FrancophonIA/ELRC3.0 huggingface dataset:
English: • after treatment while the immune system is recovering.
Slovenian: • po zdravljenju v času okrevanja imunskega sistema.
English: Effects of Kymriah on male and female fertility have not been evaluated in animal studies.
Slovenian: Vpliva zdravila Kymriah na plodnost pri moških in ženskah niso ocenjevali v študijah na živalih.
English: Updated reports: September 2019, November
Slovenian: Dopolnjena poročila: september 2019, november
English: • Check if your cancer is getting worse.
Slovenian: • preveril, ali se vaš rak poslabšuje,
English: This is because other medicines can affect the way Kymriah works.
Slovenian: To je pomembno zato, ker druga zdravila lahko vplivajo na delovanje zdravila Kymriah.
English: • Excessive sweating, night sweats
Slovenian: • prekomerno znojenje, nočno znojenje,
English: • Red or purple spots under the skin
Slovenian: • rdeče ali vijolične pike pod kožo,
English: One individual treatment dose comprises 1 to 3 infusion bags.
Slovenian: En terapevtski odmerek za posameznika obsega 1 do 3 infuzijske vrečke.
English: Package leaflet: Information for the patient or carer
Slovenian: Navodilo za uporabo: informacije za bolnika ali negovalca
English: These symptoms almost always occur within the first 10 days after infusion.
Slovenian: Ti simptomi se skoraj vedno pojavijo v prvih 10 dneh po prejemu infuzije zdravila.
English: - The information in this leaflet is for you or your child - but in the leaflet it will just say “you”.
Slovenian: - Informacije v tem navodilu za uporabo so namenjene vam ali vašemu otroku, vendar nadaljnje besedilo vsebuje samo obliko, ki se nanaša na "vas".
English: Test and checks
Slovenian: Preiskave in pregledi
English: If you have any questions about how Kymriah works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate kakršna koli vprašanja glede tega, kako zdravilo Kymriah deluje ali zakaj so vam ga predpisali, se obrnite na svojega zdravnika.
English: Do not thaw the product until it is ready to be used.
Slovenian: Zdravila ne odmrzujte, dokler ni predvideno za uporabo.
English: Your doctor will recommend that you return to the hospital daily for at least 10 days and will consider whether you need to stay at the hospital as an in-patient for the first 10 days after infusion.
Slovenian: Zdravnik vam bo priporočil, da najmanj 10 dni vsakodnevno prihajate v bolnišnico na pregled, poleg tega pa bo razmislil, ali bi bilo pri vas potrebno, da bi vas za prvih 10 dni po infuziji sprejeli v bolnišnico.
English: A genomic insertion site analysis of the lentiviral vector was performed on Kymriah products from 14 individual donors (12 patients and 2 healthy volunteers).
Slovenian: Genomsko analizo insercijskega mesta lentivirusnega vektorja so opravili na pripravkih zdravila Kymriah, ki so jih pridobili od 14 posameznih darovalcev (12 bolnikov in 2 zdravih prostovoljcev).
English: T½ (day)
Slovenian: T½ (število dni)
English: Tmax (day)
Slovenian: Tmax (število dni)
English: • You notice the symptoms of your cancer are getting worse.
Slovenian: • če opazite simptome poslabšanja vašega raka.
English: • Signs and symptoms of blood clots
Slovenian: • znaki in simptomi krvnih strdkov,
English: Do not drive, use machines, or take part in activities that need you to be alert for.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne vozite, ne upravljajte strojev in ne izvajajte dejavnosti, pri katerih morate biti pozorni.
English: Store in the original protective envelope (Tyvek) containing the cassette protecting the infusion bag.
Slovenian: Shranjujte v originalni zaščitni ovojnici (Tyvek), ki vsebuje kaseto za zaščito infuzijske vrečke.
English: Final report of study results: December 2038
Slovenian: Končno poročilo z rezultati študije: december 2038
English: Duration of response (DOR)
Slovenian: Trajanje odziva (DOR)
English: Approximately 30% of patients discontinued the study prior to Kymriah administration.
Slovenian: Približno 30 % bolnikov je prekinilo sodelovanje v študiji pred prejemom zdravila Kymriah.
English: Precautions to be taken for transport and disposal of the medicinal product
Slovenian: Previdnostni ukrepi pri transportu in odstranjevanju zdravila
English: Overall remission rate (ORR)
Slovenian: Celokupna stopnja remisije (ORR)
English: Women of childbearing potential/Contraception in males and females
Slovenian: Ženske v rodni dobi / kontracepcija pri moških in ženskah
English: Patients should be monitored for signs and symptoms of infection and treated appropriately.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov okužbe in jih ustrezno zdraviti.
English: In all indications, appropriate prophylactic and therapeutic treatment for infections should be provided, and complete resolution of any existing infections should be ensured.
Slovenian: Pri vseh indikacijah je treba zagotoviti ustrezno profilakso in zdravljenje okužb ter obstoječe okužbe popolnoma odpraviti.
English: 11.7 (6.6, NE)
Slovenian: 11,7 (6,6, NMO)
English: There is no evidence that the presence of pre-existing and treatment-induced anti-mCAR19 antibodies impacts the safety or effectiveness of Kymriah.
Slovenian: Nobenih znakov ni, da bi predhodno prisotna ali z zdravljenjem povzročena protitelesa anti-mCAR19 vplivala na varnost ali učinkovitost zdravila Kymriah.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, kar vključuje tudi zdravila, ki jih dobite brez zdravniškega recepta.
English: Genotoxicity assays and carcinogenicity studies in rodents are not appropriate to assess the risk of insertional mutagenesis for genetically-modified cell therapy products.
Slovenian: Testi genotoksičnosti in študije kancerogenosti pri glodalcih niso primerni za oceno tveganja za insercijsko mutagenezo pri gensko spremenjenih celičnih zdravilih.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: not yet assigned
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: še ni bila dodeljena
English: Common: may affect up to 1 in every 10 people
Slovenian: Pogosti: lahko prizadenejo največ 1 od 10 oseb
English: Before you are given Kymriah tell your doctor or nurse if you are taking any medicines that weaken your immune system such as corticosteroids, since these medicines may interfere with the effect of Kymriah.
Slovenian: Preden prejmete zdravilo Kymriah, morate zdravniku ali medicinski sestri povedati, če jemljete kakršnakoli zdravila, ki zavirajo delovanje imunskega sistema, kot so kortikosteroidi, ker ta zdravila lahko vplivajo na delovanje zdravila Kymriah.
English: Educational programme
Slovenian: Izobraževalni program
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: V vsaki skupini po organskem sistemu so neželeni učinki razvrščeni po pogostnosti, pri čemer so najpogostejši učinki navedeni najprej, in sicer po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Patients with active, uncontrolled infection should not start Kymriah treatment until the infection is resolved.
Slovenian: Pri bolnikih z aktivno oziroma neobvladano okužbo se ne sme začeti zdravljenja z zdravilom Kymriah, dokler okužba ni odpravljena.
English: AUC0-28d (copies/μg*day)
Slovenian: AUC0-28d (število kopij/μg*število dni)
English: Table 2 Adverse drug reactions observed in clinical studies
Slovenian: Preglednica 2 Neželeni učinki zdravila, ki so jih opažali v kliničnih študijah
English: What Kymriah is and what it is used for
Slovenian: Kaj je zdravilo Kymriah in za kaj ga uporabljamo
English: • Check your lungs, heart and blood pressure.
Slovenian: • pregledal vaša pljuča in srce ter vam izmeril krvni tlak,
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, naj najmanj 4 tedne po prejemu infuzije ostanejo v bližini kvalificiranega terapevtskega centra.
English: In Study C2201 there were 88% Caucasian, 5% Asian, 4% Black or African American patients, and 3 patients (3%) of unknown race.
Slovenian: V študiji C2201 je bilo 88 % belcev, 5 % bolnikov azijske rase, 4 % bolnikov črne ali afriško-ameriške rase in 3 bolniki (3 %) neznane rasne pripadnosti.
English: They should be monitored life-long for secondary malignancies.
Slovenian: Bolnike je treba doživljenjsko spremljati glede pojavljanja sekundarnih malignomov.
English: Disease status (%) Primary refractory1
Slovenian: Status bolezni (%) primarno neodzivna1 recidivna bolezen2
English: Availability of tocilizumab and site qualification
Slovenian: Dostopnost tocilizumaba in kvalificiranost terapevtskega centra
English: The patient's identity should be matched with the patient identifiers on the infusion bag.
Slovenian: Bolnikova identiteta se mora ujemati z identifikacijskimi podatki bolnika na infuzijski vrečki.
English: Acute lymphoblastic leukaemia (ALL)
Slovenian: Akutna limfoblastna levkemija (ALL)
English: In addition to T cells, NK cells may be present.
Slovenian: Poleg celic T so lahko prisotne tudi celice naravne ubijalke (celice NK).
English: Other medicines and Kymriah
Slovenian: Druga zdravila in zdravilo Kymriah
English: Median (months) (95% CI)
Slovenian: mediana (meseci) (95-odstotni IZ)
English: • Failure of multiple organs
Slovenian: • odpoved delovanja več organov,
English: In the event that a secondary malignancy occurs, the company should be contacted to obtain instructions on patient samples to collect for testing.
Slovenian: Če pride do razvoja sekundarnega malignoma, je treba kontaktirati farmacevtsko družbo in pridobiti navodila za odvzem bolnikovih vzorcev za preiskave.
English: In patients achieving complete remission following Kymriah, resulting low immunoglobulin levels can increase the risk for infections.
Slovenian: Pri bolnikih, ki po prejemu zdravila Kymriah dosežejo popolno remisijo, lahko posledična nizka raven imunoglobulinov poveča tveganje za okužbe.
English: This is because the effects of Kymriah in pregnant or breast-feeding women are not known, and it may harm your unborn baby or your newborn/infant.
Slovenian: To je potrebno zato, ker ne vemo, kakšne učinke ima zdravilo Kymriah pri nosečnicah in ženskah, ki dojijo, in bi morda lahko škodovalo nerojenemu, novorojenemu ali dojenemu otroku.
English: KYMRIAH will only be supplied to hospitals and associated centres that are qualified and only if the healthcare professionals involved in the treatment of a patient have completed the educational programme.
Slovenian: Dobava zdravila KYMRIAH bo zagotovljena samo tistim bolnišnicam in pridruženim terapevtskim centrom, ki so ustrezno kvalificirani, in samo v primeru, da so zdravstveni strokovnjaki, ki sodelujejo pri zdravljenju bolnikov, opravili izobraževalni program.
English: Sleep disorder includes sleep disorder, insomnia and nightmare.
Slovenian: Izraz motnje spanja vključuje motnje spanja, nespečnost in nočne more.
English: Response at month 3
Slovenian: Odziv po 3 mesecih
English: Your doctor will check if you have signs or symptoms of graft-versus-host disease.
Slovenian: Zdravnik bo preveril, ali so pri vas prisotni znaki ali simptomi reakcije presadka proti gostitelju.
English: What you need to know before you are given Kymriah
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Kymriah
English: Early Tmax may not be representative of the true maximal expansion, rather the amount of transgene present in the catheter from which sample was collected.
Slovenian: Zgodnji odziv s kratkim Tmax morda ne predstavlja prave največje ekspanzije, ampak količino transgenskih celic, ki so prisotne v katetru pri odvzemu vzorca krvi.
English: Health-related quality of life (HRQoL) was evaluated by PedsQL™ and EQ-5D questionnaires completed by patients aged 8 years and above (n=58).
Slovenian: Z zdravjem povezano kakovost življenja (HRQoL - health-related quality of life) so vrednotili s pomočjo vprašalnikov PedsQL™ in EQ-5D, ki so ju izpolnjevali bolniki stari 8 let ali več (n=58).
English: It is unknown whether Kymriah cells are excreted in human milk.
Slovenian: Ni znano, ali se celice zdravila Kymriah izločajo v materino mleko.
English: The median time to resolution of cytokine release syndrome was 7 days.
Slovenian: Mediani čas za izzvenitev sindroma sproščanja citokinov je 7 dni.
English: Headache includes headache and migraine.
Slovenian: Izraz glavobol vključuje glavobol in migreno.
English: Response at month 6
Slovenian: Odziv po 6 mesecih
English: Infections may also occur during cytokine release syndrome and may increase the risk of a fatal event.
Slovenian: Okužbe se lahko pojavljajo tudi med potekom sindroma sproščanja citokinov in povečujejo tveganje za smrtni izid.
English: For clinical management of cytokine release syndrome, see section 4.4 and Table 1.
Slovenian: Za informacije o kliničnem obvladovanju sindroma sproščanja citokinov glejte poglavje 4.4 in preglednico 1.
English: Non-responding patients (NR) N=11
Slovenian: neodzivni bolniki (BO) N=11
English: There was no evidence for preferential integration near genes of concern or preferential outgrowth of cells harbouring integration sites of concern.
Slovenian: Pri tem niso opažali znakov za preferenčno integracijo blizu genov, ki bi bili lahko problematični, oziroma znakov za preferenčno razraščanje celic, ki vsebujejo problematična integracijska mesta.
English: • Tingling or numbness, also in fingers and toes
Slovenian: • mravljinčenje ali odrevenelost, tudi v prstih rok in nog,
English: Store and transport below -120°C; do not thaw the product until use.
Slovenian: Shranjujte in transportirajte pri temperaturi pod -120 °C; zdravila ne odmrzujte, dokler ni predvideno za uporabo.
