FrancophonIA/ELRC3.0 huggingface dataset:
English: Diluent used to prepare solution for infusion
Croatian: Sredstvo za razrjeđivanje upotrijebljeno za pripremu otopine za infuziju
English: Therefore, men being treated with Polivy are advised to have sperm samples preserved and stored before treatment (see section 4.6).
Croatian: Stoga se muškarcima koji se liječe lijekom Polivy savjetuje da prije liječenja sačuvaju i pohrane uzorke sperme (vidjeti dio 4.6).
English: 20 mL vial (colourless Type 1 glass) closed with a stopper (fluororesin laminate), with an aluminum seal with plastic flip-off cap containing 140 mg polatuzumab vedotin.
Croatian: Bočica volumena 20 ml (bezbojno staklo tipa 1), zatvorena čepom (laminiranim fluorosmolom) i aluminijskim zatvaračem s plastičnom flip-off kapicom, koja sadrži 140 mg polatuzumab vedotina.
English: Liver damage
Croatian: Oštećenje jetre
English: Patients should be monitored for symptoms of PN such as hypoesthesia, hyperesthesia, paraesthesia, dysesthesia, neuropathic pain, burning sensation, muscle weakness, or gait disturbance.
Croatian: Bolesnike treba nadzirati zbog moguće pojave simptoma periferne neuropatije, kao što su hipoestezija, hiperestezija, parestezija, dizestezija, neuropatska bol, osjećaj žarenja, mišićna slabost ili poremećaj hoda.
English: • feeling tired (anaemia)
Croatian: • umor (anemija)
English: In order to further confirm the safety and efficacy of polatuzumab vedotin in combination with BR the MAH will provide the primary CSR for study GO29365 including the primary analysis of Arm H (n=64) as well as a pooled analysis of Arm G (n=42) and Arm H (n=64).
Croatian: Kako bi dodatno potvrdio sigurnost i djelotvornost polatuzumab vedotina u kombinaciji s BR-om, nositelj odobrenja mora dostaviti primarno izvješće o kliničkom ispitivanju za ispitivanje GO29365, uključujući primarnu analizu skupine H (n=64) te objedinjenu analizu skupine G (n=42) i skupine H (n=64).
English: Investigator-assessed progression free survival (PFS) was an exploratory endpoint which was not type 1 error controlled.
Croatian: Preživljenje bez progresije bolesti (engl. progression-free surival, PFS) prema ocjeni ispitivača bilo je eksploracijska mjera ishoda koja nije bila kontrolirana za pogrešku tipa 1.
English: In vivo studies in rats dosed with polatuzumab vedotin (radiolabel on MMAE) demonstrate that the majority of radioactivity is excreted in faeces and the minority of radioactivity is excreted in urine.
Croatian: Ispitivanja in vivo na štakorima koji su primali polatuzumab vedotin (s radiooznačenim MMAE-om) pokazala su da se većina radioaktivnosti izlučuje kroz feces, a manji dio kroz mokraću.
English: The median PFS in the Polivy+BR arm was 7.6 months (95% CI: 6.0, 17.0) vs 2.0 months (95% CI: 1.5, 3.7) in the control arm.
Croatian: Medijan PFS-a u skupini koja je primala Polivy + BR iznosio je 7,6 mjeseci (95% CI: 6,0; 17,0) naspram 2,0 mjeseci (95% CI: 1,5; 3,7) u kontrolnoj skupini.
English: Polivy is for intravenous use.
Croatian: Polivy je namijenjen za intravensku primjenu.
English: Follow applicable proper handling and disposal procedure (see section 6.6).
Croatian: Treba se pridržavati primjenjivog postupka za pravilno rukovanje lijekom i njegovo zbrinjavanje (vidjeti dio 6.6).
English: Withhold all treatment until ANC recovers to > 1000/µL.
Croatian: Odgoditi primjenu svih lijekova dok ABN ne poraste na > 1000/µl.
English: 5% Glucose
Croatian: Otopina glukoze (5%)
English: Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort [Hypericum perforatum]) may decrease the exposure of unconjugated MMAE.
Croatian: Snažni induktori CYP3A4 (npr. rifampicin, karbamazepin, fenobarbital, fenitoin, gospina trava [Hypericum perforatum]) mogli bi smanjiti izloženost nekonjugiranom MMAE-u.
