FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Vnaprej določena analiza PFS po IRF po podskupinah je bila opravljena glede na najboljši odziv bolnikov na reševalno zdravljenje pred avtologno PKMC, stanje HL po začetnem zdravljenju, starost, spol, izhodiščno maso, izhodiščno stanje zmogljivosti ECOG, število zdravljenj pred avtologno PKMC, geografsko regijo, stanje PET pred avtologno PKMC, stanje simptomov B po neuspešnem začetnem zdravljenju in stanje ekstranodalne bolezni pred avtologno PKMC.
English: Peripheral sensory neuropathy, peripheral motor neuropathy a,
Slovenian: periferna senzorična nevropatija, periferna motorična nevropatija periferna senzorična nevropatija, periferna motorična nevropatija a,
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.
Slovenian: Odložite zdravljenje z zdravilom ADCETRIS, dokler ni toksičnost na ≤ 2. stopnji ali izhodiščni, nato pa zdravljenje nadaljujte z zmanjšanim odmerkom 0,9 mg/kg vsaka 2 tedna.
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
Slovenian: - Stevens-Johnsonov sindrom - redka, resna bolezen, pri kateri se lahko pojavijo gripi podobni simptomi, ki jih spremlja boleč rdeč ali vijoličen izpuščaj, ki se širi, in mehurji, vključno z obsežnim luščenjem kože.
English: The appropriate amount of reconstituted Adcetris must be withdrawn from the vial(s) and added to an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection in order to achieve a final concentration of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.
Slovenian: Izvlecite ustrezno količino rekonstituiranega zdravila Adcetris iz vial(e) in jo dajte v infuzijsko vrečko, ki vsebuje raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje, da dosežete končno koncentracijo zdravila Adcetris 0,4-1,2 mg/ml.
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.
Slovenian: Izvlecite ustrezno količino rekonstituiranega zdravila ADCETRIS iz vial(e) in jo dajte v infuzijsko vrečko, ki vsebuje raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje, da dosežete končno koncentracijo zdravila ADCETRIS 0,4-1,2 mg/ml.
English: Study C25003
Slovenian: Študija C25003
English: Table 11: Summary of baseline patient and disease characteristics in the phase 2 relapsed or refractory sALCL study
Slovenian: Preglednica 11: Povzetek značilnosti bolnikov in bolezni ob izhodišču v študiji 2. faze ponovljenega ali refraktarnega sALCL
English: Of the patients treated, 8 responding patients went on to receive an allogeneic SCT.
Slovenian: Med zdravljenimi bolniki je 8 odzivnih bolnikov zdravljenje nadaljevalo s presaditvijo alogenih matičnih celic.
English: Anaemia, thrombocytopenia
Slovenian: anemija, trombocitopenija trombocitopenija
English: 48M (47%)/54F (53%)
Slovenian: 48 M (47%)/54 Ž (53%)
English: Alopecia, rash
Slovenian: alopecija pruritus
English: 37 years (18-83)
Slovenian: 37 let (18-83)
English: Anti-diabetic treatment should be administered as appropriate.
Slovenian: Po potrebi je treba uvesti zdravila proti sladkorni bolezni.
English: Patients with renal impairment should be closely monitored for adverse events.
Slovenian: Bolnike z okvaro ledvic je treba skrbno nadzirati glede pojava neželenih učinkov.
English: Gently invert the bag to mix the solution containing Adcetris.
Slovenian: Vrečko nežno obrnite, da se raztopina, ki vsebuje zdravilo ADCETRIS, premeša.
English: In the ITT population, 33% fewer patients treated with ADCETRIS + AVD in the ITT population received subsequent salvage chemotherapy (n = 66) and high-dose chemotherapy and transplant (n = 36) compared with those treated with ABVD (n = 99 and n = 54, respectively).
Slovenian: V populaciji ITT je poznejšo rešilno kemoterapijo (n = 66) ter kemoterapijo v velikih odmerkih in presaditev (n = 36) prejelo 33% manj bolnikov, zdravljenih z ADCETRIS + AVD, v primerjavi z bolniki, zdravljeni z ABVD (n = 99 oz. n = 54).
English: In combination therapy with AVD, advanced age was a risk factor for febrile neutropenia.When ADCETRIS is administered in combination with AVD, primary prophylaxis with G-CSF is recommended for all patients regardless of age beginning with the first dose.
