FrancophonIA/ELRC3.0 huggingface dataset:
English: This is equivalent to 1 to 6% of the recommended maximum daily dietary intake of 2 g sodium for an adult.
Croatian: To odgovara 1 do 6% preporučenog maksimalnog dnevnog unosa od 2 g natrija za odraslu osobu.
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).
Croatian: Unutar svakog organskog sustava, nuspojave su poredane po učestalosti, počevši od najučestalijih, prema sljedećoj konvenciji: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: During the 30 to 60 minutes before you are given Kymriah you may be given other medicines.
Croatian: Lijekovi koji se daju prije liječenja lijekom Kymriah Tijekom 30 do 60 minuta prije nego što Vam se da Kymriah možda ćete dobiti druge lijekove.
English: Each bag contains 10 mL to 50 mL of dispersion.
Croatian: Svaka vrećica sadrži 10 ml do 50 ml disperzije.
English: Do not thaw the product until it is ready to be used.
Croatian: Ne odmrzavajte lijek dok nije spreman za uporabu.
English: In the event that a secondary malignancy occurs, the company should be contacted to obtain instructions on patient samples to collect for testing.
Croatian: U slučaju da se pojavi sekundarna zloćudna bolest, potrebno je obratiti se tvrtki radi uputa o bolesnikovim uzorcima koje treba prikupiti za testiranje.
English: This is because other medicines can affect the way Kymriah works.
Croatian: Razlog tome je što drugi lijekovi mogu utjecati na djelovanje lijeka Kymriah.
English: Patients should be monitored for neurological events.
Croatian: Bolesnike je potrebno nadzirati zbog mogućih neuroloških događaja.
English: • Look for signs of graft-versus-host disease that can happen after a transplant.
Croatian: • potražiti znakove reakcije presatka protiv primatelja koja se može dogoditi nakon presađivanja.
English: See section 4.4 for the management of febrile neutropenia before and after Kymriah infusion.
Croatian: Vidjeti dio 4.4 za zbrinjavanje febrilne neutropenije prije i nakon infuzije lijeka Kymriah.
English: • Signs and symptoms of blood clots
Croatian: • Znakovi i simptomi krvnih ugrušaka
English: Acute lymphoblastic leukaemia (ALL)
Croatian: Akutna limfoblastična leukemija (ALL)
English: The median time to resolution of cytokine release syndrome was 7 days.
Croatian: Medijan vremena do povlačenja sindroma otpuštanja citokina bio je 7 dana.
English: Educational programme
Croatian: Edukacijski program
English: Warnings and precautions Kymriah is made from your own white blood cells and should only be given to you.
Croatian: Upozorenja i mjere opreza Kymriah se pripravlja od Vaših vlastitih leukocita i smije se dati samo Vama.
English: This is so your doctor can check if your treatment is working and help you if you have any side effects.
Croatian: To je zato da bi Vaš liječnik mogao provjeriti djeluje li Vaše liječenje te Vam pomoći u slučaju nuspojava.
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
Croatian: Primarna refraktorna bolest: nikada nije došlo do morfološki potpune remisije (CR) prije ispitivanja; 2Recidivirajuća bolest: postojao je najmanje jedan relaps prije ispitivanja
English: • Anxiety, irritability
Croatian: • Tjeskoba, razdražljivost
English: The primary endpoint was analysed on all patients whose Kymriah was manufactured at the Novartis US facility.
Croatian: Mjera primarnog ishoda analizirana je na svim bolesnicima čiji je lijek Kymriah bio proizveden u Novartisovom američkom postrojenju.
English: When Kymriah is infused into your blood, the modified T cells will find the cancer cells and destroy them.
Croatian: Kada se Kymriah infundira u Vašu krv, modificirane T-stanice pronaći će stanice raka i uništit će ih.
English: Pain includes pain and pain in extremity.
Croatian: Bol uključuje bol i bol u ekstremitetu.
English: - Patient weight less than 30 kg: 12 mg/kg intravenously over 1 hour - Patient weight ≥30 kg: 8 mg/kg intravenously over 1 hour (maximum dose 800 mg)
Croatian: - Bolesnik težine manje od 30 kg: 12 mg/kg intravenski tijekom 1 sata - Bolesnik težine ≥30 kg: 8 mg/kg intravenski tijekom 1 sata (maksimalna doza 800 mg)
English: • Your doctor will take some of your blood using a catheter placed in your vein (a procedure called leukapheresis).
