FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Jedna doza lijeka YESCARTA sadrži 2 x 106 CAR-pozitivnih vijabilnih T-stanica po kilogramu tjelesne mase (ili najviše 2 x 108 CAR-pozitivnih vijabilnih T-stanica za bolesnike tjelesne mase od 100 kg i više) u približno 68 ml disperzije u vrećici infuzije.
English: YESCARTA, an engineered autologous T-cell immunotherapy product, binds to CD19 expressing cancer cells and normal B cells.
Croatian: YESCARTA, lijek za autolognu imunoterapiju genetički modificiranim T-stanicama, veže se na stanice raka koje izražavaju CD19 i normalne B-stanice.
English: • During YESCARTA treatment.
Croatian: • tijekom liječenja lijekom YESCARTA
English: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion.
Croatian: Bolesnici mogu izraziti citopenije tijekom nekoliko tjedana nakon limfocitne deplecije i infuzije lijeka YESCARTA.
English: The most common Grade 3 or higher adverse reactions included encephalopathy (31%), unspecified pathogen infections (19%), CRS (11%), bacterial infection (9%), aphasia (7%), viral infection (6%), delirium (6%), hypotension (6%), and hypertension (6%).
Croatian: Najčešće nuspojave 3. ili višeg stupnja uključivale su encefalopatiju (31%), infekcije neodređenim patogenima (19%), CRS (11%), bakterijsku infekciju (9%), afaziju (7%), virusnu infekciju (6%), delirij (6%), hipotenziju (6%) i hipertenziju (6%).
English: Generally, safety and efficacy were similar between patients ≥ 65 years and patients < 65 years of age treated with
Croatian: Sigurnost i djelotvornost uglavnom su bile slične kod bolesnika u dobi
English: YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy.
Croatian: YESCARTA (aksikaptagen ciloleucel) je imunoterapija genetički modificiranim autolognim T-stanicama usmjerenim protiv CD19.
English: The median time to response was 1.0 months (range: 0.8 to 12.2 months).
Croatian: Medijan vremena do odgovora bio je 1,0 mjeseci (raspon: od 0,8 do 12,2 mjeseca).
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).
Croatian: Medijan razine Cmax anti-CD19 CAR T-stanica u bolesnika s odgovorom (N = 71) bio je 216% viši u usporedbi s odgovarajućom razinom u bolesnika bez odgovora (N = 25) (43,6 stanica/μl naspram 20,2 stanica/μl).
English: The PRAC considers that the product information of axicabtagene ciloleucel should be amended to reflect the risk of spinal cord oedema, myelitis and quadriplegia associated with axicabtagene ciloleucel therapy.
Croatian: PRAC smatra da je informacije o lijeku za aksikaptagen ciloleucel potrebno izmijeniti kako bi odražavale rizik za razvoj edema leđne moždine, mijelitisa i kvadriplegije povezan s terapijom aksikaptagen ciloleucelom.
English: Not applicable 47.7 (38.2, 56.7) Not applicable 50.5 (40.4, 59.7)
Croatian: nije primjenjivo 47,7 (38,2; 56,7) nije primjenjivo 50,5 (40,4; 59,7)
English: YESCARTA was administered as a single infusion at a target dose of 2 x 106 anti-CD19 CAR T cells/kg after lymphodepleting chemotherapy regimen of 500 mg/m2 intravenous cyclophosphamide and 30 mg/m2 intravenous fludarabine on the 5th, 4th, and 3rd day before YESCARTA.
Croatian: Lijek YESCARTA primijenjen je kao jedna infuzija u ciljnoj dozi od 2 x 106 anti-CD19 CAR T-stanica/kg nakon režima kemoterapije za limfocitnu depleciju od 500 mg/m2 ciklofosfamida intravenski i 30 mg/m2 fludarabina intravenski 5., 4. i 3. dana prije primjene lijeka YESCARTA.
English: This medicine contains genetically-modified cells.
Croatian: Ovaj lijek sadrži genetički modificirane stanice.
English: No dose adjustment is required in patients ≥ 65 years of age.
