FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases in which Zalmoxis cannot be supplied / infused In some cases, the patient may be unable to receive Zalmoxis because of manufacturing issues.
Danish: Tilfælde, hvor Zalmoxis ikke kan udleveres / infunderes I nogle tilfælde vil det ikke være muligt at give patienten Zalmoxis på grund af fremstillingsproblemer.
English: The product should be administered immediately after thawing.
Danish: Præparatet skal administreres umiddelbart efter optøning.
English: Zalmoxis contains sodium
Danish: Zalmoxis indeholder natrium
English: The primary mechanism of action of Zalmoxis relies on its ability to engraft and stimulate immunereconstitution.
Danish: Zalmoxis' primære virkningsmekanisme beror på dets evne til at facilitere og stimulere immunrekonstitution.
English: - You suffer from infections requiring administration of ganciclovir (GCV) or valganciclovir (VCV) (antiviral) at the time of infusion.
Danish: - du lider af infektioner, der kræver administration af ganciclovir (GCV) eller valganciclovir (VCV) (antiviral behandling) på infusionstidspunktet.
English: The 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.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelen, og enhver efterfølgende godkendt opdatering af RMP.
English: No implications on the use of Zalmoxis in patients of 65 and older have been established.
Danish: Der er ikke klarlagt nogen konsekvenser vedrørende brug af Zalmoxis til patienter på 65 år eller derover.
English: The treating physician must ensure that patients do not receive ganciclovir or valganciclovir within 24 hours prior to the administration of Zalmoxis.
Danish: Den behandlende læge skal sikre, at patienten ikke har fået ganciclovir eller valganciclovir inden for en periode på 24 timer forud for administration af Zalmoxis.
English: The activated, transduced T lymphocytes that are causing the GvHD should convert the GCV to its toxic form and thereby undergo apoptosis.
Danish: De aktiverede, transducerede T-lymfocytter, som forårsager GvHD, konverterer GCV til dets toksiske form og undergår derved apoptose.
English: • Once the patient is prepared for infusion, inspect the Zalmoxis bag for integrity.
Danish: • Når patienten er gjort klar til infusionen, undersøges Zalmoxis-posen for beskadigelse.
English: Via Olgettina 58 20132 Milano Italy
Danish: Via Olgettina 58 20132 Milano Italien
English: If the infusion must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (15 °C-30 °C) for more than 2 hours.
Danish: Hvis det er nødvendigt at afbryde infusionen, må den ikke genoptages, hvis infusionsposen er blevet opbevaret ved stuetemperatur (15 °C - 30 °C) i mere end 2 timer.
English: All signs and symptoms of grade 2 to 4 acute and extensive chronic GvHD fully resolved after a median treatment duration of GCV or VCV of 15 days.
Danish: Alle tegn og symptomer på grad 2 til 4 akut eller svær kronisk GvHD var helt ophørt efter en median behandlingsvarighed af GCV eller VCV på 15 dage.
English: The MAH shall ensure that in each Member State where Zalmoxis is marketed, all HCPs who are expected to prescribe, dispense, and administer Zalmoxis are provided with a guidance document containing the following key elements:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at i alle medlemsstater, hvor Zalmoxis markedsføres, bliver alle sundhedspersoner, der forventes at ordinere, udlevere og administrere Zalmoxis, forsynet med en vejledning, der indeholder følgende nøgleelementer:
English: Relevant information about the safety concern of Concomitant immunosuppressive therapy
Danish: Relevant information om sikkerhedsproblemer i relation til samtidig immunsupprimerende behandling
English: The recommended dose and schedule is 1 ± 0.2 x 107 cells/kg given as an intravenous infusion at a time interval of 21-49 days from transplantation, in the absence of spontaneous immune reconstitution and/or development of graft-versus-host disease (GvHD).
Danish: Den anbefalede dosis og doseringsskema er 1 ± 0,2 x 107 celler/kg som intravenøs infusion med et tidsinterval på 21-49 dage efter transplantation, ved fravær af spontan immunrekonstitution og/eller udvikling af graft versus host-sygdom (GvHD).
English: In particular, at immune reconstitution Zalmoxis represents a high proportion of the circulating lymphocytes, while at later time points the proportion of Zalmoxis progressively decreases and untransduced lymphocytes expand from donor-derived precursors.
Danish: Især ved immunrekonstitution repræsenterer Zalmoxis-celler en stor andel af de cirkulerende lymfocytter, mens andelen af Zalmoxis-celler på senere tidspunkter falder progressivt, og ikketransducerede lymfocytter ekspanderer fra donor-deriverede prækursorer.
