natgillin/translations-raw huggingface dataset:
Treatment with Rixathon uses four separate infusions given at weekly intervals. 
Zdravljenje z zdravilom Rixathon obsega štiri ločene infuzije, ki jih dobite v presledkih enega tedna.
In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusionrelated by investigators in the safety population. 
V kliničnem preskušanju, v katerem so proučevali indukcijo remisije pri hudi aktivni GPA in MPA, so bile z infuzijo povezane reakcije (IRR - infusion-related reactions) opredeljene kot neželeni učinki, ki so se pojavili v 24 urah po infuziji in so jih raziskovalci v varnostni populaciji ocenili kot povezane z infuzijo.
Event free survival Response rate (CR, nPR, or PR) 
preživetje brez dogodka odgovor (CR, nPR, ali PR)
The overall safety profile of rituximab in rheumatoid arthritis is based on data from patients from clinical trials and from post-marketing surveillance. 
Celokupen varnostni profil rituksimab pri revmatoidnem artritisu je osnovan na podatkih bolnikov iz kliničnih preskušanj in spremljanja po prihodu zdravila na trg.
Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy. 
Na voljo so le omejeni podatki glede učinkovitosti in varnosti pri bolnikih, ki so se predhodno zdravili z monoklonskimi protitelesi, vključno z rituksimabom, ali pri bolnikih, ki se na prejšnje zdravljenje z rituksimabom in kemoterapijo niso odzvali.
Trials of rituximab in patients with early arthritis (patients without prior methotrexate treatment and patients with an inadequate response to methotrexate, but not yet treated with TNF-alpha inhibitors) have met their primary endpoints. 
V preskušanjih z rituksimabom pri bolnikih z zgodnjim artritisom (bolniki, ki se še niso zdravili z metotreksatom in bolniki z nezadostnim odzivom na metotreksat, ki se še niso zdravili z zaviralci TNF-alfa) so bili primarni cilji doseženi.
Rixathon is for intravenous use. 
Zdravilo Rixathon je za intravensko uporabo.
• low number of white blood cells, with or without fever or blood cells called “platelets” 
• majhno število belih krvnih celic (z zvišano telesno temperaturo ali brez nje) ali krvnih celic, ki jih imenujemo trombociti (krvne ploščice),
The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3 - 15). 
Delež resnih srčnih dogodkov je bil 2,1 na 100 bolnik-let (95-% interval zaupanja, 3-15).
If the more rapid infusion is tolerated, this infusion schedule can be used when administering subsequent infusions. 
Če bolnik hitrejšo infuzijo dobro prenese, se lahko ta shema uporabi za dajanje nadaljnjih infuzij.
The overall safety profile was consistent with the well-established safety profile of rituximab in RA and GPA/MPA and no new adverse drug reactions were reported. 
Na splošno so se varnostne značilnosti ujemale z dobro znanimi varnostnimi značilnostmi rituksimaba pri RA in GPA/MPA; poročali niso o nobenih novih neželenih učinkih zdravila.
If you are having Rixathon with other medicines, some of the side effects you may get may be due to the other medicines. 
Če prejemate zdravilo Rixathon skupaj z drugimi zdravili, se nekateri neželeni učinki lahko pojavijo zaradi drugih zdravil.
The efficacy and safety of rituximab in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicenter trial (Trial 1). 
Učinkovitost in varnost rituksimaba v lajšanju simptomov in znakov revmatoidnega artritisa pri bolnikih, ki niso zadostno odgovorili na zdravljenje z zaviralci TNF, sta bili dokazani v ključnem randomiziranem, kontroliranem, dvojno slepem, multicentričnem preskušanju (preskušanje 1).
In placebo-controlled periods of clinical trials, 0.94% (13/1,382) of rituximab treated patients and 0.27% (2/731) of placebo patients developed severe neutropenia. 
V kliničnih preskušanjih, nadzorovanih s placebom, je pri 0,94 % (13/1.382) bolnikov, zdravljenih z rituksimabom, in pri 0,27 % (2/731) bolnikov, ki so prejemali placebo, prišlo do razvoja hude nevtropenije.
However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted postnatally and was accompanied by a decrease in IgG level in the newborn animals affected. 
