FrancophonIA/ELRC3.0 huggingface dataset:
English: After you receive Zynteglo, you may have a low number of platelets in your blood.
Slovenian: Po prejemu zdravila Zynteglo boste morda imeli nizko število trombocitov v krvi.
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.
Slovenian: V študiji ni bilo dokazov o toksičnosti, genotoksičnosti ali onkogenezi (tumorjih), povezanih z integracijo BB305 LVV, in o toksičnosti, povezani s proizvodnjo βA-T87Q-globina.
English: o Statement that the patient was treated with gene therapy and should not donate blood, organs, tissues, or cells.
Slovenian: o Izjava, da bolnik, zdravljen z gensko terapijo, ne sme darovati krvi, organov, tkiv ali celic.
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Slovenian: Če vas skrbi, da ne boste mogli imeti otrok, se pred zdravljenjem pogovorite z zdravnikom.
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).
Slovenian: Če po kemoterapiji ni mogoče uporabiti zdravila Zynteglo ali če se modificirane matične celice ne primejo (vsadijo) v telo, vam lahko zdravnik daje infuzije vaših lastnih izvornih krvotvornih matičnih celic, ki so bile zbrane in shranjene pred začetkom zdravljenja (glejte tudi poglavje 3, Kako uporabljati zdravilo Zynteglo).
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.
Slovenian: Približno 2 meseca pred zdravljenjem z zdravilom Zynteglo boste prejeli mobilizacijsko zdravilo, ki bo premaknilo vaše krvotvorne matične celice iz kostnega mozga v krvni obtok.
English: • increase or decrease in white blood cells
Slovenian: • povečanje ali zmanjšanje števila belih krvnih celic
English: Interim results: at each annual renewal
Slovenian: Vmesni rezultati: ob vsakoletnem podaljšanju
English: WA Hb during TI (g/dL)
Slovenian: WA Hb med TI (g/dl)
English: Each infusion bag contains approximately 20 mL of Zynteglo.
Slovenian: Vsaka infuzijska vrečka vsebuje približno 20 ml zdravila Zynteglo.
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.
Slovenian: o Pri vseh bolnikih je treba letno spremljati celotno krvno sliko in skupno raven hemoglobina zaradi spremljanja levkemije/limfoma oz. vzdrževanja učinkovitosti.
English: Adolescents were excluded from Phase 3 studies if they had a known and available HLA-matched related HSC donor.
Slovenian: Mladostniki so bili izključeni iz študij faze III, če so imeli znanega in razpoložljivega darovalca HSC z ujemajočim antigenom HLA. Mediana (min.; maks.)
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.
Slovenian: Le nekaj bolnikov je bilo vključenih v klinične študije z genotipi, za katere je značilno nizko nastajanje endogenega β-globina, ki je po fenotipu podoben bolnikom z genotipom β0/β0, kot so bonliki, homozigotni za IVS-I-110 ali IVS-I-5.
English: All patients must be advised on signs of leukaemia and to seek immediate medical attention if these signs are present.
Slovenian: Vsem bolnikom je treba svetovati glede znakov levkemije in da morajo ob njenih znakih takoj poiskati zdravniško pomoč.
English: βA-T87Q-globin can be quantified relative to other globin species in peripheral blood using high performance liquid chromatography.
Slovenian: βA-T87Q-globin lahko določimo relativno glede na druge vrste globulinov v periferni krvi z uporabo tekočinske kromatografije visoke ločljivosti.
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.
Slovenian: Dodajanje novega gena v DNK vaših krvotvornih matičnih celic lahko teoretično povzroči levkemijo ali limfom, čeprav se v kliničnih preskušanjih z zdravilom Zynteglo pri nobenem bolniku nista razvili levkemija ali limfom.
English: Exploratory analyses were performed to confirm resolution of dyserythropoiesis, the fundamental physiologic characteristic of TDT, in the bone marrow.
Slovenian: Izvedli so raziskovalne analize za potrditev, da je izvenela dizeritropoeza, osnovna fiziološka značilnost TDT v kostnem mozgu.
English: o The short-term potential risk of treatment with Zynteglo represents failure of engraftment, which shall be managed by administration of rescue cells.
Slovenian: o Kratkoročno možno tveganje zdravljenja z zdravilom Zynteglo predstavlja neuspešna vsaditev, kar se obravnava z dajanjem reševalnih celic.
