FrancophonIA/ELRC3.0 huggingface dataset:
English: No effects on the breastfed newborn/infant are anticipated as Picato is not absorbed systemically.
Danish: Der forventes ingen påvirkning af nyfødte/spædbørn, ammet af mødre i behandling, da Picato ikke absorberes systemisk.
English: If more than half of the treatment area is located in the upper part of the neck, Picato 150 mcg/g gel should be used at the posology for face and scalp.
Danish: Hvis mere end halvdelen af behandlingsområdet er placeret på den øverste del af halsen, bør doseringen med Picato 150 mikrogram/g gel for ansigt og hovedbund anvendes.
English: Please contact your doctor or pharmacist if you experience severe skin reactions.
Danish: Tal med lægen eller apotekspersonalet, hvis du oplever alvorlige hudreaktioner.
English: Cutaneous use
Danish: Kutan anvendelse
English: Uncommon side effects, may affect up to 1 in 100 people:
Danish: Ikke almindelige bivirkninger, kan påvirke op til 1 ud af 100 personer:
English: Application site pruritus
Danish: Pruritus på påføringsstedet
English: On the treatment area: - Tingling or numbness (paraesthesia) - Open sores (ulcer) - Change in skin colour (pigmentation change)
Danish: På behandlingsområdet: - Snurren eller følelsesløshed (paræstesi) - Åbne sår (ulkus) - Ændring i hudfarve (pigmenteringsændring) - Varme
English: On the treatment area: - Tingling or numbness (paraesthesia) - Open sores (ulcer) - Discharge (secretion) of fluid - Change in skin colour (pigmentation change)
Danish: På behandlingsområdet: - Snurren eller følelsesløshed (paræstesi) - Åbne sår (ulkus) - Udsivning (sekretion) af væske - Ændring i hudfarve (pigmenteringsændring)
English: Picato 150 micrograms/gram gel
Danish: Picato 150 mikrogram/gram gel
English: If more than half of the treatment area is located in the lower part of the neck, Picato 500 mcg/g gel should be used at the posology for trunk and extremities.
Danish: Hvis mere end halvdelen af behandlingsområdet er placeret på den nedre del af halsen, bør doseringen med Picato 500 mikrogram/g gel for krop og ekstremiteter anvendes.
English: Eye exposure
Danish: Øjeneksponering
English: - Treatment of actinic keratosis on the face and scalp is one tube of Picato 150 micrograms/g gel (containing 70 micrograms of ingenol mebutate) once a day for 3 days in a row.
Danish: - Behandling af aktinisk keratose i ansigtet og hovedbunden er én tube Picato 150 mikrogram/g gel (indeholder 70 mikrogram ingenolmebutat) én gang om dagen 3 dage i træk.
English: Other side effects: - Eye pain - Injury or irritation to the surface of the eye (cornea, conjunctiva) following accidental exposure
Danish: Andre bivirkninger: - Øjensmerte - Skade eller irritation på overfladen af øjet (hornhinde, bindehinde) efter utilsigtet eksponering
English: Vehicle (n=20)
Danish: Vehikel (n=20)
English: Partial Clearance Rateb (≥ 75%)
Danish: Delvis helingb (≥ 75%)
English: Other side effects: - Injury or irritation to the surface of the eye (cornea, conjunctiva) following accidental exposure
Danish: Andre bivirkninger: - Skade eller irritation på overfladen af øjet (hornhinde, bindehinde) efter utilsigtet eksponering
English: Picato 150 mcg/g gel is available in a carton containing 3 tubes with 0.47 g of gel each.
Danish: Picato 150 mikrog/g gel findes i æsker med 3 tuber á 0,47 g gel.
English: SCC in the treatment area was reported in no patients (0 of 184 patients previously treated with ingenol mebutate gel) in the three prospective, observational long term 1 year follow-up studies.
Danish: I tre prospektive, observationelle langtids-1-års-opfølgningsstudier blev SCC ikke rapporteret i behandlingsområdet (0 ud af 184 patienter, der tidligere er behandlet med ingenolmebutat-gel).
English: If you use more Picato than you should
Danish: Hvis du har brugt for meget Picato
English: If you are treating your hands you should only wash the fingertip which you used for applying the gel.
Danish: Hvis du behandler dine hænder, skal du kun vaske fingerspidsen, som du har brugt til påføring af gelen.
English: On the treatment area: - Scarring
Danish: På behandlingsområdet: - Kløe (pruritus)
English: Picato 500 mcg/g gel is available in a carton containing 2 tubes with 0.47 g of gel each.
