FrancophonIA/ELRC3.0 huggingface dataset:
English: Exacerbation reduction MEA115588 (MENSA) study
Maltese: Studju tnaqqis tat-taħrix MEA115588 (MENSA)
English: Pack sizes:
Maltese: TA' EĊĊIPJENTI Eċċipjenti:
English: Table 3 shows the results of a combined analysis of the two exacerbation studies (MEA112997 and MEA115588) by baseline blood eosinophil count.
Maltese: Tabella 3 turi r-riżultati ta' analiżi kombinata taż-żewġ studji dwar it-taħrix (MEA112997 u MEA115588) skont l-għadd ta' esinofili fid-demm fil-linja bażi.
English: The absolute subcutaneous bioavailability appears complete compared to that observed in adults and adolescents of 76%.
Maltese: Il-bijodisponibilità assoluta taħt il-ġilda tidher kompluta meta mqabbla ma' dik osservata fl-adulti u fl-adoloxxenti ta' 76%.
English: Following a single subcutaneous administration in the abdomen, thigh or arm of healthy subjects, mepolizumab absolute bioavailability was 64%, 71% and 75%, respectively.
Maltese: Wara l-għoti ta' darba taħt il-ġilda fl-addome, il-koxxa jew id-driegħ ta' individwi b'saħħithom, il bijodisponibilità assoluta ta' mepolizumab kienet 64%, 71% u 75% rispettivament.
English: No additional adverse reactions were identified.
Maltese: L-ebda reazzjonijiet avversi addizzjonali ma ġew identifikati.
English: 1st “Click”
Maltese: “Klikk”
English: MEA115588 was a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study which evaluated the efficacy and safety of mepolizumab as add-on therapy in 576 patients with severe refractory eosinophilic asthma defined as peripheral blood eosinophils greater than or equal to 150 cells/μL at initiation of treatment or greater than or equal to 300 cells/μL within the past 12 months.
Maltese: MEA115588 kien studju multi-ċentriku randomizzat, double-blind, ta' grupp parallel, ikkontrollat bi plaċebo li evalwa l-effikaċja u s-sigurtà ta' mepolizumab bħala terapija add-on f'576 pazjent b'ażżma esinofilika refrattorja severa definita bħala esinofili tad-demm periferali ikbar minn jew daqs 150 ċellola/μL fil-bidu tattrattament jew ikbar minn jew daqs 300 ċellola/μL fi żmien it-12-il xahar.
English: Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of Nucala.
Maltese: Reazzjonijiet sistemiċi akuti u ttardjati, inkluż reazzjonijiet ta' sensittività eċċessiva (eż. anafilassi, urtikarja, anġjoedema, raxx, bronkospażmu, pressjoni baxxa) seħħew wara li ngħata Nucala.
English: Exacerbation rate per year Mepolizumab vs. placebo Rate ratio (95% CI)
Maltese: Rata ta' taħrix fis-sena Mepolizumab vs. plaċebo Proporzjon tar-rata (95% CI)
English: * Systemic reactions including hypersensitivity have been reported at an overall incidence comparable to that of placebo.
Maltese: *Reazzjonijiet sistemiċi inkluż sensittività eċċessiva ġew irrappurtati f'inċidenza globali komparabbli ma' dik ta' plaċebo.
English: Adults and adolescents
Maltese: Fl-adulti,
English: Increased levels of pro-inflammatory cytokines (e.g. IL-6), via interaction with their cognate receptors on hepatocytes, have been shown to suppress the formation of CYP450 enzymes and drug transporters, however, elevation of systemic pro-inflammatory markers in severe refractory eosinophilic asthma is minimal and there is no evidence of IL-5 receptor alpha expression on hepatocytes.
Maltese: Livelli miżjuda ta' ċitokini proinfjammatorji (eż IL-6), permezz tal-interazzjoni mar-riċetturi assoċjati tagħhom fuq l-epatoċiti, kienu murija li jrażżnu l-formazzjoni tal enzimi ta' CYP450 u t-trasportaturi tal-mediċina, madankollu, iż-żieda ta' markers proinfjammatorji sistemiċi f'ażżma esinofilika refrattorja severa hija minima u ma hemm l-ebda evidenza ta' espressjoni alfa tar-riċetturi IL-5 fuq l-epatoċiti.
English: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women.
