FrancophonIA/ELRC3.0 huggingface dataset:
English: Without treatment of hypothyroidism during pregnancy, there is an increased risk for miscarriage and foetal effects such as mental retardation and dwarfism.
Maltese: Mingħajr kura għall-ipotirojdiżmu waqt it-tqala, hemm żieda fir-riskju għal korriment u effetti fetali bħal ritardament mentali u naniżmu.
English: o Kidney disease (such as anti-GBM disease)
Maltese: o Mard tal-kliewi (bħal marda anti-GBM)
English: If an additional course is administered, safety-follow up should be continued until at least 48 months after the last infusion.
Maltese: Jekk jingħata kors addizzjonali, s-segwitu ta' sigurtà għandu jitkompla sa millinqas 48 xahar wara l-aħħar infużjoni.
English: Premedication, general health, and pregnancy and contraception checks immediately before treatment Infusion instructions (before, during and after) to reduce risk for serious reactions temporally associated with the Lemtrada infusion Monitoring activities during treatment and for at least 48 months after last treatment A specific reference to the fact that the patient has been informed and understands the risks of serious autoimmune disorders, infections and malignancies, and the measures to minimize them The patient guide shall contain the following key messages: A description of the risks associated with the use of LEMTRADA namely: Immune Thrombocytopenic Purpura (ITP) Nephropathies, including anti-Glomerular Basement Membrane (anti-GBM) disease Thyroid disorders Serious infections Other secondary autoimmune or immune system diseases, including HLH, AIH, and acquired haemophilia A. Serious reactions temporally associated with LEMTRADA infusion, including myocardial ischemia, hemorrhagic stroke, cervico-cephalic arterial dissection and pulmonary alveolar haemorrhage .
Maltese: Studju mhux intervenzjonali dwar is-sigurta wara l-awtorizzazzjoni (PASS): sabiex tiġi evalwata l-konformità mal-indikazzjoni terapewtika u l-effettività tal-miżuri biex jitnaqqsu kemm jista' jkun ir-riskji ta' avvenimenti avversi kardjovaskulari u ċerebrovaskulari f'assoċjazzjoni temporali ta' viċin mal-infużjoni b'Lemtrada u r reazzjoni avversi li jinvolvu l-immunità, l-MAH għandu jissottometti r-riżultati ta' studju dwar l-utilizzazzjoni tal-mediċina.
English: Conclusions cannot be made with available data on the effect of race and gender on the pharmacokinetics of alemtuzumab.
Maltese: Ma jistgħux isiru konklużjonijiet bid-dejta disponibbli dwar l-effett tar-razza u s-sess fuq ilfarmakokinetika ta' alemtuzumab.
English: LEMTRADA may cause different types of thyroid disorders, including: Over-active thyroid gland (hyperthyroidism) when the thyroid produces too much hormone Under-active thyroid gland (hypothyroidism) when the thyroid does not produce enough hormone.
Maltese: Glandola tat-tirojde attiva żżejjed (ipertirojdiżmu) meta t-tirojde tipproduċi żżejjed ormoni Glandola tat-tirojde mhux attiva biżżejjed (ipotirojdiżmu) meta t-tirojde ma tipproduċix biżżejjed ormoni.
English: Placental transfer and potential pharmacologic activity of LEMTRADA were observed in mice during gestation and following delivery.
Maltese: It-trasferiment mill-plaċenta u l-attività farmakoloġika potenzjali ta' LEMTRADA ġew osservati filġrieden matul it-tqala u wara l-ħlas.
English: Serious and sometimes fatal autoimmune phenomena including autoimmune haemolytic anaemia, autoimmune thrombocytopenia, aplastic anaemia, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyradiculoneuropathy have been reported in alemtuzumab-treated non-MS patients.
Maltese: Fenomeni awtoimmuni serji u xi kultant fatali li jinkludu anemija emolitika awtoimmuni, tromboċitopenija awtoimmuni, anemija aplastika, is-sindrome ta' Guillain-Barré, u poliradikulonewropatija demijelinanti infjammatorja kronika, ġew irrappurtati f'pazjenti kkurati b'alemtuzumab li ma kellhomx MS.
English: Patients who developed anti-alemtuzumab antibodies did so by 15 months from initial exposure.
Maltese: Pazjenti li żviluppaw antikorpi kontra alemtuzumab għamlu dan sa 15-il xahar wara l-esponiment inizjali.
