FrancophonIA/ELRC3.0 huggingface dataset:
English: The period of administration is approximately 20 minutes (see section 6.6).
Danish: Administrationsvarigheden er ca. 20 minutter (se pkt.
English: The physician should monitor and/or treat the patient as appropriate.
Danish: Lægen skal monitorere og/eller behandle patienten efter behov.
English: Manufacturer MolMed SpA 58 Via Olgettina
Danish: Fremstiller MolMed SpA 58 Via Olgettina
English: Strimvelis goes through a range of tests before it is used.
Danish: Strimvelis underkastes en række tests, inden det bruges.
English: A completed product consent form is required prior to initiating treatment.
Danish: En udfyldt samtykkeerklæring er påkrævet, før behandling startes.
English: Orchard Therapeutics (Netherlands) BV Prins Bernhardplein 200, 1097 JB Amsterdam, the Netherlands
Danish: Orchard Therapeutics (Netherlands) BV Prins Bernhardplein 200, 1097 JB Amsterdam, Holland
English: If the tests show anything that might affect you (or your child), the doctor will treat you as appropriate.
Danish: Hvis resultaterne af testene viser noget, som kan påvirke dig (eller dit barn), vil lægen give dig en passende behandling.
English: Guillain-Barré syndrome
Danish: Guillain-Barré-syndrom
English: Strimvelis should not be used during pregnancy.
Danish: Strimvelis må ikke bruges under graviditet.
English: If you are pregnant or breast-feeding, if you think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: Patient 10 had no baseline value for T-lymphocytes.
Danish: Patient nr. 10 havde ingen baseline-værdi for T-lymfocytter.
English: After you (or your child) have been treated with Strimvelis, you or your child will not be able to donate blood, organs or tissues at any time in future.
Danish: Når du (eller dit barn) er blevet behandlet med Strimvelis, vil du eller dit barn ikke kunne donere blod, organer eller væv på noget tidspunkt i fremtiden.
English: Inserting a new gene into the DNA could cause leukaemia.
Danish: Indsættelse af et nyt gen i DNA'et kan forårsage leukæmi.
English: Use of Strimvelis in patients older than those previously studied should be carefully considered and reserved only for occasions where all other reasonable treatment options have been exhausted.
Danish: Brug af Strimvelis til patienter, som er ældre end dem, der tidligere er undersøgt, skal overvejes nøje og være forbeholdt tilfælde, hvor alle andre rimelige behandlingsmuligheder er udtømt.
English: If you have any questions about symptoms or side effects, or if any symptoms concern you
Danish: Hvis du har spørgsmål om symptomer eller bivirkninger, eller hvis du har symptomer, som bekymrer dig
English: Non-immunological manifestations of ADA-SCID may not respond to Strimvelis.
Danish: Ikke-immunologiske manifestationer af ADA-SCID responderer muligvis ikke på Strimvelis.
English: Do not use this medicine after the expiry date and time (EXP) which is stated on the container label and infusion bag label.
Danish: Brug ikke lægemidlet efter den udløbsdato og det tidspunkt (EXP), som står på etiketten på beholderen og infusionsposen.
English: As this medicine will be given by a qualified doctor, they are responsible for correct disposal of the product.
Danish: Da dette lægemiddel indgives af en læge, er denne ansvarlig for korrekt bortskaffelse af præparatet.
English: Store at 15-30°C.
Danish: Opbevares ved 15-30 °C.
English: • if there were not enough of the right type of cells to make the medicine
Danish: • hvis der ikke var et tilstrækkeligt antal af den rette type celler til at fremstille medicinen
English: For intravenous use.
Danish: Til intravenøs brug.
English: There have been cases where treatment with Strimvelis has been unsuccessful.
Danish: Der har været tilfælde, hvor behandlingen med Strimvelis ikke har været vellykket.
English: A 4-month biodistribution study was performed in mice.
Danish: Der blev udført et 4-måneders biodistributionsstudie med mus.
English: A medicine called busulfan is given four times a day for two days (total of 8 doses)
Danish: Et lægemiddel kaldet busulfan gives 4 gange dagligt i 2 dage (8 doser i alt)
English: c Severe infections are those requiring or prolonging hospitalisation.
Danish: c Svære infektioner er infektioner, som kræver indlæggelse eller forlænget indlæggelse.
English: The majority of mice showed reconstitution of the haematopoietic system by the end of the study.
Danish: Størstedelen af musene viste rekonstitution af det hæmatopoietiske system ved studiets afslutning.
English: Before Strimvelis is made, the doctor will do tests to make sure that you (or your child) are not carrying certain infections (see section 2).