Danish: Picato 500 mikrog/g gel findes i æsker med 2 tuber á 0,47 g gel.
English: Keratoacanthoma, basal cell carcinoma, Bowen's disease, squamous cell carcinoma Reports of keratoacanthoma, basal cell carcinoma, Bowen's disease, squamous cell carcinoma occurring within the treatment area with a time to onset ranging from weeks to months following use of ingenol mebutate gel have been received from a post-authorisation clinical trial (see section 5.1) and post-marketing.
Danish: 5.1) og efter markedsføring er der afrapporteret keratoakantom, basalcellekarcinom, Bowens sygdom og planocellulært karcinom påvist indenfor behandlingsområdet uger til måneder efter brug af ingenolmebutat gel.
English: - Wash your hands with soap and water immediately after applying the gel, and also in between administrations if prescribed two different strengths for two different areas.
Danish: - Vask dine hænder med sæbe og vand straks efter påføring af gelen samt mellem påføringer,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE 150 mcg/g GEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER TUBE 150 mikrog/g GEL
English: The most frequently occurring side effects when treating the trunk and extremities: Very common side effects on the treatment area, may affect more than 1 in 10 people:
Danish: De hyppigst forekommende bivirkninger ved behandling af kroppen og ekstremiteter: Meget almindelige bivirkninger på behandlingsområdet, kan påvirke mere end 1 ud af 10 personer:
English: The most frequently occurring side effects when treating the face and scalp: Very common side effects on the treatment area, may affect more than 1 in 10 people:
Danish: De hyppigst forekommende bivirkninger ved behandling af ansigt og hovedbund: Meget almindelige bivirkninger på behandlingsområdet, kan påvirke mere end 1 ud af 10 personer:
English: Actinic keratosis on the trunk and extremities in adults One tube of Picato 500 mcg/g gel (containing 235 mcg ingenol mebutate) should be applied once daily to the affected area for 2 consecutive days.
Danish: Aktinisk keratose på kroppen og ekstremiteter hos voksne Én tube Picato 500 mikrog/g gel (indeholder 235 mikrog ingenolmebutat) skal én gang dagligt påføres det angrebne område 2 dage i træk.
English: Application site ulcer
Danish: Ulcus på påføringsstedet
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE 500 mcg/g GEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER TUBE 500 mikrog/g GEL
English: What Picato is and what it is used for What you need to know before you use Picato How to use Picato
Danish: Det skal du vide, før du begynder at bruge Picato Sådan skal du bruge Picato Bivirkninger
English: How to use Picato
Danish: Sådan skal du bruge Picato
English: See section 4.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN 16.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 150 mcg/g GEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 150 mikrog/g GEL
English: Tabulated list of adverse reactions
Danish: Tabel med oversigt over bivirkninger
English: On the treatment area:
Danish: På behandlingsområdet: - Ardannelse
English: Other possible side effects when treating the face and scalp: Common side effects, may affect up to 1 in 10 people:
Danish: Andre mulige bivirkninger ved behandling af ansigt og hovedbund: Almindelige bivirkninger, kan påvirke op til 1 ud af 10 personer:
English: Other possible side effects when treating the trunk and extremities: Common side effects, may affect up to 1 in 10 people:
Danish: Andre mulige bivirkninger ved behandling af kroppen og ekstremiteter: Almindelige bivirkninger, kan påvirke op til 1 ud af 10 personer:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 500 mcg/g GEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 500 mikrog/g GEL
English: Picato 500 micrograms/g gel ingenol mebutate
Danish: Picato 500 mikrogram/g gel ingenolmebutat
English: Picato 500 mcg/g (n=226 )
Danish: Picato 500 mikrog/g (n=226 )
English: Picato 150 mcg/g (n=277)
Danish: Picato 150 mikrog/g (n=277 )
English: Picato 150 mcg/g (n=277 )
Danish: Picato 150 mikrog/g (n=277)
English: Application site pain***
Danish: Smerter på påføringsstedet*** Meget almindelig
English: Vehicle (n=270 )
Danish: Vehikel (n=270)
English: Vehicle (n=270)
Danish: Vehikel (n=270 )
English: Picato 150 micrograms/g gel ingenol mebutate
Danish: Picato 150 mikrogram/g gel ingenolmebutat
English: Vehicle (n=232 )
Danish: Vehikel (n=232 )
English: LEO Pharma S.p.A Tel: +39 06 52625500
Danish: Tel: +39 06 52625500
English: Each tube contains 235 micrograms of ingenol mebutate in 0.47 g of gel.
