natgillin/translations-raw huggingface dataset:
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).
Kemijska i fizička stabilnost u primjeni nakon razrjeđivanja u 5%-tnoj otopini glukoze ili otopini natrijeva klorida 9 mg/ml (0,9%) za injekciju dokazana je za 8 sati (uključujući vrijeme infuzije) nakon razrjeđivanja ako se čuva na temperaturi od 20 °C  5 °C ili 12 sati nakon razrjeđivanja ako se čuva na temperaturi od 2 °C - 8 °C nakon čega je uslijedilo 3 sata ako se čuva na temperaturi od 20 °C  5 °C (uključujući vrijeme infuzije).
The entire prescribed Busilvex dose should be delivered over two or three hours depending of the conditioning regimen.
Ukupna propisana doza Busilvexa mora se primijeniti tijekom dva ili tri sata ovisno o protokolu kondicioniranja.
Busilvex must always be added to the diluent, not the diluent to Busilvex.
Busilvex se uvijek mora dodati otapalu, a ne otapalo u Busilvex.
Busilvex in combination with fludarabine
Busilvex u kombinaciji s fludarabinom
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.
U pedijatrijskoj populaciji apsolutan broj neutrofila < 0,5x109/l pri medijanu od 3 dana nakon presađivanja pojavio se u 100% bolesnika te se zadržao 5 dana nakon autolognog i 18,5 dana nakon alogenog presađivanja.
Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Liječenje busulfanom djevojčica u preadolescenciji spriječilo je nastupanje puberteta zbog zatajenja jajnika.
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.
Sigurnosni profil lijeka Busilvex u kombinaciji s fludarabinom (FB) ispitan je putem pregleda nuspojava zabilježenih u objavljenim podacima iz kliničkih ispitivanja protokola kondicioniranja smanjenog intenziteta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Busilvex 6 mg/ml sterile concentrate
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Busilvex 6 mg/ml sterilni koncentrat i.v.
A reduced incidence of Hepatic Veno Occlusive Disease (HVOD) and other regimenrelated toxicity have been observed in patients when the lag time between the last dose of oral busulfan and the first dose of cyclophosphamide is > 24hours.
HVOD) i toksičnosti povezane s ostalim protokolima zabilježena je u bolesnika kada je vrijeme latencije između posljednje peroralne doze busulfana i prve doze ciklofosfamida > 24 sata.
In new-born infants, children and adolescents, Busilvex is used in combination with cyclophosphamide or melphalan.
Kod novorođenčadi, djece i adolescenata Busilvex se primjenjuje u kombinaciji s ciklofosfamidom ili melfalanom.
Diluted Busilvex is a clear colourless solution.
Razrijeđeni Busilvex je bistra, bezbojna otopina.
Renal: increase in creatinine elimination, discomfort in urination, decrease in urine output and bloody urine.
Bubrezi: povećanje uklanjanja kreatinina, nelagoda pri mokrenju, smanjeno izlučivanje urina i krvavi urin.
Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
Busilvex mora pripremiti zdravstveni radnik koristeći se sterilnim tehnikama prijenosa.
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.
Bolesnici su primili protokol kondicioniranja koji se temelji na primjeni fludarabina nakon kojeg je odmah uslijedila doza od 3,2 mg/kg busulfana jednom dnevno 2 ili 3 uzastopna dana.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pierre Fabre Médicament
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pierre Fabre Médicament
Cardiac: changes and abnormalities in heart rhythm, fluid retention or inflammation around the heart, decrease heart output.
Srce: promjene i abnormalnosti srčanog ritma, zadržavanje tekućine ili upala oko srca, smanjeni izlazni volumen srca.
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Busilvex nakon kojeg slijedi ciklofosfamid (BuCy4) ili melfalan (BuMel) indiciran je kao terapija kondicioniranja prije konvencionalnog presađivanja hematopoetskih progenitorskih stanica u pedijatrijskih bolesnika.
