FrancophonIA/ELRC3.0 huggingface dataset:
English: Total Hb remained stable at Month 24 with a median (min, max) of 10.60 (8.8, 13.7) g/dL (N=12) and at Month 36 with a median (min, max) of 11.30 (7.8, 13.5) g/dL (N=11).
Croatian: Ukupni Hb ostao je stabilan u 24. mjesecu s medijanom (min, maks) od 10,60 (8,8; 13,7) g/dl (N = 12) i u 36. mjesecu s medijanom (min, maks) od 11,30 (7,8; 13,5) g/dl (N = 11).
English: Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion.
Croatian: Zynteglo 1,2-20 × 106 stanica/ml disperzija za infuziju.
English: Zynteglo is shipped from the manufacturing facility to the infusion centre storage facility in a cryoshipper, which may contain multiple metal cassettes intended for a single patient.
Croatian: Zynteglo se iz proizvodnog pogona dostavlja u ustanove u kojoj se primjenjuje infuzija pohranjen u spremniku za kriogeno čuvanje, koji može sadržavati više metalnih kazeta namijenjenih za istog bolesnika.
English: MRI of the liver should be performed on all patients prior to myeloablative conditioning.
Croatian: MR jetre treba provesti u svih bolesnika prije mijeloablativnog kondicioniranja.
English: o Package leaflet o A patient/carer guide o A patient alert card
Croatian: o Uputu o lijeku o Vodič za bolesnika/njegovatelja o Karticu s upozorenjima za bolesnika
English: • After thaw, mix the medicinal product gently by massaging the infusion bag until all of the contents are uniform.
Croatian: • Nakon odmrzavanja, pomiješajte lijek nježnim pritiskanje infuzijske vrećice dok se sav sadržaj ne ujednači.
English: After Zynteglo infusion
Croatian: Nakon infuzije Zyntegla
English: Among these 11 patients, the median (min, max) weighted average Hb during TI was 10.51 (9.3, 13.2) g/dL (Table 5).
Croatian: Među tih 11 bolesnika medijan (min, maks) ponderiranog prosječnog Hb tijekom TI-a iznosio je 10,51 (9,3; 13,2) g/dl (tablica 5).
English: • inflamed skin lesions
Croatian: • upale kožnih lezija
English: Lot:
Croatian: DIN: Lot:
English: • Account for all infusion bags and confirm each infusion bag is within the expiry date using the accompanying Lot Information Sheet.
Croatian: • Izbrojite sve infuzijske vrećice i provjerite da je svaka infuzijska vrećica unutar roka valjanosti koristeći se priloženim listom s informacijama o lotu.
English: The minimum target number of CD34+ cells to be collected is 12 × 106 CD34+ cells/kg.
Croatian: Minimalni ciljni broj CD34+ stanica koje se prikupljaju je 12 × 106 CD34+ stanica/kg.
English: If more than one infusion bag is provided, administer each infusion bag completely before proceeding to thaw and infuse the next bag.
Croatian: Ako je priloženo više infuzijskih vrećica, primijenite svaku infuzijsku vrećicu do kraja prije nego što nastavite s odmrzavanjem i ubrizgavanjem sljedeće vrećice.
English: The Lot Information Sheet is included inside the lid of the cryoshipper used to transport Zynteglo.
Croatian: List s informacijama o lotu uključen je u poklopac kriogenog spremnika koji se koristi za transport lijeka Zynteglo.
English: • Zynteglo will only be available through bluebird bio qualified treatment centres to ensure traceability of the patient`s cells and manufactured drug product between the treating hospital and manufacturing site.
Croatian: proizvodnje, izdavanja i primjene lijeka: • Zynteglo će biti dostupan samo putem centara kvalificiranih od strane bluebird bio kompanije kako bi se osigurala sljedivost bolesnikovih stanica i proizvedenog lijeka između bolnice u kojoj se obavlja liječenja i mjesta proizvodnje.
English: • spots on skin from bleeding under the skin
Croatian: • mrlje na koži od potkožnog krvarenja
English: Name and address of the manufacturer(s) responsible for batch release apceth Biopharma GmbH Haidgraben 5
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet apceth Biopharma GmbH Haidgraben 5
English: o Enrolment in the drug product Registry.
Croatian: o Upisivanje u registar liječenih bolesnika.
