natgillin/translations-raw huggingface dataset:
For obese patients, dosing based on adjusted ideal body weight (AIBW) should be considered.
Pri debelih bolnikih je treba razmisliti o odmerku, ki temelji na prilagojeni idealni telesni masi (adjusted ideal body weight - AIBW).
In pregnant rats, busulfan produced sterility in both male and female offspring due to the absence of germinal cells in testes and ovaries.
Pri brejih podganah je uporaba busulfana povzročila neplodnost moških in ženskih mladičev zaradi odsotnosti germinalnih celic v testisih in jajčnikih.
- If Busilvex or diluted Busilvex solution contacts the skin or mucosa, wash them thoroughly with water immediately.
- Če zdravilo Busilvex ali razredčena raztopina zdravila Busilvex pride v stik s kožo ali sluznico, ju takoj temeljito sperite z vodo.
Patients who are concurrently treated with busulfan and itraconazole or metronidazole should be closely monitored for signs of busulfan toxicity.
Bolnike, ki so hkrati prejemali busulfan in itrakonazol ali metronidazol, je treba skrbno opazovati, če se pojavijo znaki toksičnosti busulfana.
15% of SAEs involved liver toxicity.
15 % resnih neželenih učinkov je vključevalo jetrno toksičnost.
Haemorrhagic cystitis including haemorrhagic cystitis induced by viral infection was reported in a range between 16% and 18.1%.
Hemoragični cistitis, vključno s hemoragičnim cistitisom zaradi virusne okužbe, so ugotovili pri 16 % do 18,1 % bolnikov.
Particular caution should be taken if you use itraconazole and metronidazole (used for certain types of infections) or ketobemidone (used to treat pain), because this may increase the side-effects.
Bodite posebno pozorni, če jemljete itrakonazol in metronidazol (ki se uporablja za zdravljenje določenih vrst okužb) ali ketobemidon (ki se uporablja proti bolečinam).
OTHER SPECIAL WARNING IF NECESSARY Cytotoxic: handle with caution.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično zdravilo, ravnajte previdno.
The principal toxic effect is profound myeloablation and pancytopenia but the central nervous system, liver, lungs, and gastrointestinal tract may also be affected.
Glavni toksični učinek je huda mieloablacija in pancitopenija, vendar so lahko prizadeti tudi centralni živčni sistem, jetra, pljuča in prebavni trakt.
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.
Vključene bolezni so bile akutna levkemija po prvi remisiji, v prvi ali naslednji ponovitvi, v prvi remisiji (veliko tveganje) ali napake v indukciji, kronična mieloidna levkemija v kronični ali napredovali fazi, primarna refraktarna ali rezistentna ponovljena Hodgkinsova bolezen ali ne-Hodgkinsov limfom ter mielodisplastični sindrom.
Busulfan and DMA can impair fertility in man or woman.
Busulfan in DMA lahko zmanjšata plodnost pri moških in ženskah.
For a microbiological point of view, the diluted solution should be used immediately.
Z mikrobiološkega vidika je priporočljivo razredčeno raztopino porabiti takoj.
In the absence of haematopoietic progenitor cell transplantation, the recommended dose of Busilvex would constitute an overdose of busulfan.
V odsotnosti transplantacije hematopoetskih progenitorskih celic bi priporočeni odmerek zdravila Busilvex povzročil prevelik odmerek busulfana.
From the assessment of these articles, the causality of busulfan in the development of tooth hypoplasia is confirmed.
Z oceno teh člankov so potrdili vzročno povezanost busulfana z razvojem zobne hipoplazije.
Busulfan is a teratogen in rats, mice and rabbits.
Busulfan je teratogen pri podganah, miših in kuncih.
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.
Populacijska farmakokinetična analiza je bila izvedena na kohorti 205 otrokglede na telesno maso (3,6 do 62,5 kg) ter biološke in bolezenske značilnosti (maligne in ne maligne bolezni) in je zato reprezantativna za visoko heterogenost otrok, podvrženih HPTC.
In one article it was studied the role of busulfan in juvenile rats resulting in abnormal root development; a review of two cases of immunodeficiency disorders treated with busulfan and cyclophosphamide in which dental orthodontic treatment was provided; additional 2 case report of hypoplasia of permanent tooth germ is presented; one review assessed the long term effects of cytotoxic therapy concluding that tooth agenesis was more prevalent in patients treated with busulfan and cyclophosphamide; a study of 81 patients concluded that busulfan is as toxic as total body irradiation in causing disturbances in dental development; finally, a study of risk factors of tooth formation anomalies in paediatric cancers concluded that the high risk group of tooth agenesis was the subject with high dose chemotherapy under 4 years old.
V enem od člankov so proučevali vpliv busulfana na nedorasle podgane, ki so se jim razvile korenine nenormalno; proučitev dveh primerov zdravljenja motenj imunske pomanjkljivosti z busulfanom in ciklofosfamidom, v katerih so bolnikom zagotovili dentalno ortodontsko zdravljenje; predstavitev dveh dodatnih poročil o primerih hipoplazije zasnove stalnih zob; v enem poročilu so proučevali dolgoročne učinke citotoksičnega zdravljenja in ugotovili, da je bila zobna ageneza bolj pogosta pri bolnikih, ki so jih zdravili z busulfanom in ciklofosfamidom; v raziskavi, v katero je bilo vključenih 81 bolnikov, so ugotovili, da je busulfan enako toksičen kot obsevanje celotnega telesa v smislu povzročanja motenj razvoja zob; ne nazadnje, v raziskavah dejavnikov tveganja nastanka motenj v razvoju zob pri pediatričnih rakavih bolnikih so ugotovili, da obstaja zelo visoko tveganje za zobno agenezo pri bolnikih, ki prejemajo zelo velike odmerke kemoterapije in so mlajši kot 4 leta.
Repeated doses of DMA produced signs of liver toxicity, the first being increases in serum clinical enzymes followed by histopatological changes in the hepatocytes.
Ponavljajoči odmerki DMA so povzročili znake jetrne toksičnosti; najprej je prišlo do povečanega izločanja serumskih encimov in nato do histopatoloških sprememb jetrnih celic.
In rats, a DMA daily dose of 450 mg/kg given to rats for nine days caused inactive spermatogenesis.
Pri podganah je 9-dnevno odmerjanje DMA v višini 450 mg/kg/dan povzročilo neaktivno spermatogenezo.
- the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent.
- vsebino brizge morate prestaviti v vrečko ali brizgo za intravensko uporabo, v katero ste že dali izračunano količino izbranega redčila.
- If you have any further questions, ask your doctor.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
Studies in renally impaired patients have not been conducted, however, as busulfan is moderately excreted in the urine, dose modification is not recommended in these patients.
Raziskave niso bile izvajane pri bolnikih z okvaro ledvic, ker pa se busulfan zmerno izloča z urinom, pri teh bolnikih odmerka ni priporočljivo spreminjati.
Nutrition: loss of appetite, decrease in magnesium, calcium, potassium, phosphate, albumine in blood, and increase in blood sugar.
Prehrana: izguba teka, zmanjšanje količine magnezija, kalcija, kalija, fosfata in albumina v krvi ter povečanje krvnega sladkorja.
What you need to know before you use Busilvex
Kaj morate vedeti, preden boste uporabili zdravilo Busilvex
Also, there are published case reports of increased plasma levels of busulfan after administration of metronidazole.
Objavljena so tudi poročila o posameznih primerih povišanih plazemskih ravni busulfana po prejemu metronidazola.
As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to Busilvex.
Kot je dokumentirano v kliničnih raziskavah, se pri nobenem zdravljenem bolniku ni pojavila srčna tamponada ali katerakoli druga značilna srčna toksičnost, povezana z zdravilom Busilvex.
These include infection and Graft-versus host disease (GVHD) which although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
Te vključujejo infekcijo in reakcijo presadka proti gostitelju (graft-versus-host disease (GVHD)), ki sta glavna vzroka za obolevnost in smrtnost, zlasti v primeru alogenske HPCT, čeprav nista neposredno povezani.
Dose and administration: The dose of Busilvex will be calculated according to your body weight.
Odmerek in uporaba: Odmerek zdravila Busilvex vam bodo izračunali na osnovi telesne mase.
Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Zdravnik bo redno spremljal število krvnih celic in jetrne encime, da bi odkril te težave in primerno ukrepal.
Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW+0.25x (actual body weight - IBW).
Izračun prilagojene idealne telesne mase (AIBW): AIBW = IBW + 0,25 x (dejanska telesna masa - IBW)
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2C - 8C)
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 C - 8 C).
Fever was reported in 87% of patients and graded as mild/moderate in 84% and severe in 3%.
Zvišana telesna temperatura se je pojavila pri 87 % bolnikov in je bila ocenjena za blago/zmerno pri 84 % in resno pri 3 %.
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.
Farmakokinetiko intravensko uporabljenega busulfana so preučevali na 124 bolnikih, ki jih je bilo možno oceniti, po 2-urni intravenski infuziji do skupno 16 odmerkov v obdobju 4 dni.
Contribution of long-lasting metabolites is not excluded.
Prispevek dolgoobstojnih presnovkov ni izključen.
The most serious side effects of Busilvex therapy or the transplant procedure may include decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and pulmonary complications.
Med najresnejše neželene učinke zdravljenja z zdravilom Busilvex in postopka presaditve sodijo zmanjšanje števila krvnih celic v krvnem obtoku (nameravani učinek zdravila, ki vas pripravi na transplantacijsko infuzijo), okužba, motnje delovanja jeter, vključno z blokiranjem jetrne vene, reakcija presadka proti gostitelju (presadek napade vaše telo) in pljučni zapleti.
For storage conditions after dilution of the medicinal product see section 6.3.
Za pogoje shranjevanja zdravila po redčenju zdravila glejte poglavje 6.3.
A majority of publications reported a complete donor chimerism at day+30 for 90-100% of patients.
V večini objavljenih študij so ugotavljali popolni donorski himerizem 30. dan po transplantaciji pri 90-100 % bolnikov.
Only a clear solution without particles should be used.
Uporabiti smete samo bistro raztopino brez delcev.
Women must stop breast-feeding before starting their treatment with Busilvex.
Ženske morajo prekiniti dojenje pred začetkom zdravljenja z zdravilom Busilvex.
in combination with other medicine as a conditioning treatment previous HCT have been seen after reviewing the literature and the cases retrieved in the safety database of the company.
v kombinaciji z drugimi pripravljalnimi zdravili pred HCT so opazili po proučitvi literature in primerov iz imetnikove baze podatkov o varnosti zdravila.
Malformations and anomalies included significant alterations in the musculoskeletal system, body weight gain, and size.
Med malformacije in anomalije so sodile pomembne spremembe mišično-skeletnega sistema, pridobivanja telesne mase in velikosti.
Blood: decrease of blood circulating cells (red and white) and platelets.
Kri: zmanjšanje števila krvnih celic (rdečih in belih) in trombocitov v krvnem obtoku.
• Quantity of Busilvex:
• Količina zdravila Busilvex:
It is recommended when treating these patients that serum transaminase, alkaline phosphatase, and bilirubin should be monitored regularly 28 days following transplant for early detection of hepatotoxicity.
Priporočamo, da med zdravljenjem teh bolnikov 28 dni po transplantaciji redno pregledujete serumske transaminaze, alkalne fosfataze in bilirubin za zgodnje odkrivanje hepatotoksičnosti.
From a microbiological point of view, the product should be used immediately after dilution.
Z mikrobiološkega stališča bi morali zdravilo uporabiti takoj po redčenju.
Busilvex is a potent cytotoxic medicine that results in profound decrease of blood cells.
Zdravilo Busilvex je močno citotoksično zdravilo, ki zelo zmanjša število krvnih celic.
The incidence of a-GVHD grades I-II was 46.4% (13/28), while the incidence of grade III-IV was 3.6% (1/28).
Pogostost a-GVHD stopnje I-II je bila 46,4 % (13/28), medtem ko je bila pojavnost stopnje III-IV 3,6 % (1/28).
The information presented on biotransformation and elimination is based on oral busulfan.
Podatki o biotransformaciji in izločanju temeljijo na peroralni uporabi busulfana.
The residual medicinal product must not be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended.
Preostalega zdravila ne smete izpirati v ceveh med uporabo, kajti hitre infuzije zdravila Busilvex še niso preizkusili in je ne priporočamo.
Busilvex may interact with other medicines.
Zdravilo Busilvex lahko medsebojno učinkuje z drugimi zdravili.
Compared to the four times a day regimen, the once-daily regimen is characterized by a higher peak concentration, no drug accumulation and a wash out period (without circulating busulfan concentration) between consecutive administrations.
Za dajanje enkrat na dan so v primerjavi z dajanjem štirikrat na dan značilni višji vrh koncentracije, odsotnost kopičenja zdravila in obdobje izpiranja zdravila (brez koncentracij krožečega busulfana) med zaporednimi dajanji.
The consequence of treatment with Busilvex at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Posledica zdravljenja z zdravilom Busilvex s priporočenim odmerkom in razporedom je globoka mielosupresija, ki se pojavlja pri vseh bolnikih.
All patients experienced a profound myelosuppression.
Vsi bolniki so izkusili hudo mielosupresijo.
However, for the safe use of Busilvex in patients older than 60 years only limited information is available.
Vendar so za varno uporabo zdravila Busilvex pri bolnikih, starejših od 60 let, na voljo le omejeni podatki.
Busulfan belongs to a class of substances which are potentially carcinogenic based on their mechanism of action.
Busulfan sodi med snovi, ki so zaradi načina delovanja potencialno rakotvorne.
All patients should be pre-medicated with anticonvulsant medicinal products to prevent seizures reported with the use of high dose busulfan.
Vsi bolniki morajo predhodno prejeti antikonvulzive, ki preprečijo epileptične napade, o katerih so poročali pri uporabi visokih odmerkov busulfana.
Ask your pharmacist how to throw away medicine you no longer use.
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
On the basis of human data, busulfan has been classified by the International Agency for Research on Cancer (IARC) as a human carcinogen.
Na podlagi podatkov o človeku je Mednarodna agencija za raziskave rakavih obolenj (International Agency for Research on Cancer (IARC)) uvrstila busulfan med človeške karcinogene.
Brain abscess, Inflammation of the skin, generalised infection.
Možganski absces, vnetje kože, generalizirana okužba.
Busilvex is available in multipacks comprising 2 packs, each containing 4 vials.
Zdravilo Busilvex je na voljo v skupnih pakiranjih, ki vsebujejo 2 škatli s po 4 vialami.
There are no or limited amount of data from the use of busulfan or DMA in pregnant women.
Podatkov o uporabi busulfana ali DMA pri nosečnicah ni oziroma so omejeni.
The amount of Busilvex and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight:
Količino zdravila Busilvex in redčila lahko izračunamo na naslednji način: za bolnika, ki tehta Y kg:
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.
Izgleda, da dajanje priporočenega intravenskega odmerka busulfana bodisi kot en odmerek (3,2 mg/kg) bodisi 4 razdeljene infuzije (0,8 mg/kg) privede do enakovredne dnevne izpostavljenosti v plazmi s podobno variabilnostjo med osebami in pri isti osebi.
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.
Dokumentacija o varnosti in učinkovitosti zdravila Busilvex v kombinaciji s fludarabinom (FB) pred alogensko HPCT izhaja iz pregleda 7 objavljenih študij pri 731 bolnikih z mieloidnimi in limfoidnimi malignimi obolenji, v katerih so uporabili intravenski busulfan, ki je bil infundiran enkrat na dan namesto 4 odmerkov na dan.
Y: body weight of the patient in kg D: dose of Busilvex (see section 4.2)
Y: telesna masa bolnika v kilogramih D: odmerek zdravila Busilvex (glejte poglavje 4.2)
Busilvex should not be given by rapid intravenous, bolus or peripheral injection.
Zdravila Busilvex ne smete uporabiti v obliki hitre intravenske injekcije, bolusa ali periferne injekcije.
No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole or metronidazole.
Specifičnega kliničnega preskušanja za oceno o medsebojni interakciji med intravensko uporabljenim busulfanom in itrakonazolom ali metronidazolom niso izvedli.
Doses of 400 mg/kg/day DMA administered during organogenesis caused significant developmental anomalies.
Med organogenezo so odmerki DMA v višini 400 mg/kg/dan povzročili pomembne anomalije v razvoju.
Precautions to be taken before handling or administering the medicinal product
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila.
From published studies in adults, administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance.
Glede na objavljene raziskave pri odraslih ima lahko uporaba itrakonazola pri bolnikih, ki jemljejo visoke odmerke busulfana, za posledico zmanjšan očistek busulfana.
Since busulfan is mainly metabolized through the liver, caution should be observed when Busilvex is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment.
Ker se busulfan v glavnem presnavlja v jetrih, je priporočljiva posebna previdnost pri uporabi zdravila Busilvex pri bolnikih z že okvarjeno jetrno funkcijo, zlasti pri tistih s hudo okvaro jeter.
- 8 hours (including infusion time) after dilution when stored at 20 °C  5 °C
- 8 ur (vključno s časom infuzije) po redčenju, če je bila raztopina shranjena pri temperaturi 20 °C ± 5 °C,
It must be considered that overdose of Busilvex will also increase exposure to DMA.
Ne smemo spregledati dejstva, da preveliko odmerjanje zdravila Busilvex povzroči povečano izpostavljenost DMA.
The safety and efficacy of FB in pediatric population has not been established.
Varnost in učinkovitost zdravljenja s kombinacijo FB pri otrocih še nista bili dokazani.
Busilvex can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Zdravilo Busilvex lahko izzove tudi znake menopavze in pri deklicah lahko prepreči začetek pubertete.
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.
Pri 40 % otrok z maso < 9 kg, ki niso dosegli ciljnih vrednosti, je bil AUC enakomerno porazdeljen pod ali nad ciljnimi omejitvami, to je 20 % < 900 in 20 % > 1500 µmol/l.minuto po 1 mg/kg.
The solvent dimethylacetamide (DMA) may also impair fertility.
Topilo dimetilacetamid (DMA) prav tako lahko zmanjšuje plodnost.
This study demonstrated that bodyweight was the predominant covariate to explain the busulfan pharmacokinetic variability in children over body surface area or age.
Ta študija je pokazala prevladujoč vpliv telesne mase na farmakokinetično variabilnost busulfana pri otrocih v primerjavi s vplivom telesne površine ali starosti.
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).
Literatura o busulfanu priporoča terapevtsko območje za AUC med 900 in 1.500 µmol/l.minuto na odmerjanje (enakovredno dnevni izpostavljenosti med 3.600 in 6.000 µmol/l.minuto).
Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen and consequently were not considered undesirable effects.
Mielosupresija in imunosupresija sta bili želena terapevtska učinka pripravljalnega zdravljenja, zato se nista šteli za neželena učinka.
In view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing busulfan were warranted.
Na podlagi podatkov iz pregleda PSUR odbor PRAC meni, da so potrebne spremembe informacij o zdravilih, ki vsebujejo busulfan.
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.
Na voljo so podatki nedavno zaključene prospektivne multicentrične študije 2. faze pri 80 bolnikih, starih od 18 do 65 let, z različnimi hematološkimi malignimi obolenji po alo-HCT s pripravljalno terapijo z zmanjšano intenzivnostjo kombinacije FB (3 dni prejemanja zdravila Busilvex).
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).
Kemijsko in fizikalno stabilnost za uporabo po redčenju v 5-odstotni raztopini glukoze ali 0,9-odstotni raztopini natrijevega klorida (9 mg/ml) za injiciranje so dokazali za 8 ur (vključno s časom infuzije) po redčenju, če je bila raztopina shranjena pri temperaturi 20 °C ± 5 °C, ali za 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).
Cases of TMA after high doses of busulfan i.v.
Primere TMA po velikih odmerkih busulfana i.v.
doses in combination with other drugs in conditioning treatment previous HCT could be an important role in the development of TMA.
odmerki busulfana v kombinaciji z drugimi zdravili pri pripravljalnem zdravljenju pred HCT imeli pomembno vlogo pri razvoju TMA.
In paediatric population, for the BuMel regimen it has been reported that the administration of melphalan less than 24 hours after the last oral busulfan administration may influence the development of toxicities.
Pri pediatrični populaciji, zdravljeni z BuMel, so poročali, da uporaba melfalana manj kot 24 ur po zadnjem peroralnem odmerku busulfana lahko vpliva na nastanek toksičnosti.
There have been two reports that busulfan is dialyzable, thus dialysis should be considered in the case of an overdose.
V dveh poročilih je omenjeno, da se busulfan dializira, zato je v primeru prevelikega odmerjanja primerno pretehtati možnost dialize.