FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: - fil-passat ingħatajt terapija tal-ġeni taċ-ċelluli staminali tad-demm tiegħek - inti allerġiku għal xi sustanza oħra fil-mediċini li ser tingħata għall-mobilizzazzjoni u l-kimoterapija (ara sezzjoni 3).
English: • low body temperature
Maltese: • temperatura baxxa tal-ġisem
English: Study HGB-205
Maltese: Studju HGB-205
English: • positive test for Apergillus (lung disease caused by fungus)
Maltese: • test pożittiv għal Apergillus (mard tal-pulmun ikkawżat minn fungu)
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.
Maltese: L-MAH għandu jiżgura li f'kull Stat Membru fejn Zynteglo jitpoġġa fis-suq, ikun hemm sistema maħsuba biex tikkontrolla d-distribuzzjoni ta' Zynteglo lil hinn mil-livell ta' kontroll żgurat permezz ta' miżuri ta' rutina tal-minimizzazzjoni tar-riskju.
English: Pre-treatment conditioning
Maltese: IL-PRODOTT MEDIĊINALI
English: (See section 4.4 for guidance on platelet monitoring and management.)
Maltese: (Ara sezzjoni 4.4 għal gwida dwar il-monitoraġġ u l-immaniġġjar tal-plejtlits.)
English: Zynteglo is prepared using parts of the human immunodeficiency virus (HIV), which have been altered so that they cannot cause HIV infection.
Maltese: Zynteglo huwa ppreparat bl-użu ta' partijiet tal-virus tal-immunodefiċjenza umana (HIV) li nbidlu sabiex ma jistgħux jikkawżaw infezzjoni tal-HIV.
English: In clinical studies doses up to 20 × 106 CD34+ cells/kg have been administered.
Maltese: Fi studji kliniċi ngħataw dożi sa 20 × 106 CD34+ ċelluli/kg.
English: Tel: +39 029 475 9755 (800 728 026)
Maltese: Italia bluebird bio (Italy) S.r.l Tel: +39 029 475 9755 (800 728 026)
English: • Thaw Zynteglo at 37°C in a water bath or dry bath.
Maltese: • Ħoll Zynteglo f'temperatura ta' 37°C f'banju tal-ilma jew banju xott.
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
Maltese: Tnaqqis fil-piż tal-ġisem, Tnaqqis fl-alkaline phosphatase fid-demm, Tnaqqis fil-magnesium fid-demm, Tnaqqis fil-fluss espiratorju furzat, Tnaqqis fit-total tal proteina, Tnaqqis fl-albumina fiddemm, Tnaqqis fl-għadd ta' retikuloċiti, Tnaqqis filperċentwal tar-retikuloċiti
English: After completion of the 4-day course of myeloablative conditioning, there must be a minimum of 48 hours of washout before Zynteglo infusion.
Maltese: Wara li jitlesta l-kors ta' 4 ijiem ta' kondizzjonament majeloablattiv, irid ikun hemm perjodu ta' washout minimu ta' 48 siegħa qabel l-infużjoni ta' Zynteglo.
English: Additional studies with human CD34+ HSCs administered to immunodeficient, myeloablated mice demonstrated no toxicity, tumorigenicity or genotoxicity.
Maltese: Studji addizzjonali fuq HSCs ta' CD34+ umani mogħtija lil ġrieden immunodefiċjenti, majeloablatadi ma wrew l-ebda tossiċità, tumiġeneniċità jew ġenotossiċità.
English: Patients should be made aware of the risk of bleeding events that are not easily identifiable, such as internal bleeding.
Maltese: Il-pazjenti għandhom jiġu mgħarrfa dwar ir-riskju ta' avvenimenti ta' fsada li mhumiex identifikabbli faċilment, bħal fsada interna.
English: Neutropenic sepsis, Systemic infection, Staphylococcal infection, Pneumonia, Lower respiratory tract infection, Urinary tract infection, Mucosal infection, Cellulitis, Vaginal infection, Rash pustular, Folliculitis, Gingivitis
Maltese: Infezzjoni fil-parti t'isfel tal apparat respiratorju, Infezzjoni flapparat tal-awrina, Infezzjoni talmukuża, Ċellulite, Infezzjoni vaġinali, Raxx pustulari, Follikulite, Ġinġivite
English: It is recommended that patients maintain haemoglobin (Hb) ≥11 g/dL for 30 days prior to myeloablative conditioning.