Opazili pa so od odmerka odvisen farmakološki upad števila celic B v limfatičnih organih ploda, ki je trajal tudi postnatalno, spremljalo ga je tudi znižanje IgG pri pri prizadetih mladičih.
Rixathon should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low). 
Zdravila Rixathon se ne sme dajati bolnikom z aktivno, hudo okužbo (npr. tuberkulozo, sepso ali oportunističnimi okužbami, glejte poglavje 4.3) ali hudo imunokompromitiranim bolnikom (npr. pri zelo nizkih vrednostih CD4 ali CD8).
Rixathon may be used for the treatment of several different conditions in adults. 
Zdravilo Rixathon se uporablja za zdravljenje več različnih bolezni pri odraslih.
Median TTF: 2.6 years Not reached p < 0.001 
mediana TTF: 2,6 leta ni doseženo p < 0,001
Rixathon 500 mg concentrate for solution for infusion EU/1/17/1185/003 
Rixathon 500 mg koncentrat za raztopino za infundiranje EU/1/17/1185/003
Your doctor may need to take special care of you during your treatment with Rixathon. 
Zdravnik bo morda moral med zdravljenjem z zdravilom Rixathon posebej poskrbeti za vas.
Of the ninety nine patients treated with rituximab, 12 (12%) experienced at least one IRR. 
Od 99 bolnikov, zdravljenih z rituksimabom, se je pri 12 (12 %) pojavila vsaj ena IRR.
Unopened vial 3 years. 
6.3 Rok uporabnosti Neodprta viala 3 leta
Rixathon is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects. 
Zdravilo Rixathon se uporablja za zdravljenje revmatoidnega artritisa pri bolnikih, ki so se že zdravili z drugimi zdravili, vendar so prenehala delovati, niso bila dovolj učinkovita ali pa so povzročala neželene učinke.
• an increase in the amount of potassium in the blood 
• povečanje količine kalija v krvi,
Rixathon 100 mg concentrate for solution for infusion EU/1/17/1185/001 
Rixathon 100 mg koncentrat za raztopino za infundiranje EU/1/17/1185/001
The final analysis confirmed that R-CHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p=0.0001). 
Končna analiza je potrdila, da je bilo zdravljenje z R-CHOP povezano s klinično pomembnim in statistično značilnim podaljšanjem trajanja preživetja brez dogodkov (primarni parameter učinkovitosti; dogodki so bili smrt, ponovitev bolezni ali napredovanje limfoma, ali uvedba novega protilimfomskega zdravljenja) (p = 0,0001).
No incompatibilities between Rixathon and polyvinyl chloride or polyethylene bags or infusion sets have been observed. 
Med zdravilom Rixathon in vrečkami iz polivinilklorida ali polietilena ali infuzijskimi seti niso ugotovili inkompatibilnosti.
Rixathon is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. 
Zdravilo Rixathon je indicirano za zdravljenje bolnikov s CD20-pozitivnim difuznim velikoceličnim B ne-Hodgkinovim limfomom v kombinaciji s kemoterapijo CHOP (ciklofosfamid, doksirubicin, vinkristin, prednizolon).
Observation (N=167) 
Opazovanje (n = 167)
• Infections, see section 4.4. 
• okužbe, glejte poglavje 4.4;
Remission-induction therapy included IV prednisone, administered as per the investigator's discretion, preceded in some patients by methylprednisolone pulses, and pulse cyclophosphamide until remission was attained after 4 to 6 months. 
Zdravljenje za indukcijo remisije je vključevalo intravenski prednizon, uporabljen po raziskovalčevi presoji, (nekateri bolniki so pred tem prejemali pulze metilprednizolona) in pulzni ciklofosfamid, dokler ni bila dosežena remisija po 4 do 6 mesecih.
In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1,000 mg rituximab separated by a 14 day interval. 
Pri bolnikih z revmatoidnim artritisom so takojšen upad števila celic B v periferni krvi opazili po dveh infuzijah 1.000 mg rituksimaba v presledku 14 dni.
This is because Rixathon can cross the placenta and may affect your baby. 
Zdravilo Rixathon namreč prehaja skozi posteljico (placento) in lahko škoduje otroku.
The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p=0.0319, log-rank test) (Table 10a). 
Analiza celokupnega preživetja je pokazala signifikantno korist zdravljenja R-FC glede na samo kemoterapijo FC (p = 0,0319, test log-rank) (preglednica 10a).
