FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have significant heart problems - if you have severe lung disease - if you have or have recently had a stomach ulcer - if you have too low numbers of blood cells or bleeding problems - if you have moderate to severe liver or kidney disease - if you cannot use vasopressors (used to increase low blood pressure), anticoagulants (used to prevent blood clotting) or radioactive tracers - if you are also using medicines with heart toxicity - if you have raised levels of calcium in your blood - if you have certain infections which do not respond to antibiotics - if you have severe swelling of the affected arm or leg due to local fluid build-up, or severe fluid build-up in the abdomen - if you are pregnant or planning to become pregnant.
Maltese: - jekk għandek problemi sinifikanti tal-qalb - jekk għandek mard sever fil-pulmun - jekk għandek jew kellek ulċera fl-istonku - jekk għandek numri baxxi wisq ta' ċelluli tad-demm jew problemi ta' ħruġ ta' demm - jekk għandek mard minn moderat sa sever tal-fwied jew tal-kliewi - jekk ma tistax tuża vasopressors (jintużaw biex iżidu pressjoni tad-demm baxxa), mediċini kontra l-koagulazzjoni tad-demm (jintużaw biex jiġu evitati emboli fid-demm) jew tracers radjuattivi
English: 10 mg/l perfused lower limb volume
Maltese: Kif jidher Beromun u l-kontenut tal-pakkett
English: If signs of systemic toxicity appear for example fever, cardiac arrhythmias, shock/hypotension, adult respiratory distress syndrome (ARDS), general supportive measures should be employed and the patient immediately transferred to an Intensive Care Unit for monitoring.
Maltese: Jekk ikun hemm xi sinjali li jindikaw li hemm effett tossiku sistemiku, bħal per eżempju deni, arritmja kardijaka, stat ta' xokk/ipotensjoni, sindrome ta' distress respiratorju ta' l-adulti (ARDS), għandhom jittieħdu l-miżuri meħtieġa ta' appoġġ u l-pazjent għandu jiġi trasferit f'Taqsima ta' Kura Intensiva.
English: Patients with contraindications to radioactive tracer monitoring.
Maltese: Dan jista' jiġi ċċarat permezz ta' arterjogramma.
English: Contraindications to the ILP procedure:
Maltese: Kontraindikazzjonijiet tal-proċedura ILP:
English: Abdominal pain upper, gastritis erosive
Maltese: - uġigħ fil-muskoli - proteina fl-awrina
English: Peripheral arterial occlusive disease Respiratory, thoracic and mediastinal disorders Common:
Maltese: Sindrome tal-kompartiment, uġigħ fil-muskoli Disturbi fil-kliewi u fis-sistema urinarja Komuni:
English: Perfusate samples of several ILPs showed plateau levels of tasonermin (as measured by ELISA) up to 100 minutes after start of perfusion, with no decay attributable to degradation.
Maltese: ILP urew livell stabbli ta' tasonermin (li ġie mkejjel b'ELISA) sa 100 minuta wara li tkun inbdiet il-perfużjoni, u ma kienx hemm l-ebda tħassir minħabba degradazzjoni.
English: Uncommon (may affect up to 1 in 100 people) - blood poisoning (sepsis) - fluid in the lungs - stomach ache - inflammation of the gastric mucosa (gastritis) - temporary loss of finger or toe nails of the affected arm or leg - kidney failure - blood tests showing changes in the way the kidneys are working - narrowing or closing of limb vessels carrying blood from the heart
Maltese: - avvelenament tad-demm (sepsis) - fluwidu fil-pulmuni - uġigħ fl-istonku - infjammazzjoni tal-mukuża tal-istonku (gastrite) - telf temporanju tad-dwiefer tas-swaba' tal-idejn jew tas-saqajn tad-driegħ jew tar-riġel affettwati
English: Beromun should only be administered if leakage is less than 10 %.
Maltese: Beromun għandu jingħata f'każi fejn in-nixxija hi inqas minn 10% biss.
English: Beromun is a white to off-white powder for solution for infusion (powder for infusion) supplied in a glass vial with rubber stopper and sealed with aluminium flip-off cap.
Maltese: Beromun hu trab ta' kulur minn abjad sa abjad jagħti fil-griż għal soluzzjoni għall-infużjoni (trab għall-infużjoni) fornut f'kunjett tal-ħġieġ b'tapp tal-lastku u ssiġillati b'għatu flip-off tal-aluminju.
English: Simultaneous treatment with cardiotoxic substances (e.g. anthracyclines).