English: No data from clinical studies are available regarding overdose of Zynteglo.
Croatian: Nisu dostupni podaci iz kliničkih ispitivanja vezani uz predoziranje lijekom Zynteglo.
English: Hepatic veno-occlusive disease
Croatian: Venookluzivna bolest jetre
English: A negative serology test for HIV is necessary to ensure acceptance of apheresis material for Zynteglo manufacturing.
Croatian: Negativni serološki test na HIV neophodan je kako bi se osiguralo da materijal dobiven aferezom bude prihvatljiv za proizvodnju lijeka Zynteglo.
English: Adverse reactions are listed by MedDRA body system organ class and by frequency.
Croatian: Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava i učestalosti.
English: Eighteen adults and adolescents with TDT with a non-β0/β0 genotype have been treated with Zynteglo in Phase 3 studies (N=15, HGB-207; N=3, HGB-212) and their median (min, max) duration of follow-up was 10.0 (1.3, 22.2) months.
Croatian: Osamnaest odraslih i adolescenata s TDT-om s ne-β0/β0 genotipom liječeni su Zynteglom u ispitivanjima faze 3 (N = 15, HGB-207; N = 3, HGB-212) i njihov medijan (min, maks) trajanja praćenja iznosio je 10,0 (1,3; 22,2) mjeseci.
English: The concentration is 1.2-20 × 106 CD34+ cells (blood stem cells) per millilitre.
Croatian: Koncentracija je 1,220 × 106 CD34+ stanica (matične stanice krvi) po mililitru.
English: Do not sample, alter, or irradiate the medicinal product.
Croatian: Nemojte uzimati uzorke, mijenjati ili ozračiti lijek.
English: Infusion related reactions to Zynteglo
Croatian: Infuzijske reakcije povezane s lijekom Zynteglo
English: All patients with non-β0/β0 genotypes received anti-seizure prophylaxis with agents other than phenytoin prior to initiating busulfan.
Croatian: Prije početka primjene busulfana, svi bolesnici s ne- β0/β0 genotipom primali su profilaktički lijekove protiv napadaja isključujući fenitoin.
English: Anti-retroviral and hydroxyurea use
Croatian: Primjena antiretrovirusnih lijekova i hidroksiureje
English: The median (min, max) total Hb at Month 6 for patients who had not received a transfusion for the prior 60 days was 10.60 (7.6, 13.4) g/dL (N=11).
Croatian: Medijan (min, maks) ukupnog Hb u 6. mjesecu za bolesnike koji nisu primali transfuziju u prethodnih 60 dana iznosio je 10,60 (7,6; 13,4) g/dl (N = 11).
English: n median (min, max)
Croatian: n medijan (min, maks)
English: No correlation was observed between incidence of bleeding adverse events (AEs) and time to platelet engraftment.
Croatian: Nije zabilježena korelacija između incidencije štetnih događaja krvarenja i vremena do oporavka stvaranja trombocita.
English: SAVE THIS DOCUMENT AND PREPARE TO HAVE IT AVAILABLE AT THE TIME OF ZYNTEGLO INFUSION.
Croatian: SPREMITE OVAJ DOKUMENT I NEKA VAM BUDE PRI RUCI U VRIJEME INFUZIJE
English: Patients who experience neutrophil engraftment failure should receive rescue treatment with the back-up collection (see section 4.2).
Croatian: Bolesnici u kojih se pojavi neuspjeh u oporavku stvaranja neutrofila trebali bi dobiti „rescue” liječenje pomoću CD34+ matičnih stanica iz rezervnog prikupljanja (vidjeti dio 4.2).
English: o Treatment with Zynteglo in the clinical trials was associated with delayed platelet engraftment.
Croatian: o Liječenje lijekom Zynteglo u kliničkim ispitivanjima bilo je povezano s odgođenim oporavkom stvaranja trombocita.
English: Precautions regarding bleeding consequences of thrombocytopenia need to be taken.
Croatian: Potrebno je poduzeti mjere opreza vezano uz krvarenje kao posljedicu trombocitopenije.
English: At 48 months after infusion of Zynteglo for patients who achieved TI, the median reduction (min, max) in serum ferritin levels from baseline was 75.02% (39.2, 84.8) (N=3, HGB-204; N=2, HGB-205).
