FrancophonIA/ELRC3.0 huggingface dataset:
English: Also, talk to your doctor or nurse when you are given CINQAERO: - if your asthma remains uncontrolled or worsens during treatment with this medicine; - if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).
Maltese: Ukoll, kellem lit-tabib jew lill-infermier tiegħek qabel ma tingħata CINQAERO: - jekk l-ażżma tiegħek tibqa' mhix ikkontrollata jew tmur għall-agħar matul il-kura b'din ilmediċina; - jekk ikollok kwalunkwe mis-sintomi ta' reazzjoni allerġika (eż. ħakk, problemi biex tieħu nnifs, tħarħir, deni, rogħda, sturdament, uġigħ ta' ras, dardir, rimettar, skonfort fiż-żaqq, raxx, ħmura jew nefħa tal-ġilda).
English: The diluted medicinal product should then be administered as a 20 - 50-minute intravenous infusion through a sterile, non-pyrogenic infusion, single-use, low protein binding filter (0.2 µm).
Maltese: Il-prodott mediċinali dilwit għandu mbagħad jingħata bħala infużjoni ġol-vini ta' 20-50 minuta, permezz ta' infużjoni mhux piroġenika sterili, bl-użu ta' filtru li jintuża darba biss, li jkollu rata baxxa ta' twaħħil ta' proteini (0.2 μm).
English: Placebo (n=380)
Maltese: Placebo (n=380) 95% CI
English: In Study III, patients receiving reslizumab 3 mg/kg had significantly larger increases in FEV1 from baseline compared to placebo (treatment difference: 160 mL, p=0.0018).
Maltese: Fi studju III, il-pazjenti li kienu qed jirċievu reslizumab 3 mg/kg, kellhom żidiet akbar li kienu ogħla b'mod sinifikanti f'FEV1 mil-linja bażi meta mqabbla mal-plaċebo (differenza fil-kura: 160 mL, p=0.0018).
English: The maximum dose is 3 mg per kg of body weight.
Maltese: 3 mg/kg meta mqabbla mal-plaċebo.
English: No data are available for children aged up to 11 years.
Maltese: M'hemm l-ebda data disponibbli fi tfal li jkollhom sa 11-il sena.
English: How to store CINQAERO
Maltese: X'inhu CINQAERO
English: There are limited data available on the use of reslizumab in patients older than 75 years of age.
Maltese: Hemm data limata disponibbli dwar l-użu ta' reslizumab f'pazjenti li jkollhom aktar minn 75 sena.
English: Talk to your doctor or nurse before you are given CINQAERO: - if you have a parasitic infection or if you live in an area where parasitic infections are common or if you are travelling to such a region, as this medicine may weaken your body's ability to fight certain types of parasitic infections.
Maltese: Kellem lit-tabib jew lill-infermier tiegħek qabel tingħata CINQAERO: - jekk ikollok infezzjoni parassitika jew jekk tgħix f'parti, fejn infezzjonijiet parassitiċi huma komuni jew jekk qed tivvjaġġa f' reġjun hekk peress li din il-mediċina tista' ddgħajjef il-ħila tal-ġisem tiegħek biex jiġġieled kontra ċerti tipi ta' infezzjonijiet parassitiċi.
English: Placebo (n=232)
Maltese: (n=232)
English: Most patients had normal liver function tests (n=766, approximately 95%) or mildly increased liver function tests (either, in the first case, total bilirubin above the upper limit of normal [ULN] but less than or equal to 1.5 times the ULN or, in the second case, aspartate aminotransferase greater than the ULN and total bilirubin less than or equal to the ULN; n=35, approximately 4%).
Maltese: Il-biċċa l-kbira tal-pazjenti kellhom testijiet tal funzjoni tal-fwied normali (n=766, bejn wieħed u ieħor 95%) jew testijiet tal-funzjoni tal-fwied b'żieda ħafifa (jew, fl-ewwel każ, bilirubina totali 'il fuq mil-limitu ta' fuq tan-normal [ULN] iżda inqas minn jew daqs 1.5 darbiet il-ULN, jew, fit-tieni każ, aspartate aminotransferase ikbar mill-ULN, u bilirubina totali imma inqas minn jew daqs il-ULN; n=35, madwar 4%).