Croatian: Prilagodba doze nije potrebna u bolesnika u dobi
English: Administer methylprednisolone 1000 mg intravenously per day for 3 days; if improves, then manage as above.
Croatian: Intravenski primijeniti 1000 mg metilprednizolona dnevno tijekom 3 dana; ako dođe do poboljšanja, liječiti prema prethodno navedenim smjernicama.
English: Prolonged (still present at Day 30 or with an onset at Day 30 or beyond) Grade 3 or higher neutropenia, thrombocytopenia, and anaemia occurred in 26%, 24%, and 10% of patients, respectively.
Croatian: Produljena (još uvijek prisutna 30. dana ili s nastupom 30. dana ili kasnije) neutropenija, trombocitopenija i anemija 3. ili višeg stupnja zabilježene su u 26%, 24% odnosno 10% bolesnika.
English: Ethylene-vinyl acetate cryostorage bag with sealed addition tube and two available spike ports, containing approximately 68 mL of cell dispersion.
Croatian: Vrećica od etilenvinilacetata za kriopohranu sa zatvorenom dodatnom cijevi i dva dostupna priključka sadrži približno 68 ml stanične disperzije.
English: YESCARTA comprises human autologous T cells.
Croatian: YESCARTA se sastoji od ljudskih autolognih T-stanica.
English: Outcomes were consistent between patients with Eastern Cooperative Oncology Group (ECOG) of 0 and 1 and by sex.
Croatian: Eastern Cooperative Oncology Group, ECOG) i prema spolu.
English: The median time to onset was 5 days (range: 1 to 17 days).
Croatian: Medijan vremena do početka bio je 5 dana (raspon: od 1 do 17 dana).
English: • Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.
Croatian: • Bolesnike treba upozoriti da još najmanje 4 tjedna nakon infuzije ostanu u blizini kvalificirane bolničke ustanove.
English: The 24-month analysis had a median follow-up of 27.1 months.
Croatian: U analizi nakon 24 mjeseca medijan praćenja iznosio je 27,1 mjesec.
English: There is no clinical experience in patients with active HIV, HBV or HCV infection.
Croatian: Ne postoji kliničko iskustvo u bolesnika s aktivnom infekcijom virusom HIV-a, hepatitisa B ili hepatitisa C.
English: Administer dexamethasone 10 mg intravenously every 6 hours.
Croatian: Intravenski primijeniti 10 mg deksametazona svakih 6 sati.
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.
Croatian: DLBCL u ispitivanju ZUMA-1 uključivao je bolesnike s DLBCL-om koji nisu drugačije specificirani, s drugim podtipovima DLBCL-a i agresivnim B-staničnim limfomom (engl. high-grade B-cell lymphoma, HGBCL) na osnovi klasifikacije Svjetske zdravstvene organizacije iz 2016. godine.
English: YESCARTA is made specially for you as a single administration of your own modified white blood cells.
Croatian: Lijek YESCARTA namijenjen je isključivo Vama, za jednu primjenu Vaših vlastitih genetički modificiranih leukocita.
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.
Croatian: Stoga će zdravstveni radnici koji rukuju lijekom YESCARTA poduzeti odgovarajuće mjere opreza (nositi rukavice i naočale) kako bi se izbjeglo moguće prenošenje zaraznih bolesti i pridržavat će se nacionalnih smjernica za biološku sigurnost, čišćenje ili zbrinjavanje materijala koji je bio u kontaktu s lijekom YESCARTA.
English: The most common signs or symptoms associated with neurologic adverse reactions included encephalopathy (58%), headache (40%), tremor (31%), dizziness (21%), aphasia (18%), and delirium (17%).
Croatian: Najčešći znakovi ili simptomi povezani s neurološkim nuspojavama uključivali su encefalopatiju (58%), glavobolju (40%), tremor (31%), omaglicu (21%), afaziju (18%) i delirij (17%).
English: Kite Pharma EU B.V. Tufsteen 1
Croatian: Kite Pharma EU B.V.
English: For severe or life-threatening CRS, consider intensive-care supportive therapy.
