FrancophonIA/ELRC3.0 huggingface dataset:
English: o Signs and symptoms of bleeding and the need to contact the physician if any signs of unusual or prolonged bleeding or any other relevant signs are present.
Croatian: o Znakovi i simptomi krvarenja te potreba za kontaktiranjem liječnika ako su prisutni bilo koji znakovi neuobičajenog ili dugotrajnog krvarenja ili bilo koji drugi značajni znakovi.
English: • abnormal sense of taste
Croatian: • nenormalan osjećaj okusa
English: Your name and date of birth, as well as coded information identifying you as the patient, are printed onto each infusion bag and each metal container.
Croatian: Vaše ime i datum rođenja, kao i kodirane informacije koje vas identificiraju kao bolesnika, otisnute su na svaku infuzijsku vrećicu i svaki metalni spremnik.
English: Zynteglo is made specifically for you, using your own blood stem cells.
Croatian: Zynteglo je napravljen posebno za vas, koristeći vaše vlastite krvne stanice.
English: This information is intended for doctors only.
Croatian: Ove su informacije namijenjene isključivo liječnicima.
English: Date of Birth (DD/MM/YYYY): Weight at First Collection (kg): Patient ID:
Croatian: Datum rođenja (DD/MM/GGGG): Težina pri prvom prikupljanju (kg): ID bolesnika:
English: Patients should be made aware of the risk of bleeding events that are not easily identifiable, such as internal bleeding.
Croatian: Bolesnici moraju biti svjesni rizika od događaja krvarenja koji nisu lako prepoznatljivi, kao što je unutarnje krvarenje.
English: • increase of certain enzymes in the blood which may indicate a problem with your liver
Croatian: • povećanje određenih enzima u krvi koje može ukazivati na problem s jetrom
English: These may be signs of a serious liver condition called veno-occlusive disease.
Croatian: To mogu biti znakovi ozbiljnog stanja jetre zvanog venookluzivna bolest.
English: Phlebotomy can be used in lieu of iron chelation, when appropriate.
Croatian: Flebotomija se može koristiti umjesto kelacije željeza, kada je to primjereno.
English: • decreased testosterone
Croatian: • smanjena razina testosterona
English: Zynteglo must not be re-frozen.
Croatian: Zynteglo se ne smije ponovno zamrznuti.
English: Interim results: at each annual renewal
Croatian: Interim rezultati: prilikom svake godišnje obnove
English: People with this condition cannot make enough haemoglobin, a protein in the blood that carries oxygen.
Croatian: Osobe s ovom bolešću ne mogu stvariti dovoljno hemoglobina, proteina u krvi koji nosi kisik.
English: Contents of the pack and other information What Zynteglo contains
Croatian: Sadržaj pakiranja i druge informacije Što Zynteglo sadrži
English: Your doctor will tell you when your platelet count has recovered to normal levels.
Croatian: Liječnik će vam reći kada se Vaš broj trombocita oporavi na normalnu razinu.
English: You should carry the Patient Alert Card with you at all times and show it to your doctor or nurse when you see them or if you are admitted to the hospital.
Croatian: U svakom trenutku trebate nositi karticu s upozorenjima za bolesnika i pokazati je svom liječniku ili medicinskoj sestri kada ih vidite ili ako ste primljeni u bolnicu.
English: Tell your doctor immediately if you get any of the following side effects after receiving chemotherapy medicine.
Croatian: Odmah obavijestite svog liječnika ako dobijete bilo koju od sljedećih nuspojava nakon primanja kemoterapijskih lijekova.
English: Some iron chelators are myelosuppressive.
Croatian: Neki kelatori željeza su mijelosupresivni.
English: You should also read the package leaflets for these medicines.
Croatian: Također biste trebali pročitati upute o lijeku za te lijekove.
English: o The potential risk of loss of response to gene therapy may lead to loss of transfusion independence or increase transfusion needs for patients who did not reach transfusionindependence.
