FrancophonIA/ELRC3.0 huggingface dataset:
English: Sivextro is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Maltese: Sivextro huwa antibijotiku li jintuża fl-adulti biex jikkura infezzjonijiet batteriċi akuti (għal żmien qasir) tal-ġilda u tal-istrutturi tal-ġilda (tessut taħt il-ġilda) bħal ċellulite (infjammazzjoni tat-tessut fil-fond tal-ġilda), axxessi tal-ġilda u infezzjonijiet fil-ġrieħi.
English: What are the risks associated with Sivextro?
Maltese: X'inhuma r-riskji assoċjati ma' Sivextro?
English: In light of the need for new antibiotics targeting multi-resistant bacteria, especially those available as an oral (given by mouth) formulation, the CHMP concluded that Sivextro could be a valuable alternative treatment option for bacterial infections of the skin and of skin structures.
Maltese: Fiddawl tal-ħtieġa għal antibijotiċi ġodda li jimmiraw batterji multi-reżistenti, speċjalment dawk disponibbli bħala formulazzjoni orali (li tingħata mill-ħalq), is-CHMP ikkonkluda li Sivextro jista' jkun għażla ta' kura alternattiva siewja għall-infezzjonijiet batteriċi tal-ġilda u tal-istrutturi tal-ġilda.
English: How does Sivextro work?
Maltese: Kif jintuża Sivextro?
English: The most common side effects with Sivextro (which may affect between 2 and 7 people in 100) are nausea (feeling sick), headache, diarrhoea and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Sivextro (li jistgħu jaffettwaw bejn żewġ persuni u 7 persuni minn kull 100) huma nawsja (tħossok ma tiflaħx), uġigħ ta' ras, dijarea u rimettar.
English: For the full list of all side effects and restrictions with Sivextro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Sivextro, ara l-fuljett ta' tagħrif.
English: A risk management plan has been developed to ensure that Sivextro is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Sivextro jintuża bl-aktar mod sigur possibbli.
English: Patients who are started on the infusion may be switched to the tablets when appropriate.
Maltese: Sivextro kien tal-inqas effikaċi daqs linezolid fil-kura tal-infezzjoni.
English: Condition considered essential for the safe and effective use of the medicinal product including pharmacovigilance
Maltese: Kundizzjoni meqjusa essenzjali għall-użu sigur u effettiv tal-prodott mediċinali inkluża l-farmakoviġilanza
English: a prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination mentioned in the opinion should be performed.
Maltese: għandu jsir studju ta' osservazzjoni prospettiv imsemmi fl-opinjoni bl-għan li jiġu vvalutati rrakkomandazzjonijiet tal-preskrizzjoni ta' Mifepristone Linepharma għat-terminazzjoni ta' tqala bikrija.
English: The National Competent Authorities coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti kkoordinati mill-Istat Membru ta' Referenza, għandhom jiżguraw li l-MAH jissodisfa l-kundizzjonijiet li ġejjin:
English: The submission of a revised protocol should take place within 10 days after the Commission Decision.
Maltese: Is-sottomissjoni ta' protokoll rivedut għandha sseħħ fi żmien għaxart (10) ijiem mid-Deċiżjoni talKummissjoni.
English: Further information on Arsenic trioxide Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
Maltese: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
English: Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Maltese: Pazjenti bl-APL huma normalment ikkurati birretinojdi (sustanzi derivati mill-vitamina A).
English: Arsenic trioxide Accord (arsenic trioxide)
Maltese: Arsenic trioxide Accord (triossidu tal-arseniku)
English: Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Maltese: Arsenic trioxide Accord jintuża għall-kura ta' adulti (minn 18-il sena 'l fuq) li jbatu minn lewkimja promjeloċitika akuta (APL), forma rari ta' lewkimja (kanċer taċ-ċelloli bojod tad-demm) ikkawżata minn “trażlokazzjoni” ġenetika (meta jkun hemm tpartit ta' ġene bejn żewġ kromożomi).
English: Arsenic trioxide Accord contains the active substance arsenic trioxide and is a ‘generic medicine'.
Maltese: Arsenic trioxide Accord fih is-sustanza attiva triossidu tal-arseniku u huwa “mediċina ġenerika”.
English: It is given as an infusion (drip) into a vein.
Maltese: Jingħata bħala infużjoni (dripp) ġolvina.
English: If this does not happen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.
