natgillin/translations-raw huggingface dataset:
Upon binding to CD19-expressing cells, the CAR transmits a signal promoting T-cell expansion and persistence of tisagenlecleucel.
Nakon vezanja za stanice koje eksprimiraju CD19, CAR odašilje signal koji potiče ekspanziju T-stanica i perzistentnost tisagenlekleucela.
The CAR is comprised of a murine single chain antibody fragment which recognises CD19 and is fused to intracellular signalling domains from 4-1BB (CD137) and CD3 zeta.
CAR se sastoji od jednolančanog fragmenta mišjeg protutijela koji prepoznaje CD19 i spojen je s intracelularnim signalnim domenama iz 4-1BB (CD137) i CD3 zeta.
In adult DLBCL patients (Study C2201), tisagenlecleucel has been detected for up to 2 years in peripheral blood and up to month 9 in bone marrow for complete responder patients.
U odraslih bolesnika s DLBCL-om (ispitivanje C2201), tisagenlekleucel je bio dokazan u razdoblju do 2 godine u perifernoj krvi te do 9. mjeseca u koštanoj srži bolesnika s potpunim odgovorom.
Of four patients with active CNS leukaemia (i.e. CNS-3) included in study B2101J, three experienced cytokine release syndrome (Grade 2-4) and transient neurological abnormalities (Grade 1-3) that resolved within 1-3 months of infusion.
Od četvero bolesnika s aktivnom leukemijom SŽS-a (tj. SŽS-3) uključenih u ispitivanje B2101J, u troje se razvio sindrom otpuštanja citokina (2.-4. stupnja) i prolazni neurološki poremećaji (1.-3. stupnja) koji su se povukli u roku od 1-3 mjeseca od infuzije.
Patient leukapheresis material and Kymriah may carry a risk of transmitting infectious viruses to healthcare professionals handling the product.
Bolesnikov pripravak dobiven leukaferezom i Kymriah mogu uključivati rizik prenošenja zaraznih virusa zdravstvenim radnicima koji rukuju lijekom.
Cytokine release syndrome was graded with the Penn scale as follows: Grade 1: mild reactions, e.g. reactions requiring supportive care; Grade 2: moderate reactions, e.g. reactions requiring intravenous therapies; Grade 3: severe reactions, e.g. reactions requiring low-dose vasopressors or supplemental oxygen; Grade 4: life-threatening reactions, e.g. those requiring high-dose vasopressors or intubation; Grade 5: death.
1. stupanj: blage reakcije, npr. reakcije koje zahtijevaju suportivnu skrb; 2. stupanj: umjerene reakcije, npr. reakcije koje zahtijevaju intravenske terapije; 3. stupanj: teške reakcije, npr. reakcije koje zahtijevaju vazopresore u niskoj dozi ili dodatni kisik; 4. stupanj: reakcije opasne po život, npr. one koje zahtijevaju vazopresore u visokoj dozi ili intubaciju; 5. stupanj: smrt.
The blood to bone marrow partitioning of tisagenlecleucel in bone marrow was 47.2% of that present in blood at day 28 while at months 3 and 6 it distributes at 68.3% and 69%, respectively (Studies B2202 and B2205J).
Tisagenlekleucel se raspodijelio između krvi i koštane srži tako da je u koštanoj srži 28. dana bilo 47,2% tisagenlekleucela prisutnog u krvi, dok je u 3., odnosno 6. mjesecu iznosio 68,3%, odnosno 69% (ispitivanja B2202 i B2205J).
- Active graft-versus-host disease (GVHD).
- Aktivna reakcija presatka protiv primatelja (engl. graft-versus-host disease, GVHD).
In the event of febrile neutropenia, infection should be evaluated and managed appropriately with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated.
U slučaju febrilne neutropenije, infekciju je potrebno evaluirati i primjereno zbrinuti antibioticima širokog spektra, infuzijskim otopinama i drugom suportivnom skrbi, sukladno medicinskim indikacijama.
Management of cytokine release syndrome associated with Kymriah Cytokine release syndrome is managed solely based on clinical presentation and according to the cytokine release syndrome management algorithm provided in Table 1.
Zbrinjavanje sindroma otpuštanja citokina povezanog s lijekom Kymriah Sindrom otpuštanja citokina se zbrinjava isključivo na temelju kliničke prezentacije i prema algoritmu za zbrinjavanje sindroma otpuštanja citokina navedenom u Tablici 1.
