FrancophonIA/ELRC3.0 huggingface dataset:
English: Methysergide binds with varying affinities to a range of serotonergic receptors (5-HT receptors).
Maltese: Methysergide jeħel ma' diversi affinitajiet ma' firxa ta' riċetturi serotonerġiċi (riċetturi 5-HT).
English: • the prophylactic treatment of episodic and chronic cluster headache in adults.
Maltese: Treatment of the cluster headache.
English: Methysergide is to be used only following unsuccessful treatment with other standard classes of drugs after sufficient treatment duration (at least 4 months) at the maximal tolerated dose.
Maltese: Methysergide għandu jintuża biss wara kura mingħajr suċċess bi klassijiet ta' mediċini standard oħrajn wara perjodu ta' kura suffiċjenti (tal-anqas 4 xhur) bid-doża massima ttollerata.
English: However, in view of the demonstrated risk of fibrosis, adequate risk minimisation measures should be put in place.
Maltese: Madankollu, fid-dawl tar-riskju indikat ta' fibrożi, għandhom jiddaħħlu fis-seħħ miżuri adegwati ta' minimizzazzjoni tar-riskju.
English: The majority of patients (92.4%) who developed fibrosis received daily doses of methysergide within the currently recommended (≤ 6 mg/day).
Maltese: Il-biċċa l-kbira tal-pazjenti (92.4 %) li żviluppaw fibrożi rċevew dożi ta' kuljum ta' methysergide skont dak li huwa rrakkomandat bħalissa (≤ 6 mg/jum).
English: The overall reduction was 54%.
Maltese: It tnaqqis globali kien ta' 54%.
English: Subgroup GINA 4 and 5
Maltese: Sottogrupp GINA 4 u 5
English: LT-08409 Vilnius Lithuania
Maltese: LT-08409 Vilnius Il-Litwanja
English: - The active substance is reslizumab.
Maltese: - Is-sustanza attiva hi reslizumab.
English: Pulmonary function tests
Maltese: Testijiet tal-funzjoni pulmonari
English: 3 mg/kg [n=14] and placebo [n=11]).
Maltese: 3 mg/kg [n=14] u plaċebo [n=11]).
English: FEV1 (mL) Mean diff (95% CIb) (p-value)
Maltese: FEV1 (mL) Differenza medja (95% CIb) (valur-p)
English: Reslizumab is a humanised monoclonal antibody (IgG4, κ) against the human interleukin-5 (IL-5).
Maltese: Reslizumab hu antikorp monoklonali umanizzat (IgG4, κ) kontra l-interleukin-5 uman (IL-5).
English: Parasitic (helminth) infections
Maltese: Infezzjonijiet parassitiċi (helminth)
English: Proteinaceous particles might be present.
Maltese: Jista' jkun hemm preżenti partikuli proteinaċeji.
English: Myalgia*
Maltese: Mijalġija*
English: ACQ Mean diff (95% CI) (p-value) AQLQ Mean diff (95% CI) (p-value)
Maltese: ACQ Differenza medja (95% CI) (valur-p) AQLQ Differenza medja (95% CI) (valur-p)
English: b CI = Confidence interval.
Maltese: b CI = Intervall ta' kunfidenza.
English: Proportions of patients in GINA steps 4 and 5c
Maltese: Proporzjonijiet ta' pazjenti f'GINA passi 4 u 5c
English: In vitro data indicate that IL-5 and reslizumab are unlikely to affect CYP1A2, 3A4 or 2B6 activity.
Maltese: Data in vitro tindika li IL-5 u reslizumab mhux probabbli li se jaffettwaw l-attività ta' CYP1A2, 3A4 jew 2B6.
