FrancophonIA/ELRC3.0 huggingface dataset:
English: The epoxides formed alkylate nucleophilic centres of deoxyribonucleic acid (DNA) and are able to induce DNA cross-links which are considered responsible for the stem cell depleting and antineoplastic effects.
Maltese: L-epoxides ffurmaw ċentri nukleofiliċi ta' alkylate ta' deoxyribonucleic acid (DNA) u huma kapaċi jwasslu għal interkonnessjonijiet tad-DNA li huma kkunsidrati responsabbli għat-tnaqqis taċ-ċelluli staminali u l-effetti antineoplastiċi.
English: Therefore, treosulfan is unlikely to participate in, or contribute to, potential CYP450-mediated interactions in vivo.
Maltese: Għalhekk, treosulfan x'aktarx li ma jipparteċipax fi, jew ma jikkontribwixxix għal, interazzjonijiet potenzjali medjati minn CYP450 in vivo.
English: Fits (seizures) may occur very rarely in infants of less than 4 months of age.
Maltese: Aċċessjonijiet (puplesiji) jistgħu jseħħu rari ħafna fi trabi ta' inqas minn 4 xhur età.
English: At concentrations up to 100 µM, treosulfan has no unequivocal effect on CYP1A2, 2C9, 2C19, 2D6, or 3A4 activities in vitro.
Maltese: F'konċentrazzjonijiet sa 100 µM, treosulfan m'għandu l-ebda effett mhux ekwivoku fuq l-attivitajiet in vitro ta' CYP1A2, 2C9, 2C19, 2D6, jew 3A4.
English: One of 564 adult patients (0.2%) developed a second malignancy (breast cancer).
Maltese: Pazjent adult wieħed minn 564 (0.2%) żviluppa tumur malinn sekondarju (kanċer tas-sider).
English: The lowest frequency of cardiac disorders was seen with the dose regimen of 10 g/m²/day, day -4 to -2 (2.7%).
Maltese: Il-frekwenza l-aktar baxxa ta' disturbi tal-qalbkienet osservata bil-kors tad-doża ta' 10 g/m²/jum, minn jum -4 sa -2 (2.7%).
English: How to store Trecondi
Maltese: X'fih Trecondi
English: Encephalopathy, intracranial haemorrhage, syncope
Maltese: Enċefalopatija, emorraġija intrakranjali, sinkope
English: Infections (bacterial, viral, fungal)
Maltese: Infezzjonijiet (batterjali, virali, fungali)
English: The treosulfan concentrations in brain tissue were 95%-98% lower than in plasma.
Maltese: Il-konċentrazzjonijiet ta' treosulfan fit-tessuti talmoħħ kienu 95%-98% iktar baxxi milli fil-plażma.
English: Rare Confusional state
Maltese: Stat ta' konfużjoni
English: For preparation of sodium chloride 4.5 mg/mL (0.45%) solution equivalent volumes of sodium chloride 9 mg/mL (0.9%) solution and water for injections can be mixed.
Maltese: Għat-tħejjija tas-soluzzjoni ta' sodium chloride 4.5 mg/mL (0.45%) jistgħu jitħalltu volumi ekwivalenti ta' soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) u ilma għall-injezzjonijiet.
English: VOD occurred only with the dose regimen of 14 g/m²/day treosulfan.
Maltese: VOD seħħ biss fil-kors tad-doża ta' 14 g/m²/jum treosulfan.
English: • problems in the nerves of the arms or legs with symptoms such as numbness, reduced or increased sensitivity, tingling, burning pain (peripheral sensory neuropathy)
Maltese: • problemi fin-nervituri fid-dirgħajn u r-riġlejn b'sintomi bħal telf ta' sensazzjoni, tnaqqis jew żieda fis-sensittività, tnemnim, jikwu bl-uġigħ (newropatija sensorjali periferali)
English: The overall survival at 12 months is 91.4% (90% CI 83.9-95.5%).
Maltese: Is-sopravivenza globali wara 12-il xahar hi 91.4% (CI ta' 90% 83.9-95.