The safety and efficacy of Kymriah treatment in paediatric and young adult patients with relapsed or refractory (r/r) B-cell ALL were evaluated in one pivotal (B2202) and two supportive (B2205J and B2101J) open-label, single-arm studies (160 patients in total, up to 25 years of age).
Sigurnost i djelotvornost terapije lijekom Kymriah u pedijatrijskih i mladih odraslih bolesnika s recidivirajućim ili refraktornim (r/r) ALL-om B-stanica bile su ocijenjene u jednom pivotalnom (B2202) i dva potporna (B2205J i B2101J) otvorena ispitivanja s jednom skupinom (ukupno 160 bolesnika u dobi do 25 godina).
Kymriah is for intravenous use only.
Način primjene Kymriah je namijenjen samo za intravensku primjenu.
In the ongoing clinical study in DLBCL (N=111), cytokine release syndrome was reported in 58% of patients, (22% with Grade 3 or 4).
U kliničkom ispitivanju koje je u tijeku za DLBCL (N=111), sindrom otpuštanja citokina je bio prijavljen u 58% bolesnika, (22% s 3. ili 4. stupnjem).
Treatment-induced anti-mCAR19 antibodies were shown in 34.6% of paediatric and young adult ALL and 5% of adult DLBCL patients.
Liječenjem inducirana anti-mCAR19 protutijela dokazana su u 34,6% pedijatrijskih i mladih odraslih bolesnika s ALL-om te u 5% odraslih bolesnika s DLBCL-om.
• Pale skin, weakness, breathlessness
• Blijeda koža, slabost, nedostatak zraka
Kymriah has major influence on the ability to drive and use machines.
Lijek Kymriah značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The MAH shall ensure that in each Member State where KYMRIAH is marketed, all HCPs who are expected to prescribe, dispense annd administer KYMRIAH shall be provided with a guidance document to: - facilitate identification of CRS and serious neurological adverse reactions - facilitate management of the CRS and serious neurological adverse reactions - ensure adequate monitoring of CRS and serious neurological 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
Nositelj odobrenja dužan je osigurati da u svakoj državi članici u kojoj je KYMRIAH u prometu, svi zdravstveni radnici za koje se očekuje da će propisivati, izdavati i primjenjivati lijek KYMRIAH dobiju dokument sa smjernicama kako bi se: - olakšalo prepoznavanje sindroma otpuštanja citokina i ozbiljnih neuroloških nuspojava - olakšalo zbrinjavanje sindroma otpuštanja citokina i ozbiljnih neuroloških nuspojava - osiguralo odgovarajuće praćenje sindroma otpuštanja citokina i ozbiljnih neuroloških nuspojava - olakšalo davanje svih relevantnih informacija bolesnicima - osiguralo da se nuspojave primjereno i pravilno prijave - osiguralo da se daju detaljne upute o postupku odmrzavanja - prije liječenja bolesnika, u bolničkoj ustanovi osigurala dostupnost 4 doze tocilizumaba za svakog bolesnika
CRi (complete remission with incomplete blood count recovery) was defined as <5% of blasts in the bone marrow, circulating blasts in blood should be <1%, no evidence of extramedullary disease, and without full recovery of peripheral blood counts with or without blood transfusion.
CRi (potpuna remisija s nepotpunim oporavkom krvne slike) bio je definiran kao <5% blasta u koštanoj srži, cirkulirajući blasti u krvi trebaju biti <1%, bez dokaza ekstramedularne bolesti te bez potpunog oporavka periferne krvne slike s transfuzijom ili bez nje.
Administer antipyretics, oxygen, intravenous fluids and/or low-dose vasopressors as needed.
Primijeniti antipiretike, kisik, infuzijske otopine i/ili vazopresore u niskoj dozi prema potrebi.
Tumour necrosis factor (TNF) antagonists are not recommended for management of Kymriah-associated cytokine release syndrome.
Antagonisti faktora nekroze tumora (TNF) ne preporučuju se za zbrinjavanje sindroma otpuštanja citokina povezanog s lijekom Kymriah.