English: CINQAERO contains sodium
Maltese: CINQAERO fih sodium
English: Study III
Maltese: Studju III
English: Study III (n=315)
Maltese: Studju III (n=315)
English: CINQAERO 10 mg/mL sterile concentrate reslizumab
Maltese: CINQAERO 10 mg/mL konċentrat sterili reslizumab
English: CINQAERO is compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, cellulose acetate (CA) low protein binding in-line infusion filters.
Maltese: CINQAERO hu kompatibbli ma' filtri tal-infużjoni in-line tal-polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, cellulose acetate (CA) li jkollhom rata baxxa ta' twaħħil ta' proteini.
English: Study II (n=464)
Maltese: Studju II (n=464)
English: CI = Confidence interval
Maltese: b CI = Intervall ta' kunfidenza
English: In pooled data, mean eosinophil counts were 655 µL-1 (n=476) and 654 µL-1 (n=477) for the placebo and reslizumab treatment groups at baseline and were 514 µL-1 (n=405) and 61 µL-1 (n=407) at week 52.
Maltese: Fid-data miġbura, il-medji tal-għadd ta' eosinofili kienu ta' 655 µL-1 (n=476) u 654 µL-1 (n=477) għall-gruppi ta' kura bil-plaċebo u reslizumab fil-linja bażi, u kienu ta' 514 µL-1 (n=405) u 61 µL-1 (n=407) f'ġimgħa 52.
English: IL-5 is a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils.
Maltese: IL-5 hu cytokine ewlieni responsabbli għad-differenzazzjoni, il-maturazzjoni, ir reklutaġġ u l-attivazzjoni ta' eosinofili umani.
English: Date of first authorisation: 16 August 2016.
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Awwissu 2016.
English: NAb a FEV1=forced expiratory volume in 1 second b NA=not available c The GINA classification is based on the Global Initiative for Asthma (GINA) definition:
Maltese: NAb a FEV1=volum espiratorju sfurzat f'sekonda b NA=mhux disponibbli c Il-klassifikazzjoni GINA hija bbażata fuq l-Inizjattiva Globali għall-Ażżma (Global Initiative for
English: Each vial of 2.5 mL contains 0.05 mmol (1.15 mg) of sodium.
Maltese: Kull kunjett ta' 2.5 mL fih 0.05 mmol (1.15 mg) ta' sodium.
English: Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL).
Maltese: Kull mL ta' konċentrat fih 10 mg ta' reslizumab (10 mg/mL).
English: The pharmacokinetics of reslizumab was similar in adults (18-65 years of age; n=759) and elderly patients (greater than 65 years of age; n=30).
Maltese: Il-farmakokinetika ta' reslizumab kienet simili fl-adulti (li kellhom 18-65 sena; n=759) u pazjenti anzjani (li kellhom aktar minn 65 sena; n=30).
English: Anaphylactic reaction*
Maltese: Reazzjoni anafilattika*
English: There are limited safety data in non-white ethnic populations.
Maltese: Hemm data limitata dwar is sigurtà f'popolazzjonijiet etniċi mhux bojod.
English: Store in a refrigerator (2 °C-8 ºC).
Maltese: Aħżen fi friġġ (2°C-8ºC).
English: Study I (n=489)
Maltese: Studju I (n=489)
English: Each vial of 10 mL contains 0.20 mmol (4.6 mg) of sodium.
Maltese: Kull kunjett ta' 10 mL fih 0.20 mmol (4.6 mg) ta' sodium.
English: Inter-individual variability in peak and overall exposure is approximately 20-30%
Maltese: Il-varjabilità bejn lindividwi fl-esponiment massimu u globali hi ta' madwar 20-30%.
English: Excipients: sodium acetate trihydrate, acetic acid glacial, sucrose, water for injections.
Maltese: Eċċipjenti: sodium acetate trihydrate, acetic acid glacial, sucrose, ilma għall-injezzjonijiet.
English: Results for FEV1, ACQ and AQLQ are shown in Table 5 below for the overall population, and subgroup GINA 4 and 5.