Danish: Hver tube indeholder 235 mikrog ingenolmebutat i 0,47 g gel.
English: Chest
Danish: Amning
English: In a double-blind, vehicle-controlled study to evaluate systemic exposure, Picato 500 mcg/g, from 4 tubes, was applied to a 100 cm2 contiguous treatment area daily for 2 consecutive days.
Danish: Picato 500 mikrog/g, fra 4 tuber blev påført dagligt i 2 dage i træk på et 100 cm2 sammenhængende behandlingsområde.
English: Each tube contains 70 micrograms of ingenol mebutate in 0.47 g of gel.
Danish: Hver tube indeholder 70 mikrog ingenolmebutat i 0,47 g gel.
English: One tube of Picato 150 mcg/g gel (containing 70 mcg ingenol mebutate) should be applied once daily to the affected area for 3 consecutive days.
Danish: Aktinisk keratose i ansigtet og hovedbunden hos voksne Én tube Picato 150 mikrog/g gel (indeholder 70 mikrog ingenolmebutat) skal én gang dagligt påføres det angrebne område 3 dage i træk.
English: Each gram of gel contains 150 micrograms of ingenol mebutate.
Danish: Hvert gram gel indeholder 150 mikrogram ingenolmebutat.
English: Each gram of gel contains 500 micrograms of ingenol mebutate.
Danish: Hvert gram gel indeholder 500 mikrogram ingenolmebutat.
English: Eye pain
Danish: Se pkt.
English: Picato 500 mcg/g gel ingenol mebutate Cutaneous use
Danish: Picato 500 mikrog/g gel ingenolmebutat Kutan anvendelse
English: Complete Clearance
Danish: Total heling
English: How to store Picato
Danish: Peeling på påføringsstedet
English: Each gram of gel contains 150 mcg of ingenol mebutate.
Danish: Hvert gram gel indeholder 150 mikrog ingenolmebutat.
English: Complete Clearance Ratea
Danish: Total helinga
English: Picato 150 mcg/g gel ingenol mebutate Cutaneous use
Danish: Picato 150 mikrog/g gel ingenolmebutat Kutan anvendelse
English: Each gram of gel contains 500 mcg of ingenol mebutate.
Danish: Hvert gram gel indeholder 500 mikrog ingenolmebutat.
English: Back of Hand
Danish: Ansigt Hovedbund
English: Eye disorders*
Danish: Øjne*
English: 29 August 2014
Danish: den 29. august 2014
English: Conditions to the marketing authorisations
Danish: Betingelser for markedsføringstilladelser
English: Within 3 months after EC decision
Danish: senest 3 måneder efter Kommissionens beslutning
English: Annex IV Conditions to the marketing authorisations
Danish: Bilag IV Betingelser for markedsføringstilladelser
English: Final study report by:
Danish: Endelig rapport over undersøgelsen skal foreligge inden:
English: Outline of the education materials within 3 months after EC decision
Danish: Skitse til informationsmateriale senest tre måneder efter Kommissionens beslutning
English: This will be included in the risk management plan, highlighting the risks and warnings of thromboembolism (by e.g. a checklist, to be implemented at national level).
Danish: Dette skal indgå i risikostyringsplanen og fremhæve risici og advarsler vedrørende tromboemboli (f.eks. ved en tjekliste, der gennemføres på nationalt plan).
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaten sikrer, at indehaveren af markedsføringstilladelsen opfylder følgende vilkår:
English: The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Danish: I forbindelse med indsendelsen af risikostyringsplanen forelægger indehaveren af markedsføringstilladelsen en protokol til en undersøgelse af lægemiddelanvendelse, hvis formål er bedre karakterisering af typisk ordinationspraksis for disse lægemidler hos repræsentative grupper af ordinerende læger og fastlæggelse af hovedgrundene til ordination.
English: The MAH(s) should provide within the risk management plan Educational material for prescribers and patients.
Danish: Indehaverne af markedsføringstilladelse forelægger sammen med risikostyringsplanen informationsmateriale til ordinerende læger og patienter.
English: The MAH(s) should provide a protocol of a PASS within the risk management plan submission, to evaluate the effectiveness of the risk minimisation activities.
Danish: Indehaverne af markedsføringstilladelse skal forelægge en protokol til en sikkerhedsundersøgelse efter markedsføring (PASS) til vurdering af effektiviteten af risikominimeringstiltagene.