Croatian: o Potencijalni rizik od gubitka odgovora na gensku terapiju može dovesti do gubitka neovisnosti o transfuziji ili povećati potrebu za transfuzijom kod bolesnika koji nisu postigli neovisnost o transfuziji.
English: Zynteglo is prepared using parts of the human immunodeficiency virus (HIV), which have been altered so that they cannot cause HIV infection.
Croatian: Zynteglo je pripremljen koristeći dijelove virusa humane imunodeficijencije (HIV) koji su promijenjeni tako da ne mogu uzrokovati HIV infekciju.
English: The blood stem cells can then be collected by a machine that separates blood components (apheresis machine).
Croatian: Matične stanice krvi zatim može prikupiti stroj koji razdvaja krvne komponente (aparat za aferezu).
English: For men, this may be sperm or testicular tissue.
Croatian: Kod muškaraca to može biti sperma ili tkivo testisa.
English: Magyarország, Malta, Norge, Österreich, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige bluebird bio (Netherlands) B.V.
Croatian: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, España, Hrvatska, Ireland, Ísland, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Norge, Österreich, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige bluebird bio (Netherlands) B.V.
English: All patients remain alive at last follow-up.
Croatian: Svi bolesnici bili su živi prilikom posljednjeg praćenja.
English: No clinical data on exposed pregnancies are available.
Croatian: Nisu dostupni klinički podaci o izloženim trudnoćama.
English: If a third day of collection was needed, plerixafor and G-CSF dosing was extended to Day 6.
Croatian: Ako je bio potreban treći dan prikupljanja, doziranje pleriksafora i G-CSF-a produljeno je na 6. dan.
English: CLINICAL PARTICULARS 4.1 Therapeutic indication
Croatian: KLINIČKI PODACI 4.1 Terapijske indikacije
English: Reliable methods of contraception include intra-uterine device or a combination of oral contraceptive (also know as the pill) and condoms.
Croatian: Pouzdane metode kontracepcije uključuju unutarmaternični uložak ili kombinaciju oralne kontracepcije (također poznate kao pilula) i kondoma.
English: It is therefore advised to cryopreserve semen or ova before treatment if possible.
Croatian: Stoga se savjetuje krioperzervacija sjemena ili jajnih stanica prije liječenja, ako je moguće.
English: Why of bags will vary by patient.
Croatian: Broj vrećica će varirati ovisno o bolesniku.
English: (First Infusion Bag)
Croatian: (Prva infuzijska vrećica)
English: Frozen: 1 year at ≤-140°C.
Croatian: Smrznuto: 1 godina na ≤-140 °C.
English: The selection of the treatment centres will be conducted in collaboration with national health authorities as appropriate.
Croatian: Odabir centara za liječenje provest će se u suradnji s nacionalnim tijelima nadležnim za zdravstvo kako je to prikladno.
English: • excess acid in the body not removed by the kidneys
Croatian: • višak kiseline u tijelu koji nije uklonjen bubrezima
English: Zynteglo can only be made if enough of the right kind of blood stem cells can be collected from your blood (CD34+ blood stem cells).
Croatian: Zynteglo se može proizvesti samo ako se dovoljno prave vrste matičnih stanica krvi može prikupiti iz vaše krvi (CD34+ matične stanice krvi).
English: Tell your doctor immediately if side effects become severe or serious.
Croatian: Odmah obavijestite svog liječnika ako nuspojave postanu teške ili ozbiljne.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego što primite ovaj lijek.
English: Also contains Cryostor CS5 and sodium chloride.
Croatian: Također sadrži Cryostor CS5 i natrijev klorid.
English: Interim results: - at each annual renewal - Dec. 2024 - Dec. 2034
Croatian: Interim rezultati: - prilikom svake godišnje obnove - prosinac 2024. - prosinac 2034.
English: - Read the Patient Alert Card carefully and follow the instructions on it.
Croatian: Pogledajte dio 4. - Pažljivo pročitajte karticu s upozorenjima za bolesnika i slijedite upute na njoj.
