FrancophonIA/ELRC3.0 huggingface dataset:
English: Before treatment with Zynteglo, you will be given medicines know as mobilisation medicine and chemotherapy medicine (see sections 3 and 4 for more information on these medicines, including possible side effects).
Croatian: Prije liječenja lijekom Zynteglo primit ćete lijekove koji se zovu lijekovi za mobilizaciju i kemoterapijski lijekovi (vidjeti dijelove 3 i 4 za dodatne informacije o ovim lijekovima, uključujući moguće nuspojave).
English: The MAH shall ensure that in each Member State where Zynteglo is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense and/or use Zynteglo have access to/are provided with the following educational package to be disseminated through professional bodies:
Croatian: Nositelj odobrenja mora osigurati da u svakoj zemlji članici u kojoj je Zynteglo stavljen u promet, svi zdravstveni radnici i bolesnici/njegovatelji za koje se očekuje da će Zynteglo propisivati, izdavati i/ili da će ga koristiti imaju pristup/dobiju sljedeći edukacijski paket koji će biti distribuiran putem stručnih tijela:
English: The dose of G-CSF should be decreased by half if white blood cell (WBC) count is >100 × 109/L prior to the day of apheresis.
Croatian: Dozu GCSF-a treba smanjiti za polovicu ako je broj bijelih krvnih stanica (WBC) > 100 × 109/l prije dana afereze.
English: Adolescents were excluded from Phase 3 studies if they had a known and available HLA-matched related HSC donor.
Croatian: Adolescenti su bili isključeni iz ispitivanja faze 3 ako su imali poznatog i dostupnog srodnog davatelja HSC-a s podudarnim sustavom HLA antigena.
English: What Zynteglo is and what it is used for
Croatian: Što je Zynteglo i za što se koristi
English: Zynteglo has no influence on the ability to drive or use machines.
Croatian: Zynteglo ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: It may take more than 1 day to collect enough blood stem cells to make Zynteglo and to store as replacement cells if Zynteglo cannot be given or does not work.
Croatian: Možda će biti potrebno više od 1 dana za prikupljanje matičnih stanica krvi dostatnih i za proizvodnju lijeka Zynteglo i za rezervnu pohranu za zamjenske stanice ako se Zynteglo ne može dati ili ne djeluje.
English: • irregular menstruation
Croatian: • neredovne menstruacije
English: • small tear in tissue that lines the anus
Croatian: • mala raspuklina u tkivu koje prekriva anus
English: A clear to slightly cloudy, colourless to yellow or pink dispersion.
Croatian: Bistra do blago zamućena, bezbojna do žuta ili ružičasta disperzija.
English: In this study, there was no evidence of toxicity, genotoxicity or oncogenesis (tumorigenicity) related to BB305 LVV integration, and no toxicity related to production of βA-T87Q-globin.
Croatian: U ovom ispitivanju nije bilo dokaza o toksičnosti, genotoksičnosti ili onkogenezi (tumorogeničnosti) koja se odnosi na integraciju BB305 LVV-a i nema toksičnosti povezane s proizvodnjom βA-T87Qglobina.
English: It is recommended that patients with MRI results demonstrating liver iron content ≥15 mg/g undergo liver biopsy for further evaluation.
Croatian: Preporučuje se da se u bolesnika s MR rezultatima koji pokazuju sadržaj željeza u jetri ≥ 15 mg/g učini biopsija jetre radi daljnje evaluacije.
English: It is recommended that patients maintain haemoglobin (Hb) ≥11 g/dL for 30 days prior to myeloablative conditioning.
Croatian: Preporučuje se da u bolesnika bude održana vrijednost hemoglobina (Hb) ≥ 11 g/dl tijekom 30 dana prije mijeloablativnog kondicioniranja.
English: It is important to note that patients who have received Zynteglo are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to LVV provirus insertion, resulting in a false positive test for HIV.
Croatian: Važno je napomenuti da će bolesnici koji su primili Zynteglo vjerojatno imati pozitivnu lančanu reakciju polimeraze (PCR) na HIV zbog umetanja LVV provirusa, što će rezultirati lažno pozitivnim testom na HIV.
English: The median (min, max) age in the studies was 19.0 (12, 34) years, 56.3% were females, 59.4% were Asian, and 40.6% White/Caucasian.