English: • high blood pressure, flushing
Maltese: • pressjoni għolja, fwawar
English: In the pivotal phase III trial, adult patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) and increased risk for standard conditioning therapies because of higher age (≥ 50 years) or comorbidities (haematopoietic cell transplantation comorbidity index [HCT-CI] score > 2) were randomised to receive a conditioning regimen with 3 × 10 g/m² treosulfan combined with fludarabine (FT10; n = 220) or a regimen of intravenous busulfan (total dose 6.4 mg/kg) combined with fludarabine (FB2; n = 240), followed by alloHSCT.
Maltese: III, pazjenti adulti b'lewkimja majelojde akuta (AML) jew sindrome majelodisplastiku (MDS) u riskju miżjud ta' terapiji ta' kkondizzjonar standard minħabba età akbar (≥ 50 sena) jew komorbiditajiet (punteġġ tal-indiċi tal-komorbidità ta' trapjant ta' ċelluli ematopojetiċi [HCT-CI] > 2) ntgħażlu b'mod każwali biex jirċievu kors ta' kkondizzjonar bi 3 x 10 g/m² treosulfan flimkien ma' fludarabine (FT10; n = 220) jew kors ta' busulfan għal ġol-vini (doża totali ta' 6.4 mg/kg) flimkien ma' fludarabine (FB2; n = 240), segwit minn alloHSCT. 64% tal-pazjenti kellhom AML u 36% MDS.
English: Treosulfan was administered in a dose range of 10-14 g/m² BSA on 3 consecutive days.
Maltese: Treosulfan ġie mogħti f'medda taddoża ta' 10-14 g/m² BSA fuq 3 ijiem konsekuttivi.
English: Trecondi contains the active substance treosulfan, which belongs to a group of medicines called alkylating agents.
Maltese: Trecondi fih is-sustanza attiva treosulfan, li tappartjeni għal grupp ta' mediċini msejħa aġenti alkilanti.
English: Regression analysis of the area under the curve (AUC0-∞) versus treosulfan dose indicated a linear correlation.
Maltese: Analiżi tar-rigressjoni tal-erja taħt il-kurva (AUC0-∞) kontra d-doża ta' treosulfan indikata f'korrelazzjoni lineari.
English: Treosulfan is considered an irritant.
Maltese: Treosulfan hu kkunsidrat bħala irritant.
English: The frequency was higher in the paediatric age group 12-17 years (6/35 [17.1%]) compared to younger children (4/53 [7.5%]).
Maltese: Il-frekwenza kienet ogħla fil-grupp tal-età pedjatrika ta' 12-17-il sena (6/35 [17.1%]) meta mqabbla ma' tfal iżgħar (4/53 [7.5%]).
English: Cardiac disorders were observed in 25 patients (4.4%).
Maltese: Disturbi fil-qalb ġew osservati f'25 pazjent (4.4%).
English: The immunosuppressive effects of treosulfan are attributed to its toxicity against primitive and committed progenitor cells, T and NK cells, reduction of cellularity of primary and secondary lymphatic organs and a preclusive effect on the ‘cytokine storm' that precedes the development of Graft-versus-Host-Disease (GvHD) and is involved in the pathogenesis of veno-occlusive disease.
Maltese: L-effetti immunosoppressivi ta' treosulfan huma attribwiti lit-tossiċità tiegħu kontra ċelluli proġenituri primittivi u kommessi, ċelluli T u NK, tnaqqis fiċ-ċellularità ta' organi limfatiċi primarji u sekondarji u effett preklużiv fuq it-‘tempesta ta' ċitokini' (cytokine storm) li tiġi qabel l-iżvilupp ta' marda tattrapjant kontra r-reċipjent (GvHD - Graft-versus-Host-Disease) u huwa involut fil-patoġenesi ta' mard okklużiv tal-vini.
English: The freedom from transplant-related mortality until day +100 after HSCT (primary endpoint) is 98.6% (90% CI 93.4-99.7%) because one of the 70 patients died due to transplantation/treatment-related cause until day +100 after HSCT.