Danish: Inden Strimvelis fremstilles, udfører lægen nogle tests for at sikre, at du (eller dit barn) ikke har visse infektioner (se punkt 2).
English: Severe infections n
Danish: Svære infektioner n
English: Milan ITALY
Danish: Milano Italien
English: Given the small patient population and size of the cohorts, adverse reactions in the table do not provide a complete perspective on the nature and frequency of these events.
Danish: Som følge af den lille patientpopulation og størrelsen af kohorten giver bivirkningerne i skemaet ikke et komplet billede af typen og hyppigheden af disse hændelser.
English: In addition, the allergy related adverse reactions in the table were reported mostly during the 3 month to 3 year follow-up period.
Danish: Derudover blev de allergirelaterede bivirkninger i tabellen oftest rapporteret i opfølgningsperioden fra 3 måneder til 3 år.
English: The effect on breast-fed infants of administration of Strimvelis to their mothers has not been studied.
Danish: Virkningen på ammede børn efter administration af Strimvelis til deres mødre er ikke undersøgt.
English: When
Danish: Hvornår
English: Because it is given soon after it is made, the final results of some of these tests will not be ready before the medicine is given.
Danish: Da lægemidlet indgives kort tid efter fremstillingen, vil de endelige resultater af nogle af disse tests ikke foreligge, før det gives.
English: This should be harvested from the patient at least 3 weeks prior to treatment with Strimvelis.
Danish: Den skal høstes fra patienten mindst 3 uger inden behandlingen med Strimvelis.
English: Elderly Strimvelis is not intended for use in patients >65 years of age, and has not been studied in this age group.
Danish: Ældre Strimvelis er ikke beregnet til brug hos patienter > 65 år og er ikke undersøgt i denne aldersgruppe.
English: Healthcare professionals handling Strimvelis should therefore take appropriate precautions to avoid potential transmission of infectious diseases.
Danish: Sundhedspersoner, som håndterer Strimvelis, skal derfor tage passende forholdsregler for at undgå potentiel overførsel af smitsomme sygdomme.
English: Patients who previously received PEG-ADA had this treatment withdrawn 10 to 22 days prior to Strimvelis therapy.
Danish: Hos patienter, som tidligere havde fået PEG-ADA, blev denne behandling seponeret 10-22 dage inden behandlingen med Strimvelis.
English: This medicine contains genetically-modified cells.
Danish: Dette lægemiddel indeholder genmodificerede celler.
English: Two samples are collected The doctor will collect two samples of bone marrow stem cells before the planned treatment:
Danish: Der indsamles to prøver Lægen udtager to prøver af stamceller fra knoglemarven inden den planlagte behandling:
English: ADA activity remained increased throughout the duration of the 3 year follow up.
Danish: ADA-aktiviteten forblev forøget i hele den 3-årige opfølgningsperiode.
English: Strimvelis has no or negligible long term influence on the ability to drive and use machines.
Danish: Strimvelis har ingen eller kun ubetydelig langtidsvirkning på evnen til at føre motorkøretøj og betjene maskiner.
English: Why
Danish: Hvorfor
English: Before and during Strimvelis treatment
Danish: Før og under behandling med Strimvelis
English: - The other ingredient is sodium chloride (see section 2, Strimvelis contains sodium).
Danish: - Øvrige indholdsstoffer: natriumchlorid (se punkt 2, Strimvelis indeholder natrium).
English: If busulfan AUC exceeds 4000 nanograms/ml*h (974 µmol/L.minute), the dose should be appropriately reduced based on the AUC.
Danish: Hvis AUC for busulfan overskrider 4.000 nanogram/ml∙t (974 µmol/l∙minut), skal dosis nedsættes på passende vis, baseret på AUC.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 May 2016
Danish: Dato for første markedsføringstilladelse: 26 maj 2016
English: Patients are expected to enrol in a post-treatment registry and will be followed-up long term.
Danish: Det forventes, at patienterne optages i et patientregister efter behandlingen og bliver fulgt i lang tid.
English: Patients treated with Strimvelis should not donate blood, organs, tissues and cells for transplantation, at any time in the future.
Danish: Patienter, som har fået Strimvelis, må ikke donere blod, organer, væv og celler til transplantation på noget tidspunkt fremover.
English: A transfusion administration set with filter should be used.
Danish: Der skal anvendes et transfusionssæt med filter.
English: • high blood pressure (hypertension)*
Danish: • forhøjet blodtryk (hypertension)*
English: Precautions to be taken before manipulating or administering the product
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet
English: Patients treated within the pivotal study
Danish: Patienter, som blev behandlet i pivotalstudiet
English: There are no data on the effects of Strimvelis on human fertility.
