FrancophonIA/ELRC3.0 huggingface dataset:
English: After 6 months of treatment, 45% of patients taking RoActemra in combination with methotrexate (130 out of 290) and 39% of patients taking RoActemra on its own (113 out of 292) achieved remission (did not show symptoms of the disease), compared with 15% of those taking placebo plus methotrexate (43 out of 287).
Danish: Efter seks måneders behandling opnåede 45 % af de patienter, der fik RoActemra sammen med methotrexat (130 ud af 290), og 39 % af de patienter, der fik RoActemra alene (113 ud af 292), remission (udviste ikke symptomer på sygdommen) sammenlignet med 15 % af de patienter, der fik placebo plus methotrexat (43 ud af 287).
English: In this study 85% (64 out of 75) patients treated with RoActemra responded to treatment and no longer had fever after 3 months, compared with 24% (9 out of 37) patients receiving placebo.
Danish: I dette studie var der behandlingsrespons hos 85 % (64 ud af 75) af de patienter, der fik RoActemra, og de havde ikke længere feber efter tre måneder sammenlignet med 24 % (9 ud af 37) af de patienter, der fik placebo.
English: RoActemra is available as a solution to be injected under the skin and as a concentrate for making a solution for infusion (drip) into a vein.
Danish: RoActemra fås som en opløsning, der skal injiceres under huden, og som et koncentrat, der blandes til en opløsning til infusion (drop) i en vene.
English: • children from 2 years of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough.
Danish: • børn fra toårsalderen med børneleddegigt i mange led (juvenil idiopatisk polyartritis), der ikke har haft tilstrækkelig gavn af methotrexat.
English: In the fourth study, which included 498 patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around 9 times more likely to respond than those receiving placebo with methotrexate.
Danish: Det fjerde studie, der omfattede 498 patienter, som ikke havde gavn af TNFblokkere, viste, at der hos patienter, som fik RoActemra sammen med methotrexat, var ca. ni gange større sandsynlighed for behandlingsrespons end hos patienter, der fik placebo sammen med methotrexat.
English: The other study, which compared RoActemra injected under the skin with RoActemra given by infusion, showed that RoActemra injected under the skin was no less effective in achieving a response after 6 months.
Danish: Det andet studie, hvor RoActemra givet som injektion under huden blev sammenlignet med RoActemra givet som infusion (drop), viste, at RoActemra givet som injektion under huden var lige så effektivt til at opnå behandlingsrespons efter seks måneder.
English: Results showed that patients adding RoActemra were around 4 times more likely to respond to treatment than those adding placebo.
Danish: Resultaterne viste, at der hos patienter, som fik RoActemra som tillægsbehandling, var ca. fire gange større sandsynlighed for behandlingsrespons end hos patienter, der fik placebo som tillægsbehandling.
English: What benefits of RoActemra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved RoActemra?
English: Rheumatoid arthritis
Danish: Leddegigt (rheumatoid artritis)
English: • adults with moderate to severe active rheumatoid arthritis whose previous treatments with disease modifying antirheumatic drugs (DMARDs), such as methotrexate or medicines known as tumour necrosis factor (TNF) blockers, have not worked well or were not tolerated;
Danish: • voksne med moderat til svær aktiv leddegigt, der ikke har haft gavn af eller ikke har kunnet tåle tidligere behandlinger med såkaldte DMARD-lægemidler (sygdomsmodificerende antirheumatiske lægemidler), som f.eks. methotrexat, eller såkaldte TNF-blokkere (tumornekrosefaktorblokkere)
English: How is RoActemra used?
Danish: Hvordan anvendes RoActemra?
English: • children from 1 year of age with active systemic juvenile idiopathic arthritis in whom other treatments (with anti-inflammatory medicines called NSAIDs and corticosteroids) have not worked well enough;
Danish: • børn fra etårsalderen med aktiv systemisk børneleddegigt (juvenil idiopatisk artritis), der ikke har haft tilstrækkelig gavn af andre behandlinger (med betændelseshæmmende lægemidler som de såkaldte NSAID'er og kortikosteroider)
English: How does RoActemra work?
