FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, women (n = 150) who received 3 doses of Gardasil 9 in Protocol 001 and a challenge dose 5 years later, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month postdose 3.
Maltese: Barra minn hekk, nisa (n = 150) li rċivew 3 dożi ta' Gardasil 9 fil-Protokoll 001 u doża ta' ċalinġ 5 snin wara, urew rispons anamnestiku malajr u qawwi li kien akbar mill-GMTs ta' kontra HPV osservati xahar wara d-doża 3.
English: On the basis of this immunogenicity bridging, the efficacy of a 2dose regimen of Gardasil 9 in girls and boys aged 9 to 14 years is inferred.
Maltese: Ma ġiex determinat it-tul ta' żmien tal-protezzjoni bi skeda ta' 2 dożi ta' Gardasil 9.
English: Additional efficacy evaluation of Gardasil 9 against vaccine HPV types Since the efficacy of Gardasil 9 could not be evaluated against placebo, the following exploratory analyses were conducted.
Maltese: Valutazzjoni addizzjonali tal-effikaċja ta' Gardasil 9 kontra t-tipi tal-HPV tal-vaċċin Minħabba li l-effikaċja ta' Gardasil 9 ma setgħetx tiġi vvalutata kontra l-plaċebo, saru l-analiżi esploratorji li ġejjin.
English: Safety and immunogenicity in individuals who have received immunoglobulin or blood-derived products during the 3 months prior to vaccination have not been studied in clinical trials.
Maltese: Is-sigurtà u l-immunoġeniċità f'individwi li rċevew immunoglobulina jew prodotti oħra li ġejjin middemm fit-3 xhur ta' qabel it-tilqim ma ġewx studjati fi provi kliniċi.
English: There are no data on the use of Gardasil 9 in individuals with impaired immune responsiveness.
Maltese: Ma teżistix dejta dwar l-użu ta' Gardasil 9 f'individwi b'indeboliment fir-rispons immuni.
English: Gardasil 9 also reduced the incidence of HPV 31-, 33-, 45-, 52-, and 58-related Pap test abnormalities, cervical and external genital procedures (i.e., biopsies), and cervical definitive therapy procedures (Table 4).
Maltese: Gardasil 9 naqqas ukoll l-inċidenza ta' anormalitajiet tat-test Pap, proċeduri tal-għonq tal-utru u tal-ġenitali esterni (i.e., bijopsiji), u proċeduri ta' terapija definittiva tal-għonq tal-utru marbuta ma' HPV 31, 33, 45, 52, u 58 (Tabella 4).
English: Tel: +386.1.520.4201 msd.slovenia@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201 msd.slovenia@merck.com
English: Anti-HPV responses at Month 7 among girls/boys aged 9 to 15 years were comparable to anti-HPV responses in women aged 16 to 26 years in the combined database of immunogenicity studies for Gardasil 9.
Maltese: Risponsi kontra HPV f'Xahar 7 fost subien/bniet b'età minn 9 snin sa 15-il sena kienu komparabbli ma' risponsi kontra HPV f'nisa b'età minn 16 sa 26 sena fid-dejtabejż ikkombinata ta' studji ta'
English: HPV 31-, 33-, 45-, 52-, 58-related Persistent Infection ≥6 Months HPV 31-, 33-, 45-, 52-, 58-related Persistent Infection ≥12 Months HPV 31-, 33-, 45-, 52-, 58-related ASC-US HR-HPV Positive or Worse Pap Abnormality
Maltese: Fi Protokoll 001 li kien l-istudju l-aktar importanti, ġiet stmata l-effikaċja ta' Gardasil 9 kontra ttipi 31, 33, 45, 52, u 58 ta' HPV meta mqabbla mal-vaċċin qHPV f'nisa b'età minn 16 sa 26 sena
English: 1 dose (0.5 ml) contains approximately:
Maltese: U KWANTITATTIVA Doża waħda (0.5 ml) fiha madwar:
English: High immunogenicity in MSM aged 16 to 26 years was also observed, although lower than in HM, similarly to qHPV vaccine.
Maltese: Kienet osservata ukoll immunoġeniċità għolja f'MSM b'età minn 16 sa 26 sena, għalkemm aktar baxxa minn f'HM, simili għall-vaċċin qHPV.