Croatian: • Vaš liječnik uzet će uzorak Vaše krvi putem katetera koji se stavlja u venu (postupkom koji se zove leukafereza).
English: The type and duration of bridging therapy was left to the discretion of the physician.
Croatian: Vrsta i trajanje terapije premošćenja bili su prepušteni odluci liječnika.
English: Nominal one-sided exact p-value based on H0: Rate of MRD negative remission ≤15% vs. Ha: >15%.
Croatian: Nominalna jednostrana egzaktna p-vrijednost temeljena na H0: stopa MRD negativne remisije ≤15% u odnosu na Ha: >15%.
English: • Look for signs of infection; any infection will be treated before you are given Kymriah.
Croatian: • potražiti znakove infekcije; svaka infekcija liječit će se prije nego
English: What Kymriah is and what it is used for What you need to know before you are given Kymriah How Kymriah is given
Croatian: Što se nalazi u ovoj uputi Što je Kymriah i za što se koristi Što morate znati prije nego primite Kymriah Kako se daje Kymriah Moguće nuspojave
English: Kymriah should not be manipulated.
Croatian: Lijekom Kymriah se ne smije manipulirati.
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).
Croatian: Kvaliteta života povezana sa zdravljem (HRQoL) bila je ocijenjena pomoću upitnika PedsQL™ i EQ-5D koje su popunjavali bolesnici u dobi od 8 i više godina (n=58).
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).
Croatian: Svaka vrećica za infuziju spremljena je u aluminijsku kasetu, zatim u plastičnu vrećicu s upijajućim materijalom i čvrsto zatvorena u zaštitni omot (Tyvek).
English: They should be monitored life-long for secondary malignancies.
Croatian: Potrebno ih je doživotno pratiti radi uočavanja mogućih sekundarnih zloćudnih bolesti.
English: Store in the original protective envelope (Tyvek) containing the cassette protecting the infusion bag.
Croatian: Čuvati u originalnom zaštitnom omotu (Tyvek) koji sadrži kasetu koja štiti vrećicu za infuziju.
English: Pregnant women should be advised on the potential risks to the foetus.
Croatian: Trudnice je potrebno obavijestiti o potencijalnim rizicima za fetus.
English: In addition the applicant should submit the final CSR including 5 years of follow-up.
Croatian: Uz to, podnositelj zahtjeva treba predati završno izvješće o kliničkom ispitivanju koje uključuje 5 godina kontrolnog praćenja.
English: Tmax (day)
Croatian: Tmax (dan)
English: • You have any lung, heart or blood pressure (low or raised) problems.
Croatian: • imate bilo kakvih problema s plućima, srcem ili krvnim tlakom (sniženim ili povišenim).
English: T cells are important for your immune system (the body's defences) to work properly.
Croatian: T-stanice su važne za normalno funkcioniranje Vašeg imunološkog sustava (obrambenog sustava tijela).
English: The majority of patients (101/111, 91%) received bridging therapy for disease stabilisation.
Croatian: Većina bolesnika (101/111, 91%) je za stabilizaciju bolesti primila terapiju premošćenja (engl. bridging therapy).
English: Corticosteroids should not be used at any time except in the case of a life-threatening emergency (see section 4.4).
Croatian: Kortikosteroidi se ne smiju rabiti ni u kojem trenutku osim u hitnom slučaju opasnom po život (vidjeti dio 4.4).
English: - Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.
Croatian: - Bolesnike je potrebno uputiti da ostanu u blizini kvalificiranog centra za liječenje najmanje 4 tjedna nakon infuzije.
English: Observe in person; exclude infection; administer antibiotics per local guidelines if neutropenic; provide symptomatic support.
Croatian: Promatrati izravno; isključiti infekciju; primijeniti antibiotike prema lokalnim smjernicama u slučaju neutropenije; pružiti simptomatsku potporu.
English: HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with medicinal products directed against B cells.
Croatian: Reaktivacija HBV-a, koja u nekim slučajevima može rezultirati fulminantnim hepatitisom, zatajivanjem jetre i smrću, može se pojaviti u bolesnika liječenih lijekovima koji su usmjereni protiv B-stanica.
English: No animal studies have been conducted with Kymriah to assess whether it can cause foetal harm when administered to a pregnant woman (see section 5.3).
Croatian: Nisu provedena ispitivanja na životinjama s lijekom Kymriah da bi se procijenilo može li naškoditi fetusu kad se primjenjuje trudnici (vidjeti dio 5.3).
