natgillin/translations-raw huggingface dataset:
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. 
Starejši bolniki, ki so prejeli primarno profilakso z G-CSF, so imeli manjšo incidenco nevtropenije in febrilne nevtropenije kot bolniki, ki niso prejeli primarne profilakse z G-CSF.
PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens. 
O PML so poročali pri bolnikih, ki so prejeli zdravilo po predhodnem zdravljenju z več režimi kemoterapije.
Unknown 
Neznano
Medical resource utilization (MRU) analysis showed that hospitalizations and outpatient visits, as well as working days/other activities missed by patients and caregivers were lower with ADCETRIS compared with placebo in patients with HL at increased risk of relapse. 
Analiza uporabe medicinskih virov (MRU, »medical resource utilization«) je pokazala, da je bilo hospitalizacij in ambulantnih obiskov, kot tudi delovnih dni/drugih dejavnosti, ki jih bolniki in skrbniki niso opravili, pri zdravljenju z zdravilom ADCETRIS manj v primerjavi z bolniki, ki so prejemali placebo, pri bolnikih s HL s povečanim tveganjem ponovitve bolezni.
You may experience the following side effects: 
Pojavijo se lahko naslednji neželeni učinki:
The pharmacokinetics of ADCETRIS in combination with AVD were evaluated in a single phase 3 study in 661 patients. 
Farmakokinetiko zdravila ADCETRIS v kombinaciji z AVD so ocenili v eni študiji 3. faze s podatki za 661 bolnikov.
Total volume per vial (10 mL/vial) 
Skupni volumen na vialo (10 ml/vialo)
• Relapsed or progressive HL that occurred <12 months from the end of frontline treatment 
• Ponovitev ali napredovanje HL, ki se je pojavilo < 12 mesecev po zaključku začetnega zdravljenja.
Insomnia a. 
nespečnost a.
Special patient populations 
Posebne populacije bolnikov
have abnormal liver test results as this may be related to a serious and potentially fatal liver injury (hepatotoxicity). 
- imate nenormalne izvide jetrnih testov, saj so ti lahko povezani z resnimi in potencialno smrtnimi poškodbami jeter (hepatotoksičnost).
The Cmax of ADC was typically observed at the end of infusion or the sampling closest to the end of infusion. 
Cmax za ADC je bil običajno opažen ob koncu infuzije ali pri vzorčenju, ki je bilo najbližje koncu infuzije.
Liver disease and other medical conditions that may have been present before you start taking Adcetris and some medications that you are currently taking might increase the risk of liver injury. 
Jetrna bolezen in druga zdravstvena stanja, ki so prisotna pred jemanjem zdravila Adcetris in druga zdravila, ki jih trenutno jemljete, lahko povečajo tveganje za poškodbe jeter.
- are currently using bleomycin, an anti-cancer agent 
- če trenutno uporabljate bleomicin, zdravilo proti raku.
Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. 
Pojavili so se tudi hujši primeri hepatotoksičnosti z nekaj smrtnimi izidi.
Name and address of the manufacturers of the biological active substance 
Ime in naslov izdelovalcev biološke zdravilne učinkovine
Adcetris is also used to lower the likelihood of classical Hodgkin Lymphoma coming back after an autologous stem cell transplant in patients with certain risk factors. 
Zdravilo Adcetris se prav tako uporablja za zmanjšanje verjetnosti ponovitve klasičnega Hodgkinovega limfoma po avtologni presaditvi matičnih celic pri bolnikih z določenimi dejavniki tveganja.
At least one metabolite of MMAE has been shown to be active in vitro. 
Pokazalo se je, da je vsaj en presnovek MMAE in vitro aktiven.
The most commonly reported opportunistic infections were herpes viral infections. 
Oportunistične okužbe, o katerih so najpogosteje poročali, so bile herpesvirusne okužbe.
Type I glass vial with a butyl rubber stopper and an aluminium/plastic flip-off seal, containing 50 mg powder. 
Steklena viala iz stekla tipa I z zamaškom iz butilne gume in aluminijasto/plastično dvižno zaporko, ki vsebuje 50 mg praška.
