FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time from leukapheresis to product delivery was 17 days (range: 14 to 51 days), and the median time from leukapheresis to infusion was 24 days (range: 16 to 73 days).
Slovenian: Mediana časa od levkafereze do vnosa zdravila je bila 17 dni (razpon: od 14 do 51 dni) in mediana časa od levkafereze do infundiranja je bila 24 dni (razpon: od 16 do 73 dni).
English: No clinical data on the effect of YESCARTA on fertility are available.
Slovenian: Kliničnih podatkov o učinkih zdravila YESCARTA na plodnost ni.
English: In addition, administer dexamethasone 10 mg intravenously with the first dose of tocilizumab and repeat dose every 6 hours.
Slovenian: Poleg tega se daje deksametazon 10 mg intravensko s prvim odmerkom tocilizumaba, odmerek pa se vsakih 6 ur ponovi.
English: Among 73 patients with evaluable samples at baseline, 40% had detectable B-cells; the B-cell aplasia observed in the majority of patients at baseline was attributed to prior therapies.
Slovenian: Ob izhodišču je bilo med 73 bolniki z vzorci, ki jih je bilo mogoče oceniti, pri 40 % mogoče zaznati B-celice; B-celično aplazijo, ki so jo ob izhodišču opazili pri večini bolnikov, so pripisali predhodnim zdravljenjem.
English: Excipients: Cryostor CS10, human albumin, sodium chloride.
Slovenian: Pomožne snovi: Cryostor CS10, humani albumin, natrijev klorid.
English: • Thaw YESCARTA at approximately 37 °C using either a water bath or dry thaw method until there is no visible ice in the infusion bag.
Slovenian: • Zdravilo YESCARTA odtajajte na temperaturi približno 37 °C v vodni kopeli ali z metodo suhega odtajanja tako dolgo, da v infuzijski vreči ni več vidnega ledu.
English: The median time to response was 1.0 months (range: 0.8 to 6.3 months).
Slovenian: Mediana časa do odziva je bila 1,0 meseca (razpon: od 0,8 do 6,3 meseca).
English: This trend of B-cell recovery continued over time, as 64% of patients had detectable B-cells at Month 18, and 77% of patients had detectable B-cells at Month 24.
Slovenian: Ta trend obnavljanja B-celic se je s časom nadaljeval, saj bilo v 18. mesecu B-celice mogoče zaznati pri 64 % bolnikov, v 24. mesecu je bilo B-celice mogoče zaznati pri 77 % bolnikov.
English: No carcinogenicity or genotoxicity studies have been conducted with YESCARTA.
Slovenian: Študij kancerogenosti ali genotoksičnosti z zdravilom YESCARTA niso izvedli.
English: In the 24-month follow-up analysis, based on the mITT population (results from an independent review committee), the ORR and the CR rate were 74% and 54%, respectively.
Slovenian: V analizi spremljanja po 24 mesecih, ki je temeljila na populaciji mITT (rezultati neodvisne ocenjevalne komisije), je bila stopnja ORR 74 % in CR 54 %.
English: Hypogammaglobulinaemia has been very commonly observed in patients treated with YESCARTA.
Slovenian: Hipogamaglobulinemija je bila pri bolnikih, ki so se zdravili z zdravilom YESCARTA, opažena zelo pogosto.
English: Gently mix the contents of the bag to disperse clumps of cellular material.
Slovenian: Vsebino vreče nežno mešajte, da se grudice celičnega materiala razpustijo.
English: • After the entire content of the bag is infused, rinse the tubing at the same infusion rate with 0.9% sodium chloride solution (0.154 mmol sodium per mL) to ensure all YESCARTA is delivered.
Slovenian: • Po infundiranju celotne vsebine vreče z zdravilom cevje splaknite z enako hitrostjo infundiranja z 0,9 % raztopino natrijevega klorida (0,154 mmol natrija na ml), da se zagotovi vnos celotne količine zdravila YESCARTA.
English: • Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.
Slovenian: • Bolnikom je treba naročiti, da naj se vsaj 4 tedne po infundiranju zadržujejo blizu usposobljene klinične ustanove.
English: Patients who experience Grade 2 or higher CRS (e.g. hypotension, not responsive to fluids, or hypoxia requiring supplemental oxygenation) should be monitored with continuous cardiac telemetry and pulse oximetry.
