FrancophonIA/ELRC3.0 huggingface dataset:
English: ETOPOPHOS and associated names in paediatric patients has been used in the range of 75 to 150 mg/m2/day (etoposide equivalent) for 2 to 5 days in combination with other antineoplastic agents.
Maltese: ETOPOPHOS u ismijiet assoċjati f'pazjenti pedjatriċi intuża fil-medda ta' 75 u 150 mg/m2/d (ekwivalenti ta' etoposide)) għal 2 sa 5 ijiem flimkien ma' sustanzi antineoplastiċi oħra.
English: Etoposide binding ratio correlates directly with serum albumin in cancer patients and normal volunteers (see section 4.4).
Maltese: Il-proporzjon tat-twaħħil ta' etoposide jikkorrela direttament mal-albumina fis-serum f'pazjenti bilkanċer u f'voluntiera normali (ara sezzjoni 4.4).
English: All steps of preparation must be carried out under Laminar Air Flow conditions.
Maltese: Il-passi kollha talpreparazzjoni jridu jitwettqu taħt kundizzjonijiet ta' Flus ta' Arja Laminari.
English: ETOPOPHOS and associated names is indicated for first line and second line therapy in combination with other approved chemotherapeutic agents for the treatment of high risk gestational trophoblastic neoplasia in adults.
Maltese: ETOPOPHOS u ismijiet assoċjati huwa indikat għal terapija primarja u sekondarja flimkien ma' sustanzi kimoterapewtiċi oħra approvati għall-kura ta' neoplażija trofoblastika waqt it-tqala fl-adulti.
English: High dose ciclosporin, resulting in plasma concentrations above 2000 ng/mL, administered with oral etoposide has led to an 80% increase in etoposide exposure (AUC) with a 38% decrease in total body clearance of etoposide compared to etoposide alone.
Maltese: mogħti flimkien ma' etoposide orali, wassal għal żieda ta' 80% fl-esponiment ta' etoposide (AUC), bi tnaqqis ta' 38% fit-tneħħija globali ta' etoposide mill-ġisem meta mqabbel ma' etoposide waħdu.
English: Total doses of 2.4 g/m to 3.5 g/m administered intravenously over three days have resulted in severe mucositis and myelotoxicity.
Maltese: Dożi totali ta' 2.4 g/m2 sa 3.5 g/m2 mogħtija ġol-vini fuq perjodu ta' tlett ijiem, irriżultaw f'mukożite severa u majelotossiċità.
English: The mean renal clearance of etoposide is 7 to 10 mL/min/m2 or about 35% of the total body clearance over a dose range of 80 to 600 mg/m2.
Maltese: Il-medja tat-tneħħija ta' etoposide mill-kliewi hi ta' 7 sa 10 mL/min/m2 jew madwar 35% tat-tneħħija totali mill-ġisem fuq medda ta' doża ta' 80 sa 600 mg/m2.
English: In a study of the effects of other therapeutic agents on in vitro binding of 14C etoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide at concentrations generally achieved in vivo (see section 4.5).
Maltese: Fi studju dwar l-effetti ta' sustanzi terapewtiċi oħra fuq it-twaħħil in vitro ta' 14C etoposide malproteini tas-serum tal-bniedem, phenylbutazone, sodium salicylate, u l-aspirina biss spostaw etoposide imwaħħal mal-proteini f'konċentrazzjonijiet ġeneralment miksuba in vivo (ara sezzjoni 4.5).
English: The recommended dose of ETOPOPHOS and associated names in adult patients is 50 to 100 mg/m2/day (etoposide equivalent) on days 1 to 5 or 100 to 120 mg/m2 on days 1, 3, and 5 every 3 to 4
Maltese: Id-doża rakkomandata ta' ETOPOPHOS u ismijiet assoċjati f'pazjenti adulti hija ta' 50 sa 100 mg/m2/jum (ekwivalenti ta' etoposide) f'jiem 1 sa 5, jew 100 sa 120 mg/m2 f'jiem 1, 3, u 5 kull 3 sa 4 ġimgħat flimkien ma' mediċini oħrajn indikati għall-użu fil-marda li tkun se tiġi kkurata.
