FrancophonIA/ELRC3.0 huggingface dataset:
English: Pixuvri is for single use only.
Croatian: Pixuvri je namijenjen samo za jednokratnu primjenu.
English: This yields a dark blue solution with a pixantrone concentration of 5.8 mg/ml.
Croatian: Tako nastaje tamnoplava otopina piksantrona u koncentraciji 5,8 mg/ml.
English: Coagulation parameters, specifically international normalised ratio (INR), should be monitored in the days immediately following the initiation of Pixuvri concurrent therapy.
Croatian: Potrebno je pratiti koagulacijske parametre, posebice INR (engl. international normalised ratio), već prvih dana nakon započetog istovremenog liječenja lijekom Pixuvri i varfarinom.
English: Pixuvri caused maternal and foetal toxicity in rats and rabbits, even at a dose as low as 1.8 mg/kg given on days 9-11 of pregnancy, higher doses resulting in abortions and total embryo resorption.
Croatian: Pixuvri je pokazao toksičnost u majke i fetusa u miševa i kunića, čak i u niskim dozama od 1,8 mg/kg, primijenjenim 9.-11. dan trudnoće.
English: Uncommon Anxiety, insomnia, sleep disorder
Croatian: Manje često Anksioznost, nesanica, poremećaj spavanja
English: 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.
Croatian: Ukupni klirens piksantrona iz plazme je umjeren do velik i iznosi 72,7 l/h, a izlučivanje putem bubrega je manje od 10% primijenjene doze unutar 0-24 sata.
English: The recommended dose is 50 mg/m2 of pixantrone on days 1, 8, and 15 of each 28-day cycle for up to
Croatian: Preporučena doza iznosi 50 mg/m2 piksantrona 1., 8., i 15. dana svakog 28-dnevnog ciklusa liječenja, do ukupno 6 ciklusa.
English: Pixuvri is given through a drip into a vein (by intravenous infusion).
Croatian: Pixuvri se daje infuzijom u venu (intravenskom infuzijom).
English: 5.2 Pharmacokinetic properties Absorption
Croatian: 5.2 Farmakokinetička svojstva
English: Reconstitution and dilution
Croatian: Rekonstitucija i razrjeđivanje
English: Bilirubin urine, blood phosphorus increased, blood urea increased, gamma-glutamyltransferase increased, neutrophil count increased, weight decreased
Croatian: Bilirubin u urinu, povišen fosfor u krvi, povišena urea u krvi, povišena gama-glutamiltransferaza, povišen broj neutrofila, pad tjelesne težine
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.
Croatian: I sa sivim čepom od butilne gume s aluminijskim prstenom i crvenom plastičnom kapicom, koja sadrži 50 mg piksantrondimaleata, što odgovara 29 mg piksantrona.
English: You might get infections more easily after you have been given Pixuvri.
Croatian: Nakon što ste primili Pixuvri možete lakše dobiti infekciju.
English: Pixantrone was a poor inhibitor of OATP1B1 and OATP1B3 uptake transporters in vitro.
Croatian: In vitro piksantron je bio slab inhibitor preuzimanja transportera OATP1B1 i OATP1B3.
English: The pharmacokinetics of Pixuvri was dose-independent in the 3 mg/m2 to105 mg/m2 dose range and no substantial differences were observed when the medicinal product was given as a single agent or in combination studies.
Croatian: Farmakokinetička svojstva lijeka Pixuvri ovise o dozi u rasponu od 3 mg/m2 do 105 mg/m2 i nisu primijećene bitne razlike u ispitivanjima u kojima se lijek koristio kao monoterapija ili u kombinaciji s drugim lijekovima.
