FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated Do not freeze.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab og transporteres nedkølet.
English: It is recommended that vasopressor therapy is also administered if necessary to restore an adequate perfusion pressure.
Danish: Det anbefales også at administrere vasopressorterapi efter behov for at genoprette et tilstrækkeligt perfusionstryk.
English: Unituxin has been shown to delay the progression or relapse of the disease and to increase survival.
Danish: Det er blevet påvist, at Unituxin forsinker progression eller tilbagefald af sygdommen samt øger sandsynligheden for at overleve.
English: Unituxin is used to treat ‘high-risk neuroblastoma' in babies, children and adolescents aged 12 months to 17 years old.
Danish: Unituxin bruges til at behandle ‘højrisiko-neuroblastom' hos spædbørn, børn og unge i alderen 12 måneder til 17 år.
English: Due to overlapping signs and symptoms, it was not possible to distinguish between infusion reactions and hypersensitivity/allergic reactions in some cases.
Danish: På grund af overlap mellem tegn og symptomer var det i visse tilfælde ikke muligt at skelne mellem infusionsreaktioner og overfølsomhedsreaktioner/allergiske reaktioner.
English: These adverse reactions are presented by MedDRA system organ class and frequency.
Danish: Bivirkningerne står anført efter MedDRA systemorganklasse og hyppighed.
English: It is not recommended to use intravenous immunoglobulin after ASCT.
Danish: Det frarådes at anvende intravenøs immunoglobulin efter ASCT.
English: Systemic infection or sepsis Grade 3 or 4
Danish: Systemisk infektion eller sepsis Grad 3 eller 4
English: The safety and efficacy of Unituxin in children aged less than 12 months have not yet been established.
Danish: Unituxins sikkerhed og virkning hos børn under 12 måneder er endnu ikke klarlagt.
English: Additional adverse reactions characteristic of an allergic response were also reported - including anaphylactic reaction (18 %) and bronchospasm (4 %).
Danish: Der blev desuden indberettet bivirkninger, der er karakteristiske for en allergisk reaktion - herunder anafylaktisk reaktion (18 %) og bronkospasme (4 %).
English: Increased gammaglutamyltransferase, increased blood creatinine, increased weight
Danish: Forhøjet gammaglutamyltransferase, forhøjet blodkreatinin, vægtstigning
English: The mean (± standard deviation) maximum plasma concentration observed after the 4th infusion was 11.5 (± 2.3) mcg/mL.
Danish: Den gennemsnitlige (± standardafvigelse) maksimale plasmakoncentration, der blev observeret efter den 4. infusion, var 11,5 (± 2,3) mcg/ml.
English: If hypotension occurs, this can be repeated, or intravenous albumin or packed red blood cells can be administered as clinically indicated.
Danish: Hvis der forekommer hypotension, kan dette gentages, eller der kan administreres intravenøst albumin eller pakkede røde blodlegemer ifølge klinisk indikation.
English: If necessary, its use must be limited to the first 100 days after ASCT, as immunoglobulin may interfere with dinutuximab-dependent cellular cytotoxicity.
Danish: Hvis det er nødvendigt, skal brugen af det begrænses til de første 100 dage efter ASCT, da immunglobulin kan interferere med den dinutuximabafhængige cellulære cytotoksicitet.
English: Symptomatic and/or systolic BP less than 70 mmHg or a decrease that is more than 15% below baseline Onset of symptoms
Danish: Symptomatisk og/eller systolisk BP under 70 mmHg eller et fald til mere end 15 % under baseline Symptomdebut
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Det gælder også medicin, der er købt uden recept, og naturlægemidler.
English: GD2 is found on the surface of neuroblastoma cells.
Danish: GD2 findes på overfladen af neuroblastomceller.
English: Nevertheless the leaflet will refer to ‘you' throughout.
Danish: Alligevel vil der stå ‘du' og ‘dig' i hele indlægssedlen.
English: In a population pharmacokinetic analysis, the geometric mean volume of distribution at steady state was estimated at 5.2 L.
Danish: I en farmakokinetisk populationsanalyse var det geometriske middelfordelingsvolumen i steady state vurderet til at være 5,2 l.
English: Unituxin recognises and attaches to a cell surface target called ‘GD2'.
Danish: Unituxin genkender og sætter sig fast på et mål på celleoverfladen, der hedder ‘GD2'.
English: • You will be given isotretinoin to take by mouth for the last 14 days of each course.
Danish: • Du får isotretinoin, som skal tages gennem munden, i de sidste 14 dage af hvert behandlingsforløb.
