FrancophonIA/ELRC3.0 huggingface dataset:
English: Vascular disorders hypotension, capillary leak syndrome hypertension hypovolaemic shock, veno-occlusive disease
Maltese: Disturbi vaskulari pressjoni baxxa, sindrome ta᾽ tnixxija kapillari pressjoni għolja xokk ipovolaemiku, marda venookkulżiva
English: The patient should be primed with 10 mg/kg/day, starting 3 days prior to dinutuximab beta infusion.
Maltese: Il-pazjenti jenħtieġ li jingħata 10 mg/kg/jum, li tibda 3 ijiem qabel l-infużjoni ta᾽ dinutuximab beta.
English: Overall, 10% of CLS were severe (grade 3-4) and their frequency decreased over the treatment courses.
Maltese: B᾽mod ġenerali, 10 % tas-CLS kienu severi (grad 3-4) u l-frekwenza tagħhom naqset matul il-korsijiet tal-kura.
English: • decreased appetite, nausea, abdominal distension, accumulation of fluid in the abdominal cavity
Maltese: • nuqqas t᾽aptit, dardir, nefħa addominali, akkumulazzjoni ta᾽ fluwidu fil-kavità addominali
English: Relapsed patients
Maltese: Pazjenti refrattarji
English: • rapid swelling of arms, legs and other body parts, rapid drop in blood pressure, light-headedness and breathing difficulties (capillary leak syndrome)
Maltese: • nefħa rapida tad-dirgħajn, tar-riġlejn u ta᾽ partijiet oħra tal-ġisem, tnaqqis rapidu fil-pressjoni tad-demm, sturdament u diffikultajiet biex tieħu nifs (sindrome ta᾽ tnixxija kapillari)
English: The daily dose of gabapentin is increased to 2×10 mg/kg/day orally, the next day and to 3×10 mg/kg/day orally, the day before the onset of dinutuximab beta infusion and thereafter.
Maltese: Iddoża ta᾽ kuljum ta᾽ gabapentin tiżdied għal 2×10 mg/kg/jum mill-ħalq, il-jum ta᾽ wara u għal 3×10 mg/kg/jum mill-ħalq, il-jum qabel il-bidu tal-infużjoni ta᾽ dinutuximab beta u minn hemm ᾽il quddiem.
English: Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25 °C (50 mL syringe) and for up to 7 days at 37 ºC (250 mL infusion bag), after cumulative storage in a refrigerator (2 °C - 8 °C) for 72 hours.
Maltese: L-istabilità kimika u fiżika waqt l-użu ntweriet sa 48 siegħa f᾽25°C (siringa ta᾽ 50 mL) u sa 7 ijiem f᾽37ºC (borża tal-infużjoni ta᾽ 250 mL), wara ħżin kumulattiv fi friġġ (2°C - 8°C) għal 72 siegħa.
English: For continuous infusions, the solution is administered at a rate of 2 mL per hour (48 mL per day) using an infusion pump.
Maltese: Għal infużjonijiet kontinwi, is-soluzzjoni tingħata b᾽rata ta᾽ 2 mL kull siegħa (48 mL kuljum) bl-użu ta᾽ pompa tal-infużjoni.
English: The first 5-day course should start 7 days prior to the first infusion of dinutuximab beta and the second 5-day course should start concurrently with dinutuximab beta infusion (days 1 to 5 of each dinutuximab beta course).
Maltese: L-ewwel kors ta᾽ 5 ijiem jenħtieġ li jibda 7 ijiem qabel l-ewwel infużjoni ta᾽ dinutuximab beta u t-tieni kors ta᾽ 5 ijiem jenħieġ li jibda fl-istess ħin mal-infużjoni ta᾽ dinutuximab beta (jiem 1 sa 5 ta᾽ kull kors ta᾽ dinutuximab beta).
English: Overall, these 98 patients had primary refractory neuroblastoma (40) or relapsed neuroblastoma (49) with an additional 9 patients enrolled after first-line therapy.
Maltese: B᾽mod ġenerali, dawn it-98 pazjent kellhom newroblastoma refrattarja primarja (40) jew newroblastoma rikaduta (49) b᾽9 pazjenti addizzjonali rreġistrati wara t-terapija tal-ewwel linja.
English: Other medicines and Qarziba
Maltese: X᾽fih Qarziba
English: • sudden constriction of the airways (bronchospasm, laryngospasm), rapid breathing
Maltese: • kostrizzjoni f᾽daqqa tal-pajpijiet tan-nifs (bronkospażmu, spażmu tal-larinġi), teħid rapidu tan nifs
English: It is recommended to prepare 50 mL solution in a 50 mL syringe, or 250 mL in an infusion bag suitable for the employed infusion pump, i.e. an overfill of 2 mL (syringe) or 10 mL (infusion bag) to allow for dead volumes of the infusion systems.
Maltese: Huwa rakkomandat li tiġi ppreparata soluzzjoni ta᾽ 50 mL f᾽siringa ta᾽ 50 mL, jew 250 mL f᾽borża tal-infużjoni adattata għall-pompa tal-infużjoni użata, jiġifieri mili żejjed ta᾽ 2 mL (siringa) jew 10 mL (borża talinfużjoni) sabiex jiġu permessi volumi mejtin tas-sistemi tal-infużjoni.
English: As they typically have a central venous catheter in situ, they are at risk of developing systemic infection.
Maltese: Peress li dawn tipikament ikollhom katiter ġol-vina ċentrali in situ, dawn ikunu f᾽riskju li jiżviluppaw infezzjoni sistemika.
English: Two modes of administration are possible:
Maltese: Huma possibbli żewġ modi ta᾽ għoti:
English: • adequate bone marrow function: absolute neutrophil count ≥ 500/µL, platelet count
Maltese: • funzjoni adegwata tal-mudullun: għadd ta᾽ newtrofili assolut ≥ 500/µL, għadd tal-pjastrini tad demm ≥ 20.
English: Premedication
Maltese: Rikorrenti
English: Ιreland
Maltese: Oħrajn
English: No non-clinical studies to evaluate the potential of dinutuximab beta to cause carcinogenicity, genotoxicity or developmental and reproductive toxicity have been conducted.
Maltese: Ma twettaq l-ebda studju mhux kliniku biex jiġi evalwat il-potenzjal ta᾽ dinutuximab beta li jikkawża karċinoġeniċità, ġenotossiċità jew tossiċità relatata mal-iżvilupp u riproduttiva.
English: • fits
Maltese: • Manifattur
English: Recurrent
Maltese: Sukrożju
English: Table 3: Event-free survival (EFS) and overall survival (OS) rates [95% confidence interval] in patients with evidence of disease at baseline (no complete response to initial treatment)
Maltese: Tabella 3: Rati ta᾽ sopravivenza mingħajr episodji (EFS) u sopravivenza globali (OS) [95 % intervall ta᾽ kunfidenza] f᾽pazjenti b᾽evidenza ta᾽ marda fil-linja bażi (l-ebda rispons komplet għall-kura talbidu)
English: The solution should be administered via a peripheral or central intravenous line.
Maltese: Is-soluzzjoni jenħtieġ li tingħata permezz ta᾽ linja ġol-vina periferali jew ċentrali.
English: Qarziba will be given to you in five treatment courses of 35 days and the infusion will last 5 or 10 days in the beginning of each course.
Maltese: Qarziba se jingħata lilek f᾽ħames korsijiet ta᾽ kura ta᾽ 35 jum u l-infużjoni se ddum 5 jew 10 ijiem filbidu ta᾽ kull kors.
English: SN:
Maltese: PC : SN : NN :
English: Treatment with opioids is standard with dinutuximab beta.
Maltese: Il-kura bl-opjojdi hija standard b᾽dinutuximab beta.
English: IL-2 is administered as 6×106 IU/m2/day, resulting in an overall dose of 60×106 IU/m2/course.