The efficacy of Kymriah was evaluated through the primary endpoint of best overall response rate (ORR), which includes complete response (CR) and partial response (PR) as determined by Independent Review Committee (IRC) assessment as well as secondary endpoints including duration of response (Table 6).
Djelotvornost lijeka Kymriah ocjenjivala se pomoću mjere primarnog ishoda u vidu najbolje ukupne stope odgovora (engl. overall response rate, ORR), koja uključuje potpuni odgovor (CR) i djelomični odgovor (PR) prema procjeni Neovisnog povjerenstva za ocjenjivanje (IRC), kao i pomoću mjera sekundarnog ishoda koje uključuju trajanje odgovora (Tablica 6).
If you have leukaemia this might include fever, feeling weak, bleeding gums, bruising.
Ako imate leukemiju to može uključivati vrućicu, osjećaj slabosti, krvarenje desni, stvaranje modrica.
• Diffuse large B-cell lymphoma (DLBCL) - another form of cancer that affects some types of white blood cells, mostly in the lymph nodes.
• Difuznog B-velikostaničnog limfoma (DLBCL) - drugi oblik raka koji zahvaća neke vrste leukocita, uglavnom u limfnim čvorovima.
Kymriah is for autologous use only.
Kymriah je namijenjen samo za autolognu primjenu.
Table 8 Cellular kinetic parameters of tisagenlecleucel in r/r DLBCL patients by clinical response at month 3
Tablica 8 Parametri kinetike stanica tisagenlekleucela u bolesnika s r/r DLBCL-om prema kliničkom odgovoru u 3. mjesecu
There is no experience with manufacturing Kymriah for patients with a positive test for active HBV, HCV or HIV.
Trenutačno nema iskustva s proizvodnjom lijeka Kymriah za bolesnike s pozitivnim testom na aktivni HBV, HCV ili HIV.
For special precautions for disposal see section 6.6.
Za posebne mjere opreza kod odlaganja vidjeti dio 6.6.
Giving blood to make Kymriah Kymriah is made from your own white blood cells.
Davanje krvi za pripravljanje lijeka Kymriah Kymriah se pripravlja od Vaših leukocita.
Encephalopathy includes depressed level of consciousness, mental status changes, automatism, cognitive disorder, confusional state, disturbance in attention, encephalopathy, posterior reversible encephalopathy syndrome, somnolence, lethargy, memory impairment, metabolic encephalopathy and thinking abnormal.
Encefalopatija uključuje sniženu razinu svijesti, promjene mentalnog stanja, automatizam, kognitivni poremećaj, stanje konfuzije, poremećaj pozornosti, encefalopatiju, sindrom posteriorne reverzibilne encefalopatije, somnolenciju, letargiju, narušeno pamćenje, metaboličku encefalopatiju i poremećeno razmišljanje.
Risk factors for developing severe cytokine release syndrome in adult DLBCL patients are not known.
Čimbenici rizika za razvoj teškog sindroma otpuštanja citokina u odraslih bolesnika s DLBCL-om nisu poznati.
The overall incidence (all grades) was 65% (unspecified 49%, viral 32%, bacterial 24% and fungal 15%) (see section 4.4).
Ukupna incidencija (svih stupnjeva) iznosila je 65% (neodređene 49%, virusne 32%, bakterijske 24% i gljivične 15%) (vidjeti dio 4.4).
In DLBCL patients severe infections (Grade 3 and higher), which can be life-threatening or fatal, occurred in 32% of patients.
U bolesnika s DLBCL-om teške infekcije (3. i višeg stupnja), koje mogu biti opasne po život ili smrtonosne, pojavile su se u 32% bolesnika.
Intravenous use Do not use leukocyte depleting filter.
Intravenski Ne koristiti filtar za leukocitnu depleciju.
Table 7 Cellular kinetic parameters of tisagenlecleucel in paediatric and young adult r/r B-cell ALL (Studies B2202 and B2205J)
Tablica 7 Parametri kinetike stanica tisagenlekleucela u pedijatrijskih i mladih odraslih bolesnika s r/r ALL-om B-stanica (ispitivanja B2202 i B2205J)
All contents of the infusion bags should be infused.
Potrebno je infundirati cjelokupni sadržaj vrećica za infuziju.
Ischaemic cerebral infarction
Ishemijski moždani udar
The majority of patients who had cytopenias at day 28 following Kymriah treatment resolved to Grade 2 or below within three months after treatment.