English: In phase 3 placebo-controlled studies with a duration of 16 to 52 weeks, low-titre, frequently transient anti-reslizumab antibodies were detected in 53 out of 983 asthma patients (5%) receiving reslizumab at 3 mg/kg.
Maltese: Fl-istudji ta' fażi 3 ikkontrollati bi plaċebo li damu minn 16 sa 52 ġimgħa, antikorpi b'titer baxx kontra reslizumab, li ta' spiss kienu temporanji, ġew osservati fi 53 minn 983 (5%) pazjent bl-ażżma li kienu qed jirċievu reslizumab 3 mg/kg.
English: Tell your doctor or nurse straight away if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).
Maltese: Għid lit-tabib jew lill-infermier tiegħek immedjatament jekk ikollok kwalunkwe mis-sintomi ta' reazzjoni allerġika (eż. ħakk, problemi biex tieħu n-nifs, tħarħir, deni, rogħda, sturdament, uġigħ ta' ras, dardir, rimettar, skumdità fiż żaqq, raxx, ħmura jew nefħa tal-ġilda).
English: Exacerbation history
Maltese: Storja ta' aggravamenti
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: CINQAERO is available in packs containing 1 or 2 vials with 2.5 mL and in packs containing 1 or 2 vials with 10 mL.
Maltese: CINQAERO huwa disponibbli f'pakketti li fihom kunjett wieħed jew 2 kunjetti b'2.5 mL u f'pakketti li fihom kunjett wieħed jew 2 kunjetti b'10 mL.
English: In a population pharmacokinetic analysis, patients were classified by baseline liver function levels.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni, il-pazjenti ġew ikklassifikati skont il-livelli tal-funzjoni tal-fwied fil-linja bażi.
English: If patients become infected whilst receiving treatment with reslizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Maltese: Jekk il-pazjenti jiġu infettati waqt li jkunu qegħdin jirċievu l-kura b'reslizumab u ma jirrispondux għall-kura kontra helminth, għandu jiġi kkunsidrat it-twaqqif temporanju tat-terapija.
English: Reslizumab is an antibody with a molecular mass of 147 kDaltons and is therefore not expected to be excreted in urine.
Maltese: Reslizumab hu antikorp b'piż molekulari ta' 147 kDaltons u għalhekk mhux mistenni li jitneħħa fl awrina.
English: PHARMACEUTICAL FORM
Maltese: Data farmakodinamika
English: You will be given CINQAERO by a doctor or nurse as an infusion (drip) into a vein.
Maltese: Inti se tingħata CINQAERO minn tabib jew infermier bħala infużjoni (dripp) ġo vina.
English: This medicine is NOT intended for use in children and adolescents below the age of 18 years.
Maltese: Din il-mediċina MHIJIEX maħsuba għall-użu fi tfal u adolexxenti ta' età inqas minn 18-il sena.
English: As a precautionary measure, it is preferable to avoid the use of CINQAERO during pregnancy.
Maltese: Bћala prekawzjoni hu preferribli li ma jintużax CINQAERO waqt it-tqala.
English: - The other excipients are sodium acetate, acetic acid glacial, sucrose and water for injections.
Maltese: - Is-sustanzi mhux attivi l-oħra huma sodium acetate, acetic acid glacial, sucrose u ilma għallinjezzjonijiet.
English: Eosinophil counts
Maltese: Reazzjoni avversa
English: Data by study Study I
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Placebo (n=244)
Maltese: (n=244)
English: In integrated Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (56% for subgroup GINA 4 and 5) compared to placebo.
Maltese: kellhom tnaqqis sinifikanti fl-aggravamenti tal-ażżma (56% għas-sottogrupp GINA 4 u 5) meta mqabbla mal-plaċebo.
English: Results of population pharmacokinetic analysis confirm that concomitant use of either leukotriene antagonists or systemic corticosteroids does not affect the pharmacokinetics of reslizumab (see section 5.2).
Maltese: leukotriene jew kortikosterojdi sistemiċi, ma jaffettwax il-farmakokinetika ta' reslizumab (ara sezzjoni 5.2).
English: In Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (50% and 59%, respectively) compared to placebo (see Table 4).
Maltese: Popolazzjoni totali Fi Studji I u II, il-pazjenti li kienu qed jirċievu reslizumab 3 mg/kg, kellhom tnaqqis sinifikanti fl aggravamenti tal-ażżma (50% u 59%, rispettivament) meta mqabbla mal-plaċebo (ara t-Tabella 4).
