FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 8 (2 packs of 4) vials of 10 ml 60 mg per vial
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni Pakkett multiplu: 8 (2 pakketti ta' 4) kunjett ta' 10 ml 60 mg kull kunjett
English: The incidence of a-GVHD grades I-II was 13% (8/61), while the incidence of grade III-IV was 5% (3/61).
Maltese: L-inċidenza tal-gradi ta' a-GVHD I-II kienu 13% (8/61), waqt li l-inċidenza ta' grad III-IV kien ta' 5% (3/61).
English: However, more than 500 patients aged ≥ 55 years were reported in publications with FB conditioning regimens, yielding efficacy outcomes similar to younger patients.
Maltese: Madankollu, aktar minn 500 pazjent li kellhom ≥ 55 sena ġew irrappurtati f'pubblikazzjonijiet ma' korsijiet FB kondizzjonarji, taw riżultati tal-effikaċja simili għal pazjenti iżgħar.
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jista' jolqot sa 1 f'10 persuna):
English: The most frequent causes of reported TRM/NRMs were infection/sepsis, GVHD, pulmonary disorders and organ failure.
Maltese: L-aktar kawżi frekwenti ta' TRM/NRMs irrappurtati kienu infezzjoni/sepsis, GVHD, disturbi pulmonari u insuffiċjenza tal-organi.
English: Doses of 400 mg/kg/day DMA administered during organogenesis caused significant developmental anomalies.
Maltese: Dożi ta' 400 mg/kg/kuljum ta' DMA mogħtija matul l-organuġenesi ikkaġunaw anomaliji sinifikanti tal-iżvilupp.
English: Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-Stransferase mediated).
Maltese: Busulfan hu prinċipalment metaboliżżat permezz tal-konjugazzjoni mal-glutatijon (spontanju u medjat mill-glutatijon-S-transferas).
English: Similar targeting rate is achieved within the daily exposure of 3600 - 6000 µmol/L.minute following the administration of intravenous busulfan 3.2 mg/kg once daily.
Maltese: Rata ta' immirar simili tinkiseb f'espożizzjoni ta' 3600 - 6000 µmol/L.minuta kuljum wara l-għoti ta' busulfan 3.2 mg/kg ġol-vini darba kuljum.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100) or not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100, < 1/10), mhux komuni (≥ 1/1,000, < 1/100) jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Similar blood exposure was observed when comparing plasma concentrations in adult patients receiving oral and intravenous busulfan at 1 mg/kg and 0.8 mg/kg respectively.
Maltese: Esponiment simili għaddemm kien osservat meta tqabblu konċentrazzjonijiet tal-plażma f'pazjenti adulti li rċevew busulfan mogħti mill-ħalq u mogħti ġol-vini f'1 mg/kg u 0.8 mg/kg rispettivament.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml
Maltese: INDIVIDWALI 60 mg/10 ml
English: In both studies, all patients received a 16/16 dose regimen of Busilvex.
Maltese: Fiż-żewġ studji, il-pazjenti kollha rċevew 16/16 regimen ta' doża tal-Busilvex.
English: Anaemia (haemoglobin< 8.0 g/dl) occurred in 69% of patients.
Maltese: Anemja (emoglobina<8.0 g/dl) seħħet f'69% tal-pazjenti.
English: In children, thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred in 100% of patients.
Maltese: Fit-tfal, it-tromboċitopenija (< 25x109/l jew kien hemm bżonn ta' transfużjoni talpjastrini) irriżultat f'100% tal-pazjenti.
English: By example:
Maltese: NN:
English: Pharmacotherapeutic group: Alkyl sulfonates, ATC code: L01AB01.
Maltese: Sulfonati alkili, Kodiċi ATC:
English: Adverse events information is derived from two clinical trials (n=103) of Busilvex.
Maltese: Tagħrif dwar reazzjonijiet avversi inkisbu minn żewġ studji kliniċi (n=103) tal-Busilvex.
English: Documentation of the safety and efficacy of Busilvex 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-Busilvex 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: Busilvex in combination with fludarabine (FB)
Maltese: Busilvex flimkien ma' fludarabine (FB)
English: The benefit risk profile of the product remains favourable in the approved indications.
Maltese: Il-profil ta' riskju u benefiċċju tal-prodott jibqa' favorevoli fl-indikazzjonijiet approvati.
English: Contribution of long-lasting metabolites is not excluded.
Maltese: Il-kontribuzzjoni għall-metaboliti li jdumu ħafna mhix eskluża.
English: Reversible binding to plasma proteins was around 7% while irreversible binding, primarily to albumin, was about 32%.
Maltese: Irbit riversibbli ma' proteini tal-plażmatiċi kien madwar 7% waqt l-irbit irreversibbli, primarjament ma' l-albumin, kien madwar 32%.
