FrancophonIA/ELRC3.0 huggingface dataset:
English: - Stevens-Johnson syndrome - a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin - new or recurring cytomegalovirus (CMV) infection
Croatian: - Stevens-Johnsonov sindrom - rijedak, ozbiljan poremećaj kod kojeg možete osjećati simptome nalik gripi praćene bolnim crvenim ili ljubičastim osipom koji se širi, te plikovima, uključujući i opsežno odvajanje kože - nastanak ili ponovna infekcija citomegalovirusom (CMV)
English: Table 11: Summary of baseline patient and disease characteristics in the phase 2 relapsed or refractory sALCL study
Croatian: Tablica 11: Sažeti opis početnih karakteristika bolesnika i bolesti u fazi 2 ispitivanja relapsa ili refraktornog oblika sALCL
English: Anaemia, thrombocytopenia
Croatian: Anemija, trombocitopenija
English: Study SGN35-006 (Retreatment study)
Croatian: Ispitivanje SGN35-006 (Ispitivanje ponovnog liječenja)
English: Study SGN35-006 (Retreatment Study)
Croatian: Ispitivanje SGN35-006 (ispitivanje ponovnog liječenja)
English: Cough, dyspnoea
Croatian: Kašalj, dispneja
English: Adverse reactions (combination therapy)
Croatian: Nuspojave (kombinirana terapija)
English: Grade 3 or Grade 4 anaemia, thrombocytopenia, and prolonged (≥ 1 week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS.
Croatian: Uz ADCETRIS mogu nastati anemija 3. stupnja ili 4. stupnja, trombocitopenija i dugotrajna (≥ 1 tjedna) neutropenija 3. stupnja ili 4. stupnja.
English: 1.92 vials
Croatian: 1.92 bočica
English: For safety information of chemotherapy agents given in combination with ADCETRIS (doxorubicin, vinblastine and dacarbazine) for newly diagnosed patients with HL, refer to their summary of product characteristics.
Croatian: Podatke o sigurnosti kemoterapeutika (doksorubicin, vinblastin i dakarbazin) koji se u bolesnika s novodijagnosticiranim HL-om primjenjuju u kombinaciji s lijekom ADCETRIS potražite u njihovim sažecima opisa svojstava lijeka.
English: - Stevens-Johnson syndrome and toxic epidermal necrolysis - a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin - decreased level of white blood cells with a fever - damage to the nerves and nerve coverings (demyelinating polyneuropathy)
Croatian: - Stevens-Johnsonov sindrom i toksična epidermalna nekroliza - rijedak, ozbiljan poremećaj kod kojeg možete osjećati simptome nalik gripi praćene bolnim crvenim ili ljubičastim osipom koji se širi, te mjehurima, uključujući i opsežno odvajanje kože - snižena razina bijelih krvnih stanica s vrućicom - oštećenje živaca i omotača živaca (demijelinizirajuća polineuropatija)
English: In the Stage IV population, 35% fewer patients treated with ADCETRIS + AVD received subsequent salvage chemotherapy (n = 45) compared with those treated with ABVD (n = 69) and 22% fewer patients treated with ADCETRIS + AVD received high-dose chemotherapy and transplant (n = 29) compared with those treated with ABVD (n = 37).
Croatian: U skupini bolesnika s bolesti u 4. stadiju, naknadnu kemoterapiju spasa primilo je 35% manje bolesnika (n = 45) koji su koristili ADCETRIS + AVD u usporedbi s bolesnicima koji su koristili ABVD (n = 69), a kemoterapiju s visokim dozama i transplantaciju primilo je 22% manje bolesnika (n = 29) koji su koristili ADCETRIS + AVD u usporedbi s bolesnicima koji su koristili ABVD (n = 37).
English: The pharmacokinetics of brentuximab vedotin ADC and MMAE following a 30-minute intravenous infusion of BV administered at 1.4 mg/kg or 1.8 mg/kg given every 3 weeks were evaluated in a phase 1/2 clinical trial of 36 paediatric patients (7-17 years of age) with r/r HL and sALCL (children aged 7-11 years, n = 12 and adolescents aged 12 to 17 years, n = 24) (see section 5.1).
