natgillin/translations-raw huggingface dataset:
1 uge (7 dage) 
1 week (7 days)
Følgende krav skal være opfyldt, inden produktet kan udleveres: 
The following requirements need to be fulfilled before the product is dispensed:
Fortsæt, indtil hele dosen er jævnt og fuldstændig fordelt. 
Continue until the full dose is evenly and completely dispersed.
Dette lægemiddel indeholder genetisk modificerede organismer. 
This medicine contains genetically modified organisms.
Disse symptomer forsvinder generelt inden for de første 72 timer efter behandling. 
These symptoms generally resolve within the first 72 hours after treatment.
30. juni 2021 
30th June, 2021
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 2.1 Generel beskrivelse 
QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
Autoimmune reaktioner 
Autoimmune reactions
Læsionsstørrelse (længste dimension) 
Lesion size (longest dimension)
Metabolisme/elimination 
Metabolism/elimination
Størstedelen af patienterne (98%) var kaukasere. 
The majority of patients, 98%, were caucasian.
Den anden injektion vil blive givet 3 uger efter den første. 
Your second injection will be given 3 weeks after the first injection.
Alle patienter 
All patients
Patienter, der opnåede respons efter 12 måneders behandling, kunne fortsætte behandlingen i op til yderligere 6 måneder. 
Patients experiencing a response at 12 months of treatment could continue treatment for up to an additional 6 months.
Derefter vil du få injektioner hver 2. uge, så længe du stadig har tumoren (tumorerne). 
After that, you will receive injections every 2 weeks for as long as you have the tumour(s).
ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC 
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
HSV-1-seronegative patienter 
HSV-1 seronegative patients
Samlet responsrate (% CR, % PR) 
Overall response rate (% CR, % PR)
Tidligere behandlede patienter 
Previously treated patients
Kaplan-Meier procent i live 
Kaplan-Meier Percent Alive
Spørg din læge til råds, hvis du: 
Ask your healthcare professional for advice if you:
Der blev ikke observeret nogen overordnede forskelle i sikkerhed eller virkning mellem ældre patienter (≥ 65 år) og yngre voksne patienter. 
No overall differences in safety or efficacy were observed between elderly (≥ 65 years old) and younger adult patients.
Tidligere systemisk behandling af melanom var tilladt, men ikke obligatorisk. 
Previous systemic treatment for melanoma was allowed but not required.
Uddannelsesprogrammet har til formål at informere om vigtige risici, der er forbundet med IMLYGIC: 
The educational programme is aimed to inform about important risks associated with IMLYGIC:
2 uger efter foregående behandling 
2 weeks after previous treatment
Undervisningsmaterialet til læger skal indeholde: 
The physician educational material should contain:
Blandt de Imlygic-behandlede respondenter var 56 (72%) responser stadig i gang på tidspunktet for den primære analyse. 
Among the Imlygic-treated responders, 56 (72%) responses were still ongoing at the time of primary analysis.
Den maksimale dosis Imlygic, som er sikker at administrere, er ikke fastlagt. 
The maximum dose of Imlygic that can be safely administered has not been determined.
Imlygic kan være skadeligt for dit ufødte barn. 
Imlygic may harm your unborn baby.
- hvis din læge har fortalt dig, at du har et kraftigt svækket immunsystem. 
- if your healthcare professional has told you that you have a severely weakened immune system.
Der er indberettet cellulitis og systemisk bakteriel infektion. 
Cellulitis and systemic bacterial infection have been reported.
Måneder 
Months
A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIG FOR BATCHFRIGIVELSE 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Dette svarer til 1,5% af den anbefalede maksimale daglige indtagelse af natrium for en voksen. 
This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
4.5 Interaktion med andre lægemidler og andre former for interaktion Der er ikke udført interaktionsstudier med Imlygic. 
4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been conducted with Imlygic.
Imlygic kan forårsage autoimmune reaktioner (en overreaktion i kroppens immunsystem). 
Imlygic may cause autoimmune reactions (an over-reaction of the body's immune system).
Gravide kvinder, nyfødte børn og immunkompromitterede personer bør ikke eksponeres for potentielt kontaminerede materialer. 
