natgillin/translations-raw huggingface dataset:
The World Health Organisation has concluded that there is a causal relationship between busulfan exposure and cancer.
Svetovna zdravstvena organizacija (World Health Organisation) je ugotovila, da obstaja vzročno razmerje med izpostavljanjem busulfanu in rakom.
Gastro-intestinal: bleeding in the stomach and/or the gut.
Prebavila: krvavitev v želodcu in/ali črevesu.
The recommended dose of Busilvex in combination with cyclophosphamide or melphalan is based on your body weight varying between 0.8 and 1.2 mg/kg.
Priporočeni odmerek zdravila Busilvex v kombinaciji s ciklofosfamidom ali melfalanom je odvisen od vaše telesne mase in sega od 0,8 do 1,2 mg/kg.
The incidence of a-GVHD grades I-II was 13% (8/61), while the incidence of grade III-IV was 5% (3/61).
Pojavnost aGVHD stopnje I-II je bila 13-odstotna (8/61), medtem ko je bila pojavnost stopnje III-IV 5-odstotna (3/61).
Not known*
Neznana pogostnost*
The FB combination allowed sufficient myeloablation modulated by the intensity of conditioning regimen through the variation of number of days of busulfan infusion.
Kombinacija FB je omogočila zadostno mieloablacijo, ki je bila modulirana z intenzivnostjo pripravljalne terapije, in sicer z različnim številom dni infundiranja busulfana.
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.
Podobna ciljna stopnja je dosegljiva z dnevno izpostavljenostjo od 3.600 do 6.000 µmol/l.minuto po intravenski uporabi busulfana v odmerku 3,2 mg/kg enkrat dnevno.
Respiratory: decrease in blood oxygen.
Dihala: zmanjšanje koncentracije kisika v krvi.
Increase of lactate dehydrogenase in the blood.
Povečane vrednosti laktat-dehidrogenaze v krvi.
No patients were discontinued from treatment due to adverse reactions related to Busilvex.
Nihče od bolnikov ni prekinil terapije zaradi neželenih učinkov, povezanih z zdravilom Busilvex.
It is recommended to administer anticonvulsants 12 h prior to Busilvex to 24 h after the last dose of Busilvex.
Antikonvulzive jim je priporočeno dajati od 12 ur pred odmerkom zdravila Busilvex do 24 ur po zadnjem odmerku.
The Kaplan-Meier estimate of DFS at 2 years was 49.9% (95%CI, 32.6-72.7).
Kaplan-Meierjeva ocena preživetja brez bolezni po 2 letih je bila 49,9 % (95-odstotni IZ 32,6-72,7).
Leukaemia patients treated with busulfan developed many different cytological abnormalities, and some developed carcinomas.
Pri bolnikih z levkemijo, zdravljenih z busulfanom, se je razvilo mnogo različnih citoloških sprememb, pri nekaterih je nastal karcinom.
Pharmacokinetic/pharmacodynamic relationships:
Farmakokinetično/farmakodinamično razmerje:
Adverse events information are derived from the clinical study in paediatrics (n=55).
Informacije o neželenih dogodkih so pridobljene iz pediatrične klinične študije (n = 55).
Busulfan was mutagenic in Salmonella typhimurium, Drosophila melanogaster and barley.
Busulfan je bil mutagen pri bakteriji Salmonella typhimurium, vinski mušici (Drosophila melanogaster) in ječmenu.
There are no cases with oral busulfan.
Ni poročil o primerih s peroralnim busulfanom.
The incidence of each adverse reactions presented in the following table has been defined according to the highest incidence observed in published clinical trials in RIC regimen for which the population treated with FB was clearly identified, whatever the schedules of busulfan administrations and endpoints.
Pojavnost vsakega neželenega učinka v spodnji preglednici je bila opredeljena z največjo pojavnostjo, ugotovljeno v objavljenih kliničnih preskušanjih zdravljenja RIC, v katerih je bila s kombinacijo FB zdravljena populacija natančno opredeljena, ne glede na razporede dajanja busulfana in cilje študij.
You will receive this preparative medicine before receiving a transplant of either bone marrow or haematopoietic progenitor cell.
To pripravljalno zdravilo boste prejeli pred presaditvijo kostnega mozga ali krvotvornih progenitorskih celic.
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.
Priporočeni odmerek in razpored uporabe: - fludarabin se daje kot 1-urna infuzija enkrat na dan v odmerku 30 mg/m², 5 dni zaporedoma, ali v odmerku 40 mg/m², 4 dni zaporedoma.
Very common (may affect more than 1 in 10 people):
Zelo pogosti neželeni učinki (ki se lahko pojavijo pri več kot 1 od 10 bolnikov):
- 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time).
- 12 ur po redčenju, če je bila raztopina shranjena pri temperaturi med 2 °C in 8 °C in nato 3 ure pri temperaturi 20 °C ± 5 °C (vključno s časom infuzije).
DMA decreases fertility in male and female rodents.
DMA zmanjšuje plodnost samcev in samic glodavcev.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Zdravila Busilvex ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in na ovojnini poleg oznake EXP.
Menopausal symptoms and female infertility.
Simptomi menopavze in neplodnosti pri ženskah.
In case of overdose, management would include general supportive care.
V primeru prevelikega odmerjanja uporabite splošno podporno nego.
A total of 11 patients (18%) experienced a-GVHD.
Skupno 11 bolnikov (18 %) je izkusilo aGVHD.
The glutathione conjugate is then further metabolised in the liver by oxidation.
Glutationski konjugat se nato z oksidacijo razgradi v jetrih.
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca (izdelovalcev) odgovornega (odgovornih) za sproščanje serij
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.
Farmakokinetično/farmakodinamično razmerje so opazili med stomatitisom in vrednostmi AUC pri avtolognih bolnikih, ter med bilirubinom in vrednostmi AUC pri analizi združenih podatkov avtolognih in alogenskih bolnikov.
Intravenous administration of busulfan to mice significantly increased the incidences of thymic and ovarian tumours.
Intravenska uporaba busulfana pri miših je pomembno povečala pojavnost tumorjev priželjca in jajčnikov.
Women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Ženskam v rodni dobi priporočamo, da med zdravljenjem in do 6 mesecev pozneje uporabljajo učinkovito kontracepcijo.
The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61).
Podatki o pojavljanju akutne reakcije presadka proti gostitelju (acute graft-versus-host disease - aGVHD) so bili zbrani v raziskavi OMC-BUS-4 (alogenska) (n = 61).
Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients.
Supresija jajčnikov in amenoreja s simptomi menopavze se pogosto pojavita pri bolnicah, ki so v predmenopavzalnem obdobju.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Neuporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi za citotoksična zdravila.
IBW women (kg) = 45 + 0.91x (height in cm-152).
IBW pri moških (kg) = 50 + 0,91 x (višina v cm - 152) IBW pri ženskah (kg) = 45 + 0,91 x (višina v cm - 152)
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).
Dokumentacija o varnosti in učinkovitosti zdravila Busilvex v kombinaciji s ciklofosfamidom v terapiji BuCy2 pred konvencionalno alogensko in/ali avtologno HPCT izhaja iz dveh kliničnih preskušanj (OMC-BUS-4 in OMC-BUS-3).
In this study, all, but one, patients engrafted, at a median of 15 (range, 10-23) days after allo-HCT.
V tej študiji je prišlo do prijetja presadka pri vseh bolnikih razen enega po 15 dneh (mediana) (razpon 10-23) po alo-HCT.
Severe granulocytopenia, thrombocytopenia, anaemia, or any combination thereof may develop.
Razvije se lahko huda granulocitopenija, trombocitopenija, anemija ali katerakoli kombinacija naštetega.
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.
Med malformacije so sodile resne anomalije srca in/ali velikih žil: truncus arteriosus in odsotnost Botallovega voda, koarktacija pljučnega debla in pljučnih arterij, intraventrikularne okvare srca.
Inter and intra patient variabilities in plasma exposure were lower than 20% and 10%, respectively.
Odstopanja izpostavljenosti v plazmi so bila med bolniki manjša od 20 %, pri posameznih bolnikih pa manjša od 10 %.
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.
Preden boste prejeli Busilvex, boste prejeli: - antikonvulzivna zdravila, ki preprečujejo epileptične napade (fenitoin ali benzodiazepini), in - antiemetična zdravila, ki preprečujejo bruhanje.