Croatian: Farmakokinetika brentuksimab vedotina kao konjugata protutijela i lijeka (engl. antibody-drug conjugate, ADC) i samog MMAE nakon 30-minutne intravenske infuzije brentuksimab vedotina primijenjenog u dozi od 1,4 mg/kg ili 1,8 mg/kg, svaka 3 tjedna, procijenjena je u kliničkom ispitivanju faze 1/2 u 36 pedijatrijskih bolesnika (u dobi od 7 do 17 godina) s r/r HL-om i sa sALCL-om (djeca u dobi od 7 do 11 godina, n=12 i adolescenti u dobi od 12 do 17 godina, n=24) (vidjeti dio 5.1).
English: For more detailed information, see “Infusion reactions” in section 4. have any problems with a change in the sensitivity of the skin, especially in the hands or feet, such as numbness, tingling, a burning sensation, pain, discomfort or weakness (neuropathy) have headaches, feel tired, experience dizziness, look pale (anaemia), or have unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (thrombocytopenia) develop chills or shivering, or feel warm; you should take your temperature as you may have a fever.
Croatian: Za detaljnije informacije, pogledajte “Reakcije na infuziju” u dijelu 4. - imate smetnje u smislu promjena osjeta po koži, osobito šaka i stopala, kao što je utrnulost, žmarci, žarenje, bol, nelagoda ili slabost (neuropatija) - imate glavobolje, osjećate umor, omaglicu, izgledate blijedo (anemija) ili imate neuobičajeno krvarenje ili modrice pod kožom, krvarite dulje nego obično nakon vađenja krvi ili imate krvarenje iz desni (trombocitopenija) - razvijete zimicu ili drhtavicu ili osjećate toplinu.
English: ADCETRIS is for single use only.
Croatian: ADCETRIS je namijenjen samo za jednokratnu primjenu.
English: Therefore, co-administration of ADCETRIS with bleomycin is contraindicated (see section 4.2).
Croatian: Stoga je istodobna primjena lijeka ADCETRIS s bleomicinom kontraindicirana (vidjeti dio 4.2).
English: Delpharm Novara S.r.l.
Croatian: Delpharm Novara S.r.l. Via Crosa 86
English: Classical HL, sALCL and subtypes of CTCL (including MF and pcALCL) express CD30 as an antigen on the surface of their malignant cells.
Croatian: Zloćudne stanice klasičnog HL-a, sALCL-a i podtipova CTCL-a (uključujući MF i pcALCL) izražavaju CD30 kao antigen na svojoj površini neovisno o stadiju bolesti, liniji liječenja ili provedenoj transplantaciji.
English: The median number of cycles was 7 (range 1 to 16 cycles).
Croatian: Medijan broja ciklusa bio je 7 (u rasponu od 1 do 16 ciklusa).
English: No pulmonary toxicity or fatal events were reported with brentuximab vedotin + AVD.
Croatian: Nije bilo prijavljenih slučajeva toksičnosti ili smrtnih ishoda pri kombiniranom liječenju brentuksimab vedotinom i AVD-om.
English: Stevens-Johnson syndrome/toxic epidermal necrolysis
Croatian: Stevens-Johnsonov sindrom/toksična epidermalna nekroliza
English: If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted.
Croatian: U slučaju pojave reakcija povezanih s infuzijom, infuziju treba prekinuti i uvesti odgovarajuće medikamentno liječenje.
English: Stevens-Johnson syndrome and toxic epidermal necrolysis
Croatian: Stevens-Johnsonov sindrom i toksična epidermalna nekroliza
English: Objective response rate (CR + PR) Complete remission (CR) Partial remission (PR)
Croatian: Stopa objektivnog odgovora (CR + PR) Potpuna remisija (CR) Djelomična remisija (PR)
English: Peripheral neuropathy led to treatment discontinuation in 7%, dose reductions in 21%, and dose delays in 1% of patients.
Croatian: Periferna neuropatija uzrokovala je prekid liječenja kod 7% bolesnika, smanjenje doze kod 21 bolesnika, a odgodu primjene doze lijeka kod 1% bolesnika.
