FrancophonIA/ELRC3.0 huggingface dataset:
English: While there are no clinical data to date on talimogene laherparepvec infections in pregnant women, there could be a risk to the foetus or neonate if talimogene laherparepvec were to act in the same manner.
Danish: Selvom der indtil dato ikke er nogen kliniske data vedrørende talimogen laherparepvec-infektioner hos gravide kvinder, kan der være en risiko for fosteret eller det nyfødte barn, hvis talimogen laherparepvec virker på samme måde.
English: Kaplan-Meier plot -overall survival (ITT population)
Danish: Kaplan-Meier kurve - samlet overlevelse (ITT-population)
English: Herpetic infection in Imlygic-treated patients
Danish: Herpetisk infektion hos Imlygic-behandlede patienter
English: Thawed Imlygic may be stored prior to administration (see section 6.3).
Danish: Optøet Imlygic kan opbevares inden administration (se pkt.
English: Talimogene laherparepvec is cleared through general host-defence mechanisms (e.g. autophagy, adaptive immune responses).
Danish: Talimogen laherparepvec udskilles gennem de generelle forsvarsmekanismer hos værten (fx autofagi, adaptive immunresponser).
English: This may impair your ability to drive or operate machinery.
Danish: Det kan nedsætte din evne til at føre motorkøretøj og betjene maskiner.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Imlygic in one or more subsets of the paediatric population in melanoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Imlygic i en eller flere undergrupper af den pædiatriske population med melanom (se pkt.
English: Adequate and well controlled studies with talimogene laherparepvec have not been conducted in pregnant women.
Danish: Der er ikke udført fyldestgørende og velkontrollerede studier med anvendelse af talimogen laherparepvec til gravide kvinder.
English: The most commonly reported adverse reactions (≥ 25%) in Imlygic-treated patients were fatigue (50.3%), chills (48.6%), pyrexia (42.8%), nausea (35.6%), influenza-like illness (30.5%), and injection site pain (27.7%).
Danish: De hyppigst indberettede bivirkninger (≥ 25%) hos de Imlygic-behandlede patienter var træthed (50,3%), kulderystelser (48,6%), pyreksi (42,8%), kvalme (35,6%), influenza-lignende sygdom (30,5%) og smerter på injektionsstedet (27,7%).
English: Exploratory subgroups
Danish: Eksploratiske delgrupper
English: In the 60 patients treated, data indicate that talimogene laherparepvec DNA was present in all sites during the study (see table 6).
Danish: Data for de 60 behandlede patienter indikerede, at der var talimogen laherparepvec-DNA til stede på alle prøvesteder under studiet (se tabel 6).
English: Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
Danish: Omhyggelig sårpleje og infektionsprofylakse anbefales - især, hvis vævsnekrose medfører åbne sår.
English: This is a weakened form of herpes simplex virus type-1 (HSV-1), which is commonly called the cold sore virus.
Danish: Dette er en svækket form af herpes simplex-virus type 1 (HSV-1), som normalt kan give anledning til forkølelsessår.
English: Biodistribution (within the body) and viral shedding (excretion/secretion)
Danish: Biodistribution (inde i kroppen) og virusspredning (udskillelse/sekretion)
English: Imlygic may cause cancerous white blood cells to collect at or near the injection site (plasmacytoma).
Danish: Imlygic kan medføre, at kræftramte hvide blodlegemer samler sig på eller i nærheden af injektionsstedet (plasmacytom).
English: Blood
Danish: Blod
English: Talimogene laherparepvec is an oncolytic immunotherapy that is derived from HSV-1.
Danish: Talimogen laherparepvec er en onkolytisk immunterapi, som er udledt af HSV-1.
English: • If storing thawed Imlygic in the original vial followed by a syringe: o the same temperature range should be maintained throughout the duration of storage until administration.