Danish: Der foreligger ingen data om virkningerne af Strimvelis på human fertilitet.
English: Baseline/ Pre-Treatmenta
Danish: Baseline/ Før behandlinga
English: The MAH will also evaluate intervention-free survival.
Danish: Indehaveren af markedsføringstilladelsen vil også evaluere interventionsfri overlevelse.
English: Strimvelis contains sodium
Danish: Strimvelis indeholder natrium
English: A cloudy to clear, colourless to pink dispersion of cells.
Danish: En uklar til klar, farveløs til lyserød dispersion af celler.
English: What is done
Danish: Hvad sker der
English: • the treatment sample, 4 to 5 days before.
Danish: • Behandlingsprøven tages 4-5 dage før.
English: Negative test results are required on at least 3 sequential occasions over a period of at least 4 weeks, after completion of treatment for hepatitis C, with the final test conducted no more than 3 days prior to cell harvest.
Danish: Der kræves mindst tre på hinanden følgende negative testresultater over en periode på mindst fire uger efter afslutning af behandling mod hepatitis C. Den sidste test må ikke udføres mere end tre dage før cellehøst.
English: Current or previous history of leukaemia or myelodysplasia.
Danish: Aktuel eller tidligere leukæmi eller myelodysplasi.
English: Older patients are typically less able to donate high numbers of CD34+ cells which may mean that older patients cannot be treated.
Danish: Ældre patienter har typisk sværere ved at donere et højt antal CD34+-celler, hvilket kan betyde, at ældre patienter ikke kan behandles.
English: The majority were reported during the 3 month to 3 year follow-up period and resolved, with the exception of hypothyroidism and positive ANA tests.
Danish: Størstedelen blev rapporteret i opfølgningsperioden fra 3 måneder til 3 år og fortog sig bortset fra hypotyroidisme og positive ANA-tests.
English: Work surfaces and material which have potentially been in contact with Strimvelis must be decontaminated with appropriate disinfectant.
Danish: Overflader og materiale, som kan have været i kontakt med Strimvelis, skal dekontamineres med et passende desinfektionsmiddel.
English: Median values at 3 years post gene therapy were below the normal range.
Danish: De mediane værdier 3 år efter genterapien lå under normalområdet.
English: If clinically relevant quality issues, such as out of specification results, are identified after Strimvelis has been infused, the treating physician will be notified.
Danish: Hvis der forekommer klinisk relevante kvalitetsproblemer, som f.eks. resultater uden for specifikationen, efter infusion af Strimvelis, vil den behandlende læge blive informeret.
English: The bags must be kept in the outer container until ready to use.
Danish: Poserne skal opbevares i den ydre beholder indtil brug.
English: Strimvelis should be used with caution in patients older than 6 years and 1 month and younger than 6 months as there are no data from clinical trials in these age ranges.
Danish: Strimvelis skal anvendes med forsigtighed hos patienter over 6 år og 1 måned og under 6 måneder, da der ikke foreligger data fra kliniske studier i disse aldersgrupper.
English: If it is possible that you could become pregnant, you must use a barrier contraceptive (such as condoms) during treatment and for at least 6 months afterwards.
Danish: Hvis der er mulighed for, at du kan blive gravid, skal du bruge en barrieremetode (f.eks. kondom) ved samleje, når behandlingen startes og i mindst 6 måneder derefter.
English: • red or purple dots on the skin, bleeding under the skin (immune thrombocytopenic purpura)
Danish: • røde eller lilla pletter på huden, blødning under huden (immun trombocytopenisk purpura)
English: The total busulfan dose is 4 mg/kg, divided into 8 doses of 0.5 mg/kg.
Danish: Den totale busulfandosis er 4 mg/kg fordelt på 8 doser a 0,5 mg/kg.
English: Carcinogenicity studies have not been conducted as no adequate animal model was available to evaluate the tumourigenic potential of Strimvelis due to the inability to achieve long-term engraftment of transduced cells in mice.
Danish: Der er ikke udført karcinogenicitetsstudier, da der ikke fandtes en passende dyremodel til vurdering af tumorpotentialet for Strimvelis, idet det ikke var muligt at opnå langvarig inkorporering af transducerede celler hos mus.
English: The safety and efficacy of Strimvelis in children less than six months of age or over 6 years 1 month has not been established (see section 4.4).
Danish: Strimvelis' sikkerhed og virkning hos børn under 6 måneder og over 6 år og 1 måned er ikke fastlagt (se pkt.
English: No clinical data on exposed pregnancies are available.