The median time from onset to resolution or improvement of peripheral neuropathy events was 10 weeks (ranged from 0 weeks to 139 weeks). 
Mediani čas od začetka do prenehanja ali izboljšanja dogodkov periferne nevropatije je znašal 10 tednov (razpon od 0 tednov do 139 tednov).
Number of events (%) 
Število dogodkov (%)
HL Status after the end of frontline standard chemotherapy 
Stanje HL po zaključku začetne standardne kemoterapije
ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness), see section 4.8. 
Zdravilo ADCETRIS ima zmeren vpliv na sposobnost vožnje in upravljanja strojev (npr. omotica), glejte poglavje 4.8.
ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus. 
Zdravila ADCETRIS ne smete uporabljati med nosečnostjo, razen če so koristi za mater večje od možnega tveganja za plod.
If your infusion is restarted, your doctor may increase the time over which your infusion is given so that you may be able to tolerate it better. 
Pri ponovnem začetku infundiranja lahko vaš zdravnik podaljša čas infundiranja, da bi zdravilo bolje prenašali.
No differences were observed in quality of life between the treatment and placebo arms. 
V kakovosti življenja med skupino zdravljeno z zdravilom ADCETRIS in skupino s placebom ni bilo opaziti nobene razlike.
Binding of the ADC to CD30 on the cell surface initiates internalisation of the ADC-CD30 complex, which then traffics to the lysosomal compartment. 
Vezava ADC na CD30 na površini celic začne internalizacijo kompleksa ADC-CD30, ki se nato prenese v lizosomalni kompartment.
Combined use of bleomycin and ADCETRIS causes pulmonary toxicity (see section 4.5). 
Kombinirana uporaba bleomicina in zdravila ADCETRIS povzroča pljučno toksičnost (glejte poglavje 4.5).
Number of deaths (%) 
Število smrti (%)
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. 
V ključni populaciji 2. faze (SG035-0003 in SG035-0004) je bilo mediano trajanje nevtropenije 3. stopnje ali 4. stopnje omejeno (1 teden); 2% bolnikov sta imela nevtropenijo 4. stopnje, ki je trajala ≥ 7 dni.
For refractory disease, or upon progression or relapse after frontline therapy. 
Za refraktarno bolezen ali ob napredovanju oz. ponovitvi po začetnem zdravljenju.
Objective Response Rate lasting at least 4 months (ORR4) per IRF n (%) 
Objektivni odziv na zdravljenje, ki traja vsaj 4 mesece (ORR4) po IRF n (%)
ADC accumulation (as assessed by AUC14D between Cycle 1 and Cycle 3) was 1.27-fold. 
Kopičenje ADC (ocenjeno z AUC14D med 1. in 3. ciklom) je bilo 1,27-kratno.
The estimated overall survival at 5 years was 60% (95% CI [47%,73%]). 
Ocenjeno celokupno preživetje pri 5 letih je znašalo 60% (95% IZ [47%, 73%]).
Alternatively, treatment may be started at the last tolerated dose (see section 5.1). 
Alternativno se zdravljenje lahko uvede tudi v zadnjem odmerku, ki ga je bolnik prenašal (glejte poglavje 5.1).
Your treatment may influence your ability to drive or operate machines. 
Zdravljenje lahko vpliva na sposobnost upravljanja vozil in strojev.
In the physician's choice arm, the median duration of treatment (number of cycles) for patients receiving bexarotene was approximately 16 weeks (5.5 cycles) and 11 weeks (3 cycles) for patients receiving methotrexate. 
V skupini z zdravilom po izbiri zdravnika je mediano trajanje zdravljenja (število ciklov) pri bolnikih, ki so prejemali beksaroten, znašalo približno 16 tednov (5,5 cikla), pri bolnikih, ki so prejemali metotreksat, pa 11 tednov (3 cikle).
Patients with rapidly proliferating tumour and high tumour burden are at risk of tumour lysis syndrome. 
