natgillin/translations-raw huggingface dataset:
Muscular weakness and leukoencephalopathy are listed in the axicabtagene ciloleucel product information.
Mišična šibkost in levkoencefalopatija sta že navedeni v informacijah o zdravilu za aksicabtagen ciloleucel.
TLS, which may be severe, has occasionally been observed.
Občasno so opazili TLS, ki je lahko resen.
• If you are pregnant or think you may be pregnant after treatment with YESCARTA, talk to your doctor immediately.
• Če ste noseči ali menite, da ste noseči po zdravljenju z zdravilom YESCARTA, se takoj posvetujte z zdravnikom.
During the 30 to 60 minutes before you are given YESCARTA you may be given other medicines.
Zdravila, ki se dajejo pred zdravljenjem z zdravilom YESCARTA V 30 do 60 minutah, preden prejmete zdravilo YESCARTA, boste morda prejeli druga zdravila.
Educational program - Prior to the launch of YESCARTA in each Member State the MAH must agree the content and format of the educational materials with the National Competent Authority.
Izobraževalni program - Pred prihodom zdravila YESCARTA na trg v vsaki državi članici mora imetnik dovoljenja za promet z zdravilom vsebino in obliko izobraževalnega gradiva dogovoriti z nacionalnim pristojnim organom.
All leukapheresed (ITT) Cohort 1 + 2 (N = 111)
Vsi z levkaferezo (ITT) Kohorta 1 + 2 (N = 111)
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali medicinsko sestro, preden boste dobili to zdravilo.
In ZUMA-1, hypogammaglobulinaemia occurred in 16% of patients.
V študiji ZUMA-1 se je hiperbilirubinemija 1. stopnje pojavila pri 16 % bolnikov.
Analyses performed to identify associations between cytokine levels and incidence of CRS or neurologic events showed that higher levels (peak and AUC at 1 month) of IL-15, as well as IL-6, were associated with Grade 3 or higher neurologic adverse reactions and Grade 3 or higher CRS.
Analize, opravljene za ugotavljanje povezave med ravnmi citokina in pojavnostjo CRS ali nevroloških dogodkov, so pokazale, da so bile višje ravni (največja raven in AUC v 1. mesecu) za IL-15 in za IL-6, povezane z nevrološkimi neželenimi učinki 3. ali večje stopnje in CRS 3. ali večje stopnje.
For patients experiencing severe CRS, consider performing an echocardiogram to assess cardiac function.
Za bolnike, ki imajo resen CRS, je treba razmisliti o izvedbi ehokardiograma za oceno srčne funkcije.
Overall Survival, median (months) [95% CI]
Celokupno preživetje (OS), mediana (meseci) [95-% IZ]
The median duration of follow up was 27.1 months (still ongoing).
Mediana trajanja spremljanja je bila 27,1 meseca (še poteka).
This is to help prevent infusion reactions and fever.
Ta pomagajo pri preprečevanju reakcij na infuzijo in zvišane telesne temperature.
Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions, or hypotension) including from preceding chemotherapies.
• Nerazrešeni resni neželeni učinki (zlasti reakcije, povezane s pljuči ali srcem, ali hipotenzija), vključno z učinki zaradi predhodnih kemoterapij.
Generally, safety and efficacy were similar between patients ≥ 65 years and patients < 65 years of age treated with
Na splošno sta bili varnost in učinkovitost pri bolnikih, starih ≥ 65 let, in pri bolnikih, starih < 65 let, zdravljenih z zdravilom YESCARTA, podobni.
• YESCARTA is the genetically modified version of your white blood cells.
• Zdravilo YESCARTA je gensko spremenjena različica vaših belih krvnih celic.
Active graft-versus-host disease (GVHD).
Aktivna bolezen presadka proti gostitelju (GVHD, graft-versus-host disease).
Five patients responded, including 4 CRs.
Pet bolnikov je bilo odzivnih, vključno s CR pri 4 bolnikih.
Summary of efficacy results for ZUMA-1 phase 2
Preglednica 5: Povzetek rezultatov učinkovitosti za 2. fazo študije ZUMA-1
The ORR was 26% [95% CI (21, 31)] and the CR rate was 7% [95% CI (3, 15)], with a median OS of 6.3 months.