Danish: Hvordan virker RoActemra?
English: • adults with severe rheumatoid arthritis that is getting worse in patients who have not been previously treated with a medicine called methotrexate;
Danish: • voksne med svær leddegigt (rheumatoid artritis), hvis sygdom er i forværring og ikke tidligere er blevet behandlet med lægemidlet methotrexat
English: RoActemra given by injection under the skin was investigated in two studies involving 1,918 patients with moderate to severe rheumatoid arthritis where previous treatment with DMARD had not worked well.
Danish: RoActemra givet som injektion under huden har også været genstand for to studier, der omfattede 1 918 patienter med moderat til svær leddegigt, som ikke har haft gavn af tidligere behandling med DMARD-lægemidler.
English: After 4 to 6 months of treatment, 26% of patients on RoActemra (21 out of 82) had a flare-up of symptoms during treatment, compared with 48% of patients taking placebo (39 out of 81).
Danish: Efter 4-6 måneders behandling vendte symptomerne tilbage under behandlingen hos 26 % af de patienter, der fik RoActemra (21 ud af 82), sammenlignet med 48 % af de patienter, der fik placebo (39 ud af 81).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of RoActemra have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af RoActemra.
English: Juvenile idiopathic polyarthritis
Danish: Børneleddegigt i mange led (juvenil idiopatisk polyartritis)
English: In juvenile idiopathic polyarthritis, RoActemra given by infusion was compared with placebo in one main study involving 166 children from 2 years of age who could not take methotrexate or it did not work well enough.
Danish: RoActemra givet som infusion (drop) til behandling af børneleddegigt i mange led blev sammenlignet med placebo i et hovedstudie med 166 børn fra toårsalderen, som ikke kunne få eller ikke havde gavn af methotrexat.
English: In systemic juvenile idiopathic arthritis, RoActemra given by infusion was compared with placebo in one main study involving 112 children in whom treatment with NSAID and corticosteroids did not work well enough.
Danish: RoActemra givet som infusion (drop) blev sammenlignet med placebo i et hovedstudie med 112 børn med systemisk børneleddegigt, der ikke havde haft gavn af NSAID og kortikosteroider.
English: In giant cell arteritis, RoActemra given by injection under the skin was found more effective than placebo in one main study involving 251 adults.
Danish: I et hovedstudie med 251 voksne med kæmpecellearteritis var RoActemra givet som injektion under huden mere effektivt end placebo.
English: For the treatment of moderate to severe rheumatoid arthritis where other medicines were unsuccessful, RoActemra given by infusion was studied in five main studies involving a total of over 4,000 adults.
Danish: RoActemra givet som infusion (drop) er blevet vurderet i fem hovedstudier med i alt over 4 000 voksne med moderat til svær leddegigt, hos hvem andre lægemidler ikke havde virket.
English: In severe rheumatoid arthritis not previously treated with methotrexate, RoActemra given by infusion was investigated in one main study involving 1,162 patients.
Danish: RoActemra givet som infusion (drop) er blevet vurderet i et hovedstudie af 1 162 patienter med svær leddegigt, som ikke tidligere er behandlet med methotrexat.
English: This summary was last updated in 12/2012.
Danish: Dette sammendrag blev sidst ajourført i 12/2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NexoBrid on 18 December 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for NexoBrid den 18. december 2012.
English: This is a summary of the European public assessment report (EPAR) for NexoBrid.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for NexoBrid.
English: Other information about NexoBrid
Danish: Andre oplysninger om NexoBrid
English: The effects of NexoBrid were first tested in experimental models before being studied in humans.
Danish: Virkningerne af NexoBrid blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It should only be used in specialised burns centres, and should not be applied to more than 15% of the patient's total body surface area.
Danish: Det må kun anvendes af brandsårsafdelinger og må ikke påføres på mere end 15 % af patientens samlede legems
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 NexoBrid.
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 anvendelsesbetingelserne for NexoBrid.