Maltese: Il-ħelsien mill-mortalità relatata mat-trapjant sa jum +100 wara HSCT (punt finali primarju) huwa 98.6% (CI ta' 90% 93.4-99.7%) għax wieħed mis70 pazjent miet minħabba kawża relatata mat-trapjant/trattament sa jum +100 wara HSCT.
English: • chills, tiredness, pain
Maltese: • tertir, għeja, uġigħ
English: Each vial contains 5 g treosulfan.
Maltese: Kull kunjett fih 5 g ta' treosulfan.
English: • leakage of fluid from the capillaries (small blood vessels), high blood pressure, low blood pressure
Maltese: • tnixxija ta' fluwidu mill-kapillari (vini tad-demm żgħar), pressjoni għolja, pressjoni baxxa
English: • infections caused by bacteria, viruses and fungi (all patients: very common)
Maltese: • infezzjonijiet ikkawżati minn batterji, viruses u fungi (il-pazjenti kollha: komuni ħafna)
English: Uncommon Confusional state
Maltese: Mhux komuni Stat ta' konfużjoni
English: The median (25%/75% percentiles) duration of neutropenia was 21 (16, 26) days in paediatric patients with malignant diseases and 24 (17, 26) days in patients with non-malignant disorders.
Maltese: It-tul medjan (perċentili ta' 25%/75%) ta' newtropenija kien 21 (16-il, 26) jum f'pazjenti pedjatriċi b'tumuri malinni u 24 (17-il, 26) jum f'pazjenti b'disturbi mhux malinni.
English: Treosulfan is a prodrug that is spontaneously converted under physiological conditions (pH 7.4; 37 °C) into a monoepoxide intermediate and L-diepoxybutane with a half-life of 2.2 hours.
Maltese: Treosulfan huwa promediċina li jiġi kkonvertit b'mod spontanju taħt kundizzjonijiet fiżjoloġiċi (pH 7.4; 37°C) f'sustanza intermedja ta' mono-epoxide u L-diepoxybutan b'half-life ta' 2.2 sigħat.
English: Prophylactic or empiric anti-infective treatment (bacterial, viral, fungal) should therefore be considered.
Maltese: Trattament antiinfettiv profilattiku jew empiriku (batterjali, virali, fungali) għandu għalhekk jiġi kkunsidrat.
English: Unopened vial 5 years
Maltese: Kunjett mhux miftuħ 5 snin
English: Table 1: Treatment results at 24 months (Full analysis set) Parameter
Maltese: Tabella 1: Riżultati tat-trattament wara 24 xahar (Sett sħiħ ta' analiżi) Parametru
English: NAME OF THE MEDICINAL PRODUCT Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion treosulfan
Maltese: IL-PRODOTT MEDIĊINALI Trecondi 1 g trab għal soluzzjoni għall-infużjoni Trecondi 5 g trab għal soluzzjoni għall-infużjoni Treosulfan
English: Alkalosis, electrolyte imbalance, hypomagnesaemia
Maltese: Mhux magħruf Alkalożi, żbilanċ tal-elettroliti, ipomanjesemija
English: Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, ATC code: L01AB02
Maltese: Aġenti antineoplastiċi; aġenti alkilanti, Kodiċi ATC:
English: The lowest frequencies of these adverse reactions were seen with the dose regimen of 10 g/m² per day, day -4 to -2 (20.4%, 30.3%, 13.1%, 5.0%, and 5.5% respectively).
Maltese: 4%, 30.3%, 13.1%, 5.0%, u 5.5% rispettivament).
English: Instructions for reconstitution of treosulfan:
Maltese: Istruzzjonijiet għar-rikostituzzjoni ta' treosulfan:
English: Blood and lymphatic system disorders*
Maltese: Disturbi tad-demm u tas-sistema limfatika*
English: Treosulfan is a prodrug of a bifunctional alkylating agent with cytotoxic activity to haematopoietic precursor cells.
Maltese: Treosulfan huwa promediċina ta' aġent alkilanti bifunzjonali b'attività ċitotossika għal ċelluli prekursuri ematopoetiċi.