English: The indication of Gardasil 9 is based on:
Maltese: Gardasil 9 jista' jingħata skont skeda ta' 3 dożi:
English: Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you or your child. - Keep this leaflet.
Maltese: Id-data ta' meta jiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: Studies supporting the efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58
Maltese: CIN3 marbuta ma' HPV 31, 33, 45, 52, 58
English: • demonstration of non-inferior immunogenicity between Gardasil 9 and the qHPV vaccine for HPV types 6, 11, 16 and 18 in girls aged 9 to 15 years, women and men aged 16 to 26 years; efficacy for Gardasil 9 against persistent infection and disease related to HPV types 6, 11, 16, or 18 can be inferred to be comparable to that of the qHPV vaccine.
Maltese: b'konsegwenza li tista' tinġibed konklużjoni li l-effikaċja ta' Gardasil 9 kontra infezzjoni persistenti u mard marbut mat-tipi 6, 11, 16, jew 18 ta' HPV hija komparabbli ma' dik tal vaċċin qHPV.
English: Individuals 15 years of age and older at time of first injection Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule.
Maltese: Gardasil 9 għandu jingħata skont skeda ta' 3 dożi (0, 2, 6 xhur).
English: Loop electrosurgical excision procedure (LEEP) or conisation.
Maltese: u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Efficacy and/or immunogenicity of Gardasil 9 were assessed in ten clinical studies.
Maltese: L-effikaċja u/jew l-immunoġeniċità ta' Gardasil 9 ġew ivvalutati f'għaxar studji kliniċi.
English: The efficacy of Gardasil 9 against CIN 3 related to vaccine HPV types compared to qHPV vaccine was 100% (95% CI 46.3, 100.0) with 0/5,952 versus 8/5,947 cases.
Maltese: Leffikaċja ta' Gardasil 9 kontra CIN 3 marbuta mat-tipi tal-HPV tal-vaċċin mqabbla mal-vaċċin qHPV kienet ta' 100% (CI ta' 95% 46.3, 100.
English: *Number of individuals with at least one follow-up visit after Month 7.
Maltese: *Numru ta' individwi b'mill-inqas vista waħda ta' segwitu wara
English: Type-specific immunoassays with type-specific standards were used to assess immunogenicity to each vaccine HPV type.
Maltese: Analiżi ta' immunità speċifika għat-tip bi standards speċifiċi għat-tip intużaw biex jistmaw limmunoġeniċità għal kull tip ta' HPV tal-vaċċin.
English: Fotivda is available as capsules (890 and 1,340 micrograms).
Maltese: Fotivda jiġi bħala kapsuli (890 u 1,340 mikrogramma).
English: The full EPAR for Fotivda 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: It contains the active substance tivozanib.
Maltese: Dan fih is-sustanza attiva tivozanib.
English: This is a summary of the European public assessment report (EPAR) for Fotivda.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Fotivda.
English: Other information about Fotivda
Maltese: Informazzjoni oħra dwar Fotivda
English: Why is Fotivda approved?
Maltese: Għaliex ġie approvat Fotivda?
English: Fotivda is a medicine for treating adults with advanced renal cell carcinoma (a kidney cancer).
Maltese: Fotivda huwa mediċina għall-kura tal-adulti b'karċinoma avvanzata fiċ-ċelloli renali (kanċer tal-kliewi).
English: On the whole, its side effects are in line with what is expected of a medicine of its class (VEGF inhibitors).
Maltese: B'mod globali, l-effetti sekondarji tiegħu huma konformi ma' dak li hu mistenni minn mediċina ta' din il-klassi (inibituri ta' VEGF).
English: If the patient has troublesome side effects, the doctor may decide to switch to the lower-strength 890-microgram capsules or interrupt treatment.
Maltese: Jekk il-pazjent ikollu effetti sekondarji inkwetanti, it-tabib jista' jiddeċiedi li jeqleb għall-kapsuli ta' qawwa inqas ta' 890 mikrogramma jew li jinterrompi l-kura.
English: What are the risks associated with Fotivda?
Maltese: X'inhuma r-riskji assoċjati ma' Fotivda?