English: Options may include providing reproductive material for storage in a tissue bank to use at a later time.
Croatian: Mogućnosti mogu uključivati pohranu reproduktivnog materijala u banku tkiva za korištenje u budućnosti.
English: Patients seropositive for human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV)
Croatian: Bolesnici seropozitivni na virus humane imunodeficijencije (HIV) ili ljudski T- limfotropni virus (HTLV)
English: Following successful engraftment and achievement of transfusion independence, the effects of the product are expected to be life-long.
Croatian: Nakon uspješnog prihvaćanja transplantata i postizanja neovisnosti od transfuzije, očekuje se da će učinci lijeka biti doživotni.
English: Because of this defect, people with TDT are anaemic and need frequent blood transfusions to survive.
Croatian: Zbog tog nedostatka, ljudi s TDT-om su anemični i trebaju česte transfuzije krvi kako bi preživjeli.
English: • low number of immature (not fully developed) red blood cells
Croatian: • nizak broj nezrelih (nepotpuno razvijenih) crvenih krvnih stanica
English: Pharmacotherapeutic group: Other haematological agents, ATC code: not yet assigned Mechanism of action
Croatian: Farmakoterapijska skupina: ostali hematološki lijekovi, ATK oznaka: nije još dodijeljena
English: Talk to your doctor before you are given Zynteglo.
Croatian: Obratite se svom liječniku prije nego primite Zynteglo.
English: o Contact details where a health care professional can receive further information.
Croatian: o Informacije za kontakt putem kojeg zdravstveni radnik može dobiti dodatne informacije.
English: Zynteglo is intended solely for autologous use.
Croatian: Zynteglo je namijenjen isključivo za autolognu uporabu.
English: Given the small patient population and size of cohorts, adverse reactions in the table below do not provide a complete perspective on the nature and frequency of these events.
Croatian: S obzirom na malu populaciju bolesnika i veličinu kohorti, nuspojave u tablici u nastavku ne pružaju cjelovitu sliku o prirodi i učestalosti tih događaja.
English: The safety of Zynteglo was evaluated in 42 patients with TDT.
Croatian: Sigurnost lijeka Zynteglo procijenjena je u 42 bolesnika s TDT-om.
English: What you need to know before you are given Zynteglo 3.
Croatian: Što morate znati prije nego primite Zynteglo 3.
English: They usually happen within the first few days and several weeks after receiving chemotherapy medicine, but can also develop much later.
Croatian: Obično se događaju unutar prvih nekoliko dana i nekoliko tjedana nakon primanja kemoterapijskih lijekova, ali se mogu razviti i mnogo kasnije.
English: • have symptoms that could be from internal bleeding, such as unusual stomach or back pain, or severe headache
Croatian: • imate simptome koji mogu biti posljedica unutarnjeg krvarenja, kao što su neuobičajeni bol u želucu ili leđima ili jaka glavobolja.
English: Thawing of each infusion bag takes approximately 2 to 4 minutes.
Croatian: Odmrzavanje svake infuzijske vrećice traje približno 2 do 4 minute.
English: Previous treatment with HSC gene therapy.
Croatian: Prethodno liječenje HSC genskom terapijom.
English: Your children are still at risk of inheriting your original beta-globin gene.
Croatian: Vaša djeca još uvijek imaju rizik nasljeđivanja Vašeg izvornog gena za beta-globin.
English: Before treatment with Zynteglo, your doctor will perform tests to make sure your heart and liver are functioning properly so you can be treated safely with Zynteglo.
Croatian: Prije liječenja Zynteglom, vaš liječnik će obaviti pretrage kako bi bili sigurni da vaše srce i jetra funkcioniraju ispravno tako da se možete sigurno liječiti Zynteglom.
English: The total number of infusion bags to be administered should also be confirmed with the Lot Information Sheet (see section 4.4).
Croatian: Ukupan broj infuzijskih vrećica koje treba primijeniti također treba potvrditi provjerom na listu s informacijama o lotu (vidjeti dio 4.4).