Croatian: U slučaju teškog i opasnog po život CRS-a razmislite o potpornoj terapiji intenzivne skrbi.
English: • Check that the patient information on the cassette label matches that on the bag label.
Croatian: • Provjerite da podaci o bolesniku na naljepnici koja se nalazi na kazeti odgovaraju podacima na naljepnici na vrećici.
English: Spinal cord oedema was reported, in the context of neurologic toxicity in the post-marketing setting.
Croatian: Edem leđne moždine zabilježen je u kontekstu neurološke toksičnosti nakon stavljanja lijeka u promet.
English: Contraindications of the lymphodepleting chemotherapy must be considered.
Croatian: Potrebno je uzeti u obzir kontraindikacije kemoterapije za limfocitnu depleciju.
English: EU/1/18/1299/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1299/001
English: NE (0.4, 29.5)
Croatian: NP (0,4; 29,5)
English: • Central venous access is recommended for the administration of YESCARTA.
Croatian: • Za primjenu lijeka YESCARTA preporučuje se centralni venski pristup.
English: Febrile neutropenia has been observed in patients after YESCARTA infusion (see section 4.8) and may be concurrent with CRS.
Croatian: Nakon infuzije lijeka YESCARTA u bolesnika je opažena febrilna neutropenija (vidjeti dio 4.8) koja se može pojaviti istodobno s CRS-om.
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.
Croatian: PRAC smatra da je informacije o lijeku za aksikaptagen ciloleucel potrebno izmijeniti kako bi odražavale rizik za razvoj disfagije povezan s terapijom aksikaptagen ciloleucelom.
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.
Croatian: Bolesnici s limfomom središnjeg živčanog sustava, alogeničnom transplantacijom matičnih stanica u anamnezi ili s prethodnom terapijom anti-CD19 CAR ili drugom terapijom genetički modificiranim T-stanicama bili su isključeni.
English: At the 12-month follow-up analysis, 3 patients remained in CR 24 months after YESCARTA infusion.
Croatian: U analizi podataka nakon 12 mjeseci praćenja, u 3 se bolesnika CR zadržao 24 mjeseca nakon infuzije lijeka YESCARTA.
English: Before you are given YESCARTA you should tell your doctor if you:
Croatian: Prije nego što primite lijek YESCARTA liječnik će Vam:
English: • The YESCARTA bag must not be removed from the cassette if the information on the patientspecific label does not match the intended patient.
Croatian: • Vrećicu lijeka YESCARTA ne smije se izvaditi iz kazete ako podaci o bolesniku na naljepnici ne odgovaraju bolesniku kojemu je vrećica namijenjena.
English: YESCARTA must be administered in a qualified clinical setting.
Croatian: Lijek YESCARTA mora se primijeniti u za to kvalificiranom bolničkom okruženju.
English: YESCARTA 0.4 - 2 x 108 cells dispersion for infusion axicabtagene ciloleucel (CAR+ viable T cells)
Croatian: YESCARTA 0,4 - 2 x 108 stanica disperzija za infuziju aksikaptagen ciloleucel (CAR+ vijabilne T-stanice)
English: • After the first 10 days following the infusion, the patient should be monitored at the physician's discretion.
Croatian: • Po isteku prvih 10 dana nakon infuzije, bolesnika je potrebno pratiti prema odluci liječnika.
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.
Croatian: U analizi podataka nakon 24 mjeseca praćenja, na temelju modificirane populacije planirane za liječenje (rezultati nezavisnog povjerenstva za procjenu), stopa ORR-a zadržala se na 74%, a stopa CR-a na 54%.
English: The stability of YESCARTA upon completion of thawing is up to 3 hours at room temperature (20 ˚C to 25 °C).
Croatian: Nakon završenog odmrzavanja lijek YESCARTA stabilan je do 3 sata na sobnoj temperaturi (20 °C do 25 °C).
English: Treatment algorithms have been developed to ameliorate some of the CRS symptoms experienced by patients on YESCARTA.