English: Store in a refrigerator (2 °C-8 °C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2°C-8°C).
English: Solutions of CINQAERO diluted in sodium chloride 9 mg/mL (0.9%) solution for infusion may be stored refrigerated at 2 °C-8 °C (or not above 25 °C if dilution has taken place in controlled and validated aseptic conditions), protected from light for up to 16 hours.
Maltese: soluzzjoni għall-infużjoni jistgħu jinħażnu fil-friġġ f'temperatura ta' 2°C-8°C (jew mhux aktar minn 25°C jekk id-dilwizzjoni tkun saret f'kondizzjonijiet asettiċi kkontrollati u validati), protetti mid-dawl għal massimu ta' 16-il siegħa.
English: 2 vials
Maltese: 1 kunjett 2 kunjetti
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Maltese: Studji f'annimali ma jurux effetti ħżiena diretti jew indiretti fuq is-sistema riproduttiva.
English: Slowly dispense the contents of the syringe(s) into an infusion bag containing 50 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion.
Maltese: Bil-mod, ferra' l-kontenut tas-siringa(i) ġo borża tal-infużjoni li jkun fiha 50 mL ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-infużjoni.
English: Eosinophils are white blood cells involved in asthma inflammation.
Maltese: Eosinofili huma huma ċelluli tad-demm bojod involuti fl-infjammazzjoni tal-ażżma.
English: One vial of 10 mL contains 100 mg reslizumab.
Maltese: Kull kunjett ta' 10 mL fih 100 mg ta' reslizumab.
English: * This dosing scheme is based on a maximum dose of 3 mg/kg.
Maltese: * Din l-iskema ta' dożaġġ hija bbażata fuq doża massima ta' 3 mg/kg.
English: The reduction in blood eosinophil counts by reslizumab in anti-reslizumab antibody-positive patients was not different from patients who were anti-reslizumab antibody-negative.
Maltese: It-tnaqqis fl-eosinofili tad-demm minn reslizumab f'pazjenti pożittivi għall-antikorpi kontra reslizumab, ma kienx differenti minn pazjenti li kienu negattivi għall-antikorpi kontra reslizumab.
English: One vial of 2.5 mL contains 25 mg reslizumab.
Maltese: Kull kunjett ta' 2.5 mL fih 25 mg ta' reslizumab.
English: Effect on sputum eosinophils
Maltese: Effett fuq l-eosinofili fid-demm
English: In both studies, an asthma exacerbation was defined as a worsening of asthma that required the following medical intervention: 1) use of systemic corticosteroids or an increase in the use of ICS treatment for 3 or more days, and/or 2) asthma-related emergency treatment including at least one of the following: an unscheduled visit to their healthcare professional for nebuliser treatment or other urgent treatment to prevent worsening of asthma symptoms; a visit to the emergency room for asthma-related treatment; or asthma-related hospitalisation.
Maltese: 1) użu ta' kortikosterojdi sistemiċi jew żieda fl-użu ta' kura ICS għal 3 ijiem jew aktar, u/jew 2) kura ta' emerġenza relatata mal-ażżma li tinkludi mill-inqas waħda minn dawn li ġejjin: żjara mhux skedata għand il-professjonista tal-kura tas-saħħa tagħhom għal kura permezz ta' nebulizzatur jew kura urġenti oħra għall-prevenzjoni ta' aggravament ta' sintomi tal-ażżma; żjara fit-taqsima tal emerġenza għal kura ta' emerġenza relatata mal-ażżma; jew li persuna tiddaħħal l-isptar minħabba lażżma.
English: Each vial of 2.5 mL contains 25 mg of reslizumab and each vial of 10 mL contains 100 mg of reslizumab.
Maltese: Kull kunjett ta' 2.5 mL fih 25 mg ta' reslizumab u kull kunjett ta' 10 mL fih 100 mg ta' reslizumab.
English: This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/mL (0.9%) solution for infusion.
Maltese: Dan il-prodott mediċinali ma jridx jitħallat ma' prodotti mediċinali oħrajn ħlief sodium chloride 9 mg/mL (0.9%)soluzzjoni għall-infużjoni.
English: The antibodies had no impact on clinical pharmacodynamics, efficacy or safety.
Maltese: L-antikorpi ma kellhom l-ebda impatt fuq il farmakodinamika klinika, l-effikaċja jew is-sigurtà.
