FrancophonIA/ELRC3.0 huggingface dataset:
English: Final results: December 2024
Slovenian: Končni rezultati: december
English: PARTICULARS TO APPEAR ON THE LOT INFORMATION SHEET INCLUDED WITH EACH SHIPMENT FOR ONE PATIENT
Slovenian: PODATKI SO NAVEDENI V DOKUMENTU Z INFORMACIJAMI O SERIJI, KI JE PRILOŽEN VSAKI POŠILJKI ZA ENEGA BOLNIKA
English: What you need to know before you are given Zynteglo You must not be given Zynteglo if you:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Zynteglo Ne uporabljajte zdravila Zynteglo, če:
English: Zynteglo must not be used during pregnancy because of myeloablative conditioning (see section 4.3).
Slovenian: Zdravila Zynteglo se ne sme uporabljati med nosečnostjo zaradi mieloablativnega postopka (glejte poglavje 4.3).
English: Zynteglo is for intravenous use only (see section 6.6 for full details on the administration process).
Slovenian: Zdravilo Zynteglo je samo za intravensko uporabo (za podrobnosti o postopku dajanja glejte poglavje 6.6).
English: 4417.0 (3030, 9087) μM*min (N=31).
Slovenian: ocenjene dnevne vrednosti AUC je bila 4417,0 (3030; 9087) μM*min (N=31).
English: • inflammation or infection of hair follicles
Slovenian: • vnetje ali okužba lasnih foliklov
English: In HGB-207 and HGB-212 prophylaxis for VOD/hepatic sinusoidal obstruction syndrome was required per institutional practice with ursodeoxycholic acid or defibrotide.
Slovenian: Pri študijah HGB-207 in HGB-212 je bila potrebna profilaksa za jetrno venookluzivno bolezen/obstrukcijski sindrom jetrnih sinusov z ursodeoksiholno kislino ali defibrotidom v skladu s prakso ustanove.
English: DONATION AND PRODUCT CODES
Slovenian: ENOTNE OZNAKE DAROVANJA IN IZDELKOV
English: See Lot Information Sheet for number of infusion bags and CD34+ cells per kg for this patient.
Slovenian: Glejte dokument z informacijami o seriji za število infuzijskih vrečk in števila celic CD34+ na kg za tega bolnika.
English: Do not infuse Zynteglo if the information on the patient specific-label on the infusion bag does not match the intended patient.
Slovenian: Zdravila Zynteglo ne infundirajte, če se informacije na nalepki na infuzijski vrečki, specifične za bolnika, ne ujemajo z bolnikom, ki bo zdravilo prejel.
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.
Slovenian: Morda bo za odvzem zadostne količine krvotvornih matičnih celic za izdelavo zdravila Zynteglo in shranjevanje za nadomestne celice, če zdravila Zynteglo ni mogoče dati ali če ne deluje, potreben več kot en dan.
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.
Slovenian: Če bolnik potrebuje protiretrovirusna zdravila po izpostavljenosti virusu HIV/HTLV, je treba zdravljenje z zdravilom Zynteglo preložiti, dokler 6 mesecev po izpostavljenosti ni bilo izvedeno testiranje na virus HIV s prenosom po Westernu in določanje virusne obremenitve.
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.
Slovenian: Preglednice 1, 2 in 3 so seznami neželenih učinkov, ki so pripisani mobilizaciji/aferezi, mieloablativnemu postopku oz. zdravilu Zynteglo pri bolnikih s TDT v kliničnih preskušanjih z zdravilom Zynteglo.
English: Expose the sterile port on the infusion bag by tearing off a protective wrap covering the port.
Slovenian: Sterilno odprtino na infuzijski vrečki razkrijte tako, da odtrgate zaščitni ovoj, ki prekriva odprtino.
English: There are no data on the effects of Zynteglo on human fertility.
Slovenian: Podatkov o učinku zdravila Zynteglo na plodnost pri človeku ni.
English: In the event that more than one infusion bag is provided, all infusion bags must be administered.