Croatian: 48 mjeseci nakon infuzije lijeka Zynteglo, u bolesnika koji su postigli TI, medijan (min, maks) smanjenja feritina u serumu u odnosu na početnu vrijednost bio je 75,02% (39,2, 84,8) (N=3, HGB-204; N=2, HGB-205).
English: Interference with serology testing
Croatian: Interferencija s testiranjem na HIV
English: In order to confirm the efficacy and safety of Zynteglo in patients 12 years and older with transfusion-dependent β-thalassaemia (TDT) who do not have a β0/β0 genotype, the MAH should submit interim and final data on Study HGB-207
Croatian: Kako bi se potvrdila djelotvornost i sigurnost lijeka Zynteglo u bolesnika u dobi od 12 godina i više s β-talasemijom ovisnom o transfuziji (TDT) koji nemaju β0/β0 genotip, nositelj odobrenja treba dostaviti interim i konačne podatke o ispitivanju HGB-207
English: o Details on reporting of adverse effects.
Croatian: o Informacije o prijavljivanju nuspojava.
English: Patients should be assessed for hepatic impairment to ensure HSC transplantation is appropriate (see section 4.4.).
Croatian: Bolesnike treba procijeniti s obzirom na oštećenje funkcije jetre kako bi se osigurala odgovarajuća transplantacija HSC-a (vidjeti dio 4.4).
English: The median (min, max) total Hb at Month 6 for patients who had not received a transfusion for the prior 60 days was 11.90 (8.4, 13.3) g/dL (N=11).
Croatian: Medijan (min, maks) ukupnog Hb-a u 6. mjesecu za bolesnike koji nisu primili transfuziju posljednjih 60 dana iznosio je 11,90 (8,4; 13,3) g/dl (N = 11).
English: How to store Zynteglo
Croatian: Kako čuvati Zynteglo
English: The entire volume of each infusion bag should be infused.
Croatian: Potrebno je infuzijom primijeniti cijelokupni volumen svake pojedine infuzijske vrećice.
English: You should not be given Zynteglo if you are breast-feeding.
Croatian: Ne smijete primiti Zynteglo ako dojite.
English: Final results: December 2021
Croatian: prosinac 2021.
English: The following requirements need to be fulfilled before the product is prescribed, manufactured, dispensed and used:
Croatian: Sljedeći zahtjevi moraju biti ispunjeni prije propisivanja,
English: Neutrophil engraftment occurred on median (min, max) Day 19.5 (13, 38) after medicinal product infusion.
Croatian: Do oporavka stvaranja neutrofila došlo je tijekom razdoblja s medijanom (minimalno, maksimalno) od 19,5 dana (13, 38) nakon infuzije lijeka.
English: (g/dL) at 24 months n median (min, max)
Croatian: (g/dl) nakon 24 mjeseca n medijan (min, maks)
English: The minimum recommended dose of Zynteglo is 5.0 × 106 CD34+ cells/kg.
Croatian: Minimalna preporučena doza lijeka Zynteglo je 5,0 × 106 CD34+ stanica/kg.
English: To add blood stem cells containing functional copies of the beta-globin into your bone marrow.
Croatian: Za dodavanje matičnih stanica krvi koje sadrže funkcionalne kopije gena za beta-globin u
English: Veno-occlusive liver disease, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased
Croatian: Poremećaji jetre i žuči venookluzivna bolest jetre, povišena alanin aminotransferaza, povišena aspartat aminotransferaza, povišen bilirubin u krvi kolecistitis, kolelitijaza,
English: • life-threatening inflammatory response to an infection along with low white blood cell count
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): • životno opasna upalna reakcija na infekciju uz nizak broj bijelih krvnih stanica
English: Women of childbearing potential/Contraception in males and females There are insufficient exposure data to provide a precise recommendation on duration of contraception following treatment with Zynteglo.
Croatian: Nema dovoljno podataka o izloženosti kako bi se pružila precizna preporuka o trajanju kontracepcije nakon liječenja lijekom Zynteglom.
English: Final results: December 2024
Croatian: prosinac 2024.
