FrancophonIA/ELRC3.0 huggingface dataset:
English: The difference in DRR between Imlygic and GM-CSF in the ITT population was statistically significant (see table 4) in favour of Imlygic.
Danish: Forskellen i DRR mellem Imlygic og GM-CSF i ITT-populationen var statistisk signifikant (se tabel 4) til Imlygics fordel.
English: The modifications to talimogene laherparepvec from HSV-1 include deletion of ICP34.5 and ICP47.
Danish: Modificeringerne af talimogen laherparepvec fra HSV-1 omfatter deletion af ICP34.5 og ICP47.
English: Unused medicine must be disposed of in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste.
Danish: Ikke anvendt lægemiddel skal bortskaffes i henhold til institutionens retningslinjer for genetisk modificerede organismer eller biologisk risikomateriale.
English: In the pivotal clinical trial (study 005/05), events of cellulitis were recorded, some of them being considered as serious adverse events.
Danish: I det pivotale kliniske studie (studie 005/05) blev der registreret hændelser med cellulitis, hvoraf nogle blev anset for at være alvorlige bivirkninger.
English: Immunocompromised patients
Danish: Immunkompromitterede patienter
English: Time to treatment failure (median)
Danish: Tid indtil behandlingssvigt (median)
English: If you have these signs, you should follow standard hygiene practices to prevent viral transmission to others.
Danish: Hvis du har disse tegn, skal du følge standardpraksis for hygiejne for at undgå, at virussen overføres til andre.
English: • Pregnant and lactating women
Danish: • Gravide og ammende kvinder
English: However, available data for talimogene laherparepvec and wild-type HSV-1 do not indicate a carcinogenic risk in humans.
Danish: De tilgængelige data for talimogen laherparepvec og vildtype-HSV-1 tyder dog ikke på nogen karcinogen risiko hos mennesker.
English: The volume of Imlygic to be injected into each lesion is dependent on the size of the lesion and should be determined according to table 2.
Danish: Den mængde Imlygic, der skal injiceres i hver læsion, afhænger af læsionens størrelse og skal fastlægges i henhold til tabel 2.
English: Exploratory subgroup analyses for DRR and overall survival by stage of disease were also carried out (see figure 5 and table 5).
Danish: Der blev også udført eksploratoriske delgruppeanalyser af DRR og samlet overlevelse (se figur 5 og tabel 5).
English: Blood and urine samples were collected during treatment and for up to 30 days after the end of treatment.
Danish: Der blev indsamlet prøver fra blod og urin under behandlingen og i op til 30 dage efter afsluttet behandling.
English: Reproductive and development toxicity
Danish: Reproduktions- og udviklingstoksicitet
English: Of the responders, 42 (54%) experienced a ≥ 25% increase in overall size of existing lesion(s) and/or developed a new lesion(s) prior to ultimately achieving a response.
Danish: Ud af respondenterne opnåede 42 (54%) en stigning på ≥ 25% i eksisterende læsions (læsioners) størrelse og/eller udviklede en ny læsion (læsioner), inden de til sidst opnåede respons.
English: No adjustment of the dose is required in patients ≥ 65 years old (see section 5.1).
Danish: Der er ikke behov for justering af dosis til patienter på ≥ 65 år (se pkt.
English: • Wear gloves while changing your dressing.
Danish: • Bruge handsker, når din bandage skiftes.
English: Negligible amounts (< 0.001% of maternal blood levels) of talimogene laherparepvec DNA were found in foetal blood.
Danish: Der blev fundet ubetydelige mængder (< 0,001% af maternelle niveauer i blod) talimogen laherparepvec-DNA i fosterblod.
English: While the pivotal study was not powered to evaluate efficacy in these individual subgroups, patients with no visceral disease derived greater benefit from Imlygic treatment than those with more advanced disease.
Danish: Mens det pivotale studie ikke havde styrke til at evaluere virkningen i disse individuelle delgrupper, opnåede patienter uden visceral sygdom øget fordel af behandling med Imlygic end patienter med mere fremskreden sygdom.
English: Patients should also be advised to avoid touching or scratching injection sites as this could lead to inadvertent transfer of Imlygic to other areas of their body or to their close contacts.
Danish: Patienterne skal desuden anbefales at undgå at berøre eller kradse i injektionsstederne, da det kan føre til utilsigtet overførsel af Imlygic til andre områder af kroppen eller til nære kontakter.
English: GM-CSF was administered subcutaneously at 125 µg/m2 delivered daily for 14 days followed by a 14-day rest period in repeating intervals.
Danish: GM-CSF blev administreret subkutant med 125 µg/m2 tilført dagligt i 14 dage efterfulgt af 14-dages pause med gentagne intervaller.
English: It is unknown whether talimogene laherparepvec is transferred into human milk.
Danish: Det er ukendt, om talimogen laherparepvec videreføres til human mælk.
English: The mean (SD) treatment duration for the intent-to-treat (ITT) population was 15.76 weeks (15.79) in the GM-CSF arm and 26.83 weeks (18.39) in the Imlygic arm.
Danish: Den gennemsnitlige (SD) behandlingsvarighed for ITT-populationen (intent to treat) var 15,76 uger (15,79) i GM-CSF-armen og 26,83 uger (18,39) i Imlygic-armen.
English: • Inject largest lesion(s) first.
Danish: • Injicér største læsion(er) først.
English: • Combination with other therapies like chemotherapy or immunosuppressive agents
Danish: • Kombination med andre behandlinger såsom kemoterapi eller immunsuppressive midler
English: • Avoid direct contact with your body fluids or injection sites.
Danish: • Undgå direkte kontakt med dine kropsvæsker og injektionsstederne.
English: Follow local institutional guidelines for handling and administration, personal protective equipment, accidental spills, and waste disposal.
Danish: Institutionens retningslinjer for håndtering og administration, personligt beskyttelsesudstyr, uforsætlige spild og bortskaffelse af affald skal følges.
English: Caution should be used when injecting lesions close to major airways.
Danish: Der skal udvises forsigtighed i forbindelse med injektion i læsioner tæt på de store luftveje.
English: Symptomatic herpetic infection due to possible reactivation of Imlygic should be considered.
Danish: Symptomatisk herpetisk infektion, der skyldes en mulig reaktivering af Imlygic, skal overvejes.
English: Multiple insertion points may be used if a lesion is larger than the radial reach of the needle.
Danish: Der kan bruges flere indføringspunkter, hvis læsionen er større end kanylens radiale rækkevidde.
English: There is no clinical experience with overdose with Imlygic.
Danish: Der er ingen klinisk erfaring med overdosering af Imlygic.
English: If you have never had herpes infection in the past, you may be more likely to get fever, chills, and flulike illnesses within the period of the first 6 treatments with Imlygic.
Danish: Hvis du aldrig før har haft en herpes-infektion, kan det være mere sandsynligt, at du får feber, kulderystelser og influenza-lignende sygdom inden for perioden med de første 6 behandlinger med Imlygic.
English: Inform your healthcare professional if you have a history of blood cancer including multiple myeloma.
Danish: Fortæl det til din læge eller sundhedspersonalet, hvis du har haft blodkræft, herunder multipelt myelom.
English: Imlygic can be spread to other parts of your body or to other people through direct contact with your body fluids or injection sites.
Danish: Imlygic kan spredes til andre dele af kroppen eller til andre personer gennem direkte kontakt med dine kropsvæsker eller injektionsstederne.
English: • The injection site may be treated with a topical anaesthetic agent.
Danish: • Injektionsstedet kan behandles med et topisk anæstetikum.
English: If you miss an appointment, ask your healthcare professional when to schedule your next dose.
Danish: Hvis du glemmer en aftale, så spørg din læge, hvornår næste dosis skal gives.
