natgillin/translations-raw huggingface dataset:
HGB-204 and HGB-205 were Phase 1/2 open-label, single-arm 24-month studies that included 22 patients with TDT treated with Zynteglo (N=18, HGB-204; N=4, HGB-205), of whom 14 had a non-β0/β0 genotype (N=10, HGB-204; N=4, HGB-205) and 8 had a β0/β0 genotype in HGB-204.
HGB-204 in HGB-205 sta bila nezaslepljeni 24-mesečni študiji faze I/II z eno skupino bolnikov, ki sta vključevali 22 bolnikov s TDT, ki so se zdravili z zdravilom Zynteglo (N=18, HGB-204; N=4, HGB-205), od katerih je bilo 14 bolnikov z genotipom, ki ni genotip β0/β0 (N=10, HGB-204; N=4, HGB-205), in 8 bolnikov z genotipom β0/β0 v študiji HGB-204.
For 8 patients who had sufficient on-study follow-up to obtain a 12-month follow-up bone marrow assessment, myeloid/erythroid ratios for 7 patients increased from a range of 0.1 to 0.5 at baseline to a range of 0.6 to 1.9 approximately 12 months after Zynteglo infusion, suggesting that Zynteglo improves erythropoiesis in patients with TDT.
7 bolnikov povečala v razponu od 0,1 do 0,5 ob izhodišču in v razponu od 0,6 do 1,9 približno 12 mesecev po infundiranju zdravila Zynteglo, kar kaže, da zdravilo Zynteglo izboljša eritropoezo pri bolnikih s TDT.
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).
Mediana (min; maks) feritina v serumu ob izhodišču je bila 3778,7 (784; 22517) pmol/l in mediana (min; maks) koncentracija železa v jetrih je bila 6,75 (1,0; 41,0) mg/g
Bag ID:
ID COI:
Data are available on the risk of infertility with myeloablative conditioning.
Na voljo pa so podatki o tveganju neplodnosti pri mieloablativnem postopku.
Dyspnoea
disgevzija
Zynteglo in patients 12 years and older with transfusion-dependent β thalassaemia (TDT) who do not have a β0/β0 genotype, the MAH should conduct and submit the results of a study based on data from a product registry (REG501) and use data on patients treated with transfusions and/or HLA-matched allogenic HSCT treated patients from an established European registry as a comparator group.
Neintervencijska študija varnost in učinkovitosti po začetku trženja: Za dodatno določitev značilnosti in določitev okvira dolgoročne varnosti in učinkovitosti zdravila Zynteglo pri bolnikih, starih 12 let in več, s β-talasemijo, odvisno od transfuzije (TDT), ki nimajo genotipa β0/β0, mora imetnik dovoljenja za promet z zdravilom izvesti študijo in predložiti rezultate na podlagi podatkov registra (REG-501) in uporabiti podatke o bolnikih, zdravljenih s transfuzijami in/ali bolnikov, zdravljenih z alogeno HSCT, ki se ujemajo s HLA, iz uveljavljenega evropskega registra kot primerjalna skupina.
Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion (autologous CD34+ cells encoding βA-T87Q-globin gene) For intravenous use.
Zynteglo 1,2-20 × 106 celic/ml disperzija za infundiranje (avtologne celice CD34+, ki kodirajo gen za βA-T87Q-globin) za intravensko uporabo
You should stop taking medicines to remove iron from your body (so-called chelating agents: deferoxamine, deferiprone and/or deferasirox) 7 days before you start the chemotherapy before the infusion of Zynteglo (see section 3, How Zynteglo is given).
7 dni pred začetkom kemoterapije, ki ji sledi infuzija zdravila Zynteglo, morate prenehati jemati zdravila za odstranjevanje železa iz telesa (tako imenovane kelatorje: deferoksamin, deferipron in/ali deferasiroks) (glejte poglavje 3, Kako uporabljati zdravilo Zynteglo).
Full myeloablative conditioning must be administered before infusion of Zynteglo (see section 5.1 for a description of the myeloablative regimen used in clinical studies).
Pred infuzijo zdravila Zynteglo je treba izvesti celoten mieloablativni postopek (glejte poglavje 5.1 za opis mieloablativnega režima, ki je bil uporabljen v kliničnih študijah).