English: • weight decreased
Croatian: • smanjena težina
English: After Zynteglo infusion, avoid use of these iron chelators for 6 months.
Croatian: Nakon infuzije lijeka Zynteglo, izbjegavajte korištenje tih kelatora željeza tijekom idućih 6 mjeseci.
English: Strength cells/mL)
Croatian: Jačina stanica/ml)
English: - The other ingredients are a solution used to preserve frozen cells and sodium chloride.
Croatian: - Drugi sastojci su otopina koja se koristi za čuvanje zamrznutih stanica i natrijev klorid.
English: Effects on male and female fertility have not been evaluated in animal studies.
Croatian: Učinci na plodnost mužjaka i ženki nisu procijenjeni u ispitivanjima na životinjama.
English: Do not re-freeze after thawing.
Croatian: Nemojte ponovno zamrzavati nakon odmrzavanja.
English: The nature of Zynteglo is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Croatian: Priroda lijeka Zynteglo je takva da konvencionalna ispitivanja farmakokinetike, apsorpcije, distribucije, metabolizma i eliminacije nisu primjenjiva.
English: • premature menopause
Croatian: • preuranjena menopauza
English: • skin that is discoloured, blotchy, or darker or lighter than normal.
Croatian: • kože koja je promijenila boju, zamrljana, tamnija ili svjetlija od normalne
English: The added gene from Zynteglo will not be passed on to your children.
Croatian: Dodani gen iz lijeka Zynteglo neće se prenijeti na Vašu djecu.
English: In order to further confirm the appropriateness of the acceptance criteria, the MAH should re-evaluate the acceptance criteria for attributes related to potency tests using batch release data and clinical results after 6 months follow-up of 20 patients treated with commercial batches.
Croatian: U cilju dodatnog potvrđivanja prikladnosti kriterija prihvatljivosti nositelj odobrenja treba ponovno procijeniti kriterije prihvatljivosti za atribute povezane s testovima potentnosti na osnovu podataka o stavljanju serije u promet i kliničkih rezultata nakon 6 mjeseci praćenja 20 bolesnika liječenih komercijalnim serijama.
English: Zynteglo must not be used during pregnancy because of myeloablative conditioning (see section 4.3).
Croatian: Zynteglo se ne smije koristiti tijekom trudnoće zbog mijeloablativnog kondicioniranja (vidjeti dio 4.3).
English: Patients are expected to enrol in a registry and will be followed long term in the registry in order to better understand the long-term safety and efficacy of Zynteglo.
Croatian: Očekuje se da će se bolesnici upisati u registar te će biti dugoročno praćeni kroz registar kako bi se bolje razumjela dugoročna sigurnost i djelotvornost lijeka Zynteglo.
English: Lot Number / COI ID
Croatian: Lot broj/COI
English: What Zynteglo is and what it is used for 2.
Croatian: Što je Zynteglo i za što se koristi 2.
English: Once thawed: maximum 4 hours at room temperature (20°C-25°C).
Croatian: Nakon odmrzavanja: najviše 4 sata na sobnoj temperaturi (20 °C-25 °C).
English: After you receive Zynteglo, you may have a low number of platelets in your blood.
Croatian: Nakon što primite Zynteglo, možda ćete imati nizak broj trombocita u krvi.
English: It is made specifically for each patient, using the patient's own (also called autologous) blood stem cells.
Croatian: Napravljen je posebno za svakog bolesnika, koristeći bolesnikove vlastite (također poznate pod nazivom autologne) matične stanice krvi.
English: Busulfan dose adjustments were made as needed based on pharmacokinetic monitoring.
Croatian: Prilagodbe doze busulfana načinjene su prema potrebi na osnovu farmakokinetičkog praćenja.
English: ***No patients are currently evaluable for these endpoints.
Croatian: ***Trenutačno nema bolesnika koji se mogu ocijeniti za ove mjere ishoda.
English: There are no reports of LVV-mediated insertional mutagenesis resulting in oncogenesis.
