FrancophonIA/ELRC3.0 huggingface dataset:
English: Minimal to no accumulation of ADC was observed with multiple doses at the every 3-week schedule, consistent with the terminal half-life estimate.
Croatian: Minimalno do nikakvo nakupljanje ADC bilo je opaženo nakon višestrukih doza kod rasporeda primjene svaka 3 tjedna, što je sukladno procjeni terminalnog poluvijeka.
English: ORR4 was 50% and 75% in the ADCETRIS arm versus 10.2% and 20% in the physician's choice arm for MF and pcALCL, respectively.
Croatian: ORR4 bio je 50% i 75% u skupini koja je primala ADCETRIS naspram 10,2% odnosno 20% u bolesnika u skupini koja je primala lijek po izboru liječnika za MF i pcALCL.
English: Advanced age was a risk factor for febrile neutropenia in patients in both arms.
Croatian: Starija dob bila je čimbenik rizika za razvoj febrilne neutropenije u bolesnika u oba režima liječenja.
English: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence.
Croatian: Veličina učinka liječenja drugih podtipova CD30+ CTCL osim fungoidne mikoze (MF) i primarnog kožnog anaplastičnog velikostaničnog limfoma (pcALCL) nije jasna zbog nedostatka dokaza visoke razine.
English: ADCETRIS must not be administered as an intravenous push or bolus.
Croatian: ADCETRIS se ne smije primijeniti kao brza intravenska infuzija ili u bolusu.
English: Table 2: Dosing recommendations for new or worsening peripheral sensory or motor neuropathy
Croatian: Tablica 2: Preporuke za doziranje kod pogoršanja postojeće ili novonastale periferne senzorne ili motoričke neuropatije
English: Combined use of bleomycin and ADCETRIS causes pulmonary toxicity (see section 4.5).
Croatian: Kombinirana primjena bleomicina i lijeka ADCETRIS uzrokuje plućnu toksičnost (vidjeti dio 4.5).
English: Fatigue, pyrexia
Croatian: Umor, pireksija
English: Median per IRF
Croatian: Medijan po IRF
English: Median Overall survival
Croatian: Medijan Ukupno preživljenje
English: Total volume per vial (10 mL/vial)
Croatian: Ukupni volumen po bočici (10 ml/bočica)
English: Patients with pcALCL received either prior radiation therapy or at least 1 prior systemic therapy and patients with MF received at least 1 prior systemic therapy.
Croatian: Bolesnici s pcALCL-om su prethodno ili liječeni zračenjem ili su primili najmanje 1 prethodno sistemsko liječenje, a bolesnici s MF-om primili su najmanje 1 prethodno sistemsko liječenje.
English: ADCETRIS dosing should be permanently discontinued if a diagnosis of PML is confirmed.
Croatian: Liječenje lijekom ADCETRIS treba trajno prekinuti ako se potvrdi dijagnoza PML.
English: After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin.
Croatian: Nakon rekonstitucije (vidjeti dio 6.6), jedan ml sadrži 5 mg brentuksimab vedotina.
English: Complete blood counts should be monitored prior to administration of each dose of this treatment (see section 4.4).
Croatian: Potrebno je kontrolirati kompletnu krvnu sliku prije primjene svake doze ovog lijeka (vidjeti dio 4.4).
English: Primary refractory HL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Croatian: Primarni refraktorni HL definira se kao neuspjeh postizanja potpune remisije ili progresija unutar od 3 mjeseca nakon završene prve linije terapije.
English: Type I glass vial with a butyl rubber stopper and an aluminium/plastic flip-off seal, containing 50 mg powder.
Croatian: I s čepom od butilne gume i aluminijskim/plastičnim “flip-off” zatvaračem, koja sadrži 50 mg praška.
English: CD30 positivity was defined as ≥10% target lymphoid cells demonstrating membrane, cytoplasmic, and/or Golgi staining pattern based on an immunohistochemistry assay (Ventana anti-CD30 [Ber-H2]).
Croatian: CD30-pozitivnost definirana je kao ≥ 10% ciljnih limfoidnih stanica koje pokazuju membranski, citoplazmatski i/ili Golgijev uzorak bojenja na temelju imunohistokemijske analize (Ventana anti-CD30 [Ber-H2]).