Maltese: Trattament fl-istess ħin b'sustanzi kardjotossiċi (eg antraċiklini).
English: The toxicological profile of tasonermin has been investigated in preclinical studies using mice, rats, rabbits, dogs and monkeys.
Maltese: Il-profil tossiku ta' tasonermin kien investigat fi studji ta' qabel l-użu kliniku li saru fuq ġrieden, firien, fniek, klieb u xadini.
English: Infections and infestations
Maltese: Disturbi gastro-intestinali
English: Removab 50 microgram Concentrate for solution for
Maltese: Removab 50 mikrogramma Konċentrat għal soluzzjoni għall
English: Removab 10 microgram Concentrate for solution for infusion
Maltese: Removab 10 mikrogrammi Konċentrat għal soluzzjoni għallinfużjoni
English: Ventricular Extrasystoles Bradycardia
Maltese: Ekstrasistoli ventrikulari Bradicardija
English: 60 mg per vial
Maltese: 60 mg kull kunjett
English: Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Maltese: It-tneħħija totali fil-plażma kienet minn 2.25 - 2.74 ml/minuta/kg.
English: Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
Maltese: Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF Renju Unit
English: At 2 years, the cumulative incidence of NRM was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI, 31.1-55.7%).
Maltese: NRM kienet ta' 11.3% (95%CI, 5.5-19.3%), u dik tar-rikaduta jew il-progressjoni minn allo-HCT kienet ta' 43.8% (95CI, 31.1-55.7%).
English: D: dose of busulfan (see SPC section 4.2)
Maltese: D: id-doża ta' busulfan (ara SPC sezzjoni 4.2)
English: 93% of allogeneic patients showed complete chimerism.
Maltese: 93% tal-pazjenti alloġenejiċi wrew kimeriżmu komplet.
English: Busulfan in combination with fludarabine (FB)
Maltese: Busulfan flimkien ma' fludarabine (FB)
English: Busulfan dose (mg/kg)
Maltese: Doża ta' Busulfan (mg/kg)
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Maltese: Il-proċeduri kollha ta' trasferiment jirrikjedu osservanza stretta ta' tekniċi asettiċi, preferabbilment barnuża tas-sigurtà vertikali bi fluss laminari.
English: Pack size 1 pack containing 8 vials (8 cartons of 1 vial).
Maltese: 1 f'pakkett li fih 8 kunjetti (8 kartuni ta' kunjett 1).
English: Pregnancy (see section 4.6).
Maltese: Tqala (ara sezzjoni 4.6)
English: A total of 14 patients (50%) experienced a-GVHD.
Maltese: Total ta' 14-il pazjent (50%) mardu b'a-GVHD.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 September 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta 'Settembru 2014
English: Veno occlusive disease (VOD) was reported in 15% (4/27) and 7% (2/28) of the autologous and allogenic transplant respectively.
Maltese: Mard okklużżiv tal-vini (vein occlusive disease, VOD) kien irrapportat f'15% (4/27) u 7% (2/28) tat-trapjant awtologuż u dak alloġenejiku rispettivament.
English: A total of 11 patients (18%) experienced a-GVHD.
Maltese: Total ta' 11-il pazjent (18%) mardu b' a-GVHD.
English: Low inter (CV=21%) and intra (CV=12%) patient variability on busulfan exposure was demonstrated through a population pharmacokinetic analysis, performed on 102 patients.
Maltese: (CV=21%) u intra (CV=12%) fil-pazjenti dwar esponiment għal-busulfan intwera permezz ta' analiżi farmakokinetika tal-popolazzjoni, li sar fuq 102 pazjent.
English: A continuous variation of clearance ranging from 2.49 to 3.92 ml/minute/kg has been established in children from < 6 months up to 17 years old.
Maltese: Kien hemm varjazzjoni kontinwa ta' tneħħija minn 2.49 sa 3.92 ml/minuta/kg fi tfal minn <6 xhur sa 17-il sena.
English: The pharmacokinetics of busulfan has been investigated.
Maltese: Il-farmakokinetiċi ta' busulfan kienu investigati.
English: Dimethylacetamide Macrogol 400
Maltese: Dimethylaċetamide u Macrogol 400
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61) .
Maltese: Id-dejta dwar l-inċidenza ta' mard akut tat-trapjant kontra r-riċevitur (a-GVHD) inġabar fi studju (alloġenejiku) (n=61) OMC-BUS-4.
English: Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-S-transferase mediated).