Slovenian: Pri aplikaciji zdravila ADCETRIS v kombinaciji z AVD je priporočljiva primarna profilaksa z G-CSF, in sicer pri vseh bolnikih ne glede na starost, ki začenjajo s prvim odmerkom.
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 (n = 4), moderate (n = 3) and severe (n = 3) renal impairment.
Slovenian: Izvedena je bila študija, ki je ovrednotila farmakokinetiko brentuksimaba vedotina in MMAE po aplikaciji zdravila ADCETRIS v odmerku 1,2 mg/kg pri bolnikih z blago (n = 4), zmerno (n = 3) in s hudo (n = 3) okvaro ledvic.
English: Twenty-eight patients (47%) went on to receive SCT after a median of 7 cycles (range, 4 to 16 cycles) of ADCETRIS treatment.
Slovenian: Osemindvajset bolnikov (47%) je prejelo PKMC po mediani 7 ciklov zdravljenja z zdravilom ADCETRIS (razpon od 4 do 16 ciklov).
English: After multiple-dose, IV infusion of 1.2 mg/kg brentuximab vedotin every two weeks, steady-state trough concentrations of ADC and MMAE were achieved by Cycle 3.
Slovenian: Po več odmerkih 1,2 mg/kg brentuksimaba vedotina v obliki intravenske infuzije vsaka dva tedna so bile najmanjše koncentracije ADC in MMAE v stanju dinamičnega ravnovesja dosežene do 3. cikla.
English: The efficacy and safety of ADCETRIS as a single agent was evaluated in an open-label, single-arm, multicenter study in 58 patients with relapsed or refractory sALCL.
Slovenian: Učinkovitost in varnost zdravila ADCETRIS kot edinega zdravila sta bili ovrednoteni v odprti, multicentrični študiji z enim krakom pri 58 bolnikih s ponovljenim ali z refraktarnim sALCL.
English: Refractory
Slovenian: Refraktarno
English: • Best response of PR or SD to most recent salvage therapy as determined by CT and/or PET scanning
Slovenian: • Najboljši delni odziv (PR) ali stabilna bolezen (SD) po zadnjem reševalnem zdravljenju,
English: Post-hoc subgroup analyses of modified PFS per IRF for patients with Stage IV disease were performed including age, region, baseline extranodal sites, number of IPFP risk factors, baseline B symptoms, baseline ECOG status and gender.
Slovenian: Za modificirano PFS po IRF so bile opravljene naknadne analize podskupin bolnikov z boleznijo stadija IV, in sicer glede na starost, geografsko regijo, ekstranodalne metastaze ob izhodišču, število dejavnikov tveganja po IPFP, simptome B ob izhodišču, izhodiščno stanje zmogljivosti ECOG in spol.
English: DO NOT SHAKE.
Slovenian: Ne zamrzujte.
English: (95% CI [0.60, 4.55])
Slovenian: (95% IZ [0,60, 4,55])
English: Study SG035-0003
Slovenian: Študija SG035-0003
English: Hyperglycaemia has been reported during clinical trials in patients with an elevated Body Mass Index (BMI) with or without a history of diabetes mellitus.
Slovenian: Med kliničnimi preskušanji pri bolnikih z zvišanim indeksom telesne mase s sladkorno boleznijo v anamnezi ali brez nje so poročali o hiperglikemiji.
English: One patient had a baseline ECOG status of 2, which was prohibited by protocol and is captured as Inclusion Criteria Not Met. b. Primary refractory sALCL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Slovenian: En bolnik je imel izhodiščni status ECOG 2, kar je bilo po protokolu prepovedano, in je zabeleženo kot “neizpolnjevanje kriterijev za vključitev”.
English: 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.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom ADCETRIS, so poročali o primerih toksičnih učinkov na pljuča, vključno s pnevmonitisom, intersticijsko pljučno boleznijo in sindromom akutne dihalne stiske (ARDS, »acute respiratory distress syndrome«), z nekaj smrtnimi izidi.
English: Patients with hepatic impairment should be closely monitored for adverse events.
Slovenian: Bolnike z okvaro jeter je treba skrbno nadzirati glede pojava neželenih učinkov.
