natgillin/translations-raw huggingface dataset:
For the study overall, patient median age was 59, 61% were male, 64% were Caucasian, 76% had Ann Arbor stage III/IV disease at baseline, 74% had a baseline
V celotni študiji je bila mediana starosti bolnikov 59 let, 61 % bolnikov je bilo moških, 64 % bolnikov je bilo belcev, 76 % bolnikov je imelo ob izhodišču III./IV.
In dogs, the heart was not affected by treatment, as no ECG changes were seen at different treatment times, nor heart changes were detected at gross- and histopathology.
Pri psih zdravljenje ni vplivalo na srce, saj niso opazili nobenih sprememb EKG pri različnih časih zdravljenja ali sprememb na srcu pri anatomski in histološki patologiji.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Če se ne porabi takoj, je uporabnik odgovoren za čas in pogoje shranjevanja pred uporabo, to pa ne bi smelo trajati dlje kot 24 ur pri 2 °C do 8 °C.
Unlike approved anthracyclines (doxorubicin and others) and anthracenediones (mitoxantrone), pixantrone is only a weak inhibitor of topoisomerase II.
Za razliko od odobrenih antraciklinov (doksorubicin in drugi) in antracenedionov (mitoksantron) je piksantron le šibki zaviralec topoizomeraze II.
In repeated-dose studies in mice, rats, and dogs, the main findings were myelotoxicity, nephrotoxicity (except dogs), and testicular damage.
Pri študijah s ponavljajočimi se odmerki na miših, podganah in psih so opazili predvsem mielotoksičnost, nefrotoksičnost (razen pri psih) in poškodbe testisov.
Table 2 Treatment modifications for non-hematologic toxicities
Tabela 2 Spreminjanje odmerka zaradi nehematološke toksičnosti
In the EU recommended dose refers to the base of the active substance (pixantrone).
V EU se priporočeni odmerek nanaša na zdravilno učinkovino (piksantron).
Pixuvri has been shown to cause phototoxic effects on 3T3 cells in vitro.
Pokazali so, da zdravilo Pixuvri povzroča fototoksične učinke pri celicah 3T3 in vitro.
In addition, caution should be taken when pixantrone is continuously co-administered with efflux transport inducers such as rifampicin, carbamazepin and glucocorticoids, as pixantrone excretion might be increased with a consequent decrease of systemic exposure.
Poleg tega je pozornost potrebna, kadar se piksantron neprekinjeno sočasno uporablja z induktorji efluksnega transporta, kot so rifampicin, karbamazepin in glukokortikoidi, saj se izločanje piksantrona lahko poveča, kar posledično zmanjša sistemsko izpostavitev.
In dogs, Pixuvri given at 0.5 to 0.9 mg/kg for six cycles did not cause mortality or severe clinical signs, including ECG or body weight changes.
Pri psih odmerki zdravila Pixuvri od 0,5 do 0,9 mg/kg, ki so jih dajali šest ciklov, niso povzročili smrti ali hudih kliničnih znakov, vključno sprememb EKG ali telesne mase.
The most common toxicity is bone marrow suppression, particularly of the neutrophil lineage.
Najpogostejša toksičnost je bila supresija kostnega mozga, zlasti linije nevtrofilcev.
Patients on a sodium restricted diet
Bolniki na dieti z omejenim vnosom natrija
Effects on hepatic or renal function were minimal.
Učinki na delovanje jeter in ledvic so bili majhni.
After a single intravenous administration of Pixuvri at 29 mg/kg and 38 mg/kg, immediate deaths were seen in mice (114 mg/m2, LD10).
Po enkratnem intravenskem dajanju zdravila Pixuvri pri odmerkih 29 mg/kg in 38 mg/kg so pri miših opazili takojšnjo smrt (114 mg/m2, LD10).
What Pixuvri is and what it is used for What you need to know before you use Pixuvri How to use Pixuvri
Kaj je zdravilo Pixuvri in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Pixuvri Kako uporabljati zdravilo Pixuvri
Figure 2 PIX 301 Overall survival-end of study
Slika 2 Skupno preživetje ob koncu študije PIX 301
Moreover, unlike anthracyclines or anthracenediones, pixantrone directly alkylates DNA forming stable DNA adducts and cross-strand breaks.