English: • Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -7, -6, -5, -4, -3) before stem cell infusion (day 0).
Maltese: • Fludarabine 30 mg/m² BSA kuljum bħala infużjoni ġol-vini ta' nofs siegħa, mogħti fuq ħamest ijiem konsekuttivi (jum -7, -6, -5, -4, -3) qabel l-infużjoni taċ-ċelluli staminali (jum 0).
English: Trecondi may increase the risk of having another cancer in the future.
Maltese: Trecondi jista' jżid ir-riskju li jkollok kanċer ieħor fil-futur.
English: • Treosulfan should be administered before fludarabine;
Maltese: • Treosulfan għandu jingħata qabel fludarabine;
English: Dermatitis exfoliative, maculo-papular rash, rash, erythema, pain of skin, skin hyperpigmentationb, alopecia
Maltese: Dermatite bil-qxur, raxx makulari bl-infafet, raxx, eritema, uġigħ fil-ġilda, pigmentazzjoni eċċessiva talġildab, alopeċja
English: Not known Treatment-related second malignancy
Maltese: Mhux magħruf Tumur malinn sekondarju relatat mat-trattamenta
English: Septic shockc
Maltese: • ħakk
English: In order to prevent and treat infections, you will be given medicines, such as antibiotics, antifungals or antivirals.
Maltese: Sabiex jiġu evitati u ttrattati l-infezzjonijiet, se tingħata mediċini, bħal antibijotiċi, antifungali jew antivirali.
English: Published literature data report on gonadotoxicity of treosulfan in pre-pubertal and pubertal male and female mice.
Maltese: Ir-rapport tad-data tal-letteratura ppubblikata dwar il-gonadotossiċità ta' treosulfan fi ġrieden irġiel u nisa qabel il-pubertà u waqt il-pubertà.
English: Contaminated body parts should be carefully rinsed with water and soap, the eyes should be rinsed with sodium chloride 9 mg/mL (0.9%) solution.
Maltese: Partijiet tal-ġisem ikkontaminati għandhom jiġu mlaħalħa b'ilma u sapun bir-reqqa, l-għajnejn għandhom jiġu mlaħalħa b'soluzzjoni ta' sodium chloride 9 mg/mL (0.9%).
English: Children younger than one year (mainly non-malignant diseases, especially immunodeficiencies) experienced more respiratory grade III/IV toxicity, possibly due to pulmonary infections already existing before the start of conditioning treatment.
Maltese: Tfal iżgħar minn sena (prinċipalment tumuri mhux malinni, speċjalment immunodefiċjenzi) esperjenzaw aktar tossiċità respiratorja ta' grad III/IV, possibbilment minħabba infezzjonijiet pulmonari li diġà kienu jeżistu qabel il-bidu tat-trattament ta' kkondizzjonar.
English: • Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0).
Maltese: • Fludarabine 30 mg/m² BSA kuljum bħala infużjoni ġol-vini ta' nofs siegħa, mogħti fuq ħamest ijiem konsekuttivi (jum -6, -5, -4, -3, -2) qabel l-infużjoni taċ-ċelluli staminali (jum 0).
English: • tiredness
Maltese: • reazzjonijiet allerġiċi
English: * See detailed sections below a Case reports (> 1) after treosulfan-based conditioning obtained from other sources b Bronze pigmentation c Fever in the absence of neutropenia where neutropenia is defined as ANC < 1.0 x 109/L
Maltese: * Ara s-sezzjonijiet dettaljati hawn taħt a Rapporti tal-każ (> 1) wara kkondizzjonar ibbażat fuq treosulfan miksub minn sorsi oħra b Pigmentazzjoni kulur il-bronż c Deni fin-nuqqas ta' newtropenija fejn newtropenija hi definita bħala ANC < 1.0 x 10
English: Very common Myelosuppression, pancytopenia
Maltese: Komuni ħafna Majelosoppressjoni, panċitopenija
English: Other medicines and Trecondi
Maltese: Mediċini oħra u Trecondi
English: Gastrointestinal haemorrhage, neutropenic colitis, oesophagitis, anal inflammation, mouth ulceration
Maltese: Emorraġija gastrointestinali, kolite newtropenika, esofaġite, infjammazzjoni anali, ulċerazzjoni fil-ħalq
English: Trecondi is available in packs of 1 or 5 vials.