Pri bolnikih s hitro proliferacijskimi tumorji in veliko tumorsko obremenitvijo obstaja tveganje za sindrom tumorske lize.
This medicine has been given ‘conditional approval'. 
Zdravilo je pridobilo tako imenovano “pogojno dovoljenje za promet”.
The other chemotherapy medicines are doxorubicin, vinblastine and dacarbazine. 
Druga kemoterapevtska zdravila so doksorubicin, vinblastin in dakarbazin.
In older patients (≥ 60 years of age; n = 83 [13%]), the incidence of adverse events was similar across treatment arms. 
Pri starejših bolnikih (≥ 60 let; n = 83 [13%]) je bila incidenca neželenih dogodkov podobna v vseh skupinah zdravljenih bolnikov.
The pharmacokinetics of brentuximab vedotin were evaluated in phase 1 studies and in a population pharmacokinetic analysis of data from 314 patients. 
Farmakokinetiko brentuksimaba vedotina so ocenili v študijah 1. faze in v farmakokinetični analizi populacije s podatki za 314 bolnikov.
Progression Free Survival (PFS) per IRF Median (months) 
Preživetje brez napredovanja bolezni (PFS) po IRF Mediana (meseci)
Keep the vial in the original carton in order to protect from light. 
Vialo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (17%), pyrexia (6%), and neutropenia (3%). 
Resni neželeni učinki, ki so se pojavili ≥3% bolnikov, so vključevali febrilno nevtropenijo (17%), pireksijo (6%) in nevtropenijo (3%).
In clinical trials, the majority of patients had resolution or improvement of their symptoms (see section 4.8). 
Pri večini bolnikov v kliničnih preskušanjih so simptomi izzveneli ali so se izboljšali (glejte poglavje 4.8).
For further efficacy results see Table 10. 
Za nadaljnje rezultate učinkovitosti glejte preglednico 10.
Patients should be closely monitored for new or worsening neurological, cognitive, or behavioural signs or symptoms, which may be suggestive of PML. 
Bolnike je treba skrbno nadzirati glede nastanka novih ali poslabšanja obstoječih nevroloških, kognitivnih ali vedenjskih znakov ali simptomov, ki lahko nakazujejo na PML.
Immediate and delayed infusion-related reactions (IRR), as well as anaphylactic reactions, have been reported. 
Poročali so tako o takojšnjih in zakasnelih reakcijah, povezanih z infundiranjem (IRR, »infusion-related reactions«), kot o anafilaktičnih reakcijah.
The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration. 
Rekonstituirano raztopino vizualno preglejte glede morebitne vsebnosti tujih delcev in/ali spremembe barve.
See Table 1 below for appropriate dosing recommendations (see also section 4.4). 
Za ustrezna priporočila za odmerjanje glejte preglednico 1 spodaj (glejte tudi poglavje 4.4).
ADCETRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents. 
Zdravilo ADCETRIS se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil proti raku.
Overall response rates for MF were 54-66%; pcALCL, 67%; SS, 50%; LyP, 92%; and mixed CTCL histology, 82-85%. 
Celokupni odziv (ORR) za MF je bil 54-66%, za pcALCL 67%, SS 50%, LyP 92% in CTCL mešanega tipa 82-85%.
Not reached 
Ni dosežena
See section 2 for further information about sodium. 
Za dodatne informacije o natriju glejte poglavje 2.
6.7 months 
6,7 mesecev
Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. 
Vzročna povezava z zdravilom ADCETRIS sicer ni bila ugotovljena, vendar pa tveganja toksičnosti za pljuča ni mogoče izključiti.
For a reduced dose, use 1.2 mg/kg for the calculation. 
Za zmanjšani odmerek pri izračunu uporabite 1,2 mg/kg.
The exposure of MMAE (as assessed by AUC14D between Cycle 1 and Cycle 3) appeared to decrease with time by approximately 50%. 
Izpostavljenost MMAE (ocenjeno z AUC14D med 1. in 3. ciklom) se je zmanjšala za približno 50%.
In clinical trials, serious infections and opportunistic infections occurred in 10% of patients, sepsis or septic shock occurred in < 1% of the patients. 
