natgillin/translations-raw huggingface dataset:
6 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).
A total of 11 patients (18%) experienced a-GVHD.
Skupno 11 bolnikov (18%) je izkusilo aGVHD.
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 vrst III- IV 5 -
Chronic GVHD (c-GVHD) was reported if serious or the cause of death, and was reported as the cause of death in 3 patients.
Poročali so, da je bila vzrok smrti pri 3 bolnikih.
39% of patients (40/ 103) experienced one or more episodes of infection, of which 83% (33/ 40) were rated as mild or moderate.
39% bolnikov (40/ 103) je izkusilo eno ali več epizod infekcij, od katerih jih je bilo 83% (33/ 40) ocenjenih za blage ali zmerne.
Pneumonia was fatal in 1% (1/ 103) and life-threatening in 3% of patients.
Pljučnica je bila smrtna pri 1% (1/ 103) in smrtno nevarna pri 3% bolnikov.
Other infections were considered severe in 3% of patients.
Preostale infekcije so bile resne pri 3% bolnikov.
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%.
47% of patients experienced chills which were mild/ moderate in 46% and severe in 1%.
47% bolnikov je izkusilo mrzlico, ki je bila blaga/ zmerna pri 46% in resna pri 1%.
15% of SAEs involved liver toxicity.
15% resnih neželenih učinkov vključuje jetrno toksičnost.
Six of 103 patients (6%) experienced HVOD.
Šest od 103 bolnikov (6%) je izkusilo HVOD.
HVOD occurred in:
Ta se je pojavila pri:
8.2% (5/ 61) allogeneic patients (fatal in 2 patients) and 2.5% (1/ 42) of autologous patients.
8, 2% (5/ 61) alogenskih bolnikov (smrtna pri 2 bolnikih) in 2, 5% (1/ 42) avtolognih bolnikov.
Elevated bilirubine (n=3) and elevated AST (n=1) were also observed.
Zaznali so tudi povišano vrednost bilirubina (n = 3) in povišano AST (n = 1).
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 Busilvexa je bil izid akutnega sindroma dihalne stiske s posledično respiratorno okvaro, povezano z intersticijsko fibrozo pljuč, pri enem bolniku smrten.
In addition the literature review reports alterations of cornea and lens of the eye with oral busulfan.
Neželeni učinki pri pediatričnih bolnikih
Adverse events in paediatric patients Adverse events information are derived from the clinical study in paediatrics (n=55).
Informacije o neželenih učinkih so pridobljene iz pediatrične klinične študije (n = 55).
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 upoštevali kot pričakovane posledice pripravljalne terapije in transplantacijskega procesa.
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.
A total of 14 patients (50%) experienced a-GVHD.
Skupno 14 bolnikov (50%) je imelo a- GVHD.
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 vrst III- IV 3, 6% (1/ 28).
Infections (documented and non documented febrile neutropenia) were experienced in 89% of patients (49/ 55).
Infekcije (ugotovljeno in neugotovljeno febrilno nevtropenijo) je imelo 89% bolnikov (49/ 55).
Mild/ moderate fever was reported in 76% of patients.
Pri 76% bolnikov so poročali o blago do zmerno povečani telesni temperaturi.
Grade 3 elevated transaminases were reported in 24% of patients.
O povečani ravni transaminaz tretje stopnje so poročali pri 24% bolnikov.
Veino 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 tranplantacijo so poročali o veno- okluzivni bolezni (VOD).
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.
Neželeni učinki pri odraslih in pediatričnih bolnikih, o katerih so poročali, so po organskih sistemih in pogostosti našteti spodaj.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100).
Pogostost pojavljanja je opredeljena na naslednji način: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100).
