FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Enpaxiq, pacritinib, blocks the action of JAK2 and FLT3, two proteins involved in the production and growth of blood cells.
Maltese: LT3, żewġ proteini involuti fil-produzzjoni u t-tkabbir taċ-ċelloli tad-demm.
English: Enpaxiq was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 25 August 2010 for different types of myelofibrosis.
Maltese: 2010 għal tipi differenti ta' mjelofibrożi.
English: The company said that it intends to integrate the new data from the study into its current dossier before approaching EMA to discuss a new application.
Maltese: -kumpanija qalet li hi għandha l-intenzjoni li tintegra d-data l-ġdida mill-istudju fid-dossier attwali tagħha qabel ma tavviċina lill-EMA biex tiddiskuti applikazzjoni ġdida.
English: Enpaxiq was expected to be used to treat patients with an enlarged spleen or other symptoms of myelofibrosis - a disorder in which scar tissue builds up in the bone marrow where blood cells are produced.
Maltese: 'Enpaxiq; u kie i rċevew l-aqwa terapija disponibbli, inkluż imwiet minħabba fsada u l-effetti fuq il-qalb.
English: On 20 February 2017, CTI BioPharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Enpaxiq, for treating patients with an enlarged spleen or other symptoms of myelofibrosis.
Maltese: BioPharma għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Enpaxiq, għall-kura ta
English: Further information on its orphan designations can be found here.
Maltese: 'sintomi oħra ta' mjelofibrożi.
English: Further information on Mulpleo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/mulpleo.
Maltese: ema.europa.eu/medicines/human/EPAR/mulpleo.
English: Mulpleo is available as 3 mg tablets.
Maltese: Mulpleo jiġi bħala pilloli ta' 3 mg.
English: Other information about Mulpleo
Maltese: Informazzjoni oħra dwar Mulpleo
English: Mulpleo1 (lusutrombopag)
Maltese: (lusutrombopag)
English: Mulpleo received a marketing authorisation valid throughout the EU on 18 February 2019.
Maltese: Mulpleo ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-18 ta' Frar 2019.
English: Mulpleo contains the active substance lusutrombopag.
Maltese: Mulpleo fih is-sustanza attiva lusutrombopag.
English: 1 Previously known as Lusutrombopag Shionogi.
Maltese: 1 Preċedentement magħruf bħala Lusutrombopag Shionogi.
English: The second study involving 215 adults found that 65% of patients who took Mulpleo did not require platelet transfusion before their procedure, compared with 29% of patients who received placebo.
Maltese: It-tieni studju li involva 215-il adult sab li 65 % tal-pazjenti li ħadu Mulpleo ma kellhomx bżonn trasfużjoni ta' pjastrini qabel il-proċedura tagħhom, meta mqabbla ma' 29 % talpazjenti li rċevew plaċebo.
English: Similar effects occurred in patients receiving placebo.
Maltese: Effetti simili seħħew fil-pazjenti li rċevew plaċebo.
English: What are the risks associated with Mulpleo?
Maltese: X'inhuma r-riskji assoċjati ma' Mulpleo?
English: The first study, involving 96 adults, found that 79% of patients who took Mulpleo did not require a transfusion of platelets before their procedure, compared with 13% of patients who received placebo (a dummy treatment).
Maltese: L-ewwel studju, li involva 96 adult, sab li 79 % tal-pazjenti li ħadu Mulpleo ma kellhomx bżonn trasfużjoni ta' pjastrini qabel il-proċedura tagħhom, meta mqabbla ma' 13 % tal-pazjenti li rċevew plaċebo (kura finta).
English: Unwanted effects that occurred in studies involving patients taking Mulpleo were headache, nausea (feeling sick), portal vein thrombosis (a blockage in the blood vessel that carries blood from the intestines to the liver) and rash.
Maltese: Effetti mhux mixtieqa li seħħew fl-istudji li involvew pazjenti li ħadu Mulpleo kienu wġigħ ta' ras, nawżja (tħossok ma tiflaħx), trombożi tal-vini portali (imblukkar fil-vażu li jġorr id-demm mill-intestini għall-fwied) u raxx.
English: As for all medicines, data on the use of Mulpleo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Mulpleo hija ssorveljata kontinwament.
English: Mulpleo is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to longstanding liver disease.
Maltese: Mulpleo huwa mediċina li tintuża biex tipprevjeni emorraġija eċċessiva fl-adulti bi tromboċitopenija minħabba mard tal-fwied fit-tul.