V kliničnih preskušanjih so se resne okužbe in oportunistične okužbe pojavile pri 10% bolnikov, sepsa ali septični šok pa sta se pojavila pri < 1% bolnikov.
In case of overdose, the patient should be closely monitored for adverse reactions, particularly neutropenia, and supportive treatment should be administered (see section 4.4). 
V primeru prevelikega odmerjanja je treba bolnika skrbno nadzirati glede pojava neželenih učinkov, zlasti nevtropenije, in uvesti podporno zdravljenje (glejte poglavje 4.4).
The primary endpoint of PFS was met and showed a difference in median PFS of 18.8 months in favour of the treatment arm. 
Primarni opazovani dogodek PFS je bil dosežen in je pokazal mediano razliko PFS 18,8 mesecev v korist skupine z zdravilom ADCETRIS.
Modification of dose and schedule 
Sprememba odmerka in režim
The median observation time (time to death or last contact) from first dose was 71.4 months. 
Mediani čas opazovanja bolnikov (čas do smrti ali zadnjega stika) od prvega odmerka je bil 71,4 meseca.
Patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately 1 year) (see section 5.1). 
Bolniki, pri katerih se bolezen stabilizira ali izboljša, naj prejmejo vsaj 8 ciklov in do največ 16 ciklov (približno 1 leto) (glejte poglavje 5.1).
Not reached (95% CI [26.4, ) 
Ni doseženo (95% IZ [26,4, )
Percent Difference (95% CI) 
Odstotek razlike (95% CI)
Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage. 
Znotraj celice se s proteolitičnim cepljenjem sprošča ena sama opredeljena aktivna komponenta, MMAE.
If Grade 3 or Grade 4 neutropenia develops, refer to section 4.2. 
Če se razvije nevtropenija 3. ali 4. stopnje, glejte poglavje 4.2.
Table 2: Dosing recommendations for new or worsening peripheral sensory or motor neuropathy 
Preglednica 2: Priporočila za odmerjanje za primere nove ali poslabšane periferne senzorične ali motorične nevropatije
The most commonly reported opportunistic infections were herpes zoster and herpes simplex. 
Oportunistični okužbi, o katerih so najpogosteje poročali, sta bili herpes zoster in herpes simpleks.
The primary endpoint was objective response rate that lasts at least 4 months (ORR4) (duration from first response to last response ≥ 4 months), as determined by an independent review of the Global Response Score (GRS) consisting of skin evaluations (modified severity weighted assessment tool [mSWAT] as assessed per investigator), nodal and visceral radiographic assessment, and detection of circulating Sézary cells (Olsen 2011). 
Primarni opazovani dogodek je bil objektivni odziv na zdravljenje, ki traja vsaj 4 mesece (ORR4) (trajanje od prvega odziva do zadnjega odziva ≥ 4 mesece), kot ga določa neodvisni pregled ocene globalnega odziva (GRS, “Global Response Score”), ki ga sestavljajo ocene kože (prilagojeno orodje za ocenjevanje z uteženimi stopnjami resnosti [mSWAT, “modified severity weighted assessment tool﻿ po oceni raziskovalca), radiografska ocena bezgavk in visceralnih organov ter odkrivanje Sézaryjevih celic v obtoku (Olsen 2011).
Interaction with medicinal products metabolised through CYP3A4 route (CYP3A4 inhibitors/inducers) 
Medsebojno delovanje z zdravili, ki se presnavljajo z encimom CYP3A4 (zaviralci/induktorji CYP3A4)
To perform a single-arm study in a similar patient population as the sALCL population investigating response rate, duration of response, rate of (second) ASCT and data in subpopulations (including but not necessarily restricted to ALK status and age) based on a CHMP agreed protocol (Study C25006). 
Izvesti študijo z enim krakom na populaciji bolnikov, ki je podobna populaciji s sALCL ter preučiti delež odzivnosti, trajanje odziva, pogostnost (druge) presaditve avtolognih matičnih celic in podatke v pod-populacijah (vključno z, a ne nujno omejeno na, stanje anaplastične limfomske kinaze in starost) po dogovorjenem protokolu CHMP (Študija C25006).