English: • Zalmoxis is shipped directly to the medical facility where the infusion will be administered.
Danish: • Zalmoxis forsendes direkte til den afdeling, hvor infusionen skal administreres.
English: One year post-Zalmoxis administration the newly reconstituted T cell repertoire is dominated by untransduced cells of donor origin which displayed a polyclonal pattern comparable to healthy individuals.
Danish: Et år efter Zalmoxisadministrationen domineredes det nye rekonstituerede T-celle-repertoire af ikke-transducerede celler af donoroprindelse, som viste et polyklonalt mønster, som kan sammenlignes med raske personers.
English: • The cryobag and any unused product or waste material contains genetically modified organisms and should be disposed of in accordance with local requirements.
Danish: • Kryoposen og evt. ikke anvendt lægemiddel eller affald heraf indeholder genetisk modificerede organismer og skal bortskaffes i henhold til lokale retningslinjer.
English: Immunosuppressive therapy also affects immunocompetent cells as such infused with Zalmoxis.
Danish: Immunsupprimerende behandling påvirker også immunkompetente celler, der infunderes med Zalmoxis.
English: If the bag appears to have clear breaks or to be non-intact, do not use the product.
Danish: Hvis posen ser ud til at være beskadiget eller ikke er intakt, må præparatet ikke anvendes.
English: Additional infusions are administered at approximately one month intervals for a maximum of four times, until a circulating T lymphocyte count is equal to or more than 100 per µL.
Danish: Yderligere infusioner administreres med ca. 1 måneds intervaller maksimalt fire gange, indtil antal cirkulerende T-lymfocytter er ≥ 100/µl.
English: o The room requirements for Zalmoxis administration o Storage, transport and thawing of Zalmoxis bag o Surveillance of Zalmoxis efficacy (Immune reconstitution - IR)
Danish: o Kravene til omgivelserne ved administration af Zalmoxis o Opbevaring, transport og optøning af posen med Zalmoxis o Overvågning af effekten ved Zalmoxis (immunrekonstitution - IR)
English: • When completely thawed, remove the Zalmoxis bag out from the double envelopment, dry it off and disinfect the outside.
Danish: • Når Zalmoxis-posen er helt optøet, fjernes den fra den dobbelte indpakning, hvorefter ydersiden tørres og desinficeres.
English: Zalmoxis is given to prevent a complication of transplantations that are not fully matched known as ‘graft-versus-host disease' whereby the cells of the donor attack the patient's own cells.
Danish: Zalmoxis gives for at forebygge en komplikation ved transplantationer, hvor transplantatet ikke matcher fuldt ud, den såkaldte graft versus host-sygdom, hvor donorens celler angriber patientens egne celler.
English: In the event of pregnancy following Zalmoxis treatment adverse effect on pregnancy and the developing foetus are not expected as lymphocytes do not pass the placenta.
Danish: I tilfælde af graviditet efter behandling med Zalmoxis forventes der ikke negative virkninger på graviditeten og fosterudviklingen, da lymfocytter ikke passerer placenta.
English: It must not be administered if the following conditions occur: a) infections requiring administration of ganciclovir (GCV) or valganciclovir (VCV) at the time of infusion; b) GvHD requiring systemic immunosupressive therapy; c) ongoing systemic immunosupressive therapy or administration of granulocyte colony stimulating factor (G-CSF) after haploidentical HSCT.
Danish: Det må ikke administreres, hvis følgende tilstande opstår: a) infektioner, der kræver administration af ganciclovir (GCV) eller valganciclovir (VCV) på infusionstidspunktet; b) GvHD, der kræver systemiske immunsuppressiva; c) igangværende behandling med systemiske immunsuppressiva eller administration af granulocyt-koloni-stimulerende faktor (G-CSF) efter haploidentisk HSCT.
English: OTHER MolMed SpA
Danish: ANDET MolMedSpA
English: Patients characterized by condition a) could be administered Zalmoxis 24 hours following the antiviral therapy discontinuation; patients characterized by conditions b) and c) could be administered Zalmoxis after an adequate wash out period.
Danish: Patienter, som karakteriseres ved tilstand a), kan få Zalmoxis 24 timer efter seponering af den antivirale behandling; patienter, som karakteriseres ved tilstand b) eller c), kan få Zalmoxis efter en tilstrækkelig udvaskningsperiode.