English: The active substance in Mulpleo, lusutrombopag, attaches to the same receptors as thrombopoietin, helping to increase the platelet count.
Maltese: Is-sustanza attiva f'Mulpleo, il-lusutrombopag, teħel mal-istess riċetturi bħal trombopojetin, u b'hekk tgħinhom iżidu l-għadd tal-pjastrini.
English: How is Mulpleo used?
Maltese: Kif jaħdem Mulpleo?
English: For more information on the side effects and restrictions of Mulpleo, see the package leaflet.
Maltese: Għal iktar informazzjoni dwar l-effetti sekondarji u r-restrizzjonijiet ta' Mulpleo, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Mulpleo?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Mulpleo?
English: The European Medicines Agency decided that Mulpleo's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Mulpleo huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: Patients with thrombocytopenia have reduced number of platelets (components in the blood that help it to clot), which can cause excessive bleeding.
Maltese: Il-pazjenti bi tromboċitopenija għandhom għadd imnaqqas ta' pjastrini (komponenti fid-demm li jgħinuh jagħqad), li jistgħu jikkawżaw emorraġija eċċessiva.
English: What benefits of Mulpleo have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Mulpleo li ħarġu mill-istudji?
English: Unwanted effects that occurred in studies are thought to result from patients' medical condition and the nature of the invasive procedure for which Mulpleo was used.
Maltese: Hu maħsub li l-effetti mhux mixtieqa li seħħew fl-istudji jirriżultaw mill-kundizzjoni medika tal-pazjenti u n-natura talproċedura invażiva li għaliha ntuża Mulpleo.
English: Important!
Maltese: Importanti!
English: Nijmegen, 6545CG Netherlands
Maltese: Nijmegen, 6545CG In-Netherlands
English: Rate a.
Maltese: Rata a.
English: Difference
Maltese: Differenza
English: Parasitic (Helminth) Infection
Maltese: Infezzjoni Parassita (Helminth)
English: Gender, Race
Maltese: Sess, Razza
English: Benra 30 mg q. 8 weeks n =
Maltese: Benra 30 mg q. 8 ġimgħat n =
English: Store in a refrigerator (2°C to 8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: MedImmune UK Ltd 6 Renaissance Way Liverpool, L24 9JW United Kingdom
Maltese: MedImmune UK Ltd 6 Renaissance Way Liverpool, L24 9JW Ir-Renju Unit
English: The active substance is benralizumab.
Maltese: Is-sustanza attiva hi benralizumab.
English: Name and address of the manufacturer of the biological active substance AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court
Maltese: AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court
English: • fever (high temperature)
Maltese: • deni (temperatura għolja)
English: Benralizumab is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa).
Maltese: Benralizumab huwa antikorp kontra l-eosinofili, afucosylated umanizzat, monoklonali (IgG1, kappa).
English: Step 7 - Inject Fasenra
Maltese: Pass 7 - Injetta Fasenra
English: Date of first authorisation: 8 January 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 8 ta' Jannar 2018
English: Trial 4 EOT
Maltese: c Prova 4 EOT
English: EU/1/17/1252/001 1 pre-filled syringe EU/1/17/1252/002 1 pre-filled pen
Maltese: EU/1/17/1252/001 siringa 1 mimlija għal-lest EU/1/17/1252/002 pinna 1 mimlija għal-lest
English: Difference (95% CI)
Maltese: Differenza (95 % CI)
English: Benralizumab has not been studied in children (5 to 11 years old) (see section 4.2).
Maltese: Benralizumab ma ġiex studjat fit-tfal (5 sa 11-il sena) (ara sezzjoni 4.2).
English: Trial 1, 2 & 4
Maltese: Prova 1, 2 u 4
English: b. Integrated analysis of Trial 1 and 2 baseline includes adults and adolescents.
Maltese: b. Analiżi integrata ta' Prova 1 u 2 fil-linja bażi tinkludi adulti u adolexxenti..
English: Pre-bronchodilator FEV1 (L)
Maltese: FEV1 pre-bronkodilatur(L)
English: No data are available for children aged 6 to 11 years old.
Maltese: M'hemm l-ebda data disponibbli għal tfal minn età ta' 6 snin sa 11-il sena.
English: This generally takes 30 minutes.
Maltese: Dan ġeneralment jieħu 30 minuta.
English: Sverige AstraZeneca AB
Maltese: AstraZeneca AB
English: There are limited data in paediatric patients (see section 5.1).