Maltese: Hemm data limitata (inqas minn 300 riżultat ta' tqala) dwar l-użu ta' mepolizumab f'nisa tqal.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal mediċini.
English: Additional maintenance treatments included long-acting beta2 -adrenergic agonists (LABA), leukotriene modifiers, long-acting muscarinic antagonists (LAMA), theophylline, and oral corticosteroids (OCS).
Maltese: It-trattamenti ta' manteniment addizzjonali kienu jinkludu agonisti beta2-adrenerġiċi li jaħdmu fit-tul (LABA), leukotriene modifiers, antagonisti muskariniċi li jaħdmu fit-tul
English: mg (for a weight < 40kg) or 100 mg (for a weight ≥ 40 kg) was 1.32 and 1.97 times of that observed in adults at 100 mg.
Maltese: L-esponiment wara amministrazzjoni taħt il-ġilda ta' jew 40 mg (għal piż ta' < 40kg) jew 100 mg (għal piż ta' ≥ 40 kg) kien ta' 1.32 u 1.97 darba ta' dak osservat fl-adulti b'100 mg.
English: Administration-related reactions (systemic non allergic)***
Maltese: Reazzjonijiet relatati mal-għoti (sistemiċi mhux allerġiċi)***
English: Mepolizumab is a humanised monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Maltese: Mepolizumab huwa antikorp monoklonali umanizzat prodott fiċ-ċelloli tal-ovarji tal-ħemster Ċiniż b'teknoloġija b'DNA rikombinanti.
English: PARTICULARS TO APPEAR ON OUTER PACKAGING MULTIPACK CARTON (3 PACKS OF 1 VIAL - WITH BLUE BOX)
Maltese: KARTUNA TA' BARRA TAL-PAKKETT MULTIPLU (3 PAKKETTI TA' KUNJETT WIEĦED IMGEŻWRA - B'KAXXA BLU)
English: EU/1/15/1043/005 1 pre-filled syringe EU/1/15/1043/006 3 (3 x 1) pre-filled syringes (multipack)
Maltese: EU/1/15/1043/006 3 (3 x 1) siringi mimljin għal-lest (pakkett multiplu)
English: Thirty-seven adolescents (aged 12-17) were enrolled in four placebo-controlled studies (25 mepolizumab treated intravenously or subcutaneously) of 24 to 52 weeks duration.
Maltese: Sebgħa u tletin adoloxxent (li għandhom bejn 12-17) ġew irreġistrati f'erba' studji kkontrollati bi plaċebo (25 mepolizumab trattat fil-vina jew taħt il-ġilda) li damu 24 sa 52 ġimgħa.
English: Chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours when stored below 30°C.
Maltese: Intweriet stabilità fiżika u kimika tal-prodott mediċinali rikostitwit għal 8 sigħat meta jinħażen taħt 30°C.
English: Mepolizumab pharmacokinetics in adolescent subjects with severe refractory eosinophilic asthma included in the phase 3 studies were consistent with adults (see section 4.2).
Maltese: Il-farmakokinetika ta' mepolizumab f'individwi adolexxenti b'ażżma esinofilika refrattorja severa inklużi fl-istudji tal-fażi 3 kienet konsistenti mal-adulti (ara sezzjoni 4.2).
English: SC
Maltese: SN:
English: In MEA112997, a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of 52 weeks duration in 616 patients with severe refractory eosinophilic asthma, mepolizumab significantly reduced clinically significant asthma exacerbations (defined as worsening of asthma requiring use of oral/systemic corticosteroids and/or hospitalisation and/or emergency department visits) when administered in doses of 75 mg, 250 mg or 750 mg intravenously compared to placebo (see Table 1).
Maltese: F'MEA112997, studju multi-ċentriku randomizzat, double-blind, ta' grupp parallel, ikkontrollat bi plaċebo li dam 52 ġimgħa f'616-il pazjent b'ażżma esinofilika refrattorja severa, mepolizumab naqqas b'mod sinifikanti l-aggravar tal-ażżma klinikament sinifikanti (iddefinit bħala l-aggravar ta' ażżma li jkun jeħtieġ lużu ta' kortikosterojdi orali/sistemiċi u/jew rikoveru l-isptar u/jew żjarat fid-dipartiment tal-emerġenza) meta jingħata f'dożi ta' 75 mg, 250 mg jew 750 mg ġol-vina meta mqabbel ma' plaċebo (ara Tabella 1).