Maltese: Huwa rrakkomandat li l-pazjenti jżommu l emoglobina (Hb) ≥11 g/dL għal 30 jum qabel il-kondizzjonament majeloablattiv.
English: LIST OF EXCIPIENTS
Maltese: Deskrizzjoni ġenerali
English: Confirm that Zynteglo is printed on the infusion bag(s).
Maltese: Ikkonferma li Zynteglo huwa stampat fuq il-borża (boroż) tal-infużjoni.
English: • abnormal heart rhythm
Maltese: • bidliet u anormalitajiet fir-ritmu tal-qalb
English: Hepatic veno-occlusive disease
Maltese: Marda veno-okklussiva tal-fwied
English: Patients should not take anti-retroviral medicinal products or hydroxyurea from at least one month prior to mobilisation until at least 7 days after Zynteglo infusion (see section 4.4).
Maltese: Il-pazjenti m'għandhomx jieħdu prodotti mediċinali antiretrovirali jew hydroxyurea minn mill-inqas xahar qabel il-mobilizzazzjoni sa mill-inqas 7 ijiem wara l-infużjoni ta' Zynteglo (ara sezzjoni 4.4).
English: Zynteglo is an autologous gene therapy medicinal product consisting of autologous cells that have been genetically modified ex vivo.
Maltese: Zynteglo huwa prodott mediċinali ta' terapija tal-ġeni awtologu li jikkonsisti f'ċelluli awtologi li ġew modifikati ġenetikament ex vivo.
English: 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.
Maltese: Zynteglo huwa popolazzjoni ta' ċelluli CD34+ awtologi ġenetikament modifikata li fiha ċelluli staminali ematopojetiċi trasdotti b'vettur lentivirali li jikkodifika l-βA-T87Qġene globina.
English: This is because Zynteglo is a gene therapy medicine.
Maltese: Dan għaliex Zynteglo huwa mediċina tat-terapija tal-ġeni.
English: Hypoxia, Dyspnoea, Pleural effusion, Rales, Upper-airway cough syndrome, Cough, Laryngeal pain, Hiccups
Maltese: Ipossija, Dispnea, Effużjoni millplewra, Ħsejjes tal-pulmun (Rales), Sindrome ta' sogħla tal parti ta' fuq tal-passaġġ tal-arja,
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.
Maltese: Jekk id-doża minima ta' Zynteglo ta' 5.0 × 106 ċelluli CD34+/kg ma tiġix sodisfatta wara l-manifattura tal-prodott mediċinali inizjali, il-pazjent jista' jgħaddi minn ċiklu wieħed addizzjonali jew aktar ta' mobilizzazzjoni u aferesi, separati b'mill-inqas 14-il jum, sabiex jikseb aktar ċelluli għal manifattura addizzjonali.
English: cell/mL.
Maltese: Xhur Wara l-Infużjoni
English: • pain in larynx (voice box)
Maltese: • uġigħ fil-larinġi (kaxxa tal-vuċi)
English: At 48 months after infusion of Zynteglo for patients who achieved TI, the median reduction (min, max) in serum ferritin levels from baseline was 75.02% (39.2, 84.8) (N=3, HGB-204; N=2, HGB-205).
Maltese: Wara 48 xahar wara l-infużjoni ta' Zynteglo għal pazjenti li kisbu TI, it-tnaqqis medjan (min, mass) fil-livelli ta' ferritin fis-serum mil-linja bażi kien 75.02% (39.2, 84.
English: The minimum target number of CD34+ cells to be collected is 12 × 106 CD34+ cells/kg.
Maltese: In-numru ta' mira minimu ta' ċelluli CD34+ li għandhom jinġabru huwa 12 × 106 ċelluli CD34+/kg.
English: All patients with TDT with a non-β0/β0 genotype who received Zynteglo with at least 3 months of follow-up produced HbAT87Q (N=10, HGB-204; N=4, HGB-205; N=14, HGB-207; N=1, HGB-212).
Maltese: Il-pazjenti kollha b'TDT b'ġenotip mhux β0/β0 li rċivew Zynteglo b'mill-inqas 3 xhur ta' segwitu pproduċew HbAT87Q (N=10, HGB-204; N=4, HGB-205; N=14, HGB-207; N=1, HGB-212).
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: DOSE OF THE MEDICINAL PRODUCT Total Number of Infusion Bags: __
Maltese: Numru Totali ta' Boroż tal-Infużjoni: __
English: Ovarian failure, Menstruation irregular, Premature menopause, Blood follicle stimulating hormone increased, Blood testosterone decreased
Maltese: Insuffiċjenza fl-ovarji, Menstruwazzjoni irregolari, Menopawża prematura, Żieda fl ormon li jistimula l-follikolu tad demm, Tnaqqis fit-testosteron fid demm
English: Breast-feeding
Maltese: tal-borża
English: Infusion related reactions to Zynteglo
Maltese: Bidu tal-kura b'Zynteglo
English: *Patients who have not received transfusions in the prior 60 days.
Maltese: *Pazjenti li ma ngħatawx trasfużjonijiet fis-60 jum ta' qabel.
English: Chemotherapy medicine
Maltese: Proprjetajiet farmakodinamiċi
English: A back-up collection of CD34+ stem cells of at least 1.5 × 106 CD34+ cells/kg (if collected by apheresis) or >1.0 × 108 TNC/kg (if collected by bone marrow harvest) is required.
Maltese: Hija meħtieġa kollezzjoni ta' backup ta' ċelluli CD34+ staminali ta' mill-inqas 1.5 × 106 ċelluli CD34+/kg (jekk miġbura bl-aferesi) jew >1.0 × 108 TNC/kg (jekk miġbura bil-ħsad tal-mudullun).
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)}>.
Maltese: Mediċini: http://www.ema.europa.eu
English: Serological testing
Maltese: Ittestjar seroloġiku
English: Dizziness, Lethargy, Dysgeusia
Maltese: Sturdament, Letarġija, Disgewżja
English: • stomach pain
Maltese: • fwied imkabbar
English: Patients should not take anti-retroviral medications or hydroxyurea from at least one month prior to mobilisation until at least 7 days after Zynteglo infusion (see section 4.5).
Maltese: Il-pazjenti m'għandhomx jieħdu mediċini antiretrovirali jew hydroxyurea minn mill-inqas xahar qabel il-mobilizzazzjoni sa mill-inqas 7 ijiem wara l-infużjoni ta' Zynteglo (ara sezzjoni 4.5).
English: • changes in blood chemistry which may indicate low calcium, low potassium, low magnesium,
Maltese: • bidliet fil-kimika tad-demm li jistgħu jindikaw calcium baxx, potassium baxx, magnesium baxx,
English: Patients should be assessed for renal impairment defined as creatinine clearance ≤70 mL/min/1.73 m2 to ensure HSC transplantation is appropriate.
Maltese: Il-pazjenti għandhom jiġu evalwati għal indeboliment tal-kliewi definit bħala tneħħija tal-krejatinina ≤70 mL/min/1.73 m2 biex jiġi żgurat li t-trapjant HSC huwa xieraq.
English: The Lot Information Sheet is included inside the lid of the cryoshipper used to transport Zynteglo.
Maltese: L-Iskeda ta' Informazzjoni tal-Lott hija inkluża fl-għatu tal-cryoshipper użat għat-trasport ta' Zynteglo.
English: • Confirm that patient identity matches the unique patient identification information located on the Zynteglo infusion bag(s).
Maltese: • Ikkonferma li l-identità tal-pazjent taqbel mal-informazzjoni unika ta' identifikazzjoni tal-pazjent li tinsab fuq il-borża (boroż) tal-infużjoni ta' Zynteglo.
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.
Maltese: LVV użati għat-trasduzzjoni fil-manifattura ta' Zynteglo ġew evalwati in vitro u in vivo.
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.
Maltese: Għall-uniku pazjent li ma kisibx it-TI, kienu osservati tnaqqis ta' 75.8% fir-rekwiżiti tal-volum ta' trasfużjoni u tnaqqis ta' 74.9% fil-frekwenza tat-trasfużjoni bejn il-ħruġ mill-isptar u matul l-aħħar żjara ta' studju meta mqabbla mal-livelli ta' qabel l-istudju tagħhom ta' trasfużjonijiet ta' RBC.