Danish: Der foreligger ingen kliniske data om eksponerede graviditeter.
English: In those patients treated in the pivotal study, the rate of severe infections declined throughout the follow-up period (Table 2).
Danish: Hos patienter, som blev behandlet i pivotalstudiet, faldt forekomsten af svære infektioner i opfølgningsperioden (tabel 2).
English: Patient 8 withdrew from the study before 3 year visit, and thus had no data for T-lymphocytes and dAXP.
Danish: Patient nr. 8 udgik af studiet før 3-års-besøget og havde således ingen data for Tlymfocytter og dAXP.
English: It is recommended that 0.5 mg/kg intravenous busulfan be administered every 6 hours on two consecutive days starting three days before administration of Strimvelis.
Danish: Det anbefales at administrere 0,5 mg/kg busulfan intravenøst hver 6. time i to på hinanden følgende dage, startende tre dage før administration af Strimvelis.
English: • decreases in the number of red or white blood cells (anaemia, neutropenia)*
Danish: • nedsat antal røde eller hvide blodceller (anæmi, neutropeni)*
English: Results at 3 years for the ITT population in the pivotal study*
Danish: Resultater efter 3 år for ITT-populationen i pivotalstudiet* Endepunkt
English: • the backup sample, at least 3 weeks before.
Danish: • Reserveprøven tages mindst 3 uger før.
English: It will be used to make the Strimvelis, by putting a new gene into the cells.
Danish: Den bruges til at fremstille Strimvelis ved at indføre et nyt gen i cellerne.
English: Time period (Years)
Danish: Tidsperiode (år) Ikke relevant
English: Strimvelis can only be made if the doctor can collect enough of the right kind of cells from the patient's own bone marrow.
Danish: Strimvelis kan kun fremstilles, hvis lægen kan udtage et tilstrækkeligt antal af den rette type celler fra patientens egen knoglemarv.
English: The safety of Strimvelis was evaluated in 18 subjects, with a median duration of follow-up of 7 years.
Danish: Strimvelis' sikkerhed blev vurderet hos 18 forsøgspersoner med en median opfølgningsvarighed på 7 år.
English: With this condition the immune system does not work properly to defend the body against infections.
Danish: Denne sygdom betyder, at immunsystemet ikke fungerer, som det skal, og derfor ikke kan forsvare kroppen mod infektioner.
English: Rate of severe infections per person-year of observation (95% confidence
Danish: Forekomst af svære infektioner pr. personår (95 % konfidensinterval)
English: dAXP results are based on a responder analysis of the percentage of patients following gene therapy who met the definition of adequate metabolic detoxification, therefore baseline value is not applicable.
Danish: Resultaterne af dAXP er baseret på en respondentanalyse af procentdelen af patienter efter genterapi, som opfyldte kravet til tilstrækkelig metabolisk afgiftning, hvorfor baseline-værdi ikke er relevant.
English: Positive test for human immunodeficiency virus (HIV) or presence of any other transmissible infectious agent listed in the current EU Cell and Tissue Directive prior to bone marrow harvest.
Danish: Positiv test for hiv (humant immundefektvirus) eller tilstedeværelse af et andet overførbart infektiøs agens, som er anført i EU's gældende celle- og vævsdirektiv, før høstning af knoglemarv.
English: These may affect more than 1 in 10 people:
Danish: Meget almindelige bivirkninger Kan forekomme hos flere end 1 ud af 10 personer:
English: In clinical trials of gene therapy for other diseases (not ADA-SCID), some patients developed leukaemia or other cancers of the blood system.
Danish: I kliniske studier med genterapi for andre sygdomme (men ikke ADA-SCID) udviklede nogle patienter leukæmi eller andre former for blodkræft.
English: Retroviral insertion sites (RIS) have been detected adjacent to or within CCND2 and LMO2 and there is a potential risk of leukaemic transformation following treatment with Strimvelis.
Danish: Retrovirale indsættelsessteder (RIS) er påvist ved siden af eller inden i CCND2 og LMO2, og der er en potentiel risiko for leukæmisk transformation efter behandling med Strimvelis.
English: x 106 METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: x 106 ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants , ATC code: not yet assigned
Danish: Farmakoterapeutisk klassifikation: Immunstimulerende midler, andre immunstimulerende midler, ATCkode: endnu ikke tildelt.
English: Low levels of human cells and vector sequences were also detected in non-haematopoietic organs consistent with the presence of blood containing transduced human cells.
Danish: Der blev også påvist lave niveauer af humane celler og vektorsekvenser i ikke-hæmatopoietiske organer svarende til tilstedeværelse af blod indeholdende transducerede humane celler.