English: This allows the selective killing of dividing cells upon administration of the pro-drug GCV, which is enzymatically phosphorylated to an active triphosphate analogue by HSV-TK.
Danish: Dette muliggør det selektive drab af celler i deling ved administration af prodruget GCV, som er enzymatisk fosforyleret til en aktiv triphosphatanalog af HSV-TK.
English: Of 30 patients receiving Zalmoxis, 23 patients (77%) obtained immune reconstitution, with a median time of 31 days after the first infusion.
Danish: Ud af de 30 patienter, der fik Zalmoxis, opnåede 23 patienter (77 %) immunrekonstitution med en mediantid på 31 dage efter den første infusion.
English: Globally, acute episodes of GvHD occurred in 10 patients (33%) with a median time to onset of 90 days after HSCT and 42 days after last infusion of Zalmoxis cells.
Danish: Globalt forekom akutte episoder af GvHD hos 10 patienter (33 %) med en mediantid til start på 90 dage efter HSCT og 42 dage efter sidste infusion af Zalmoxis.
English: The clinical study report should be submitted by Q4 2022.
Danish: Rapporten fra det kliniske studie skal fremsendes i 4. kvartal 2022.
English: Intestinal haemorrhage
Danish: Intestinal blødning
English: Please inform your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Zalmoxis has no or negligible influence on the ability to drive and use machines.
Danish: Zalmoxis påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: In case of GvHD progression after 3 days of treatment with ganciclovir or valganciclovir alone, a standard immunosuppressive therapy has to be added.
Danish: I tilfælde af progression af GvHD efter 3 dages behandling kun med ganciclovir eller valganciclovir, skal standard immunsupprimerende behandling tilføjes.
English: Precautions to be taken before handling or administering the medicinal product Before infusion it must be confirmed that the patient identity matches the essential unique information reported on the Zalmoxis bag label and on the related Certificate of Analysis (CoA).
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Før infusion skal det bekræftes, at patientens identitet svarer til den obligatoriske unikke information, som er anført på Zalmoxis-posens etiket og på det relevante analysecertifikat (CoA).
English: Both male and female patients (to be) treated with Zalmoxis and their partners need to use effective contraception during and up to 6 months after treatment with Zalmoxis.
Danish: Både mandlige og kvindelige patienter, der (skal) behandles med Zalmoxis og deres partnere skal anvende sikker kontraception under og i 6 måneder efter behandlingen med Zalmoxis.
English: • Shelf life after thawing is of 2 hours.
Danish: • Opbevaringstiden efter optøning er 2 timer.
English: If you have any questions about symptoms or side effects, or if any symptoms concern you
Danish: Hvis du har nogen spørgsmål vedrørende symptomer eller bivirkninger, eller hvis nogen symptomer bekymrer dig, så kontakt straks din læge.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Dette gælder også mulige bivirkninger, der ikke er nævnt i denne indlægseddelDu eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen viadet nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The bag should appear as an opaque, off-white frozen cell dispersion.
Danish: Posen skal fremtræde som en uigennemsigtig off-white frossen celledispersion.
English: It is recommended not to breast-feed during or after treatment with Zalmoxis therapy.
Danish: Det anbefales ikke at amme under og efter behandling med Zalmoxis.
English: If at any time during or after treatment with Zalmoxis an acute GvHD of grade equal to or greater than 2 or a chronic GvHD develop, the patient has to be treated with ganciclovir at a dose of 10 mg/kg/day divided into 2 administrations intravenously, or valganciclovir 900 mg two times per day orally for 14 days.
Danish: Hvis akut GvHD grad ≥ 2 eller kronisk GvHD opstår på noget tidpunkt under eller efter behandling med Zalmoxis, skal patienten behandles med ganciclovir i en dosis på 10 mg/kg/dag fordelt på 2 intravenøse administrationer eller valganciclovir 900 mg oralt to gange dagligt i 14 dage.
English: During and after treatment with Zalmoxis the physician must be aware of acute and chronic sign and symptoms of GvHD at any time and ensure that either ganciclovir or valganciclovir is available at ward for early treatment of GvHD.
Danish: Under og efter behandling med Zalmoxis skal lægen når som helst være opmærksom på symptomer på akut og kronisk GvHD og sikre, at enten ganciclovir eller valganciclovir forefindes på afdelingen til tidlig behandling af GvHD.
English: However myeloablative conditioning regimens performed in the context of a haploidentical bone marrow transplantation is associated with sterility.