English: Citric acid monohydrate (for pH-adjustment) Sodium citrate dihydrate (for pH-adjustment) α,α-Trehalose dihydrate Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari citratna kiselina hidrat (za podešavanje pH vrijednosti) natrijev citrat dihidrat (za podešavanje pH vrijednosti) α,α-trehaloza dihidrat polisorbat 80
English: 35 years (18-82)
Croatian: 35 godina (18-82)
English: Relapsed or refractory HL
Croatian: Relaps ili refraktorni oblik HL-a
English: Table 14: Efficacy results in CTCL patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks (ITT population)
Croatian: Tablica 14: Rezultati djelotvornosti u bolesnika s CTCL-om liječenih s 1,8 mg/kg lijeka ADCETRIS svaka 3 tjedna (ITT populacija)
English: 3.6 vials
Croatian: 3,6 bočica
English: Pre-specified subgroup analyses of PFS per IRF were performed by patients' best response to pre-ASCT salvage therapy, HL status after frontline therapy, age, gender, baseline weight, baseline ECOG performance status, number of treatments pre-ASCT, geographic region, pre-ASCT PET status, B symptom status after failure of frontline therapy, and pre-ASCT extranodal disease status.
Croatian: Provedene su unaprijed određene analize podskupina za PFS po IRF-u po najboljim odgovorima bolesnika na terapiju spasa prije ASCT-a, statusu HL-a nakon prve linije liječenja, dobi, spolu, početnoj težini, početnom ECOG funkcionalnom statusu, broju liječenja prije ASCT-a, zemljopisnom području, statusu PET snimanja prije ASCT-a, statusu B simptoma nakon neuspjeha liječenja prve linije i statusu ekstranodularne bolesti prije ASCT-a.
English: The efficacy and safety of ADCETRIS as a single agent was evaluated in a pivotal phase 3, openlabel, randomised, multicentre study in 128 patients with histologically confirmed CD30+ CTCL.
Croatian: Djelotvornost i sigurnost lijeka ADCETRIS koji se primjenjivao kao monoterapija procijenjene su u otvorenom, randomiziranom, multicentričnom pivotalnom ispitivanju faze 3 u 128 bolesnika s histološki potvrđenim CD30+ CTCL-om.
English: Following dilution, infuse the ADCETRIS solution immediately at the recommended infusion rate.
Croatian: Nakon razrjeđenja, infuziju otopine lijeka ADCETRIS primijenite odmah uz preporučenu brzinu infuzije.
English: Brentuximab vedotin is an antibody drug conjugate (ADC) that delivers an antineoplastic agent that results in apoptotic cell death selectively in CD30-expressing tumour cells.
Croatian: Brentuksimab vedotin je konjugat protutijela i lijeka (ADC) kojim se antineoplastički lijek selektivno dostavlja u tumorske stanice s izraženim CD30 biljegom i dovodi do apoptoze tih stanica.
English: There was a higher incidence of infusion-related reactions observed in patients with antibodies to brentuximab vedotin relative to patients who tested transiently positive or negative.
Croatian: Viša incidencija reakcija povezanih s infuzijom opažena je u bolesnika sa stalno pozitivnim protutijelima na brentuksimab vedotin u odnosu na bolesnike u kojih su protutijela na brentuksimab vedotin bila prolazno pozitivna ili negativna.
English: Special patient populations
Croatian: Posebne skupine bolesnika
English: A lesser amount of MMAE (28%) was excreted in the urine.
Croatian: Od izmjerenog MMAE, približno 72% izlučeno je u stolici, a manja količina (28%) bila je izlučena mokraćom.
English: 32 years (18-76)
Croatian: 32 godine (18-76)
English: • Extranodal disease at pre-ASCT relapse
Croatian: • Ekstranodularna bolest u vrijeme relapsa prije ASCT-a
English: Powder for concentrate for solution for infusion 1 vial
Croatian: Prašak za koncentrat za otopinu za infuziju 1 bočica
English: 9/L, fever ≥ 38.5
Croatian: 9/l, vrućicom ≥ 38,5°C; ref. CTCAE v3).
English: Excipients: Citric acid monohydrate, sodium citrate dihydrate, α,α-trehalose dihydrate, polysorbate 80 See package leaflet for further information
Croatian: Pomoćne tvari: citratna kiselina hidrat, natrijev citrat dihidrat, α,α-trehaloza dihidrat, polisorbat 80 Vidjeti uputu o lijeku za dodatne informacije
English: Study SG035-0004
Croatian: Ispitivanje SG035-0004
English: The median duration of response was 8.8 and 12.3 months in patients who achieved OR (CR+PR) and CR, respectively.
Croatian: Medijan trajanja odgovora bio je 8,8 mjeseci u bolesnika koji su postigli objektivni odgovor (CR+PR), odnosno 12,3 mjeseci u bolesnika koji su postigli potpunu remisiju (CR).