U većine bolesnika koji su bili citopenični 28. dan nakon terapije lijekom Kymriah, unutar tri mjeseca nakon liječenja došlo je do smanjenja citopenije na 2. ili niži stupanj.
43% of the patients experienced an infection of any type within 8 weeks after Kymriah infusion.
U 43% bolesnika razvila se neka infekcija bilo kojeg tipa u roku od 8 tjedana od infuzije lijeka Kymriah.
Disseminated intravascular coagulation
Diseminirana intravaskularna koagulacija
There is limited evidence that race/ethnicity impact the expansion of Kymriah in paediatric and young adult ALL and DLBCL patients.
Postoje ograničeni dokazi da rasa/etničko podrijetlo utječu na ekspanziju lijeka Kymriah u pedijatrijskih i mladih odraslih bolesnika s ALL-om i DLBCL-om.
Grade 3 and 4 adverse reactions were more often observed within the initial 8 weeks post-infusion (85%) compared to after 8 weeks post-infusion (49%).
Nuspojave 3. i 4. stupnja češće su zabilježene u prvih 8 tjedana nakon infuzije (85%) u usporedbi s razdobljem poslije 8. tjedna nakon infuzije (49%).
Carcinogenicity and mutagenicity
Kancerogenost i mutagenost
This medicine contains genetically-modified blood cells.
Ovaj lijek sadrži genetički modificirane krvne stanice.
If there is a delay of more than 4 weeks between completing lymphodepleting chemotherapy and the infusion and the WBC count is >1,000 cells/μL, then the patient should be re-treated with lymphodepleting chemotherapy prior to receiving Kymriah.
Ako razmak između završetka kemoterapije za limfocitnu depleciju i infuzije bude više od 4 tjedna, a broj leukocita je >1000 stanica/μL, bolesnik treba ponovno primiti kemoterapiju za limfocitnu depleciju prije nego što primi lijek Kymriah.
The product should be administered immediately after thawing.
Lijek je potrebno odmah primijeniti nakon odmrzavanja.
Oedema includes oedema peripheral, generalised oedema, localised oedema and face oedema.
Edem uključuje periferni edem, generalizirani edem, lokalizirani edem i edem lica.
Additional organ system adverse reactions, including transient cardiac insufficiency and arrhythmia, renal insufficiency, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT) and elevated bilirubin have been observed.
Opažene su nuspojave koje zahvaćaju druge organske sustave, uključujući prolaznu srčanu insuficijenciju i aritmiju, bubrežnu insuficijenciju, povišenu aspartat aminotransferazu (AST), povišenu alanin aminotransferazu (ALT) i povišeni bilirubin.
Signs and symptoms of TLS should be monitored and events managed according to standard guidelines.
Potrebno je pratiti znakove i simptome TLS-a te zbrinuti događaje prema standardnim smjernicama.
Administration of low-dose steroids as per the cytokine release syndrome treatment algorithm does not impact the expansion and persistence of CAR-T cells.
Primjena niske doze steroida prema algoritmu liječenja sindroma otpuštanja citokina ne utječe na ekspanziju i perzistentnost CAR T-stanica.
- Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it. - Always show the Patient Alert Card to the doctor or nurse when you see them or if you go to hospital.
- Uvijek pokažite karticu s upozorenjima za bolesnika liječniku ili medicinskoj sestri pri svakom posjetu liječniku ili odlasku u bolnicu.
• B-cell acute lymphoblastic leukaemia (B-cell ALL) - a form of cancer that affects some other types of white blood cells.
• Akutne limfoblastične leukemije B-stanica (ALL B-stanica) - oblik raka koji zahvaća neke druge vrste leukocita.
Grade 3 and 4 adverse reactions were reported in 89% of patients.
Nuspojave 3. i 4. stupnja bile su zabilježene u 89% bolesnika.
Abdominal compartment syndrome
Sindrom abdominalnog odjeljka
Kymriah intravenous infusion should be administered by a healthcare professional experienced with immunosuppressed patients and prepared to manage anaphylaxis.
Intravensku infuziju lijeka Kymriah mora primijeniti zdravstveni radnik koji ima iskustva s imunosuprimiranim bolesnicima i koji je osposobljen za postupanje u slučaju anafilaksije.
