FrancophonIA/ELRC3.0 huggingface dataset:
English: After you have been treated with Zynteglo, you will not be able to donate blood, organs, or tissues in the future.
Croatian: Nakon liječenja lijekom Zynteglom nećete moći donirati krv, organe ili tkiva u budućnosti.
English: Therefore, patients who have received Zynteglo should not be screened for HIV infection using a PCR-based assay.
Croatian: Stoga bolesnici koji su primili Zynteglo ne smiju biti ispitani na HIV infekciju pomoću testa baziranog na PCR-u.
English: Women who could become pregnant and men capable of fathering a child must start using a reliable method of contraception from before their blood stem cells are collected and continue until at least 6 months after receiving Zynteglo.
Croatian: Žene koje mogu zatrudnjeti i muškarci sposobni začeti dijete moraju početi koristiti pouzdan način kontracepcije prije prikupljanja matičnih stanica krvi i nastaviti je koristiti još najmanje 6 mjeseci nakon primanja lijeka Zynteglo.
English: • enlarged spleen which may result in pain in your upper left belly or left shoulder
Croatian: • osip • povećana slezena koja može izazvati bol u gornjem lijevom dijelu trbuha ili lijevom ramenu
English: Although this medicine will not give you HIV infection, having Zynteglo in your blood may cause a false positive HIV test result with some commercial tests that recognise a piece of HIV used to make Zynteglo.
Croatian: Iako vas ovaj lijek neće zaraziti HIVom, Zynteglo u vašoj krvi može uzrokovati lažno pozitivan rezultat testa na HIV kod nekih komercijalnih testova koji prepoznaju dio HIV-a koji se koristi za proizvodnju lijeka Zynteglo.
English: In HGB-207 and HGB-212 prophylaxis for VOD/hepatic sinusoidal obstruction syndrome was required per institutional practice with ursodeoxycholic acid or defibrotide.
Croatian: U HGB-207 i HGB-212 bila je potrebna profilaksa za venookluzivnu bolest jetre / sindrom sinusoidalne opstrukcije jetre primjenom ursodeoksikolne kiseline ili defibrotide sukladno praksi ustanove.
English: • yellowing of skin and eyes
Croatian: • žuta boja kože i očiju
English: Each infusion bag contains approximately 20 mL of Zynteglo.
Croatian: Jedna infuzijska vrećica sadrži približno 20 ml lijeka Zynteglo.
English: Events were mild and included abdominal pain, hot flush, dyspnoea, and non-cardiac chest pain in 9.5%, 2.4%, 2.4%, and 2.4% of patients, respectively.
Croatian: Nuspojave su bile blage i uključivale su bol u abdomenu kod 9,5 % bolesnika, napadaje vrućine u 2,4 %, dispneju u 2,4 %, i bol u prsima u 2,4 % bolesnika.
English: It can only be given in a specialised hospital by doctors who are experienced in treating patients with TDT, administering bone marrow transplants, and using gene therapy medicines.
Croatian: Može se dati samo u specijaliziranoj bolnici od strane liječnika koji su iskusni u liječenju bolesnika s TDT-om, primjenom transplantata koštane srži i korištenjem genske terapije.
English: Expose the sterile port on the infusion bag by tearing off a protective wrap covering the port.
Croatian: Izložite sterilni priključak na infuzijskoj vrećici tako što ćete otrgnuti zaštitni omotač koji pokriva priključak.
English: The planned dose of G-CSF was 10 µg/kg/day in patients with a spleen, and 5 µg/kg/day in patients without a spleen, given on Days 1 through 5 of mobilisation in the morning.
Croatian: Planirana doza G-CSF-a iznosila je 10 μg/kg/dan u bolesnika sa slezenom, a 5 μg/kg/dan u bolesnika bez slezene, koje su se davale od 1. do 5. dana mobilizacije, ujutro.
English: After completion of the 4-day course of myeloablative conditioning, there must be a minimum of 48 hours of washout before Zynteglo infusion.
Croatian: Nakon završetka 4-dnevnog režima mijeloablativnog kondicioniranja, razdoblje ispiranja (engl. washout) mora trajati najmanje 48 sati prije infuzije lijeka Zynteglo.
