natgillin/translations-raw huggingface dataset:
Frekvenserne defineres således: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Talimogen laherparepvec kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
Talimogene laherparepvec may have a minor influence on the ability to drive and use machines.
• Allergisk reaktion (overfølsomhed)
• Allergic reaction (hypersensitivity)
Dette fører til ødelæggelse af inficerede tumorceller.
This leads to destruction of infected tumour cells.
5 (19%)a a For det anogenitale område blev 26 patienter testet for Imlygic-DNA.
5 (19%)a aFor the anogenital area, 26 patients were tested for Imlygic DNA.
Dato for første markedsføringstilladelse: 16. december 2015
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 December 2015
Patienter med detekterbart DNA under behandlingen (n = 60)
Patients with detectable DNA during treatment (n = 60)
Op til 25 °C
up to 25°C
Patienter med detekterbart DNA under behandlingen
Patients with detectable DNA during treatment
Imlygic virker desuden ved at hjælpe immunsystemet med at genkende og ødelægge tumorceller i hele kroppen.
Imlygic also works by helping your immune system to recognise and destroy tumours throughout your body.
2 °C til 8 °C
2°C to 8°C
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intralæsional anvendelse.
METHOD AND ROUTE(S) OF ADMINISTRATION Intralesional use.
Eventuelle synlige sår skal dækkes inden administration.
Cover any exposed wounds before administering.
Navn og adresse på fremstilleren af det biologisk aktive stof BioVex Inc. - Subsidiary of Amgen, Inc.
Name and address of the manufacturer of the biological active substance BioVex Inc. - Subsidiary of Amgen, Inc.
Inden for hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Der kan opstå transplacentale metastaser af malignt melanom.
Transplacental metastases of malignant melanoma can occur.
Din læge vil finde ud af, om Imlygic er det rigtige til dig.
Your healthcare professional will determine if Imlygic is right for you.
Effektdata for Imlygic i det aktuelle andet eller senere behandlingsforløb er begrænsede.
Efficacy data for Imlygic in the current second or later line treatment settings are limited.
Vær forsigtig, hvis du kører bil eller betjener maskiner, indtil du er sikker på, at Imlygic ikke påvirker dig negativt.
Use caution when driving or operating machinery until you are certain that Imlygic does not adversely affect you.
Grundet analysens eksploratoriske form og baseret på aktuel evidens er det ikke blevet fastslået, at Imlygic kan sættes i forbindelse med en virkning på den samlede overlevelse.
Due to the exploratory nature of the analysis and based on the current evidence, it has not been established that Imlygic is associated with an effect on overall survival.
Du kan forvente at blive behandlet med Imlygic i mindst 6 måneder.
You can expect to be treated with Imlygic for at least 6 months or longer.
Maksimal total injektionsvolumen
Maximum total injection volume
Farmakokinetikken i specielle populationer
Pharmacokinetics in special populations
Det kan indeholde hvide, synlige virusholdige partikler i forskellige former.
It may contain white, visible, variously shaped, virus-containing particles.
Hvis du er gravid eller ammer, skal du spørge din læge til råds, inden du får dette lægemiddel.
If you are pregnant or breast-feeding, ask your healthcare professional for advice before being given this medicine.
Behandling med Imlygic kan reinitieres, hvis der dukker nye læsioner op efter komplet respons, og lægen mener, at patienten vil have fordel af behandlingen.
Imlygic treatment may be reinitiated if new lesions appear following a complete response and the physician considers that the patient will benefit from treatment.
Imlygic er ikke undersøgt på immunkompromitterede patienter.
Imlygic has not been studied in immunocompromised patients.
26 patienter blev eksponeret for Imlygic i mindst et år.
Twenty six (26) patients were exposed to Imlygic for at least one year.
Når du behandles med Imlygic, kan du få symptomer såsom svimmelhed eller forvirring.
When you are being treated with Imlygic you may experience symptoms such as dizziness or confusion.
Forekomsten af bivirkninger er inddelt efter systemorganklasse og frekvens.
Incidence of adverse reactions are presented by system organ class and by frequency.
Du skal gøre følgende for at undgå at sprede Imlygic til andre steder på kroppen eller til nære kontakter (for eksempel medlemmer af husstanden, omsorgspersoner, seksualpartnere eller personer, du deler seng med):
You should do the following to avoid spreading Imlygic to other areas of your body or to your close contacts (close contacts include household members, caregivers, sex partners, or someone you share a bed with):
Mus, som havde komplet regression af deres primære tumorer efter behandling, var resistente over for efterfølgende rechallenge af tumorerne.
Mice that had complete regression of theirprimary tumours following treatment were resistant to subsequent tumour rechallenge.
Efter 6 måneders behandling skulle patienterne fortsætte med behandlingen indtil klinisk relevant sygdomsprogression (dvs. at sygdomsprogression var ledsaget af et fald i performance status, og/eller alternativ terapi var nødvendig efter investigators mening).
After 6 months of treatment, patients were to continue treatment until clinically relevant disease progression (i.e. disease progression associated with a decline in performance status and/or alternative therapy was required in the opinion of the investigator).
Gennemsnitsalderen var 63 år (inden for intervallet 22 til 94); 26,5% var over 65 år, og 23,3% var over 74 år.
The mean age was 63 (range: 22 to 94) years; 26.5% were over 65 years old and 23.3% were over 74 years old.
Samlet set var 58% af alle patienter, der var inkluderet i studiet, seropositive for vildtype-HSV-1 ved baseline, og 32,6% var seronegative; de resterende 9,4%'s HSV-1-serostatus var ukendt.
Overall, 58% of all patients enrolled into the study were seropositive for wild-type HSV-1 at baseline and 32.6% were seronegative; the HSV-1 serostatus of the remaining 9.4% was unknown.
Det menes, at det sammen med GM-CSF vil fremme en systemisk antitumor-immunrespons og en effektor-T-cellerespons.
It is thought that together with GM-CSF, it will promote a systemic anti tumour immune response and an effector T-cell response.
Forskellen i DRR mellem Imlygic og GM-CSF i ITT-populationen var statistisk signifikant (se tabel 4) til Imlygics fordel.
The difference in DRR between Imlygic and GM-CSF in the ITT population was statistically significant (see table 4) in favour of Imlygic.
Modificeringerne af talimogen laherparepvec fra HSV-1 omfatter deletion af ICP34.5 og ICP47.
The modifications to talimogene laherparepvec from HSV-1 include deletion of ICP34.5 and ICP47.
Ikke anvendt lægemiddel skal bortskaffes i henhold til institutionens retningslinjer for genetisk modificerede organismer eller biologisk risikomateriale.
Unused medicine must be disposed of in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste.
I det pivotale kliniske studie (studie 005/05) blev der registreret hændelser med cellulitis, hvoraf nogle blev anset for at være alvorlige bivirkninger.
In the pivotal clinical trial (study 005/05), events of cellulitis were recorded, some of them being considered as serious adverse events.
Immunkompromitterede patienter
Immunocompromised patients
Tid indtil behandlingssvigt (median)
Time to treatment failure (median)
Hvis du har disse tegn, skal du følge standardpraksis for hygiejne for at undgå, at virussen overføres til andre.
If you have these signs, you should follow standard hygiene practices to prevent viral transmission to others.
• Gravide og ammende kvinder
• Pregnant and lactating women
De tilgængelige data for talimogen laherparepvec og vildtype-HSV-1 tyder dog ikke på nogen karcinogen risiko hos mennesker.
However, available data for talimogene laherparepvec and wild-type HSV-1 do not indicate a carcinogenic risk in humans.
Den mængde Imlygic, der skal injiceres i hver læsion, afhænger af læsionens størrelse og skal fastlægges i henhold til tabel 2.
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.
Der blev også udført eksploratoriske delgruppeanalyser af DRR og samlet overlevelse (se figur 5 og tabel 5).
Exploratory subgroup analyses for DRR and overall survival by stage of disease were also carried out (see figure 5 and table 5).
Der blev indsamlet prøver fra blod og urin under behandlingen og i op til 30 dage efter afsluttet behandling.
Blood and urine samples were collected during treatment and for up to 30 days after the end of treatment.
Reproduktions- og udviklingstoksicitet
Reproductive and development toxicity
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.
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.
Der er ikke behov for justering af dosis til patienter på ≥ 65 år (se pkt.
No adjustment of the dose is required in patients ≥ 65 years old (see section 5.1).
• Bruge handsker, når din bandage skiftes.
• Wear gloves while changing your dressing.
Der blev fundet ubetydelige mængder (< 0,001% af maternelle niveauer i blod) talimogen laherparepvec-DNA i fosterblod.
Negligible amounts (< 0.001% of maternal blood levels) of talimogene laherparepvec DNA were found in foetal blood.
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.
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.
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.
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.
GM-CSF blev administreret subkutant med 125 µg/m2 tilført dagligt i 14 dage efterfulgt af 14-dages pause med gentagne intervaller.
GM-CSF was administered subcutaneously at 125 µg/m2 delivered daily for 14 days followed by a 14-day rest period in repeating intervals.
Det er ukendt, om talimogen laherparepvec videreføres til human mælk.
It is unknown whether talimogene laherparepvec is transferred into human milk.
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.
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.
• Injicér største læsion(er) først.
• Inject largest lesion(s) first.
• Kombination med andre behandlinger såsom kemoterapi eller immunsuppressive midler
• Combination with other therapies like chemotherapy or immunosuppressive agents
• Undgå direkte kontakt med dine kropsvæsker og injektionsstederne.
• Avoid direct contact with your body fluids or injection sites.
Institutionens retningslinjer for håndtering og administration, personligt beskyttelsesudstyr, uforsætlige spild og bortskaffelse af affald skal følges.
Follow local institutional guidelines for handling and administration, personal protective equipment, accidental spills, and waste disposal.
Der skal udvises forsigtighed i forbindelse med injektion i læsioner tæt på de store luftveje.
Caution should be used when injecting lesions close to major airways.
Symptomatisk herpetisk infektion, der skyldes en mulig reaktivering af Imlygic, skal overvejes.
Symptomatic herpetic infection due to possible reactivation of Imlygic should be considered.
Der kan bruges flere indføringspunkter, hvis læsionen er større end kanylens radiale rækkevidde.
Multiple insertion points may be used if a lesion is larger than the radial reach of the needle.
Der er ingen klinisk erfaring med overdosering af Imlygic.
There is no clinical experience with overdose with Imlygic.
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.
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.
Fortæl det til din læge eller sundhedspersonalet, hvis du har haft blodkræft, herunder multipelt myelom.
Inform your healthcare professional if you have a history of blood cancer including multiple myeloma.
Imlygic kan spredes til andre dele af kroppen eller til andre personer gennem direkte kontakt med dine kropsvæsker eller injektionsstederne.
Imlygic can be spread to other parts of your body or to other people through direct contact with your body fluids or injection sites.
• Injektionsstedet kan behandles med et topisk anæstetikum.
• The injection site may be treated with a topical anaesthetic agent.
Hvis du glemmer en aftale, så spørg din læge, hvornår næste dosis skal gives.
If you miss an appointment, ask your healthcare professional when to schedule your next dose.
Hvis qPCR-test for talimogen laherparepvec-DNA var positiv, blev der udført en TCID50-analyse for at måle virusinfektivitet.
If the qPCR testing for talimogene laherparepvec DNA was positive, then a TCID50 assay was performed to measure viral infectivity.
Der kan opstå livstruende herpes-infektion hos patienter med svækket immunsystem.
Life-threatening herpes infection may occur in patients with weakened immune systems.
Flyt kanylens retning så ofte, det er nødvendigt, mens den resterende dosis Imlygic injiceres.
Redirect the needle as many times as necessary while injecting the remainder of the dose of Imlygic.
Nære kontakter, der er gravide eller har svækket immunsystem samt nyfødte
Close contacts who are pregnant or who have a weakened immune system, and newborns
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.
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.
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.
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.
Ikke opnået (interval: > 0,0 til > 16,8 mdr.)
Not reached (Range: > 0.0 to > 16.8 months)
Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, ATC-kode: L01XX51.
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, ATC code: L01XX51.
Op til 4 ml
Up to 4 mL
Pyreksi, kulderystelser og influenza-lignende sygdom, der kan opstå når som helst under behandling med Imlygic, svandt generelt inden for 72 timer.
Pyrexia, chills, and influenza like illness, which can occur any time during Imlygic treatment, generally resolved within 72 hours.
Patienter uden tidligere herpes-infektion
Patients with no prior herpes infection
Talimogen laherparepvec er en genetisk modificeret og replikationskompetent HSV-1-virus.
Talimogene laherparepvec is a genetically modified and replication-competent HSV-1 virus.
• Kræftramte hvide blodlegemer på eller tæt ved injektionsstedet (plasmacytom)
• Cancerous white blood cells at or near the injection site (plasmacytoma).
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.
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.
Den anbefalede doseringsplan for Imlygic vises i tabel 1.
The recommended dosing schedule for Imlygic is shown in table 1.
Patienter med svækket immunsystem
Patients with weakened immune systems
Acyclovir og andre antivirale behandlinger kan nedsætte Imlygics virkninger.
Acyclovir and other anti-viral treatments may decrease the effects of Imlygic.
Kvinder i den fertile alder/kontraception
Women of childbearing potential/contraception
• Patientinformationspakken skal indeholde: o Indlægssedlen o En vejledning til patient/omsorgsperson og nære kontakter
• The patient information pack should contain: o Patient information leaflet o A patient/carer and close contacts guide
• Imlygic skal efter optøning administreres så hurtigt som praktisk muligt.
• After thawing, administer Imlygic as soon as practically feasible.
Det vides ikke, om Imlygic udskilles i modermælk.
It is not known whether Imlygic is excreted in breast milk.
Det vides ikke, om Imlygic kan overføres gennem seksuel kontakt, men man ved, at vildtype-HSV-1 kan overføres på denne måde.
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.
Ingen førte dog til permanent seponering af behandlingen med Imlygic.
However, none lead to permanent discontinuation of Imlygic treatment.
Imlygics sikkerhed blev undersøgt i det pivotale studie, hvor 292 patienter fik mindst 1 dosis af Imlygic (se pkt.
The safety of Imlygic was evaluated in the pivotal study where 292 patients received at least 1 dose of Imlygic (see section 5.1).
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.
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.
Deletion af ICP47 forhindrer nedregulering af antigenpræsenterende molekyler, øger ekspressionen af HSV US11-genet og styrker derved virusreplikationen i tumorceller.
Deletion of ICP47 prevents downregulation of antigen presentation molecules and increases the expression of HSV US11 gene, thereby enhancing viral replication in tumour cells.
• Vejledning til sundhedspersonale
• Guide for healthcare professionals
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.
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.
• Hætteglassene skal optøs og opbevares i den originale pakning indtil administration for at beskytte mod lys.
• Vials should be thawed and stored in the original carton until administration in order to protect from light.
Log-rank p-værdi = 0,0511 Hazard ratio [95% CI] = 0,79 [0,62, 1,00]
Log-rank p-value = 0.0511 Hazard Ratio [95% CI] = 0.79 [0.62, 1.00]
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.
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.
• De anførte sikkerhedsinformationer skal være udleveret til patienterne, og patienterne skal være oplyst om vigtigheden af, at disse informationer videregives til familie og omsorgspersoner;
• Provide specified safety information to patients and communicate to patients the importance for sharing this information with family and caregivers;
Den mest almindelige bivirkninger (grad 3 eller derover) var cellulitis (2,1%) (se pkt.
The most common grade 3 or higher adverse reaction was cellulitis (2.1%) (see section 4.4).
• Spredning af IMLYGIC til nære kontakter eller sundhedspersonale efter direkte kontakt med injicerede læsioner eller kropsvæsker
• Spread of IMLYGIC to close contacts or healthcare providers after direct contact with injected lesions or body fluids
Følgende bivirkninger er indberettet for patienter, der har fået Imlygic:
The following side effects have been reported in patients receiving Imlygic:
• Patienter med svækket immunsystem (immunkompromitterede patienter), der behandles med IMLYGIC og lider af samtidig infektion
• Patients with a weakened immune system (immunocompromised patients) treated with IMLYGIC and suffering from concomitant infection
Hvis du har en tumor i halsen, vil din læge muligvis advare dig om, at dine luftveje kan blive sammenpressede under behandling med Imlygic.
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.
Prioritering af læsioner, der skal injiceres
Prioritisation of lesions to be injected
• Symptomatisk herpetisk infektion som følge af latens og reaktivering af IMLYGIC eller herpes (vildtype-HSV-1) hos patienterne
• Symptomatic herpetic infection due to latency and reactivation of IMLYGIC or herpes (wildtype HSV-1) in patients
Det er dog ikke nødvendigt at justere dosis til patienter med lever- eller nyresvækkelse.
However, no adjustment in dosage is necessary for patients with hepatic or renal impairment.
Engangshætteglas uden et gennemsigtigt plasthylster
Single-use vial without a clear plastic sleeve
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.
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).
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.
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.
Der kan opstå forkølelsessår eller en mere alvorlig herpes-infektion under eller efter behandling med Imlygic.
Cold sores or a more serious herpes infection may occur during or after treatment with Imlygic.