System organ class
Organski sistem Infekcijske in parazitske bolezni
Very common
Zelo pogosti Rinitis Faringitis
7 Infections and infestations
7 Bolezni krvi in limfatičnega sistema
Neutropenia Thrombocytopenia Febrile neutropenia Anaemia Pancytopenia
Nevtropenija Trombocitopenija Febrilna nevtropenija Anemija Pancitopenija
Anorexia Hyperglycaemia Hypocalcaemia Hypokalaemia Hypomagnesaemia Hypophosphatemia
Anoreksija Hiperglikemija Hipokalciemija Hipokaliemija Hipomagnezemija Hipofosfatemija
Anxiety Depression Insomnia
Tesnoba Depresija Nespečnost
Delirium Nervousness Hallucination Agitation
Delirij Živčnost Halucinacije Vznemirjenost
Headache Dizziness
Glavobol Omotica
Seizure Encephalopathy Cerebral haemorrhage
Epileptični napad Encefalopatija Cerebralna hemoragija
Arrhythmia Atrial fibrillation Cardiomegaly Pericardial effusion Pericarditis
Aritmija Atrijska fibrilacija Kardiomegalija Perikardialni izliv Perikarditis
Ventricular extrasystoles Bradycardia
Ventrikularna ekstrasistola Bradikardija
Hypertension Hypotension Thrombosis Vasodilatation
Hipertenzija Hipotenzija Tromboza Vazodilacija
Femoral artery thrombosis Capillary leak syndrome
Femoralna arterijska tromboza Sindrom kapilarnega prepuščanja
Dyspnoea Epistaxis Cough Hiccup
Dispneja Epistaksa Kašelj Kolcanje
Hyperventilation Respiratory failure Alveolar haemorrhages Asthma Atelectasis Pleural effusion
Hiperventilacija Okvara respiratorne funkcije Alveolarne hemoragije Astma Atelektaza Plevralni izliv
Stomatitis Diarrhoea Abdominal pain Nausea Vomiting Dyspepsia Ascites
Stomatitis Diareja Bolečine v trebuhu Navzea Bruhanje Dispepsija Ascites Zaprtost Bolečina v zadnjiku
Gastrointestinal haemorrhage
Gastrointestinalna hemoragija
Constipation
Hepatomegalija Zlatenica
Anus discomfort
Bolezni kože in podkožja
8 Hepato-biliary disorders
8 Bolezni mišično - skeletnega sistema in vezivnega tkiva
Skin and subcutaneous tissue disorders
Mialgija Bolečine v hrbtu Artralgija
Arthralgia Renal and urinary disorders
Bolezni sečil
Dysuria Oligurea
Disurija Oligourija
Haematuria Moderate renal insufficiency
Hematurija Zmerna ledvična insuficienca
Pain or inflammation at injection site
Astenija Mrzlica Zvišana telesna temperatura Bolečine v prsnem košu Edem Generaliziran edem Bolečina Bolečina ali vnetje na mestu injiciranja Mukozitis
Mucositis Investigations
Preiskave
Transaminases increased Bilirubin increased GGT increased Alkaline phosphatases increased Weight increased
Povečane vrednosti transaminaz Povečane vrednosti bilirubina Povečane vrednosti GGT Povečane vrednosti alkalnih fosfataz Povečanje telesne mase Neobičajni zvoki pri dihanju Povečane vrednosti kreatinina
Bun increase Decrease ejection fraction
Povišan dušik sečnine v krvi Zmanjšan iztisni delež prekata
Abnormal breath sounds Creatinine elevated
4. 9 Preveliko odmerjanje
There is no known antidote to Busilvex other than haematopoietic progenitor cell transplantation.
Razen transplantacije progenskih hematopoetskih celic ni znanega antidota za Busilvex.
In the absence of haematopoietic progenitor cell transplantation, the recommended dosage of Busilvex would constitute an overdose of busulfan.
V odsotnosti transplantacije hematopoetskih progenskih celic bi priporočeno odmerjanje Busilvexa povzročil prevelik odmerek busulfana.
9 It must be considered that overdose of Busilvex will also increase exposure to DMA.
Ne smemo spregledati dejstva, da preveliko odmerjanje Busilvexa povzroči povečano izpostavljenost DMA.
CNS changes precede any of the more severe side effects.
Spremembe v centralnem živčnem sistemu nastopijo pred katerimkoli hudim neželenim učinkom.
Pharmacotherapeutic group:
9 Farmakoterapevtska skupina:
Alkyl sulfonates, ATC code:
Alkilsulfonati, Oznaka ATC:
Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Busulfan je učinkovita citotoksična in difunkcionalna alkilirajoča učinkovina.
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.
Ta biološki mehanizem je pomemben za njegov citotoksični učinek.
Clinical trials in adults Documentation of the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy2 regimen prior to conventional allogeneic and/ or autologous HPCT derive from two clinical trials (OMC-BUS-4 and OMC-BUS-3).
Dokumentacija o varnosti in učinkovitosti Busilvexa v kombinaciji s ciklofosfamidom v terapiji BuCy2 pred konvencionalnim alogenskim in/ ali avtolognim zdravljenjem HPCT izhaja iz dveh kliničnih preskušanj (OMC- BUS- 4 in OMC- BUS- 3).
Diseases included were acute leukemia past first remission, in first or subsequent relapse, in first remission (high risk), or induction failures; chronic melogenous leukemia 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.
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).
In both studies, all patients received a 16/ 16 dose regimen of Busilvex.
Pri obeh raziskavah so vsi bolniki prejeli terapevtski odmerek 16/ 16 Busilvexa.
No patients were discontinued from treatment due to adverse reactions related to Busilvex.
Nihče od bolnikov ni prekinil terapije zaradi neželenih učinkov, povezanih z Busilvexom.
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 (range 8-19 days) in autologous patients (OMC-BUS 3).
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).
There is no primary nor secondary graft rejection.
Pri vseh bolnikih, ki jih je bilo mogoče ovrednotiti, je presaditev uspela brez primarne ali sekundarne zavrnitve.
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.
Končna smrtnost in neponovljivost smrtnosti pri več kot 100 dnevih po transplantaciji je bila 13- odstotna (8/ 61) in 10- odstotna (6/ 61) pri alogenskih bolnikih.
Clinical trials in paediatric patients 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 Busilvexa v kombinaciji s ciklofosfamidom v terapiji BuCy2 ali Melphalanom v terapiji BuMel pred konvencionalnim alogenskim in/ ali avtolognim zdravljenjem HPCT izhaja iz kliničnega preskušanja F60002 IN 101 G0.
The patients received the dosing mentioned in section 4.2.
Bolniki so prejeli odmerke, omenjene v poglavju 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.
Čas, potreben, da skupno število nevtrofilcev (Absolute Neutrophil Count – ANC) preseže 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).
There is no primary or secondary graft rejection.
Pri vseh bolnikih je presaditev uspela brez primarne ali sekundarne zavrnitve.
93% of allogeneic patients showed complete chimerism.
Pri 93% alogenskih bolnikov je prišlo do popolnega himerizma.
10 The pharmacokinetics of Busilvex has been investigated.
Raziskovali so farmakokinetiko Busilvexa.
The information presented on metabolism and elimination is based on oral busulfan.
Podatki o presnovi in izločanju temeljijo na peroralni uporabi busulfana.
Pharmacokinetics in adults Absorption The pharmacokinetics of intravenous busulfan was studied in 124 evaluable patients following a 2- hour intravenous infusion for a total of 16 doses over four days.
10 Absorpcija Farmakokinetiko intravensko uporabljenega busulfana so preučevali na 124 določenih bolnikih po 2 - urni intravenski infuziji do skupno 16 odmerkov v obdobju 4 dni.
Similar blood exposure was observed when comparing plasma concentrations in adult patients receiving oral and intravenous busulfan at 1 mg/ kg and 0.8 mg/ kg respectively.
Med primerjavo plazemskih koncentracij odraslih bolnikov s peroralno in intravensko uporabo busulfana (odmerki 1 mg/ kg in 0, 8 mg/ kg) so opazili podobno prisotnost učinkovine v krvi.
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 prikazali nizko inter - (CV = 21%) in intravariabilnost (CV = 12%) bolnikov pri izpostavitvi busulfanu.
Distribution Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/ kg.
Porazdelitev Končni volumen porazdelitve Vz je bil med 0, 62 in 0, 85 l/ kg.
Reversible binding to plasma proteins was around 7% while irreversible binding, primarily to albumin, was about 32%.
Reverzibilna vezava na plazemske beljakovine je bila približno 7- odstotna, medtem ko je bila ireverzibilna vezava, predvsem na albumin, približno 32- odstotna.
Metabolism Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-S- transferase mediated).
Presnova Busulfan se presnavlja predvsem s konjugacijo z glutationom (ki je lahko sponatana ali pa pri njej sodeluje glutation- S- transferaza).
None of the metabolites is thought to contribute significantly to either efficacy or toxicity.
Noben od presnovkov naj ne bi značilno prispeval k učinkovitosti ali toksičnosti.
Elimination Total clearance in plasma ranged 2.25 - 2.74 ml/ minute/ kg.
Izločanje Skupni plazemski očistek je bil med 2, 25 in 2, 74 ml/ minuto/ kg.
The terminal half-life ranged from 2.8 to 3.9 hours.
Končna razpolovna doba je bila med 2, 8 in 3, 9 ure.
Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Približno 30% uporabljenega odmerka se v 48 urah izloči z urinom, od tega 1% kot nespremenjen busulfan.
Elimination in faeces is negligible.
Izločanje v fecesu je zanemarljivo.
Contribution of long-lasting metabolites is not excluded.
Prispevek dolgotrajnih presnovkov ni izključen.
Pharmacokinetic linearity The dose proportional increase of busulfan exposure was demonstrated following intravenous busulfan up to 1 mg/ kg.
Farmakokinetična linearnost Po intravenski uporabi busulfana v odmerkih do 1 mg/ kg se opazili povečanje izpostavitve busulfanu, odvisno od odmerka.
Pharmacokinetic/ pharmacodynamic relationships The literature on busulfan suggests a therapeutic window between 900 and 1500 µMol. minute for AUC.
Farmakokinetična/ farmakodinamična razmerja Literatura o busulfanu priporoča terapevtsko območje med 900 in 1. 500 µmol. minuto za AUC.
