FrancophonIA/ELRC3.0 huggingface dataset:
English: Zalmoxis is constituted of donor's T lymphocytes genetically modified to express the HSV-TK Mut2, as suicide gene.
Danish: Zalmoxis består af donor-T-lymfocytter, der er genetisk modificerede til at udtrykke HSV-TK Mut2, som er et selvmordsgen.
English: There are no data on the effect of Zalmoxis treatment on fertility.
Danish: Der foreligger ingen data om Zalmoxis' indvirkning på fertilitet.
English: Zalmoxis shall not be administered to patients with concurrent systemic immunosuppressive therapy as the efficacy of Zalmoxis treatment in early immune reconstitution may be reduced.
Danish: Zalmoxis må ikke administreres til patienter i samtidig systemisk immunsupprimerende behandling, da effekten af behandling med Zalmoxis på tidlig immunrekonstitution kan reduceres.
English: The MAH shall complete, within the stated timeframe, the below measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den angivne tidsfrist gennemføre nedenstående foranstaltninger:
English: There are no data from the use of Zalmoxis in pregnant women.
Danish: Der er ingen data fra anvendelse af Zalmoxis til gravide kvinder.
English: In the clinical study TK007, 30 patients with high-risk haematological malignancies undergoing HSCT received Zalmoxis monthly up to a maximum of four infusions.
Danish: I det kliniske studie TK007 fik 30 patienter med hæmatologisk højrisiko-malignitet, der gennemgik HSCT, Zalmoxis hver måned op til maksimalt fire infusioner.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Patient specific product not to be administered to other patients
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Patientspecifikt produkt, som ikke må administreres til andre patienter
English: Zalmoxis is therefore not recommended for use in children and adolescent below 18 years.
Danish: Zalmoxis anbefales derfor ikke til brug hos børn og unge under 18 år.
English: Only one 17-year-old male, affected by T lymphoblastic lymphoma, was treated in the TK007 trial with two infusions of Zalmoxis.
Danish: Kun en 17-årig ung mand, som havde T-celle lymfoblastisk lymfom, blev behandlet i TK007-studiet med to infusioner af Zalmoxis.
English: The use of Zalmoxis is not recommended for children and adolescents under the age of 18.
Danish: Anvendelse af Zalmoxis anbefales ikke til børn og unge under 18 år.
English: In order to confirm the efficacy and safety of Zalmoxis as an adjunctive treatment in haploidentical haematopoietic stem-cell transplantation of adult patients with high-risk haematological malignancies, the MAH should submit the results of study TK008, a randomized phase III trial of haploidentical HCT with an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukaemia.
Danish: For at bekræfte effektiviteten og sikkerheden af Zalmoxis som supplerende behandling ved haploidentisk hæmatopoietisk stamcelletransplantation hos voksne patienter med hæmatologiske højrisiko-maligniteter skal indehaveren af markedsføringstilladelsen fremsende resultaterne af studie TK008, et randomiseret fase III-studie af haploidentisk hæmatopoietisk celletransplantation (HCT) med en tilbageførsels-strategi af HSV-TK-donorlymfocytter hos patienter med højrisiko akut leukæmi.
English: Dispersion for infusion Bag volume:___________mL Dose: 1x107 cells /kg Concentration: _____x10x cells/mL Total cell number: _____x10X
Danish: Dispersion til infusion Posevolumen:___________ml Dosis: 1x107celler /kg Koncentration: ______x10x celler/ml Totalt celleantal: ______x10X
English: If leakage occurs during thawing, do not use the product.
Danish: Hvis der er lækage under optøningen, må præparatet ikke anvendes.
English: Acute graft-versus-host disease (a complication that can occur after a stem-cell or bone marrow transplantation in which the newly transplanted donor cells attack the patient's body).
Danish: Akut graft-versus-host sygdom (en komplikation, som kan optræde efter en stamcelle- eller knoglemarvstransplantation, hvor de nyligt transplanterede donorceller angriber patientens krop).
English: GvHD requiring systemic immunosupressive therapy.
Danish: GvHD, hvor systemisk immunsupprimerende behandling er nødvendig.
English: Zalmoxis consists of white blood cells called T cells that are obtained from the donor.
Danish: Zalmoxis indeholder hvide blodlegemer, såkaldte T-celler, som skaffes fra en donor.
English: One individual treatment dose in 50-500 mL ethylene-vinyl-acetate cryo bag, inside a plastic bag and then a metal box.