Pregnant women, neonates, and immunocompromised individuals should not be exposed to potentially contaminated materials.
Det kontrollerede distributionsprogram har til formål at administrere produktleverandørkæden for at sikre, at kravene til kølig opbevaring er opfyldt, og at kontrollere distributionen af IMLYGIC til kompetente centre og til patienterne. 
The controlled distribution programme is aimed to manage the product supply chain to ensure that cold storage requirements are observed and to control the distribution of IMLYGIC to qualified centres and up to the patients.
BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET 
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnummer registreres tydeligt (eller angives) i patientjournalen. 
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Imlygic anbefales ikke til børn og unge, da man ikke kender Imlygics virkninger hos personer under 18 år. 
Imlygic is not recommended for children and adolescents since the effects of Imlygic in people younger than 18 years old are not known.
Tid indtil respons (median) 
Time to response (median)
Det anogenitale område 
Anogenital area
Opbevares i den originale karton for at beskytte mod lys. 
Store in the original carton in order to protect from light.
Overordnet var otteoghalvfems procent (98%) af disse indberettede bivirkninger milde eller moderate i styrke. 
Overall, ninety eight per cent (98%) of these adverse reactions reported were mild or moderate in severity.
Medianvarigheden af eksponering for Imlygic var 23 uger (5,3 måneder). 
The median duration of exposure to Imlygic was 23 weeks (5.3 months).
Behandling med talimogen laherparepvec skal initieres og overvåges af en kvalificeret læge med erfaring inden for cancerbehandling. 
Treatment with talimogene laherparepvec should be initiated and supervised by a qualified physician experienced in the treatment of cancer.
• Prioritér injektion af resterende læsioner baseret på læsionsstørrelse, indtil maksimal injektionsvolumen er nået. 
• Prioritise injection of remaining lesions based on lesion size until maximum injection volume is reached.
Antal patienter med risiko 
Number of Patients at Risk
Utilsigtet spredning af Imlygic til dig selv eller andre 
Accidental spread of Imlygic to yourself and others
• har mistanke om, at du er gravid 
• think you may be pregnant
o Instruktioner til, hvordan man skal forholde sig efter utilsigtet overførsel. 
o Instruction on how to behave after accidental transmission.
Den additive virkning af samtidigt administrerede produkter indeholdende sorbitol (eller fructose) og indtagelse af sorbitol i kosten (eller fructose) bør tages i betragtning. 
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
• Lavt antal røde blodlegemer (anæmi) 
• Low red blood cell numbers (anaemia)
Disse hændelser blev indberettet hyppigere inden for perioden med de første 6 behandlinger - især hos patienter, der var HSV-1-negative ved baseline. 
These events were reported more frequently within the period of the first 6 treatments, particularly in patients who were HSV-1 negative at baseline.
Imlygic indeholder natrium og sorbitol 
Imlygic contains sodium and sorbitol
Talimogen laherparepvec er følsomt over for acyclovir. 
Talimogene laherparepvec is sensitive to acyclovir.
• Læg pres på injektionsstedet med en steril serviet i mindst 30 sekunder. 
• Apply pressure to the injection site with a sterile gauze for at least 30 seconds.
Der blev ikke observeret nogen neuropatologi eller uønskede neurologiske virkninger. 
No neuropathology or adverse neurological effects were observed.
De mandlige patienter udgjorde 57% af studiepopulationen, og 70% af patienterne havde ECOG performance status 0 ved baseline. 
Male patients comprised 57% of study population and 70% of patients were baseline ECOG 0 performance status.
• Imlygic må ikke nedfryses igen, når først det er optøet. 
• Imlygic must not be refrozen once it has thawed.
90% af de patienter, der blev behandlet med Imlygic, fik influenza-lignende symptomer. 
90% of patients treated with Imlygic experienced influenza-like symptoms.
Det primære endemål var varig responsrate (DRR) [defineret som procentdelen af patienter med komplet respons (CR) eller partiel respons (PR), opretholdt kontinuerligt i mindst 6måneder] pr. blindet central gennemgang. 
The primary endpoint was durable response rate (DRR) [defined as the percent of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of 6 months] per blinded central review.
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.