FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop Polivy infusion immediately.
Croatian: Odmah prekinuti infuziju lijeka Polivy.
English: Based on population pharmacokinetics simulations, a sensitivity analysis predicted exposure to unconjugated MMAE for patients with bodyweight over 100 kg to be increased by 27%.
Croatian: Na temelju simulacija populacijske farmakokinetike, analizom osjetljivosti predviđeno je povećanje izloženosti nekonjugiranom MMAE-u za 27% u bolesnika tjelesne težine veće od 100 kg.
English: Randomized patients in the treatment arm received a median of 5 cycles of treatment while randomized patients in the comparator arm received a median of 3 cycles of treatment.
Croatian: Bolesnici randomizirani za liječenje ispitivanom terapijom primili su medijan od 5 ciklusa liječenja, dok su oni randomizirani u usporednu skupinu primili medijan od 3 ciklusa liječenja.
English: There are no data in pregnant women using Polivy.
Croatian: Nema podataka o primjeni lijeka Polivy u trudnica.
English: • discomfort or weakness.
Croatian: • nelagoda ili slabost
English: Day 1 of any cycle
Croatian: 1. dana svakog ciklusa.
English: If recovered to Grade ≤ 1 on or before Day 14, restart Polivy at a permanently reduced dose of 1.4 mg/kg.
Croatian: Ako se nuspojava ublaži do ≤ 1. stupnja unutar 14 dana, Polivy treba ponovno uvesti u trajno smanjenoj dozi od 1,4 mg/kg.
English: Drug interactions with concomitant medicines that are CYP3A4 inhibitors, substrates or inducers and co-medications that are P-gp inhibitors
Croatian: Interakcije s istodobno primijenjenim lijekovima koji su inhibitori, supstrati ili induktori CYP3A4 i lijekovima koji su inhibitori P-gp-a
English: CD79b expression is restricted to normal cells within the B-cell lineage (with the exception of plasma cells) and malignant B-cells; it is expressed in > 95% of diffuse large B-cell lymphoma.
Croatian: Ekspresija CD79b ograničena je na normalne stanice unutar obitelji B-stanica (uz izuzetak plazma stanica) i zloćudne B-stanice; eksprimira se kod > 95% difuznih B-velikostaničnih limfoma.
English: Tell your doctor or nurse if you are taking, have recently taken or might start taking any other medicines.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli početi uzimati bilo koje druge lijekove, uključujući one koje ste nabavili bez recepta i biljne lijekove.
English: • feeling weak or generally unwell.
Croatian: • slabost ili opće loše osjećanje
English: MMAE is a weak time-dependent inhibitor of CYP3A4/5 but does not competitively inhibit CYP3A4/5 at clinically relevant concentrations.
Croatian: MMAE je slab inhibitor CYP3A4/5 ovisan o vremenu, ali ne dovodi do kompetitivne inhibicije CYP3A4/5 pri klinički relevantnim koncentracijama.
English: When accounting for the influence of baseline covariates the OS HR was adjusted to 0.59.
Croatian: Kada se uzme u obzir utjecaj početnih kovarijabli, prilagođeni HR za OS bio je 0,59.
English: Otherwise, upon complete resolution of symptoms, infusion may be resumed at 50% of the rate achieved prior to interruption.
Croatian: Kod ostalih se reakcija nakon potpunog povlačenja simptoma infuzija može nastaviti brzinom 50% manjom od one koja se postigla prije prekida.
English: Injured liver cells may leak high amounts of certain substances (liver enzymes and bilirubin) into the bloodstream, in which can be detected by blood tests.
Croatian: Oštećene stanice jetre mogu u krvotok otpuštati velike količine određenih tvari (jetrenih enzima i bilirubina), što se može utvrditi krvnim pretragama.
English: Patients with high tumour burden and rapidly proliferative tumour may be at increased risk of TLS.
Croatian: U bolesnika s velikim tumorskim opterećenjem i brzo proliferirajućim tumorom može postojati povećan rizik od sindroma tumorske lize.
English: Based on population PK analysis, the predicted acMMAE concentration at the end of cycle 6 is approximately 80% of the theoretical steadystate value.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, predviđena koncentracija acMMAE-a na kraju 6. ciklusa iznosi približno 80% teoretske vrijednosti u stanju dinamičke ravnoteže.