English: Lactose monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid laktoza hidrat natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
English: - Warfarin to prevent blood clot formation - Theophylline to treat lung conditions like emphysema or asthma - Amitriptyline to treat depression - Olanzapine, Clozapine to treat schizophrenia or maniac depression - Haloperidol to treat anxiety and sleeplessness - Ondansetron to prevent nausea and vomiting during chemotherapy - Propranolol to treat high blood pressure
Croatian: - Varfarina za sprječavanje zgrušavanja krvi - Teofilina za liječenje stanja poput emfizema ili astme - Amitriptilina za liječenje depresije - Olanzapina, klozapina za liječenje shizofrenije ili manične depresije - Haloperidola za liječenje anksioznosti ili poremećaja spavanja - Ondansetrona za prevenciju mučnine i povraćanja tijekom kemoterapije - Propranolola za liječenje visokog tlaka
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.
Croatian: U 11 bolesnika liječenih lijekom Pixuvri ovi su događaji bili stupnja 1-2, a u 2
English: This medicinal product contains approximately 1000 mg (43 mmol) sodium per dose after dilution.
Croatian: Ovaj lijek, nakon razrjeđenja, sadrži oko 1000 mg (43 mmol) natrija po dozi.
English: The mixture should be a clear and dark blue solution.
Croatian: Mješavina mora biti bistra otopina tamnoplave boje.
English: Theophylline: when co-administering the narrow-therapeutic index medicinal product theophylline, which is primarily metabolised by CYP1A2, there is a theoretical concern that this substrate may increase in concentration resulting in theophylline toxicity.
Croatian: Teofilin: kada se istovremeno primjenjuje teofilin, lijek uskog terapijskog indeksa, a koji se prvenstveno metabolizira pomoću CYP1A2, postoji teoretska mogućnost porasta koncentracije teofilina i njegove posljedične toksičnosti.
English: The other ingredients are lactose monohydrate, sodium hydroxide, hydrochloric acid, and sodium chloride.
Croatian: Drugi sastojci su laktoza hidrat, natrijev hidroksid, kloridna kiselina i natrijev klorid.
English: * ADRs discussed below
Croatian: * rasprava o nuspojavama u nastavku
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).
Croatian: Medijan ukupnog preživljenja za bolesnike liječene lijekom Pixuvri bio je 2,6 mjeseca duži u usporedbi s bolesnicima iz kontrolne skupine (omjer hazarda=0,79, log rang p=0,25) (vidjeti Sliku 2 u nastavku).
English: Hepatic uptake of pixantrone is possibly mediated by OCT1 active transporters and biliary excretion by P-gp and BCRP.
Croatian: U preuzimanju (engl. uptake) piksantrona u jetru vjerojatno sudjeluju aktivni transporteri OCT1, a u izlučivanju u žuč P-gp i BCRP.
English: Pixuvri is used for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin Lymphomas.
Croatian: Pixuvri se koristi za liječenje odraslih bolesnika s višekratno relapsirajućim ili refraktornim agresivnim ne-Hodgkinovim limfomom.
English: The safety and efficacy of Pixuvri in patients with impaired hepatic function has not been established.
Croatian: Sigurnost i djelotvornost lijeka Pixuvri u bolesnika s oštećenom funkcijom jetre nisu ustanovljene.
English: Any grade 3 or 4 NYHA* cardiovascular toxicity or persistent LVEF** decline
Croatian: 4 prema NYHA* ili trajno smanjena LVEF**
English: Dose modification guidelines
Croatian: Smjernice za prilagođavanje doze
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.
Croatian: Varfarin se djelomično metabolizira pomoću CYP1A2, zbog toga kod istovremene primjene postoji teoretska mogućnost učinka inhibicije njegovog metabolizma na očekivano djelovanje.
English: Very common Nausea, vomiting
Croatian: Vrlo često Mučnina, povraćanje Često
English: Breast-feeding It is unknown whether Pixuvri/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se Pixuvri/metaboliti u majčino mlijeko.
English: Pixuvri contains sodium
Croatian: Pixuvri sadrži natrij
English: There is currently no information on the safety and efficacy of patients with poor performance status (ECOG > 2).
