natgillin/translations-raw huggingface dataset:
Radioactivity in the Lutathera vial should be measured immediately before infusion using a calibrated radioactivity measurement system. 
Radioaktivnost v viali zdravila Lutathera je treba izmeriti tik pred infuzijo z uporabo umerjenega sistema za merjenje radioaktivnosti.
Lutathera should be administered over 20 to 30 minute time span. 
Zdravilo Lutathera je treba aplicirati v od 20 do 30
Each vial contains a volume varying from 20.5 to 25.0 mL of solution corresponding to an activity of 7,400 MBq at date and time of infusion. 
Ena viala vsebuje količino, ki variira od 20,5 do 25,0 ml raztopine, kar ustreza aktivnosti 7.400 MBq na datum in čas infuzije.
What Lutathera looks like and contents of the pack Lutathera is a clear and colourless solution for infusion, supplied in a colourless glass vial closed with a rubber stopper and sealed with an aluminium capsule. 
Izgled zdravila Lutathera in vsebina pakiranja Zdravilo Lutathera je bistra in brezbarvna raztopina za infundiranje v brezbarvni stekleni viali, ki je zaprta z gumijastim zamaškom in zatesnjena z aluminijasto kapsulo.
• Renal or urinary tract morphological abnormalities; 
• Morfološke abnormalnosti ledvic ali urinarnega trakta;
Staphylococcal infections Streptococcal bacteraemia 
Stafilokokne okužbe Streptokokna bakteriemija
The total amount of radioactivity per single dose vial is 7,400 MBq at the date and time of infusion. 
Skupna količina radioaktivnosti na vialo z enim odmerkom je 7.400 MBq ob datumu in uri infuzije.
• Care supplies and equipment: 
• Material in oprema za nego:
It is strongly recommended to limit contact with children and pregnant women for 7 days after the administration. 
Stik z otroki in nosečnicami je zelo priporočljivo omejiti še 7 dni po tem, ko ste prejeli zdravilo.
The most common side effect seen in patients being treated with Lutathera is the impact on the bone marrow. 
Najpogostejši neželeni učinek pri bolnikih, ki se zdravijo z zdravilom Lutathera, je vpliv na kostni mozeg.
Frequency of adverse reactions reported from clinical trials and from post-marketing surveillance 
Preglednica 7: Pogostost neželenih učinkov, o katerih so poročali v kliničnih preskušanjih in v času spremljanja zdravila v obdobju trženja
therefore treatment with Lutathera in those patients is not recommended. 
Lutathera pri teh bolnikih ni priporočljivo.
Clear colourless Type I glass vial, closed with a bromobutyl rubber stopper and aluminium seal. 
Bistra, brezbarvna steklena viala tipa I, zaprta z bromobutilnim gumijastim zamaškom in aluminijasto folijo.
When testing the cold compound (non-radioactive lutetium (175Lu) oxodotreotide) as a single intravenous injection in rats and dogs at doses up to 20,000 µg/kg (rats) and 3,200 µg/kg (dogs), the compound was well tolerated in both species and no deaths were observed. 
Pri testiranju hladne spojine (neradioaktivnega lutecijevega (175Lu) oksodotreotida) v obliki posamične intravenske injekcije pri podganah in psih v odmerkih do 20.000 µg/kg (podgane) in 3.200 µg/kg (psi), so živali spojino dobro prenašale, smrti niso opazili.
These finding are supported by in vitro metabolism data in human hepatocytes, in which no metabolic degradation of lutetium (175Lu) oxodotreotide was observed. 
Ti rezultati so potrjeni s podatki o presnovi in vitro za humane hepatocite, v katerem niso opazili nobene presnovne degradacije lutecijevega (175Lu) oksodotreotida.
Blood catecholamines c-reactive protein increased 
Zvečanje vrednosti c reaktivnega proteina
• Blood chemistry monitoring: serum creatinine and glycaemia. 
• kemijske preiskave krvi: serumsko koncentracijo kreatinina in glikemije.
The patient should be encouraged to urinate as much as possible after Lutathera adminiastration. 
Bolnika je treba spodbuditi, da po uporabi zdravila Lutathera čim več urinira.