English: If the prepared infusion will be transported, remove air from the infusion bag and limit transportation to 30 minutes room temperature (9°C − 25°C) or 24 hours refrigerated (2°C − 8°C).
Croatian: Ako će se pripremljena infuzija prevoziti, uklonite zrak iz infuzijske vrećice i ograničite prijevoz na 30 minuta na sobnoj temperaturi (9°C - 25°C) odnosno 24 sata u hladnjaku (2°C - 8°C).
English: Polivy is given under the supervision of a doctor experienced in giving such treatments.
Croatian: Polivy se daje pod nadzorom liječnika koji ima iskustva s primjenom takvih terapija.
English: Polivy is given to treat “diffuse large B-cell lymphoma” that has come back or has not got better with at least one previous therapy and when you cannot receive a stem cell transplant.
Croatian: Polivy se daje za liječenje “difuznog B-velikostaničnog limfoma“ koji se vratio ili se nije poboljšao uz najmanje jednu prethodnu terapiju te u slučajevima kada nije moguće provesti presađivanje matičnih stanica.
English: Swirl the vial gently until completely dissolved.
Croatian: Nježno okrećite bočicu dok se prašak potpuno ne otopi.
English: PET-CT PR required meeting both PET-CT criteria and CT criteria.
Croatian: Djelomičan odgovor prema nalazima PET-CT oslikavanja morao je ispunjavati i kriterije za PET-CT oslikavanje i kriterije za CT oslikavanje.
English: • yellowing of skin or whites of your eyes
Croatian: • žuta boja kože ili bjeloočnica
English: Your doctor or nurse will check for side effects during your infusion and for 30 to 90 minutes afterwards.
Croatian: Vaš liječnik ili medicinska sestra nadzirat će Vas tijekom infuzije i još 30 do 90 minuta nakon toga, kako bi uočili moguće nuspojave.
English: Patients should be monitored closely for new or worsening neurological, cognitive, or behavioural changes suggestive of PML.
Croatian: Bolesnike treba pažljivo nadzirati zbog moguće pojave ili pogoršanja neuroloških, kognitivnih ili bihevioralnih promjena koje ukazuju na PML.
English: Men must use contraception during treatment and for 6 months after the last dose of Polivy.
Croatian: Muškarci moraju koristiti kontracepciju tijekom liječenja i još 6 mjeseci nakon posljednje doze lijeka Polivy.
English: MMAE was not mutagenic in the bacterial reverse mutation assay (Ames test) or the L5178Y mouse lymphoma forward mutation assay.
Croatian: MMAE nije bio mutagen u bakterijskom testu reverzne mutacije (Amesov test) ni u testu mutacija na stanicama mišjeg limfoma (L5178Y).
English: Sixty-four out of 80 patients (80%) had ECOG performance score (PS) of 0-1 and 14 out of 80 patients (18%) had ECOG PS of 2.
Croatian: Šezdeset i četiri (64) od 80 bolesnika (80%) imala su funkcionalni ECOG status 0 - 1, dok je 14 od 80 bolesnika (18%) imalo funkcionalni ECOG status 2. Većina je bolesnika (98%) imala DLBCL koji nije drugačije specificiran.
English: Patients aged ≥65 had a numerically higher incidence of serious adverse reactions (64%) than patients aged
Croatian: Bolesnici u dobi od ≥ 65 godina imali su brojčano višu incidenciju ozbiljnih nuspojava (64%) nego bolesnici mlađi od 65 godina (53%).
English: Bendamustine does not affect acMMAE and unconjugated MMAE plasma AUC.
Croatian: Bendamustin ne utječe na plazmatski AUC acMMAE-a ni nekonjugiranog MMAE-a.
English: In vitro data indicate that MMAE is a P-gp substrate but does not inhibit P-gp at clinically relevant concentrations.
Croatian: Podaci in vitro ukazuju na to da je MMAE supstrat P-gp-a, ali ne inhibira P-gp u klinički relevantnim koncentracijama.
English: Withhold Polivy dosing until improvement to ≤ Grade 1.
Croatian: Odgoditi primjenu lijeka Polivy dok se nuspojava ne ublaži do ≤ 1. stupnja.
English: Unconjugated MMAE is not predicted to alter the AUC of concomitant medicines that are CYP3A4 substrates (e.g., midazolam).