Slovenian: Bolniki, ki imajo CRS 2. ali višje stopnje (npr. hipotenzijo, neodzivnost na tekočine ali hipoksijo, zaradi katere je potrebna dodatna oksigenacija), je treba spremljati s stalno srčno telemetrijo in pulzno oksimetrijo.
English: Symptoms require and respond to aggressive intervention.
Slovenian: Za zdravljenje simptomov in dosego odziva je potrebno agresivno ukrepanje.
English: Patients who were refractory to chemotherapy or who relapsed after two or more lines of systemic therapy were generally ineligible for haematopoietic stem cell transplantation.
Slovenian: Bolniki, ki se na kemoterapijo niso odzivali ali se je bolezen po dveh ali več vrstah sistemskega zdravljenja ponovno pojavila, načeloma niso bili primerni za presaditev krvotvornih matičnih celic.
English: The median duration was 13 days (range: 1 to 191 days).
Slovenian: Mediani čas trajanja je bil 13 dni (razpon: od 1 do 191 dni).
English: Febrile neutropenia has been observed in patients after YESCARTA infusion (see section 4.8) and may be concurrent with CRS.
Slovenian: Pri bolnikih so po infundiranju zdravila YESCARTA opazili febrilno nevtropenijo (glejte poglavje 4.8), ki je lahko sočasna s CRS.
English: DLBCL in ZUMA-1 included patients with DLBCL NOS, other DLBCL subtypes, and high-grade B-cell lymphoma (HGBCL) based on the 2016 WHO-classification.
Slovenian: DLBCL in ZUMA-1 sta vključevala bolnike z DLBCL NOS, drugimi podtipi DLBCL in B-celičnim limfomom visoke stopnje (HGBCL) na podlagi razvrstitve SZO 2016.
English: • Bleeding or bruising more easily, which may be symptoms of low levels of cells in the blood known as platelets.
Slovenian: • hitrejše krvavitve ali podplutbe, kar so lahko simptomi nizke ravni celic v krvi, imenovanih trombociti.
English: YESCARTA continues to expand and persist following administration of tocilizumab and corticosteroids.
Slovenian: Zdravilo YESCARTA se širi in je obstojno po dajanju tocilizumaba in kortikosteroidov.
English: There is limited experience with YESCARTA in patients ≥ 75 years of age.
Slovenian: Izkušnje z zdravilom YESCARTA pri bolnikih, starih ≥ 75 let, so omejene.
English: Monitoring of vital signs and organ functions should be considered depending on the severity of the reaction.
Slovenian: Glede na resnost reakcije je treba razmisliti o spremljanju vitalnih znakov in delovanja organov.
English: Oxygen requirement greater than or equal to 40% FiO2 or hypotension requiring high-dose or multiple vasopressors or Grade 3 organ toxicity or Grade 4 transaminitis.
Slovenian: Potreba po kisiku 40 % FiO2 ali več ali hipotenzija, pri kateri so potrebni veliki odmerki ali več vazopresorjev, ali toksičnost organov 3. stopnje ali transaminitis 4. stopnje.
English: The median time to onset was 2 days (range: 1 to 12 days) and the median duration was 7 days (range: 2 to 29 days).
Slovenian: Mediani čas do pojava je bil 2 dni (razpon: od 1 do 12 dni), mediani čas trajanja pa je bil 7 dni (razpon: od 2 do 29 dni).
English: • Check for hepatitis B, hepatitis C or HIV infection.
Slovenian: • preveril okužbo s hepatitisom B, hepatitisom C ali HIV.
English: Three patients tested positive for anti-FMC63 prior to being treated with YESCARTA.
Slovenian: Trije bolniki so bili pred zdravljenjem z zdravilom YESCARTA pozitivni na anti-FMC63.
English: - the risks of CRS and serious neurologic adverse reactions, associated with YESCARTA - the need to report the symptoms to their treating doctor immediately - the need to remain in the proximity of the location where YESCARTA was received for at least 4 weeks following YESCARTA infusion - the need to carry the patient alert card at all times
Slovenian: Da se bolnike obvesti in jim pojasni: - tveganja CRS in resnih nevroloških neželenih učinkov, povezanih z zdravilom YESCARTA, - potrebo po takojšnjem poročanju simptomov zdravniku, ki vodi zdravljenje, - potrebo, da ostanejo blizu lokacije, kjer so prejeli zdravilo YESCARTA, vsaj 4 tedne po infundiranju zdravila YESCARTA,
English: Administer methylprednisolone 1000 mg intravenously per day with first dose of tocilizumab and continue methylprednisolone 1000 mg intravenously per day for 2 more days; if improves, then manage as above.
