FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline.
Maltese: Fil-pazjenti inklużi fil-prova klinika, 40%-50%
English: The most common adverse reactions reported in clinical studies with Zavesca were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati fi studji kliniċi b'Zavesca kienu dijarea, gass flistonku, uġigħ addominali, telf ta' piż u rogħda (ara sezzjoni 4.4).
English: Use of Zavesca in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Maltese: (b'rata ta' tneħħija tal-krejatinina ta' < 30 ml/min/1.73 m2) mhux irrakkomandat.
English: After 3 years of continuous Zavesca treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Maltese: 17.5% u 29.6%, rispettivament.
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Maltese: FARMAĊEWTIKA U KONTENUT
English: Other studies revealed changes in sperm parameters (motility and morphology) consistent with an observed reduction in fertility.
Maltese: Studji oħrajn urew bidliet fil-parametri ta' l-isperma (moviment u morfoloġija) li kienu konsistenti mat-tnaqqis fil-fertilità osservata.
English: Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Maltese: Zavesca jista' jintuża biss għall-kura ta' dawk il-pazjenti fejn it terapija ta' sostituzzjoni ta' l-enzimi mhijiex adattata (ara sezzjonijiet 4.4 u 5.1).
English: • Zavesca is used to treat mild to moderate type 1 Gaucher disease in adults.
Maltese: • Zavesca huwa wżat għall-kura tal-marda ta' Gaucher ta' tip 1 ħafifa sa moderata fl-adulti.
English: Capsule, hard White capsules with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Maltese: Kapsuli bojod b'“OGT 918” miktub bl-iswed fuq l-għatu u “100” miktub bl-iswed fuq il-korp talkapsula.
English: For the full list of excipients, see section 6.1.
Maltese: Kull kapsula fiha 100mg ta' miglustat Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: You must use effective birth control while taking Zavesca.
Maltese: Għandek tuża metodu ta' kontraċezzjoni effettiv waqt li tieħu Zavesca.
English: GENERAL CLASSIFICATION FOR SUPPLY 15.
Maltese: Issepara fil-perforazzjonijiet 2.
English: There is no experience with the use of Zavesca in patients over the age of 70.
Maltese: M'hemmx esperjenza bl-użu ta' Zavesca f'pazjenti b'età 'l fuq minn 70 sena.
English: Renal impairment
Maltese: Doża rrakkomandata
English: Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia
Maltese: Tqalligħ, rimettar, nefħa/skomdu addominali, stitikezza, dispepsja
English: Printing ink
Maltese: X'fih Zavesca
English: The 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: maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Zavesca contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Maltese: Zavesca fih is-sustanza attiva miglustat li tappartieni għal grupp ta' mediċini li jaffettwaw il metaboliżmu.
English: Repeated-dose toxicity studies in rats showed effects on the seminiferous epithelium of the testes.
Maltese: Studji dwar l-effett tossiku minn dożi ripetuti fil-firien juru effetti fuq l-epitelju seminiferu tat testikoli.
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Zavesca (see section 4).
Maltese: It-tabib tiegħek jista' jnaqqas id-doża tiegħek, eż., għall-kapsula waħda (100 mg) darba jew darbtejn kuljum, jekk inti ssofri minn dijarea meta tieħu Zavesca (ara sezzjoni 4).
English: Male patients should maintain reliable contraceptive methods while taking Zavesca (see sections 4.4 and 5.3).
Maltese: Pazjenti rġiel għandhom jibqgħu jużaw metodu affidabbli ta' kontraċezzjoni waqt it-teħid ta' Zavesca (ara sezzjonijiet 4.4 u
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: TAL-UŻU SIGUR EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Pharmacokinetic parameters of miglustat were assessed in healthy subjects, in a small number of patients with type 1 Gaucher disease, Fabry disease, HIV-infected patients, and in adults, adolescents and children with Niemann-Pick type C disease or type 3 Gaucher disease.
Maltese: pazjenti li kellhom il-marda ta' Gaucher ta' tip 1, il-marda ta' Fabry, pazjenti infetti bl-HIV, u f'adulti adoloxxenti u tfal bil-marda ta' Niemann-Pick ta' tip Ċ jew il-marda ta' Gaucher ta' tip 3.
English: The survey included a case series of 66 patients treated with Zavesca outside of the clinical trial for a mean duration of 1.5 years.
Maltese: każijiet ta' 66 pazjent ikkurati b'Zavesca barra mill-prova klinika għal medja ta' tul ta' żmien ta' 1.5 snin.