Stopnja ORR je bila 26 % [95-% IZ (21; 31)] in stopnja CR je bila 7 % [95-% IZ (3; 15)], z mediano OS 6,3 meseca.
The analysis included patients who had not responded (SD or PD) to their last line of therapy, or had relapsed within 12 months after ASCT.
V analizo so bili vključeni bolniki, ki se niso odzvali (SB ali PB) na svoje zadnje zdravljenje ali pri katerih se je bolezen v 12 mesecih po ASCT ponovila.
Patients with active CNS disorder or inadequate renal, hepatic, pulmonary, or cardiac function are likely to be more vulnerable to the consequences of the adverse reactions described below and require special attention.
Bolniki z aktivno boleznijo osrednjega živčnega sistema ali nezadostno ledvično, jetrno, pljučno ali srčno funkcijo so verjetno bolj ranljivi za posledice spodaj opisanih neželenih učinkov in potrebujejo dodatno pozornost.
Work surfaces and material which have potentially been in contact with YESCARTA must be decontaminated with appropriate disinfectant.
Delovne površine in materiale, ki bi lahko bili v stiku z zdravilom YESCARTA, dekontaminirajte z ustreznim razkužilom.
In the event that a secondary malignancy occurs, contact the company to obtain instructions on patient samples to collect for testing.
V primeru pojava sekundarnega malignega obolenja se je treba povezati s podjetjem za pridobitev navodil o vzorcih, ki jih je treba pri bolniku odvzeti za testiranje.
The ORR results within PMBCL and DLBCL arising from follicular lymphoma were both 88%.
Rezultat ORR pri PMBCL in DLBCL, ki nastane iz folikularnega limfoma, je bil pri obeh 88 %.
Assessment of immunoglobulin levels and B-cells in newborns of mothers treated with YESCARTA should be considered.
Razmisliti je treba o oceni ravni imunoglobulina in B-celic pri novorojenčkih mater, zdravljenih z zdravilom YESCARTA.
What YESCARTA is and what it is used for
Kaj je zdravilo YESCARTA in za kaj ga uporabljamo
Patients should be monitored for signs and symptoms of infection before, during, and after YESCARTA infusion and treated appropriately.
Bolnike je treba spremljati glede znakov in simptomov okužb pred infundiranjem zdravila YESCARTA, med njim in po njem, ter jih ustrezno zdraviti.
(b) Refer to Table 2 for management of neurologic adverse reactions.
(b) Glejte preglednico 2 za obravnavo nevroloških neželenih učinkov.
• Plan to stay within proximity from the hospital where you were treated for at least 4 weeks after you have been given YESCARTA.
• Načrtujte zadrževanje v bližini bolnišnice, kjer ste se zdravili, še vsaj 4 tedne po prejemu zdravila YESCARTA.
There is no clinical experience in patients with active HIV, HBV or HCV infection.
Kliničnih izkušenj pri bolnikih z aktivno okužbo s HIV, HBV ali HCV ni.
Patients must have received at least prior anti-CD20 antibody therapy and an anthracycline containing regimen.
Bolniki so morali prejeti vsaj predhodno zdravljenje s protitelesi proti CD20 in režim, ki je vseboval antraciklin.
This is so your doctor can check if your treatment is working and help you if you have any side effects.
To zdravniku omogoči, da preverja delovanje zdravila in vam pomaga, če se pojavijo neželeni učinki.
The median duration of follow up was 27.4 months.
Mediana trajanja spremljanja je bila 27,4 meseca.
Febrile neutropenia was observed in 36% of patients after YESCARTA infusion.
Febrilno nevtropenijo so opazili pri 36 % bolnikov po infundiranju zdravila YESCARTA.
The anti-CD19 CAR-positive viable T cells are expanded and infused back into the patient, where they can recognise and eliminate CD19-expressing target cells.
Anti-CD19 CAR-pozitivne viabilne T-celice se ekspandirajo in infundirajo nazaj v bolnika, kjer prepoznajo in eliminirajo ciljne celice, ki izražajo CD19.
