FrancophonIA/ELRC3.0 huggingface dataset:
English: No specific paediatric group has been studied at present.
Danish: Ingen specifik pædiatrisk gruppe er blevet undersøgt på nuværende tidspunkt.
English: Acute GvHD (33% of patients)
Danish: Akut GvHD (33 % af patienterne)
English: Currently, no data are available for these patients.
Danish: På nuværende tidspunkt foreligger der ingen data for disse patienter.
English: The clinical study report should be submitted by March 2021.
Danish: Rapporten fra det kliniske studie skal indsendes i marts 2021.
English: Progress updates should be submitted yearly with the annual renewal.
Danish: Opdateringer om fremdrift skal fremsendes årligt sammen med den årlige fornyelse.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette bør tages i betragtning hos patienter på en kontrolleret natriumkost.
English: In vitro evaluation of oncological potential indicate that the risk of malignant transformation is low.
Danish: In vitro-evaluering af onkologisk potentiale indikerer, at risikoen for malign transformation er lav.
English: • The Certificate of Analysis is marked as rejected.
Danish: • analysecertifikatet er markeret som forkastet.
English: • The expiry date has passed.
Danish: • udløbsdatoen er overskredet.
English: The hospital staff are responsible for the correct storage of the product both before and during its use, as well as for correct disposal.
Danish: Hospitalspersonalet er ansvarligt for den korrekte opbevaring af præparatet både før og under brug samt for korrekt bortskaffelse.
English: After the infusion
Danish: Efter infusion
English: It has been shown that Zalmoxis cells may circulate for years after the last administration.
Danish: Det er påvist, at Zalmoxis-celler kan cirkulere i årevis efter den sidste administration.
English: Additional infusions are given once a month, for up to 4 months.
Danish: Yderligere infusioner gives én gang om måneden i op til 4 måneder.
English: Immune cells are excreted in human milk in low amounts.
Danish: Immunceller udskilles i human mælk i lave mængder.
English: Non clinical safety data obtained in two different immunedeficient animal models for GvHD did not indicate special hazards for humans, but allowed only a very limited safety assessment.
Danish: Non-kliniske sikkerhedsdata, indhentet i to forskellige modeller for GvHD hos immundefekte dyr, viste ingen specielle risici for mennesker, men muliggjorde kun en meget begrænset sikkerhedsvurdering.
English: Do not use this medicine after the expiry date which is stated on the container.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på emballagen.
English: Your doctor will closely supervise the treatment therapy.
Danish: Din læge vil føre nøje opsyn med behandlingen.
English: Patient code:
Danish: Patientkode:
English: The cellular composition and the final cell number will vary according to the weight of the patient.
Danish: Den cellulære sammensætning og det endelige antal celler varierer efter patientens vægt.
English: A longer interval might apply in case of renal failure.
Danish: Et længere tidsinterval kan være gældende i tilfælde af nyreinsufficiens.
English: This medicine is prescribed by a doctor and given in a hospital under strict survelliance and predetermined schedule so that you cannot forget your dose.
Danish: Dette lægemiddel er ordineret af en læge og gives på et hospital under strengt opsyn og efter en forudbestemt plan, så du kan ikke glemme din dosis.
English: If GvHD occurs, GCV/VCV will be administered.
Danish: Hvis GvHD opstår, skal der administreres GCV/VCV.
English: Frequency and Adverse reactions Very common
Danish: Hyppighed og bivirkninger Meget almindelig
English: The amount of cells to be administered depends on your body weight.
Danish: Mængden af celler, du skal have, afhænger af din kropsvægt.
English: One patient with grade 1 acute GvHD did not receive any treatment.
Danish: En patient med grad 1 akut GvHD fik ikke nogen behandling.
English: An adequate wash-out period shall be applied prior to infusion of this medicinal product.
Danish: En tilstrækkelig udvaskningsperiode skal anvendes forud for infusion af dette lægemiddel.
English: Donor code:
Danish: Donorkode:
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk. 7, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger: Beskrivelse
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: not yet assigned
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske midler, ATC-kode: endnu ikke tildelt
English: • Put the bag into two plastic envelopes (double envelopment) to avoid direct contact with water.
Danish: • Anbring posen i to plastlommer (dobbelt indpakning) for at undgå kontakt med vandet.
English: Relevant information about the safety concerns of Graft versus Host Disease (GvHD)
Danish: Relevant information om sikkerhedsproblemer i relation til graft versus host-sygdom (GvHD)
English: Severity of acute GvHD was grade 1 in one case (3%), grade 2 in seven (23%), grade 3 in one (3%) and grade 4 in one (3%).