English: Instructions for administration of 40 mg dose 1.
Maltese: Istruzzjonijiet għall-għoti tad-doża ta' 40 mg 1.
English: Multipack: 3 pre-filled syringes (3 packs of 1 pre-filled syringe).
Maltese: Pakkett multiplu: 3 siringi mimlijin għal-lest (3 pakketti ta‘ siringa mimlija għal-lest 1).
English: Following subcutaneous administration of mepolizumab the mean terminal half-life (t1/2) ranged from 16 to 22 days.
Maltese: Wara l-għoti ta' mepolizumab taħt il-ġilda, il-half-life terminali medja (t1/2) varjat minn 16 sa 22 ġurnata).
English: • Check the expiry date on the label of the syringe.
Maltese: • Iċċekkja d-data ta' skadenza fuq it-tikketta tas-siringa.
English: EU/1/15/1043/003 1 pre-filled pen EU/1/15/1043/004 3 (3 x 1) pre-filled pens (multipack)
Maltese: EU/1/15/1043/004 3 (3 x 1) pinen mimljin għal-lest (pakkett multiplu) EU/1/15/1043/005 siringa mimlija għal-lest 1
English: Based on population pharmacokinetic analyses, no dose adjustment is required in patients with creatinine clearance values between 50-80 mL/min.
Maltese: Skont l-analiżi farmakokinetika tal-popolazzjoni, m'hemm bżonn ebda aġġustament tad-doża f'pazjenti b'valuri ta' eliminazzjoni tal-kreatinina ta' bejn 50-80 mL/min.
English: Each vial contains 100 mg mepolizumab (100 mg/ml after reconstitution)
Maltese: Kull kunjett fih 100 mg mepolizumab (100 mg/ml wara r-rikostituzzjoni)
English: The two exacerbations studies MEA112997 and MEA115588 enrolled a total of 1192 patients, 60% females, with a mean age of 49 years (range 12- 82).
Maltese: 1192 pazjent, 60% nisa, b'età medja ta' 49 sena (medda ta' 12-82).
English: Consistent with the potentially immunogenic properties of protein and peptide therapeutics, patients may develop antibodies to mepolizumab following treatment.
Maltese: B'mod konsistenti mal-karatteristiċi potenzjalment immunoloġiċi tal-proteini u tat-terapewtiċi peptide, ilpazjenti jistgħu jiżviluppaw antikorpi għal mepolizumab wara t-trattament.
English: Mepolizumab, the active substance in Nucala, blocks a protein called interleukin-5.
Maltese: Mepolizumab, is-sustanza attiva f'Nucala, timblokka proteina li tissejjaħ interleukin 5.
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of mepolizumab.
Maltese: L-enzimi ta' Cytochrome P450, il-pompi tal-effluss u l-mekkaniżmi ta' twaħħil tal-proteina mhumiex involuti fl-eliminazzjoni ta' mepolizumab.
English: Instructions for administration of 100 mg dose 1.
Maltese: Istruzzjonijiet għall-għoti tad-doża ta' 100 mg 1.
English: Single doses of up to 1,500 mg were administered intravenously in a clinical trial to patients with eosinophilic disease without evidence of dose-related toxicities.
Maltese: Dożi singoli sa massimu ta' 1,500 mg ġew amministrati ġol-vina fi prova klinika lil pazjenti b'marda esinofilika mingħajr evidenza ta' tossiċitajiet relatati mad-doża.
English: Paediatric pharmacokinetics were broadly consistent with adults and adolescents after accounting for bodyweight and bioavailability.
Maltese: Il-farmakokinetika pedjatrika kienet ġeneralment konsistenti mal-adulti u l-adoloxxenti wara li ġew ikkunsidrati il-piż tal-ġisem u l-bijodisponibilità.
English: In patients with asthma the absolute bioavailability of mepolizumab administered subcutaneously in the arm ranged from 74-80%.
Maltese: F'pazjenti bl-ażżma, il bijodisponibilità assoluta ta' mepolizumab mogħti taħt il-ġilda fid-driegħ varjat minn 74-80%.
English: Parasitic infections
Maltese: Infezzjonijiet parassitiċi
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Subcutaneous use.
Maltese: mepolizumab.
English: The table below presents the adverse reactions from the two placebo-controlled studies in patients receiving mepolizumab 100 mg subcutaneously (n=263).