English: If patients meet criteria for discontinuation of these medications, treatment may continue with isotretinoin as clinically indicated.
Danish: Hvis patienten opfylder kriterierne for seponering af disse lægemidler, kan behandling med isotretinoin fortsætte ifølge klinisk indikation.
English: Some neuroblastomas are classed as ‘high risk' if the cancer has spread to various parts of the body and contains certain types of cells.
Danish: Visse neuroblastomer er klassificeret som neuroblastomer med høj risiko, hvis kræften har spredt sig til forskellige dele af kroppen og indeholder visse typer celler.
English: Patients should be monitored for signs and symptoms of infusion reactions for 4 hours after the completion of the Unituxin infusion.
Danish: Patienterne bør monitoreres for tegn og symptomer på infusionsreaktioner i 4 timer efter afslutning af Unituxininfusionen.
English: In addition, it has been shown to induce both antibody dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity in vitro.
Danish: Derudover er det påvist, at det inducerer både antistofafhængig cellemedieret cytotoksicitet (ADCC) og komplement-afhængig cytotoksicitet in vitro.
English: Clear, colourless liquid.
Danish: Klar, farveløs væske.
English: • Allergic reactions, which may be severe (anaphylactic reactions), or other reactions to the infusion - Tell your doctor or nurse straight away if you have any kind of reaction during or after the infusion.
Danish: • Allergiske reaktioner, der kan være alvorlige (anafylaktiske reaktioner), eller andre reaktioner på infusionen - Fortæl det straks til lægen eller sundhedspersonalet, hvis du får nogen form for reaktion under eller efter infusionen.
English: Delay initiation of courses 2-6 until ALT is less than 10 times ULN.
Danish: Udsæt initiering af behandlingsforløb 2-6, indtil ALAT er under 10 gange ULN.
English: Respiratory dysfunction
Danish: Respiratorisk dysfunktion
English: Human IgG is known to be secreted in human milk.
Danish: Human IgG udskilles i human mælk.
English: United Kingdom Tel: +44 (0)1932 664884 Fax: +44 (0)1932 573800 E-mail: druginfo@unither.com
Danish: Tlf.: +44 (0)1932 664884 Fax: +44 (0)1932 573800 E-mail:druginfo@unither.com
English: Unituxin will be given to you in five of the six courses.
Danish: Du får Unituxin i fem af de seks behandlingsforløb.
English: Unituxin has many side effects, and this will affect your ability to drive and use machines
Danish: Unituxin har mange bivirkninger, og dette vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: The incidence of antibody formation is highly dependent on the sensitivity and the specificity of the assay and for these reasons, comparison of the incidence of antibodies to dinutuximab with the incidence of antibodies to other products may be misleading.
Danish: Forekomsten af antistofdannelse er stærkt afhængig af assayets følsomhed og specificitet, og derfor kan en sammenligning af forekomsten af antistoffer mod dinutuximab med forekomsten af antistoffer mod andre produkter være misvisende.
English: Patients typically have a central venous catheter in situ and as a consequence of prior ASCT are likely to be immunocompromised during therapy, and therefore, at risk of developing systemic infection.
Danish: Patienter har typisk et fast centralt venøst kateter og er som følge af tidligere ASCT sandsynligvis immunkompromitterede under behandlingen og har derfor risiko for at udvikle systemisk infektion.
English: Gabapentin may be administered at the time of starting morphine premedication, at an oral dose of 10 mg/kg/day.
Danish: Der kan administreres gabapentin samtidig med, at præmedicineringen med morfin påbegyndes, i en oral dosis på 10 mg/kg/dag.
English: The primary efficacy outcome measure was investigator-assessed event-free survival (EFS) defined as time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy, or death.
Danish: Det primære resultatmål for effekt var investigator-vurderet hændelsesfri overlevelse (EFS), defineret som tid fra randomisering til første forekomst af recidiv, progredierende sygdom, sekundær malignitet eller død.
English: The effects of dinutuximab on fertility in humans are unknown.
Danish: Dinutuximabs virkning på menneskers fertilitet kendes ikke.
English: To reduce the risk of the cancer coming back, Unituxin is given at the last stage of the treatment to eliminate small amounts of disease which may still be present after the cancer has responded to chemotherapy, surgery, and an autologous (self-donating) blood cell transplant.
Danish: For at reducere risikoen for, at kræften kommer tilbage, gives der Unituxin ved det sidste behandlingsstadium for at eliminere små sygdomsmængder, der stadig kan være tilbage, efter at kræften har responderet på kemoterapi, kirurgiske indgreb og en autolog (selvdonerende) blodcelletransplantation.