Slovenian: Če je na voljo več kot ena infuzijska vrečka, uporabite vse infuzijske vrečke.
English: Zynteglo is a type of medicine called gene therapy.
Slovenian: Zynteglo je vrsta zdravila za tako imenovano gensko zdravljenje.
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.
Slovenian: Vsaditev trombocitov je opredeljena kot 3 zaporedne vrednosti trombocitov ≥ 20 × 109/l, pridobljene ob različnih dneh po infuziji zdravila Zynteglo, in brez transfuzije trombocitov, aplicirane 7 dni neposredno pred obdobjem ocenjevanja in med njim.
English: At least 6 days before Zynteglo infusion
Slovenian: Vsaj 6 dni pred infuzijo zdravila Zynteglo
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu <, and on the website of {name of MS Agency (link)}>.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu< in na spletni strani {ime agencije v državi članici (povezava)}.
English: You can help by reporting any side effects you may get.
Slovenian: Tudi sami lahko k temu prispevate tako, da poročate o vsakem neželenem učinku zdravila, ki bi se utegnil pojaviti pri vas.
English: o A negative serology test for HIV is necessary to ensure acceptance of apheresis material for Zynteglo manufacturing.
Slovenian: o Negativen serološki test za HIV je potreben za zagotovitev sprejetja afereznega materiala za izdelavo zdravila Zynteglo.
English: Precautions regarding bleeding consequences of thrombocytopenia need to be taken.
Slovenian: Upoštevati je treba previdnostne ukrepe glede posledic krvavitev zaradi trombocitopenije.
English: An in vitro immortalisation (IVIM) assay conducted with BB305 LVV-transduced mouse bone marrow cells (BMCs) showed minimal mutagenic potential (Fitness Score ≈ 0.1 × 10-4).
Slovenian: In vitro test imortalizacije (IVIM), ki je bil izveden z BB305 LVV-transduciranimi celicami kostnega mozga (CKM) miši, je pokazal minimalno možnost mutagenosti (rezultat primernosti = 0,1×10-4).
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).
Slovenian: Dodatno zbrane celice bodo morda potrebne za rešilno zdravljenje v naslednjih primerih: 1) ogrozitev zdravila Zynteglo po uvedbi mieloablativnega postopka in pred infuzijo zdravila Zynteglo, 2) primarna odpoved presadka ali 3) izguba presadka po infundiranju zdravila Zynteglo (glejte poglavje 4.4).
English: • skin that is discoloured, blotchy, or darker or lighter than normal.
Slovenian: • koža, ki je spremenjene barve, lisasta, temnejša ali svetlejša od normalne • tekočina v pljučih ali okrog njih
English: Patient ID: COI ID:
Slovenian: ID bolnika:
English: • abnormal liver tests
Slovenian: • nenormalni izvidi jetrnih testov
English: o Patient alert card and the need to carry it on their person and tell any treating healthcare professional that they were treated with Zynteglo.
Slovenian: o Opozorilna kartica za bolnika in potreba, da jo ima bolnik vedno s seboj ter vsakemu zdravstvenemu delavcu, ki sodeluje pri njegovem zdravljenju pove, da se zdravi z zdravilom Zynteglo.
English: For the only patient who did not achieve TI, a reduction of 75.8% in transfusion volume requirements and a reduction of 74.9% in transfusion frequency were observed between hospital discharge and through last study visit when compared to their pre-study levels of RBC transfusions.
Slovenian: Pri edinem bolniku, ki TI ni dosegel, so opazili zmanjšanje potrebne količine transfuzije za 75,8 % in zmanjšanje za 74,9 % pri pogostnosti infuzije od odpusta iz bolnišnice do zadnjega pregleda za študijo v primerjavi z vrednostmi za transfuzijo RBC pred študijo.
English: Hb (g/dL) at 6 months*
Slovenian: Hb (g/dl) pri 6. mesecih*
English: In order to further confirm the appropriateness of the acceptance criteria, the MAH should re-evaluate the acceptance criteria for attributes related to potency tests using batch release data and clinical results after 6 months follow-up of 20 patients treated with commercial batches.