Croatian: Medijan (min, maks) starosne dobi u ispitivanjima iznosio je 19,0 (12, 34) godina, 56,3% bile su žene, 59,4% bili su azijati i 40,6% bijelci.
English: DOSE OF THE MEDICINAL PRODUCT Total Number of Infusion Bags: __
Croatian: DOZA LIJEKA Ukupan broj infuzijskih vrećica: __
English: However, G-CSF use was not recommended for 21 days after Zynteglo infusion in Phase 3 studies.
Croatian: Međutim, G-CSF-a se nije preporučavao za primjenu tijekom 21 dana nakon infuzije lijeka Zynteglo u ispitivanjima faze 3.
English: Local biosafety guidelines should be followed for unused medicinal products or waste material.
Croatian: Nacionalne smjernice za biološku sigurnost moraju se primjenjivati za neiskorištene lijekove ili otpadni materijal.
English: Conventional mutagenicity, carcinogenicity and reproductive and developmental toxicity studies have not been conducted.
Croatian: Nisu provedena konvencionalna ispitivanja mutagenosti, kancerogenosti i reproduktivne i razvojne toksičnosti.
English: o Statement that the patient was treated with Zynteglo, including LOT number and treatment date(s).
Croatian: o Izjavu da je bolesnik liječen lijekom Zynteglo, uključujući LOT broj i datum(e) liječenja.
English: Each infusion bag should be administered in less than 30 minutes.
Croatian: Svaka infuzijska vrećica treba se primijeniti u manje od 30 minuta.
English: Signs of leukaemia and the need to obtain urgent medical care if these signs are present.
Croatian: Znakovi leukemije i potreba da se odmah zatraži liječnička pomoć ako su prisutni ovi znakovi.
English: Zynteglo is intended for autologous use (see section 4.4) and should only be administered once.
Croatian: Zynteglo je namijenjen za autolognu primjenu (vidjeti dio 4.4) i smije se primijeniti samo jednom.
English: INSTRUCTIONS FOR STORAGE AND USE
Croatian: UPUTE ZA ČUVANJE I UPORABU
English: What you need to know before you are given Zynteglo You must not be given Zynteglo if you:
Croatian: Što morate znati prije nego primite Zynteglo Ne smijete primiti Zynteglo:
English: This is equivalent to 20-78% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 2078% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: HSC transplantation with myeloablative conditioning is not appropriate for patients with TDT who have evidence of severely elevated iron in the heart i.e., patients with cardiac T2* <10 msec by magnetic resonance imaging (MRI).
Croatian: HSC transplantacija s mijeloablativnim kondicioniranjem nije prikladna za bolesnike s TDT-om koji imaju dokaze o izrazito povišenim razinama željeza u srcu, tj., u bolesnika sa srčanim T2* < 10 ms na pretragama magnetskom rezonanciijom (MR).
English: Infusion related reactions to Zynteglo were observed in 11.9% of patients and occurred on the day of Zynteglo infusion.
Croatian: Infuzijske reakcije povezane s lijekom Zynteglo zabilježene su kod 11,9 % bolesnika, a javile su se na dan primjene infuzije lijeka Zynteglo.
English: • rash with lesions, sometimes with pus
Croatian: • osip s lezijama, ponekad s gnojem
English: Mobilisation and blood stem cell collection
Croatian: Mobilizacija i prikupljanje matičnih stanica krvi
English: If iron chelation is needed, consider administration of non-myelosuppressive iron chelators (see sections 4.2 and 5.1).
Croatian: Ako je potrebna kelacija željeza, razmotrite primjenu nemijelosupresivnih kelatora željeza (vidjeti dijelove 4.2 i 5.1).
English: The pharmacology, toxicology and genotoxicity of the BB305 LVV used for transduction in the manufacture of Zynteglo were evaluated in vitro and in vivo.
Croatian: Farmakologija, toksikologija i genotoksičnost BB305 LVV-a koji se koristi za transdukciju u proizvodnji lijeka Zynteglo procijenjene su in vitro i in vivo.
English: If the minimum dose of Zynteglo of 5.0 × 106 CD34+ cells/kg is not met after initial medicinal product manufacturing, the patient may undergo one or more additional cycles of mobilisation and apheresis, separated by at least 14 days, in order to obtain more cells for additional manufacture.