English: If the qPCR testing for talimogene laherparepvec DNA was positive, then a TCID50 assay was performed to measure viral infectivity.
Danish: Hvis qPCR-test for talimogen laherparepvec-DNA var positiv, blev der udført en TCID50-analyse for at måle virusinfektivitet.
English: Life-threatening herpes infection may occur in patients with weakened immune systems.
Danish: Der kan opstå livstruende herpes-infektion hos patienter med svækket immunsystem.
English: Redirect the needle as many times as necessary while injecting the remainder of the dose of Imlygic.
Danish: Flyt kanylens retning så ofte, det er nødvendigt, mens den resterende dosis Imlygic injiceres.
English: Close contacts who are pregnant or who have a weakened immune system, and newborns
Danish: Nære kontakter, der er gravide eller har svækket immunsystem samt nyfødte
English: In an analysis to evaluate systemic activity of Imlygic, 27 of 79 patients (34.2%) had a ≥ 50% overall decrease in non-visceral lesions that were not injected with Imlygic, and 8 of 71 patients (11.3%) had a ≥ 50% overall decrease in visceral lesions that were not injected with Imlygic.
Danish: I en analyse til undersøgelse af Imlygics systemiske aktivitet havde 27 ud af 79 patienter (34,2%) et samlet fald på ≥ 50% i ikke-viscerale læsioner, der ikke blev injiceret med Imlygic, og 8 ud af 71 patienter (11,3%) havde et samlet fald på ≥ 50% i viscerale læsioner, der ikke blev injiceret med Imlygic.
English: Prior to launch of IMLYGIC in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational and controlled distribution programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden lancering af IMLYGIC i hvert medlemsland skal indehaveren af markedsføringstilladelsen være enig med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet og det kontrollerede distributionsprogram, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: Not reached (Range: > 0.0 to > 16.8 months)
Danish: Ikke opnået (interval: > 0,0 til > 16,8 mdr.)
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, ATC code: L01XX51.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, ATC-kode: L01XX51.
English: Up to 4 mL
Danish: Op til 4 ml
English: Pyrexia, chills, and influenza like illness, which can occur any time during Imlygic treatment, generally resolved within 72 hours.
Danish: Pyreksi, kulderystelser og influenza-lignende sygdom, der kan opstå når som helst under behandling med Imlygic, svandt generelt inden for 72 timer.
English: Patients with no prior herpes infection
Danish: Patienter uden tidligere herpes-infektion
English: Talimogene laherparepvec is a genetically modified and replication-competent HSV-1 virus.
Danish: Talimogen laherparepvec er en genetisk modificeret og replikationskompetent HSV-1-virus.
English: • Cancerous white blood cells at or near the injection site (plasmacytoma).
Danish: • Kræftramte hvide blodlegemer på eller tæt ved injektionsstedet (plasmacytom)
English: To allow for delayed immune-mediated anti-tumour effects to occur, patients were treated for a minimum of 6 months or until there were no longer any injectable lesions.
Danish: For at give plads til, at forsinkede immunmedierede antitumor-virkninger opstod, blev patienterne behandlet i mindst 6 måneder, eller indtil der ikke længere var nogen injicerbare læsioner.
English: The recommended dosing schedule for Imlygic is shown in table 1.
Danish: Den anbefalede doseringsplan for Imlygic vises i tabel 1.
English: Patients with weakened immune systems
Danish: Patienter med svækket immunsystem
English: Acyclovir and other anti-viral treatments may decrease the effects of Imlygic.
Danish: Acyclovir og andre antivirale behandlinger kan nedsætte Imlygics virkninger.
English: Women of childbearing potential/contraception
Danish: Kvinder i den fertile alder/kontraception
English: • The patient information pack should contain: o Patient information leaflet o A patient/carer and close contacts guide
Danish: • Patientinformationspakken skal indeholde: o Indlægssedlen o En vejledning til patient/omsorgsperson og nære kontakter
English: • After thawing, administer Imlygic as soon as practically feasible.