Croatian: Izrađeni su algoritmi liječenja kako bi se ublažili neki simptomi CRS-a koji se pojave u bolesnika na terapiji lijekom YESCARTA.
English: Grade 3 or higher neutropenia (including febrile neutropenia), anaemia, and thrombocytopenia occurred in 80%, 45%, and 40% of patients, respectively.
Croatian: Neutropenija (uključujući febrilnu neutropeniju), anemija i trombocitopenija 3. ili višeg stupnja pojavile su se u 80%, 45% odnosno 40% bolesnika.
English: After you have been given YESCARTA Tell your doctor or nurse immediately if you have any of the following:
Croatian: Odmah se obratite liječniku ili medicinskoj sestri ako imate bilo što od sljedećeg:
English: • Check for hepatitis B, hepatitis C or HIV infection.
Croatian: • provjeriti imate li infekciju virusom hepatitisa B, hepatitisa C ili HIV-a
English: 17.4 (11.6, NE) 17.4 (11.6, NE) NE (12.8, NE)
Croatian: 17,4 (11,6; NP)
English: Sixty-six patients were evaluable for cell-of-origin classifications (germinal center B-cell type [GCB] or activated B-cell type [ABC]).
Croatian: Šezdeset šest bolesnika bilo je procjenjivo za klasifikacije prema staničnom podrijetlu (B-stanični limfom stanica germinativnog centra [GCB] ili aktivirani B-stanični limfom [ABC]), a od njih je 49 bolesnika imalo tip GCB, a 17 tip ABC.
English: • Paracetamol 500-1,000 mg given orally and diphenhydramine 12.5 to 25 mg intravenous or oral
Croatian: • Približno 1 sat prije infuzije lijeka YESCARTA preporučuje se peroralna primjena 500-1000 mg paracetamola i 12,5 do 25 mg difenhidramina intravenski ili oralno (ili ekvivalentno).
English: Grade 3 or higher neutropenia, thrombocytopenia, and anaemia present after Day 93 occurred in 11%, 7%, and 3% of patients, respectively.
Croatian: Neutropenija, trombocitopenija i anemija 3. ili višeg stupnja bile su prisutne nakon 93. dana u 11%, 7% odnosno 3% bolesnika.
English: • Gently agitate the bag during YESCARTA infusion to prevent cell clumping.
Croatian: • Tijekom infuzije vrećicu lijeka YESCARTA lagano protresite kako bi se spriječilo nakupljanje stanica.
English: Treatment algorithms have been developed to ameliorate the neurologic adverse reactions experienced by patients on YESCARTA.
Croatian: Izrađeni su algoritmi liječenja kako bi se ublažile neurološke nuspojave koje su se pojavile u bolesnika na terapiji lijekom YESCARTA.
English: • Verify that the patient's identity (ID) matches the patient identifiers on the YESCARTA cassette.
Croatian: • Provjerite odgovara li bolesnikov identitet (ID) identifikacijskim oznakama bolesnika na kazeti lijeka YESCARTA.
English: Dehydration Decreased appetite Hypophosphataemia Hyponatraemia Weight decrease
Croatian: Poremećaji metabolizma i prehrane vrlo često dehidracija smanjen apetit hipofosfatemija hiponatrijemija smanjenje tjelesne težine često hipokalcijemija hipoalbuminemija
English: The pregnancy status of women of child bearing potential must be verified before starting YESCARTA treatment.
Croatian: Status trudnoće u žena reproduktivne dobi mora biti potvrđen prije početka terapije lijekom
English: There is no experience of use of YESCARTA in patients with primary CNS lymphoma.
Croatian: Ne postoji iskustvo s primjenom lijeka YESCARTA u bolesnika s primarnim limfomom središnjeg živčanog sustava.
English: • Once thawed, YESCARTA is stable at room temperature (20 °C-25 °C) for up to 3 hours.
Croatian: • Nakon odmrzavanja lijek YESCARTA stabilan je na sobnoj temperaturi (20 °C do 25 °C) do 3 sata.
English: Do not infuse YESCARTA if the information on the patient-specific label does not match the intended patient.