English: • Low blood pressure - this may make you feel dizzy or faint.
Danish: • Lavt blodtryk - det kan gøre dig svimmel eller mat.
English: The clinical study report should be submitted by PASS: In order to better characterise the safety and immunogenicity of Unituxin and its impact on drug exposure, the applicant should conduct and submit the results of a safety study.
Danish: Den kliniske studierapport skal indsendes inden PASS: For bedre at karakterisere Unituxins sikkerhed og immunogenicitet og dets virkning på lægemiddeleksponering skal ansøgeren udføre og indsende resultaterne af et sikkerhedsstudie.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosering skal patienter monitoreres tæt for tegn eller symptomer på bivirkninger, og der skal iværksættes relevant symptomatisk behandling.
English: Dinutuximab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Danish: Dinutuximab er et protein, for hvilket den forventede metaboliske signalvej er nedbrydning i små peptider og individuelle aminosyrer af ubikvitære proteolytiske enzymer.
English: In particular, tell your doctor or nurse if you have recently received: - medicines called ‘corticosteroids' - these can affect the activity of your immune system which is important for Unituxin to work.
Danish: Du skal især fortælle det til lægen eller sundhedspersonalet, hvis du har fået følgende for nylig: - medicin, der hedder ‘kortikosteroider' - de kan påvirke dit immunforsvars aktivitet, som er vigtig for, at
English: During course (month) 6
Danish: I behandlingsforløb (måned) 6
English: • If blood pressure (BP) remains stable for at least 2 hours, resume GM
Danish: • Hvis blodtrykket (BP) forbliver stabilt i mindst 2 timer, genoptages GM
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for de enkelte frekvensgrupper er bivirkningerne anført efter faldende alvorlighed.
English: Patients should have no evidence of systemic infection and any identified infection should be under control before beginning therapy.
Danish: Patienter må ikke have tegn på systemisk infektion, og en eventuel konstateret infektion skal være under kontrol, før behandlingen påbegyndes.
English: High-risk neuroblastoma was based on the patient age (greater than 12 months) and tumour stage at diagnosis and / or the presence of biological risk factors, such as MYCN amplification.
Danish: Højrisiko-neuroblastom var baseret på patientens alder (over 12 måneder) og tumorstadie på diagnosetidspunktet og/eller tilstedeværelse af biologiske risikofaktorer, såsom MYCN-amplificering.
English: Neuroblastoma is a type of cancer that grows from abnormal nerve cells in the body.
Danish: Neuroblastom er en slags kræft, der vokser ud fra unormale nerveceller i kroppen.
English: Each carton contains one vial.
Danish: Hver karton indeholder ét hætteglas.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Danish: Dette lægemiddel indeholder op til 1 mmol (23 mg) natrium pr. dosis.
English: The dose may be subsequently increased (up to a maximum of 60 mg/kg/day or 3600 mg/day) as needed for pain management.
Danish: Dosis kan efterfølgende øges (op til højst 60 mg/kg/dag eller 3600 mg/dag) efter behov til behandling af smerter.
English: Pharmacokinetic interactions No interaction studies have been performed.
Danish: Farmakokinetiske interaktioner Der er ikke udført interaktionsstudier.
English: Data from 409 subjects participating in several neuroblastoma studies and having samples available for the determination of human anti-chimeric antibodies (HACA) demonstrated that 71 (17%) developed binding antibodies and 15 (4%) developed a neutralising antibody response.
Danish: Data fra 409 forsøgspersoner, der deltog i flere neuroblastom-studier og havde prøver tilgængelige til bestemmelse af humane anti-kimære antistoffer (HACA), viste, at 71 (17 %) udviklede bindende antistoffer, og 15 (4 %) udviklede et neutraliserende antistofrespons.
English: Patients were aged 11 months to 15 years and had previously achieved at least a partial response to induction chemotherapy, followed by ASCT and radiotherapy.
Danish: Patienterne havde alderen 11 måneder til 15 år og havde tidligere opnået i det mindste et partielt respons på induktionskemoterapi efterfulgt af ASCT og radioterapi.
English: Supplemental oxygen, respiratory support, and albumin replacement therapy should be used as necessary according to clinical response.
Danish: Oxygentilskud, vejrtrækningsstøtte og albuminerstatningsterapi bør anvendes efter behov ifølge klinisk respons.
English: No clinical signs of CNS toxicity were observed.
Danish: Der blev ikke observeret tegn på CNS-toksicitet.
English: - The other ingredients are histidine, polysorbate 20 (E 432), sodium chloride and water for injection.