English: The usual dose is one 1,340-microgram capsule once a day for three weeks, followed by a week when the patient does not take any capsules.
Maltese: Id-doża normali hija ta' kapsula waħda ta' 1,340 mikrogramma darba kuljum għal tliet ġimgħat, segwita minn ġimgħa meta l-pazjent ma jieħu lebda kapsula.
English: The active substance in Fotivda, tivozanib, works by blocking the activity of proteins known as VEGF, which stimulate the formation of new blood vessels.
Maltese: Is-sustanza attiva f'Fotivda, tivozanib, taħdem billi timblokka l-attività tal-proteini magħrufa bħala VEGF, li jistimulaw il-formazzjoni ta' vażi ġodda.
English: By blocking this protein, tivozanib stops the formation of new blood vessels that the tumour needs, thereby cutting off its blood supply and reducing the growth of the cancer.
Maltese: Billi jimblokka din il-proteina, tivozanib iwaqqaf ilformazzjoni ta' vażi ġodda li jkun jeħtieġ it-tumur, u b'hekk jaqta' l-provvista tad-demm tiegħu u jnaqqas it-tkabbir tal-kanċer.
English: The most important serious side effect with Fotivda is high blood pressure.
Maltese: L-effett sekondarju serju l-aktar importanti b'Fotivda huwa pressjoni tad-demm għolja.
English: How is Fotivda used?
Maltese: Kif jaħdem Fotivda?
English: The most common side effects are high blood pressure (which occurs in almost half of patients) and voice changes, tiredness and diarrhoea (which occur in about a quarter of patients).
Maltese: L-effetti sekondarji l-aktar komuni huma pressjoni tad-demm għolja (li sseħħ fi kważi nofs il-pazjenti) u tibdil fil-vuċi, għeja u dijarea (li jseħħu f'madwar kwart tal-pazjenti).
English: Patients must not take St John's wort (a herbal remedy for depression) during treatment with Fotivda.
Maltese: Il-pazjenti m'għandhomx jieħdu St John's wort (rimedju erbali għad-dipressjoni) matul il-kura b'Fotivda.
English: What measures are being taken to ensure the safe and effective use of Fotivda?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Fotivda?
English: A main study showed that Fotivda increased the time it took for the disease to get worse by almost 3 months when compared with another approved medicine sorafenib.
Maltese: Għaldaqstant l-Aġenzija Ewropea għall-Mediċini kkonkludiet li l-benefiċċji ta' Fotivda huma akbar mirriskji tiegħu u rrakkomandat li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: In this study, patients taking Fotivda lived for longer without their disease worsening (12 months) than those given another approved medicine sorafenib (9 months).
Maltese: F'dan l-istudju, il-pazjenti li kienu qed jieħdu Fotivda għexu għal aktar żmien mingħajr ma l-marda tagħhom iggravat (12-il xahar) minn dawk li ngħataw mediċina approvata oħra, sorafenib (9 xhur).
English: What benefits of Fotivda have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Fotivda li ħarġu mill-istudji?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fotivda have been included in the summary of product characteristics and the package leaflet.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif ġew inklużi r-rakkomandazzjonijiet u lprekawzjonijiet li għandhom ikunu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u millpazjenti għall-użu sigur u effettiv ta' Fotivda.
English: 12 May 2016 EMA/89167/2016
Maltese: EMA/89167/2016
English: More information on Uptravi 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: Uptravi contains the active substance selexipag.
Maltese: Uptavi fih is-sustanza attiva selexipag.
English: Uptravi is available in different strengths (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms).
Maltese: Uptravi huwa disponibbli f'qawwiet differenti (200; 400; 600; 800; 1,000; 1,200; 1,400 u 1,600 mikrogramma).
English: • Uptravi is available as tablets in different strengths (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms).
Maltese: • Uptravi huwa disponibbli bħala pilloli f'qawwiet differenti (200; 400; 600; 800; 1,000; 1,200; 1,400 u 1,600 mikrogramma).
English: During titration, the 200 and 800 micrograms strengths are used.
Maltese: Waqt it-titrazzjoni, jintużaw ilqawwiet ta' 200 u 800 mikrogramma.