English: The entire volume of each infusion bag should be infused.
Slovenian: Infundirati morate celotno količino vsake infuzijske vrečke.
English: • rash with lesions, sometimes with pus
Slovenian: • izpuščaj z lezijami, včasih z gnojem
English: A risk of bleeding exists before platelet engraftment and may continue after platelet engraftment in patients who have continued thrombocytopenia.
Slovenian: Tveganje krvavitve obstaja pred vsaditvijo trombocitov in se lahko nadaljujejo po vsaditvi trombocitov pri bolnikih, ki imajo še naprej trombocitopenijo.
English: • changes in blood chemistry which may indicate low calcium, low potassium, low magnesium,
Slovenian: • spremembe biokemijskih izvidov krvi, ki lahko kažejo na nizko raven kalcija, nizko raven kalija,
English: Healthcare professionals are asked to report any suspected adverse reactions.
Slovenian: Zdravstvene delavce prosimo, da poročajo o vseh domnevnih neželenih učinkih zdravila.
English: You should discuss possible side effects due to the mobilisation medicines and chemotherapy medicine with your doctor.
Slovenian: O morebitnih neželenih učinkih zaradi zdravil za mobilizacijo in kemoterapijo se morate pogovoriti z zdravnikom.
English: You will remain in the hospital for approximately 3-6 weeks
Slovenian: Po infuziji zdravila Zynteglo Ostali boste v bolnišnici približno 3-6 tednov
English: For most patients, the minimum number of CD34+ cells to manufacture Zynteglo was collected with 1 cycle of mobilisation and apheresis.
Slovenian: Za večino bolnikov je bilo zbrano najmanjše število celic CD34+ za izdelavo zdravila Zynteglo z enim ciklom mobilizacije in aferezo.
English: Zynteglo is intended solely for autologous use.
Slovenian: Zdravilo Zynteglo je namenjeno izključno avtologni uporabi.
English: Cardiac T2* at baseline was >20 msec.
Slovenian: Vrednost T2* srca ob izhodišču je bila >20 msek.
English: Additional studies with human CD34+ HSCs administered to immunodeficient, myeloablated mice demonstrated no toxicity, tumorigenicity or genotoxicity.
Slovenian: Dodatne študije s humanimi celicami CD34+ HSC, ki so jih dali mieloablativnim mišim z imunsko pomanjkljivostjo, niso pokazale toksičnosti, tumorogenosti ali genotoksičnosti.
English: o Statement that the patient was treated with Zynteglo, including LOT number and treatment date(s).
Slovenian: o Izjava, da je bil bolnik zdravljen z zdravilom Zynteglo, vključno s številko serije zdravila in datumom/datumi zdravljenja.
English: Patients should be made aware of the risk of bleeding until platelet recovery has been achieved.
Slovenian: Bolnike je treba obvestiti o možnosti krvavitev, dokler ni dosežena obnova trombocitov.
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.
Slovenian: Pri bolnikih, ki so bili deležni vsaj 6-mesečnega nadaljnjega spremljanja, se je vrednost HbAT87Q običajno enakovredno poviševala po infuziji zdravila Zynteglo in se stabilizirala približno 6 do 9 mesecev po infuziji.
English: Most of these side effects occur during or within a few days after mobilisation and blood stem cell collection but can occur later.
Slovenian: Večina neželenih učinkov se pojavi med ali v nekaj dneh po mobilizaciji in odvzemu krvotvornih matičnih celic, a se lahko pojavijo tudi pozneje.
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus
Slovenian: • bolečina in otekanje sluznice prebavnega trakta, ki poteka od ust do anusa
English: This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Slovenian: Zdravilo je pridobilo tako imenovano »pogojno dovoljenje za promet«.
English: Adverse reactions are listed by MedDRA body system organ class and by frequency.
Slovenian: Neželeni učinki so navedeni po organskih sistemih MedDRA in pogostnosti.
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.
Slovenian: Bolniki so bili obravnavani kot odvisni od transfuzije, če so imeli anamnezo transfuzije vsaj 100 ml celic RBC/kg/leto ali ≥ 8 transfuzij celic RBC na leto v 2 letih pred vključitvijo v študijo.
English: Hb (g/dL) at 24 months*
Slovenian: Hb (g/dl) pri 24. mesecih*
English: Patients treated with Zynteglo should not donate blood, organs, tissues or cells for transplantation at any time in the future.