Danish: Én individuel behandlingsdosis i en 50-500 ml ethylenvinylacetat-kryopose i en plastikpose og derefter en metalæske.
English: The entire volume of the bag has to be infused.
Danish: Hele posens volumen skal infunderes.
English: Zalmoxis should not be administered if the circulating T lymphocytes are ≥100 per μL at the day of planned infusion after haploidentical HSCT.
Danish: Zalmoxis bør ikke administreres, hvis cirkulerende T-lymfocytter er ≥100/µl på dagen for den planlagte infusion efter haploidentisk HSCT.
English: CONTENTS OF THE PACK AND OTHER INFORMATION What Zalmoxis contains
Danish: PAKNINGSSTØRRELSER OG YDERLIGERE OPLYSNINGER Zalmoxis indeholder:
English: - If, before infusion, the value of CD3+ lymphocytes in your tests is equal to or more than 100 per μL.
Danish: - hvis dit tal for CD3+-lymfocytter inden infusionen er lig med eller højere end 100 pr. μl.
English: Zalmoxis has been manufactured specifically for you and cannot be administered to any other patient.
Danish: Zalmoxis er blevet fremstillet specielt til dig og må ikke gives til en anden patient.
English: Zalmoxis was evaluated in a phase I/II clinical study (TK007) in adult patients with haematological malignancies at high risk of relapse who have received a stem-cell transplantation from a human leukocyte antigen (HLA) mismatched (haploidentical) donor.
Danish: Zalmoxis blev evalueret i et klinisk fase I/II-studie (TK007) med voksne patienter med hæmatologiske maligniteter med høj risiko for relaps, som havde gennemgået en stamcelletransplantation fra en human leukocyt-antigen (HLA)-mismatchet (haploidentisk) donor.
English: Patients could be treated with Zalmoxis 24 hours after the antiviral or immunosuppressive therapy discontinuation.
Danish: Patienterne kan behandles med Zalmoxis 24 timer efter seponering af den antivirale eller immunsupprimerende behandling.
English: Zalmoxis must not be used in pregnant and breast-feeding women.
Danish: Zalmoxis må ikke anvendes til gravide og ammende kvinder.
English: The other ingredients are sodium chloride, human serum albumin and dimethyl sulfoxide (see section
Danish: Øvrige indholdsstoffer: natriumchlorid, humant serumalbumin og dimethylsulfoxid (se punkt 2).
English: Zalmoxis should be administered after a 24-hour discontinuation period of ganciclovir or valganciclovir and immunosuppressive therapy.
Danish: Zalmoxis bør administreres efter en periode på 24-timer efter seponering af ganciclovir eller valganciclovir og immunsupprimerende behandling.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BAG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGE POSE
English: The safety and efficacy in children and adolescents (less than 18 years) have not been established.
Danish: Zalmoxis' sikkerhed og virkning hos børn og unge (under 18 år) er ikke klarlagt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske
English: Even if donors are preliminary tested and found negative for transmissible infectious disease, precautions should be employed when handling Zalmoxis (see section 4.4).
Danish: Selv hvis donorer i forvejen er testede og fundet negative for overførbare infektionssygdomme, skal der tages forholdsregler ved håndtering af Zalmoxis (se pkt.
English: If not used immediately, transfer the Zalmoxis bag from the shipping container to liquid nitrogen vapour.
Danish: Hvis lægemidlet ikke skal anvendes med det samme, overføres Zalmoxis-posen fra forsendelsesbeholderen til en beholder med flydende kvælstof.
English: What Zalmoxis is and what it is used for What you need to know before you are given Zalmoxis How Zalmoxis is given to you Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du får Zalmoxis Sådan får du Zalmoxis Bivirkninger
English: For treating Zalmoxis-related GvHD through activation of the suicide gene, patients received GCV intravenously or VCV orally, for better patient convenience.
Danish: Til behandling af Zalmoxis-relateret GvHD ved aktivering af selvmordsgenet fik patienter ganciclovir (GCV) intravenøst eller − mere patientvenligt − valganciclovir (VCV) oralt.
English: Zalmoxis is a patient specific product and should under no circumstances be administered to other patients.
Danish: Zalmoxis er et patientspecifikt præparat og må under ingen omstændigheder administreres til andre patienter.
English: Each bag contains approximately 13.3 mmol (305.63 mg) of sodium per dose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver pose indeholder cirka 13,3 mmol (305,63 mg) natrium pr. dosis.