Severe febrile neutropenia (Grade 3 or 4) was observed in 36% of paediatric and young adult B-cell ALL patients and 15% of DLBCL patients.
Teška febrilna neutropenija (3. ili 4. stupnja) bila je opažena u 36% pedijatrijskih i mladih odraslih bolesnika s ALL-om B-stanica te u 15% bolesnika s DLBCL-om.
Grade 3 and 4 adverse reactions were more often observed within the initial 8 weeks post-infusion (83% of patients) compared to after 8 weeks post-infusion (46% of patients).
Nuspojave 3. i 4. stupnja češće su opažene tijekom prvih 8 tjedana nakon infuzije (83% bolesnika) u usporedbi s razdobljem poslije 8. tjedna nakon infuzije (46% bolesnika).
Women who are breast-feeding should be advised of the potential risk to the breast-fed infant.
Žene koje doje potrebno je upozoriti na mogući rizik za dojenče.
Tachycardia includes sinus tachycardia and tachycardia.
Tahikardija uključuje sinusnu tahikardiju i tahikardiju.
To minimise risk of TLS, patients with elevated uric acid or high tumour burden should receive allopurinol, or an alternative prophylaxis, prior to Kymriah infusion.
Da bi se smanjio rizik od TLS-a, bolesnici s povišenom mokraćnom kiselinom ili visokim opterećenjem tumorom trebaju primati alopurinol ili drugu profilaksu prije infuzije lijeka Kymriah.
Kymriah should be administered as an intravenous infusion through latex-free intravenous tubing without a leukocyte depleting filter, at approximately 10 to 20 mL per minute by gravity flow.
Kymriah se mora primijeniti kao intravenska infuzija gravitacijskom metodom kroz set za infuziju bez lateksa i bez filtera za leukocitnu depleciju, brzinom od otprilike 10 do 20 mL u minuti.
Febrile neutropenia was frequently observed in patients after Kymriah infusion (see section 4.8) and may be concurrent with cytokine release syndrome.
Febrilna neutropenija učestalo je opažena u bolesnika nakon infuzije lijeka Kymriah (vidjeti dio 4.8) i može se javiti istodobno sa sindromom otpuštanja citokina.
Kymriah can cause problems such as altered or decreased consciousness, confusion and seizures (fits) in the 8 weeks following infusion.
Kymriah može izazvati probleme poput izmijenjene ili smanjene svijesti, smetenosti i epileptičkih napadaja tijekom 8 tjedana nakon primanja lijeka Kymriah.
If the infusion bag appears to have been damaged or to be leaking, it should not be infused and should be disposed of according to local biosafety procedures.
Ako vrećica za infuziju izgleda kao da je oštećena ili curi, ne smije se infundirati već se mora zbrinuti sukladno nacionalnim smjernicama za biološku sigurnost.
Local biosafety guidelines should be followed for disposal.
Potrebno je slijediti nacionalne smjernice o biološkoj sigurnosti za zbrinjavanje.
• Abnormal blood test results (high level of: phosphorus, magnesium, an enzyme called alkaline phosphatase to help detect liver disease, fibrin d-dimer, serum ferritin; low level of: sodium)
• Odstupanja u rezultatima krvnih pretraga (visoka razina: fosfora, magnezija, enzima koji se naziva alkalna fosfataza koji pomaže otkriti bolest jetre, fibrin d-dimera, serumskog feritina;
Speech disorders includes speech disorders, dysarthria and aphasia.
Poremećaji govora uključuju poremećaje govora, dizartriju i afaziju.
Not reached (8.6, NE9) Not reached (8.6, NE)
Nije postignut (8,6; NE)
Updated reports: September 2019, November
Ažurirana izvješća: rujan 2019., studeni 2020.
Infused patients
Uključeni bolesnici
• Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
• odraslih bolesnika s recidivirajućim ili refraktornim difuznim B-velikostaničnim limfomom (DLBCL) nakon dvije ili više linija sistemske terapije.
Adverse drug reactions from these clinical studies (Table 2) are listed by MedDRA system organ class.
Nuspojave iz ovih kliničkih ispitivanja (Tablica 2) navedene su prema klasifikaciji organskih sustava iz Medicinskog rječnika za regulatorne poslove (MedDRA).