Croatian: Ako minimalna doza lijeka Zynteglo od 5,0 × 106 CD34+ stanica/kg nije postignuta nakon početne proizvodnje lijeka, bolesnik može proći jedan ili više dodatnih ciklusa mobilizacije i afereze, odvojen najmanje 14 dana, kako bi se dobilo više stanica za dodatnu proizvodnju.
English: NA = Not applicable.
Croatian: NP = nije primjenjivo.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zynteglo in one or more subsets of the paediatric population in β-thalassaemia (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Zynteglo u jednoj ili više podskupina pedijatrijske populacije s β-talasemijom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you test positive for HIV following treatment, please contact your doctor or nurse.
Croatian: Ako imate pozitivan test na HIV nakon liječenja, obratite se svom liječniku ili medicinskoj sestri.
English: For patients with at least 6 months of follow-up, HbAT87Q generally increased steadily after Zynteglo infusion and stabilised by approximately Month 6 to 9 post infusion.
Croatian: U bolesnika s najmanje 6 mjeseci praćenja, HbAT87Q općenito je bio u kontinuiranom porastu nakon infuzije Zynteglom i stabilizirao za približno 6 do 9 mjeseci nakon infuzije.
English: Cryostor CS5 Sodium chloride
Croatian: Cryostor CS5 Natrijev klorid
English: This medicine contains 391-1564 mg sodium (main component of cooking/table salt) in each dose.
Croatian: Ovaj lijek sadrži 391-1564 mg natrija (glavni sastojak kuhinjske soli) u jednoj dozi.
English: Approximately 2 months before treatment with Zynteglo, you will be given a mobilisation medicine that will move your blood stem cells from your bone marrow into your blood stream.
Croatian: Otprilike 2 mjeseca prije liječenja Zynteglom, dobit ćete mobilizacijski lijek koji će premjestiti vaše matične stanice krvi iz koštane srži u krvotok.
English: Other medicines and Zynteglo
Croatian: Drugi lijekovi i Zynteglo
English: Do not overthaw the medicinal product.
Croatian: Nemojte prekomjerno odmrzavati lijek.
English: Iron chelators should be discontinued 7 days prior to initiation of conditioning.
Croatian: Potrebno je prekinuti primjenu kelatora željeza 7 dana prije započinjanja kondicioniranja.
English: • Thaw Zynteglo at 37°C in a water bath or dry bath.
Croatian: • Odmrznite Zynteglo na 37 °C u vodenoj kupelji ili suhoj kupelji.
English: Phenytoin was not used for anti-seizure prophylaxis because of its well understood induction of glutathione-S-transferase and cytochrome P450 and resultant increased clearance of busulfan, and because of the widespread availability of effective anti-seizure medications that do not affect busulfan metabolism.
Croatian: Fenitoin nije korišten za profilaksu protiv napadaja zbog njegove dobro poznate indukcije glutation-S-transferaze i citokroma P450, što dovodi do povećanja klirensa busulfana te zbog rasprostranjene dostupnosti učinkovitih lijekova protiv napadaja koji ne utječu na metabolizam busulfana.
English: DONATION AND PRODUCT CODES
Croatian: OZNAKE DONACIJE I PROIZVODA
English: Only a few patients have been included in the clinical studies with genotypes characterised by low endogenous β-globin production phenotypically similar to patients with a β0/β0 genotype, such as patients homozygous for IVS-I-110 or IVS-I-5.
Croatian: Samo nekoliko bolesnika uključeno je u klinička ispitivanja s genotipovima koje karakterizira niska proizvodnja endogenog β-globina fenotipski sličnih bolesnicima s β0/β0 genotipom, kao što su bolesnici homozigotni za IVS-I 110 ili IVS-I-5.
English: ISA of post-transplantation BMCs demonstrated no preferred integration in the proximity of or within genes associated clinically (for gamma retroviral vectors) with either clonal dominance or leukaemia, and no evidence of clonal dominance was observed.
Croatian: ISA BMC-a nakon transplantacije nije pokazala preferencijalnu integraciju u neposrednoj blizini ili unutar gena klinički povezanih (za gama retrovirusne vektore) bilo s klonalnom dominacijom ili leukemijom, te nije opažen nikakav dokaz o klonalnoj dominaciji.
English: A pharmacology, biodistribution, toxicity and genotoxicity study was conducted in a mouse model of β-thalassaemia.
Croatian: Ispitivanje farmakologije, biodistribucije, toksičnosti i genotoksičnosti provedeno je na mišjem modelu β-talasemije.
English: Three patients in HGB-205 started phlebotomy.
Croatian: Tri bolesnika u HGB-205 započeli su s flebotomijom.
English: If Zynteglo cannot be administered after chemotherapy or if the modified stem cells do not take hold (engraft) in your body, the doctor may give you an infusion of your own original blood stem cells that were collected and stored before the treatment started (see also section 3, How Zynteglo is given).
Croatian: Ako se Zynteglo ne može primijeniti nakon kemoterapije ili ako se modificirane matične stanice neće prihvatiti (engl. engraft) u tijelu, liječnik vam može dati infuziju vaših vlastitih izvornih matičnih stanica koje su prikupljene i pohranjene prije liječenja (vidjeti također dio 3, Kako se primjenjuje Zynteglo).
English: Zynteglo has not been studied in patients with HIV-1, HIV-2, HTLV-1, or HTLV-2.
Croatian: Zynteglo nije ispitivan u bolesnika s HIV 1, HIV 2, HTLV 1 ili HTLV
English: Of the 11 patients followed for at least 6 months after Zynteglo infusion, 6 patients did not restart iron chelation or receive phlebotomy, 3 patients restarted iron chelation, and 2 patients received phlebotomy to reduce iron levels.
Croatian: Od 11 bolesnika praćenih najmanje 6 mjeseci nakon infuzije lijeka Zynteglo, 6 bolesnika nije ponovno započelo s kelacijom željeza ili primilo flebotomiju, 3 bolesnika ponovno su započela s kelacijom željeza, a 2 bolesnika su imala flebotomiju za smanjenje razine željeza.
English: Consult the SmPC of the myeloablative conditioning agent for information on the need for effective contraception in patients who undergo conditioning.
Croatian: Pročitajte sažetak opisa svojstava lijeka za mijeloablativno kondicioniranje za informacije o potrebi za učinkovitom kontracepcijom u bolesnika koji se podvrgavaju kondicioniranju.
English: Bars represent interquartile ranges.
Croatian: Stupci predstavljaju interkvartilni raspon.
English: Zynteglo is for intravenous use only (see section 6.6 for full details on the administration process).
Croatian: Zynteglo je samo za intravensku primjenu (vidjeti dio 6.6 za detaljne informacije o procesu primjene).
English: The MAH shall ensure that in each Member State where Zynteglo is marketed, a system aimed to control distribution to Zynteglo beyond the level of control ensured by routine risk minimisation measures.
Croatian: Nositelj odobrenja mora osigurati da u svakoj zemlji članici u kojoj je Zynteglo stavljen u promet postoji sustav za kontrolu distribucije lijeka Zynteglo koji je opsežniji od razine kontrole osigurane rutinskim mjerama minimizacije rizika.
English: The planned dose of plerixafor was 0.24 mg/kg/day, given on Days 4 and 5 of mobilisation in the evening.
Croatian: Planirana doza pleriksafora iznosila je 0,24 mg/kg/dan, koja se davala 4. i 5. dana mobilizacije, navečer.
English: Most of these side effects occur during or within a few days after mobilisation and blood stem cell collection but can occur later.
Croatian: Većina ovih nuspojava se javlja tijekom ili unutar nekoliko dana nakon mobilizacije i prikupljanja matičnih stanica krvi, ali se može pojaviti i kasnije.
English: If an infusion bag is compromised, follow the local guidelines and contact bluebird bio immediately.
Croatian: Ako je infuzijska vrećica oštećena, slijedite lokalne smjernice i odmah kontaktirajte bluebird bio.
English: • inflammation or infection of hair follicles
Croatian: • upala ili infekcija folikula kose
English: The back-up collection may be needed for rescue treatment if there is: 1) compromise of Zynteglo after initiation of myeloablative conditioning and before Zynteglo infusion, 2) primary engraftment failure, or 3) loss of engraftment after infusion with Zynteglo (see section 4.4).