Maltese: Ir-riżultati għall-FEV1, ACQ u AQLQ qed jintwerew f'Tabella 5 hawn taħt għall-popolazzjoni globali, u sottogrupp GINA 4 u 5.
English: No apparent deviation from dose-proportional reslizumab pharmacokinetics was noted over the dose range of 0.3 mg/kg to 3.0 mg/kg.
Maltese: Ma ġiet osservata l-ebda devjazzjoni apparenti mill-farmakokinetika ta' reslizumab kien proporzjonali għad-doża fuq il-medda tad-doża ta' 0.3 mg/kg sa 3.0 mg/kg.
English: Other medicines and CINQAERO
Maltese: Mediċini oħra u CINQAERO
English: Pre-bronchodilator FEV1a, mean % predicted
Maltese: Qabel ilbronkodilatur FEV1a, medja ta' % imbassar
English: Studies I and II
Maltese: Studji I u II
English: Table 2: Adverse reactions System organ class
Maltese: Tabella 2: Reazzjonijiet avversi
English: In this study, the percentage of sputum eosinophils was reduced from a mean baseline value of 17.4% (standard deviation: 15.9%) by 82% at end of therapy in the reslizumab group.
Maltese: F'dan l-istudju, il-perċentwali ta' eosinofili flisputum tnaqqas minn valur medju fil-linja bażi ta' 17.4% (devjazzjoni standard: 15.9%) bi 82% fittmiem tat-terapija fil-grupp ta' reslizumab.
English: ● Risk management plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Patients below 35 kg or above 199 kg
Maltese: Pazjenti li jiżnu inqas minn 35 kg jew aktar minn 199 kg
English: The data did not indicate a difference in the safety profile of reslizumab in paediatric patients compared with that in adult patients.
Maltese: Id-data ma indikatx differenza fil-profil tas-sigurtà ta' reslizumab f'pazjenti pedjatriċi meta mqabbel ma' dak f'pazjenti adulti.
English: A reduction in asthma exacerbations resulting in hospitalisation or an emergency room visit was observed with reslizumab 3 mg/kg that was not statistically significant (34% [p=0.2572] and 31% [p=0.4020] in Study I and Study II, respectively).
Maltese: 3 mg/kg li ma kienx statistikament sinifikanti (34% [p=0.2572] u 31% [p=0.4020] fi Studju I u Studju II, rispettivament.
English: Table 3 presents the demographics and baseline characteristics of Studies I, II and III.
Maltese: Tabella 3 tippreżenta d-demografija u l-karatteristiċi fil-linja bażi ta' Studji I, II u III.
English: Hypersensitivity and administration-related reactions Acute systemic reactions, including anaphylactic reactions, have been reported in association with reslizumab (see section 4.8).
Maltese: Reazzjonijiet sistemiċi severi akuti li jinkludu reazzjonijiet anafilattiċi, ġew irrappurtati f'assoċjazzjoni ma' reslizumab (ara sezzjoni 4.8).
English: Asthma exacerbation ratea
Maltese: Rata ta' aggravamenti tal ażżmaa
English: Table 4: Frequency of asthma exacerbations during the 52-week treatment period - Studies I and II, integrated data (Studies I and II) for the overall population and subgroup GINA 4 and 5 Treatment arms (n)
Maltese: Tabella 4: Frekwenza ta' aggravamenti tal-ażżma matul il-perjodu ta' kura ta' 52 ġimgħaStudji I and II, data integrata (Studji I u II) għall-popolazzjoni globali u sottogrupp GINA 4 u 5
English: Systemic exposure to reslizumab appears to be unaffected by anti-reslizumab antibodies.
Maltese: Esponiment sistemiku għal reslizumab jidher li ma jiġix affettwat min antikorpi kontra reslizumab.
English: Adverse reactions are listed below in Table 2 by system organ class and frequency (frequencies are defined as: 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), not known
Maltese: 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 magħrufa (ma tistax tittieħed stima mid-data disponibbli)).