English: Dose: {N.N} × 106 CD34+ cells/kg
Maltese: (× 106 ċelluli CD34+)
English: This will take place in a hospital and will take less than 30 minutes for each infusion bag.
Maltese: Dan ser iseħħ fi sptar u ser jieħu inqas minn 30 minuta għal kull borża tal-infużjoni.
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.
Maltese: o Il-pazjenti kollha għandhom jirċievu monitoraġġ annwali ta' għadd tad-demm kompleti u livelli tal-emoglobina totali biex jimmonitorjaw il-lewkimja/limfoma u l-manteniment tal effikaċja, rispettivament.
English: Frequencies are defined as: very common (≥1/10), and common (≥1/100 and <1/10).
Maltese: (≥1/100 u <1/10).
English: (g/dL) at 24 months n median (min, max)
Maltese: (g/dL) wara 24 xahar n medjan
English: Number of Infusion Bags
Maltese: BORŻA TAL-INFUŻJONI
English: Treatment with Zynteglo involves the infusion and engraftment of CD34+ HSCs that have been genetically modified ex vivo with a LVV.
Maltese: Il-kura b'Zynteglo tinvolvi l-infużjoni u t-trapjant ta' HSCs ta' CD34+ li ġew modifikati ġenetikament ex vivo b'LVV.
English: Epistaxis, Pharyngeal inflammation
Maltese: Tagħrif farmakokinetiku
English: EU/1/19/1367/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1367/001
English: NA = Not applicable.
Maltese: NA = Mhux applikabbli.
English: Zynteglo adds functional copies of a modified β-globin gene into the patients' HSCs through transduction of autologous CD34+ cells with BB305 LVV, thereby addressing the underlying genetic cause of the disease.
Maltese: Zynteglo jżid kopji funzjonali ta' ġene β-globin modifikat fl-HSCs tal-pazjenti permezz ta' trasduzzjoni ta' ċelluli CD34+ awtologi b'BV305 LVV, b'hekk jindirizzaw il-kawża ġenetika sottostanti tal-marda.
English: o Treatment with Zynteglo is in theory associated with the risk of insertional mutagenesis, potentially leading to development of malignancy.
Maltese: o Teoretikament, il-kura b'Zynteglo hija assoċjata mar-riskju ta' mutaġenesi inserzjonali, li potenzjalment twassal għall-iżvilupp ta' tumur malinni.
English: What Zynteglo looks like and contents of the pack
Maltese: Kif jidher Zynteglo u l-kontenut tal-pakkett
English: Adverse reactions attributed to Zynteglo
Maltese: Tabella 3 Reazzjonijiet avversi attribwiti għal Zynteglo
English: The educational and controlled distribution programme is aimed at providing information on the safe use of Zynteglo.
Maltese: Il-programm edukattiv u ta' distribuzzjoni kkontrollata għandu l-għan li jipprovdi informazzjoni dwar l-użu sigur ta' Zynteglo.
English: Patients had a Month 6 median (min, max) HbAT87Q of 4.90 (1.0, 9.6) g/dL in the Phase 1/2 studies (N=14, HGB-204 and HGB-205) and 9.49 (3.4, 10.6) g/dL in the ongoing Phase 3 study (N=11, HGB-207).
Maltese: Il-pazjenti kellhom HbAT87Q medjan ta' Xahar 6 (min, mass) ta' 4.90 (1.0, 9.6) g/dL fl-istudji ta' Fażi 1/2 (N=14, HGB-204 u HGB-205) u 9.
English: • skin abrasion/scrape
Maltese: • skumdità fir-ras
English: 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).
Maltese: Kondizzjonament majeloablattiv sħiħ irid jingħata qabel l-infużjoni ta' Zynteglo (ara sezzjoni 5.1 għal deskrizzjoni tal-kors majeloablattiv użat fi studji kliniċi).
English: Expiry Date
Maltese: Data mistennija
English: Efficacy outcomes for non-β0/β0 TDT patients treated with Zynteglo (Studies
Maltese: Riżultati tal-effikaċja għal pazjenti b'TDT mhux β0/β0 ikkurati b'Zynteglo (Studji
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.