Maltese: IL-2 jingħata bħala 6×106 IU/m2/jum, li jirriżulta f᾽doża totali ta᾽ 60×106
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi approvazzjoni għat-tqegħid fis-suq taħt ċirkustanzi ta᾽ eċċezzjoni u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:
English: • are allergic to dinutuximab beta or any of the other ingredients of this medicine (listed in section 6)
Maltese: • allerġiku għal dinutuximab beta jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6).
English: Haematologic toxicities
Maltese: Tossiċitajiet ematoloġiċi
English: For patients with moderate (Grade 2) neuropathy (motor with or without sensory), treatment should be interrupted and may be resumed after neurologic symptoms resolve.
Maltese: Għall-pazjenti b᾽newropatija (ta᾽ Grad 2) moderata (talmoviment b᾽newropatija sensorjali jew mingħajr), il-kura jenħtieġ li tiġi interrotta u tista᾽ titkompla wara li jiġu risolti s-sintomi newroloġiċi.
English: Sucrose
Maltese: Tfal
English: These were 61 boys and 37 girls, aged 1 to 26 years (median 5 years).
Maltese: Dawn kienu 61 tifel u 37 tifla, li kellhom minn 1 sa 26 sena (medjan ta᾽ 5 snin).
English: The marketing authorisation holder (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: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta᾽ farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul talRMP.
English: Interrupt infusion, After resolution, resume infusion at 50% rate
Maltese: Interrompi l-infużjoni Wara r-riżoluzzjoni, kompli linfużjoni b᾽rata ta᾽ 50 %
English: Treatment should be permanently discontinued in patients experiencing any objective prolonged weakness attributable to dinutuximab beta administration.
Maltese: Ma ġie rrappurtat l-ebda każ ta᾽ doża eċċessiva ta᾽ dinutuximab beta.
English: When IL-2 is combined with Qarziba, it should be administered as subcutaneous injections of 6×106 IU/m2/day, for 2 periods of 5 consecutive days, resulting in an overall dose of 60×106 IU/m2 per course.
Maltese: Meta IL-2 jiġi kkombinat ma᾽ Qarziba, dan jenħtieġ li jingħata bħala injezzjonijiet taħt il-ġilda ta᾽ 6×106 IU/m2/jum, għal 2 perjodi ta᾽ 5 ijiem konsekuttivi, li jirriżultaw f᾽doża totali ta᾽ 60×106 IU/m2
English: • recurrent or grade 4 capillary leak syndrome (requires ventilator support)
Maltese: • sindrome ta᾽ tnixxija kapillari rikorrenti jew ta᾽ grad 4 (jeħtieġ appoġġ bil-ventilatur)
English: Opioids
Maltese: FARMAĊEWTIKU
English: Table 1: Event-free survival (EFS) and overall survival (OS) rates in relapsed and refractory patients
Maltese: Tabella 1: Rati ta᾽ sopravivenza mingħajr episodji (EFS) u sopravivenza globali f᾽pazjenti rikaduti jew refrattarji
English: Most had an initial diagnosis of INSS stage 4 disease without MYCN amplification (16% of the subjects had MYCN amplified tumours and in 14% this information was missing).
Maltese: Ħafna minnhom kellhom dijanjożi inizjali ta᾽ marda fl-stadju 4 tal-INSS mingħajr amplifikazzjoni ta᾽ MYCN (16 % talindividwi kellhom tumuri amplifikati ta᾽ MYCN u f᾽14 % din l-informazzjoni kienet nieqsa).
English: Treatment of disease before immunotherapy included intensive chemotherapy regimen followed by autologous stem cell transplantation (ASCT), radiotherapy, and surgery.
Maltese: Il-kura tal-marda qabel l-immunoterapija kienet tinkludi skeda ta᾽ kimoterapija intensiva segwita minn trapjant ta' ċelloli staminali awtologi (ASCT), radjoterapija, u operazzjoni.
English: Dinutuximab beta has been shown in vitro to bind to neuroblastoma cell lines known to express GD2 and to induce both complement dependent cytoxicity (CDC) and antibody dependent cell-mediated cytoxicity (ADCC).