English: The effect of reslizumab 3 mg/kg administered once every 4 weeks on secondary endpoints, including FEV1, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and Asthma Symptom Utility Index (ASUI), further supports the efficacy of reslizumab 3 mg/kg compared to placebo.
Maltese: L-effett ta' reslizumab 3 mg/kg mogħti darba kull 4 ġimgħat fil-punti ta' żmien sekondarji, li jinkludu FEV1, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ), u
English: Patients between 35 kg and 199 kg
Maltese: 199 kg
English: Patients with severe refractory eosinophilic asthma Reslizumab produced significant reductions in asthma exacerbations relative to placebo in the refractory population (59%) and non-refractory population (49%).
Maltese: Pazjenti b'ażżma eosinofilika refrattarja severa Reslizumab ipproduċa tnaqqis sinifikanti fl-aggravamenti fl-ażżma meta mqabbel mal-plaċebo fil popolazzjoni refrattarja (59%) u fil-popolazzjoni mhux refrattarja (49%).
English: Reslizumab has a long half-life (see section 5.2).
Maltese: Reslizumab għandu halflife twila (ara sezzjoni 5.2).
English: CINQAERO is compatible with polyvinylchloride (PVC) or polyolefin (PO) infusion bags.
Maltese: CINQAERO hu kompatibbli ma' boroż tal-infużjoni tal-polyvinylchloride (PVC) jew talpolyolefin (PO).
English: Table 3: Demographics and baseline characteristics of asthma studies I - III Demographic or baseline characteristic
Maltese: Tabella 3: Demografija u karatteristiċi fil-linja bażi tal-istudji dwar l-ażżma I-III Demografiċi jew karatteristika fil-linja bażi
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases; ATC code: R03DX08
Maltese: Mediċini għal mard tal-imblokkar tal-passaġġi tan-nifs, mediċini sistemiċi oħrajn għal mard tal-imblokkar tal-passaġġi tan-nifs; kodiċi ATC: R03DX08
English: 39 paediatric asthma patients from 12 to 17 years were randomised to reslizumab 0.3 mg/kg, reslizumab 3 mg/kg or placebo as part of two 52-week exacerbation studies (Studies I and II) and one 16-week lung function study (Study III).
Maltese: 39 pazjent pedjatriku bl-ażżma li kellhom minn 12 sa 17-il sena, intgħażlu b'mod każwali għal reslizumab 0.3 mg/kg, reslizumab 3 mg/kg jew plaċebo, bħala parti minn żewġ studji li damu 52 ġimgħa (Studji I u II) dwar aggravamenti, u studju wieħed li dam 16-il ġimgħa dwar il-funzjoni tal pulmun (Studju III).
English: EU/1/16/1125/001 1 vial of 10 mL EU/1/16/1125/002 - 1 vial of 2.5 mL EU/1/16/1125/003 - 2 vials of 10 mL EU/1/16/1125/004 - 2 vials of 2.5 mL
Maltese: EU/1/16/1125/003 - 2 kunjetti ta' 10 mL EU/1/16/1125/004 - 2 kunjetti ta' 2.5 mL
English: This is not unusual for proteinaceous solutions.
Maltese: Dan hu normali għal soluzzjonijiet proteinaċeji.
English: EU/1/16/1125/001 1 vial of 10 mL EU/1/16/1125/002 1 vial of 2.5 mL EU/1/16/1125/003 2 vials of 10 mL EU/1/16/1125/004 2 vials of 2.5 mL
Maltese: EU/1/16/1125/003 2 kunjetti ta' 10 mL EU/1/16/1125/004 2 kunjetti ta' 2.5 mL
English: Overall population
Maltese: Popolazzjoni globali
English: The solution for infusion should be infused intravenously over 20 - 50 minutes.
Maltese: Is-soluzzjoni għall-infużjoni għandha tiġi infuża ġol-vini matul 20-50 minuta.