English: Studies HGB-207 and HGB-212
Croatian: Ispitivanja HGB-207 i HGB-212
English: • changes in blood chemistry which may indicate low calcium, low potassium, low magnesium,
Croatian: • promjene u kemijskom profilu krvi koje mogu ukazivati na nizak kalcij, nizak kalij, nizak magnezij, nizak natrij, nizak fosfat, smanjenje proteina ili smanjenje albumina
English: The median (min, max) serum ferritin at baseline was 3778.7 (784, 22517) pmol/L and median (min, max) liver iron concentration was 6.75 (1.0, 41.0) mg/g (N=10, HGB-204; N=4, HGB-205; N=15, HGB-207; N=3, HGB-212).
Croatian: Medijan (min, maks) vrijednosti serumskog feritina na početku liječenja iznosio je 3778,7 (784, 22517) pmol/l i medijan (min, maks) koncentracije željeza u jetri bio je 6,75 (1,0; 41,0) mg/g (N=10, HGB-204; N=4, HGB 205; N=15, HGB-207; N=3,
English: Pre-treatment transfusions per year median (min, max)
Croatian: Broj transfuzija prije liječenja, godišnje medijan (minimalno, maksimalno)
English: Chemotherapy medicine
Croatian: • povraćanje Kemoterapijski lijek
English: You should not take hydroxyurea (a medicine for blood disorders) or any medicines for HIV infection from at least one month before you undergo mobilisation until at least 7 days after Zynteglo infusion (see also section 3, How Zynteglo is given).
Croatian: Ne smijete uzimati hidroksiureju (lijek za poremećaje krvi) ni bilo kakve lijekove za infekciju HIV-om ili hidroksiureju najmanje mjesec dana prije nego što prođete mobilizaciju i još najmanje 7 dana nakon infuzije lijeka Zynteglo (vidjeti također dio 3, Kako se primjenjuje Zynteglo).
English: The effect of administration of Zynteglo to mothers on their breast-fed children has not been studied.
Croatian: Učinak koji primjena lijeka Zynteglo u majki ima na dojenčad nije ispitivan.
English: • Confirm that patient identity matches the unique patient identification information located on the Zynteglo infusion bag(s).
Croatian: • Provjerite da identitet bolesnika odgovara jedinstvenim identifikacijskim podacima bolesnika koji su navedeni na infuzijskoj vrećici lijeka Zynteglo.
English: The planned dose of busulfan was 3.2 mg/kg/day for patients ≥18 years as a 3-hour IV infusion daily for 4 days with a recommended target AUC0-24h of 3800-4500 µM*min.
Croatian: ≥ 18 godina kao 3-satna i.v. infuzija primjenjena jednom dnevno tijekom 4 dana s preporučenom ciljnom vrijednošću za AUC0-24h od 3800-4500 μM*min.
English: EU/1/19/1367/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1367/001
English: Hypokalaemia, Hypomagnesaemia
Croatian: hipomagnezemija, hiponatremija, hipofosfatemija
English: Neutropenic sepsis, Systemic infection, Staphylococcal infection, Pneumonia, Lower respiratory tract infection, Urinary tract infection, Mucosal infection, Cellulitis, Vaginal infection, Rash pustular, Folliculitis, Gingivitis
Croatian: Infekcije i infestacije neutropenična sepsa, sistemska infekcija, stafilokokna infekcija, upala pluća, infekcija donjih dišnih puteva, infekcija mokraćnog sustava, infekcija sluznice, celulitis, vaginalna infekcija, pustularni osip, folikulitis, gingivitis
English: Patients should not take anti-retroviral medications or hydroxyurea from at least one month prior to mobilisation until at least 7 days after Zynteglo infusion (see section 4.5).
Croatian: Bolesnici ne smiju uzimati antiretrovirusne lijekove ili hidroksiureju najmanje mjesec dana prije mobilizacije do najmanje 7 dana nakon infuzije lijeka Zynteglo (vidjeti dio 4.5).
English: In clinical trials, no patients failed to engraft bone marrow, as measured by neutrophil engraftment (N=42).
Croatian: U kliničkim ispitivanjima, kod svih bolesnike je prihvaćena koštana srž, mjereno u na temelju oporavka stvaranja neutrofila (N=42).
English: 3521AZ Utrecht The Netherlands medinfo@bluebirdbio.com
Croatian: 3521AZ Utrecht Nizozemska e-mail: medinfo@bluebirdbio.com
English: After Zynteglo infusion, patient iron levels were managed at physician discretion.
Croatian: Nakon infuzije lijeka Zynteglo, kelacija željezom u provodila se u bolesnika sukladno procjeni liječnika.
English: Account for all infusion bags and confirm each infusion bag of Zynteglo is within the expiry date using the accompanying Lot Information Sheet.
Croatian: Izbrojite sve infuzijske vrećice i provjerite da je svaka infuzijska vrećica lijeka Zynteglo unutar roka valjanosti koriteći se priloženim listom s informacijama o lotu.
English: (DD/MM/ YYYY)
Croatian: {DD/MM/ GGGG}
English: All patients received full myeloablative conditioning with busulfan prior to treatment with Zynteglo.
Croatian: Prije liječenja lijekom Zynteglo svi bolesnici primili su cjelovito mijeloablativno kondicioniranje s busulfanom.
English: • Each infusion bag should be inspected for any breaches of integrity before thawing and infusion.
Croatian: • Svaku infuzijsku vrećicu potrebno je pregledati prije odmrzavanja i infuzije kako bi bili sigurni da je neoštećena.
English: (g/dL) at 6 months n median (min, max)
Croatian: (g/dl) nakon 6 mjeseci n medijan (min, maks)
English: All patients with TDT with a non-β0/β0 genotype who received Zynteglo with at least 3 months of follow-up produced HbAT87Q (N=10, HGB-204; N=4, HGB-205; N=14, HGB-207; N=1, HGB-212).
Croatian: U svih bolesnika s TDT-om s ne-β0/β0 genotipom koji su primili Zynteglo uz najmanje 3 mjeseca praćenja, došlo je do stvaranja HbAT87Q (N=10, HGB-204; N=4, HGB-205; N=14, HGB-207; N = 1, HGB-212).
English: Patients had a Month 6 median (min, max) HbAT87Q of 4.90 (1.0, 9.6) g/dL in the Phase 1/2 studies (N=14, HGB-204 and HGB-205) and 9.49 (3.4, 10.6) g/dL in the ongoing Phase 3 study (N=11, HGB-207).
Croatian: Medijan vrijednosti (min, maks) HbAT87Q u 6. mjesecu iznosio je 4,90 (1,0; 9,6) g/dl u ispitivanjima faze 1/2 (N=14, HGB-204 i HGB-205) i 9,49 (3,4; 10,6) g/dl ispitivanju faze 3 (N = 11, HGB-207) koje je u tijeku.
English: • flushing (redness and warmth of skin) • pain in legs
Croatian: • navala vrućine (crvenilo i toplina kože)
English: (months) n median (min, max)
Croatian: (mjeseci) n medijan (min, maks)
English: Standard procedures for patient management after HSC transplantation should be followed after Zynteglo infusion.
Croatian: Nakon infuzije lijeka Zynteglo trebaju slijediti standardne procedure za zbrinjavanje bolesnika nakon transplantacije HSC-a.
English: Efficacy was based on 32 adult and adolescent patients with TDT and a non-β0/β0 genotype treated with Zynteglo (N=10, HGB-204; N=4, HGB-205; N=15, HGB-207; N=3, HGB-212) (see Table 4).
Croatian: Djelotvornost se temeljila na ispitivanju u 32 odrasla i adolescentna bolesnika s TDT-om i ne-β0/β0 genotipom liječena lijekom Zynteglo (N=10, HGB-204; N=4, HGB-205; N=15, HGB207; 207; N=3, HGB 212) (vidjeti tablicu 4).
English: In clinical studies doses up to 20 × 106 CD34+ cells/kg have been administered.
Croatian: U kliničkim ispitivanjima primjenjivane su doze do 20 x 106 CD34+ stanica/kg.
English: • The Guide to handling and method of administration for healthcare professionals shall contain the following key elements: o Instructions on receiving and storing of Zynteglo and how to check Zynteglo prior to administration o Instructions about the thawing of Zynteglo o Instructions on protective equipment and treatment of spills.
Croatian: o Upute o zaprimanju i pohrani lijeka Zynteglo te kako provjeriti Zynteglo prije primjene o Upute o odmrzavanju lijeka Zynteglo o Upute o zaštitnoj opremi i postupcima u slučaju izlijevanja.