Contraindications of the lymphodepleting chemotherapy must be considered.
Potrebno je uzeti u obzir kontraindikacije za kemoterapiju za limfocitnu depleciju.
Prior stem-cell transplantation - n (%)
Prethodna transplantacija matičnih stanican (%)
Other side effects are listed below.
Druge nuspojave navedene su u nastavku.
Patients are counted only for the worst grade observed post baseline.
Bolesnici se broje samo za najgori stupanj uočen nakon početka ispitivanja.
Attention to signs and symptoms of infection should be implemented according to age and standard specific guidelines.
Potrebno je reagirati na znakove i simptome infekcije, sukladno dobi i standardnim specifičnim smjernicama.
• high fever and chills.
• visoka vrućica i zimica.
The safety and efficacy of Kymriah treatment in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who received ≥2 lines of chemotherapy, including rituximab and anthracycline, or relapsed following autologous haematopoietic stem cell transplantation (HSCT), was evaluated in an open-label, pivotal, single-arm study.
Sigurnost i djelotvornost liječenja lijekom Kymriah u odraslih bolesnika s recidivirajućim ili refraktornim (r/r) difuznim B-velikostaničnim limfomom (DLBCL) koji su primili ≥2 linije kemoterapije, uključujući rituksimab i antraciklin, ili imali relaps nakon autologne transplantacije krvotvornih matičnih stanica bile su ocijenjene u otvorenom, pivotalnom ispitivanju s jednom skupinom.
For storage conditions after thawing of the medicinal product, see section 6.3.
Uvjete čuvanja nakon odmrzavanja lijeka vidjeti u dijelu 6.3.
Haemoglobin decreased* Lymphocyte count decreased* White blood cell count decreased* Neutrophil count decreased* Platelet count decreased* Aspartate aminotransferase increased Alanine aminotransferase increased Blood bilirubin increased International normalised ratio increased
Sniženi hemoglobin* Sniženi broj limfocita* Sniženi broj leukocita* Sniženi broj neutrofila* Sniženi broj trombocita* Povišena aspartat aminotransferaza Povišena alanin aminotransferaza Povišeni bilirubin u krvi Povišeni internacionalni normalizirani omjer (INR)
Grade 3 and 4 adverse reactions were reported in 88% of patients.
Nuspojave 3. i 4. stupnja bile su zabilježene u 88% bolesnika.
Anti-IL-6 based therapy such as tocilizumab has been administered for moderate or severe cytokine release syndrome associated with Kymriah and a minimum of four doses of tocilizumab must be on site and available for administration prior to Kymriah infusion.
Terapija koja se temelji na blokiranju IL-6 kao što je tocilizumab primjenjivana je za umjereni ili teški sindrom otpuštanja citokina povezan s lijekom Kymriah te najmanje četiri doze tocilizumaba moraju biti u bolničkom centru prije infuzije lijeka Kymriah i dostupne za primjenu.
In B-cell ALL patients severe infections (Grade 3 and higher), which can be life-threatening or fatal, occurred in 44% of patients after Kymriah infusion.
U bolesnika s ALL-om B-stanica, teške infekcije (3. i višeg stupnja), koje mogu biti opasne po život ili smrtonosne, pojavile su se u 44% bolesnika nakon infuzije lijeka Kymriah.
Serious infections, including life-threatening or fatal infections, occurred frequently in patients after Kymriah infusion (see section 4.8).
Ozbiljne infekcije, uključujući one opasne po život ili smrtonosne, zabilježene su učestalo u bolesnika nakon infuzije lijeka Kymriah (vidjeti dio 4.8).
To inform and explain to patients: - the risks of CRS and serious neurological adverse reactions associated with KYMRIAH - the need to report the symptoms to their treating doctor immediately - the need to remain in the proximity of the location where KYMRIAH was received for at least
Za informiranje i pružanje objašnjenja bolesnicima o: - rizicima od sindroma otpuštanja citokina i ozbiljnih neuroloških nuspojava povezanima s lijekom KYMRIAH - potrebi prijavljivanja simptoma svome liječniku bez odgađanja - potrebi da ostanu u blizini bolnice u kojoj su primili lijek KYMRIAH tijekom najmanje 4 tjedna nakon infuzije lijeka - potrebi da uvijek sa sobom nose karticu s upozorenjima za bolesnika