Danish: Sværhedsgraden af akut GvHD var grad 1 i ét tilfælde (3 %), grad 2 i syv (23 %), grad 3 i ét (3 %) og grad 4 i ét (3 %) tilfælde.
English: Studies in animals have not been performed.
Danish: Der er ikke udført studier hos dyr.
English: MolMed SpA Via Olgettina 58
Danish: MolMedSpA Via Olgettina 58
English: 20132 Milano Italy
Danish: 20132 Milano Italien
English: BATCH NUMBER, DONATION AND PRODUCT CODES Batch:
Danish: BATCHNUMMER, DONATIONS- OG PRODUKTKODER Batch:
English: Women of childbearing potential have to provide a negative pregnancy test (serum or urine) within 14 days prior to start the treatment.
Danish: Kvinder i den fertile alder skal udvise en negativ graviditetstest (serum eller urin) inden for 14 dage før behandlingsstart.
English: A Detailed step-by step description of Zalmoxis administration procedure, also focusing on:
Danish: En detaljeret trin-for-trin beskrivelse af administrationsproceduren for Zalmoxis, hvor der også fokuseres på:
English: The whole package is secured in a liquid nitrogen container designed to maintain the appropriate transportation and storage temperature until the time of infusion.
Danish: Hele pakningen er placeret i en beholder med flydende kvælstof, der er beregnet til at opretholde den korrekte transport- og opbevaringstemperatur indtil infusionstidspunktet.
English: • Proceed with the infusion as quickly as possible, avoiding keeping the bag in the water bath after thawing.
Danish: • Start infusionen hurtigst muligt; undgå at opbevare posen i vandbadet efter optøning.
English: • Check that the Certificate of Analysis containing the patient identifiers, expiry date and approval for infusion has been received from the Marketing Authorization Holder.
Danish: • Kontrollér, at analysecertifikatet med patientidentifikation, udløbsdato og godkendelse til infusion er modtaget fra indehaveren af markedsføringstilladelsen.
English: In addition updates on recruitment should be submitted within the PSURs.
Danish: Derudover skal opdateringer vedrørende rekruttering fremsendes i forbindelse med
English: Annex IV Conclusions on the granting of the conditional marketing authorisation and similarity presented by the European Medicines Agency
Danish: BILAG IV KONKLUSIONER VEDRØRENDE UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER BETINGEDE OMSTÆNDIGHEDER OG LIGHED FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: The recommended infusion time is around 20-60 minutes
Danish: Den anbefalede infusionstid er ca. 20-60 minutter.
English: Milan Italy
Danish: Milano Italien
English: MolMed S.p.A.
Danish: MolMedS.p.A.
English: The median interval time between the first and the subsequent infusions of Zalmoxis cells was 30 days.
Danish: Det mediane tidsinterval mellem den første og de efterfølgende infusioner af Zalmoxis var 30 dage.
English: 6.6 Special precautions for disposal and other handling Zalmoxis is a patient specific medicinal product.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Zalmoxis er et patientspecifikt lægemiddel.
English: The nature and the intended use of the product are such that conventional studies on pharmacokinetics including absorption, distribution, metabolism and excretion are not applicable.
Danish: Præparatets art og tilsigtede brug er således, at konventionelle studier vedrørende farmakokinetiske forhold, herunder absorption, fordeling, metabolisme og elimination ikke er relevante.
English: In this case, Zalmoxis may be administered after an adequate wash out period (the time necessary to remove a medicine from your body).
Danish: I så fald kan Zalmoxis administreres efter en tilstrækkelig lang udvaskningsperiode (den tid, som er nødvendig for at fjerne medicinen fra din krop).
English: Both acute and chronic GvHD events developed only in patients who had achieved immune reconstitution.
Danish: Både akut og kronisk GvHD udvikledes kun hos patienter, som havde opnået immunrekonstitution.
English: In addition to T cells, NK cells and residual levels of monocytes and of B cells may be present.
Danish: Ud over T-cellernes kan der være NK-celler og restniveauer af monocytter og B-celler til stede.
English: There may be cases in which the treating physician may still consider preferable to give the treatment or select an alternative treatment.
Danish: Der kan være tilfælde, hvor den behandlende læge stadigt finder det formålstjenligt at give behandlingen eller vælger en alternativ behandling.