English: HL Status after the end of frontline standard chemotherapy
Croatian: HL status po završetku standardne kemoterapije prve linije liječenja Refraktorni
English: Acute pancreatitis has been observed in patients treated with ADCETRIS.
Croatian: Akutni pankreatitis je uočen kod bolesnika liječenih lijekom ADCETRIS.
English: Patients experiencing hepatotoxicity may require a delay, change in dose or discontinuation of ADCETRIS.
Croatian: U bolesnika u kojih se pojave slučajevi hepatotoksičnosti može biti potrebno odgoditi primjenu doze, promijeniti dozu ili prekinuti primjenu lijeka ADCETRIS.
English: If the patient's weight is more than 100 kg, the dose calculation should use 100 kg (see section 6.6).
Croatian: Ako bolesnik ima tjelesnu težinu veću od 100 kg, za izračunavanje doze koristi se težina od 100 kg (vidjeti dio 6.6).
English: Calculation to determine the total ADCETRIS dose (mL) to be further diluted (see section 4.2):
Croatian: Izračun za određivanje ukupne doze lijeka ADCETRIS (ml) koji treba dodatno razrijediti (vidjeti dio 4.2)
English: Provision of the results of the ongoing Non-Interventional Post-Authorization Safety Study (PASS) conducted in HL and sALCL patient populations (Study MA25101).
Croatian: Pribavljanje rezultata neintervencijskog ispitivanja sigurnosti primjene nakon dobivanja odobrenja za stavljanje lijeka u promet (PASS) koje je u tijeku, a koje se provodi u populaciji bolesnika s HL-om i sALCL-om (Ispitivanje MA25101).
English: Complete Response (CR) per IRF n (%)
Croatian: Potpuni odgovor (CR) po IRF-u n (%)
English: The elimination of MMAE was limited by its rate of release from ADC, typical apparent CL and half life of MMAE was 19.99 l/day and 3-4 days respectively.
Croatian: Eliminacija MMAE je ograničena brzinom njegovog oslobađanja iz ADC, uobičajeni prividni CL bio je 19,99 l/dan, a poluvijek MMAE 3-4 dana.
English: The median overall survival (OS) is 40.5 months (the median observation time (time to death or last contact) from first dose was 35.1 months (range 1.8 to 72.9+ months).
Croatian: Medijan ukupnog preživljenja (OS) iznosio je 40,5 mjeseci (medijan trajanja motrenja (vrijeme proteklo do smrti ili zadnjeg kontakta) od prve doze bio je 35,1 mjesec (raspon 1,8 do 72,9+ mjeseci).
English: Consider holding ADCETRIS dosing during evaluation and until symptomatic improvement.
Croatian: Razmotrite odgodu sljedeće primjene lijeka ADCETRIS tijekom procjene i dok se simptomi ne poboljšaju.
English: Percent Difference (95% CI)
Croatian: Postotak razlike (95% CI)
English: Febrile neutropenia
Croatian: Febrilna neutropenija
English: The median number of cycles was approximately 12 cycles in the ADCETRIS arm.
Croatian: Medijan primljenih ciklusa bio je oko 12 ciklusa u skupini liječenoj lijekom ADCETRIS.
English: Older patients who received G-CSF primary prophylaxis had lower incidence of neutropenia and febrile neutropenia than those who did not receive G-CSF primary prophylaxis.
Croatian: Kod starijih bolesnika koji su primili primarnu profilaksu sa G-CSF incidencija neutropenije i febrilne neutropenije bila je niža u usporedbi s bolesnicima koji nisu primili primarnu profilaksu sa G-CSF.
English: Hodgkin lymphoma
Croatian: Hodgkinov limfom
English: Alternatively, treatment may be started at the last tolerated dose (see section 5.1).
Croatian: Alternativno, liječenje se može započeti prethodno primijenjenom podnošljivom dozom (vidjeti dio 5.1).
English: In all clinical trials, brentuximab vedotin was administered as an intravenous infusion.
Croatian: U svim kliničkim ispitivanjima brentuksimab vedotin bio je primijenjen kao intravenska infuzija.