Croatian: Ne očekuje se da će nekonjugirani MMAE izmijeniti AUC istodobno primijenjenih lijekova koji su supstrati CYP3A4 (npr. midazolam).
English: Pre-existing liver disease, elevated baseline liver enzymes, and concomitant medicinal products may increase the risk.
Croatian: Otprije postojeća jetrena bolest, povišene početne vrijednosti jetrenih enzima i istodobna primjena drugih lijekova mogu povećati taj rizik.
English: Procedures for proper handling and disposal of antineoplastic and cytotoxic medicines should be used.
Croatian: Potrebno je pridržavati se postupaka za pravilno rukovanje i zbrinjavanje antineoplastičnih i citotoksičnih lijekova.
English: If ANC recovers to > 1000/µL after Day 7:
Croatian: Ako ABN poraste na > 1000/µl nakon 7. dana:
English: From a microbiological point of view, the reconstituted solution should be used immediately.
Croatian: S mikrobiološkog stanovišta, rekonstituiranu otopinu treba odmah primijeniti.
English: Based on a population PK analysis, the conjugate (acMMAE) is primarily eliminated by non-specific linear clearance pathway with a value of 0.9 L/day.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, konjugat (acMMAE) se prvenstveno eliminira nespecifičnim linearnim klirensom, uz vrijednost od 0,9 l na dan.
English: No dose adjustment of Polivy is required in patients with creatinine clearance (CrCL) ≥ 30 mL/min.
Croatian: Nije potrebno prilagođavati dozu lijeka Polivy u bolesnika kojima je klirens kreatinina (CrCL) ≥ 30 ml/min.
English: Systemic exposure (AUC) in rats at a dose of 0.2 mg/kg MMAE is approximately 50% of the AUC in patients who received the recommended dose of 1.8 mg/kg Polivy every 21-days.
Croatian: Sistemska izloženost MMAE-u (AUC) u štakora nakon primjene doze od 0,2 mg/kg iznosila je približno 50% AUC-a u bolesnika koji su primali preporučenu dozu lijeka Polivy od 1,8 mg/kg svakih 21 dan.
English: Liver enzymes and bilirubin level should be monitored.
Croatian: Potrebno je pratiti vrijednosti jetrenih enzima i bilirubina.
English: IRC: Independent Review Committee; INV: Investigator; HR: Hazard Ratio; CI: Confidence Interval, NE: Not evaluable; CMH Cochran-Mantel-Haenszel *Per modified Lugano 2014 criteria: Bone marrow confirmation of PET-CT CR required.
Croatian: IRC: Neovisno ocjenjivačko povjerenstvo; HR (engl. hazard ratio): omjer hazarda; CI (engl. confidence interval): interval pouzdanosti; NP: ne može se procijeniti; CMH: Cochran-Mantel-Haenszelov
English: What Polivy contains
Croatian: Što Polivy sadrži
English: Prophylactic granulocyte colony stimulating factor (G-CSF) administration was required in the clinical development and should be considered.
Croatian: Tijekom kliničkog razvoja lijeka bila je potrebna profilaktička primjena faktora stimulacije rasta kolonija granulocita (engl. granulocyte colony stimulating factors, G-CSF) pa je treba razmotriti.
English: • have a fever
Croatian: • ako imate vrućicu
English: Do not use if the reconstituted solution is discoloured, is cloudy, or contains visible particulates.
Croatian: Nemojte upotrijebiti rekonstituiranu otopinu ako je promijenila boju, ako je mutna ili ako sadrži vidljive čestice.
English: Polivy has a minor influence on your ability to drive, cycle or use any tools or machines.
Croatian: Polivy malo utječe na sposobnost upravljanja vozilima, vožnje bicikla ili rukovanja bilo kakvim alatima ili strojevima.
English: Polivy has minor influence on the ability to drive and use machines.
Croatian: Polivy malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The terminal half-life at Cycle 6 was approximately 12 days (95% CI of 8.1-19.5 days) for acMMAE.
Croatian: Terminalni poluvijek acMMAE-a u 6. ciklusu iznosio je približno 12 dana (95% CI: 8,1 - 19,5 dana).
English: However, treatment of pregnant rats with MMAE at 0.2 mg/kg caused embryolethality and foetal malformations (including protruding tongue, malrotated limbs, gastroschisis, and agnathia).