Maltese: Huwa importanti li wieħed jinnota li l-pazjenti li rċivew Zynteglo x'aktarx li jittestjaw pożittivi permezz ta' assaġġi ta' reazzjoni katina bil-polimerażi (PCR) għall-HIV minħabba l-inserzjoni provirus LVV, li jirriżultaw f'test pożittiv falz għall-HIV.
English: ≥100 × 109/L were 52 (20, 268) days and 63 (20, 1231) days, respectively.
Maltese: Il-ħinijiet medjani (min, mass) għal għadd ta' plejtlits mingħajr appoġġ ta' ≥50 × 109/L u ≥100 × 109/L kienu 52 (20, 268) jum u 63 (20, 1231) jum, rispettivament.
English: Adverse reactions attributed to myeloablative conditioning
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: Each infusion bag contains approximately 20 mL of Zynteglo.
Maltese: U KONTENUT Dispersjoni għall-infużjoni 20 mL
English: A negative serology test for HIV is necessary to ensure acceptance of apheresis material for Zynteglo manufacturing.
Maltese: o Test seroloġiku negattiv għall-HIV huwa neċessarju biex tiġi żgurata l-aċċettazzjoni tal materjal tal-aferesi għall-manifattura ta' Zynteglo.
English: • vomiting
Maltese: Infużjoni)
English: • Remove each metal cassette from liquid nitrogen storage and remove each infusion bag from the metal cassette.
Maltese: • Neħħi kull kasett tal-metall mill-ħażna ta' nitroġenu likwidu u neħħi kull borża tal-infużjoni mill-kasett tal-metall.
English: Zynteglo is not expected to interact with the hepatic cytochrome P-450 family of enzymes or drug transporters.
Maltese: Zynteglo mhux mistenni li jinteraġixxi mal-familja ta' enzimi jew trasportaturi tal-mediċina taċ-ċitokromu epatiku P-450.
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.
Maltese: Aħsel il-bqija ta' Zynteglo li jkun fadal fil-borża tal-infużjoni u kwalunkwe tubu assoċjat b'mill-inqas 50 mL ta' soluzzjoni ta' 0.9% sodium chloride biex tiżgura li kemm jista' jkun iċ-ċelluli jkunu infużi fil-pazjent.
English: Consult the SmPC of the myeloablative conditioning agent for information on the need for effective contraception in patients who undergo conditioning.
Maltese: Ikkonsulta l-SmPC tal-aġent ta' kondizzjonament majeloablattiv għal informazzjoni dwar il-ħtieġa ta' kontraċezzjoni effettiva f'pazjenti li jsirilhom kondizzjonament.
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)}>.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu.
English: After Zynteglo infusion, transduced CD34+ HSCs engraft in the bone marrow and differentiate to produce RBCs containing biologically active βA-T87Q-globin (a modified β-globin protein) that will combine with α-globin to produce functional Hb containing βA-T87Q-globin (HbAT87Q).
Maltese: Wara l-infużjoni ta' Zynteglo, HSCs trasdotti ta' CD34+ jiġu trapjantati fil-mudullun u jiddifferenzjaw biex jipproduċu RBCs li fihom βA-T87Q-globin (proteina β-globina modifikata) bijoloġikament attiv li ser jikkombina ma' α-globin biex jipproduċi
English: In the 3 patients who did not achieve TI, reductions of 100%, 86.9% and 26.8% in transfusion volume requirements and of 100%, 85.3% and 20.7% in transfusion frequency were observed between Month 6 through Month 24 visit when compared to their pre-study levels of RBC transfusions.
Maltese: 3% u 20.7% fil-frekwenza ta' trasfużjoni kienu osservati bejn ix-Xahar 6 sa żjara f'Xahar 24 meta mqabbla ma' livelli ta' qabel l-istudju ta' trasfużjonijiet ta' RBC.
English: All patients completed HGB-204 and HGB-205 and enrolled for long-term follow-up in the LTF-303 study.
Maltese: Il-pazjenti kollha temmew HGB-204 u HGB-205 u rreġistraw għal segwitu fit-tul fl-istudju LTF-303.
English: 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).
Maltese: deferoxamine, deferiprone u jew deferasirox) 7 ijiem qabel tibda l-kimoterapija qabel l-infużjoni ta' Zynteglo (ara sezzjoni 3, Kif jingħata Zynteglo).