English: In the pivotal phase 2 population (SG035-0003 and SG035-0004), the median duration of Grade 3 or Grade 4 neutropenia was limited (1 week); 2% of patients had Grade 4 neutropenia that lasted ≥ 7 days.
Croatian: U populaciji pivotalnih ispitivanja faze 2 (SG035-0003 i SG035-0004), medijan trajanja neutropenije 3. stupnja ili 4. stupnja bio je ograničen (1 tjedan); 2% bolesnika imalo je neutropeniju 4. stupnja koja je trajala ≥ 7 dana.
English: The European Organization for Research and Treatment of Cancer Quality of Life 30-Item Questionnaire (EORTC-QLQ-C30) showed no clinically meaningful difference between the two arms in both the ITT and Stage IV population.
Croatian: Upitnik o kvaliteti života s 30 pitanja Europske organizacije za istraživanje i liječenje raka (EORTC-QLQ-C30) nije pokazao klinički značajnu razliku između dva terapijska režima u ITT skupini i u bolesnika s bolesti u 4. stadiju.
English: Median age, years (range)
Croatian: Medijan dobi, godine (raspon)
English: Bleomycin
Croatian: Bleomicin
English: The most common prior skin directed therapies in the ITT population were radiotherapy (64%), phototherapy (48%) and topical steroids (17%).
Croatian: Najčešća prethodna ciljana liječenja kože u populaciji ITT bila su zračenje (64%), fototerapija (48%) i topikalni steroidi (17%).
English: ADCETRIS may cause peripheral neuropathy, both sensory and motor.
Croatian: ADCETRIS može uzrokovati perifernu neuropatiju, i senzornu i motoričku.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o rekonstituciji i razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: Weight decreased
Croatian: Gubitak težine
English: Neutropenia a, anaemia, febrile neutropenia
Croatian: Neutropenija a, anemija, febrilna neutropenija
English: Patients were stratified by these disease types and randomised 1:1 to receive either ADCETRIS or the physician's choice of either methotrexate or bexarotene.
Croatian: Bolesnici su stratificirani na temelju ovih tipova bolesti i randomizirani 1:1 za primanje lijeka ADCETRIS ili, po izboru liječnika, metotreksata ili beksarotena.
English: 24.1 months (95% CI [11.5, -])
Croatian: 24,1 mjeseci (95% CI [11,5; -])
English: Liver function should be tested before initiating the treatment and routinely monitored in patients receiving ADCETRIS.
Croatian: Prije početka liječenja potrebno je ispitati funkciju jetre i redovito je pratiti u bolesnika koji primaju ADCETRIS.
English: There is limited experience in patients with renal and hepatic impairment.
Croatian: Postoji ograničeno iskustvo u bolesnika s oštećenjem bubrega i jetre.
English: In clinical trials, serious infections and opportunistic infections occurred in 10% of patients, sepsis or septic shock occurred in < 1% of the patients.
Croatian: U kliničkim ispitivanjima javile su se ozbiljne infekcije i oportunističke infekcije u 10% bolesnika, a sepsa ili septički šok javili su se u < 1% bolesnika.
English: Pulmonary toxicity
Croatian: Plućna toksičnost
English: Calculated from a weighted Holm's procedure
Croatian: Izračunato ponderiranim Holmovim postupkom
English: Febrile neutropenia was reported in 21% of the patients who did not receive primary prophylaxis with G-CSF (see section 4.2).
Croatian: Febrilna neutropenija je prijavljena u 21% bolesnika koji nisu primili primarnu profilaksu sa G-CSF (vidjeti dio 4.2).
English: Severity of peripheral sensory or motor neuropathy (signs and symptoms [abbreviated description of CTCAE
Croatian: Težina periferne senzorne ili motoričke neuropatije (znakovi i simptomi [skraćeni opis CTCAE
English: Though PK data are limited, co administration of rifampicin appeared to reduce plasma concentrations of MMAE metabolites that could be assayed.
Croatian: Iako su farmakokinetički podaci ograničeni, čini se da istodobna primjena rifampicina smanjuje koncentraciju metabolita MMAE u plazmi koji se mogu testirati.