English: Pre-treatment transfusion volumes
Croatian: Volumeni transfuzije prije liječenja
English: • tingling or numbness of the hands, feet, or mouth
Croatian: • trnci ili utrnulost šaka, stopala ili usta
English: If a patient requires anti-retrovirals following exposure to HIV/HTLV, initiation of Zynteglo treatment should be delayed until an HIV western blot and viral load assay have been performed at 6 months post-exposure.
Croatian: Ako je u bolesnika potrebno liječenje antiretrovirusnim lijekovima nakon izlaganja HIV-u/HTLV-u, početak liječenja lijekom Zynteglo treba odgoditi sve dok se ne napravi Western blot i test virusnog opterećenja 6 mjeseci nakon izloženosti HIV-u.
English: The patient information pack should contain:
Croatian: • Paket informacija za bolesnika treba sadržavati:
English: Zynteglo works by adding functional copies of the beta-globin gene into these cells, so that the patient can make enough beta-globin to increase total haemoglobin, improve anaemia, and carry more oxygen around their body.
Croatian: Zynteglo djeluje dodavanjem funkcionalne kopije gena za beta-globin u ove stanice, tako da bolesnik može stvarati dovoljno beta-globina koji bi omogućio povećanje ukupnog hemoglobina, poboljšanje anemije i veći prijenos kisika u tijelu.
English: During the long-term follow-up, your doctor will monitor you for any signs of leukaemia or lymphoma.
Croatian: Tijekom dugotrajnog praćenja nakon liječenja lijekom Zynteglo, liječnik će vas nadzirati u vezi bilo kakvih znakova leukemije ili limfoma.
English: • flu like illness
Croatian: • bolest slična gripi
English: Talk to your doctor if you need to have any vaccinations.
Croatian: Obratite se svom liječniku ako biste se trebali cijepiti.
English: 3521AZ Utrecht The Netherlands
Croatian: 3521AZ Utrecht Nizozemska
English: Cardiac T2* at baseline was >20 msec.
Croatian: Srčani T2* na početku je bio > 20 ms.
English: Of the patients with a non-β0/β0 genotype, 11/14 (78.6%, 95% CI 49.2%-95.3%) achieved TI by Month 24 (Table 5).
Croatian: Među bolesnicima s ne-β0/β0 genotipom, 11/14 (78,6%, 95% CI 49,2%95,3%) postiglo je TI do 24. mjeseca (Tablica 5).
English: βA-T87Q-globin expression is designed to correct the β/α-globin imbalance in erythroid cells of patients with TDT and has the potential to increase total Hb to normal levels and eliminate dependence on chronic RBC transfusions.
Croatian: Ekspresija gena za βA-T87Q-globin osmišljena je kako bi se ispravila neravnoteža β/α-globina u eritroidnim stanicama bolesnika s TDT-om i ima potencijal za povećanje ukupnog Hb na normalne razine i eliminiranje ovisnosti o kroničnim transfuzijama RBC-a.
English: • Prolonged bleeding or bleeding without injury such as nosebleeds, bleeding from gums, or vaginal bleeding.
Croatian: • Dugotrajno krvarenje ili krvarenje bez ozljeda kao što su krvarenje iz nosa, krvarenje desni ili krvarenje iz rodnice.
English: Nevertheless, there is a theoretical risk of leukaemia or lymphoma after treatment with Zynteglo.
Croatian: Ipak, postoji teoretski rizik od leukemije ili limfoma nakon liječenja lijekom
English: - If you have any further questions, ask your doctor or nurse.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku ili medicinskoj sestri.
English: 20 mL fluoro-ethylenepropylene infusion bag(s), each packed in a transparent pouch inside a metal cassette.
Croatian: Fluoroetilenpropilenska infuzijska vrećica(e) od 20 ml, svaka pakirana u prozirnu vrećicu unutar metalne kazete.
English: All patients must be advised on signs of leukaemia and to seek immediate medical attention if these signs are present.
Croatian: Sve bolesnike treba upoznati sa znakovima leukemije i upozoriti ih da odmah zatraže liječničku pomoć ako primijete te znakove.
English: Bleeding is a potential complication of thrombocytopenia subsequent to myeloablative conditioning and treatment with Zynteglo.
Croatian: Krvarenje predstavlja potencijalnu komplikaciju trombocitopenije nakon mijeloablativnog kondicioniranja i liječenja lijekom Zynteglo.
