natgillin/translations-raw huggingface dataset:
Patients who discontinued due to peripheral neuropathy received a median of 8 doses of ADCETRIS+AVD (A+AVD) before discontinuation of one or more agents.
Bolesnici kod kojih je liječenje prekinuto zbog periferne neuropatije primili su, prije prekida primjene jednog ili više lijekova, kombiniranu terapiju ADCETRIS+AVD (A+AVD) s medijanom broja primijenjenih doza koji je iznosio 8.
Men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Muškarcima koji se liječe ovim lijekom savjetuje se da daju zamrznuti i pohraniti uzroke sperme prije liječenja.
378M (57) 286F (43)
378M (57) 286Ž (43)
Median number of prior chemotherapy regimens (range)
Medijan broja prethodnih kemoterapijskih režima (raspon)
Alanine aminotransferase (ALT) increased
Povišena vrijednost alanin aminotransferaze (ALT)
Two percent of patients required dose reduction and < 1% discontinued one of more of the study drugs due to neutropenia.
U dva posto bolesnika dozu se moralo smanjiti, a u < 1% bolesnika terapija s jednim ili više ispitivanih lijekova je zbog neutropenije prekinuta.
PET scan Status prior to ASCT FDG-AVID
Status PET snimanja prije ASCT-a NAKUPLJANJE FDG-a NEGATIVAN FDG
If you have any other questions on the use of this medicine, ask your doctor.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.
Psychiatric Disorders Very common:
Psihijatrijski poremećaji Vrlo često:
CR was 59% (34 of 58 patients in the ITT set) and tumour reduction (of any degree) was achieved in 97% of patients.
Potpuna remisija postignuta je u 59% (34 od 58 bolesnika u ITT skupini), a smanjenje tumora (bilo kojeg stupnja) u 97% bolesnika.
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA KOD UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Number of vials needed = total volume to be diluted divided by total volume per vial [10 mL/vial])
Broj potrebnih bočica = ukupni volumen koji treba razrijediti podijeljen ukupnim volumenom po bočici [10 ml/bočica])
Objective response rate (CR + PR)
Stopa objektivnog odgovora (CR + PR)
Discontinue treatment
Prekinite liječenje
IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin (see section 4.8).
Reakcije povezane s infuzijom su češće i teže u bolesnika s protutijelima na brentuksimab vedotin (vidjeti dio 4.8).
Contributions to the mechanism of action by other antibody associated functions have not been excluded.
Nije isključeno da i druge funkcije protutijela pridonose ovom mehanizmu djelovanja.
ADCETRIS is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE).
ADCETRIS je konjugat protutijela i lijeka kojeg čini monoklonsko protutijelo protiv CD30 (rekombinantni kimerni imunoglobulin G1 [IgG1] proizvedeno tehnologijom rekombinantne DNK na stanicama jajnika kineskog hrčka), koje je kovalentno vezano za antimikrotubularnu tvar monometil auristatin E (MMAE).
Cases of pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), some with fatal outcomes, have been reported in patients receiving ADCETRIS.
Slučajevi plućne toksičnosti, uključujući pneumonitis, intersticijsku plućnu bolest i akutni respiratorni distres sindrom (ARDS), neki sa smrtnim ishodom, bili su prijavljeni kod bolesnika koji su primali ADCETRIS.
Patients with a diagnosis of mycosis fungoides [MF] or primary cutaneous anaplastic large cell lymphoma [pcALCL] were considered eligible for the study.
Bolesnici s dijagnozom fungoidne mikoze [MF] ili primarnim kožnim anaplastičnim velikostaničnim limfomom [pcALCL] procijenjeni su kao prikladni za ispitivanje.
Extranodal involvement at time of diagnosis, n (%) IPFP
Ekstranodalna bolest pri dijagnozi, n (%) IPFP
Table 14 includes the results for ORR4 and other key secondary endpoints.
Tablica 14 uključuje rezultate objektivne stope odgovora koja traje najmanje 4 mjeseca (ORR4) i druge ključne sekundarne mjere ishoda.
Number of Risk Factors ≥ 3
Broj čimbenika rizika ≥ 3
No differences were observed in quality of life between the treatment and placebo arms.
Nisu zapažene razlike u kvaliteti života između skupine koja je primala liječenje i skupine koja je primala placebom.
Population pharmacokinetic analysis indicated that the pharmacokinetics of ADCETRIS in combination with AVD were consistent to that in monotherapy.
Farmakokinetička analiza populacije pokazala je da je farmakokinetika lijeka ADCETRIS u kombinaciji s AVD odgovara onoj u monoterapiji.
398M (59) 272F (41)
398M (59) 272Ž (41)
Primary prophylaxis with growth factor support (G-CSF) is recommended for all patients with previously untreated HL receiving combination therapy beginning with the first dose (see section 4.4).
Primarna profilaksa s faktorom rasta (G-CSF) preporučuje se za sve bolesnike s prethodno neliječenim HL-om koji primaju kombiniranu terapiju, počevši od prve doze (vidjeti dio 4.4).
Total dose = patient weight multiplied by recommended dose [1.2 mg/kg a])
Ukupna doza = težina bolesnika pomnožena s preporučenom dozom [1,2 mg/kg a])
Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; see Neutrophils/granulocytes; LLN = lower limit of normal b.
Stupnjevanje na temelju verzije 3.0 Zajedničkih terminoloških kriterija za nuspojave (CTCAE) Nacionalnog instituta za rak (NCI); vidjeti neutrofili/granulociti; DGN= donja granica normale b.
Reconstituted vial concentration (5 mg/ml)
Koncentracija u rekonstituiranoj bočici (5 mg/ml)
These patients should be monitored closely and managed according to best medical practice.
Ove bolesnike treba pažljivo nadzirati i liječiti sukladno dobroj kliničkoj praksi.
Prior chemotherapy Regimens (range) Histologically confirmed CD30-expressing disease Anaplastic lymphoma kinase (ALK)-negative disease Disease characteristics
Prethodni kemoterapijski režimi (raspon) Histološki potvrđena bolest s izražavanjem CD30 Bolest s negativnom kinazom anaplastičnog limfoma (ALK) Karakteristike bolesti
Overall Survival
Ukupno preživljenje
Physician's Choice (Methotrexate or Bexarotene) n = 64
Izbor liječnika (metotreksat ili beksaroten) n = 64
Total dose = patient weight multiplied by recommended dose [1.8 mg/kg a])
Ukupna doza = težina bolesnika pomnožena s preporučenom dozom [1,8 mg/kg a])
Patients with CTCL should receive up to 16 cycles (see section 5.1).
Bolesnici s CTCL-om trebaju primiti do 16 ciklusa (vidjeti dio 5.1).
• HL that was refractory to frontline treatment
• HL koji je refraktoran na prvu liniju liječenja
Grade 3 neutropenia was reported in 13% and Grade 4 neutropenia was reported in 5% of patients.
Neutropenija 3. stupnja prijavljena je u 13%, a neutropenija 4. stupnja prijavljena je u 5% bolesnika.
15.8 months (95% CI [8.5, -])
15,8 mjeseci (95% CI [8,5; -])
Compared to patients with normal hepatic function, MMAE exposure increased approximately 2.3-fold (90% CI 1.27-4.12-fold) in patients with hepatic impairment.
U usporedbi s bolesnicima s normalnom funkcijom jetre, izloženost MMAE povećala se približno 2,3 puta (90% CI 1,27-4,12 puta) u bolesnika s oštećenjem jetre.
ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD)(see sections 4.2 and 5.1).
ADCETRIS je indiciran za liječenje odraslih bolesnika s prethodno neliječenim CD30+ Hodgkinovim limfomom (HL) u 4. stadiju, u kombinaciji s doksorubicinom, vinblastinom i dakarbazinom (AVD) (vidjeti dio 4.2 i 5.1).
Adjusted p-value
Prilagođena p-vrijednost
Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops.
Bolesnike treba pažljivo nadzirati i paziti na pojavu vrućice, te ih liječiti sukladno najboljoj kliničkoj praksi i postojećim smjernicama za liječenje febrilne neutropenije ako se ona razvije.
Retreatment with ADCETRIS resulted in 6 CRs (55%) and 4 PRs (36%), for an ORR of 91%.
Ponovno liječenje lijekom ADCETRIS rezultiralo je u 6 potpunih remisija (55%) i 4 djelomične remisije (36%), što čini stopu objektivnog odgovora od 91%.
Figure 3: Kaplan-Meier Plot of PFS per IRF in Patients with ≥ 2 Risk Factors
Slika 3: Kaplan-Meierova krivulja PFS-a po IRF-u u bolesnika s brojem čimbenika rizika ≥ 2
Patients were treated on days 1 and 15 of each 28-day cycle with 1.2 mg/kg of ADCETRIS administered as an intravenous infusion over 30 minutes + doxorubicin 25 mg/m vinblastine 6 mg/m2, and dacarbazine 375 mg/m2.
Bolesnici su 1. i 15. dana svakog 28-dnevnog ciklusa primali 1,2 mg/kg lijeka ADCETRIS u obliku 30-minutne infuzije + doksorubicin 25 mg/m2, vinblastin 6 mg/m2 i dakarbazin 375 mg/m2.
For a reduced dose, use 1.2 mg/kg for the calculation.
Za smanjenu dozu koristiti 0,9 mg/kg za izračun b.
Approximately 24% of the total MMAE administered as part of the ADC during a brentuximab vedotin infusion was recovered in both urine and faeces over a 1-week period.
Približno 24% ukupnog MMAE primijenjenog u sklopu ADC tijekom infuzije brentuksimab vedotina prisutno je u mokraći i stolici tijekom razdoblja od jednog tjedna.
Data were also collected from patients (n = 15) in phase 1 dose escalation and clinical pharmacology studies, and from patients (n = 26) in a NPP, with relapsed or refractory HL who had not received an ASCT, and who were treated with 1.8 mg/kg of ADCETRIS every 3 weeks.
Podaci su također bili prikupljeni od bolesnika (n = 15) u fazi 1 ispitivanja povećanja doze i kliničke farmakologije te od bolesnika u NPP (n = 26) s relapsom ili refraktornim HL koji nisu podvrgnuti autolognoj transplantaciji matičnih stanica (ASCT), a koji su bili liječeni dozom od 1,8 mg/kg lijekom ADCETRIS svaka 3 tjedna.
For the patients who received 1 prior cancer-related treatment, CR was reported for 1 patient (9%) and PR was reported for 4 patients (36%).
Za bolesnike koji su primili 1 prethodno liječenje zbog raka CR je prijavljen u 1 bolesnika (9%), a PR je prijavljen u 4 bolesnika (36%).
Table 5: Efficacy results for previously untreated HL patients treated with 1.2 mg/kg of ADCETRIS + AVD on days 1 and 15 of a 28-day cycle (ITT and Stage IV)
Tablica 5: Rezultati djelotvornosti u prethodno neliječenih bolesnika s HL-om liječenih sa 1,2 mg/kg ADCETRIS + AVD 1. i 15. dana 28-dnevnog ciklusa (ITT i 4. stadij)
Eight HL patients and 9 sALCL patients went on to receive SCT following treatment with ADCETRIS.
Osam bolesnika s HL-om i 9 bolesnika sa sALCL-om podvrgnuto je transplantaciji matičnih stanica nakon liječenja lijekom ADCETRIS.
In non-clinical studies, brentuximab vedotin treatment has resulted in testicular toxicity, and may alter male fertility.
U nekliničkim ispitivanjima liječenje brentuksimab vedotinom dovelo je do testikularne toksičnosti i može promijeniti mušku plodnost.
The best overall response rate (ORR) per independent review facility (IRF) was analysed across both study phases at the RP2D.
Najbolja stopa ukupnog odgovora prema skupini za neovisnu procjenu (IRF) analizirana je u obje faze ispitivanja pri primjeni preporučene doze za fazu 2.
In the pooled dataset of ADCETRIS as monotherapy across HL, sALCL and CTCL studies (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 and C25007, see section 5.1) the most frequent adverse reactions (≥ 10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain.
U objedinjenim podacima o primjeni lijeka ADCETRIS kao monoterapije u ispitivanjima HL-a, sALCL-a i CTCL-a (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 i C25007, vidjeti dio 5.1), najčešće nuspojave (≥ 10%) bile su infekcije, periferna senzorna neuropatija, mučnina, umor, proljev, vrućica, infekcija gornjih dišnih puteva, neutropenija, osip, kašalj, povraćanje, artralgija, periferna motorna neuropatija, reakcije povezane s infuzijom, pruritis, konstipacija, dispneja, gubitak težine, mialgija i bol u abdomenu.
In the clinical trial of ADCETRIS as combination therapy, serious infections including opportunistic infections occurred in 15% of patients; sepsis, neutropenic sepsis, septic shock or bacteraemia occurred in 4% of the patients.
U kliničkim ispitivanjima lijeka ADCETRIS u kombiniranoj terapiji javile su se ozbiljne infekcije, uključujući i oportunističke, kod 15% bolesnika; sepsa, neutropenijska sepsa, septički šok ili bakterijemija pojavili su se kod 4% bolesnika.
Grade 3 neutropenia was reported in 18% and Grade 4 neutropenia was reported in 47% of patients.
Neutropenija 3. stupnja je prijavljena u 18% bolesnika, a neutropenija 4. stupnja je prijavljena u 47% bolesnika.
Serious adverse drug reactions occurred in 12% of patients.
Ozbiljne nuspojave lijeka javile su se u 12% bolesnika.
There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with renal impairment, where serum creatinine is ≥ 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance is ≤ 40 mL/minute.
Nema podataka iz kliničkih ispitivanja o primjeni lijeka ADCETRIS u kombinaciji s kemoterapijom u bolesnika s oštećenjem funkcije bubrega, gdje je vrijednost serumskog kreatinina ≥ 2,0 mg/dl i/ili su klirens kreatinina ili izračunati klirens kreatinina ≤ 40 ml/minuti.
In older patients (≥ 60 years of age; n = 83 [13%]), the incidence of adverse events was similar across treatment arms.
Incidencija štetnih događaja u starijih bolesnika, (≥ 60 godina; n = 83[13%]) bila je slična u svim terapijskim režimima.
Table 16: Sample calculations for patients receiving the recommended dose of 1.2 mg/kg of ADCETRIS for weights ranging from 60 kg to 120 kg as combination therapy or when a reduced dose is required
Tablica 16: Primjeri izračuna za bolesnike koji primaju preporučenu dozu od 1,2 mg/kg lijeka ADCETRIS za tjelesne težine u rasponu od 60 kg do 120 kg kao dio kombinirane terapije ili kad je potrebno smanjenje doze
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following ASCT, or 2. following at least two prior therapies when ASCT or multi -agent chemotherapy is not a treatment option.
ADCETRIS je indiciran za liječenje odraslih bolesnika s relapsom ili refraktornim oblikom CD30+ Hodgkinovog limfoma (HL): 1. nakon ASCT-a ili 2. nakon najmanje dva prethodna ciklusa liječenja kad ASCT ili kombinirana kemoterapija nije terapijska opcija.
Of the 20 evaluable patients with HL, 6 patients (30%) achieved a CR and 6 patients (30%) achieved a PR with ADCETRIS retreatment, for an ORR of 60%.
Od 20 bolesnika s HL-om koji su se mogli ocijeniti, njih 6 (30%) postiglo je potpunu remisiju (CR), a 6 (30%) postiglo je djelomičnu remisiju (PR) s lijekom ADCETRIS, što čini stopu objektivnog odgovora od 60%.
The serum and plasma pharmacokinetic characteristics of ADC and MMAE respectively following administration of brentuximab vedotin in combination with AVD were similar to that in monotherapy.
Farmakokinetika ADC-a i MMAE u serumu i plazmi nakon primjene brentuksimab vedotina u kombinaciji s AVD-om bile su slične kao kod primjene monoterapije.
Combination therapy Note: Primary prophylaxis with G-CSF is recommended for all patients receiving combination therapy beginning with the first dose.
Kombinirana terapija Napomena: Primarna profilaksa sa G-GSF se preporučuje u svih bolesnika koji primaju kombiniranu terapiju, počevši s prvom dozom.
Peripheral neuropathy led to treatment discontinuation in 15%, dose reductions in 15%, and dose delays in 17% of patients.
Periferna neuropatija dovela je do prekida liječenja u 15%, smanjenja doze u 15% i odgode primjene doze u 17% bolesnika.
Other secondary efficacy endpoints including CR rate and ORR at the end of randomisation regimen, CR rate at the end of first-line therapy, and the rate of PET negativity at the end of Cycle 2, duration of response (DOR), duration of complete remission (DOCR), disease-free survival (DFS,) and event-free survival (EFS) all trended in favour of ADCETRIS + AVD in both the ITT and Stage IV population.
Ostale sekundarne mjere ishoda vezane uz djelotvornost, uključujući stopu CR i ORR na kraju primanja randomizirane terapije, stopu CR na kraju prve linije terapije, te stopu negativnih PET nalaza na kraju 2. ciklusa, trajanje odgovora (DOR), trajanje potpune remisije (DOCR), preživljenje bez znakova bolesti (DFS,) i preživljenje bez događaja (EFS), svi su pokazivali trend prednosti u korist liječenja s režimom ADCETRIS + AVD, i u ITT skupini i u bolesnika s bolesti u 4. stadiju.
The effects of brentuximab vedotin on human male and female fertility have not been studied.
Učinci brentuksimab vedotina na mušku i žensku plodnost u ljudi nisu ispitani.
The analyses showed a consistent trend towards benefit for patients who received ADCETRIS compared with patients who received physician's choice.
Analize su pokazale konzistentan trend koristi za bolesnike koji su primali ADCETRIS u usporedbi s bolesnicima koji su primali lijek po izboru liječnika.
The analysis indicated that MMAE clearance was 2-fold lower in patients with low serum albumin concentrations <3.0 g/dl compared with patients with serum albumin concentrations within the normal range.
Klirens MMAE bio dvostruko niži u bolesnika s niskim koncentracijama albumina u serumu od < 3,0 g/dl u usporedbi s bolesnicima čije su koncentracije albumina u serumu bile unutar normalnog raspona.
Gently invert the bag to mix the solution containing Adcetris.
Nježno okrećite vrećicu kako biste promiješali otopinu koja sadrži ADCETRIS.
Each single use vial must be reconstituted with 10.5 mL of water for injections to a final concentration of 5 mg/mL.
Jedna bočica za jednokratnu primjenu mora se rekonstituirati s 10,5 ml vode za injekcije do konačne koncentracije od 5 mg/ml.
Nonclinical data suggest that the biological activity of brentuximab vedotin results from a multi-step process.
Neklinički podaci pokazuju da biološko djelovanje brentuksimab vedotina uključuje nekoliko koraka.
Figure 1: Modified progression-free survival per IRF in the ITT population (ADCETRIS + AVD vs. ABVD)
Slika 1: Modificirano preživljenje bez progresije bolesti prema IRF u ITT populacji (ADCETRIS + AVD u usporedbi s ABVD)
Out of the 49 patients receiving > 1 line of prior treatment, 22 patients (45%) received subsequent SCT; of the 11 patients who had received 1 prior treatment, 6 patients (55%) received subsequent SCT.
Od 49 bolesnika koji su primili > 1 linije prethodnog liječenja, u 22 bolesnika (45%) su kasnije transplantirane matične stanice; od 11 bolesnika koji su primili 1 prethodno liječenje, u 6 bolesnika (55%) su kasnije transplantirane matične stanice.
Not estimable.
Ne može se procijeniti.
• B symptoms at pre-ASCT relapse
• B simptomi u vrijeme relapsa prije ASCT-a
Anaphylactic reactions have been reported (see section 4.4).
Zabilježene su anafilaktičke reakcije (vidjeti dio 4.4).
Hepatotoxicity in the form of elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) has been reported with ADCETRIS.
Uz lijek ADCETRIS prijavljena je hepatotoksičnost u obliku povišenja vrijednosti alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST).
Grade 4 (< 500/mm < 0.5 x 10
Stupanj 4 (<500/mm <0,5 x 10
Compared to patients with normal renal function, MMAE exposure increased approximately 1.9-fold (90% CI 0.85-4.21-fold) in patients with severe renal impairment (creatinine clearance < 30 mL/min).
U usporedbi s bolesnicima s normalnom funkcijom bubrega, izloženost MMAE povećala se približno 1,9 puta (90% CI 0,85-4,21 puta) u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min).
Adcetris is used to treat systemic anaplastic large cell lymphoma which is found in your lymph nodes and/or throughout other parts of your body that has: not responded to other types of anti-cancer treatments, or come back after previous anti-cancer treatment.
Adcetris se primjenjuje za liječenje sistemskog anaplastičnog velikostaničnog limfoma u limfnim čvorovima i/ili u drugim dijelovima tijela koji: - nije odgovorio na druge vrste antitumorskih liječenja, ili - se vratio nakon prethodnog antitumorskog liječenja.
After reconstitution each mL of solution contains 5 mg of Adcetris.
Nakon pripreme, jedan ml otopine sadrži 5 mg lijeka Adcetris.
The presence of antibodies to brentuximab vedotin did not correlate with a clinically meaningful reduction in serum brentuximab vedotin levels and did not result in a decrease in the efficacy of brentuximab vedotin.
Prisutnost protutijela na brentuksimab vedotin nije korelirala s klinički značajnim sniženjem razina brentuksimab vedotina u serumu i nije rezultirala smanjenjem djelotvornosti brentuksimab vedotina.
Dose and frequency
Doza i učestalost
Patients with Stage IV disease for whom extranodal disease was reported ([n = 722] [HR = 0.69, 95% CI (0.50, 0.94)]) showed an mPFS (per IRF) benefit.
U bolesnika s bolesti u 4. stadiju sa zabilježenom ekstranodalnom bolesti ([n = 722] [HR = 0,69, 95% CI (0,50; 0,94)]) pokazana je mPFS korist (prema IRF).
In patients with Stage IV disease for whom no extranodal disease was reported, no benefit has been shown at time of analysis ([n = 85] [HR = 1.49, 95% CI (0.51, 4.31)]).
U bolesnika s bolesti u 4. stadiju bez zabilježene ekstranodalne proširenosti nije dokazana korist u vrijeme analize ([n = 85] [HR = 1,49; 95% CI (0,51; 4,31)]).
In clinical trials, patients were periodically tested for antibodies to brentuximab vedotin using a sensitive electrochemiluminescent immunoassay.
U kliničkim ispitivanjima bolesnici su periodički ispitivani na protutijela na brentuksimab vedotin osjetljivim elektrokemiluminiscentnim imunotestom.
In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 36% of patients.
U bolesnika koji su primali kombiniranu terapiju s lijekom ADCETRIS, ozbiljne nuspojave su se javile kod 36% bolesnika.
For intravenous use after reconstitution and dilution Read the package leaflet
Za intravensku primjenu nakon rekonstitucije i razrjeđivanja Pročitajte uputu o lijeku
Figure 4: Kaplan-Meier Plot of PFS per Investigator in Patients with ≥ 2 Risk Factors
Slika 4: Kaplan-Meierova krivulja PFS-a po ispitivaču u bolesnika s brojem čimbenika rizika ≥ 2
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
U svakoj skupini učestalosti nuspojave su navedene prema opadajućem stupnju ozbiljnosti.
Systemic anaplastic large cell lymphoma
Sistemski anaplastični velikostanični limfom
At the time of last evaluation, most of the patients (76%) who experienced peripheral neuropathy had resolution or improvement of their peripheral neuropathy symptoms.
Pri posljednjem posjetu, većina bolesnika (76%) kod kojih se pojavila periferna neuropatija prijavila je povlačenje ili poboljšanje simptoma periferne neuropatije.
Number of Risk Factors
Broj čimbenika rizika
Patients were treated with 1.8 mg/kg of ADCETRIS every 3 weeks.
Bolesnici su liječeni s 1,8 mg/kg lijeka ADCETRIS svaka 3 tjedna.
Co-administration of brentuximab vedotin with ketoconazole, a strong CYP3A4 and P-gp inhibitor, increased the exposure to the antimicrotubule agent MMAE by approximately 73%, and did not alter the plasma exposure to brentuximab vedotin.
Istodobna primjena brentuksimab vedotina s ketokonazolom, jakim inhibitorom CYP3A4 i P-gp, povećala je izloženost antimikrotubularnom lijeku MMAE za približno 73% i nije promijenila izloženost brentuksimab vedotinu u plazmi.
ADCETRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents.
ADCETRIS treba primjenjivati pod nadzorom liječnika s iskustvom u primjeni antitumorskih lijekova.