English: ETOPOPHOS and associated names should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician.
Maltese: ETOPOPHOS u ismijiet assoċjati għandhom jitwaqqfu immedjatament, u jiġu segwiti mill-għoti ta' sustanzi pressor, kortikosterojdi, antistamini, jew expanders tal-volum, fid-diskrezzjoni tat-tabib.
English: The recommended dose of ETOPOPHOS and associated names is 50 to 100 mg/m2/day (etoposide equivalent) on days 1 to 5 or 100 to 120 mg/m2 on days 1, 3, and 5 every 3 to 4 weeks in combination with other drugs indicated in the disease to be treated.
Maltese: Id-doża rakkomandata ta' ETOPOPHOS u ismijiet assoċjati hija ta' 50 sa 100 mg/m2/jum (ekwivalenti ta' etoposide) f'jiem 1 sa 5, jew 100 sa 120 mg/m2 f'jiem 1, 3, u 5 kull 3 sa 4 ġimgħat flimkien ma' mediċini oħrajn indikati għall-użu fil-marda li tkun se tiġi kkurata.
English: The resulting stock solution may be administered without further dilution or can be further diluted with 5% glucose solution or 0.9% sodium chloride solution to a final concentration 0.1 mg/ml etoposide.
Maltese: Is-soluzzjoni stock li tirriżulta tista' tingħata mingħajr dilwizzjoni addizzjonali, jew tista' tiġi dilwita b'mod ulterjuri b'soluzzjoni ta' 5% glucose jew soluzzjoni ta' 0.9% sodium chloride sabiex tinkiseb konċentrazzjonijiet finali ta' 0.1 mg/mL ta' etoposide.
English: Each vial contains etoposide phosphate equivalent to etoposide 100 mg or 1000 mg as the active ingredient.
Maltese: Kull kunjett fih etoposide phosphate ekwivalenti għal etoposide 100 mg jew 1000 mg bħala s-sustanza attiva.
English: Two dose-dependent responses are seen: At high concentrations (10 mcg/mL or more), cells entering mitosis are lysed; at low concentrations (0.3 to 10 mcg/mL), cells are inhibited from entering prophase.
Maltese: (10 mcg/mL jew aktar), iċ-ċelluli li jidħlu fil-mitożi jiġu lysed; f'konċentrazzjonijiet baxxi (0.3 sa 10 mcg/mL), iċ-ċelluli jiġu inibiti milli jidħlu fil-profażi.
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari] {Isem u Indirizz} <{tel}> <{fax}> <{e-mail}>
English: The usual dose, based on etoposide, is 50 to100mg/m2 body surface area, daily for 5 days in a row or 100 to 120 mg/ m2 body surface area on days 1, 3 and 5.
Maltese: Id-doża normali, ibbażata fuq etoposide, hi ta' 50 sa 100 mg/m2 tas-superfiċje tal-ġisem, kuljum għal 5 ijiem wara xulxin, jew 100 sa 120 mg/m2 tas-superfiċje tal-ġisem f'jiem 1, 3 u 5.
English: What ETOPOPHOS and associated names is and what it is used for What you need to know before you are given ETOPOPHOS and associated names How you will be given ETOPOPHOS and associated names Possible side effects
Maltese: Kif se tingħata ETOPOPHOS u ismijiet assoċjati Effetti sekondarji possibbli
English: Exp.
Maltese: ETOPOPHOS.