Slovenian: Za potrditev ustreznosti kriterijev za sprejetje bo imetnik dovoljenja za promet z zdravilom ponovno ocenil kriterije za sprejemljivost za lastnosti, povezane s testi jakosti, z uporabo podatkov o sprostitvi serije in kliničnih rezultatov po 6
English: CD34+ Cells
Slovenian: CD34+
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.
Slovenian: Zdravilo Zynteglo je bistra do rahlo motna, brezbarvna do rumena ali rožnata disperzija celic, ki je dobavljena v eni ali več prozornih infuzijskih vrečkah, pakiranih v prozorno vrečico v zaprtem kovinskem vsebniku.
English: INSTRUCTIONS FOR STORAGE AND USE
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE NAVODILA ZA SHRANJEVANJE IN UPORABO
English: If an infusion bag is compromised, follow the local guidelines and contact bluebird bio immediately.
Slovenian: Če je infuzijska vrečka na kakršen koli način poškodovana, sledite lokalnim smernicam in se takoj obrnite na družbo bluebird bio.
English: Pre-treatment transfusions per year median (min, max)
Slovenian: Transfuzije na leto pred zdravljenjem mediana (min, maks)
English: What Zynteglo is and what it is used for
Slovenian: Kaj je zdravilo Zynteglo in za kaj ga uporabljamo
English: However, G-CSF use was not recommended for 21 days after Zynteglo infusion in Phase 3 studies.
Slovenian: V študijah faze III pa uporaba G-CSF ni bila priporočena 21 dni po infuziji zdravila Zynteglo.
English: Chemotherapy medicine
Slovenian: Zdravilo za kemoterapijo
English: The median reduction in liver iron content from baseline was 67.14%, ranging from an 83.3% reduction to a 269.2% increase (N=3, HGB-204; N=2, HGB-205).
Slovenian: Mediano zmanjšanje vsebnosti železa v jetrih od izhodišča je bilo 67,14 %, z razponom od zmanjšanja za 83,3 % do povečanja za 269,2 % (N=3, HGB-204; N=2, HGB-205).
English: A negative serum pregnancy test must be confirmed prior to the start of mobilisation and re-confirmed prior to conditioning procedures and before medicinal product administration.
Slovenian: Pred začetkom mobilizacije je treba potrditi negativen serumski test za ugotavljanje nosečnosti in ga ponovno potrditi pred mieloablativnim postopkom in pred uporabo zdravila.
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.
Slovenian: Ženske v rodni dobi in moški, ki so zmožni spočeti otroka, morajo uporabljati učinkovito kontracepcijo (intrauterini pripomoček ali kombinacijo hormonske in mehanske kontracepcije) od začetka mobilizacije do vsaj 6 mesecev po uporabi zdravila Zynteglo.
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.
Slovenian: Zdravilo lahko v specializirani bolnišnici dajejo le zdravniki z izkušnjami pri zdravljenju bolnikov s TDT, dajanjem presadkov kostnega mozga in uporabo zdravil za gensko zdravljenje.
English: Zynteglo is made specifically for you, using your own blood stem cells.
Slovenian: Zdravilo Zynteglo je izdelano posebej za vas iz vaših lastnih krvnih matičnih celic.
English: 20 mL fluoro-ethylenepropylene infusion bag(s), each packed in a transparent pouch inside a metal cassette.
Slovenian: Infuzijske vrečke s po 20 ml fluoro-etilenpropilena, posamično pakirane v prozorno vrečico v kovinski kaseti.
English: **Transfusion independence (TI): a weighted average Hb ≥9 g/dL without any RBC transfusions for a continuous period of ≥12 months at any time during the study after medicinal product infusion.