Danish: • Imlygic skal efter optøning administreres så hurtigt som praktisk muligt.
English: It is not known whether Imlygic is excreted in breast milk.
Danish: Det vides ikke, om Imlygic udskilles i modermælk.
English: Although it is not known if Imlygic could be transmitted through sexual contact, it is known that wildtype HSV-1 can be transmitted through sexual contact.
Danish: Det vides ikke, om Imlygic kan overføres gennem seksuel kontakt, men man ved, at vildtype-HSV-1 kan overføres på denne måde.
English: However, none lead to permanent discontinuation of Imlygic treatment.
Danish: Ingen førte dog til permanent seponering af behandlingen med Imlygic.
English: The safety of Imlygic was evaluated in the pivotal study where 292 patients received at least 1 dose of Imlygic (see section 5.1).
Danish: Imlygics sikkerhed blev undersøgt i det pivotale studie, hvor 292 patienter fik mindst 1 dosis af Imlygic (se pkt.
English: The MAH shall ensure that in each Member State where IMLYGIC is marketed, a system aimed to control distribution to IMLYGIC beyond the level of control ensured by routine risk minimisation measures.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at der i hvert medlemsland, hvor IMLYGIC markedsføres, forefindes et system, der har til formål at kontrollere distributionen af IMLYGIC udover det niveau af kontrol, der er allerede er sikret som følge af de rutinemæssige risikominimeringsforanstaltninger.
English: Deletion of ICP47 prevents downregulation of antigen presentation molecules and increases the expression of HSV US11 gene, thereby enhancing viral replication in tumour cells.
Danish: Deletion af ICP47 forhindrer nedregulering af antigenpræsenterende molekyler, øger ekspressionen af HSV US11-genet og styrker derved virusreplikationen i tumorceller.
English: • Guide for healthcare professionals
Danish: • Vejledning til sundhedspersonale
English: This medicinal product contains approximately 30 mg sodium per 4 mL dose, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder cirka 30 mg natrium pr. dosis på 4 ml, svarende til 1,5% af den WHOanbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: • Vials should be thawed and stored in the original carton until administration in order to protect from light.
Danish: • Hætteglassene skal optøs og opbevares i den originale pakning indtil administration for at beskytte mod lys.
English: Log-rank p-value = 0.0511 Hazard Ratio [95% CI] = 0.79 [0.62, 1.00]
Danish: Log-rank p-værdi = 0,0511 Hazard ratio [95% CI] = 0,79 [0,62, 1,00]
English: Of the enrolled patients, 22% had stage IV M1c disease and 53% of patients had received prior therapy for melanoma such as chemotherapy and cytokine-based immunotherapy in addition to surgery, adjuvant therapy or radiation.
Danish: Ud af de inkluderede patienter havde 22% M1c-sygdom i stadie IV, og 53% af patienterne havde fået tidligere behandling af melanom, såsom kemoterapi og cytokin-baseret immunterapi, foruden adjuverende behandling eller strålebehandling.
English: • Provide specified safety information to patients and communicate to patients the importance for sharing this information with family and caregivers;
Danish: • De anførte sikkerhedsinformationer skal være udleveret til patienterne, og patienterne skal være oplyst om vigtigheden af, at disse informationer videregives til familie og omsorgspersoner;
English: The most common grade 3 or higher adverse reaction was cellulitis (2.1%) (see section 4.4).
Danish: Den mest almindelige bivirkninger (grad 3 eller derover) var cellulitis (2,1%) (se pkt.