English: Intravenous use Do not use leukocyte depleting filter.
Slovenian: intravenska uporaba Ne uporabljajte filtra za odstranjevanje levkocitov.
English: • Do not donate blood, organs, tissues or cells for transplants.
Slovenian: • ne darujte krvi, organov, tkiv ali celic za presaditev.
English: If you miss an appointment, call your doctor or the hospital as soon as possible to reschedule.
Slovenian: Če ne uspete priti na dogovorjeni obisk, čimprej pokličite zdravnika oziroma v bolnišnico in se dogovorite za nov datum.
English: Limit to a maximum total of 4 tocilizumab doses.
Slovenian: Bolniku smete skupno dati največ 4 odmerke tocilizumaba.
English: Corticosteroids should not be used at any time except in the case of a life-threatening emergency (see section 4.4).
Slovenian: Kortikosteroidov se ne sme uporabljati v nobenem primeru, razen v nujnem primeru, ko je ogroženo življenje bolnika (glejte poglavje 4.4).
English: ORR was consistent across all subgroups.
Slovenian: Celokupna stopnja remisije (ORR) je bila približno enaka pri vseh podskupinah.
English: • You have any lung, heart or blood pressure (low or raised) problems.
Slovenian: • če imate kakršne koli težave s pljuči, srcem ali krvnim tlakom (zvišanim ali znižanim);
English: 19.4 (14.8, NE)
Slovenian: 19,4 (14,8, NMO)
English: Each infusion bag is placed into an aluminum cassette, then put in a plastic overwrap bag with absorbent sheets and sealed in a protective envelope (Tyvek).
Slovenian: Vsaka infuzijska vrečka leži v aluminijasti kaseti, ki je zavita v plastični ovojni vrečki skupaj z absorbentnimi lističi in je neprodušno zaprta v zaščitni ovojnici (Tyvek).
English: Read all of this leaflet carefully before you (or your child) are given this medicine because it contains important information.
Slovenian: Pred začetkom prejemanja zdravila (ali preden zdravilo prejme vaš otrok) natančno preberite navodilo, ker vsebuje pomembne podatke!
English: Clinical assessment prior to infusion
Slovenian: Klinični pregled pred infundiranjem
English: The primary endpoint was analysed on all patients whose Kymriah was manufactured at the Novartis US facility.
Slovenian: primarni cilj opazovanja so analizirali na podatkih bolnikov, za katere so zdravilo Kymriah izdelali v Novartisovi enoti v ZDA.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kymriah in one or more subsets of the paediatric population in the following conditions: a) treatment of B-cell lymphoblastic lymphoma, and b) treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Kymriah za eno ali več skupin pediatrične populacije v naslednjih pogojih: a) za zdravljenje B-celičnega limfoblastnega limfoma in b) za zdravljenje novotvorb zrelih celic B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: To minimise potential acute infusion reactions, it is recommended that patients be pre-medicated with paracetamol and diphenhydramine or another H1 antihistamine within approximately 30 to 60 minutes prior to Kymriah infusion.
Slovenian: Za zmanjševanje možnosti za akutno infuzijsko reakcijo je priporočeno bolnike premedicirati s paracetamolom in difenhidraminom ali drugim H1 antihistaminikom v času približno 30 do 60 minut pred infundiranjem zdravila Kymriah.
English: 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.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom preden prejmete to zdravilo.
English: Warnings and precautions Kymriah is made from your own white blood cells and should only be given to you.
Slovenian: Opozorila in previdnostni ukrepi Zdravilo Kymriah je izdelano iz vaših lastnih levkocitov in ga smete prejeti samo vi.
English: This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially “potassium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na odmerek, kar v bistvu pomeni ‘brez kalija'.
English: If no response to second dose of tocilizumab, consider a third dose of tocilizumab or pursue alternative measures for treatment of cytokine release syndrome.
Slovenian: Če pri bolniku ne pride do odziva na drugi odmerek tocilizumaba, razmislite o tretjem odmerku tocilizumaba ali o uvedbi drugih ukrepov pri zdravljenju sindroma sproščanja citokinov.
English: To minimise the risks associated with KYMRIAH treatment, the MAH must ensure that hospitals and their associated centres that dispense KYMRIAH are specially qualified in accordance with the agreed control distribution programme.
Slovenian: Da bi kar najbolj zmanjšali tveganja, ki so povezana z zdravljenjem z zdravilom KYMRIAH, mora imetnik dovoljenja za promet z zdravilom zagotoviti, da so bolnišnice in pridruženi terapevtski centri, v katerih dajejo zdravilo KYMRIAH, posebej kvalificirani v skladu s sprejetim programom nadzora distribucije.