English: If an additional third or fourth course is administered, continue safety follow-up for at least 48 months after the last infusion (see section 4.4).
Maltese: Jekk jingħata it-tielet jew ir-raba' kors, kompli s-segwitu ta' sigurtà għal mill-inqas 48 xahar wara l-aħħar infużjoni (ara sezzjoni 4.4).
English: • LEMTRADA Prescriber's Check-list
Maltese: • Kanċer iddijanjostikat fil-passat
English: An additional 12 serious events of ITP has been observed through a median of 6.1 years (maximum 12 years) of follow-up (cumulative annualised rate of 2.8 events/1000 patient years).
Maltese: segwitu (rata annwalizzata kumulattiva ta' 2.8 każ/1,000 sena ta' esponiment ta' pazjent).
English: Neutropenia Cases of severe (including fatal) neutropenia have been reported within 2 months of LEMTRADA infusion.
Maltese: Każijiet ta' newtropenja severa (inkluż dik fatali) ġew irrapportati fi żmien xahrejn mill-infużjoni b'LEMTRADA.
English: Blister, night sweats, swelling face, eczema
Maltese: epistassi, sulluzzu, uġigħ orofarinġeali, ażma
English: Two treatment courses may reduce MS activity for up to 6 years.
Maltese: Żewġ korsijiet ta' kura jistgħu jnaqqsu l attività tal-MS għal 6 snin.
English: o uncontrolled hypertension,
Maltese: oftalmopatija endokrinarja,
English: Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology.
Maltese: Hu rakkomandat li l-prodott jintuża immedjatament wara d-dilwizzjoni, minħabba riskju possibbli ta' kontaminazzjoni mikrobjali.
English: Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy.
Maltese: Pazjenti b'koagulopatija magħrufa, li qed jirċievu terapija kontra l-plejtlits jew antikoagulanti.
English: nephropathies, including anti-Glomerular Basement Membrane (anti-GBM) disease, autoimmune hepatitis (AIH), acquired haemophilia A, and HLH Serious infections Serious reactions temporally associated with LEMTRADA infusion, including myocardial ischaemia, haemorrhagic stroke, cervico-cephalic arterial dissection and pulmonary alveolar haemorrhage .
Maltese: Reazzjonijiet serji assoċjati b'mod temporali mal-infużjoni ta' LEMTRADA, inkluż iskemija mijokardjali, puplesija emorraġika, dissezzjoni arterjali ċerviko-ċefalika u emorraġija alveolari pulmonarja
English: bacterial skin infection, pneumonitis, cytomegalovirus infection
Maltese: Fil-provi kliniċi, il-pazjenti ngħataw aciclovir
English: - Keep this leaflet.
Maltese: Segwir ta' pazjenti
English: Controlled, randomised, raterblinded
Maltese: Pazjent wieħed żviluppa
English: Dyspnoea*, cough, epistaxis, hiccups, oropharyngeal pain, asthma
Maltese: (anti-GBM), epatite awtoimmuni (AIH). emofilja A akwiżita u HLH
English: The pharmacokinetics of alemtuzumab in RRMS has not been studied in patients aged 55 years and older.
Maltese: Il-farmakokinetika ta' alemtuzumab f'RRMS ma ġietx studjata f'pazjenti li għandhom 55 sena jew aktar.
English: therapies
Maltese: infezzjoni
English: Onychomycosis, gingivitis, fungal skin infection,
Maltese: gastroenterite, pnewmonja, erpete żoster, u infezzjoni fis-snien.
English: • inflammation of the mouth/gums/tongue
Maltese: • sistema immuni mnaqqsa/dgħajfa
English: It is unknown whether alemtuzumab is excreted in human milk.
Maltese: M'hemm ebda evidenza li LEMTRADA għandu xi impatt fuq il-fertilità maskili.
English: A description of the risks associated with the use of LEMTRADA namely: Immune Thrombocytopenic Purpura (ITP) Nephropathies including anti-Glomerular Basement Membrane (anti-GBM) disease Thyroid disorders Serious infections Other secondary autoimmune or immune system diseases, including HLH, AIH, and acquired haemophilia A. Serious reactions temporally associated with LEMTRADA infusion, including myocardial ischaemia, haemorrhagic stroke, cervico-cephalic arterial dissection and pulmonary alveolar haemorrhage.