English: The appropriate volume of CINQAERO should be dispensed into an infusion bag containing 50 mL sodium chloride 9 mg/mL (0.9%) solution for infusion.
Maltese: Il-volum xieraq ta' CINQAERO għandu jitpoġġa ġo borża tal-infużjoni li jkun fiha 50 mL sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-infużjoni.
English: Improvements were observed as early as 4 weeks following the first dose of reslizumab (AQLQ at 16 weeks) and sustained through week 52.
Maltese: reslizumab (AQLQ wara 16-il ġimgħa) u kien sostnut sa ġimgħa 52.
English: Patients with severe eosinophilic asthma
Maltese: Ħarsa ġenerali lejn l-effikaċja klinika
English: Reslizumab has a volume of distribution of approximately 5 L, suggesting minimal distribution to the extravascular tissues.
Maltese: Reslizumab għandu volum ta' distribuzzjoni ta' bejn wieħed u ieħor 5 L, li jissuġġerixxi distribuzzjoni minima għat-tessuti extravaskulari.
English: If an anaphylactic reaction occurs, administration of reslizumab should be stopped immediately and appropriate medical treatment should be provided; reslizumab must be discontinued permanently (see section 4.3).
Maltese: reslizumab irid jitwaqqaf b'mod permanenti (ara sezzjoni 4.3).
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of reslizumab in pregnant women.
Maltese: Tqala Għal reslizumab m'hemmx data jew hemm data limitata (inqas min 300 riżultat ta' tqala) dwar l-użu fin-nisa tqal.
English: d The percentage of patients with refractory asthma (based on the American Thoracic Society
Maltese: d Il-perċentwali ta' pazjenti b'ażżma refrattarja (ibbażat fuq id-definizzjoni tal-workshop tal-American Thoracic Society [ATS]/European Respiratory Society [ERS] 2000 għal ażżma refrattorja) minn
English: Anaphylactic reaction (see section 4.4) occurred in less than 1% of patients.
Maltese: Reazzjoni anafilattika (ara sezzjoni 4.4) seħħet f'inqas minn 1% tal-pazjenti.
English: In Studies I and II, severe eosinophilic asthma is defined as any patients falling into GINA steps 4 and 5 (medium- to high-dose ICS [≥ 440 µg fluticasone propionate] plus another controller, with or without maintenance OCS) with a blood eosinophil count of ≥400 µL-1 at start of treatment.
Maltese: passi 4 u 5 (doża medja sa għolja ta' ICS [≥ 440 µg fluticasone propionate] flimkien ma' kontrollur ieħor, bi jew mingħajr OCS ta' manteniment), b'għadd ta' eosinofili fid-demm ta' ≥400 µL-1 fil-bidu tal-kura.
English: CINQAERO blocks interleukin-5 activity and reduces the number of eosinophils in your blood and lungs.
Maltese: CINQAERO jimblokka attività ta' interleukin-5 u jnaqqas in-numru ta' eosinofili fid-demm u filpulmun tiegħek.
English: Manifestations included skin or mucosal involvement, dyspnoea, wheezing, gastrointestinal symptoms and chills.
Maltese: Is-sintomi kienu jinkludu involviment tal-ġilda jew tal-mukoża, qtugħ ta' nifs, tħarħir, sintomi gastrointestinali u tertir ta' bard.
English: Fertility There are no fertility data in humans.
Maltese: Fertilità M'hemmx data disponibbli dwar il-fertilità fil-bnedmin.
English: The malignancies observed in reslizumab-treated patients were diverse in nature and without clustering of any particular tissue type.
Maltese: It-tumuri malinni osservati fil-pazjenti kkurati b'reslizumab kienu differenti fin-natura u mingħajr clustering ta' kwalunkwe tip ta' tessut partikulari.
English: CINQAERO 10 mg/mL concentrate for solution for infusion
Maltese: CINQAERO 10 mg/mL konċentrat għal soluzzjoni għall-infużjoni
English: Baseline mean blood eosinophil count, µL-1
Maltese: Għadd ta' eosinofili fid-demm fil-linja bażi, µL-1
English: CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4 of Summary of Product Characteristics).
Maltese: CINQAERO għandu jingħata minn professjonist tal-kura tas-saħħa li jkun ippreparat biex jimmaniġġja reazzjonijiet ta' sensittività eċċessiva li jinkludu anafilassi (ara sezzjoni 4.4, Sommarju tal-karatteristiċi tal-prodott).