English: • Spread of IMLYGIC to close contacts or healthcare providers after direct contact with injected lesions or body fluids
Danish: • Spredning af IMLYGIC til nære kontakter eller sundhedspersonale efter direkte kontakt med injicerede læsioner eller kropsvæsker
English: The following side effects have been reported in patients receiving Imlygic:
Danish: Følgende bivirkninger er indberettet for patienter, der har fået Imlygic:
English: • Patients with a weakened immune system (immunocompromised patients) treated with IMLYGIC and suffering from concomitant infection
Danish: • Patienter med svækket immunsystem (immunkompromitterede patienter), der behandles med IMLYGIC og lider af samtidig infektion
English: If you have a tumour in your neck, your healthcare professional may warn you that you might experience compression of your airways during treatment with Imlygic.
Danish: Hvis du har en tumor i halsen, vil din læge muligvis advare dig om, at dine luftveje kan blive sammenpressede under behandling med Imlygic.
English: Prioritisation of lesions to be injected
Danish: Prioritering af læsioner, der skal injiceres
English: • Symptomatic herpetic infection due to latency and reactivation of IMLYGIC or herpes (wildtype HSV-1) in patients
Danish: • Symptomatisk herpetisk infektion som følge af latens og reaktivering af IMLYGIC eller herpes (vildtype-HSV-1) hos patienterne
English: However, no adjustment in dosage is necessary for patients with hepatic or renal impairment.
Danish: Det er dog ikke nødvendigt at justere dosis til patienter med lever- eller nyresvækkelse.
English: Single-use vial without a clear plastic sleeve
Danish: Engangshætteglas uden et gennemsigtigt plasthylster
English: Talimogene laherparepvec is an attenuated herpes simplex virus type-1 (HSV-1) derived by functional deletion of 2 genes (ICP34.5 and ICP47) and insertion of coding sequence for human granulocyte macrophage colony-stimulating factor (GM-CSF) (see section 5.1).
Danish: Talimogen laherparepvec er en svækket herpes simplex-virus type-1 (HSV-1), der er udledt ved funktionel deletion af 2 gener (ICP34.5 og ICP47) og insertion af en kodningssekvens for human granulocyt-makrofag-koloni-stimulerende faktor (GM-CSF) (se pkt.
English: As long as there are injectable lesion(s) remaining, Imlygic should be continued for at least 6 months unless the physician considers that the patient is not benefitting from Imlygic treatment or that other treatment is required.
Danish: Så længe der stadig er injicerbare læsioner, skal behandling med Imlygic fortsætte i mindst 6 måneder, medmindre lægen mener, at patienten ikke har fordel af behandling med Imlygic, eller at der er behov for anden behandling.
English: Cold sores or a more serious herpes infection may occur during or after treatment with Imlygic.
Danish: Der kan opstå forkølelsessår eller en mere alvorlig herpes-infektion under eller efter behandling med Imlygic.
English: Accidental exposure may lead to transmission of Imlygic and herpetic infection.
Danish: Utilsigtet eksponering kan føre til overførsel af Imlygic og herpetisk infektion.
English: Patients were randomised in a 2:1 ratio to receive either Imlygic or GM-CSF (N = 436; 295 Imlygic, 141 GM-CSF).
Danish: Patienterne blev randomiseret i forholdet 2:1 til at få enten Imlygic eller GM-CSF (N = 436; 295 Imlygic, 141 GM-CSF).
English: To minimise the risk of viral transmission, patients should keep their injection site covered for at least 8 days from the last treatment or longer if the injection site is weeping or oozing.
Danish: For at minimere risikoen for overførsel af virus skal patienterne holde injektionsstederne dækkede i mindst 8 dage efter sidste behandling eller længere, hvis der kommer væske eller siveblødning fra injektionsstedet.
English: Elderly population
Danish: Ældre personer
English: Symptoms of a local or systemic infection possibly related to Imlygic are anticipated to be similar to symptoms caused by wild-type HSV-1 infections.
Danish: Symptomerne på en lokal eller systemisk infektion, der kan være forbundet med Imlygic, forventes at være de samme symptomer som dem, der skyldes vildtype-HSV-1-infektioner.