English: • dizziness, or sensation of feeling off balance or like the room is spinning
Croatian: • omaglica ili osjećaj neravnoteže ili osjećaj vrtnje prostorije u kojoj se nalazite
English: The busulfan SmPC was used for information on appropriate method for determination of patient weight-based dosing.
Croatian: Sažetak opisa svojstava lijeka za busulfan korišten je za informacije o odgovarajućoj metodi za određivanje doze na temelju tjelesne težine bolesnika.
English: o Information on the possibility of false positivity of certain commercial HIV tests because of Zynteglo.
Croatian: o Informacije o mogućnosti lažno pozitivnih rezultata dobivenih određenim komercijalnim testovima na HIV zbog liječenja lijekom Zynteglo.
English: • The patient alert card shall contain the following key messages: o Information of risk of delayed platelet engraftment, potentially leading to bleeds, and theoretical risks.
Croatian: • Kartica s upozorenjima za bolesnika mora sadržavati sljedeće klučne poruke: o Informacije o rizicima odgođenog oporavka stvaranja trombocita, koje potencijalno dovodi do krvarenja, i teoretskim rizicima.
English: Patients were considered to be transfusion-dependent if they had a history of transfusions of at least 100 mL/kg/year of RBCs or with ≥8 transfusions of RBCs per year in the 2 years preceding enrolment.
Croatian: Smatralo se da su bolesnici ovisni o transfuziji ako su primali transfuziju eritrocita od najmanje 100 ml/kg/godinu ili ≥ 8 transfuzija eritrocita godišnje tijekom 2 godine prije uključivanja u ispitivanje.
English: • numbness and pain in hands and feet
Croatian: • utrnulost i bol u šakama i stopalima
English: • unusual hair loss or thinning
Croatian: • neobičan gubitak ili prorjeđivanje kose
English: All patients completed HGB-204 and HGB-205 and enrolled for long-term follow-up in the LTF-303 study.
Croatian: Svi su bolesnici dovršili HGB-204 i HGB-205 te su se uključili u dugotrajno praćenje u ispitivanju LTF-303.
English: The finished product is composed of one or more infusion bags which contain a dispersion of 1.2-20 × 106 cells/mL suspended in cryopreservative solution.
Croatian: Gotovi lijek sastoji se od jedne ili više infuzijskih vrećica koje sadrže disperziju 1,2-20 × 106 stanica/ml suspendiranih u otopini za krioprezervaciju.
English: Do not leave the medicinal product unattended and do not submerge the infusion ports if thawed in a water bath.
Croatian: Ne ostavljajte lijek bez nadzora i ako se lijek odmrzava u vodenoj kupelji, nemojte uroniti priključke (portove) za infuziju u vodenu kupelj.
English: Some side effects observed in clinical studies with Zynteglo are related to mobilisation and blood stem cell collection or to the chemotherapy medicine used to prepare your bone marrow for treatment with Zynteglo.
Croatian: Neke nuspojave opažene u kliničkim ispitivanjima s lijekom Zynteglo povezane su s mobilizacijom i prikupljanjem matičnih stanica krvi ili kemoterapijskim lijekom koji se koristi za pripremu koštane srži za liječenje lijekom Zynteglo.
English: o Treatment with Zynteglo is in theory associated with the risk of insertional mutagenesis, potentially leading to development of malignancy.
Croatian: o Liječenje lijekom Zynteglo u teoriji je povezano s rizikom od insercijske mutageneze, koja može potencijalno dovesti do razvoja maligne bolesti.
English: Pre-medication for infusion reactions was managed at physician discretion.
Croatian: Predmedikacija zbog infuzijske reakcije provođena je prema odluci liječnika.
English: Zynteglo infusion should be completed as soon as possible and no more than 4 hours after thawing.
Croatian: Infuziju Zynteglom treba dovršiti što je prije moguće i ne kasnije od 4 sata nakon odmrzavanja.
English: Patients should be made aware of the risk of bleeding until platelet recovery has been achieved.
Croatian: Bolesnici moraju biti upoznati s rizikom od krvarenja dok se ne postigne oporavak trombocita.