Maltese: Dinutuximab beta ġie muri in vitro li jorbot il-linji taċ-ċelloli tan-newroblastoma magħrufa li jesprimu GD2 u li jinduċu kemm ċitotossiċità dipendenti mill-kompliment (CDC) kif ukoll ċitotossiċità medjata miċ-ċellola dipendenti fuq l-antikorp (ADCC).
English: Efficacy without IL-2 N=104
Maltese: Effikaċja mingħajr IL2 N=104
English: Nonopioid analgesics Nonopioid analgesics should be used permanently during the treatment, e.g. paracetamol or ibuprofen.
Maltese: L-analġeżiċi mhux opjojdi jenħtieġ li jintużaw b᾽mod permanenti waqt il-kura, eż. paracetamol jew ibuprofen.
English: Neurological disorders of the eye
Maltese: • problemi fin-nervituri tiegħek
English: Effects of gender and age were not found to influence the pharmacokinetics of dinutuximab beta but data in children less than 2 years of age are very limited and insufficient to support dosing.
Maltese: L-effetti tas-sess u l-età ma nstabux li jinfluwenzaw il-farmakokinetika ta᾽ dinutuximab beta iżda d-data fi tfal li għandhom anqas minn sentejn hija limitata ħafna u insuffiċjenti biex tappoġġja ddożaġġ.
English: Treatment of hypersensitivity reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: Dinutuximab beta was administered at a dose of 20 mg/m2/day on 5 consecutive days, given by 8-hour intravenous infusion in a 5-week treatment course, and was combined with 13-cis-RA and with or without additional subcutaneous IL-2 at the same posologies as in the previous studies.
Maltese: Dinutuximab beta ngħata f᾽doża ta᾽ 20 mg/m2/jum f᾽5 ijiem konsekuttivi, mogħti minn infużjoni ġol-vina ta᾽ 8 sigħat f᾽kors ta᾽ kura ta᾽ 5 ġimgħat, u ġie kkombinat ma᾽ 13-cis-RA bi jew mingħajr IL-2 ta᾽ taħt il-ġilda addizzjonali bl-istess pożoloġiji bħal fl-istudji preċedenti.
English: • grade 3 vision eye toxicity
Maltese: • tossiċità tal-għajnejn ta᾽ vista ta᾽ grad 3
English: It usually occurs at the beginning of infusion.
Maltese: Dan normalment iseħħ fil-bidu tal-infużjoni.
English: Any
Maltese: JIS
English: NAME OF THE MEDICINAL PRODUCT Qarziba 4.5 mg/mL concentrate for solution for infusion
Maltese: Qarziba 4.5 mg/mL konċentrat għal soluzzjoni għall-infużjoni
English: In the repeat-dose toxicity studies in Guinea pigs and cynomolgus monkeys, no adverse effects of dinutuximab beta were observed on reproductive organs at exposure levels above clinical levels.
Maltese: Fl-istudji dwar effett tossiku minn dożi ripetuti fil-Fniek tal-Indi u fix-xadini cynomolgus, ma ġie osservat l-ebda effett avvers ta᾽ dinutuximab beta fuq l-organi riproduttivi f᾽livelli ta᾽ esponiment ᾽l fuq mil-livelli kliniċi.
English: In order to evaluate the add-on effect of IL-2 in patients with relapsed refractory neuroblastoma, the MAH will submit the results of study APN311202v3.
Maltese: Sabiex jiġi evalwat effett miżjud ta᾽ IL-2 f᾽pazjenti b᾽newroblastoma rikaduta jew rifrattarja, l-MAH se jippreżenta r-riżultati tal-istudju APN311202v3.
English: Antihistamine premedication (e.g. diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab beta infusion.
Maltese: Il-premedikazzjoni bl-antistamini (eż. diphenhydramine) jenħtieġ li tingħata b᾽injezzjoni ġol-vina madwar 20 minuta qabel il-bidu ta᾽ kull infużjoni ta᾽ dinutuximab beta.
English: This has to be taken into consideration when interpreting PK parameters (Cmax, exposure, half-life) listed below.
Maltese: Dan għandu jittieħed inkunsiderazzjoni meta jiġu interpretati il-parametri PK (Cmax, esponiment, nofs ħajja) elenkati hawn taħt.
English: Interrupt infusion and administer supportive measures, Resume at 50% rate if ADR resolves or improves to Grade 1 - 2
Maltese: Kompli l-infużjoni b᾽rata ta᾽ 50 % jekk l-ADR tirrisolvi jew titjieb għal Grad 1-2
English: A triple therapy, including nonopioid analgesics (according to WHO guidelines), gabapentin and opioids, is recommended for pain treatment.
Maltese: Għall-kura tal-uġigħ, hija rakkomandata terapija trippla, inklużi analġeżiċi mhux opjojdi (skont il-linji gwida tal-WHO), gabapentin u opjojdi, Id-doża individwali tista᾽ tvarja ħafna.
English: Occurrence of a severe infusion related reaction (including CRS) requires immediate discontinuation of dinutuximab beta therapy and may necessitate emergency treatment.
Maltese: L-okkorrenza ta' reazzjoni severa relatata mal-infużjoni (inkluż CRS) teħtieġ ittwaqqif immedjat tat-terapija ta᾽ dinutuximab beta u tista᾽ tkun teħtieġ kura ta᾽ emerġenza.
English: Classical biotransformation studies have not been performed.
Maltese: L-istudji ta᾽ bijotrasformazzjoni klassiċi ma twettqux.
English: These included impaired visual accommodation that is correctable with eye glasses, as well as mydriasis (13%), blurred vision (3%) or photophobia (3%), which were usually reversible after treatment discontinuation.
Maltese: Dawn kienu jinkludu akkomodazzjoni viżwali batuta li tista᾽ titranġa b᾽nuċċali, kif ukoll mijadrijażi (13 %), viżjoni mċajpra (3 %) jew fotofobija (3 %), li normalment kienu riversibbli wara l-waqfien talkura.
English: Examples of medicines that suppress the immune system are corticosteroids used to reduce inflammation or prevent organ transplant rejection.
Maltese: Eżempji ta᾽ mediċini li jrażżnu s-sistema immuni huma kortikosterojdi użati biex inaqqsu l-infjammazzjoni jew jipprevjenu r-rifjut tat-trapjant ta' organu.
English: Both motor and sensory peripheral neuropathies have been reported, overall in 9% of the patients.
Maltese: Ġew irrappurtati kemm newropatiji periferali tal-moviment kif ukoll sensorjali, b᾽mod ġenerali f᾽9 % tal-pazjenti.
English: Dinutuximab beta binds to the molecule known as disialoganglioside 2 (GD2), which is present on cancer cells, and this activates the body's immune system, causing it to attack the cancer cells.
Maltese: Dinutuximab beta jingħaqad mal-molekula magħrufa bħala disialoganglioside 2 (GD2), li hija preżenti fuq ċelloli tal-kanċer, u dan jattiva s-sistema immuni tal-ġisem, fejn iwassal biex din tattakka ċ-ċelloli tal-kanċer.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni 1 kunjett
English: • nerve disorder in the arms and/or legs (with abnormal sensations or weakness), light headedness, trembling, muscle spasms
Maltese: • disturbi fin-nervituri fid-dirgħajn u/jew fir-riġlejn (b᾽sensazzjonijiet anormali jew dgħjufija),
English: • a continuous infusion over the first 10 days of each course (a total of 240 hours) at the daily dose of 10 mg/m2
Maltese: • infużjoni kontinwa matul l-ewwel 10 ijiem ta᾽ kull kors (total ta᾽ 240 siegħa) bid-doża ta᾽
English: The most common adverse reactions were pyrexia (88%) and pain (77%) that occurred despite analgesic treatment.
Maltese: L-aktar reazzjonijiet avversi komuni kienu deni (88 %) u uġigħ (77 %) li seħħew minkejja l-kura blanalġeżiċi.
English: • abnormal blood or urine tests (blood cells and other components, liver function, renal function)
Maltese: • testijiet tad-demm jew tal-awrina anormali (ċelloli tad-demm jew komponenti oħrajn, funzjoni tal-fwied, funzjoni tal-kliewi)
English: • oxygen deficiency
Maltese: GĦAMLA KWALITATTIVA
English: • kidney failure
Maltese: • żieda fil-piż
English: Mean plasma Cmax levels (around 12 micrograms/mL) were reached on the last day of infusion.
Maltese: Fl-aħħar jum tal-infużjoni ntlaħqu livelli Cmax medji fil-plażma (madwar 12-il mikrogramma/mL).
English: Qarziba contains dinutuximab beta, which belongs to a group of medicines called ‘monoclonal antibodies'.
Maltese: Qarziba fih dinutuximab beta, li jappartjeni għal grupp ta᾽ mediċini msejħin "antikorpi monoklonali".
English: After weaning off intravenous morphine, in case of severe neuropathic pain, oral morphine sulphate (0.2 to 0.4 mg/kg every 4 to 6 hours) can be administered on demand.
Maltese: Wara l-waqfa kompletament tal-morfina ġol-vina f᾽każ ta᾽ uġigħ newropatiku sever, jista᾽ jingħata fuq talba sulfat tal-morfina mill-ħalq (0.2 sa 0.4 mg/kg kull 4 sa 6 sigħat).
English: If IL-2 is combined with dinutuximab beta, it should be given as subcutaneous injections for 5 consecutive days twice during each course.
Maltese: Jekk IL-2 jiġi kkombinat ma᾽ dinutuximab beta, dan għandu jingħata bħala injezzjonijiet taħt il-ġilda għal 5 ijiem konsekuttivi darbtejn matul kull kors.
English: • inflammation of the mouth and lips (stomatitis)
Maltese: • infjammazzjoni tal-ħalq u x-xufftejn (stomatite)
English: Neuropathic pain usually occurs at the beginning of the treatment and premedication with analgesics, including intravenous opioids, prior to each infusion of dinutuximab beta is required.
Maltese: L-uġigħ newropatiku normalment iseħħ fil-bidu tal-kura u hija meħtieġa premedikazzjoni b᾽analġeżiċi, inkluż opjojdi ġol-vina, qabel kull infużjoni ta᾽ dinutuximab beta.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of concentrate contains 4.5 mg dinutuximab beta.
Maltese: U KWANTITATTIVA 1 mL ta᾽ konċentrat fih 4.5 mg ta' dinutuximab beta.
English: Given the limitation of the bioanalytical methods, data are currently insufficient to properly evaluate the impact of the formation of anti-drug antibodies on pharmacokinetic and pharmacodynamic parameters, as well as on the efficacy and safety of dinutuximab beta.
Maltese: Minħabba l-limitazzjoni ta᾽ metodi bijoanalitiċi, id-data bħalissa hija insuffiċjenti biex tevalwa kif xieraq l-impatt tal-formazzjoni ta᾽ antikorpi kontra l-mediċina fuq parametri farmakokinetiċi u farmakodinamiċi, kif ukoll fuq l-effikaċja u s-sigurtà ta᾽ dinutuximab beta.
English: Second 5-day treatment with IL-2 should start concurrently with dinutuximab beta infusion (days 1 to 5 of each course).
Maltese: It-tieni kura ta᾽ 5 ijiem b᾽ IL-2 jenħtieġ li tibda fl-istess ħin ma᾽ infużjoni ta᾽ dinutuximab beta (jiem 1 sa 5 ta᾽ kull kors).
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Maltese: U MANIFATTUR(I) RESPONSABBLI
English: Refractory patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: Cardiac disorders tachycardia cardiac failure, left ventricular dysfunction, pericardial effusion
Maltese: Disturbi fil-qalb takikardija insuffiċjenza kardijaka, disfunzjoni talventrikolu tax-xellug, effużjoni perikardjali
English: Based on the physician's evaluation of the severity of adverse drug reactions to dinutuximab beta, patients may undergo a dose reduction of 50% or a temporary interruption of the infusion.
Maltese: Abbażi tal-evalwazzjoni mit-tabib tas-severità tar-reazzjonijiet avversi tal-mediċini għal dinutuximab beta, il-pazjenti jista᾽ jsirilhom tnaqqis fid-doża ta᾽ 50 % jew interruzzjoni temporanja tal-infużjoni.
English: Hepatobiliary disorders hepatocellular injury
Maltese: (sindrome tal-enċefalopatija riversibbli posterjuri)
English: • vomiting, diarrhoea, constipation
Maltese: • rimettar, dijarea, stitikezza
English: • Product information (SPC)
Maltese: • Tagħrif dwar il-prodott (SPC)
English: • Abnormal liver function tests
Maltese: • Testijiet dwar funzjoni tal-fwied mhux normali
English: The safety checklist about Esbriet should contain the following key elements related to liver function and photosensitivity:
Maltese: Il-lista ta' kontroll tas-sigurtà dwar Esbriet għandha tinkludi l-elementi prinċipali li ġejjin relatati malfunzjoni tal-fwied u l-fotosensittività:
English: • Physician information (safety checklists)
Maltese: • Tagħrif għat-tabib (listi ta' kontroll tas-sigurtà)
English: • Photosensitivity reactions and skin rashes
Maltese: • Reazzjonijiet ta' fotosensittività u raxx fil-ġilda
English: The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on the correct prescription of Esbriet.
Maltese: L-MAH, bi qbil mal-awtoritajiet kompetenti fl-Istati Membri, għandu jimplimenta, qabel it-tnedija, programm edukattiv għat-tobba li għandu l-għan li jipprovdi materjal edukattiv dwar il-preskrizzjoni korretta ta' Esbriet.
English: • Patients should be informed that Esbriet is known to be associated with photosensitivity reactions and that preventative measures have to be taken.
Maltese: • Il-pazjenti għandhom jiġu informati li Esbriet huwa magħruf li huwa assoċjat ma' reazzjonijiet ta' fotosensittività u li għandhom jittieħdu miżuri preventivi.
English: • Esbriet is contraindicated in patients with severe hepatic impairment or end stage liver disease.
Maltese: • Esbriet huwa kontra-indikat f'pazjenti b'indeboliment sever tal-fwied jew marda tal-fwied fl aħħar stadju.
English: • There is a need to monitor liver function tests prior to initiation of treatment with Esbriet and at regular intervals thereafter.
Maltese: • Hemm ħtieġa li jkunu sorveljati t-testijiet tal-funzjoni tal-fwied qabel tibda l-kura b'Esbriet u f'intervalli regolari wara dan.
English: • Patient information (PIL)
Maltese: Tagħrif għall-pazjent (PIL)
English: Liver function
Maltese: Funzjoni tal-fwied
English: • Elevations of serum transaminases can occur during treatment with Esbriet.
Maltese: • Jista' jkun hemm żidiet tat-transaminasi tas-serum matul il-kura b'Esbriet.
English: • Patients are advised to avoid or reduce exposure to direct sunlight (including sunlamps).
Maltese: • Il-pazjenti huma avżati biex jevitaw jew inaqqsu l-esponiment għax-xemx (inklużi lampi li jitfgħu raġġi ultra-vjola).
English: • Any other clinically significant ADRs based on the judgment of the prescriber
Maltese: • Kwalunkwe ADR klinikament sinifikanti oħra abbażi tal-ġudizzju ta' min jippreskrivi
English: The physician information should encourage the prescribers to report serious adverse reactions and clinically significant ADRs of special interest including:
Maltese: It-tagħrif għat-tabib għandu tħeġġeġ lil min jippreskrivi biex jirrapporta reazzjonijiet avversi serji u ADRs klinikament sinifikanti ta' interess speċjali inklużi: