FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inductos on 9 September 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Inductos den 9. september 2002.
English: • patients who are still growing;
Danish: • patienter, som stadig vokser
English: The full EPAR for Inductos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Inductos findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Inductos.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Inductos.
English: A risk management plan has been developed to ensure that Inductos is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Inductos anvendes så sikkert som muligt.
English: • treating a fracture that is related to a disease such as Paget's disease or cancer.
Danish: • behandling af et brud, der er relateret til en sygdom som f.eks. Pagets sygdom eller kræft.
English: Other information about Inductos
Danish: Andre oplysninger om Inductos
English: After two years, 57% of the patients treated with Inductos (69 out of 122) had responded to treatment, compared with 59% of the patients treated with a bone graft (78 out of 133).
Danish: Efter to år havde 57 % af de patienter, som blev behandlet med Inductos (69 af 122), responderet på behandlingen, sammenlignet med 59 % af de patienter, som fik et knogletransplantat (78 af 133).
English: Inductos should be used by a qualified surgeon.
Danish: Inductos skal anvendes af en kvalificeret kirurg.
English: In addition, the company that markets Inductos will make sure that educational material is available in all Member States for all healthcare professionals expected to use the medicine.
Danish: Derudover vil den virksomhed, der markedsfører Inductos, sørge for, at der i samtlige medlemsstater stilles oplysningsmateriale til rådighed for alle de sundhedsmedarbejdere, der forventes at anvende lægemidlet.
English: • patients diagnosed with or being treated for cancer;
Danish: • patienter, som har fået diagnosticeret kræft, eller som behandles for kræft
English: This material will include information on the risk of heterotopic ossification and the potential risk of medication errors and incorrect use of Inductos.
Danish: Dette materiale vil omfatte oplysninger om risikoen for heterotopisk ossifikation og den potentielle risiko for fejlmedicinering og ukorrekt brug af Inductos.
English: What measures are being taken to ensure the safe and effective use of Inductos?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Inductos?
English: For more information about treatment with Inductos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Inductos, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Inductos.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Inductos skal anvendes.
English: The newly formed bone grows into the matrix, which then degrades.
Danish: Den nydannede knogle vokser ind i matrixen, som derefter nedbrydes.
English: Inductos is a kit for implant.
Danish: Inductos er et sæt til implantation.
English: Inductos is used together with approved medical devices that correct the position of the spine.
Danish: Inductos bruges sammen med godkendt medicinsk udstyr, som korrigerer rygsøjlens stilling.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Inductos are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Inductos opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: • patients with an inadequate blood supply at the fracture site;
Danish: • patienter med utilstrækkelig blodtilførsel på brudstedet
English: Of the patients in the standard care group, 46% needed a further intervention within a year to repair their fracture, while the proportion was 26% for those also receiving Inductos.
Danish: 46 % af patienterne i den gruppe, som fik standardbehandling, havde inden for et år behov for yderligere intervention for at reparere bruddet, sammenlignet med 26 % af de patienter, som også blev behandlet med Inductos.
English: Inductos is made up into a solution before use, applied to the matrix and left for at least 15 minutes (but no more than two hours).
Danish: Inductos blandes til en opløsning før brug, påføres matrixen og skal sidde i mindst 15 minutter (men højst i to timer).
English: For lower back spine fusion, the damaged disc between the vertebrae is removed and replaced with one or more medical devices and Inductos.
Danish: I forbindelse med fusion i den nedre del af rygsøjlen fjernes den ødelagte diskus mellem ryghvirvlerne og erstattes med en eller flere medicinske anordninger og Inductos.
English: Inductos must not be used in the following situations:
Danish: Inductos må ikke anvendes til:
English: The matrix is then cut, if needed, to the correct size before use.
Danish: Hvis det er nødvendigt, skæres matrixen til i den rigtige størrelse, inden den implanteres.
English: Additional studies and analysis of data from the published literature showed that Inductos was more effective than bone graft at inducing fusion of the lower back vertebrae, irrespective of the surgical technique or the type of approved medical device used to hold the bone in position.
Danish: Yderligere undersøgelser og analyse af data fra den offentliggjorte litteratur viste, at Inductos var mere effektivt end knogletransplantat til at fremme en fusion i den nedre del af rygsøjlen, uanset operationsteknikken eller typen af det godkendte medicinske udstyr, der blev anvendt til at fastholde knoglen i den rigtige stilling.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inductos, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Inductos, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The medical devices fix the position of the vertebrae, and Inductos encourages bone to grow between the two vertebrae to join them permanently in the correct position.
Danish: De medicinske anordninger fastlåser ryghvirvlernes stilling, og Inductos fremmer knogledannelsen mellem de to ryghvirvler, så de vokser sammen permanent i den rigtige stilling.