Croatian: Trenutno nema podataka o sigurnoj i djelotvornoj primjeni ovog lijeka u bolesnika lošeg funkcionalnog stanja (prema ECOG > 2) Potreban je oprez pri liječenju ovih bolesnika.
English: Immunisation may be ineffective when given during Pixuvri therapy.
Croatian: Imunizacija provedena za vrijeme terapije lijekom Pixuvri može biti neučinkovita.
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.
Croatian: Korist od liječenja piksantronom nije utvrđena u bolesnika kod kojih se on koristio kao peta ili kasnija linija kemoterapije a koji su bili refraktorni na prethodnu terapiju.
English: Upon reconstitution and dilution, this medicinal product contains approximately 1g (43 mmol) sodium per dose, equivalent to 50% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Nakon rekonstitucije i razrjeđivanja, ovaj lijek sadrži otprilike 1 g (43 mmol) natrija po dozi, što odgovara 50% maksimalnog dnevnog unosa od 2 g natrija prema preporukama Svjetske zdravstvene organizacije za odraslu osobu.
English: Pharmacotherapeutic group: Antineoplastic agents, anthracyclines, and related substances.
Croatian: Farmakoterapijska skupina: Antineoplastici (citostatici), antraciklini, i srodne tvari.
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).
Croatian: Rezultati za bolesnike prethodno liječene rituksimabom još uvijek pokazuju veću korist od liječenja lijekom Pixuvri u usporedbi s usporednim lijekom u smislu stope sveukupnog odgovora (31,6% u skupini liječenoj lijekom Pixuvri u odnosu na 17,9% u skupini liječenoj usporednim lijekom) i medijana vremena preživljenja do progresije bolesti (3,3 mjeseca u skupini liječenoj lijekom Pixuvri u usporedbi s 2,5 mjeseca u skupini liječenoj usporednim lijekom).
English: Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL).
Croatian: Pixuvri je indiciran kao monoterapija u liječenju odraslih bolesnika s višekratno relapsirajućim ili refraktornim agresivnim B-staničnim ne-Hodgkinovim limfomima (NHL).
English: How often Pixuvri is given
Croatian: Kako često se primjenjuje Pixuvri
English: After reconstitution, each ml of concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone.
Croatian: Nakon rekonstitucije, jedan ml koncentrata sadrži količinu piksantrondimaleata koja odgovara 5,8 mg piksantrona.
English: Decreases in white and red blood cells and alterations in bone marrow, spleen, kidney, and testes were observed.
Croatian: Primijećen je pad broja leukocita i eritrocita i promjene u koštanoj srži, slezeni, bubrezima i testisima.
English: Common Neutropenic infection, respiratory tract infection, infection, sepsis
Croatian: Infekcija zbog neutropenije, infekcija dišnih puteva, infekcija, sepsa
English: - if you follow a specific sodium restricted diet. - if you are taking other medicines which could interact with Pixuvri (see ‘Taking other medicines' below).
Croatian: - ako uzimate druge lijekove koje mogu međusobno djelovati s lijekom Pixuvri (pogledajte dio
English: The terminal half-life ranged from 14.5 to 44.8 hr with a mean of 23.3 ± 8.0 (n=14, CV=34%) and a median of 21.2 hr. Due to the limited contribution of renal clearance, plasma clearance is mainly non-renal.
Croatian: Terminalni poluvijek se kreće od 14,5 do 44,8 h sa srednjom vrijednošću od 23,3 ± 8,0 (n=14, CV=34%) i medijanom od 21,2 h.
English: Average exposures as single agent accounted for:
Croatian: Prosječne ekspozicije kada se primjenjuje kao monoterapija:
English: Common Taste disturbances, paraesthesia, headache,
Croatian: Poremećaji osjeta okusa, parestezija, glavobolja,
English: Common Anorexia, hypophosphataemia Uncommon Hyperuricaemia, hypocalcaemia, hyponatraemia,
Croatian: Anoreksija, hipofosfatemija Manje često Hiperuricemija, hipokalcemija, hiponatremija
English: Lactose monohydrate, sodium chloride, hydrochloric acid, sodium hydroxide.