English: • skin abrasion/scrape
Croatian: • abrazija/ogrebotina na koži
English: Ovarian failure, Menstruation irregular, Premature menopause, Blood follicle stimulating hormone increased, Blood testosterone decreased
Croatian: Poremećaji reproduktivnog sustava i dojki vaginalno krvarenje zatajenje jajnika, nepravilna menstruacija, prijevremena menopauza, povišen folikul stimulirajući hormon u krvi, snižen testosteron u krvi
English: Mobilisation medicine is given To move the blood stem cells from your bone marrow into your blood stream.
Croatian: Za premještanje matičnih stanica krvi iz koštane srži u krvotok.
English: • soreness of the mouth
Croatian: • ranice u ustima
English: Patients should not take anti-retroviral medicinal products or hydroxyurea from at least one month prior to mobilisation until at least 7 days after Zynteglo infusion (see section 4.4).
Croatian: Bolesnici ne smiju uzimati antiretrovirusne lijekove ili hidroksiureju najmanje mjesec dana prije mobilizacije i još najmanje 7 dana nakon infuzije lijeka Zynteglo (vidjeti dio 4.4).
English: • soreness of the rectum area
Croatian: • bol u području rektuma
English: Patients with TDT may be at an increased risk of VOD following myeloablative conditioning compared with other patient populations.
Croatian: Izgleda da su bolesnici koji nisu primali profilaksu za venookluzivnu bolest bili izloženi povišenom riziku od venookluzivne bolesti nakon mijeloablativnog kondicioniranja u usporedbi s drugim populacijama bolesnika.
English: • Infuse Zynteglo as soon as possible and no more than 4 hours after thawing.
Croatian: Primijenite infuziju lijek Zynteglo što je prije moguće i ne kasnije od 4 sata nakon odmrzavanja.
English: Blood magnesium decreased
Croatian: Pretrage snižen magnezij u krvi
English: The median (min, max) duration of follow-up was 40.48 (29.3, 58.6) months.
Croatian: Medijan (min, maks) trajanja praćenja iznosio je 40,48 (29,3; 58,6) mjeseci.
English: After Zynteglo infusion, transduced CD34+ HSCs engraft in the bone marrow and differentiate to produce RBCs containing biologically active βA-T87Q-globin (a modified β-globin protein) that will combine with α-globin to produce functional Hb containing βA-T87Q-globin (HbAT87Q).
Croatian: Nakon infuzije lijeka Zynteglo, transducirane CD34+ HSC stanice budu prihvaćene u koštanu srž i diferenciraju se kako bi proizvodile eritrocite koji sadrže biološki aktivni βA-T87Q-globin (modificirani β-globin protein) koji će se kombinirati s α-globinom za proizvodnju funkcionalnog Hba koji sadrži βA-T87Q-globin (HBAT87Q). βA-T87Q-globin se može kvantificirati u odnosu na ostale vrste globina u perifernoj krvi pomoću tekućinske kromatografije visoke djelotvornosti.
English: Contraindications to the mobilisation agents and the myeloablative conditioning agent must be considered.
Croatian: Moraju se uzeti u obzir kontraindikacije za lijekove za mobilizaciju i mijeloablativne lijekove za kondicioniranje.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: • Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u
English: • Physician educational material • Patient information pack
Croatian: • Edukacijski materijal za liječnike
English: • inflammation of the throat
Croatian: • upala grla
English: (mL/kg/year) median (min, max)
Croatian: (ml/kg/godina) medijan (minimalno, maksimalno)
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava glavobolja,
English: Studies HGB-204 and HGB-205
Croatian: Ispitivanja HGB-204 i HGB-205
English: Warnings and precautions of the mobilisation agents and the myeloablative conditioning agent must be considered.
Croatian: Potrebno je razmotriti upozorenja i mjere opreza za lijekove za mobilizaciju i mijeloablativne lijekove za kondicioniranje.
English: Baseline characteristics for non-β0/β0 patients with TDT ≥12 years of age treated with Zynteglo (Studies HGB-204, HGB-205, HGB-207, HGB-212, LTF-303)
Croatian: Tablica 4 Početne karakteristike za bolesnike koji nisu β0/β0 i s TDT-om u dobi od ≥12 godina liječene Zynteglom (ispitivanja HGB-204, HGB-205, HGB-207, HGB-212, LTF-303)
English: Marketing Authorisation Holder and Manufacturer bluebird bio (Netherlands) B.V. Stadsplateau 7
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač bluebird bio (Netherlands) B.V.