English: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection with an absolute neutrophil count < 1.0 x 10
Croatian: Uz liječenje lijekom ADCETRIS zabilježena je febrilna neutropenija (vrućica nepoznatog porijekla bez klinički ili mikrobiološki dokazane infekcije s apsolutnim brojem neutrofila < 1,0 x 10
English: Adverse events that led to treatment discontinuation in ≥ 2% of patients included peripheral sensory neuropathy, peripheral neuropathy, and peripheral motor neuropathy.
Croatian: Štetni događaji koji su bili razlog prekida liječenja u ≥ 2% bolesnika uključuju perifernu senzornu neuropatiju, perifernu neuropatiju i perifernu motoričku neuropatiju.
English: The most common prior systemic therapies in the ITT population were chemotherapy (71%), immunotherapy (43%) and bexarotene (38%).
Croatian: Najčešća prethodna sistemska liječenja u populaciji ITT bila su kemoterapija (71%), imunoterapija (43%) i beksaroten (38%).
English: Herpes zoster, Pneumocystis jiroveci pneumonia
Croatian: Herpes zoster, pneumonija uzrokovana s Pneumocistis jiroveci
English: For intravenous use after reconstitution and dilution
Croatian: Za intravensku primjenu nakon rekonstitucije i razrjeđivanja
English: The most commonly reported opportunistic infections were herpes zoster and herpes simplex.
Croatian: Najčešće prijavljene oportunističke infekcije bile su herpes zoster i herpes simplex.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji iza “EXP”.
English: Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased
Croatian: Povišena vrijednost alanin aminotransferaze/aspartat aminotransferaze (ALT/AST)
English: The estimated overall survival at 5 years was 60% (95% CI [47%,73%]).
Croatian: Procijenjeno ukupno preživljenje po isteku 5 godina iznosilo je 60% (95% CI [47%,73%]).
English: Brentuximab vedotin caused embryo-foetal lethality in pregnant female rats.
Croatian: Brentuksimab vedotin uzrokovao je embriofetalnu smrt u skotnih ženki štakora.
English: Table 8: Summary of PFS per IRF and OS by number of risk factors in the phase 3 HL post-ASCT Study
Croatian: Tablica 8: Sažetak PFS-a po IRF-u i OS-a po broju čimbenika rizika u ispitivanju faze 3 HL-a nakon ASCT-a
English: The estimated overall survival rate at 5 years was 41% (95% CI [31%, 51%]).
Croatian: Procijenjena stopa petogodišnjeg ukupnog preživljenja bila je 41% (95% CI [31%, 51%]).
English: 52 years (14-76)
Croatian: 52 godine (14-76)
English: Arthralgia, myalgia
Croatian: Artralgija, mialgija
English: The population pharmacokinetics of brentuximab vedotin were examined from several studies, including data from 380 patients up to 87 years old (34 patients ≥65-< 75 and 17 patients ≥75 years of age).
Croatian: Populacijska farmakokinetika brentuksimab vedotina istražena je u nekoliko ispitivanja, uključujući podatke od 380 bolesnika u dobi do 87 godina (34 bolesnika ≥ 65-< 75 i 17 bolesnika ≥ 75 godina).
English: If neutropenia develops, refer to Table 1: Dosing recommendations for neutropenia (see section 4.2).
Croatian: Ako se razvije neutropenija, pogledajte tablicu 1: Preporuke za doziranje kod neutropenije (vidjeti dio 4.2).
English: 2.4 vials a.
Croatian: 2.4 bočica a.
English: The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration.
Croatian: 4. Rekonstituiranu otopinu treba vizualno pregledati zbog prisutnosti stranih čestica i/ili promjene boje.
English: The median duration of treatment for patients who discontinued due to peripheral neuropathy was 12 cycles.
Croatian: Medijan trajanja liječenja bolesnika koji su liječenje prekinuli zbog periferne neuropatije bio je 12 ciklusa.
English: Treatment response was assessed by spiral CT of chest, neck, abdomen and pelvis; PET scans and clinical data.
Croatian: Terapijski odgovor procijenjen je prema spiralnom CT-u prsnog koša, vrata, abdomena i zdjelice, PET snimanju i kliničkim podacima.