Maltese: Busulfan hu prinċipalment metaboliżżat permezz tal-konjugazzjoni mal-glutatijon (spontanju u medjat mill-glutathione-S-transferase).
English: Contribution of long-lasting metabolites is not excluded.
Maltese: Il-kontribuzzjoni tal-metaboliti li jdumu ħafna mhix eskluża.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
Maltese: U KWANTITATTIVA Millilitru wieħed ta' konċentrat fih 6 mg ta' busulfan (60 mg f'10 ml).
English: Hypertension Hypotension Thrombosis Vasodilatation
Maltese: Ipertensjoni Ipotensjoni Vasodilatatazzjoni Trombożi
English: Platelet engraftment occurred at a median of 9 (range, 1-16) days after allo-HCT.
Maltese: Lengraftment tal-plejtlits seħħ f'medjan ta' 9 (medda, 1-16) ijiem wara allo-HCT.
English: Data from a recently completed prospective multicentre phase 2 study including 80 patients, aged 18 to 65 years old, diagnosed with different hematologic malignancies who underwent allo-HCT with an FB (3 days of busulfan) reduced intensity conditioning regimen became available.
Maltese: Dejta minn studju prospettiv li tlesta dan l-aħħar, multiċentriku, ta' fażi 2, li kien jinkludi 80 pazjent, li kellhom bejn 18 u 65 sena, iddijanjostikati b'tumuri malinni ematoloġiċi differenti, li kellhom allo-HCT b'kors ta' kundizzjonar b'intensità mnaqqsa b'FB (3 ijiem ta' Busulfan), saret disponibbli.
English: Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, alkyl sulfonates, ATC code: L01AB01.
Maltese: Sustanzi antineoplastiċi, sustanzi alkylating, sulfonati alkyl, Kodiċi ATC:
English: In both studies, all patients received a 16/16 dose regimen of busulfan.
Maltese: Fiż-żewġ studji, il-pazjenti kollha rċevew 16/16 regimen ta' doża ta' busulfan.
English: A majority of publications reported a complete donor chimerism at day+30 for 90-100% of patients.
Maltese: Ilmaġġoranza tal-pubblikazzjonijiet irrappurtaw kimeriżmu tad-donatur komplet f'jum+30 għal 90-100% tal-pazjenti.
English: Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW + 0.25x (actual body weight-IBW).
Maltese: Piż aġġustat ideali tal-ġisem (AIBW) huwa kkalkulat kif ġej: AIBW=IBW + 0.25x (piż attwali tal-ġisem - IBW).
English: • Quantity of Busulfan Fresenius Kabi:
Maltese: • Kwantità ta' Busulfan Fresenius Kabi:
English: Each vial contains 10 ml of concentrate.
Maltese: Kull kunjett fih 10 ml ta' konċentrat.
English: In this study, 24 adult patients received clonazepam (0.025-0.03 mg/kg/day as IV continuous infusions) as anticonvulsant therapy and the PK data of these patients were compared to historical data collected in patients treated with phenytoin.
Maltese: F'dan l-istudju 24 pazjenti adulti ingħataw clonazepam (0.025-0.03 mg/kg/kuljum bħala infużjonijiet IV kontinwi) bħala terapija antikonvulsanti u d-dejta PK ta' dawn il-pazjenti kienu mqabbla ma' dejta storika miġbura f'pazjenti kkurati bi phenytoin.
English: followed by: - 4 cycles of 50 mg/kg body weight (BW) cyclophosphamide (BuCy4) or - one administration of 140 mg/m² melphalan (BuMel) initiated for at least 24 hours following the 16th dose of busulfan (see section 4.5).
Maltese: 4 ċikli ta' 50 mg/kg piż tal-ġisem (BW) cyclosphosphamide (BUCy4) jew għotja waħda ta' 140 mg/m² melphalan (BuMel) li jibdew mill-24 siegħa wara s-16-il doża ta' busulfan (ara sezzjoni 4.5).
English: However cardiac function should be monitored regularly in patients receiving busulfan (see section 4.8).
Maltese: Biss il-funzjoni kardijaka għandha tiġi mgħassa regolarment f'pazjenti li qed jirċievu busulfan (ara sezzjoni 4.8).
English: Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 8 hours (including infusion time) after dilution when stored at 25°C ± 2°C or 12 hours after dilution when stored at 2°C-8°C followed by 3 hours stored at 25°C ± 2°C (including infusion time).