Croatian: Rezervno prikupljanje može biti potrebno za „rescue” liječenje ako postoji: 1) kompromis o lijeku Zynteglo nakon početka mijeloablativnog kondicioniranja i prije infuzije lijeka Zynteglo, 2) neuspjeh prihvaćanja (engl. primary engraftment failure) ili 3) gubitak prihvaćanja (engl. loss of engraftment) transplanatata nakon infuzije lijeka Zynteglo (vidjeti dio 4.4).
English: • low oxygen level in blood
Croatian: • niska razina kisika u krvi
English: Store at ≤-140°C for up to a year.
Croatian: Čuvajte na ≤-140 °C do godine dana.
English: PATIENT INFORMATION
Croatian: INFORMACIJE ZA BOLESNIKA
English: If an infusion bag is compromised, follow the local biosafety guidelines and contact bluebird bio immediately.
Croatian: Ako je infuzijska vrećica oštećena, slijedite lokalne smjernice za biološku sigurnost i odmah kontaktirajte bluebird bio.
English: These studies are conducted with improved transduction compared to Phase 1/2 studies, resulting in increased average number of functional copies of the transgene (βA-T87Q-globin) integrated in the autologous CD34+ cells.
Croatian: Ova ispitivanja su provedena s poboljšanom transdukcijom u usporedbi s ispitivanjima faze 1/2, što je rezultiralo povećanim prosječnim brojem funkcionalnih kopija transgena (za βA-T87Q-globin) integriranih u autologne CD34+ stanice.
English: For most patients, the minimum number of CD34+ cells to manufacture Zynteglo was collected with 1 cycle of mobilisation and apheresis.
Croatian: Kod većine bolesnika minimalni broj CD34+ stanica za proizvodnju lijeka Zynteglo prikupljen je s 1 ciklusom mobilizacije i afereze.
English: Zynteglo is used to treat a serious genetic disease called transfusion-dependent beta-thalassaemia (TDT), which includes the disease commonly known as beta-thalassaemia major, in people 12 years and older.
Croatian: Zynteglo se koristi za liječenje ozbiljne genetske bolesti koja se zove beta-talasemija ovisna o transfuziji (TDT), a uključuje bolest poznatu pod nazivom beta-talasemija major, u osoba u dobi od 12 i više godina.
English: The infusion bag(s) must be kept inside the metal cassette(s) until ready to thaw and use.
Croatian: Infuzijska(e) vrećica(e) moraju se čuvati u metalnoj(im) kazeti(ama) dok sve ne bude spremno za odmrzavanje i primjenu.
English: o Statement that the patient was treated with gene therapy and should not donate blood, organs, tissues, or cells.
Croatian: o Izjavu da je bolesnik liječen genskom terapijom i ne smije darivati krv, organe, tkiva ili stanice.
English: What Zynteglo looks like and contents of the pack
Croatian: Kako Zynteglo izgleda i sadržaj pakiranja
English: No formal drug interaction studies have been performed.
Croatian: Nisu provedena službena klinička ispitivanja interakcije lijekova.
English: • increase or decrease in white blood cells
Croatian: • povećanje ili smanjenje broja bijelih krvnih stanica
English: Exploratory analyses were performed to confirm resolution of dyserythropoiesis, the fundamental physiologic characteristic of TDT, in the bone marrow.
Croatian: Obavljene su eksploratorne analize kako bi se potvrdio nestanak diseritropoeze, osnovne fiziološke karakteristike TDT-a, u koštanoj srži.
English: Iron chelation should be stopped at least 7 days prior to myeloablative conditioning.
Croatian: Kelaciju željeza treba prekinuti najmanje 7 dana prije mijeloablativnog kondicioniranja.
English: o All patients should receive annual monitoring of complete blood counts and total haemoglobin levels to monitor for leukaemia/lymphoma and maintenance of efficacy, respectively.
Croatian: o U svih bolesnika treba se provesti godišnja kontrola kompletne krvne slike i razine ukupnog hemoglobina u svrhu praćenja pojave leukemije/limfoma odnosno održavanja djelotvornosti.