Maltese: It-tabella hawn taħt tippreżenta r-reazzjonijiet avversi miż-żewġ studji kkontrollati bi plaċebo f'pazjenti li kienu qed jirċievu mepolizumab 100 mg taħt il-ġilda (n=263).
English: Children aged 6 to 11 years old
Maltese: Tfal li għandhom bejn 6 sa 11-il sena
English: There are limited pharmacokinetic data available in elderly patients (≥65 years old) across all clinical studies
Maltese: Hemm tagħrif farmakokinetiku limitat disponibbli f'pazjenti anzjani (≥65 sena) fl-istudji kliniċi kollha
English: In adults, adolescents and children, this magnitude of reduction was observed within 4 weeks of treatment.
Maltese: Fl-adulti, adoloxxenti u tfal, dan id-daqs ta' tnaqqis ġie osservat fi żmien 4 ġimgħat ta' trattament.
English: Patients were required to have a history of two or more severe asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months and reduced lung function at baseline (pre-bronchodilator FEV1<80% in adults and <90% in adolescents).
Maltese: 12-il xahar u tnaqqis fil-funzjoni tal-pulmuni fil-linja bażi (FEV1 ta' qabel il-bronkodilatur ta' <80 % fl-adulti u ta' <90 % fl-adolexxenti).
English: Mepolizumab inhibits the bioactivity of IL-5 with nanomolar potency by blocking the binding of IL-5 to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface, thereby inhibiting IL-5 signalling and reducing the production and survival of eosinophils.
Maltese: Mepolizumab jinibixxi lbijoattività ta' IL-5 b'potenza nanomolari billi jimblokka l-għaqid tal-IL-5 mal-katina tal-alfa tal-kumpless tar-riċettur IL-5 espress fuq il-wiċċ taċ-ċellula esinofilika, b'hekk jinibixxi s-senjalazzjoni ta' IL-5 u jnaqqas il-produzzjoni u s-sopravvivenza tal-esinofili..
English: The posology of Nucala in children and adolescents aged between 6 to 17 years old with severe refractory eosinophilic asthma has been determined by limited efficacy, pharmacokinetic and pharmacodynamic studies and supported by modelling and simulation data (see sections 5.1 and 5.2).
Maltese: Il-pożoloġija ta' Nucala fi tfal u adoloxxenti li għandhom bejn 6 u 17-il sena b'ażżma esinofilika refrattorja severa ġiet stabbilita b'effikaċja limitata, studji farmakokinetiċi u farmakodinamiċi u appoġġjata minn data ta' mudellar u simulazzjoni (ara sezzjonijiet 5.1 u 5
English: Just prior to administration, remove 0.4mL of reconstituted Nucala.
Maltese: Eżatt qabel jingħata, neħħi 0.4 mL Nucala rikostitwit.
English: Nucala contains the active substance mepolizumab, a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body.
Maltese: Nucala fih is-sustanza attiva mepolizumab, antikorp monoklonali, tip ta' proteina ddisinjata biex tagħraf sustanza fil-mira speċifika fil-ġisem.
English: • If you do not hear the 2nd “click”:
Maltese: • Jekk ma tismax it-2ni “klikk”:
English: The primary endpoint was the percent reduction in daily OCS dose (weeks 20-24), whilst maintaining asthma control by defined dose reduction categories (see Table 4).
Maltese: Il-punt ta' tmiem primarju kien it-tnaqqis perċentwali fid-doża OCS ta' kuljum (ġimgħa 20-24), filwaqt li nżamm il-kontroll tal-ażżma b'kategoriji ta' tnaqqis tad-doża definite (ara Tabella 3).
English: Do not use Nucala after the expiry date which is stated on the label and carton after EXP.
Maltese: Tużax Nucala wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara EXP.
English: Animal studies showed no adverse effects of anti-IL5 treatment on fertility (see section 5.3).
Maltese: IL5 fuq il-fertilità (ara sezzjoni 5.3).
English: Mepolizumab is a humanized IgG1 monoclonal antibody degraded by proteolytic enzymes which are widely distributed in the body and not restricted to hepatic tissue.
Maltese: Mepolizumab hu antikorp monkolonali umanizzat IgC1 degradat b'enżimi proteolitiċi li huma distribwiti b'mod wiesa' fil-ġisem u mhux restritti għat-tessut epatiku.
