FrancophonIA/ELRC3.0 huggingface dataset:
English: Haemorrhagic cystitis including haemorrhagic cystitis induced by viral infection was reported in a range between 16% and 18.1%.
Maltese: Ċistite emorraġika li tinkludi ċistite emorraġika indotta minn infezzjoni virali ġiet irrappurtata f'medda ta' bejn 16% u 18.1%.
English: Posology
Maltese: Iponatremija
English: To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%) Preparation of the solution for infusion
Maltese: Biex tipprepara s-soluzzjoni finali għall-infużjoni, żid (A) ml ta' Busilvex ma' (B) ml tad-dilwent (soluzzjoni ta' klorid tas-sodju ta' 9 mg/ml (0.9%) għall-injezzjoni jew is-soluzzjoni tal-glukows għall-injezzjoni ta' 5%)
English: A cumulative review of the literature and safety database has been performed.
Maltese: Reviżjoni kumulattiva tal-letteratura u dejtabejż ta' sigurtà ġiet imwettaqa.
English: CNS changes precede any of the more severe side effects.
Maltese: Ittibdil ta' CNS jiġu qabel kwalunkwe effetti severi oħra.
English: Do not use polycarbonate syringes with Busilvex.
Maltese: Tużax is-sirinġi polikarbonati mal-Busilvex.
English: - Busilvex will be administered at 3.2 mg/kg as a single daily three-hour infusion immediately after fludarabine for 2 or 3 consecutive days.
Maltese: - Busilvex se jingħata f'doża ta' 3.2 mg/kg bħala infużjoni ta' tliet sigħat, darba kuljum immedjatament wara fludarabine għal 2 jew 3 ijiem konsekuttivi.
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 l-istudji, total ta' 1574 pazjent irċivew FB bħala regimen kondizzjonarju b'intensità mnaqqsa (RIC) qabel trapjant taċ-ċelluli amatopojetiċi proġenitriċi.
English: The time to Absolute Neutrophil Count (ANC) greater than 0.5x109/l was 21 days (range 12-47 days) in allogenic patients, and 11 days (range 10-15 days) in autologous patients.
Maltese: Il-ħin għall-Għadd Assolut Newtrofil (ANC) akbar minn 0.5x109/1 kien 21-il ġurnata (minn 12 sa 47-il ġurnata) f'pazjenti alloġenejiċi, u 11-il ġurnata (minn 10 sa 15-il ġurnata) f'pazjenti awtologużi.
English: Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
Maltese: Busilvex jingħata bħala soluzzjoni ċara u bla kulur f'kunjetti ta' 10 ml ċari tal-ħġieġ (tip I).
English: After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan.
Maltese: Wara li tkun miżjuda bl-ilma, 1 ml tas-soluzzjoni għall-infużjoni fiha 0.5 mg ta' busulfan.
English: No interaction was observed when busulfan was combined with fluconazole (antifungal agent) Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.
Maltese: Ma kienet osservata l-ebda interazzjoni meta busulfan ingħaqad ma' fluconazole (sustanzi antifungali) Studji ppubblikati dwar adulti ddiskrivew li ketobemidon (analġesiku) għandu mnejn ikun assoċjat ma' livelli għoljin plażmatiċi ta' busulfan.
English: Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Maltese: L-użu profilaktiku jew empiriku tal-anti-infettivi (batterjali, fungali, virali) għandhom jiġu meqjusa għall-fini tal-prevenzjoni u l-immaniġġjar tal-infezzjonijiet matul il-perijodu newtropeniku.
English: Respiratory: shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds.
Maltese: Respiratorji: qtugħ ta' nifs, tnixxija mill-imnieħer (rinite), mard tal-gerżuma, sogħla, sulluzzu, ħruġ ta' demm mill-imnieħer, ħsejjes annormali tan-nifs.
English: Pneumonia was fatal in 1% (1/103) and life-threatening in 3% of patients.
Maltese: Il-Pnewmonja kienet fatali f'1% (1/103) u kienet meqjusa bħala theddida għall-ħajja fi 3% tal-pazjenti.