English: It is not recommended that patients receive Kymriah within 4 months of undergoing an allogeneic stem cell transplant (SCT) because of the potential risk of Kymriah worsening GVHD.
Croatian: Ne preporučuje se da bolesnici prime lijek Kymriah u roku od 4 mjeseca od transplantacije alogenih matičnih stanica (TMS) zbog mogućeg rizika da Kymriah pogorša GVHD.
English: Common: may affect up to 1 in every 10 people
Croatian: Često: mogu se javiti u do 1 na 10 osoba
English: Store and transport below -120°C; do not thaw the product until use.
Croatian: Čuvati i transportirati ispod -120°C; ne odmrzavati lijek prije vremena uporabe.
English: Therefore, leukapheresis material from these patients will not be accepted for Kymriah manufacturing.
Croatian: Stoga, pripravak dobiven leukaferezom od ovih bolesnika neće biti prihvaćen za proizvodnju lijeka Kymriah.
English: Non-responding patients (SD/PD/Unknown) N=58
Croatian: Bolesnici bez odgovora (SD/PD/nepoznato) N=58
English: • Your doctor will give you Kymriah by infusion, which means it will be given as a drip through a tube in your vein.
Croatian: • Vaš liječnik dat će Vam lijek Kymriah pomoću infuzije, što znači da ćete ga dobiti kao infuziju kap po kap (drip) u venu kroz cjevčicu.
English: Availability of tocilizumab and site qualification
Croatian: Dostupnost tocilizumaba i kvalifikacija centra za liječenje
English: The cellular composition and the final cell number varies between individual patient batches.
Croatian: Stanični sastav i konačan broj stanica varira između serija za pojedinačne bolesnike.
English: • You have had a stem cell transplant in the last 4 months.
Croatian: • ste bili podvrgnuti presađivanju matičnih stanica unutar zadnja 4 mjeseca.
English: ** With reported sequelae of secondary cerebral oedema.
Croatian: ** Uz prijavljene posljedice sekundarnog moždanog edema.
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.
Croatian: KYMRIAH će se dostaviti samo kvalificiranim bolnicama i centrima i samo ako su zdravstveni radnici uključeni u liječenje bolesnika završili poseban edukacijski program.
English: Hypogammaglobulinaemia and agammaglobulinaemia can occur in patients with a complete remission after Kymriah infusion.
Croatian: Hipogamaglobulinemija i agamaglobulinemija mogu se pojaviti u bolesnika s potpunom remisijom nakon infuzije lijeka Kymriah.
English: Responding patients (CR and PR) N=35
Croatian: Bolesnici s odgovorom (CR i PR) N=35
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.
Croatian: Vam da ovaj lijek zato što učinci lijeka Kymriah kod trudnica ili dojilja nisu poznati i mogu naštetiti Vašem nerođenom djetetu ili Vašem novorođenčetu/dojenčetu.
English: Prior to the launch of KYMRIAH in each Member State, the MAH must agree about the content and format of the educational materials with the National Competent Authority.
Croatian: Prije stavljanja lijeka KYMRIAH u promet u svakoj državi članici, nositelj odobrenja mora usuglasiti sadržaj i oblik edukacijskih materijala s nacionalnim nadležnim tijelom.
English: Due to limited short spans of identical genetic information between the lentiviral vector used to create Kymriah and HIV, some commercial HIV nucleic acid tests (NAT) may give a false positive result.
Croatian: Zbog ograničenog broja kratkih sekvenci identičnih genetskih informacija između lentivirusnog vektora koji se koristi za proizvodnju lijeka Kymriah i HIV-a, neki komercijalni testovi za otkrivanje nukleinske kiseline (NAT) virusa HIV-a mogu dati lažno pozitivan rezultat.
English: Kymriah treatment should be delayed in some patient groups at risk (see section 4.4).
Croatian: Liječenje lijekom Kymriah potrebno je odgoditi kod nekih rizičnih skupina bolesnika (vidjeti dio 4.4).
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.
Croatian: Zbog mogućnosti pojave neuroloških događaja, uključujući promijenjeno mentalno stanje ili napadaje, bolesnici koji primaju lijek Kymriah izloženi su riziku od promijenjene ili smanjene svijesti ili koordinacije tijekom 8 tjedana nakon infuzije.
English: Do not use this medicine after the expiry date which is stated on the infusion bag label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici vrećice za infuziju iza oznake EXP.
English: Pregnant women who have received Kymriah may have hypogammaglobulinaemia.
Croatian: Trudnice koje su primile lijek Kymriah mogu imati hipogamaglobulinemiju.
English: Genotoxicity assays and carcinogenicity studies in rodents are not appropriate to assess the risk of insertional mutagenesis for genetically-modified cell therapy products.
Croatian: Testovi genotoksičnosti i ispitivanja kancerogenosti na glodavcima nisu prikladni da bi se procijenio rizik insercijske mutageneze za genski modificirane stanične terapije.
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.
Croatian: Kako bi se minimizirali rizici povezani s liječenjem lijekom KYMRIAH, nositelj odobrenja dužan je osigurati da su bolnice i povezani centri koji primjenjuju lijek posebno kvalificirani u skladu s dogovorenim programom kontrolirane distribucije.
English: • An antihistamine such as diphenhydramine.
Croatian: • antihistaminik poput difenhidramina.
English: If your temperature is high, see your doctor immediately.
Croatian: Ako imate visoku temperaturu, odmah se obratite svome liječniku.
English: There are no data on the effect of Kymriah on fertility.
Croatian: Nema podataka o učinku lijeka Kymriah na plodnost.
English: Overall remission rate (ORR)
Croatian: Ukupna stopa remisije (ORR)
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Kymriah u jednoj ili više podskupina pedijatrijske populacije u sljedećim bolestima: a) liječenje limfoblastičnog limfoma B-stanica, i b) liječenje neoplazmi zrelih B-stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: AUC0-28d (copies/μg*day)
Croatian: AUC0-28d (kopije/μg*dan)
English: Kymriah should be thawed at 37°C using either a water bath or dry thaw method until there is no visible ice in the infusion bag.
Croatian: Kymriah se mora odmrzavati na 37°C pomoću vodene kupelji ili pomoću metode suhog odmrzavanja dok se više ne vidi led u vrećici za infuziju.
English: If you have not been previously exposed to dextran or DMSO you should be observed closely during the first minutes of the infusion period.
Croatian: Ako ranije niste bili izloženi dekstranu ili DMSO-u, potrebno Vas je pažljivo promatrati tijekom prvih minuta primjene infuzije.
English: % relapse free probability at 6 months % relapse free probability at 12 months Other secondary endpoints
Croatian: % vjerojatnosti izostanka relapsa u 6. mjesecu % vjerojatnosti izostanka relapsa u 12. mjesecu Ostale mjere sekundarnog ishoda
English: For clinical management of cytokine release syndrome, see section 4.4 and Table 1.
Croatian: Za kliničko zbrinjavanje sindroma otpuštanja citokina, vidjeti dio 4.4 i Tablicu 1.
English: Package leaflet: Information for the patient or carer
Croatian: Uputa o lijeku: Informacije za bolesnika ili njegovatelja
English: Women of childbearing potential/Contraception in males and females
Croatian: Žene reproduktivne dobi/Kontracepcija kod muškaraca i žena
English: In patients achieving complete remission following Kymriah, resulting low immunoglobulin levels can increase the risk for infections.
Croatian: U bolesnika koji postignu potpunu remisiju nakon primjene lijeka Kymriah, posljedične niske razine imunoglobulina mogu povećati rizik od infekcija.
English: Each of these excipients are known to possibly cause anaphylactic reaction following parenteral administration.
Croatian: Za svaku od tih pomoćnih tvari poznato je da može uzrokovati anafilaktičku reakciju nakon parenteralne primjene.
English: B-cell ALL: No formal studies have been performed in paediatric patients below 3 years of age.
Croatian: ALL B-stanica: Nisu provedena formalna ispitivanja u pedijatrijskih bolesnika mlađih od 3 godine.
English: This can lead to weight gain and difficulty breathing
Croatian: To može dovesti do porasta tjelesne težine i poteškoća s disanjem.
English: Geometric mean (CV%), n
Croatian: Geometrijska srednja vrijednost (CV%), n
English: See the prescribing information for lymphodepleting chemotherapy for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy.
Croatian: Vidjeti informacije o lijeku za kemoterapiju za limfocitnu depleciju radi informacija o potrebi za učinkovitom kontracepcijom u bolesnika koji primaju kemoterapiju za limfocitnu depleciju.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM Nije primjenjivo
English: In addition to T cells, NK cells may be present.
Croatian: Uz T-stanice mogu biti prisutne i NK stanice.
English: In vitro expansion studies with CAR-positive T cells (Kymriah) from healthy donors and patients showed no evidence for transformation and/or immortalisation of T cells.