English: • severe infections
Croatian: • teške infekcije
English: NAME OF THE MEDICINAL PRODUCT Polivy 140 mg powder for concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Polivy 140 mg prašak za koncentrat za otopinu za infuziju.
English: Across seven clinical studies, 14 out of 536 (2.6%) patients tested positive for anti-polatuzumab vedotin antibodies at one or more post-baseline time points.
Croatian: U sedam je kliničkih ispitivanja 14 od 536 bolesnika (2,6%) bilo pozitivno na protutijela na polatuzumab vedotin u jednoj ili više vremenskih točaka nakon početka ispitivanja.
English: Gastrointestinal toxicity events were reported in 80.0% of patients in the Polivy plus BR arm compared to 64.1% of patients in the BR arm.
Croatian: Slučajevi gastrointestinalne toksičnosti prijavljeni su u 80,0% bolesnika u skupini koja je primala Polivy plus BR, u usporedbi sa 64,1% bolesnika koji su primali samo BR.
English: • pneumonia (lung infection)
Croatian: • upala pluća (plućna infekcija)
English: If a prior dose reduction to 1.4 mg/kg has occurred, discontinue Polivy.
Croatian: Ako je doza prethodno već smanjena na 1,4 mg/kg, liječenje lijekom Polivy treba obustaviti.
English: • viral infections
Croatian: • virusne infekcije
English: If you are a woman of childbearing age, you must use effective contraception during treatment and for 9 months after the last dose of Polivy.
Croatian: Ako ste žena koja može zatrudnjeti, morate koristiti učinkovitu kontracepciju tijekom liječenja i još 9 mjeseci nakon posljednje doze lijeka Polivy.
English: Very common weight decreased Common transaminase elevation, lipase increase, hypophosphataemia Injury, poisoning and procedural complications Very Common infusion-related reactionsb a
Croatian: Pretrage vrlo često smanjenje tjelesne težine često povišene vrijednosti transaminaza, povišene vrijednosti lipaze, hipofosfatemija Ozljede, trovanja i proceduralne komplikacije vrlo često reakcije povezane s infuzijom b a
English: Patients with pre-existing PN may experience worsening of this condition.
Croatian: U bolesnika s otprije postojećom perifernom neuropatijom može doći do pogoršanja toga stanja.
English: The adverse drug reactions (ADRs) described in this section were identified during treatment and follow-up of previously treated DLBCL patients from the pivotal clinical trial GO29365.
Croatian: Nuspojave opisane u ovom dijelu utvrđene su tijekom liječenja i praćenja prethodno liječenih bolesnika s DLBCL-om iz pivotalnog kliničkog ispitivanja GO29365.
English: In order to provide further evidence of efficacy and safety of polatuzumab vedotin in DLBCL, the MAH will provide Study GO39942, a randomized, double-blind, placebo controlled trial that evaluates polatuzumab vedotin in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone) versus R-CHOP in patients with previously untreated diffuse large B-cell lymphoma.
Croatian: Kako bi osigurao daljnje dokaze o sigurnosti i djelotvornosti polatuzumab vedotina u liječenju DLBCL-a, nositelj odobrenja mora provesti randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje GO39942 radi ocjene polatuzumab vedotina u kombinaciji s protokolom R-CHP (rituksimab, ciklofosfamid, doksorubicin, prednizon) u odnosu na protokol R-CHOP u bolesnika s prethodno neliječenim difuznim B-velikostaničnim limfomom.
English: Pack size of one vial.
Croatian: Veličina pakiranja: 1 bočica.
English: Withdraw the required volume of reconstituted solution from the Polivy vial using a sterile syringe and dilute into the intravenous infusion bag.
Croatian: Sterilnom štrcaljkom izvucite potreban volumen rekonstituirane otopine iz bočice lijeka Polivy i dodajte ga u vrećicu za intravensku infuziju.
English: • Do not use this medicine after the expiry date which is stated on the carton and the vial after
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake “Rok valjanosti“ ili „EXP“.
English: How Polivy works
Croatian: Kako Polivy djeluje
English: Polivy and any concomitant chemotherapy should be withheld if PML is suspected and permanently discontinued if the diagnosis is confirmed.