English: In clinical practice, miglustat-induced gastrointestinal events have been observed to respond to individualised diet modification (for example reduction of sucrose, lactose and other carbohydrate intake), to taking Zavesca between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
Maltese: (per eżempju tnaqqis f'sucrose, lactose u fit-teħid ta' karboidrati oħra), għat-teħid ta' Zavesca bejn likliet, u/jew għal prodotti mediċinali kontra d-dijarea bħal loperamide.
English: The efficacy of Zavesca in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Maltese: L-effikaċja ta' Zavesca fi tfal u adoloxxenti b'età minn 0-17-il sena bil-marda ta' Gaucher tat-tip 1 għada ma ġietx determinata s'issa.
English: Nerve conduction studies abnormal
Maltese: Studji ta' trasmissjoni tan-nervaturi mhux normali
English: Overall the data show that treatment with Zavesca can reduce the progression of clinically relevant neurological symptoms in patients with Niemann-Pick type C disease.
Maltese: Globalment it-tagħrif wera li kura b'Zavesca tista' tnaqqas il-progressjoni tas-sintomi newroloġiċi klinikament rilevanti f'pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ.
English: Psychiatric disorders Common
Maltese: Disturbi psikjatriċi
English: Your doctor will perform some tests before and during treatment with Zavesca to assess this (see section 2).
Maltese: It-tabib tiegħek se jagħmel xi testijiet qabel u waqt kura b'Zavesca sabiex jivvaluta dan (ara sezzjoni 2).
English: The benefit of treatment with Zavesca for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Zavesca, (see section 4.4).
Maltese: Il-benefiċċju ta' kura b'Zavesca għall-manifestazzjonijiet newroloġiċi f'pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ għandu jiġi evalwat fuq bażi regolari, eż. kull 6 xhur; jekk għandhiex titkompla it-terapija għandu jiġi ivvalutat mill-ġdid wara mill-inqas sena ta' kura b'Zavesca, (ara sezzjoni 4.4).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC Code: A16AX06
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Janssen-Cilag Ltd. Tel: +44 1 494 567 444
Maltese: Tel: +44 1 494 567 444
English: Among the 41 patients enrolled in the trial 14 patients were treated with Zavesca for more than 3 years.
Maltese: Fost il-41 pazjent li ħadu sehem fil-prova 14-il pazjent kienu kkurati b'Zavesca għal aktar minn 3 snin.
English: Thrombocytopenia Metabolism and nutrition disorders Very common
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall
English: The recommended dose for the treatment of adolescent patients (12 years of age and above) with Niemann-Pick type C disease is 200 mg three times a day.
Maltese: Id-doża rrakkomandata għall-kura ta' pazjenti adoloxxenti (età minn 12-il sena 'l fuq) li għandhom ilmarda Niemann Pick tip Ċ hija ta' 200 mg tliet darbiet kuljum.
English: Zavesca has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Maltese: Zavesca ma ġiex studjat f'pazjenti b'passat ta' mard gastro-intestinali sinifikanti, inkluż il-marda ta'
English: Diarrhoea, flatulence, abdominal pain
Maltese: Komuni ħafna Dijarea, gass, uġigħ addominali
English: The usual dose of Zavesca in adult patients was 200 mg t.i.d., and was adjusted according to body surface area in paediatric patients.
Maltese: Id-doża tas-soltu ta' Zavesca f'pazjenti adulti kienet 200 mg t.i.d., u kienet aġġustata kif meħtieġ skond l-erja tas-superfiċje tal-ġisem f'pazjenti pedjatriċi.
English: Pharmacokinetic data were obtained in paediatric patients with type 3 Gaucher disease aged 3 to 15 years, and patients with Niemann-Pick type C disease aged 5-16 years.
Maltese: Tagħrif farmakokinetiku kien miksub minn pazjenti pedjatriċi bil-marda ta' Gaucher ta' tip 3 b'età minn 3 snin sa 15-il sena u minn pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ b'età minn 5 snin sa
English: Gaucher disease is an inherited metabolic disorder caused by a failure to degrade glucosylceramide resulting in lysosomal storage of this material and widespread pathology.
Maltese: Il-marda ta' Gaucher hi marda metabolika li tintiret ġenetikament li hi kkawżata min-nuqqas fil-kapaċità tal-ġisem biex ikisser il-glucosylceramide, li jirriżulta fil-ħżin ta' lysosomal ta' dan il-materjal u f'patoloġija mifruxa.