Maltese: Stabilita kimika u fiżika stabbilita wara d-dilwizzjoni ta' soluzzjoni għall-injezzjoni ta' glucose 5% jew klorur tas-sodju 9 mg/ml (0.9%) ġiet murija għal 8 sigħat (inkluż il-ħin tal-infużjoni) wara d dilwizzjoni meta maħżuna f'temperaturi ta' 25 °C  2 °C jew 12-il siegħa wara d-dilwizzjoni meta maħżuna f'temperaturi bejn 2 °C-8 °C segwiti bi ħżin ta' tliet sigħat f'temperaturi ta' bejn 25 °C
English: Documentation of the safety and efficacy of busulfan in combination with cyclophosphamide in the BuCy4 or with melphalan in the BuMel regimen prior to conventional allogeneic and/or autologous HPCT derives from clinical trial F60002 IN 101 G0.
Maltese: Id-dokumentazzjoni dwar is-sigurtà u l-effikaċja tal- Busulfan flimkien mas-ċiklofosfamid fir-regimen BuCy4 jew mal-melfalan fir-regimen BuMel qabel l-HPCT konvenzjonali alloġenejiku u/jew awtologuż irriżultaw minn studju kliniku F60002 IN 101 G0.
English: During clinical trials with intravenous busulfan administered as 0.80 mg/kg four-times daily, 90% of patients AUCs were below the upper AUC limit (1500 µmol/L.minute) and at least 80% were within the targeted therapeutic window (900 - 1500 µmol/L.minute).
Maltese: Matul l-istudji kliniċi b'busulfan mogħti ġol-vini mogħti bħala 0.80 mg/kg erba' darbiet kuljum, 90% tal-AUCs tal-pazjenti kienu aktar baxxi mill-ogħla limitu AUC (1500-µMol/L.minuta) u tal-anqas 80% kienu fi ħdan it-tieqa terapewtika mmirata (minn 900 sa 1500 µMol/L.minuta).
English: The time to Absolute Neutrophil Count (ANC) greater than 0.5x109 /l was 13 days (range 9-29 days) in allogenic patients (OMC-BUS 4), and 10 days (range 8-19 days) in autologous patients (OMC-BUS 3).
Maltese: 9/1 kien 13-il ġurnata (minn 9 sa 29 ġurnata) f'pazjenti alloġenejiċi (OMC-BUS 4), u 10 ġranet (minn 8 sa 19-il ġurnata) f'pazjenti awtologużi (OMC-BUS 3).
English: Busulfan in combination with cyclophosphamide
Maltese: Kabi flimkien ma' cyclophosphamide:
English: 8 MARKETING AUTHORISATION NUMBER(S) EU/1/14/951/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/951/001
English: Tabulated lists of adverse reactions
Maltese: Lista tar-reazzjonijiet avversi miġbura f'tabella
English: The safety profile of busulfan combined with fludarabine (FB) has been examined through a review of adverse reactions reported in published data from clinical trials in RIC regimen.
Maltese: Il-profil tas-sigurtà ta' Busulfan flimkien ma' fludarabine (FB) ġie eżaminat permezz ta' reviżjoni talreazzjonijiet avversi li ġew irrappurtati f'dejta ppubblikata minn provi kliniċi fir-regimen RIC.
English: Rhinitis Pharyngitis
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Atelectasis Pleural effusion
Maltese: Ażma Atelektasi Effużżjoni Plewrali
English: - 12 hours after dilution when stored at 2°C-8°C followed by 3 hours stored at 25°C ± 2°C (including infusion time).
Maltese: 12-il siegħa wara d-dilwazzjoni meta tkun maħżuna f'temperatura minn 2°C sa 8°C u wara tkun maħżuna għal 3 sigħat f'temperatura ta' 25°C  2°C (inkluż il-ħin tal-infużjoni).
English: Vials 2 years.
Maltese: 2 snin
English: Y: body weight of the patient in kg D: dose of busulfan (see section 4.2)
Maltese: Y: piż tal-ġisem tal-pazjent f'kg D: doża ta' busulfan (ara sezzjoni 4.2)
English: The literature on busulfan suggests a therapeutic AUC window between 900 and 1500 µmol/L.minute per administration (equivalent to a daily exposure between 3600 and 6000 µmol/L.minute).
Maltese: Il-letteratura medika dwar busulfan tissuġġerixxi li hemm tieqa terapewtika tal-AUC bejn 900 u 1500 µMol/L.minutagħal kull għoti (ekwivalenti għal espożizzjoni ta' bejn 3600 u 6000 µmol/L.minuta kuljum)..