English: Local biosafety guidelines applicable for such products should be followed for unused medicinal product or waste material.
Danish: Lokale retningslinjer for biosikkerhed gældende for sådanne produkter bør følges for ubrugt lægemiddel eller affaldsprodukter.
English: The bag is put in a second bag (intermediate container) and this one is placed in an aluminium box (outer container).
Danish: Posen anbringes i en anden pose (mellemliggende emballage), og denne placeres i en aluminiumsæske (ydre emballage).
English: Before handling or administering Zalmoxis
Danish: Inden håndtering og administration af Zalmoxis
English: It is important that you read the entire content of this procedure prior to administering Zalmoxis.
Danish: Det er vigtigt, at du gennemlæser alle oplysningerne om proceduren, før du administrerer Zalmoxis.
English: Seven patients needed to add an immunosuppressive treatment consisting of steroids, mycophenolate and/or cyclosporine.
Danish: Syv patienter havde behov for supplerende immunsupprimerende behandling bestående af steroider, mycophenolat og/eller ciclosporin.
English: PHARMACEUTICAL FORM Dispersion for infusion.
Danish: LÆGEMIDDELFORM Infusionsvæske, dispersion.
English: There was no significant difference regarding leukaemia free survival and the chance for relapse.
Danish: Der var ingen signifikant forskel med hensyn til leukæmifri overlevelse og risikoen for recidiv.
English: INSTRUCTIONS ON USE Not applicable
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN Ikke relevant
English: Remarks on the importance of reporting ADRs and encourage patients to be enrolled into study TK011 (linked with the EBMT registry)
Danish: Bemærkninger om vigtigheden af at rapportere bivirkninger og opmuntre patienten til at indgå i studie TK011 (knyttet til EBMT-registret)
English: However, the risk of transmitting infectious viruses to healthcare professionals cannot be totally excluded.
Danish: Risikoen for at smitte sundhedspersonale med infektiøse vira kan dog ikke udelukkes.
English: Donors are tested for transmissible infectious agents in line with applicable local requirements.
Danish: Donorer testes for smitsomme sygdomme i henhold til gældende lokale krav.
English: • Zalmoxis is prepared from human blood of a specific donor and it consists of genetically modified cells.
Danish: • Zalmoxis er fremstillet af humant blod fra en specifik donor og består af genetisk modificerede celler.
English: As this medicine is prescribed by a doctor, each dose is prepared for you only and each preparation consists of a single dose.
Danish: Dette lægemiddel er ordineret af en læge, hver dosis er fremstillet udelukkende til dig, og der fremstilles kun en enkelt dosis ad gangen.
English: The course of treatment is a maximum of four infusions at approximately one month intervals.
Danish: Behandlingsforløbet er maksimalt fire infusioner med ca. 1 måneds interval.
English: Relevant information about the safety concern of Concomitant administration of Ganciclovir and Valganciclovir
Danish: Relevant information om sikkerhedsproblemer i relation til samtidig administration af ganciclovir og valganciclovir
English: • While holding the top of the envelope bag out of the water, put it in a 37±1°C water bath being careful not to allow water to penetrate the seal.
Danish: • Mens det øverste af plastlommen holdes ude af vandet, anbringes den i et 37±1 °C vandbad, idet man skal være omhyggelig med, at der ikke trænger vand igennem forseglingen.
English: This strategy allows the direct targeting of those T lymphocytes that are initiating the GvHD response.
Danish: Denne strategi muliggør det direkte angreb (targeting) mod de T-lymfocytter, som initierer GvHD-responset.
English: Practical information for medical or healthcare professionals on the handling and administration of Zalmoxis.
Danish: Praktiske oplysninger til læger og sundhedspersonale om håndtering og administration af Zalmoxis.
English: What to check before infusion
Danish: Følgende skal kontrolleres før infusion
English: Zalmoxis adverse reactions recorded in TK007 study
Danish: Zalmoxis' bivirkninger registreret i TK007 studiet
English: In some cases you may not be able to receive a scheduled infusion of Zalmoxis.
Danish: I visse tilfælde vil det måske ikke være muligt, at du får en planlagt infusion af Zalmoxis.
English: However, you should pay attention to your overall status when considering performing tasks that require judgment, motor or cognitive skills.
Danish: Du skal dog tage hensyn til din generelle helbredsstatus, når du tænker på at udføre opgaver, der kræver dømmekraft og fysiske og erkendelsesmæssige færdigheder.