English: Zavesca has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Maltese: Zavesca kien studjat f'indikazzjonijiet fejn ċertu avvenimenti rrapportati bħala reazzjonijiet avversi, bħal sintomi/sinjali newroloġiċi u newropsikoloġiċi, disfunzjoni konoxxittiva u tromboċitopenja jista' jkunu kkawżata wkoll mill-marda li ġa hemm.
English: Miglustat did not show any potential for mutagenic or clastogenic effects in the standard battery of genotoxicity tests.
Maltese: Miglustat ma wera l-ebda potenzjal għal effetti mutaġeniċi jew klastoġeniċi fit-testijiet stàndard ta'
English: The mechanism is most likely inhibition of intestinal disaccharidases such as sucrase-isomaltase in the gastrointestinal tract leading to reduced absorption of dietary disaccharides.
Maltese: Billi tirrapporta l effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din ilmediċina.
English: Concomitant administration of food decreases the rate of absorption (Cmax was decreased by 36% and tmax delayed 2 hours), but has no statistically significant effect on the extent of absorption of miglustat (AUC decreased by 14%).
Maltese: Zavesca jittieħed ma' l-ikel, ir-rata ta' l-assorbiment tonqos (Cmax naqset b'36% u tmax intlaħaq sagħtejn iktar tard min-normal), imma dan m'għandu l-ebda effett statistikament sinifikanti fuq l ammont ta' assorbiment ta' miglustat (AUC naqset b'14%).
English: Zavesca works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Maltese: Zavesca jaħdem billi jinibixxi l-enzima msejjħa ‘glucosylceramide synthase' li hija responsabbli għall ewwel pass fis-sintesi tal-biċċa l-kbira tal-glycosphingolipids.
English: Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas,
Maltese: Effetti oħrajn li dehru fl-annimali b'dożi li jirriżultaw f'livelli ta' espożizzjoni simili għal jew moderatament ogħla mil-livelli ta' espożizzjoni kliniċi kienu: bidliet fl-organi tal-limfojde fl-ispeċi kollha ttestjati, bidliet fit-transaminase,
English: Blood and lymphatic system disorders Common
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni
English: How to store Zavesca
Maltese: Kif taħżen Zavesca
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Maltese: UŻU Prodott mediċinali jingħata li b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: The neurological manifestations are considered secondary to the abnormal accumulation of glycosphingolipids in neuronal and glial cells.
Maltese: Il manifestazzjonijet newroloġiċi huma kkunsidrati sekondarji għall-akkumulazzjoni mhux normali ta' glycosphingolipids fiċ-ċelluli newronali u glijali.
English: For the suspensions of intravenous gadodiamide, gadopentetic acid, and gadoversetamide containing medicinal products to be lifted, the Marketing Authorisation Holder(s) shall provide evidence
Maltese: Biex jitneħħew is-sospensjonijiet ta' prodotti mediċinali li fihom gadodiamide, gadopentetic acid, u gadoversetamide ġol-vini, id-Detentur(i) tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu/għandhom jippreżenta(w) evidenza
English: Annex IV Conditions for lifting the suspension of the marketing authorisations
Maltese: Anness IV Kondizzjonijiet għat-tneħħija tas-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq
English: • for clinically important benefits that are currently not established in an identified population or indication and which outweigh the risks related to the product.
Maltese: • għal benefiċċji klinikament importanti li bħalissa mhumiex stabbiliti f'popolazzjoni jew f'indikazzjoni identifikata u li huma akbar mir-riskji relatati mal-prodott.
English: • or that the product (potentially modified or not) does not undergo significant dechelation and does not lead to retention of gadolinium in tissues.
Maltese: • jew li l-prodott (potenzjalment modifikat jew le) ma jgħaddix minn dekelazzjoni sinifikanti u ma jwassalx għaż-żamma ta' gadolinium fit-tessuti.
English: Conditions for lifting the suspension of the marketing authorisation(s)
Maltese: Kondizzjonijiet għat-tneħħija tas-sospensjoni talawtorizzazzjoni(jiet) għat-tqegħid fis-suq
English: EMA/78726/2014 EMEA/H/C/000606
Maltese: EMEA/H/C/000606
English: The full EPAR for Xolair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The effects were maintained after 6 months of treatment.
Maltese: L-effetti nżammu wara 6 xhur ta' trattament.
English: The active substance in Xolair, omalizumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva fi Xolair, l-omalizumab, hi antikorp monoklonali.
English: This document is a summary of the European public assessment report (EPAR) for Xolair.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Xolair.
English: Patients aged 12 years or over must also have reduced lung function (less than 80% of normal).
Maltese: Pazjenti minn 12-il sena 'l fuq għandu jkollhom ukoll funzjoni pulmonari mnaqqsa (inqas minn 80% tan-normal).
English: Each vial and syringe contains 75 or 150 mg of omalizumab.
Maltese: Kull kunjett u siringa jkun fiha 75 jew 150 mg omalizumab.
English: In patients with chronic spontaneous urticaria, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are sinusitis (inflammation of the sinuses), headache, arthralgia (joint pain), injection site reactions and upper respiratory tract infection (colds).
Maltese: F'pazjenti b'urtikarja spontanja kronika, l-effetti sekondarji l-aktar komuni bi Xolair (li dehru f'bejn pazjent 1 u 10 minn kull 100) kienu sinusitis (infjammazzjoni tas-sinus), uġigħ ta' ras, artralġija (uġigħ fil-ġogi), reazzjonijiet fis-sit tal-injezzjoni u infezzjoni fil-passaġġ respiratorju tan-naħa ta' fuq (irjiħat).
English: Xolair is a medicine that contains the active substance omalizumab.
Maltese: Xolair huwa mediċina li fiha s-sustanza attiva omalizumab.
English: This summary was last updated in 02-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'02-2014.
English: Why has Xolair been approved?
Maltese: Għaliex ġie approvat Xolair?
English: In the studies in patients with chronic spontaneous urticaria, following 12 weeks of treatment, Xolair 300 mg improved the symptoms of itching by 4.5 to 5.8 points more than placebo.
Maltese: Fl-istudji fil-pazjenti b'urtikarja spontanja kronika, wara 12-il ġimgħa ta' trattament, 300 mg ta' Xolair tejjeb is-sintomi tal-ħakk b'4.5 sa 5.8 punti aktar minn plaċebo.
English: Xolair has also been investigated in 3 main studies involving a total of 978 patients with chronic spontaneous urticaria who did not respond to antihistamine-based treatment.
Maltese: Xolair kien investigat ukoll fi 3 studji ewlenin li fihom ħadu sehem total ta' 978 pazjent b'ultikarja spontanja kronika li ma kinux irrispondew għal trattament ibbażat fuq antiistamina.
English: Xolair has been studied in over 2,000 patients aged 12 years or over with allergic asthma in five main studies, including one study involving 482 patients with severe allergic asthma that was not controlled by conventional treatments.
Maltese: Xolair ġie studjat f'aktar minn 2 000 pazjent minn 12-il sena 'l fuq b'ażma allerġika f'ħames studji ewlenin, inkluż wieħed li fih ħadu sehem 482 pazjent b'ażma allerġika gravi li ma kinitx ikkontrollata bit-trattamenti konvenzjonali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xolair on 25 October 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Xolair valida fl-Unjoni Ewropea kollha fil-25 ta' Ottubru 2005.
English: The usual dose range is between 75 and 600 mg in one to four injections, and the maximum recommended dose is 600 mg every two weeks.
Maltese: Il-medda tad-doża normali hija bejn 75 u 600 mg f'bejn injezzjoni waħda u erbgħa, u d-doża massima rakkomandata hi 600 mg kull ġimagħtejn.
English: Xolair is also used to treat chronic (long-term) spontaneous urticaria (itchy rash).
Maltese: Xolair jintuża wkoll għat-trattament ta' urtikarja (raxx bil-ħakk) spontanja kronika (fit-tul).
English: Patients with low IgE levels are less likely to benefit from the medicine.
Maltese: Hu inqas probabbli li l-pazjenti b'livelli baxxi ta' IgE jibbenefikaw mill-mediċina.
English: What is Xolair?
Maltese: X'inhu Xolair?
English: It usually takes 12 to 16 weeks for Xolair to show a benefit.
Maltese: Biex Xolair juri benefiċċju, normalment idum minn 12 sa 16-il ġimgħa.
English: In patients with allergic asthma aged 12 years and over, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are headache and injection site reactions, including swelling, redness, pain and itching.
Maltese: Fil-pazjenti minn 12-il sena 'l fuq li kellhom ażma allerġika, l-effetti sekondarji l-aktar komuni bi Xolair (li dehru f'bejn pazjent 1 u 10 minn kull 100) kienu l-uġigħ ta' ras u r-reazzjonijiet fis-sit tal-injezzjoni, inklużi nefħa, ħmura, uġigħ u ħakk.
English: A risk management plan has been developed to ensure that Xolair is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Xolair jintuża bl-aktar mod sigur possibbli.
English: Among the 235 children who were being treated with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist before the start of the study, there was an average of 0.4 exacerbations over the first 24 weeks of treatment in those receiving Xolair, compared with 0.6 in those receiving placebo.