English: The content of each injection vial of ETOPOPHOS and associated names 1000 mg has to be diluted in 100 ml of:
Maltese: Il-kontenut ta' kull kunjett għall-injezzjoni ta' ETOPOPHOS u ismijiet assoċjati 1000 mg għandu jiġi dilwit f'100 mL ta':
English: Ovarian cancer; small cell lung cancer; gestational trophoblastic neoplasia; testicular cancer
Maltese: Kanċer tal-ovarji; kanċer tal-pulmun ta' ċelluli mhux żgħar; neoplażija trofoblastika waqt it-tqala; kanċer testikulari
English: ETOPOPHOS and associated names should be given only by slow intravenous infusion (usually over a 30 to 60 minute period) since hypotension has been reported as a possible side effect of rapid intravenous injection.
Maltese: ETOPOPHOS u ismijiet assoċjati għandhom jingħataw biss permezz ta' infużjoni ġol-vini bil-mod (normalment fuq perjodu ta' 30 sa 60 minuta), billi l-pressjoni baxxa ġiet irrappurtata bħala effett sekondarju possibbli ta' injezzjoni mgħaġġla ġol-vini.
English: ETOPOPHOS and associated names is indicated for the treatment of platinum-resistant/refractory epithelial ovarian cancer in adults.
Maltese: ETOPOPHOS u ismijiet assoċjati huwa indikat għall-kura ta' kanċer tal-ovarji epiteljali reżistenti/refrattarju għall-platinum fl-adulti.
English: In patients with creatinine clearance less than 15 mL/min and on dialysis further dose reduction is likely to be required as etoposide clearance is further reduced in these patients (see section 4.4).
Maltese: F'pazjenti bi tneħħija tal-kreatinina ta' inqas minn 15 mL/min u li jkunu fuq id-dijalisi, tnaqqis addizzjonali fid-doża x'aktarx li jkun meħtieġ, għax it-tneħħija ta' etoposide titnaqqas b'mod ulterjuri f'dawn il-pazjenti (ara sezzjoni 4.4).
English: <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Maltese: DATA TA' SKADENZA Data Meta Jiskadi:
English: Thrombocytopenia and severe thrombocytopenia (less than 50,000 platelets/mm
Maltese: Ż-ŻGĦAR EWLENIN Tikketta tal-Kunjett (100 mg)
English: In patients with creatinine clearance less than 15 mL/min and on dialysis further dose reduction should be considered.
Maltese: F'pazjenti bi tneħħija tal-kreatinina ta' inqas minn 15 mL/min u li jkunu fuq id-dijalisi, għandu jiġi kkunsidrat tnaqqis addizzjonali fid-doża.
English: Gestational trophoblastic neoplasia
Maltese: INDIKAZZJONIJIET TERAPEWTIĊI
English: • skin problems such as itching or rash
Maltese: • problemi biex tieħu n-nifs
English: ETOPOPHOS and associated names (see Annex I) 100 mg powder for solution for infusion ETOPOPHOS and associated names (see Annex I) 1000 mg powder for solution for infusion
Maltese: ETOPOPHOS u ismijiet assoċjati (ara Anness I) 100 mg trab għal soluzzjoni għall-infużjoni ETOPOPHOS u ismijiet assoċjati (ara Anness I) 1000 mg trab għal soluzzjoni għall-infużjoni Ara Anness I - Biex timtela mill-pajjiż partikolari
English: The predominant macromolecular effect of etoposide seems to be the rupture of the double strand by an interaction with DNAtopoisomerase II or by the formation of free radicals.
Maltese: L-effett makromolekulari predominanti ta' etoposide jidher li huwa l-qtugħ tad-double strand permezz ta' interazzjoni mad-DNA-topoisomerase II jew permezz tal-formazzjoni tar-radikali ħielsa.
English: Preparation of ETOPOPHOS and associated names 1000 mg powder for solution for infusion
Maltese: Il-preparazzjoni ta' ETOPOPHOS u ismijiet assoċjati 1000 mg trab għal soluzzjoni għall-infużjoni
English: Nausea and vomiting are the major gastrointestinal toxicities of etoposide phosphate.
Maltese: Id-dardir u r-rimettar huma t-tossiċitajiet gastrointestinali maġġuri ta' etoposide phosphate.
English: Before use the content of each vial must be reconstituted with 5 ml or 10 ml of:
Maltese: il-kontenut ta' kull kunjett irid jiġi rikostitwit b'5 mL jew 10 mL ta':
English: ETOPOPHOS and associated names is used in the treatment of certain types of cancers in adults:
Maltese: ETOPOPHOS u ismijiet assoċjati jintużaw fil-kura ta' ċerti tipi ta' kanċer fl-adulti:
English: Facial flushing was reported in 2% of patients and skin rashes in 3%.
Maltese: Ħmura tal-wiċċ ġiet irrappurtata 2% tal-pazjenti, u raxx tal-ġilda fi 3%.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains etoposide 100 mg (as phosphate) Each vial contains etoposide 1000 mg (as phosphate)
Maltese: Kull kunjett fih etoposide 100 mg (bħala phosphate)
English: Tumour lysis syndrome (sometimes fatal) has been reported following the use of etoposide phosphate in association with other chemotherapeutic drugs (see section 4.4).
Maltese: Sindrome tal-lisi tat-tumur (xi kultant fatali) ġie rrappurtat wara l-użu ta' etoposide phosphate flimkien ma' mediċini kimoterapewtiċi oħra (ara sezzjoni 4.4).
English: For children being treated for cancer of the blood or lymphatic system the dose used is 75 to 150 mg/m2 body surface area daily for 2 to 5 days.
Maltese: Għal tfal li jkunu qed jiġu kkurati għall-kanċer tad-demm jew tas-sistema limfatika, id-doża użata hi ta' 75 ta' 150 mg/m2 tas-superfiċje tal-ġisem kuljum għal 2 sa 5 ijiem.
English: Doses subsequent to initial dose should be adjusted if neutrophil count less than 500 cells/mm3 occurs for more than 5 days or is associated with fever or infection, if platelet count less than 25,000 cells/mm3 occurs, if any grade 3 or 4 toxicity develops or if renal clearance is less than 50 ml/min.
Maltese: Id-dożi sussegwenti wara l-ewwel doża għandhom jiġu aġġustati jekk ikun hemm għadd ta' newtrofili ta' inqas minn 500 ċellula/mm3 għal aktar minn 5 ijiem, jew jekk dan ikun assoċjat ma' deni jew infezzjoni, jekk ikun hemm għadd ta' plejtlits ta' inqas minn 25,000 ċellula/mm3, jekk tiżviluppa kwalunkwe tossiċità ta' grad 3 jew 4, jew jekk it-tneħħija mill-kliewi tkun ta' inqas minn 50 mL/min.
English: In animal studies etoposide was associated with dose-related embryotoxicity and teratogenicity.
Maltese: Fi studji fuq l-annimali, etoposide kien assoċjat ma' embrijotossiċità u teratoġeniċità relatati mad doża.
English: This will yield a reconstituted stock solution containing 10 mg/ml etoposide.
Maltese: Dan se jipproduċi soluzzjoni stock rikostitwita (reconstituted stock solution) li jkun fiha 10 mg/mL ta' etoposide.
English: Immune system disorders common anaphylactic reactions** not known angioedema, bronchospasm Metabolism and nutrition disorders not known tumour lysis syndrome
Maltese: Disturbi fis-sistema immuni komuni reazzjonijiet anafilattiċi** mhux magħruf anġjoedema, bronkospażmu
English: In clinical studies involving etoposide phosphate, episodes of hypertension have been reported.
Maltese: Fi studji kliniċi li kienu jinvolvu etoposide phosphate, episodji ta' pressjoni għolja ġew irrappurtati.
English: Dextran 40 [To be completed nationally]
Maltese: Dextran 40 [Biex timtela mill-pajjiż partikolari] 6.2 Inkompatibbiltajiet
English: Effects of other drugs on the pharmacokinetics of etoposide phosphate
Maltese: L-effett ta' mediċini oħrajn fuq il-farmakokinetika ta' etoposide phosphate
English: • a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis)
Maltese: • raxx qisu ħruq mix-xemx, li jista' jseħħ fuq il-ġilda li fil-passat tkun ġiet esposta għal radjuterapija u li jista' jkun sever (dermatite tat-tip radiation recall)
English: After either intravenous infusion or oral capsule administration, the Cmax and AUC values exhibit marked intra- and inter-subject variability.
Maltese: Wara jew infużjoni ġol-vini jew l-għoti orali tal-kapsula, il-valuri tas-Cmax u tal-AUC juru varjabilità fl-individwu nnifsu u bejn individwi differenti.
English: Since etoposide and its metabolites are not dialyzable, it can be administered pre- and post-haemodialysis (see section 4.9).
Maltese: Billi etoposide u l-metaboliti tiegħu mhumiex dijalizzabbli, din il-mediċina tista' tingħata qabel u wara lemodijalisi (ara sezzjoni 4.9).
English: The safety profile between paediatric patients and adults is expected to be similar.
Maltese: Il-profil tas-sigurtà bejn pazjenti pedjatriċi u adulti hu mistenni li jkun l-istess.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of Hodgkin's lymphoma in adult and paediatric patients.
Maltese: ETOPOPHOS u ismijiet assoċjati huwa indikat flimkien ma' sustanzi kimoterapewtiċi oħra approvati għall-kura ta' limfoma ta' Hodgkin f'pazjenti adulti u pedjatriċi.
English: ETOPOPHOS and associated names solutions must be prepared under aseptic conditions.
Maltese: Soluzzjonijiet ta' ETOPOPHOS u ismijiet assoċjati jridu jiġu ppreparati taħt kundizzjonijiet asettiċi.
English: ETOPOPHOS and associated names 100mg Powder for Solution for Infusion ETOPOPHOS and associated names 1000mg Powder for Solution for Infusion [See Annex I - To be completed nationally]
Maltese: ETOPOPHOS u ismijiet assoċjati 100mg Trab għal Soluzzjoni għall-Infużjoni ETOPOPHOS u ismijiet assoċjati 1000 mg Trab għal Soluzzjoni għall-Infużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari] Etoposide
English: Impaired renal function
Maltese: TAGĦRIF
English: Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people) • tingling or numbness in hands and feet
Maltese: • infezzjoni Effetti sekondarji mhux komuni (li jaffettwaw bejn 1 u 100 u 1 minn kull 1,000 persuna)
English: Dose limiting bone marrow suppression is the most significant toxicity associated with ETOPOPHOS and associated names therapy.
Maltese: Soppressjoni tal-mudullun li tillimita d-doża hi l-aktar tossiċità sinifikanti assoċjata ma' terapija b'ETOPOPHOS u ismijiet assoċjati.
English: In vitro plasma protein binding is 97%.
Maltese: In vitro, it-twaħħil tal-proteini mal-plażma hu ta' 97%.
English: Fatal myelosuppression has been reported following etoposide phosphate administration.
Maltese: Majelosoppressjoni fatali ġiet irrappurtata wara l-għoti ta' etoposide phosphate.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Acute fatal reactions associated with bronchospasm have also been reported with etoposide phosphate.
Maltese: Reazzjonijiet fatali akuti assoċjati ma' bronkospażmu ġew irrappurtati wkoll b'etoposide phosphate.
English: infections, or at a thrombocyte count below 25,000 cells/mm3, which is not caused by the disease.
Maltese: Tromboċitopenija u tromboċitopenija severa (inqas minn 50,000 ċellula/mm3) ġew osservati fi 23% u
English: The following haematological parameters should be measured at the start of therapy and prior to each subsequent dose of ETOPOPHOS and associated names: platelet count, haemoglobin, white blood cell count and differential.
Maltese: Il-parametri ematoloġiċi li ġejjin għandhom jitkejlu fil-bidu tat-terapija u qabel kull doża sussegwenti ta' ETOPOPHOS u ismijiet assoċjati: għadd tal-plejtlits, emoglobina, għadd taċ-ċelluli tad-demm bojod u differential.
English: ****Postmarketing complications reported for extravasation included local soft tissue toxicity, swelling, pain, cellulitis, and necrosis including skin necrosis.
Maltese: ****Kumplikazzjonijiet wara t-tqegħid fis-suq irrappurtati għall-ħruġ tal-mediċina mis-sit tal injezzjoni, nefħa, uġigħ, ċellulite, u n-nekrożi, li tinkludi nekrożi tal-ġilda.
English: Severe liver, kidney or heart damage from a condition called tumour lysis syndrome, caused by harmful amounts of substances from the cancer cells getting into the blood stream, has been seen sometimes when ETOPOPHOS and associated names is taken along with other drugs used to treat cancer.
Maltese: Il parametri ematoloġiċi għandhom jitkejlu, u għandhom jiġu kkunsidrati aġġustamenti f'ċikli sussegwenti skont it-tossiċità ematoloġika u l-effett kliniku f'pazjenti b'indeboliment moderat u sever tal-kliewi.
English: Pregnancy
Maltese: epatotossiċità
English: - if you have any infections.
Maltese: - jekk għandek kwalunkwe infezzjonijiet.
English: Co-administration of antiepileptic drugs and ETOPOPHOS and associated names can lead to decreased seizure control due to pharmacokinetic interactions between the drugs.
Maltese: L-effett ta' etoposide phosphate fuq il-farmakokinetika ta' mediċini oħrajn L-għoti flimkien ta' mediċini antiepilettiċi u ETOPOPHOS u ismijiet assoċjati, jista' jwassal għal tnaqqis fil-kontroll ta' aċċessjonijiet minħabba interazzjonijiet farmakokinetiċi bejn il-mediċini.
English: Etoposide phosphate may cause adverse reactions that affect the ability to drive or use machines such as fatigue, somnolence, nausea, vomiting, cortical blindness, hypersensitivity reactions with hypotension.
Maltese: Etoposide phosphate jista' jikkawża reazzjonijiet avversi li jaffettwaw il-ħila biex issuq jew tħaddem magni bħal għeja, ħedla, dardir, rimettar, għama kortikali, reazzjonijiet ta' sensittività eċċessiva bi pressjoni baxxa.
English: Dose of Etoposide Phosphate
Maltese: Tneħħija Mkejla tal-Kreatinina Doża ta' Etoposide Phosphate
English: A decision must be made whether to discontinue breast-feeding or to discontinue ETOPOPHOS and associated names, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman (see section 4.3).
Maltese: Gћandha tittieћed deċiżjoni jekk il-mara twaqqafx it-treddigћ jew twaqqafx it-trattament b'ETOPOPHOS, wara li jigi kkunsidrat il-benefiċċju ta' treddigћ gћat-tarbija u l-benefiċċju tat-trattament gћall-mara (ara sezzjoni 4.3).
English: Etoposide belongs to the group of medicines called cytostatics which are used in the treatment of cancer.
Maltese: Etoposide jappartjeni għall-grupp ta' mediċini msejħa ċitostatiċi li jintuża fil-kura tal-kanċer.
English: Bacterial infections should be brought under control before treatment with ETOPOPHOS and associated names.
Maltese: Infezzjonijiet batterjali għandhom jiġu kkontrollati qabel il-kura b'ETOPOPHOS u ismijiet assoċjati.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults.
Maltese: ETOPOPHOS u ismijiet assoċjati huwa indikat flimkien ma' sustanzi kimoterapewtiċi oħra approvati għall-kura ta' kanċer tal-pulmun ta' ċelluli mhux żgħar fl-adulti.
English: Mutagenicity
Maltese: Anzjani
English: December 2025
Maltese: Diċembru 2025
English: CA Papaellinas Ltd.
Maltese: Papaellinas Ltd.
English: PK Parameters
Maltese: Parametri PK
English: t1/2 (day)
Maltese: t1/2 (jum)
English: - prednisone, a steroid medicine.
Maltese: - prednisone, mediċina sterojdi.
English: Arithmetic Mean (SD)
Maltese: Medja Aritmetika (SD)
English: MedDRA standard system organ class
Maltese: Sistema tal-klassifika tal-organi MedDRA standard
English: AUC0-t (mUday/mL)* AUC0-∞ (mUday/mL)
Maltese: AUC0-t (mUjum/ml)* AUC0-∞ (mUjum/ml)
English: 8 months.
Maltese: 8 xhur.
English: Carcinogenicity, mutagenicity, fertility
Maltese: Karċinoġeniċità, mutaġeniċità, fertilità
English: Table 1: Adverse reactions reported with Oncaspar therapy MedDRA standard system organ class
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati bit-terapija b'Oncaspar Sistema tal-klassifika tal-organi MedDRA standard
English: Paediatric patients and adults ≤21 years
Maltese: Pazjenti pedjatriċi u adulti ≤21 sena
English: Severe hepatic impairment (bilirubin >3 times upper limit of normal [ULN]; transaminases >10 times ULN).
Maltese: Indeboliment sever tal-fwied (bilirubina >3 darbiet tal-limitu normali ta' fuq [ULN]; transaminases >10 darbiet tal-ULN).
English: ǂ N= 46 evaluable subjects.
Maltese: ǂ N=46 individwu evalwabbli.
English: * N=47 evaluable subjects.
Maltese: * N=47 individwu evalwabbli.
English: Name and address of the manufacturer of the biological active substance Exelead, Inc.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Exelead, Inc.
English: The active substance is pegaspargase.
Maltese: Is-sustanza attiva hi pegaspargase.
English: Not known: Renal failure acute*
Maltese: Insuffiċjenza renali akuta*
English: Cmax (mU/mL)* Tmax (hr)*
Maltese: Cmax (mU/ml)*
English: Hyperammonaemia
Maltese: Iperammonaemija
English: June 2020
Maltese: Ġunju 2020
English: At 4-years, the EFS and overall survival (OS) for the Oncaspar treatment arm were 81.8% [95% CI 62.9-91.7%] and 90.4% [95% CI 78.5-95.9%], respectively.
Maltese: 8% [95% CI 62.9-91.7%] u 90.4% [95% CI 78.5-95.9%], rispettivament.
English: Asparaginase antibodies
Maltese: Antikorpi ta' asparaginase
English: Impaired protein synthesis can lead to a decline in the serum proteins.
Maltese: Indeboliment fis-sintesi tal-proteini jista' jwassal għal tnaqqis fil-proteini tas-serum.
English: Oncaspar efficacy in ALL in patients with relapse/refractory disease and a history of prior clinical allergic reaction to native E. coli L-asparaginase was based on a pool of 94 patients from six open-label studies [ASP-001, ASP-201A, ASP-302, ASP-304, ASP-400 and ASP-001C/003C].
Maltese: L-effikaċja ta' Oncaspar f'ALL f'pazjenti b'mard li jirkadi/refrattorju u bi storja medika ta' reazzjoni allerġika klinika fil-passat għal native E. coli L-asparaginase kienet ibbażata fuq grupp ta' 94 pazjent minn sitt studji open-label [ASP-001, ASP-201A, ASP-302, ASP-304, ASP-400 and ASP001C/003C].
English: Frequencies are defined by the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti mill-konvenzjoni li ġejja: 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), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1070/002
Maltese: EU/1/15/1070/002