FrancophonIA/ELRC3.0 huggingface dataset:
English: Long-term PEG-ADA (exceeding 3 months of continuous duration) was used by three subjects; two of these subjects subsequently received a sibling-matched stem cell transplant and one subject remained on chronic PEG-ADA treatment.
Danish: PEG-ADA (over 3 måneder kontinuerligt); to af disse forsøgspersoner undergik efterfølgende en matchende stamcelletransplantation fra en søskende, og en forsøgsperson forblev på kronisk PEG-ADA-behandling.
English: The MAH will follow up on the risk of immunogenicity, insertional mutagenesis and oncogenesis as well as hepatic toxicity.
Danish: Indehaveren af markedsføringstilladelsen vil følge op på risikoen for immungenicitet, insertionel mutagenese og onkogenese samt levertoksicitet.
English: About 4 to 5 days before treatment
Danish: Ca. 4-5 dage før behandlingen
English: One year post treatment, median ADA activity (mononuclear cells adenosine deaminase) in peripheral blood lymphocytes was 181.2 (range 42.11678.2) nmol/h/mg protein, compared to a baseline median (range) of 80.6 (30.5-92.3) nmol/h/mg protein.
Danish: Et år efter behandlingen var den mediane ADA-aktivitet (adenosindeaminase i mononukleære celler) i lymfocytter i perifert blod 181,2 (42,1-1.678,2) nmol/t/mg protein sammenlignet med en baseline-median (interval) på 80,6 (30,5-92,3) nmol/t/mg protein.
English: T cell function: In the patients treated in the pivotal study, T cell proliferation was demonstrated in response to stimulation with anti-CD3 antibodies (median 62629 cpm, range 4531 to 252173) and phytohemaglutinin (median 140642 cpm, range 11119 to 505607) at 1 year post gene therapy, and these responses were sustained through Year 3.
Danish: T-cellefunktion: Hos patienterne, som blev behandlet i pivotalstudiet, blev der påvist T-celleproliferation som respons på stimulation med anti-CD3-antistoffer (median 62.629 cpm, interval 4.531 til 252.173) og fytohæmagglutinin (median 140.642 cpm, interval 11.119 til 505.607) 1 år efter genterapien, og disse responser blev opretholdt til år 3.
English: The MAH will review the occurrence of angioedema, anaphylactic reactions, systemic allergic events and severe cutaneous adverse reactions during the FU period, particularly in those patients who had unsuccessful response and received ERT or SCT.
Danish: Indehaveren af markedsføringstilladelsen vil vurdere forekomsten af angioødem, anafylaktiske reaktioner, systemiske allergiske reaktioner og alvorlige hudreaktioner i opfølgningsperioden, særligt hos de patienter, som ikke opnåede succesfuldt respons, og som fik enzymsubstitutionsterapi eller stamcelletransplantation.
English: Pre-treatment conditioning
Danish: Konditionering før behandling
English: Backup sample of stem cells collected to be stored as a backup (see above)
Danish: Reserveprøve af stamceller udtages gemmes som reserve (se ovenfor)
English: How Strimvelis is given
Danish: Sådan gives Strimvelis
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Strimvelis 1-10 million cells/ml dispersion for infusion.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Strimvelis 1-10 millioner celler/ml infusionsvæske, dispersion.
English: Serious adverse reactions include autoimmunity (e.g. autoimmune haemolytic anaemia, autoimmune aplastic anaemia, autoimmune hepatitis, autoimmune thrombocytopenia and Guillain-Barré syndrome).
Danish: Alvorlige bivirkninger inkluderer autoimmunitet (f.eks. autoimmun hæmolytisk anæmi, autoimmun aplastisk anæmi, autoimmun hepatitis, autoimmun trombocytopeni og Guillain-Barré-syndrom).
English: OUTER CONTAINER
Danish: YDRE EMBALLAGE
English: All these patients had previously taken PEG-ADA.
Danish: Alle disse patienter havde tidligere fået PEGADA.
English: 50 ml ethylene vinyl acetate (EVA) infusion bag, with a luer spike interconnector closed with a luer lock cap, packed in a re-usable outer container.
Danish: 50 ml infusionspose af ethylenvinylacetat (EVA) med luer-lock sammenkobling, som er lukket med en hætte.