English: To monitor IR, the quantification analyses of CD3+ cells should be performed weekly during the first month after Zalmoxis administration.
Danish: For at monitorere IR bør kvantifikationanalyse af CD3+-celler udføres ugentligt den første måned efter administration af Zalmoxis.
English: Via Olgettina 58 20132 Milano Italy e-mail: info@molmed.com
Danish: Via Olgettina 58 20132 Milano Italien e-mail: info@molmed.com
English: Work surfaces and material which have potentially been in contact with Zalmoxis must be decontaminated with appropriate disinfectant.
Danish: Arbejdsoverflader og materialer, der kan have været i kontakt med Zalmoxis, skal dekontamineres med et passende desinfektionsmiddel.
English: Only one patient (3%) developed an extensive chronic GvHD that occurred 159 days and 129 days from HSCT and last infusion, respectively, and fully resolved after 107 days.
Danish: Kun én patient (3 %) udviklede svær kronisk GvHD, som indtraf henholdsvis 159 dage efter HSCT og 129 dage efter sidste infusion og var helt ophørt efter 107 dage.
English: Undesirable effects recorded in the clinical study TK007 are listed in Table 1 by system organ class and by frequency of occurrence.
Danish: Bivirkninger, som blev registreret i det kliniske studie TK007, er anført i tabel 1 efter systemorganklasse og hyppighed.
English: Women of childbearing potential / Contraception in males and females The risk on virus shedding vertical viral transmission is theoretically negligible however not excluded.
Danish: Kvinder i den fertile alder / Kontraception hos mænd og kvinder Risikoen for vertikal viral transmission ved spredning af virus er teoretisk ubetydelig, men kan dog ikke udelukkes.
English: Conventional toxicology, carcinogenicity, mutagenicity and reproductive toxicology studies have not been performed.
Danish: Der er ikke udført konventionelle studier vedrørende toksikologi, karcinogenicitet, mutagenicitet og reproduktionstoksicitet.
English: All acute GvHD events fully resolved after a median duration of 12 days.
Danish: Alle tilfælde af akut GvHD var helt ophørt efter en median varighed på 12 dage.
English: Results from a matched-pair analyses that included 36 Zalmoxis patients (22 from TK007 trial and 14 from the ongoing phase III TK008 trial) and 127 control patients, showed that the Zalmoxis treated patients that had survived the first 3 weeks post-transplant without relapse benefited in terms of 1 year overall survival (OS) (40% vs 51% (p=0.03)) and 1-year NRM (42% vs 23% (p=0.04)).
Danish: Resultater fra en parret analyse, der omfattede 36 Zalmoxis-patienter (22 fra TK007-forsøget og 14 fra det igangværende fase III TK008-forsøg) og 127 kontrolpatienter viste, at patienter behandlet med Zalmoxis, der havde overlevet de første 3 uger efter transplantationen uden recidiv, havde fordel med hensyn til 1 års generel overlevelse (40 % vs 51 % (p=0,03)) og 1-årig NRM (42 % vs 23 % (p=0,04)).
English: • Zalmoxis must be used be immediately after removal from the shipping container.
Danish: • Zalmoxis skal anvendes omgående efter fjernelse fra forsendelsesbeholderen.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted immediately.
Danish: I tilfælde af overdosering skal patienter overvåges nøje for symptomer på bivirkninger, og relevant symptomatisk behandling skal straks iværksættes.
English: WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZALMOXIS Do not use Zalmoxis: - If you are allergic to the active substance or any of the ingredients of this medicine (listed in section 6).
Danish: DET SKAL DU VIDE, FØR DU FÅR ZALMOXIS Du må ikke få Zalmoxis: - hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i Zalmoxis (angivet i punkt 6).
English: In absence of IR, an additional Zalmoxis dose has to be administered with an interval of 30 days up to a maximum number of four doses.
Danish: Ved fravær af IR skal yderligere en dosis Zalmoxis administreres med et interval på 30 dage op til et maksimum på fire doser.
English: Haploidentical means that the cells have been obtained from a donor whose tissues partially match the patient's tissue.
Danish: Haploidentisk betyder, at cellerne stammer fra en donor, hvis vævstype kun delvist matcher patientens vævstype.
English: In such cases your physician will be informed and may still consider preferable to give the treatment or may select an alternative treatment for you.
Danish: I sådanne tilfælde vil din læge blive informeret herom og vil måske stadig finde det formålstjenligt, at du får behandlingen, eller vil måske vælge en anden behandling til dig.