Maltese: Jekk dan ma jseħħx sal jum 50 (għall-pazjenti li kienu kkurati preċedentement) jew sal-jum 60 (għall-pazjenti li jkunu għadhom kemm ġew dijanjostikati), il-kura għandha titwaqqaf.
English: Other information about Arsenic trioxide Accord
Maltese: Informazzjoni oħra dwar Arsenic trioxide Accord
English: Because Arsenic trioxide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Arsenic trioxide Accord huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu listess bħal dawk tal-mediċina ta' referenza.
English: • Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid.
Maltese: • Pazjenti li għadhom kemm ġew dijanjostikati b'riskju żgħir jew intermedju ta' APL meta jintuża flimkien mal-mediċina aċidu transretinojtiku kollu.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Accord.
Maltese: Studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użijiet awtorizzati diġà twettqu bil-mediċina ta' referenza, Trisenox, u m'għandhomx għalfejn jiġu ripetuti għal Arsenic trioxide Accord.
English: Arsenic trioxide Accord is used in:
Maltese: Arsenic trioxide Accord jintuża fuq:
English: There was no need for ‘bioequivalence' studies to investigate whether Arsenic trioxide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' “bijoekwivalenza” biex jiġi investigat jekk Arsenic trioxide Accord jiġix assorbit b'mod simili bħall-mediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fid-demm.
English: Treatment is divided into 2 phases: induction and consolidation.
Maltese: Il-kura hija maqsuma f'żewġ fażijiet: l-induzzjoni u l-konsolidazzjoni.
English: What are the benefits and risks of Arsenic trioxide Accord?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Arsenic trioxide Accord?
English: This means that Arsenic trioxide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Trisenox.
Maltese: Dan ifisser li Arsenic trioxide Accord fih l-istess sustanza attiva u jaħdem bl-istess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Trisenox.
English: What measures are being taken to ensure the safe and effective use of Arsenic trioxide Accord?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Arsenic trioxide Accord?
English: This is because Arsenic trioxide Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Maltese: Dan minħabba li Arsenic trioxide Accord jingħata permezz ta' infużjoni ġol-vina, u għalhekk is-sustanza attiva tmur direttament fid-demm.
English: The active substance in the medicine, arsenic trioxide, has been used in medicines for many years, including for the treatment of leukaemia.
Maltese: Is-sustanza attiva fil-mediċina, it-triossidu tal-arseniku, intużat f'mediċini għal ħafna snin, inkluż għallkura tal-lewkimja.
English: The recommended dose of Arsenic trioxide Accord depends on the patient's weight.
Maltese: Id-doża rrakkomandata ta' Arsenic trioxide Accord tiddependi mill-piż tal-pazjent.
English: Side effects reported with Arsenic trioxide Accord are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Arsenic trioxide Accord huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: As for all medicines, data on the use of Arsenic trioxide Accord are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Arsenic trioxide Accord hija ssorveljata kontinwament.
English: • Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
Maltese: • Pazjenti li jbatu minn APL li l-marda tagħhom ma rrispondietx għall-kura preċedenti bir-retinojdi u l-mediċini kontra l-kanċer, jew meta l-marda tagħhom tkun reġgħet feġġitilhom wara dan it-tip ta' kura.
English: How has Arsenic trioxide Accord been studied?
Maltese: Kif ġie studjat Arsenic trioxide Accord?
English: The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).
Maltese: Ittrażlokazzjoni taffettwa l-mod ta' kif jikbru ċ-ċelloli bojod tad-demm, u b'riżultat ta' dan ma jkollhomx il-kapaċità li jużaw l-aċidu retinojiku (vitamina A).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Accord has been shown to be comparable to Trisenox.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, f'konformità mar-rekwiżiti tal-UE, Arsenic trioxide Accord intwera li huwa komparabbli ma' Trisenox.
English: EMA/453925/2014 EMEA/H/C/000441
Maltese: EMEA/H/C/000441
English: The full EPAR for Insulatard 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 active substance in Insulatard, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Maltese: Is-sustanza attiva f'Insulatard, linsulina umana, hi prodotta b'metodu magħruf bħala ‘teknoloġija rekombinanti': dan isir minn ċelloli tal-ħmira li fihom tkun ġiet introdotta ġene (DNA) li tagħmilhom kapaċi jipproduċu l-insulina.
English: What is Insulatard?
Maltese: Insulatard?
English: This is a summary of the European public assessment report (EPAR) for Insulatard.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Insulatard.
English: Insulatard is a suspension for injection that contains the active substance human insulin.
Maltese: Insulatard huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva insulina umana.