English: • increase or decrease in blood protein
Croatian: • povećanje ili smanjenje razine proteina u krvi
English: INFORMATION ON SUPPLIED LOT(S) The following lot(s) was manufactured and included in the shipment:
Croatian: Sljedeći lotovi su proizvedeni i uključeni u pošiljku:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING - METAL CASSETTE NAME OF THE MEDICINAL PRODUCT
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU - METALNA KAZETA
English: Failure of neutrophil engraftment is a short-term but potentially severe risk, defined as failure to achieve 3 consecutive absolute neutrophil counts (ANC) ≥500 cells/µL obtained on different days by Day 43 after infusion of
Croatian: Neuspjeh u oporavku stvaranja neutrofila je kratkoročan, ali potencijalno težak rizik, definiran kao neuspjeh u postizanju 3 uzastopne vrijednosti apsolutnog broja neutrofila (ANC) ≥ 500 stanica/μl dobiveno u različitim danima do 43. dana nakon infuzije lijeka Zynteglo.
English: Work surfaces and material which have potentially been in contact with Zynteglo must be decontaminated with a viricidal disinfectant according to the manufacturer's instructions.
Croatian: Radne površine i materijali koji su potencijalno bili u dodiru s lijekom Zynteglo moraju se dekontaminirati viricidnim dezinfekcijskim sredstvom prema uputama proizvođača.
English: One serious event of hypotension due to epistaxis occurred in a patient, with onset 11 days after Zynteglo treatment.
Croatian: Jedan ozbiljan događaj hipotenzije izazvane epistaksom zabilježen je kod jednog bolesnika, a javio se 11 dana nakon liječenja lijekom Zynteglo.
English: • loss of function of your ovaries
Croatian: • gubitak funkcije jajnika
English: Headache, Peripheral sensory neuropathy
Croatian: periferna senzorna neuropatija omaglica,
English: Hb (g/dL) at 24 months*
Croatian: Hb (g/dl) nakon 24 mjeseca*
English: Zynteglo is a clear to slightly cloudy, colourless to yellow or pink dispersion of cells that is supplied in one or more clear infusion bags, each packed in a transparent pouch inside a closed metal container.
Croatian: Zynteglo je bistra do blago zamućena, bezbojna do žuta ili ružičasta disperzija stanica koja se isporučuje u jednoj ili više prozirnih infuzijskih vrećica, svaka pakirana u prozirnu vrećicu unutar zatvorenog metalnog spremnika.
English: Each metal cassette contains one infusion bag with Zynteglo.
Croatian: Svaka metalna kazeta sadrži jednu infuzijsku vrećicu s lijekom Zynteglo.
English: Hb (g/dL) at 6 months*
Croatian: Hb (g/dl) nakon 6 mjeseci*
English: - are allergic to any of the ingredients of this medicine (listed in section 6) - are pregnant or breast-feeding - have previously received gene therapy of your blood stem cells - are allergic to any of the ingredients in the medicines you will be given for mobilisation and chemotherapy (see section 3).
Croatian: - ako ste alergični na bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.), - ako ste trudni ili dojite, - ako ste ranije primali gensku terapiju koja se sastoji od vaših matičnih stanica krvi - ako ste alergični na bilo koji sastojak lijeka koji ćete dobiti za mobilizaciju i kemoterapiju
English: These cells must be collected from the patient and be cryopreserved prior to myeloablative conditioning and infusion with Zynteglo.
Croatian: Te se stanice moraju prikupiti od bolesnika i biti krioprezervirane prije mijeloablativnog kondicioniranja i infuzije lijeka Zynteglo.
English: Once thawed store at room temperature (20°C-25°C) and use within 4 hours.
Croatian: Nakon odmrzavanja čuvati na sobnoj temperaturi (20 °C - 25 °C) i primijeniti u roku od 4 sata.
English: All patients should be tested for HIV-1/2 and HTLV-1/2 prior to mobilisation and apheresis to ensure acceptance of the apheresis material for Zynteglo manufacturing (see section 4.2).
Croatian: Sve bolesnike treba testirati na HIV-1/2 i HTLV-1/2 prije mobilizacije i afereze kako bi se osiguralo da materijal dobiven aferezom bude prihvatljiv za proizvodnju lijeka Zynteglo (vidjeti dio 4.2).