FrancophonIA/ELRC3.0 huggingface dataset:
English: * ADRs discussed below
Slovenian: *Neželeni učinki, ki so opisani spodaj.
English: As metabolism appears to be limited, biliary excretion of unchanged pixantrone may be the major elimination pathway.
Slovenian: Videti je, da je presnova omejena, zato naj bi bilo izločanje nespremenjenega piksantrona z žolčem glavna pot izločanja.
English: Pharmacokinetics of pixantrone proved to be linear in a broad range of doses, from 3 mg/m2 to 105 mg/m2.
Slovenian: Linearnost/nelinearnost Farmakokinetika piksantrona je bila linearna v širokem razponu odmerkov od 3 mg/m2 do 105 mg/m2.
English: Pixuvri may be metabolised in the liver and/or excreted in the bile.
Slovenian: Zdravilo Pixuvri se lahko presnavlja v jetrih in/ali izloča z žolčem.
English: Pixuvri is for intravenous use only.
Slovenian: Zdravilo Pixuvri je le za intravensko uporabo.
English: Importantly, growth factor support was not routinely required and transfusions with red blood cells and platelets were uncommon.
Slovenian: Pomembno je, da podpora z rastnimi faktorji ni bila rutinsko potrebna ter da so bile transfuzije eritrocitov in trombocitov občasne.
English: Use gloves, masks, and protective eyewear when handling and during decontamination procedures.
Slovenian: Pri ravnanju in med postopki dekontaminacije uporabljajte rokavice, masko in zaščito za oči.
English: Hepatic uptake of pixantrone is possibly mediated by OCT1 active transporters and biliary excretion by P-gp and BCRP.
Slovenian: Jetrni privzem piksantrona morda uravnavajo aktivni transporterji OCT1, izločanje v žolču pa P-gp in BCRP.
English: The safety and efficacy of Pixuvri as single-agent therapy were evaluated in a multicentre, randomised, active controlled trial in patients with relapsed or refractory aggressive NHL after receiving at least two prior therapies.
Slovenian: Varnost in učinkovitost zdravila Pixuvri kot učinkovine pri samostojnem zdravljenju so ocenili v multicentričnem, randomiziranem, aktivno nadzorovanem preskušanju pri bolnikih s ponovljenimi ali refraktorno agresivnimi ne-Hodgkinovimi limfomi, ki so predhodno prejeli vsaj dve terapiji (PIX301).
English: Mechanism of action The active substance of Pixuvri is pixantrone , a cytotoxic aza-anthracenedione.
Slovenian: Mehanizem delovanja Zdravilna učinkovina v zdravilu Pixuvri je piksantron, citotoksični aza-antracenedion.
English: Except for a transient increase in exposure in females after the third cycle, there were no marked differences in pharmacokinetic parameters.
Slovenian: Po tretjem ciklu pri samicah ni bilo pomembnih razlik pri farmakoloških parametrih, razen prehodnega povečanja izpostavitve.
English: Amitriptyline, haloperidol, clozapine, ondansetron and propranolol are metabolised by CYP1A2, and therefore, a theoretical concern exists that co-administration of Pixuvri may increase blood levels of this medicinal product.
Slovenian: CYP1A2 presnavlja amitriptilin, haloperidol, klozapin, ondansetron in propranolol, zato obstaja teoretična skrb, da sočasna uporaba zdravila Pixuvri lahko poveča koncentracije teh zdravil v krvi.
English: The recommended dose is 50 mg/m2 of pixantrone on days 1, 8, and 15 of each 28-day cycle for up to
Slovenian: Odmerjanje Priporočeni odmerek je 50 mg/m2 piksantrona 1., 8. in 15. dan vsakega 28-dnevnega cikla, do 6 ciklov.
English: Pixuvri has a deep blue colour and for several days after receiving Pixuvri, your skin and eyes may develop a bluish discolouration, and your urine may have a bluish discolouration.
Slovenian: Zdravilo Pixuvri je temno modre barve, zato lahko nekaj dni po prejemanju zdravila Pixuvri vaša koža postane modrikasta, modrikast pa lahko postane tudi vaš urin.