English: Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Maltese: Insulatard ġie studjat f'erba' provi kliniċi ewlenin, li inkludew total ta' 557 pazjent bid-dijabete tat-tip 1, li fiha l-frixa ma tkunx tista' tipproduċi insulina (żewġ studji li involvew 81 pazjent), jew dijabete tattip 2, meta l-ġisem ma jkunx jista' juża l-insulina b'mod effikaċi (żewġ studji li involvew 476 pazjent).
English: Insulatard is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Maltese: Insulatard jingħata bħala injezzjoni taħt il-ġilda, normalment fil-koxxa, fl-addome (fil-parti ta' quddiem tal-qadd), fil-parti tal-glutei (il-warrani), jew fil-parti deltojde (l-ispalla).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard on 7 October 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Insulatard valida fl-Unjoni Ewropea kollha fis-7 ta' Ottubru 2002.
English: It is available as vials, cartridges (Penfill), or pre-filled pens (InnoLet or FlexPen).
Maltese: Jiġi fi vjali, stoċċijiet (Penfill), jew pinnen mimlija minn qabel (InnoLet jew FlexPen).
English: The studies measured the levels of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached).
Maltese: L-istudji kejlu l-livelli tal-glukożju tad-demm waqt sawm jew l-emoglobina glikosilatata (HbA1c, l-emoglobina fid-demm li għandha l-glukożju magħha).
English: Insulatard is a replacement insulin which is very similar to the insulin made by the pancreas.
Maltese: Insulatard huwa insulina ta' sostituzzjoni simili ħafna għall-insulina prodotta mill-frixa.
English: In most patients, Insulatard was compared with other types of human insulin or insulin analogues.
Maltese: Fil-biċċa l-kbira tal-pazjenti, Insulatard tqabbel ma' tipi oħra ta' insulina umana jew analogi talinsulina.
English: Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day.
Maltese: Insulatard fih insulina mħallta ma' sustanza oħra, il-protamina, f'forma ‘iżofana' li tiġi assorbita iktar bil-mod matul il-jum.
English: Why has Insulatard been approved?
Maltese: Għaliex ġie approvat Insulatard?
English: Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins.
Maltese: Insulatard wassal għal tnaqqis fil-livell ta' HbA1c, li jindika li l-livelli ta' zokkor fid-demm kienu ġew ikkontrollati f'livell simili bħal dak b'insulini umani oħra.
English: A risk management plan has been developed to ensure that Insulatard is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Insulatard jintuża bl-aktar mod sigur possibbli.
English: How has Insulatard been studied?
Maltese: Kif ġie studjat Insulatard?
English: Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
Maltese: Insulatard kien effettiv għad-dijabete kemm tat-tip 1 kif ukoll tat-tip 2, u meta tintuża injezzjoni standard jew waħda mill-pinen mimlija minn qabel.
English: The CHMP decided that Insulatard's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Insulatard huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Insulatard is a long-acting insulin.
Maltese: X'inhu Insulatard?
English: The most common side effect with Insulatard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Maltese: L-effett sekondarju l-aktar komuni b'Insulatard (li deher f'iktar minn pazjent 1 minn kull 10) huwa ipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: What is the risk associated with Insulatard?
Maltese: X'inhu r-riskju assoċjat ma' Insulatard?
English: System Organ Class (SOC)
Maltese: Organi (SOC - System Organ Class)
English: ORR (%) [95% CI] CR (%)
Maltese: ORR (%) [CI ta' 95%] CR (%)
English: The active substance is axicabtagene ciloleucel.
Maltese: Is-sustanza attiva hi axicabtagene ciloleucel.
English: 2132 NT Hoofddorp The Netherlands
Maltese: 2132 NT Hoofddorp In-Netherlands
English: N/A = not available/not applicable (a) Lee et al 2014.
Maltese: N/A = mhux disponibbli/mhux applikabbli (a) Lee et al 2014.
English: Kite Pharma, Inc. 2355 Utah Avenue El Segundo California CA 90245
Maltese: Kite Pharma, Inc. 2355 Utah Avenue El Segundo
English: Sodium chloride Human albumin
Maltese: Sodium chloride Albumin uman
English: 1098 XH Amsterdam The Netherlands
Maltese: 1098 XH Amsterdam In-Netherlands
English: Excipients: Cryostor CS10, human albumin, sodium chloride.
Maltese: Eċċipjenti: Cryostor CS10, albumin uman, sodium chloride.
English: Outcomes were consistent between patients with Eastern Cooperative Oncology Group (ECOG) of 0 and 1 and by sex.