Slovenian: **Neodvisnost od transfuzije (IT): obtežena povprečna vrednost Hb ≥ 9 g/dl brez transfuzije RBC za neprekinjeno obdobje ≥ 12 mesecev kadar koli med študijo po infuziji zdravila.
English: Therefore, patients who have received Zynteglo should not be screened for HIV infection using a PCR-based assay.
Slovenian: Zato bolniki, ki so prejeli zdravilo Zynteglo, ne smejo biti testirani za okužbo z virusom HIV s pomočjo testa PCR.
English: Zynteglo is indicated for the treatment of patients 12 years and older with transfusion-dependent β-thalassaemia (TDT) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available (see sections 4.4 and 5.1).
Slovenian: Zdravilo Zynteglo je indicirano pri bolnikih, starih 12 let in več, z β-talasemijo, ki zahteva transfuzijo (TDT - transfusion-dependent β-thalassaemia), ki nimajo β0/β0 genotipa, za katere je presaditev hematopoetskih matičnih celic (HSC - haematopoietic stem cell) primerna, a darovalec HSC z ustreznim humanim levkocitnim antigenom (HLA) ni na voljo (glejte poglavji 4.4 in 5.1).
English: If more than one infusion bag is provided, administer each infusion bag completely before proceeding to thaw and infuse the next bag.
Slovenian: Če je na voljo več kot ena infuzijska vrečka, vsako vrečko porabite do konca, preden odtajate in infundirate naslednjo vrečko.
English: One serious event of hypotension due to epistaxis occurred in a patient, with onset 11 days after Zynteglo treatment.
Slovenian: Pri bolniku se je pojavil en resen dogodek hipotenzije zaradi epistakse z začetkom 11 dni po zdravljenju z zdravilom Zynteglo.
English: • changes and abnormalities in heart rhythm
Slovenian: • spremembe in nepravilnosti srčnega ritma
English: These cells must be collected from the patient and be cryopreserved prior to myeloablative conditioning and infusion with Zynteglo.
Slovenian: Te celice je treba pridobiti pri bolniku in jih shraniti z zamrzovanjem pred mieloablativnim postopkom in infuzijo zdravila Zynteglo.
English: If leukaemia or lymphoma is detected in any patient who received Zynteglo, blood samples should be collected for integration site analysis.
Slovenian: Če je pri katerem koli bolniku, ki je prejel zdravilo Zynteglo, zaznana levkemija ali limfom, je treba odvzeti vzorce krvi za analizo mesta integracije.
English: Iron chelation should be stopped at least 7 days prior to myeloablative conditioning.
Slovenian: Kelacijo železa je treba prekiniti vsaj 7 dni pred mieloablativnim postopkom.
English: All patients in HGB-204 restarted iron chelation and continue to use iron chelators.
Slovenian: Vsi bolniki v HGB-204 so ponovno pričeli s kelacijo železa in so še naprej uporabljali železove kelate.
English: Flush all Zynteglo remaining in the infusion bag and any associated tubing with at least 50 mL of 0.9% sodium chloride solution to ensure as many cells as possible are infused into the patient.
Slovenian: Vse ostanke zdravila Zynteglo v infuzijski vrečki in vse uporabljene cevke izperite z vsaj 50 ml 0,9-odstotne raztopine natrijevega klorida, da se zagotovi, da je v bolnika infundiranih čim več celic.
English: Treatment with Zynteglo involves the infusion and engraftment of CD34+ HSCs that have been genetically modified ex vivo with a LVV.
Slovenian: Zdravljenje z zdravilom Zynteglo vključuje infuzijo in vsaditev celic CD34+ HSC, ki so bile gensko spremenjene ex vivo z LVV.
English: o Information on the possibility of false positivity of certain commercial HIV tests because of Zynteglo.
Slovenian: o Informacije o možnosti lažno pozitivnih rezultatov nekaterih komercialnih testov za HIV
English: Restarting iron chelation after Zynteglo infusion may be necessary and should be based on clinical practice (see sections 4.5 and 5.1).
