FrancophonIA/ELRC3.0 huggingface dataset:
English: Examination of surrogate fertility parameters (including organ weights and histopathology of reproductive tissues) in animals treated with benralizumab suggested no impairment of fertility.
Maltese: Eżaminazzjoni ta' parametri tal-fertilità tas-surrogat (inkluż il-piżijiet tal-organi u l-istopatoloġija tat-tessuti riproduttivi) f'annimali kkurati b'benralizumab ma ssuġġeriet l-ebda indeboliment tal-fertilità.
English: The recommended dose is an injection of 30 mg.
Maltese: Id-doża rakkomandata hija injezzjoni ta' 30 mg.
English: In a randomized, double-blind parallel-group study of 103 patients aged between 12 and 21 years with severe asthma, the humoral antibody responses induced by seasonal influenza virus vaccination do not appear to be affected by benralizumab treatment.
Maltese: Fi studju randomized, double-blind ta' grupp parallel ta' 103 pazjenti ta' bejn 12 u 21 sena b'ażma severa, ir-risponsi għall-antikorp umorali indotti mit-tilqima tal-virus tal-influwenza staġjonali ma jidhrux li jiġu affettwati minn kura b'benralizumab.
English: You will hear a second ‘click'.
Maltese: Ser tisma' t-tieni “klikk”.
English: PRE-FILLED SYRINGE LABEL
Maltese: Protezzjoni tal-Labra
English: Store Fasenra in a refrigerator between 2°C to 8°C in its carton until you are ready to use it. Fasenra may be kept at room temperature up to 25
Maltese: Aħżen Fasenra fi friġġ bejn 2°C sa 8°C fil-kartuna tiegħu sakemm tkun lest biex tużah. Fasenra jista' jinżamm f'temperatura ambjentali sa 25°C għal massimu ta' 14-il jum.
English: Other medicines and Fasenra
Maltese: Mediċini oħra u Fasenra
English: Placebo (n a=248)
Maltese: Plaċebo (n a=248)
English: An effect of benralizumab on the pharmacokinetics of co-administered medicinal products is not expected.
Maltese: Mhuwiex mistenni effett ta' benralizumab fuq il-farmakokinetika ta' prodotti mediċinali mogħtija flimkien.
English: Currently available data in children 12 to less than 18 years old are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Data attwalment disponibbli fi tfal li għandhom minn 12 sa inqas minn 18-il sena hi deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2, imma ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: It binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and specificity.
Maltese: Dan jingħaqad mas-sottounità alfa tar-riċettur tal-interlukin-5 tal-bniedem (IL-5Rα) b'affinità u speċifiċità għolja.
English: Place the needle guard of the Fasenra Pen flat against your skin (90-degree angle).
Maltese: Poġġi l-protezzjoni tal-labra tal-Fasenra Pen ċatta mal-ġilda tiegħek (angolu ta' 90 grad).
English: The effect of benralizumab on eosinophils in the airway mucosa in asthmatic patients with elevated sputum eosinophil counts (at least 2.5%) was evaluated in a 12-week, phase 1, randomised, doubleblind, placebo-controlled clinical study with benralizumab 100 or 200 mg SC.
Maltese: L-effett ta' benralizumab fuq l-eosinofili fil-mukoża tal-pajp tan-nifs f'pazjenti ażmatiċi b'għadd ta' eosinofili ta' sputum elevat (mill-inqas 2.5 %) ġie evalwat fi studju kliniku ta' 12-il ġimgħa, ta' fażi 1, randomizzat, double-blind, u kkontrollat bi plaċebo b'benralizumab ta' 100 jew 200 mg SC.
English: Trial 1 & 2
Maltese: Prova 1 u 2
English: Improvement from baseline Difference (95% CI) p-value
Maltese: Titjib mil-linja bażi Differenza (95 % CI) valur-p
English: Fasenra is a medicine containing the active substance benralizumab, which is a monoclonal antibody, a type of protein that recognises and attaches to a specific target substance in the body.
Maltese: Fasenra huwa mediċina li fiha s-sustanza attiva benralizumab, li huwa antikorp monoklonali, tip ta' proteina li tagħraf u teħel ma' sustanza fil-mira speċifika fil-ġisem.
English: PC: SN: NN:
Maltese: M'għandekx:
English: From population pharmacokinetic analysis, benralizumab exhibited linear pharmacokinetics and no evidence of target receptor-mediated clearance pathway.