Slovenian: Bolniki, zdravljeni z zdravilom Zynteglo, ne smejo darovati krvi, organov, tkiv ali celic za presaditev kadarkoli v prihodnosti.
English: You should also read the package leaflets for these medicines.
Slovenian: Za ta zdravila preberite tudi navodila za uporabo.
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.
Slovenian: ISA CKM po transplantaciji ni pokazala preference za integracijo v genih, klinično povezanih s (za gama-retrovirusne vektorje) prevlado klonov ali levkemijo oziroma v njihovi bližini, opazili pa tudi niso nobenih dokazov o prevladi klonov.
English: Precautions to be taken for the disposal of the medicinal product
Slovenian: Previdnostni ukrepi za odstranjevanje zdravila
English: Approximately 2 months before Zynteglo infusion
Slovenian: Približno 2 meseca pred infuzijo zdravila Zynteglo
English: Healthcare professionals handling Zynteglo should take standard precautions (wearing gloves, protective clothing and eye protection) to avoid potential transmission of infectious diseases.
Slovenian: Zdravstveni delavci, ki rokujejo z zdravilom Zynteglo, morajo upoštevati standardne previdnostne ukrepe (uporaba rokavic, zaščitne obleke in zaščite za oči), da preprečijo morebitni prenos kužnih bolezni.
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.
Slovenian: Izražanje βA-T87Q-globina je zasnovano tako, da popravi neravnovesje β/α-globina v eritroidnih celicah bolnikov s TDT in ima potencial za povečanje skupne vrednosti Hb do normalne ravni ter odpravljanje odvisnosti od kroničnih transfuzij rdečih krvnih celic.
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.
Slovenian: Zdravilo Zynteglo se uporablja za zdravljenje hude genske bolezni, imenovane beta-talasemija, ki zahteva transfuzijo (TDT), ki vključuje bolezen, pogosto poznano kot beta-talasemija major pri bolnikih, starih 12 let in več.
English: Do not use this medicine after the expiry date which is stated on the outer container label(s) and infusion bag label(s).
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki škatle ter na nalepki infuzijske vrečke.
English: • bruising, bleeding or pain from catheter or injection site
Slovenian: • modrice, krvavitev ali bolečina na mestu vstavitve katetra ali injiciranja
English: o Treatment with Zynteglo is in theory associated with the risk of insertional mutagenesis, potentially leading to development of malignancy.
Slovenian: o Zdravljenje z zdravilom Zynteglo je teoretično povezano s tveganjem insercijske mutageneze, ki lahko vodi v razvoj malignosti.
English: Contents of the pack and other information What Zynteglo contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zynteglo
English: If you test positive for HIV following treatment, please contact your doctor or nurse.
Slovenian: Če ste po zdravljenju pri testiranju pozitivni na virus HIV, se posvetujte z zdravnikom ali medicinsko sestro.
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.
Slovenian: • Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila: o Informacije o tveganju zapoznele vsaditve trombocitov, kar lahko povzroči krvavitve, in teoretičnih tveganjih.
English: Zynteglo is not expected to interact with the hepatic cytochrome P-450 family of enzymes or drug transporters.
Slovenian: Ni pričakovati, da bi zdravilo Zynteglo medsebojno delovalo z družino encimov citokroma P-450 ali prenašalcev zdravil.
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.
Slovenian: Ženske, ki lahko zanosijo in moški, ki so sposobni oploditve, morajo začeti uporabljati zanesljivo metodo kontracepcije pred zbiranjem krvnih matičnih celic in jo uporabljati do vsaj 6 mesecev po prejemu zdravila Zynteglo.
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).
Slovenian: Presaditev celic HSC z mieloablativnim postopkom ni primerna za bolnike s TDT, ki imajo dokazano močno povišano raven železa v srcu, tj. bolnike s spinsko-spinskim relaksacijskim časom MRI T2* < 10 msek.
English: Hepatic veno-occlusive disease
Slovenian: Jetrna vensko-okluzivna bolezen
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Slovenian: Neporabljeno zdravilo je treba odstraniti v skladu z lokalnimi smernicami o biološki varnosti.
English: • irregular menstruation
Slovenian: • neredna menstruacija
English: More specifically, people with TDT do not make enough of a part of the haemoglobin called beta-globin, due to a gene defect.