English: • if the medicine got contaminated while it was being made
Danish: • hvis medicinen blev forurenet (kontamineret) under fremstillingen
English: Autoimmune haemolytic anaemia, autoimmune aplastic anaemia, autoimmune thrombocytopenia
Danish: Autoimmun hæmolytisk anæmi, autoimmun aplastisk anæmi, autoimmun trombocytopeni
English: Dermatitis atopic, eczema
Danish: Atopisk dermatitis, eksem
English: Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Danish: Bivirkningerne er anført nedenfor efter systemorganklasse og hyppighed i henhold til MedDRA. Der benyttes følgende frekvenser:
English: Immune reconstitution
Danish: Immunrekonstitution
English: Following administration, a saline filled 50 ml syringe should be used to flush the bag through.
Danish: Efter administration skal posen skylles igennem med en 50 ml-sprøjte fyldt med saltvand.
English: → Talk to your doctor or nurse.
Danish: → Kontakt lægen eller sundhedspersonalet.
English: Strimvelis is intended for autologous use only (see section 4.4).
Danish: Strimvelis er udelukkende beregnet til autolog brug (se pkt.
English: Strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), for whom no suitable human leukocyte antigen (HLA)matched related stem cell donor is available (see section 4.2 and section 4.4).
Danish: Strimvelis er indiceret til behandling af svær kombineret immundefekt (SCID) forårsaget af adenosindeaminase-mangel (ADA-SCID) hos patienter, til hvem det ikke har været muligt at finde en egnet HLA (human leukocytantigen)-matchende beslægtet stamcelledonor (se pkt.
English: This medicinal product contains 0.15 mmol sodium per ml (see section 4.4).
Danish: Dette lægemiddel indeholder 0,15 mmol natrium pr. ml (se pkt.
English: Posology The recommended dose range of Strimvelis is between 2 and 20 million CD34+ cells/kg.
Danish: Dosering Det anbefalede dosisinterval for Strimvelis er mellem 2 og 20 millioner CD34+-celler/kg.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift.
English: T-lymphocyte (x106/l) n median (range) % subjects with venous RBC dAXP <100 nmol/ml after Strimvelisd n
Danish: Median (interval) % forsøgspersoner med venøs RBCdAXP < 100 nmol/ml efter Strimvelisd n
English: Antineutrophil cytoplasmic antibody positive, smooth muscle antibody positive aAdverse reactions considered potentially related to busulfan conditioning
Danish: Positivitet for antineutrofilocyt cytoplasmaantistof og glat muskelantistof a Bivirkninger, som skønnes muligvis at være forbundet med konditionering med busulfan.
English: Reproductive and developmental toxicity studies were not performed.
Danish: Der er ikke udført studier af reproduktions- og udviklingstoksicitet.
English: Eighty three percent were white (56% Caucasian/European heritage and 28% Arabic/North African heritage), 11% African American/African, and 6% Asian.
Danish: Medianalderen i programmet var 1,7 år (0,5-6,1 år), 61 % var drenge, 83 % var hvide (56 % kaukasisk/europæisk afstamning og 28 % arabisk/nordafrikansk afstamning), 11 % var afroamerikanere/afrikanere, og 6 % var asiatere.
English: After infusion, CD34+ cells engraft in the bone marrow where they repopulate the haematopoetic system with a proportion of cells that express pharmacologically active levels of the ADA enzyme.
Danish: Efter infusion inkorporeres CD34+-cellerne i knoglemarven og vil igen være til stede i det hæmatopoietiske system i et størrelsesforhold, som udtrykker farmakologisk aktive niveauer af ADA-enzymet.
English: Strimvelis is not expected to interact with the hepatic cytochrome P-450 family of enzymes or drug transporters.
Danish: Strimvelis forventes ikke at interagere med hepatiske CYP-enzymer eller lægemiddeltransportører.
English: Patients should be closely monitored for the occurrence of severe and opportunistic infections, immune reconstitution parameters and the need for replacement intravenous immunoglobulin (IVIG); in case of lack of response, it is recommended to introduce other ADA-SCID treatments under the supervision of a physician.
Danish: Patienterne skal monitoreres tæt for forekomst af alvorlige og opportunistiske infektioner, immunrekonstitutionsparametre og behov for substitutionsbehandling med intravenøs immunglobulin (IVIG).
English: This is because Strimvelis is a gene therapy product.
Danish: Grunden til dette er, at Strimvelis er et genterapipræparat.
English: Strimvelis should not be administered to women who are breast-feeding.
Danish: Strimvelis må ikke gives til ammende kvinder.