Maltese: Hemm data limitata f'pazjenti pedjatriċi (ara sezzjoni 5.1).
English: n= number of patients with data at timepoint.
Maltese: n= numru ta' pazjenti b'dejta fil-punt taż-żmien.
English: Hypersensitivity reactions** Anaphylactic reaction
Maltese: Reazzjonijiet ta' sensittività eċċessiva**
English: The estimated systemic clearance (CL) for benralizumab was at 0.29 L/d.
Maltese: It-tneħħija sistemika stmata (CL) għal benralizumab kienet b'0.29 L/d.
English: Exacerbation rate Difference Rate ratio (95% CI) Pre-bronchodilator FEV1 mean change Difference (95% CI)
Maltese: Differenza Proporzjon tar-rata (95 % CI) Bidla medja ta' FEV1 prebronkodilatur Differenza (95 % CI)
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita billi tintuża l-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: Fasenra 30 mg injection benralizumab SC
Maltese: Fasenra 30 mg injezzjoni benralizumab SC
English: Acute systemic reactions including anaphylactic reactions and hypersensitivity reactions (e.g. urticaria, papular urticaria, rash) have occurred following administration of benralizumab (see section 4.8).
Maltese: Seħħew reazzjonijiet sistemiċi akuti inkluż reazzjonijiet anafilattiċi u ta' sensittività eċċessiva (eż. urtikarja, urtikarja papulari, raxx) wara l-għoti ta' benralizumab (ara sezzjoni4.8).
English: *Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Maltese: *Benralizumab huwa antikorp monoklonali umanizzat prodott fiċ-ċelloli tal-ovarji tal-ħemster Ċiniż (CHO) b'teknoloġija b'DNA rikombinanti.
English: The depletion of blood eosinophils is accompanied by a reduction in serum eosinophil granule proteins eosinophil derived neurotoxin (EDN) and eosinophil cationic protein (ECP) and a reduction in blood basophils.
Maltese: It-tnaqqis tal-eosinofili tad-demm huwa akkumpanjat mittnaqqis fi neurotoxin derivat mill-eosinofili (eosinophil derived neurotoxin - EDN) tal-proteini granuli tal-eosinofili fis-serum u proteini katajoniċi tal-eosinofili (eosinophil cationic protein-ECP) u t-tnaqqis fil-bażofili fid-demm.
English: Similar maintenance of effect was observed throughout Trial 4 in lung function, ACQ-6 and AQLQ(S)+12 (Table 7).
Maltese: Ġie osservat manteniment tal-effett simili matul Prova 4 fil-funzjoni tal-pulmun, ACQ-6 u AQLQ(S)+12 (Tabella 7).
English: Based on population pharmacokinetic analysis, central and peripheral volume of distribution of benralizumab was 3.1 L and 2.5 L, respectively, for a 70 kg individual.
Maltese: Abbażi tal-analiżi tal-popolazzjoni farmakokinetika, il-volum ċentrali u periferali tad-distribuzzjoni ta' benralizumab kien 3.1 L u 2.5 L, rispettivament, għal individwu ta' 70 kg.
English: Södertälje Sweden
Maltese: Södertälje L-Iżvezja
English: Placebo (N=75)
Maltese: Plaċebo (N=75)
English: The two exacerbation trials, SIROCCO (Trial 1) and CALIMA (Trial 2), enrolled a total of 2,510 patients with severe uncontrolled asthma, 64% females, with a mean age of 49 years.
Maltese: Iż-żewġ provi tal-aggravament, SIROCCO (Prova 1) u CALIMA (Prova 2), irreġistraw total ta' 2,510 pazjenti b'ażma severa mhux ikkontrollata, 64 % kienu nisa, b'età medja ta' 49 sena.
English: Do not use Fasenra:
Maltese: Tużax Fasenra:
English: In these trials, the asthma exacerbation rate in adolescent patients treated with Fasenra administered at the recommended dosing regimen was 0.70 (n=40, 95% CI: 0.42, 1.18) compared to 0.41 for placebo (n=46, 95% CI: 0.23, 0.73) [rate ratio 1.70, 95% CI: 0.78, 3.69].
Maltese: F'dawn il-provi, ir-rata ta' taħrix tal-ażma fil-pazjenti adolexxenti kkurati bi Fasenra mogħti birreġimen tad-dożaġġ rakkomandat kienet 0.70 (n=40, 95 % CI: 0.42, 1.18) imqabbla ma 0.41 għallplaċebo (n=46, 95% CI: 0.23, 0.73) [proporzjon tar-rata 1.70, 95 % CI: 0.78, 3.69].