English: Shelf life after thawing: 2 hours
Danish: Opbevaringstid efter optøning: 2 timer
English: - Post-transplantation lymphoproliferative disorder (increase in the number of white blood cells in the blood after a transplantation) - Chronic graft-versus-host disease (a complication that can occur after a stem-cell or bone marrow transplantation in which the newly transplanted donor cells attack the patient's body) - Intestinal haemorrage (bleeding in the gut) - Hepatic failure (liver malfunction) - Febrile neutropenia (fever associated with reduction of the number of white blood cells) - Decreased haemoglobin (reduction of the number of red blood cells)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - Post-transplantation lymfoproliferativ sygdom (forhøjet antal hvide blodlegemer i blodet efter en transplantation - Kronisk graft-versus-host sygdom (en komplikation, som kan optræde efter en stamcelle- eller knoglemarvstransplantation, hvor de nyligt transplanterede donorceller angriber patientens krop) - Intestinal blødning (blødning i tarmsystemet) - Leversvigt (nedsat leverfunktion) - Febril neutropeni (feber forbundet med et nedsat antal hvide blodlegemer)
English: The package is checked for the presence of any abnormality in the outer box and the label is checked for patient/donor correspondance.
Danish: Den ydre emballage skal kontrolleres for beskadigelse, og etiketten skal kontrolleres for overensstemmelse mellem patient og donor.
English: If you forget to use Zalmoxis
Danish: Hvis du har glemt at få Zalmoxis
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGSIK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Immune reconstitution defined as circulating T lymphocytes ≥100 per μL at the day of planned infusion after haploidentical HSCT.
Danish: Immunrekonstitution defineret som cirkulerende T-lymfocytter ≥100/μl på dagen for den planlagte infusion efter haploidentisk HSCT.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total cell number: ____x10X
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Totalt celleantal: ______x10X
English: o Onset of GVHD requiring systemic immunosuppressive therapy o Ongoing systemic immunosuppressive therapy or administration of granulocyte colony stimulating factor (G-CSF) after haploidentical hematopoietic stem-cell transplantation
Danish: o Optræden af GvHD, hvor systemisk immunsupprimerende behandling er nødvendig o Igangværende systemisk immunsupprimerende behandling eller administration af granulocytkolonistimulerende faktor (G-CSF) efter haploidentisk hæmatopoietisk stamcelletransplantation
English: Zalmoxis is intended for use in adults with certain tumours of the blood known as high-risk haemotological malignancies.
Danish: Zalmoxis er beregnet til brug hos voksne med visse kræftformer i blodet, såkaldte hæmatologiske maligniteter med høj risiko.
English: The identity of the patient must be matched with the essential unique donor information prior to infusion.
Danish: Før infusion skal det bekræftes, at patientens identitet svarer til den obligatoriske unikke donorinformation.
English: - If you have any further questions, ask your doctor, or a physician experienced in the medical treatment of blood cancer.
Danish: - Spørg din læge eller en læge, der har erfaring i medicinsk behandling af blodkræft, hvis der er mere, du vil vide.
English: Once the bag is infused, it is flushed 2 to 3 times with sodium chloride solution in order to completely administer Zalmoxis.
Danish: Når dispersionen er infunderet, skylles posen 2 til 3 gange med natriumchloridinfusionsvæske for at sikre, at hele Zalmoxis-dosen administreres.
English: As a precautionary measure, Zalmoxis must not be administered during pregnancy and in women of childbearing potential not using contraception.
Danish: For en sikkerheds skyld må Zalmoxis ikke administreres under graviditet eller til kvinder i den fertile alder, der ikke anvender kontraception.
English: Practical information for handling and administration of Zalmoxis for the doctor or nurse can be found at the end of this leaflet.
Danish: Praktiske oplysninger til lægen eller sygeplejersken om håndtering og administration af Zalmoxis findes sidst i indlægssedlen.
English: Zalmoxis is solely for use as patient specific medicinal product to be administered after HSCT and it is administered by intravenous infusion.
Danish: Zalmoxis er udelukkende til brug som et patientspecifikt lægemiddel, der administreres efter HSCT.
English: 18 months when stored in liquid nitrogen vapour.
Danish: 18 måneder ved opbevaring i flydende kvælstof.
English: - Decreased platelet count (reduction of the number of platelets in the blood) - Bronchitis (lung infection) - Pyrexia (fever)
Danish: - Nedsat hæmoglobin (nedsat antal røde blodlegemer) - Nedsat trombocyttal (nedsat antal blodplader) - Bronkitis - Feber
English: No adverse reactions were reported for this patient.