English: Non-β0/β0 patients
Maltese: TA' EĊĊIPJENTI
English: Three patients in HGB-205 started phlebotomy.
Maltese: Tliet pazjenti f'HGB-205 bdew il-flebotomija.
English: (g/dL) at 6 months n median (min, max)
Maltese: (g/dL) wara 6 xhur n medjan
English: Each metal cassette contains one infusion bag with Zynteglo.
Maltese: Kull kassett tal-metall fih borża tal-infużjoni waħda b'Zynteglo.
English: You should not take hydroxyurea (a medicine for blood disorders) or any medicines for HIV infection from at least one month before you undergo mobilisation until at least 7 days after Zynteglo infusion (see also section 3, How Zynteglo is given).
Maltese: M'għandekx tieħu hydroxyurea (mediċina għad-disturbi fid-demm) jew xi mediċini għall-infezzjoni tal-HIV minn tal-inqas xahar qabel ma ssirlek mobilizzazzjoni sa mill-inqas 7 ijiem wara l-infużjoni ta' Zynteglo (ara wkoll sezzjoni 3, Kif jingħata Zynteglo).
English: Date of Birth (DD/MM/YYYY): Weight at First Collection (kg): Patient ID:
Maltese: Piż tal-Ġisem fl-Ewwel Ġbir (kg): ID tal-pazjent:
English: The quantitative information regarding strength, CD34+ cells, and dose for the medicinal product is provided in the Lot Information Sheet.
Maltese: L-informazzjoni kwantitattiva rigward is-saħħa, iċ-ċelluli CD34+, u d-doża għall-prodott mediċinali hija pprovduta fil-Iskeda ta' Informazzjoni tal-Lott.
English: • abnormal liver tests
Maltese: • għaraq eċċessiv
English: • lip swelling
Maltese: • demm fl-awrina
English: • small tear in tissue that lines the anus
Maltese: • tiċrit żgħir fit-tessut li jgħaqqad l-anus
English: • injection site reaction
Maltese: • tnaqqis fil-piż
English: Autologous CD34+ cells encoding βA-T87Q-globin gene This medicine is subject to additional monitoring.
Maltese: Ċelluli CD34+ awtologi li jikkodifika l-ġene βA-T87Q-globin
English: The traceability requirements of cell-based advanced therapy medicinal products must apply.
Maltese: Għandhom japplikaw ir-rekwiżiti tat-traċċabilità ta' prodotti mediċinali ta' terapija avvanzata bbażata fuq iċ-ċelluli.
English: Nausea
Maltese: Dispnea
English: • inflammation of the gallbladder
Maltese: • infjammazzjoni fl-apparat tad-diġestjoni
English: Keep infusion bag(s) in the metal cassette(s).
Maltese: Żomm il- borża (boroż) tal-infużjoni fil-kasett(i) tal-metall.
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.
Maltese: • Il-karta ta' twissija tal-pazjent għandu jkun fiha l-messaġġi ewlenin li ġejjin: o Informazzjoni tar-riskju tat-trapjant tal-plejtlits mdewwem, li potenzjalment iwassal għal fsada, u r-riskji teoretiċi.
English: Contents of the pack and other information What Zynteglo contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Zynteglo
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.
Maltese: Nisa li jistgħu joħorġu tqal u rġiel li jistgħu jnisslu t-tfal għandhom jużaw metodu ta' kontraċezzjoni affidabbli (apparat ġewwa l-utru jew kombinazzjoni ta' kontraċezzjoni ormonali u ta' barriera) mill-bidu tal-mobilizzazzjoni sa mill-inqas 6 xhur wara l-għoti ta' Zynteglo.
English: • fever
Maltese: Fwawar
English: More specifically, people with TDT do not make enough of a part of the haemoglobin called beta-globin, due to a gene defect.
Maltese: B'mod aktar speċifiku, persuni b'TDT ma jipproduċux biżżejjed minn parti tal-emoglobina msejħa beta-globin, minħabba difett fil-ġene.
English: Do not use an in-line blood filter or an infusion pump.
Maltese: Tużax filtru tad-demm fil-linja jew pompa tal-infużjoni.