Maltese: Ir-riżultati kienu konsistenti bejn pazjenti b'Eastern Cooperative Oncology Group (ECOG) ta' 0 u 1 u skont is-sess.
English: CRS occurred in 93% of patients.
Maltese: CRS seħħ fi 93% tal-pazjenti.
English: Each bag of YESCARTA contains 300 mg sodium.
Maltese: Kull borża ta' YESCARTA fiha 300 mg sodium.
English: • An antihistamine such as diphenhydramine.
Maltese: • Antistamina bħal diphenhydramine.
English: CR rates were 75% and 56%, respectively.
Maltese: Ir-rati ta' CR kienu 75% u 56%, rispettivament.
English: HCP Educational program
Maltese: Programm Edukattiv għall-HCP
English: Levels of cytokines and chemokines such as IL-6, IL-8, IL-10, IL-15, TNF-α, IFN-γ, and IL2Rα were analyzed.
Maltese: Il-livelli ta' ċitokini u kimokini bħal IL-6, IL-8, IL-10, IL-15, TNF-α, IFN-γ, u IL2Rα ġew analizzati.
English: 6229 EV Maastricht The Netherlands
Maltese: 6229 EV Maastricht In-Netherlands
English: Availability of tocilizumab and site qualification
Maltese: Disponibbiltà ta' tocilizumab u kwalifika tas-sit
English: Secondary endpoints included duration of response (DOR), overall survival (OS), and severity of adverse events.
Maltese: L-iskopijiet finali sekondarji inkludew tul tar-rispons (DOR - duration of response), sopravivenza globali (OSoverall survival), u severità tal-avvenimenti avversi.
English: Active uncontrolled infection.
Maltese: • Infezzjoni attiva mhux ikkontrollata.
English: Primary central nervous system (CNS) lymphoma
Maltese: Limfoma primarja tas-sistema nervuża ċentrali (CNS - central nervous system)
English: Prior treatment with anti-CD19 therapy
Maltese: Trattament fil-passat b'terapija kontra CD19
English: - Confusion.
Maltese: Konfużjoni.
English: 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
Maltese: Il-frekwenzi huma ddefiniti bħala: 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).
English: 6229EV Maastricht The Netherlands
Maltese: 6229EV Maastricht In-Netherlands
English: The ORR was 26% [95% CI (21, 31)] and the CR rate was 7% [95% CI (3, 15)], with a median OS of 6.3 months.
Maltese: L-ORR kienet ta' 26% [CI ta' 95% (21, 31)] u r-rata ta' CRkienet ta' 7% [CI ta' 95% (3, 15)], b'OS medjana ta' 6.3 xhur.
English: Generally, safety and efficacy were similar between patients ≥ 65 years and patients < 65 years of age treated with
Maltese: Ġeneralment, is-sigurtà u leffikaċja kienu simili bejn pazjenti ta' ≥ 65 sena u pazjenti ta' età < 65 sena ttrattati b'YESCARTA.
English: See section 2 “YESCARTA contains sodium”.
Maltese: Ara sezzjoni 2 “YESCARTA fih sodium”.
English: • YESCARTA is a one-time treatment.
Maltese: • YESCARTA huwa trattament ta' darba.
English: For example:
Maltese: JIS:
English: Tumour lysis syndrome (TLS)
Maltese: Sindrome ta' liżi tat-tumur (TLS - tumour lysis syndrome)
English: - Hypersensitivity.
Maltese: Sensittività eċċessiva.
English: Dysphagia*
Maltese: Disfaġja*
English: YESCARTA contains sodium
Maltese: YESCARTA fih sodium
English: YESCARTA is a type of medicine called a “genetically modified cell therapy”.
Maltese: YESCARTA huwa tip ta' mediċina msejħa “terapija ta' ċelluli ġenetikament modifikati”.
English: YESCARTA 0.4 - 2 x 108 cells dispersion for infusion
Maltese: YESCARTA 0.4 - 2 x 108 ċelluli dispersjoni għal infużjoni
English: NE (12.8, NE)
Maltese: (11.6, NE) NE (12.8, NE) NE (12.8, NE)
English: There is limited experience with YESCARTA in patients ≥ 75 years of age.
Maltese: Hemm esperjenza limitata b'YESCARTA f'pazjenti b'età ta' ≥ 75 sena.
English: In the phase 1 part of ZUMA-1, 7 patients were treated.