Poleg tega za razliko od antraciklinov ali antracenedionov piksantron neposredno alkilira DNK, pri čemer nastajajo stabilni adukti DNK in prelomi dvojne verig.
There is limited data in patients previously treated with rituximab (38 patients in the Pixuvri arm and 39 patients in the comparator arm).
Podatki o bolnikih, ki so v preteklosti prejemali rituksimab, so omejeni (38 bolnikov v skupini, ki je prejemal zdravilo Pixuvri, in 39 bolnikov v primerjalni skupini).
This yields a dark blue solution with a pixantrone concentration of 5.8 mg/ml.
Pri tem nastane temno modra raztopina s koncentracijo piksantrona 5,8 mg/ml.
Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton, Lancashire BL5 3XX United Kingdom
Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton, Lancashire BL5 3XX Velika Britanija
Due to this unique structure, pixantrone produced minimal cardiotoxicity in animal models compared with doxorubicin or mitoxantrone.
Zaradi svoje edinstvene strukture je piksantron v primerjavi z doksorubicinom ali mitoksantronom povzročil minimalno kardiotoksičnost pri živalskih modelih.
Although the incidence of severe marrow suppression with clinical consequences is relatively low, patients have been treated with Pixuvri were closely monitored by frequent blood counts, particularly for neutropenia.
Čeprav je pojavnost hude supresije kostnega mozga s kliničnimi posledicami sorazmerno majhna, so pri bolnikih, ki so prejemali zdravilo Pixuvri, pozorno pogosto spremljali krvno sliko, zlasti zaradi nevtropenije.
The occurrence of secondary cancers, including AML and MDS, may occur during or after treatment with Pixuvri.
Sekundarna rakava obolenja, vključno z AML in MDS, se lahko pojavijo med ali po zdravljenju z zdravilom Pixuvri.
Mantle cell lymphoma patients were not included in the pivotal study.
Bolniki z limfomom plaščnih celic niso bili vključeni v to ključno študijo.
During treatment with pixantrone, you should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment).
Občutljivost kože na sončno svetlobo Med zdravljenjem s piksantronom morate zmanjšati ali se izogibati izpostavljenosti naravni ali umetni sončni svetlobi (solariji ali zdravljenje z žarki UVA/B).
Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton Lancashire BL5 3XX United Kingdom
Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton Bolton, Lancashire BL5 3XX Velika Britanija
If cardiac toxicity is demonstrated during treatment, the risk versus benefit of continued therapy with Pixuvri must be evaluated.
Če se med zdravljenjem pojavi kardiotoksičnost, je treba oceniti tveganja in koristi nadaljevanja zdravljenja z zdravilom Pixuvri.
* NYHA: New York Heart Association ** LVEF: Left Ventricular Ejection Fraction
** LVEF: Left Ventricular Ejection Fraction (iztisni delež levega prekata).
Any grade 3 or 4 drug-related non cardiac toxicity other than nausea or vomiting
Katera koli nekardiološka toksičnost 3. ali 4. stopnje, povezana z zdravilom, razen slabosti ali bruhanja
It is not known whether Pixuvri has an effect on the ability to drive a car or use machines.
Ni znano, ali zdravilo Pixuvri vpliva na sposobnost vožnje in upravljanja strojev.
Pixuvri kills cancer cells by binding to DNA, resulting in cell death.
Zdravilo Pixuvri ubija rakaste celice tako, da se veže na DNK, kar povzroči smrt teh celic.
Hydration, urine alkalinisation, and prophylaxis with allopurinol or other agents to prevent hyperuricaemia may minimise potential complications of tumour lysis syndrome.
Hidracija, alkalizacija urina in profilaksa z alopurinolom ali drugimi učinkovinami za preprečevanje hiperurikemije lahko zmanjšajo morebitne zaplete sindroma lize tumorja.
The mixture should be a dark blue solution.
Zmes mora biti temno modra raztopina.
The BSA should be determined using the institutional standard for BSA calculation and should use a weight measured on day 1 of every cycle.