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: Fl-istudji li saru f'adulti u studji pedjatriċi, il-pazjenti ngħataw fenitojin jew benżodjażepini bħala kura għall-profilasi tal-puplesija (ara sezzjonijiet 4.4 u 4.5).
English: Thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred at a median of 5-6 days in 98% of patients.
Maltese: Tromboċitopenia (<25x109/l jew li għandhom bżonn transfużjoni tal-pjastrini) seħħet fil-medjan ta' bejn 5-6 ġurnata f'98% tal-pazjenti.
English: • Quantity of diluent: (A ml Busilvex) x (10) = B ml of diluent To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%) Preparation of the solution for infusion
Maltese: Biex tipprepara s-soluzzjoni finali għall-infużjoni, żied (A) ml ta' Busilvex ma' (B) ml tad-dilwent (soluzzjoni ta' klorid tas-sodju ta' 9 mg/ml (0.9%) għall-injezzjoni jew is-soluzzjoni tal-glukows għall-injezzjoni ta' 5%)
English: No pharmacokinetic explanation justifies this interaction.
Maltese: L-ebda spjegazzjoni farmakokinetika ma tiġġustifika din l-interazzjoni.
English: Arrhythmia Atrial fibrillation Cardiomegaly Pericardial effusion
Maltese: Arritmija Fibrillazzjoni atrijali
English: Cases of thrombotic microangiopathy after hematopoietic cell transplantation (HCT), including fatal cases, have been reported in high-dose conditioning regimens in which busulfan was administered in combination with another conditioning treatment.
Maltese: Każijiet ta' mikroanġjopatija trombotika wara trapjant ta' ċelluli emapoetiċi (HCT), inklużi każijiet fatali, kienu rrappurtati f' regimen kondizzjonarji ta' doża għolja fejn busulfan ingħata flimkien ma' trattament ieħor ta' kondizzjonament.
English: Interaction between busulfan and metronidazol has been reported in literature reviews and post marketing cases.
Maltese: Interazzjoni bejn busulfan u metronidazole ġiet rrappurtata fir-reviżjonijiet ta' letteratura u każijiet ta' wara t-tqegħid fis-suq.
English: Fever
Maltese: PREŻENTAZZJONI
English: Haematemesis Ileus
Maltese: Ilejus Ematemesi Esofagite
English: The safety and efficacy of FB in pediatric population has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' FB fil-popolazzjoni pedjatrika ma ġewx determinati s'issa.
English: Diseases included were acute leukaemia past first remission, in first or subsequent relapse, in first remission (high risk), or induction failures; chronic melogenous leukaemia in chronic or advanced phase; primary refractory or resistant relapsed Hodgkin's disease or non-Hodgkin's lymphoma, and myelodysplastic syndrome.
Maltese: Il-mard kien jinkludi l-lewkimja akuta li għaddiet l-ewwel stadju ta' remissjoni, fl-ewwel rikaduta jew dik sussegwenti, fl-ewwel remissjoni (riskju għoli), jew fallimenti induttivi; il-lewkimja melogenuża kronika fil-fażi kronika jew avvanzata, il-marda primarja refraktorja jew reżistenti reċidivanti ta' Hodgkin jew limfoma li mhix ta' Hodgkin u sindrom mijelodisplastiku.
English: However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900-1500 µmol/L.minute).
Maltese: Madankollu varjabilità ogħla kienet osservata fi tfal <9 kg li wasslet għal 60% tat-tfal li kisbu t-tieqa terpewtika (900-1500 μmol/L.kull minuta).
English: ** reported in post marketing with IV busulfan *** reported in post marketing with oral busulfan
Maltese: * marda venokklussiva tal-fwied hi aktar frekwenti fil-populazzjoni pedjatrika **rapportati wara tqegħid fis-suq bi busulfan IV **rapportati wara tqegħid fis-suq bi busulfan orali
English: Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with Busilvex due to a possible decrease in the metabolism of busulfan (See section 4.5).