Croatian: Međutim, primjena MMAE-a u dozi od 0,2 mg/kg skotnim ženkama štakora uzrokovala je smrt zametka i malformacije ploda (uključujući protruziju jezika, malrotaciju ekstremiteta, gastroshizu i agnatiju).
English: The primary endpoint of the study was complete response (CR) rate at end of treatment (6-8 weeks after Day 1 of Cycle 6 or last study treatment) as assessed by PET-CT by an Independent Review Committee (IRC).
Croatian: Primarna mjera ishoda ispitivanja bila je stopa potpunog odgovora na kraju liječenja (6 - 8 tjedana nakon 1. dana 6. ciklusa ili posljednje doze ispitivane terapije) prema ocjeni neovisnog ocjenjivačkog povjerenstva (engl.
English: Based on the mechanism of action and nonclinical studies, Polivy can be harmful to the foetus when administered to a pregnant woman (see section 5.3).
Croatian: S obzirom na mehanizam djelovanja i podatke iz nekliničkih ispitivanja, Polivy može naškoditi plodu kada se primjenjuje u trudnica (vidjeti dio 5.3).
English: Patients receiving concomitant strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) should be monitored more closely for signs of toxicities.
Croatian: Bolesnike koji istodobno primaju snažne inhibitore CYP3A4 (npr. boceprevir, klaritromicin, kobicistat, indinavir, itrakonazol, nefazodon, nelfinavir, posakonazol, ritonavir, sakvinavir, telaprevir, telitromicin, vorikonazol) treba pažljivije nadzirati kako bi se uočili mogući znakovi toksičnosti.
English: For these reasons, comparison of incidence of antibodies to polatuzumab vedotin with the incidence of antibodies to other products may be misleading.
Croatian: Zbog toga usporedba incidencije protutijela na polatuzumab vedotin s incidencijom protutijela na druge lijekove može navesti na krivi trag.
English: Infections, including pneumonia and other types of infections, were reported in 53.3% of patients in the Polivy plus BR arm and 51.3% of patients in the BR arm.
Croatian: Infekcije, uključujući pneumoniju i druge vrste infekcija, prijavljene su u 53,3% bolesnika koji su primali Polivy plus BR i 51,3% onih koji su primali samo BR.
English: Polivy is compatible with intravenous infusion bags with product contacting materials of polyvinyl chloride (PVC) or polyolefins such as polyethylene (PE) and polypropylene.
Croatian: Polivy je kompatibilan s vrećicama za intravensku infuziju kod kojih su dijelovi koji dolaze u doticaj s lijekom izrađeni od polivinilklorida (PVC) ili poliolefina, kao što su polietilen (PE) i polipropilen.
English: In women of childbearing potential, the pregnancy status shall be checked prior to treatment.
Croatian: U žena reproduktivne dobi će se prije liječenja provjeriti jesu li trudne.
English: Serious adverse reactions were reported in 27% of Polivy plus BR treated patients, which includes febrile neutropenia (6.7%), pyrexia (4.4%), and pneumonia (4.4%).
Croatian: Ozbiljne nuspojave prijavljene su u 27% bolesnika koji su primali Polivy plus BR, a uključivale su febrilnu neutropeniju (6,7%), pireksiju (4,4%) i pneumoniju (4,4%).
English: Overall survival (OS) was an exploratory endpoint which was not type 1 error controlled.
Croatian: Ukupno preživljenje (engl. overall survival, OS) bilo je eksploracijska mjera ishoda koja nije bila kontrolirana za pogrešku tipa 1.
English: You will be given 6 treatment cycles of Polivy in combination with two other medicines called rituximab and bendamustine.
Croatian: Primit ćete 6 ciklusa liječenja lijekom Polivy u kombinaciji s još dva lijeka, koji se zovu rituksimab i bendamustin.
English: The monoclonal antibody binds with high affinity and selectivity to CD79b, a cell surface component of the B-cell receptor.
Croatian: Monoklonsko se protutijelo s visokim afinitetom i selektivnošću vezuje za CD79b, komponentu B-staničnog receptora koja se nalazi na staničnoj površini.
English: The active substance in Polivy is made up of a monoclonal antibody linked to MMAE, a substance that can kill cancer cells.
Croatian: Djelatna tvar u lijeku Polivy sastoji se od monoklonskog protutijela vezanog za MMAE, tvar koja može uništiti stanice raka.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution Read the package leaflet before use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu nakon rekonstitucije i razrjeđivanja Prije uporabe pročitajte uputu o lijeku.