Telesno površino je treba določiti skladno z bolnišničnim standardom za njen izračun ter pri tem uporabiti telesno maso, izmerjeno 1. dan vsakega cikla.
Skin discolouration and chromaturia are known related effects of Pixuvri administration due to the colour of the compound (blue).
Sprememba barve kože in kromaturija sta znana učinka, povezana z uporabo zdravila Pixuvri, zaradi barve spojine (modra).
Hematologic toxicities and complications of neutropenia Hematologic toxicities have been the most frequent toxicity observed but they have, in general, been easily managed with granulocyte-colony stimulating factor (G-CSF) and transfusion support as needed.
Hematološka toksičnost je bila najpogostejša toksičnost, ki so jo opazili, vendar je bila na splošno lahko obvladljiva z granulocitne kolonije spodbujajoči dejavnikom (G-CSF) in podporo s transfuzijo po potrebi.
Photosensitivity is a potential risk based on in vitro and in vivo non-clinical data.
Preprečevanje fotosenzitivnostnih reakcij Fotosenzitivnost je možno tveganje, ki temelji na in vitro ter nekliničnih in vivo podatkih.
log rank p-value = 0.251 HR = 0.79 (95% CI 0.53, 1.18)
P vrednost logrank = 0,251 HR = 0,79 (95-odstotni IZ 0,53, 1,18)
All initial treatment with Pixuvri should be preceded by a careful baseline assessment of blood counts, serum levels of total bilirubin, serum levels of total creatinine, and cardiac function as measured by left ventricular ejection fraction (LVEF).
Pred vsemi začetnimi zdravljenji z zdravilom Pixuvri je treba opraviti natančno izhodiščno oceno krvne slike, ravni celokupnega bilirubina v serumu, ravni skupnega kreatinina v serumu in srčne funkcije, izmerjene kot iztisni delež levega prekata (LVEF).
Pixuvri with food and drink You do not have to change your diet after treatment with Pixuvri unless instructed by your doctor.
Zdravilo Pixuvri skupaj s hrano in pijačo Po zdravljenju z zdravilom vam ni treba spremeniti prehrane, razen če vam tega ne naroči zdravnik.
What Pixuvri is and what it is used for
Kaj je zdravilo Pixuvri in za kaj ga uporabljamo
Patients with cardiac disease or risk factors such as a baseline LVEF value of < 45% by multigated radionuclide (MUGA) scan, clinically significant cardiovascular abnormalities (equal to New York Heart Association [NYHA] grade 3 or 4), myocardial infarction within the last 6 months, severe arrhythmia, uncontrolled hypertension, uncontrolled angina, or prior cumulative doses of doxorubicin or equivalent exceeding 450 mg/m2 should receive careful risk versus benefit consideration before receiving treatment with Pixuvri.
Pri bolnikih s srčno boleznijo ali dejavniki tveganja, kot so izhodiščna vrednost LVEF < 45 % pri večkratno proženem radionuklidnem slikanju (multigated radionuclide scan, MUGA), klinično pomembne kardiovaskularne nepravilnosti (3. ali 4. stopnje po lestvici Newyorškega združenja za srce [NYHA]), miokardni infarkt v zadnjih 6 mesecih, huda aritmija, nenadzorovana hipertenzija, nenadzorovana angina pektoris ali predhodni kumulativni odmerki doksorubicina ali enakovrednega zdravila, ki presegajo 450 mg/m2, je treba pozorno oceniti tveganje in koristi pred začetkom zdravljenja z zdravilom Pixuvri.
What you need to know before you use Pixuvri
Kaj morate vedeti, preden boste uporabili zdravilo Pixuvri
When these symptoms go away or improve, the infusion can be continued.
Infundiranje se lahko nadaljuje, ko ti simptomi izginejo ali se izboljšajo.
Although a risk to inhibition of pixantrone towards CYP2C8 could not be ascertained, caution should be observed when co-administering substances that are primarily metabolised via CYP2C8, such as repaglinide, rosiglitazone, or paclitaxel e.g. by careful monitoring for side effects.
Čeprav tveganja za zaviranje CYP2C8 s piksantronom ni mogoče potrditi, je pri sočasni uporabi zdravil, ki jih presnavlja predvsem CYP2C8, kot so na primer repaglinid, rosiglitazon ali paklitaksel, potrebna previdnost, in pozorno spremljanje neželenih učinkov.
Three Pixuvri patients (4.4%) had tachycardia, arrhythmia, sinus tachycardia, supraventricular tachycardia or bradycardia.
Pri treh bolnikih, ki so prejemali zdravilo Pixuvri (4,4 %), so se pojavili tahikardija, aritmija, sinusna tahikardija, supraventrikularna tahikardija ali bradikardija.
The powder should completely dissolve in 60 seconds with agitation.
Prašek se mora ob tresenju popolnoma raztopiti v 60 sekundah.
With the recommended dose and schedule, neutropenia is usually transient, reaching its nadir on days 15-22 following administration on days 1, 8, and 15 with recovery usually occurring by day 28.
Pri priporočenem odmerku in razporedu odmerjanja je nevtropenija po navadi prehodna, najnižjo točko pa doseže od 15. do 22. dneva po dajanju zdravila 1., 8, in 15. dan, do okrevanja pa po navadi pride do 28. dneva.
Patients treated with Pixuvri showed a significantly higher rate of complete responses and unconfirmed complete responses (CR/CRu), and a higher objective response rate (ORR), compared to the comparator group (see Table 4).
Pri bolnikih, ki so prejemali zdravilo Pixuvri, je bila stopnja popolnega odziva ali nepotrjenega popolnega odziva (CR/CRu) pomembno večja, objektivna stopnja odziva (ORR) pa večja kot v primerjalni skupini (glejte tabelo 4).
While grade 3-4 neutropenia occurred in randomised trials more frequently among Pixuvri recipients, they were uncomplicated in the majority of cases, noncumulative and associated with a low incidence of febrile neutropenia or infections, none leading to fatal outcome.
V randomiziranih preskušanjih so bile nevtropenije 3.- 4. stopnje pogostejše pri bolnikih, ki so prejemali zdravilo Pixuvri, vendar v večini primerov niso bile zapletene, niso bile kumulativne, povezane so bile z majhno pogostnostjo febrilne nevtropenije ali okužb, nobena pa ni bila smrtna.
- Hypersensitivity to pixantrone dimaleate, or to any of the excipients listed in section 6.1 - Immunisation with live virus vaccines - Profound bone marrow suppression - Severe abnormal hepatic function.
- Preobčutljivost za piksantronijev dimaleat ali katero koli pomožno snov, navedeno v poglavju 6.1; - imunizacija z živimi cepivi; - huda supresija kostnega mozga; - hude okvare delovanja jeter.
The development of haematological malignancies such as secondary acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) is a recognised risk associated with anthracycline treatment and other topoisomerase II inhibitors.
Pojav hematoloških malignosti, kot sta sekundarna akutna mieloidna levkemija (AML) ali mielodisplastični sindrom (MDS) je dobro znano tveganje, povezano z zdravljenjem z antraciklinom in drugimi zaviralci topoizomeraze II.
Active or dormant cardiovascular disease, prior therapy with anthracyclines or anthracenediones, prior or concurrent radiotherapy to the mediastinal area, or concurrent use of other cardiotoxic medicinal products may increase the risk of cardiac toxicity.
Aktivna ali mirujoča kardiovaskularna bolezen, predhodno zdravljenje z antraciklini ali antracenedioni, predhodno ali sočasno obsevanje mediastinalnega območja ali sočasna uporaba drugih kardiotoksičnih zdravil lahko povečajo tveganje toksičnosti za srce.
This study randomised 140 patients (1:1) to treatment with either Pixuvri or to an investigator chosen single-agent chemotherapy on the comparator arm.
V študiji so 140 bolnikov naključno razdelili (1 : 1) v skupino, ki je prejemala zdravilo Pixuvri, ali primerjalno skupino, ki je prejemala samostojno kemoterapijo z eno učinkovino po izboru raziskovalca.
Breast-feeding It is unknown whether Pixuvri/metabolites are excreted in human milk.
Dojenje Ni znano, ali se zdravilo Pixuvri/presnovki izločajo v materino mleko.
A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity.
Priporočljiva je izhodiščna ocena srca s slikanjem MUGA ali ehokardiografijo, zlasti pri bolnikih z dejavniki tveganja za povečano kardiotoksičnost.
Experience administering Pixuvri to patients with more significant cardiac compromise is limited and should only be undertaken in the context of a clinical trial.
Izkušnje pri uporabi zdravila Pixuvri pri bolnikih s pomembnejšo oslabelostjo srca so omejene in jih je treba upoštevati samo v kontekstu kliničnih preskušanj.
Embryotoxicity was characterised by reduced mean foetal weight, foetal malformations and incomplete or delayed foetal ossification.
Embriotoksičnost se je kazala kot zmanjšana povprečna masa ploda, deformacije ploda in nepopolna ali zapoznela osifikacija ploda.
For subsequent courses, the prior dose can usually be repeated if white blood cell and platelet counts have returned to acceptable levels.
Pri nadaljnjih ciklih zdravljenja je običajno mogoče ponoviti prejšnji odmerek, če se število levkocitov in trombocitov vrne na sprejemljivo raven.
As with other agents in the general class of deoxyribonucleic acid (DNA) damaging agents, Pixuvri may be associated with fertility impairment.
Kot pri drugih učinkovinah v splošnem razredu učinkovin, ki poškodujejo deoksiribonukleinsko kislino (DNK), je lahko tudi zdravilo Pixuvri povezano s slabšo plodnostjo.
Devices and surfaces accidentally contaminated with Pixuvri must be treated with a solution of sodium hypochlorite (100 µl of water and 20 µl of sodium hypochlorite [7 ± 2% of available chlorine] for 0.58 mg of Pixuvri).
Naprave in površine, ki so kontaminirane z zdravilom Pixuvri, je treba očistiti z raztopino natrijevega hipoklorita (100 µl vode in 20 µl natrijevega hipoklorita [7 ± 2 % razpoložljivega klora] za 0,58 mg zdravila Pixuvri).
Healthcare professionals are asked to report any suspected adverse reactions via the national system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V. 4.9 Preveliko odmerjanje
Pixantrone has a moderate to high total plasma clearance of 72.7 l/hr and a low renal excretion accounting for less than 10% of the administered dose in 0-24 hours.
Piksantron ima zmeren do velik skupni očistek iz plazme 72,7 l/h, majhna stopnja izločanja skozi ledvice pa prispeva k izločanju manj kot 10 % uporabljenega odmerka v 0-24 urah.
The non-vesicant properties of Pixuvri minimise the risk of local reaction following extravasation.
Zdravilo Pixuvri ni vezikant, zato je tveganje za lokalne reakcije po ekstravazaciji majhno.
Based on in vitro studies, pixantrone was found to be a substrate for the membrane transport proteins P-gp/BRCP and OCT1 and agents which inhibit these transporters have the potential to decrease hepatic uptake and excretion efficiency of pixantrone.
Na podlagi študij in vitro so ugotovili, da je piksantron substrat za beljakovine za membranski transport P-gp/BRCP in OCT1, učinkovine, ki zavirajo te transportne beljakovine, pa lahko zmanjšajo jetrni privzem in učinkovitost izločanja piksantrona.
Pixantrone did inhibit OCT1-mediated metformin transport in vitro, but is not expected to inhibit OTC1 in vivo at clinically relevant concentrations.
Piksantron je in vitro zaviral transport metformina, ki ga uravnava OCT1, vendar ni pričakovati, da zavira OTC1 in vivo v klinično pomembnih koncentracijah.
Although the occurrence of cardiac toxicity manifested by CHF appears to be lower than that would be expected with related medicinal products such as anthracyclines, monitoring of LVEF either by MUGA scans or ECHO is recommended to assess subclinical cardiotoxicity.
Čeprav je videti, da je pojavnost kardiotoksičnosti, ki se kaže kot kongestivno srčno popuščanje, manjša, kot bi pričakovali pri sorodnih zdravilih, kot so antraciklini, je priporočeno spremljanje vrednosti LVEF s slikanjem MUGA ali ehokardiografijo, da se oceni subklinična kardiotoksičnost.