During clinical trials with intravenous busulfan, 90% of patients AUCs were below the upper AUC limit (1500 µMol. minute) and at least 80% were within the targeted therapeutic window (900- 1500 µMol. minute).
Med kliničnimi preskušanji z intravensko uporabo busulfana je bilo 90% bolnikov pod zgornjo mejo površine pod krivuljo (1. 500 µmol. minuto) in vsaj 80% bolnikov je bilo znotraj terapevtskega območja (900— 1. 500 µmol. minuto).
Special populations The effects of renal dysfunction on intravenous. busulfan disposition have not been assessed.
Posebne skupine bolnikov Ni ocene učinkov okvarjenega delovanja ledvic na delovanje intravensko uporabljenega busulfana.
Nevertheless the risk of liver toxicity may be increased in this population.
Vendar pri tej skupini bolnikov obstaja povečano tveganje toksičnosti na jetra.
Pharmacokinetics in paediatric patients 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.
Farmakokinetika pri pediatričnih bolnikih 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.
The terminal half life ranged from 2.26 to 2.52 h.
Končni razpolovni čas je bil od 2, 26 do 2, 52 h.
The dosing recommended in section 4.2. allows to achieve a similar AUC whatever the children's age, the targeted range of AUCs being the one used for adults.
Pri tem je ciljna vrednost AUC enaka kot pri odraslih.
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%.
11 Pharmacokinetic/ pharmacodynamic relationships:
11 Uspešno presajanja pri vseh bolnikih v preskušanjih druge faze kaže na ustreznost ciljnih vrednosti AUC.
The successful engraftment achieved in all patients during phase II trials suggests the appropriateness of the targeted AUCs.
Pogostost veno- okluzivne bolezni ni bila povezana s preveliko izpostavljenostjo.
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 kombinacije avtolognih in alogenskih bolnikov.
Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and in vivo (rodents and humans).
Busulfan je povzročil kromosomske aberacije in vitro (v celicah glodalcev in v človeških celicah) ter in vivo (pri glodalcih in človeku).
Intravenous administration of busulfan to mice significantly increased the incidences of thymic and ovarian tumours.
Intravenska uporaba busulfana pri miših je značilno povečala pojavnost tumorjev priželjca in jajčnikov.
Busulfan is teratogen in rats, mice and rabbits.
Busulfan je teratogen pri podganah, miših in zajcih.
Malformations and anomalies included significant alterations in the musculoskeletal system, body weight gain, and size.
Med malformacije in anomalije so sodile značilne spremembe mišično- skeletnega sistema, pridobivanja telesne mase in velikosti.
Busulfan was shown to cause sterility in rodents.
Raziskave so pokazale, da busulfan povzroča neplodnost pri glodalcih.
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 neplodnost.
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 dimetilacemida so povzročili znake jetrne toksičnosti; najprej je prišlo do povečanega izločanja serumskih encimov in nato do histopatoloških sprememb jetrnih celic.
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 značilne anomalije v razvoju.
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.
DMA decreases fertility in male and female rodents.
DMA zmanjšuje plodnost samcev in samic glodalcev.
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.
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.
6 PHARMACEUTICAL PARTICULARS
FARMACEVTSKI PODATKI
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zaradi pomanjkanja raziskav kompatibilnosti, zdravila ne smete sočasno uporabljati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6. 6.
Do not use polycarbonate syringes with Busilvex.
Pri uporabi Busilvexa ne uporabljate polikarbonatnih brizg.
Vials:
Viale:
2 years 12 Diluted solution
2 leti Razredčena raztopina:
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:
12 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 pokazali v času:
- 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 ±
- 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C ± 5 °C
12 ur po redčenju, če je bila raztopina shranjena pri temperaturi med 2 °C in 8 °C in nato 3 ure pri
(including infusion time).
temperaturi 20 °C ± 5 °C (vključno s časom infuzije).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
6. 4 Posebna navodila za shranjevanje
Storein a refrigerator (2 ° C-8 °C).
Shranjujte v hladilniku (2 °C - 8 °C).
For storage conditions of the diluted medicinal product see section 6.3
Pogoji shranjevanja razredčenega zdravila so navedeni v poglavju 6. 3.
Pack size:
10 ml koncentrata za raztopino za infundiranje v prozornih steklenih vialah (tipa I) z zamaškom iz butilne gume in vijolično aluminijasto zaščitno zaporko. Velikost pakiranja:
8 vials per box
8 vial v škatli
Preparation of Busilvex Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Priprava Busilvexa Upoštevati morate ustrezne postopke za ravnanje in odstranjevanje zdravil proti raku.
As with other cytotoxic compounds, caution should be exercised in handling and preparing the Busilvex solution:
Kot pri vseh citotoksičnih spojinah morate biti pri ravnanju z Busilvexom in njegovi pripravi previdni: