natgillin/translations-raw huggingface dataset:
Arthralgia, myalgia
Artralgija, mialgija
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).
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).
If neutropenia develops, refer to Table 1: Dosing recommendations for neutropenia (see section 4.2).
Ako se razvije neutropenija, pogledajte tablicu 1: Preporuke za doziranje kod neutropenije (vidjeti dio 4.2).
2.4 vials a.
2.4 bočica a.
The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration.
4. Rekonstituiranu otopinu treba vizualno pregledati zbog prisutnosti stranih čestica i/ili promjene boje.
The median duration of treatment for patients who discontinued due to peripheral neuropathy was 12 cycles.
Medijan trajanja liječenja bolesnika koji su liječenje prekinuli zbog periferne neuropatije bio je 12 ciklusa.
Treatment response was assessed by spiral CT of chest, neck, abdomen and pelvis; PET scans and clinical data.
Terapijski odgovor procijenjen je prema spiralnom CT-u prsnog koša, vrata, abdomena i zdjelice, PET snimanju i kliničkim podacima.
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.
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.
a per IRF at 2 Year (%)
a prema IRF nakon 2 godine (%)
Median time from HL diagnosis to first dose (range)
Medijan vremena od dijagnoze HL-a do prve doze (raspon)
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)]).
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)]).
Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Stoga se muškarcima koji se liječe ovim lijekom savjetuje da prije liječenja daju uzorke sperme na zamrzavanje i čuvanje.
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.
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.
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.
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.
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.
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.
Figure 5: Kaplan-Meier Plot of OS
Slika 5: Kaplan-Meierova krivulja OS-a
The ADC is eliminated by catabolism with a typical estimated CL and half life of 1.5 l/day and 4-6 days respectively.
ADC se eliminira putem katabolizma uz uobičajeni procijenjeni CL od 1,5 l/dan i poluvijek od 4-6 dana.
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).
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).
Haematological toxicities
Hematološke toksičnosti
Stage IV
Stadij IV
Adverse events led to treatment discontinuation in 13% of patients.
Štetni događaji su uzrokovale prekid liječenja u 13% bolesnika.
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.
Procjena bolesnika može uključivati fizički pregled, određivanje laboratorijske vrijednosti serumske amilaze i serumske lipaze, snimanje abdomena ultrazvukom i drugim odgovarajućim dijagnostičkim mjerama.
ADC accumulation (as assessed by AUC14D between Cycle 1 and Cycle 3) was 1.27-fold.
Akumulacija ADC-a (prema analizi AUC14D između 1. i 3. Ciklusa) bila je 1,27 puta veća.
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).
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).
This substance is delivered to cancer cells by the monoclonal antibody.
Ta tvar se dostavlja u stanice raka pomoću monoklonskog protutijela.
Per IRF, the objective response rate (ORR) in the ITT population was 50% (95% CI, 37; 63%).
Objektivna stopa odgovora po IRF-u u populaciji ITT bila je 50% (95% CI, 37%; 63%).
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.
Adcetris se koristi za liječenje kožnog limfoma T-stanica (CTCL) u bolesnika koji su prethodno primili najmanje jedan lijek koji prolazi kroz krvotok.
Investigations Very common:
Pretrage Vrlo često:
Relapsed or refractory sALCL
Relaps ili refraktorni oblik sALCL-a
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
ADCETRIS je indiciran za liječenje odraslih bolesnika s relapsom ili refraktornim oblikom sistemskog anaplastičnog velikostaničnog limfoma (sALCL).
• HL that occurred <12 months or HL that was refractory to frontline therapy
• HL koji se pojavio nakon < 12 mjeseci ili HL koji je bio refraktoran na prvu liniju terapije
Once steady-state was achieved, the PK of ADC did not appear to change with time.
U stanju dinamičke ravnoteže čini se da se farmakokinetika ADC-a nije mijenjala s vremenom.
Do not use this medicine if you notice any particulate matter or discoloration prior to administration.
Ovaj lijek se ne smije upotrijebiti ako primijetite ikakve čestice ili promjenu boje prije primjene.
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.
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.
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.
Muškarcima se savjetuje da ne začinju dijete tijekom liječenja ovim lijekom i do 6 mjeseci nakon zadnje doze lijeka.
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.
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.
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 bio je procijeniti učinak brentuksimab vedotina na repolarizaciju srčanih klijetki, a unaprijed je definirano da će se analizirati promjena QTc od početne do više vremenskih točki u ciklusu 1.
In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology.
U dva ispitivanja lijeka ADCETRIS faze II s jednom skupinom, aktivnost bolesti pokazana je u podtipovima Sézary sindroma (SS), limfomatoidne papuloze (LyP) i CTCL-a miješane histologije.
Pneumonia, oral candidiasis, sepsis/septic shock, herpes simplex
Pneumonija, oralna kandidijaza, sepsa/septički šok, herpes simplex
In vivo data in animals and humans suggest that only a small fraction of MMAE released from brentuximab vedotin is metabolised.
In vivo podaci u životinja i ljudi pokazuju da se metabolizira samo mali dio MMAE oslobođenog iz brentuksimab vedotina.
The efficacy and safety of ADCETRIS were evaluated in two additional open-label studies in 108 patients with relapsed CD30+ CTCL (including MF and pcALCL as well as SS, LyP and mixed CTCL histology), regardless of CD30 expression level.
Djelotvornost i sigurnost lijeka ADCETRIS procijenjene su u dva dodatna otvorena ispitivanja u 108 bolesnika s relapsom CD30+ CTCL-a (uključujući MF i pcALCL kao i SS, LyP i CTCL miješane histologije), bez obzira na razinu ekspresije CD30.
In patients with relapsed or refractory HL or sALCL who were retreated with ADCETRIS (SGN35-006), the majority of patients (80%) also had improvement or resolution of their peripheral neuropathy symptoms at the time of last evaluation.
U skupini bolesnika s relapsom ili refraktornim oblikom HL-a ili sALCL-a koji su ponovno primali ADCETRIS (SGN35-006), simptomi periferne neuropatije su se u vrijeme zadnje procjene također poboljšali ili povukli u većine bolesnika (80%).
If you are breast-feeding, you should discuss with your doctor whether you should receive this medicine.
Ako dojite, razgovarajte sa svojim liječnikom trebate li uzimati ovaj lijek.
Per IRF, the ORR was 51% (95% CI [36%, 66%]) for the patients who had received > 1 prior cancer-related treatment and 45% (95% CI [17%, 77%]) for the patients who had received 1 prior cancer-related treatment.
Po IRF-u, objektivna stopa odgovora bila je 51% (95% CI [36%; 66%]) za bolesnike koji su primili >1 prethodno liječenje zbog raka, a 45% (95% CI [17%; 77%]) za bolesnike koji su primili 1 prethodno liječenje zbog raka.
The safety profile of ADCETRIS is based on available clinical trial data, the Named Patient Program (NPP), and post-marketing experience to date.
Sigurnosni profil lijeka ADCETRIS temelji se na do danas dostupnim podacima iz kliničkih ispitivanja, projekta Programa imenovanih bolesnika (engl.
Patients with a concurrent diagnosis of systemic ALCL, Sezary syndrome and other nonHodgkin lymphoma (except for lymphomatoid papulosis [LyP]) were excluded from this study.
Bolesnici s istovremenom dijagnozom sistemskog ALCL-a, Sézary sindroma i drugog ne-Hodgkinovog limfoma (osim limfomatoidne papuloze [LyP]) bili su isključeni iz ovog ispitivanja.
Percent Difference (95% CI) p-value
Postotak razlike (95% CI) p-vrijednost
Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; see neuropathy: motor; neuropathy: sensory; and neuropathic pain.
Stupnjevanje na temelju verzije 3.0 Zajedničkih terminoloških kriterija za nuspojave (CTCAE) Nacionalnog instituta za rak (NCI); vidjeti neuropatija: motorička; neuropatija: senzorna i neuropatska bol.
Pancreatitis acute
Akutni pankreatitis
The recommended dose in combination with chemotherapy (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]) is 1.2 mg/kg administered as an intravenous infusion over 30 minutes on days 1 and 15 of each 28-day cycle for 6 cycles (see section 5.1).
Preporučena doza u kombinaciji s kemoterapijom (doksorubicin [A], vinblastin [V] i dakarbazin [D] [AVD]) je 1,2 mg/kg primijenjena kao intravenska infuzija u trajanju od 30 minuta na 1. i 15. dan svakog 28-dnevnog ciklusa, tijekom 6 ciklusa (vidjeti dio 5.1).
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.
Početne osobine bolesnika pokazale su da je više prethodnih kemoterapijskih režima (medijan od 3 s rasponom od 1 do 7) bilo neuspješno prije prve primjene lijeka ADCETRIS.
MMAE is the major metabolite of brentuximab vedotin.
MMAE je glavni metabolit brentuksimab vedotina.
After multiple-dose, IV infusion of 1.2 mg/kg brentuximab vedotin every two weeks, maximal serum concentrations of ADC were observed near the end of the infusion and elimination exhibited a multi-exponential decline with a t1/2z of approximately 4 to 5 days.
Nakon višestruke primjene intravenske infuzije 1,2 mg/kg brentuksimab vedotina svaka dva tjedna, maksimalna serumska koncentracija ADC-a je bila opažena na kraju infuzije, a eliminacija je pokazivala multieksponencijalni pad sa t1/2z od približno 4 do 5 dana.
The analyses showed a consistent trend towards benefit for patients who received ADCETRIS compared with patients who received placebo with the exception of patients ≥65 years of age (n = 8).
Analize su pokazale dosljedan trend prema koristi za bolesnike koji su primali ADCETRIS u usporedbi s bolesnicima koji su primali placebo, s izuzetkom bolesnika starosti ≥ 65 godina (n=8).
In the event of new or worsening pulmonary symptoms (e.g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients should be treated appropriately.
U slučaju pojave ili pogoršanja plućnih simptoma (npr. kašalj, dispneja), treba se provesti brza dijagnostička procjena i bolesnika treba liječiti na odgovarajući način.
Patients experiencing new or worsening peripheral neuropathy may require a delay and a dose reduction of ADCETRIS or discontinuation of treatment (see section 4.2).
U bolesnika s novonastalom perifernom neuropatijom ili pogoršanjem postojeće može biti potrebno odgoditi primjenu ili sniziti dozu lijeka ADCETRIS ili prekinuti liječenje (vidjeti dio 4.2).
Modification of dose and schedule
Prilagodba doze i rasporeda Prilagodba doze i rasporeda
The CD30-targeted mechanism of action of brentuximab vedotin, the consistent expression of CD30 throughout the classical HL, sALCL and CD30+ CTCL disease and therapeutic spectrums and clinical evidence in CD30-positive malignancies following multiple lines of treatment provide a biologic rationale for its use in patients with relapsed and refractory classical HL, sALCL with or without prior ASCT and CD30+ CTCL after at least 1 prior systemic therapy.
Mehanizam djelovanja brentuksimab vedotina usmjeren na CD30, dosljedno izražavanje CD30 tijekom cijelog trajanja klasičnog HL-a, sALCL-a i CD30+ CTCL bolesti te terapijski rasponi i klinički dokazi zloćudnih bolesti s pozitivnim CD30 nakon višestrukih linija liječenja čine biološku osnovu za primjenu brentuksimab vedotina u bolesnika s relapsom ili refraktornim oblikom klasičnog HL-a, sALCL-a sa ili bez prethodnog ASCT-a i s CD30+ CTCL-om nakon najmanje 1 prethodnog sistemskog liječenja.
If neutropenia develops during treatment it should be managed by dose delays.
Ako se neutropenija razvije tijekom liječenja, treba odgoditi primjenu sljedeće doze.
Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose.
Muškarcima koji se liječe ovim lijekom savjetuje se da ne začinju dijete tijekom liječenja i do 6 mjeseci nakon zadnje doze.
Adverse reactions for ADCETRIS are listed by MedDRA System Organ Class and Preferred Term (see Table 3).
Nuspojave lijeka ADCETRIS navedene su prema MedDRA klasifikaciji organskih sustava i preporučenim izrazima (vidjeti tablicu 3).
Maximum concentrations of brentuximab vedotin ADC were typically observed at the end of infusion or the sampling timepoint closest to the end of infusion.
Maksimalne koncentracije brentuksimab vedotin ADC obično su bile opažene na kraju infuzije ili u vremenskoj točki uzimanja uzorka koja je bila najbliža završetku infuzije.
Pneumocystis jiroveci pneumonia, staphylococcal bacteraemia, cytomegalovirus infection or reactivation, sepsis/septic shock
Pneumonija uzrokovana s Pneumocystis jiroveci, stafilokokna bakterijemija, infekcija citomegalovirusom ili reaktivacija, sepsa/septički šok
Adcetris contains sodium
Adcetris sadrži natrij
Tumour lysis syndrome (TLS) has been reported with ADCETRIS.
Sindrom lize tumora (TLS) zabilježen je uz lijek ADCETRIS.
These patients should receive up to 16 cycles (see section 5.1).
Ti bolesnici trebaju primiti do 16 ciklusa (vidjeti dio 5.1).
Procedures for proper handling and disposal of anticancer medicines should be considered.
Potrebno je razmotriti postupke za ispravno rukovanje antitumorskim lijekovima i njihovo odlaganje.
Among patients who experienced peripheral neuropathy, the median follow up time from end of treatment until last evaluation was approximately 91 weeks.
Među bolesnicima kod kojih se pojavila periferna neuropatija, medijan vremena od kraja liječenja do posljednje posjete iznosio je oko 91 tjedan.
Safety was evaluated in a phase 1/2 study in paediatric patients aged 7-17 years of age (n = 36) with relapsed or refractory (r/r) HL and sALCL (see section 5.1).
Sigurnost je procijenjena u ispitivanju faze 1/2 u pedijatrijskih bolesnika u dobi od 7-17 godina (n = 36) s relapsom ili refraktornim (r/r) oblikom HL-a i sALCL-a (vidjeti dio 5.1).
The objective response rate (ORR) per IRF assessment was 75% (76 of 102 patients in the intent-to-treat [ITT] set) and tumour reduction was achieved in 94% of patients.
Stopa objektivnog odgovora (ORR) po procjeni IRF-a bila je 75% (76 od 102 bolesnika u grupi bolesnika predviđenih za liječenje, [ITT, intent-to-treat]), a smanjenje tumora bilo je postignuto u 94% bolesnika.
Of the study's 60 patients, 49 patients (82%) received > 1 prior cancer-related treatment and 11 patients (18%) received 1 prior cancer-related treatment.
Od 60 bolesnika u ispitivanju, 49 bolesnika (82%) primilo je > 1 prethodno liječenje zbog raka, a 11 bolesnika (18%) primilo je 1 prethodno liječenje zbog raka.
Because of the CD30-targeted mechanism of action brentuximab vedotin is able to overcome chemo-resistance as CD30 is consistently expressed in patients who are refractory to multi-agent chemotherapy, irrespective of prior transplant status.
Zbog svog mehanizma djelovanja usmjerenog na CD30, brentuksimab vedotin može nadjačati kemorezistenciju jer je CD30 dosljedno izražen u bolesnika koji su refraktorni na više različitih antineoplastičnih lijekova, bez obzira na prethodni transplantacijski status.
Patients should be closely monitored for new or worsening neurological, cognitive, or behavioural signs or symptoms, which may be suggestive of PML.
Bolesnike treba pažljivo nadzirati zbog mogućih nastanka novih ili pogoršanja postojećih neuroloških, kognitivnih ili bihevioralnih znakova i simptoma koji mogu upućivati na PML.
The significance of this finding in stage IV HL patients with no extranodal disease is not established due to small patient numbers and low event rates (14 events).
Značaj ovog rezultata za bolesnike sa HL u 4. Stadiju bez ekstranodalne bolesti nije ustanovljen zbog malog broja bolesnika
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.
47%, u bolesnika s r/r sALCL-om iznosila je 53% te 60% u bolesnika sa sALCL-om u prvom relapsu.
The reconstituted solution in the vial is a clear to slightly opalescent, colourless solution with a final pH of 6.6.
Rekonstituirana otopina u bočici bistra je do blago opalescentna, bezbojna otopina s konačnim pH od 6,6.
The primary endpoint in Study C25003 was modified PFS (mPFS) per independent review facility (IRF), defined as time from randomisation to disease progression, death, or evidence of non-complete response (non-CR) after completion of first-line therapy per IRF followed by subsequent anticancer therapy.
Primarna mjera ishoda ispitivanja C25003 je bilo modificirano preživljenje bez progresije bolesti (mPFS), prema skupini za neovisnu procjenu (IRF), definirano vremenom proteklim od randomizacije do progresije bolesti, smrti ili dokaza o nepotpunom odgovoru na terapiju (non-CR) prema IRF nakon završetka primjene prve linije terapije, praćeno sljedećom antitumorskom terapijom.
You may be given other medicines such as anti-histamines, corticosteroids or paracetamol to help reduce any of the reactions above if you have already experienced these when receiving this type of medicine.
- antihistaminici, kortikosteroidi ili paracetamol radi smanjivanja navedenih simptoma, posebno ako ste već prije imali reakcije na infuziju kada ste primali ovu vrstu lijeka.
Patients ≥ 65 years old n (%) Gender n (%)
Bolesnici ≥ 65 godina n (%) Spol n (%)
Additionally, the population pharmacokinetics of brentuximab vedotin in combination with AVD were examined, including data from 661 patients up to 82 years old (42 patients ≥ 65-< 75 and 17 patients ≥ 75 years of age).
Dodatno, ispitana je populacijska farmakokinetika brentuksimab vedotina u kombinaciji s AVD, uključujući podatke o 661 bolesniku u dobi do 82 godine (42 bolesnika ≥ 65-< 75 i 17 bolesnika
Herpes zoster, pneumonia, herpes simplex, oral candidiasis
Herpes zoster, pneumonija, herpes simplex, oralna kandidijaza
Eighteen (18) patients (18%) received 16 cycles of ADCETRIS; and the median number of cycles received was 9 (ranging from 1 to 16).
Osamnaest (18) bolesnika (18%) primilo je 16 ciklusa lijeka ADCETRIS, a medijan primljenih ciklusa bio je 9 (u rasponu od 1 do 16).
0.89 mo (0.0-81.4)
0,89 mj. (0,0-81,4)
Phase 1 included 3 r/r HL patients treated at 1.4 mg/kg and 9 patients (7 r/r HL and 2 sALCL) treated at 1.8 mg/kg.
Faza 1 uključila je 3 r/r bolesnika s HL-om liječena s 1,4 mg/kg i 9 bolesnika (7 s r/r HL-om i 2 sa sALCL-om) liječena s 1,8 mg/kg.
The Cmax of ADC was typically observed at the end of infusion or the sampling closest to the end of infusion.
Cmax za ADC obično je zabilježen na kraju infuzije ili u vremenskoj točki uzimanja uzorka koja je bila najbliža završetku infuzije.
Hyperglycaemia has been reported during clinical trials in patients with an elevated Body Mass Index (BMI) with or without a history of diabetes mellitus.
Hiperglikemija je zabilježena tijekom kliničkih ispitivanja u bolesnika s povećanim indeksom tjelesne mase (BMI) s dijabetesom melitusom ili bez njega u anamnezi.