Croatian: Lijek YESCARTA nemojte primijeniti ako podaci na naljepnici specifičnoj za bolesnika ne odgovaraju bolesniku u kojega ćete primijeniti lijek.
English: See the prescribing information for lymphodepleting chemotherapy for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy.
Croatian: Pojedinosti o potrebi učinkovite kontracepcije u bolesnika koji primaju kemoterapiju za limfocitnu depleciju vidjeti u informacijama o lijeku za kemoterapiju za limfocitnu depleciju.
English: A minimum of four doses of tocilizumab for use in the event of cytokine release syndrome (CRS) and emergency equipment must be available prior to infusion of YESCARTA.
Croatian: Prije primjene infuzije lijeka YESCARTA moraju biti dostupne najmanje četiri doze tocilizumaba za primjenu u slučaju sindroma otpuštanja citokina (engl. cytokine release syndrome, CRS), kao i oprema za hitne slučajeve.
English: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (CAR) with a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg.
Croatian: Autologne T-stanice transducirane retrovirusnim vektorom koji kodira anti-CD19 CD28/CD3-zeta kimerični antigenski receptor (CAR) s ciljnom dozom od 2 x 106 anti-CD19 CAR-pozitivnih vijabilnih
English: Patients with refractory disease to ≥ 2 prior lines of therapy
Croatian: Medijan broja prethodnih terapija (min; maks) Bolesnici s refraktornom bolesti do ≥ 2 prethodne linije terapije
English: Age (years) Median (min, max)
Croatian: Medijan (min; maks) Muški spol
English: • Prime the tubing with 0.9% sodium chloride solution (0.154 mmol sodium per mL) prior to infusion.
Croatian: • Prije infuzije napunite cijevi 0,9%-tnom otopinom natrijeva klorida (0,154 mmol natrija po ml).
English: The safety of immunisation with live viral vaccines during or following YESCARTA treatment has not been studied.
Croatian: Sigurnost cijepljenja živim virusnim cjepivima tijekom ili nakon liječenja lijekom YESCARTA nije ispitana.
English: No concurrent CRS
Croatian: Bez istodobnog CRS-a
English: ITT was defined as all patients who underwent leukapheresis; mITT was defined as all patients who received YESCARTA.
Croatian: Populacija planirana za liječenje (engl. intent-to-treat population, ITT) bila je definirana kao svi bolesnici kojima je provedena leukafereza, a modificirana populacija planirana za liječenje (engl. modified intent-to-treat population, mITT) kao svi bolesnici koji su primili lijek YESCARTA.
English: Patients should be monitored at least daily for 10 days at the qualified healthcare facility following infusion for signs and symptoms of neurologic toxicity.
Croatian: Bolesnike treba svakodnevno pratiti najmanje 10 dana nakon infuzije u kvalificiranoj bolničkoj ustanovi zbog moguće pojave znakova i simptoma neurološke toksičnosti.
English: After the first 10 days following the infusion, the patient should be monitored at the physician's discretion.
Croatian: Po isteku prvih 10 dana nakon infuzije bolesnika je potrebno pratiti prema odluci liječnika.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Cryostor CS10
English: Per Grade 2
Croatian: Kao za 2. stupanj
English: • Extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells.
Croatian: • izniman umor, slabost i nedostatak zraka, što mogu biti simptomi manjka eritrocita
English: Store frozen in vapour phase of liquid nitrogen ≤ -150˚C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati zamrznuto u plinovitoj fazi tekućeg dušika ≤ -150 °C.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija s lijekom YESCARTA.
English: Each patient specific single infusion bag of YESCARTA contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg body weight (range: 1 x 106 - 2 x 106 cells/kg), with a maximum of 2 x 108 anti-CD19 CAR T cells.
Croatian: Jedna vrećica za infuziju lijeka YESCARTA specifična za bolesnika sadrži disperziju anti-CD19 CAR T-stanica u približno 68 ml za ciljnu dozu od 2 x 106 anti-CD19 CAR-pozitivnih vijabilnih T-stanica/kg tjelesne mase (raspon: 1 x 106 - 2 x 106 stanica/kg), s najviše 2 x 108 anti-CD19 CAR T-stanica.