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).
Po infuziji zdravila Zynteglo se transducirane matične hematopoetske celice v CD34+ vsadijo v kostnem mozgu in se diferencirajo za proizvodnjo rdečih krvnih celic (RBC - red blood cells), ki vsebujejo biološko aktiven βA-T87Q-globin (modificiran protein β-globin), ki se združi z α-globinom, da proizvede funkcionalni Hb, ki vsebuje βA-T87Q-globin (HbAT87Q).
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).
vrednost HbAT87Q 4,90 (1,0; 9,6) g/dL v študijah faze I/II (N=14, HGB-204 in HGB-205) in 9,49 (3,4; 10,6) g/dL v potekajoči študiji faze III (N=11, HGB-207).
Studies HGB-207 and HGB-212
Študiji HGB-207 in HGB-212
Drug-drug interactions between iron chelators and the myeloablative conditioning agent must be considered.
Upoštevati je treba medsebojno delovanje železovih kelatov in sredstev za mieloablativni postopek.
(g/dL) at 24 months n median (min, max)
(g/dl) pri 24. mesecih n mediana (min, maks)
• flushing (redness and warmth of skin) • pain in legs
• zardevanje (pordela in topla koža)
Blood magnesium decreased
Preiskave zmanjšana raven magnezija v krvi
Zynteglo infusion should be completed as soon as possible and no more than 4 hours after thawing.
Infundirajte zdravilo Zynteglo čim prej oziroma ne kasneje kot v 4 urah po odtajanju.
Do not sample, alter, or irradiate the medicinal product.
Zdravila ne smete vzorčiti, spremeniti ali obsevati.
• Account for all infusion bags and confirm each infusion bag is within the expiry date using the accompanying Lot Information Sheet.
• Preglejte vse infuzijske vrečke in na priloženem dokumentu z informacijami o seriji preverite, ali so vse vrečke znotraj datuma izteka roka uporabnosti.
• loss of function of your ovaries
• prenehanje delovanja jajčnikov
Marketing Authorisation Holder and Manufacturer bluebird bio (Netherlands) B.V. Stadsplateau 7
Imetnik dovoljenja za promet z zdravilom in izdelovalec bluebird bio (Netherlands) B.V.
Among these 11 patients, the median (min, max) weighted average Hb during TI was 10.51 (9.3, 13.2) g/dL (Table 5).
obtežena povprečna vrednost Hb med TI znašala 10,51 (9,3; 13,2) g/dl (tabela 5).
(months) n median (min, max)
(meseci) n mediana (min, maks)
Warnings and precautions of the mobilisation agents and the myeloablative conditioning agent must be considered.
Upoštevati je treba opozorila in previdnostne ukrepe za sredstva za mobilizacijo in sredstva za mieloablativni postopek.
o The Summary of Product Characteristics o Guide for healthcare professionals o Guide for handling and method of administration
• Izobraževalno gradivo za zdravnike mora vsebovati: o povzetek glavnih značilnosti zdravila o vodnik za zdravstvene delavce o vodnik glede ravnanja z zdravilom in načina uporabe
Studies HGB-204 and HGB-205
Študiji HGB-204 in HGB-205
Patients with TDT treated with Zynteglo who achieved platelet engraftment had a median (min, max) platelet engraftment on Day 41.0 (19, 191) in clinical trials (N=39).
Bolniki s TDT, zdravljeni z zdravilom Zynteglo, ki so dosegli vsaditev trombocitov, je v kliničnih preskušanjih (N=39) do vsaditve trombocitov prišlo mediano (min.; maks.)
Mobilisation medicine is given To move the blood stem cells from your bone marrow into your blood stream.
Za premik krvnih matičnih celic iz kostnega mozga v krvni obtok
It is unknown whether Zynteglo is excreted in human milk.
Ni znano, ali se zdravilo Zynteglo izloča v materino mleko.
All patients were administered Zynteglo with a median (min, max) dose of 7.80 × 106 (5.0, 19.4) CD34+ cells/kg as an intravenous infusion (N=32).
odmerka 7,80 × 106 (5,0; 19,4) celic CD34+/kg kot intravensko infuzijo (N=32).