Maltese: Wieħed għandu joqgħod attent meta jieħu l-paracetamol qabel (inqas minn 72 siegħa) jew fl-istess ħin mal-Busilvex minħabba l-possibilità ta' tnaqqis fil-metaboliżmu tal-busulfan (ara sezzjoni 4.5).
English: Busilvex is administered as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses prior to cyclophosphamide or melphalan and haematopoietic progenitor cell transplantation (HPCT).
Maltese: Busilvex jingħata bħala infużjoni ta' sagħtejn kull 6 sigħat fuq medda ta' 4 ġranet konsekuttivi għal total ta' 16-il doża qabel iċ-ċiklofosfamid jew il-melfalan u t-trapjant taċ-ċelluli ematopojetiċi proġenitriċi (HPCT).
English: STATEMENT OF ACTIVE SUBSTANCE One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Ml wieħed ta' konċentrat fih 6 mg ta' busulfan u jipprovdi 0.5 mg/ml ta' busulfan wara lis-sustanza tkun miżjuda bl-ilma
English: Fever was reported in 87% of patients and graded as mild/moderate in 84% and severe in 3%.
Maltese: Id-deni kien irrapportat f'87% tal-pazjenti u kklassifikat bħala ħafif/moderat f'84% u sever fi 3%. 47% tal-pazjenti ħassew kesħa li kienet ħafifa/moderata fi 46% tal-pazjenti u severa f'1%.
English: A phase II clinical trial was performed to evaluate the influence of seizure prophylaxis treatment on intravenous busulfan pharmacokinetics.
Maltese: II saret biex tevalwa l-influwenza tal-kura għall-profilassi tal-puplesija fuq farmakokinetiċi busulfan ġol-vini.
English: In paediatric population, absolute neutrophil counts < 0.5x109/l at a median of 3 days post transplant occurred in 100% of patients and lasted 5 and 18.5 days in autologous and allogeneic transplant respectively.
Maltese: Fil-popolazzjoni pedjatrika, l-għadd assolut newtrofil <0.5 x 109/1 f'medjan ta' 3 ġranet ta' wara ttrapjant ġie irreġistrat f'100% tal-pazjenti u dam 5 u 18.5 ġranet fi trapjant awtologuż u alloġenejiku rispettivament.
English: Haematuria Moderate renal Insufficiency
Maltese: Ematurija Insuffiċjenza moderata tal-kliewi
English: All patients experienced a profound myelosuppression.
Maltese: Il-pazjenti kollha kellhom mijelosuppressjoni profonda.
English: The pharmacokinetics of intravenous busulfan was studied in 124 evaluable patients following a 2hour 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: Dyspnoea Epistaxis Cough Hiccup
Maltese: Kif gћandek tuża Busilvex
English: The signals concerning busulfan oral formulations and hepatic veno-oclusive disease risk in patients who have received prior radiation therapy /chemotherapy /HSCT, sterility, overdose treatment can be closed.
Maltese: Is-sinjali li jikkonċernaw formulazzjonijiet orali ta' busulfan u riskju tal-marda epatika ta' okklużjoni fil-vini f'pazjenti li rċevew terapija ta' radjazzjoni minn qabel/kimoterapija/HSCT, sterilità, it-trattament b'doża eċċessiva jistgħu jingħalqu.
English: Documentation on the safety and efficacy of Busilvex in combination with fludarabine (FB) prior to allogeneic HPCT derives from the literature review of 7 published studies involving 731 patients with myeloid and lymphoid malignancies reporting the use of intravenous busulfan infused once daily instead of four doses per day.
Maltese: Id-dokumentazzjoni dwar is-sigurtà u l-effikaċja tal-Busilvex flimimkien ma' fludarabine (FB) qabel HPCT alloġeniku toħroġ mir-reviżjoni tal-letteratura ta' 7 studji ppubblikati li kienu jinvolvu 731 pazjent b'tumuri malinni majelojdi u limfojdi li rrappurtaw l-użu ta' busulfan ġol-vini mogħti bħala infużjoni darba kuljum minflok erba' dożi kuljum.