Due to the risks associated with YESCARTA treatment, infusion should be delayed if a patient has any of the following conditions:
Zaradi tveganj, povezanih z zdravljenjem z zdravilom YESCARTA, je treba z infundiranjem počakati, če se pri bolniku pojavi katero od naslednjih stanj:
• A leukodepleting filter must not be used.
• Filtra za odstranjevanje levkocitov ne smete uporabiti.
Thus, the infused CAR T cells are expected to be cleared over time.
Zato se čez čas pričakuje očistek infundiranih CAR T-celic.
If no improvement within 24 hours after starting tocilizumab, administer dexamethasone 10 mg intravenously every 6 hours if not already taking other corticosteroids.
Če v 24 urah po uvedbi tocilizumaba ni izboljšanja, se daje deksametazon 10 mg intravensko vsakih 6 ur, če bolnik ne jemlje drugih kortikosteroidov.
If any of the above apply to you (or you are not sure), talk to your doctor before being given YESCARTA.
Če kar koli od zgoraj navedenega velja za vas (ali niste prepričani), se pogovorite z zdravnikom ali medicinsko sestro, preden boste prejeli zdravilo YESCARTA.
Patients treated with YESCARTA should not donate blood, organs, tissues, and cells for transplantation.
Bolniki, zdravljeni z zdravilom YESCARTA, ne smejo darovati krvi, organov, tkiva ali celic za presaditev.
For severe or life-threatening CRS, consider intensive-care supportive therapy.
Pri resnem ali življenje ogrožajočem CRS razmislite o podpornem zdravljenju z intenzivno nego.
Patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection
Bolniki, okuženi z virusom humane imunske pomanjkljivosti (HIV), virusom hepatitisa B (HBV) in virusom hepatitisa C (HCV)
Contents: approximately 68 mL of cell dispersion.
Vsebina: približno 68 ml celične disperzije.
YESCARTA is intended for autologous use only (see section 4.4).
Zdravilo YESCARTA je namenjeno samo za avtologno uporabo (glejte poglavje 4.4).
YESCARTA should not be administered to patients with active infections or inflammatory disease until these conditions have resolved.
Zdravila YESCARTA se ne sme dajati bolnikom z aktivno okužbo ali vnetno boleznijo, dokler ta stanja ne izzvenijo.
On the basis of the scientific conclusions for axicabtagene ciloleucel the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing axicabtagene ciloleucel is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za aksicabtagen ciloleucel odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) aksicabtagen ciloleucel, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
The safety of immunisation with live viral vaccines during or following YESCARTA treatment has not been studied.
Varnosti imunizacije z živimi virusnimi cepivi med zdravljenjem z zdravilom YESCARTA ali po njem niso preučili.
Prior treatment with anti-CD19 therapy
Predhodno zdravljenje s terapijo proti CD19
Adverse reactions reported from clinical trials and post-marketing setting are presented below.
Neželeni učinki iz kliničnih preskušanj in obdobja trženja, o katerih so poročali, so predstavljeni spodaj.
N/A
n/s n/s
YESCARTA can cause side effects to your immune system that may be serious or life-threatening, and can lead to death.
Zdravilo YESCARTA lahko povzroči neželene učinke za imunski sistem, ki so lahko resni ali smrtno nevarni in povzročijo smrt.
Small clumps of cellular material should disperse with gentle manual mixing.
Majhne grudice celičnega materiala se morajo z nežnim ročnim mešanjem razpustiti.
This sequence of events leads to apoptosis and necrosis of CD19-expressing target cells.
To sosledje dogodkov povzroči apoptozo in nekrozo ciljnih celic, ki izražajo CD19.
Precautions to be taken for the disposal of the medicinal product
Varnostni ukrepi za odstranjevanje zdravila
Serious hypersensitivity reactions including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA.
Resne preobčutljivostne reakcije, vključno z anafilakso, so lahko posledica dimetilsulfoksida (DMSO) ali rezidualnega gentamicina v zdravilu YESCARTA.
• Fever, which may be a symptom of an infection.
• zvišano telesno temperaturo, ki je lahko simptom okužbe.
(c) Refer to tocilizumab summary of product characteristics for details.
(c) Za podrobnosti glejte povzetek glavnih značilnosti zdravila za tocilizumab.
Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment with YESCARTA.
Cepljenja z živimi virusnimi cepivi se ne priporoča najmanj 6 tednov pred začetkom kemoterapije za uničenje limfocitov, med zdravljenjem z zdravilom YESCARTA in do imunskega okrevanja po zdravljenju z zdravilom YESCARTA.
YESCARTA is a clear to opaque, white to red dispersion for infusion, supplied in an infusion bag individually packed in a metal cassette.
Zdravilo YESCARTA je bistra do motna, bela do rdeča disperzija za infuzijo, na voljo v infuzijski vreči, posamično pakirani v kovinsko kaseto.
Life-threatening symptoms.
Smrtno nevarni simptomi.
YESCARTA comprises engineered human T cells, therefore there are no representative in vitro assays, ex vivo models, or in vivo models that can accurately address the toxicological characteristics of the human product.
Zdravilo YESCARTA so umetno proizvedene človeške T-celice, zato ni reprezentativnih testov in vitro, modelov ex vivo ali modelov in vivo, s katerimi bi lahko natančno preučili toksikološke značilnosti zdravila za ljudi.
Only cytopenias that resulted in (i) new or worsening clinical sequelae or (ii) that required therapy or (iii) adjustment in current therapy are included in Table 3.
V preglednico 3 so vključene samo citopenije, ki so privedle do (i) novih kliničnih posledic ali do njihovega poslabšanja ali (ii) zaradi katerih je bilo potrebno zdravljenje ali (iii) prilagoditev trenutnega zdravljenja.
Grade 3 or higher (severe, life-threatening, or fatal) infections occurred in 26% of patients.
Okužbe 3. ali višje stopnje (hude, življenje ogrožajoče ali usodne) so se pojavile pri 26 % bolnikov.
Due to the on-target, off-tumour effect of YESCARTA, a period of B-cell aplasia is expected following treatment.
Zaradi učinka zdravila YESCARTA na ciljno mesto zunaj tumorja se po zdravljenju pričakuje obdobje B-celične aplazije.
The safety data described in this section reflect exposure to YESCARTA in ZUMA-1, a Phase 1/2 study in which 108 patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) received CAR-positive T cells based on a recommended dose which was weightbased.
Podatki o varnosti, opisani v tem poglavju, odražajo izpostavljenost zdravilu YESCARTA v ZUMA-1, študiji faze 1/2, v kateri je 108 bolnikov s ponovljenim/neodzivnim B-celičnim ne-Hodgkinovim limfomom (NHL) prejelo CAR-pozitivne T-celice, na osnovi priporočenega odmerka glede na telesno maso.
These include the use of tocilizumab or tocilizumab and corticosteroids for moderate, severe, or life-threatening CRS as summarised in Table 1.
Ti vključujejo uporabo tocilizumaba ali tocilizumaba in kortikosteroidov pri zmernem, hudem ali smrtno nevarnem CRS, kot je povzeto v preglednici 1.
For special precautions for disposal, see section 6.6.
Za posebna navodila za odstranjevanje glejte poglavje 6.6.
A causal relationship between dysphagia and axicabtagene ciloleucel was confirmed, based on the evidence from 15 post-marketing cases and 4 clinical trial cases of dysphagia.
Vzročna povezava med disfagijo in aksicabtagen ciloleucelom je bila potrjena na podlagi dokazov iz 15 primerov v obdobju trženja in 4 primerov iz kliničnih preskušanj.
For storage conditions after thawing of the medicinal product, see section 6.3.
Za pogoje shranjevanja odtajanega zdravila glejte poglavje 6.3.
YESCARTA is made from your own white blood cells and should only be given to you.
Zdravilo YESCARTA je narejeno iz vaših lastnih belih krvnih celic in ga lahko prejmete samo vi.
No studies have been conducted to evaluate the effects of YESCARTA on fertility, reproduction, and development.
Študij za oceno vpliva zdravila YESCARTA na plodnost, sposobnost razmnoževanja in razvoj niso izvedli.
In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.
V primeru febrilne nevtropenije je treba oceniti prisotnost okužbe in jo zdraviti s širokospektralnimi antibiotiki, tekočinami in drugo podporno oskrbo, kot je zdravstveno indicirano.
