FrancophonIA/ELRC3.0 huggingface dataset:
English: ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1).
Slovenian: Zdravilo ADCETRIS je indicirano za zdravljenje odraslih bolnikov s CD30-pozitivnim HL s povečanim tveganjem ponovitve ali napredovanja bolezni po avtologni presaditvi krvotvornih matičnih celic (PKMC) (glejte poglavje 5.1).
English: Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased
Slovenian: zvišanje vrednosti alanin-aminotransferaze/aspartat-aminotransf eraze (ALT/AST)
English: Grade 4 (< 500/mm < 0.5 x 10
Slovenian: ali 4. stopnja (< 500/mm < 0,5 x 10
English: In all clinical trials, brentuximab vedotin was administered as an intravenous infusion.
Slovenian: V vseh kliničnih preskušanjih so brentuksimab vedotin dali v obliki intravenske infuzije.
English: Minimal to no accumulation of ADC was observed with multiple doses at the every 3-week schedule, consistent with the terminal half-life estimate.
Slovenian: Kopičenje ADC, ki so ga opazili z večkratnim odmerjanjem z režimom vsake 3 tedne, je bilo minimalno ali ga ni bilo, skladno z ocenjenim končnim razpolovnim časom.
English: An exploratory intra-patient analysis showed that approximately 64% of the HL patients treated with ADCETRIS as part of the SG035-0003 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.
Slovenian: Preiskovalna analiza med bolniki je pokazala, da je pri približno 64% bolnikov s HL, ki so bili zdravljeni z zdravilom ADCETRIS v okviru klinične študije SG035-0003, prišlo do izboljšanja kliničnih koristi, izmerjeno kot daljše preživetje brez napredovanja bolezni (PFS) v primerjavi z zadnjim zdravljenjem, ki so ga prejemali.
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).
Slovenian: V populaciji bolnikov z boleznijo stadija IV je poznejšo rešilno kemoterapijo (n = 45) prejelo 35% manj bolnikov, zdravljenih z ADCETRIS + AVD, v primerjavi z bolniki, zdravljeni z ABVD (n = 69), kemoterapijo v velikih odmerkih in presaditev (n = 29) pa je prejelo 22% manj bolnikov, zdravljenih z ADCETRIS + AVD, v primerjavi z bolniki, zdravljeni z ABVD (n = 37).
English: The ORR per IRF assessment was 86% (50 of 58 patients in the ITT set).
Slovenian: Delež objektivnega odziva (ORR) je po oceni IRF znašal 86% (50 od vseh 58 bolnikov, ki so bili vključeni v študijo [ITT]).
English: Study C25001
Slovenian: Študija C25001
English: Median Cmax, AUC and Tmax of MMAE after a single 1.8 mg/kg of the ADC in a phase 1 study was approximately 4.97 ng/ mL, 37.03 ng/ mL x day and 2.09 days respectively.
Slovenian: Mediane vrednosti Cmax, AUC in Tmax za MMAE po enkratnem odmerku 1,8 mg/kg ADC v študiji 1. faze so bile približno 4,97 ng/ml, 37,03 ng/ml x dan in 2,09 dni.
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.
Slovenian: Preiskovalna analiza med bolniki je pokazala, da je pri približno 69% bolnikov s sALCL, ki so bili zdravljeni z zdravilom ADCETRIS v okviru klinične študije SG035-0004, prišlo do izboljšanja kliničnih koristi, izmerjeno kot daljše preživetje brez napredovanja bolezni (PFS) v primerjavi z zadnjim zdravljenjem, ki so ga prejemali.
English: Table 15: Sample calculations for patients receiving the recommended dose of 1.8 mg/kg of ADCETRIS for weights ranging from 60 kg to 120 kg
Slovenian: Preglednica 15: Primer izračuna pri bolnikih, ki prejemajo priporočeni odmerek zdravila ADCETRIS, 1,8 mg/kg, za telesne mase od 60 kg do 120 kg
English: Stevens-Johnson syndrome and toxic epidermal necrolysis
Slovenian: Stevens-Johnsonov sindrom in toksična epidermalna nekroliza
English: Number of Risk Factors ≥ 2
Slovenian: Število dejavnikov tveganja ≥ 2
English: ADCETRIS n = 144
Slovenian: Zdravilo ADCETRIS n = 144
English: Median ADC AUC in children and adolescents from this study was approx. 14% and 3% lower than in adult patients, respectively, while MMAE exposures were 53% lower and 13% higher, respectively, than in adult patients.