English: Name and address of the manufacturer of the biological active substance MolMed SpA
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof MolMed SpA
English: A 100% survival rate was observed for all 12 subjects treated within the pivotal study and also for the 18 subjects in the integrated analysis, with a median follow up duration of approximately 7 years.
Danish: Der blev observeret en 100 % overlevelsesrate for alle 12 forsøgspersoner, som blev behandlet i pivotalstudiet, og også for de 18 forsøgspersoner i den integrerede analyse, med en median opfølgning på ca. 7 år.
English: Results at 3 years for patients treated within the pivotal study are presented in Table 1.
Danish: Resultaterne efter 3 år for patienter, som blev behandlet i pivotalstudiet, er vist i tabel 1.
English: After notification, the treating physician may need to modify the treatment program of the patient accordingly (i.e. terminating the busulfan conditioning and/or administration of the stem cell back up treatment if appropriate).
Danish: Når den behandlende læge har fået besked, bliver denne muligvis nødt til at ændre behandlingsprogrammet for patienten (dvs. afslutte konditioneringen med busulfan og/eller administrere stamcellereserven, hvis det er relevant).
English: e At baseline 9 of 11 (82%) patients had dAXP <100 nmol/ml.
Danish: e Ved baseline havde 9 ud af 11 patienter (82 %) dAXP < 100 nmol/ml.
English: The final clinical study report should be submitted after the 50th patient has 15 year follow-up visit; Q4 2037.
Danish: Den endelige studierapport skal indsendes efter den 50. patient har været til 15 årsopfølgningsbesøget; 4. kvartal
English: History of previous gene therapy.
Danish: Tidligere genterapi.
English: In such cases, the doctor will give you (or your child) replacement stem cells, using the backup sample that was collected and stored before treatment started (see also section 3, How Strimvelis is given).
Danish: I disse tilfælde vil lægen give dig (eller dit barn) erstatningsstamceller fra den reserveprøve, som blev taget og gemt, inden behandlingen startede (se også punkt 3, Sådan gives Strimvelis).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total cell number:
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Samlet celleantal:
English: Strimvelis is not tested for transmissible infectious agents.
Danish: Strimvelis er ikke testet for overførbare infektiøse agenser.
English: It is recommended that an intravenous antihistamine be administered 15-30 minutes before the infusion of Strimvelis.
Danish: Præmedicinering Det anbefales at give intravenøs antihistamin 15-30 minutter inden infusion af Strimvelis.
English: Following successful engraftment in the patient, the effects of the product are expected to be life-long.
Danish: Efter vellykket inkorporering hos patienten forventes virkningerne af præparatet at vare resten af livet.
English: The long term effects and durability of response to Strimvelis on ADA-SCID are unknown (see section 5.1).
Danish: Langtidsvirkningerne og varigheden af respons på Strimvelis ved ADA-SCID kendes ikke (se pkt.
English: Busulfan plasma levels should be measured after the first dose of each day by serial blood sampling using an appropriate method.
Danish: Plasmakoncentrationen af busulfan skal måles med en passende metode ved seriel blodprøvetagning efter den første dosis hver dag.
English: It will be stored, to be given to the patient as replacement stem cells if Strimvelis cannot be given or does not work (see ‘When Strimvelis treatment cannot be completed' in section 2)
Danish: Den gemmes, så den kan gives til patienten som erstatningsstamceller, hvis Strimvelis ikke kan gives eller ikke virker (se ‘Når behandlingen med Strimvelis ikke kan gennemføres' i punkt 2).
English: • if there was a problem at the time the cells were taken for making the medicine
Danish: • hvis der opstod et problem på det tidspunkt, hvor cellerne blev udtaget for at fremstille medicinen
English: The nature of Strimvelis is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Danish: Strimvelis' beskaffenhed bevirker, at konventionelle studier af farmakokinetik, absorption, fordeling, biotransformation og elimination ikke er relevante.
English: • blood test results positive for antinuclear antibody If you have any questions about symptoms or side effects, or if any symptoms concern you → Talk to your doctor or nurse.
Danish: • positive blodprøveresultater for antinukleære antistoffer Hvis du har spørgsmål om symptomer eller bivirkninger, eller hvis du har symptomer, som bekymrer dig → Kontakt lægen eller sundhedspersonalet.
English: Strimvelis is a cloudy to clear, colourless to pink dispersion of cells for infusion, which is supplied in one or more infusion bags.
Danish: Strimvelis er en uklar til klar, farveløs til lyserød dispersion (opslæmning) af celler til infusion, som leveres i en eller flere infusionsposer.