English: ** The nominal volume of the vials (10 mL or 2.5 mL for each vial) has to be used.
Maltese: ** Irid jintuża l-volum nominali tal-kunjetti (10 mL jew 2.5 mL għal kull kunjett).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment
English: In clinical Studies I and II with reslizumab 3 mg/kg, decreases in blood eosinophil counts were seen following the first dose and maintained through 52 weeks of treatment with no signs of tachyphylaxis.
Maltese: Fi studji kliniċi I u II b'reslizumab 3 mg/kg, ġie osservat tnaqqis fl-għadd ta' eosinofili fid-demm wara l-ewwel doża, u dan inżamm matul it-52 ġimgħa ta' kura mingħajr ebda sinjal ta' takifilassi.
English: No noteworthy differences in the pharmacokinetics of reslizumab were observed across these renal function groups.
Maltese: Ma ġiet osservata l-ebda differenza sinifikanti fil-farmakokinetika ta' reslizumab f'dawn il-gruppi.
English: [ATS]/European Respiratory Society [ERS] 2000 workshop definition for refractory asthma) from Studies I and II was analysed post hoc.
Maltese: Studji I u II, ġiet analizzata post hoc.
English: Vials with 2.5 mL concentrate (25 mg reslizumab)
Maltese: (25 mg reslizumab)
English: The effect of reslizumab in patients with asthma and elevated sputum eosinophil counts (at least 3%) was evaluated in a 15-week, phase 2, randomised, double-blind, placebo-controlled clinical study with reslizumab 3 mg/kg.
Maltese: ġie evalwat fi studju kliniku ta' fażi 2, li dam 15-il ġimgħa, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi plaċebo, b'reslizumab 3 mg/kg.
English: Interleukin-5 is a protein your body makes that plays a key role in inflammation in asthma by activating eosinophils.
Maltese: Interleukin-5 hi proteina li l-ġisem tiegħek jagħmel, li għandha rwol kruċjali fl-infjammazzjoni flażżma billi tattiva lill-eosinofili.
English: In the subset of patients requiring courses of OCS treatment for management of their asthma exacerbation, reslizumab was shown to reduce the frequency of asthma exacerbations by 56% (p<0.0001) and 60% (p<0.0001) in Study I and Study II, respectively.
Maltese: (p<0.0001) u 60% (p<0.0001) fi Studju I u Studju II, rispettivament.
English: GINA step 4 patients received medium- to high-dose ICS plus another controller.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Reslizumab has not been studied in patients concurrently taking immunosuppressant medicinal products other than oral corticosteroids (OCS); therefore, the safety and efficacy profile of reslizumab in these patients is unknown.
Maltese: Reslizumab ma ġiex studjat f'pazjenti li kienu qegħdin jieħdu fl-istess ħin prodott mediċinali immunosoppressanti ħlief kortikosterojdi orali (OCS); għalhekk, il-profil tas-sigurtà u l-effikaċja ta' reslizumab f'dawn il-pazjenti mhuwiex magħruf.
English: Do not use this medicine after the expiry date which is stated on the outer carton and label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u t-tikketta wara
English: CINQAERO is supplied in glass vials containing 2.5 mL or 10 mL.
Maltese: CINQAERO hu fornut f'kunjetti tal-ħġieġ li fihom 2.5 mL jew 10 mL.
English: (p<0.0001) a The values represent the treatment difference between placebo and reslizumab 3 mg/kg based on adjusted means over the specified time period for each treatment group, except for the change to week 16 for AQLQ, which was the first timepoint where AQLQ was assessed.
Maltese: Il-valuri jirrappreżentaw id-differenza fil-kura bejn il-plaċebo u reslizumab 3 mg/kg, ibbażata fuq ilmedji aġġustati matul il-perjodu ta' żmien speċifikat għal kull grupp ta' kura, ħlief għall-bidla sa ġimgħa 16 għal AQLQ, li kienet l-ewwel punt ta' żmien fejn AQLQ ġiet evalwata.
English: No treatment effect on asthma exacerbations was observed for this age group (asthma exacerbation rate ratio [reslizumab/placebo] of 2.09).
Maltese: Asthma Symptom Utility Index (ASUI), jappoġġja b'mod addizzjonali l-effikaċja ta' reslizumab
English: CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4).