Maltese: Mill-analiżi farmakokinetika tal-popolazzjoni, benralizumab wera farmakokinetika lineari u l-ebda evidenza ta' passaġġ ta' eliminazzjoni medjata tar-riċettur fil-mira.
English: Open the carton.
Maltese: Iftaħ il-kartuna.
English: There are limited data available in subjects with creatinine clearance values less than 30 mL/min; however, benralizumab is not cleared renally.
Maltese: Hemm data limitata disponibbli f'indivdiwi b'valur ta' tneħħija tal-kreatinina inqas minn 30 mL/min; madankollu, benralizumab ma jitneħħiex mill-kliewi.
English: Placebo (n a=267)
Maltese: Plaċebo (n a=267)
English: The syringe may be kept at room temperature up to 25°C for a maximum of 14 days.
Maltese: Is-siringa tista' tinżamm f'temperatura ambjentali sa 25°C għal massimu ta' 14-il jum.
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 talfarmakoloġija tas-sigurtà jew studji dwar it-tossiċità minn dożi ripetuti fix-xadini.
English: The overall adverse event profile was similar to the asthma trials described above.
Maltese: Il-profil tal-avvenimenti avversi globali kien simili għall-provi tal-ażma deskritti hawn taħt.
English: Placebo (N=267)
Maltese: Plaċebo (N=267)
English: Placebo (N=248)
Maltese: Plaċebo (N=248)
English: The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils.
Maltese: Ir-riċettur IL-5 huwa espress speċifikament fuq is-superfiċje tal-eosinofilji u lbażofilji.
English: Alcohol wipe
Maltese: Wajp tal-alkoħol
English: Paediatric population The safety and efficacy of Fasenra in children aged 6 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Fasenra fit-tfal minn età ta' 6 snin sa 18-il sena ma ġewx determinati s'issa.
English: Median percent reductions in daily OCS over time (Trial 3 and 4)
Maltese: Tnaqqis perċentwali medjan fl-OCS ta' kuljum maż-żmien (Prova 3 u 4)
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of benralizumab.
Maltese: L-enzimi taċ-ċitokromu P450, il-pompi tal-effluss u mekkaniżmi tat-twaħħil tal-proteini mhumiex involuti fit-tneħħija ta' benralizumab.
English: The rate of exacerbations requiring hospitalisation and/or emergency room visits for patients receiving Fasenra compared to placebo for Trial 1 were 0.09 versus 0.25 (rate ratio 0.37, 95% CI: 0.20, 0.67, p=<0.001) and for Trial 2 were 0.12 versus 0.10 (rate ratio 1.23, 95% CI: 0.64, 2.35, p=0.538).
Maltese: 12 kontra 0.10 (proporzjon tar-rata 1.23, 95 % CI: 0.64, 2.35, p=0.538).
English: Of these, 46 received placebo, 40 received Fasenra every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received Fasenra every 4 weeks.
Maltese: Minn dawn, 46 irċevew plaċebo, 40 irċevew Fasenra kull 4 ġimgħat għal 3 dożi, segwiti minn kull 8 ġimgħat minn hemm 'il quddiem, u 22 rċevew Fasenra kull 4 ġimgħat.
English: One mL solution in a single-use pre-filled syringe made from type I glass with a staked 29-gauge ½-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated plunger stopper in a passive safety device.
Maltese: Soluzzjoni waħda ta' mL f'siringa mimlija għal-lest li tintuża darba biss magħmula minn ħġieġ ta' tip I b'labra tal-azzar inossidabbli ta' gejġ 29 ta' nofs pulzier (12.7 mm) imwaħħla magħha, protezzjoni tallabra riġida, u tapp planġer miksi bil-Fluorotec f'apparat ta' sigurtà passiva.
English: Pre-bronchodilator FEV1 (L) Mean baseline
Maltese: FEV1 ta' qabel il-bronkodilatur(L)
English: Paediatric
Maltese: FARMAĊEWTIKU
English: Step 8 - Check the viewing window
Maltese: Pass 8 - Iċċekkja t-tieqa ta' spezzjoni
English: Based on population pharmacokinetic analysis, baseline hepatic function biomarkers (ALT, AST, and bilirubin) had no clinically relevant effect on benralizumab clearance.
Maltese: Abbażi talanaliżi farmakokinetika tal-popolazzjoni, il-bijomarkaturi tal-funzjoni tal-fwied fil-linja bażi (ALT, AST, u bilirubina) ma kellhom l-ebda effett klinikament rilevanti fuq it-tneħħija ta' benralizumab.