Slovenian: Natančneje povedano, ljudje s TDT zaradi prirojene okvare ne tvorijo dovolj tistega dela hemoglobina, ki se imenuje beta-globin.
English: If iron chelation is needed, consider administration of non-myelosuppressive iron chelators (see sections 4.2 and 5.1).
Slovenian: Če je potrebna kelacija, razmislite o uporabi železovih kelatov, ki niso mielosupresivni (glejte poglavje 4.2 in 5.1).
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.
Slovenian: Nekateri neželeni učinki, ki so jih opazili v kliničnih študijah zdravila Zynteglo, so povezani z mobilizacijo in odvzemom krvnih matičnih celic ali s kemoterapijo za pripravo vašega kostnega mozga za zdravljenje z zdravilom Zynteglo.
English: The following requirements need to be fulfilled before the product is prescribed, manufactured, dispensed and used:
Slovenian: Preden se zdravilo predpiše, izdela, izda ali uporabi, je treba izpolniti naslednje zahteve:
English: Tell your doctor immediately if you get any of the following side effects after receiving chemotherapy medicine.
Slovenian: Takoj povejte zdravniku, če se po kemoterapiji pojavijo kateri koli od naslednjih neželenih učinkov.
English: • enlarged spleen which may result in pain in your upper left belly or left shoulder
Slovenian: • povečana vranica, kar lahko povzroči bolečine na zgornji levi strani trebuha ali v levem ramenu • bruhanje
English: The infusion bag(s) must be kept inside the metal cassette(s) until ready to thaw and use.
Slovenian: Infuzijske vrečke morate hraniti v kovinski kaseti, dokler niso pripravljene za odtajanje in uporabo.
English: Store at ≤-140°C for up to a year.
Slovenian: Shranjujte pri temperaturi ≤ -140 °C za obdobje do enega leta.
English: The total number of infusion bags to be administered should also be confirmed with the Lot Information Sheet (see section 4.4).
Slovenian: Skupno število infuzijskih vrečk za aplikacijo mora biti potrjeno z dokumentom z informacijami o seriji (glejte poglavje 4.4).
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.
Slovenian: Ti študiji se izvajata z izboljšano transdukcijo v primerjavi s študijami faze I/II, kar pripelje do višjega povprečnega števila funkcionalnih kopij transgena (βA-T87Q-globin), integriranega v avtologne celice CD34+.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo v vseh državah članicah, kjer bo zdravilo Zynteglo na trgu, vzpostavljen sistem nadzorovane distribucije zdravila Zynteglo, ki presega raven, ki jo zagotavlja nadzorovanje z rednimi ukrepi za zmanjševanje tveganj.
English: AUC0-24h was measured on Day 1 and informed the dose for Day 3; the median (min, max) estimated daily AUC was
Slovenian: AUC0-24 h je bila izmerjena 1. dan in je dala podatke za odmerek 3. dne; mediana (min.; maks.)
English: Following platelet engraftment, all patients maintained platelet levels of ≥20 × 109/L in the absence of platelet transfusions.
Slovenian: Po vsaditvi trombocitov se je pri vseh bolnikih ohranila raven trombocitov ≥ 20 × 109/l v odsotnosti transfuzij trombocitov.
English: The quantitative information regarding strength, CD34+ cells, and dose for the medicinal product is provided in the Lot Information Sheet.
Slovenian: Kvantitativne informacije glede jakosti, števila celic CD34+ in odmerka zdravila so na voljo v dokumentu z informacijami o seriji.
English: • Each infusion bag should be inspected for any breaches of integrity before thawing and infusion.
Slovenian: • Za vsako infuzijsko vrečko je treba pred odtajanjem in infuzijo opraviti pregled celovitosti.
English: After Zynteglo infusion, avoid use of these iron chelators for 6 months.
Slovenian: Po infuziji zdravila Zynteglo se 6 mesecev izogibajte uporabi železovih kelatov.
English: • Remove each metal cassette from liquid nitrogen storage and remove each infusion bag from the metal cassette.
Slovenian: • Odstranite vsako kovinsko kaseto iz hrambe v tekočem dušiku in odstranite vsako infuzijsko vrečko iz kovinske kasete.
English: After completion of the 4-day course of myeloablative conditioning, there must be a minimum of 48 hours of washout before Zynteglo infusion.