English: Healthcare professionals expected to prescribe and dispense Uptravi (selexipag) will be given an educational brochure to ensure that the medicine is used correctly.
Maltese: Il-professjonisti tal-kura tas-saħħa li huma mistennija li jagħtu b'riċetta u jqassmu Uptravi (selexipag) għadhom jingħataw fuljett edukattiv sabiex jiżguraw li l-mediċina tintuża b'mod tajjeb.
English: • If you tolerate this dose, your doctor will then increase your dose usually every week by 200 micrograms twice daily, up to a maximum of 1,600 micrograms twice daily as detailed in the following diagram:
Maltese: • Jekk inti tittollera din id-doża, it-tabib tiegħek ser iżid id-doża tiegħek normalment kull ġimgħa b'200 mikrogramma darbtejn kuljum, sa massimu ta' 1,600 mikrogramma darbtejn kuljum kif imniżżel fid-dijagramma li ġejja:
English: • Before prescribing or dispensing Uptravi, healthcare professionals should give patients a titration guide and diary to help them keep track of the number of tablets they take.
Maltese: • Jekk waqt it-titrazzjoni jkollok diffikultà biex tittollera ċerti effetti sekondarji, it-tabib tiegħek jista' jnaqqaslek id-doża billi jnaqqas n-numru ta' pilloli li tieħu.
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Maltese: Il-PAH hija marda debilitanti fejn ikun hemm tidjiq sostanzjali tal-vini tad-demm tal-pulmuni.
English: Educational brochure for healthcare professionals and diary for patients using Uptravi
Maltese: Informazzjoni għall-professjonisti tal-kura tas-saħħa
English: If the patient tolerates the dose, the doctor may increase the dose every week by 200 micrograms twice daily, up to a maximum of 1,600 micrograms twice daily.
Maltese: Jekk il-pazjent jittollera d-doża, ittabib jista' jżid id-doża kull ġimgħa b'200 mikrogramma darbtejn kuljum, sa massimu ta' 1,600 mikrogramma darbtejn kuljum.
English: Underdosing may result in lack of effect whereas overdosing may lead to side effects such as headache, diarrhoea, nausea and vomiting.
Maltese: Doża anqas tista' tirriżulta f'nuqqas ta' effett filwaqt li doża eċċessiva tista' twassal għal effetti sekondarji bħal uġigħ ta' ras, dijarea, nawżja u rimettar.
English: • If the patient tolerates the dose, the dose can be increased weekly by 200 micrograms twice daily, up to a maximum of 1,600 micrograms twice daily.
Maltese: • Jekk il-pazjent jittollera d-doża, id-doża tista' tiżdied kull ġimgħa b'200 mikrogramma darbtejn kuljum, sa massimu ta' 1,600 mikrogramma darbtejn kuljum.
English: The fact that Uptravi is available in different strengths and that the dose is changed usually weekly during the titration phase may lead to confusion and errors by patients when taking the medicine.
Maltese: Il-fatt li Uptravi huwa disponibbli f'qawwiet differenti u li ġeneralment id-doża hija mibdula darba filġimgħa waqt il-fażi tat-titrazzjoni jista' jwassal għal konfużjoni u żbalji mill-pazjenti meta jieħdu lmediċina.
English: • You will start treatment with one 200 microgram tablet twice a day, in the morning and in the evening (approximately 12 hours apart).
Maltese: • Inti ser tibda l-kura b'pillola waħda ta' 200 mikrogramma darbtejn kuljum, filgħodu u filgħaxija (bejn wieħed u ieħor f'intervalli ta' 12-il siegħa).
English: • When prescribing Uptravi, healthcare professionals should follow the instructions provided in the summary of product characteristics and the educational material for Uptravi (brochure).
Maltese: • Meta jagħtu Uptravi b'riċetta, il-professjonisti tal-kura tas-saħħa għandhom isegwu l-istruzzjonijiet ipprovduti fis-sommarju tal-karatteristiċi tal-prodott u l-materjal edukattiv għal Uptravi (fuljett).
English: Once you have gone through the 4 steps of increasing the dose and are at step 5, you will be taking both the 200 microgram and the 800 microgram strengths at the same time.