Maltese: Trecondi hu disponibbli f'pakketti li fihom 1 jew 5 kunjetti.
English: Published data concerning treatment of mice and rats with L-diepoxibutane (the alkylating transformation product of treosulfan) revealed impairment of fertility, uterine-ovarian and sperm development.
Maltese: Id-data ppubblikata rigward it-trattament ta' ġrieden u l-firien b'L-diepoxibutane (il-prodott tattrasformazzjoni alkilanti ta' treosulfan) kixfet indeboliment tal-fertilità, tal-iżvilupp tal-utru u l-ovarji, u tal-iżvilupp tal-isperma.
English: Trecondi 5 g powder for solution for infusion 1 vial contains 5 g of treosulfan.
Maltese: Trecondi 5 g trab għal soluzzjoni għall-infużjoni 1 kunjett fih 5 g ta' treosulfan.
English: Treosulfan does not bind to plasma proteins.
Maltese: Treosulfan ma jeħilx mal-proteini fil-plażma.
English: a Adjusted for donor type as factor, and risk group and centre as strata using Cox regression model.
Maltese: a Aġġustat għat-tip ta' donatur bħala fattur, u l-grupp u ċ-ċentru tar-riskju bħala strata bl-użu talmudell ta' rigressjoni Cox.
English: Dermatitis diaper
Maltese: Dermatite tal-ħrieqi
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)*
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)*
English: The main indications for an alloHSCT with treosulfan conditioning in adult NMD patients are haemoglobinopathies (e.g. sickle cell disease, thalassaemia major [TM]), primary immune deficiency, hemophagocytic disorder, immune dysregulatory disorder and bone marrow failure).
Maltese: L-indikazzjonijiet ewlenin ta' alloHSCT b'kondizzjonar bi treosulfan f'pazjenti adulti b'NMD huma emoglobinopatiji (eż. marda li tirriżulta minn ċelluli tad-demm li għandhom sura ta' minġel, talassemija maġġuri [TM]), immunodefiċjenza primarja, disturb emofagoċitiku, disturb disregolatorju tas-sistema immuni u insuffiċjenza tal-mudullun.
English: Maculo-papular rash, purpura, erythema
Maltese: Mhux komuni Raxx makulari bl-infafet, purpura,
English: The cumulative incidence of relapse/progression is 15.7% (90% CI 8.6-22.9%) at month +12.
Maltese: 7% (CI ta' 90% 8.6-22.9%) f'xahar +12.
English: Oral mucositis (including high-grade severity) is a very common undesirable effect of treosulfan-based conditioning followed by alloHSCT (see section 4.8).
Maltese: Mukożite orali (inkluża severità ta' grad għoli) hija effett mhux mixtieq komuni ħafna ta' kkondizzjonar ibbażat fuq treosulfan segwit minn alloHSCT (ara sezzjoni 4.8).
English: The efficacy and safety of treosulfan-based conditioning was evaluated in 70 patients with acute lymphoblastic leukaemia (ALL), AML, MDS, or juvenile myelomonocytic leukaemia (JMML) who received a conditioning regimen with treosulfan and fludarabine with (n = 65) or without (n = 5) thiotepa (see section 4.2).
Maltese: L-effikaċja u s-sigurtà ta' kkondizzjonar ibbażat fuq treosulfan ġew evalwati f'70 pazjent b'lewkimja limfoblastika akuta (ALL - acute lymphoblastic leukaemia), AML, MDS, jew lewkimja majelomonoċitika fil-minorenni (JMML - juvenile myelomonocytic leukaemia) li rċivew kors ta' kkondizzjonar bi treosulfan u fludarabine bi (n = 65) jew mingħajr (n = 5) thiotepa (ara sezzjoni 4.2).