Vomiting Dyspepsia Ascites
Povraćanje Dispepsija Ascites
Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Živčani sustav: delirij, nervoza, halucinacije, nemir, nenormalno funkcioniranje mozga, krvarenje u mozgu i napadaji.
Adverse events information are derived from the clinical study in paediatrics (n=55).
Informacije o nuspojavama dobivene su iz kliničkog ispitivanja pedijatrijske populacije (n=55).
The median duration of neutropenia was 6 days and 9 days for autologous and allogeneic patients.
Medijan trajanja neutropenije bio je 6 dana za autologne i 9 dana za alogene bolesnike.
There are no or limited amount of data from the use of busulfan or DMA in pregnant women.
Podataka o primjeni busulfana ili DMA u trudnica nema ili su ograničeni.
Interstitial lung disease**
Intersticijska bolest pluća **
Bilirubin increased GGT increased Alkaline phosphatases increased
Povišeni bilirubin Povišeni GGT Povišena alkalna fosfataza
Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
Busilvex se na tržištu nalazi kao bistra, bezbojna otopina u staklenim, prozirnim bočicama od 10 ml (staklo tip I).
Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Nuspojave prijavljene kao više od jednog izoliranog slučaja navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
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.
Busilvex nakon kojeg slijedi ciklofosfamid (BuCy2) indiciran je kao terapija kondicioniranja prije konvencionalnog presađivanja hematopoetskih progenitorskih stanica u odraslih bolesnika kada se ta kombinacija smatra najboljom raspoloživom mogućnošću.
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 Francuska
Busilvex as well as busulfan has not been studied in patients with hepatic impairment.
Ni Busilvex ni busulfan nisu ispitivani na bolesnicima s oštećenjem funkcije jetre.
Haematemesis Ileus
Hematemeza Ileus
Increase of lactate dehydrogenase in the blood.
Povišenje laktat dehidrogenaze u krvi.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima
was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI,
Nakon 2 godine, ukupna incidencija smrtnosti koja nije povezana s relapsom iznosila je 11,3% (95%-tni CI, 5,5 - 19,3%), a ona od relapsa ili progresije od alogenog HCT-a iznosila 43,8% (95%-tni CI, 31,155,7%).
Hyperglycaemia Hypocalcaemia Hypokalaemia Hypomagnesaemia Hypophosphatemia
Anoreksija Hiperglikemija Hipokalcijemija Hipokalijemija Hipomagnezijemij a
The MAH of Busilvex has responded to the question of “Thrombotic microangiopathy” (TMA) after hematopoietic cell transplantation (HCT) requested as supplementary information.
Nositelj odobrenja za stavljanje lijeka u promet za lijek Busilvex dao je odgovor na pitanje „trombotičke mikroangiopatije“ (TMA, engl. thrombotic microangiopathy) nakon transplantacije hematopoetskih matičnih stanica (HCT, engl. hematopoietic cell transplantation) koje je postavljeno radi dobivanja dodatnih informacija.
Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Primjenu lijeka Busilvex mora nadzirati liječnik iskusan u terapiji kondicioniranja koje prethodi presađivanju hematopoetskih progenitorskih stanica.
In adults and children studies, data with Busilvex were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis.
U ispitivanjima na odraslima i djeci podaci za Busilvex dobiveni su kada se za profilaksu napadaja istodobno primjenjivao ili fenitoin ili benzodiazepini.
Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Busulfan je učinkovito citotoksično sredstvo i bifunkcionalno alkalizirajuće sredstvo.
Busilvex must be diluted prior to administration.
Busilvex se prije primjene mora razrijediti.
In adults Busilvex is used in combination with cyclophosphamide or fludarabine.
U odraslih se Busilvex primjenjuje u kombinaciji s ciklofosfamidom ili fludarabinom.