English: • decrease in magnesium, calcium, potassium, phosphate, albumin, sodium in blood
Croatian: • smanjena razina magnezija, kalcija, kalija, fosfata, albumina, natrija u krvi
English: In the 3 patients who did not achieve TI, reductions of 100%, 86.9% and 26.8% in transfusion volume requirements and of 100%, 85.3% and 20.7% in transfusion frequency were observed between Month 6 through Month 24 visit when compared to their pre-study levels of RBC transfusions.
Croatian: U 3 bolesnika koja nisu postigli TI, smanjenje od 100%, 86,9% i 26,8% u zahtjevima za transfuzijom prema volumenu i od 100%, 85,3% i 20,7% u učestalosti transfuzije opaženi su u posjetima između 6. i 24. mjeseca u usporedbi s njihovim razinama transfuzija eritrocita prije ispitivanja.
English: Store in the vapour phase of liquid nitrogen at ≤-140°C until ready for thaw and administration.
Croatian: Čuvati u plinovitoj fazi tekućeg dušika na ≤-140 °C dok sve ne bude spremno za odmrzavanje i primjenu.
English: Non-β0/β0 patients
Croatian: Bolesnici koji nisu β0/β0
English: Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na poseban i ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: Women of childbearing potential and men capable of fathering a child must use a reliable method of contraception (intra-uterine device or combination of hormonal and barrier contraception) from start of mobilisation through at least 6 months after administration of Zynteglo.
Croatian: Žene u reproduktivnoj dobi i muškarci koji mogu začeti dijete moraju koristiti pouzdnu metodu kontracepcije (intrauterini sustav ili kombinaciju hormonske i barijerne kontracepcije) od početka mobilizacije kroz najmanje 6 mjeseci nakon primjene lijeka Zynteglo.
English: Tables 1, 2, and 3 are lists of adverse reactions attributed to mobilisation/apheresis, myeloablative conditioning, and Zynteglo, respectively, experienced by patients with TDT in clinical trials with Zynteglo.
Croatian: Tablice 1, 2 i 3 predstavljaju popise nuspojava pripisanih mobilizaciji/aferezi odnosno mijeloablativnom kondicioniranju odnosno lijeku Zynteglo koji su doživjeli bolesnici s TDT-om u kliničkim ispitivanjima lijeka Zynteglo.
English: There are no data on the effects of Zynteglo on human fertility.
Croatian: Ne postoje podaci o utjecaju lijeka Zynteglo na plodnost u ljudi.
English: Adding a new gene into the DNA of your blood stem cells could theoretically cause leukaemia or lymphoma, although no patients have developed leukaemia or lymphoma in clinical trials with Zynteglo.
Croatian: Dodavanje novog gena u DNK matičnih stanica krvi teoretski može uzrokovati leukemiju ili limfom iako u kliničkim ispitivanjima s lijekom Zynteglo nijedan bolesnik nije razvio leukemiju ili limfom.
English: You should stop taking medicines to remove iron from your body (so-called chelating agents: deferoxamine, deferiprone and/or deferasirox) 7 days before you start the chemotherapy before the infusion of Zynteglo (see section 3, How Zynteglo is given).
Croatian: Morate prestati uzimati lijekove za uklanjanje željeza iz tijela (takozvane lijekove za kelaciju: deferoksamin, deferipron i/ili deferasiroks) 7 dana prije početka kemoterapije koja prethodi infuziji lijeka Zynteglo (vidjeti dio 3, Kako se primjenjuje Zynteglo).
English: Local biosafety guidelines applicable for such products should be followed.
Croatian: Potrebno je pridržavati se nacionalne smjernice o biološkoj sigurnosti koja se primjenjuju za takve lijekove.
English: Prophylaxis for hepatic veno-occlusive disease (VOD) is recommended.
Croatian: Preporučuje se profilaksa za jetrenu venookluzivnu bolest (engl. veno-occlusive disease, VOD).
English: Before receiving Zynteglo you will be given chemotherapy in order to remove your existing bone marrow.
Croatian: Prije nego što primite lijek Zynteglo, primit ćete kemoterapiju kako bi se uklonila vaša postojeća koštana srž.
English: This medicinal product contains 391-1564 mg sodium per dose equivalent to 20 to 78% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 391-1564 mg natrija po dozi, što odgovara 20 do 78% preporučenog maksimalnog dnevnog unosa od 2 g natrija prema preporuci SZO za odraslu osobu.