English: The MAH shall complete, within the stated timeframe, the below measure:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltning:
English: Exp.: {DD MMM YY} {hh:mm} BATCH NUMBER, DONATION AND PRODUCT CODES
Danish: BATCHNUMMER, DONATIONS- OG PRODUKTKODER
English: Strimvelis will be administered at a specialist transplant centre, and by physicians with previous experience in the treatment and management of patients with ADA-SCID and the use of autologous CD34+ ex vivo gene therapy products.
Danish: Strimvelis vil blive administreret på et specialiseret transplantationscenter af læger med erfaring i behandling og håndtering af patienter med ADA-SCID og brug af autologe CD34+ ex vivo-genterapi-præparater.
English: Local biosafety guidelines applicable should be followed (see section 4.2).
Danish: Lokale retningslinjer for biosikkerhed skal følges (se pkt.
English: Hepatic enzyme increaseda, antinuclear antibody (ANA) positive
Danish: Forhøjede leverenzymera, positivitet for antinukleære antistoffer (ANA)
English: Exp.: {DD MMM YY} {hh:mm} SPECIAL STORAGE CONDITIONS
Danish: UDLØBSDATO EXP: {DD MMM ÅÅ} {tt:mm}
English: NAME OF THE MEDICINAL PRODUCT Strimvelis 1-10 million cells/ml dispersion for infusion.
Danish: LÆGEMIDLETS NAVN Strimvelis 1-10 millioner celler/ml infusionsvæske, dispersion.
English: Local biosafety guidelines applicable for such products should be followed (see section 6.6).
Danish: Lokale retningslinjer for biosikkerhed for sådanne præparater skal følges (se pkt.
English: Store at 15-30°C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved 15-30 °C
English: The infusion bags are provided in a closed container.
Danish: Infusionsposerne leveres i en lukket beholder.
English: This medicinal product contains 0.15 mmol sodium per ml.
Danish: Dette lægemiddel indeholder 0,15 mmol natrium/ml.
English: Strimvelis must be administered in a specialist transplant centre, by a physician with previous experience in the treatment and management of patients with ADA-SCID and in the use of autologous CD34+ ex vivo gene therapy products.
Danish: Strimvelis skal administreres på et specialiseret transplantationscenter af en læge med erfaring inden for behandling og håndtering af patienter med ADA-SCID og brug af autologe CD34+ ex vivogenterapipræparater.
English: Studies evaluated the use of Strimvelis with a range of 0.9 million - 18.2 million CD34+ cells/kg.
Danish: Studierne vurderede Strimvelis i en dosering på 0,9-18,2 millioner CD34+-celler/kg.
English: No evidence of causality to the product has been established.
Danish: Der er ikke evidens for, at der er en årsagssammenhæng med præparatet.
English: It is recommended that patients be monitored long term with at least annual visits for the first eleven years and then at 13 and 15 years post treatment with Strimvelis, to include a complete blood count with differential, biochemistry and thyroid stimulating hormone.
Danish: Det anbefales, at patienterne monitoreres langvarigt med kontroller mindst én gang om året i de første 11 år og derefter det 13. og 15. år efter behandling med Strimvelis.
English: Only filters intended for use with transfusion sets should be used to prevent inadvertent removal of cells from the product.
Danish: For at hindre utilsigtet fjernelse af celler fra præparatet bør der kun anvendes filtre, der er beregnet til at blive brugt med transfusionssæt.
English: It is not known whether the ingredients of Strimvelis can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Strimvelis udskilles i din mælk.
English: Very common side effects
Danish: Almindelige bivirkninger
English: Prior to launch of Strimvelis in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for parents/carers and health professionals,
Danish: • Yderligere risikominimeringsforanstaltninger Før lancering af Strimvelis i hvert enkelt medlemsland skal indehaveren af markedsføringstilladelsen og den nationale lægemiddelmyndighed blive enige omkring indholdet og udformningen af uddannelsesmaterialet til forældre/plejepersonale og sundhedspersonale, om detaljer vedrørende den begrænsede ordination og om kontrolleret adgang/samtykkeerklæring, herunder mediekommunikation, distributionsmetoder og andre aspekter af programmet.