English: The efficacy of Fasenra was evaluated in 3 randomised, double-blind, parallel-group, placebo-controlled clinical trials between 28 to 56 weeks duration, in patients aged 12 to 75 years.
Maltese: L-effikaċja ta' Fasenra ġiet evalwata fi 3 provi kliniċi randomizzati, double-blind, bi grupp parallel, u kkontrollati bi plaċebo li damu bejn 28 u 56 ġimgħa, f'pazjenti li għandhom minn 12 sa 75 sena.
English: There were 108 adolescents aged 12 to 17 with asthma enrolled in the phase 3 trials (Trial 1: n=53, Trial 2: n=55).
Maltese: Fil-provi tal-fażi 3 kien hemm 108 adolexxenti ta' età minn 12 sa 17-il sena bl-ażma rreġistrati (Prova 1: n=53, Prova 2: n=55).
English: This will allow quick identification of new safety information.
Maltese: Jista' jkun hemm informazzjoni ġdida.
English: Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20, water for injections.
Maltese: Eċċipjenti: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20, ilma għall-injezzjonijiet.
English: AstraZeneca AB SE-151 85 Södertälje Sweden
Maltese: SE-151 85 Södertälje L-Iżvezja
English: Trial 1 & 2 EOT
Maltese: Prova 1 u 2 EOT
English: Trial 2
Maltese: Prova 2
English: Green plunger
Maltese: Ras ilplanġer
English: Most antibodies were neutralising and persistent.
Maltese: Ħafna mill-antikorpi kienu newtralizzanti u persistenti.
English: An effect of benralizumab on the pharmacokinetics of co-administered medicinal products is not expected (see section 5.2).
Maltese: Mhuwiex mistenni effett ta' benralizumab fuq ilfarmakokinetika ta' prodotti mediċinali mogħtija flimkien (ara sezzjoni 5.2).
English: • 1 alcohol wipe
Maltese: • Wajp tal-alkoħol 1
English: Trial 3
Maltese: Prova 3
English: Asthma symptom scale: total score from 0 (least) to 6 (most); day and night time asthma symptom scores from 0 (least) to 3 (most) symptoms.
Maltese: Skala tas-sintomi tal-ażma: punteġġ totali minn 0 (l-inqas) sa 6 (l-aktar); punteġġi tas-sintomi tal-ażma ta' bi nhar u bil-lejl minn 0 (l-inqas) għal 3 (l-aktar) sintomi.
English: Based on the population pharmacokinetic analysis, commonly co-administered medicinal products (montelukast, paracetamol, proton pump inhibitors, macrolides and theophylline/aminophylline) had no effect on benralizumab clearance in patients with asthma.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, il-prodotti mediċinali mogħtija flimkien b'mod komuni (montelukast, paracetamol, inibituri tal-pompa tal-proton, makrolidi u theophylline/aminophylline) ma kellhom l-ebda effett fuq it-tneħħija ta' benralizumab f'pazjenti blażma.
English: It is preferable to avoid the use of Fasenra during pregnancy.
Maltese: Huwa preferibbli li jiġi evitat l-użu ta' Fasenra waqt it-tqala.
English: Τηλ: +357 22490305
Maltese: Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305
English: Difference (95% CI) AQLQ(S)+12
Maltese: Titjib mil-linja bażi Differenza (95 % CI) AQLQ(S)+12
English: Trial 4
Maltese: Prova 4
English: Total duration of treatment: 104 - 112 weeks
Maltese: Tul totali tal-kura: 104 - 112-il ġimgħa
English: A total of 2,514 patients, out of whom 1,663 patients had severe uncontrolled eosinophilic asthma, received benralizumab during clinical studies of 48 to 56 weeks duration.
Maltese: Total ta' 2,514-il pazjent, li minnhom 1,663 pazjent kellhom ażma eosinofilika severa mhux ikkontrollata, irċevew benralizumab waqt studji kliniċi li damu minn 48 sa 56 ġimgħa.
English: Rate ratio (95% CI)
Maltese: Proporzjon tar-rata (95 % CI)
English: Adolescent patients aged 12 to 17 (n=86) from Trials 1 and 2 continued treatment with Fasenra in Trial 4 for up to 108 weeks.