Maltese: Wara r-rieżami, ġie kkonfermat mill-ġdid li Lemtrada jikkawża mard awtoimmuni sekondarju inklużi epatite awtoimmuni, tirojdite, purpura tromboċitopenika immuni, emofilja A akkwiżita, nefropatiji, ċitopenji, u reazzjonijiet immunoloġiċi serji bħal limfoistjoċitożi emofagoċitika.
English: Mean Age (years) Mean/Median Disease duration
Maltese: Età Medja (snin)
English: LEMTRADA 12 mg concentrate for solution for infusion alemtuzumab
Maltese: LEMTRADA 12-il mg konċentrat għal soluzzjoni għall-infużjoni.
English: The following adverse reactions were identified prior to registration of LEMTRADA during use of alemtuzumab for the treatment of B-cell chronic lymphocytic leukaemia (B-CLL), as well as for the treatment of other disorders, generally at higher and more frequent doses (e.g. 30 mg) than that recommended in the treatment of MS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to alemtuzumab exposure.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew identifikati qabel ir-reġistrazzjoni ta' LEMTRADA waqt l-użu ta' alemtuzumab għall-kura ta' lewkimja limfoċitika kronika ta' ċelluli B (B-CLL), kif ukoll għall-kura ta' disturbi oħrajn, ġeneralment b'dożi ogħla u aktar frekwenti (eż. 30 mg) minn dak irrakkomandat fil-kura ta' MS.
English: 1 Co-primary endpoints: ARR & CDW.
Maltese: 1 Punti aħħarin koprimarji:
English: Most cases occurred within two months of alemtuzumab dosing.
Maltese: Disturbi ġenerali u kondizzjonijie t ta' mnejn jingħata
English: Duration
Maltese: Tilqim
English: Symptoms of acute acalculous cholecystitis include abdominal pain, abdominal tenderness, fever, nausea, and vomiting.
Maltese: Is-sintomi ta' koleċistite akalkuluża akuta jinkludu wġigħ addominali, sensittività fl-addome, deni, dardir u rimettar.
English: In patients continuing from controlled clinical studies and who did not receive any additional LEMTRADA after the initial 2 treatment courses, the rate (events per person-year) of most adverse reactions was comparable to or reduced in years 3-6 as compared to years 1 and 2.
Maltese: F'pazjenti li komplew minn studji kliniċi kkontrollati u li ma rċivew l-ebda LEMTRADA addizzjonali wara l-ewwel 2 korsijiet inizjali ta' trattament, ir-rata (avvenimenti għal kull sena ta' esponiment ta' pazjent) tal-biċċa l-kbira tar-reazzjonijiet kienet kumparabbli jew imnaqqsa fis-snin 3-6 meta mqabbla mas-snin 1 u 2.
English: • Additional risk minimisation measures
Maltese: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskji Programm edukattiv
English: In clinical trials patients were administered cyclovir 200 mg twice a day or equivalent.
Maltese: 200 mg darbtejn kuljum jew ekwivalenti.
English: Active and latent tuberculosis, including a few cases of disseminated tuberculosis, have been reported in 0.3% of the patients treated with LEMTRADA, most often in endemic regions.
Maltese: Tuberkulożi attiva u moħbija, inkluż xi ftit każijiet ta' tuberkulożi mifruxa, ġew irrappurtati f'0.3% tal-pazjenti kkurati b'LEMTRADA, l-iktar ta' spiss f'reġjuni endemiċi.
English: Pulmonary alveolar haemorrhage
Maltese: infezzjoni fissnien
English: Signs and symptoms of ITP are described in section 4.
Maltese: Sinjali u sintomi ta' ITP huma deskritti f'sezzjoni 4.
English: Patients with a history of angina pectoris or myocardial infarction.
Maltese: Pazjenti b'passat mediku ta' anġina pektoris jew infart mijokardijaku.
English: The MAH shall ensure that, following agreement with the National Competent Authorities in each Member State where LEMTRADA is marketed, at launch and after launch, all physicians who intend to prescribe LEMTRADA are provided with an updated physician educational pack containing the following elements: The Summary of Product Characteristics HCP guide Prescriber checklist Patient guide Patient alert card The HCP guide shall contain the following key messages: 1.