English: Talimogene laherparepvec DNA was quantified with a highly sensitive and specific quantitative Polymerase Chain Reaction (qPCR) assay which may not correlate with viral infectivity risk.
Danish: Talimogen laherparepvec-DNA blev kvantificeret med en særdeles følsom og specifik kvantitativ polymerasekædereaktionsanalyse (qPCR), der muligvis ikke korrelerer med risikoen for virusinfektivitet.
English: You should tell your close contacts to:
Danish: Du skal bede dine pårørende og andre tætte kontaktpersoner om at:
English: Talimogene laherparepvec has been modified to replicate within tumours and to produce the immune stimulatory protein human GM-CSF.
Danish: Talimogen laherparepvec er blevet modificeret, så det kopierer sig selv inde i tumorer og producerer det immunstimulerende protein human GM-CSF.
English: • When removing the needle, withdraw it from the lesion slowly to avoid leakage or splash back of Imlygic at the insertion point.
Danish: • Træk kanylen langsomt ud af læsionen, når den skal fjernes, for at undgå lækage eller tilbagesprøjt af Imlygic på indføringspunktet.
English: If a pregnant woman has an infection with wild type HSV-1 (primary or reactivation), there is potential for the virus to cross the placental barrier, and also a risk of transmission during birth due to viral shedding.
Danish: Hvis en gravid kvinde er inficeret med vildtype-HSV-1 (primær eller reaktivering), er der mulighed for, at virusset passerer placenta og desuden risiko for overførsel under fødslen som følge af virusspredningen.
English: Plasmacytoma has been reported in proximity to the injection site after administration of Imlygic.
Danish: Der er indberettet plasmacytom i nærheden af injektionsstedet efter administration af Imlygic.
English: Summary of results from exploratory subgroup analysis from Imlygic study 005/05
Danish: Resumé af resultater fra eksploratoriske delgruppeanalyser fra Imlygic-studie 005/05
English: In clinical trials, one case of plasmacytoma at injection site was observed in a patient who was found to have multiple myeloma.
Danish: I kliniske studier blev der observeret et enkelt tilfælde af plasmacytom på injektionsstedet hos en patient, der viste sig at have multipelt myelom.
English: Adverse reactions from clinical trials in patients with melanoma and post-marketing experience
Danish: Bivirkninger fra kliniske studier med patienter med melanom og erfaringer efter markedsføringen
English: • Avoid touching or scratching the injection sites.
Danish: • Lad være med at berøre eller kradse i injektionsstederne.
English: • Dehydration
Danish: • Dehydrering
English: No effects on embryo-foetal development have been observed in animal studies (see section 5.3).
Danish: Der er ikke observeret nogen effekter på embryoets/fosterets udvikling i dyrestudier (se pkt.
English: * See description of selected adverse reactions
Danish: * Se beskrivelse af udvalgte bivirkninger
English: Patients treated with Imlygic must be given the patient alert card and be informed about the risks of Imlygic (see also package leaflet).
Danish: Patienter, der behandles med Imlygic, skal have udleveret patientkortet og informeres om risiciene ved Imlygic (se også indlægssedlen).
English: Injury, poisoning and procedural complications Common
Danish: Traumer, forgiftninger og behandlingskomplikationer Almindelig
English: During this period, treatment was to continue despite an increase in size in existing lesion(s) and/or development of new lesion(s) unless the patient developed intolerable toxicity or the investigator believed that it was in the best interest of the patient to stop treatment or to be given other therapy for melanoma.
Danish: I dette tidsrum skulle behandlingen fortsætte på trods af en stigning i den eller de eksisterende læsioners størrelse og/eller udvikling af nye læsioner, medmindre patienten udviklede uudholdelig toxicitet, eller det efter investigators mening var i patientens bedste interesse at seponere behandlingen eller få en anden behandling af melanom.
English: • Physician educational material
Danish: • Undervisningsmateriale til læger