Maltese: Pazjenti adolexxenti li kellhom 12 sa 17 (n=86) minn Provi 1 u 2 komplew kura b'Fasenra fi Prova 4 sa 108 ġimgħat.
English: Mean baseline (SD) Change from baseline (SD) ACQ-6
Maltese: Linja bażi medja (SD) Bidlal mil-linja bażi (SD) ACQ-6
English: Inject Fasenra by following the steps in figures a, b and c.
Maltese: Injetta Fasenra billi ssegwi l-passi fil-figuri a, b u ċ.
English: Step 10 - Dispose of the used Fasenra Pen safely
Maltese: Pass 10 - Armi l-Fasenra Pen użata b'mod sigur)
English: • 1 Fasenra Pen from the refrigerator • 1 alcohol wipe
Maltese: • Fasenra Pen 1 mill-friġġ
English: Rate ratio (95% CI) p-value
Maltese: Proporzjon tar-rata (95 % CI) valur-p
English: Based on the population pharmacokinetic analysis, the pharmacokinetics of benralizumab in adolescents aged 12 to 17 years were consistent with adults.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, il-farmakokinetika ta' benralizumab fladolexxenti ta' età minn 12 sa 17-il sena kienet konsistenti ma dik fl-adulti.
English: Similar improvement in favour of Fasenra was observed for the Asthma Control Questionnaire-6 (ACQ-6) and Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) (Table 3).
Maltese: Ġie osservat titjib simili favur Fasenra għall-Kwestjonarju tal-Kontroll tal-Ażma-6 (Asthma Control Questionnaire - ACQ-6) u l-Kwestjonarju tal-Kwalità tal-Ħajja tal-Ażma Standardizzat għal 12-il Sena jew Akbar (Asthma Quality of Life Questionnaire - AQLQ(S)+12) (Tabella 3).
English: Trial 1
Maltese: Prova 1
English: Liquid medicine
Maltese: Mediċina likwida
English: The long-term efficacy and safety of Fasenra was evaluated in a phase 3, 56-week extension trial BORA (Trial 4).
Maltese: L-effikaċja u s-sigurtà fit-tul ta' Fasenra ġiet evalwata fi prova ta' estensjoni ta' fażi 3, ta' 56 ġimgħa BORA (Prova 4).
English: Κύπρος Αλέκτωρ Φαρµακευτική Λτδ
Maltese: Kun ċert li tista' tara t-tieqa ta' spezzjoni.
English: Placebo (N=338)
Maltese: Plaċebo (N=338)
English: • pharyngitis (sore throat)
Maltese: • farinġite (uġigħ fil-griżmejn)
English: The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effector cells such as natural killer (NK) cells.
Maltese: In-nuqqas ta' fukożju fid-dominju Fc ta' benralizumab jirriżulta f'affinità għolja għal riċetturi FcɣRIII fuq ċelloli immuni affettwatur bħal ċelloli qattiela naturali (natural killer - NK).
English: Patients had a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment (mean of 3) in the past 12 months, ACQ-6 score of 1.5 or more at screening, and reduced lung function at baseline (mean predicted pre-bronchodilator forced expiratory volume in 1 second [FEV1] of 57.5%), despite regular treatment with high-dose inhaled corticosteroid (ICS) (Trial 1) or with medium or high-dose ICS (Trial 2) and a long-acting β-agonist (LABA); at least one additional controller was administered to 51% and 41% of these patients, respectively.
Maltese: Il-pazjenti kellhom storja ta' 2 taħrixiet jew aktar ta' ażma li kienu jirrikjedu kura b'kortikosterojdi orali jew sistemiċi (medja ta' 3) fl-aħħar 12-il xahar, punteġġ ACQ-6 ta' 1.5 jew aktar fl-iskrinjar, u funzjoni talpulmun imnaqqsa fil-linja bażi (volum espiratorju sfurzat [FEV1] pre-bronkodilatur imbassar medju f'sekonda ta' 57.5 %), minkejja l-kura regolari b'kortikosterojdi li jittieħdu man-nifs b'doża għolja (ICS) (Prova 1) jew b'ICS b'doża medja jew għolja (Prova 2) u agonisti β li jaġixxu fit-tul (LABA); tal-inqas kontrollur addizzjonali wieħed ingħata lil 51 % u 41 % ta' dawn il-pazjenti, rispettivament.