English: Inductos has been studied in 450 patients with a fractured tibia.
Danish: Inductos er blevet undersøgt hos 450 patienter med skinnebensbrud.
English: It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Danish: Det er en kopi af proteinet knoglemorfogenetisk protein 2 (BMP-2), der produceres naturligt i kroppen og fremmer dannelsen af nyt knoglevæv.
English: The replacement dibotermin alfa acts in same way as BMP-2 produced naturally by the body.
Danish: Det supplerende dibotermin alfa fungerer på samme måde som BMP-2, der produceres naturligt i kroppen.
English: The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (collagen sponge).
Danish: Sættet består af et pulver, der indeholder det aktive stof dibotermin alfa, en solvens og en matrix (kollagensvamp).
English: In this type of surgery, Inductos can be used instead of an autogenous bone graft (bone taken from one part of a person's body and placed in another part of the body).
Danish: Ved denne form for operation kan Inductos benyttes i stedet for et autogent knogletransplantat (knoglevæv, der er taget fra en persons kropsdel og overført til en anden kropsdel).
English: Inductos has been studied in 279 patients having lower back spine fusion.
Danish: Inductos er blevet undersøgt hos 279 patienter, der har fået foretaget en fusion i den nedre del af rygsøjlen.
English: The most common side effects with Inductos (seen in more than 1 patient in 10) are radiculopathic events (problems occurring at or near the root of the nerve, along the spine, resulting in pain, weakness, numbness, or difficulty controlling specific muscles) when used in spine surgery, and localised infection when used in tibia fracture surgery.
Danish: De hyppigste bivirkninger ved Inductos (som optræder hos flere end 1 ud af 10 patienter) er radikulopatiske hændelser (problemer i eller tæt på nerven langs rygsøjlen, som medfører smerter, kraftesløshed, følelsesløshed eller besvær med at styre bestemte muskler), når det anvendes i forbindelse med operation i rygsøjlen, samt lokal infektion, når det anvendes ved operation af skinnebensbrud.
English: Patients undergoing treatment with Inductos may be at risk of heterotopic ossification (the growth of bone in abnormal places like soft tissue); this risk is considered to be manageable with the proposed risk minimisation measures.
Danish: Patienter, der behandles med Inductos, kan have risiko for heterotopisk ossifikation (knoglevækst i unormale områder, såsom bløddele), men risikoen anses for at være håndterbar med de foreslåede risikominimeringsforanstaltninger.
English: The CHMP considered that Inductos is effective in single-level lumbar spine fusion as a substitute for autogenous bone graft and for the treatment of acute tibia fractures in adults, as an adjunct to standard care.
Danish: CHMP fandt, at Inductos er effektivt ved lumbal spinalfusion i et enkelt niveau som erstatning for et autogent knogletransplantat samt til behandling af akutte skinnebensbrud hos voksne som et supplement til standardbehandling.
English: • patients with an active infection at the surgery site;
Danish: • patienter med en aktiv infektion på operationsstedet
English: Inductos was compared with standard care.
Danish: Inductos blev sammenlignet med standardbehandling.
English: When implanted, dibotermin alfa stimulates the bone tissue around the matrix to make new bone.
Danish: Når det implanteres, stimulerer dibotermin alfa dannelsen af nyt knoglevæv omkring matrixen, så der dannes en ny knogle.
English: What is the risk associated with Inductos?
Danish: Hvilken risiko er der forbundet med Inductos?
English: This is a type of surgery used to relieve back pain due to a damaged disc where the disc between two vertebrae (the bones in the spine) is removed and the vertebrae are fused (joined) together.
Danish: Dette er en operation, der benyttes til at lindre rygsmerter som følge af en ødelagt diskus, hvor diskussen mellem to ryghvirvler (knoglerne i rygsøjlen) fjernes, og ryghvirvlerne fusioneres (sættes sammen).
English: The main measure of effectiveness was the number of patients who did not need further treatment for their fractured tibia (such as a bone graft or changes to the nail used to fix the bones together) in the year following surgery.
Danish: Virkningen blev hovedsagelig bedømt på antallet af patienter, som ikke havde behov for yderligere behandling af skinnebensbruddet (f.eks. et knogletransplantat eller ændringer i forbindelse med det søm, der blev brugt til at sætte knoglerne sammen) i året efter operationen.
English: Inductos is used in addition to standard treatment and care.
Danish: Inductos anvendes som et supplement til standardbehandling og -pleje.
English: The main measure of effectiveness was fusion of the vertebrae confirmed by X-ray, and improvement in the pain and disability reported by the patient, measured two years after surgery.