Danish: Der er ikke indrettet nogen bivirkninger for denne patient.
English: In-use storage times and conditions should not exceed 2 hours at room temperature (15 °C - 30 °C).
Danish: Under brug må opbevaringstid og -forhold ikke overstige 2 timer ved stuetemperatur (15 °C-30 °C).
English: The cells are of human origin and genetically modified with a replicationdefective γ-retroviral vector coding for the HSV-TK and ΔLNGFR genes so that these sequences are integrated in the genome of the host cells.
Danish: Cellerne er af human oprindelse og er genetisk modificerede med en replikationsdefekt γ-retroviral vektor, der koder for HSV-TK- og ΔLNGFR-generne således, at disse sekvenser integreres i værtscellernes genom.
English: Obligation to complete post-authorisation measures
Danish: Forpligtelse til at fuldføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: Zalmoxis 5-20 x 106 cells/mL cell dispersion for infusion contains 13.3 mmol (305.63 mg) of sodium per dose.
Danish: Zalmoxis 5-20 x 106 celler/ml infusionsvæske, celledispersion (opslæmning af celler) indeholder 13,3 mmol (305,63 mg) natrium pr. dosis.
English: Zalmoxis must be administered under the supervision of a physician experienced in HSCT for haematological malignancies.
Danish: Zalmoxis skal administreres under supervision af en læge med erfaring i HSCT ved hæmatologiske maligniteter.
English: • Upon completion of washing, the patient specific label on the bag should be removed and adhered to the patient specific file.
Danish: • Derefter fjernes den patientspecifikke etiket på posen og anbringes i patientjournalen.
English: Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies (see section 5.1).
Danish: Zalmoxis er indiceret som adjuverende behandling i forbindelse med haploidentisk hæmatopoietisk stamcelletransplantation (HSCT) hos voksne patienter med hæmatologisk højrisiko-malignitet (se pkt.
English: Other medicines and Zalmoxis
Danish: Brug af anden medicin sammen med Zalmoxis
English: For the patients who achieved immune reconstitution, a nonrelapse mortality (NRM) of 17% was reported, with 35% of these patients being disease free at 5 years and 34% alive at 10 years.
Danish: 35 % af patienterne, der opnåede immunrekonstitution, var sygdomsfrie efter 5 år, og 34 % var i live efter 10 år.
English: Febrile neutropenia Haemoglobin decreased Platelet count decreased
Danish: Febril neutropeni Nedsat hæmoglobin Nedat trombocyttal
English: You should tell your doctor before using Zalmoxis if:
Danish: Før du får Zalmoxis, skal du fortælle din læge, hvis:
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDELSAMT AFFALD HERAF
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PLASTIC BAG
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PLASTPOSE
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMTÆNDIGHEDER
English: EXP: Shelf life after thawing: 2 hours at room temperature (15 °C - 30 °C)
Danish: EXP: Opbevaringstid efter optøning: 2 timer ved stuetemperatur (15 °C-30 °C)
English: Human serum albumine, dimethyl sulphoxide, sodium chloride.
Danish: LISTE OVER HJÆLPESTOFFER Human serumalbumin, dimethylsulfoxid, natriumchlorid.
English: • At the end of infusion, wash the bag 2 or 3 times with a physiological solution using a sterile technique, in order to completely administer Zalmoxis.
Danish: • Når infusionen er afsluttet, skylles posen 2 til 3 gange med natriumchlorid-infusionsvæske ved brug af steril teknik for at sikre, at hele Zalmoxis-dosen administreres.
English: Overall, in the clinical study TK007, the 30 treated patients received their first infusion of Zalmoxis cells at a median time of 43 days from the date of HSCT.
Danish: I det kliniske studie TK007 fik de 30 behandlede patienter den første infusion af Zalmoxis mediant 43 dage efter HSCT.
English: One bag contains donor T cells genetically modified to express HSV-TK and ΔLNGFR at the concentration of 5-20 x 106 cells/mL.
Danish: En pose indeholder donor-T-celler, der er genetisk modificerede til at udtrykke HSV-TK og ΔLNGFR, i en koncentration på 5-20 x 106 celler/ml.
English: What Zalmoxis looks like and contents of the pack Zalmoxis is a cell dispersion for infusion appearing as opaque, off-white frozen dispersion of cells.