Maltese: Ladarba tkun għaddejt mill-4 stadji ta' żieda fid-doża u tinsab fi stadju 5, inti ser tkun qed tieħu kemm il-qawwa ta' 200 mikrogramma kif ukoll il-qawwa ta' 800 mikrogramma fl-istess ħin.
English: Treatment with Uptravi includes an initial titration phase, whereby the patient receives a low starting dose which is gradually increased over several weeks to a maintenance dose, which is continued longterm.
Maltese: Il-kura b'Uptravi tinkludi fażi ta' titrazzjoni inizjali, fejn il-pazjent jirċievi doża baxxa tal-bidu li tiżdied bil-mod fuq diversi ġimgħat għal doża ta' manteniment, li titkompla fit-tul.
English: • Once a suitable dose for you has been established (known as the maintenance dose), the doctor may prescribe a different strength of Uptravi tablet so you only need to take one tablet in the morning and one in the evening to get the right amount of the medicine.
Maltese: • Ladarba tiġi stabbilita doża xierqa għalik (magħrufa bħala doża ta' manteniment), it-tabib jista' jagħtik b'riċetta qawwa differenti tal-pillola Uptravi sabiex inti tkun teħtieġ biss pillola waħda filgħodu u waħda filgħaxija sabiex tieħu l-ammont tajjeb tal-mediċina.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations.
Maltese: ema.europa.eu/mt/medicines/human/orphan-designations.
English: Further information on Blincyto can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/blincyto.
Maltese: ema.europa.eu/medicines/Human/EPAR/blincyto.
English: Blincyto received a conditional marketing authorisation valid throughout the EU on 23 November 2015.
Maltese: Blincyto rċieva awtorizzazzjoni kondizzjonali għat-tqegħid fis-suq valida fl-UE kollha fit-23 ta' Novembru 2015.
English: Other information about Blincyto
Maltese: Informazzjoni oħra dwar Blincyto
English: The most common side effects with Blincyto (which may affect more than 1 in 10 people) are infections, fever, infusion-related reactions (like fever, changes in blood pressure and rash), headache, febrile neutropenia (low levels a type of white blood cell counts called neutrophils with fever), anaemia (low red blood cell counts), oedema (swelling because of fluid retention), neutropenia, leukopenia (low levels of white blood cell), thrombocytopenia (low platelet count), blood tests showing changes in liver function, tremor (shaking), back pain, chills, low blood pressure, low levels of immunoglobulins (antibodies), cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), rapid heartbeat, insomnia (difficulty sleeping), pain in the arms and legs, cough and rash.
Maltese: L-effetti sekondarji l-aktar komuni bi Blincyto (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet, deni, reazzjonijiet relatati mal-infużjoni (bħal deni, tibdil fil-pressjoni tad-demm u raxx), uġigħ ta' ras, newtropenija bid-deni (livelli baxxi fl-għadd ta' tip ta' ċellola bajda tad-demm imsejħa newtrofili bid-deni), anemija (għadd baxx taċ-ċelloli ħomor tad-demm), edema (nefħa minħabba żamma ta' fluwidu), newtropenija, lewkopenija (livelli baxxi ta' ċelloli bojod tad-demm), tromboċitopenja (għadd baxx tal-pjastrini), testijiet tad-demm li juru tibdil fil-funzjoni tal-fwied, tertir (rogħda), uġigħ fid-dahar, dehxiet ta' bard, pressjoni baxxa tad-demm, livelli baxxi ta' immunoglobini
English: Treatment may be interrupted or stopped altogether in case of certain side effects.
Maltese: Il-kura tista' tiġi interrotta jew imwaqqfa kompletament f'każ ta' ċerti effetti sekondarji.
English: ALL is rare, and Blincyto was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009.
Maltese: ALL hija rari, u Blincyto ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl24 ta' Lulju 2009.
English: The active substance in Blincyto, blinatumomab, is an antibody that has been designed to attach to a protein (CD19) found on B cells, including ALL cells.
Maltese: Is-sustanza attiva fi Blincyto, il-blinatumomab, hija antikorp li tfassal biex jeħel ma' proteina (CD19) li tinstab fuq iċ-ċelloli B, inklużi ċ-ċelloli tal-ALL.