English: Driving and using machines It is not known whether Pixuvri has an effect on your ability to drive a car or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali zdravilo Pixuvri vpliva na sposobnost vožnje in upravljanja s stroji.
English: Pixuvri is used for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin Lymphomas.
Slovenian: Zdravilo Pixuvri se uporablja za zdravljenje odraslih bolnikov z večkratno ponovljenim ali neodzivnim agresivnim ne-Hodgkinovim limfomom.
English: Hepatic clearance approximates the hepatic plasma flow, suggesting a high hepatic extraction ratio and, therefore, efficient parent active substance elimination.
Slovenian: Jetrni očistek je podoben jetrnemu pretoku plazme, kar kaže na velik delež izločanja skozi jetra, in torej na učinkovito izločanje izvorne zdravilne učinkovine.
English: The results in the rituximab pretreated patients still showed superior treatment benefit with Pixuvri over the comparator for overall response rate (31.6% with Pixuvri versus 17.9% with the comparator) and median progression-free survival (3.3 months with Pixuvri versus 2.5 months with the comparator).
Slovenian: Rezultati pri bolnikih, ki so predhodno prejemali rituksimab, še vedno kažejo korist zdravljenja z zdravilom Pixuvri v primerjavi s primerjalnim zdravilom pri stopnji skupnega odziva (31,6 % pri zdravilu Pixuvri v primerjavi s 17,9 % pri primerjalnem zdravilu) in mediani preživetja brez napredovanja bolezni (3,3 meseca pri zdravilu Pixuvri v primerjavi z 2,5 meseca pri primerjalnem zdravilu).
English: The mixture should be a clear and dark blue solution.
Slovenian: Zmes mora biti bistra temno modra raztopina.
English: Since most medicinal product-induced photosensitivity reactions are caused by wavelengths within the UV-A range, sunscreen that strongly absorbs UV-A is recommended.
Slovenian: Večino fotosenzitivnostnih reakcij, povezanih z uporabo zdravil, povzročajo valovne dolžine v ultravijoličnem razponu, zato je priporočljiva uporaba kreme za sončenje, ki močno absorbira žarke UV-A.
English: Reconstituted pixantrone solution is stable for up to 24 hours at room temperature (15°C to 25°C) in standard infusion bags.
Slovenian: Rekonstituirana raztopina piksantrona ostane stabilna 24 ur, če je shranjena pri sobni temperaturi (od 15 °C do 25 °C) v standardnih vrečkah za infundiranje.
English: Tabulated list of adverse reactions Adverse drug reactions (ADR) reported with Pixuvri are from final data from all completed single agent studies (n=197).
Slovenian: Neželeni učinki zdravila, o katerih so poročali pri uporabi zdravila Pixuvri, temeljijo na končnih podatkih vseh dokončanih študij z enim zdravilom (N=197).
English: Table 3 Adverse drug reactions reported related to Pixuvri in completed Pixuvri single agent studies by frequency System Organ Class
Slovenian: Tabela 3 Neželeni učinki zdravila, o katerih so poročali v povezavi z zdravilom Pixuvri v dokončanih študijah z zdravilom Pixuvri kot edinim zdravilom, razvrščeni po pogostnosti
English: Careful monitoring of blood counts is required, including leukocyte, red blood cells, platelet, and absolute neutrophil counts.
Slovenian: Treba je pozorno spremljati krvno sliko, vključno s številom levkocitov, eritrocitov in trombocitov ter absolutnim številom nevtrofilcev.
English: * LLN: Lower Limit of the Normal range ** ANC: Absolute Neutrophil Count
Slovenian: ** ANC: absolutno število nevtrofilcev
English: The other ingredients are lactose monohydrate, sodium hydroxide, hydrochloric acid, and sodium chloride.
Slovenian: Druge sestavine zdravila so laktoza monohidrat, natrijev hidroksid, klorovodikova kislina in natrijev klorid.
English: To avoid the risk of long term infertility, sperm banking should be considered.
Slovenian: Treba je pretehtati možnost uporabe banke sperme, da se prepreči tveganje dolgoročne neplodnosti.
English: Patients with impaired hepatic function
Slovenian: Bolniki z okvaro delovanja jeter
English: Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL).