English: An exploratory intra-patient analysis showed that approximately 69% of the sALCL patients treated with ADCETRIS as part of the SG035-0004 clinical study experienced an improvement in clinical benefit as measured by longer progression free survival (PFS) compared with their most recent prior line of therapy.
Croatian: Eksplorativna analiza podataka kod pojedinog bolesnika pokazala je da je približno 69% bolesnika s sALCL liječenih lijekom ADCETRIS u sklopu kliničkog ispitivanja SG035-0004 imalo kliničku korist prema izmjerenom duljem preživljenju bez progresije bolesti (PFS) u usporedbi s njihovom zadnjom linijom terapije.
English: MMAE were observed approximately 2 days after the end of infusion, and exhibited a mono-exponential decline with a t1/2z of approximately 3 to 4 days.
Croatian: Maksimalna koncentracija MMAE u plazmi je primijećena 2 dana nakon infuzije, te je pokazala monoeksponencijalni pad sa t1/2z od približno 3 do 4 dana.
English: While the presence of antibodies to brentuximab vedotin does not necessarily predict the development of an IRR, there was a higher incidence of IRRs observed in patients with persistently positive anti-drug antibodies (ADA) relative to patients with transiently positive ADA and never positive ADA.
Croatian: Iako prisutnost protutijela na brentuksimab vedotin ne pretkazuje nužno nastanak reakcija povezanih s infuzijom, viša incidencija reakcija povezanih s infuzijom opažena je u bolesnika sa trajno pozitivnim protutijelima na lijek u odnosu na bolesnike u kojih su protutijela na lijek bila prolazno pozitivna i one u kojih protutijela na lijek nikad nisu bila pozitivna.
English: 10.8, NE
Croatian: 10,8; NP
English: The analyses showed a consistent trend towards benefit for patients who received ADCETRIS + AVD compared with patients who received ABVD in most subgroups.
Croatian: Analize su u većini podskupina pokazale konzistentan trend prema koristi za bolesnike koji su primali ADCETRIS + AVD, u usporedbi s bolesnicima koji su primali ABVD.
English: Estimated 5-year OS Rate a.
Croatian: Procijenjena stopa 5-godišnjeg OS
English: Note: If patient's weight is more than 100 kg, the dose calculation should use 100 kg.
Croatian: Ako je tjelesna težina bolesnika veća od 100 kg, za izračun doze treba koristiti 100 kg.
English: It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, važno je da o tome obavijestite svog liječnika prije i tijekom liječenja.
English: How Adcetris is given
Croatian: Kako se Adcetris daje
English: See Table 11 below for a summary of baseline patient and disease characteristics.
Croatian: Pogledajte tablicu 11 niže za sažeti opis početnih karakteristika bolesnika i bolesti.
English: A study evaluated the PK of brentuximab vedotin and MMAE after the administration of 1.2 mg/kg of ADCETRIS to patients with mild (Child-Pugh A; n = 1), moderate (Child-Pugh B; n = 5) and severe (Child-Pugh C; n = 1) hepatic impairment.
Croatian: U ispitivanju je ocijenjena farmakokinetika brentuksimab vedotina i MMAE nakon primjene 1,2 mg/kg lijeka ADCETRIS u bolesnika s blagim (Child-Pugh A; n=1), umjerenim (Child-Pugh B; n=5) i teškim (Child-Pugh C; n=1) oštećenjem jetre.
English: Objective response (CR + PR) Complete remission (CR)
Croatian: Objektivni odgovor (CR + PR) Potpuna remisija (CR)
English: Table 3: Adverse reactions to ADCETRIS
Croatian: Tablica 3: Nuspojave lijeka ADCETRIS
English: Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage.
Croatian: Unutar stanice proteolitičkim cijepanjem se iz kompleksa oslobađa jedina definirana djelatna tvar, MMAE.
English: The infusion line should be flushed following administration with sodium chloride 9 mg/ mL (0.9%) solution for injection, 5% dextrose for injection, or Lactated Ringer's for injection.
Croatian: Infuzijsku liniju nakon primjene treba isprati otopinom natrijevog klorida od 9 mg/ml (0,9%) za injekciju, 5% otopinom glukoze za injekciju ili Ringerovom otopinom s laktatom za injekciju.
English: 37 years (18-83)
Croatian: 37 godina (18-83)
English: IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus and cough were reported in 13% of patients.
Croatian: Reakcije povezane s infuzijom, kao što su glavobolja, osip, bol u leđima, povraćanje, zimica, mučnina, dispneja, pruritus i kašalj, prijavljene su u 13% bolesnika.
English: Complete blood counts should be monitored prior to administration of each dose.
Croatian: Prije primjene svake doze potrebno je kontrolirati kompletnu krvnu sliku.
English: The already reconstituted Adcetris can also be diluted into 5% dextrose for injection or Lactated Ringer's for injection.
Croatian: Već rekonstituirani Adcetris također se može razrijediti 5% otopinom glukoze za injekciju ili Ringerovom otopinom s laktatom za injekciju.
English: The already reconstituted ADCETRIS can also be diluted into 5% dextrose for injection or Lactated Ringer's for injection.
Croatian: Već rekonstituirani ADCETRIS također se može razrijediti 5% otopinom glukoze za injekciju ili Ringerovom otopinom s laktatom za injekciju.
English: Patients who have experienced a prior IRR should be premedicated for subsequent infusions.
Croatian: Bolesnicima koji su prethodno imali reakciju povezanu s infuzijom prije sljedećih infuzija treba dati premedikaciju.
English: Co-administration of brentuximab vedotin with rifampicin, a strong CYP3A4 inducer, did not alter the plasma exposure to brentuximab vedotin.
Croatian: Istodobna primjena brentuksimab vedotina s rifampicinom, jakim induktorom CYP3A4, nije promijenila izloženost brentuksimab vedotinu u plazmi.
English: Table 7: Efficacy results in HL patients at increased risk of relapse or progression following ASCT treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Croatian: Tablica 7: Rezultati djelotvornosti u bolesnika s HL-om s povećanim rizikom od relapsa ili progresije nakon ASCT-a, liječenih s 1,8 mg/kg lijeka ADCETRIS svaka 3 tjedna
English: Study SG035-0003
Croatian: Ispitivanje SG035-0003
English: Twenty-eight patients (47%) went on to receive SCT after a median of 7 cycles (range, 4 to 16 cycles) of ADCETRIS treatment.
Croatian: Dvadeset osam bolesnika (47%) podvrgnuto je transplantaciji matičnih stanica nakon medijana od 7 ciklusa liječenja lijekom ADCETRIS (u rasponu od 4 do 16 ciklusa).
English: These data indicate the absence of clinically relevant QT prolongation due to brentuximab vedotin administered at a dose of 1.8 mg/kg every 3 weeks in patients with CD30-expressing malignancies.
Croatian: Ovi podaci pokazuju da nema klinički važnog produljenja QT intervala uzrokovanog brentuksimab vedotinom primijenjenim u dozi od 1,8 mg/kg svaka 3 tjedna.
English: - The active substance is brentuximab vedotin.
Croatian: - Djelatna tvar je brentuksimab vedotin.
English: Progression Free Survival per IRF
Croatian: Preživljenje bez progresije bolesti po IRF-u
English: Study C25003
Croatian: Ispitivanje C25003
English: Intent to Treat (ITT) Population
Croatian: Skupina bolesnika s namjerom liječenja (ITT)
English: Infusion reactions
Croatian: Reakcije na infuziju
English: The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Croatian: Preporučena doza je 1,8 mg/kg primijenjena kao intravenska infuzija u trajanju od 30 minuta svaka 3 tjedna.
English: Of the patients treated, 8 responding patients went on to receive an allogeneic SCT.
Croatian: Od liječenih bolesnika, 8 bolesnika s odgovorom nastavilo je liječenje do transplantacije alogenih matičnih stanica.
English: Grade 3 (< 1,000-500/mm < 1.0-0.5 x 10 9/L) or
Croatian: Stupanj 3 (<1000 - 500/mm <1,0 - 0,5 x 10 9/l) ili
English: Withhold treatment with ADCETRIS until toxicity is ≤ Grade 2, then restart treatment at a reduced dose to 0.9 mg/kg every 2 weeks.
Croatian: Odgodite liječenje lijekom ADCETRIS dok se toksičnost ne vrati na stupanj ≤ 2, a zatim ponovno započnite liječenje smanjenom dozom od 0,9 mg/kg svaka 2 tjedna.
English: Stratified Hazard Ratio and p-value
Croatian: Stratificirani omjer rizika i p-vrijednost
English: If SJS or TEN occur, ADCETRIS should be discontinued and appropriate medical therapy should be administered.
Croatian: Ako nastane SJS ili TEN, liječenje lijekom ADCETRIS treba prekinuti i primijeniti odgovarajuće liječenje.
English: 2.16 vials
Croatian: 2,16 bočica
English: Infusion-related reactions a, chills
Croatian: Zimica reakcije vezane uz infuziju a,
English: The efficacy in elderly patient population (patients ≥ 60 years of age [n = 186] [HR = 1.00, 95% CI (0.58, 1.72)] and ≥ 65 years of age [n = 122] [HR = 1.01, 95% CI (0.53, 1.94)]) and patients with no extranodal sites (n = 445) (HR = 1.04, 95% CI [0.67, 1.62]) showed no clinically meaningful difference between the two arms.
Croatian: Nije bilo značajne razlike u djelotvornosti ispitivanih terapijskih režima u starijih bolesnika (bolesnici ≥ 60 [n = 186] [HR = 1.00, 95% CI (0,58; 1,72)] i ≥ 65 [n = 122] [HR = 1,01, 95% CI (0,53; 1,94)]) i bolesnika bez ekstranodalne bolesti (n = 445) (HR = 1,04; 95% CI [0,67; 1,62]).
English: The frequency of febrile neutropenia was 11% in patients who received primary prophylaxis with G-CSF.
Croatian: Učestalost febrilne neutropenije u bolesnika koji su primili primarnu profilaksu sa G-CSF bila je 11%.
English: Anaphylactic reaction
Croatian: Anafilaktička reakcija
English: Uncommon side effects (may affect up to 1 in 100 people) - Tumour lysis syndrome - a potentially-life threatening condition in which you may experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.
Croatian: Manje česte nuspojave (mogu se javiti u najviše 1 na 100 osoba) - sindrom lize tumora - potencijalno po život opasno stanje koje može biti praćeno omaglicom, smanjenim mokrenjem, smetenosti, povraćanjem, mučninom, oticanjem, nedostatkom zraka ili poremećenim srčanim ritmom.
English: The appropriate amount of reconstituted Adcetris must be withdrawn from the vial(s) and added to an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection in order to achieve a final concentration of 0.4-1.2 mg/mL Adcetris.
Croatian: Iz bočice(a) se mora izvući odgovarajuća količina rekonstituiranog lijeka ADCETRIS i dodati u infuzijsku vrećicu koja sadrži otopinu natrijevog klorida od 9 mg/ml (0,9%) za injekciju da bi se dobila konačna koncentracija od 0,4-1,2 mg/ml lijeka ADCETRIS.
English: b. To be diluted in 150 mL of diluent and administered by intravenous infusion over 30 minutes every 3 weeks.
Croatian: b. Razrijediti u 150 ml otopine za razrjeđivanje i primijeniti intravenskom infuzijom u trajanju od 30 minuta svaka 3 tjedna.
English: Disease stage at initial diagnosis of HL Stage I
Croatian: Stadij bolesti kod početne dijagnoze HL-a Stadij I
English: Extracutaneous disease
Croatian: Ekstrakutana bolest
English: The median duration of response was 9.2 and 9.4 months in patients who achieved OR (CR+PR) and CR, respectively.
Croatian: Medijan trajanja odgovora iznosio je 9,2 mjeseci u bolesnika kod kojih je postignut objektivni odgovor (CR+PR), odnosno 9,4 mjeseci u bolesnika kod kojih je postignuta potpuna remisija (CR).
English: Withhold dose until toxicity returns to ≤ Grade 1 or baseline, then restart treatment at a reduced dose of 1.2 mg/kg up to a maximum of 120 mg every 3 weeks
Croatian: Odgodite primjenu doze sve dok se toksičnost ne vrati na stupanj ≤ 1 ili početnu vrijednost, a onda ponovno započnite liječenje smanjenom dozom od 1,2 mg/kg, do maksimalnih 120 mg svaka 3 tjedna
English: Forty-six (46) patients with CD30-expressing haematologic malignancies were evaluable of the 52 patients who received 1.8 mg/kg of brentuximab vedotin every 3 weeks as part of a phase 1, single-arm, open-label, multicenter cardiac safety study.
Croatian: Procjena srčane sigurnosti je provedena u 46 od ukupno 52 bolesnika s hematološkom zloćudnom bolesti i izraženim CD30 koji su primali 1,8 mg/kg brentuksimab vedotina svaka 3 tjedna u sklopu otvorenog, multicentričnog ispitivanja faze 1 s jednom skupinom.