English: For more information about treatment with NexoBrid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med NexoBrid, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The full EPAR for NexoBrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for NexoBrid findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe use of NexoBrid?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af NexoBrid?
English: The most commonly reported side effects with NexoBrid are local pain, and pyrexia (fever) or hyperthermia (high body temperature).
Danish: De hyppigst indberettede bivirkninger med NexoBrid er lokale smerter og pyreksi (feber) eller hypertermi (forhøjet legemstemperatur).
English: It is available as a powder and gel, which are mixed together to make a gel (2 g/22 g or 5 g/55 g).
Danish: Det leveres som et pulver og en gel, der blandes til en gel med enten 2 g/22 g eller 5 g/55 g.
English: Because the number of patients with deep partial thickness and full thickness thermal burn wounds is low, the disease is considered ‘rare', and NexoBrid was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 July 2002.
Danish: Da antallet af patienter med dybe delhudsforbrændinger og helhudsforbrændinger er lavt, betragtes sygdommen som sjælden”, og NexoBrid blev udpeget som ”lægemiddel til sjældne sygdomme” den 30. juli 2002.
English: The company will also carry out a long-term study in adults and children comparing NexoBrid with standard debridement treatment to investigate the outcome of patients including cosmetic considerations.
Danish: Virksomheden skal desuden udføre en langsigtet undersøgelse hos voksne og børn, hvor NexoBrid sammenlignes med sædvanlig debridering med hensyn til udfaldet for patienterne, herunder det kosmetiske resultat.
English: NexoBrid concentrate of proteolytic enzymes enriched in bromelain
Danish: NexoBrid koncentrat af proteolytiske enzymer beriget med bromelain
English: NexoBrid was studied in one main study involving 156 patients, who were hospitalised with deep partial thickness or full thickness burn wounds.
Danish: NexoBrid blev undersøgt i én hovedundersøgelse med 156 patienter, der blev indlagt med dybe delhuds- eller fuldhudsforbrændinger.
English: What is the risk associated with NexoBrid?
Danish: Hvilken risiko er der forbundet med NexoBrid?
English: Why has NexoBrid been approved?
Danish: Hvorfor blev NexoBrid godkendt?
English: The CHMP decided that NexoBrid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP afgjorde, at fordelene ved NexoBrid overstiger risiciene, og anbefalede udstedelse af en markedsføringstilladelse for NexoBrid.
English: In addition, it was found that NexoBrid removed eschar from wounds faster than standard treatments.
Danish: Derudover fandtes NexoBrid at fjerne dødt væv fra sårene hurtigere end standardbehandling.
English: The company that markets NexoBrid must ensure that healthcare professionals in specialised burns centres who are expected to use NexoBrid receive appropriate training and an educational pack including a step-by-step guide to NexoBrid treatment, covering important safety considerations before and after using NexoBrid.
Danish: Den virksomhed, der markedsfører NexoBrid, skal sørge for, at det personale på brandsårsafdelingerne, der skal anvende NexoBrid, får den nødvendige oplæring og en uddannelsespakke med trin-for-trin vejledning i behandling med NexoBrid, herunder vigtige sikkerhedsovervejelser før og efter anvendelse af NexoBrid.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for NexoBrid 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 NexoBrid findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: A second application is not recommended.
Danish: Det frarådes at gentage påføringen.
English: NexoBrid is a medicine that contains the active substance ‘concentrate of proteolytic enzymes enriched in bromelain'.
Danish: NexoBrid er et lægemiddel, der indeholder det aktive stof “koncentrat af proteolytiske enzymer beriget med bromelain”.
English: The active substance in NexoBrid is a mixture of enzymes extracted from the stem of the pineapple plant.
Danish: Det aktive stof i NexoBrid er en blanding af enzymer udvundet af ananasplantens stok.
English: NexoBrid must not be used in people who are hypersensitive (allergic) to the active substance, pineapples, papain (an enzyme found in papaya fruit) or any of the other ingredients.