Slovenian: Zdravilo Pixuvri je indicirano kot monoterapija za zdravljenje odraslih bolnikov z večkrat ponovljenimi ali neodzivnimi agresivnimi ne-Hodgkinovimi B-celičnimi limfomi (NHL).
English: Your doctor will monitor your heart function if there is any sign or symptom of your heart being affected.
Slovenian: Če se pojavi kakršen koli znak ali simptom vpliva na srce, bo zdravnik spremljal delovanje vašega srca.
English: However, the benefit of Pixuvri has not been established when used as fifth line or greater in patients refractory to last therapy, and there is very limited data in this group of patients.
Slovenian: Vendar koristi zdravljenja z zdravilom Pixuvri niso pokazali, ko je bilo to zdravilo uporabljeno kot zdravilo pete ali kasnejše izbire pri bolnikih, ki se niso odzvali na zadnje zdravljenje Pri tej skupini bolnikov pa so podatki zelo omejeni.
English: Lactose monohydrate, sodium chloride, hydrochloric acid, sodium hydroxide.
Slovenian: Laktoza monohidrat, natrijev klorid, klorovodikova kislina, natrijev hidroksid.
English: The median overall survival for patients treated with Pixuvri was 2.6 months longer compared to patients treated with comparator (HR=0.79, logrank p=0.25) (see Figure 2 below).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Pixuvri, je bila mediana splošnega preživetja 2,6 mesecev daljša kot pri bolnikih, ki so prejemali primerjalno zdravilo (HR = 0,79, logrank p = 0,25) (glejte sliko 2 spodaj).
English: 3 < 50 - 25 x 109/l
Slovenian: < 50 - 25 x 10
English: Type I glass vial with grey butyl rubber stopper with aluminium seal and red plastic cap containing 50 mg pixantrone dimaleate equivalent to 29 mg pixantrone.
Slovenian: Viala iz stekla vrste I s sivim zamaškom iz butilne gume z aluminijastim tesnilom in rdečo plastično zaporko, ki vsebuje 29 mg piksantrona v obliki 50 mg piksantronijevega dimaleata.
English: Immunisation with live virus vaccines is contraindicated due to the immunosuppression associated with Pixuvri therapy (see section 4.3).
Slovenian: Zaradi imunosupresije, povezane z zdravljenjem z zdravilom Pixuvri, je imunizacija s cepivi z živimi virusi kontraindicirana (glejte poglavje 4.3).
English: Warfarin is partially metabolised by CYP1A2, therefore, a theoretical concern exists with regard to co-administration of this medicinal product and the effect inhibition of its metabolism might have on its intended action.
Slovenian: Varfarin delno presnavlja encim CYP1A2, zato obstaja teoretična skrb glede sočasne uporabe tega zdravila in učinka zaviranja njegove presnove na njegovo delovanje.
English: Acetylated metabolites are the major biotransformation products of pixantrone.
Slovenian: Glavni produkti biotransformacije piksantrona so acetilirani presnovki.
English: Single doses of pixantrone up to 158 mg/m2 have been given in dose-escalation clinical trials without evidence of dose-related toxicity.
Slovenian: V kliničnih preskušanjih s povečevanjem odmerka so dajali posamezne odmerke piksantrona do 158 mg/m2 brez znakov od odmerka odvisne toksičnosti.
English: Delay treatment until recovery to platelet count ≥ 50 x 109/l and ANC** ≥ 1.0 x 109/l.
Slovenian: Počakajte z zdravljenjem, dokler se število trombocitov ne vrne na ≥ 50 x 109/l, ANC** pa na ≥ 1,0 x 109/l.
English: Patients in PIX 301 were required to have been sensitive to prior anthracycline therapy (confirmed or unconfirmed CR or PR).
Slovenian: Bolniki v študiji PIX 301 so morali biti občutljivi na predhodno zdravljenje z antraciklini (potrjeni ali nepotrjeni popolni odziv (Complete Response, CR) ali relativni odziv (Relative Response, RR)).
English: Infusion reactions
Slovenian: Reakcije na infundiranje
English: The safety and efficacy of Pixuvri in patients with impaired hepatic function has not been established.
