FrancophonIA/ELRC3.0 huggingface dataset:
English: Considering the global implications of the findings at Castlebar, and proposed improvements at this manufacturing site, global corrective and preventive actions (CAPA) should be drawn up and used to audit other sites producing dialysis solutions, including those authorised in the framework of this procedure at the time of the first and second opinions.
Maltese: Minħabba l-implikazzjonijiet globali tas-sejbiet f'Castlebar, u t-titjib propost f'dan is-sit ta' manifattura, azzjonijiet globali korrettivi u preventivi (global corrective and preventive actions - CAPA) għandhom jiġu mfassla u użati għall-verifika ta' siti oħrajn li jipproduċu soluzzjonijiet għad-dijaliżi, inklużi dawk awtorizzati fil-qafas ta' din il-proċedura fi żmien l-ewwel u t-tieni opinjoni.
English: Other enhanced pharmacovigilance activities include the clinical audit that will collect data on the number of peritonitis events in the EU and an observational study to assess the severity of peritonitis episodes (including fatal outcomes) and the impact on longer term clinical outcome.
Maltese: Attivitajiet ta' farmakoviġilanza mtejba oħrajn jinkludu l-verifika klinika li sejra tiġbor id-dejta dwar l-għadd ta' każijiet ta' peritonite fl-UE u studju ta' osservazzjoni li jevalwa s-severità tal-episodji ta' peritonite (inklużi eżiti fatali) u l-impatt fuq l-eżitu kliniku fit-tul.
English: • The Committee considered all data submitted by the MAH, in writing and at oral explanations, including the overall root cause investigation report, and concludes that the MAH has performed a comprehensive investigation of the root cause leading to the out-of-specifications for endotoxins in dialysis solutions produced at particular lines of manufacture in Castlebar.
Maltese: • Il-Kumitat ikkunsidra d-dejta kollha sottomessa mill-MAH, bil-miktub u waqt spjegazzjonijiet orali, inkluż ir-rapport ta' investigazzjoni tal-kawża ewlenija ġenerali, u jikkonkludi li l-MAH wettaq investigazzjoni komprensiva tal-kawża ewlenija li wasslet għar-riżultati mhux fl-ispeċifikazzjonijiet għal endotossini fis-soluzzjonijiet għad-dijaliżi prodotti f'linji partikolari ta' manifattura f'Castlebar.
English: The CHMP requests that the inspection of the Castlebar site be performed by the end of December 2011 and that the outcome of the inspection be provided to national competent authorities.
Maltese: Is-CHMP qed jitlob li l-ispezzjoni tas-sit ta' Castlebar issir sal-aħħar ta' Diċembru 2011 u li r-riżultat tal-ispezzjoni jiġi ppreżentat lill-awtoritajiet nazzjonali kompetenti.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations presented by the EMA
Maltese: Konklużjonijiet xjentifiċi u raġunijiet għall-varjazzjoni tat-termini talawtorizzazzjonijiet għat-tqegħid fis-suq ippreżentati mill-EMA
English: To meet supply demands, the unprecedented importation of PD solutions from Canada, Turkey and USA increased.
Maltese: Sabiex jiġu ssodisfati t-talbiet għall-provvista, żdiedet limportazzjoni bla preċedent ta' soluzzjonijiet għall-PD mill-Kanada, it-Turkija u l-Istati Uniti talAmerika.
English: Modern rapid microbial methods should be applied on site to raw materials, excipients and finished product, to reduce variability, improve turn around time and improve the quality of information.
Maltese: Metodi moderni u rapidi kontra l-mikrobi għandhom ikunu applikati fis-sit fuq il-materja prima, fuq l-eċċipjenti u l-prodott lest, sabiex tonqos il-varjabbiltà, jitjieb il-ħin tal-proċess u titjieb ilkwalità tal-informazzjoni.
English: • Finally, the Committee considers that a pharmacovigilance inspection should be carried out for completeness and to ensure that communication of safety signals to healthcare professionals and competent authorities is adequate, and the systems in place to collect safety information and provide it to the regulatory networks are accurately and consistently applied.