Danish: NexoBrid må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for det aktive indholdsstof, ananas, papain (et enzym i papayafrugt) eller andre af indholdsstofferne.
English: What is NexoBrid?
Danish: Hvad er NexoBrid?
English: NexoBrid is applied to the area of burnt skin after the wound has been appropriately prepared.
Danish: NexoBrid påføres på det forbrændte hudområde efter passende forberedelse af såret.
English: In patients receiving NexoBrid, in around 15% (16 out of 106) of the wounds the eschar needed to be removed by surgery and around 18% (19 out of 106) required a skin graft, compared with around 63% (55 out of 88) and around 34% (30 out of 88) respectively in patients receiving standard debridement treatment.
Danish: De tilsvarende tal var henholdsvis ca. 63 % (55 ud af 88) og ca. 34 % (30 ud af 88) hos de patienter, der blev behandlet med sædvanlig debridering.
English: For the full list of all side effects reported with NexoBrid, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med NexoBrid fremgår af indlægssedlen.
English: The study showed that NexoBrid was more effective than standard of care treatment (surgical and non-surgical) at reducing the proportion of the deep partial thickness burn wounds that needed surgery to remove skin tissue or required a skin graft.
Danish: Undersøgelsen viste, at NexoBrid var mere effektivt end standardbehandling (kirurgisk og ikkekirurgisk) til at mindske andelen af de dybe delhudsforbrændinger, der krævede operativ fjernelse af hudvæv eller hudtransplantation.
English: NexoBrid is used in adults to remove eschar (dead tissue which is dried-out, thick, leathery and black) from deep partial thickness and full thickness burns of the skin caused by heat or fire.
Danish: NexoBrid anvendes hos voksne til at fjerne brændt væv (dødt væv, der er udtørret, tykt, læderagtigt og sort) fra dybe delhudsforbrændinger (forbrændinger i en del af hudens tykkelse) og fuldhudsforbrændinger (forbrændinger i hele hudens tykkelse).
English: The results were also considered for burn wounds of all thicknesses, including full thickness wounds.
Danish: Resultaterne blev desuden vurderet for forbrændinger af alle dybder, herunder fuldhudsforbrændinger.
English: The main measure of effectiveness was the proportion of deep partial thickness wounds that needed surgery to remove further skin tissue or that required a skin graft from another area of the patient's body.
Danish: Virkningen blev hovedsagelig bedømt på, hvor stor en andel af de dybe delhudsforbrændinger, der krævede operativ fjernelse af yderligere hudvæv eller transplantation af hud fra et andet område af patientens krop.
English: Deep partial thickness burns (sometimes called ‘second degree' burns) extend into a deep region of an inner layer of the skin called the dermis, while full thickness burns (sometimes called ‘third degree' burns) extend even deeper, through the whole dermis.
Danish: Dybe delhudsforbrændinger (som også kaldes 2. grads forbrændinger) strækker sig ned i den dybere del af læderhuden, mens helhudsforbrændinger (som også kaldes 3. grads forbrændinger) omfatter hele læderhudens tykkelse.
English: NexoBrid was also seen to be an effective debridement treatment for burn wounds of all thicknesses, including full thickness wounds.
Danish: NexoBrid blev desuden anset for at være effektivt til debridering af brandsår af alle tykkelser, herunder helhudsforbrændinger.
English: The CHMP concluded that NexoBrid effectively removes eschar from deep partial thickness and full thickness wounds and reduces the need for surgery to remove further skin tissue in deep partial thickness wounds.
Danish: CHMP konkluderede, at NexoBrid effektivt fjerner dødt væv fra delhudsforbrændinger og fuldhudsforbrændinger og mindsker behovet for operativ fjernelse af yderligere hudvæv fra dybe delhudsforbrændinger.
English: What is NexoBrid used for?
Danish: Hvad anvendes NexoBrid til?
English: Removing the eschar helps to allow the living skin tissue to be treated and to heal.
Danish: Når det døde væv fjernes, kan det levende væv i huden bedre behandles og hele.
English: How has NexoBrid been studied?