English: Documentation on the safety and efficacy of busulfan in combination with cyclophosphamide in the BuCy2 regimen prior to conventional allogeneic and/or autologous HPCT derives from two clinical trials (OMC-BUS-4 and OMC-BUS-3).
Maltese: Id-dokumentazzjoni fuq is-sigurtà u l-effikaċja ta' busulfan flimkien ma' cyclosphosphamide firregimen BuCy2 qabel HPCT alloġenejiku konvenzjonali u/jew awtologuż huma bbażati fuq żewġ studji kliniċi (OMC-BUS-4 u OMC-BUS-3).
English: No interaction was observed when busulfan was combined with fluconazole (antifungal agent).
Maltese: Ma kienet osservata lebda interazzjoni meta busulfan ingħaqad ma' fluconazole (sustanzi antifungali)
English: Busulfan following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.
Maltese: Busulfan segwit minn Fludarabine (FB) hu indikat bħala trattament kondizzjonarju qabel trapjant taċċelluli amatopojetiċi proġenitriċi (HPCT) f'pazjenti adulti li huma kandidati għar-regimen kondizzjonarju b'intensità mnaqqsa.
English: Hepato-biliary disorders VOD was reported with a range between 3.9% and 15.4%.
Maltese: Disturbi fil-fwied u fil-marrara VOD kien irrappurtat b'medda ta' bejn 3.9% u 15.
English: LIST OF EXCIPIENTS Excipients: Dimethylacetamide and Macrogol 400
Maltese: Dimethyacetamide u Macrogol 400
English: Patients received doses of 0.8 mg/kg busulfan every 6 hours infusion for a total 16 doses followed by cyclophosphamide at 60 mg/kg once per day for two days (BuCy2 regimen).
Maltese: Pazjenti li ngħataw dożi ta' 0.8 mg/kg ta' busulfan f'infużjoni kull 6 sigħat għal total ta' 16-il doża u wara ngħataw cyclosphosphamide f'doża ta' 60 mg/kg darba kuljum għal jumejn (BuCy2 regimen).
English: A population pharmacokinetic analysis has been performed in a cohort of 205 children adequately distributed with respect to bodyweight (3.5 to 62.5 kg), biological and diseases (malignant and non-malignant) characteristics, thus representative of the high heterogeneity of children undergoing HPCT.
Maltese: Analiżi farmakokinetika tal-popolazzjoni sar f''koorti ta' 205 tifel u tifla imqassma adegwatament skont il-piż tal-ġisem (3.5 sa 62.5 kg), karatteristiċi bijoloġiċi u tal-mard (malinn u mhux malinn), b'hekk rappreżentattivi ta' l-eteroġeneità għolja ta' tfal għaddejjin minn HPCT.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 8 vials of 10 ml 60 mg per vial
Maltese: Konċentrat għal soluzzjoni għall-infużjoni 8 kunjetti ta' 10 ml
English: - 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses, - followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16th dose of busulfan (see section 4.5).
Maltese: 0.8 mg/kg piż tal-ġisem (BW) ta' busulfan bħala infużjoni ta' sagħtejn kull 6 sigħat fuq medda ta' 4 ġranet konsekuttivi għal total ta' 16-il doża, segwit minn cyclosphosphamide b'60mg/kg/jum għal jumejn li jibdew mhux inqas minn 24 siegħa wara s-16-il doża ta' busulfan (ara sezzjoni 4.5).
English: In adults, absolute neutrophil counts < 0.5x109/l at a median of 4 days post transplant occurred in 100% of patients and recovered at median day 10 and 13 days following autologous and allogeneic transplant respectively (median neutropenic period of 6 and 9 days respectively).
Maltese: 9/l fil-medjan ta' 4 ġranet wara t-trapjant f'100% tal-pazjenti u kien hemm fejqan fil-gurnata medjana 10 u 13-il ġurnata wara t-trapjant awtologuż u alloġenejiku rispettivament (perijodu medjan newtropeniku ta' 6 u 9 ġranet rispettivament).
English: Gastrointestinal disorders The highest frequency of nausea and vomiting was 59.1% and the highest frequency of stomatitis was
Maltese: L-ogħla frekwenza ta' dardir u rimettar kienet ta' 59.1% u l-ogħla frekwenza ta' stomatite kienet ta'
English: Nutrition: loss of appetite, decrease in magnesium, calcium, potassium, phosphate, albumine in blood, and increase in blood sugar.
Maltese: Nutriment: nuqqas ta' aptit, tnaqqis fil-manjesju, kalċju, potassju, fosfat, albumina fid-demm, u żjieda taz-zokkor fiddemm.
English: The medicinal product is not recommended in obese children and adolescents with body mass index Weight (kg)/ (m2) > 30 kg/m² until further data become available.
Maltese: Il-prodott mediċinali mhuwiex rakkomandat fi tfal u adolexxenti ħoxnin iżżejjed li għandhom indiċi tal-massa tal-ġisem Piż (kg)/(m2) > 30 kg/m² sakemm ma jkunx hemm aktar dejta disponibbli.
English: Adverse reactions information are derived from the clinical study in paediatrics (n=55).
Maltese: Tagħrif dwar reazzjonijiet avversi jistgħu jinkisbu mill-istudju kliniku fil-pedjatriċi (n=55).
English: Busulfan Fresenius Kabi in combination with cyclophosphamide: - The recommended dose of Busulfan Fresenius Kabi is 0.8 mg/kg
Maltese: − Id-doża rakkomandata ta' Busulfan Fresenius Kabi hi ta' 0.8 mg/kg
English: Either phenytoin or benzodiazepines were administered for seizure prophylaxis in patients participating to the clinical trials conducted with intravenous busulfan (see section 4.2 and 4.4).
Maltese: Jew phenytoin jew benzodiazepines ngħataw għall-profilasi tal-puplesija fil-pazjenti li ħadu sehem fl-istudji kliniċi li saru b'busulfan mogħti ġol-vini (ara sezzjoni 4.2 u 4.4).
English: In these studies, a total of 1574 patients received FB as a reduced intensity conditioning (RIC) regimen prior to haematopoietic progenitor cell transplantation.
Maltese: F'dawn listudji, total ta' 1574 pazjent irċivew FB bħala regimen kondizzjonarju b'intensità mnaqqsa (RIC) qabel trapjant taċ-ċelluli amatopojetiċi proġenitriċi.
English: Studies in animals have shown reproductive toxicity (embryo-foetal lethality and malformations) (see section 5.3)
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva (mewt tal-embriju/fetu u malformazzjonijiet) (ara sezzjoni 5.3).
English: In this study, all, but one, patients engrafted, at a median of 15 (range, 10-23) days after allo-HCT.
Maltese: F'dan listudju, il-pazjenti kollha, ħlief wieħed, tlaqqmu, f'medjan ta' 15-il jum (medda, 10-23) wara allo-HCT.
English: The pharmacokinetics of intravenous busulfan was studied in 124 evaluable patients following a 2-hour intravenous infusion for a total of 16 doses over four days.
Maltese: Il-farmakokinetiċi ta' busulfan mogħti ġol-vini kien studjat f'124 pazjent evalwabbli wara infużjoni minn ġol-vina ta' 2 sigħat għal total ta' 16-il doża fuq firxa ta' erbat ijiem.
English: The recommended posology for children as detailed in section 4.2 enabled over 70% up to 90% of children ≥ 9kg in achieving the therapeutic window (900 - 1500 µmol/L.minute).
Maltese: Il-pożoloġija rakkomandata għat-tfal kif iddettaljata f'sezzjoni 4.2 ppermettiet aktar minn 70% sa 90% tat-tfal ≥ 9 kg biex jiksbu t-tieqa terapewtika (900 - 1500 μmol/L.kull minuta).
English: The concomitant systemic administration of phenytoin to patients receiving high-dose of oral busulfan has been reported to increase busulfan clearance, due to induction of glutathion-S-transferase whereas no interaction has been reported when benzodiazepines such as diazepam, clonazepam or lorazepam have been used to prevent seizures with high-dose busulfan.
Maltese: L-għoti sistematiku konkomitanti tal-phenytoin lill-pazjenti li ngħataw doża għolja tal-busulfan kien irrapportat li wassal għal żjieda fit-tkeċċija tal-busulfan, minħabba l-induzzjoni ta' glutathion-S-transferase filwaqt li ma kienet irrapportata l-ebda interazzjoni meta benzodiazepines bħal diazepam, clonazepam jew lorazepam kienu użati biex jimpedixxu l-puplessiji b'doża għolja ta'busulfan.
English: Hypogonadism**
Maltese: Ċistite emorraġika**
English: Busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Maltese: Busulfan li jingħata qabel cyclosphosphamide (BuCy4) jew melphalan (BuMel) hu indikat bħala trattament kondizzjonarju qabel it-trapjant konvenzjonali taċ-ċelluli ematopojetiċi proġenitriċi f'popolazzjoni pedjatrika.