Zynteglo, therefore the likelihood that an offspring would have general somatic expression of the βA-T87Q-globin gene is considered negligible.
Ni priložnosti za prenos gena za βA-T87Q-globin po zdravljenju z zdravilom Zynteglo, zato je verjetnost, da bi imel otrok splošni somatski izraz gena za βA-T87Q-globin, zanemarljiva.
cell/mL.
{DD/MM/LLLL
Bag ID
ID COI
Prophylaxis for hepatic veno-occlusive disease (VOD) is recommended.
Priporočamo profilakso za jetrno venookluzivno bolezen.
No cases of leukaemia or lymphoma have been reported in clinical studies with Zynteglo in patients with TDT.
V kliničnih študijah z zdravilom Zynteglo pri bolnikih s TDT niso poročali o primerih levkemije ali limfoma.
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)
Preglednica 4 Izhodiščne značilnosti za bolnike z ne-β0/β0 s TDT ≥ 12 let, zdravljene z zdravilom Zynteglo (študije HGB-204, HGB-205, HGB-207, HGB-212, LTF-303) Bolniki z ne-β0/β0
• dry, itchy skin
• suha, srbeča koža
All patients who have achieved TI have maintained TI with a min, max duration of TI of 12.0+, 18.2+ months (N=4).
trajanjem TI 12,0+, 18,2+ mesecev (N=4).
Local biosafety guidelines should be followed for unused medicinal products or waste material.
Za neuporabljeno zdravilo ali odpadni material je treba upoštevati lokalne smernice za biološko varnost.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INFUSION BAG
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• spots on skin from bleeding under the skin
• pikčasta koža zaradi podkožnih krvavitev
Hypocalcaemia, Hypokalaemia, Metabolic acidosis, Fluid overload, Fluid retention, Hypomagnesaemia, Hyponatraemia, Hypophosphataemia
metabolna acidoza, tekočinska preobremenjenost, zastajanje tekočine, hipomagneziemija,
Citrate toxicity, Contusion, Procedural pain
Poškodbe, zastrupitve in zapleti pri posegih citratna toksičnost, kontuzija, bolečina ob postopku
Cryostor CS5 Sodium chloride
Cryostor CS5.
• tingling or numbness of the hands, feet, or mouth
• mravljinčenje ali odrevenelost rok, nog ali ust
After Zynteglo infusion, patient iron levels were managed at physician discretion.
Po infuziji zdravila Zynteglo so zdravniki po lastni presoji uravnavali ravni železa pri bolnikih.
(g/dL) at 6 months n median (min, max)
(g/dl) pri 6. mesecih n mediana (min, maks)
Atrial fibrillation
Srčne bolezni atrijska fibrilacija
• weight decreased
• zmanjšan tek
After Zynteglo infusion patient iron chelation was managed at physician discretion.
Po infuziji zdravila Zynteglo so kelacijo železa pri bolnikih uravnavali zdravniki po lastni presoji.
Preparation for the infusion
Priprava na infuzijo
Zynteglo has not been studied in patients with hepatic impairment.
Zdravila Zynteglo niso preučili pri bolnikih z okvaro ledvic.
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).
Vsi bolniki s TDT z genotipom, ki ni genotip β0/β0, ki so prejeli zdravilo Zynteglo in bili deležni vsaj 3-mesečnega nadaljnjega spremljanja, so proizvedli HbAT87Q (N=10, HGB-204; N=4, HGB-205;
n median (min, max)
n mediana (min, maks)
• inflamed skin lesions
• srbeča koža
• swelling of the face
• otekanje obraza
Non-β0/β0 patients
Število bolnikov
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).
Učinkovitost temelji na 32 odraslih bolnikih in mladostnikih s TDT in genotipom, ki ni genotip β0/β0, zdravljenih z zdravilom Zynteglo (N=10, HGB-204; N=4, HBG-205, N=15, HGB-207; N=3,
A genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene with a strength of 1.2-20 × 106
Gensko spremenjena obogatena populacija avtolognih celic CD34+, ki vsebuje hematopoetske matične celice, transducirane z lentivirusnim vektorjem, ki kodira gen za βA-T87Q-globin, z jakostjo 1,2-20 × 106 celic/m.