The DOR was longer in patients who achieved CR compared to patients with a best response of PR (Table 5).
DOR je bilo daljše pri bolnikih, ki so dosegli CR, v primerjavi z bolniki z najboljšim odzivom PR (preglednica 5).
The median dose was 2.0 x 106 anti-CD19 CAR T cells/kg.
Mediana odmerka je bila 2,0 x 106 anti-CD19 CAR T-celic/kg.
Concomitant disease
Sočasna bolezen
The other ingredients (excipients) are: Cryostor CS10, sodium chloride, human albumin.
Druge sestavine (pomožne snovi) so: Cryostor CS10, natrijev klorid, humani albumin.
Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered.
Bolnike z zdravstveno pomembno okvaro delovanja srca je treba obravnavati po standardih intenzivne nege in razmisliti o ukrepih, kot je ehokardiografija.
Due to the potential for neurologic events, including altered mental status or seizures, patients should refrain from driving or operating heavy or potentially dangerous machines until at least 8 weeks after infusion or until resolution of neurologic adverse reactions.
Zaradi možnih nevroloških dogodkov, vključno s spremenjenim duševnim stanjem ali epileptičnimi napadi, naj bolniki vsaj 8 tednov po infundiranju, ali dokler nevrološki neželeni učinki ne izzvenijo, ne vozijo in ne upravljajo nevarnih strojev.
- have signs or symptoms of graft-versus-host disease.
- če imate znake ali simptome bolezni presadka proti gostitelju.
Tumour lysis syndrome (TLS)
Sindrom tumorske lize (TLS, tumour lysis syndrome)
• Look for signs of infection; any infection will be treated before you are given YESCARTA.
• preveril znake okužbe; morebitno okužbo bodo zdravili, preden boste prejeli zdravilo
• Tocilizumab and emergency equipment should be available prior to infusion and during the monitoring period.
• Pred infundiranjem in v obdobju spremljanja morata biti pripravljena tocilizumab in oprema za ukrepanje v nujnih primerih.
YESCARTA therapy should be initiated under the direction of and supervised by a healthcare professional experienced in the treatment of haematological malignancies and trained for administration and management of patients treated with YESCARTA.
Zdravljenje z zdravilom YESCARTA mora uvesti in potek zdravljenja nadzorovati zdravstveni delavec, ki ima izkušnje z zdravljenjem hematoloških malignih obolenj in je usposobljen za dajanje zdravila in obravnavo bolnikov, zdravljenih z zdravilom YESCARTA.
Cumulatively, 33 (31%) of 108 subjects received intravenous immunoglobulin therapy at the time of the 24-month analysis.
Skupno 33 (31 %) od 108 bolnikov je ob času analize po 24 mesecih prejelo intravensko imunoglobulinsko zdravljenje.
* Dysphagia has been reported in the setting of neurologic toxicity and encephalopathy
* O disfagiji so poročali ob prisotnosti nevrološke toksičnosti in encefalopatije.
The MAH shall ensure that in each Member State where YESCARTA is marketed, all HCPs who are expected to prescribe, dispense, and administer YESCARTA shall be provided with a guidance document to: - facilitate identification of CRS and serious neurologic adverse reactions - facilitate management of the CRS and serious neurologic adverse reactions - ensure adequate monitoring of CRS and serious neurologic adverse reactions - facilitate provision of all relevant information to patients - ensure that adverse reactions are adequately and appropriately reported - ensure that detailed instructions about the thawing procedure are provided - before treating a patient, ensure that 4 doses of tocilizumab for each patient are available on site
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo v vsaki državi članici, kjer je zdravilo YESCARTA na trgu, vsem zdravstvenim delavcem, za katere se pričakuje, da bodo zdravilo YESCARTA predpisovali, izdajali in dajali, predloženo gradivo s smernicami za: - lažjo identifikacijo CRS in resnih nevroloških neželenih učinkov, - lažjo obravnavo CRS in resnih nevroloških neželenih učinkov, - zagotovitev primernega spremljanja glede CRS in resnih nevroloških neželenih učinkov, - lažje podajanje vseh pomembnih informacij bolnikom, - zagotovitev ustreznega in primernega poročanja neželenih učinkov,
The DOR was longer in patients who achieved CR, as compared to patients with a best response of partial response (PR).