Danish: • Hvis det optøede Imlygic opbevares i det originale hætteglas efterfulgt af sprøjte: o skal det samme temperaturinterval opretholdes under hele opbevaringsperioden indtil administration.
English: To provide preliminary efficacy results from the phase III part of the Study 20110265 (a multicentre trial evaluating the combination of talimogene laherparepvec with pembrolizumab)
Danish: Udlevering af de foreløbige effektresultater fra fase III-delen af studie 20110265 (et multicenterforsøg med undersøgelse af kombination af talimogen laherparepvec og pembrolizumab)
English: • Draw the desired amount of Imlygic from the vial into a syringe using aseptic technique.
Danish: • Træk den ønskede mængde Imlygic ud af hætteglasset og ind i en sprøjte ved hjælp af aseptisk teknik.
English: It is recommended to keep injection sites covered with airtight and watertight dressings at all times, if possible.
Danish: Det anbefales, at injektionsstederne om muligt altid er dækkede med luft- og vandtætteforbindinger.
English: Patients who develop herpetic infections should be advised to follow standard hygienic practices to prevent viral transmission.
Danish: Patienter, der får herpetiske infektioner, skal anbefales at følge standardpraksis for hygiejne for at forebygge overførsel af virus.
English: Do NOT shake.
Danish: Må IKKE omrystes.
English: Herpes infection
Danish: Herpes-infektion
English: Selection of Imlygic injection volume based on lesion size
Danish: Valg af injektionsvolumen af Imlygic baseret på læsionsstørrelse
English: Whereas anti-viral immune responses defend normal cells following infection by talimogene laherparepvec, tumours have been shown to be susceptible to injury and cell death from ICP34.5deficient HSV-1 viruses, including talimogene laherparepvec.
Danish: Mens antivirale immunresponser forsvarer normale celler efter infektion med talimogen laherparepvec, har tumorer vist sig at være følsomme over for skader og celledød fra ICP34.5-fattige HSV-1-virusser, herunder talimogen laherparepvec.
English: Patients may experience increase in size of existing lesion(s) or the appearance of a new lesion prior to achieving a response.
Danish: Patienterne kan opleve forøget størrelse af eksisterende læsion(er) eller nye, tilkomne læsioner, inden der opnås respons.
English: to 26-gauge needle is recommended.
Danish: Det anbefales at bruge en 22-26 gauge nål.
English: Imlygic will be stored by the healthcare professionals at your healthcare facility.
Danish: Imlygic vil blive opbevaret af sundhedspersonalet på hospitalet.
English: • Trained HCPs and support personnel regarding safe and appropriate storage, handling, and administration of IMLYGIC, and clinical follow-up for patients treated with IMLYGIC;
Danish: • Sundhedspersonale og assisterende personale skal være instrueret i sikker og korrekt opbevaring, håndtering og administration af IMLYGIC og i den kliniske opfølgning på patienter, der er behandlet med IMLYGIC;
English: If the dressing comes loose or falls off, replace it immediately with a clean dressing.
Danish: Hvis forbindingerne går løs eller falder af, skal du straks sætte en ny på.
English: If you miss a dose of Imlygic
Danish: Hvis du har glemt at få en dosis Imlygic
English: Talimogene laherparepvec was also quantified in selected patient samples in clinical studies using viral infectivity assays at the injection sites and in some cases of potential herpetic lesions.
Danish: Talimogen laherparepvec blev desuden kvantificeret i udvalgte patientprøver i kliniske studier med anvendelse af virusinfektivitetsanalyser på injektionsstederne og i nogle tilfælde af potentielle herpetiske læsioner.
English: It is important to tell your healthcare professional if you are breast-feeding or plan to do so.
Danish: Det er vigtigt at fortælle det til din læge eller sundhedspersonalet, hvis du ammer eller planlægger at amme.
English: Vitiligo, Rash, Dermatitis
Danish: Vitiligo, udslæt, dermatitis
English: • 108 (100 million) PFU/mL - For all subsequent doses.
Danish: • 108 (100 millioner) PFU/ml - til alle efterfølgende doser.
English: Close contacts who are pregnant or immunocompromised should not change the patient's dressing or clean their injection site.
Danish: Nære kontakter, der er gravide eller immunkompromitterede, skal ikke skifte patientens forbinding eller rense injektionsstedet.
English: Single-use vial permanently inserted into a clear copolyester plastic sleeve
Danish: Engangshætteglas, der sidder permanent i et gennemsigtigt plasthylster af copolyester
English: Therefore, its pharmacokinetics and biodistribution are driven by the site of intralesional injection, tumour-selective replication, and release from tumour tissue.
Danish: Dens farmakokinetik og biodistribution er derfor drevet af det intralæsionale injektionssted, tumorselektiv replikation og frigivelse fra tumorvæv.
English: Your healthcare professional will decide which tumour(s) to inject and may not inject every tumour.
Danish: Din læge vil beslutte, hvilken eller hvilke tumorer, der skal injiceres i, og vil muligvis ikke injicere i hver eneste tumor.
English: • Keep injection sites covered with airtight and watertight dressings at all times.
Danish: • Hold injektionsstederne dækkede med luft- og vandtætte forbindinger hele tiden.
English: Number of Subjects at Risk:
Danish: Antal patienter med risiko:
English: Talk to your healthcare professional about suitable methods of contraception.
Danish: Tal med lægen eller sundhedspersonalet om egnede præventionsformer.
English: Kaplan-Meier estimate of overall survival by randomised treatment arm for disease stage IIIB/IIIC/ stage IVM1a (exploratory subgroup analysis)
Danish: Kaplan-Meier-estimat af samlet overlevelse, inddelt efter randomiseret behandlingsarm for sygdomsstadie IIIB/IIIC/stadie IVM1a (eksploratorisk delgruppeanalyse)
English: • Clean the lesion and surrounding areas with an alcohol swab and let dry.
Danish: • Rens læsionen og det omgivende område med en alkoholserviet og lad det tørre.
English: Duration of response (ongoing response at last tumour evaluation)
Danish: Responsvarighed (vedvarende respons ved sidste tumorundersøgelse)
English: Individuals with wild-type HSV-1 infection are known to be at a lifelong risk for symptomatic herpetic infection due to reactivation of latent wild-type HSV-1.
Danish: Personer med vildtype-HSV-1-infektion vides at have en livslang risiko for symptomatisk herpetisk infektion, der skyldes reaktivering af latent vildtype-HSV-1.
English: Because wild-type HSV-1 does not integrate into the host genome, the risk of insertional mutagenesis with talimogene laherparepvec is negligible.
Danish: Da vildtype-HSV-1 ikke integreres i værtsgenomet, er risikoen for insertionel mutagenese ved talimogen laherparepvec ubetydelig.
English: Healthcare professionals and close contacts (e.g. household members, caregivers, sex partners or persons sharing the same bed) should avoid direct contact with injected lesions or body fluids of treated patients during the entirety of the treatment period and up to 30 days after the last treatment administration (see section 6.6).
Danish: Sundhedspersonale og nære kontakter (fx medlemmer af husstanden, omsorgspersoner, seksualpartnere eller personer, der deler samme seng) skal undgå direkte kontakt med de injicerede læsioner eller kropsvæsker fra behandlede patienter i hele behandlingsperioden og op til 30 dage efter sidste administration af behandlingen (se pkt.
English: • Adequately trained and experienced HCPs in order to minimise the risk of occurrence of specified adverse drug reactions in patients, HCPs, and close contacts of the patients;
Danish: • Sundhedspersonalet skal være tilstrækkeligt uddannet og erfarent for at minimere risikoen for forekomst af de anførte lægemiddelbivirkninger hos patienterne, sundhedspersonalet og patienternes nære kontakter;
English: Determining Imlygic dose volume (per lesion)
Danish: Fastlæggelse af dosisvolumen af Imlygic (pr. læsion)
English: Caregivers should be advised to wear protective gloves when assisting patients in applying or changing occlusive dressings and to observe safety precautions for disposal of used dressings and cleaning materials (see sections 4.2 and 6.6).
Danish: Omsorgspersoner skal anbefales at bruge beskyttelseshandsker, når de hjælper patienterne i forbindelse med påsætning eller skift af okklusionsforbindinger, og at følge sikkerhedsforanstaltningerne for bortskaffelse af brugte forbindinger og rensematerialer (se pkt.
English: As talimogene laherparepvec is injected and replicates intratumourally, bioavailability and systemic concentration of talimogene laherparepvec are not predictive of drug substance activity and therefore have not been evaluated.
Danish: Da talimogen laherparepvec injiceres og kopierer sig selv intratumoralt, siger biotilgængeligheden og den systemiske koncentration af talimogen laherparepvec ikke noget om lægemiddelstoffets aktivitet og er derfor ikke undersøgt.
English: 31th December,
Danish: 31. december 2019
English: - The active substance is talimogene laherparepvec.
Danish: - Aktivt stof: talimogen laherparepvec.
English: Plasmacytoma
Danish: Plasmacytom
English: The risks and benefits of treatment should be considered before administering Imlygic to these patients.
Danish: Risici og fordele ved behandlingen skal overvejes, inden Imlygic administreres til disse patienter.
English: Talimogene laherparepvec is produced in Vero cells by recombinant DNA technology.
Danish: Talimogen laherparepvec fremstilles i Vero-celler ved rekombinant DNA-teknologi.
English: Imlygic may increase the risk of impaired healing in patients with underlying risk factors (e.g. previous radiation at the injection site, or lesions in poorly vascularised areas).
Danish: Imlygic kan forhøje risikoen for forringet opheling hos patienter med underliggende faktorer (fx tidligere bestråling på injektionsstedet eller læsioner i områder med ringe vaskularisering).
English: United States
Danish: USA
English: • Disperse Imlygic evenly and completely within the lesion by pulling the needle back without exiting the lesion.
Danish: • Spred Imlygic jævnt og fuldstændigt inde i læsionen ved at trække kanylen tilbage uden at gå ud af læsionen.
English: For patients with detectable DNA in injected lesions, no samples had detectable talimogene laherparepvec DNA 60 days after end of treatment.
Danish: For patienter med detekterbart DNA i injicerede læsioner havde ingen prøver detekterbart talimogen laherparepvec-DNA 60 dage efter afsluttet behandling.
English: Imlygic is provided in single use vials of 1 mL each in two different concentrations:
Danish: Imlygic leveres i engangshætteglas på hver 1 ml i to forskellige koncentrationer:
English: Your healthcare professional will inject Imlygic directly into your tumour(s) with a needle and syringe.
Danish: Lægen eller sundhedspersonalet vil injicere Imlygic direkte ind i din(e) tumor(er) med en kanyle og en sprøjte.
English: Across studies, fatal disseminated viral infection was observed in 14% of nude mice following treatment with talimogene laherparepvec at doses that are 10 to 100-fold higher than those that result in 100% lethality with wild-type HSV-1.
Danish: Der blev på tværs af studierne observeret fatal dissemineret virusinfektion hos 14% af nude-musene efter behandling med talimogen laherparepvec i doser, som var 10 til 100 gange højere end dem, der medfører 100% letalitet med vildtype-HSV-1.
English: Accidental exposure
Danish: Utilsigtet eksponering
English: Proportion Alive
Danish: Andel i live
English: Censor indicated by vertical bar ׀ NE = not estimable
Danish: Censurering vist som lodret streg ׀ NE = kan ikke estimeres
English: • Using a single insertion point, inject Imlygic along multiple tracks as far as the radial reach of the needle allows within the lesion to achieve even and complete dispersion.
Danish: • Injicér Imlygic med anvendelse af et enkelt indføringspunkt langs flere spor, så langt som kanylens radiale rækkevidde tillader det inde i læsionen, så der opnås en ensartet og fuldstændig spredning.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan ramme mere end 1 ud af 10 personer):
English: Treatment visit
Danish: Behandlingsbesøg
English: Injectable anaesthetic may be injected around the periphery of the lesion but should not be injected directly into the lesion.
Danish: Et injicerbart anæstetikum kan injiceres i læsionens omkreds, men skal ikke injiceres direkte i læsionen.
English: Intralesional use
Danish: Intralæsional anvendelse
English: Infections with wild-type HSV-1 have been associated with serious adverse effects, including multi-organ failure and death, if a foetus or neonate contracts the wild type herpes infection.
Danish: Infektioner med vildtype-HSV-1 har været forbundet med alvorlige bivirkninger, herunder multiorgansvigt og dødsfald, hvis et foster eller et nyfødt barn pådrager sig en vildtypeherpesinfektion.
English: Healthcare professionals should ensure that patients are able to comply with the requirement to cover injection sites with occlusive dressings (see section 6.6).
Danish: Sundhedspersonalet skal sikre, at patienterne kan opfylde kravet til afdækning af injektionsstederne med okklusionsforbindinger (se pkt.
English: Influenza-like symptoms
Danish: Influenza-lignende sygdom
English: • Infection caused by bacteria (cellulitis), cold sores (oral herpes)
Danish: • Infektion, der skyldes bakterier (cellulitis), forkølelsessår (oral herpes)
English: Patients with active brain metastases, bone metastases, extensive visceral disease, primary ocular or mucosal melanoma, evidence of immunosuppression, or receiving treatment with a systemic anti-herpetic agent were excluded from the study.
Danish: Patienter med aktive hjernemetastaser, knoglemetastaser, omfattende visceral sygdom, primært okulært eller mucosalt melanom, tegn på immunsuppression, eller som fik behandling med et systemisk middel mod herpes, var udelukket fra studiet.
English: Lethal systemic viral infection was observed in up to 20% of nude mice (primarily deficient in T lymphocyte function) and 100% of SCID mice (devoid of both T and B lymphocytes).
Danish: Der blev observeret letal systemisk virusinfektion hos op til 20% af nude-musene (primært utilstrækkelige i T-lymfocyt-funktion) og 100% af SCID-musene (blottede for både T- og B-lymfocytter).
English: • In the event of an accidental occupational exposure to Imlygic (e.g. through a splash to the eyes or mucous membranes) during preparation or administration, flush with clean water for at least 15 minutes.
Danish: • I tilfælde af, at personale utilsigtet eksponeres for Imlygic (fx på grund af sprøjt i øjne eller slimhinder) i forbindelse med klargøring eller administration, skylles med rent vand i mindst 15 minutter.
English: This medicine contains approximately 30 mg sodium (main component of cooking/table salt) in each 4 mL dose.
Danish: Dette lægemiddel indeholder cirka 30 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. dosis på 4 ml.
English: It is important for you to keep all your appointments to receive Imlygic.
Danish: Det er vigtigt, at du overholder alle aftaler om behandling med Imlygic.
English: The active ingredient of Imlygic is talimogene laherparepvec.
Danish: Det aktive stof i Imlygic er talimogen laherparepvec.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS
English: These agents may interfere with the effectiveness of Imlygic if administered systemically or topically directly to the injection site.
Danish: Disse præparater kan indvirke på effekten af Imlygic, hvis de administreres systemisk eller topisk direkte på injektionsstedet.
English: Occlusive dressings samples were collected during treatment.
Danish: Der blev indsamlet prøver fra okklusionsforbindinger under behandlingen.
English: The total injection volume for each treatment visit should be up to a maximum of 4 mL.
Danish: Den totale injektionsvolumen ved hver behandling skal maksimalt være 4 ml.
English: Sixty patients with melanoma received Imlygic intralesional injection at a dose and schedule same as clinical study 005/05 (see section 5.1).
Danish: Tres (60) patienter med melanom fik Imlygic som intralæsional injektion i en dosis og efter en doseringsplan svarende til det kliniske studie 005/05 (se pkt.
English: To submit the preliminary results from Study 20110266 (a phase 2, multicentre, randomised, open-label trial assessing the efficacy and safety of talimogene laherparepvec neoadjuvant treatment plus surgery vs surgery alone for resectable stage IIIB to IVM1a melanoma)
Danish: Indsendelse af de foreløbige resultater fra studie 20110266 (et åbent, randomiseret fase 2-multicenterforsøg med undersøgelse af virkningen og sikkerheden ved neoadjuverende behandling med talimogen laherparepvec plus kirurgi vs. kirurgi alene ved resekterbart melanom stadie IIIB til IVM1a)
English: In clinical studies, herpetic infections (including cold sores and herpes keratitis) have been reported in patients treated with Imlygic.
Danish: I kliniske studier er der indberettet herpetiske infektioner (herunder forkølelsessår og herpes keratitis) hos patienter, der blev behandlet med Imlygic.
English: Because talimogene laherparepvec is designed to enter and replicate in the tumour tissue, there could be a risk of foetal exposure to talimogene laherparepvec from tumour tissue that has crossed the placenta.
Danish: Da talimogen laherparepvec er udviklet til at trænge ind i og kopiere sig selv i tumorvæv, kan der være risiko for, at fosteret eksponeres for talimogen laherparepvec fra tumorvæv, der har krydset placenta.
English: The safety and efficacy of Imlygic monotherapy compared with subcutaneously administered GM-CSF were evaluated in a phase 3, multinational, open-label, and randomised clinical study of patients with stage IIIB, IIIC, and IV melanoma that was not considered to be surgically resectable.
Danish: Sikkerheden og virkningen ved monoterapi med Imlygic sammenlignet med subkutant administreret GM-CSF blev undersøgt i et multinationalt, åbent, randomiseret fase 3-studie med patienter med melanom i stadie IIIB, IIIC og IV, der ikke blev anset for at være kirurgisk resekterbart.
English: • After administration, change gloves prior to applying occlusive dressings to injected lesions.
Danish: • Der skal skiftes handsker efter administration og inden påsætning af okklusionsforbindinger på de injicerede læsioner.
English: • Patient information pack
Danish: • Patientinformationspakke
English: No pharmacokinetic studies using talimogene laherparepvec have been conducted in special populations.
Danish: Der er ikke udført farmakokinetiske studier med talimogen laherparepvec i specielle populationer.
English: In an in vivo study of intracerebral injection, talimogene laherparepvec was 10,000-fold less neurovirulent as compared to the wild-type HSV-1 dose that results in death 50% of the time in mice.
Danish: I et studie in vivo med intracerebral injektion var talimogen laherparepvec 10.000 gange mindre neurovirulent end vildetype-HSV-1-dosen, der i 50% af tilfældene medfører dødsfald hos mus.
English: The secondary endpoints included overall survival (OS), overall response rate (ORR) [PR+CR], time to response, duration of response, and time to treatment failure (time from randomisation until the first episode of clinically relevant disease progression where there is no response achieved after the progression event, or until death).
Danish: [PR+CR], tid indtil respons, responsvarighed og tid indtil behandlingssvigt (tiden fra randomisering indtil første episode med klinisk relevant sygdomsprogression, hvor der ikke er opnået nogen respons efter progressionen, eller indtil dødsfald).
English: • Patients with a history of hypersensitivity to talimogene laherparepvec or any of its excipients.
Danish: • Patienter med tidligere overfølsomhed over for talimogen laherparepvec eller et eller flere af hjælpestofferne.