disponibbli)
English: 30 sprays 60 sprays 120 sprays
Maltese: 30 sprejjatura 60 sprejjatura 120 sprejjatura
English: The principal route of metabolism was hydrolysis of the Sfluoromethyl carbothioate function to form the 17β-carboxylic acid metabolite.
Maltese: Ir-rotta prinċipali ta' metaboliżmu kienet l-idrolisi tal-funzjoni S-fluoromethyl carbothioate biex tifforma l-metabolit 17-carboxylic acid.
English: Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects.
Maltese: 110 mikrogrammi ta' fluticasone furoate darba kuljum ma ġewx assoċjati ma' hypothalamic-pituitary-adrenal (HPA) axis suppression f'suġġetti adulti, adolexxenti jew pedjatriċi.
English: In a drug interaction study of intranasal fluticasone furoate with the potent CYP3A4 inhibitor ketoconazole there were more subjects with measurable fluticasone furoate concentrations in the ketoconazole group (6 of the 20 subjects) compared to placebo (1 out of 20 subjects).
Maltese: Fi studju dwar interazzjoni ta' fluticasone furoate flimnieħer bl-inibitur potenti CYP3A4 ketoconazole, kien hemm aktar suġġetti b'konċentrazzjonijiet jitkejlu ta' fluticasone furoate fil-grupp ketoconazole (6 minn 20 suġġett) meta mqabbla ma' dawk bi plaċebo (1 minn 20 suġġett).
English: In a two-year study designed to assess the ocular safety of fluticasone furoate (110 micrograms once daily intranasal spray), adults and adolescents with perennial allergic rhinitis received either fluticasone furoate (n=367) or placebo (n=181).
Maltese: Fi studju ta' sentejn maħsub biex jevalwa s-sigurtà okulari ta' fluticasone furoate (110 mikrogrammi darba kuljum bħala sprej għall-imnieħer), adulti u adolexxenti b'rinite allerġika tal-istaġun irċevew fluticasone furoate (n=367) jew plaċebo (n=181).
English: Also contains: Glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.
Maltese: Fih ukoll: Glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, ilma purifikat
English: Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Maltese: Avamys hu indikat għat-trattament tas-sintomi ta' rinite allerġika.
English: 7 If your dose is 2 sprays in each nostril repeat steps 4 to 6.
Maltese: 7 Jekk id-doża tiegħek hija 2 sprejjaturi f'kull imnifsejn irrepeti passi 4 sa 6.
English: Nasal spray, suspension 1 bottle - 30 sprays 1 bottle - 60 sprays 1 bottle - 120 sprays
Maltese: Sprej għal użu fl-imnieħer, suspensjoni Flixkun 1 - 30 sprejjatura Flixkun 1 - 60 sprejjatura Flixkun 1 - 120 sprejjatura
English: The other ingredients are glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water (see section 2).
Maltese: Is-sustanzi l-oħra huma glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, ilma purifikat (ara sezzjoni 2).
English: Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Maltese: Effetti sistematiċi potenzjali jistgħu jinkludu s-sindrome ta' Cushing, karatteristiċi Cushingoid, soppressjoni adrenali, ittartjar tat-tkabbir fi tfal u adoloxxenti, katarretti, glawkoma u aktar rari, firxa ta' effetti psikoloġiċi jew ta' imġieba inkluż iperattività psikomotorja, disturbi fl-irqad, ansjetà, depressjoni jew aggressjoni (speċjalment fit-tfal It-trattament b'dożi ta' corticosteroids nażali akbar minn dawk rakkomandati jista' jirriżulta' f'soppressjoni adrenali klinika ta' ċerta sinifikanza.
English: In vivo studies have revealed no evidence of cleavage of the furoate moiety to form fluticasone.
Maltese: Studji in vivo ma wrew ebda evidenza ta' qsim tal-fuorate moiety li jifforma fluticasone.
English: Fluticasone furoate is rapidly cleared (total plasma clearance of 58.7 l/h) from systemic circulation principally by hepatic metabolism to an inactive 17β-carboxylic metabolite (GW694301X), by the cytochrome P450 enzyme CYP3A4.
Maltese: Fluticasone furoate jitneħħa malajr (tneħħija totali ta' 58.7 l/s ta' plażma) miċ-ċirkolazzjoni sistemika prinċipalment b'metaboliżmu tal-fwied għal metabolit 17-carboxylic mhux attiv (GW694301X), blenzima CYO3A4 taċ-ċitokromu P450.