DOR je bilo daljše pri bolnikih, ki so dosegli CR, v primerjavi z bolniki, katerih najboljši odziv je bil delni odziv (PR, partial response).
Peak levels of anti-CD19 CAR T cells occurred within the first 8 to 15 days after YESCARTA infusion.
Največje vrednosti anti-CD19 CAR T-celic so se pojavile v prvih 8 do 15 dneh po infundiranju zdravila YESCARTA.
• Since YESCARTA is made from your own white blood cells, your cells will be collected from you to prepare your medicine.
• Ker se zdravilo YESCARTA izdela iz vaših lastnih krvnih celic, vam bodo za pripravo zdravila vzeli vaše celice.
Patients who experience Grade 2 or higher neurologic toxicities should be monitored with continuous cardiac telemetry and pulse oximetry.
Bolnike, pri katerih se pojavijo znaki nevrološke toksičnosti 2. ali višje stopnje, je treba spremljati s stalno srčno telemetrijo in pulzno oksimetrijo.
Patients with a history of CNS disorders such as seizures or cerebrovascular ischaemia may be at increased risk.
Pri bolnikih z motnjami osrednjega živčnega sistema v anamnezi, kot so epileptični napadi ali cerebrovaskularna ishemija, je tveganje lahko večje.
Serious adverse reactions that may be associated with CRS included acute kidney injury, atrial fibrillation, ventricular tachycardia, cardiac arrest, cardiac failure, capillary leak syndrome, hypotension, hypoxia, and HLH/MAS.
Resni neželeni učinki, ki so lahko povezani s CRS, so vključevali akutno poškodbo ledvic, atrijsko fibrilacijo, ventrikularno tahikardijo, zastoj srca, srčno popuščanje, sindrom kapilarne krvavitve, hipotenzijo, hipoksijo in HLH/MAS.
Sixty-six patients were evaluable for cell-of-origin classifications (germinal center B-cell type [GCB] or activated B-cell type [ABC]).
Pri 66 bolnikih je bilo mogoče oceniti razvrstitev celice, iz katere se je limfom razvil (germinalni center B-celičnega tipa [GCB] ali aktiviran B-celični tip [ABC]).
In addition worsening of underlying organ pathologies can occur in the setting of CRS.
Ob CRS se lahko pojavi tudi poslabšanje predhodnih patologij organov.
Thirty were found to have double expressor DLBCL (overexpression of both MYC and BCL-2 protein); 5 were found to have HGBCL with MYC, BCL-2 or BCL-6 gene rearrangement (double- and triple-hit); and 2 were found to have HGBCL not otherwise specified.
Pri 30 bolnikih je bilo ugotovljeno, da imajo dvojno ekspresijo DLBCL (čezmerna ekspresija beljakovin MYC in BCL-2); pri 5 bolnikih je bilo ugotovljeno, da imajo HGBCL s preureditvijo genov v MYC, BCL-2 ali BCL-6 (»double-hit« in »triple-hit« limfom); in pri 2 je bilo ugotovljeno, da imata HGBCL, ki ni drugače opredeljen.
The safety and efficacy of YESCARTA in children and adolescents below 18 years of age have not yet been established.
Pediatrična populacija Varnost in učinkovitost zdravila YESCARTA pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
Anti-CD19 CAR T cell levels decreased toward background levels by Month 3 after infusion.
Stopnje anti-CD19 CAR T-celic so se do 3. meseca po infundiranju znižale proti izvornim stopnjam.
See section 4.4 for monitoring and management guidance.
Za spremljanje in navodila za ukrepanje glejte poglavje 4.4.
The initiation of B-cell recovery was first noted at Month 9, when 56% of patients had detectable B-cells.
Začetek obnavljanja B-celic so prvič opazili v 9. mesecu, ko je bilo B-celice mogoče zaznati pri 56 % bolnikov.
• Extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells.
• izjemno utrujenost, šibkost ali kratko sapo, kar so lahko simptomi pomanjkanja rdečih krvnih celic.