Slovenian: Varnost in učinkovitost zdravila Pixuvri pri bolnikih z okvarjenim delovanjem jeter nista bili dokazani.
English: After reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection, each ml of concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone.
Slovenian: Po rekonstituciji s 5 ml 9 mg/ml raztopine natrijevega klorida (0,9-odstotne) za injekcije en ml koncentrata vsebuje 5,8 mg piksantrona v obliki piksantronijevega dimaleata.
English: How much of Pixuvri is given
Slovenian: Koliko zdravila Pixuvri se daje
English: Secondary malignancy (including reports of AML and MDS)
Slovenian: (vključno s poročili o AML in MDS
English: How to use Pixuvri
Slovenian: Kako uporabljati zdravilo Pixuvri
English: Pixuvri is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Pixuvri ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: In 11 Pixuvri-treated patients, these events were grade 1-2 and in 2 patients they were grade 3; these events were transient and not Pixuvri dose related.
Slovenian: Pri 11 bolnikih, ki so prejemali zdravilo Pixuvri, so bili ti dogodki 1.- 2. stopnje, pri 2 bolnikih so bili 3. stopnje.
English: Very common: may affect more than 1 in 10 people - nausea, vomiting - skin discolouration - thinning or loss of hair - abnormal colouration of the urine - physical weakness - low number of white blood cells, low number of red blood cells (anaemia), and low number of platelets in the blood (may require transfusion).
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - slabost, bruhanje, - sprememba barve kože, - izpadanje ali izguba las, - nenormalno obarvanje urina, - telesna šibkost, - majhno število levkocitov, majhno število eritrocitov (anemija) in majhno število trombocitov v krvi (morda bo potrebna transfuzija).
English: Each vial contains 50 mg pixantrone dimaleate (equivalent to 29 mg pixantrone).
Slovenian: Ena viala vsebuje 50 mg piksantronijevega dimaleata (kar ustreza 29 mg piksantrona).
English: Special precautions for use
Slovenian: Posebna navodila za uporabo
English: This medicinal product contains approximately 1000 mg (43 mmol) sodium per dose after dilution.
Slovenian: Po redčenju zdravilo vsebuje približno 1000 mg (43 mmol) natrija na odmerek.
English: Secondary malignancy
Slovenian: Sekundarne maligne bolezni
English: Lactose monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid laktoza monohidrat natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
English: Uncommon Spontaneous penile erection
Slovenian: Motnje reprodukcije in dojk občasni spontana erekcija penisa
English: Figure 1 PIX301 Progression-free survival - end of study
Slovenian: Slika 1 Preživetje brez napredovanja bolezni ob koncu študije PIX 301
English: Any unused medicinal product or waste material, including materials used for reconstitution, dilution, and administration should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material, vključno z materialom, ki ste ga uporabili za rekonstitucijo, redčenje in dajanje zdravila, zavrzite v skladu z lokalnimi predpisi.
English: Immunisation may be ineffective when given during Pixuvri therapy.
Slovenian: Med zdravljenjem z zdravilom Pixuvri je lahko imunizacija neučinkovita.
English: Severe myelosuppression may occur.
Slovenian: Lahko se pojavi huda mielosupresija.
English: Pixuvri is intended for administration as a slow intravenous infusion using an in-line filter (over a minimum of 60 minutes) only after reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection and after further dilution with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml.
Slovenian: Zdravilo Pixuvri je namenjeno uporabi s počasnim intravenskim infundiranjem z linijskim filtrom (infundiranje mora trajati najmanj 60 minut) po rekonstituciji s 5 ml 9 mg/ml raztopine natrijevega klorida (0,9-odstotne) za injekcije in po dodatnem redčenju z 9 mg/ml raztopino natrijevega klorida (0,9-odstotno) za injekcije do končne prostornine 250 ml.
English: Breast-feeding should be discontinued during treatment with Pixuvri.
Slovenian: Med zdravljenjem z zdravilom Pixuvri je treba prenehati z dojenjem.
English: It appears as a dark blue powder which comes in vials containing 29 mg of pixantrone.