English: Only a small number of elderly patients (≥ 65 years, n=23/872; 2.6 %) provided pharmacokinetic data.
Maltese: Ħareġ tagħrif farmakokinetiku minn numru tassew żgħir ta' pazjenti anzjani ( 65 sena, n=23/872; 2.6 %).
English: Headache.
Maltese: Għatu
English: • steroid creams
Maltese: • sterojdi forma ta' dlik
English: At 110 micrograms, median concentrations in those subjects with quantifiable levels were 14.3 pg/ml and 14.4 pg/ml for 2-5 yrs and 6-11 yrs, respectively.
Maltese: Wara doża ta' 110 mikrogrammi, il-medja ta' konċentrazzjonijiet f'dawk il-persuni b'livelli kwantifikabbli kienet ta' 14.3 pg/ml u 14.4 pg/ml għal sentejn sa 5 snin u għal 6 snin sa 11-il sena, rispettivament.
English: study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment (Child-Pugh B) resulted in increased Cmax (42 %) and AUC(0-∞) (172 %) and a modest (on average 23 %) decrease in cortisol levels in patients compared to healthy subjects.
Maltese: Studju fuq doża waħda ta' 400 mikrogrammi ta' fluticasone furoate meħuda mill-ħalq minn pazjenti b'indeboliment moderat (Child-Pugh B) tal-fwied wera żieda ta' Cmax (42 %) u AUC(0-) (172 %) u tnaqqis moderat (medja ta' 23 %) fil-livelli ta' kortisol fil-pazjenti meta mqabbla ma' suġġetti f'saħħithom.
English: A reduction in growth velocity has been observed in children treated with fluticasone furoate 110 micrograms daily for one year (see section 4.8 and section 5.1).
Maltese: Tnaqqis fil-veloċità tat-tkabbir kien osservat fi tfal ikkurati bi fluticasone furoate 110 mikrogrammi kuljum għal sena waħda (ara sezzjoni 4.8 u sezzjoni 5.1).
English: Quantifiable levels were observed in 15.1 % of paediatric patients following intranasal dosing of 110 micrograms once daily and only 6.8 % of paediatric patients following 55 micrograms once daily.
Maltese: Livelli kwantifikabbli ġew osservati f'15.1 % ta' pazjenti pedjatriċi wara dożaġġ fl-imnieħer ta' 110 mikrogrammi darba kuljum u f'6.8 % biss ta' pazjenti pedjatriċi wara doża ta' 55 mikrogrammi darba kuljum.
English: The primary outcomes [time to increase in posterior subcapsular opacity (0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III grade)) and time to increase in intraocular pressure (IOP; 7 mmHg from baseline)] were not statistically significant between the two groups.
Maltese: Ir-riżultati primarji [ħin saż-żieda fl-opaċità subkapsulari posterjuri (0.3 mil-linja bażi fis-Sistema tal-Klassifika tal-Opaċitajiet tal-Lenti, Verżjoni III (LOCS grad III)) u l-ħin sa żieda fil-pressjoni tal-għajn (IOP; 7 mmHg mil-linja bażi)] ma kienux statistikament sinifikanti bejn iż-żewġ gruppi.
English: Increases in posterior subscapsular opacity (0.3 from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms [14 (4%)] versus placebo [4 (2%)] and were transient in nature for ten subjects in the fluticasone furoate group and two subjects in the placebo group.
Maltese: Żidiet fl-opaċità subkapsulari posterjuri (0.3 mil-linja bażi) kienu aktar frekwenti f'individwi kkurati b'110 mikrogrammi ta' fluticasone furoate [14 (4%)] kontra plaċebo [4 (2%)] u kienu ta' natura temporanja għal għaxar individwi fil-grupp ta' fluticasone furoate u żewġ individwi fil-grupp tal-plaċebo.
English: The most serious undesirable effects are rare reports of hypersensitivity reactions, including anaphylaxis (less than 1 case per 1000 patients).
Maltese: L-aktar effetti mhux mixtieqa serji huma rapporti rari ta' reazzjonijiet ta' sensittività eċċessiva, inkluż anafilassi (anqas minn każ wieħed minn kull 1,000 pazjent).
English: Median fluticasone furoate concentrations in those subjects with quantifiable levels at 55 micrograms were 18.4 pg/ml and 18.9 pg/ml for 2-5 yrs and 6-11 yrs, respectively.
Maltese: Il-medja ta' konċentrazzjonijiet ta' fluticasone furoate f'dawk il-persuni b'livelli kwantifikabbli wara doża ta' 55 mikrogrammi, kienet ta' 18.4 pg/ml u 18.9 pg/ml għal sentejn sa 5 snin u għal 6 snin sa 11-il sena, rispettivament.
English: At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular opacity values within ± 0.1 of baseline values for each eye and, at week 104, ≤1% of subjects in both treatment groups had 0.3 increase from baseline in posterior subcapsular opacity.
Maltese: F'ġimgħat 52 u 104, 95% tal-individwi fiż-żewġ gruppi ta' kura kellhom valuri ta' opaċità subkapsulari posterjuri f'± 0.1 tal-valuri fil-linja bażi għal kull għajn u, f'ġimgħa 104, ≤1% talindividwi fiż-żewġ gruppi ta' kura kellhom żieda ta' 0.3 mil-linja bażi fl-opaċità subkapsulari posterjuri.
English: Epistaxis *Epistaxis was generally mild to moderate in intensity.
Maltese: *Epistassi kienet ġeneralment ħafifa sa moderata f'dik li hi intensita`.
English: Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very high affinity for the glucocorticoid receptor and has a potent anti-inflammatory action.
Maltese: Fluticasone furoate huwa corticosteroid trifluworinat sintetiku b'affinita` kbira ħafna għar-riċettur talglucocorticoid u għandu effett qawwi kontra l-infjammazzjoni.
English: Fluticasone furoate undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut resulting in negligible systemic exposure.
Maltese: Fluticasone furoate jiġi assorbit mhux kompletament u metabolizzat b'mod first-pass estensivament fil-fwied u l-imsaren li jirriżulta f'esponiment sistemiku negliġibbli.
English: Increases in IOP (7 mmHg from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms: 7 (2%) for fluticasone furoate 110 micrograms once daily and 1 (<1%) for placebo.
Maltese: 7 (2%) għal fluticasone furoate 110 mikrogrammi darba kuljum u 1 (<1%) għall-plaċebo.
English: Paediatric exposure to fluticasone furoate in safety and efficacy studies in seasonal and perennial allergic rhinitis included 243 patients 12 to <18 years, 790 patients 6 to <12 years and 241 patients 2 to <6 years.
Maltese: Esponiment pedjatriku għal fluticasone furoate fi studji ta' sigurtà u effikaċja f'rinite allerġika tal-istaġun u rinite li ddum għal tul ta' żmien kien jinkludi 243 pazjent minn 12 sa <18-il sena, 790 pazjent minn 6 sa <12-il sena u 241 pazjent minn sentejn sa <6 snin.
English: • Check you still have medicine left.
Maltese: • Iċċekkja li baqalek mediċina.
English: • ritonavir or cobicistat, used to treat HIV
Maltese: • ritonavir jew cobicistat, li jintuża għat-trattament ta' l-HIV
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Maltese: Jistgħu jiġu rrappurtati disturbi fil-vista bl-użu ta' kortikosterojdi sistemiċi u topiċi.
English: Children 6 to 11 years
Maltese: Tfal minn 6 sa 11-il sena
English: Nasal ulceration
Maltese: Ulċeri fl-imnieħer
English: Avamys is indicated in adults, adolescents and children (6 years and over)
Maltese: Avamys huwa indikat f'adulti u adolexxenti u tfal (minn 6 snin 'l fuq).
English: Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.
Maltese: Fluticasone fuorate jitneħħa malajr b'metaboliżmu first pass estensiv medjat biċ-ċitokromju P450 3A4.
English: There was no effect on serum cortisol in subjects with severe hepatic impairment (fluticasone furoate/vilanterol 100/12.5 micrograms).
Maltese: Ma kien hemm l-ebda effett fuq kortisol fis-serum f'individwi b'indeboliment sever tal-fwied (fluticasone furoate/vilanterol 100/12.5 mikrogramma).
English: Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate (see section 4.5).
Maltese: Għoti flimkien ma' ritonavir mhux irrakkomandat minħabba r-riskju ta' esponiment sistemiku akbar għal fluticasone furoate (ara sezzjoni 4.5).
English: Compared with placebo, fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms (comprising rhinorrhoea, nasal congestion, sneezing and nasal itching) and ocular symptoms (comprising itching/burning, tearing/watering and redness of the eyes) in all 4 studies.