English: Zynteglo is not expected to interact with the hepatic cytochrome P-450 family of enzymes or drug transporters.
Croatian: Ne očekuje se da će doći do interakcije lijeka Zynteglo s porodicom jetrenih enzima citokroma P-450 ili prijenosnicima lijekova.
English: • injection site reaction
Croatian: • reakcija na mjestu primjene injekcije
English: The median (min, max) busulfan dose was 3.50 (2.5, 5.0) mg/kg/day (N=32).
Croatian: Medijan (min, maks) doze busulfana iznosio je 3,50 (2,5; 5,0) mg/kg/dan (N=32).
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Croatian: Neiskorišteni lijek mora se zbrinuti u skladu s lokalnim smjernicama za biološku sigurnost.
English: Healthcare professionals handling Zynteglo should take standard precautions (wearing gloves, protective clothing and eye protection) to avoid potential transmission of infectious diseases.
Croatian: Zdravstveni radnici koji rukuju lijekom Zynteglo trebaju poduzeti standardne mjere opreza (nošenje rukavica, zaštitne odjeće i zaštite za oči) kako bi se izbjegao potencijalni prijenos zaraznih bolesti.
English: (See section 4.4 for guidance on platelet monitoring and management.)
Croatian: (Vidjeti dio 4.4 za smjernice o praćenju trombocita i terapiji poremećaja njihovih vrijednosti.)
English: If leukaemia or lymphoma is detected in any patient who received Zynteglo, blood samples should be collected for integration site analysis.
Croatian: Ako se u bilo kojeg bolesnika koji je primio Zynteglo otkrije leukemija ili limfom, uzorci krvi trebaju se prikupiti za analizu mjesta integracije.
English: Zynteglo is a type of medicine called gene therapy.
Croatian: Zynteglo spada u vrstu lijekova koja se zove genska terapija.
English: The quantitative information regarding strength, CD34+ cells, and dose for the medicinal product is provided in the Lot Information Sheet.
Croatian: Kvantitativne informacije o lijeku vezane uz jačinu, CD34+ stanice i dozu lijeka nalaze se u listu s informacijama o lotu.
English: Following platelet engraftment, all patients maintained platelet levels of ≥20 × 109/L in the absence of platelet transfusions.
Croatian: Nakon obnove stvaranja trombocita, svi bolesnici održali su razine trombocita od ≥20 × 109/l u odsutnosti transfuzija trombocita.
English: • Pain in the right upper abdomen under the ribs, yellowing of eyes or skin, rapid weight gain, swelling of arms, legs and abdomen, and trouble breathing.
Croatian: • Bol u desnom gornjem dijelu trbuha, ispod rebara, žutilo očiju ili kože, ubrzano povećanje tjelesne težine, oticanje ruku, nogu i trbuha te poteškoće s disanjem.
English: All patients who experienced VOD received treatment with defibrotide and recovered.
Croatian: Svi bolesnici kod kojih se javila venookluzivna bolest primali su liječenje defibrotidom i oporavili su se.
English: Patients treated with Zynteglo should not donate blood, organs, tissues or cells for transplantation at any time in the future.
Croatian: Bolesnici liječeni ljekom Zynteglo ne smiju donirati krv, organe, tkiva ili stanice za transplantaciju u bilo kojem trenutku u budućnosti.
English: At least 6 days before Zynteglo infusion
Croatian: Najmanje 6 dana prije infuzije lijeka Zynteglo
English: Approximately 2 months before Zynteglo infusion
Croatian: Približno 2 mjeseca prije infuzije lijeka Zynteglo
English: The modified virus is used to insert a functional beta-globin gene into your blood stem cells.
Croatian: Modificirani virus se koristi za umetanje funkcionalnog gena za beta-globin u vaše matične stanice krvi.
English: • bruising, bleeding or pain from catheter or injection site
Croatian: • modrice, krvarenje ili bol na mjestu umetanja katetera ili primjene injekcije
English: • The patient/carer guide shall contain the following key messages: o Treatment with Zynteglo is in theory associated with the risk of development of malignancy.
Croatian: • Vodič za bolesnika/njegovatelja mora sadržavati sljedeće ključne poruke: o Liječenje lijekom Zynteglo u teoriji je povezano s rizikom od razvoja maligne bolesti.