English: For the oral corticosteroid (OCS) reduction trial ZONDA (Trial 3), a total of 220 asthma patients (61% female; mean age of 51 years) were enrolled; they were treated with daily OCS (8 to 40 mg per day; median of 10 mg) in addition to regular use of high-dose ICS and LABA with at least one additional controller to maintain asthma control in 53% of the cases.
Maltese: Għall-prova tat-tnaqqis tal-kortikosterojdi orali (OCS) ZONDA (Prova 3), ġie rreġistrat total ta' 220 pazjent li jbatu bl-ażma (61 % nisa; età medja ta' 51 sena); dawn kienu qed jiġu kkurati b'OCS ta' kuljum (8 sa 40 mg kuljum; medjan ta' 10 mg) flimkien mal-użu regolari ta' ICS u LABA b'doża għolja b'tal-inqas kontrollur addizzjonali wieħed biex jinżamm kontroll tal-ażma fi 53 % tal-każijiet.
English: Treatment difference in mean change from baseline in total asthma symptom score, ACQ-6 and AQLQ(s)+12 at end of treatment - Patients on high-dose ICS and blood eosinophils ≥300 cells/μL
Maltese: Tabella 3. Differenza tal-kura fil-bidla mejda mil-linja bażi fil-punteġġ totali ta' sintomi talażma, ACQ-6 u AQLQ(s)+12 fi tmiem il-kura - Pazjenti fuq doża għolja ta' ICS u eosinofili taddemm ≥300 ċellola/μL
English: In this study there was a median reduction from baseline in airway mucosa eosinophils of 96% in the benralizumab treated group compared to a 47% reduction in the placebo group (p=0.039).
Maltese: F'dan listudju kien hemm tnaqqis medjan mil-linja bażi fl-eosinofili fil-mukoża tal-pajp tan-nifs ta' 96 % filgrupp ikkurat b'benralizumab meta mqabbel mat-tnaqqis ta' 47 % fil-grupp tal-plaċebo (p=0.039).
English: Fasenra is used to treat severe eosinophilic asthma in adults.
Maltese: Fasenra jintuża biex jikkura ażma eosinofilika severa fl-adulti.
English: Do not:
Maltese: NN:
English: Let Fasenra warm up at room temperature 20°C to 25°C for about 30 minutes before giving the injection.
Maltese: Fasenra jisħon f'temperatura ambjentali ta' 20°C sa 25°C għal madwar 30 minuta qabel tagħti l-injezzjoni.
English: Hold down firmly for 15 seconds.
Maltese: Żomm 'l isfel b'mod sod għal 15-il sekonda.
English: Fasenra may be kept at room temperature up to 25°C for a maximum of 14 days.
Maltese: Fasenra jista' jinżamm f'temperatura ambjentali sa 25°C għal massimu ta' 14-il jum.
English: No benralizumab-related impairment was observed in reproductive parameters of male and female cynomolgus monkeys.
Maltese: Ma ġie osservat l-ebda indeboliment relatat ma' benralizumab f'parametri riproduttivi ta' xadini cynomolgus ta' sess maskil u femminil.
English: Animal toxicology and/or pharmacology
Maltese: Tossikoloġija u/jew farmakoloġija tal-annimali
English: Inject Fasenra by following the steps in figures a, b, c and d.
Maltese: Injetta Fasenra billi ssegwi l-passi li ġejjin f'figuri a, b, ċ u d.
English: Change from baseline for lung function, ACQ-6, and AQLQ(S)+12
Maltese: Bidla mil-linja bażi għall-funzjoni tal-pulmun, ACQ-6, u AQLQ(S)+12
English: Lung function, asthma symptom score, ACQ-6 and AQLQ(S)+12 were also assessed in Trial 3 and showed results similar to those in Trials 1 and 2.
Maltese: Il-funzjoni tal-pulmun, il-punteġġ tas-sintomi tal-ażma, l-ACQ-6 u l-AQLQ(S)+12 ġew ivvalutati wkoll fil-Prova 3 u wrew riżultati simili għal dawk fil-Provi 1 u 2.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Maltese: NUMRU TAL-LOTT <, DONAZZJONI U KOWD TAL-PRODOTT>
English: Trial 3 evaluated the effect of Fasenra on reducing the use of maintenance oral corticosteroids.
Maltese: Prova 3 evalwat l-effett ta' Fasenra fuq it-tnaqqis tal-użu ta' kortikosterojdi orali ta' manteniment.
English: AstraZeneca A.E. Τηλ: +30 210 6871500
Maltese: Τηλ: +30 210 6871500