Do not use this medicine after the expiry date which is stated on the vial label and carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Therefore, metabolism does not appear to be an important elimination pathway for pixantrone.
Zato ni videti, da je presnova pomembna pot izločanja piksantrona.
One case of photosensitivity reaction has been reported in the clinical trial program considered as non-serious and with outcome recovered.
V programu kliničnega preskušanja so poročali o enem primeru fotosenzitivnostne reakcije, ki je bila ocenjena kot neresna in po kateri je bolnik okreval.
From an analysis of population PK data, for a target recorded dose of 50 mg/m2 of pixantrone the median 28-day cycle exposure was 6320 ng.hr/ml (90% CI, 5990-6800 ng.hr/ml), for 3 doses / 4 week cycle.
Iz analize farmakokinetičnih podatkov za ciljni zabeleženi odmerek 50 mg/m2 piksantrona je bila mediana izpostavitve pri 28-dnevnem ciklu zdravljenja 6320 ng.h/ml (90-odstotni IZ, 5990-6800 ng.h/ml), za cikel 3 odmerkov/4 tedne.
Other medicines and Pixuvri
Druga zdravila in zdravilo Pixuvri
The lyophilised powder should completely dissolve in 60 seconds with agitation.
Liofilizirani prašek se mora ob tresenju popolnoma raztopiti v 60 sekundah.
Infections, including pneumonia, cellulitis, bronchitis, and sepsis have been reported during clinical trials (see section 4.8).
Med kliničnimi preskušanji so poročali o okužbah, vključno s pljučnico, flegmono, bronhitisom in sepso (glejte poglavje 4.8).
Table 1 Dose modifications for hematologic toxicity on days 8 and 15 of any cycle Grade Platelet count
Tabela 1 Spreminjanje odmerka zaradi hematološke toksičnosti 8. in 15. dan katerega koli cikla
Some caution is advised in obese patients as data on BSA- based dosing is very limited for this group.
Pri bolnikih s čezmerno telesno maso je potrebna previdnost, saj so podatki o odmerjanju na podlagi telesne površine pri tej skupini zelo omejeni.
Furthermore, because it incorporates a nitrogen heteroatom into the ring structure and does not have ketone groups, pixantrone has less potential for generating reactive oxygen species, binding iron, and forming alcohol metabolites that are felt to cause the cardiac toxicity of anthracyclines.
Poleg tega ima piksantron dušikov heteroatom v obroču in nima ketonske skupine, zato je verjetnost nastanka reaktivnih kisikovih vrst, vezave železa in nastajanja alkoholnih presnovkov, za katere menijo, da povzročajo kardiotoksičnost pri antraciklinih, manjša.
Pixantrone was a poor inhibitor of OATP1B1 and OATP1B3 uptake transporters in vitro.
Piksantron je šibek zaviralec privzemnih transporterjev OATP1B1 in OATP1B3 in vitro.
Kidney function and histology were similarly not affected both in 4- and 26-week studies.
Pri 4- in 26-tedenskih študijah podobno ni bilo učinka na delovanje in histologijo ledvic.
Skin and subcutaneous tissue disorders*
Bolezni kože in podkožja*
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 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Če se zdravilo ne porabi takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo, ti pa ne bi smeli trajati dlje kot 24 ur pri temperaturi od 2 °C do 8 °C, razen če sta rekonstitucija in redčenje opravljena v nadzorovanih in preverjeno aseptičnih pogojih.
METHOD AND ROUTE(S) OF ADMINISTRATION Reconstitute and dilute before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo rekonstituirajte in razredčite.
In a colony-forming units study in mice, the myelotoxicity of Pixuvri and mitoxantrone administered at their LD10 (pixantrone dimaleate 38 mg/kg and mitoxantrone 6.1 mg/kg) was similar.
Pri študiji enot, ki tvorijo kolonije, pri miših, je bila mielotoksičnost zdravila Pixuvri in mitoksantrona, ki so jo dajali pri odmerku LD10 (38 mg/kg piksantronijevega dimaleata in 6,1 mg/kg mitoksantrona), podobna.
Pixuvri is given through a drip into a vein (by intravenous infusion).
Zdravilo Pixuvri se daje s kapanjem v veno (z intravenskim infundiranjem).