English: Zynteglo must be administered in a qualified treatment centre by a physician(s) with experience in HSC transplantation and in the treatment of patients with TDT.
Croatian: Zynteglo se mora primijeniti u kvalificiranom centru za liječenje od strane liječnika s iskustvom u transplantaciji HSC-a i u liječenju bolesnika s TDT-om.
English: Insertion site analysis (ISA) of pre-transplantation transduced mouse BMCs and human CD34+ HSCs showed no enrichment for insertion in or near cancer-related genes.
Croatian: Analize mjesta umetanja (engl. insertion site analysis, ISA) predtransplantacijskih transduciranih mišjih BMC stanica i ljudskih CD34+ HSC stanica nisu pokazale obogaćivanje za umetanje u ili u blizini gena povezanih s rakom.
English: No cases of leukaemia or lymphoma have been reported in clinical studies with Zynteglo in patients with TDT.
Croatian: Nisu zabilježeni slučajevi leukemije ili limfoma u kliničkim ispitivanjima s lijekom Zynteglo u bolesnika s TDT-om.
English: Transfusion-dependent β-thalassaemia (TDT)
Croatian: Β-talasemija ovisna o transfuziji (TDT)
English: See Lot Information Sheet for number of infusion bags and CD34+ cells per kg for this patient.
Croatian: Vidjeti list s informacijama o lotu za podatak o broj vrećica infuzije i CD34+ stanica po kilogramu za ovog bolesnika.
English: Healthcare professionals handling Zynteglo should take appropriate precautions (wearing gloves, protective clothing and eye protection) to avoid potential transmission of infectious diseases.
Croatian: Zdravstveni radnici koji rukuju s lijekom Zynteglo trebaju poduzeti odgovarajuće mjere opreza (nošenje rukavica, zaštitne odjeće i zaštite za oči) kako bi izbjegli potencijalni prijenos zaraznih bolesti.
English: 85521 Ottobrunn GERMANY
Croatian: 85521 Ottobrunn NJEMAČKA
English: • changes and abnormalities in heart rhythm
Croatian: • promjene i poremećaji srčanog ritma
English: All patients were administered G-CSF and plerixafor to mobilise stem cells prior to the apheresis procedure.
Croatian: Svi su bolesnici primali G-CSF i pleriksafor kako bi mobilizirali matične stanice prije postupka afereze.
English: A patient may have multiple infusion bags.
Croatian: Za jednog bolesnika može biti namjenjeno više infuzijskih vrećica.
English: More specifically, people with TDT do not make enough of a part of the haemoglobin called beta-globin, due to a gene defect.
Croatian: Točnije, zbog nedostatka na genu, osobe s TDT-om ne proizvode dovoljnu količinu jednog dijela hemoglobina koji se naziva beta-globin.
English: Platelet engraftment is defined as 3 consecutive platelet values ≥20 × 109/L obtained on different days after Zynteglo infusion, with no platelet transfusions administered for 7 days immediately preceding and during the evaluation period.
Croatian: Oporavak stvaranja trombocita definira se kao 3 uzastopne vrijednosti trombocita ≥ 20 × 109/l dobivene u različitim danima nakon infuzije lijeka Zynteglo, bez transfuzije trombocita primijenjene 7 dana neposredno prije i tijekom razdoblja procjene.
English: The traceability requirements of cell-based advanced therapy medicinal products must apply.
Croatian: Sljedivost Moraju se primjenjivati zahtjevi sljedivosti lijekova za naprednu terapiju temeljenu na stanicama.
English: Apheresis material from patients with a positive test for HIV will not be accepted for Zynteglo manufacturing.
Croatian: Materijal dobiven aferezom u bolesnika s pozitivnim testom na HIV neće biti prihvaćen za proizvodnju lijeka Zynteglo.
English: HSC transplantation must be appropriate for a patient with TDT to be treated with Zynteglo (see section 4.4).
Croatian: Transplantacija HSC-a mora biti prikladna za bolesnika s TDT-om koji će se liječiti lijekom Zynteglo (vidjeti dio 4.4).
English: This is because Zynteglo is a gene therapy medicine.
Croatian: To je zato što je Zynteglo lijek za gensku terapiju.
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus
Croatian: • bol i oticanje sluznice probavnog trakta od usta do anusa