English: The MAH(s) should submit the core elements (including outline of DUS, PASS and educational materials) of a risk management plan in EU format.
Danish: Indehaverne af markedsføringstilladelse forelægger kerneelementerne til en risikostyringsplan i EU-format (herunder undersøgelse af lægemiddelanvendelse, sikkerhedsundersøgelse efter godkendelse samt informationsmateriale)
English: The MAH(s) should submit the next PSUR by:
Danish: Indehaverne af markedsføringstilladelse indsender den næste periodiske opdaterede sikkerhedsindberetning senest:
English: This summary was last updated on 12-2017.
Danish: Denne oversigt blev sidst ajourført i 12-2017.
English: However, more data are needed to fully understand the medicine's effectiveness.
Danish: Der er dog behov for flere data for fuldt ud at forstå lægemidlets virkning.
English: The recommended dose depends on the patient's weight and height.
Danish: Den anbefalede dosis afhænger af patientens vægt og højde.
English: In addition, the company will report on the 5-year survival rates of patients who took part in studies.
Danish: Derudover vil virksomheden indberette 5 års-overlevelsesrater for de patienter, der har deltaget i undersøgelserne.
English: The company will also perform tests to obtain more information on how the medicine is processed by the body and how the immune system responds to the medicine.
Danish: Virksomheden vil også gennemføre undersøgelser for at fremskaffe flere oplysninger om, hvordan kroppen behandler lægemidlet, og hvordan immunsystemet reagerer på lægemidlet.
English: Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Danish: Hvert år gennemgår Det Europæiske Lægemiddelagentur alle nye oplysninger, der måtte foreligge, og ajourfører om nødvendigt dette sammendrag.
English: Qarziba has been authorised under ‘exceptional circumstances'.
Danish: Qarziba er godkendt under "særlige omstændigheder".
English: This is a summary of the European public assessment report (EPAR) for Qarziba.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Qarziba.
English: Each course of treatment with the medicine is given for 5 or 10 days every 35 days.
Danish: Behandling med lægemidlet gives i forløb a 510 dage hver 35. dag.
English: The doctor may need to reduce or delay doses if certain side effects occur, or stop treatment altogether if side effects are severe.
Danish: Lægen kan være nødt til at reducere eller udsætte doserne, hvis der opstår visse bivirkninger, eller helt standse behandlingen, hvis bivirkningerne er alvorlige.
English: If the neuroblastoma has come back after previous treatment, it should be stabilised (stopped from getting worse) before treatment with Qarziba is started.
Danish: Hvis neuroblastomet er vendt tilbage efter tidligere behandling, bør det stabiliseres (forhindres i at blive værre), før behandling med Qarziba påbegyndes.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dinutuximab beta Apeiron on 8 May 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dinutuximab beta Apeiron den 8. maj 2017.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted the lack of treatment options to prevent high-risk neuroblastoma from coming back.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konstaterede, at der manglede behandlingsmuligheder til at forhindre højrisiko-neuroblastom i at vende tilbage.
English: Although treatment with Qarziba can cause serious side effects, the safety of the medicine is considered acceptable.
Danish: Selvom behandling med Qarziba kan medføre alvorlige bivirkninger, vurderes sikkerheden ved lægemidlet at være acceptabel.
English: At the start of treatment some of these patients had no sign of neuroblastoma and some still had some sign of the disease.
Danish: I starten af behandlingen havde nogle af disse patienter ingen tegn på neuroblastom, mens andre stadig havde tegn på sygdommen.
English: • patients who have had some improvement with previous treatments, which included blood stem cell transplantation (a transplant of blood-producing cells);
Danish: • patienter, som har oplevet en vis bedring med tidligere behandlinger, der omfattede transplantation af blodstamceller (transplantation af bloddannende celler)
English: Qarziba must not be used in patients with severe or widespread graft-versus-host disease (when transplanted cells attack the body).
Danish: Qarziba må ikke anvendes hos patienter med alvorlig eller udbredt Graft-versus-Host-sygdom (en tilstand, hvor transplanterede celler angriber kroppen).
English: What measures are being taken to ensure the safe and effective use of Qarziba?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Qarziba?
English: It must be given in hospital by a doctor or nurse who can manage severe allergic reactions and who has full resuscitation services immediately available if needed.