Maltese: • Fl-aħħar nett, il-Kumitat jikkunsidra li għandha ssir spezzjoni tal-farmakoviġilanza għallkompletezza u sabiex ikun żgurat li l-komunikazzjoni tas-sinjali ta' sigurtà lill-professjonisti tal-kura tas-saħħa u lill-awtoritajiet kompetenti hija adegwata, u li s-sistemi stabbiliti għall-ġbir ta' informazzjoni dwar is-sigurtà u t-twassil tagħha lin-netwerks regolatorji ikunu applikati b'mod eżatt u konsistenti.
English: • The Committee considers that the establishment of a 12 month monitoring period, upon qualification of the Castlebar plant by the IMB, is appropriate.
Maltese: • Il-Kumitat jikkunsidra li l-istabbiliment ta' perjodu ta' monitoraġġ ta' 12-il xahar, mal-kwalifika talimpjant ta' Castlebar mill-IMB, huwa xieraq.
English: A plan for maintenance of existing manufacturing sites, registration of additional sites located in Italy and the UK, expansion of different sites to increase its capacity and contingency for sufficient alternative providers/stocks for raw materials was agreed.
Maltese: Sar qbil dwar pjan għall-manutenzjoni ta' siti ta' manifattura eżistenti, għar-reġistrazzjoni ta' siti addizzjonali li jinsabu fl-Italja u fir-Renju Unit, għat-tkabbir ta' diversi siti sabiex tiżdied il-kapaċità tagħhom u għallkontinġenza għal fornituri/ħażniet alternattivi suffiċjenti għall-materja prima.
English: Strength Pharmaceutical Form Route of Administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 5 g
Maltese: 1 g 5 g
English: EU/1/18/1351/001 (1 g, 1 vial) EU/1/18/1351/002 (1 g, 5 vials) EU/1/18/1351/003 (5 g, 1 vial) EU/1/18/1351/004 (5 g, 5 vials)
Maltese: EU/1/18/1351/001 (1 g, 1 kunjett) EU/1/18/1351/002 (1 g, 5 kunjetti) EU/1/18/1351/003 (5 g, 1 kunjett) EU/1/18/1351/004 (5 g, 5 kunjetti)
English: • Hypersensitivity to the active substance
Maltese: • Sensittività eċċessiva għas-sustanza attiva
English: System Organ Class (SOC)
Maltese: Sistema tal-Klassifika talOrgani (SOC, System Organ Class)
English: Grade 3-4 Adverse Reactions / Frequency
Maltese: Reazzjonijiet Avversi ta' Grad 3−4 / Frekwenza
English: The overall incidence of infections was 13.1% (74/564).
Maltese: L-inċidenza globali ta' infezzjonijiet kienet 13.1% (74/564).
English: 1 vial 5 vials
Maltese: 1 kunjett 5 kunjetti
English: The active substance is treosulfan.
Maltese: Is-sustanza attiva hi treosulfan.
English: Gastrointestinal disorders were observed in 357 patients (63.3%).
Maltese: Disturbi gastrointestinali ġew osservati f'357 pazjent (63.3%).
English: Cumulative incidence of relapse/progression; % (95% CI)
Maltese: Inċidenza kumulattiva ta' rikaduta/progressjoni tal-marda; % (CI ta' 95%)
English: Complete disease responses were observed in 28 patients (90%), as measured by clinical symptoms and laboratory assays (Burroughs LM et al., Biology of Blood and Marrow Transplantation 2014; 20(12):1996-2003).
Maltese: Risponsi kompleti tal-marda ġew osservati fi 28 pazjent (90%), kif imkejla minn sintomi kliniċi u assaġġi tal-laboratorju (Burroughs LM et al., Biology of Blood and Marrow Transplantation 2014; 20(12):1996-2003).
English: Pathogens included bacteria (e.g. Staphylococcus, Enterococcus, Corynebacterium), viruses (e.g. cytomegalovirus [CMV], Epstein-Barr virus [EBV], herpes) as well as fungi (e.g. candida).