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 bil-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: One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
Maltese: Millilitru wieħed ta' ċonċentrat fih 6 mg ta' busulfan (60 m f'10 ml).
English: However cardiac function should be monitored regularly in patients receiving Busilvex (see section 4.8).
Maltese: Biss il-funzjoni kardijaka għandha tiġi mgħassa regolarment f'pazjenti li qed jirċievu l-Busilvex (ara sezzjoni 4.8).
English: Transaminases increased Bilirubine increased Alkaline phosphatases increased
Maltese: Żieda fit-transaminases Żieda fil-bilirubina Żieda fl-alkaline phosphatases
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 bil-fenitojin.
English: The safety profile of Busilvex combined with fludarabine (FB) has been examined through a review of adverse events reported in published data from clinical trials in RIC regimen.
Maltese: Il-profil tas-sigurtà ta' Busilvex flimkien ma' fludarabine (FB) ġie eżaminat permezz ta' reviżjoni talavvenimenti avversi li ġew irrappurtati f'dejta ppubblikata minn provi kliniċi fir-regimen RIC.
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 Busilvex) 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 alloHCT b'kors ta' kundizzjonar b'intensità mnaqqsa b'FB (3 ijiem ta' Busilvex), saret disponibbli.
English: - 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time).
Maltese: sa 8°C u wara tkun maħżuna għal 3 sigħat f'20°C  5°C (inkluż il-ħin tal-infużjoni).
English: Hyperglycaemia Hypocalcaemia Hypokalaemia Hypomagnesaemia Hypophosphatemia
Maltese: Anoreksja Ipergliċemija Ipokalċemija Ipokalemija Ipomagnesemija Ipofosfatemija
English: HVOD is a recognized potential complication of conditioning therapy post-transplant.
Maltese: HVOD kienet rikonoxxuta bħala komplikazzjoni potenzjali tat-terapija kondizzjonarja ta' wara t-trapjant.
English: Hypogonadism
Maltese: Ipogonadiżmu
English: The cumulative incidence of neutrophil recovery at day 28 was 98.8% (95%CI, 85.7-99.9%).
Maltese: L-inċidenza kumulattiva tal-irkupru tan-newtrofili f'jum 28 kienet ta' 98.8% (95%CI, 85.
English: was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI,
Maltese: Wara sentejn, l-inċidenza kumulattiva ta' NRM kienet ta' 11.3% (95%CI, 5.5-19.3%), u dik tar-rikaduta jew il-progressjoni minn allo-HCT
English: Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Maltese: Sistema nervuża: delirjum, nervożità, alluċinazzjoni, aġitazzjoni, funzjoni annormali tal-moħħ, emoraġija ċerebrali, u puplessija.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2C - 8C)
Maltese: Aħżen fi friġġ (2C - 8C)
English: The treatment-related mortality/non-relapse mortality (TRM/NRM) reported until day+100 posttransplant has also been examined through a review of published data from clinical trials.
Maltese: Il-mortalità relatata mal-kura/mortalità mhux minn rikaduta (TRM/NRM) irrappurtata sa jum+100 wara t-trapjant, ġiet eżaminata wkoll permezz ta' reviżjoni ta' dejta ppubblikata minn provi kliniċi.
English: Component of a multipack, cannot be sold separately.
Maltese: Komponent f'pakketti multipli, ma jistax jinbiegħ separatament.
English: The effect of those anticonvulsant agents on busulfan pharmacokinetics was investigated in a phase II study (see section 4.5).
Maltese: L-effett ta' dawk l-aġenti antikonvulżanti fuq il-farmakokinetiċi busulfankienet investigata fi studju fil-fażi II (ara sezzjoni 4.5).
English: There is no common metabolism pathway between busulfan and fludarabine.
Maltese: M'hemm l-ebda passaġġ komuni tal-metaboliżmu bejn busulfan u fludarabine.
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 Busilvex.
Maltese: u wara ikun hemm: - 4 ċikli ta' 50 mg/kg piż tal-ġisem (BW) ċiklofosfamid (BUCy4) jew - għotja waħda ta' 140 mg/m² melfalan (BuMel) li jibdew mill-24 siegħa wara s-16-il doża ta' Busilvex (ara sezzjoni 4.5).
English: 15% of SAEs involved liver toxicity.
Maltese: 15% tas-SAEs kienu jinvolvu tossiċità fil-fwied.
English: The solvent dimethylacetamide (DMA) may also impair fertility.
Maltese: Is-solvent dimetilaċetamide (DMA) għandu mnejn ifixkel il-fertilità.
English: The recommended dose of Busilvex is 3.2 mg/kg Each infusion will last 3 hours
Maltese: Id-doża rakkomandata ta' Busilvex hi ta' 3.2 mg/kg Kull infużjoni se ddum 3 sigħat
English: Cerebral haemorrhage Encephalo-pathy
Maltese: Emorraġija ċerebrali Enċefalopatija
English: Hypoalbuminaemia Electrolyte disturbance Hyperglycaemia
Maltese: Ipoalbuminemija Disturb tal-elettroliti Ipergliċemija
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: Fl-adulti kien hemm għadd assolut newtrofil < 0.5x109/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: Respiratory: increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung.
Maltese: Respiratorji: żjieda fir-ritmu tan-nifs, falliment respiratorju, emoraġiji alveolari, ażma, kollass ta' parti żgħira tal-pulmun, fluwidu madwar il-pulmun.
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 90100% tal-pazjenti.
English: Creatinine elevated Blood lactate dehydrogenase increased
Maltese: Żieda ta' lactate dehydrogenase fiddemm
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 dwar il-busulfan tissuġġerixxi li hemm tieqa terapewtika tal-AUC bejn 900 u 1500 µMol/L.minuta għal kull għoti (ekwivalenti għal espożizzjoni ta' bejn 3600 u 6000 µmol/L.minuta kuljum).
English: 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: 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 20 °C  5 °C or 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time).
Maltese: Stabilita kimika u fiżika stabbilita wara d-dilwizzjoni f' soluzzjoni għall-injezzjoni ta' glukosju 5% jew klorid 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' 20 °C  5
English: Atelectasis Pleural effusion
Maltese: Atelektasi Effużżjoni Plewrali
English: 39% of patients (40/103) experienced one or more episodes of infection, of which 83% (33/40) were rated as mild or moderate.
Maltese: 39% tal-pazjenti (40/103) kellhom episodju wieħed jew aktar ta' infezzjoni, li minnhom 83% (33/40) kienu kklasifikati bħala ħfief jew moderati.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi ta' aġġornament għal dan il-prodott mediċinali huma stabbiliti fil-lista ta' dati ta' referenza tal-Unjoni mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew talmediċini.
English: After dilution: 1 ml of solution contains 0.5 mg of busulfan For the full list of excipients see section 6.1
Maltese: Wara lis-sustanza tkun dilwita: 1 ml tat-soluzzjoni fih 5 mg ta' busulfan Għall-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1
English: Y: body weight of the patient in kg D: dose of Busilvex (see section 4.2)
Maltese: Y: piż tal-ġisem tal-pazjent f'kg D: id-doża ta' Busilvex (ara SPC sezzjoni 4.2)
English: Busilvex can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Maltese: Busilvex jista 'wkoll jipproduċi sintomi ta' menopawża u f'tfajliet pre-adolexxenti jista' jipprevjenji lbidu tal-pubertà.
English: Hyperventilation Respiratory failure Alveolar haemorrhages Asthma
Maltese: Iperventilazzjoni Difett respiratorju Emorraġiji Alveolari
English: Haemorrhagic cystitis**
Maltese: Ipoplażja fissnien**
English: In human the principal toxic effects were hepatotoxicity and central nervous system (CNS) effects.
Maltese: Fil-każ tal-bnedmin l-effetti prinċipali tossiċi kienu epatotossiċità u l-effetti tas-sistema ċentrali nervuża.
English: Agitation Confusional state Hallucination
Maltese: Stat ta' konfużjoni Alluċinazzjoni
English: Busilvex 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: Busilvex 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: 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 nonmalignant) 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: The incidence of acute graft versus host disease (a-GVHD) data was collected in allogeneic patients (n=28).
Maltese: Id-dejta dwar l-inċidenza ta' mard akut tat-trapjant kontra r-riċevitur (a-GVHD) inġabar minn pazjenti alloġenejiċi (n=28).
English: A final concentration of approximately 0.5 mg/ml busulfan should be achieved.
Maltese: Għandha tintlaħaq konċentrazzjoni finali ta' madwar 0.5 mg/ml busulfan.
English: Inter and intra patient variabilities in plasma exposure were lower than 20% and 10%, respectively.
Maltese: Varjabilitajiet inter u intra pazjent fl-esponiment għall-plażma kienu aktar baxxi minn 20% u 10% rispettivament.
English: There are no cases with oral busulfan.
Maltese: M'hemmx każijiet b'busulfan orali.
English: Pericarditis
Maltese: Takikardija
English: Rhinitis Pharyngitis
Maltese: 5. PROPRJETAJIET FARMAKOLOĠIĊI
English: Headache Dizziness
Maltese: Stomatite Dijarea
English: Documentation on the safety and efficacy of Busilvex 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 tal-Busilvex flimkien mal-ċiklofosfamid fir-regimen BuCy2 qabel ll-HPCT alloġenejiku konvenzjonali u/jew awtologuż huma bbażati fuq żewġ studji kliniċi (OMC-BUS-4 u OMC-BUS-3).