Slovenian: 3% nižja kot pri odraslih bolnikih, medtem ko so bile izpostavljenosti MMAE pri otrocih za 53% nižje in pri mladostnikih za 13% višje kot pri odraslih bolnikih.
English: Disease stage at initial diagnosis of HL Stage I
Slovenian: Stadij bolezni ob začetni diagnozi HL Stadij I
English: The usual dose of Adcetris given in combination with other chemotherapy medicines is 1.2 mg/kg given every 2 weeks for 6 months.
Slovenian: Običajni odmerek zdravila Adcetris v kombinaciji z drugimi kemoterapevtskimi zdravili je 1,2 mg/kg, ki se ga daje vsaka 2 tedna.
English: Grade 3 neutropenia was reported in 13% and Grade 4 neutropenia was reported in 5% of patients.
Slovenian: O nevtropeniji 3. stopnje so poročali pri 13% bolnikov, o nevtropeniji 4. stopnje pa pri 5% bolnikov.
English: Stevens-Johnson syndrome/toxic epidermal necrolysis
Slovenian: Stevens-Johnsonov sindrom/toksična epidermalna nekroliza
English: Stage II
Slovenian: Stadij II
English: In the event of new or worsening GI symptoms, perform a prompt diagnostic evaluation and treat appropriately.
Slovenian: V primeru novih gastrointestinalnih simptomov ali poslabšanja teh simptomov je nemudoma treba izvesti ustrezne diagnostične postopke in bolnika ustrezno zdraviti.
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.
Slovenian: Pri bolnikih s protitelesi proti brentuksimabu vedotinu so opazili višjo incidenco reakcij, povezanih z infundiranjem, v primerjavi z bolniki, pri katerih je bil test prehodno pozitiven ali negativen.
English: 33 years (18-71)
Slovenian: 33 let (18-71)
English: In the clinical trial of ADCETRIS as combination therapy, neutropenia led to dose delays in 24% of patients.
Slovenian: V kliničnih preskušanjih zdravila ADCETRIS v obliki kombiniranega zdravljenja je nevtropenija povzročila odložitev odmerka pri 24% bolnikov.
English: Primary Refractory to frontline therapy Refractory to most recent therapy Baseline B symptoms Stage III at initial diagnosis Stage IV at initial diagnosis a.
Slovenian: Primarno refraktarna na začetno zdravljenje Refraktarna na zadnje zdravljenje Simptomi B v izhodišču Stadij III ob prvotni diagnozi Stadij IV ob prvotni diagnozi a.
English: Stage III
Slovenian: Stadij III
English: 2.4 vials
Slovenian: 2,4 viale
English: Serious infections such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock (including fatal outcomes) and herpes zoster, cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS.
Slovenian: Pri bolnikih, zdravljenih z zdravilom ADCETRIS, so poročali o resnih okužbah, kot so pljučnica, stafilokokna bakteriemija, sepsa/septični šok (vključno s smrtnimi izidi) in herpes zoster, okužbi s citomegalovirusom (CMV) (reaktivaciji), ter o oportunističnih okužbah, kot so pljučnica, ki jo povzroča Pneumocystis jiroveci, in oralna kandidoza.
English: a per IRF at 2 Year (%)
Slovenian: Ocena mPFS po IRF po 2 letih (%)
English: General precautions
Slovenian: Splošni varnostni ukrepi
English: ADCETRIS is for single use only.
Slovenian: Zdravilo ADCETRIS je namenjeno samo za enkratno uporabo.
English: Toxic epidermal necrolysis was not reported in the combination therapy setting.
Slovenian: Pri kombiniranem zdravljenju niso poročali o toksični epidermalni nekrolizi.