English: In children aged 6 to 11 years old with severe refractory eosinophilic asthma administered mepolizumab subcutaneously every 4 weeks for 52 weeks, blood eosinophils were reduced from a geometric mean count at baseline to week 52 of 306 (n=16) to 48 (n=15) following 40 mg (for a weight < 40kg) and 331 to
Maltese: Fi tfal li għandhom bejn 6 u 11-il sena b'ażżma esinofilika refrattorja mogħtija mepolizumab taħt il-ġilda kull 4 ġimgħat għal 52 ġimgħa, l-esinofili tad-demm tnaqqsu minn medja ġeometrika f'linja bażi għall ġimgħa 52 ta' 306 (n=16) għal 48 (n=15) wara 40 mg (għal piż ta' < 40kg) u 331 għal 44 ċellola/µL (n=10) wara 100 mg (għal piż ta' ≥ 40 kg), tnaqqis minn linja bażi ta' 85% u 87% rispettivament.
English: Stopper
Maltese: Tqala
English: The efficacy of mepolizumab in the treatment of a targeted group of patients with severe refractory eosinophilic asthma was evaluated in 3 randomised, double-blind, parallel-group clinical studies of between 24-52 weeks duration, in patients aged 12 years and older.
Maltese: L-effikaċja ta' mepolizumab fit-trattament ta' grupp ta' pazjenti fil-mira b'ażżma esinofilika refrattorja severa ġiet evalwata fi 3 studji kliniċi randomizzati, double-blind, ta' grupp parallel li damu 24-52 ġimgħa, f'pazjenti ta' 12-il sena jew iktar.
English: The most common manifestations reported with these events included pain, erythema, swelling, itching, and burning sensation.
Maltese: Il-manifestazzjonijiet l-aktar komuni rrapportati b'dawn l avvenimenti kienu jinkludu uġigħ, nefħa, ħakk, u sensazzjoni ta' ħruq.
English: In the placebo-controlled trials, 15/260 (6%) of adults and adolescents treated with 100 mg dose subcutaneously had detectable anti-mepolizumab antibodies after having received at least one dose of mepolizumab.
Maltese: Fil-provi kliniċi kkontrollati bi plaċebo, 15/260 (6%) tal-adulti u adoloxxenti trattati bid-doża ta' 100 mg taħt il-ġilda kellhom antikorpi antimepolizumab li setgħu jinstabu wara li rċevew tal-inqas doża waħda ta' mepolizumab.
English: Table 2 provides the results of the primary and secondary endpoints for patients treated with subcutaneous mepolizumab or placebo.
Maltese: It-Tabella 2 tipprovdi r-riżultati tal-punti ta' tmiem primarji u sekondarji għal pazjenti trattati b'mepolizumab taħt il-ġilda jew plaċebo.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeated dose toxicity studies in monkeys.
Maltese: Data mhux klinika turi li m'hemm ebda perikli speċjali għall-umani skont studji konvenzjonali tal farmakoloġija tas-sigurtà jew studji dwar it-tossiċità minn dożi ripetuti fix-xadini.
English: Intravenous Mepolizumab
Maltese: Mepolizumab vs. plaċebo
English: The potential for harm to a human fetus is unknown.
Maltese: Id-dannu potenzjali għall-fetu mhux magħruf.
English: IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation and survival of eosinophils.
Maltese: IL-5 hija ċ-ċitokina ewlenija responsabbli għat-tkabbir u d differenzjazzjoni, ir-reklutaġġ, l-attivazzjoni u s-sopravivenza tal-esinofili.
English: GlaxoSmithKline LLC 893 River Road Conshohocken, PA 19428
Maltese: 893 River Road
English: However, in the population pharmacokinetic analysis, there were no indications of an effect of age on the pharmacokinetics of mepolizumab over the age range of 12 to 82 years.
Maltese: Madankollu, fl-analiżi farmakokinetika tal-popolazzjoni, ma kien hemm l-ebda indikazzjoni ta' effett tal-età fuq il-farmakokinetika ta' mepolizumab tul il-medda ta' etajiet ta' 12 sa 82 sena.
English: Intravenous mepolizumab pharmacokinetics was evaluated by population pharmacokinetic analysis in a paediatric study conducted in subjects aged 2-17 years old with eosinophilic esophagitis.
Maltese: Il-farmakokinetika ta' mepolizumab fil-vina kienet evalwata b'analiżi farmakokinetika tal-popolazzjoni fi studju pedjatriku li sar f'individwi li kellhom bejn 217-il sena b'esofaġite esinofilika.