English: Oral pain, gastritis, dyspepsia, constipation, dysphagia
Maltese: Uġigħ orali, gastrite, dispepsija, stitikezza, disfaġija
English: Uncommon Hyperglycaemia
Maltese: Wedel Il-Ġermanja
English: • bruising, low blood pressure
Maltese: • tbenġil, pressjoni baxxa
English: * See detailed sections below a Clinically or microbiologically documented infection with grade 3 or 4 neutropenia (absolute neutrophil count [ANC] < 1.0 x 109/L) and sepsis b Acidosis might be a consequence of the release of methanesulfonic acid through treosulfan activation/cleavage in the plasma c Case reports (> 2) after treosulfan-based conditioning obtained from other sources d Bronze pigmentation e Fever in the absence of neutropenia where neutropenia is defined as ANC < 1.0 x 109/L
Maltese: Infezzjoni klinikament jew mikrobijoloġikament dokumentata b'newtropenija ta' grad 3 jew 4 (għadd assolut tan-newtrofili [ANC - absolute neutrophil count] < 1.0 x 10 9/L) u sepsis b Aċidożi tista' tkun konsegwenza tal-ħruġ ta' methanesulfonic acid permezz tal-attivazzjoni/qsim ta' treosulfan fil-plażma c Rapporti tal-każ (> 2) wara kkondizzjonar ibbażat fuq treosulfan miksub minn sorsi oħra d Pigmentazzjon kulur il-bronż e Deni fin-nuqqas ta' newtropenija fejn newtropenija hi definita bħala ANC < 1.0 x 10
English: Treosulfan can impair fertility.
Maltese: Treosulfan jista' jaffettwa b'mod ħażin il-fertilità.
English: The primary endpoint of this study was event-free survival (EFS) after 2 years.
Maltese: Il-punt finali primarju tal-istudju kien is-sopravivenza mingħajr avvenimenti (EFS - event-free survival) wara sentejn.
English: Myelosuppression, pancytopenia, febrile neutropenia
Maltese: Majelosoppressjoni, panċitopenija, newtropenija bid-deni
English: Use Luer-lock fittings on all syringes and sets.
Maltese: Uża fittings tat-tip Luer-lock fuq is-siringi u s-settijiet kollha.
English: The lowest incidence was noted with the dose regimen of 10 g/m²/day, day -4 to -2 (4.1%).
Maltese: L-inċidenza l-aktar baxxa kienet innotata bil-kors taddoża ta' 10 g/m²/jum, minn jum -4 sa -2 (4.1%).
English: • fluid around the lung (pleural effusion), inflammation of throat, inflammation of or pain in voice box, cough, hiccups
Maltese: • fluwidu madwar il-pulmun (effużjoni plewrali), infjammazzjoni tal-gerżuma, infjammazzjoni ta' jew uġigħ fil-larinġi (larynx, jew voice box), sogħla, sulluzzu
English: Generalised erythema, dermatitis, skin necrosis or ulcer, skin hyperpigmentationd, dry skin
Maltese: Eritema ġeneralizzata, dermatite, nekrożi tal-ġilda jew ulċera, pigmentazzjoni eċċessiva tal-ġildad, ġilda xotta
English: The infection rate was lowest in patients treated with the dose regimen of 10 g/m² of treosulfan per day, from day -4 to -2 (7.7%).
Maltese: Ir-rata tal-infezzjoni kienet l-aktar baxxa f'pazjenti ttrattati bil-kors tad-doża ta' 10 g/m² ta' treosulfan kuljum, minn jum -4 sa -2 (7.7%).
English: Trecondi 1 g powder for solution for infusion 1 vial contains 1 g of treosulfan.
Maltese: Trecondi 1 g trab għal soluzzjoni għall-infużjoni 1 kunjett fih 1 g ta' treosulfan.
English: Seizures
Maltese: Tilqim
English: • decreased appetite
Maltese: • tnaqqis fl-aptit
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna)
English: Vomiting, oral pain, dysphagia, mouth haemorrhage, oesophageal or gastrointestinal pain
Maltese: Rimettar, uġigħ orali, disfaġija, emorraġija fil-ħalq, uġigħ esofagali jew gastrointestinali
English: • reddening of the skin(generalised erythema), inflammation of skin (dermatitis), death of skin tissue, skin ulcer, bronze pigmentation of skin, dry skin
Maltese: • tiħmar il-ġilda (eritema ġeneralizzata), infjammazzjoni tal-ġilda (dermatite), mewt ta' tessuti talġilda, ulċera tal-ġilda, pigmentazzjoni kulur il-bronż fil-ġilda, ġilda xotta
English: Intravenous administration should be performed using a safe technique to avoid extravasation (see section 4.4).
Maltese: L-għoti ġol-vini għandu jsir bl-użu ta' teknika sigura biex tiġi evitata l-estravażjoni (ara sezzjoni 4.4).
English: Dermatitis exfoliative, maculo-papular rash, erythema
Maltese: Dermatite bil-qxur, raxx makulari bl-infafet, eritema
English: There have been isolated reports of seizures in infants (≤ 4 months of age) with primary immunodeficiencies after conditioning treatment with treosulfan in combination with fludarabine or cyclophosphamide.
Maltese: Kien hemm rapporti iżolati ta' aċċessjonijiet fit-trabi (≤ 4 xhur età) b'immunodefiċjenzi primarji wara t-trattament ta' kkondizzjonar bi treosulfan flimkien ma' fludarabine jew cyclophosphamide.
English: Reconstitute each vial of Trecondi containing 1 g treosulfan in 20 mL of pre-warmed (maximum 30 °C) sodium chloride 4.5 mg/mL (0.45%) solution by shaking.
Maltese: Irrikostitwixxi kull kunjett ta' Trecondi li fih 1 g treosulfan f'20 mL ta' soluzzjoni ta' sodium chloride 4.5 mg/mL (0.45%) imsaħħna minn qabel (sa massimu ta' 30°C) billi tħawwad.
English: There was a significant association between age and respiratory toxicity in paediatric patients treated with treosulfan-based conditioning.
Maltese: Kien hemm assoċjazzjoni sinifikanti bejn l-età u t-tossiċità respiratorja f'pazjenti pedjatriċi ttrattati b'kondizzjonar ibbażat fuq treosulfan.
English: The most frequent adverse reaction was febrile neutropenia (11.3%).
Maltese: Ir-reazzjoni avversa l-aktar frekwenti kienet newtropenija bid-deni (11.3%).
English: Reconstitute each vial of Trecondi containing 5 g treosulfan in 100 mL of pre-warmed (maximum 30 °C) sodium chloride 4.5 mg/mL (0.45%) solution by shaking.
Maltese: Irrikostitwixxi kull kunjett ta' Trecondi li fih 5 g treosulfan f'100 mL ta' soluzzjoni ta' sodium chloride 4.5 mg/mL (0.45%) imsaħħna minn qabel (sa massimu ta' 30°C) billi tħawwad.
English: CI)
Maltese: a
English: To avoid solubility problems, warm the solvent, sodium chloride 4.5 mg/mL (0.45%) solution, to 25 °C - 30 °C (not higher), for example by using a water bath.
Maltese: Biex tevita problemi ta' solubbiltà, saħħan is-solvent, is-soluzzjoni ta' sodium chloride 4.5 mg/mL (0.45%), għal 25°C-30°C (mhux aktar), pereżempju permezz ta' banjumarija.
English: Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients (see section 4.6).
Maltese: Is-soppressjoni tal-ovarji u amenorrea b'sintomi tal-menopawsa jseħħu b'mod komuni f'pazjenti qabel il-menopawsa (ara sezzjoni 4.6).
English: All patients engrafted, with a median time to neutrophil engraftment of 21 (range, 12-46) days.
Maltese: Il-pazjenti kollha tlaqqmu, bi żmien medjan għat-tlaqqim tan-newtrofili ta' 21 (medda, 12-46) jum.
English: Hepatic failure, hepatomegaly, hepatic pain
Maltese: Insuffiċjenza epatika, epatomegalija, ugigħ epatiku