Danish: - Øvrige indholdsstoffer: histidin, polysorbat 20 (E 432), natriumklorid og vand til injektioner.
English: These changes were noted to be very slight to slight in severity and recovered or tended to recover following the cessation of dosing.
Danish: Sværhedsgraden af disse forandringer blev noteret som meget let til let, og de bedredes eller viste tegn på bedring efter ophør af doseringen.
English: • IL-2 is given as a drip into one of your veins for four days in a row (continuous infustion) - for the first four days of the first week and the first four days of the second week of each course.
Danish: • Du får IL-2 som drop i en af dine vener i fire dage i træk (kontinuerlig infusion) - de første fire dage af den første uge og de første fire dage af den anden uge i hvert behandlingsforløb.
English: Do not take Unituxin if - you are allergic to dinutuximab or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Unituxin, hvis - du er allergisk over for dinutuximab eller et af de øvrige indholdsstoffer i Unituxin (angivet i punkt 6).
English: They help the immune system to target certain cells, such as cancer cells, by ‘sticking' to them.
Danish: De hjælper immunforsvaret med målrettet at ramme bestemte celler ved at ‘klæbe' til dem.
English: Dinutuximab was administered to cynomolgous monkeys resulting in effects on the cardiovascular system, which consisted of moderate increases in blood pressure (one of three animals) and heart rate (two of three animals).
Danish: Dinutuximab blev administreret til makakaber og medførte virkninger på det kardiovaskulære system bestående af moderate blodtryksstigninger (et af tre dyr) og hjertefrekvens (to af tre dyr).
English: • Delay course initiation until systemic infection or sepsis has resolved.
Danish: • Udsæt initiering af behandlingsforløbet, indtil ophør af systemisk infektion eller sepsis.
English: Dinutuximab (or the murine monoclonal antibody 14.18) has been administered to mice, rabbits, rats, and dogs in single- or repeat-dose regimens that exceed the dose that is used clinically.
Danish: Dinutuximab (eller det murine monoklonale antistof 14.18) er blevet administreret til mus, kaniner, rotter og hunde som enkeltdosis eller gentagne doser, der oversteg de klinisk anvendte doser.
English: It is not recommended to use systemic corticosteroid medicinal products due to possible interference with immune activation which is necessary for the therapeutic action of dinutuximab.
Danish: Det frarådes at anvende systemiske kortikosteroidlægemidler på grund af muligheden for interferens med den immunaktivering, der er nødvendig for dinutuximabs terapeutiske virkning.
English: • Unituxin is given as a drip into one of your veins - for about 10 hours each day for four days.
Danish: • Du får Unituxin som drop i en af dine vener - i ca. 10 timer hver dag i fire dage.
English: • Problems with your eyes - tell your doctor or nurse if you notice any problems with your eyes or changes to your vision.
Danish: • Problemer med øjnene - fortæl det til lægen eller sundhedspersonalet, hvis du bemærker problemer med øjnene eller synsforandringer.
English: Pre-medication should always be considered before starting each infusion.
Danish: Præmedicinering skal altid overvejes, før den enkelte infusion påbegyndes.
English: • Delay initiation of first course until alanine aminotransferase (ALT) is less than 5 times upper limit of normal (ULN).
Danish: • Udsæt initiering af første behandlingsforløb, indtil alaninaminotransferase (ALAT) er under 5 gange den øvre normalgrænse (ULN).
English: Unituxin is a clear, colourless solution for infusion, provided in a clear glass vial.
Danish: Unituxin er en klar, farveløs opløsning til infusion, som leveres i et klart hætteglas.
English: Grade 4(life-threatening) - < 120 mmol/L despite appropriate fluid management
Danish: Grad 4(livstruende) - < 120 mmol/l trods korrekt håndtering af væske
English: The geometric mean clearance was estimated at 0.025 L/hr and increased with body size.
Danish: Den geometriske middelclearance var vurderet til at være 0,025 l/time og steg med kropsstørrelse.
English: Depending on the severity of the allergic reaction, the rate of infusion should be reduced or treatment discontinued.
Danish: Afhængigt af sværhedsgraden af den allergiske reaktion bør infusionshastigheden nedsættes, eller behandlingen bør seponeres.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON
English: Additionally, in vivo studies demonstrate that dinutuximab either alone or in combination with IL-2 can partially inhibit tumour growth in mice.
Danish: Studier in vivo har desuden vist, at dinutuximab enten alene eller i kombination med IL-2 delvis kan hæmme tumorvækst hos mus.