Room and equipment preparation: 
Priprava prostora in opreme: • Prostor za aplikacijo:
The ORR (including complete response (CR) and partial response (PR) according to RECIST criteria) and duration of response (DoR) for the FAS Dutch population with gastroenteropancreatic (GEP) and bronchial NETs (360 patients) as well as per tumour type are presented in Table 10. 
Podatki ORR (vključno s popolnim odzivom (CR) in delnim odzivom (PR) v skladu z merili RECIST) in trajanje odziva (DoR) za FAS nizozemske populacije z gastroenteropankreatičnimi (GEP) in bronhialnimi nevroendokrinimi tumorji (NET) (360 bolnikov) in po vrstah tumorjev so predstavljeni v preglednici 10.
The median PFS for Lutathera was not reached at the time of analysis whereas the one of octreotide LAR was 8.5 months. 
Mediana PFS za zdravilo Lutathera v času analize ni bila dosežena, medtem ko je pri oktreotidu LAR znašala 8,5 mesecev.
01630, Saint Genis Pouilly France 
01630, Saint Genis Pouilly Francija
Cryopreservation of sperm or eggs may be offered to you before the treatment. 
Morda vam bodo pred zdravljenjem ponudili krioprezervacijo sperme ali jajčec.
Organ uptake At 4 hours after administration, the distribution pattern of lutetium (177Lu) oxodotreotide shows a rapid uptake in kidneys, tumour lesions, liver and spleen, and in some patients in the pituitary gland and in the thyroid. 
Po 4 urah po aplikaciji distribucijski vzorec lutecijevega (177Lu) oksodotreotida kaže hiter privzem v ledvicah, tumorskih lezijah, jetrih in vranici in pri nekaterih bolnikih v hipofizi ter v ščitnici.
Other side effects include: nausea and vomiting (usually during the first 24 hours) and decreased appetite. 
Drugi neželeni učinki vključujejo: občutek siljenja na bruhanje in bruhanje (običajno v prvih 24 urah)
Due to the bone marrow toxicity of Lutathera, the most expected adverse reactions were related to haematological toxicity: thrombocytopenia (25%), lymphopenia (22.3%), anaemia (13.4%), pancytopenia (10.2%). 
Zaradi toksičnosti zdravila Lutathera za kostni mozeg so bili najpogosteje pričakovani neželeni učinki, povezani s hematološko toksičnostjo: trombocitopenija (25 %), limfopenija (22,3 %), anemija (13,4
For instructions on the medicinal product before administration, see section 12. 
Za navodila glede zdravila pred dajanjem glejte poglavje 12.
OS Time (months) 
OS Čas (mesecev)
The flow of Lutathera from the vial to the patient should be monitored during the entire infusion. 
Pretok zdravila Lutathera iz viale k bolniku je treba nadzorovati ves čas infundiranja.
Late-onset myelodisplastic syndrome (MDS) and acute leukaemia (AL) have been observed after treatment with Lutathera (see section 4.8), occurring approximately 28 months (9 - 41) for MDS and 55 months (32 - 125) for AL after the end of treatment. 
Mielodisplastični sindrom in akutna levkemija Po zdravljenju z zdravilom Lutathera so opazili pozen pojav mielodisplastičnega sindroma (MDS) in akutne levkemije (AL) (glejte poglavje 4.8), s pojavnostjo po približno 28 mesecih (9-41) za MDS in in 55 mesecih (32-125) za AL po koncu zdravljenja.
− Two (2) gravity intravenous infusion sets with a clamp to regulate or stop the flow (one for Lutathera, one for amino acid solution administration) 
− dva (2) kompleta za gravitacijsko intravensko infuzijo s sponko za uravnavanje ali ustavitev pretoka (eno za zdravilo Lutathera in eno za aplikacijo raztopine aminokislin);
Mechanism of action Lutetium (177Lu) oxodotreotide has a high affinity for subtype 2 somatostatin receptors (sst2). 
Lutecijev (177Lu) oksodotreotid ima visoko afiniteto za podtip 2 somatostatinskih receptorjev (sst2).
The use of Lutathera is contraindicated in patients with severe kidney failure (see section 4.3). 
Uporaba zdravila Lutathera je kontraindicirana pri bolnikih s hudo ledvično odpovedjo (glejte poglavje 4.3).