Slovenian: Po infuziji zdravila Zynteglo bo morda treba ponovno začeti s kelacijo železa skladno s klinično prakso (glejte poglavji 4.5 in 5.1).
English: o Treatment with Zynteglo in the clinical trials was associated with delayed platelet engraftment.
Slovenian: o Zdravljenje z zdravilom Zynteglo v kliničnih preskušanjih je bilo povezano z zakasnjeno vsaditvijo trombocitov.
English: Mobilisation and blood stem cell collection
Slovenian: Mobilizacija in odvzem krvnih matičnih celic
English: n/N^ [95% CI]
Slovenian: n/N^ (%) interval zaupanja]
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.
Slovenian: Zdravilo Zynteglo deluje tako, da v te celice doda funkcionalne kopije gena za beta-globin, tako da lahko bolnik tvori dovolj beta-globina za povečanje skupnega hemoglobina, je manj anemičen in ima v krvi več kisika.
English: Myeloablative conditioning should not begin until the complete set of infusion bag(s) constituting the dose of Zynteglo has been received and stored at the administration site, and the availability of the back-up collection is confirmed.
Slovenian: Mieloablativni postopek se ne sme začeti, dokler ni celotni komplet infuzijskih vrečk, ki sestavlja odmerek zdravila Zynteglo, prejet in shranjen na mestu, kjer bo uporabljen, in je potrjena razpoložljivost dodatno zbranih celic CD34+.
English: There are no reports of LVV-mediated insertional mutagenesis resulting in oncogenesis.
Slovenian: Prav tako niso poročali o insercijski mutagenezi z lentivirusnim vektorjem (LVV - lentiviral vector), ki bi privedla do onkogeneze.
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).
Slovenian: Med bolniki z genotipom, ki ni genotip β0/β0, jih je 11/14 (78;6 %, 95-odstotni interval zaupanja 49,2 %-95,3%), doseglo TI do 24. meseca (preglednica 5).
English: To add blood stem cells containing functional copies of the beta-globin into your bone marrow.
Slovenian: Za dodajanje krvotvornih matičnih celic, ki vsebujejo delujoče kopije beta-globina, v vaš kostni mozeg.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu<, and on the website of {name of MS Agency (link)}>.
Slovenian: {DD. mesec LLLL} Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/<in na spletni strani {ime agencije v državi članici (povezava)}>.
English: Zynteglo has not been studied in patients >65 years of age.
Slovenian: Zdravila Zynteglo niso preučili pri bolnikih, starejših od 65 let.
English: • decrease in speed of air leaving your lungs
Slovenian: • nižja hitrost zraka, ki prihaja iz pljuč
English: A total of 28.6% of patients (12/42; HGB-204, HGB-205, HGB-207, HGB-212) received G-CSF within 21 days after Zynteglo infusion.
Slovenian: Skupno 28.6 % bolnikov (12/42; HGB-204, HGB-205, HGB-207, HGB-212) je 21 dni po infuziji zdravila Zynteglo prejemalo G-CSF.
English: • low blood calcium level
Slovenian: • nizke ravni kalcija v krvi
English: See Method of Administration below and section 6.6 for details on Zynteglo administration and handling.
Slovenian: Glejte spodnje poglavje Način uporabe in poglavje 6.6 za podrobnosti o dajanju in uporabi zdravila
English: One patient in HGB-205 restarted iron chelation and continues to use iron chelators.
Slovenian: En bolnik v HGB-205 je ponovno pričel s kelacijo železa in nadaljeval z uporabo železovih kelatov.
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.
Slovenian: Zdravilo Zynteglo mora v pristojnem centru za zdravljenje bolniku dati zdravnik z izkušnjami s področja presaditve HSC in zdravljenja bolnikov s TDT.
English: Patients with TDT may be at an increased risk of VOD following myeloablative conditioning compared with other patient populations.
Slovenian: Pri bolnikih s TDT je lahko po mieloablativnem postopku tveganje za jetrno vensko-okluzivno bolezen večje kot pri drugih populacijah bolnikov.