Slovenian: Po koncu 4-dnevnega mieloablativnega postopka mora poteči vsaj 48-urno obdobje izpiranja pred infundiranjem zdravila Zynteglo.
English: Paediatric population The safety and efficacy of Zynteglo in children <12 years of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Zynteglo pri otrocih, mlajših od 12 let, še nista bili dokazani.
English: DOSE OF THE MEDICINAL PRODUCT Total Number of Infusion Bags: __
Slovenian: Skupno število infuzijskih vrečk: __
English: Each infusion bag should be administered in less than 30 minutes.
Slovenian: Vsako infuzijsko vrečko je treba infundirati v manj kot 30 minutah.
English: Once thawed store at room temperature (20°C-25°C) and use within 4 hours.
Slovenian: Po odtajanju shranjujte pri sobni temperaturi (20-25 °C) in porabite v 4 urah.
English: • decrease in magnesium, calcium, potassium, phosphate, albumin, sodium in blood
Slovenian: • znižanje koncentracije magnezija, kalcija, kalija, fosfata, albumina, natrija v krvi
English: The modified virus is used to insert a functional beta-globin gene into your blood stem cells.
Slovenian: Spremenjen virus se uporablja za vstavljanje funkcionalnega gena za beta-globin v vaše krvotvorne matične celice.
English: The planned dose of plerixafor was 0.24 mg/kg/day, given on Days 4 and 5 of mobilisation in the evening.
Slovenian: Načrtovani odmerek pleriksaforja je bil 0,24 mg/kg/dan, bolniki pa so ga prejeli zvečer 4. in 5. dan mobilizacije.
English: All patients received full myeloablative conditioning with busulfan prior to treatment with Zynteglo.
Slovenian: Vsi bolniki so bili izpostavljeni celotnemu mieloablativnemu postopku z busulfanom pred zdravljenjem z zdravilom Zynteglo.
English: Three patients in HGB-205 started phlebotomy.
Slovenian: Trije bolniki v HGB-205 so razvili flebotomijo.
English: ≥100 × 109/L were 52 (20, 268) days and 63 (20, 1231) days, respectively.
Slovenian: časa do nepodprtega števila trombocitov ≥ 50 × 109/l in ≥ 100 × 109/l je bila 52 (20, 268) dni oz. 63 (20, 1231) dni.
English: • Prolonged bleeding or bleeding without injury such as nosebleeds, bleeding from gums, or vaginal bleeding.
Slovenian: • Dolgotrajna krvavitev ali krvavitev brez poškodbe, kot je krvavitev iz nosu, krvavitev iz dlesni ali krvavitev iz nožnice.
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.
Slovenian: To zdravilo vsebuje 391-1564 mg natrija na odmerek, kar je enako 20 do 78 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
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.
Slovenian: Pripravljeno zdravilo je sestavljeno iz ene ali več infuzijskih vrečk, ki vsebujejo disperzijo 1,2-20 × 106 celic/ml, raztopljenih v kriokonzervativni raztopini.
English: • low oxygen level in blood
Slovenian: • nizka raven kisika v krvi
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.
Slovenian: • Vodnik za bolnika/skrbnika mora vsebovati naslednja ključna sporočila: o Zdravljenje z zdravilom Zynteglo je teoretično povezano s tveganjem za razvoj malignosti.
English: Dispersion for infusion.
Slovenian: Disperzija za infundiranje.
English: Before receiving Zynteglo you will be given chemotherapy in order to remove your existing bone marrow.
Slovenian: Pred zdravljenjem z zdravilom Zynteglo boste prejeli kemoterapijo za odstranitev obstoječega kostnega mozga.
English: Zynteglo must not be re-frozen.
Slovenian: Zdravila Zynteglo ne smete ponovno zamrzniti.
English: Do not re-freeze after thawing.
Slovenian: Po odtajanju ne zamrzujte ponovno.
English: CLINICAL PARTICULARS 4.1 Therapeutic indication
Slovenian: KLINIČNI PODATKI Terapevtske indikacije
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).
Slovenian: Pred mobilizacijo in aferezo je treba vse bolnike testirati za virus HIV-1/2 in HTLV-1/2, da se zagotovi sprejemljivost materiala za aferezo za izdelavo zdravila Zynteglo (glejte poglavje 4.2).