natgillin/translations-raw huggingface dataset:
Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex France
Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex Francija
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:
Kemijsko in fizikalno stabilnost med uporabo, po redčenju v 5-odstotni raztopini glukoze ali 0,9odstotni raztopini natrijevega klorida (9 mg/ml) za injiciranje so dokazali za:
Renal: increase in creatinine elimination, discomfort in urination, decrease in urine output and bloody urine.
Ledvica: povečanje kreatininskega očistka, bolečine pri uriniranju, zmanjšanje količine urina in kri v urinu.
Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen.
Mielosupresija in imunosupresija sta zaželena terapevtska učinka pripravljalne terapije.
The pharmacokinetics of Busilvex has been investigated.
Raziskovali so farmakokinetiko zdravila Busilvex.
However, more than 500 patients aged ≥ 55 years were reported in publications with FB conditioning regimens, yielding efficacy outcomes similar to younger patients.
Vendar je bilo v objavljenih študijah pripravljalna terapija s FB uporabljena pri več kot 500 bolnikih, starih ≥55 let.
The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.
Hematološki status mora biti pod strogim nadzorom, in če je klinično nakazano, je treba poseči po učinkovitih podpornih ukrepih.
Concentrate 4 vials of 10ml.
Škatla s 4 vialami po 10 ml
Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
Zdravilo Busilvex je v obliki bistre, brezbarvne raztopine v prozornih steklenih vialah (tipa I) s prostornino 10 ml.
Mainly studies from literature have shown that high busulfan i.v.
Predvsem po ugotovitvah iz literature bi lahko veliki i.v.
was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI,
Po 2 letih je bila kumulativna pojavnost NRM 11,3 % (95-odstotni IZ 5,5-19,3 %), stopnja ponovitve ali napredovanja po alo-HCT pa 43,8 % (95-odstotni IZ 31,1-55,7 %).
Skin: Skin colour disorder, redness of the skin, skin desquamation.
Koža: motnje obarvanosti kože, rdečica kože, luščenje kože.
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.
Dajanje zdravila Busilvex po fludarabinu (FB) je indicirano kot pripravljalna terapija pred transplantacijo hematopoetskih progenitorskih celic (HPCT) pri odraslih bolnikih, ki so kandidati za zdravljenje z zmanjšano intenzivnostjo (RIC).
Busulfan is thought to be leukemogenic.
Busulfan se obravnava kot levkemogen.
Viral infection CMV reactivation EBV reactivation Bacterial infection
Infekcijske in parazitske bolezni virusna okužba reaktivacija CMV reaktivacija EBV bakterijska okužba invazivna glivna okužba okužba pljuč možganski absces celulitis sepsa
The use of paracetamol during the 72 hours prior to or with Busilvex administration should be used with caution.
Bodite zelo previdni pri uporabi paracetamola 72 ur pred uporabo ali sočasno z uporabo zdravila Busilvex.
Obese patients In adults
Debeli bolniki Odrasli
Busilvex will be administered every 6 hours during 4 consecutive days prior to transplant.
Zdravilo Busilvex boste prejeli vsakih 6 ur, 4 zaporedne dni pred presaditvijo.
A phase II clinical trial was performed to evaluate the influence of seizure prophylaxis treatment on intravenous busulfan pharmacokinetics.
Za oceno vpliva zdravljenja za preprečevanje epilepsije na farmakokinetiko intravensko uporabljenega busulfana so izvedli klinično preskušanje 2. faze.
Do not use Busilvex: if you are allergic to busulfan or any of the other ingredients of Busilvex listed in section 6, if you are pregnant, or think you may be pregnant.
Ne uporabljajte zdravila Busilvex: - če ste alergični na busulfan ali katero koli drugo sestavino zdravila Busilvex, navedeno v poglavju
Calculation of the quantity of Busilvex to be diluted and of the diluent
Izračun količine zdravila Busilvex, ki ga morate razredčiti, in redčila
Busilvex must not be infused concomitantly with another intravenous solution.
Zdravila Busilvex ne uporabljajte sočasno z drugo intravensko raztopino.
Other frequent anomalies included cleft palate, anasarca and skeletal anomalies of the vertebrae and ribs.
Med preostale pogoste anomalije sodi volčje žrelo, ansarka in anomalije vretenc in reber.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neuporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi.
Multipack containing 8 (2 packs of 4) vials.