English: Year 3/ 3 Years Post-Treatmentb
Danish: År 3/ 3 år efter behandlingb
English: • increases in liver enzymes*
Danish: • forhøjede leverenzymer*
English: Table 2 Rate of severe infections per person year of exposure (pivotal population)* Pre treatment
Danish: Forekomst af svære infektioner observeret pr. patientår med eksponering (pivotal population)*
English: • reduced numbers of blood cells (autoimmune haemolytic anaemia, autoimmune aplastic anaemia)
Danish: • nedsat antal blodceller (autoimmun hæmolytisk anæmi, autoimmun aplastisk anæmi)
English: Before infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the Strimvelis infusion bag(s) and/or container (see sections 4.4 and 6.6).
Danish: Inden infusion skal det bekræftes, at patientens identitet stemmer overens med de unikke patientoplysninger på Strimvelis infusionsposen/-poserne og/eller -beholderen (se pkt.
English: The identity of the patient must be matched with the essential unique patient information on the primary and/or outer container prior to infusion.
Danish: Inden infusion skal det sikres, at patientens identitet svarer til de unikke patientoplysninger på den primære og/eller ydre beholder.
English: Also contains sodium chloride.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også natriumchlorid
English: Asthma, rhinitis allergic
Danish: Hypertensiona Luftveje, thorax og mediastinum Astma, allergisk rhinitis
English: • inflamed thyroid gland (autoimmune thyroiditis)
Danish: • betændelseslignende reaktion (inflammation) i skjoldbruskkirtlen (autoimmun thyroiditis)
English: Strimvelis has not been studied in patients with renal impairment.
Danish: Strimvelis er ikke undersøgt hos patienter med nedsat nyrefunktion.
English: PHARMACEUTICAL FORM Dispersion for infusion.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Infusionsvæske, dispersion.
English: Package leaflet: Information for the patient or carer Strimvelis 1-10 million cells/ml dispersion for infusion Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Danish: Indlægsseddel: Information til patienten eller omsorgspersonen Strimvelis 1-10 millioner celler/ml infusionsvæske, dispersion Autolog CD34+-beriget cellefraktion, som indeholder CD34+-celler transduceret med retroviral vektor, som koder for den humane ADA-cDNA-sekvens
English: Strimvelis has not been studied in patients with hepatic impairment.
Danish: Strimvelis er ikke undersøgt hos patienter med nedsat leverfunktion.
English: The infusion bag is placed inside a closed outer container.
Danish: Infusionsposen er placeret i en lukket ydre beholder.
English: Hypersensitivity to the product or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: No. of infusion bags:
Danish: Antal infusionsposer:
English: The 3 month hospitalisation period immediately post gene therapy was excluded from the calculation d dAXP=dAMP+dADP+dATP.
Danish: d dAXP=dAMP+dADP+dATP.
English: The infusion bag(s) is/are placed inside a closed outer container.
Danish: Infusionsposen/-poserne er placeret i en lukket ydre beholder.
English: * Including data from one patient collected post intervention with PEG-ADA (>3 months treatment) or hematopoietic stem cell transplantation a Based on the entire pre-treatment period for severe infections (retrospectively collected), and the data collected at the baseline visit for T-lymphocytes.
Danish: * Inklusive data fra én patient indsamlet efter intervention med PEG-ADA (≥ 3 måneders behandling) eller hæmatopoietisk stamcelletransplantation.
English: An autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells.
Danish: En autolog CD34+-beriget cellefraktion, som indeholder CD34+-celler transduceret med retroviral vektor, som koder for den humane adenosindeaminase (ADA)-cDNA-sekvens fra humane hæmatopoietiske stamceller/progenitorceller (CD34+).
English: The finished product is composed of one or more ethylene vinyl acetate (EVA) bags which contain an autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence.
Danish: Det færdige præparat består af en eller flere ethylenvinylacetat- (EVA) poser, som indeholder en autolog CD34+-beriget cellefraktion indeholdende CD34+-celler transduceret med retroviral vektor, som koder for den humane ADA-cDNA-sekvens.
English: An autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence with a concentration of 1-10 million CD34+ cells/ml.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En autolog CD34+-beriget cellefraktion, som indeholder CD34+-celler transduceret med retroviral vektor, som koder for den humane ADA-cDNA-sekvens, med en koncentration på 1-10 millioner CD34+-celler/ml.
English: What Strimvelis looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: The identity of the patient must be matched with the essential unique patient information on the infusion bag(s) and/or outer container prior to infusion.
Danish: Inden infusion skal det sikres, at patientens identitet svarer til de unikke patientoplysninger på infusionsposen/-poserne og/eller den ydre beholder.
English: You should not be given Strimvelis if you are breast-feeding.