English: Among patients who experienced peripheral neuropathy in the pivotal phase 2 studies (SG035-0003 and SG035-0004) and randomised phase 3 monotherapy studies (SGN35-005 and C25001), the median follow up time from end of treatment until last evaluation ranged from 48.9 to 98 weeks.
Croatian: Među bolesnicima koji su razvili perifernu neuropatiju u pivotalnim ispitivanjima faze 2 (SG035-0003 i SG035-0004) i u randomiziranim ispitivanjima faze 3 (SGN35-005 i C25001) u kojima se ispitivala monoterapija, medijan praćenja od kraja liječenja do zadnje procjene kretao se od 48,9 do 98 tjedana.
English: a per IRF at 2 Year (%)
Croatian: a prema IRF nakon 2 godine (%)
English: Median time from HL diagnosis to first dose (range)
Croatian: Medijan vremena od dijagnoze HL-a do prve doze (raspon)
English: An updated analysis conducted after 3 years of follow-up showed a sustained PFS improvement per IRF (HR = 0.58 [95% CI (0.41, 0.81)]).
Croatian: Ažurirana analiza provedena nakon 3 godine praćenja pokazala je održano poboljšanje PFS-a po IRF-u (HR = 0,58 [95% CI (0,41; 0,81)]).
English: Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Croatian: Stoga se muškarcima koji se liječe ovim lijekom savjetuje da prije liječenja daju uzorke sperme na zamrzavanje i čuvanje.
English: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 13,2 mg natrija po bočici, što odgovara 0,7% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: In nonclinical studies, lymphoid depletion and reduced thymic weight were observed, consistent with the pharmacologic disruption of microtubules caused by MMAE derived from brentuximab vedotin.
Croatian: U nekliničkim ispitivanjima bile su opažene limfoidna deplecija i smanjena težina timusa, što je sukladno farmakološkom prekidu mikrotubula prouzročenom MMAE koji potječe iz brentuksimab vedotina.
English: There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with hepatic impairment, where total bilirubin is > 1.5 times the upper limit of normal (ULN) (unless due to Gilbert syndrome), or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are > 3 times the ULN, or > 5 times the ULN if their elevation may be reasonably ascribed to the presence of HL in the liver.
Croatian: Nema podataka iz kliničkih ispitivanja o upotrebi lijeka ADCETRIS u kombinaciji s kemoterapijom u bolesnika s oštećenjem funkcije jetre, gdje je vrijednost ukupnog bilirubina > 1,5 puta veća od gornje granice normale (GGN) (osim ako se ne radi o Gilbertovom sindromu), ili su aspartat aminotransferaza (AST) ili alanin aminotransferaza (ALT) > 3 puta veći od GGN-a, ili > 5 puta veći od GGN ako se njihova povišena vrijednost može opravdano povezati s prisustvom HL-a u jetri.
English: Figure 5: Kaplan-Meier Plot of OS
Croatian: Slika 5: Kaplan-Meierova krivulja OS-a
English: The ADC is eliminated by catabolism with a typical estimated CL and half life of 1.5 l/day and 4-6 days respectively.
Croatian: ADC se eliminira putem katabolizma uz uobičajeni procijenjeni CL od 1,5 l/dan i poluvijek od 4-6 dana.
English: Nevertheless, ADCETRIS should be used with caution in other CD30+ CTCL patients after careful consideration of the potential benefit-risk on an individual basis (see section 5.1).
Croatian: Ipak, ADCETRIS se mora koristiti s oprezom u ostalih bolesnika sa CD30+ CTCL-om nakon pažljive ocjene potencijalne koristi/rizika na individualnoj razini (vidjeti dio 5.1).
English: Haematological toxicities
Croatian: Hematološke toksičnosti
English: Stage IV
Croatian: Stadij IV
English: Adverse events led to treatment discontinuation in 13% of patients.
Croatian: Štetni događaji su uzrokovale prekid liječenja u 13% bolesnika.
English: Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures.
Croatian: Procjena bolesnika može uključivati fizički pregled, određivanje laboratorijske vrijednosti serumske amilaze i serumske lipaze, snimanje abdomena ultrazvukom i drugim odgovarajućim dijagnostičkim mjerama.