Danish: Virkningen blev hovedsagelig bedømt på sammenvoksningen af ryghvirvlerne bekræftet ved en røntgenundersøgelse samt smertelindring og nedsat invaliditet bekræftet af patienten, begge dele målt to år efter operationen.
English: • surgery to heal fractures (breaks) of the tibia (shin bone).
Danish: • i forbindelse med operation til heling af brud på tibia (skinnebenet).
English: The active substance in Inductos, dibotermin alfa, acts on the bone structure.
Danish: Det aktive stof i Inductos, dibotermin alfa, indvirker på knoglestrukturen.
English: Spinal fusion using Inductos was compared with fusion using a bone graft removed from the hip during surgery.
Danish: Spinalfusion (sammensætning af ryghvirvler) ved hjælp af Inductos blev sammenlignet med fusion ved hjælp af et knogletransplantat, der blev taget fra hoften under operationen.
English: Inductos is used in adults who have been treated for at least six months for back pain due to a damaged disc but have not had an operation.
Danish: Inductos anvendes hos voksne, der ikke er blevet opereret, men som i mindst seks måneder er blevet behandlet for rygsmerter på grund af en ødelagt diskus
English: Inductos is used to help new bone develop.
Danish: Inductos anvendes til at fremme dannelsen af nyt knoglevæv.
English: In patients with a fractured tibia, using Inductos in addition to standard care was more effective than standard care alone in reducing the risk of treatment failure.
Danish: Brugen af Inductos sammen med standardbehandlingen hos patienter med skinnebensbrud havde større effekt end standardbehandlingen alene i forbindelse med at nedsætte risikoen for behandlingssvigt.
English: The most severe side effect is localised oedema (swelling at the surgery site) when used in upper spine (neck) surgery.
Danish: Den mest alvorlige bivirkning er lokalt ødem (hævelse på operationsstedet), når det anvendes i forbindelse med operation i den øvre del af rygsøjlen (nakken).
English: For the full list of restrictions with Inductos, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Inductos fremgår af indlægssedlen.
English: Why has Inductos been approved?
Danish: Hvorfor blev Inductos godkendt?
English: What benefit has Inductos shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Inductos?
English: For the full list of all side effects reported with Inductos, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Inductos fremgår af indlægssedlen.
English: What is Inductos?
Danish: Hvad er Inductos?
English: Dibotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Danish: Det dannes af celler, som har fået indsat et gen (DNA), som sætter dem i stand til at producere dibotermin alfa.
English: For a fractured tibia, Inductos is placed around the broken bone to aid healing.
Danish: Ved et skinnebensbrud placeres Inductos omkring den brækkede knogle for at fremme helingen.
English: It is only used when the nail to fix the bone does not need ‘reaming' (drilling to make room for nail placement).
Danish: Det anvendes kun, når det ikke er nødvendigt at bore op for at lave plads til det søm, der skal holde knoglen sammen.
English: How has Inductos been studied?
Danish: Hvordan blev Inductos undersøgt?
English: In spinal fusion, Inductos was as effective as bone grafts.
Danish: Ved spinalfusion havde Inductos samme virkning som knogletransplantater.
English: What is Inductos used for?
Danish: Hvad anvendes Inductos til?
English: How is Inductos used?
Danish: Hvordan anvendes Inductos?
English: • lower back spine fusion surgery.
Danish: • ved kirurgisk fusion af ryghvirvler i den nedre del af rygsøjlen.
English: How does Inductos work?
Danish: Hvordan virker Inductos?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Scenesse on 22 December 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Scenesse den 22. december 2014.
English: Scenesse has been authorised under ‘exceptional circumstances'.
Danish: Scenesse er godkendt under “særlige omstændigheder”.
English: Doctors will also be given information on the EU registry.
Danish: Lægerne skal også informeres om EU-registeret.
English: The number of implants per year depends on how much protection from the sun is needed.
Danish: Antallet af implantater pr. år afhænger af, hvor meget beskyttelse mod solen der er brug for.
English: The Committee also consulted individual patients and experts on their experience with Scenesse.
Danish: Udvalget rådførte sig også med individuelle patienter og eksperter om deres erfaringer med Scenesse.
English: Other information about Scenesse
Danish: Andre oplysninger om Scenesse
English: Scenesse afamelanotide
Danish: Scenesse afamelanotid
English: Patients should be observed for allergic reactions for 30 minutes after the injection of each implant.
Danish: Patienterne skal observeres for allergiske reaktioner i 30 minutter efter injektionen af implantatet.
English: A risk management plan has been developed to ensure that Scenesse is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Scenesse anvendes så sikkert som muligt.
English: This is a summary of the European public assessment report (EPAR) for Scenesse.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Scenesse.
English: These affected around 1 in 5 patients and were generally mild in severity.