English: Excipients: Sucrose, sodium phosphate dibasic heptahydrate and polysorbate 80
Maltese: Sucrose, sodium phosphate dibasic heptahydrate u polysorbate 80
English: • Remove the clear needle cap from the pen by firmly pulling it straight off.
Maltese: • Iċċekkja d-data ta' skadenza fuq it-tikketta tal-pinna.
English: Multipack comprising 3 (3 packs of 1) vials
Maltese: Pakkett multiplu: 3 (3 pakketti ta' 1) kunjett(i)
English: • injection-site reaction (pain, redness, swelling, itching, and burning sensation of the skin near where the injection was given)
Maltese: • reazzjoni fis-sit tal-injezzjoni (uġigħ, ħmura, nefħa, ħakk u sensazzjoni ta' ħruq fuq il-ġilda fejn ingħatat l-injezzjoni)
English: Start your injection
Maltese: Infezzjonijiet u infestazzjonijiet
English: Rate ratio (95% CI) p-value
Maltese: Proporzjon tar-rata (95% CI) valur-p
English: Headache
Maltese: tnaqqis
English: Summary of the safety profile
Maltese: Sommarju tal-profil tas-sigurtà Adulti u adoloxxenti
English: 1 ml solution in a Type 1 glass syringe with a fixed needle (stainless steel) and passive safety needle guard.
Maltese: 1 mL soluzzjoni f'siringa tal-ħġieġ tat-Tip I b'labra mwaħħla (azzar inossidabbli) u protezzjoni tal-labra tassigurtà passiva.
English: If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Maltese: Jekk ilpazjenti jiġu infettati waqt li jkunu qed jirċievu t-trattament b'Nucala u ma jirrispondux għat-trattament kontra d-dud (helminth), għandu jiġi kkunsidrat li t-terapija titwaqqaf temporanjament.
English: GlaxoSmithKline Trading Services Ltd. Currabinny
Maltese: GlaxoSmithKline Trading Services Ltd.
English: Following subcutaneous dosing in patients with asthma, mepolizumab exhibited approximately doseproportional pharmacokinetics over a dose range of 12.5 mg to 250 mg.
Maltese: Wara d-dożaġġ taħt il-ġilda f'pazjenti bl-ażżma, mepolizumab wera farmakokinetika proporzjonali mad-doża bejn wieħed u ieħor fuq medda ta' doża ta' 12.5 mg sa 250 mg.
English: Studies conducted in mice treated with anti-IL-5 antibodies or genetically deficient in IL-5 or eosinophils have not shown impaired ability to clear parasitic infections.
Maltese: Studji li saru fil-ġrieden trattati b'antikorpi anti-IL-5 jew ġenetikament defiċjenti fl-IL-5 jew fl esinofili ma urewx indeboliment fl-abilità biex jitneħħew infezzjonijiet parassitiċi.
English: The solution for injection can be stored between 2°C to 30°C for no more than 8 hours.
Maltese: Is-soluzzjoni għal injezzjoni tista' tinħażen f'bejn 2°C sa 30°C għal mhux iktar minn 8 sigħat.
English: • Do not use the syringe if dropped onto a hard surface.
Maltese: • Tinkwetax jekk tara qatra ta' likwidu fit-tarf tal-labra.
English: Check the expiry date
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: The safety profile of mepolizumab in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies.
Maltese: Il-profil tas-sigurtà ta' mepolizumab f'pazjenti b'ażżma esinofilika refrattorja severa (n=998) ittrattati għal medjan ta' 2.8 snin (medda 4 ġimgħat sa 4.5 snin) fi studji ta' estensjoni miftuħa kien simili għal dak li ġie osservat fl-istudji kkontrollati bi plaċebo.
English: MEA115575 evaluated the effect of mepolizumab 100 mg administered subcutaneously on reducing the requirement for maintenance oral corticosteroids (OCS) while maintaining asthma control in subjects with severe refractory eosinophilic asthma.
Maltese: MEA115575 evalwa l-effett ta' mepolizumab 100 mg mogħti taħt il-ġilda biex inaqqas ir-rekwiżit għallkortikosterojdi orali ta' manteniment (OCS) waqt li jinżamm il-kontroll tal-ażżma f'individwi b'ażżma esinofilika refrattorja severa.