Agitation Confusional state Hallucination
Agitacija Stanje smetenosti Halucinacija
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 sprječavanje i liječenje infekcija tijekom neutropeničnog razdoblja mora se razmotriti preventivna ili empirijska upotreba lijekova protiv infekcija (bakterijskih, gljivičnih, virusnih).
The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61).
Graft-versus host disease) prikupljeni su u ispitivanju OMC-BUS-4 (alogeno) (n=61).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima za citotoksične lijekove.
Vascular disorders Hypertension Hypotension
Hipertenzija Hipotenzija Tromboza Vazodilatacija
Impotence, sterility, azoospermia, and testicular atrophy have been reported in male patients.
U muških bolesnika prijavljena je impotencija, sterilnost, azoospermija i testikularna atrofija.
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).
Bolesnici su primali busulfan u dozama od 0,8 mg/kg svakih 6 sati u infuziji u ukupno 16 doza nakon čega je uslijedio ciklofosfamid 60 mg/kg jednom na dan tijekom dva dana (protokol BuCy2).
- the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent.
izračunati volumen Busilvexa mora se ukloniti iz bočice. sadržaj štrcaljke mora se ubrizgati u intravensku vrećicu (ili štrcaljku) koja već sadrži izračunatu količinu odabranog otapala.
There is no known antidote to Busilvex other than haematopoietic progenitor cell transplantation.
Ne postoji poznati protulijek za Busilvex osim presađivanja hematopoetskih progenitorskih stanica.
One ml of concentrate contains 6 mg busulfan (60 mg in the vial).
Jedan ml koncentrata sadrži 6 mg busulfana (60 mg u bočici).
Weight increased Abnormal breath sounds
Abnormalni zvukovi disanja Povišeni kreatinin
• 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
• Količina otapala: (A ml Busilvex) x (10) = B ml otapala Za pripremu konačne otopine za infuziju, dodajte (A) ml Busilvexa u (B) ml otapala (otopina natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tna otopina glukoze za injekciju) Priprema otopine za infuziju
Y: body weight of the patient in kg D: dose of Busilvex (see section 4.2)
6 (mg/ml) Y: tjelesna težina bolesnika u kg D: doza Busilvexa (vidjeti dio 4.2)
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.
Vrijeme do apsolutnog broja neutrofila (ABN) većeg od 0,5x109 /l bilo je 21 dan (raspon od 12-47 dana) u alogenih bolesnika i 11 dana
Cardiac: clotting of femoral artery, extra heart beats, decrease in heart rate, diffuse leak of fluid from the capillaries (small blood vessels).
Srce: ugrušci u femoralnoj arteriji, dodatni otkucaji srca, smanjenje otkucaja srca, difuzan gubitak tekućine iz kapilara (krvnih žilica).
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).
Za profilaksu napadaja u bolesnika koji su sudjelovali u kliničkim ispitivanjima provedenim s intravenskim busulfanom primjenjivao se ili fenitoin ili benzodiazepini (vidjeti dio 4.2 i 4.4).
General: fever, headache, weakness, chills, pain, allergic reaction, oedema, general pain or inflammation at injection site, chest pain, inflammation of the mucosa.
Općenito: vrućica, glavobolja, slabost, zimica, bol, alergijska reakcija, edem, općenita bol ili upala na mjestu injiciranja, bol u prsištu, upala sluznice.
Respiratory: increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung.
Disanje: ubrzanje ritma disanja, zatajenje disanja, alveolarno krvarenje, astma, kolaps manjih dijelova pluća, tekućina oko pluća.
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:
Kemijska i fizička stabilnost u primjeni nakon razrjeđivanja u 5%-tnoj otopini glukoze ili 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za injekciju dokazana je za:
Transaminases increased Bilirubine increased Alkaline phosphatases increased
Povišeni bilirubin Povišena alkalna fosfataza
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to restricted medical prescription.
Lijek se izdaje na ograničeni recept.
In paediatric population
U pedijatrijskoj populaciji
- 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time).
5 °C - 12 sati nakon razrjeđivanja ako se čuva na temperaturi od 2 °C - 8 °C nakon čega je uslijedilo 3 sata čuvanja na temperaturi od 20 °C  5 °C (uključujući vrijeme infuzije).
The most frequent causes of reported TRM/NRMs were infection/sepsis, GVHD, pulmonary disorders and organ failure.
Najčešći uzroci prijavljene smrtnosti povezane s liječenjem/smrtnosti koja nije povezana s relapsom bili su infekcija/sepsa, GVHD, plućni poremećaji i zatajenje organa.
Periodic monitoring of renal function should be considered during therapy with Busilvex (see section
Periodični nadzor funkcije bubrega mora se razmotriti u bolesnika tijekom liječenja Busilvexom (vidjeti dio 4.8).
Busilvex in combination with cyclophosphamide:
Busilvex u kombinaciji s ciklofosfamidom:
Veno occlusive liver disease *
Vensko-okluzivna bolest jetre *
On the basis of human data, busulfan has been classified by the IARC as a human carcinogen.
IARC) klasificirala je busulfan kao humani karcinogen.
Hepatomegaly Jaundice
Hepatomegalija Žutica
Respiratory failure
Respiratorno zatajenje
The active substance is busulfan.
Što Busilvex sadrži - Djelatna tvar je busulfan.
Arrhythmia Atrial fibrillation Cardiomegaly Pericardial effusion
Fibrilacija atrija Kardiomegalija
How to use Busilvex
Kako primjenjivati Busilvex
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.
4 ciklusa sa 50 mg/kg tjelesne težine (TT) ciklofosfamida (BuCy4) ili jedna primjena 140 mg/m² melfalana (BuMel) s početkom najmanje 24 sata nakon 16. doze lijeka Busilvex (vidjeti dio 4.5).
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
How to store Busilvex
Kako čuvati Busilvex
Increase of uric acid and urea in the blood.
Povišena mokraćna kiselina u krvi Povišena urea u krvi
Nutrition: low blood sodium.
Prehrana: niska koncentracija natrija u krvi.
Haemorrhagic cystitis**
Hemoragični cistitis**
93% of allogeneic patients showed complete chimerism.
Potpuni kimerizam primijećen je u 93% alogenih bolesnika.
Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Busilvex se ne smije unositi u intravensku vrećicu koja ne sadrži otopinu natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tnu otopinu glukoze za injekciju.
RECOMMENDATION FOR SAFE HANDLING
PREPORUKE ZA SIGURNO RUKOVANJE
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.
Busilvex koji slijedi nakon fludarabina (FB) indiciran je kao terapija kondicioniranja prije presađivanja hematopoetskih progenitorskih stanica u odraslih bolesnika koji su kandidati za protokol kondicioniranja smanjenog intenziteta.
Invasive fungal infection
Invazivna gljivična infekcija Plućna infekcija
A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Low inter (CV=21%) and intra (CV=12%) patient variability on busulfan exposure was demonstrated through a population pharmacokinetic analysis, performed on 102 patients.
Populacijskom farmakokinetičkom analizom provedenom na 102 bolesnika dokazana je niska inter- (CV=21%) i intravarijabilnost (CV=12%) bolesnika na izloženost busulfanu.
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.
Kada je to medicinski indicirano, potrebno je primijeniti potporna sredstva za porast broja trombocita i crvenih krvnih stanica i upotrijebiti faktore rasta kao što je sredstvo za stimulaciju rasta granulocitnih kolonija (G-CSF).
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: ubrzanje srčanog ritma, povećanje ili smanjenje krvnog tlaka, vazodilatacija (širenje krvnih žila) i krvni ugrušci.
Busilvex is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Primjena lijeka Busilvex prethodi presađivanju hematopoetskih progenitorskih stanica (HPCT, engl. haematopoietic progenitor cell transplantation).
Respiratory: shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds.
Disanje: nedostatak zraka, curenje nosa (rinitis), grlobolja, kašalj, štucanje, krvarenje iz nosa, neuobičajeni zvukovi disanja.
The effects of hepatic dysfunction on intravenous busulfan disposition have not been assessed.
Učinci disfunkcije bubrega na djelovanje intravenskog busulfana nisu procijenjeni.
Myalgia Back pain Arthralgia
Mialgija Bol u leđima Artralgija
One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the Busilvex studies.
U ispitivanjima Busilvexa jedan je bolesnik doživio smrtonosni slučaj akutnog respiratornog distres sindroma s posljedičnim zatajenjem pluća povezanog s intersticijskom fibrozom pluća.
Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients.
U bolesnica u predmenopauzi često se pojavljuje supresija jajnika i amenoreja sa simptomima menopauze.
After dilution: one ml of solution contains approximately 0.5 mg of busulfan.
Nakon razrjeđivanja: Jedan ml otopine sadrži približno 0,5 mg busulfana.
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.
U ispitivanjima lijeka Busilvex kod jednog bolesnika koji je preminuo prijavljena je pojava akutnog respiratornog distres sindroma s posljedičnim zatajenjem pluća povezanog s intersticijskom fibrozom pluća, premda nije utvrđena jasna etiologija.
EXP: Read the leaflet for the shelf life of diluted medicine
Rok valjanosti: Pročitajte uputu o lijeku za rok valjanosti razrijeđenog lijeka.
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.
uočeni su nakon pregleda literature te u slučajevima preuzetima iz sigurnosne baze podataka kompanije.
Confusion
Smetenost
In that case infusion sets with minimal priming space should be used (i.e. 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
U tom je slučaju potrebno primjenjivati komplete za infuziju s minimalnim prostorom za ubrizgavanje (tj. 0,3 - 0,6 ml), u kojima je otopina lijeka infundirana prije početka stvarne infuzije Busilvexom i potom isprana otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopinom glukoze (5%) za injekciju.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 12.
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Creatinine elevated Blood lactate dehydrogenase increased
Povišena laktat dehidrogenaza u krvi
STATEMENT OF ACTIVE SUBSTANCE One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Jedan ml koncentrata sadrži 6 mg busulfana i nakon razrjeđivanja osigurava 0,5 mg/ml busulfana
Nausea Vomiting Diarrhoea Stomatitis
Mučnina Povraćanje Proljev Stomatitis
Hepatic: enlarged liver, jaundice, blocking of a liver vein.
Jetra: povećana jetra, žutica, začepljenje jetrene vene.
= A ml of Busilvex to be diluted
A ml Busilvexa koji je potrebno razrijediti
Busulfan is mutagenic and clastogenic.
Busulfan je mutagen i klastogen.
All evaluable patients engrafted.
Presađivanje je provedeno kod svih uključenih bolesnika.
Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Prije i nakon svake infuzije isperite umetnutu katetersku liniju s približno 5 ml otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopine glukoze (5%) za injekciju.
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).
0,8 mg/kg tjelesne težine (TT) busulfana u obliku dvosatne infuzije svakih 6 sati tijekom 4 uzastopna dana u ukupno 16 doza, potom slijedi ciklofosfamid u dozi od 60 mg/kg/dan tijekom 2 dana s početkom najmanje 24 sata nakon 16. doze lijeka Busilvex (vidjeti dio 4.5).
After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan.
Nakon razrjeđivanja 1 ml otopine za infuziju sadrži 0,5 mg busulfana.
Lens disorders including clouding of the lens of the eye (cataract), and blurred vision (corneal thinning).
Poremećaji leće uključujući zamućenost leće oka (katarakta) i zamagljeni vid (stanjivanje rožnice) Simptomi menopauze i ženska neplodnost.