Maltese: Staphylococcus, Enterococcus, Corynebacterium), viruses (eż. cytomegalovirus [CMV], Epstein-Barr virus [EBV], herpes) kif ukoll fungi (eż. candida).
English: The most frequent type was lung infection (12/74 [16.2%]).
Maltese: It-tip l-aktar frekwenti kien infezzjoni filpulmun (12/74 [16.2%]).
English: Mean apparent terminal half-life of treosulfan was comparable between the different age groups and ranged between 1.3 and 1.6 hours.
Maltese: Il-half-life terminali apparenti medja ta' treosulfan kienet komparabbli bejn il-gruppi tal-età differenti u varjat bejn 1.3 u 1.6 sigħat.
English: Infections (bacterial, viral, fungal), sepsis a
Maltese: Infezzjonijiet (batterjali, virali, fungali), sepsis a
English: Table 2: Cumulative incidence of GvHD (Full analysis set) Parameter
Maltese: Tabella 2: Inċidenza kumulattiva ta' GvHD (Sett sħiħ ta' analiżi) Parametru
English: The most frequent adverse reactions were cardiac arrhythmias, e.g. atrial fibrillation (1.2%), sinus tachycardia (0.9%), supraventricular tachycardia (0.4%), and ventricular extrasystole (0.4%).
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti kienu arritmiji kardijaċi, eż. fibrillazzjoni atrijali (1.2%), takikardija tas-sinus (0.9%), takikardija supraventrikulari (0.4%), u ekstrasistoli ventrikulari (0.4%).
English: Blood disorders were observed in 67 of 564 adult patients (11.9%).
Maltese: Disturbi tad-demm ġew osservati f'67 minn 564 pazjent adult (11.9%).
English: Figure 1: Kaplan-Meier estimates of event-free survival (Full Analysis Set)
Maltese: Figura 1: Stimi Kaplan-Meier tas-sopravivenza mingħajr avvenimenti (Sett Sħiħ ta' Analiżi)
English: The total fludarabine dose is 150 mg/m²;
Maltese: Id-doża totali ta' fludarabine hi 150 mg/m²;
English: Non-inferiority of FT10 versus the reference FB2 was statistically proven (Figure 1).
Maltese: FB2 ġiet ippruvata statistikament (Figura 1).
English: Trecondi may cause symptoms of the menopause (absence of menstrual periods).
Maltese: Trecondi jista' jikkawża sintomi tal-menopawsa (nuqqas ta' menstrwazzjoni (periods)).
English: P value
Maltese: Valur P
English: Maximum plasma levels (mean ± SD) in adult patients after a 2-hour intravenous infusion of 10, 12, or 14 g/m² treosulfan were 306 ± 94 µg/mL, 461 ± 102 µg/mL, and 494 ± 126 µg/mL, respectively.
Maltese: Il-livelli massimi fil-plażma (medja ± SD) f'pazjenti adulti wara sagħtejn infużjoni ġol-vini ta' 10, 12, jew 14 g/m² treosulfan kienu 306 ± 94 µg/mL, 461 ± 102 µg/mL, u 494 ± 126 µg/mL, rispettivament.
English: Common Hypersensitivity
Maltese: Komuni Sensittività eċċessiva
English: Blood alkaline phosphatase increased, C-reactive protein increased
Maltese: Żieda fl-alkaline phosphatase fiddemm, żieda fil-proteina C-reattiva
English: The activity of treosulfan is due to the spontaneous conversion into a mono-epoxide intermediate and L-diepoxybutan (see section 5.2).
Maltese: L-attività ta' treosulfan hija minħabba l-konverżjoni spontanja f'sustanza intermedja ta' mono-epoxide u L-diepoxybutan (ara sezzjoni 5.2).
English: Name and address of the manufacturer(s) responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: The most commonly observed adverse reactions (adults/paediatric patients) after treosulfan-based conditioning followed by alloHSCT include infections (13.1% /11.4%), gastrointestinal disorders (nausea [39.5%/30.7%], stomatitis [36.0%/69.3%], vomiting [22.5%/43.2%], diarrhoea [15.6%/33.0%], abdominal pain [10.4%/17%]), fatigue (15.1%/2.3%), febrile neutropenia (11.3%/1.1%), oedema (7.8%/0%), rash (7.2%/12.5%), and increases of alanine transaminase (ALT [5.1%/9.1%]), aspartate transaminase (AST [4.4%/8.0%]), gamma-glutamyl transferase (γGT [3.7%/2.3%]), and bilirubin (18.8%/5.7%).