English: OTHER
Maltese: Ħalli
English: No formal clinical studies have been conducted to investigate the effect of hepatic impairment on benralizumab.
Maltese: Ma sar l-ebda studju kliniku formali biex jiġi investigat l-effett tal-indeboliment tal-kliewi fuq benralizumab.
English: Patients with known helminth infections were excluded from participation in clinical trials.
Maltese: Il-pazjenti b'infezzjonijiet minn xi dud (helminth) magħrufa ġew esklużi millparteċipazzjoni fil-provi kliniċi.
English: Intent to treat population (patients on high-dose ICS and blood eosinophils ≥300 cells/μl).
Maltese: Popolazzjoni bl-iskop li tiġi kkurata (pazjenti fuq doża għolja ta' ICS u eosinofili fid-demm ≥300/ċelloli/μl).
English: The most commonly reported adverse reactions during treatment are headache (8%) and pharyngitis (3%).
Maltese: L-iktar reazzjonijiet avversi rrapportati b'mod komuni waqt il-kura kienu uġigħ ta' ras (8 %) u farinġite (3 %).
English: Wilcoxon rank sum test (primary analysis method) Median % reduction in daily OCS dose from baseline (95% CI) 75 (60, 88) Wilcoxon rank sum test p-value
Maltese: Test tat-total tal-livell ta' Wilcoxon (metodu ta' analiżi primarja) % Medjan ta' tnaqqis fid-doża OCS ta' kuljum mil-linja bażi (95 % CI) valur-p tat-test tas-somma tal-livell ta' Wilcoxon Mudell ta'odds proporzjonali (analiżi ta' sensittività) Tnaqqis perċentwali f'OCS mil-linja bażi fil-Ġimgħa 28 tnaqqis ta' ≥90 % tnaqqis ta' ≥75 % tnaqqis ta' ≥50 % tnaqqis ta' >0 %
English: AUTHORISATION
Maltese: Κύπρος
English: Eosinophils are white blood cells involved in asthma inflammation.
Maltese: L-eosinofili huma ċelloli bojod involuti fl-infjammazzjoni.
English: Anti-benralizumab antibodies were associated with increased clearance of benralizumab and increased blood eosinophil levels in patients with high anti-drug antibody titres compared to antibody negative patients; in rare cases, blood eosinophil levels returned to pre-treatment levels.
Maltese: L-antikorpi anti-benralizumab kienu assoċjati ma' żieda fit-tneħħija ta' benralizumab u żieda fil-livelli ta' eosinofili fid-demm f'pazjenti b'titri għoljin ta' antikorpi kontra l-mediċina meta mqabbla ma' pazjenti b'antikorpi negattivi; f'każijiet rari, il-livelli tal-eosinofili fiddemm reġgħu lura għal-livelli ta' qabel il-kura.
English: Based on population pharmacokinetic analysis, the estimated absolute bioavailability was approximately 59% and there was no clinically relevant difference in relative bioavailability in the administration to the abdomen, thigh, or upper arm.
Maltese: Abbażi talanaliżi tal-popolazzjoni farmakokinetika, il-bijodisponibiltà assoluta stmata kienet madwar 59 % u ma kien hemm l-ebda differenza klinikament rilevanti fil-bijodisponibiltà relattiva fl-għoti fiż-żaqq, filkoxxa, jew fin-naħa ta' fuq tad-driegħ.
English: Blood eosinophil count <300 cells/μL
Maltese: Għadd eosinofiliku taddemm <300 ċelloli/μLb n =131
English: Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see section 5.1).
Maltese: Fasenra huwa indikat bħala kura ta' manteniment addizzjonali f'pazjenti adulti b'ażma eosinofilika severa mhux ikkontrollata b'mod adegwat minkejja l-kortikosterojdi li jittieħdu man-nifs b'doża għolja flimkien ma' agonisti β li jaġixxu fit-tul (ara sezzjoni 5.1).
English: Tel: +46 8 553 26 000
Maltese: AstraZeneca AB Tel: +46 8 553 26 000
English: Position the Fasenra Pen at the injection site.
Maltese: Ippożizzjona l-Fasenra Pen fis-sit tal-injezzjoni.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: Needle guard activation clips
Maltese: Klipep ta' attivazzjoni talprotezzjoni tallabra
English: Syringe body
Maltese: Bidla medja
English: It is unknown if Fasenra may influence a patient's response against helminth infections.