Slovenian: Dajanje metilprednizolona 1.000 mg intravensko na dan s prvim odmerkom tocilizumaba, nato pa se 2 dni nadaljuje z metilprednizolonom 1.000 mg intravensko na dan; pri izboljšanju obravnava kot zgoraj.
English: This is because the effects of YESCARTA in pregnant or breast-feeding women are not known, and it may harm your unborn baby or your breast-fed child.
Slovenian: YESCARTA pri nosečnicah ali doječih materah niso znani in bi lahko zdravilo škodovalo vašemu nerojenemu ali dojenemu otroku.
English: Requirements for ventilator support or continuous veno-venous haemodialysis or Grade 4 organ toxicity (excluding transaminitis).
Slovenian: Potrebna uporaba ventilatorja ali kontinuirana venovenska hemodializa ali toksičnost organa 4. stopnje (brez transaminitisa).
English: Following anti-CD19 CAR T-cell engagement with CD19 expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signalling cascades that lead to T-cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines.
Slovenian: Ko anti-CD19 CAR T-celice reagirajo s ciljnimi celicami, ki izražajo CD19, kostimulativne domene CD28 in CD3-zeta aktivirajo navzdolne signalne kaskade, kar pri T-celicah povzroči aktivacijo, proliferacijo, pridobitev efektorske funkcije ter izločanje vnetnih citokinov in kemokinov.
English: Administer methylprednisolone 1 mg/kg intravenously twice daily or equivalent dexamethasone (e.g., 10 mg intravenously every 6 hours).
Slovenian: Dajanje metilprednizolona 1 mg/kg intravensko dvakrat na dan ali ustrezni odmerek deksametazona (npr. 10 mg intravensko vsakih 6 ur).
English: The active substance is axicabtagene ciloleucel.
Slovenian: Učinkovina je aksicabtagen ciloleucel.
English: These include the use of tocilizumab (if concurrent CRS) and/or corticosteroids for moderate, severe, or life-threatening neurologic adverse reactions as summarised in Table 2.
Slovenian: Ti vključujejo uporabo tocilizumaba (pri sočasnem CRS) in/ali kortikosteroidov pri zmernih, hudih ali smrtno nevarnih nevroloških neželenih učinkih, kot je povzeto v preglednici 2.
English: • For autologous use only.
Slovenian: • Samo za avtologno uporabo.
English: All patients were hospitalized for observation for a minimum of 7 days after YESCARTA infusion.
Slovenian: Vsi bolniki so bili po infundiranju zdravila YESCARTA vsaj 7 dni hospitalizirani zaradi opazovanja.
English: At the 24-month follow-up analysis, these 3 patients remained in CR at 30 to 35 months after YESCARTA infusion.
Slovenian: Ob analizi spremljanja po 24 mesecih so ti 3 bolniki ohranili CR 30 do 35 mesecev po infundiranju zdravila YESCARTA.
English: In the 12-month follow-up analysis (Table 5), the ORR was 72% and the CR rate was 51%.
Slovenian: V analizi spremljanja po 12 mesecih (preglednica 5) je bila stopnja ORR 72 % in stopnja CR 51 %.
English: Grade 3 or higher unspecified pathogen, bacterial, and viral infections occurred in 19%, 9%, and 6% of patients respectively.
Slovenian: Okužbe 3. ali višje stopnje zaradi neugotovljenega povzročitelja, bakterijske in virusne okužbe so se pojavile pri 19 %, 9 % oz. 6 % bolnikov.
English: Accordingly, healthcare professionals should take appropriate precautions (wearing gloves and glasses) when handling leukapheresis material or YESCARTA to avoid potential transmission of infectious diseases.
Slovenian: Skladno s tem morajo zdravstveni delavci uporabljati primerne previdnostne ukrepe (nošenje rokavic in očal), ko ravnajo z materialom levkafereze ali zdravilom YESCARTA, da preprečijo potencialni prenos kužnih bolezni.
English: Efficacy was based on 101 patients in phase 2, including histologically confirmed DLBCL (N = 77), PMBCL (N = 8), or DLBCL arising from follicular lymphoma, (N = 16) based on the 2008 WHO-classification.