Skupno pakiranje vsebuje 8 vial (v 2 škatlah po 4).
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.
Čas, potreben, da je skupno število nevtrofilcev (Absolute Neutrophil Count - ANC) preseglo 0,5 x 109/l, je bil pri alogenskih bolnikih 21 dni (interval 12-47 dni), pri avtolognih bolnikih pa 11 dni (interval 10-15 dni).
Immediate and complete availability of the dose is obtained after intravenous infusion of busulfan.
Po intravenski infuziji busulfana so dosegli takojšnjo in popolno razpoložljivost odmerka.
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).
Pri odraslih se je absolutno število nevtrofilcev < 0,5 x 109/l pri mediano 4 dneh po transplantaciji pojavilo pri 100 % bolnikov in se je popravilo pri mediano 10 dneh po avtologni oziroma 13 dneh po alogenski transplantaciji (mediano trajanje nevtropenije je znašalo 6 oziroma 9 dni).
Two prospective, single arm, open-label, uncontrolled phase II studies were conducted in patients with haematological disease, the majority of whom had advanced disease.
V drugi klinični fazi sta bili na bolnikih s hematološkimi obolenji, pri večini katerih je bolezen že napredovala, opravljeni dve enokraki, odprti, nekontrolirani raziskavi možnosti zdravljenja.
Special caution should be exercised when administering the recommended dose of Busilvex to patients with a history of seizures.
Posebna previdnost pri uporabi priporočenega odmerka zdravila Busilvex je potrebna pri bolnikih z anamnezo epileptičnih napadov.
Frequent complete blood counts, including differential white blood cell counts, and platelet counts should be monitored during the treatment and until recovery is achieved.
Med zdravljenjem ter do končne ozdravitve je potrebno pogosto pregledovati popolno krvno sliko, vključno z diferencialno sliko belih krvnih celic in trombocitov.
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.
Pri alogenskih bolnikih je bila celokupna smrtnost pri več kot 100 dnevih po transplantaciji 13-odstotna (8/61), smrtnost, ki ni bila povezana s ponovitvijo bolezni, pa 10-odstotna (6/61).
In adults Busilvex is used in combination with cyclophosphamide or fludarabine.
Pri odraslih se zdravilo Busilvex uporablja v kombinaciji s ciklofosfamidom ali fludarabinom.
Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Za preprečevanje in nadzorovanje okužb v nevtropeničnem obdobju je treba pretehtati možnost preventivne ali empirične uporabe zdravil proti okužbam (bakterijskim, glivičnim in virusnim).
Component of a multipack, cannot be sold separately.
Koncentrat 4 viale po 10 ml. Del skupnega pakiranja, ne smejo se prodajati ločeno.
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.
Temu sledijo: - 4 cikli po 50 mg/kg telesne mase (TM) ciklofosfamida (BuCy4) ali - en odmerek 140 mg/m2 melfalana (BuMel),
Delirium Nervousness Hallucination Agitation
Psihiatrične motnje vznemirjenost zmedenost halucinacije
Studies in animals have shown reproductive toxicity (embryo-fetal lethality and malformations).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (embriofetalno smrtnost in malformacije) (glejte poglavje 5.3).
Therefore, attention should be paid to this pulmonary issue in patients with prior history of mediastinal or pulmonary radiation (see section 4.8).
Zato morate biti pri bolnikih z anamnezo obsevanja pljuč ali medpljučnega prostora na ta pojav pozorni (glejte poglavje 4.8).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING WITH BLUE BOX {Box containing 8 vials of 10ml}
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Z MODRIM OKENCEM Škatla z 8 vialami po 10 ml
• The diluted solution must be mixed thoroughly by inverting several times.
• Vrečko morate temeljito premešati z nekajkratnim obračanjem .
Respiratory: increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung.
Dihala: povečanje frekvence dihanja, dihalna odpoved, alveolarne krvavitve, astma, ohlapnost majhnih delov pljuč, nabiranje tekočine okrog pljuč.
Renal: increase in the amount of nitrogen components in the blood stream, moderate renal insufficiency, renal disorder.
Ledvica: povečanje količine dušikovih spojin v krvnem obtoku, zmerno zmanjšano delovanje ledvic, ledvična bolezen.
Preparation of Busilvex
Priprava zdravila Busilvex
One ml of concentrate contains 6 mg busulfan (60 mg in the vial).
En mililiter koncentrata vsebuje 6 mg busulfana (60 mg v eni viali).