Danish: Myeloablative konditioneringsregimer udført i forbindelse med en haploidentisk knoglemarvstransplantation er dog blevet forbundet med sterilitet.
English: In case of IR achievement, documented by two consecutive CD3+ cell counts ≥ 100/µL, Zalmoxis treatment has to be stopped.
Danish: Ved opnåelse af IR, dokumenteret ved to konsekutive CD3+-celletællinger ≥ 100/µl, skal behandlingen med Zalmoxis stoppes.
English: It is strongly recommended that, at the end of Zalmoxis infusion, the product label is removed from the bag and placed in the patient record sheet.
Danish: Det anbefales stærkt, at præparatets etiket efter afslutning af Zalmoxis-infusionen fjernes fra posen og anbringes i patientjournalen.
English: The decision to proceed with a new treatment depends on the immune reconstitution status of the patient achieved when a circulating T lymphocyte count is equal to or more than 100 per µL.
Danish: Beslutningen om at fortsætte med en ny behandling afhænger af patientens status med hensyn til immunrestitution, som er opnået, når antal cirkulerende T-lymfocyt er ≥ 100/µl.
English: - If you are taking medicines to suppress your immune system or you are taking G-CSF (that stimulates the bone marrow to produce blood cells) after receiving stem-cell transplantation .
Danish: - hvis du tager medicin, som undertrykker dit immunsystem, eller tager granulocytkolonistimulerende faktor (G-CSF) (som stimulerer knoglemarven til at danne blodceller) efter at have gennemgået en stamcelletransplantation.
English: - You suffer from graft-versus-host disease which requires the use of medicines to suppress your immune system.
Danish: - du lider af graft-versus-host sygdom, der kræver brug af medicin til at undertrykke dit immunsystem.
English: Zalmoxis is given intravenously (into a vein) as a drip infusion over approximately 20-60 minutes at a time interval of 21-49 days from transplantation.
Danish: Zalmoxis gives som intravenøs infusion via et drop (i en blodåre) i løbet af ca. 20-60 minutter 21-49 dage efter transplantationen.
English: It is given after haploidentical bone marrow transplantation (haematopoietic cell transplantation).
Danish: Det gives efter haploidentisk knoglemarvstransplantation (hæmatopoietisk celletransplantation).
English: Zalmoxis is supplied as one individual treatment dose in a 50-500 mL ethylene-vinyl-acetate cryo bags.
Danish: Zalmoxis udleveres som én individuel behandlingsdosis i en 50-500 ml ethylen-vinyl-acetat-kryopose.
English: • The product integrity has been breached in anyway.
Danish: • præparatet på nogen måde er beskadiget.
English: The most common adverse reaction reported by patients treated with Zalmoxis in clinical trial TK007 was acute GvHD.
Danish: Den hyppigste bivirkning, som blev rapporteret af patienter, behandlet med Zalmoxis i det kliniske studie TK007, var akut GvHD.
English: - If you suffer from graft-versus-host disease which requires the use of medicines to suppress your immune system.
Danish: - hvis du lider af graft-versus-host sygdom, som kræver brug af medicin til at undertrykke dit immunsystem.
English: • The entire volume of the bag must be infused.
Danish: • Hele posens volumen skal infunderes.
English: Zalmoxis is obtained by donor blood cells.
Danish: Zalmoxis udvindes fra bloddonorceller.
English: In this case treatment with Zalmoxis should be delayed until 24 hours after the end of the antiviral therapy.
Danish: I så fald skal behandlingen med Zalmoxis udsættes indtil 24 timer efter afslutningen af den antivirale behandling.
English: No detrimental effects on such activities are predicted from the pharmacology of the medicinal product.
Danish: Ud fra lægemidlets farmakologiske egenskaber kan der ikke forudsiges skadelig indvirkning på sådanne aktiviteter.
English: This medicine has been given ‘conditional approval'.
Danish: Dette lægemiddel er godkendt under "betingende omstændigheder".
English: - If you have previously experienced any adverse reaction following Zalmoxis administration and this has not been resolved within 30 days after its occurrence.
Danish: - hvis du tidligere har fået en bivirkning efter, du har fået Zalmoxis, og den ikke er ophørt inden for 30 dage efter forekomsten.
English: Treatment should be discontinued in case of occurrence of any 3-4 grade event related to Zalmoxis administration or grade 2 adverse event not resolving in a grade 1 or less in the next 30 days.