Maltese: Mhuwiex magħruf jekk Fasenra jistax jinfluwenza r-rispons talpazjent kontra infezzjonijiet minn xi dud (helminth).
English: Blood eosinophil count ≥300 cells/μL
Maltese: Għadd eosinofiliku taddemm ≥300 ċelloli/μLa n = 267
English: Fasenra is available in a pack containing 1 pre-filled syringe.
Maltese: Fasenra huwa disponibbli f'pakkett li fih siringa 1 mimlija għallest.
English: Effect of Fasenra on OCS dose reduction, Trial 3
Maltese: Effett ta' Fasenra fuq tnaqqis fid-doża OCS, Prova 3
English: Based on population pharmacokinetic analysis, benralizumab clearance was comparable in subjects with creatinine clearance values between 30 and 80 mL/min and patients with normal renal function.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, it-tneħħija ta' benralizumab kienet komparabbli f'individwi b'valuri ta' tneħħija tal-kreatinina bejn 30 u 80 mL/min u pazjenti f''funzjoni tal-kliewi normali.
English: Label with expiry date
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Exacerbation rate and pulmonary function (FEV1) at end of treatment by number of exacerbations in the previous year - Patients on high-dose ICS and blood eosinophils ≥300 cells/μL
Maltese: Rata ta' taħrix u funzjoni pulmonari (FEV1) fi tmiem il-kura skont in-numru ta' taħrix fis-sena preċedenti - Pazjenti fuq doża għolja ta' ICS u eosinofili tad-demm ≥300 ċellola/μL
English: Step 1 - Gather Supplies
Maltese: Pass 1 - Iġbor il-Provvisti
English: Week(s)
Maltese: MANIFATTUR(I)
English: The Fasenra Pen may be kept at room temperature up to 25°C for a maximum of 14 days.
Maltese: Il-Fasenra Pen tista' tinżamm f'temperatura ambjentali sa 25 C għal massimu ta' 14-il jum.
English: Mean baseline (SD) Change from baseline (SD)
Maltese: Linja bażi medja (SD) Bidlal mil-linja bażi (SD)
English: Not powered to detect a treatment difference in patients with blood eosinophils <300 cells/μl.
Maltese: Mhux fornut biex jidentifika differenza fil-kura f'pazjenti b'eosinofili fid-demm <300 ċelloli/μl.
English: Maintenance of the reduction in daily OCS dose was also observed over the extension trial in patients enrolled from Trial 3 (Figure 1).
Maltese: Il-manteniment tat-tnaqqis fid-doża ta' kuljum ta' OCS ġie osservat ukoll matul il-prova ta' estensjoni f'pazjenti rreġistrati minn Prova 3 (Figura 1).
English: Step 3 - Check the liquid
Maltese: Pass 3 - Iċċekkja l-likwidu
English: After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary.
Maltese: Wara taħriġ xieraq fit-teknika tal-injezzjoni taħt il-ġilda u edukazzjoni dwar is-sinjali u s-sintomi ta' reazzjonijiet ta' sensittività eċċessiva (ara sezzjoni 4.4), il-pazjenti bl-ebda storja magħrufa ta' anafilassi jew il-persuni li jieħdu ħsiebhom jistgħu jagħtu Fasenra jekk it-tabib tagħhom jiddetermina li dawn huwa xieraq, b'segwitu mediku kif meħtieġ.
English: Oral corticosteroid dose reduction trial
Maltese: Taħrix klinikament sinifikanti Rata
English: Total asthma symptom score Mean baseline
Maltese: Punteġġ totali tas-sintomi tal-ażma Linja bażi medja
English: Tel: +421 2 5737 7777
Maltese: AstraZeneca AB, o.z. Tel: +421 2 5737 7777
English: • injection site reaction (for example pain, redness, itching, swelling near where the injection was given)
Maltese: • reazzjonijiet fis-sit tal-injezzjoni (pereżempju uġigħ, ħmura, ħakk, nefħa fejn tkun ingħatat linjezzjoni)
English: In a 56-week extension trial in patients with asthma from Trials 1, 2 and 3, 842 patients were treated with Fasenra at the recommended dose and remained in the trial.
Maltese: Fi prova ta' estensjoni ta' 56 ġimgħa f'pazjenti bl-ażma minn Provi 1, 2 u 3, 842 pazjent ġew ikkurati b'Fasenra bid-doża rakkomandata u baqgħu fil-prova.
English: However, no data are available in patients over 75 years of age.