Slovenian: Videti je kot temno moder prašek v vialah po 29 mg piksantrona.
English: Patients treated with Pixuvri are likely to experience myelosuppression (neutropenia, leukopenia, anaemia, thrombocytopenia, and lymphopenia) with the predominant manifestation being neutropenia.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Pixuvri, obstaja verjetnost, da se bo pojavila mielosupresija (nevtropenija, levkopenija, anemija, trombocitopenija in limfopenija), najverjetneje v obliki nevtropenije.
English: Pixantrone had only a weak or no capability to inhibit P-gp, BCRP, and BSEP transport mechanism in vitro.
Slovenian: Piksantron lahko le šibko zavira P-gp, BCRP in transportni mehanizem BSEP in vitro ali pa ga sploh ne more zavirati.
English: Cardiac toxicity with Pixuvri may occur whether or not cardiac risk factors are present.
Slovenian: Pri uporabi zdravila Pixuvri se tveganje za kardiotoksičnost lahko pojavi ne glede na prisotnost dejavnikov tveganja za bolezni srca.
English: gastroenteritis - viral infections such as shingles or reactivation of other virus such as herpes in the mouth - nervousness, sleeplessness - loss of energy - dizziness, vertigo - dryness of the eye - numbness of the mouth - infection of the cornea - allergy to the medicine - decrease in blood calcium and sodium level; increase in blood uric acid level - inflammation or fluid accumulation around the lungs - runny nose - bleeding such as gut bleed, purple spots on body due to broken blood vessels - vein irritation - night sweats - irregular heartbeat - spontaneous erection - skin rash and/or ulceration - pain, swelling, weakness, stiffness in joints or muscles - decreased urinary output - loss of weight - increased bilirubin in blood or urine - inflammation of the gullet - pain in neck, back, extremities - nail infection - neoplasm (tumour) progression - new cancers of the bone marrow or blood, such as acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) - liver damage - bone marrow failure - increased eosinophils in blood.
Slovenian: gastroenteritis, - virusne okužbe, kot je pasovec, ali ponovna aktivacija drugih virusov, kot je herpes v ustih, - nervoznost, nespečnost, - izguba energije, - omotica, vrtoglavica, - suhe oči, - otrplost ust, - okužba roženice, - alergija na zdravilo, - zmanjšanje ravni kalcija in natrija v krvi, povečanje ravni sečne kisline v krvi, - vnetje ali nabiranje tekočine okrog pljuč, - izcejanje iz nosu, - krvavitve, kot so krvavitve v črevesju, vijoličaste pike po telesu zaradi počenih krvnih žil, - draženje ven, - nočno znojenje, - nereden srčni utrip, - spontana erekcija, - izpuščaj in/ali nastanek razjed na koži, - bolečina, otekanje, šibkost, otrdelost v sklepih ali mišicah, - zmanjšanje količine urina, - izguba telesne teže, - povišan bilirubin v krvi ali urinu, - vnetje požiralnika, - bolečina v vratu, hrbtu, udih, - okužba nohtov, - napredovanje novotvorb (tumorjev), - nova rakava obolenja kostnega mozga ali krvi, kot sta akutna mieloidna levkemija (AML) ali mielodisplastični sindrom (MDS),
English: Pixuvri is for single use only.
Slovenian: Zdravilo Pixuvri je namenjeno le za enkratno uporabo.
English: The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.
Slovenian: Koristi zdravljenja s piksantronom niso bile dokazane, ko je bil uporabljen kot kemoterapevtsko zdravljenje pete ali kasnejše izbire pri bolnikih, ki se niso odzvali na zadnje zdravljenje.
English: - If you get any side effect, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: Pixuvri is given on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles.
Slovenian: Kako pogosto se daje zdravilo Pixuvri Zdravilo Pixuvri se daje 1., 8. in 15. dan vsakega 28-dnevnega cikla, do največ 6 ciklov.
English: The Fisher exact test was used to compare proportions in the Pixuvri and comparator chemotherapeutic groups.
Slovenian: Za primerjavo deležev v skupinah, ki sta prejemali zdravilo Pixuvri in primerjalni kemoterapevtik, so uporabili Fisherjev eksaktni test.