Maltese: Meta mqabbla ma' plaċebo, 110 mikrogrammi kuljum ta' l-isprej nażali fluticasone furoate tejbu ssintomi nażali (li jinkludu rinorrea, konġestjoni nażali, għatis u ħakk fl-imnieħer) u sintomi fl-għajnejn (li jinkludu ħakk/ħruq, dmugħ u ħmura fl-għajnejn) f'kull wieħed mill-erba' studji.
English: The enzyme induction and inhibition data suggest that there is no theoretical basis for anticipating metabolic interactions between fluticasone furoate and the cytochrome P450 mediated metabolism of other compounds at clinically relevant intranasal doses.
Maltese: It-tagħrif dwar l-inibizzjoni u l-induzzjoni ta' enzimi jindika li m'hemmx bażi teoretika li fuqha wieħed jantiċipa interazzjonijiet metaboliċi bejn fluticasone furoate u l-metaboliżmu medjat biċċitokromu P450 ta' komposti oħra f'dożi fl-imnieħer klinikament rilevanti.
English: Transient ocular changes (see Clinical experience), vision blurred (see also section 4.4) Respiratory, thoracic and mediastinal disorders Very common
Maltese: Bidliet temporanji fl-għajnejn (ara Esperjenza klinika), vista mċajpra (ara wkoll sezzjoni 4.4) Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna
English: The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms).
Maltese: Id-doża rakkomandata għall-bidu hi ta' żewġ sprejjaturi (27.5 mikrogrammi ta' fluticasone furoate f'kull sprejjatura li tiġi attwata) f'kull minħar darba kuljum (doża totali tal-ġurnata, 110 mikrogrammi).
English: Following repeat dosing of orally inhaled fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (on average two-fold as measured by AUC(0-24)) in subjects with moderate or severe hepatic impairment (Child-Pugh B or C) compared with healthy subjects.
Maltese: Wara dożi ripetuti ta' fluticasone furoate/vilanterol meħudin mill-ħalq għal 7 ijiem, kien hemm żieda fl-esponiment sistemiku għal fluticasone furoate (bħala medja darbtejn ogħla minn kif imkejjel mill-AUC(0-24)) f'individwi b'indeboliment moderat jew sever talfwied (Child-Pugh B jew C) meta mqabbla ma' individwi b'saħħithom.
English: Post-hoc analysis over 6 and 12 weeks in the same study, as well as 6-week HPA axis safety study, supported the efficacy of fluticasone furoate nasal spray 110 micrograms once daily.
Maltese: Analiżi post-hoc matul 6 u 12-il ġimgħa fl-istess studju, kif ukoll studju ta' 6 ġimgħat dwar sigurta` ta' HPA axis, urew tisħiħ fleffikaċja ta' 110 mikrogrammi ta' sprej nażali fluticasone furoate darba kuljum.
English: The values are similar to those seen in adults (12+) where median concentrations in those subjects with quantifiable levels were 15.4 pg/ml and 21.8 pg/ml at 55 micrograms and 110 micrograms, respectively.
Maltese: Dawn il-valuri huma simili għal dawk li dehru fl-adulti (12+) fejn il-medja ta' konċentrazzjonijiet f'dawk il-persuni b'livelli kwantifikabbli kienet ta' 15.4 pg/ml u 21.8 pg/ml wara doża ta' 55 mikrogrammi u 110 mikrogrammi, rispettivament.
English: The increase in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (fluticasone furoate/vilanterol 200/25 micrograms) was associated with an average 34% reduction in serum cortisol compared with healthy subjects.
Maltese: Iż-żieda fl-esponiment sistemiku għal fluticasone furoate f'individwu b'indeboliment moderat tal-fwied (fluticasone furoate/vilanterol 200/25 mikrogramma) kienet assoċjata ma' tnaqqis medju ta' 34 % fil-kortisol tasserum meta mqabbla ma' individwi b'saħħithom.
English: Other medicines and Avamys
Maltese: Mediċini oħra u Avamys
English: In seasonal allergic rhinitis, fluticasone furoate nasal spray 110 micrograms once daily was effective but no significant differences were observed between fluticasone furoate nasal spray 55 micrograms once daily and placebo on any endpoint.
Maltese: Fil-każ ta' rinite allerġika ta' l-istaġun, 110 mikrogrammi darba kuljum ta' sprej fluticasone furoate kienu effettivi iżda ma kienu osservati ebda differenzi sinifikanti fil-każ ta' 55 mikrogrammi darba kuljum ta' sprej nażali fluticasone furoate u plaċebo fuq l-ebda endpoint.