Croatian: In vitro ispitivanja ekspanzije s CAR-pozitivnim T-stanicama (Kymriah) od zdravih davatelja i bolesnika nisu pokazala dokaze transformacije i/ili imortalizacije T-stanica.
English: There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with Kymriah.
Croatian: Nema dovoljno podataka o izloženosti da bi se mogla dati preporuka oko trajanja kontracepcije nakon primanja lijeka Kymriah.
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.
Croatian: Ako nema odgovora na drugu dozu tocilizumaba, razmotriti treću dozu tocilizumaba ili primijeniti druge mjere za liječenje sindroma otpuštanja citokina.
English: Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Croatian: Bolesnici seropozitivni na virus hepatitisa B (HBV), virus hepatitisa C (HCV) ili virus humane imunodeficijencije (HIV)
English: 34% of the patients experienced an infection of any type within 8 weeks.
Croatian: U 34% bolesnika razvila se neka infekcija bilo kojeg tipa u roku od 8 tjedana.
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.
Croatian: Da bi se smanjile moguće akutne reakcije na infuziju, preporučuje se premedikacija bolesnika paracetamolom i difenhidraminom ili drugim H1 antihistaminikom unutar otprilike 30 do 60 minuta prije infuzije lijeka Kymriah.
English: Table 2 Adverse drug reactions observed in clinical studies
Croatian: Tablica 2 Nuspojave zabilježene u kliničkim ispitivanjima
English: Peripheral neuropathy includes paraesthesia, peripheral sensory neuropathy, neuropathy peripheral, hyperaesthesia and hypoaesthesia.
Croatian: Periferna neuropatija uključuje paresteziju, perifernu senzornu neuropatiju, perifernu neuropatiju, hiperesteziju i hipoesteziju.
English: Prior treatment with anti-CD19 therapy
Croatian: Prethodno liječenje anti-CD19 terapijom
English: Dispersion for infusion.
Croatian: Disperzija za infuziju.
English: What Kymriah contains
Croatian: Što Kymriah sadrži
English: In Study C2201 there were 88% Caucasian, 5% Asian, 4% Black or African American patients, and 3 patients (3%) of unknown race.
Croatian: U ispitivanju C2201 bilo je 88% bijelaca, 5% Azijata, 4% crnaca ili Afroamerikanaca te 3 bolesnika (3%) nepoznate rase.
English: • problems such as altered or decreased consciousness, delirium, confusion, agitation, seizures, difficulty speaking and understanding speech, loss of balance.
Croatian: • problemi poput izmijenjene ili snižene razine svijesti, delirija, smetenosti, uznemirenosti, napadaja, teškoća u govoru i razumijevanju govora, gubitka ravnoteže.
English: Talk to your doctor or nurse before you are given Kymriah if you have a history of:
Croatian: Obratite se liječniku ili medicinskoj sestri prije nego što Vam se da Kymriah ako u anamnezi imate:
English: Cytokine release syndrome requiring mild intervention - one or more of the following: High fever Hypoxia Mild hypotension
Croatian: Sindrom otpuštanja citokina koji zahtijeva blagu intervenciju - jedno ili više od sljedećeg: visoka vrućica hipoksija blaga hipotenzija
English: Tell your doctor immediately if you get any of the following side effects after the Kymriah infusion.
Croatian: Odmah obavijestite svog liječnika ako dobijete bilo koju od dolje navedenih nuspojava nakon infuzije lijeka Kymriah.
English: Kymriah is intended for autologous use only (see section 4.4).
Croatian: Kymriah je namijenjen samo za autolognu primjenu (vidjeti dio 4.4).
English: • Check your blood for uric acid and for how many cancer cells there are in your blood.
Croatian: • provjeriti krv zbog mokraćne kiseline te da se utvrdi koliko se stanica raka nalazi u Vašoj krvi.
English: B-cell ALL
Croatian: ALL B-stanica
English: Kymriah, also known as tisagenlecleucel, is made from some of your own white blood cells called T cells.
Croatian: Kymriah, također poznat kao tisagenlekleucel, je napravljen od nekih Vaših leukocita koji se nazivaju T-stanice.
English: Pre-existing and treatment-induced antibodies were not associated with an impact on clinical response nor did they have an impact on the expansion and persistence of tisagenlecleucel.
Croatian: Već postojeća i liječenjem inducirana protutijela nisu bila povezana s utjecajem na klinički odgovor, niti su imala utjecaj na ekspanziju ili perzistentnost tisagenlekleucela.