English: Table 3: Adverse reactions to ADCETRIS
Slovenian: Preglednica 3: Neželeni učinki zdravila ADCETRIS
English: The median number of cycles was 7 (range, 2 to 37 cycles).
Slovenian: Mediano število ciklov je bilo 7 (razpon od 2 do 37 ciklov).
English: Hepatotoxicity in the form of elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) has been reported with ADCETRIS.
Slovenian: Pri zdravljenju z zdravilom ADCETRIS so poročali o hepatotoksičnosti v obliki zvišanih vrednostih alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (AST).
English: 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.
Slovenian: V primerjavi z bolniki z normalnim delovanjem jeter se je pri bolnikih z okvaro jeter izpostavljenost MMAE povečala za približno 2,3-krat (90% interval zaupanja: 1,27-krat do 4,12-krat).
English: Objective response rate (CR + PR) Complete remission (CR) Partial remission (PR)
Slovenian: Objektivni odziv (CR + PR) Popolna remisija (CR) Delna remisija (PR)
English: Patients were treated with 1.8 mg/kg of ADCETRIS every 3 weeks.
Slovenian: Bolniki so bili vsake 3 tedne zdravljeni z 1,8 mg/kg zdravila ADCETRIS.
English: Of the 8 sALCL patients, 3 were retreated twice for a total of
Slovenian: Od 8 bolnikov s sALCL so se 3 bolniki ponovno zdravili dvakrat, tako je na voljo skupaj 11 izkušenj s ponovno uvedbo zdravljenja.
English: Primary Refractory to frontline therapy Refractory to most recent therapy Relapsed to most recent therapy Baseline B symptoms Stage III at initial diagnosis Stage IV at initial diagnosis a.
Slovenian: Primarno refraktarna na začetno zdravljenje Refraktarna na zadnje zdravljenje Ponovitev po zadnjem zdravljenju Simptomi B v izhodišču Stadij III ob prvotni diagnozi Stadij IV ob prvotni diagnozi a.
English: 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%.
Slovenian: Pri ponovni uvedbi zdravljenja z zdravilom ADCETRIS je od 20 ovrednotenih bolnikov s HL 6 bolnikov (30%) doseglo popolno remisijo (CR), 6 bolnikov (30%) pa delno remisijo (PR).
English: Adjusted p-value a
Slovenian: Prilagojena vrednost p a.
English: Dose adjustments
Slovenian: Prilagoditev odmerka
English: 32 years (18-76)
Slovenian: 32 let (18-76)
English: 33M (52%)/31F (48%)
Slovenian: 33 M (52%)/31 Ž (48%)
English: The median number of cycles was 7 (range 1 to 16 cycles).
Slovenian: Mediano število ciklov je bilo 7 (z razponom od 1 do 16 ciklov).
English: In non-clinical studies, brentuximab vedotin treatment has resulted in testicular toxicity, and may alter male fertility.
Slovenian: V predkliničnih študijah je zdravljenje z brentuksimabom vedotinom povzročilo testikularno toksičnost, lahko pa spremeni tudi plodnost pri moškem.
English: If SJS or TEN occur, ADCETRIS should be discontinued and appropriate medical therapy should be administered.
Slovenian: Če se pojavi SJS ali TEN, je treba uporabo zdravila ADCETRIS prekiniti in uvesti ustrezno zdravljenje.
English: ORR4 was 50% and 75% in the ADCETRIS arm versus 10.2% and 20% in the physician's choice arm for MF and pcALCL, respectively.
Slovenian: ORR4 v skupini, ki je prejemala zdravilo ADCETRIS, je bil 50% pri bolnikih z MF in 75% pri bolnikih s pcALCL v primerjavi s skupino, ki je prejemala zdravilo po izbiri zdravnika, kjer je znašal 10,2% pri bolnikih z MF in 20% pri bolnikih s pcALCL.
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.
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 (Child-Pugh A; n = 1), zmerno (Child-Pugh B; n = 5) in s hudo (Child-Pugh C; n = 1) okvaro jeter.
English: Population pharmacokinetic analysis indicated that the pharmacokinetics of ADCETRIS in combination with AVD were consistent to that in monotherapy.
Slovenian: Analiza populacijske farmakokinetike je pokazala, da je farmakokinetika zdravila ADCETRIS v kombinaciji z AVD primerljiva s farmakokinetiko zdravila pri samostojnem zdravljenju.
English: 35 years (18-82)
Slovenian: 35 let (18-82)
English: The analyses showed a consistent trend towards benefit for patients who received ADCETRIS compared with patients who received physician's choice.
Slovenian: Analize so pokazale stalen trend koristi za bolnike, ki so prejemali zdravilo ADCETRIS, v primerjavi z bolniki, ki so prejemali zdravilo po izbiri zdravnika.
English: The median duration of treatment for patients who discontinued due to peripheral neuropathy was 12 cycles.
Slovenian: Pri bolnikih, ki so prenehali uporabljati zdravilo zaradi periferne nevropatije, je zdravljenje mediano trajalo 12 ciklov.
English: Pre-specified subgroup analyses of modified PFS per IRF were performed for the ITT population including age, region, cancer stage at baseline, baseline extranodal sites, number of IPFP risk factors, baseline B symptoms, Cycle 2 PET assessment, Cycle 2 PET Deauville score, and receipt of alternative first-line medication (AFM).
Slovenian: Za modificirano PFS po IRF so bile pri populaciji ITT opravljene vnaprej določene analize podskupin po starosti, geografski regiji, stadiju raka ob izhodišču, ekstranodalnih meatstazah ob izhodišču, številu dejavnikov tveganja po IPFP, simptomih B ob izhodišču, oceni PET v 2. ciklu, točkah po lestvici Deauville na podlagi slikanja PET v 2. ciklu in prejemanju drugih zdravil prvega izbora (AFM, alternative first-line medication).
English: ADCETRIS must not be administered as an intravenous push or bolus.
Slovenian: Zdravila ADCETRIS se ne sme aplicirati v obliki hitre intravenske ali bolusne infuzije.
English: Co-administration of brentuximab vedotin did not affect the plasma exposure of AVD.
Slovenian: Sočasno dajanje brentuksimaba vedotina ni vplivalo na plazemsko izpostavljenost AVD.
English: Patients with hepatic impairment should be closely monitored for adverse events (see section 5.2).
Slovenian: Bolnike z okvaro jeter je treba skrbno nadzirati glede pojava neželenih učinkov (glejte poglavje 5.2).
English: Stratified Hazard Ratio and p-value
Slovenian: Stratificirano razmerje ogroženosti in p-vrednost
English: A multiexponential decline in ADC serum concentrations was observed with a terminal half-life of approximately 4 to 5 days.
Slovenian: Večstopenjsko zmanjšanje koncentracij ADC v serumu je bilo opaženo ob končni razpolovni dobi, ki je bila približno 4 do 5 dni.
English: • HL that occurred <12 months or HL that was refractory to frontline therapy
Slovenian: • HL, ki se je pojavil < 12 mesecev po začetnem zdravljenju oz. HL, ki je bil refraktaren na začetno zdravljenje.
English: IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus, cough, infusion site pain and pyrexia were reported in 9% of patients.
Slovenian: O IRR, kot so glavobol, izpuščaj, bolečine v hrbtu, bruhanje, mrzlica, navzea, dispneja, pruritus, kašelj, bolečina na mestu infundiranja in pireksija, so poročali pri 9% bolnikov.
English: Among these 30 patients, the median time to response, defined as the time from first dose to the soonest of PR or CR, was 6 weeks (range, 5 to 39 weeks).
Slovenian: Pri teh 30 bolnikih je bil mediani čas odziva, to je čas od prvega odmerka do najhitrejše delne remisije ali popolne remisije, 6 tednov (razpon od 5 do 39 tednov).
English: A pre-specified subgroup analysis of mPFS by disease stage showed that patients with Stage IV disease had a larger effect compared with the ITT population, with an unstratified hazard ratio of 0.71 (95% CI, 0.53; 0.96), compatible with a 29% reduction in the risk of modified PFS events for ADCETRIS+ AVD versus ABVD.
Slovenian: Vnaprej določena analiza mPFS po podskupinah glede na stadij bolezni je pokazala večji učinek pri bolnikih z boleznijo stadija IV kot pri populaciji ITT, z nestratificiranim razmerjem ogroženosti 0,71 (95% CI, 0,53; 0,96), kar je skladno z 29-odstotnim zmanjšanjem tveganja dogodkov modificiranega
English: Infusion-related reactions
Slovenian: Reakcije, povezane z infudiranjem
English: ADCETRIS n = 82
Slovenian: Zdravilo ADCETRIS n = 82
English: Complete blood counts should be monitored prior to administration of each dose of treatment.
Slovenian: Pred aplikacijo vsakega odmerka zdravila je treba preveriti celotno krvno sliko.
English: For patients who experienced peripheral neuropathy the median time of onset of peripheral neuropathy was 8 weeks.
Slovenian: Pri bolnikih s periferno nevropatijo je bil mediani čas do nastopa periferne nevropatije 8 tednov.
English: Musculoskeletal and connective tissue disorders Very common:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti:
English: Ten (10) patients (17%) received 16 cycles of ADCETRIS; the median number of cycles received was 7 (range, 1 to 16).
Slovenian: Deset (10) bolnikov (17%) je prejelo 16 ciklov zdravila ADCETRIS, mediano število prejetih ciklov je bilo 7 (v razponu med 1 in 16).
English: The efficacy and safety of ADCETRIS were evaluated in a randomised, double-blind, placebo-controlled, 2-arm multicenter trial in 329 patients with HL at risk of relapse or progression following ASCT.
Slovenian: Učinkovitost in varnost zdravljenja z zdravilom ADCETRIS sta bili ovrednoteni v randomizirani, dvojno slepi, multicentrični, s placebom nadzorovani študiji z dvema krakoma, kjer je bilo vključenih 329 bolnikov s HL s tveganjem ponovitve ali napredovanja bolezni po avtologni PKMC.
English: Pneumocystis jiroveci pneumonia, staphylococcal bacteraemia, cytomegalovirus infection or reactivation, sepsis/septic shock
Slovenian: pljučnica, ki jo povzroča Pneumocystis jiroveci, stafilokokna bakteriemija, okužba s citomegalovirusom ali reaktivacija okužbe, sepsa/septični šok herpes zoster, pljučnica, ki jo povzroča Pneumocystis jiroveci
English: Adcetris contains the active substance brentuximab vedotin, an anti-cancer agent, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells.
Slovenian: Zdravilo Adcetris vsebuje zdravilno učinkovino brentuksimab vedotin, zdravilo proti raku, narejeno iz monoklonskega protitelesa, vezanega na snov, ki ubija rakave celice.
English: Citric acid monohydrate (for pH-adjustment) Sodium citrate dihydrate (for pH-adjustment) α,α-Trehalose dihydrate Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi citronska kislina monohidrat (za uravnavanje pH) natrijev citrat dihidrat (za uravnavanje pH) α,α-trehaloza dihidrat polisorbat 80
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.
Slovenian: Učinkovitost in varnost zdravila ADCETRIS kot samostojnega zdravila sta bili ovrednoteni v ključni, odprti, randomizirani, multicentrični študiji 3. faze pri 128 bolnikih s histološko potrjenim CD30-pozitivnim CTCL.
English: Patients with renal impairment should be closely monitored for adverse events (see section 5.2).
Slovenian: Bolnike z okvaro ledvic je treba skrbno nadzirati glede pojava neželenih učinkov (glejte poglavje 5.2).
English: Objective response (CR + PR) Complete remission (CR)
Slovenian: Objektivni odziv (CR + PR) Popolna remisija (CR)
English: In the clinical trial of ADCETRIS as combination therapy, treatment emergent neuropathy occurred in 67% of the population; peripheral motor neuropathy occurred in 11% of patients.
Slovenian: V kliničnih preskušanjih zdravila ADCETRIS v obliki kombiniranega zdravljenja se je nevropatija zaradi zdravljenja pojavila pri 67% bolnikov v populaciji, periferna motorična nevropatija pa se je pojavila pri 11% bolnikov.
English: Sodium content in excipients
Slovenian: Vsebnost natrija v pomožnih snoveh
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.
Slovenian: Infuzijsko linijo morate po dajanju zdravila sprati z raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje, raztopino glukoze (5%) za injiciranje ali raztopino Ringerjevega laktata za injiciranje.
English: Not applicable
Slovenian: Ni relevantno
English: 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).
Slovenian: V primerjavi z bolniki z normalnim delovanjem ledvic se je pri bolnikih s hudo okvaro ledvic (kreatininski očistek < 30 ml/min) izpostavljenost MMAE povečala za približno 1,9-krat (90% interval zaupanja: 0,85-krat do 4,21-krat).
English: Weight decreased
Slovenian: zmanjšan tek
English: A best overall response of CR was reported for 7 patients (12%); PR was reported for 23 patients (38%).
Slovenian: Pri 7 bolnikih (12%) so poročali o popolni remisiji (CR); pri 23 bolnikih (38%) pa so poročali o delni remisiji (PR).
English: Nausea, constipation, vomiting, diarrhoea, abdominal pain, stomatitis
Slovenian: navzea, driska, bruhanje, zaprtje, bolečine v trebuhu navzea, zaprtje, bruhanje, driska, bolečine v trebuhu, stomatitis
English: Co-administration of brentuximab vedotin with rifampicin, a strong CYP3A4 inducer, did not alter the plasma exposure to brentuximab vedotin.
Slovenian: Sočasno dajanje brentuksimaba vedotina z rifampicinom, močnim induktorjem CYP3A4, ni spremenilo izpostavljenosti brentuksimaba vedotina v plazmi.
English: Of the recovered MMAE, approximately 72% was recovered in the faeces.
Slovenian: Približno 72% izločenega MMAE je bilo izločenega z blatom.
English: Back pain
Slovenian: bolečina v hrbtu
English: Consider holding ADCETRIS dosing during evaluation and until symptomatic improvement.
Slovenian: Razmisliti je treba o začasni prekinitvi uporabe zdravila ADCETRIS med diagnostičnimi postopki in do izboljšanja simptomov.
English: A multiexponential decline in ADC serum concentrations was observed with a terminal half-life of approximately 4 to 6 days.
Slovenian: Opazili so multieksponentno upadanje koncentracij ADC v serumu s končnim razpolovnim časom približno 4 do 6 dni.
English: Each vial contains 50 mg of brentuximab vedotin.
Slovenian: Ena viala vsebuje 50 mg brentuksimaba vedotina.
English: Following dilution, infuse the ADCETRIS solution immediately at the recommended infusion rate.
Slovenian: Po redčenju raztopino zdravila ADCETRIS takoj infundirajte s priporočeno hitrostjo infundiranja.
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.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - sindrom tumorske lize - potencialno življenjsko nevarno stanje, pri katerem se lahko pojavijo omotica, zmanjšano odvajanje urina, zmedenost, bruhanje, slabost, oteklost, zasoplost ali motnje srčnega ritma.
English: 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).
Slovenian: Zdravilo ADCETRIS je v kombinaciji z doksorubicinom, vinblastinom in dakarbazinom (AVD) indicirano za odrasle bolnike s predhodno nezdravljenim CD30-pozitivnim Hodgkinovim limfomom (HL) stadija IV (glejte poglavji 4.2 in 5.1).
English: Note: If patient's weight is more than 100 kg, the dose calculation should use 100 kg.
Slovenian: Opomba: Pri bolnikih s telesno maso, večjo od 100 kg, je treba za izračun odmerka uporabiti 100 kg.
English: Study SG035-0004
Slovenian: Študija SG035-0004
English: Disease characteristics
Slovenian: Značilnosti bolezni
English: ADCETRIS n = 21
Slovenian: Zdravilo ADCETRIS n = 21