Croatian: Laktoza hidrat, natrijev klorid, kloridna kiselina, natrijev hidroksid.
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.
Croatian: Dokazana kemijska i fizikalna stabilnost u primjeni je 24 sata na sobnoj temperaturi (15°C do 25°C) i uz izlaganje danjem svjetlu u standardnim polietilenskim (PE) vrećicama za infuziju.
English: Importantly, growth factor support was not routinely required and transfusions with red blood cells and platelets were uncommon.
Croatian: Važno je napomenuti da nije rutinski zahtijevala potporno liječenje faktorom rasta, a transfuzije eritrocita i trombocita nisu bile česte.
English: After repeated administrations of Pixuvri at doses as low as 0,1 mg/kg/day, a dose-dependent testicular atrophy was detected in the dogs.
Croatian: Plodnost Nakon ponovljenih primjena lijeka Pixuvri već u niskim dozama od 0,1 mg/kg/dan, zabilježena je atrofija testisa u pasa, ovisna o dozi.
English: 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
Croatian: Medijan dobi bolesnika bio je 59 godina, 61% su bili muškarci, 64% bijelci, 76% bolesnika je prema polaznim karakteristikama bolesti prema Ann Arbor-klasifikaciji pripadalo stadiju III/IV, 74% je imalo polaznu vrijednost prema rezultatu internacionalnog prognostičkog indeksa (IPI - engl. international prognostic index) ≥ 2 boda, a 60% je ranije primilo ≥ 3 kemoterapije.
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.
Croatian: Nakon rekonstitucije s 5 ml 0,9 %-tne otopine natrijevog klorida za injekcije (9 mg/ml) jedan ml koncentrata sadrži piksantrondimaleat koji odgovara 5,8 mg piksantrona.
English: Reconstituted pixantrone solution is stable for up to 24 hours at room temperature (15°C to 25°C) in standard infusion bags.
Croatian: Pripremljena otopina piksantrona stabilna je do 24 sata na sobnoj temperaturi (15 °C do 25 °C) u standardnim vrećicama za infuziju.
English: Progression Free Survival Probability
Croatian: Vjerojatnost preživljenja bez progresije bolesti
English: Uncommon Chills, injection site coldness, local reaction
Croatian: Manje često Zimica, osjećaj hladnoće na mjestu injekcije, lokalna reakcija
English: Mechanism of action The active substance of Pixuvri is pixantrone , a cytotoxic aza-anthracenedione.
Croatian: Djelatna tvar lijeka Pixuvri je piksantron koji je citotoksični aza-antracendion.
English: Blood counts should be closely monitored when co-administered with agents which inhibit such transporters such as cyclosporine A or tacrolimus, commonly used to control chronic graft-versus-host disease, and the anti-HIV agents ritonavir, saquinavir, or nelfinavir.
Croatian: Potrebno je pažljivo pratiti kompletnu krvnu sliku kada se piksantron istovremeno primjenjuje s tvarima koje inhibiraju ove transportere, kao što su ciklosporin A ili takrolimus, koji se obično koriste kod kontrole kronične bolesti transplantata protiv domaćina (GvHD) ili anti-HIV lijekovima ritonavirom,
English: Pixuvri with food and drink You do not have to change your diet after treatment with Pixuvri unless instructed by your doctor.
Croatian: Nije potrebno mijenjati način prehrane nakon liječenja lijekom Pixuvri, osim ako Vam to ne savjetuje liječnik.
English: Table 3 Adverse drug reactions reported related to Pixuvri in completed Pixuvri single agent studies by frequency System Organ Class
Croatian: Tablica 3 Nuspojave povezane s primjenom lijeka Pixuvri zabilježene u dovršenim ispitivanjima lijeka Pixuvri kao jedinog lijeka, prema učestalosti Klasifikacija organskog sustava
English: Adequate contraceptive precautions must be used when receiving Pixuvri and for up to 6 months after treatment.