Danish: Disse bivirkninger optrådte hos ca. 1 ud af 5 patienter og var sædvanligvis af mild grad.
English: This is because it has not been possible to obtain complete information about the benefits of Scenesse, in part due to the rarity of the disease.
Danish: Det skyldes, at det ikke har været muligt at indhente fyldestgørende oplysninger om fordelene ved Scenesse, fordi sygdommen er sjælden.
English: Scenesse contains the active substance afamelanotide.
Danish: Scenesse indeholder det aktive stof afamelanotid.
English: Scenesse is used to help prevent or reduce these symptoms so that these patients can lead more normal lives.
Danish: Scenesse anvendes til at forebygge eller mindske disse symptomer, så patienterne kan føre et mere normalt liv.
English: Why is Scenesse approved?
Danish: Hvorfor blev Scenesse godkendt?
English: What is Scenesse and what is it used for?
Danish: Hvad er Scenesse, og hvad anvendes det til?
English: Because the number of patients with EPP is low, the disease is considered ‘rare', and Scenesse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 May 2008.
Danish: Da antallet af patienter med EPP er lavt, betragtes sygdommen som “sjælden”, og Scenesse blev udpeget som “lægemiddel til sjældne sygdomme” den 8. maj 2008.
English: What measures are being taken to ensure the safe and effective use of Scenesse?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Scenesse?
English: It is not intended to provide practical advice on how to use Scenesse.
Danish: Det er ikke en praktisk vejledning i, hvordan Scenesse bør anvendes.
English: One Scenesse implant is injected under the patient's skin once every 2 months, before and during periods of high sunlight exposure, e.g. from spring to autumn.
Danish: Der injiceres ét implantat af Scenesse under patientens hud én gang hver anden måned før og i perioder med stærkt sollys, f.eks. fra forår til efterår.
English: In the study, involving 93 patients with EPP, patients were treated with either Scenesse or a placebo (a dummy treatment) over a six-month period.
Danish: I undersøgelsen, hvor der deltog 93 patienter med EPP, modtog patienterne enten Scenesse eller virkningsløs behandling (placebo) i en periode på seks måneder.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Scenesse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Scenesse opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Scenesse.
English: Patients with EPP have high levels of a substance called protoporphyrin IX in the body.
Danish: Patienter med EPP har høj koncentration af stoffet protoporfyrin IX i kroppen.
English: The most common side effects seen in studies with Scenesse were nausea (feeling sick), headache and reactions at the implant site (such as discoloration, pain and redness).
Danish: De hyppigste bivirkninger, der blev iagttaget i undersøgelserne med Scenesse, var kvalme, hovedpine og reaktioner på implantationsstedet (såsom affarvning, smerter og rødme).
English: What information is still awaited for Scenesse?
Danish: Hvilke oplysninger afventes der stadig for Scenesse?
English: Scenesse must not be used in patients with reduced liver or kidney function.
Danish: Scenesse må ikke anvendes hos patienter med nedsat lever- eller nyrefunktion.
English: What are the risks associated with Scenesse?
Danish: Hvilke risici er der forbundet med Scenesse?
English: The full EPAR and risk management plan summary for Scenesse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Scenesse findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Scenesse is only prescribed by specialist doctors in recognised centres for treating EPP and should only be used by doctors who have been properly trained.
Danish: Scenesse ordineres kun af speciallæger på særlige centre, der behandler EPP, og bør kun anvendes af læger, der har fået den nødvendige oplæring.
English: Since Scenesse has been approved under exceptional circumstances, the company that markets Scenesse will provide longer-tem data on the benefits and safety of the medicine from an EU registry of patients taking the medicine.
Danish: Da Scenesse er godkendt under særlige omstændigheder, skal virksomheden, der markedsfører Scenesse, fremlægge mere langsigtede oplysninger om fordelene ved og sikkerheden af lægemidlet fra et EU-register over patienter, der får lægemidlet.
English: By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, thus helping to prevent the painful reactions.
Danish: Ved at stimulere produktionen af eumelanin i huden nedsætter Scenesse lysets indtrængen gennem huden og medvirker derved til at forhindre de smertefulde reaktioner.
English: Three implants per year are recommended;
Danish: Der anbefales tre implantater årligt, og der må højst gives fire.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Scenesse 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 Scenesse findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For the full list of all side effects and restrictions with Scenesse, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Scenesse fremgår af indlægssedlen.
English: Scenesse is an implant used to treat patients with erythropoietic protoporphyria (EPP), a rare disease that causes intolerance to light.
Danish: Scenesse er et implantat, der anvendes til behandling af patienter med den sjældne sygdom erythropoietisk protoporfyri (EPP), der bevirker, at patienten ikke tåler lys.