Maltese: CINQAERO għandu jingħata minn professjonist tal-kura tas-saħħa li jkun ippreparat biex jimmaniġġja reazzjonijiet ta' sensittività eċċessiva li jinkludu anafilassi (ara sezzjoni 4.4).
English: During controlled clinical studies, the proportion of patients who discontinued due to any adverse event was 5% for both the 3 mg/kg reslizumab and placebo groups.
Maltese: Matul l-istudji kliniċi kkontrollati, il-proporzjon ta' pazjenti li waqfu minħabba kwalunkwe avveniment avvers, kien ta' 5% kemm għall-grupp ta' 3 mg/kg reslizumab kif ukoll għall-grupp tal plaċebo.
English: For dosing instructions see section 4.2 of Summary of Product Characteristics.
Maltese: Għal istruzzjonijiet dwar id-dożaġġ, ara sezzjoni 4.2 tas-Sommarju tal-Karatteristiċi tal-Prodott.
English: Chemical and physical in-use stability has been demonstrated at 2 °C-8 °C and at 25 °C in sodium chloride 9 mg/mL (0.9%) solution for infusion protected from light for up to 16 hours.
Maltese: 9 mg/mL (0.9%) soluzzjoni għall-infużjoni protetta mid-dawl għal sa 16-il siegħa.
English: Based on the characteristics of reslizumab, drug-drug interactions are not expected.
Maltese: Ibbażat fuq il karatteristiċi ta' reslizumab, interazzjonijiet bejn mediċina u oħra mhumiex mistennija.
English: Improvements were noted in FEV1 at 4 weeks following the first dose of reslizumab.
Maltese: Ġie osservat titjib f'FEV1 4 ġimgħat wara l-ewwel doża ta' reslizumab.
English: Patients with refractory asthmad
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: *See subsection “Description of selected adverse reactions” below
Maltese: *Ara subsezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” hawn taħt Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: 10 6336 Langkampfen Austria
Maltese: 10 6336 Langkampfen L-Awstrija
English: Date of first authorisation: 06 February 2009 Date of latest renewal: 13 November 2013
Maltese: Data tal-ewwel awtorizzazzjoni: 06 ta' Frar 2009 Data tal-aħħar tiġdid: 13 ta' Novembru 2013
English: Meta-Analysis
Maltese: Meta-Analiżi
English: Chronic GvHD TRM
Maltese: GvHD kronika TRM
English: N Acute Grade II - IV GvHD
Maltese: GvHD akuta ta' grad II - IV
English: European Retrospective Study (2004)
Maltese: Retrospettiva Ewropea Studju (2004)
English: * recombinant methionylated human granulocyte-colony stimulating factor (G-CSF) produced in E. coli by recombinant DNA technology.
Maltese: * recombinant methionylated human granulocyte-colony stimulating factor (G-CSF) magħmul f'E. coli b'teknoloġija tad-DNA rikombonanti.
English: HEXAL AG Industriestr.
Maltese: HEXAL AG
English: Common (≥ 1/100 to
Maltese: (≥1/100 sa
English: > 1.0 x 109/l for 3 consecutive days
Maltese: > 1.0 x 109/l għal 3 jiem konsekuttivi
English: Uncommon (≥ 1/1,000 to
Maltese: Mhux komuni (≥1/1,000 sa
English: Pulmonary adverse events
Maltese: Avvenimenti pulmonari avversi
English: Haemoptysis Dyspnoea Cougha Oropharyngeal paina, e
Maltese: Il-likwidu għandu jkun ċar u bla kulur sa ftit safrani.
English: Timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient.
Maltese: Meta tingħata l-lewkaferesi: 1 jew 2 lewkaferesi f'jiem 5 u 6 ta' spiss ikunu suffiċjenti.
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Maltese: Is-sigurtà u l-effikaċja tal-għoti ta' filgrastim f'pazjenti AML de novo li kellhom < 55 sena b'ċitoġeniċi tajbin [t(8;21), t(15;17), u inv(16)] ma kinux stabbiliti.
English: International Retrospective Study (2006)
Maltese: Studju (2006)
English: Filgrastim HEXAL contains sorbitol
Maltese: Filgrastim HEXAL fih sorbitol
English: SC/IV
Maltese: Filgrastim SC/IV