English: The recommended dose of Polivy is 1.8 mg/kg, given as an intravenous infusion every 21 days in combination with bendamustine and rituximab for 6 cycles.
Croatian: Preporučena doza lijeka Polivy je 1,8 mg/kg, a primjenjuje se intravenskom infuzijom svakih 21 dan u kombinaciji s bendamustinom i rituksimabom tijekom 6 ciklusa.
English: Anti-infective prophylaxis should be considered throughout treatment with Polivy.
Croatian: Treba razmotriti antimikrobnu profilaksu tijekom cijelog liječenja lijekom Polivy.
English: Covariates included primary refractory status, number of prior lines of therapy, IPI, and prior stem cell transplant.
Croatian: Kovarijable su uključivale primarni refraktorni status, broj prethodnih terapijskih linija, međunarodni prognostički indeks (engl. international prognostic index, IPI) i prethodno presađivanje matičnih stanica.
English: It is not known whether polatuzumab vedotin or its metabolites are excreted in human breast milk.
Croatian: Nije poznato izlučuju li se polatuzumab vedotin ili njegovi metaboliti u majčino mlijeko u ljudi.
English: Patients were randomized 1:1 to receive Polivy plus BR or BR alone for six 21-day cycles.
Croatian: Bolesnici su bili randomizirani u omjeru 1:1 za primanje lijeka Polivy plus BR-a ili samo BR-a tijekom šest 21-dnevnih ciklusa.
English: If an IRR occurs, the infusion should be interrupted and appropriate medical management should be instituted (see section 4.2).
Croatian: Ako nastupi reakcija povezana s infuzijom, potrebno je privremeno prekinuti njezinu primjenu i uvesti odgovarajuće liječenje (vidjeti dio 4.2).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: PML is a very rare and life threatening infection in the brain, that has occured in one patient treated with Polivy together with bendamustine and another medicine called obinutuzumab.
Croatian: PML je vrlo rijetka i po život opasna infekcija u mozgu koja se javila u jednog bolesnika liječenog lijekom Polivy u kombinaciji s bendamustinom i još jednim lijekom koji se zove obinutuzumab.
English: If platelets recover to > 75,000/µL after Day 7:
Croatian: Ako broj trombocita poraste na > 75 000/µl nakon 7. dana:
English: MMAE plasma concentrations followed formation rate limited kinetics.
Croatian: Plazmatske koncentracije MMAE-a slijedile su kinetiku ograničenu brzinom nastanka.
English: See section “Polivy contains sodium”.
Croatian: Pogledajte odlomak „Polivy sadrži natrij“ u dijelu 2.
English: MMAE was genotoxic in the rat bone marrow micronucleus study probably through an aneugenic mechanism.
Croatian: MMAE je ostvario genotoksične učinke u mikronukleusnom testu na koštanoj srži štakora, vjerojatno aneugenim mehanizmom.
English: Permanently discontinue Polivy.
Croatian: Trajno obustaviti liječenje lijekom Polivy.
English: In the Polivy plus BR arm, serious infections were reported in 28.9% of patients and fatal infections were reported in 8.9% of patients.
Croatian: U skupini koja je primala Polivy plus BR ozbiljne su infekcije prijavljene u 28,9% bolesnika, a infekcije sa smrtnim ishodom u 8,9% bolesnika.
English: In vitro studies indicate that MMAE is a substrate for CYP3A4/5 but does not induce major CYP enzymes.
Croatian: Ispitivanja in vitro ukazuju na to da je MMAE supstrat CYP3A4/5, ali ne inducira glavne CYP enzime.
English: The highest dose tested to date is 2.4 mg/kg administered as an intravenous infusion; it was associated with a higher frequency and severity of PN events.
Croatian: Najveća dosad ispitana doza je 2,4 mg/kg, primijenjena u obliku intravenske infuzije, koja je bila povezana s većom učestalošću i težinom događaja periferne neuropatije.
English: • infusion-related reactions
Croatian: • reakcije povezane s infuzijom
English: The most frequently-reported (≥ 30%) ADRs in patients treated with Polivy in combination with BR were anaemia (46.7%), thrombocytopenia (46.7%), neutropenia (46.7%), fatigue (40.0%), diarrhoea (37.8%), nausea (33.3%), and pyrexia (33.3%).