English: ADC accumulation (as assessed by AUC14D between Cycle 1 and Cycle 3) was 1.27-fold.
Croatian: Akumulacija ADC-a (prema analizi AUC14D između 1. i 3. Ciklusa) bila je 1,27 puta veća.
English: When you first receive this medicine and during the course of treatment, tell your doctor if you: have confusion, trouble thinking, memory loss, blurred or loss of vision, decreased strength, decreased control or sensation in one arm or leg, a change in the way of walking, or loss of balance, as these may be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Croatian: Kad prvi put primite ovaj lijek i tijekom liječenja, obavijestite liječnika ako: - osjećate smetenost, otežano mišljenje, gubitak pamćenja, zamagljen vid ili gubitak vida, smanjenu snagu, smanjenu kontrolu ili osjet u jednoj ruci ili nozi, promjenu u načinu hodanja ili gubitak ravnoteže, jer to mogu biti simptomi ozbiljnog i potencijalno smrtonosnog oštećenja mozga koje se zove progresivna multifokalna leukoencefalopatija (PML).
English: This substance is delivered to cancer cells by the monoclonal antibody.
Croatian: Ta tvar se dostavlja u stanice raka pomoću monoklonskog protutijela.
English: Per IRF, the objective response rate (ORR) in the ITT population was 50% (95% CI, 37; 63%).
Croatian: Objektivna stopa odgovora po IRF-u u populaciji ITT bila je 50% (95% CI, 37%; 63%).
English: Adcetris is used to treat cutaneous T-cell lymphoma (CTCL) in patients who have previously received at least one medicine that travels through the bloodstream.
Croatian: Adcetris se koristi za liječenje kožnog limfoma T-stanica (CTCL) u bolesnika koji su prethodno primili najmanje jedan lijek koji prolazi kroz krvotok.
English: Investigations Very common:
Croatian: Pretrage Vrlo često:
English: Relapsed or refractory sALCL
Croatian: Relaps ili refraktorni oblik sALCL-a
English: ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Croatian: ADCETRIS je indiciran za liječenje odraslih bolesnika s relapsom ili refraktornim oblikom sistemskog anaplastičnog velikostaničnog limfoma (sALCL).
English: • HL that occurred <12 months or HL that was refractory to frontline therapy
Croatian: • HL koji se pojavio nakon < 12 mjeseci ili HL koji je bio refraktoran na prvu liniju terapije
English: Once steady-state was achieved, the PK of ADC did not appear to change with time.
Croatian: U stanju dinamičke ravnoteže čini se da se farmakokinetika ADC-a nije mijenjala s vremenom.
English: Do not use this medicine if you notice any particulate matter or discoloration prior to administration.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite ikakve čestice ili promjenu boje prije primjene.
English: The safety data in patients retreated with ADCETRIS (SGN35-006, see section 5.1) were consistent with those observed in the combined pivotal phase 2 studies, with the exception of peripheral motor neuropathy, which had a higher incidence (28% vs. 9% in the pivotal phase 2 studies) and was primarily Grade 2.
Croatian: Sigurnosni podaci u bolesnika ponovo liječenih lijekom ADCETRIS (SGN35-006, vidjeti dio 5.1) odgovarali su onima opaženim u kombiniranim pivotalnim ispitivanjima faze 2, uz izuzetak periferne motorne neuropatije, koja je imala višu incidenciju (28% naspram 9% u pivotalnim ispitivanjima faze 2) i primarno je bila 2. stupnja.
English: Men are advised not to father a child during treatment with this medicine and for up to 6 months following the last dose of this medicine.
Croatian: Muškarcima se savjetuje da ne začinju dijete tijekom liječenja ovim lijekom i do 6 mjeseci nakon zadnje doze lijeka.
English: Across the study, a total of 16 patients with r/r HL and 17 patients with r/r sALCL, of whom 10 were in first relapse, were treated with 1.8 mg/kg of ADCETRIS.
Croatian: U ispitivanju, ukupno 16 bolesnika s r/r HL-om i 17 bolesnika s r/r sALCL-om, od kojih je 10 bilo u prvom relapsu, liječeno je s 1,8 mg/kg lijeka ADCETRIS.