English: Healthcare professionals handling Zalmoxis should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Danish: Sundhedspersonale, der håndterer Zalmoxis, skal derfor tage passende forholdsregler (bære handsker og briller) for at undgå mulig overførsel af infektionssygdomme.
English: Given the intended clinical use in the context of a haploidentical bone marrow transplantation, a need for treatment during pregnancy is not expected.
Danish: I betragtning af den tilsigtede kliniske anvendelse i forbindelse med en haploidentisk knoglemarvstransplantation forventes der ikke at være behov for behandling under graviditet.
English: Criteria for receiving Zalmoxis infusions included the lack of both immune reconstitution and GvHD.
Danish: Kriterier for at få Zalmoxis-infusioner inkluderede fravær af både immunrekonstitution og GvHD.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Indenfor hver hyppighedsgruppe vises bivirkningerne efter faldende sværhedsgrad.
English: The decision to proceed with the next treament is determined by your physician/doctor and is related to your immune status.
Danish: Beslutningen om at fortsætte med den næste behandling træffes af din læge og afhænger af dit immunforsvar.
English: Patients should not be administered Zalmoxis in case of:
Danish: Patienterne bør ikke få Zalmoxis i tilfælde af:
English: The clinical status of the patient and the ADR profile of Zalmoxis should be born in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Danish: Patientens kliniske status og Zalmoxis' bivirkningsprofil skal tages i betragtning, når patientens evne til at udføre opgaver, der kræver dømmekraft og motoriske eller kognitive færdigheder, vurderes.
English: Opaque, off-white frozen dispersion.
Danish: Uigennemsigtig offwhite frossen dispersion.
English: The dose corresponds to 1 ± 0.2 x 107 cells/kg.
Danish: Dosis svarer til 1 ± 0,2 x 107 celler/kg.
English: Primary aims of the TK007 study were to evaluate incidence and time to immune reconstitution, defined by the number of circulating CD3+ ≥ 100/μL for two consecutive observations, and incidence of GvHD and response to GCV.
Danish: De primære mål i TK007-studiet var at evaluere incidens og tid til immunrekonstitution, defineret ved antallet af cirkulerende CD3+ ≥ 100/μl ved to konsekutive observationer, samt incidens af GvHD og respons på GCV.
English: Treatment plan consisted of the administration of genetically modified donor's T lymphocytes (ranging from 1 x 106 to 1 x 107 cells/kg body weight).
Danish: Behandlingsplanen bestod af administration af genetisk modificerede donor-T-lymfocytter (fra 1 x 106 til 1 x 107 celler/kg kropsvægt).
English: Any unused medicine or waste should be disposed of as biological hazard material containing genetically modified organisms and in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes som biologisk farligt materiale, der indeholder genetisk modificerede organismer, og i henhold til lokale retningslinjer.
English: Accordingly, healthcare professionals should take appropriate precautions (e.g. wearing gloves and glasses) when handling Zalmoxis.
Danish: Derfor skal sundhedspersonalet træffe passende sikkerhedsforanstaltninger (f.eks. brug af handsker og briller) ved håndtering af Zalmoxis.
English: The patient did not experience any adverse reactions.
Danish: Patienten oplevede ingen bivirkninger.
English: Zalmoxis should be infused intravenously over a period of 20-60 minutes.
Danish: Zalmoxis skal infunderes intravenøst over en periode på 20-60 minutter.
English: Post transplant lymphoproliferative disorder
Danish: Post-transplantation lymfoproliferativ sygdom
English: The bag should be removed from the liquid nitrogen, put in a double bag container and thawed in a pre-warmed water bath at 37 °C.
Danish: Posen skal fjernes fra det flydende kvælstof, anbringes i en dobbelt posebeholder og optøs i et vandbad, der på forhånd er opvarmet til 37 °C.
English: Zalmoxis can only be prescribed and administered in a hospital by a doctor or a nurse who is trained in administering this medicine.
Danish: Zalmoxis må kun ordineres og gives på et hospital af en læge eller sygeplejerske, som er uddannet i at give dette lægemiddel.
English: • Zalmoxis has a shelf life of 18 months when stored in liquid nitrogen vapour.
Danish: • Zalmoxis har en opbevaringstid på 18 måneder, når det opbevares i flydende kvælstof.
English: • The unique patient information on the infusion bag does not match that of the scheduled patient.
Danish: • den unikke patientinformation på infusionsposen ikke svarer til den pågældende patient.