English: International Prognostic Index (IPI) score ≥ 2, and 60% had received ≥ 3 prior chemotherapies.
Slovenian: stopnjo bolezni po razvrstitvi Ann Arbor, 74 % bolnikov je imelo ob izhodišču rezultat ≥ 2 po Mednarodnem prognostičnem indeksu (IPI), 60 % bolnikov pa je v preteklosti prejelo ≥ 3 kemoterapij.
English: The cardiotoxic potential of Pixuvri compared with equiactive doses of doxorubicin and mitoxantrone in treatment-naïve and doxorubicin-pre-treated mice was evaluated.
Slovenian: Ocenili so potencial zdravila Pixuvri za povzročanje kardiotoksičnosti v primerjavi z enako učinkovitimi odmerki doksorubicina in mitoksantrona pri miših, ki predhodno niso prejemale zdravljenja, in miših, ki so predhodno prejemale doksorubicin.
English: Decreases in white and red blood cells and alterations in bone marrow, spleen, kidney, and testes were observed.
Slovenian: Opazili so zmanjšanje števila levkocitov in eritrocitov ter spremembe v kostnem mozgu, vranici, ledvicah in testisih.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (15°C to 25°C) and daylight exposure in polyethylene (PE) standard infusion bags.
Slovenian: Raztopina ostane kemično in fizično stabilna 24 ur, če je shranjena pri sobni temperaturi (15 °C do 25 °C), in pri izpostavljenosti dnevni svetlobi v standardnih vrečkah za infundiranje iz polietilena (PE).
English: Adequate contraceptive precautions must be used when receiving Pixuvri and for up to 6 months after treatment.
Slovenian: Med uporabo zdravila Pixuvri in do 6 mesecev po njej morate uporabljati ustrezne kontracepcijske metode.
English: Pixuvri 29 mg powder for concentrate for solution for infusion pixantrone
Slovenian: Pixuvri 29 mg prašek za koncentrat za raztopino za infundiranje
English: < 0.5 x 109/l
Slovenian: < 0,5 x 10
English: Patients treated with Pixuvri demonstrated 40% improvement in progression-free-survival compared to patients treated with comparator agents with 2.7 months longer median PFS ( hazard ratio (HR)=0.60, logrank p=0.005) (see Figure 1 below).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Pixuvri, je bilo preživetje brez napredovanja bolezni 40 % daljše, mediana preživetja brez napredovanja bolezni pa 2,7 mesecev daljša kot pri bolnikih, ki so prejemali primerjalno zdravilo (razmerje ogroženosti (HR) = 0,60, logrank p = 0,005) (glejte sliko 1 spodaj).
English: Coagulation parameters, specifically international normalised ratio (INR), should be monitored in the days immediately following the initiation of Pixuvri concurrent therapy.
Slovenian: V dneh takoj po začetku sočasnega zdravljenja z zdravilom Pixuvri je treba spremljati parametre koagulacije, predvsem mednarodno normalizirano razmerje (INR).
English: Pain/redness of the injection site may occur rarely during infusion of Pixuvri.
Slovenian: Med infundiranjem zdravila Pixuvri se lahko na mestu injiciranja redko pojavi bolečina/rdečica.
English: Reconstitution/preparation for intravenous administration Each single-use vial of Pixuvri contains pixantrone dimaleate equivalent to 29 mg pixantrone.
Slovenian: Rekonstitucija/priprava za intravensko infundiranje Ena viala zdravila Pixuvri za enkratno uporabo vsebuje piksantronijev dimaleat, ki ustreza 29 mg piksantrona.
English: Reconstitution and dilution
Slovenian: Rekonstitucija in redčenje
English: Special precautions for disposal and handling Pixuvri is a cytotoxic agent.
Slovenian: Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Pixuvri je citotoksično.
English: Delay treatment and monitor until recovery.Consider discontinuation for persistent decline in LVEF** of ≥ 15% of baseline value.
Slovenian: Pri vztrajajočem zmanjševanju LVEF** ≥ 15 % izhodiščne vrednosti pretehtajte možnost prekinitve zdravljenja.