Croatian: Kada se prima Pixuvri, mora se koristiti adekvatna kontracepcija do 6 mjeseci nakon liječenja.
English: The cardiotoxic potential of Pixuvri compared with equiactive doses of doxorubicin and mitoxantrone in treatment-naïve and doxorubicin-pre-treated mice was evaluated.
Croatian: Ispitan je kardiotoksični potencijal lijeka Pixuvri u usporedbi s jednako aktivnim dozama doksorubicina i mitoksantrona u miševa koji nisu prethodno liječeni i onih već liječenih doksorubicinom.
English: The reconstituted and diluted solution is stable for up to 24 hours at room temperature (15°C to 25°C) and daylight exposure in standard polyethylene (PE) infusion bags.
Croatian: Rekonstituirana i razrijeđena otopina stabilna je do 24 sata na sobnoj temperaturi (15°C do 25°C) i izložena svjetlosti u standardnim polietilenskim (PE) vrećicama za infuziju.
English: It appears as a dark blue powder which comes in vials containing 29 mg of pixantrone.
Croatian: Dolazi u obliku tamnoplavog praška koji se isporučuje u bočicama koje sadrže 29 mg piksantrona.
English: Uncommon Hyperbilirubinaemia, hepatotoxicity
Croatian: Manje često Hiperbilirubinemija, hepatotoksičnost
English: Patients treated with Pixuvri are likely to experience myelosuppression (neutropenia, leukopenia, anaemia, thrombocytopenia, and lymphopenia) with the predominant manifestation being neutropenia.
Croatian: Bolesnici koji su primali Pixuvri skloni su razviti mijelosupresiju (neutropenija, leukopenija, anemija, trombocitopenija i limfopenija) koja se prvenstveno manifestira neutropenijom.
English: Single doses of pixantrone up to 158 mg/m2 have been given in dose-escalation clinical trials without evidence of dose-related toxicity.
Croatian: U kliničkim ispitivanjima povećavanja doze, primjenjivane su pojedinačne doze piksantrona do 158 mg/m2 bez znakova toksičnosti ovisne o dozi.
English: The mixture should be a dark blue solution.
Croatian: Mješavina mora biti otopina tamnoplave boje.
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).
Croatian: Bolesnici liječeni lijekom Pixuvri pokazali su 40% bolje preživljenje bez progresije bolesti, u usporedbi s bolesnicima liječenim kontrolnim lijekom, s medijanom vremena preživljenja do progresije bolesti dužim za 2,7 mjeseci (omjer hazarda [engl. hazard ratio -HR]=0,60, log rang p=0,005) (vidjeti Sliku 1 u nastavku).
English: Each vial contains 50 mg pixantrone dimaleate (equivalent to 29 mg pixantrone).
Croatian: Jedna bočica sadrži 50 mg piksantrondimaleata (što odgovara 29 mg piksantrona).
English: Photosensitivity is a potential risk based on in vitro and in vivo non-clinical data.
Croatian: Potencijalni rizik za pojavu fotosenzitivnih reakcija utemeljen je na podacima dobivenim in vitro i in vivo pretkliničkim ispitivanjima.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: Ovo treba uzeti u obzir kod bolesnika na dijeti s ograničenjem unosa soli.
English: Kidney function and histology were similarly not affected both in 4- and 26-week studies.
Croatian: Slično, nije promijenjena ni funkcija bubrega niti su nastale histološke promjene na bubregu, kako tijekom 4-tjednog, tako i tijekom 26-tjednog ispitivanja.
English: 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.
Croatian: Heart Association [NYHA]), infarktom miokarda u zadnjih 6 mjeseci, teškom aritmijom, nekontroliranom hipertenzijom, nekontroliranom anginom pektoris ili ranijom terapijom kumulativnim dozama doksorubicina ili njegovog ekvivalenta koje prelaze 450 mg/m2, potrebno je pažljivo procijeniti odnos rizika i koristi od terapije prije samog započinjanja liječenja lijekom Pixuvri.
English: Reconstitution/preparation for intravenous administration Each single-use vial of Pixuvri contains pixantrone dimaleate equivalent to 29 mg pixantrone.
Croatian: Rekonstitucija/priprema za intravensku primjenu Jedna bočica za jednokratnu primjenu lijeka Pixuvri sadrži piksantrondimaleat koji odgovara 29 mg piksantrona.
English: - taste disturbances - abnormal sensations of the skin such as numbness, tingling, pricking (paraesthesia) - headache - sleepiness - tiredness - inflammation of the eyes (conjunctivitis) - diarrhoea - pain in the abdomen - inflammation and/or ulceration of the throat and the mouth - dry mouth, constipation, indigestion, loss of appetite - skin changes such as redness and itching of the skin, nail changes - damage to the heart, decrease in heart's ability to pump blood, blockage of electrical signals in your heart, uneven or fast heartbeat.
Croatian: - abnormalan osjet na koži poput utrnulosti, trnaca, bockanja (parestezija) - glavobolja - pospanost - umor - upale očiju (konjunktivitis) - proljev - bol u trbuhu - upala i/ili ulceracije u grlu i ustima - suha usta, zatvor, probavne tegobe, gubitak apetita - promjene na koži poput crvenila i svrbeža kože, promjene na noktima
English: Pixuvri is for intravenous use only.
Croatian: Pixuvri je namijenjen isključivo za intravensku primjenu.
English: Common Conjunctivitis Uncommon Dry eye, keratitis
Croatian: Konjunktivitis Manje često Suho oko, keratitis
English: Calculation of the individual dose to be administered to a patient must be based on the strength of the reconstituted solution that contains 5.8mg/ml pixantrone and the dose recommendation of 50 mg/m2.
Croatian: Izračun pojedinačne doze koju treba primijeniti pojedinom bolesniku mora se temeljiti na jačini rekonstituirane otopine koja sadrži 5,8 mg/ml piksantrona i preporučenoj dozi od 50 mg/m2 . U nekim ispitivanjima i objavljenim radovima preporučena doza se temelji na djelatnoj tvari u obliku soli (piksantrondimaleatu).
English: Delay treatment until recovery to platelet count ≥ 50 x 109/l and ANC** ≥ 1.0 x 109/l.
Croatian: Odgoditi primjenu do oporavka broja trombocita ≥ 50 x 109/l i ABN** ≥ 1,0 x 109/l
English: Hepatic clearance approximates the hepatic plasma flow, suggesting a high hepatic extraction ratio and, therefore, efficient parent active substance elimination.
Croatian: Jetreni klirens odgovara protoku plazme kroz jetru, ukazujući na visoku stopu izlučivanja putem jetre, dakle učinkoviti put eliminacije ishodišnog spoja.
English: In the EU recommended dose refers to the base of the active substance (pixantrone).
Croatian: U EU se preporučena doza odnosi na djelatnu tvar (piksantron) u obliku baze.
English: Thus, Pixuvri should be used with caution in patients with renal impairment.
Croatian: Stoga Pixuvri treba primjenjivati s oprezom u bolesnika s oštećenom funkcijom bubrega.
English: Aseptically withdraw the volume needed for the required dose (based on 5.8 mg/ml concentration) and transfer to a 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Aseptički uvucite volumen potreban za željenu dozu (bazirano na koncentraciji od 5,8 mg/ml) i prenesite u vrećicu za infuziju s 250 ml 0,9 %-tne otopine natrijevog klorida (9 mg/ml) za injekcije.
English: Common: may affect up to 1 in 10 people - infection such as lung infection, skin infections, infections with low white blood cells, thrush - fever - severe blood infection (sepsis)
Croatian: Česte nuspojave, mogu se javiti u do 1 na 10 osoba: - infekcije poput upale pluća, kožnih infekcija, infekcija koje prati nizak broj bijelih krvnih stanica, kandidijaza