English: In common with other monoclonal antibodies, reslizumab is believed to be degraded by enzymatic proteolysis into small peptides and amino acids.
Maltese: B'mod komuni ma' antikorpi monoklonali oħrajn, hu maħsub li reslizumab jiġi ddegradat minn proteolisi enzimatika fil-peptides iż-żgħar u fl-amino acids.
English: Population pharmacokinetic analyses indicated that the pharmacokinetics of reslizumab is not significantly different between ethnic groups (white, black and Asian).
Maltese: Analiżi farmakokinetika tal-popolazzjoni indikat li l-farmakokinetika ta' reslizumab mhijiex differenti b'mod sinifikanti bejn gruppi etniċi differenti (bojod, suwed u Asjatiċi).
English: The safety and efficacy of CINQAERO in children and adolescents aged up to 17 years have not been established for the indication of CINQAERO.
Maltese: Is-sigurtà u l-effikaċja ta' CINQAERO fit-tfal u adolexxenti li jkollhom sa 17-il sena ma ġewx determinati għall-indikazzjoni ta' CINQAERO.
English: Currently available data in adolescents from 12 to 17 years are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Id-data attwalment disponibbli f'adolexxenti li jkollhom minn 12 sa 17-il sena hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Maintenance OCS (up to 10 mg per day prednisone equivalent) were allowed.
Maltese: 10 mg kuljum ta' prednisone) kien permess.
English: Blood creatine phosphokinase increased*
Maltese: Żieda fil-creatine phosphokinase fid-demm*
English: Myalgia was reported in 0.97% of patients (10 out of 1,028) in the 3 mg/kg reslizumab group of the placebo-controlled asthma studies compared with 0.55% of patients (4 out of 730) in the placebo group.
Maltese: Mijalġija ġiet irrappurtata f'0.97% tal-pazjenti (10 minn 1,028) fil-grupp ta' 3 mg/kg reslizumab talistudji dwar l-ażżma kkontrollati bi plaċebo, meta mqabbla ma' 0.55% tal-pazjenti (4 minn 730) filgrupp tal-plaċebo.
English: Maintenance OCS was not allowed.
Maltese: OCS ta' manteniment ma kienx permess.
English: Table 5: Treatment difference in mean change from baseline for selected secondary efficacy variables - Integrated data (Studies I and II) for the overall population and subgroup GINA 4 and 5
Maltese: Differenza fil-kura f'bidla medja mil-linja bażi għal varjabbli sekondarji magħżula tal-effikaċja - Data integrata (Studji I u II) għall-popolazzjoni globali u sottogrupp GINA 4 u 5
English: Reslizumab is a humanised monoclonal antibody produced in mouse myeloma cells (NS0) by recombinant DNA technology.
Maltese: Reslizumab hu antikorp monoklonali umanizzat prodott fiċ-ċelluli tal-majeloma tal-ġrieden (NS0)
English: 2.5 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a white plastic flip-off cap.
Maltese: 2.5 mL ta' konċentrat f'kunjett tal-ħġieġ trasparenti tat-tip I magħluq b'tapp tal-gomma butyl miksija bil-poly(ethylene-co-tetrafluoroethylene) miksi b'ċirku tal-aluminju crimped-on u għatu flip-off talplastik abjad.
English: The proportion of patients who did not experience an asthma exacerbation during the 52-week treatment period was higher in the reslizumab 3 mg/kg group (62% and 75%) compared with the placebo group (46% and 55%), in Studies I and II, respectively.
Maltese: Il-proporzjon ta' pazjenti li ma kellhomx aggravament tal-ażżma matul il-perjodu ta' kura ta' 52 ġimgħa kien ogħla fil-grupp ta' reslizumab 3 mg/kg (62% u 75%) meta mqabbel mal-grupp talplaċebo (46% u 55%) fi Studji I u II, rispettivament.
English: Sputum eosinophils were measured in a subset of 38 adult patients at the end of therapy.
Maltese: L-eosinofili fl-isputum tkejlu f'subsett ta' 38 pazjent adult fit-tmiem tat-terapija.
English: Most patients in the population pharmacokinetic analysis had normal renal function (estimated glomerular filtration rate [eGFR]) greater than or equal to 90 mL/min/1.73 m2; n=294, approximately 37%), mild renal impairment (eGFR 60-89 mL/min/1.73 m2; n=446, approximately 56%), or moderate renal impairment (eGFR 30-59 mL/min/1.73 m2; n=63, approximately 8%).
Maltese: Il-biċċa l-kbira tal-pazjenti fl-analiżi farmakokinetika tal-popolazzjoni, kellhom funzjoni normali tal-kliewi (rata ta' filtrazzjoni glomerulari stmata [eGFR]) iktar minn jew daqs 90 mL/min/1.73 m2; n=294, madwar 37%), indeboliment ħafif tal-kliewi (eGFR
English: No formal clinical drug interaction studies have been performed with reslizumab.
Maltese: Ma sarux studji formali dwar interazzjonijiet tal-mediċina b'reslizumab.
English: The serious adverse reaction of anaphylactic reaction was reported and considered related to reslizumab in 3 patients (0.19%) during placebo-controlled and open-label asthma studies.
Maltese: Ir-reazzjoni avversa serja ta' reazzjoni anafilattika ġiet irrappurtata u kienet ikkunsidrata li hi relatata ma' reslizumab f'3 pazjenti (0.19%) matul l-istudji kkontrollati bi plaċebo u open-label dwar l-ażżma.
English: In placebo-controlled clinical studies, 6 out of 1,028 patients (0.6%) receiving 3 mg/kg reslizumab had at least one malignant neoplasm reported compared to 2 out of 730 patients (0.3%) in the placebo group.
Maltese: Fl-istudji kliniċi kkontrollati bi plaċebo, 6 minn 1,028 pazjent (0.6%) li kienu qed jirċievu 3 mg/kg reslizumab, kellhom mill-inqas neoplażmu malinn waħda irrappurtat meta mqabbla ma' 2 pazjenti minn 730 (0.3%) fil-grupp tal-plaċebo.
English: Eosinophils began to return towards baseline in those reslizumab patients completing a 90-day follow-up assessment (394 µL-1, n=36).
Maltese: L-eosinofili bdew jirritornaw lejn il-linja bażi f'dawk il-pazjenti fuq reslizumab li lestew evalwazzjoni ta' follow-up wara 90 jum (394 µL-1, n=36).
English: Peak serum concentrations of approximately 80 µg/mL are typically observed at the end of the infusion.
Maltese: Konċentrazzjonijiet massimi fis-serum ta' madwar 80 µg/mL jiġu osservati tipikament fit-tmiem talinfużjoni.
English: Particles might be present.
Maltese: Jista' jkun hemm preżenti partikuli.
English: ● Periodic safety update reports (PSURs)
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs)
English: Gently invert the bag to mix the solution.
Maltese: permezz ta' teknoloġija ta' DNA rikombinanti.
English: Experience in paediatric patients is limited (see section 5.1).
Maltese: L-esperjenza f'pazjenti pedjatriċi hi limitata (ara sezzjoni 5.1).
English: Blood creatine phosphokinase elevations were transient and asymptomatic, and did not lead to treatment discontinuation.
Maltese: Żidiet ta' creatine phosphokinase fid-demm kienu temporanji u mingħajrsintomi, u ma wasslux għattwaqqif tal-kura.
English: Reslizumab has a half-life of about 24 days.
Maltese: Reslizumab għandu half-life ta' madwar 24 jum.
English: *** Patients weighing more than 188 kg were not studied.