Hypotension, Haematoma
Žilne bolezni hipotenzija, hematom
No correlation was observed between incidence of bleeding and delayed platelet engraftment.
Med incidenco neželenih učinkov krvavitev in časom do vsaditve trombocitov niso opazili korelacije.
Study HGB-207
Študija HGB-207
Administer each infusion bag via intravenous infusion over a period of less than 30 minutes.
Vsako infuzijsko vrečko je treba kot intravensko infuzijo dati v manj kot 30 minutah.
• inflammation of the gallbladder
• vnetje žolčnika
This medicine contains genetically-modified cells.
To zdravilo vsebuje gensko spremenjene celice.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v okončinah
It may no longer be possible for you to become pregnant or father a child after receiving chemotherapy medicine.
Morda po prejemu zdravila za kemoterapijo ne boste več mogli zanositi ali zaploditi otroka.
Study HGB-205
Študija HGB-205
CD34+ cells)
(× 106 celic CD34+)
Study HGB-204
Študija HGB-204
• Confirm that patient identity matches the unique patient identification information located on the Zynteglo infusion bag(s).
• Preverite, ali se identiteta bolnika ujema z edinstvenimi informacijami o bolniku na infuzijski/-ih vrečki/-ah zdravila Zynteglo.
• stomach pain
• bolezen dlesni
Contraindications to the mobilisation agents and the myeloablative conditioning agent must be considered.
Upoštevati je treba kontraindikacije na učinkovine, uporabljene za mobilizacijo, in učinkovino za mieloablativni postopek.
Anal haemorrhage, Gastritis, Gastrointestinal inflammation, Abdominal distension, Abdominal pain upper, Anal fissure, Dyspepsia, Dysphagia, Oesophagitis, Haemorrhoids, Proctalgia.
konstipacija, bolečine v trebuhu, analno vnetje analna krvavitev, gastritis, vnetje prebavil, abdominalna distenzija, bolečine v zgornjem delu trebuha, analna fisura, dispepsija, disfagija, ezofagitis, hemoroidi, proktalgija, suhe ustnice
BATCH NUMBER, CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT, AND EXPIRY DATE
ŠTEVILKA SERIJE, VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI
All patients who have achieved TI at any time have maintained TI at Month 30 with a min, max duration of TI of 21.2+, 56.3+ months (N=11).
trajanjem TI 21,2+ oz. 56,3+ mesecev (N=11).
After you have been treated with Zynteglo, you will not be able to donate blood, organs, or tissues in the future.
Po zdravljenju z zdravilom Zynteglo v prihodnosti ne boste mogli darovati krvi, organov ali tkiva, ker je zdravilo Zynteglo zdravilo za gensko zdravljenje.
In the clincal studies, patients received a median (min, max) RBC transfusion volume of 175.7 (139, 251) mL/kg/year and a median (min, max) number of 14.8 (10, 40) RBC transfusions per year.
količine transfuzije celic RBC 175,7 (139; 251) ml/kg/leto in mediano (min.; maks.)
• Confirm that Zynteglo is printed on the infusion bag(s).
• Preverite, ali je na infuzijski(h) vrečki(vrečkah) natisnjeno ime Zynteglo.
Reproductive and developmental toxicity studies with Zynteglo were not performed.
Študije vpliva zdravila Zynteglo na sposobnost razmnoževanja in razvoja niso bile izvedene.
Talk to your doctor if you need to have any vaccinations.
Če potrebujete kakršno koli cepljenje, se posvetujte z zdravnikom.
• chest pain or discomfort
• nelagodje ali bolečina v prsnem košu
Engraftment failure as measured by neutrophil engraftment
Odpoved presadka, merjena z vsaditvijo nevtrofilcev
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).
Vsaj en mesec pred izvajanjem mobilizacije in najmanj 7 dni po infuziji zdravila Zynteglo ne smete jemati hidroksisečnine (zdravilo za bolezni krvi) ali katerega koli zdravila za okužbo z virusom HIV (glejte tudi poglavje 3, Kako uporabljati zdravilo Zynteglo).
• head discomfort
• nelagodje v glavi
• soreness of the mouth
• bolečina v ustih
Confirm that Zynteglo is printed on the infusion bag(s).
Preverite, ali je na infuzijski(h) vrečki(ah) natisnjeno ime Zynteglo.
Keep infusion bag(s) in the metal cassette(s).
vrečki(vrečkah) in kovinski(h) kaseti(kasetah).
The Summary of Product Characteristics (SmPC) for the iron chelator and the myeloablative conditioning agent must be consulted for the recommendations regarding co-administration with CYP3A substrates.
Za priporočila glede sočasne uporabe s substrati CYP3A je treba upoštevati povzetek glavnih značilnosti zdravila (SmPC) za železov kelat in sredstva za mieloablativni postopek.
The medicinal product contains genetically-modified cells.
Zdravilo vsebuje gensko spremenjene celice.
Ovarian failure, Menstruation irregular, Premature menopause, Blood follicle stimulating hormone increased, Blood testosterone decreased
folikle stimulirajočega hormona v krvi, zmanjšana raven testosterona v krvi
Psychiatric disorders
Psihiatrične motnje agitacija
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).
10,60 (8,8; 13.7) g/dL (N=12), v 36. mesecu pa je bila mediana (min.; maks.)
Petechiae, Ecchymosis, Pain of skin, Palpable purpura, Petechiae, Pruritus generalised, Purpura, Sweat gland disorder, Urticaria, Dry skin
hiperpigmentacija kože petehije, ekhimoza, bolečine kože, tipna purpura, petehije,
There is no clinical experience with the use of erythropoiesis-stimulating agents in patients treated with Zynteglo.
Kliničnih izkušenj z zdravili za spodbujanje eritropoeze pri bolnikih, zdravljenih z zdravilom
Age median (min, max)
Starost mediana (min, maks)
Figure 1 Median total haemoglobin over time in non-β0/β0 TDT patients treated with Zynteglo who have achieved transfusion independence (Studies HGB-204,
Slika 1 Mediana skupne koncentracije hemoglobina v odvisnosti od časa za bolnike s TDT in genotipom, ki ni genotip β0/β0, ki so se zdravili z zdravilom Zynteglo in so dosegli neodvisnost od transfuzije (študije HGB-204, HGB-205, HGB-207, LTF-303)
Zynteglo is a genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene.
Zdravilo Zynteglo je gensko modificirana obogatena populacija avtolognih celic CD34+, ki vsebuje hematopoetske matične celice, transducirane z lentivirusnim vektorjem, ki kodira gen za βA-T87Q-globin.
Talk to your doctor before you are given Zynteglo.
Pred začetkom uporabe zdravila Zynteglo se posvetujte z zdravnikom.
Healthcare professionals handling Zynteglo should take appropriate precautions (wearing gloves, protective clothing and eye protection) to avoid potential transmission of infectious diseases.
zaščitnih oblačil in zaščite za oči), da se prepreči morebitni prenos kužnih bolezni.
Last Name First Name: Date of Birth: DIN:
Datum rojstva:
Driving and using machines
Odtajanje in uporaba
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.
18 odraslih in mladostnikov s TDT in genotipom, ki ni β0/β0 genotip, se je zdravilo z zdravilom Zynteglo v študijah faze III (N=15, HGB-207; N=3, HGB-212), mediano (min.; maks.)
Expose the sterile port on the infusion bag by tearing off the protective wrap covering the port. Access the infusion bag and infuse per the administration site's standard procedures for administration of cell therapy products.
Vzemite infuzijsko vrečko z zdravilom in jo infundirajte v skladu s standardnimi postopki na mestaza dajanje zdravil pri celičnem zdravljenju.
HGB-207 and HGB-212 are ongoing Phase 3 open-label, single-arm 24-month studies that are planned to include approximately 39 adults, adolescents, and children with TDT (N=23, HGB-207;
HGB-207 in HGB-212 sta potekajoči, nezaslepljeni 24-mesečni študiji faze III z eno skupino bolnikov, v kateri naj bi se vključilo približno 39 odraslih bolnikov, mladostnikov in otrok s TDT (N=23, HGB-207; N=16, HGB-212), od katerih je 29 bolnikov z genotipom, ki ni β0/β0 genotip (N=23, HGB-207; N=6, HGB-212), in 10 bolnikov z genotipom β0/β0 v študiji HGB-212.