English: PK/PD relationship was observed between stomatitis and AUCs in autologous patients and between bilirubin increase and AUCs in a combined autologous and allogeneic patient analysis.
Maltese: PK/PD kien osservat bejn l-istomatite u l-AUCs f'pazjenti awtologużi u bejn żjieda fil-bilirubin u l-AUCs f'analiżi magħdud ta' pazjenti li għamlu trapjant awtologuż u alloġenejiku.
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 ċ-ċiklofosfamid f'doża ta' 60 mg/kg darba kuljum għal jumejn (BuCy2 regimen).
English: Therefore careful monitoring will be performed.
Maltese: Għalhekk ser isir monitoraġġ bir-reqqa.
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
Maltese: Il-ħin għall-Għadd Asolut Newtrofil (ANC) akbar minn 0.5 x 109/1 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: The recommended dose and schedule of administration is: - fludarabine administered as a single daily one-hour infusion at 30 mg/m² for 5 consecutive days or 40 mg/m² for 4 consecutive days.
Maltese: Id-doża rakkomandata u l-iskeda tal-għoti hi: - fludarabine mogħti bħala infużjoni ta' siegħa, darba kuljum f'doża ta' 30 mg/m² għal 5 ijiem konsekuttivi jew 40 mg/m² għal 4 ijiem konsekuttivi.
English: Interstitial lung disease**
Maltese: Mard interstizjali talpulmun**
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 fid-demm.
English: One ml of concentrate contains 6 mg busulfan (60 mg in the vial).
Maltese: Millilitru wieħed ta' konċnetrat fih 6 mg busulfan (60 mg filkunjett).
English: As a conclusion, busulfan could be one risk factor of development TMA and a warning is section 4.4 of the Busilvex SmPC is considered warranted.
Maltese: Bħala konklużjoni, busulfan jista' jkun wieħed millfatturi ta' riskju ta' żvilupp ta' TMA u twissija fis-sezzjoni 4.4 tal-SmPC Busilvexhuwa meqjus ġustifikat.
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 adoloxxenti ħoxnin iżżejjed li għandhom indiċi tal-massa tal-ġisem Piż (kg)/(m²) > 30 kg/m² sakemm ma jkunx hemm aktar dejta disponibbli.
English: Hepatomegaly Jaundice
Maltese: Deskwamazzjoni tal-ġilda
English: Premature menopause Ovarian failure**
Maltese: Menopawża prematura Falliment talovarju
English: Constipation Anus discomfort
Maltese: Stitikezza Skomfort anali
English: Detailed information on this product is available on the website of European Medicinal Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu
English: The recommended dose of Busilvex is 0.8 mg/kg Each infusion will last 2 hours
Maltese: Id-doża rakkomandata ta' Busilvex hi ta' 0.8 mg/kg Kull infużjoni se ddum sagħtejn
English: Renal disorder
Maltese: Disturbi fil-lenti
English: The recommended posology for children as detailed in section 4.2 enabled over 70% up to 90% of children ≥ 9 kg 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: Overall mortality and non- relapse mortality at more than 100 days post-transplant was (8/61) 13% and (6/61) 10% in allotransplanted patients, respectively.
Maltese: Kollox ma' kollox, il-mortalità u l-mortalità fejn ma kienx hemm rikaduta ta' aktar minn 100 ġurnata wara ttrapjant kien (8/61) 13% u (6/61) 10% f'pazjenti allotrapjantati, rispettivament.
English: It is recommended to administer anticonvulsants 12 h prior to Busilvex to 24 h after the last dose of Busilvex.
Maltese: Hu rrakkomandat li għandhom jingħataw antikonvulżivi 12-il s. qabel il-Busilvex sa 24 s. wara l-aħħar doża ta' Busilvex.
English: Chest pain Oedema
Maltese: Uġigħ fis-sider Edema
English: Adverse events 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: Femoral artery thrombosis Capillary leak syndrome
Maltese: Trombożi talarterja femorali Sindrom ta' nixxija kapillari
English: Headache Nervous system disorders [Not Elsewhere Classified]
Maltese: Uġigħ ta' ras Disturbi fis-sistema nervuża [Mhux Ikklassifikati X'imkien ieħor]
English: Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood.
Maltese: Gastrointestinali: infjammazzjoni tal-mukoża tal-esofagu, paraliżi tal-imsaren, rammettar tad-demm.
English: One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the Busilvex studies.
Maltese: Pazjent bata minn każ fatali ta' sindrom akut ta' periklu respiratorju b'difett sussegwenti respiratorju assoċjat ma' fibrożi pulmonari interstitjali fl-istudji tal-Busilvex.
English: Increase of lactate dehydrogenase in the blood.
Maltese: Żieda ta' lactate dehydrogenase fid-demm.
English: Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Maltese: Busulfan hu aġent qawwi ċitotossiku u aġent alkilatinku bifunzjonali.