English: In rats, a DMA daily dose of 450 mg/kg given to rats for nine days caused inactive spermatogenesis.
Maltese: Fil-firien, doża ta' kuljum ta' DMA ta' 450 mg/kg li ngħatat lil firien għal disgħat ijiem ikkaġunat spermatoġenesi inattiva.
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:
Maltese: Kien hemm stabilità kemikali u fiżika meta tintuża u wara lis-sustanza kienet miżjuda bl-ilma f'soluzzjoni tal-glukows 5% jew f'soluzzjoni ta' klorid tas-sodju 9 mg/ml (0.9%) għall-injezzjoni:
English: Increase of uric acid and urea in the blood.
Maltese: Żieda tal-uric acid u tal-urea fid-demm.
English: Dysuria Oligurea
Maltese: Disurija Oligureja
English: It seems that the recommended intravenous busulfan dose administered either as an individual infusion (3.2 mg/kg) or into 4 divided infusions (0.8 mg/kg) provided equivalent daily plasma exposure with similar both inter-and intrapatient variability.
Maltese: (3.2 mg/kg) jew f'4 infużjonijiet maqsuma (0.8 mg/kg) pprovdiet espożizzjoni għall-plażma kuljum ekwivalenti ma' varjabilità simili kemm bejn pazjenti differenti kif ukoll fil-pazjent innifsu.
English: Busulfan was shown to cause sterility in rodents.
Maltese: Kien stabbilit li l-Busulfan jikkaġuna sterilità fil-firien.
English: Therefore it is advised not to father child during the treatment and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility (see section 4.4).
Maltese: Għalhekk hu rrikkmandat biex ma tkunx missier wild waqt it-trattament u sa 6 xhur wara t-trattament u li tfittex parir dwar krijokonservazzjoni ta' sperma qabel it-trattament minħabba il-possibbiltà ta' infertilità irriversibbli (ara sezzjoni 4.4).
English: For storage conditions after dilution of the medicinal product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali wara li jkun dilwit, ara sezzjoni 6.3.
English: The Kaplan-Meier estimate of DFS at 2 years was 49.9% (95%CI, 32.6-72.7).
Maltese: (95%CI, 32.6-72.7).
English: The FB combination allowed sufficient myeloablation modulated by the intensity of conditioning regimen through the variation of number of days of busulfan infusion.
Maltese: Il-kombinazzjoni ta' FB ħalliet majeloablazzjoni suffiċjenti modulata mill-intensità tal-kors kondizzjonarju permezz tal-varjazzjoni tan-numru ta' ġranet tal-infużjoni ta' busulfan.
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-fenitojin lill-pazjenti li ngħataw doża għolja tal-busulfan kien irrapportat li wassal għal żjieda fit-tkeċċija tal-busulfan, minħabba l-induzzjoni tal-glutatijon-Stransferasi filwaqt li ma kienet irrapportata l-ebda interazzjoni meta l-benżodijażepini bħal ngħidu aħna dijażepam, klonażepam jew lorażepam kienu wżati biex jimpedixxu l-puplessiji b'doża għolja ta' busulfan.
English: Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients.
Maltese: Pazjenti premenopawsali spiss ikollhom suppressjoni ovariana u amenorrea b'sintomi menopawsali.
English: Brain abscess Cellulitis Sepsis
Maltese: Axxess tal-moħħ Ċellulite Sepsis
English: The warning for TMA after HCT only applies to one pharmaceutical form: the intravenous.
Maltese: It-twissija għal TMA wara HCT tapplika biss għal forma farmaċewtika waħda: għoti minn ġol-vina.
English: Busulfan is a teratogen in rats, mice and rabbits.
Maltese: Busulfan hu teratoġeniku fil-firien, ġrieden u l-fniek.
English: Impotence, sterility, azoospermia, and testicular atrophy have been reported in male patients.
Maltese: Kien irrapportat li pazjenti maskili esperjenzaw impotenza, sterilità, ażoospermja, u atrofija testikulari.