English: The study found that ALL improved in 43% (81 out of 189) of patients given Blincyto.
Maltese: L-istudju sab li l-ALL tjiebet fi 43 % (81 minn 189) tal-pazjenti li ngħataw Blincyto.
English: What are the risks associated with Blincyto?
Maltese: X'inhuma r-riskji assoċjati ma' Blincyto?
English: As for all medicines, data on the use of Blincyto are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Blincyto hija ssorveljata kontinwament.
English: A study in 70 children aged 1 year and above with Philadelphia-chromosome-negative B-precursor ALL found that in 33% of patients treatment with Blincyto led to a resolution of the disease.
Maltese: Studju f'70 tifel u tifla li kellhom sena u aktar b'ALL prekursura B negattiva għall-kromożoma Philadelphia sab li fi 33 % tal-pazjenti, il-kura bi Blincyto wasslet għall-għajbien tal-marda.
English: The most serious side effects were infections, neutropenia with or without fever, neurological events (such as confusion, shaking, dizziness, numbness or tingling), cytokine release syndrome, and tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Maltese: L-effetti sekondarji l-aktar serji kienu infezzjonijiet, newtropenija bid-deni jew mingħajr deni, avvenimenti newroloġiċi (bħal konfużjoni, rogħda, sturdament, tnemnim jew tingiż), sindrome ta' rilaxx ta' ċitokini u sindrome ta' liżi tat-tumur (kumplikazzjoni minħabba t-tkissir taċ-ċelloli tal-kanċer).
English: Blincyto is used in patients who are ‘Philadelphia-chromosome-negative' which means that the patients' cancer cells do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their cancer cells (CD19-positive).
Maltese: Blincyto jintuża għal pazjenti li huma "negattivi għall-kromożoma Philadelphia" li jfisser li ċ-ċelloli talkanċer tal-pazjenti ma jkollhomx kromożoma anormali msejħa l-kromożoma Philadelphia, u f'pazjenti li jkollhom il-proteina CD19 fuq iċ-ċelloli tal-kanċer tagħhom (pożittivi għas-CD19).
English: Patients should also be given chemotherapy medicines injected in the spine area to prevent leukaemia in the nervous system.
Maltese: Il-pazjenti għandhom jingħataw ukoll mediċini tal-kimoterapija injettati fil-parti talispina biex tiġi evitata lewkimja fis-sistema nervuża.
English: Blincyto is given by infusion (drip) into a vein using a pump device.
Maltese: Blincyto jingħata permezz ta' infużjoni (dripp) ġo vina billi jintuża apparat tal-ippumpjar.
English: Blincyto has been studied in one main study in 189 Philadelphia-chromosome-negative adults with Bprecursor ALL whose leukaemia had come back or had not improved with treatment.
Maltese: Blincyto ġie studjat fi studju ewlieni wieħed f'189 adult negattivi għall-kromożoma Philadelphia b'ALL prekursura B li l-lewkimja tagħhom tkun irritornat jew li ma marrux għall-aħjar bil-kura.
English: It also attaches to a protein (CD3) on T cells (another type of white blood cell).
Maltese: Dan jeħel ukoll ma' proteina (CD3) li tinstab fuq iċ-ċelloli T (tip ieħor ta' ċellola bajda tad-demm).
English: Blincyto contains the active substance blinatumomab and is used on its own.
Maltese: Blincyto fih is-sustanza attiva blinatumomab u jintuża waħdu.
English: For the full list of side effects of Blincyto, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Blincyto, ara l-fuljett ta' tagħrif.
English: Blincyto (blinatumomab)
Maltese: Kif jintuża Blincyto?
English: The Agency noted that Blincyto is beneficial for high-risk adults and children with Philadelphia-chromosome-negative B-precursor ALL who have few therapeutic options and who generally have a poor prognosis.
Maltese: L-Aġenzija nnutat li Blincyto huwa ta' benefiċċju għal adulti u tfal b'riskju kbir b'ALL prekursura B negattiva għall-kromożoma Philadelphia li jkollhom ftit għażliet terapewtiċi u li ġeneralment ikollhom pronjożi ħażina.
English: Side effects reported with Blincyto are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Blincyto huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.