English: What Adcetris contains
Slovenian: Kaj vsebuje zdravilo Adcetris
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
Slovenian: Odložite odmerek, dokler se toksičnost ne vrne na ≤ 1. stopnjo ali izhodiščno, nato pa zdravljenje nadaljujte z zmanjšanim odmerkom 1,2 mg/kg do največ 120 mg vsake 3 tedne.
English: ADCETRIS n = 64
Slovenian: Zdravilo ADCETRIS n = 64
English: (95% CI [0.45, 1.88])
Slovenian: (95% IZ [0,45, 1,88])
English: 37M (58%)/27F (42%)
Slovenian: 37 M (58%)/27 Ž (42%)
English: The recommended starting dose for the retreatment of patients who have previously responded to treatment with ADCETRIS is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Slovenian: Priporočeni začetni odmerek za ponovno uvedbo zdravljenja pri bolnikih, ki so se predhodno odzvali na zdravljenje z zdravilom ADCETRIS, je 1,8 mg/kg v obliki 30-minutne intravenske infuzije vsake 3 tedne.
English: Extranodal involvement at time of diagnosis, n (%) IPFP
Slovenian: Ekstranodalne metastaze ob postavitvi diagnoze, n (%) 411 (62) Dejavniki tveganja po IPFP
English: - The active substance is brentuximab vedotin.
Slovenian: - Zdravilna učinkovina je brentuksimab vedotin.
English: ADCETRIS should be administered through a dedicated intravenous line and it must not be mixed with other medicinal products (see section 6.2).
Slovenian: Ne sme se ga mešati z drugimi zdravili (glejte poglavje 6.2).
English: 0.89 mo (0.0-81.4)
Slovenian: 0,92 meseca (0,1-21,4) 0,89 meseca
English: Patients were treated with 1.8 mg/kg of ADCETRIS intravenously over 30 minutes every 3 weeks for up to 16 cycles or physician's choice for up to 48 weeks.
Slovenian: Bolniki so bili zdravljeni z 1,8 mg/kg zdravila ADCETRIS v obliki 30-minutne intravenske infuzije vsake 3 tedne v do 16 ciklih ali z zdravilom po izbiri zdravnika do 48 tednov.
English: Table 14: Efficacy results in CTCL patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks (ITT population)
Slovenian: Preglednica 14: Rezultati učinkovitosti zdravljenja z 1,8 mg/kg zdravila ADCETRIS vsake 3 tedne pri bolnikih s CTCL (populacija ITT)
English: Cutaneous T-cell lymphoma
Slovenian: Kožni T-celični limfom (CTCL)
English: How to store Adcetris
Slovenian: Shranjevanje zdravila Adcetris
English: Pneumonia, oral candidiasis, sepsis/septic shock, herpes simplex
Slovenian: herpes zoster, pljučnica, herpes simpleks, oralna kandidoza pljučnica, oralna kandidoza, sepsa/septični šok, herpes simpleks
English: Complete blood counts should be monitored prior to administration of each dose.
Slovenian: Pred vsakim odmerkom je treba preveriti celotno krvno sliko.
English: 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).
Slovenian: Pri vseh bolnikih s predhodno nezdravljenim HL, ki prejemajo kombinirano zdravljenje in so začeli s prvim odmerkom, je priporočljiva primarna profilaksa s podporo z rastnim faktorjem (G-CSF) (glejte poglavje 4.4).
English: Prior chemotherapy Regimens Time from ASCT to first post-transplant relapse
Slovenian: Predhodna avtologna PKMC Število predhodnih kemoterapij Čas od avtologne PKMC do prve ponovitve po presaditvi
English: Median age (range)
Slovenian: Mediana starost (razpon)
English: Median Cmax, AUC, and Tmax of MMAE after a single 1.8 mg/kg dose were 3.73 ng/mL, 17.3 ng*day/mL, and 1.92 days, respectively, in patients < 12 years of age and 6.33 ng/mL, 42.3 ng*day/mL, and 1.82 days, respectively, in patients ≥ 12 years of age.
Slovenian: Po enkratnem odmerku 1,8 mg/kg je bila mediana vrednost Cmax za MMAE pri bolnikih, starih < 12 let, 3,73 ng/ml in pri bolnikih, starih ≥ 12 let, 6,33 ng/ml, mediana vrednost AUC za MMAE pri bolnikih, starih < 12 let, 17,3 ng*day/ml in pri bolnikih, starih ≥ 12 let, 42,3 ng*day/ml, mediana vrednost Tmax za MMAE pa pri bolnikih, starih < 12 let, 1,92 dneva in pri bolnikih, starih ≥ 12 let, 1,82 dneva.
English: Grade 1 (< LLN-1500/mm < LLN-1.5 x 10
Slovenian: 1. stopnja (< LLN - 1.500/mm < LLN - 1,5 x 10 9/l)
English: For patients who experienced peripheral neuropathy the median time of onset of peripheral neuropathy was 12 weeks.
Slovenian: Pri bolnikih s periferno nevropatijo je bil mediani čas do nastopa periferne nevropatije 12 tednov.
English: Tumour lysis syndrome (TLS) has been reported with ADCETRIS.
Slovenian: Pri zdravilu ADCETRIS so poročali o sindromu tumorske lize (TLS).
English: This substance is delivered to cancer cells by the monoclonal antibody.
Slovenian: Monoklonsko protitelo dostavi to snov v rakave celice.
English: ECOG status, n (%)
Slovenian: Stanje zmogljivosti po ECOG, n (%)
English: Infections and infestations Very common:
Slovenian: Infekcijske in parazitske bolezni Zelo pogosti:
English: Table 12: Efficacy results in relapsed or refractory sALCL patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Slovenian: Preglednica 12: Rezultati učinkovitosti pri bolnikih s ponovljenim ali z refraktarnim sALCL, zdravljenih z 1,8 mg/kg zdravila ADCETRIS vsake 3 tedne
English: ADCETRIS 50 mg powder for concentrate for solution for infusion.
Slovenian: ADCETRIS 50 mg prašek za koncentrat za raztopino za infundiranje
English: 9/L, fever ≥ 38.5
Slovenian: 9/l, telesno temperaturo ≥ 38,5 °C; ref. CTCAE v3).
English: Withhold dose until toxicity returns to ≤ Grade 1 or baseline, then restart treatment at a reduced dose of 1.2 mg/kg every 3 weeks
Slovenian: Odložite odmerek, dokler se toksičnost ne vrne na ≤ 1. stopnjo ali izhodiščno, nato pa zdravljenje nadaljujte z zmanjšanim odmerkom 1,2 mg/kg vsake 3 tedne.
English: Table 10: Efficacy results in relapsed or refractory Hodgkin lymphoma patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Slovenian: Preglednica 10: Rezultati učinkovitosti pri bolnikih s ponovljenim ali z refraktarnim Hodgkinovim limfomom, zdravljenih z 1,8 mg/kg zdravila ADCETRIS vsake 3 tedne
English: The following side effects have been reported with Adcetris in combination with chemotherapy medicines:
Slovenian: Pri zdravljenju z zdravilom Adcetris v kombinaciji s kemoterapevtskimi zdravili so poročali o naslednjih neželenih učinkih:
English: (95% CI [0.34, 0.71])
Slovenian: (95% IZ [0,34, 0,71])
English: 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%).
Slovenian: Pri bolnikih, ki so prejeli 1 predhodno zdravljenje, povezano z rakom, so poročali o popolni remisiji pri 1 bolniku (9%); pri 4 bolnikih (36%) pa so poročali o delni remisiji.
English: The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Slovenian: Priporočeni odmerek je 1,8 mg/kg v obliki 30-minutne intravenske infuzije vsake 3 tedne.
English: = Total ADCETRIS dose (mL) to be further diluted
Slovenian: = Skupni odmerek zdravila ADCETRIS (ml), ki se redči
English: b. To be diluted in 150 mL of diluent and administered by intravenous infusion over 30 minutes every 3 weeks.
Slovenian: b. Za razredčitev s 150 ml vehikla in dajanje v obliki 30 minutne intravenske infuzije vsake 3 tedne.
English: Table 4: Summary of baseline patient and disease characteristics in the phase 3 previously untreated HL study
Slovenian: Preglednica 4: Povzetek značilnosti bolnikov in bolezni ob izhodišču v študiji 3. faze v okviru zdravljenja predhodno nezdravljenega HL
English: (95% CI [0.27, 0.68])
Slovenian: (95% IZ [0,27, 0,68])
English: Patients also had a higher incidence of arthralgia, Grade 3 anaemia, and back pain compared to patients observed in the combined pivotal phase 2 studies.
Slovenian: Pri teh bolnikih so bile v primerjavi z bolniki, opazovanimi v kombiniranih ključnih študijah 2. faze, pogostejše tudi artralgija, anemija 3. stopnje in bolečine v hrbtu.
English: (95% CI [0.53, 1.67])
Slovenian: (95% IZ [0,53, 1,67])
English: ECOG status n (%)
Slovenian: Stanje zmogljivosti po ECOG n (%)
English: 33M (57%)/25F (43%)
Slovenian: 33 M (57%)/25 Ž (43%)
English: Adverse reactions (combination therapy)
Slovenian: Neželeni učinki (samostojno zdravljenje) Neželeni učinki (kombinirano zdravljenje)
English: Twenty patients with relapsed or refractory HL received a starting dose of 1.8 mg/kg and one patient received a starting dose of 1.2 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks.
Slovenian: Dvajset bolnikov s ponovljenim ali z refraktarnim HL je zdravilo ADCETRIS prejemalo v začetnem odmerku 1,8 mg/kg, en bolnik pa v začetnem odmerku 1,2 mg/kg v obliki 30-minutne intravenske infuzije vsake 3 tedne.
English: Overall Survival Number of deaths (%)
Slovenian: Celokupno preživetje Število smrti
English: Adverse reactions for ADCETRIS are listed by MedDRA System Organ Class and Preferred Term (see Table 3).
Slovenian: Neželeni učinki zdravila ADCETRIS so navedeni po MedDRA podatkovni bazi glede na organske sisteme (glejte preglednico 3).
English: Tlf: +47 6676 3030 infonorge@takeda.com
Slovenian: Takeda Nycomed AS Tlf: +47 6676 3030 infonorge@takeda.com
English: How Adcetris is given
Slovenian: Kako se daje zdravilo Adcetris
English: The median duration of response was 8.8 and 12.3 months in patients who achieved OR (CR+PR) and CR, respectively.
Slovenian: Pri bolnikih z objektivnim odzivom (CR+PR) je mediani čas trajanja odziva znašal 8,8 meseca, pri bolnikih s popolno remisijo (CR) pa 12,3 meseca.
English: A phase 4 single-arm study was conducted in patients with relapsed or refractory HL (n = 60) who had received at least one prior chemotherapeutic regimen and at the time of treatment initiation with ADCETRIS were not considered candidates for SCT or multiagent chemotherapy.
Slovenian: Pri bolnikih s ponovljenim ali neodzivnim HL (n = 60), ki so prejeli vsaj en predhodni kemoterapevtski režim in v času zdravljenja z zdravilom ADCETRIS niso bili kandidati za PKMC ali večtirno kemoterapijo, je bila izvedena študija z enim krakom 4. faze.
English: Patients ≥ 65 years old n (%) Gender, n (%)
Slovenian: Bolnki, stari ≥ 65 let n (%) Spol, n (%)
English: The efficacy and safety of ADCETRIS as a single agent was evaluated in a pivotal open-label, single-arm, multicenter study in 102 patients with relapsed or refractory HL.
Slovenian: Učinkovitost in varnost zdravila ADCETRIS kot edinega zdravila sta bili ovrednoteni v ključni, odprti, multicentrični študiji z enim krakom pri 102 bolnikih s ponovljenim ali z refraktarnim HL.
English: Patients were treated with ADCETRIS 1.8 mg/kg intravenously over 30 minutes every 3 weeks for up to 16 cycles.
Slovenian: Bolniki so bili zdravljeni z zdravilom ADCETRIS 1,8 mg/kg intravensko v času 30 minut vsake 3 tedne v do 16 ciklih.
English: Median Cmax and AUC of ADC after a single 1.8 mg/kg dose were 29.8 µg/ mL and 67.9 µg*day/ mL, respectively, in patients < 12 years of age and 34.4 µg/mL and 77.8 µg*day/mL, respectively, in patients ≥ 12 years of age.
Slovenian: Po enkratnem odmerku 1,8 mg/kg je bila mediana vrednost Cmax za ADC pri bolnikih, starih < 12 let, 29,8 μg/ml in pri bolnikih, starih ≥ 12 let, 34,4 μg/ml, mediana vrednost AUC za ADC pa pri bolnikih, starih < 12 let, 67,9 μg*dan/ml in pri bolnikih, starih ≥ 12 let, 77,8 μg*dan/ml.
English: See Table 6 for patient characteristics.
Slovenian: Značilnosti bolnikov so v preglednici 6.
English: Patients were treated with 1.8 mg/kg of ADCETRIS or matching placebo intravenously over 30 minutes every 3 weeks for up to 16 cycles.
Slovenian: Bolniki so prejeli 1,8 mg/kg zdravila ADCETRIS ali ustrezen placebo intravensko v trajanju 30 minut vsake 3 tedne, do 16 ciklov.
English: Gastrointestinal (GI) complications including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, some with fatal outcomes, have been reported in patients treated with ADCETRIS.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom ADCETRIS, so poročali o gastrointestinalnih zapletih, vključno z obstrukcijo črevesja, ileusom, enterkolitisom, nevtropeničnim kolitisom, erozijo, ulkusom, perforacijo in krvavitvijo, z nekaj smrtnimi izidi.
English: Uncommon:
Slovenian: Neznana:
English: (95% CI [0.67, 1.97]
Slovenian: (95% IZ [0,67, 1,97])
English: Combination therapy Note: Primary prophylaxis with G-CSF is recommended for all patients receiving combination therapy beginning with the first dose.
Slovenian: Kombinirano zdravljenje Opomba: pri vseh bolnikih, ki prejemajo kombinirano zdravljenje in so začeli s prvim odmerkom, je priporočljiva primarna profilaksa z G-CSF.
English: See Table 11 below for a summary of baseline patient and disease characteristics.
Slovenian: Glejte spodnjo preglednico 11 za povzetek značilnosti bolnikov in bolezni ob izhodišču.
English: Seven patients with relapsed sALCL received a starting dose of 1.8 mg/kg and one patient received a starting dose of 1.2 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks.
Slovenian: Sedem bolnikov s ponovljenim sALCL je zdravilo ADCETRIS prejemalo v začetnem odmerku 1,8 mg/kg, en bolnik pa v začetnem odmerku 1,2 mg/kg v obliki 30-minutne intravenske infuzije
English: Table 9: Summary of baseline patient and disease characteristics in the phase 2 relapsed or refractory HL study
Slovenian: Preglednica 9: Povzetek značilnosti bolnikov in bolezni ob izhodišču v študiji 2. faze ponovljenega ali refraktarnega HL
English: Do not freeze.
Slovenian: NE STRESAJTE.
English: Excipients: Citric acid monohydrate, sodium citrate dihydrate, α,α-trehalose dihydrate, polysorbate 80 See package leaflet for further information
Slovenian: Pomožne snovi: citronska kislina monohidrat, natrijev citrat dihidrat, α,α-trehaloza dihidrat, polisorbat 80.
English: Grade 3 (< 1,000-500/mm < 1.0-0.5 x 10 9/L) or
Slovenian: 3. stopnja (< 1.000 - 500/mm < 1,0 - 0,5 x 10 9/l)
English: The European Organization for Research and Treatment of Cancer Quality of Life 30-Item Questionnaire (EORTC-QLQ-C30) showed no clinically meaningful difference between the two arms in both the ITT and Stage IV population.
Slovenian: Pri populaciji ITT in populaciji bolnikov z boleznijo stadija IV med krakoma niso zaznali klinično pomembnih razlik glede kakovosti življenja, ki so jo ocenjevali z vprašalnikom s 30 vprašanji Evropske organizacije za raziskave in zdravljenje raka (EORTC-QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life 30-Item Questionnaire).
English: The analyses showed a consistent trend towards benefit for patients who received ADCETRIS + AVD compared with patients who received ABVD in most subgroups.
Slovenian: Za večino podskupin so analize pokazale dosleden trend koristi za bolnike, ki so prejemali zdravilo ADCETRIS v kombinaciji z AVD v primerjavi z bolniki, ki so prejemali ABVD.
English: See Table 9 below for a summary of baseline patient and disease characteristics.
Slovenian: Glejte spodnjo preglednico 9 za povzetek značilnosti bolnikov in bolezni ob izhodišču.
English: Do not add other medicinal products to the prepared ADCETRIS infusion solution or intravenous infusion set.
Slovenian: Pripravljeni raztopini za infundiranje ali intravenskemu kompletu za infundiranje z zdravilom Adcetris ne dodajajte drugih zdravil.