Danish: Behandlingen skal gives på et hospital af en læge eller sygeplejerske, der kan behandle alvorlige allergiske reaktioner, og som har adgang til livreddende hjælp, hvis det skulle blive nødvendigt.
English: Because the number of patients with neuroblastoma is low, the disease is considered ‘rare', and Qarziba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 November 2012.
Danish: Da antallet af patienter med neuroblastom er lavt, betragtes sygdommen som "sjælden", og Qarziba blev udpeget som "lægemiddel til sjældne sygdomme" den 8. november 2012.
English: Therefore the CHMP decided that Qarziba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP konkluderede derfor, at fordelene ved Qarziba overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
English: The most common side effects with Qarziba (which may affect more than 7 in 10 people) are pyrexia (fever) and pain.
Danish: De hyppigste bivirkninger ved Qarziba (som kan forekomme hos mere end 7 ud af 10 personer) er feber og smerter.
English: Other information about Qarziba
Danish: Andre oplysninger om Qarziba
English: When Qarziba attaches to the neuroblastoma cells, it makes them a target for the body's immune system (the body's natural defences), which then kills the cancer cells.
Danish: Når Qarziba binder sig til neuroblastomcellerne, gør det dem til et mål for kroppens immunsystem (kroppens naturlige forsvar), som så slår kræftcellerne ihjel.
English: Since Qarziba has been approved under exceptional circumstances, the company that markets Qarziba will monitor the safety of the medicine using a patient registry and provide yearly updates.
Danish: Da Qarziba er godkendt under særlige omstændigheder, skal den virksomhed, der markedsfører Qarziba, overvåge sikkerheden ved Qarziba gennem et patientregister og fremlægge årlige opdateringer.
English: dinutuximab beta
Danish: Qarziba dinutuximab beta
English: The full EPAR for Qarziba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Qarziba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The name of the product was changed to Dinutuximab beta EUSA on 4 August 2017 and to Qarziba on 27 November 2017.
Danish: Lægemidlets navn blev ændret til Dinutuximab beta EUSA den 4. august 2017 og til Qarziba den 27. november 2017.
English: Qarziba is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a structure called GD2 that is present in high amounts on the surface of neuroblastoma cells, but not normal cells.
Danish: Qarziba er et monoklonalt antistof (en type protein), der er designet til at genkende og binde til en struktur, der hedder GD2, som findes i store mængder på overfladen af neuroblastomceller, men ikke normale celler.
English: This is because it has not been possible to obtain complete information about Qarziba for ethical reasons.
Danish: Det skyldes, at det af etiske hensyn ikke har været muligt at indhente fyldestgørende oplysninger om Qarziba.
English: Qarziba is given as an infusion (drip) into a vein.
Danish: Qarziba gives som infusionsvæske (drop) i en vene.
English: As dinutuximab is a recommended treatment for high-risk neuroblastoma, it would not be ethical to carry out a trial in which some patients were given placebo (a dummy treatment).
Danish: Da dinutuximab er en anbefalet behandling for højrisiko-neuroblastom, vil det ikke være etisk forsvarligt at gennemføre et forsøg, hvor nogle patienter får placebo (et uvirksomt stof).
English: Previously known as Dinutuximab beta Apeiron and Dinutuximab beta EUSA.
Danish: Tidligere kendt som Dinutuximab beta Apeiron og Dinutuximab beta EUSA.
English: Qarziba is used together with another medicine called interleukin-2 (aldesleukin) in some cases where previous treatments have not worked well enough.
Danish: Qarziba anvendes sammen med et andet lægemiddel, der hedder interleukin-2, (aldesleukin) i tilfælde, hvor tidligere behandling ikke har virket godt nok.
English: It is given for a total of 5 courses.
Danish: Der gives i alt 5 behandlingsforløb.
English: The medicine contains the active substance dinutuximab beta.
Danish: Lægemidlet indeholder det aktive stof dinutuximab beta.
English: Why is Qarziba approved?
Danish: Hvorfor blev Qarziba godkendt?
English: What is Qarziba and what is it used for?
Danish: Hvad er Qarziba, og hvad anvendes det til?
English: It is used in 2 groups of patients who have high-risk neuroblastoma (which has a high chance of coming back):
Danish: Det anvendes hos to grupper af patienter, der har højrisiko-neuroblastom (dvs. de har en høj risiko for, at kræften vender tilbage):
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Qarziba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Qarziba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For more information about treatment with Qarziba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Qarziba, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Qarziba.
Danish: Det er ikke en praktisk vejledning i, hvordan Qarziba bør anvendes.