Danish: Zalmoxis er en infusionsvæske, dispersion, der fremtræder som en uigennemsigtig off-white frossen dispersion af celler.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDFØRINGSTILLADELEN
English: Maximum time elapsed from thawing and infusion is 2 hours at room temperature (15 °C - 30 °C).
Danish: Den maksimale tid, der må forløbe fra optøning til infusion, er 2 timer ved stuetemperatur (15 °C-30 °C).
English: Zalmoxis must be administered under the supervision of a physician experienced in haematopoietic stem cell transplantation for haematological malignacies.
Danish: Zalmoxis skal administreres under supervision af en læge med erfaring i hæmatopoietisk stamcelletransplantation for hæmatologiske maligniteter.
English: These cells will be genetically modified by introducing a “suicide” gene (HSV-TK Mut2) in their genetic code which can be activated later on in case of graft-versus-host disease.
Danish: Disse celler modificeres genetisk ved at introducere et “selvmordsgen” (HSV-TK) i deres genetiske kode.
English: The safe use of Zalmoxis has not been demonstrated during pregnancy and breast-feeding.
Danish: Sikkerheden ved brug af Zalmoxis under graviditet og ved amning er ikke blevet undersøgt.
English: Women of childbearing potential have to use effective contraception during and up to 6 months after treatment with Zalmoxis.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med Zalmoxis og i 6 måneder efter, behandlingen er stoppet.
English: SPECIAL STORAGE CONDITIONS Store in liquid nitrogen vapour.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i flydende kvælstofdamp.
English: Do not infuse Zalmoxis if
Danish: Zalmoxis må ikke infunderes, hvis
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zalmoxis 5-20x106 cells/mL dispersion for infusion Intravenous use
Danish: LÆGEMIDLETS NAVN,STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zalmoxis 5-20 x 106 celler/ml dispersion til infusion Intravenøs anvendelse
English: The shipping is performed in liquid nitrogen vapour.
Danish: Forsendelsen sker i flydende kvælstof.
English: Zalmoxis 5-20 x 106 cells/mL dispersion for infusion
Danish: Zalmoxis5-20 x 106 celler/ml infusionsvæske, dispersion
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresume, pkt.
English: Shelf life and special precautions for storage
Danish: Opbevaringstid og særlige forsigtighedsregler vedrørende brugen
English: There are no data on the use of Zalmoxis during breast-feeding.
Danish: Der foreligger ingen data om anvendelse af Zalmoxis under amning.
English: Each bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL.
Danish: Hver pose indeholder et volumen på 10-100 ml frossen dispersion i en koncentration på 5-20 x 106 celler/ml.
English: NAME OF THE MEDICINAL PRODUCT Zalmoxis 5-20 x 106 cells/mL dispersion for infusion
Danish: LÆGEMIDLETS NAVN Zalmoxis 5-20 x 106 celler/ml infusionsvæske, dispersion
English: Each bag of Zalmoxis contains a volume of 10-100 mL of frozen dispersion at the concentration of 5-20 x 106 cells/mL.
Danish: Hver pose Zalmoxis indeholder et volumen på 10-100 ml frossen dispersion i en koncentration på 5-20 x 106 celler/ml.
English: When Zalmoxis cannot be given
Danish: Hvis du ikke kan få Zalmoxis
English: HOW TO STORE ZALMOXIS
Danish: SÅDAN FÅR DU ZALMOXIS
English: STATEMENT OF ACTIVE SUBSTANCE(S) The bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Posen indeholder et volumen af 10-100 ml frossen dispersion med en koncentration af 5-20 x 106 celler/ml.
English: If you receive more Zalmoxis than you should
Danish: Hvis du har fået for meget Zalmoxis
English: - If you get any side effects, talk to your doctor, or a physician experienced in the medical treatment of blood cancer.
Danish: - Kontakt din læge eller en læge, der har erfaring i medicinsk behandling af blodkræft, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: EXPIRY DATE Expiry date:
Danish: Udløbsdato: .
English: The active substance consists of allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2).
Danish: Det aktive stof betår af allogene T-celler, der er genetisk modificerede med retroviral vektorindkodning til en afkortet form af human lavaffinitets-nervevækstfaktorreceptor (ΔLNGFR) og herpes simplex I-virus-tymidinkinase (HSV-TK Mut2).
English: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Danish: Allogene T-celler, der er genetisk modificerede med retroviral vektorindkodning til en afkortet form af human lavaffinitets-nervevækstfaktorreceptor (ΔLNGFR) og herpes simplex I-virus-tymidinkinase (HSV-TK Mut2)