Maltese: Ir-reazzjonijiet avversi l-aktar osservati b'mod komuni (adulti/pazjenti pedjatriċi) wara likkondizzjonar ibbażat fuq treosulfan segwit minn alloHSCT jinkludu infezzjonijiet (13.1%/11.4%), disturbi gastrointestinali (dardir [39.5%/30.7%], stomatite [36.0%/69.3%], rimettar [22.5%/43.2%], dijarea [15.6%/33.0%], uġigħ addominali [10.4%/17%]), għeja kbira (15.1%/2.3%), newtropenija biddeni (11.3%/1.1%), edema (7.8%/0%), raxx (7.2%/12.
English: • problems sleeping (insomnia)
Maltese: • problemi biex torqod (insomnja)
English: Skin ulcer, erythema multiforme, urticaria, dermatitis bullous, dermatitis acneiform, palmar-plantar erythrodysaesthesia syndrome, dermatitis diapera
Maltese: Mhux magħruf Ulċera tal-ġilda, eritema multiforme, urtikarja, dermatite bl-imsiemer, dermatite akneiforma, sindrome ta' eritrodisastesija palmari-plantar, dermatite tal-ħrieqia
English: Cardiac arrhythmias (e.g. atrial fibrillation, sinus arrhythmia)
Maltese: Arritmiji kardijaċi (eż. fibrillazzjoni atrijali, arritmija tas-sinus)
English: Cumulative incidence of transplant-related mortality; % (95% CI) a Based on Kaplan-Meier estimates; b adjusted for donor type, risk group and centre using Cox regression model
Maltese: Inċidenza kumulattiva ta' mortalità relatata ma' trapjant; % (CI ta' 95%) a Ibbażata fuq stimi ta' Kaplan-Meier; b aġġustat għat-tip ta' donatur, grupp u ċentru tar-riskju blużu tal-mudell ta' rigressjoni Cox.
English: • increased blood level of a liver enzyme (gamma-glutamyl transferase)
Maltese: • żieda fil-livell ta' enzimi tal-fwied fid-demm (gamma-glutamyl transferase)
English: Common Transaminases (ALT/AST)
Maltese: Mhux komuni Żieda fit-transaminases (ALT/AST)
English: Gastrointestinal haemorrhage, neutropenic colitis
Maltese: Emorraġija gastrointestinali, kolite newtropenika
English: Chronic GvHDa; % (95% CI)
Maltese: GvHD kronikaa; % (CI ta' 95%) GvHD kronika estensivaa; % (CI ta'
English: Body surface area (m²) Treosulfan dose (g/m²)
Maltese: Doża ta' treosulfan (g/m²)
English: The age of the patients ranged from 0.4 to 30.5 years, and 29% had HCT-CI scores > 2.
Maltese: L-età talpazjenti varjat minn 0.4 sa 30.5 snin, u 29% kellhom punteġġi HCTCI > 2.
English: • inflammation of the lung (pneumonitis) (adults: uncommon)
Maltese: • infjammazzjoni tal-pulmun (pulmonite) (adulti: mhux komuni)
English: An Italian group treated 60 TM patients (age range 1-37 years; including 12 adults) with the FT14 plus thiotepa regimen.
Maltese: Grupp Taljan ittratta 60 pazjent b'TM (medda ta' età minn 1-37 sena, inklużi 12-il adult) bil-kors ta' FT14 u thiotepa.