Maltese: *** Pazjenti li jiżnu aktar minn 188 kg ma ġewx studjati.
English: Overview of clinical efficacy The efficacy of reslizumab in eosinophilic asthma (blood eosinophils ≥400 µL-1) was evaluated in three randomised, double-blind, placebo-controlled studies (Studies I to III) from 16 to 52 weeks' duration involving 1268 patients with moderate to severe asthma inadequately controlled on mediumto high-dose inhaled corticosteroids (ICS) (at least 440 μg of fluticasone propionate daily or equivalent) with or without other controllers; prior stable allergen immunotherapy was allowed.
Maltese: L-effikaċja ta' reslizumab f'ażżma eosinofilika (eosinofili tad-demm ≥400 µL-1) ġiet evalwata fi tliet studji li fihom, il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo (Studji I sa III), li damu minn 16 sa 52 ġimgħa, u li kienu jinvolvu 1,268 pazjent b'ażżma moderata sa severa li ma kinitx ikkontrollata b'mod adegwat minn dożi medji sa għoljin ta' kortikosterojdi li jittieħdu man nifs (ICS - inhaled corticosteroids) (mill-inqas 440 μg ta' fluticasone propionate kuljum jew ekwivalenti) bi jew mingħajr kontrolluri oħrajn; immunoterapija ta' allerġeni stabbli qabel il-kura kienet permessa.
English: In this short period, a risk to the suckling child cannot be excluded.
Maltese: F'dan il-perjodu qasir, ir-riskju gћat-trabi tat-twelid li jkunu qed jerdgħu mhux eskluż.
English: The concentrate does not contain any preservatives.
Maltese: Il-konċentrat ma fihx preservattivi.
English: Blood creatine phosphokinase increased
Maltese: Żieda fil-creatine phosphokinase fid-demm
English: The infusion will take about 20 to 50 minutes.
Maltese: L-infużjoni se tieħu madwar 20 sa 50 minuta.
English: Mean number of exacerbations in previous year
Maltese: Numru medju ta' aggravamenti fis-sena preċedenti
English: 10 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a blue plastic flip-off cap.
Maltese: 10 mL ta' konċentrat f'kunjett tal-ħġieġ ċar ta' tip 1, magħluq b'tapp tal-gomma tal-butyl miksi bilpoly(ethylene-co-tetrafluoroethylene) miksi b'ċirku tal-aluminju crimped-on u għatu flip-off talplastik blu.
English: CINQAERO is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment (see section 5.1).
Maltese: CINQAERO huwa indikat bħala terapija addizzjonali f'pazjenti adulti b'ażżma eosinofilika severa mhux ikkontrollata b'mod adegwat minkejja doża għolja ta' kortikosterojdi miġbuda man-nifs flimkien ma' prodott mediċinali ieħor għal trattament ta' manteniment (ara sezzjoni 5.1).
English: Reslizumab binds human IL-5 with picomolar affinity blocking its biological function; consequently survival and activity of eosinophils are reduced.
Maltese: Reslizumab iwaħħal IL-5 b'affinità pikomolari u jimblokka l-funzjoni bijoloġika tagħha; konsegwentement, is-sopravivenza u l-attività tal-eosinofili jitnaqqsu.
English: GINA step 5 patients received in addition, as an add-on, maintenance OCS.
Maltese: Pazjenti f'GINA pass 5 irċivew, flimkien ma' dan, bħala terapija addizzjonali, OCS ta' manteniment.
English: Eosinophils may be involved in the immunological response to some helminth infections.
Maltese: L-eosinofili jistgħu jiġu involuti fir-reazzjoni immunoloġika għal xi infezzjonijiet b'helminth.
English: Asthma exacerbations were evaluated only in the exacerbation studies (Studies I and II: reslizumab
Maltese: L-aggravamenti tal-ażżma ġew evalwati biss fl-istudji dwar l-aggravamenti (Studji I u II: reslizumab