The cumulative incidence rate curves showed that time to first major relapse was longer in patients with rituximab starting from month 2 and was maintained up to month 28 (Figure 3). 
Krivulje kumulativnih stopenj incidence so pokazale, da je bil čas do prvega hujšega recidiva pri bolnikih, ki so prejemali rituksimab, daljši, in sicer od 2. meseca naprej; to se je ohranilo do 28. meseca (slika 3).
Rixathon should be used in combination with CHOP chemotherapy. 
Zdravilo Rixathon je treba uporabljati v kombinaciji s kemoterapijo CHOP.
The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028). 
Po 8 ciklih zdravljenja je bil popolni odgovor v skupini R-CHOP 76,2 %, v skupini CHOP pa 62,4 % (p = 0,0028).
The overall safety profile was consistent with the well-established safety profile for rituximab in approved autoimmune indications, including GPA/MPA. 
Na splošno so se varnostne značilnosti ujemale z dobro znanimi varnostnimi značilnostmi rituksimaba pri odobrenih avtoimunskih indikacijah, vključno z GPA/MPA.
Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML. 
Pri bolnikih je treba redno spremljati pojave novih ali poslabšanje nevroloških simptomov ali znakov, ki bi lahko nakazovali na
Radiographic analysis at 2 years in Trial 1 demonstrated significantly reduced progression of structural joint damage in patients receiving rituximab in combination with methotrexate compared to methotrexate alone as well as a significantly higher proportion of patients with no progression of joint damage over the 2 year period. 
Radiološka analiza v preskušanju 1 je po 2 letih pokazala značilno manjše napredovanje strukturnih okvar sklepov pri bolnikih, ki so prejemali rituksimab v kombinaciji z metotreksatom, kot pri tistih, ki so prejemali samo metotreksat; prav tako je pokazala značilno večji delež bolnikov brez napredovanja okvar sklepov v
For patients who may be at higher risk for relapse, physicians should consider a longer duration of Rixathon maintenance therapy, up to 5 years. 
Pri bolnikih z večjim tveganjem za recidiv je treba razmisliti o dolgotrajnejšem vzdrževalnem zdravljenju z zdravilom Rixathon, do 5 let.
Significance levels were defined as * p <0.05, ** p < 0.001, *** p < 0.0001. 
DAS28-ESR Ravni signifikantnosti so bile opredeljene kot *p < 0,05; **p < 0,001; ***p < 0,0001.
• heart problems - such as reduced heart rate or chest pain (angina) 
• težave s srcem - na primer upočasnjen srčni utrip ali bolečina v prsih (angina pektoris),
Your doctor may prescribe Rixathon for the treatment of: 
Zdravnik vam lahko zdravilo Rixathon predpiše za zdravljenje:
In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the rituximab group. 
V opazovani skupini se je mediana koncentracije IgG postopno povečevala nad spodnjo mejo normalne vrednosti, v skupini, ki je prejemala rituksimab, pa je ostala nespremenjena.
• feeling restless, problems falling asleep 
• nemir, bolnik težko zaspi,
• blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes 
• motnje strjevanja krvi, zmanjšano nastajanje rdečih krvnih celic in povečano propadanje rdečih krvnih celic (aplastična hemolitična anemija), oteklost ali povečanje bezgavk,
A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to rituximab maintenance therapy (n=167) or observation (n=167). 
Skupno je bilo 334 bolnikov, ki so po indukcijskem zdravljenju dosegli popolni ali delni odgovor, randomiziranih v drugi del zdravljenja, v katerem so prejemali vzdrževalno zdravljenje z rituksimabom (n = 167), ali v opazovano skupino (n = 167).
If you are not sure, talk to your doctor, pharmacist or nurse before you are given Rixathon. 
Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Rixathon.
Patients with a high tumour burden or with a high number (≥ 25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution. 
Bolnike z veliko tumorsko maso ali velikim številom (≥ 25 x 109/l) krožečih malignih celic, kot so bolniki s KLL, pri katerih obstaja večje tveganje izjemno hudega sindroma sproščanja citokinov,
4 see also section infusion related reactions below. 
4 Glejte tudi poglavje reakcije, povezane z infuzijo, spodaj.
All patients were followed until month 28 (10 or 6 months, respectively, after the last rituximab infusion or azathioprine dose). 
Vse bolnike so spremljali do 28. meseca (10 mesecev po zadnji infuziji rituksimaba ali 6 mesecev po zadnjem odmerku azatioprina).
The safety of immunisation with live viral vaccines following rituximab therapy has not been studied. 
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z rituksimabom niso proučevali.
1 vial of 50 mL 2 vials of 50 mL 
1 viala po 50 ml 2 viali po 50 ml
In a prospective, open label, international, multi-centre, phase III trial 1,193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice. 
V prospektivnem, odprtem, mednarodnem, multicentričnem preskušanju III. faze je 1.193 bolnikov s predhodno nezdravljenimi folikularnimi limfomi prejelo indukcijsko zdravljenje z R-CHOP (n = 881), R-CVP (n = 268) ali R-FCM (n = 44) po presoji raziskovalca.
• you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6). 
• ste alergični na rituksimab, druge podobne beljakovine ali katero koli sestavino tega zdravila
Talk to your doctor, pharmacist or nurse before you are given Rixathon if: 
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Rixathon:
Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients. 
Rituksimab je pri 70 do 80 % bolnikov povzročilo zmanjšanje števila celic B, z zmanjšanjem koncentracije imunoglobulinov v serumu pa je bilo povezano le malo primerov.
Patients in the rituximab group who relapsed could receive an additional infusion of rituximab 1000 mg in combination with reintroduced or escalated prednisone dose. 
Bolniki v skupini z rituksimabom, ki se jim je pojavil recidiv, so lahko prejeli dodatno infuzijo 1.000 mg rituksimaba v kombinaciji s ponovno uvedenim prednizonom ali povečanjem odmerka prednizona.
• high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “LDH” in the blood, low calcium levels in the blood 
• velika koncentracija krvnega sladkorja, hujšanje, oteklost obraza in telesa, visoka raven encima LDH v krvi, majhna koncentracija kalcija v krvi,
No dose reductions of Rixathon are recommended. 
Odmerka zdravila Rixathon ni priporočljivo zmanjšati.
Cumulative incidence over time of first major relapse 
Slika 3: Kumulativna incidenca glede na čas prvega hujšega recidiva
The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared to younger patients (< 65 years). 
Incidenca neželenih učinkov vseh stopenj ter učinkov 3. ali 4. stopnje je bila pri starejših bolnikih podobna kot pri mlajših (< 65 let).
What Rixathon is and what it is used for What you need to know before you are given Rixathon How Rixathon is given 
Kaj je zdravilo Rixathon in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Rixathon Kako se daje zdravilo Rixathon
Following induction of remission with Rixathon, maintenance treatment should be initiated no sooner than 16 weeks after the last rituximab infusion. 
Po indukciji remisije z zdravilom Rixathon se vzdrževalno zdravljenje ne sme začeti prej kot 16 tednov po zadnji infuziji rituksimaba.
When Rixathon is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied. 
Če zdravilo Rixathon uporabimo v kombinaciji s kemoterapijo, je treba uporabiti standardno zmanjšanje odmerkov citostatikov.
All patients in the cyclophosphamide arm received azathioprine maintenance therapy in during follow-up. 
Vsi bolniki v skupini s ciklofosfamidom so med obdobjem spremljanja prejemali vzdrževalno zdravljenje z azatioprinom.
Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41%. 
Kaplan-Meierjeva ocena mediane trajanja preživetja brez dogodkov po Kaplan-Meierju je bila 35 mesecev v skupini R-CHOP v primerjavi s 13 meseci v skupini CHOP; to pomeni zmanjšanje tveganja za dogodke za 41 %.
• Infections such as pneumonia (bacterial) 
• okužbe, kot je pljučnica (bakterijska okužba),
If patients did not experience a serious infusion related reaction with their first or subsequent infusions of a dose of 1,000 mg Rixathon administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/mL in a 250 mL volume). 
Če bolniki niso imeli resne reakcije, povezane z infuzijo, pri prvem ali nadaljnjem infundiranju odmerka 1.000 mg zdravila Rixathon, ki je potekalo v skladu z originalno shemo dajanja, lahko drugo in nadaljnje infuzije prejmejo hitreje z enako koncentracijo kot v prejšnjih infuzijah (4 mg/ml v 250
The best responses to Rixathon are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti- Cyclic Citrullinated Peptide (anti-CCP). 
Na zdravljenje z zdravilom Rixathon se najbolje odzovejo tisti bolniki, pri katerih je krvni test za revmatoidni faktor (RF) in/ali anti-ciklični citrulinirani peptid (anti-CCP) pozitiven.
Make sure you have a list of all your medicines when you see a health care professional. 
Poskrbite, da boste na vsak pregled pri zdravniku prinesli seznam vseh drugih zdravil, ki jih uporabljate.
The proportions of rituximab treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of > 0.22) was also higher than among patients receiving methotrexate alone (Table 14). 
Tudi delež z rituksimabom zdravljenih bolnikov, pri katerih se je pojavila minimalna klinično pomembna razlika (MCID, Minimal Clinically Important Difference) v HAQ-DI (opredeljena kot zmanjšanje individualne celotne ocene za > 0,22), je bil večji kot pri bolnikih, ki so prejemali samo metotreksat (preglednica 14).
The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test). 
Mediano trajanje odgovora je bilo 37,7 meseca v skupini z R-CVP in 13,5 meseca v skupini s CVP (p < 0,0001, log-rank test).
Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL. 
Okužbe (predvsem bakterijske in virusne) so v kliničnih preskušanjih opazili pri 30-55 % bolnikov z ne-Hodgkinovim limfomom in pri 30-50 % bolnikov s KLL.
Granulomatosis with polyangiitis and microscopic polyangiitis Rixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA). 
Granulomatoza s poliangiitisom in mikroskopski poliangiitis Zdravilo Rixathon je v kombinaciji z glukokortikoidi indicirano za zdravljenje odraslih bolnikov s hudo, aktivno granulomatozo s poliangiitisom (GPA, Wegenerjevo granulomatozo) in z mikroskopskim poliangiitisom (MPA).
• bacterial or viral infections, bronchitis 
• bakterijske ali virusne okužbe, bronhitis,
Safety and efficacy of rituximab have not been established in combination with other chemotherapies in diffuse large B cell non- Hodgkin's lymphoma. 
Varnosti in učinkovitosti rituksimaba v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
The Patient educational leaflet about Rixathon contains the following key elements: - Detailed information on the risk of infections and PML - Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any - The importance of sharing this information with their partner or caregiver - Information on the Patient Alert Card 
Izobraževalni letak za bolnika o zdravilu Rixathon vsebuje naslednje ključne vsebine: - podrobne podatke o tveganju za okužbe in PML, - informacije o znakih in simptomih okužb, še posebno PML, in informacije o nujnosti, da nemudoma obvestijo svojega zdravnika, če izkusijo katerega od znakov ali simptomov, - pomembno dejstvo, da te informacije delijo s svojim partnerjem ali skrbnikom, - informacije o opozorilni kartici za bolnika.
Should non-live vaccinations be required whilst receiving rituximab therapy, these should be completed at least 4 weeks prior to commencing the next course of rituximab. 
Če je potrebno cepljenje z mrtvimi cepivi med zdravljenjem z rituksimabom, mora biti zaključeno najmanj 4 tedne pred začetkom naslednjega cikla rituksimaba.
In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%). 
V študijah z rituksimabom v kombinaciji s kemoterapijo je bila incidenca motenj srčnega ritma 3. ali 4. stopnje, predvsem supraventrikularnih aritmij, kot sta tahikardija in atrijska fibrilacija/undulacija, višja v skupini R-CHOP (14 bolnikov, 6,9 %) kot pa v skupini CHOP (3 bolniki, 1,5 %).
• The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections (see section 2). 
• Pomožne snovi so natrijev citrat, polisorbat 80, natrijev klorid, natrijev hidroksid, klorovodikova kislina in voda za injekcije (glejte poglavje 2).
The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days). 
(n = 15) je bila 408 µg/ml (od 97 do 764 µg/ml) po peti infuziji 500 mg/m2, povprečni končni razpolovni čas pa je bil 32 dni (od 14 do 62 dni).
2 vials of 10 mL 3 vials of 10 mL 
2 viali po 10 ml 3 viale po 10 ml
10 mL vial - Pack of 2 or 3 vials. 
10-ml viale - pakiranje po 2 ali 3 viale.