English: Erythema multiforme, dermatitis acneiform, rash, hyperhidrosis
Maltese: Mhux komuni Eritema multiforme, dermatite akneiforma, raxx, iperidrosi
English: • different cancer caused by chemotherapeutic treatment (second malignancy)
Maltese: • kanċer differenti kkawżat minn trattament kimoterapewtiku (tumur malinn sekondarju)
English: The total treosulfan dose is 42 g/m²;
Maltese: Id-doża totali ta' treosulfan hi 42 g/m²;
English: The median (25%/75% percentiles) duration of neutropenia was 14 (12, 20) days with the 10 g/m² treosulfan dose and 17.5 (14, 21) days with the 14 g/m² treosulfan dose.
Maltese: It-tul medjan (perċentili ta' 25%/75%) ta' newtropenija kien 14-il (12-il, 20) jum bid-doża ta' treosulfan ta' 10 g/m² u 17.5 (14-il, 21) jum bid-doża ta' treosulfan ta' 14 g/m².
English: Not known Alkalosis
Maltese: Mhux magħruf Alkalożi
English: A total of 37 patients (52.9%) were younger than 12 years.
Maltese: Total ta' 37 pazjent (52.9%) kienu iżgħar minn 12-il sena.
English: White crystalline powder.
Maltese: Trab kristalizzat abjad.
English: The recommended dose is 10-14 g/m² body surface area.
Maltese: Iddoża rakkomandata hi ta' 10-14 g/m² tal-erja tas-superfiċje tal-ġisem.
English: Treosulfan is given in combination with fludarabine, with thiotepa (intensified regimen; FT10-14TT regimen) or without thiotepa (FT10-14 regimen).
Maltese: Treosulfan jingħata flimkien ma' fludarabine, b'thiotepa (kors intensifikat; kors FT10-14TT) jew mingħajr thiotepa (kors FT10-14).
English: When reconstituted according to section 6.6, 1 mL of the solution for infusion contains 50 mg treosulfan.
Maltese: Meta rikostitwit skont is-sezzjoni 6.6, 1 mL tas-soluzzjoni għall-infużjoni fih 50 mg treosulfan.
English: About 25-40% of treosulfan is excreted in urine; however, an influence of renal function on renal clearance of treosulfan was not observed.
Maltese: Madwar 25-40% ta' treosulfan jiġu eliminati fl-awrina; madanakollu, ma ġietx osservata influwenza tal-funzjoni tal-kliewi fuq ittneħħija mill-kliewi ta' treosulfan.
English: The overall incidence of veno-occlusive liver disease (VOD) was 0.9% (5/564).
Maltese: L-inċidenza globali ta' mard okklużiv tal-vini tal-fwied (VOD) kienet 0.9% (5/564).
English: All Adverse Reactions / Frequency
Maltese: Kollha / Frekwenza
English: After long-term therapy with conventional doses of oral treosulfan in patients with solid tumours acute myeloid leukaemia was observed in 1.4% of 553 patients.
Maltese: Wara terapija fit-tul b'dożi konvenzjonali ta' treosulfan orali f'pazjenti b'tumuri solidi, lewkimja majelojde akuta ġiet osservata f'1.4% minn 553 pazjent.
English: Adverse reactions are listed below, by system organ class and by frequency: 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: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi u l-frekwenza: 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: Under physiological conditions (pH 7.4, temperature 37 °C), the pharmacologically inactive treosulfan is converted spontaneously (non-enzymatically) into the active monoepoxide intermediate (S,S-EBDM = (2S,3S)-1,2-epoxybutane-3,4-diol-4-methanesulfonate) and finally to L-diepoxibutane (S,S-DEB = (2S,3S)-1,2:3,4-diepoxybutane).
Maltese: Taħt kundizzjonijiet fiżjoloġiċi (pH 7.4, temperatura 37°C), it-treosulfan li hu farmakoloġikament inattiv jiġi kkonvertit b'mod spontanju (mhux permezz ta' enzimi) fis-sustanza intermedja ta' mono-epoxide attiva (S,S-EBDM = (2S,3S)-1,2-epoxybutane-3,4-diol-4-methanesulfonate) u fl-aħħar fi
English: There is limited information available on treosulfan-based conditioning (FT14 regimen ± thiotepa; see section 4.2) in adult patients with non-malignant disorders (NMD).