Other medicines and Busilvex
Druga zdravila in zdravilo Busilvex
Patients received a conditioning regimen based on the administration of fludarabine immediately followed by single daily dose of 3.2 mg/kg busulfan over 2 or 3 consecutive days.
Bolniki so prejeli pripravljalno terapijo na osnovi dajanja fludarabina, kateremu je nemudoma sledil enkratni dnevni odmerek 3,2 mg/kg busulfana, 2 ali 3 dni zaporedoma.
Platelet engraftment occurred at a median of 9 (range, 1-16) days after allo-HCT.
Prijetje presajenih trombocitov se je zgodilo 9 dni (mediana) (razpon 1-16) po alo-HCT.
Busilvex dose (mg/kg)
Odmerek zdravila Busilvex (mg/kg)
Thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred at a median of 5-6 days in 98% of patients.
Trombocitopenija (< 25 x 109/l ali zahtevana transfuzija trombocitov) se je pojavilo pri mediano 5-6 dneh pri 98 % bolnikov.
The other ingredients are dimethylacetamide and macrogol 400.
- Pomožni snovi sta dimetilacetamid in makrogol 400.
A single s.c. dose of 2.2 g/kg administered on gestation day 4 terminated pregnancy in 100% of tested hamster.
Enkratni subkutani odmerek v višini 2,2 g/kg v četrtem dnevu brejosti je prekinil brejost pri 100 % testiranih samic hrčkov.
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).
Busilvex se uporablja v obliki dveurne infuzije vsakih 6 ur 4 zaporedne dni, kar je skupaj 16 odmerkov pred uporabo ciklofosfamida ali melfalana in transplantacijo hematopoetskih progenitorskih celic (HPCT).
Busilvex contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.
Zdravilo Busilvex vsebuje učinkovino busulfan, ki spada v skupino zdravil, ki jim pravimo alkilirajoče učinkovine.
WHO has concluded that there is a causal relationship between busulfan exposure and cancer.
WHO je ugotovila, da obstaja vzročno razmerje med izpostavljanjem busulfanu in rakom.
Veno occlusive disease (VOD) was reported in 15% (4/27) and 7% (2/28) of the autologous and allogenic transplant respectively.
Pri 15 % (4/27) bolnikov z avtologno in 7 % (2/28) bolnikov z alogensko transplantacijo so poročali o veno-okluzivni bolezni (VOD).
The analysis of data through a population pharmacokinetic method indicated no difference on intravenous busulfan clearance between phenytoin and clonazepam based therapy and therefore similar busulfan plasma exposures were achieved whatever the type of seizure prophylaxis.
Analiza podatkov z metodo populacijske farmakokinetike je pokazala, da ni razlik v očistku intravensko uporabljenega busulfana pri zdravljenju, ki temelji na fenotoinu ali klonazepamu, torej so pri obeh vrstah preprečevanja epileptičnih napadov bile dosežene podobne izpostavitve busulfanu v plazmi.
Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Resne toksičnosti, ki vključujejo hematološki, jetrni in respiratorni sistem, so smatrali kot pričakovane posledice pripravljalne terapije in transplantacijskega procesa.
On the basis of the scientific conclusions for busulfan the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing busulfan is unchanged subject to the proposed changes to the product information
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za busulfan odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) busulfan, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
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).
Med kliničnimi preskušanji z intravensko uporabo busulfana v odmerku 0,80 mg/kg štirikrat dnevno je bilo 90 % bolnikov pod zgornjo mejo površine pod krivuljo (1.500 µmol/l.minuto) in vsaj 80 % bolnikov je bilo znotraj ciljnega terapevtskega območja (900-1.500 µmol/.minuto).
The recommended dose of Busilvex is as follows: Actual body weight (kg)
Priporočeni odmerki zdravila Busilvex so: Dejanska telesna masa (kg)
Nervous system: insomnia, anxiety, dizziness, and depression.
Živčni sistem: nespečnost, tesnoba, omotica in depresija.
METHOD AND ROUTE OF ADMINISTRATION Intravenous use (IV)
POSTOPEK IN POT(I) UPORABE ZDRAVILA intravenska uporaba (i.v.)
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Vsi postopki prenašanja zahtevajo strogo upoštevanje aseptičnih pogojev, po možnosti uporabo laminarija.
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.