English: During courses (months) 1, 3 and 5
Danish: I behandlingsforløb (måned) 1, 3 og 5
English: Patients should have an ophthalmic examination before initiating therapy and be monitored for visual changes.
Danish: Patienter bør have foretaget en øjenundersøgelse, før behandlingen initieres, og de bør monitoreres for synsforandringer.
English: Hepatic dysfunction Regular monitoring of liver function is recommended during dinutuximab immunotherapy.
Danish: Leverdysfunktion Regelmæssig monitorering af leverfunktionen anbefales under dinutuximab-immunterapi.
English: The most frequently occurring (more than 30% of patients) adverse reactions reported during the neuroblastoma studies were hypotension (67 %), pain (66 %), hypersensitivity (56 %), pyrexia (53 %), urticaria (49 %), capillary leak syndrome (45 %), anaemia (45 %), hypokalaemia (41 %), platelet count decreased (40 %), hyponatraemia (37 %), alanine aminotransferase increased (35 %), decreased lymphocyte count (34%) and decreased neutrophil count (31%).
Danish: De hyppigst forekommende (mere end 30 % af patienterne) bivirkninger, der blev indberettet under neuroblastom-studierne, var hypotension (67 %), smerte (66 %), overfølsomhed (56 %), pyreksi (53 %), urticaria (49 %), kapillærlækagesyndrom (45 %), anæmi (45 %), hypokaliæmi (41 %), nedsat trombocyttal (40 %), hyponatriæmi (37 %), forhøjet alaninaminotransferase (35 %), nedsat lymfocyttal (34 %) og nedsat neutrofiltal (31 %).
English: The solution should be mixed by gentle inversion.
Danish: Opløsningen skal blandes ved at vende den forsigtigt.
English: Eye disorders may occur, especially with repeated courses.
Danish: Øjenlidelser kan forekomme, især med gentagne behandlingsforløb.
English: • Administer supportive measures.
Danish: • Giv understøttende behandling.
English: No non-clinical studies to evaluate the potential of dinutuximab to cause carcinogenicity, genotoxicity, or developmental and reproductive toxicity have been conducted.
Danish: Der er ikke udført ikke-kliniske studier til evaluering af dinutuximabs potentiale for at forårsage karcinogenicitet, genotoksicitet eller udviklings- eller reproduktionstoksicitet.
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC16
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC16
English: Epinephrine (adrenaline) and hydrocortisone for intravenous administration should be immediately available at the bedside during administration of dinutuximab to manage life-threatening allergic reactions.
Danish: Epinephrin (adrenalin) og hydrocortison til intravenøs administration bør være umiddelbart tilgængeligt ved hospitalssengen under administration af dinutuximab til håndtering af livstruende allergiske reaktioner.
English: The recommended dose is 17.5 mg/m2.
Danish: Den anbefalede dosis er 17,5 mg/m2.
English: If required for persistent pain, ibuprofen should be administered orally every 6 hours between doses of paracetamol.
Danish: Hvis det er nødvendigt til behandling af vedvarende smerter, bør ibuprofen administreres oralt hver 6. time imellem paracetamoldoserne.
English: Stridor, laryngeal oedema
Danish: Stridor, laryngealt ødem
English: Posterior reversible encephalopathy syndrome
Danish: Posterior reversibel encefalopati-syndrom
English: The infusion duration may be extended up to 20 hours to help minimise reactions during infusion that do not respond adequately to other supportive measures.
Danish: Infusionens varighed kan øges til 20 timer som en hjælp til at minimere reaktioner under infusionen, som ikke responderer tilstrækkeligt på understøttende foranstaltninger.
English: Lidocaine infusion should be discontinued if the patient develops dizziness, perioral numbness, or tinnitus.
Danish: Infusion af lidocain bør seponeres, hvis patienten udvikler svimmelhed, perioral følelsesløshed eller tinnitus.
English: Non-clinical studies demonstrate that dinutuximab-induced neurotoxicity is likely due to the induction of mechanical allodynia that may be mediated by reactivity of dinutuximab with GD2 antigen located on the surface of peripheral nerve fibres and/or myelin.
Danish: Ikke-kliniske studier viser, at dinutuximab-induceret neurotoksicitet sandsynligvis skyldes induktion af mekanisk allodyni, som kan være medieret af dinutuximabs reaktivitet med GD2-antigen, som findes på overfladen af perifere nervefibre og/eller myelin.
English: Immunoglobulin must not be given within two weeks before and one week after completing each course of Unituxin.
Danish: Der må ikke gives immunglobulin inden for to uger før og én uge efter afslutning af det enkelte behandlingsforløb med Unituxin.