Danish: Du må ikke få Strimvelis, hvis du ammer.
English: EXPIRY DATE
Danish: UDLØBSDATO EXP: {DD MM ÅÅ} {tt:mm}
English: Strimvelis should not be given to you if you are pregnant.
Danish: Du må ikke få Strimvelis, hvis du er gravid.
English: - The active substance is autologous (the patient's own) CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence.
Danish: Strimvelis indeholder: - Aktivt stof: autolog CD34+-beriget cellefraktion, som indeholder CD34+-celler transduceret med retroviral vektor, som koder for den humane ADA-cDNA-sekvens.
English: Premedication
Danish: Amning
English: • raised temperature (pyrexia)
Danish: • forhøjet temperatur
English: What you need to know before you (or your child) are given Strimvelis 3.
Danish: Det skal du vide, før du (eller dit barn) får Strimvelis 3.
English: Hypertensiona
Danish: Hypotyroidisme
English: • inflamed itchy skin (atopic dermatitis, eczema)
Danish: • irriteret, kløende hud (eksem)
English: (pomalidomide)
Danish: (pomalidomid)
English: This overview was last updated in 04-2019.
Danish: Denne oversigt blev sidst ajourført i 04-2019.
English: Imnovid received a marketing authorisation valid throughout the EU on 5 August 2013.
Danish: Imnovid fik en markedsføringstilladelse med gyldighed i hele EU den 5. august 2013.
English: The recommended starting dose is 4 mg once a day, taken at the same time each day.
Danish: Den anbefalede startdosis er 4 mg, der skal tages én gang dagligt på samme tidspunkt hver dag.
English: Imnovid is available as capsules (1, 2, 3 and 4 mg).
Danish: Imnovid fås som kapsler (1, 2, 3 og 4 mg).
English: Therefore, Imnovid must not be used in women who are pregnant.
Danish: Derfor må Imnovid ikke gives til kvinder, der er gravide.
English: Other information about Imnovid
Danish: Andre oplysninger om Imnovid
English: As for all medicines, data on the use of Imnovid are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Imnovid løbende overvåget.
English: The company that makes Imnovid will set up a pregnancy-prevention programme in each Member State.
Danish: Virksomheden, der markedsfører Imnovid, vil oprette et graviditetsforebyggende program i hver medlemsstat.
English: Further information on the orphan designation can be found on ema.europa.eu/medicines/human/orphan-designations/EU309672.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes herema.europa.eu/medicines/human/orphan-designations/EU309672.
English: Previously known as Pomalidomide Celgene.
Danish: Tidligere kaldet Pomalidomide Celgene.
English: It must not be used in women who could become pregnant, unless they take all the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment.
Danish: Det må ikke anvendes til kvinder i den fødedygtige alder, medmindre de træffer alle de nødvendige foranstaltninger for at sikre, at de ikke er gravide ved behandlingens begyndelse og ikke bliver det under eller i den første tid efter behandlingen.
English: What measures are being taken to ensure the safe and effective use of Imnovid?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imnovid?
English: As the medicine can pass into semen, the medicine must also not be used in men who are unable to comply with the required contraceptive measures.
Danish: Da lægemidlet kan gå over i sæden, må lægemidlet heller ikke anvendes hos mænd, der ikke er i stand til at anvende passende prævention.
English: For more information about using Imnovid, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Imnovid, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Further information on Imnovid can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/imnovid-previously-pomalidomide-celgene
Danish: Yderligere information om Imnovid findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/imnovid-previously-pomalidomide-celgene
English: What is Imnovid and what is it used for?
Danish: Hvad er Imnovid, og hvad anvendes det til?
English: An overview of Imnovid and why it is authorised in the EU
Danish: En oversigt over Imnovid, og hvorfor det er godkendt i EU
English: Side effects reported with Imnovid are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Imnovid vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: It will also supply cards for patients to ensure that all appropriate safety measures have been taken by each patient.
Danish: Virksomheden vil også sørge for patientkort for at sikre, at alle relevante sikkerhedsforanstaltninger er blevet fulgt af den enkelte patient.
English: Pomalidomide is expected to be harmful to the unborn child, causing severe and life-threatening birth defects.
Danish: Pomalidomid forventes at være skadeligt for det ufødte barn og at forårsage alvorlige og livstruende fosterskader.
English: The European Medicines Agency decided that Imnovid's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Imnovid opvejer risiciene, og at det kan godkendes til anvendelse i EU.