Danish: Behandlingen skal seponeres ved forekomst af enhver grad 3-4 bivirkning relateret til administration af Zalmoxis eller ved en grad 2 bivirkning, der ikke er bedret til grad 1 eller mindre inden for de næste 30 dage.
English: • The outer and intermediate package should be checked to verify the product and patient-specificlabel located on the top of the box and on the intermediate bag.
Danish: • Den ydre og mellemliggende emballage skal kontrolleres for at verificere præparatet, og den patientspecifikke etiket, der sidder på æsken og på den mellemliggende pose, skal tjekkes.
English: Non Interventional PASS: In order to investigate the safety and effectiveness in real clinical practice as well as long-term safety and effectiveness in all patients treated with Zalmoxis, the MAH should conduct and submit the results of study TK011 using the EBMT registry including all patients treated with Zalmoxis.
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS): For at kunne undersøge sikkerheden og effektiviteten i klinisk praksis såvel som den langtidsvarende sikkerhed og effektivitet hos alle patienter, der er behandlet med Zalmoxis, skal indehaveren af markedsføringtilladelsen gennemføre og fremsende resultaterne af studie TK011 ved brug af EBMT-registret omfattende alle patienter behandlet med Zalmoxis.
English: Even if donors are preliminary tested and found negative for transmissible infectious disease, precautions should be employed when handling Zalmoxis.
Danish: Selv hvis donorer i forvejen er testede og fundet negative for overførbare infektionssygdomme, skal der tages forholdsregler ved håndtering af Zalmoxis.
English: Upon full cell dispersion thawing, the bag is dried, disinfected and ready to be infused at a rate prescribed by the physician.
Danish: Når celledispersionen er helt optøet, tørres og desinficeres posen, hvorefter dispersionen er klar til at blive infunderet ved den af lægen ordinerede hastighed.
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
Danish: Efter at have vurderet ansøgningen er CHMP af den opfattelse, at benefit/risk-forholdet er positivt for anbefaling af udstedelse af en betinget markedsføringstilladelse.
English: Immune-reconstituted patients reached a CD3+ cell count ≥ 100/μL at a median of 77 days after
Danish: Immunrekonstituerede patienter opnåede et CD3+-celletal på ≥ 100/μl mediant 77 dage efter HSCT.
English: High-risk haematological malignancies treated with Zalmoxis included acute myeloid leukaemia (AML), secondary AML, acute lymphoblastic leukaemia, myelodysplastic syndrome and non-Hodgkin lymphoma.
Danish: Hæmatologiske maligniteter med høj risiko, hvor patienten fik Zalmoxis, omfattede akut myeloid leukæmi (AML), sekundær AML, akut lymfoblastisk leukæmi, myelodysplastisk syndrom og non-Hodgkin lymfom.
English: Triphosphate GCV competitively, inhibits incorporation of deoxyguanosine triphosphate (dGTP) into elongating DNA, thus killing the proliferating cells.
Danish: TriphosphatGCV hæmmer kompetitivt inkorporering af deoxyguanosintriphosphat (dGTP) i det voksende DNA og dræber således de prolifererende celler.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zalmoxis in one or more subsets of the paediatric population in the following condition: adjunctive treatment in haematopoietic cell transplantation (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Zalmoxis i en eller flere undergrupper af den pædiatriske population med følgende tilstand: adjuverende behandling til hæmatopoietisk celletransplantation (se pkt.
English: • Check that the patient identity matches the essential and unique patient information reported on the Zalmoxis bag and on the Certificate of Analysis.
Danish: • Kontrollér, om patientidentifikationen svarer til den obligatoriske unikke patientinformation, der er anført på Zalmoxis-posen og på analysecertifikatet.
English: In the TK007 clinical study only one 66-year-old female was treated with one infusion of Zalmoxis.
Danish: I det kliniske TK007-studie blev én 66-årig gammel kvinde behandlet med én infusion af Zalmoxis.
English: Prior to launch of Zalmoxis in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for the Health Care Professionals (HCPs), with the National Competent Authority.
Danish: Forud for markedsføring af Zalmoxis i hver medlemsstat skal indehaveren af markedsføringstilladelsen være enig med den relevante nationale myndighed om indholdet og formen af undervisningsmaterialet til sundhedspersoner.
English: If the medicinal product is not immediately prepared for infusion, transfer the bag in liquid nitrogen vapour.
Danish: Hvis lægemidlet ikke klargøres til infusion med det samme, overføres posen til en beholder med flydende kvælstof.