Maltese: L-MAH għandu jiżgura li, wara ftehim mal-Awtoritajiet Kompetenti Nazzjonali f'kull Stat Membru fejn LEMTRADA ikun imqiegħed fis-suq, fit-tnedija u wara t-tnedija, it-tobba kollha li huma mistennija li jagħtu riċetta għal LEMTRADA jiġu pprovduti b'pakkett aġġornat ta' informazzjoni għat-tobba li jkun fih dawn l-elementi li ġejjin:
English: shingles, cold sore, swollen or enlarged glands, influenza, herpes zoster infection, tooth infection
Maltese: • akne, ħmura tal-ġilda, għaraq eċċessiv, telf ta' kulur fil-ġilda, ferita fil-ġilda, dermatite
English: Until 4 years after your last LEMTRADA infusion
Maltese: Sa 4 snin wara l-aħħar infużjoni tiegħek b'LEMTRADA
English: Intravenous use.
Maltese: Immunosoppressanti.
English: Serious endocrine events occurred in 4.4% of patients, with Basedow's disease (also known as Graves' disease), hyperthyroidism, hypothyroidism, autoimmune thyroiditis, and goitre occurring in more than 1 patient.
Maltese: Avvenimenti endokrinarji serji seħħew f'4.4% tal-pazjenti, bil-marda ta' Basedow (magħrufa wkoll bħala l-marda ta' Graves), ipertirojdiżmu, ipotirojdiżmu, tirojdite awtoimmuni, u goitre li seħħew f'iktar minn pazjent wieħed.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: In a sub-study in 13 male LEMTRADA-treated patients (treated with either 12 mg or 24 mg), there was no evidence of aspermia, azoospermia, consistently depressed sperm count, motility disorders or an increase in sperm morphological abnormalities.
Maltese: F'sottostudju fi 13-il pazjent raġel ikkurati b'LEMTRADA (ikkurati jew bi 12-il mg jew 24 mg), ma kien hemm l-ebda evidenza ta' aspermija, ażoospermija, għadd ta' sperma li jkun baxx b'mod konsistenti, disturbi fil-motilità jew żieda fl-anormalitajiet morfoloġiċi tal-isperma.
English: Varicella zoster virus antibody testing/vaccination
Maltese: Test tal-awrina (test addizzjonali biex jiddijanjostika disturbi
English: Serious and sometimes fatal viral, bacterial, protozoan, and fungal infections, including those due to reactivation of latent infections, have been reported in non-MS patients treated with alemtuzumab at higher and more frequent doses than used in MS. Progressive multifocal leukoencephalopathy (PML) has been reported in patients with B-CLL with or without treatment with alemtuzumab.
Maltese: Infezzjonijiet virali, batteriċi, protożoani, u fungali serji u xi kultant fatali, li jinkludu dawk li seħħew minħabba l-attivazzjoni mill-ġdid ta' infezzjonijiet moħbija, ġew irrappurtati f'pazjenti li ma kellhomx MS ikkurati b'alemtuzumab f'dożi ogħla u iktar frekwenti minn dawk użati f'MS. Lewkoenċefalopatija multifokali progressiva (PML) ġiet irrappurtata f'pazjenti b'B-CLL b'kura b'alemtuzumab jew mingħajrha.
English: Wait 30 minutes
Maltese: Stenna 30 minuta
English: Anaphylaxis**
Maltese: Anafilassi**
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BAR CODE 2D
English: Common Rare
Maltese: Komuni Rari
English: Baseline (SD)
Maltese: Linja Bażi (SD)
English: Date of first authorisation: 02 December 2015
Maltese: Data tal-ewwel awtorizzazzjoni : 02 Diċembru 2015
English: St. George's Respiratory Questionnaire (SGRQ) at week 32
Maltese: George's Respiratory Questionnaire (SGRQ) fil-Ġimgħa 32
English: Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT United Kingdom
Maltese: Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT Ir-Renju Unit
English: Secondary endpoints (weeks 20-24)
Maltese: Punti ta' tmiem sekondarji (ġimgħat 20-24)
English: Dispose 9.
Maltese: Armi 9.
English: Hypersensitivity reactions (systemic allergic)*
Maltese: Reazzjonijiet ta' sensittività eċċessiva (allerġiċi sistemiċi)*
English: Pre-bronchodilator FEV1 (mL) at week 32
Maltese: FEV1 Pre-bronkodilatur (mL) fil-ġimgħa 32
English: In MEA115588 and in the double-blind placebo-controlled study 200862, there were 34 adolescents (12 to 17 years old).