• inflammation of the throat
• bolečina v grlu (glasilkah)
Package leaflet: Information for the patient or carer Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion
Navodilo za uporabo Zynteglo 1,2-20 × 106 celic/ml disperzija za infundiranje
Neutropenic sepsis, Systemic infection, Staphylococcal infection, Pneumonia, Lower respiratory tract infection, Urinary tract infection, Mucosal infection, Cellulitis, Vaginal infection, Rash pustular, Folliculitis, Gingivitis
infekcija sluznice, celulitis, vaginalna infekcija, pustularni izpuščaj, folikulitis, gingivitis
Back pain, Musculoskeletal discomfort
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v kosteh bolečine v hrbtu, mišično skeletno nelagodje
Cardiac disorders
Srčne bolezni srčna undulacija
Efficacy outcomes for non-β0/β0 TDT patients treated with Zynteglo (Studies
Preglednica 3 Neželeni učinki, ki so pripisani zdravilu Zynteglo Organski sistem
Consult the SmPC of the myeloablative conditioning agent for information on the need for effective contraception in patients who undergo conditioning.
Za informacije o potrebi po učinkoviti kontracepciji pri bolnikih, ki so opravili mieloablativni postopek, je treba upoštevati SmPC mieloablativnega zdravila.
Hypoxia, Dyspnoea, Pleural effusion, Rales, Upper-airway cough syndrome, Cough, Laryngeal pain, Hiccups
Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa, faringealno vnetje hipoksija, dispneja, plevralna efuzija, piskanje, sindrom kašlja zgornjih dihal, kašelj,
A negative serology test for HIV is necessary to ensure acceptance of apheresis material for Zynteglo manufacturing.
Za zagotovitev sprejetja afereznega materiala za izdelavo zdravila Zynteglo je potreben negativen serološki test za
Transfusion reaction, Skin abrasion
Poškodbe in zastrupitve in zapleti pri posegih reakcija na transfuzijo, kožna abrazija
Stomatitis, Vomiting, Nausea, Diarrhoea, Gingival bleeding, Constipation, Abdominal pain, Anal inflammation,
Bolezni prebavil stomatitis, bruhanje, navzea, driska, krvavitev dlesni,
• dry lips
• otekanje ustnic
Delayed platelet engraftment
Zapoznela vsaditev trombocitov
Mucosal inflammation, Face oedema, Hypothermia, Feeling cold, Pain, Xerosis
hipotermija, občutek mrazenja, bolečina, kseroza
A genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells (HSC) transduced with lentiviral vector (LVV) encoding the βA-T87Q-globin gene.
Gensko modificirana obogatena populacija avtolognih celic CD34+, ki vsebuje hematopoetske matične celice, transducirane z lentivirusnim vektorjem, ki kodira gen za βA-T87Q-globin.
Zynteglo must not be administered to women who are breast-feeding.
Zdravila Zynteglo ni dovoljeno dajati doječim materam.
After Zynteglo infusion
Po uporabi zdravila Zynteglo
• tiredness
• kolcanje
• Obligation to conduct post-authorisation measures
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI
• inflammation in the digestive tract
• vnetje prebavnega trakta
Zynteglo administration
Uporaba zdravila Zynteglo
How to store Zynteglo
Shranjevanje zdravila Zynteglo
Lip dry
Okvara jeter
Inspect each infusion bag for any breaches of integrity before thawing and infusion.
Pred odtajanjem in infundiranjem preglejte vsako infuzijsko vrečko za morebitne poškodbe.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI Seznam pomožnih snovi
Veno-occlusive liver disease, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased
Bolezni jeter, žolčnika in žolčevodov veno-okluzivna jetrna bolezen, zvišanje ravni alaninaminotransferaze, zvišanje ravni aspartataminotransferaze, zvišanje ravni bilirubina v krvi holecistitis, holelitiaza, hepatomegalija, zlatenica, zvišanje ravni transaminaze, zvišanje ravni gamaglutamiltransferaze
Keep the infusion bag(s) in the metal cassette(s).
Infuzijske vrečke pustite v kovinski kaseti.