Slovenian: Učinkovitost je temeljila na 101 bolniku v 2. fazi, vključno s histološko potrjenim difuznim velikoceličnim B-limfomom (DLBCL) (N = 77), primarnim mediastinalnim velikoceličnim B-limfomom (PMBCL) (N = 8) ali DLBCL, ki nastane iz folikularnega limfoma (N = 16), na podlagi razvrstitve SZO 2008.
English: • Gently agitate the bag during YESCARTA infusion to prevent cell clumping.
Slovenian: • Vrečo z zdravilom med infundiranjem zdravila YESCARTA nežno obračajte, da se prepreči nastajanje celičnih grudic.
English: This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhoea and bloody stools.
Slovenian: To se zgodi, ko presajene celice napadajo vaše telo in povzročijo simptome, kot so izpuščaj, siljenje na bruhanje, bruhanje,
English: All material that has been in contact with YESCARTA (solid and liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local biosafety guidelines.
Slovenian: Z vsem materialom, ki je bil v stiku z zdravilom YESCARTA (trdni in tekoči odpadki), je treba ravnati kot s potencialno kužnimi odpadki in ga odstraniti v skladu z lokalnimi smernicami za zagotavljanje biološke varnosti.
English: Your healthcare professional handling YESCARTA will therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases and will follow local biosafety guidelines to clean up or dispose of any material that has been in contact with YESCARTA.
Slovenian: Vaš zdravstveni delavec, ki ravna z zdravilom YESCARTA, bo zato z ustreznimi previdnostnimi ukrepi (nošenje rokavic in očal) preprečil morebitni prenos kužnih bolezni in upošteval lokalne smernice za zagotavljanje biološke varnosti pri čiščenju ali odstranjevanju vsega materiala, ki je bil v stiku z zdravilom YESCARTA.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja z zdravilom YESCARTA niso izvedli.
English: Following YESCARTA treatment, the proportion of patients with detectable B-cells decreased: 20% had detectable B-cells at Month 3, and 22% had detectable B-cells at Month 6.
Slovenian: Po zdravljenju z zdravilom YESCARTA se je delež bolnikov, pri katerih je bilo mogoče zaznati B-celice, zmanjšal: v 3. mesecu je bilo B-celice mogoče zaznati pri 20 % bolnikov, v 6. mesecu pa je bilo B-celice mogoče zaznati pri 22 % bolnikov.
English: A clear to opaque, white to red dispersion.
Slovenian: FARMACEVTSKA OBLIKA disperzija za infundiranje Bistra do motna, bela do rdeča disperzija.
English: Symptoms require symptomatic treatment only (e.g., fever, nausea, fatigue, headache, myalgia, malaise).
Slovenian: Simptome je treba zdraviti samo simptomatsko (npr. zvišana telesna temperatura, navzea, utrujenost, glavobol, mialgija, splošno slabo počutje).
English: The median anti-CD19 CAR T cell Cmax level in responders (N = 71) was 216% higher compared to the corresponding level in nonresponders (N = 25) (43.6 cells/μL versus 20.2 cells/μL).
Slovenian: Mediana ravni Cmax anti-CD19 CAR T-celic pri odzivnih osebah (N = 71) je bila za 216 % višja v primerjavi s pripadajočo ravnijo pri neodzivnih osebah (N = 25) (43,6 celice/μl v primerjavi z 20,2 celice/μl).
English: Studies of YESCARTA in patients with hepatic and renal impairment were not conducted.
Slovenian: Študij z zdravilom YESCARTA pri bolnikih z okvaro jeter in ledvic niso izvedli.
English: • YESCARTA is a one-time treatment.
Slovenian: • Zdravilo YESCARTA je namenjeno za enkratno zdravljenje.
English: Patients with CNS lymphoma, a history of allogeneic stem cell transplantation (SCT) or prior anti-CD19 CAR or other genetically modified T-cell therapy were excluded.
Slovenian: Bolniki z limfomom OŽS, alogenično presaditvijo matičnih celic (SCT) v anamnezi ali predhodnim anti-CD19 CAR ali drugim zdravljenjem z gensko spremenjenimi T-celicami so bili izključeni.
English: Symptoms require and respond to moderate intervention.
Slovenian: Za zdravljenje simptomov in dosego odziva je potrebno zmerno ukrepanje.