Croatian: Ne postoje izvješća o insercijskoj mutagenezi posredovanoj LVV-om koja rezultira onkogenezom.
English: You will be given a Patient Alert Card which contains important safety information that you need to know about your treatment with Zynteglo.
Croatian: Dobit ćete karticu s upozorenjima za bolesnika koja sadrži važne sigurnosne informacije koje trebate znati o Vašem liječenju Zynteglom.
English: Very Common (≥10%)
Croatian: Vrlo često (≥10 %)
English: Zynteglo has not been studied in patients >65 years of age.
Croatian: Zynteglo nije ispitivan u bolesnika u dobi od > 65 godina.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje PSUR-eva periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: • infections which may make you feel warm, chilly, or sweaty
Croatian: • infekcije koje mogu izazvati osjećaj topline, zimicu ili znojenje
English: The educational and controlled distribution programme is aimed at providing information on the safe use of Zynteglo.
Croatian: Program edukacije i kontrolirane distribucije ima za cilj pružiti informacije o sigurnoj primjeni lijeka Zynteglo.
English: Blood cell count determination and other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise.
Croatian: Određivanje broja krvnih stanica i druga odgovarajuća ispitivanja treba odmah razmotriti kad god se pojave klinički simptomi koji ukazuju na pojavu krvarenja.
English: Number of Infusion Bags
Croatian: Broj infuzijskih vrećica
English: According to available data, the frequency, type, and severity of adverse reactions in adolescents 12-17 years of age are similar to adults with the exception of VOD and pyrexia that occurred more frequently in adolescents.
Croatian: Prema dostupnim podacima, učestalost, vrsta i težina nuspojava u adolescenata u dobi od 12-17 godina slične su onima u odraslih osoba, izuzev venookluzivne bolesti i pireksije koje su se češće javljale kod adolescenata.
English: The most serious adverse reaction attributed to Zynteglo was thrombocytopenia (2.4%).
Croatian: Najozbiljnija nuspojava pripisana lijeku Zynteglo bila je trombocitopenija (2,4 %).
English: If you are a woman, you will be given a pregnancy test before starting mobilisation, before you are given chemotherapy, and before Zynteglo treatment in order to confirm that you are not pregnant.
Croatian: Ako ste žena, obavit ćete test na trudnoću prije početka mobilizacije, prije primanja kemoterapije i prije liječenja lijekom Zynteglo kako bi se potvrdilo da niste trudni.
English: Hb = Total Hb. WA Hb = Weighted average Hb.
Croatian: Hb = Ukupni Hb.
English: Common (≥1% - <10%)
Croatian: Često (≥1 % - <10 %)
English: Restarting iron chelation after Zynteglo infusion may be necessary and should be based on clinical practice (see sections 4.5 and 5.1).
Croatian: Ponovno uvođenje kelacije željeza nakon infuzije lijeka Zynteglo može biti potrebno i treba se temeljiti na kliničkoj praksi (vidjeti dijelove 4.5 i 5.1).
English: Patients should be assessed for renal impairment defined as creatinine clearance ≤70 mL/min/1.73 m2 to ensure HSC transplantation is appropriate.
Croatian: Bolesnike treba procijeniti s obzirom na oštećenje bubrežne funkcije definirano kao klirens kreatinina ≤ 70 ml/min/1,73 m2 kako bi se osigurala odgovarajuća transplantacija HSC-a.
English: Duration of TI
Croatian: Trajanje TI-a
English: All patients had a Karnofsky performance score ≥80 and the majority had a performance score of 100 at baseline.
Croatian: Svi bolesnici imali su rezultat za funkcionalni status prema Karnofskom ≥ 80, a većina je imala rezultat od 100 na početku liječenja.
English: ^N represents the total number of patients evaluable for TI, defined as patients who have completed their parent study (i.e., 24 months of follow-up), or achieved TI, or will not achieve TI in their parent study.