Danish: Hvordan blev NexoBrid undersøgt?
English: For a burn wound area of 250 cm2, NexoBrid 5 g/50 g gel is used.
Danish: Til en forbrænding med et areal på 100 cm2 anvendes NexoBrid gel, 2 g/20 g. Til en forbrænding med et areal på 250 cm2 anvendes NexoBrid gel, 5 g/50 g. NexoBrid skal anvendes senest 15 minutter efter sammenblanding og skal være i kontakt med huden i 4 timer.
English: How is NexoBrid used?
Danish: Hvordan anvendes NexoBrid?
English: The Committee considered that NexoBrid was shown to be an effective debridement treatment with an acceptable safety profile which complements available surgical techniques.
Danish: havde en acceptabel sikkerhedsprofil, og at det supplerer de eksisterende kirurgiske teknikker.
English: What benefit has NexoBrid shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved NexoBrid?
English: The patients received either NexoBrid or standard debridement treatment (surgical or non-surgical treatments to remove the eschar) before receiving further treatment if required, such as surgery or a skin graft.
Danish: Patienterne fik enten NexoBrid eller sædvanlig debriderende behandling (fjernelse af dødt væv ved operativt indgreb eller på anden måde).
English: The CHMP noted the importance of prompt skin grafting of areas of full thickness and deep burn directly after debridement with NexoBrid, in line with the standard of care in European burns centres.
Danish: CHMP bemærkede, at det er vigtigt, at der straks efter debridering med NexoBrid foretages hudtransplantation på områder med dyb forbrænding, herunder fuldhudsforbrænding.
English: This mixture of enzymes acts as a debriding agent, a substance used to remove dead tissue from areas of the skin such as burn wounds, by dissolving the burn wound eschar.
Danish: Denne enzymblanding virker som et middel til debridering, dvs. et middel, der bevirker, at dødt væv i brandsåret opløses og kan fjernes.
English: How does NexoBrid work?
Danish: Hvordan virker NexoBrid ?
English: Since some of the side effects seen, including delay in complete wound healing, may have been related to wound care procedures, the Committee decided that NexoBrid should only be used in specialised burns centres by healthcare professionals who have been trained to use it.
Danish: Derfor afgjorde udvalget, at NexoBrid kun bør anvendes på brandsårsafdelinger af plejepersonale, der er oplært i dets brug.
English: The maximum number of broachings should be limited to 20.
Danish: Det maksimale antal af perforeringer bør begrænses til 20.
English: The active substance in Melovem is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: De aktive substans i Melovem er godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: Waste materials should be disposed of in accordance with local requirements.
Danish: Affaldsmateriale skal destrueres i overensstemmelse med de lokale krav.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: I mangel af undersøgelser af forligelighed må dette veterinærlægemiddel ikke blandes med andre veterinærlægemidler.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07-07-2009
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 07-07-2009
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: It is recommended to administer the second injection at a different site since local tolerance has been assessed after single injection only.
Danish: Det anbefales at give den anden injektion på et andet sted, da er konstateret lokal tolerance efter blot en enkelt injektion.
English: Melovem alone will not provide adequate pain relief during the dehorning procedure.
Danish: Melovem alene vil ikke give tilstrækkelig smertelindring under afhorning.
English: For lactating animals see section 4.11.
Danish: For information om lakterende dyr se afsnit 4.11.
English: Injection site swelling may be painful.
Danish: Hævelse på injektionsstedet kan være smertefuld.
English: This veterinary medicinal product does not require any special temperature storage conditions.
Danish: Dette veterinærlægemiddel kræver ikke opbevaring ved en bestemt temperatur.
English: When treating groups of animals, use a draw-off needle to avoid excessive broaching of the stopper.
Danish: Ved behandling af flokke af dyr skal der anvendes en aftapningskanyle for at undgå overdreven perforering af proppen.
English: Do not use this veterinary medicinal product after the expiry date (EXP) stated on the carton and bottle.
Danish: Må ikke anvendes efter den udløbsdato (EXP), som er angivet på karton og flaske.