English: A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: A MANIFATTUR(I) RESPONSABBLI
English: Tabulated summaries of adverse reactions
Maltese: Sommarji tar-reazzjonijiet avversi miġbura f'tabella
English: The malformations included serious heart and/or major vessels anomalies: a common truncus arteriosis and no ductus arteriosis, coarctation of the pulmonary trunk and the pulmonary arteries, intraventricular defects of the heart.
Maltese: Il-malformazzjonijiet jinkludu anomaliji serji fil-qalb u/jew fil-vini/arterji maġġuri: arterjosi komuni taz-zokk tal-ġisem u l-ebda arterjosi tal-kanal, koarktazjoni taz-zokk pulmonari u l-arteriji pulmonari, difetti intraventrikulari tal-qalb.
English: Patients older than 50 years of age (n=23) have been successfully treated with Busilvex without doseadjustment.
Maltese: Pazjenti li għandhom aktar minn 50 sena (n=23) ġew ikkurati b'suċċess b'Busilvex mingħajr aġġustament tad-doża.
English: EXP
Maltese: Ażma
English: In pregnant rats, busulfan produced sterility in both male and female offspring due to the absence of germinal cells in testes and ovaries.
Maltese: Fil-każ ta' firien tqal, il-busulfan ikkaġuna sterilità kemm fil-frieħ maskili u dawk feminili minħabba n-nuqqas ta' ċelluli ġerminali fit-testes u l-ovarji.
English: Gastro-intestinal haemorrhage Tooth hypoplasia*
Maltese: Disturbi gastro-intestinali Dardir Rimettar
English: busulfan.
Maltese: Pereżempju:
English: DMA is teratogenic in rats.
Maltese: Id-DMA hi teratoġenika fil-firien.
English: The recommended dose and schedule of administration is: - 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 Busilvex (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 miċ-ċiklofosfamid b'60mg/kg/jum għal jumejn li jibdew mhux inqas minn 24 siegħa wara s-16-il doża ta' Busilvex (ara sezzjoni 4.5).
English: Skin desquamation Erythema Pigmentation disorder
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni
English: A single s.c. dose of 2.2 g/kg administered on gestation day 4 terminated pregnancy in 100% of tested hamster.
Maltese: Doża waħda s.c. ta' 2.2 g/kg mogħtija fir-raba' ġurnata tat-tqala ikkawżat l-abort f'100% tal-ħamsters li ġew ittestjati.
English: Oesophagitis
Maltese: TWISSIJA SPEĊJALI
English: Veno occlusive liver disease *
Maltese: Marda tal-vini okklussivi epatiċi*
English: Paracetamol is described to decrease glutathione levels in blood and tissues, and may therefore decrease busulfan clearance when used in combination (see section 4.4).
Maltese: Il-paracetamol hu deskritt li kapaċi jnaqqas il-livelli tal-glutatijon fid-demm u fit-tessuti, u għalhekk għandu mnejn inaqqas it-tkeċċija tal-busulfan meta jintużaw flimkien (ara sezzjoni 4.4).
English: Mucositis
Maltese: Treddigħ
English: Busilvex 6 mg/ml concentrate for solution for infusion Busulfan
Maltese: Busilvex 6 mg/ml konċentrat għal soluzzjoni għall-infużjoni Busulfan
English: Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Maltese: It-trattament bil-Busulfan f'tifla preadoloxxenti fixkel il-bidu tal-pubertà minħabba l-falliment ovarjan.
English: Neutropenia Thrombocytopenia Febrile neutropenia Anaemia
Maltese: Uġigħ jew infjammazzjoni fis-sit tal-injezzjoni Mukositi
English: Infections (documented and non documented febrile neutropenia) were experienced in 89% of patients (49/55).
Maltese: 89% tal-pazjenti (49/55) kellhom infezzjonijiet ta' (newtropenija febrili dokumentata u mhux dokumentata).
English: For the 40% of children < 9 kg outside the target, the AUC was evenly distributed either below or above the targeted limits; i.e. 20% each < 900 and > 1500 µmol/L.min following 1 mg/kg.