Varnostni profil zdravila Busilvex v kombinaciji s fludarabinom (FB) je bil pripravljen s pregledom neželenih učinkov v objavljenih podatkih kliničnih preskušanj zdravljenja RIC.
Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Skupni plazemski očistek je bil med 2,25 in 2,74 ml/minuto/kg.
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.
Zapremo lahko tudi signale v zvezi s peroralnimi oblikami busulfana in tveganjem hepatične veno-okluzivne bolezni pri bolnikih, ki so predhodno prejeli zdravljenje z obsevanjem/kemoterapijo/HSCT, signal v povezavi s sterilnostjo, ukrepanjem ob prekomernem odmerku.
Busulfan is mutagenic and clastogenic.
Busulfan je mutagen in klastogen.
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).
Priporočeno odmerjanje zdravila pri otrocih je podrobno navedeno v poglavju 4.2 in omogoča da 70 % do 90 % otrok s telesno maso ≥9 kg doseže terapevtsko okno (900-1500 µmol/l.minuto).
Busilvex must always be added to the diluent, not the diluent to Busilvex.
Busilvex morate vedno dodajati v redčilo, in ne redčila v Busilvex.
10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper covered by a purple flip-off aluminium seal cap.
10 ml koncentrata za raztopino za infundiranje v prozornih steklenih vialah (tipa I) z zamaškom iz butilne gume in vijolično aluminijasto snemno (flip-off) zaporko.
Anaemia (haemoglobin< 8.0 g/dl) occurred in 69% of patients.
Anemija (hemoglobin < 8,0 g/dl) se je pojavila pri 69 % bolnikov.
Uncommon (may affect up to 1 in 100 people):
Občasni neželeni učinki (ki se lahko pojavijo pri največ 1 od 100):
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).
Bolniki so prejemali odmerke po 0,8 mg/kg busulfana vsakih 6 ur z infuzijo do skupno 16 odmerkov, ki so jim sledili odmerki 60 mg/kg ciklofosfamida enkrat dnevno dva dneva (terapija BuCy2).
Serious toxicities involving the hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Resne toksičnosti, ki vključujejo jetrni in respiratorni sistem, so smatrali kot pričakovane posledice pripravljalne terapije in transplantacijskega procesa.
• Quantity of diluent: (A ml Busilvex) x (10) = B ml of diluent
• Količina redčila: (A ml zdravila Busilvex) x (10) = B ml redčila
A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Busilvex will be administered once daily during 2 or 3 consecutive days prior to transplant.
Zdravilo Busilvex boste prejeli enkrat na dan, 2 ali 3 zaporedne dni pred presaditvijo.
One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
En ml koncentrata vsebuje 6 mg busulfana (60 mg v 10 ml).
if you have a liver, kidney, heart or lung problem,
Morate povedati zdravniku: - če imate težave z jetri, srcem ali pljuči,
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.
Pri pediatrični populaciji se je absolutno število nevtrofilcev < 0,5x109/l pri mediani 3 dni po transplantaciji pojavilo pri 100 % bolnikov in je trajalo 5 dni pri avtologni ter 18,5 dneva pri alogenski transplantaciji.
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).
Pri predhodni (manj kot 72 ur) ali sočasni uporabi paracetamola z zdravilom Busilvex morate biti previdni zaradi možne upočasnjene presnove busulfana (glejte poglavje 4.5).
Anaemia (haemoglobin< 8.0 g/dl) occurred in 100% of patients.
Anemija (hemoglobin < 8,0 g/dl) se je pojavila pri 100 % bolnikov.
There was no regimen-related death through the first 100-day post-transplant and up to one year post-transplant.
V prvih 100 dneh po transplantaciji in do enega leta po transplantaciji ni bilo niti enega primera smrti, povezanega z zdravljenjem.
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.
Dokumentacija o varnosti in učinkovitosti zdravila Busilvex v kombinaciji s ciklofosfamidom v terapiji BuCy4 ali melfalanom v terapiji BuMel pred konvencionalnim alogensko in/ali avtologno HPCT izhaja iz kliničnega preskušanja F60002 IN 101 G0.
Cardiac: changes and abnormalities in heart rhythm, fluid retention or inflammation around the heart, decrease heart output.
Srce: spremembe in nepravilnosti srčnega utripa, zadrževanje tekočine ali vnetje okoli srca, zmanjšan izhodni volumen srca.