Maltese: Fil-parti ta' fażi 1 ta' ZUMA-1, ġew ittrattati 7 pazjenti.
English: • After treatment while the immune system is recovering.
Maltese: • Wara t-trattament waqt li s-sistema immuni tkun qed tirkupra.
English: Administer tocilizumab per Table 1 for management of Grade 2 CRS.
Maltese: Agħti tocilizumab skont it-Tabella 1 għall-immaniġġjar ta' CRS ta' Grad 2.
English: • Paracetamol 500-1,000 mg given orally and diphenhydramine 12.5 to 25 mg intravenous or oral
Maltese: • Hu rakkomandat li jingħata paracetamol 500-1,000 mg oralment u diphenhydramine 12.5 sa 25 mg ġol-vini jew orali (jew ekwivalenti) madwar siegħa qabel l-infużjoni ta' YESCARTA.
English: Administer methylprednisolone 1 mg/kg intravenously twice daily or equivalent dexamethasone (e.g., 10 mg intravenously every 6 hours).
Maltese: Agħti methylprednisolone 1 mg/kg ġol-vini darbtejn kuljum jew dexamethasone ekwivalenti (eż., 10 mg ġol-vini kull 6 sigħat).
English: Diagnosis of CRS requires excluding alternate causes of systemic inflammatory response, including infection.
Maltese: Id-dijanjosi ta' CRS teħtieġ li jiġu esklużi kawżi alternattivi ta' rispons infjammatorju sistemiku, inkluża infezzjoni.
English: Of the 111 patients in the ITT population, the ORR was 66% and the CR was 47%.
Maltese: Mill-111-il pazjent fil-popolazzjoni ITT, l-ORR kienet ta' 66% u s-CR kien ta' 47%.
English: Patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection
Maltese: Pazjenti b'infezzjoni tal-virus tal-immunodefiċjenza umana (HIV - human immunodeficiency virus), tal-virus tal-epatite B (HBV - hepatitis B virus) u tal-virus tal-epatite Ċ (HCV - hepatitis C virus) M'hemm l-ebda esperjenza klinika f'pazjenti b'infezzjoni attiva tal-HIV, HBV jew HCV.
English: 17.4 (11.6, NE) 17.4 (11.6, NE) NE (12.8, NE)
Maltese: 17.4 (11.6, NE) 17.4
English: Annual safety reports and 5-yearly interim reports
Maltese: 5 rapporti interim ta' kull sena
English: • Prime the tubing with 0.9% sodium chloride solution (0.154 mmol sodium per mL) prior to infusion.
Maltese: • Ipprajmja t-tubi b'soluzzjoni ta' 0.9% sodium chloride (0.154 mmol ta' sodium f'kull mL) qabel l-infużjoni.
English: The most common Grade 3 or higher adverse reactions included encephalopathy (31%), unspecified pathogen infections (19%), CRS (11%), bacterial infection (9%), aphasia (7%), viral infection (6%), delirium (6%), hypotension (6%), and hypertension (6%).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni ta' Grad 3 jew ogħla inkludew enċefalopatija (31%), infezzjonijiet ta' patoġenu mhux speċifikat (19%), CRS (11%), infezzjoni batterika (9%), afasja (7%), infezzjoni virali (6%), thewdin (6%), pressjoni baxxa (6%), u pressjoni għolja (6%).
English: DLBCL in ZUMA-1 included patients with DLBCL NOS, other DLBCL subtypes, and high-grade B-cell lymphoma (HGBCL) based on the 2016 WHO-classification.
Maltese: DLBCL f'ZUMA-1 inkludiet pazjenti b'DLBCL NOS, sottotipi ta' DLBCL oħra, u limfoma taċċellula B ta' grad għoli (HGBCL - high-grade B-cell lymphoma) abbażi tal-klassifikazzjoni tad-WHO tal-2016.
English: YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy.
Maltese: YESCARTA (axicabtagene ciloleucel) huwa immunoterapija taċ-ċelluli T awtologi ġenetikament modifikati diretta lejn CD19.
English: EU/1/18/1299/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1299/001
English: Of these, 49 patients had GCB-type and 17 patients had ABC-type.
Maltese: Minn dawn, 49 pazjent kellhom tip GCB u 17-il pazjent kellhom tip ABC.
English: • Infuse the entire content of the YESCARTA bag within 30 minutes by either gravity or a peristaltic pump.
Maltese: • Infuża l-kontenut kollu tal-borża ta' YESCARTA fi 30 minuta bil-gravità jew b'pompa peristaltika.