Croatian: ^N predstavlja ukupan broj bolesnika se mogu ocijeniti za TI, definirani kao bolesnici koji su dovršili svoje prvotno ispitivanje (tj. 24 mjeseca praćenja) ili postigli TI, ili neće postići TI u svom prvotnom ispitivanju.
English: After carefully removing the outer metal container, thaw each infusion bag at 37°C in a water bath or dry bath for approximately 2-4 minutes.
Croatian: Nakon što pažljivo uklonite vanjski metalni spremnik, odmrznite svaku infuzijsku vrećicu na 37 °C u vodenoj kupelji ili suhoj kupelji približno 2-4 minute Nemojte prekomjerno odmrzavati lijek.
English: Patients should be monitored annually for leukaemia or lymphoma (including with a complete blood count) for 15 years post treatment with Zynteglo.
Croatian: Bolesnike treba svake godine kontrolirati zbog leukemije ili limfoma (uključujući i kompletnu krvnu sliku) tijekom 15 godina nakon liječenja Zynteglom.
English: Serological testing
Croatian: Serološka ispitivanja
English: Your doctor will advise you if and when you should start taking these medicines after Zynteglo infusion.
Croatian: Liječnik će vas savjetovati ako i kada nakon infuzije lijeka Zynteglo trebate početi uzimati ove lijekove.
English: • positive test for Apergillus (lung disease caused by fungus)
Croatian: • pozitivan test na Apergillus (bolest pluća uzrokovana gljivicama)
English: • increased concentration of haemoglobin in cells
Croatian: • povećana koncentracija hemoglobina u stanicama
English: After treatment with Zynteglo, you will be asked to enrol in a registry for at least 15 years in order to better understand the long-term effects of Zynteglo.
Croatian: Nakon liječenja lijekom Zynteglo bit ćete zatraženi da se upišete u registar u trajanju od najmanje 15 godina kako bi se postiglo bolje razumijevanje dugoročnih učinaka lijeka Zynteglo.
English: In the event that more than one infusion bag is provided, all infusion bags must be administered.
Croatian: U slučaju da je dostavljeno više od jedne infuzijske vrećice, moraju se primijeniti sve infuzijske vrećice.
English: • chest pain not due to a heart problem
Croatian: • bol u prsištu koja nije uzrokovana srčanim problemima
English: If the liver biopsy demonstrates bridging fibrosis, cirrhosis, or active hepatitis, HSC transplantation with myeloablative conditioning is not appropriate.
Croatian: Ako biopsija jetre pokazuje premošćujuću fibrozu, cirozu ili aktivni hepatitis, nije primjerena HSC transplantacija s mijeloablativnim kondicioniranjem.
English: Serious events of hepatic VOD occurred in 11.9% of patients following myeloablative conditioning; 80% of these patients did not receive prophylaxis for VOD.
Croatian: Ozbiljni događaji venookluzivne bolesti jetre zabilježeni su kod 11,9 % bolesnika nakon mijeloablativnog kondicioniranja; 80 % od tih bolesnika nisu primali profilaksu za venookluzivnu bolest.
English: • abnormal blood test results (decrease in magnesium and potassium, too much citrate, or increase in white blood cells)
Croatian: • odstupanja rezultata krvnih pretraga (smanjenje razine magnezija i kalija), previše citrata ili povećanje broja bijelih krvnih stanica)
English: Patients should be monitored for thrombocytopenia and bleeding according to standard guidelines.
Croatian: Bolesnike treba nadzirati zbog trombocitopenije i krvarenja sukladno standardnim smjernicama.
English: All material that has been in contact with Zynteglo (solid and liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local biosafety guidelines.
Croatian: Svim materijalom koji je bio u dodiru s lijekom Zynteglo (krutim i tekućim otpadom) treba rukovati i zbrinuti ga kao potencijalno infektivni otpad u skladu s nacionalnim smjernicama za biološku sigurnost.
English: This information is provided in the Patient Alert Card which should be given to the patient after treatment.
Croatian: Te informacije navedene su u kartici s upozorenjima za bolesnika koju treba dati bolesniku nakon liječenja.