All patients had a histologically confirmed CD30-expressing disease. 
Vsi bolniki so imeli histološko potrjeno bolezen z izraženim CD30.
Adcetris is to be given to adults only. 
Zdravilo Adcetris se daje samo odraslim.
Adcetris is used to treat patients with advanced classical Hodgkin lymphoma who have not had treatment before. 
Zdravilo Adcetris uporabljamo za zdravljenje bolnikov z napredovalim klasičnim Hodgkinovim limfomom, ki se predhodno še niso zdravili.
Store in a refrigerator (2 °C-8 °C). 
Shranjujte v hladilniku (2 ºC-8 ºC).
MMAE is further metabolised mainly to an equally potent metabolite; however, its exposure is an order of magnitude lower than that of MMAE. 
MMAE se nadalje presnovi, pretežno v enako učinkovit presnovek; vendar je njegova izpostavljenost za red velikosti manjša od MMAE, zato ni verjetno, da znatno prispeva k sistemskim učinkom MMAE.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6. 
Za navodila glede rekonstitucije in redčenja zdravila pred dajanjem glejte poglavje 6.6.
At the time of the primary analysis, the median follow-up time for both arms was 30 months (range, 0 to 50). 
V času primarne analize, je bil mediani čas spremljanja za obe skupini 30 mesecev [razpon od 0 do 50].
Best response to salvage therapy pre-ASCT Complete Response 
Najboljši odziv na reševalno zdravljenje pred avtologno PKMC Popolni odziv
The primary objective was to evaluate the effect of brentuximab vedotin on cardiac ventricular re-polarization and the predefined primary analysis was the change in QTc from baseline to multiple time points in Cycle 1. 
Primarni cilj je bil ocenitev učinka brentuksimaba vedotina na repolarizacijo srčnih ventriklov in predefinirana primarna analiza je bila sprememba intervala QTc od izhodišča do številnih časovnih točk v 1. ciklu.
Relapse occurred <12 months Relapse occurred > = > 12 months a. 
Ponovitev s pričetkom < 12 mesecev Ponovitev s pričetkom ≥ 12 mesecev a.
Patient characteristics n = 58 
Značilnosti bolnika n = 58
Complete remission (CR) was 33% (34 of 102 patients in the ITT set). 
Popolno remisijo (CR) je doseglo 33% (34 od vseh 102 bolnikov, ki so bili vključeni v študijo [ITT]).
Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops. 
Bolnike je treba skrbno nadzirati glede pojava zvišane telesne temperature in jo zdraviti po najboljši medicinski praksi, če se pojavi febrilna nevtropenija.
Patients should be monitored for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paraesthesia, discomfort, a burning sensation, neuropathic pain or weakness. 
Bolnike je treba spremljati glede simptomov nevropatije, kot so hipestezija, hiperestezija, parestezija, nelagodje, pekoč občutek, nevropatska bolečina ali oslabelost.
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. 
Bolniki s pcALCL so bili podvrženi predhodni radiacijski terapiji ali vsaj enemu predhodnemu sistemskemu zdravljenju, bolniki z MF pa so prejemali vsaj eno predhodno sistemsko zdravljenje.
The RP2D was determined to be 1.8 mg/kg. 
Priporočeni odmerek faze II (RP2D) je bil 1,8 mg/kg.
Overall Survival 
Celokupno preživetje
Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. 
Predlagano vrednotenje PML vključuje nevrološko posvetovanje, magnetnoresonančno slikanje možganov, poudarjeno z gadolinijem, in analizo cerebrospinalne tekočine za DNA JCV s pomočjo polimerazne verižne reakcije ali biopsijo možganov z dokazi za JCV.
The doctor or nurse will dispose of this medicine. 
Zdravilo bo zavrgel zdravnik ali medicinska sestra.
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]). 
Pozitivnost na CD30 je bila opredeljena kot ≥ 10% ciljnih limfoidnih celic z dokazanimi vzorci membranskega, citoplazemskega in/ali Golgijevega barvanja na podlagi imunohistokemijske preiskave (Ventana anti-CD30 [Ber-H2]).
If peripheral sensory or motor neuropathy emerges or worsens during treatment see Table 2 below for appropriate dosing recommendations (see section 4.4). 
Če se med zdravljenjem pojavi ali poslabša periferna senzorična ali motorična nevropatija, glejte spodnjo preglednico 2 za ustrezna priporočila za odmerjanje (glejte poglavje 4.4).
Patient characteristics n = 102 
Značilnosti bolnika n = 102
It is given by your doctor or nurse over 30 minutes. 
Dal vam ga bo zdravnik ali medicinska sestra v obliki 30-minutne infuzije.
In vivo data in animals and humans suggest that only a small fraction of MMAE released from brentuximab vedotin is metabolised. 
Podatki in vivo pri živalih in ljudeh kažejo, da se le majhen del MMAE, ki se sprosti iz brentuksimaba vedotina, presnovi.
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. 
Izločanje MMAE omejuje stopnja njegovega izločanja iz ADC, običajni navidezni očistek MMAE je 19,99 l/dan in njegov razpolovni čas 3-4 dni.
The ORR was 47% in response-evaluable patients with r/r HL, 53% in patients with r/r sALCL and 60% in sALCL patients in first relapse. 
Delež ORR je bil 47% pri bolnikih z r/r HL, pri katerih je bilo mogoče oceniti odziv, pri bolnikih z r/r sALCL je bil ta delež 53% in pri bolnikih sALCL pri prvi ponovitvi 60%.
In a phase 1 dose finding and safety study (SGN35-009), unacceptable pulmonary toxicity (including 2 fatal events) was noted in 11 of 25 patients (44%) treated with brentuximab vedotin plus ABVD. 
Pri študiji 1. faze za določanje odmerka in varnosti zdravila (SGN35-009) so opazili nesprejemljive toksične učinke na pljuča (vključno z 2 smrtnima primeroma) pri 11 od 25 bolnikov (44%), zdravljenih z brentuksimabom vedotinom v kombinaciji z ABVD.
Median number of skin-directed therapies (range) Median number of systemic therapies (range) MF, n (%) 
Mediano število predhodnih zdravljenj (razpon) Mediano število zdravljenj, usmerjenih na kožo (razpon) Mediano število sistemskih zdravljenj (razpon) MF, n (%)
MMAE exposures decreased after multiple doses of brentuximab vedotin with approximately 50% to 80% of the exposure of the first dose being observed at subsequent doses. 
Izpostavljenost MMAE se je zmanjšala po več odmerkih brentuksimaba vedotina, pri čemer je bilo pri naslednjih odmerkih opaženih približno 50% do 80% izpostavljenosti prvega odmerka.
Post-hoc Risk Factor Analyses 
Naknadne analize dejavnikov tveganja
The European Medicines Agency has deferred the obligation to submit the results of studies with ADCETRIS in one or more subsets of the paediatric population in the treatment of Hodgkin lymphoma and treatment of anaplastic large cell lymphoma (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom ADCETRIS za eno ali več podskupin pediatrične populacije pri zdravljenju Hodgkinovega limfoma in pri zdravljenju anaplastičnega velikoceličnega limfoma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment. 
Zato je treba moškim, ki se zdravijo s tem zdravilom, svetovati, da si dajo pred zdravljenjem zamrzniti in shraniti vzorce sperme.
IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin (see section 4.8). 
IRR so lahko pogostejše in hujše pri bolnikih s protitelesi proti brentuksimabu vedotinu (glejte poglavje 4.8).
Baseline patient characteristics showed failure from multiple prior chemotherapy regimens (median of 3 with a range of 1 to 7) before first administration with ADCETRIS. 
Lastnosti bolnikov v izhodišču so izkazovale neuspešnost številnih predhodnih vrst kemoterapije (mediana 3 z razponom od 1 do 7) pred prvo uporabo zdravila ADCETRIS.