English: Each patient-specific single infusion bag contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg.
Croatian: Jedna vrećica za infuziju specifična za bolesnika sadrži disperziju anti-CD19 CAR T-stanica u približno 68 ml za ciljnu dozu od 2 x 106 anti-CD19 CAR pozitivnih vijabilnih T-stanica/kg.
English: The MAH must ensure on-site, immediate access to 4 doses of tocilizumab for each patient as CRS management medication prior to treating patients.
Croatian: Nositelj odobrenja mora osigurati da su u bolničkoj ustanovi prije liječenja za svakog bolesnika odmah dostupne 4 doze tocilizumaba kao lijek za zbrinjavanje CRS-a.
English: Studies of YESCARTA in patients with hepatic and renal impairment were not conducted.
Croatian: Ispitivanja lijeka YESCARTA u bolesnika s oštećenjem jetrene i bubrežne funkcije nisu provedena.
English: Any unused medicine or waste material must be disposed of in accordance with local biosafety guidelines.
Croatian: Neiskorišteni lijek ili otpadni materijal mora se zbrinuti sukladno nacionalnim smjernicama za biološku sigurnost.
English: Provide intensive-care supportive therapy for severe or lifethreatening neurologic toxicities.
Croatian: U slučaju teških ili opasnih po život neuroloških toksičnosti provedite potpornu terapiju intenzivne skrbi.
English: Patient DOB:
Croatian: Dob (godine)
English: There is limited experience with YESCARTA in patients exposed to prior CD19-directed therapy.
Croatian: Iskustva s primjenom lijeka YESCARTA u bolesnika koji su ranije primali terapiju usmjerenu protiv CD19 su ograničena.
English: Screening for HBV, HCV, and HIV should be performed in accordance with clinical guidelines before collection of cells for manufacturing of YESCARTA.
Croatian: Prije prikupljanja stanica za proizvodnju lijeka YESCARTA potrebno je provesti testiranje na HBV, HCV i HIV u skladu s kliničkim smjernicama.
English: - Inflammation and swelling of spinal cord which may cause partial or total paralysis of limbs and torso.
Croatian: Manje česte (mogu se pojaviti u do 1 na 100 osoba) upala i oticanje leđne moždine što može izazvati djelomičnu ili potpunu paralizu udova i trupa.
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Croatian: Neiskorišteni lijek mora se zbrinuti sukladno nacionalnim smjernicama za biološku sigurnost.
English: Counsel patients to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion and to seek immediate medical attention should signs or symptoms of neurologic toxicity occur.
Croatian: Bolesnicima savjetujte da još najmanje 4 tjedna nakon infuzije ostanu u blizini kvalificirane bolničke ustanove i da odmah potraže medicinsku pomoć ako primijete znakove ili simptome neurološke toksičnosti.
English: How to store YESCARTA
Croatian: Kako čuvati lijek YESCARTA
English: Pre-medication
Croatian: LIJEKA
English: • Verify the patient ID again to match the patient identifiers on the YESCARTA bag.
Croatian: • Ponovno potvrdite identitet bolesnika koji mora odgovarati identifikacijskim oznakama bolesnika na vrećici lijeka YESCARTA.
English: Store frozen in vapour phase of liquid nitrogen ≤ -150 °C until thawed for use.
Croatian: Čuvajte zamrznuto u plinovitoj fazi tekućeg dušika na temperaturi od ≤ -150 °C do odmrzavanja radi primjene.
English: See section 4.4 for management guidance.
Croatian: Smjernice za liječenje vidjeti u dijelu 4.4.
English: Non-sedating, anti-seizure medicines should be considered as clinically indicated for Grade 2 or higher adverse reactions.
Croatian: Za nuspojave 2. ili višeg stupnja potrebno je razmotriti primjenu lijekova protiv napadaja koji nemaju sedacijski učinak, kako je klinički indicirano.