Maltese: Għall-40% tat-tfal <9 kg barra l-mira, l-AUC kien imqassam b'mod bilanċjat jew taħt jew fuq il-limiti mmirati; jiġifieri 20% kull wieħed <900 u> 1500 μmol/L.min wara l-1 mg/kg.
English: In adults, for the FB regimen, published studies did not report any mutual drug-drug interaction between intravenous busulfan and fludarabine.
Maltese: Fl-adulti, għall-kors FB, studji ppubblikati ma rrappurtaw l-ebda interazzjoni reċiproka bejn mediċina u oħra bejn busulfan ġol-vini u fludarabine.
English: Medicines before you receive Busilvex: Before receiving Busilvex, you will be medicated with anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and antiemetic medicines to prevent vomiting.
Maltese: Qabel ma tibda tieħu l-Busilvex int ser tingħata l-mediċini li ġejjin: mediċini antikonvulsivi biex jimpedixxu puplessiji (fenitojn jew benżodjażepini) u mediċini antjemetiċi biex jimpedixxu r-ramettar.
English: Asthenia
Maltese: Stomatite
English: Not known (frequency cannot be estimated from the available data) Sex glands dysfunction.
Maltese: Mhux magħruf (frekwenza ma tistax tinħadem mid-dejta disponibbli) Disfunzjoni tal-glandoli sesswali.
English: Busilvex contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.
Maltese: Busilvex fih is-sustanza attiva busulfan, li tappartjeni għall-grupp ta' mediċini msejħa aġenti alkilatini.
English: Cataract Corneal thinning Lens disorders
Maltese: Kif jidher Busilvex u l-kontenut tal-pakkett
English: Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Maltese: Madwar 30% tad-doża mogħtija hi mkeċċija fl-awrina fuq firxa ta' 48 sigħat b'1% bħala busulfan mhux mibdul.
English: The World Health Organisation has concluded that there is a causal relationship between busulfan exposure and cancer.
Maltese: Il-WHO ikkonkluda li hemm relazzjoni kawżali bejn l-esponiment għall-busulfan u l-kanċer.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for busulfan, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal busulfan, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: • Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
Maltese: • Busilvex għandu jiġi ppreparat minn professjonista fil-kura tas-saħħa billi tuża tekniċi sterili għat transferiment.
English: Undesirable effects coming from post-marketing survey have been implemented in the tables with the incidence “not known”.
Maltese: Effetti mhux mixtieqa li ġejjin minn stħarriġ ta' wara t-tqegħid fis-suq ġew implimentati fit-tabelli bl-inċidenza “mhux magħruf”.
English: Immediate and complete availability of the dose is obtained after intravenous infusion of busulfan.
Maltese: Id-disponibilità immedjata u kompleta tad-doża inkisbet wara l-infużjoni minn ġol-ġilda tal-busulfan.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Maltese: Annex IV Konklużjonijiet xjentifiċi u raġunijiet għall-varjazzjoni għat-termini tal-awtorizzazzjoni(jiet) għat tqegħid fis-suq
English: The MAH of Busilvex has responded to the question of “Thrombotic microangiopathy” (TMA) after hematopoietic cell transplantation (HCT) requested as supplementary information.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ta' Busilvex wieġeb għall-mistoqsija ta' "Mikroanġjopatija Trombotika" (TMA) wara trapjant ta' ċelluli emapoetiċi (HCT) kien mitlub bħala informazzjoni supplimentari.
English: • Using a non polycarbonate syringe fitted with a needle:
Maltese: • Uża sirinġa polikarbonata iffittjata b'labra:
English: Myalgia Back pain Arthralgia
Maltese: Majalġja Uġigħ fid-dahar Artralġja
English: Busilvex 6 mg/ml concentrate for solution for infusion
Maltese: Busilvex 6 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: Studies in animals have shown reproductive toxicity (embryo-fetal lethality and malformations).
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva (mewt tal-embriju/fetu u malformazzjonijiet) (ara sezzjoni 5.3).
English: Viral infection CMV reactivation EBV reactivation Bacterial infection
Maltese: Infezzjoni virali Attivazzjoni mill-ġdid ta' CMV