FrancophonIA/ELRC3.0 huggingface dataset:
English: Other frequent adverse reactions were hypersensitivity (63%), vomiting (57%), diarrhoea (51%), capillary leak syndrome (40%) and hypotension (39%).
Maltese: Reazzjonijiet frekwenti oħrajn kienu sensittività eċċessiva (63 %), rimettar (57 %), dijarea (51 %), sindrome ta᾽ tnixxija kapillari (40 %) u pressjoni baxxa (39 %).
English: The pharmacokinetics of dinutuximab beta, based on 10-day continuous intravenous infusion of 10 mg/m2/day (equal to a total dose of 100 mg/m2/course) were evaluated in studies 1 and 2.
Maltese: Il-farmakokinetiċi ta᾽ dinutuximab beta, ibbażati fuq infużjoni ġol-vina kontinwa ta᾽ 10 ijiem ta᾽ 10 mg/m2/jum (ugwali għal doża totali ta᾽ 100 mg/m2/kors) ġew evalwati fl-istudji 1 u 2.
English: Study 2 N=25
Maltese: Studju 2 N=25
English: Respiratory, thoracic and mediastinal disorders hypoxia, cough bronchospasm , dyspnoea, respiratory failure, lung infiltration, pulmonary oedema, pleural effusion, tachypnoea, laryngospasm
Maltese: Disturbi respiratorji, toraċiċi u medjastinali ipoksja, sogħla bronkospażmu, dispnea, insuffiċjenza respiratorja, infiltrazzjoni fil-pulmun, edema pulmonari, effużjoni plewrali, takipenja, spażmu tallarinġi
English: 6.3 Shelf life
Maltese: 6.3 Perjodu ta᾽ stabilità
English: ophthalmoplegia, papilloedema, accommodation disorder, blurred vision, photophobia
Maltese: oftalmopleġja, papilloedema, disturb ta᾽ akkomodazzjoni, vista mċajpra, fotofobija
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: • prolonged grade 2 peripheral motor neuropathy
Maltese: • newropatija motorja periferali ta᾽ grad 2 mtawla
English: • grade 4 hyponatremia (< 120 mEq/L) despite appropriate fluid management
Maltese: • iponatremija ta᾽ grad 4 (<120 mEq/L) minkejja ġestjoni tal-fluwidu mhux xierqa
English: The observed Cmax levels were slightly higher (16.5 micrograms/mL) and were reached on the fifth infusion.
Maltese: Il-livelli Cmax osservati kienu ftit ogħla (16.5 mikrogrammi/mL) u ntlaħqu fil-ħames infużjoni.
English: Laboratory abnormalities Regulatory monitoring of liver function and electrolytes is recommended.
Maltese: Abnormalitajiet tal-laboratorju Huwa rrakkomandat monitoraġġ regolatorju tal-funzjoni tal-fwied u l-elettroliti.
English: Skin and subcutaneous tissue disorders pruritus , rash, urticaria dermatitis (including exfoliative) , erythema, dry skin, hyperhidrosis, petechiae, photosensitivity reaction
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt ilġilda ħakk, raxx, urtikarja dermatite (inkluż bilqxur), eritema, ġilda xotta, iperidrożi, petechiae, reazzjoni għal fotosensittività
English: • Marketing Authorisation Holder EUSA Pharma (Netherlands) B.V.
Maltese: • Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq EUSA Pharma (Netherlands) B.V.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati (PSURs) għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta᾽ referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Most events were of grade 1-2 and resolved.
Maltese: Ħafna mill-episodji kienu ta᾽ grad 1-2 u ġew solvuti.
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-kategoriji talfrekwenza huma definiti bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) u mhux komuni
English: Hypersensitivity reaction e.g. bronchospasm, angioedema
Maltese: Reazzjoni ta' sensittività eċċessiva eż. bronkospażmu, anġjoedema
English: Dilated pupils with sluggish light reflex +/- photophobia
Maltese: Pupilli dilatati b᾽rifless ta᾽ dawl batut +/- fotofobija
English: Immune system disorders hypersensitivity , cytokine release syndrome anaphylactic reaction serum sickness
Maltese: Disturbi fis-sistema immuni sensittività eċċessiva, sindrome tar-rilaxx taċ-ċitokina reazzjoni alafilattika marda tas-serum
English: CLS is characterised by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space.
Maltese: Is-CLS huwa kkaratterizzat minn telf ta᾽ ton vaskulari u ekstravażazzjoni ta᾽ proteini tal-plażma u fluwidu fl-ispazju extravaskulari.
English: A risk for indirect reduction of CYP activity due to higher TNF-α and IL-6 levels and, therefore, interactions with concomitantly used medicinal products, cannot be excluded.
Maltese: Riskju ta᾽ tnaqqis indirett tal-attività tas-CYP minħabba livelli għolja ta᾽ TNF-α u IL-6 u, għalhekk, l-interazzjonijiet ma᾽ prodotti mediċinali użati fl-istess ħin ma jistgħux jiġu esklużi.
English: Infections and infestations infection (including pneumonia, skin infection, herpes virus infection, myelitis, encephalomyelitis), device related infection sepsis
Maltese: Infezzjonijiet u infestazzjonijiet infezzjoni (inkluż pnewmonja, infezzjoni tal-ġilda, infezzjoni tal-virus tal-herpes, mjelite, enċefalomjelite), infezzjoni relatata malapparat sepsi
English: The same treatment regimen was used in a Phase II study (study 2), which enrolled 44 patients.
Maltese: II (studju 2), li fih ħadu sehem 44 pazjent.
English: The exposure (Cmax and AUC24h on day 1 and day 10 during a 10-day infusion) is predicted to be similar in subjects with ages less than or equal to 12 years and decreases slightly for older, heavier subjects.
Maltese: L-esponiment (Cmax u AUC24h f᾽jum 1 u jum 10 waqt infużjoni ta᾽ 10 ijiem) huwa previst li jkun simili f᾽individwi b᾽età inqas minn jew ugwali għal 12-il sena u jonqos xi ftit għal individwi akbar fl-età u itqal.
English: The most frequent hypersensitivity reactions included hypotension (39%), urticaria (18%) and bronchospasm (4%).
Maltese: L-aktar reazzjonijiet ta᾽ sensittività eċċessiva frekwenti kienu jinkludu pressjoni baxxa (39 %), urtikarja (18 %) u bronkospażmu (4%).
English: Renal and urinary disorders oliguria, urinary retention, hyperphosphaturia, haematuria, proteinuria renal failure
Maltese: Disturbi fil-kliewi u fis-sistema urinarja oliguria, żamma talawrina, iperfosfaturija, ematurja, proteinurja
English: • With continuous infusion, in response to the patient's pain perception, it may be possible to wean off morphine over 5 days by progressively decreasing its dosing rate (e.g. to 0.02 mg/kg/hour, 0.01 mg/kg/hour, 0.005 mg/kg/hour).
Maltese: • B᾽infużjoni kontinwa, bħala rispons għall-perċezzjoni tal-uġigħ tal-pazjent, jista᾽ jkun possibbli li titwaqqaf kompletament il-morfina fi żmien 5 ijiem billi titnaqqas progressivament ir-rata taddożaġġ (eż. għal 0.02 mg/kg/siegħa, 0.01 mg/kg/siegħa, 0.005 mg/kg/siegħa).
English: These included 64% male and 36% female patients with a median age of 3 years (0.6 to 20); 89% had a tumour INSS stage 4 and MYCN amplification was reported in 44% of the cases.
Maltese: Dawn kienu jinkludu 64 % pazjenti maskili u 36 % pazjenti femminli b᾽età medjana ta᾽ 3 snin (0.6 sa 20); 89 % kellhom tumur fl-istadju 4 tal-INSS u l-amplifikazzjoni ta᾽ MYCN ġiet irrappurtata f᾽44 % tal-każijiet.
English: Mean plasma Cmax levels, observed during 8-hour infusions (20 mg/m2/day on five consecutive days), were determined in another study (n=15).
Maltese: Il-livelli Cmax medji fil-plażma, osservati waqt infużjonijiet ta᾽ 8 sigħat (20 mg/m2/jum fuq ħamest ijiem konsekuttivi), ġew iddeterminati fi studju ieħor (n=15).
English: • adequate renal function: creatinine clearance or glomerular filtration rate (GRF)
Maltese: • funzjoni adegwata tal-kliewi: tneħħija tal-kreatinina jew rata tal-filtrazzjoni glomerulari (GRF)
English: LIST OF EXCIPIENTS Histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid.
Maltese: TA' EĊĊIPJENTI Histidine, sukrożju, polysorbate 20, ilma għall-injezzjonijiet, aċidu idrokloriku.
English: Gastrointestinal disorders vomiting , diarrhoea, constipation, stomatitis nausea, lip oedema, ascites, abdominal distension, ileus, dry lips enterocolitis
Maltese: Disturbi gastrointestinali rimettar, dijarea, stitikezza, stomatite dardir, edema taxxufftejn, axxite, nefħa addominali, ileus, xufftejn niexfa enterokolite
English: Dinutuximab beta is a mouse-human chimeric monoclonal IgG1 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Maltese: Dinutuximab beta huwa antikorp IgG1 monoklonali kimeriku ġurdien-bniedem prodott f'linja ta' ċelluli mammiferi (CHO) permezz ta' teknoloġija rikombinanti tad-DNA.
English: This medicinal product has been authorised under ‘exceptional circumstances'.
Maltese: Dan il-prodott mediċinali ġie awtorizzat taħt ‘ċirkostanzi eċċezzjonali'.
English: The safety of dinutuximab beta has been evaluated in 514 patients with high-risk and relapsed/refractory neuroblastoma, who received it as a continuous infusion (98) or as repeated daily infusions (416).
Maltese: Is-sigurtà ta᾽ dinutuximab beta ġiet evalwata f᾽514-il pazjent b᾽newroblastoma ta᾽ riskju għoli u rikaduta/refrattarja, li rċevewh bħala infużjoni kontinwa (98) jew bħala infużjonijiet ripetuti kuljum (416).
English: The overall response rate (complete response plus partial response) in patients with evidence of disease at baseline was 36% (95% confidence interval [25; 48]) and was more favourable in patients with refractory disease (41% [23; 57]) than in patients with relapsed disease (29% [15; 46]).
Maltese: Ir-rata ta᾽ rispons globali (rispons komplet flimkien ma᾽ rispons parzjali) f᾽pazjenti b᾽evidenza ta᾽ mard fil-linja bażi kienet 36 % (95 % intervall ta᾽ kunfidenza [25; 48]) u kienet aktar favorevoli f᾽pazjenti b᾽marda refrattarja (41 % [23; 57]) milli f᾽pazjenti b᾽marda rikaduta (29 % [15;
English: In order to evaluate the long-term survival effect of dinutuximab, the MAH will submit at least 5-year survival data for patients included in studies APN311-202 and APN311-302.
Maltese: Sabiex jiġi evalwat l-effett ta᾽ sopravivenza fit-tul ta᾽ dinutuksimab, l-MAH se jippreżenta data ta᾽ sopravivenza fuq mill-inqas 5 snin għal pazjenti inklużi fl-istudji APN311-202 u APN311-302.
English: Qarziba 4.5 mg/mL concentrate for solution for infusion dinutuximab beta
Maltese: Qarziba 4.5 mg/mL konċentrat għal soluzzjoni għall-infużjoni dinutuximab beta
English: 1 mL concentrate contains 4.5 mg dinutuximab beta.
Maltese: 1 mL ta᾽ konċentrat fih 4.5 mg ta᾽ dinutuximab beta.
English: Efficacy without IL-2 N=73
Maltese: Effikaċja mingħajr IL2 N=73
English: • agitation, anxiety
Maltese: • aġitazzjoni, ansjetà
English: • Subsequently, a dosing rate of 0.03 mg/kg/hour is recommended concomitantly with dinutuximab beta infusion.
Maltese: • Sussegwentement, hija rakkomandata rata ta᾽ dożaġġ ta᾽ 0.03 mg/kg/siegħa fl-istess ħin malinfużjoni ta᾽ dinutuximab beta.
English: • paralysis of eye muscles, blurred vision, light sensitivity, swelling in the retina
Maltese: • paraliżi tal-muskoli tal-għajnejn, vista mċajpra, sensittività għad-dawl, nefħa fir-retina
English: In order to better define the posology in children over the entire age range and the impact of HACAs on PD, efficacy and safety, the MAH will submit the results of an evaluation of plasma samples collected from patients in studies APN311-202v1-2-3 and APN311-304 according to an agreed protocol.
Maltese: Sabiex tiġi definita aħjar il-pożoloġija fit-tfal fuq medda sħiħa tal-età u limpatt ta᾽ HACAs fuq PD, l-effikaċja u s-sigurtà, il-MAH se jippreżenta rriżultati ta᾽ evalwazzjoni ta᾽ kampjuni ta᾽ plażma miġbura minn pazjenti flistudji APN311-202v1-2-3 u APN311-304 skont protokoll li ġie maqbul.
English: Elimination The half-life observed in studies 1 and 2 was in the range of 190 hours, i.e. 8 days.
Maltese: Eliminazzjoni In-nofs ħajja osservata fl-istudji 1 u 2 kienet fil-medda ta᾽ 190 siegħa, jiġifieri 8 ijiem.
English: Eye disorders mydriasis, pupillotonia, eye oedema (eyelid, periorbital)
Maltese: Disturbi fl-għajnejn mijadrijażi, pupillotonia, edema tal-għajnejn (talkappell tal-għajn, periorbitali)
English: Markers for renal (eGFR) and hepatic (bilirubin) function did not show a relationship with exposure (Cmax and AUC24h on day 1 and day 10 during a 10-day infusion).
Maltese: Il-markaturi għall-funzjoni tal-kliewi (eGFR) u tal-fwied (bilirubina) ma wrew l-ebda relazzjoni malesponiment (Cmax u AUC24h f᾽jum 1 u jum 10 waqt infużjoni ta᾽ 10 ijiem).
English: Dinutuximab beta is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzmes.
Maltese: Dinutuximab beta huwa proteina li l-passaġġ metaboliku mistenni tagħha huwa degradazzjoni għal peptidi żgħar u aċidi amminiċi individwali minn enżimi proteolitiċi li jinsabu kullimkien.
English: Other intravenously co-administered agents should be delivered via a separate infusion line (see section 6.6).
Maltese: Aġenti oħrajn li jingħataw flimkien ġol-vina jenħtieġ li jingħataw permezz ta᾽ linja tal-infużjoni separata (ara sezzjoni 6.6).
English: In a compassionate use programme (study 1), 54 patients received 10 mg/m2/day dinutuximab beta given by continuous 10-day intravenous infusion in a 5-week treatment course, concurrently with subcutaneous IL-2 (6×106 IU/m²/day given on days 1-5 and 8-12 of each course) and followed by oral
Maltese: Fi programm ta᾽ użu ta᾽ kompassjoni (studju 1), 54 pazjent irċevew 10 mg/m2/jum ta᾽ dinutuximab beta mogħti minn infużjoni ġol-vina kontinwa ta᾽ 10 ijiem f᾽kors ta᾽ kura ta᾽ 5 ġimgħat, fl-istess ħin ma᾽ IL-2 taħt il-ġilda (6x106 IU/m²/jum mogħti f᾽jiem 1-5 u 8-12 ta᾽ kull kors) u segwit minn kura b᾽13-cis-RA orali (160 mg/m2/jum għal 14-il jum għal kull kors).
English: In the presence of human effector cells, including peripheral blood nuclear cells and granulocytes from normal human donors, dinutuximab beta was found to mediate the lysis of human neuroblastoma and melanoma cell lines in a dose-dependent manner.
Maltese: Fil-preżenza ta᾽ ċelloli affettwaturi tal-bniedem, inkluż ċelloli nukleari fid-demm periferali u granuloċiti minn donaturi bnedmin normali, dinutuximab beta nstab li jimmedja l-lisi tal-linji ta᾽ ċelloli tan-newroblastoma u tal-melanoma tal-bniedem f᾽manjiera dipendenti fuq id-doża.
English: • grade 3 peripheral neuropathy
Maltese: • newropatija periferika ta᾽ grad 3
English: The development of anti-drug antibodies is a class effect of monoclonal chimeric antibodies.
Maltese: L-iżvilupp ta' antikorpi kontra l-mediċina hu effett ta' klassi ta ' antikorpi kimeriċi monoklonali.
English: Diluted solution (solution for infusion)
Maltese: Soluzzjoni dilwita (soluzzjoni għal infużjoni)
English: Preparation of the infusion
Maltese: Preparazzjoni tal-infużjoni
English: Each 4.5 mL vial contains 20 mg dinutuximab beta.
Maltese: Kull kunjett ta᾽ 4.5 mL fih 20 mg ta᾽ dinutuximab beta.
English: The population pharmacokinetic model included allometric scaling (reference weight of 18.1 kg) on clearance and volume of distribution with exponents of 0.75 and 1, respectively.
Maltese: Il-mudell tal-farmakokinetika tal-popolazzjoni kien jinkludi skalar allometriku (piż ta᾽ referenza ta᾽ 18.1 kg) fuq it-tneħħija u l-volum ta᾽ distribuzzjoni b᾽esponenti ta᾽ 0.75 u 1, rispettivament.
English: Nervous system disorders headache peripheral neuropathy, seizure, paraesthesia, dizziness, tremor intracranial pressure increased, posterior reversible encephalopathy syndrome
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras newropatija periferali, aċċessjoni, parasteżija, sturdament, rogħda pressjoni intrakranjali miżjuda, sindrome talenċefalopatija riversibbli posterjuri
English: The maximum single dose of gabapentin is 300 mg.
Maltese: Id-doża waħdanija massima ta᾽ gabapentin hija ta᾽ 300 mg.
English: Calculations of pharmacokinetic parameters for dinutuximab beta are based upon measurements using non-validated bioanalytical methods.
Maltese: Il-kalkoli ta᾽ parametri farmakokinetiċi għal dinutuximab beta huma bbażati fuq kejl bl-użu ta᾽ metodi bijoanalitiċi mhux validati.
English: • The other ingredients are histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid (for pH adjustment).
Maltese: • L-ingredjenti l-oħra huma histidine, sukrożju, polysorbate 20, ilma għall-injezzjonijiet, aċidu idrokloriku (għall-aġġustament tal-pH).
English: It is recommended that a 0.22 micrometre in-line filter is used during infusion.
Maltese: Huwa rrakkomandat li waqt l-infużjoni jintuża filtru fil-linja ta᾽ 0.22 mikrometru.
English: • life-threatening infection (sepsis)
Maltese: • infezzjoni ta᾽ theddida għall-ħajja (sepsis)
English: Blood and lymphatic system disorders anaemia,leukopenia, neutropenia, thrombocytopenia lymphopenia disseminated intravascular coagulation, eosinophilia
Maltese: Disturbi tad-demm u tas-sistema limfatika anemija, lewkopenija, newtropenija, tromboċitopenija limfopenija koagulazzjoni intravaskulari mifruxa, eosinofilija
English: • With daily infusions of dinutuximab beta, morphine infusion should be continued at a decreased rate (e.g. 0.01 mg/kg/h) for 4 hours after the end of dinutuximab beta infusion.
Maltese: • Bl-infużjonijiet ta᾽ kuljum ta᾽ dinutuximab beta, l-infużjoni tal-morfina jenħtieġ li titkompla b᾽rata mnaqqsa (eż. 0.01 mg/kg/h) għal 4 sigħat wara t-tmiem tal-infużjoni ta᾽ dinutuximab beta.
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 (see section 6.6).
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 (ara sezzjoni 6.6).
English: Dinutuximab beta is a chimeric monoclonal IgG1 antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells.
Maltese: Dinutuximab beta huwa antikorp IgG1 monoklonali kimeriku li huwa speċifikament dirett kontra lfrazzjoni karboidrata ta᾽ disialoganglioside 2 (GD2), li huwa espress iżżejjed fuq iċ-ċelloli ta᾽ newroblastoma.
English: Each vial contains 20 mg dinutuximab beta in 4.5 mL.
Maltese: Kull kunjett fih 20 mg ta' dinutuximab beta f'4.5 mL.
English: For continuous infusions, any medical device suitable for infusion at a rate of 2 mL per hour can be applied, e.g. syringe infusion pumps/infusors, electronic ambulatory infusion pumps.
Maltese: Għall-infużjonijiet kontinwi, jista᾽ jintuża kwalunkwe apparat mediku adattat għal infużjoni b᾽rata ta᾽ 2 mL fis-siegħa, eż. pompi/infusors tal-infużjoni tas-siringa, pompi tal-infużjoni ambulatorji elettroniċi.
English: • Before initiation of a continuous intravenous morphine infusion, a bolus infusion of 0.02 to 0.05 mg/kg/hour morphine should be started 2 hours before dinutuximab beta infusion.
Maltese: • Qabel il-bidu ta᾽ infużjoni tal-morfina ġol-vina kontinwa, jenħtieġ li tinbeda infużjoni bolus ta᾽ 0.02 sa 0.05 mg/kg/siegħa morfina sagħtejn qabel l-infużjoni ta᾽ dinutuximab beta.
English: Overall, measurable ADA titres were detected in 65 (62%) of the 105 patients examined.
Maltese: B᾽mod ġenerali, ġew osservati titri ta᾽ ADA miżurabbli f᾽65 (62 %) mill-105 pazjenti eżaminati.
English: Severe eye disorders were also reported including ophthalmoplegia (2%) and optic atrophy.
Maltese: Ġew irrappurtati wkoll disturbi fl-għajnejn severi inkluż oftalmopleġja (2 %) u atrofija ottika.
English: For patients without evidence of disease at baseline, addition of IL-2 did not improve EFS and OS.
Maltese: Għall-pazjenti mingħajr evidenza ta᾽ marda fil-linja bażi, iż-żieda ta᾽ IL-2 ma tejbitx l-EFS and OS.
English: Qarziba should be diluted aseptically to the patient specific concentration/dose with sodium chloride 9 mg/mL (0.9%) solution for infusion containing 1% human albumin (e.g. 5 mL of human albumin 20% per 100 mL sodium chloride solution).
Maltese: Qarziba jenħtieġ li jiġi dilwit b᾽mod asettiku għad-doża/konċentrazzjoni speċifika għall-pazjent b᾽soluzzjoni ta᾽ 9 mg/mL (0.9%) ta᾽ klorur tas-sodju għal infużjoni li fiha 1 % albumina umana (eż. 5 mL albumina umana 20 % għal kull 100 mL ta᾽ soluzzjoni tal-klorur tas-sodju).
English: Psychiatric disorders agitation, anxiety
Maltese: Disturbi psikjatriċi aġitazzjoni, ansjetà
English: • dilated pupils or abnormal pupil reactions
Maltese: • pupilli dilatati jew reazzjonijiet anormali tal-pupilli
English: It was combined with 13-cis retinoic in most patients and with IL-2 in 307 patients.
Maltese: Dan ġie kkombinat ma᾽ 13-cis retinoic f᾽ħafna mill-pazjenti u ma᾽ IL-2 fi 307 pazjenti.
English: Investigations increased weight , increased transaminases, increased gamma glutamyltransferase, increased blood bilirubin increased blood creatinine decreased weight, decreased glomerular filtration rate, hypertriglyceridaemia, prolonged activated partial thromboplastin time, prolonged prothrombin time, prolonged thrombin time
Maltese: Investigazzjonijiet żieda fil-piż, żieda fittransaminases, żieda fil-gamma glutamyltransferase, żieda fil-bilirubina fiddemm, żieda talkreatini fid-demm tnaqqis fil-piż, tnaqqis fir-rata ta᾽ filtrazzjoni glomerulari, ipertrigliċeridimija, ħin tat-tromboplastina parzjali attivata mtawwal, ħin talprotrombina mtawwal, ħin tat-trombina mtawwal *jinkludi wġigħ addominali, uġigħ fl-estremitajiet, uġigħ muskoskeletrali, uġigħ fis-sider, artralġja
English: Neurotoxicity associated to dinutuximab beta is likely due to the induction of mechanical allodynia that may be mediated by the reactivity of dinutuximab beta with the GD2 antigen located on the surface of peripheral nerve fibres and myelin.
Maltese: In-newrotossiċità assoċjata ma᾽ dinutuximab beta hija x᾽aktarx minħabba l-induzzjoni ta᾽ allodynia mekkanika li tista᾽ tiġi medjata mir-reattività ta᾽ dinutuximab beta mal-antiġen GD2 li jinsab fuq issuperfiċje tal-fibri tan-nerv periferali u l-mijelina.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza/sustanzi bioloġika/bioloġiċi attiva/attivi
English: Metabolism and nutrition disorders fluid retention decreased appetite, hypoalbuminaemia, hyponatraemia, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, dehydration
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni żamma ta᾽ fluwidu nuqqas ta᾽aptit, ipoalbuminemija, iponatremja, ipokalimja, ipofosfatimja, ipomanjesimja, ipokalċemija, deidrazzjoni
English: Table 2: Event-free survival (EFS) and overall survival (OS) rates [95% confidence interval] in patients without evidence of disease at baseline (complete response to initial treatment)
Maltese: Tabella 2: Rati ta᾽ sopravivenza mingħajr episodji (EFS) u sopravivenza globali (OS) [95 % intervall ta᾽ kunfidenza] f᾽pazjenti mingħajr evidenza ta᾽ marda fil-linja bażi (rispons komplet għall-kura talbidu)
English: STATEMENT OF ACTIVE SUBSTANCE 1 mL of concentrate contains 4.5 mg dinutuximab beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA 1 mL ta᾽ konċentrat fih 4.5 mg ta᾽ dinutuximab beta.
English: • For repeated daily infusions, the daily dose is 20 mg/m2 and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.
Maltese: • Għal infużjonijiet ripetuti kuljum, id-doża ta᾽ kuljum hija 20 mg/m2 u d-doża kkalkulata jenħtieġ li tiġi dilwita f᾽100 mL ta᾽ klorur tas-sodju 9 mg/mL (0.9 %) li fih 1% albumina umana.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/4.5 mL
Maltese: INDIVIDWALI 20 mg/4.5 mL
English: For repeated daily 8-hour infusions, the daily dose is 20 mg/m2 and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.
Maltese: Għal infużjonijiet ripetuti ta᾽ 8 sigħat kuljum, id-doża ta᾽ kuljum hija 20 mg/m2 u d-doża kkalkulata jenħtieġ li tiġi dilwita f᾽100 mL ta᾽ sodium chloride 9 mg/mL (0.9 %) li fih 1% albumina umana.