Maltese: F'MEA115588 u fl-istudju double-blind ikkontrollat bi plaċebo 200862, kien hemm 34 adolexxent (ta' bejn 12 sa 17-il sena).
English: MEA112997+MEA115588 <150 cells/µL
Maltese: MEA112997+MEA115588
English: 2nd “Click”
Maltese: It-2ni “Klikk”
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, No 90 43056 San Polo di Torrile, Parma Italy
Maltese: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, 90 43056 San Polo di Torrile, Parma L-Italja
English: GlaxoSmithKline Trading Services Ltd, Currabinny, Co. Cork, Ireland.
Maltese: GlaxoSmithKline Trading Services Ltd, Currabinny, Co. Cork, l-Irlanda.
English: • Stored below 30°C, not frozen
Maltese: • Tinħażen f'temperatura inqas minn 30°C, mhux iffriżata
English: The active substance is mepolizumab.
Maltese: Is-sustanza attiva hi mepolizumab.
English: A total of 135 patients were enrolled: mean age was 50 years, 55% were female, and 48% had been receiving oral steroid therapy for at least 5 years.
Maltese: Total ta' 135 pazjent kienu rreġistrati: l-età medja kienet ta' 50 sena, 55% kienu nisa, u 48% kienu qed jirċievu terapija bi sterojdi orali għal tal-inqas 5 snin.
English: Placebo N=346
Maltese: N=346
English: Nucala 100 mg injection mepolizumab SC
Maltese: Nucala 100 mg injezzjoni mepolizumab SC
English: Table 4: Results of the primary and secondary endpoints in MEA115575
Maltese: Tabella 4: Riżultati tal-punti ta' tmiem primarji u sekondarji f'MEA115575
English: The proportion of patients on maintenance OCS was 31% and 24%, respectively.
Maltese: manteniment kien ta' 31% u 24% rispettivament.
English: ≥500 cells/µL
Maltese: ≥500 ċellola/µL
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji , toraċiċi u mediastinali
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
Maltese: komuni ((≥1/100 sa <1/10); mhux komuni ((≥1/1,000 sa <1/100); rari ((≥1/10,000 sa <1/1,000); rari ħafna
English: Dose-ranging efficacy MEA112997 (DREAM) study
Maltese: Studju dose-ranging efficacy (Effikaċja skont Varjazzjoni fid-Doża) MEA112997 (DREAM)
English: Table 1: Frequency of clinically significant exacerbations at week 52 in the intent to treat population
Maltese: Tabella 1: Frekwenza ta' aggravar klinikament sinifikanti fil-ġimgħa 52 fil-popolazzjoni intenzjonata għat-trattament
English: There are limited pharmacokinetic data available in the paediatric population (59 subjects with eosinophilic esophagitis, 55 subjects with severe refractory eosinophilic asthma).
Maltese: Teżisti data farmakokinetika limitata dwar il-popolazzjoni pedjatrika (59 individwu b'esofaġite esinofilika, 55 individwu b'ażżma esinofilika refrattorja severa).
English: 150 to <300 cells/µL
Maltese: 150 sa <300 ċellola/µL
English: Reduction in the daily OCS dose to ≤5mg/day
Maltese: OCS għal ≤5mg/jum
English: Table 2: Results of primary and secondary endpoints at week 32 in the intent to treat population (MEA115588)
Maltese: Tabella 2: Riżultati tal-punti ta' tmiem primarji u sekondarji f'ġimgħa 32 fil-popolazzjoni intenzjonata għat-trattament (MEA115588)
English: Predefined categories included percent reductions ranging from 90-100% reduction, to no decrease in the prednisone dose from the end of the optimisation phase.
Maltese: Kategoriji predefiniti inkludew tnaqqis perċentwali li jvarja minn tnaqqis ta' 90-100%, għal ebda tnaqqis fid-doża ta' prednisone mit-tmiem tal-fażi ta' ottimizzazzjoni.
English: EDTA disodium dihydrate Water for injections
Maltese: EDTA disodium dihydrate Ilma għall-injezzjonijiet
English: In a combined analysis of these studies, a 40% reduction in clinically significant exacerbations was observed in adolescents following mepolizumab treatment compared to placebo (rate ratio 0.60; 95% CI: 0.17, 2.10).
Maltese: F'analiżi kkombinata ta' dawn l-istudji, tnaqqis ta' 40% f'aggravar klinikament sinifikanti kien osservat f'adoloxxenti wara trattament b'mepolizumab meta mqabbel ma' plaċebo (proporzjon tar-rata 0.60; 95% CI: 0.17, 2.10).
English: Security seals
Maltese: Siġilli tas-sigurtà
English: Human Genome Sciences, Inc. 9911 Belward Campus Drive Rockville, MD 20850
Maltese: 9911 Belward Campus Drive
English: The comparison between mepolizumab and placebo was statistically significant (p=0.008).
Maltese: plaċebo kienu statistikament sinifikanti (p<0.001).
English: There are limited data available in patients with creatinine clearance values <50 mL/min.
Maltese: Hemm tagħrif limitat disponibbli f'pazjenti b'valuri ta' eliminazzjoni tal-kreatinina <50 mL/min.
English: *** The most common manifestations associated with reports of systemic non-allergic administration-related reactions were rash, flushing and myalgia; these manifestations were reported infrequently and in <1% of subjects receiving mepolizumab 100 mg subcutaneously.
Maltese: *** L-aktar manifestazzjonijiet komuni assoċjati mar-rapporti ta' reazzjonijiet sistemiċi mhux allerġiċi relatati mal-għoti, kienu raxx, fwawar u uġigħ fil-muskoli; dawn il-manifestazzjonijiet kienu rrapportati b'mod mhux frekwenti u f'<1 % tal-individwi li rċevew mepolizumab 100 mg taħt il-ġilda.
English: 300 to <500 cells/µL
Maltese: 300 sa <500 ċellola/µL
English: Primary endpoint Frequency of clinically significant exacerbations
Maltese: Punt ta' tmiem primarju Frekwenza ta' aggravar klinikament sinifikanti
English: Alternatively, swirling at 1000 rpm for no longer than 5 minutes is acceptable.
Maltese: Inkella, tista' tħawwad b'1000 rpm għal mhux iktar minn 5 minuti.
English: Placebo N= 191
Maltese: N=191
English: The long-term efficacy profile of Nucala 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 MEA115666, MEA115661 and 201312 was generally consistent with the 3 placebo-controlled studies.
Maltese: Il-profil tal-effikaċja fit-tul ta' Nucala 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 MEA115666, MEA115661 u 201312 kienu ġeneralment konsistenti mat-3 studji kkontrollati bi plaċebo.
English: Ireland.
Maltese: L-Irlanda.
English: • Alcohol wipe (not included)
Maltese: • Wajp tal-alkoħol (mhux inkluża)
English: In the population pharmacokinetic analysis estimated mepolizumab systemic clearance was 3.1 mL/day/kg.
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni, l-istima tal-eliminazzjoni sistemika ta' mepolizumab kienet 3.1 mL/kuljum/kg.
English: The safety profile was similar to that seen in adults.
Maltese: Il-profil tas-sigurtà kien simili għal dak osservat fl-adulti.
English: Mepolizumab 75 mg IV/100 mg SC N=538
Maltese: Mepolizumab 75 mg filvina/100 mg taħt il ġilda
English: Nucala contains sodium
Maltese: Nucala fih sodium
English: Mepolizumab is a humanised monoclonal antibody (IgG1, kappa), which targets human interleukin-5 (IL-5) with high affinity and specificity.
Maltese: Mepolizumab huwa antikorp monoklonali umanizzat (IgG1, kappa), li jimmira l-interleukin uman-5 (IL-5)
English: Open-label extension studies in severe refractory eosinophilic asthma MEA115666 (COLUMBA), MEA115661 (COSMOS) and 201312 (COSMEX)
Maltese: Studji ta' estensjoni miftuħa f'ażżma esinofilika refrattorja severa MEA115666 (COLUMBA), MEA115661
English: • Wait 30 minutes (and no more than 8 hours) before use.
Maltese: • Stenna 30 minuta (u mhux aktar minn 8 sigħat) qabel l-użu.
English: Reduction in the daily OCS dose to 0 mg/d
Maltese: OCS għal 0 mg/jum
English: The mean number of exacerbations in the previous year was 3.6 and the mean predicted pre-bronchodilator FEV1 was 60%.
Maltese: In-numru medju ta' taħrixiet fis-sena preċedenti kien ta' 3.6 % u l-FEV1 medju mbassar ta' qabel il-bronkodilatur kien ta' 60%.
English: Placebo N= 66
Maltese: N= 66