English: Dehydration Decreased appetite Hypophosphataemia Hyponatraemia Weight decrease
Slovenian: Zelo pogosti dehidracija zmanjšan apetit hipofosfatemija hiponatriemija zmanjšanje telesne mase
English: Other medicines and YESCARTA
Slovenian: Druga zdravila in zdravilo YESCARTA
English: CRS has been known to be associated with end organ dysfunction (e.g., hepatic, renal, cardiac, and pulmonary).
Slovenian: Znano je, da je CRS povezan z okvaro delovanja končnega organa (npr. jeter, ledvic, srca in pljuč).
English: YESCARTA is stable for 1 year when stored frozen in the vapour phase of liquid nitrogen (≤ -150 ˚C).
Slovenian: Zdravilo YESCARTA je stabilno 1 leto, če se shranjuje zamrznjeno v parni fazi tekočega dušika (≤ -150 °C).
English: Alanine aminotransferase increased Aspartate aminotransferase increased
Slovenian: Zelo pogosti povišana raven alaninaminotransferaze povišana raven aspartataminotransferaze
English: • During YESCARTA treatment.
Slovenian: • Med zdravljenjem z zdravilom YESCARTA.
English: Healthcare professionals handling YESCARTA should take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Slovenian: Zdravstveni delavci morajo pri ravnanju z zdravilom YESCARTA upoštevati ustrezne previdnostne ukrepe (nošenje rokavic in očal), da preprečijo možnost prenosa nalezljivih bolezni.
English: • Check your blood for uric acid and for how many cancer cells there are in your blood.
Slovenian: • preveril prisotnost sečne kisline v krvi in število rakavih celic v krvi.
English: Sodium chloride Human albumin
Slovenian: Cryostor CS10 natrijev klorid humani albumin
English: YESCARTA, an engineered autologous T-cell immunotherapy product, binds to CD19 expressing cancer cells and normal B cells.
Slovenian: Zdravilo YESCARTA, umetno proizvedeno avtologno T-celično zdravilo za imunoterapijo, se veže na rakave celice, ki izražajo CD19, in na normalne B-celice.
English: Serious infections have been very commonly observed with YESCARTA (see section 4.8).
Slovenian: Pri uporabi zdravila YESCARTA so zelo pogosto opazili resne okužbe (glejte poglavje 4.8).
English: YESCARTA is not recommended if the patient has relapsed with CD19-negative disease after prior anti-CD19 therapy.
Slovenian: Zdravila YESCARTA se ne priporoča pri bolnikih s ponovljeno CD19-negativno boleznijo po predhodnem zdravljenju proti CD19.
English: Of the 55 patients who achieved CR, 7 patients had SD and 10 had PR at their initial tumour assessment and converted to CR as late as 12 months after YESCARTA infusion.
Slovenian: Med 55 bolniki, ki so dosegli CR, je imelo 7 bolnikov SB in 10 jih je imelo PR ob začetni oceni tumorja, ki se je v CR spremenil šele 12 mesecev po infundiranju zdravila YESCARTA.
English: The PRAC considers that the product information of axicabtagene ciloleucel containing products should be amended to reflect the risk of dysphagia associated with axicabtagene ciloleucel therapy.
Slovenian: Odbor PRAC meni, da je treba informacije o zdravilih, ki vsebujejo aksicabtagen ciloleucel, spremeniti tako, da bodo odražale tveganje za disfagijo, povezano z zdravljenjem z aksicabtagen ciloleucelom.
English: Ethylene-vinyl acetate cryostorage bag with sealed addition tube and two available spike ports, containing approximately 68 mL of cell dispersion.
Slovenian: Vreča iz etilenvinil acetata za krioshranjevanje z zatesnjeno cevko za dodajanje in dvema razpoložljivima vbodnima priključkoma, ki vsebuje približno 68 ml celične disperzije.
English: Based on the mechanism of action, if the transduced cells cross the placenta, they may cause foetal toxicity, including B-cell lymphocytopenia.
Slovenian: Na podlagi mehanizma delovanja lahko transducirane celice povzročijo toksičnost za plod, vključno z B-celično limfocitopenijo, če prehajajo skozi placento.
English: Do not infuse YESCARTA if the information on the patient-specific label does not match the intended patient.