Maltese: Fost il-235 tifel u tifla li ġew ittrattati b'dożi għoljin ta' kortikosterojdi li jingħataw man-nifs u agonista beta2 li jaġixxi fit-tul u jittieħed man-nifs qabel il-bidu tal-istudju, kien hemm medja ta' 0.4 tqanqiliet fuq l-ewwel 24 ġimgħa ta' trattament f'dawk li ħadu Xolair, meta mqabbel ma' 0.6 f'dawk li ħadu plaċebo.
English: Xolair treatment should only be considered when the asthma is caused by an antibody called immunoglobulin E (IgE).
Maltese: It-trattament bi Xolair għandu jkun ikkunsidrat biss meta l-ażma tkun ikkawżata minn antikorp imsejjaħ immunoglobulin E (IgE).
English: Xolair is used to improve the control of severe persistent asthma that is caused by an allergy.
Maltese: Xolair jintuża għat-titjib tal-kontroll ta' ażma gravi persistenti kkawżata minn allerġija.
English: It has also been studied in 627 children aged between six and 12 years.
Maltese: Ġie studjat ukoll f'627 tifel u tifla bejn is-6 snin u t-12-il sena.
English: The CHMP also concluded that Xolair (300 mg) was shown to significantly improve the symptoms of chronic spontaneous urticaria when used as add-on to the patients' existing treatment, but noted that study data on long-term use beyond 6 months are limited.
Maltese: IsCHMP ikkonkluda wkoll li Xolair (300 mg) intwera li jtejjeb b'mod sinifikanti s-sintomi ta' urtikarja spontanja kronika meta ntuża bħala żieda għat-trattament eżistenti tal-pazjenti, iżda nnota li d-dejta minn studji dwar l-użu fit-tul ta' aktar minn 6 xhur hija limitata.
English: For the treatment of chronic spontaneous urticaria, Xolair is given by a healthcare professional by injection under the skin of the shoulder or the thigh, in a dose of 300 mg every four weeks.
Maltese: Għat-trattament ta' urtikarja spontanja kronika, Xolair jingħata minn professjonist tal-kura tas-saħħa bħala injezzjoni taħt il-ġilda tal-ispalla jew il-koxxa, b'doża ta' 300 mg kull erba' ġimgħat.
English: • they must have had a positive skin test result for an allergy caused by an allergen (a stimulus that causes an allergy) in the air, such as house dust mites, pollen or mould;
Maltese: • irid ikollhom riżultat pożittiv ta' test tal-ġilda għal allerġija kkawżata minn allerġen (stimolu li jikkawża allerġija) fl-arja, bħal insetti mikroskopiċi tat-trab li jinsabu fid-djar, polline jew moffa;
English: What is the risk associated with Xolair?
Maltese: Għal xiex jintuża Xolair?
English: The Committee concluded that, overall, there was a pattern of results in the studies of Xolair in asthma that show that the medicine is effective in treating severe allergic asthma.
Maltese: Il-Kumitat ikkonkluda li, globalment, kien hemm tendenza ta' riżultati fl-istudji ta' Xolair għall-ażma, li turi li hu effikaċi fit-trattament tal-ażma allerġika gravi.
English: Xolair treatment should be started by a doctor who has experience in the treatment of severe persistent asthma or chronic spontaneous urticaria.
Maltese: It-trattament bi Xolair għandu jinbeda minn tabib li jkollu esperjenza fit-trattament tal-ażma gravi persistenti jew urtikarja spontanja kronika.
English: The main measure of effectiveness was the change in itching severity after 12 weeks of treatment, as measured on a scale ranging from 0 (no itch) to 21 (maximum itch severity).
Maltese: Il-kejl ewlieni taleffikaċja kien il-bidla fil-gravità tal-ħakk wara 12-il ġimgħa ta' trattament, imkejla fuq skala b'firxa minn 0 (l-ebda ħakk) sa 21 (il-massimu tal-gravità tal-ħakk.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Maltese: Antikorp monoklonali hu antikorp (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' struttura speċifika (imsejħa antiġen) fil-ġisem.
English: Omalizumab has been designed to attach to human IgE, which is produced in large quantities in patients with allergies and triggers an allergic reaction in response to an allergen.
Maltese: Lomalizumab tfassal biex jeħel mal-IgE uman, li jiġi prodott fi kwantitajiet kbar fil-pazjenti li jkollhom allerġiji u jqanqal reazzjoni allerġika b'rispons għall-allerġen.
English: Other information about Xolair:
Maltese: Tagħrif ieħor dwar Xolair: