FrancophonIA/ELRC3.0 huggingface dataset:
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentement, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjenti Histidine
English: CSF or IL-2.
Maltese: jew IL-2.
English: Data from 409 subjects participating in several neuroblastoma studies and having samples available for the determination of human anti-chimeric antibodies (HACA) demonstrated that 71 (17%) developed binding antibodies and 15 (4%) developed a neutralising antibody response.
Maltese: Dejta minn 409 individwu li ipparteċipaw f'diversi studji dwar newroblastoma u li kellhom kampjuni disponibbli għad-determinazzjoni ta' antikorpi antikimeriċi umani (HACA), uriet li 71 (17%) żviluppaw antikorpi li jeħlu, u 15 (4%) żviluppaw rispons għal antikorpi newtralizzanti.
English: Unituxin is a cancer medicine that contains the active substance dinutuximab.
Maltese: Unituxin hu mediċina kontra l-kanċer li fih is-sustanza attiva dinutuximab.
English: Pain Grade 4
Maltese: Grad 4
English: Urinary retention, proteinuria, haematuria
Maltese: proteinurija, ematurija
English: 2/day on Days 8-11. and4.5 MIU/m 2.
Maltese: MIU/m2/jum f'Jiem 8-11.
English: Table 4 provides dose modification guidance for dinutuximab, GM-CSF and IL-2.
Maltese: Tabella 4 tipprovdi gwida għal modifikazzjoni tad-doża għal dinutuximab, GM-CSF u IL-2.
English: Peripheral sensory neuropathy was reported in 3% of patients and peripheral motor neuropathy in 2% of patients; less than 1% of patients experienced serious peripheral neuropathy.
Maltese: Newropatija periferali ġiet irrappurtata fi 3% tal-pazjenti u newropatija tal-moviment periferali fi 2% talpazjenti; inqas minn 1% tal-pazjenti kellhom newropatija periferali serja.
English: It is not recommended to use intravenous immunoglobulin after ASCT.
Maltese: Mhux rakkomandat li tuża immunoglobulina ġol-vini wara ASCT.
English: Dinutuximab reacts specifically with the ganglioside GD2, which is highly expressed on the surface of neuroblastoma cells and minimally expressed on the surface of normal human neurons, peripheral pain fibres, and skin melanocytes.
Maltese: Dinutuximab jirreaġixxi speċifikament mal-ganglioside GD2, li hi espressa b'mod qawwi fuq il-wiċċ ta' ċelluli ta' newroblastoma u minimament espressa fuq il-wiċċ ta' newroni umani normali, fibri periferali tal-uġigħ, u melanoċiti tal-ġilda.
English: See section 2 for further information about sodium.
Maltese: Ara sezzjoni 2 għal aktar informazzjoni dwar is-sodium.
English: Dinutuximab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Maltese: Dinutuximab hu proteina li għaliha, ir-rotta metabolika mistennija hi degradazzjoni għal peptides żgħar u amino acids individwali permezz ta' enzimi proteolitiċi li jkunu preżenti kullimkien.
English: Delay initiation of courses 2-6 until ALT is less than 10 times ULN.
Maltese: Dewwem il-bidu ta' korsijiet 2-6 sakemm ALT ikun ta' inqas minn 10 darbiet tal-ULN.
English: Serious anaphylactic/allergic reactions were reported in 14% of patients.
Maltese: Reazzjonijiet anafilattiċi/allerġiċi serji ġew irrappurtati f'14% tal-pazjenti.
English: IL-2 was administered concurrently with dinutuximab as a continuous intravenous infusion for four days during Week 1 of Courses 2 and 4 at a dose of 3.0 MIU/m2/day, and during Week 2 of Courses 2 and 4 at a dose of 4.5 MIU/m2/day.
Maltese: IL-2 ingħata flimkien ma' dinutuximab bħala infużjoni kontinwa ġol-vini għal erbat ijiem matul Ġimgħa 1 ta' Korsijiet 2 u 4 f'doża ta' 3.0 MIU/m2/jum, u matul Ġimgħa 2 ta' Korsijiet 2 u 4
English: Specifically, in the presence of human effector cells including peripheral blood mononuclear cells (PBMC) and granulocytes from normal human donors, dinutuximab was found to mediate the lysis of several neuroblastoma cell lines in a dose-dependent manner.
Maltese: Speċifikament, fil-preżenza ta' ċelluli effector umani, li jinkludu ċelluli mononukleari periferali tad-demm (PBMC) u granuloċiti minn donaturi umani normali, instab li dinutuximab jimmedja l-lisi ta' diversi razez ta' ċelluli ta' newroblastoma b'mod li jiddependi fuq id-doża.
English: During courses (months) 1, 3 and 5
Maltese: Waqt korsijiet (xhur) 1, 3 u 5
English: GM-CSF was administered at a dose of 250 μg/m2/day during Courses 1, 3, and 5 and dosed daily for 14 days.
Maltese: GM-CSF ingħata f'doża ta' 250 μg/m2/jum matul Korsijiet 1, 3, u 5 u ngħata f'doża ta' kuljum għal 14-il jum.
English: Hypersensitivity (Grade 4) to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva (Grad 4) għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Neuralgia, peripheral neuropathy, headache
Maltese: Nevralġija, newropatija periferali, uġigħ ta' ras
English: No direct effects on electrocardiogram parameters or on the respiratory system were observed.
Maltese: Ma ġew osservati l-ebda effetti diretti fuq il-parametri talelettrokardjogramma jew fuq is-sistema respiratorja.
English: Each 5 mL vial contains 17.2 mg sodium.
Maltese: Kull kunjett ta' 5 mL fih 17.2 mg ta' sodium.
English: Intravenous immunoglobulin
Maltese: Immunoglobulina għal ġol-vini
English: Device-related infection, infection susceptibility increased, bacteraemia, enterocolitis
Maltese: Mhux komuni infezzjoni, batteremija, enterokolite
English: Maculo-papular rash
Maltese: Raxx makulopapulari
English: The 2-year estimates of EFS were 66 % among subjects receiving dinutuximab immunotherapy plus isotretinoin as compared with 48 % in subjects receiving isotretinoin alone (log-rank test p = 0.033) although this difference did not reach formal statistical significance according to the pre-specified plan for interim analyses.
Maltese: L-istimi ta' sentejn ta' EFS kienu 66% fost individwi li kienu qed jirċievu immunoterapija b'dinutuximab flimkien ma' isotretinoin meta mqabbla ma' 48% f'individwi li kienu qed jirċievu isotretinoin waħdu (log-rank test p = 0.033) għalkemm din id-differenza ma laħqitx sinifikat statistiku formali skont ilpjan speċifikat minn qabel għal analiżijiet interim.
English: Following ASCT, 226 subjects were randomly assigned 1:1 to either a standard therapy arm (six courses of isotretinoin) or a dinutuximab immunotherapy arm (five courses of dinutuximab in combination with alternating GM-CSF and IL-2; combined with isotretinoin concurrently for six courses).
Maltese: Wara ASCT, 226 individwu ġew assenjati b'mod każwali fi proporzjon ta' 1:1 jew għall-parti tal-istudju dwar terapija standard (sitt korsijiet ta' isotretinoin) jew għall-parti tal-istudju dwar immunoterapija b'dinutuximab (ħames korsijiet ta' dinutuximab flimkien ma' GM-CSF u IL-2 alternanti; flimkien ma' isotretinoin fl-istess ħin għal sitt korsijiet).
English: • Reduce rate of infusion to 0.875 mg/m2/h.
Maltese: • Naqqas ir-rata ta' infużjoni għal 0.875 mg/m2/siegħa.
English: Dinutuximab: 17.5 mg/m2/day, administered by intravenous infusion over 10-20 hours.
Maltese: Dinutuximab: 17.5 mg/m2/jum, mogħtija jew permezz ta' infużjoni ġol-vini fuq perjodu ta' 10-20 siegħa.
English: Table 2: Courses 2 and 4 dosing schedule for Unituxin and IL-2; Courses 2, 4, and 6 dosing schedule for isotretinoin
Maltese: Tabella 2: Skeda ta' dożaġġ ta' Korsijiet 2 u 4 għal Unituxin u IL-2; Skeda ta' dożaġġ ta' Korsijiet 2, 4, u 6 għal isotretinoin
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża.
English: 1 mL of concentrate contains 3.5 mg of dinutuximab.
Maltese: konċentrat fih 3.5 mg ta' dinutuximab.
English: Characteristic symptoms and signs include hypotension, generalized oedema, ascites, dyspnoea, pulmonary oedema and acute renal failure associated with hypoalbuminaemia and haemoconcentration.
Maltese: Sintomi u sinjali karatteristiċi jinkludu pressjoni baxxa, edema ġeneralizzata, axxite, dispnea, edema pulmonari u insuffiċjenza akuta tal-klieiwi assoċjata ma' ipoalbuminemija u emakonċentrazzjoni.
English: Unituxin 3.5 mg/mL sterile concentrate dinutuximab
Maltese: Informazzjoni għall-utent Unituxin 3.5 mg/mL konċentrat għal soluzzjoni għall-infużjoni dinutuximab
English: If not tolerated, reduce rate to 0.875 mg/m2/h.
Maltese: Jekk ma tkunx ittollerata, naqqas ir rata għal 0.875 mg/m2/siegħa.
English: Hypomagnesaemia, acidosis, hypoglycaemia,
Maltese: ipofosfatemija, ipoalbuminemija,
English: In male and female rats, administration of dinutuximab resulted in no adverse effects on reproductive organs at exposures that were at least 60-fold higher than those observed clinically.
Maltese: dinutuximab ma rriżulta fl-ebda effetti negattivi fuq l-organi riproduttivi f'esponimenti li kienu mill-inqas 60
English: Paracetamol should be administered orally 20 minutes prior to starting each dinutuximab infusion, and repeated every 4-6 hours as needed.
Maltese: Paracetamol għandu jingħata b'mod orali 20 minuta qabel il-bidu ta' kull infużjoni b'dinutuximab, u jiġi ripetut kull 4-6 sigħat kif meħtieġ.
English: Lidocaine may be administered as an intravenous infusion (2 mg/kg in 50 mL of 0.9 % sodium chloride) over 30 minutes prior to the start of each dinutuximab infusion and continued via intravenous infusion at 1 mg/kg/h up to 2 hours after completion of the treatment.
Maltese: Lidocaine jista' jingħata bħala infużjoni ġol-vini (2 mg/kg f'50 mL ta' 0.9% sodium chloride) fuq perjodu ta' 30 minuta qabel il-bidu ta' kull infużjoni b'dinutuximab u jitkompla permezz ta' infużjoni ġol-vini b'rata ta'
English: Hepatic dysfunction Regular monitoring of liver function is recommended during dinutuximab immunotherapy.
Maltese: Disfunzjoni tal-fwied Monitoraġġ regolari tal-funzjoni tal-fwied hu rakkomandat matul l-immunoterapija b'dinutuximab.
English: Intravenous sodium chloride 9 mg/mL (0.9%) solution for injection (10 mL/kg) should be administered over one hour just prior to the dinutuximab infusion.
Maltese: Sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni (10 mL/kg) ġol-vini għandha tingħata fuq perjodu ta' siegħa dritt qabel l-infużjoni b'dinutuximab.
English: Dinutuximab (or the murine monoclonal antibody 14.18) has been administered to mice, rabbits, rats, and dogs in single- or repeat-dose regimens that exceed the dose that is used clinically.
Maltese: Dinutuximab (jew l-antikorp monoklonali murine 14.18) ingħata lil ġrieden, fniek, firien, u klieb, f'korsijiet ta' doża waħda jew ta' dożi ripetuti li jaqbżu d-doża li tintuża klinikament.
English: It belongs to a group of medicines called ‘monoclonal antibodies'.
Maltese: Jappartjeni għal grupp ta' mediċini msejħa ‘antikorpi monoklonali'.
English: 160 mg/m2/day; for body weight up to 12 kg: 2.67 mg/kg administered orally twice daily for a total daily dose of 5.33 mg/kg/day (round dose up to nearest 10 mg).
Maltese: Isotretinoin: għal piż tal-ġisem ta' aktar minn 12 kg: 80 mg/m2 mogħtija mill-ħalq darbtejn kuljum għal doża totali ta' 160 mg/m2/jum; għal piż tal-ġisem sa 12 kg: 2.67 mg/kg mogħtija mill-ħalq darbtejn kuljum għal doża totali ta' kuljum ta' 5.33 mg/kg/jum (qarreb id-doża għall-eqreb 10 mg).
English: 1 Includes preferred terms abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain, pain in extremity, and proctalgia.
Maltese: 1 Jinkludi t-termini ppreferuti wġigħ addominali, uġigħ addominali fin-naħa ta' fuq, artralġja, uġigħ fid-dahar, uġigħ filbużżieqa tal-awrina, uġigħ fl-għadam, uġigħ fis-sider, uġigħ fil-wiċċ, uġigħ ġinġivali, uġigħ muskuloskeletali fis-sider, mijalġja, uġigħ fl-għonq, nevralġija, uġigħ orofarineġali, uġigħ, uġigħ fl-estremitajiet, u proktalġija.
English: • Administer supportive measures (see section 4.4).
Maltese: • Agħti miżuri ta' appoġġ (ara sezzjoni 4.4)
English: Pain typically occurred during the Unituxin infusion and was most commonly reported as abdominal pain, generalized pain, extremity pain, back pain, neuralgia, musculoskeletal chest pain, and arthralgia; 41% of patients suffered severe pain.
Maltese: Uġigħ tipiku seħħ waqt l-infużjoni ta' Unituxin u kien irrappurtat bl-aktar mod komuni bħala wġigħ addominali, uġigħ ġeneralizzat, uġigħ fl-estremitajiet, uġigħ fid-dahar, nevralġija, uġigħ muskuloskeletali fis-sider, u artralġija; 41% of patients suffered severe pain.
English: In animals, fertility studies have not been conducted; however in male and female rats, no adverse effects on reproductive organs were observed (see section 5.3).
Maltese: Ma sarux studji dwar il-fertilità flannimali; madankollu f'firien irġiel u nisa, ma ġew osservati l-ebda effetti avversi fuq l-organi riproduttivi (ara sezzjoni 5.3).
English: Haemolytic uraemic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anaemia, and hypertension has been reported.
Maltese: Sindromu uremiku emolitiku fl-ssenza ta' infezzjoni dokumentata u li tirriżulta f'insuffiċjenza tal-kliewi, anormalitajiet fl-elettroliti, anemija, u pressjoni għolja ġew irrappurtati.
English: The recommended dose is 17.5 mg/m2.
Maltese: 17.5 mg/m2.
English: Recurrence
Maltese: Iponatremija
English: See section 4 for more information about pain side effects.
Maltese: Ara sezzjoni 4 għal aktar informazzjoni dwar l-effetti sekondarji tal-uġigħ.
English: Patients were aged 11 months to 15 years and had previously achieved at least a partial response to induction chemotherapy, followed by ASCT and radiotherapy.
Maltese: Il-pazjenti kellhom minn 11-il xahar sa 15-il sena u fil-passat kien kisbu mill-inqas rispons parzjali għal kimoterapija ta' induzzjoni, segwita minn ASCT u radjuterapija.
English: Adverse reactions are defined as those adverse events that occurred at a higher frequency in the dinutuximab, GMCSF, IL-2 and isotretinoin-treated group compared with the isotretinoin-treated control group during the ANBL0032 randomised, controlled, pivotal study, and that have a plausible mechanistic relationship to treatment with dinutuximab.
Maltese: Reazzjonijiet avversi huma definiti bħala dawk l-avvenimenti avversi li seħħew bi frekwenza ogħla fil-grupp ikkurat b'dinutuximab, GM-CSF, IL-2 u isotretinoin meta mqabbel mal-grupp ta' kontroll ikkurat b'isotretinoin matul l-istudju importanti ħafna ANBL0032, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat, u li kellhom relazzjoni mekkanistika plawsibbli għall-kura b'dinutuximab.
English: It is administered on Days 4-7 during Courses 1, 3, and 5 (each course lasting approximately 24 days) and on Days 8-11 during Courses 2 and 4 (each course lasting approximately 28 days).
Maltese: Jingħata f'Jiem 4-7 matul Korsijiet 1, 3, u 5 (kull kors idum madwar 24 jum) u f'Jiem 8-11 matul Korsijiet 2 u 4 (kull kors idum madwar 28 jum).
English: • Administer dinutuximab at 0.875 mg/m2/h and resume GM-CSF or IL-2.
Maltese: • Agħti dinutuximab b'rata ta' 0.875 mg/m2/siegħa u erġa' ibda GM-CSF
English: Reporting of suspected adverse reactions that occur after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: It is not recommended to use systemic corticosteroid medicinal products due to possible interference with immune activation which is necessary for the therapeutic action of dinutuximab.
Maltese: Mhux rakkomandat li jintużaw prodotti mediċinali kortikosterojdi sistemiċi minħabba interferenza possibbli b'attivazzjoni immunitarja li hi meħtieġa għall-azzjoni terapewtika ta' dinutuximab.
English: • If patient has CNS metastases, delay course initiation and give platelet transfusion to maintain platelet count at least 50,000/μL.
Maltese: • Jekk pazjent ikollu metastasi tas-CNS, dewwem il-bidu kors u agħti trasfużjoni tal-plejtlets biex iżżomm l-għadd tal-plejtlits mill-inqas 50,000/μL.
English: Grade 3 (sensory changes for more than 2 weeks, objective motor weakness) or Grade 4
Maltese: Grad 3 (tibdil sensorju għal aktar minn ġimagħtejn, dgħufija objettiva tal-moviment) jew Grad 4
English: Sodium chloride
Maltese: Sodium chloride Ilma għall-injezzjonijiet
English: As with all therapeutic proteins, there is potential for immunogenicity.
Maltese: Bħal proteini terapewtiċi kollha, hemm il-potenzjal għal immunoġeniċità.
English: Findings of note included treatment related adverse reactions of the liver in rats (characterized by centrilobular congestion, abnormal cell division, hepatocellular necrosis and pericentral vein/interlobular fibrosis) which may be related to circulatory disturbances and changes indicative of increased haematopoiesis (high reticulocyte ratio and/or platelet count, increased cellularity of the haematopoietic cells in the femoral and sternal bone marrow, and/or extramedullary haematopoiesis in the liver and spleen).
Maltese: Riżultati importanti kienu jinkludu reazzjonijiet avversi relatati mal-kura, tal-fwied fil-firien (ikkaratterizzati minn konġestjoni ċentrilobulari, diviżjoni anormali taċ-ċelluli, nekrożi epatoċellulari u tal-vini periċentrali/fibrożi interlobulari) li jistgħu jkunu relatati ma' disturbi ċirkolatorji u tibdil indikattiv ta' żieda fl-ematopoiesi (proporzjon għoli ta' retikuloċiti u/jew għadd ta' plejtlits, żieda fiċ-ċellularità ta' ċelluli ematopoetiċi fl għadam tal-mudullun femorali u sternali, u/jew ematopoiesi extramedullari fil-fwied u fil-milsa).
English: Non-clinical studies demonstrate that dinutuximab-induced neurotoxicity is likely due to the induction of mechanical allodynia that may be mediated by reactivity of dinutuximab with GD2 antigen located on the surface of peripheral nerve fibres and/or myelin.
Maltese: Studji mhux kliniċi juru li newrotossiċità indotta minn dinutuximab x'aktarx li sseħħ minħabba l-induzzjoni ta' allodynia mekkanika li tista' tiġi medjata mir-reattività tal dinutuximab ma' antiġen ta' GD2 li jinsab fuq il-wiċċ ta' fibri ta' nervituri periferali u/jew myelin.
English: Symptomatic and/or systolic BP less than 70 mmHg or a decrease that is more than 15% below baseline Onset of symptoms
Maltese: BP sintomatika u/jew sistolika ta' inqas minn 70 mmHg jew tnaqqis li jkun aktar minn 15% taħt il-linja bażi
English: Capillary leak syndrome was a very common adverse reaction (45 % of patients) that occurred more frequently when Unituxin was co-administered with IL-2; it was severe (> Grade 3) in 14% of patients.
Maltese: Sindrome ta' tnixxija kapillari kienet reazzjoni avversa komuni ħafna (45% tal-pazjenti) li seħħet b'mod iktar frekwenti meta Unituxin ingħata flimkien ma' IL-2; kien sever (> Grad 3) f'14% tal-pazjenti.
English: The 3-year estimates of OS were 80 % compared with 67 % among subjects receiving dinutuximab immunotherapy plus isotretinoin and isotretinoin alone, respectively (log-rank test p = 0.0165).
Maltese: isotretinoin u isotretinoin waħdu, rispettivament (log-rank test p = 0.0165).
English: A population pharmacokinetic analysis conducted on all clinical data available suggests that the disposition of dinutuximab is not altered by age, race, gender, concomitant medications (IL-2, GM-CSF) and the presence of capillary leak syndrome, renal or hepatic impairment.
Maltese: Analiżi farmakokinetika tal-popolazzjoni li saret fuq id-dejta klinika kollha disponibbli, tissuġġerixxi li ddispożizzjoni ta' dinutuximab ma tinbidilx skont l-età, razza, sess tal-persuna, medikazzjonijiet li jingħataw fl-istess ġin (IL-2, GM-CSF) u l-preżenza tas-sindrome ta' tnixxija kapillari, indeboliment tal-kliewi jew talfwied.
English: Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).
Maltese: Unituxin hu indikat għall-kura ta' newroblastoma ta' riskju għoli f'pazjenti li jkollhom minn 12-il xahar sa 17-il sena, li fil-passat irċivew kimoterapija ta' induzzjoni u kisbu mill-inqas rispons parzjali, segwita minn kura majeloablattiva u trapjant awtologu ta' ċelluli staminali (a, autologous stem cell transplantation ASCT).
English: • If IL-2 is not tolerated at 50 % of the dose, administer dinutuximab alone
Maltese: • Jekk IL-2 ma jiġix ittollerat fir-rata ta' 50% tad-doża, agħti dinutuximab
English: Chemical and physical in-use stability has been demonstrated at ambient conditions (less than 25 °C).
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet f'kundizzjonijiet ambjentali (inqas minn 25°C).
English: Electrolyte abnormalities occurring in at least 25 % of patients who received Unituxin included hyponatraemia and hypokalaemia.
Maltese: Anormalitajiet fl-elettroliti seħħew f'mill-inqas 25% tal-pazjenti li rċivew Unituxin, li jinkludu iponatremija u ipokalemija.
English: 6.6 Special precautions for disposal and other handling The exact volume of Unituxin concentrate for solution for infusion required for the patient dose (see section 4.2) must be injected into a 100 mL bag of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Maltese: .6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor Il-volum eżatt ta' Unituxin konċentrat għal soluzzjoni għall-infużjoni meħtieġa għad-doża tal-pazjent (ara sezzjoni 4.2) irid jiġi injettat ġo borża ta' 100 mL ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall injezzjoni.
English: For instructions on dilution of the medicinal product before administration see section 6.6 of the SmPC.
Maltese: Għal istruzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6 talSmPC.
English: • Any kind of pain: in the stomach, throat, chest, face, hands, feet, legs or arms (such as numbness, tingling or burning) back, neck, joint, bone, muscle, mouth, eye, genitals.
Maltese: • Kwalunkwe tip ta' wġigħ: fl-istonku, gerżuma, sider, wiċċ, idejn, saqajn, riġlejn jew dirgħajn (bħal tmewwit, tnemnim jew ħruq), dahar, għonq, ġogi, għadam, muskoli, ħalq, għajnejn, partijiet ġenitali.
English: ANBL0032 was a randomised, controlled study that evaluated the effects of dinutuximab administered in combination with GM-CSF, IL-2, and isotretinoin compared with isotretinoin alone in high-risk neuroblastoma subjects.
Maltese: ANBL0032 kien studju kkontrollat li fih il-parteċipanti ntgħażlu b'mod każwali, li evalwa l-effetti ta' dinutuximab mogħti flimkien ma' GM-CSF, IL-2, u isotretinoin, imqabbla ma' isotretinoin waħdu f'individwi b'newroblastoma ta' riskju għoli.
English: Pain
Maltese: KUNJETT
English: • For GM-CSF courses, administer GM-CSF at 50 % of the dose starting the next day, and if tolerated, GM-CSF may be given at full dose after completing dinutuximab dosing for that course.
Maltese: • Jekk GM-CSF ma jiġix ittollerat fir-rata ta' 50% tad-doża, agħti dinutuximab waħdu għall-bqija tal-kors.
English: See section 4 for a full list of known side effects.
Maltese: Ara sezzjoni 4 għal-lista sħiħa ta' effetti sekondarji magħrufa.
English: • If patient tolerated 50 % dose of GM-CSF or IL-2, start at this dose and dinutuximab rate of 0.875 mg/m2/h.
Maltese: • Jekk pazjent ikun ittollera doża ta' 50% ta' GM-CSF jew IL-2, ibda f'dik id-doża u rata ta' dinutuximab ta' 0.875 mg/m2/siegħa.
English: Urticaria, pruritus
Maltese: Ipokalemija, iponatremija,
English: Atypical Haemolytic Uraemic Syndrome
Maltese: Sindrome Uremiku Emolitiku Atipiku