Slovenian: Zdravila YESCARTA ne infundirajte, če se podatki na nalepki, specifični za bolnika, ne ujemajo s podatki bolnika, ki mu je zdravilo namenjeno.
English: The immunogenicity of YESCARTA has been evaluated using an enzyme-linked immunosorbent assay (ELISA) for the detection of binding antibodies against FMC63, the originating antibody of the anti-CD19 CAR.
Slovenian: Imunogenost zdravila YESCARTA so ocenili z uporabo encimsko-imunskega testa (ELISA) za zaznavanje vezave protiteles proti FMC63, protiteles, ki nastanejo iz anti-CD19 CAR.
English: One sterile infusion bag.
Slovenian: INFUZIJSKA VREČA
English: Severe neurologic adverse reactions have been very commonly observed in patients treated with YESCARTA, which could be life-threatening or fatal (see section 4.8).
Slovenian: Nevrološki neželeni učinki Pri bolnikih, zdravljenih z zdravilom YESCARTA, so zelo pogosto opazili hude nevrološke neželene učinke, ki so lahko smrtno nevarni ali smrtni (glejte poglavje 4.8).
English: What YESCARTA looks like and contents of the pack
Slovenian: Izgled zdravila YESCARTA in vsebina pakiranja
English: See section 4.4 for management guidance.
Slovenian: Za navodila za ukrepanje glejte poglavje 4.4.
English: These reactions are presented by system organ class and by frequency.
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
English: Eligible patients were ≥ 18 years of age with refractory disease defined as progressive disease (PD) or stable disease (SD) as best response to last line of therapy, or disease progression within 12 months after autologous stem cell transplant (ASCT).
Slovenian: (PB) ali stabilna bolezen (SB) kot najboljši odgovor na zadnjo vrsto zdravljenja, ali napredovanje bolezni v 12 mesecih po avtologni presaditvi matičnih celic (ASCT, autologous stem cell transplant).
English: Each bag of YESCARTA contains 300 mg sodium.
Slovenian: Pomožne snovi z znanim učinkom Ena vreča zdravila YESCARTA vsebuje 300 mg natrija.
English: Pre-treatment (lymphodepleting chemotherapy)
Slovenian: Predzdravljenje (kemoterapija za uničenje limfocitov)
English: Tumour necrosis factor (TNF) antagonists are not recommended for management of YESCARTA-associated CRS.
Slovenian: Uporabe antagonistov tumorje nekrotizirajočega faktorja (TNF) se ne priporoča za obravnavo CRS zaradi zdravila YESCARTA.
English: Note: The 12-month analysis had a median follow-up of 15.1 months.
Slovenian: Opombe: Mediano spremljanje v analizi po 12 mesecih je bilo 15,1 meseca.Mediano spremljanje v analizi po 24 mesecih je bilo 27,1 meseca.
English: The most common serious adverse reactions included encephalopathy (22%), unspecified pathogen infections (16%), bacterial infections (6%), febrile neutropenia (6%), viral infections (5%), and pyrexia (5%).
Slovenian: Najpogostejši resni neželeni učinki so vključevali encefalopatijo (22 %), okužbe z neugotovljenimi povzročitelji (16 %), bakterijske okužbe (6 %), febrilno nevtropenijo (6 %), virusne okužbe (5 %) in pireksijo (5 %).
English: - notice the symptoms of your cancer are getting worse.
Slovenian: - če opazite simptome slabšanja svoje rakave bolezni.
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Slovenian: Neporabljeno zdravilo morate odstraniti v skladu z lokalnimi smernicami za zagotavljanje biološke varnosti.
English: A single dose of YESCARTA contains 2 x 106 CAR-positive viable T cells per kg of body weight (or maximum of 2 x 108 CAR-positive viable T cells for patients 100 kg and above) in approximately 68 mL dispersion in an infusion bag.
Slovenian: Enkratni odmerek zdravila YESCARTA vsebuje 2 x 106 CAR-pozitivnih viabilnih T-celic na kg telesne mase (ali največ 2 x 108 CAR- pozitivnih viabilnih T-celic za bolnika s 100 kg in več) v približno 68 ml disperzije v vreči za infundiranje.
English: The most significant and frequently occurring adverse reactions were CRS (93%), encephalopathy (58%), and infections (39%).
Slovenian: Najpomembnejši in najpogostejši neželeni učinki so bili CRS (93 %), encefalopatija (58 %) in okužbe