Maltese: L-informazzjoni disponibbli dwar kondizzjonar ibbażat fuq treosulfan (kors FT14 ± thiotepa; ara sezzjoni 4.2) f'pazjenti adulti b'disturbi mhux malinni (NMD, non-malignant disorders) hija limitata.
English: Use in adults
Maltese: Użu fl-adulti
English: No difference in terms of outcome was observed between children and adults (Bernardo ME et al.; Blood 2012; 120(2):473-6).
Maltese: Ma ġiet osservata lebda differenza f'termini tar-riżultat bejn it-tfal u l-adulti (Bernardo ME et al.; Blood 2012;
English: Headache, peripheral sensory neuropathy
Maltese: Mhux komuni Newropatija sensorjali periferali
English: Maculo-papular rash, purpura, erythema, palmar-plantar erythrodysaesthesia syndrome, pruritus, alopecia
Maltese: Raxx makulari bl-infafet, purpura, eritema, sindrome ta' eritrodisastesija palmari-plantari, ħakk, alopeċja
English: The terminal half-life (T1/2ß) of intravenously administered treosulfan (up to 47 g/m²) is approximately 2 hours.
Maltese: Il-half-life terminali (T1/2ß) ta' treosulfan mogħti ġol-vini (sa 47 g/m²) hija ta' madwar sagħtejn.
English: The overall incidence of infections in 88 paediatric patients was 11.4% (10/88) and thus comparable to that seen in adults.
Maltese: L-inċidenza globali ta' infezzjonijiet fi 88 pazjent pedjatriku kienet 11.4% (10/88) u għalhekk kienet komparabbli ma' dik osservata fl-adulti.
English: Treosulfan has mutagenic and carcinogenic potential.
Maltese: Treosulfan għandu potenzjal mutaġeniku u karċinoġeniku.
English: Treosulfan has a broad antineoplastic and antileukaemic activity.
Maltese: Treosulfan għandu attività antineoplastika u antilewkimika wiesgħa.
English: • bloodstream infection (sepsis)
Maltese: • infezzjoni fil-fluss tad-demm (sepsis)
English: Neutropenic colitis, anal inflammation, dyspepsia, proctitis, gastrointestinal pain, constipation
Maltese: Mhux magħruf Kolite newtropenika, infjammazzjoni anali, dispepsija, proktite, uġigħ gastrointestinali, stitikezza
English: • Treosulfan should be administered before fludarabine on days -4, -3, -2 (FT10 regimen).
Maltese: • Treosulfan għandu jingħata qabel fludarabine f'jiem -4, -3, -2 (kors FT10).
English: Blood creatinine increased, blood lactate dehydrogenase (LDH) increased
Maltese: Żieda fil-kreatinina fid-demm, żieda fil-lactate dehydrogenase (LDH) fid demm
English: A retrospective comparison of treosulfan-based (n = 16) versus busulfan-based (n = 81) conditioning in adult patients revealed quite comparable survival rates (70.3 ± 15.1% vs. 69.3 ± 5.5%), while risk for acute GvHD was lower in the treosulfan group (odds ratio 0.28; 95% CI 0.12-0.67; P = 0.004) (Caocci G et al.; American Journal of Hematology 2017; 92(12):1303-1310).
Maltese: 1% kontra 69.3 ± 5.5%), filwaqt li r-riskju ta' GvHD akuta kien iktar baxx fil-grupp ta' treosulfan (proporzjon ta' probabbiltajiet ta' 0.28, 95% CI 0.12-0.67; P = 0.004) (Caocci G et al.; American Journal of Hematology 2017;
English: Acidosisb, glucose tolerance impaired, electrolyte imbalance
Maltese: Aċidożib, impediment fit-tolleranza tal-glucose, żbilanċ tal-elettroliti
English: The frequencies of adverse reactions reported in the table below are derived from 5 clinical trials (including a total of 564 patients) where treosulfan combined with fludarabine was investigated as conditioning treatment prior to alloHSCT in adult patients.
Maltese: Il-frekwenzi tar-reazzjonijiet avversi rrappurtati fit-tabella t'hawn taħt huma derivati minn 5 provi kliniċi (inkluż total ta' 564 pazjent) fejn treosulfan flimkien ma' fludarabine ġie investigat bħala trattament ta' kkondizzjonar qabel alloHSCT f'pazjenti adulti.
English: The most frequent adverse reactions reported were nausea (39.5%), stomatitis (36%), vomiting (22.5%), diarrhoea (15.6%), and abdominal pain (10.4%).
Maltese: Ir-reazzjonijiet avversi rrappurtati laktar frekwenti kienu dardir (39.5%), stomatite (36%), rimettar (22.5%), dijarea (15.
English: Secondary malignancies
Maltese: Tumuri malinni sekondarji
English: Sepsisa
Maltese: Tqala
English: Cardiac disorders* Common Cardiac arrhythmias (e.g. atrial fibrillation, sinus arrhythmia)
Maltese: Disturbi fil-qalb* Komuni Arritmiji kardijaċi (eż. fibrillazzjoni atrijali, arritmija tas-sinus)
English: The total treosulfan dose is 30 g/m²;
Maltese: Id-doża totali ta' treosulfan hi 30 g/m²;
English: Transplant-related mortality at 12 months is 2.9% (90% CI 0.9 - 8.9%).
Maltese: Il-mortalità relatata ma' trapjant wara 12-il xahar hi 2.9% (CI ta' 90% 0.9 - 8.9%).
English: Encephalopathy, intracranial haemorrhage, extrapyramidal disorder, syncope, paraesthesia
Maltese: Enċefalopatija, emorraġija intrakranjali, disturb ekstrapiramidali, sinkope, parastesija
English: Blood cell counts usually recover after HSCT.
Maltese: L-għadd ta' ċelluli tad-demm normalment jirkupra wara HSCT.
English: The incidence of complete donor-type chimerism was 94.2% (90% CI 87.2-98.0%) at day +28 visit, 91.3% (90% CI 83.6-96.1%) at day +100 visit and 91.2% (90% CI 82.4-96.5%) at month 12 visit.
Maltese: L-inċidenza tal-kimeriżmu tat-tip ta' donatur komplet kienet 94.2% (CI ta' 90% 87.2-98.0%) fil-vista ta' jum +28, 91.3% (CI ta' 90% 83.6-96.
English: • Treosulfan should be administered before fludarabine on days -6, -5, -4 (FT14 regimen).
Maltese: • Treosulfan għandu jingħata qabel fludarabine f'jiem -6, -5, -4 (kors FT14).
English: The median age of patients was 60 years (range 31-70 years); 25% of patients were older than 65 years.
Maltese: L-età medjana tal-pazjenti kienet 60 sena (medda ta' 31-70 sena); 25% tal-pazjenti kellhom iktar minn 65 sena.
English: In one study, 31 NMD patients were treated with the FT14 regimen plus anti-thymocyte globulin.
Maltese: Fi studju wieħed, 31 pazjent b'NMD ġew ittrattati bil-kors FT14 u globulina kontra t-timoċiti.
English: Common Dysphagia, oral pain
Maltese: Komuni Disfaġija, uġigħ orali
English: During phases of severe neutropenia (median duration of neutropenic period is 14-17.5 days in adults and 21-24 days in paediatric patients) the risk of infection is increased.
Maltese: Waqt fażijiet ta' newtropenija severa (it-tul medju tal-perjodu newtropeniku hu 14-17.5 jiem fl-adulti u 21-24 jum f'pazjenti pedjatriċi) ir-riskju ta' infezzjoni jiżdied.
English: Common Oropharyngeal pain, epistaxis
Maltese: Komuni Uġigħ orofarinġeali, epistassi
English: Hazard ratiob (95% CI)
Maltese: Rata wara 24 xahar [%] CI ta' 95%
English: With a median follow-up of 36 months (range, 4-73), the 5-year overall survival probability was 93% (95% CI 83-97%).
Maltese: B'segwitu medjan ta' 36 xahar (medda, 4-73), ilprobabbiltà ta' sopravivenza globali fuq 5 snin kienet ta' 93% (95% CI 83-97%).