Croatian: Najčešće nuspojave (≥ 30%) prijavljene u bolesnika liječenih lijekom Polivy u kombinaciji s BR-om bile su anemija (46,7%), trombocitopenija (46,7%), neutropenija (46,7%), umor (40,0%), proljev (37,8%), mučnina (33,3%) i pireksija (33,3%).
English: Testicular seminiferous tubule degeneration did not reverse following a 6-week treatment-free period and correlated with decreased testes weight and gross findings at recovery necropsy of small and/or soft testes in males given ≥ 2 mg/kg.
Croatian: Degeneracija sjemenih kanalića nije se povukla nakon 6-tjednog razdoblja bez primjene lijeka, a bila je u korelaciji sa smanjenom masom testisa i makroskopskim nalazom malih i/ili mekanih testisa pri nekropsiji provedenoj radi ocjene reverzibilnosti učinaka u mužjaka koji su primali dozu od ≥ 2 mg/kg.
English: Progressive multifocal leukoencephalopathy (PML) One case of PML, which was fatal, occurred in one patient treated with Polivy plus bendamustine and obinutuzumab.
Croatian: Progresivna multifokalna leukoencefalopatija (PML) Prijavljen je jedan slučaj PML-a, koji je imao smrtni ishod, u jednog bolesnika koji je primao Polivy u kombinaciji s bendamustinom i obinutuzumabom.
English: With regard to co-administration of CYP3A-inhibitors see section 4.5.
Croatian: Za informacije o istodobnoj primjeni inhibitora CYP3A vidjeti dio 4.5.
English: No studies have been conducted to investigate the pharmacokinetics of polatuzumab vedotin in the paediatric population (<18 years old).
Croatian: Nisu provedena ispitivanja kojima bi se ocijenila farmakokinetika polatuzumab vedotina u pedijatrijskoj populaciji (dob < 18 godina).
English: Polivy should be discontinued immediately and permanently if the patient experiences a life-threatening reaction.
Croatian: Liječenje lijekom Polivy mora se odmah trajno obustaviti ako u bolesnika nastupi reakcija opasna po život.
English: Based on physiological-based pharmacokinetic (PBPK) model simulations of MMAE released from polatuzumab vedotin, strong CYP3A4 and P-gp inhibitors (e.g., ketoconazole) may increase the area under the concentration-time curve (AUC) of unconjugated MMAE by 48%.
Croatian: Prema simulacijama oslobađanja MMAE-a iz polatuzumab vedotina dobivenima fiziološkim farmakokinetičkim modelom, snažni inhibitori CYP3A4 i P-gp-a (npr. ketokonazol) mogli bi povećati područje ispod krivulje koncentracije nekonjugiranog MMAE-a kroz vrijeme (AUC) za 48%.
English: Across all arms of study GO29365, 8 out of 134 (6.0%) patients tested positive for anti-polatuzumab vedotin antibodies at one or more post-baseline time points.
Croatian: U svim skupinama u ispitivanju GO29365, 8 od 134 bolesnika (6,0%) bilo je pozitivno na protutijela na polatuzumab vedotin u jednoj ili više vremenskih točaka nakon početka ispitivanja.
English: After the first 1.8 mg/kg polatuzumab vedotin dose, the Cmax was 6.82 (± 4.73) ng/mL, the time to maximum plasma concentration is approximately 2.5 days, and the terminal half-life is approximately 4 days.
Croatian: Nakon prve doze polatuzumab vedotina od 1,8 mg/kg, Cmax je iznosio 6,82 (± 4,73) ng/ml, vrijeme do maksimalne plazmatske koncentracije približno 2,5 dana, a terminalni poluvijek približno 4 dana.
English: Patients experiencing new or worsening PN may require a delay, dose reduction, or discontinuation of Polivy (see section 4.2).
Croatian: U bolesnika kod kojih se razvije ili pogorša periferna neuropatija možda će trebati odgoditi primjenu, smanjiti dozu ili prekinuti liječenje lijekom Polivy (vidjeti dio 4.2).
English: • restart all treatment with a dose reduction of bendamustine from 90 mg/m2 to 70 mg/m2 or 70 mg/m2 to 50 mg/m2.
Croatian: • treba ponovno uvesti sve lijekove, uz smanjenje doze bendamustina s 90 mg/m na 70 mg/m ili sa 70 mg/m na