English: Overall response rate (ORR) (CR+PR)1, n (%) 95% CI
Slovenian: Celokupna stopnja odziva (ORR) (CR+PR)1, n (%) 95-odstotni IZ
English: 1Primary refractory: Never had a morphologic complete remission (CR) prior to the study; 2Relapsed disease: Had at least one relapse prior to the study
Slovenian: 1primarno neodzivna: pred študijo ni nikoli prišlo do morfološke popolne remisije (CR) 2recidivna bolezen: pred študijo je že prišlo do najmanj enega recidiva
English: There are no data on the effect of Kymriah on fertility.
Slovenian: Na voljo ni nobenih podatkov o vplivu zdravila Kymriah na plodnost.
English: There are not enough data to determine whether there are any differences in efficacy or safety between different age subgroups, although the clinical benefit and safety experience in elderly patients with DLBCL above the age of 65 years (23% of the study population) were comparable to the overall population.
Slovenian: Na voljo ni dovolj podatkov, da bi lahko ugotovili, ali med različnimi podskupinami po starosti obstajajo kakršnekoli razlike glede učinkovitosti in varnosti zdravila, čeprav so bile pri starejših bolnikih, ki so imeli difuzni velikocelični limfom B in so bili stari več kot 65 let, (23 % študijske populacije) klinične koristi in varnostne izkušnje podobne kot pri splošni populaciji.
English: Mean (standard deviation) Median (minimum - maximum) Age category (years) - n (%) <10 years ≥10 years and <18 years ≥18 years
Slovenian: Starostna skupina (leta) - n (%) <10 let ≥10 let in <18 let ≥18 let
English: • Low or raised blood pressure
Slovenian: • znižan ali zvišan krvni tlak,
English: Kymriah is for intravenous use only.
Slovenian: Zdravilo Kymriah je namenjeno samo intravenski uporabi.
English: In almost all cases, development of cytokine release syndrome occurred between 1 to 10 days (median onset 3 days) after Kymriah infusion.
Slovenian: V skoraj vseh primerih se je sindrom sproščanja citokinov razvil v času 1 do 10 dni (z začetkom mediano v 3 dneh) po infuziji zdravila Kymriah.
English: Store and transport below -120°C.
Slovenian: Shranjujte in transportirajte pri temperaturi, ki je nižja od -120 °C.
English: Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered.
Slovenian: Bolnike z medicinsko pomembno disfunkcijo srca je treba zdraviti v skladu s standardi obravnave bolnikov kritičnem stanju in razmisliti o dodatnih ukrepih, kot je pregled z ehokardiografijo.
English: Kymriah is recommended to be infused 2 to 14 days after completion of the lymphodepleting chemotherapy.
Slovenian: Zdravilo Kymriah je priporočeno infundirati 2 do 14 dni po zaključku izvajanja limfodeplecije s kemoterapijo.
English: They usually happen in the first 8 weeks after the infusion, but can also develop later:
Slovenian: Običajno se pojavijo v prvih 8 tednih po prejemu infuzije, lahko pa tudi kasneje.
English: Due to the potential for neurological events, including altered mental status or seizures, patients receiving Kymriah are at risk for altered or decreased consciousness or coordination in the 8 weeks following infusion.
Slovenian: Zaradi možnosti pojavljanja nevroloških dogodkov, med drugim spremenjenega psihičnega stanja ali konvulzij, so bolniki, ki prejemajo zdravilo Kymriah, 8 tednov po prejemu infuzije v nevarnosti, da pri njih pride do stanj spremenjene ali zmanjšane zavesti ali zmanjšane sposobnosti koordinacije gibov.
English: Dispersion for infusion 10 mL - 50 mL per bag.
Slovenian: disperzija za infundiranje 10 ml - 50 ml na infuzijsko vrečko
English: • The active substance of Kymriah is called tisagenlecleucel.
Slovenian: • Učinkovina zdravila Kymriah se imenuje tisagenlecleucel.
English: Talk to your doctor or nurse before you are given Kymriah if you have a history of:
Slovenian: Posvetujte se z zdravnikom ali medicinsko sestro, preden prejmete zdravilo Kymriah, če ste opazili:
English: In addition the applicant should submit the final CSR including 5 years of follow-up.
Slovenian: Predlagatelj mora predložiti tudi končno poročilo klinične študije, vključno s podatki 5-letnega spremljanja bolnikov.
English: Kymriah must be administered in a qualified treatment centre.
Slovenian: Zdravilo Kymriah je treba aplicirati v kvalificiranem terapevtskem centru.