The entire prescribed Busilvex dose should be delivered over two or three hours depending on the conditioning regimen.
Infuzija celotnega predpisanega odmerka zdravila Busilvex mora trajati dve ali tri ure, odvisno od pripravljalne terapije.
- the calculated volume of Busilvex must be removed from the vial.
- izračunano prostornino zdravila Busilvex morate odstraniti iz viale.
In new-born infants, children and adolescents, Busilvex is used in combination with cyclophosphamide or melphalan.
Pri novorojencih, otrocih in mladostnikih se zdravilo Busilvex uporablja v kombinaciji s ciklofosfamidom ali melfalanom.
In aqueous media, release of the methanesulphonate groups produces carbonium ions which can alkylate DNA, thought to be an important biological mechanism for its cytotoxic effect.
V vodnem mediju sproščanje metansulfonatnih skupin povzroči nastanek ogljikovih ionov, ki lahko alkilirajo DNA.
Busilvex destroys the original bone marrow before the transplant.
Zdravilo Busilvex uniči izvorni kostni mozeg bolnika pred presaditvijo.
Irreversible protein binding may explain the incomplete recovery.
Vzrok za nepopoln izkoristek je lahko ireverzibilna vezava na beljakovine.
Occurrence of VOD was not related to overexposure.
Pogostost veno-okluzivne bolezni ni bila povezana s preveliko izpostavljenostjo.
Chronic GVHD (c-GVHD) was reported if serious or the cause of death, and was reported as the cause of death in 3 patients.
O kronični GVHD (cGVHD) so poročali, če je bila resna ali vzrok smrti.
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.
Dokler ne bodo na voljo dodatni podatki, uporaba zdravila pri debelih otrocih in mladostnikih z indeksom BMI (masa (kg)/višina (m2)) nad 30 kg/m2 ni priporočljiva.
LIST OF EXCIPIENTS Each vial contains Dimethylacetamide and Macrogol 400
SEZNAM POMOŽNIH SNOVI Vsaka viala vsebuje dimetilacetamid in makrogol 400.
Muscle and bone: back, muscle and joint pain.
Mišice in kosti: bolečine v hrbtu, mišicah in sklepih.
In adults, for the FB regimen, published studies did not report any mutual drug-drug interaction between intravenous busulfan and fludarabine.
V objavljenih študijah pri uporabi zdravljenja FB pri odraslih niso ugotovili medsebojnega delovanja med intravenskim busulfanom in fludarabinom.
No specific antidote for DMA overdose is known.
Pri prevelikem odmerjanju DMA ni znanega antidota.
- 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.
- Zdravilo Busilvex se daje v odmerku 3,2 mg/kg kot 3-urna infuzija enkrat na dan nemudoma po fludarabinu, 2 ali 3 dni zaporedoma.
Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Uporabo zdravila Busilvex mora nadzorovati zdravnik, izkušen v pripravljalnih terapijah pred transplantacijo hematopoetskih progenitorskih celic.
Busulfan can impair fertility.
Busulfan lahko zmanjša plodnost.
Taking into account the PRAC Assessment Report on the PSUR(s) for busulfan, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za busulfan je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
In adults, for the BuCy2 regimen it has been reported that the time interval between the last oral busulfan administration and the first cyclophosphamide administration may influence the development of toxicities.
Poročali so, da lahko pri odraslih bolnikih, ki se zdravijo z BuCy2, časovni interval med zadnjim peroralnim odmerkom busulfana in prvim odmerkom ciklofosfamida vpliva na razvoj toksičnosti.
Busilvex should be administered by intravenous infusion via central venous catheter.
Zdravilo Busilvex morate intravensko infundirati skozi osrednji venski kateter.
Cardiac: clotting of femoral artery, extra heart beats, decrease in heart rate, diffuse leak of fluid from the capillaries (small blood vessels).
Srce: zamašitev femoralne arterije, dodatni utripi srca, zmanjšanje hitrosti srčnega utripa, difuzno prepuščanje tekočine iz kapilar (majhnih krvnih žil).
However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900-1500 µmol/L.minute).
Pri otrocih s telesno maso < 9 kg je bila opažena večja variabilnost, ki je , da je 60 % otrok doseglo terapevtsko okno (900-1500 µmol/l·min).