If the half dose is well tolerated (i.e. no DMT reoccurrence), the next remaining treatment administration(s) should continue with full dose (i.e. 7,400 MBq); but, if DMT recurs after treatment with a half dose, treatment with Lutathera must be definitively stopped. 
(tj. DMT se ne ponovi), je treba naslednjo(-e) preostalo(-e) aplikacijo zdravila nadaljevati s polnim odmerkom (tj. 7.400 MBq); če pa se po zdravljenju s polovičnim odmerkom
• The long needle should be connected to the pre-filled tubing line and then inserted into the Lutathera vial, so that it touches the bottom of the vial. 
• Dolgo iglo je treba priključiti na predhodno napolnjen vod cevke in nato vstaviti v vialo zdravila Lutathera, tako da se bo dotikala dna viale.
• Or hypoalbuminemia < 30 g/L with a decreased prothrombin ratio < 70%. 
• ali hipoalbuminemija < 30 g/l z zmanjšanim deležem protrombina < 70
The level of solution in the vial should remain constant during the entire infusion. 
Raven raztopine v viali mora ostati konstantna med celotno infuzijo.
The catheters should be connected to the infusion sets (one for Lutathera, one for amino acid solution). 
Katetre je treba priključiti na komplete za infuzijo (enega na zdravilo Lutathera in enega na raztopino aminokislin).
Soon after the start of the infusion, the radioactivity emission over the patient's thorax should be measured using Geiger counter to verify the presence of Lutathera in the bloodstream. 
Kmalu po začetku infuzije je treba z Geigerjevim števcem izmeriti radioaktivno sevanje nad bolnikovim prsnim košem, da se preveri prisotnost zdravila Lutathera v krvnem obtoku.
Marketing Authorisation Holder Advanced Accelerator Applications 20 rue Diesel 
Imetnik dovoljenja za promet Advanced Accelerator Applications 20 rue Diesel
The high performance liquid chromatography (HPLC) analyses performed on urine samples collected up to 48 hours post infusion showed lutetium (177Lu) oxodotreotide radiochemical purity close to 100% in most of the analysed samples (with lowest radiochemical purity value being greater than 92%), indicating that the compound is eliminated in urine mainly as intact compound. 
Analize visokozmogljivostne tekočinske kromatografije (HPLC) vzorcev urina, zbranih do 48 ur po infuziji, so pokazale radiokemijsko čistoto lutecijevega (177Lu) oksodotreotida blizu 100 % v večini analiziranih vzorcev (z najnižjo radiokemijsko vrednostjo čistote, večjo od 92 %), kar kaže, da je spojina v glavnem izloči v urinu kot intaktna spojina.
However, since increased risk of presenting haematotoxicity has been described in elderly patients (≥ 70 years old), a close follow up allowing for prompt dose adaptation (DMT) in this population is advisable. 
Je pa bilo pri starejših bolnikih (starih ≥ 70 let) opisano povečano tveganje pojava hematotoksičnosti, zato je pri tej populaciji priporočljivo skrbno spremljanje, ki bo omogočilo takojšnjo prilagoditev odmerka (DMT).
To continue Lutathera infusion, it is mandatory to use a new catheter possibly placing it in a contralateral venous access. 
V nadaljevanju infuzije zdravila Lutathera je treba obvezno uporabiti novi kateter, ki ga je treba po možnosti vstaviti v kontralateralni venski dostop.
Store in the original package to protect from ionizing radiation (lead shielding). 
Shranjujte v originalni ovojnini za zagotovitev zaščite pred ionizirajočim sevanjem (svinčena zaščita).
• Liver impairment with either total bilirubinemia > 3 times the upper limit of normal or albuminemia < 30 g/L and prothrombin ratio decreased < 70%; 
• jetrna okvara s popolno bilirubinemijo > 3-kratne zgornje meje normalnih vrednosti ali albuminemija < 30 g/L z zmanjšanim deležem protrombina < 70 %;
CR = Complete response; PR = Partial response; SD = Stable disease; ORR = Objective response (CR+PR); DoR = Duration of response * Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic 
CR = popolni odziv (Complete response); PR = delni odziv (Partial response); SD = stabilna bolezen (Stable disease); ORR - objektivni odziv (Objective response) (CR+PR); DoR (Duration of response) = trajanje odziva
The medicinal product should be infused through an intravenous catheter placed in the vein exclusively for its infusion. 
Zdravilo je treba infundirati po intravenskem katetru, ki je v veno vstavljen izključno za to infuzijo.
Lutathera side effects are mainly linked to radioactivity. 
Neželeni učinki zdravila Lutathera so v glavnem povezani z radioaktivnostjo.
Absorbed dose estimates for lutetium (177Lu) oxodotreotide from NETTER-1 phase III study (Olinda output) 
Preglednica 12: Ocene absorbiranega odmerka za lutecijev (177Lu) oksodotreotid iz študije NETTER-1 III. faze (izid Olinda)
Atrial fibrillation Palpitations Myocardial infarction Angina pectoris Cardiogenic shock 
Atrijska fibrilacija Palpitacije Miokardni infarkt Angina pektoris Kardiogeni šok
Administration of the amino acid solution should be initiated 30 minutes before Lutathera infusion, with an infusion rate of 250 to 550 mL/h (depending on the solution type). 
Apliciranje raztopine aminokislin je treba začeti 30 minut pred infundiranjem zdravila Lutathera z hitrostjo infundiranja od 250 do 550 ml/h (odvisno od vrste raztopine).
Gravity infusion method - tubing connection scheme 
Slika 2: Metoda gravitacijske infuzije - shema priključitve cevke
To ensure complete administration, the Lutathera vial should be kept under even pressure. 
Da se zagotovi celotna aplikacija je potrebno vialo zdravila Lutathera vzdrževati pod enakomernim tlakom.
See Table 5. 
Glejte preglednico 5.
- The other ingredients are: acetic acid, sodium acetate, gentisic acid, ascorbic acid, diethylene triamine pentaacetic acid (DTPA), sodium chloride 9 mg/mL (0.9%) solution for injection, water for injections (see section 2 “Lutathera contains sodium”). 
- Druge sestavine so: ocetna kislina, natrijev acetat, gentizinska kislina, askorbinska kislina, dietilen-triamin-pentaetanojska kislina (DTPA), natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje, voda za injekcije (glejte poglavje 2 z naslovom Zdravilo Lutathera vsebuje natrij).
Lutetium (177Lu) decays by β- emission to stable Hafnium (177Hf) with the most abundant β- (79.3%) having a maximum energy of 0.497 MeV. 
(177Hf), pri čemer ima najbogatejša β- (79,3 %) največjo energijo 0,497 MeV.
If you have been given more Lutathera than you should An overdose is unlikely because you will only receive a single dose of Lutathera precisely controlled by the nuclear medicine doctor supervising the administration procedure. 
Preveliko odmerjanje ni verjetno, saj boste prejeli le en odmerek zdravila pod nadzorovanimi pogoji s strani zdravnika nuklearne medicine, ki bo nadzoroval postopek aplikacije.
• Hypersensitivity to the active substance, to any of the excipients listed in section 6.1. 
Nosečnost Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
The MAH shall ensure that in each Member State where Lutathera is marketed, all patients/carers who are expected to be administered Lutathera have access to/are provided with a patient educational material containing: 
Lutathera, zagotoviti, da vsi bolniki, ki bodo prejeli zdravilo Lutathera, in njihovi negovalci, prejmejo ali imajo dostop do gradiva za izobraževanje bolnikov, ki vsebuje:
In the case where the treatments previously provided for nausea and vomiting are insufficient, a single dose of corticosteroids can be used, as long as it is not given before initiating or within one hour after the end of Lutathera infusion. 
V primeru, kadar predhodno zdravljenje proti navzei in bruhanju ne zadostuje, se lahko uporabi enkratni odmerek kortikosteroidov, če se že ni apliciral pred začetkom infundiranja zdravila
NETTER-1 phase III study was a multicentre stratified, open labelled, randomized, comparator-controlled, parallel-group study comparing treatment with Lutathera (4 doses of 7,400 MBq every 8 weeks) co-administered with amino acid solution plus best supportive care (BSC; octreotide long acting release [LAR] 30 mg every 4 weeks for symptoms control, replaced by short acting octreotide in the 4 weeks interval before Lutathera administration) to high dose octreotide LAR (60 mg every 4 weeks) in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumours. 
Študija NETTER-1 III. faze je bila multicentrična stratificirana, odprta, randomizirana, s primerjalnim zdravilom kontrolirana študija s vzporednimi študijskimi skupinami za primerjavo zdravljenja z zdravilom Lutathera (4 odmerki po 7.400 MBq vsakih 8 tednov) sočasno z raztopino aminokislin in najboljšo podporno oskrbo (NPO; 30 mg okreotida z dolgotrajnim sproščanjem [LAR] vsake 4 tedne za nadzor simptomov, nato okreotid s kratkotrajnim delovanjem v obdobju 4 tednov pred aplikacijo zdravila Lutathera) z visokim odmerkom oktreotida LAR (60 mg vsake 4 tedne) pri bolnikih z neoperabilnimi, progresivnimi, karcinoidnimi tumorji s pozitivnimi somatostatinskimi receptorji v srednjem črevesju.
Any haematological toxicity of grade 3 or superior (CTCAE)**, except lymphopenia. 
Vsakršna hematološka toksičnost 3. ali višje stopnje (CTCAE)**, razen limfopenije.
It is strongly recommended to move your bowels every day and use a laxative if necessary. 
Zelo priporočljivo je, da greste na blato vsak dan in po potrebi vzamete tudi odvajala.
Therefore, administration of long acting somatostatin analogues should be avoided within 30 days prior to the administration of this medicinal product. 
Apliciranju dolgodelujočih somatostatinskih analogov se je treba zato izogibati v obdobju 30 dni pred aplikacijo tega zdravila.
Lutathera must not be used after the expiry date which is stated on the label after EXP. Store below 25 ºC. 
Zdravila Lutathera se ne sme uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP.
Lutathera is a radiopharmaceutical medicine used for the treatment of certain tumours (gastroenteropancreatic neuroendocrine tumours), which cannot be completely removed from your body by surgery, have spread in your body (metastatic) and does not respond more to your current treatment. 
(gastroenteropankreatskih nevroendokrinih tumorjev), ki jih iz telesa ni mogoče v celoti odstraniti z operacijo, so se razširili v telesu (metastatsko) in se ne odzivajo več na trenutno zdravljenje.
Visual controls of the solution levels should be repeated during the administration by direct visual control (when PMMA container is used) or using a pair of tongs to handle the vial when the lead shipping container is used. 
Med aplikacijo je treba redno preverjati raven raztopine z neposredno vizualno kontrolo (pri uporabi vsebnika PMMA) ali s kleščami za prijemanje viale v primeru uporabe svinčenega vsebnika.
The overall safety profile of Lutathera is based on pooled data from patients from clinical trials (NETTER-1 phase III and Erasmus phase I/II Dutch patients) and from compassionate use programs. 
Splošni varnostni profil zdravila Lutathera temelji na združenih podatkih bolnikov iz kliničnih preskušanj (NETTER-1, III. faza in Erasmus I./II.
You do not need to use bleach and do not need extra rinses. 
Ni vam treba uporabljati belila ali dodanih ciklov izpiranja.
Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC} 
Aktivnost v času infundiranja: {Z} MBq - {DD/MM/LLLL uu:mm UTC}
It is considered unlikely that Lutathera will affect your ability to drive or to use machines; however, your general condition and the possible adverse reactions to treatment must be taken into account to assess this ability before driving or using machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bo zdravilo Lutathera vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev; vendar pa je treba pri oceni sposobnosti za vožnjo ali uporabo strojev upoštevati možne neželene učinke zdravljenja.
Store in the original package to protect from radiation. 
Shranjujte v originalni ovojnini za zagotovitev zaščite pred sevanjem.
Other medicines and Lutathera 
Druga zdravila in zdravilo Lutathera
− Two (2) infusion poles 
− dve (2) infuzijski stojali;
The median PFS for Lutathera was 28.4 months whereas the one of octreotide LAR was 8.5 months. 
Mediana PFS za zdravilo Lutathera je bila 28,4 meseca, za oktreotid LAR pa 8,5 meseca.
Take special care with Lutathera - if your kidney or urinary track are not correctly developed - if you are suffering from urinary incontinence 
Bodite posebno pozorni pri zdravilu Lutathera: - če vaše ledvice ali urinarni trakt niso pravilno razviti;
In some circumstances, it might be necessary to temporarily discontinue treatment with Lutathera, adapt the dose after the first administration or even discontinue the treatment (see Table 3 - Table 5 and Figure 1). 
Prilagajanje odmerka V nekaterih okoliščinah bo morda treba začasno prekiniti zdravljenje z zdravilom Lutathera, po prvi aplikaciji prilagoditi odmerek ali celo dokončno ukiniti zdravljenje (glejte preglednico 3
• Hematologic toxicity greater or equal to grade 2 (CTCAE) before treatment other than lymphopenia; 
• hematološka toksičnost, večja ali enaka 2. stopnji (CTCAE) pred zdravljenjem, razen limfopenije; • metastaze v kosti;
Hormonal crises related to bioactive substances release (probably due to lysis of the neuroendocrine tumour cells) have rarely been observed and resolved after appropriate medical treatment (section 4.4). 
Redko so opazili pojav hormonskih kriz, povezanih s sproščanjem bioaktivne snovi (verjetno zaradi lize celic nevroendokrinega tumorja), ki so izginile po ustreznem zdravljenju (glejte poglavje 4.4).
Storage of the vial 
Zahteve Shranjevanje vial
• Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6). 
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1., • ugotovljena nosečnost, sum nanjo ali primeri, kadar nosečnost ni izključena (glejte poglavje 4.6),
When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure. 
Če ste v dvomih, je pomembno, da se posvetujte z zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
Transchelation of lutetium from lutetium (175Lu) oxodotreotide into serum proteins has not been observed. 
Transhelacije lutecija iz lutecijevega (175Lu) oksodotreotida v serumske proteine niso opazili.
Lutathera infusion should start 30 minutes after the beginning of the amino acid solution infusion, with the infusion rate of approximately 400 mL/h (this infusion rate is the reference rate and can be adapted depending on the patient's venous status). 
Infuzijo zdravila Lutathera je treba začeti 30 minut po začetku infuzije raztopine aminokislin pri hitrosti infundiranja približno 400 ml/h (to je referenčna hitrost infundiranja in jo je mogoče prilagoditi glede na bolnikovo stanje ven).
Abdominal distension Diarrhoea 
Abdominalna distenzija Diareja
• Mild to moderate chronic kidney disease with creatinine clearance ≥ 50 mL/min; 
• blaga do zmerna kronična bolezen ledvic s kreatininskim očistkom ≥ 50 ml/min;
This should be taken into consideration in patient on controlled sodium diet. 
To je treba upoštevati pri bolnikih na dieti z nadzorovanim vnosom natrija.
Lutathera must be administered by slow intravenous infusion over approximately 30 minutes, concomitantly with amino acid solution administered by contralateral intravenous infusion. 
Zdravilo Lutathera je treba dajati s počasnim intravenskim infundiranjem v približno 30 minutah sočasno z raztopino aminokislin, aplicirano s kontralateralno intravensko infuzijo.
During the infusion, the radioactivity emission from the patient's thorax should steadily increase while the one from the Lutathera vial should decrease. 
Med infuzijo se mora radioaktivno sevanje na bolnikovem prsnem košu enakomerno povečevati, medtem ko se mora sevanje iz viale zdravila Lutathera zmanjševati.
Bone marrow toxicity (myelo-/hematotoxicity) manifested with reversible / transient reductions in blood counts affecting all lineages (cytopenias in all combinations, i.e., pancytopenia, bicytopenias, isolated monocytopenias - anemia, neutropenia, lymphocytopenia, and thrombocytopenia). 
Toksični učinek na kostni mozeg (mielo-/hematotoksičnost) se kaže s povratnim/prehodnim zmanjšanjem števila krvnih celic, ki vpliva na vse vrste celic (citopenije v vseh kombinacijah, tj. pancitopenija, bicitopenije, izolirane monocitopenije - anemija, nevtropenija, limfocitopenija in trombocitopenija).
The vial is enclosed within a plastic sealed, lead shielded container. 
Viala je zaprta v zatesnjenem plastičnem vsebniku, zaščitenem s svincem.