Maltese: Madankollu, m'hemm l-ebda data disponibbli f'pazjenti ta' 'l fuq mill-età ta' 75 sena.
English: For patients on maintenance oral corticosteroids, this was defined as a temporary increase in stable oral/systemic corticosteroids for at least 3 days or a single depo-injectable dose of corticosteroids.
Maltese: Għal pazjenti fuq kortikosterojdi orali ta' manteniment, dan ġie definit bħala żieda temporanja fil-kortikosterojdi orali/sistemiċi stabbli għal mill-inqas 3 ijiem jew doża waħda depo-injetabbli ta' kortikosterojdi.
English: Efficacy in Trial 4 was also evaluated in patients with baseline blood eosinophil counts <300 cells/µl and was consistent with Trials 1 and 2.
Maltese: L-effikaċja fi Prova 4 ġiet evalwata wkoll f'pazjenti b'għadd ta' eosinfili fid-demm fil-linja bażi <300 ċellula/µl u kien konsistenti mal-Provi 1 u 2.
English: Look out for signs of serious allergic reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: Monoclonal antibodies, such as benralizumab, are transported across the placenta linearly as pregnancy progresses; therefore, potential exposure to a fetus is likely to be greater during the second and third trimester of pregnancy.
Maltese: L-antikorpi monoklonali, bħal benralizumab, jiġu ttrasportati tul il-plaċenta b'mod lineari hekk kif ittqala tavvanza; għalhekk, l-esponiment potenzjali għall-fetu x'aktarx li jkun akbar waqt it-tieni u tielet trimestru tat-tqala.
English: • the expiry date (EXP) has passed
Maltese: • għaddiet id-data ta' skadenza (JIS)
English: Clinically significant exacerbations Rate
Maltese: GĦAMLA KWALITATTIVA
English: e. Baseline is prior to Fasenra treatment in Trial 1 and 2.
Maltese: Linja bażi hija qabel kura b'Fasenra fi Prova 1 u 2.
English: Effect on blood eosinophils
Maltese: Parti ewlenija tas-siringa
English: This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which reduces eosinophilic inflammation.
Maltese: Dan iwassal għall-apoptożi tal-eosinofili u l-bażofili permezz ta' ċitotossiċità medjata miċ-ċellola dipendenti fuq lantikorp (ADCC, antibody-dependent cell-mediated cytotoxicity) imsaħħa, li jnaqqas l-infjammazzjoni eosinofilika.
English: How to store Fasenra Pen
Maltese: X'fiha Fasenra Pen
English: Hepatic impairment
Maltese: Planġer aħdar
English: The pharmacokinetics of benralizumab were dose-proportional in patients with asthma following subcutaneous administration over a dose range of 2 to 200 mg. Absorption
Maltese: Il-farmakokinetika ta' benralizumab kienet proporzjonali mad-doża f'pazjenti bl-ażma wara għoti taħt il-ġilda fuq medda ta' doża ta' 2 sa 200 mg.
English: • into the 5 cm area around your belly-button
Maltese: • fil-parti ta' 5 cm madwar iż-żokra tiegħek
English: Prior to administration, warm Fasenra by leaving carton at room temperature.
Maltese: Qabel l-għoti, saħħan Fasenra billi tħalli l-kartuna f'temperatura ambjentali.
English: In both Trials 1 and 2, patients receiving Fasenra experienced statistically significant reductions in asthma symptoms (Total Asthma Score) compared to patients receiving placebo.
Maltese: Kemm fi Prova 1 kif ukoll fi Prova 2, il-pazjenti li kienu qed jirċievu Fasenra esperjenzaw tnaqqis statistikament sinifikanti fis-sintomi tal-ażma (Punteġġ Totali tal-Ażma) meta mqabbla mal-pazjenti li kienu qed jirċievu l-plaċebo.
English: Pre-filled syringe Each pre-filled syringe contains 30 mg benralizumab* in 1 mL.
Maltese: Siringa waħda mimlija għal lest fih 30 g benralizumab f'1 mL.
English: Infections & infestations
Maltese: Infezzjonijiet u infestazzjonijiet Farinġite*
English: Fasenra is available in a pack containing 1 pre-filled pen.
Maltese: Fasenra huwa disponibbli f'pakkett li fih pinna 1 mimlija għal-lest.
English: Common Not known
Maltese: L-Istati Uniti
English: Benralizumab is a humanised IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue.
Maltese: Benralizumab hu antikorp monkolonali umanizzat IgC1 li huwa degradat b'enżimi proteolitiċi li huma distribwiti b'mod wiesa' fil-ġisem u mhux ristretti għat-tessut epatiku.
English: Pre-filled pen Each pre-filled pen contains 30 mg benralizumab* in 1 mL.
Maltese: Pinna waħda mimlija għal lest fiha 30 g benralizumab f'1 mL.
English: If patients become infected, while receiving treatment with Fasenra and do not respond to anti-helminth treatment, treatment with Fasenra should be discontinued until infection resolves.
Maltese: Jekk il-pazjenti jiġu infettati, waqt li jkunu qed jirċievu l-kura bi Fasenra u ma jirrispondux għall-kura kontra d-dud (helminth), il-kura bi Fasenra għandha titwaqqaf sakemm tirrisolvi l-infezzjoni.
English: Step 9 - Dispose the used pre-filled syringe
Maltese: Pass 9 - Iċċekkja s-sit tal-injezzjoni
English: Overall, treatment-emergent anti-drug antibody response developed in 107 out of 809 (13%) patients treated with Fasenra at the recommended dosing regimen during the 48 to 56 week treatment period of the phase 3 placebo controlled exacerbation trials.
Maltese: B'mod ġenerali, ir-rispons tal-antikorpi kontra l-mediċina li ħareġ mill-kura żviluppa f'107 minn 809 (13 %) pazjenti li ngħataw kura bi Fasenra fir-reġim tad-dożaġġ rakkomandat matul il-perjodu ta' kura li dam bejn 48 u 56 ġimgħa tal-provi ta' taħrix ta' fażi 3 ikkontrollati bil-plaċebo.
English: • 1 cotton ball or gauze
Maltese: • Tajjara jew garża 1
English: Doses of up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic asthma without evidence of dose-related toxicities.
Maltese: Dożi sa massimu ta' 200 mg ingħataw taħt il-ġilda fi provi kliniċi lil pazjenti b'ażma eosinofilika mingħajr evidenza ta' tossiċitajiet relatati mad-doża.
English: Cotton ball or gauze
Maltese: Tmissx il-parti nadifa qabel tinjetta.
English: Fasenra 30 mg solution for injection in pre-filled syringe Fasenra 30 mg solution for injection in pre-filled pen
Maltese: Fasenra 30 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Fasenra 30 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest
English: Hold the Fasenra Pen in place for the entire injection.
Maltese: Żomm il-Fasenra Pen f'postha għall-injezzjoni kollha.
English: Pregnancy
Maltese: Assorbiment
English: d. EOT for Trial 4 was Week 48 (the last timepoint for adults and adolescent data).
Maltese: Analiżi integrata fi Tmiem il-Kura (EOT) ta' Prova 1(Ġimgħa 48) u Prova 2 (Ġimgħa 56). d. EOT għal Prova 4 kien Ġimgħa 48 (l-aħħar punt taż-żmien għal dejta tal-adulti u adolexxenti).
English: In patients who received Fasenra in predecessor Trials 1 and 2, 73% were exacerbation-free in the extension Trial 4.
Maltese: F'pazjenti li rċivew Fasenra fil-Provi 1 u 2 ta' qabel, 73 % kienu mingħajr taħrix fl-estensjoni Prova 4.
English: Pre-filled syringe
Maltese: Reazzjonijiet allerġiċi serji
English: Reduction in the daily OCS dose to 0 mg/day* Odds ratio (95% CI)
Maltese: Rata ta' taħrix li teħtieġ kura fl-isptar/viżta fi swali ta' emerġenza 0.02 Proporzjon tar-rata (95 % CI)
English: • anaphylaxis symptoms usually include: o swelling of your face, tongue, or mouth o breathing problems o fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)
Maltese: • anafilassi is-sintomi normalment jinkludu: o jintnefaħlek wiċċek, ilsienek jew ħalqek o problemi biex tieħu n-nifs o ħass ħażin, sturdament, tħossok qed tistordi (minħabba li titbaxxa l-pressjoni tad-demm)
English: In placebo-controlled studies, injection site reactions (e.g. pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with the recommended benralizumab dose compared with 1.9% in patients treated with placebo.
Maltese: Fi studji kkontrollati bi plaċebo, ir-reazzjonijiet fis-sit tal-injezzjoni (eż. uġigħ, eritema, ħakk, papule) seħħew b'rata ta' 2.2 % f'pazjenti kkurati bid-doża rrakkomandata ta' benralizumab meta mqabbla mal1.