Croatian: Posumnja li se na PML, primjenu lijeka Polivy i svake istodobne kemoterapije treba odgoditi te trajno prekinuti ako se dijagnoza potvrdi.
English: If ANC recovers to > 1000/µL on or before Day 7, resume all treatment without any additional dose reductions.
Croatian: Ako ABN poraste na > 1000/µl unutar 7 dana, liječenje svim lijekovima treba nastaviti bez dodatnih smanjenja doza.
English: For the first instance of Grade 3 wheezing, bronchospasm, or generalized urticaria, permanently discontinue Polivy.
Croatian: Kod prvog nastupa piskanja pri disanju, bronhospazma ili generalizirane urtikarije 3. stupnja treba trajno obustaviti liječenje lijekom Polivy.
English: Tumour lysis syndrome
Croatian: Sindrom tumorske lize
English: For recurrent Grade 2 wheezing or urticaria, or for recurrence of any Grade 3 symptoms, permanently discontinue Polivy.
Croatian: Kod ponovljenog nastupa piskanja pri disanju ili urtikarije 2. stupnja odnosno ponovljenog nastupa bilo kojeg simptoma 3. stupnja treba trajno obustaviti liječenje lijekom Polivy.
English: Polatuzumab vedotin is expected to undergo catabolism in patients, resulting in the production of small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE related catabolites.
Croatian: U bolesnika se očekuje katabolizam polatuzumab vedotina, kojim dolazi do nastanka malih peptida, aminokiselina, nekonjugiranog MMAE-a i katabolita povezanih s nekonjugiranim MMAE-om.
English: Eye disorders Common vision blurred
Croatian: Poremećaji oka često zamagljen vid
English: p-value (Log-Rank test, stratified***) Overall Response Rate* (INV-assessed) at End of Treatment** Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Complete Response (%) (CR) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Partial Response (%) (PR) 95% CI Clopper-Pearson Best Overall Response Rate* (INV-assessed) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] Complete Response (%) (CR) 95% CI Clopper-Pearson Partial Response (%) (PR) 95% CI Clopper-Pearson
Croatian: p-vrijednost (log-rang test, stratificiran***) Stopa ukupnog odgovora* (prema ocjeni ispitivača) na kraju liječenja** Bolesnici s odgovorom (%) (potpun odgovor, djelomičan odgovor) Razlika u stopi odgovora (%) [95% CI] p-vrijednost (CMH hi-kvadrat test***) Potpun odgovor (%) Razlika u stopi odgovora (%) [95% CI] p-vrijednost (CMH hi-kvadrat test***) Djelomičan odgovor (%) 95% CI prema Clopper-Pearsonu
English: Women should discontinue breast-feeding during treatment with Polivy.
Croatian: Žene trebaju prestati dojiti tijekom liječenja lijekom Polivy.
English: If air is removed, an infusion set with a vented spike is required to ensure accurate dosing during the infusion.
Croatian: Ako se iz vrećice ukloni zrak, za točno doziranje tijekom infuzije bit će potreban infuzijski set opremljen šiljkom s odzračnikom.
English: Withhold all treatment until platelets recover to >75,000/µL.
Croatian: Odgoditi primjenu svih lijekova dok broj trombocita ne poraste na > 75 000/µl.
English: The unadjusted estimate for OS HR was 0.42.
Croatian: Neprilagođen procijenjeni HR za OS iznosio je 0,42.
English: Polivy is given in combination with two other cancer medicines called rituximab and bendamustine.
Croatian: Polivy se daje u kombinaciji s još dva lijeka za liječenje raka, koji se zovu rituksimab i bendamustin.
English: The administration of Polivy in patients with moderate or severe hepatic impairment (bilirubin greater than 1.5 × upper limit of normal [ULN]) should be avoided.
Croatian: Treba izbjegavati primjenu lijeka Polivy u bolesnika s umjerenim ili teškim oštećenjem jetrene funkcije (bilirubin > 1,5 × gornja granica normale [GGN]).
English: In the BR arm, serious infections were reported in 30.8% of patients and fatal infections were reported in 10.3% of patients.
Croatian: U skupini koja je primala samo BR ozbiljne su infekcije prijavljene u 30,8% bolesnika, a infekcije sa smrtnim ishodom u 10,3% bolesnika.
English: Appropriate measures/prophylaxis in accordance with local guidelines should be taken prior to treatment with Polivy.
Croatian: Prije liječenja lijekom Polivy treba poduzeti odgovarajuće mjere/primijeniti profilaksu u skladu s lokalnim smjernicama.
English: In addition, no incompatibilities have been observed with infusion sets or infusion aids with product contacting materials of PVC, PE, polyurethane, polybutadiene, acrylonitrile butadiene styrene, polycarbonate, polyetherurethane, fluorinated ethylene propylene, or polytetrafluorethylene and with filter membranes composed of polyether sulfone or polysulfone.
Croatian: Uz to, nisu opažene ni inkompatibilnosti između lijeka Polivy i infuzijskih kompleta ili infuzijskih pomagala kod kojih su dijelovi koji dolaze u doticaj s lijekom izrađeni od PVC-a, PE-a, poliuretana, polibutadiena, akrilonitril-butadien-stirena, polikarbonata, polieteruretana, fluoriranog etilen propilena ili politetrafluoretilena, kao ni između lijeka Polivy i filtarskih membrana načinjenih od polietersulfona ili polisulfona.
English: • The other ingredients are: succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Croatian: • Drugi sastojci su sukcinatna kiselina, natrijev hidroksid, saharoza, polisorbat 20.
English: However, motor and sensorimotor PN have also been reported.
Croatian: Međutim, prijavljene su i motorička te senzomotorička periferna neuropatija.
English: Proper aseptic technique throughout the handling of this medicinal product should be followed.
Croatian: Tijekom rukovanja ovim lijekom treba se cijelo vrijeme pridržavati odgovarajuće aseptične tehnike.
English: PN has been reported in patients treated with Polivy as early as the first cycle of treatment, and the risk increases with sequential doses.
Croatian: U bolesnika liječenih lijekom Polivy već je u prvom ciklusu liječenja prijavljena periferna neuropatija, a rizik od nje povećava se sa svakom sljedećom dozom.
English: The study excluded patients with prior allogeneic HSCT, central nervous system lymphoma, transformed indolent lymphoma, grade 3b FL, significant cardiovascular or pulmonary disease, active infections, AST or alanine transaminase (ALT) >2.5× ULN or total bilirubin ≥1.5 x ULN, creatinine >1.5 x ULN (or CrCl <40 mL/min) unless due to underlying lymphoma.
Croatian: U ispitivanju nisu mogli sudjelovati bolesnici koji su prethodno bili podvrgnuti alogenom HSCT-u, kao ni oni koji su imali limfom u središnjem živčanom sustavu, transformirani indolentni limfom, folikularni limfom (FL) stadija 3b, značajnu kardiovaskularnu ili plućnu bolest, aktivne infekcije, AST ili alanin transaminazu (ALT) > 2,5 × GGN ili ukupni bilirubin ≥ 1,5 × GGN te kreatinin > 1,5 × GGN (ili CrCL < 40 ml/min), osim ako je uzrok odstupanja bio podležeći limfom.
English: In the Polivy plus BR arm, Grade 3 or higher neutropenia, thrombocytopenia, and anaemia were reported in 40%, 37.8%, and 24.4% of patients, respectively.
Croatian: U skupini koja je primala Polivy plus BR neutropenija, trombocitopenija i anemija 3. ili višeg stupnja težine prijavljene su u 40%, 37,8% odnosno 24,4% bolesnika.
English: Serious, life threatening or fatal infections, including opportunistic infections, such as pneumonia (including pneumocystis jirovecii and other fungal pneumonia), bacteraemia, sepsis, herpes infection, and cytomegalovirus infection have been reported in patients treated with Polivy (see section 4.8).
Croatian: U bolesnika liječenih lijekom Polivy prijavljene su ozbiljne, po život opasne ili smrtonosne infekcije, uključujući oportunističke infekcije, kao što su pneumonija (uključujući pneumoniju uzrokovanu gljivicom Pneumocystis jirovecii i druge gljivične pneumonije), bakterijemija, sepsa, herpesna infekcija i citomegalovirusna infekcija (vidjeti dio 4.8).
English: The monoclonal antibody part of the medicine attaches to a target on B cells.
Croatian: Monoklonsko protutijelo iz lijeka vezuje se za ciljni receptor na B-stanicama.
English: Tell your doctor or nurse if you notice any of the following side effects:
Croatian: Obratite se svom liječniku ili medicinskoj sestri ako primijetite bilo koju od sljedećih nuspojava:
English: INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: If platelets recover to > 75,000/µL on or before Day 7, resume all treatment without any dose reductions.
Croatian: Ako broj trombocita poraste na > 75 000/µl unutar 7 dana, liječenje svim lijekovima treba nastaviti bez smanjenja doza.
English: Polivy contains a cytotoxic component.
Croatian: Polivy sadrži citotoksičnu sastavnicu.
English: Most events were Grade 1-2, and Grade 3-4 events were reported in 22.2% of patients in the Polivy plus BR arm compared to 12.8% of patients in the BR arm.
Croatian: Većina događaja bila je 1. - 2. stupnja, dok su događaji 3. - 4. stupnja prijavljeni u 22,2% bolesnika koji su primali Polivy plus BR te 12,8% onih koji su primali samo BR.
English: • Keep the container in the outer carton in order to protect from light.
Croatian: • Spremnik čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: • if a bendamustine dose reduction to 50 mg/m2 has already occurred, discontinue all treatment.
Croatian: • ako je doza bendamustina prethodno već smanjena na 50 mg/m treba obustaviti primjenu svih lijekova
English: After the first 1.8 mg/kg polatuzumab vedotin dose, the acMMAE mean maximum concentration (Cmax) was 803 (± 233) ng/mL and the area under the concentration-time curve from time zero to infinity (AUCinf) was 1860 (±966) day•ng/mL.
Croatian: Srednja vrijednost maksimalne koncentracije (Cmax) acMMAE-a nakon prve doze polatuzumab vedotina od 1,8 mg/kg iznosila je 803 (± 233) ng/ml, a područje ispod krivulje koncentracije kroz vrijeme od nulte vremenske točke do beskonačnosti (AUCinf) iznosilo je 1860 (± 966) dan•ng/ml.
English: What Polivy is used for
Croatian: Za što se Polivy koristi
English: Per studied population in mild hepatic impairment (defined as AST or ALT >1.0 to 2.5 × ULN or total bilirubin >1.0 to 1.5 × ULN), there was a 40% increase in unconjugated MMAE exposure, which was not deemed clinically significant.
Croatian: U ispitivanoj populaciji s blagim oštećenjem jetrene funkcije (koje se definiralo kao AST ili ALT > 1,0 do 2,5 × GGN ili ukupni bilirubin > 1,0 do 1,5 × GGN) zabilježeno je povećanje izloženosti nekonjugiranom MMAE-u za 40%, koje se nije smatralo klinički značajnim.
English: What Polivy is
Croatian: Što je Polivy
English: ANNEX IV CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Croatian: ZAKLJUČCI EUROPSKE AGENCIJE ZA LIJEKOVE O DAVANJU UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Inspect the intravenous bag for particulates and discard if present.
Croatian: Provjerite ima li u vrećici za intravensku infuziju čestica i bacite je ako ih ima.
English: Up to 72 hours refrigerated (2 °C − 8 °C) or up to 8 hours at room temperature (9 °C − 25 °C) 1 To ensure product stability, do not exceed specified storage durations.
Croatian: Do 72 sata u hladnjaku (2°C - 8°C) ili do 8 sati na sobnoj temperaturi (9°C - 25°C) 1 Da bi se osigurala stabilnost lijeka, navedena vremena čuvanja ne smiju se prekoračiti.
English: Discard any unused portion left in the vial.
Croatian: Bacite svu neupotrijebljenu otopinu koja je preostala u bočici.
English: Polivy must be diluted to a final concentration of 0.72-2.7 mg/mL in an intravenous infusion bag, with a minimum volume of 50 mL, containing 9 mg/mL sodium chloride solution for injection, or 4.5 mg/mL sodium chloride solution for injection, or 5% glucose.
Croatian: Polivy se mora razrijediti do konačne koncentracije od 0,72 - 2,7 mg/ml u vrećici za intravensku infuziju volumena najmanje 50 ml, koja sadrži otopinu natrijeva klorida za injekciju od 9 mg/ml, otopinu natrijeva klorida za injekciju od 4,5 mg/ml ili 5%-tnu otopinu glukoze.
English: If not already premedicated, premedication with an antihistamine and anti-pyretic should be administered to patients prior to Polivy.
Croatian: Ako bolesnici već nisu primili premedikaciju, prije primjene lijeka Polivy treba im dati premedikaciju antihistaminikom i antipiretikom.
English: When administered with Polivy, the recommended dose of bendamustine is 90 mg/m2/day on Day 1 and Day 2 of each cycle and the recommended dose of rituximab is 375 mg/m2 on Day 1 of each cycle.
Croatian: Kod istodobne primjene s lijekom Polivy preporučena doza bendamustina je 90 mg/m na dan 1. dana i 2. dana svakog ciklusa, dok je preporučena doza rituksimaba 375 mg/m
English: LIST OF EXCIPIENTS succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Croatian: POPIS POMOĆNIH TVARI Sukcinatna kiselina, natrijev hidroksid, saharoza, polisorbat 20.
English: Respiratory, thoracic and mediastinal disorders Very common cough Common pneumonitis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često kašalj često pneumonitis
English: Dose modification1
Croatian: Prilagodba doze1
English: Sodium chloride 9 mg/mL (0.9%)
Croatian: 4,5 mg/ml (0,45%)
English: Tabulated list of ADRs from clinical trials
Croatian: Tablični prikaz nuspojava iz kliničkih ispitivanja
English: Serious cases of hepatic toxicity that were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, have occurred in patients treated with Polivy (see section 4.8).
Croatian: U bolesnika liječenih lijekom Polivy zabilježeni su ozbiljni slučajevi hepatotoksičnosti koji su odgovarali hepatocelularnom oštećenju, uključujući povišene vrijednosti transaminaza i/ili bilirubina (vidjeti dio 4.8).
English: 6.6 Special precautions for disposal and other handling General precautions
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: Complete blood counts should be monitored prior to each dose of Polivy.
Croatian: Prije svake doze lijeka Polivy potrebno je provjeriti kompletnu krvnu sliku.
English: Polatuzumab vedotin is an antibody-drug conjugate composed of the anti-mitotic agent monomethyl auristatin E (MMAE) covalently conjugated to a CD79b-directed monoclonal antibody (recombinant humanized immunoglobulin G1 [IgG1], produced in Chinese Hamster Ovary cells by recombinant DNA technology).
Croatian: Polatuzumab vedotin je konjugat protutijela i lijeka, koji se sastoji od antimitotskog lijeka monometilauristatina E (MMAE) kovalentnom vezom konjugiranog s monoklonskim protutijelom koje ciljano djeluje na CD79b (rekombinantni humanizirani imunoglobulin G1 [IgG1], proizveden u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK).
English: If not recovered to Grade ≤ 1 on or before Day 14, discontinue Polivy.
Croatian: Ako se nuspojava ne ublaži do ≤ 1. stupnja unutar 14 dana, liječenje lijekom Polivy treba obustaviti.
English: Chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 6.
Croatian: Kemijska i fizikalna stabilnost pripremljene otopine za infuziju dokazana je tijekom razdoblja navedenih u Tablici 6.
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 72 hours refrigerated (2 °C − 8 °C) and up to 24 hours at room temperature (9 °C − 25 °C).
Croatian: Dokazana je kemijska i fizikalna stabilnost rekonstituirane otopine tijekom najviše 72 sata u hladnjaku (2°C - 8°C) te tijekom najviše 24 sata na sobnoj temperaturi (9°C - 25°C).
English: Bendamustine was administered at 90 mg/m2 intravenously daily on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6.
Croatian: Bendamustin se primjenjivao intravenski u dnevnoj dozi od 90 mg/m2. i 3. dana 1. ciklusa te 1. i 2. dana 2. - 6. ciklusa.
English: The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency.
Croatian: Nuspojave u nastavku navedene su prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
English: The median OS in the Polivy+BR arm was 12.4 months (95% CI: 9.0, NE) vs 4.7 months (95% CI: 3.7, 8.3) in the control arm.
Croatian: Medijan OS-a u skupini koja je primala Polivy + BR iznosio je 12,4 mjeseca (95% CI: 9,0; NP) naspram 4,7 mjeseci (95% CI: 3,7; 8,3) u kontrolnoj skupini.
English: • herpes infection
Croatian: • infekcija virusom herpesa