The increased risk of a second malignancy should be explained to the patient.
Bolnika je treba opozoriti na povečano tveganje ponovne malignosti.
Since, busulfan is metabolized through conjugation with glutathione, administration of glutathione might be considered.
Ker pa se busulfan presnavlja s konjugacijo z glutationom, pride v poštev tudi uporaba glutationa.
Polycarbonate syringes must not be used with Busilvex.
Pri uporabi zdravila Busilvex ne smete uporabljati polikarbonatnih brizg.
Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Živčni sistem: delirij, živčnost, prividi, nemirnost, nenormalno delovanje možganov, možganske krvavitve in epileptični napadi.
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).
Priporočamo, da se pred zdravljenjem posvetujejo o shranjevanju sperme z zamrznitvijo, kajti zaradi zdravljenja obstaja možnost ireverzibilne neplodnosti (glejte poglavje 4.4).
Cardiac: increase in heart rate, increase or decrease of blood pressure, vasodilatation (a state of increased calibre of the blood vessels), and blood clots.
Srce: povečanje hitrosti srčnega utripa, povišanje ali znižanje krvnega tlaka, vazodilatacija (širjenje krvnih žil) in krvni strdki.
Busilvex in combination with fludarabine (FB)
Zdravilo Busilvex v kombinaciji s fludarabinom (FB)
Busilvex is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Zdravilo Busilvex se daje pred transplantacijo hematopoetskih progenitorskih celic (HPCT).
The median duration of neutropenia was 6 days and 9 days for autologous and allogeneic patients.
Pri avtolognih in alogenskih bolnikih je bila mediana trajanja nevtropenije 6 in 9 dni.
Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.
Postopek z zdravilom Busilvex in nato s ciklofosfamidom (BuCy2) se uporablja kot pripravljalna terapija pred transplantacijo hematopoetskih progenitorskih celic (HPCT - Haematopoietic Progenitor Cell Transplantation) pri odraslih bolnikih, kadar ocenimo, da je ta kombinacija najboljša možnost.
The dose proportional increase of busulfan exposure was demonstrated following intravenous busulfan up to 1 mg/kg.
Po intravenski uporabi busulfana v odmerkih do 1 mg/kg se opazili povečanje izpostavljenosti busulfanu, sorazmerno odmerku.
Lens disorders including clouding of the lens of the eye (cataract), and blurred vision (corneal thinning).
Bolezni očesne leče, vključno s sivo mreno (katarakto) in motnjami vida (tanjšanjem roženice).
Men treated with Busilvex are advised not to father child during and up to 6 months after treatment.
Moškim, ki prejemajo zdravilo Busilvex, svetujemo, naj ne spočnejo otroka med zdravljenjem in še vsaj 6 mesecev po zdravljenju.
Impotence, sterility, azoospermia, and testicular atrophy have been reported in male patients.
Pri moških bolnikih so poročali o impotenci, sterilnosti, azoospermiji in testikularni atrofiji.
Busulfan depleted oocytes of female rats, and induced sterility in male rats and hamster.
Busulfan je pri samicah podgan uničil oocite; pri samcih podgan in hrčkov je povzročil sterilnost.
In adults and children studies, data with Busilvex were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis.
Vsi podatki o zdravilu Busilvex v študijah pri odraslih in otrocih so bili pridobljeni pri sočasni uporabi fenitoina ali benzodiazepinov za profilakso epileptičnih napadov.
Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Busulfan je učinkovita citotoksična in bifunkcionalna alkilirajoča učinkovina.
The MAH of Busilvex has responded to the question of “Thrombotic microangiopathy” (TMA) after hematopoietic cell transplantation (HCT) requested as supplementary information.
Imetnik dovoljenja za promet z zdravilom Busilvex se je odzval na zahtevo, naj zagotovi dodatne podatke glede „trombotične mikroangiopatije” (TMA) po presaditvi hematopoetskih celic (HCT).
The incidence of acute graft versus host disease (a-GVHD) data was collected in allogeneic patients (n=28).
Podatki o pogostosti akutne reakcije presadka proti gostitelju (acute graft-versus-host disease - a-GVHD) so bili zbrani pri alogenskih bolnikih.
Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Zdravljenje z busulfanom pri je pri dekletu pred adolescenco zaradi okvare jajčnikov preprečilo začetek pubertete.
No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.
Ko so busulfan kombinirali s 5-HT3-antiemetiki, kot sta ondansetron ali granisetron, niso opazili interakcij.
HVOD is a recognized potential complication of conditioning therapy post-transplant.
Znan možni zaplet pripravljalne terapije po transplantaciji je HVOD.
However cardiac function should be monitored regularly in patients receiving Busilvex (see section 4.8).
Vendar je pri bolnikih, ki so prejemali Busilvex, potreben reden nadzor delovanja srca (glejte poglavje 4.8).
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Postopek z zdravilom Busilvex in nato s ciklofosfamidom (BuCy4) ali melfalanom (BuMel) je indiciran za pripravljalno terapijo pred transplantacijo hematopoetskih progenitorskih celic pri pediatričnih bolnikih.
A continuous variation of clearance ranging from 2.49 to 3.92 ml/minute/kg has been established in children from < 6 months up to 17 years old.
Pri otrocih, starih od < 6 mesecev do 17 let, so ugotovili stalno nihanje očistka v intervalu od 2,49 do 3,92 ml/minuto/kg.
Nutrition: low blood sodium.
Prehrana: nizka koncentracija natrija v krvi.
Caution is recommended, particularly in those patients with severe hepatic impairment (see section
Bodite previdni, zlasti pri bolnikih s hudo okvaro jeter (glejte poglavje 4.4).
Gastro-intestinal haemorrhage Tooth hypoplasia*
Bolezni prebavil navzea bruhanje diareja stomatitis gastrointestinalna hemoragija zobna hipoplazija*
Premature menopause Ovarian failure**
Motnje reprodukcije in dojk predčasna menopavza odpoved jajčnikov**
busulfan.
dajanju busulfana.
Busulfan was shown to cause sterility in rodents.
Raziskave so pokazale, da busulfan povzroča neplodnost pri glodavcih.
Increase of uric acid and urea in the blood.
Povečane vrednosti sečne kisline in sečnine v krvi.
Hepatic: enlarged liver, jaundice, blocking of a liver vein.
Jetra: povečana jetra, zlatenica, zaprtje jetrne vene.
Platelet and red blood cell support, as well as the use of growth factors such as granulocyte colony stimulating agent (G-CSF), should be employed as medically indicated.
Kadar so prisotne zdravstvene indikacije, je treba nuditi trombocitno ali eritrocitno podporo in uporabiti rastne faktorje, kot je granulocitne kolonije stimulirajoči faktor (G-CSF).
Read this guide prior to the preparation and administration of Busilvex.
Pred pripravo in uporabo zdravila Busilvex preberite to navodilo.
Antiemetics should be administered prior to the first dose of Busilvex and continued on a fixed schedule according to local practice through its administration.
Pred prvim odmerkom zdravila Busilvex morajo bolniki prejeti antiemetike in nadaljevati z njihovo uporabo po vnaprej določeni shemi odmerjanja, skladni z lokalno prakso, ves čas uporabe zdravila Busulfan.
General: fever, headache, weakness, chills, pain, allergic reaction, oedema, general pain or inflammation at injection site, chest pain, inflammation of the mucosa.
Splošno: povišana telesna temperatura, glavobol, oslabelost, mrzlica, bolečine, alergijske reakcije, edem, bolečina ali vnetje na mestu vboda, bolečine v prsih, vnetje sluznice.
Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-Stransferase mediated).
Busulfan se presnavlja predvsem s konjugacijo z glutationom (ki je lahko spontana ali pa pri njej sodeluje glutation-S-transferaza).
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.
S pregledom objavljenih podatkov kliničnih preskušanj so preiskali tudi z zdravljenjem povezano smrtnost in smrtnost, ki ni povezana s ponovitvijo bolezni (treatment-related mortality/non-relapse mortality [TRM/NRM]) do 100. dneva po transplantaciji.
* reported in post marketing experience ** include haemorrhagic cystitis induced by viral infection
** vključno s hemoragičnim cistitisom zaradi virusne okužbe
Low inter (CV=21%) and intra (CV=12%) patient variability on busulfan exposure was demonstrated through a population pharmacokinetic analysis, performed on 102 patients.
Med farmakokinetično analizo, izvedeno na 102 bolnikih, so znotraj populacije ugotovili nizko inter- (CV = 21 %) in intravariabilnost (CV = 12 %) bolnikov pri izpostavljenosti busulfanu.
No evidence of an induction effect of phenytoin has been seen on Busilvex data.
V podatkih o zdravilu Busilvex ni bilo dokazov za indukcijski učinek fenitoina.
Encephalopathy Cerebral haemorrhage
cerebralna hemoragija encefalopatija
8 MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Women must not be pregnant during treatment with Busilvex and up to 6 months after treatment.
Ženske, ki prejemajo zdravilo Busilvex, ne smejo biti noseče med zdravljenjem in ne smejo zanositi še do 6 mesecev po zdravljenju.
Diluted Busilvex is a clear colourless solution.
Razredčeno zdravilo Busilvex je prozorna, brezbarvna raztopina.
Hyperglycaemia Hypocalcaemia Hypokalaemia Hypomagnesaemia Hypophosphatemia
Presnovne in prehranske motnje anoreksija hiperglikemija hipokalciemija hipokaliemija hipomagneziemija hipofosfatemija hiponatriemija
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.
Pri bolnikih, ki so sodelovali v kliničnih preskušanjih z intravensko uporabo busulfana so za preprečevanje epileptičnih napadov uporabili fenitoin ali benzodiazepine (glejte poglavji 4.2 in 4.4) Poročali so, da sočasna sistemska uporaba fenitoina pri bolnikih, ki prejemajo visoke peroralne odmerke busulfana, poveča očistek busulfana zaradi indukcije glutation-S-transferaze, medtem ko pri uporabi benzodiazepinov, kot so diazepam, klonazepam ali lorazepam za preprečevanje epileptičnih napadov pri visokih odmerkih busulfana, niso poročali o nikakršnih interakcijah.
One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the Busilvex studies.
Pri raziskavah zdravila Busilvex je bil izid akutnega sindroma dihalne stiske s posledično respiratorno odpovedjo, povezano z intersticijsko fibrozo pljuč, pri enem bolniku smrten.
Respiratory: shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds.
Dihala: težave pri dihanju, izcedek iz nosu (rinitis), vneto grlo, kašelj, kolcanje, krvavenje iz nosu, neobičajni zvoki pri dihanju.
Occurrence of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis was reported in Busilvex studies in one patient who died, although, no clear aetiology was identified.
V raziskavah zdravila Busilvex je bil pri enem bolniku, ki je umrl, zabeležen pojav sindroma akutne dihalne stiske, ki ji je sledila respiratorna odpoved, povezana z intersticijsko fibrozo pljuč, vendar jasne etiologije niso identificirali.
Busilvex in combination with fludarabine
Zdravilo Busilvex v kombinaciji s fludarabinom
Vascular disorders Hypertension Hypotension
Žilne bolezni hipertenzija
Busilvex in combination with fludarabine (FB) In adults
Zdravilo Busilvex v kombinaciji s fludarabinom (FB) Odrasli
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
Čas za doseg absolutnega števila nevtrofilcev, večjega od 0,5 x 109/l , je bil pri alogenskih bolnikih (OMC-BUS-4) 13 dni (v razponu 9-29 dni), pri avtolognih bolnikih (OMC-BUS-3) pa 10 dni (v razponu 8-19 dni).
On the basis of human data, busulfan has been classified by the IARC as a human carcinogen.
IARC je na osnovi podatkov pri človeku uvrstila busulfan med rakotvorne snovi.
D: dose of Busilvex (see SPC section 4.2)
D: odmerek zdravila Busilvex (glejte Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Adverse reactions reported both in adults and paediatric patients as more than an isolated case are listed below, by system organ class and by frequency.
Spodaj so po organskih sistemih in pogostnosti navedeni neželeni učinki, ugotovljeni pri odraslih in otrocih pri več kot enem osamljenem primeru.
In children, thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred in 100% of patients.
Trombocitopenija (< 25 x 109/l ali taka, da je bila potrebna transfuzija trombocitov) se je pojavila pri 100 % bolnikov.
There is no known antidote to Busilvex other than haematopoietic progenitor cell transplantation.
Razen transplantacije hematopoetskih progenitorskih celic ni znanega antidota za Busilvex.
Haemorrhagic cystitis**
Bolezni sečil hemoragični cistitis**
How to use Busilvex
Kako jemati zdravilo Busilvex
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 8 (2 packs of 4) vials of 10 ml 60 mg per vial
Skupno pakiranje z 8 vialami (2 škatli po 4) volumna 10 ml 60 mg v vsaki viali