English: In clinical trials, no patients failed to engraft bone marrow, as measured by neutrophil engraftment (N=42).
Slovenian: V kliničnih preskušanjih so vsi bolniki uspešno prestali vsaditev kostnega mozga, merjeno z vsaditvijo nevtrofilcev (N=42).
English: The minimum target number of CD34+ cells to be collected is 12 × 106 CD34+ cells/kg.
Slovenian: Najmanjše ciljno število celic CD34+, ki jih je treba zbrati, je 12 × 106 celic CD34+/kg.
English: Each metal cassette contains one infusion bag with Zynteglo.
Slovenian: Vsaka kovinska kaseta vsebuje eno infuzijsko vrečko z zdravilom Zynteglo.
English: 3521AZ Utrecht The Netherlands
Slovenian: 3521AZ Utrecht Nizozemska
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.
Slovenian: Zdravilo Zynteglo iz proizvodnega obrata v skladišče centra za infundiranje pošljejo v kriogenskem transportnem tanku, ki lahko vsebuje več kovinskih kaset za enega bolnika.
English: C-reactive protein increased, Aspergillus test positive, Blood potassium decreased, Weight decreased, Blood alkaline phosphatase decreased, Blood magnesium decreased, Forced expiratory flow decreased, Protein total decreased, Blood albumin decreased, Reticulocyte count decreased, Reticulocyte percentage decreased
Slovenian: Preiskave zvišana vrednost C-reaktivnega proteina, pozitiven test na Aspergillus, zmanjšana raven kalija v krvi, zmanjšanje telesne mase, zmanjšana raven alkalne fosfataze v krvi, zmanjšana raven magnezija v krvi, zmanjšan pretok forsiranega zraka med izdihom, zmanjšana raven skupnih beljakovin, zmanjšana raven albumina v krvi, zmanjšano število retikulocitov, zmanjšan odstotek retikulocitov
English: • Access the medicinal product infusion bag and infuse per the administration site's standard procedures for administration of cell therapy products.
Slovenian: • Vzemite infuzijsko vrečko z zdravilom in jo infundirajte v skladu s standardnimi postopki na mesta za dajanje zdravil pri celičnem zdravljenju.
English: This medicine contains 391-1564 mg sodium (main component of cooking/table salt) in each dose.
Slovenian: Vsak odmerek zdravila vsebuje 391-1564 mg natrija (glavna sestavina kuhinjske soli).
English: All patients were administered G-CSF and plerixafor to mobilise stem cells prior to the apheresis procedure.
Slovenian: Vsi bolniki so pred postopkom afereze prejeli G-CSF in pleriksafor za mobilizacijo matičnih celic.
English: It is unknown whether Zynteglo transduced cells have the potential to be transferred in utero to a foetus.
Slovenian: Ni znano, ali imajo transducirane celice zdravila Zynteglo možnost, da se v maternici prenašajo na plod.
English: Name and address of the manufacturer(s) responsible for batch release apceth Biopharma GmbH Haidgraben 5
Slovenian: NEMČIJA Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij apceth Biopharma GmbH Haidgraben 5
English: o Treatment with Zynteglo is associated with the risk of delayed platelet engraftment that could lead to an increased tendency for bleeding.
Slovenian: o Zdravljenje z zdravilom Zynteglo je povezano s tveganjem zapoznele vsaditve trombocitov, kar lahko poveča nagnjenost h krvavitvam.
English: Zynteglo is given by a drip (infusion) into a vein.
Slovenian: Zdravilo Zynteglo se daje s kapljanjem (infuzijo) v veno.
English: Bleeding is a potential complication of thrombocytopenia subsequent to myeloablative conditioning and treatment with Zynteglo.
Slovenian: Krvavitev je možni zaplet trombocitopenije, ki sledi mieloablativnem postopku in zdravljenju z zdravilom Zynteglo.
English: • stomach discomfort with nausea and vomiting
Slovenian: • neugodje v želodcu s slabostjo in bruhanjem