FrancophonIA/ELRC3.0 huggingface dataset:
English: These medicines were reviewed following concerns that alcohol might have an effect on the way they release the active substance in the body.
Danish: Disse lægemidler blev vurderet igen som følge af betænkeligheder med hensyn til alkohols virkning på den måde, de aktive stoffer frigives på i kroppen.
English: Because some of the chemicals used in the controlled-release systems dissolve in alcohol, there is a theoretical possibility that taking these medicines together with alcohol may cause the active substance to be released too quickly.
Danish: Eftersom nogle af de kemikalier, der anvendes i systemerne med kontrolleret udløsning, opløses i alkohol, er der en teoretisk mulighed for, at de aktive stoffer kan blive frigivet for hurtigt, hvis disse lægemidler tages sammen med alkohol.
English: However, for one of the controlled-release systems tested - once-daily capsules using a polymethacrylate-triethylcitrate coating to control the release of morphine - there was a significant interaction with alcohol.
Danish: For et af de undersøgte systemer med kontrolleret udløsning - kapsler til indtagelse én gang dagligt, hvor der anvendes et polymethacrylat-triethylcitrat-overtræk til at kontrollere frigivelsen af morfinvar der en signifikant interaktion med alkohol.
English: The CHMP reviewed the results of laboratory studies looking at the way that controlled-release systems act when they are placed in solutions containing alcohol.
Danish: CHMP vurderede resultaterne af laboratorieundersøgelserne og så på den måde, som systemer med kontrolleret udløsning fungerer på, når de placeres i opløsninger, der indeholder alkohol.
English: They should consider switching patients currently taking opioids containing the polymethacrylate-triethylcitrate controlled-release system to alternatives while the suspension is in force.
Danish: De bør overveje at lade patienter, som i øjeblikket tager opioider, der indeholder det polymethacrylat-triethylcitrat-kontrollerede udløsningssystem, skifte til andre lægemidler, så længe suspenderingen er gældende.
English: Questions and answers on the review of modified-release oral opioid medicines of the WHO level III scale for the management of pain
Danish: Spørgsmål og svar vedrørende revurderingen af orale opioide lægemidler med modificeret udløsning omfattet af WHO's niveau III-skala for smertebehandling
English: The European Medicines Agency has completed a review of the safety and effectiveness of modifiedrelease oral opioid medicines of the WHO level III scale for the management of pain.
Danish: Det Europæiske Lægemiddelagentur har foretaget en revurdering af sikkerhed og virkning af orale opioide lægemidler med modificeret udløsning omfattet af WHO's niveau III-skala for smertebehandling.
English: The CHMP also took information from studies looking at the drinking habits of patients with severe pain into account.
Danish: CHMP tog også højde for information fra undersøgelser, hvor man så på drikkevanerne hos patienter med stærke smerter, herunder patienter med kræft i et fremskredent stadium.
English: What are modified-release oral medicines of the WHO level III scale for the management of pain?
Danish: Hvad er orale opioide lægemidler med modificeret udløsning omfattet af WHO's niveau III-skala for smertebehandling?
English: Therefore, the CHMP concluded that modified-release opioids using the polymethacrylate-triethylcitrate controlled-release system are highly sensitive to alcohol and that there is a risk of dose dumping if patients drink alcohol while taking them.
Danish: Derfor konkluderede CHMP, at opioider med modificeret udløsning, hvor der anvendes et polymethacrylat-triethylcitrat-kontrolleret udløsningssystem, er yderst følsomme over for alkohol, og at der er risiko for dosisdumping, hvis patienterne drikker alkohol, når de tager dem. Udvalget anbefalede således, at markedsføringstilladelserne for disse lægemidler suspenderes, indtil de virksomheder, der fremstiller disse lægemidler, har reformuleret dem, så de er mere stabile i alkohol.
English: However, for modified-release medicines that contain a ‘polymethacrylate-triethylcitrate controlled release system', the Committee concluded that the marketing authorisations should be suspended.
Danish: Udvalget konkluderede dog, at markedsføringstilladelserne for lægemidler med modificeret udløsning, som indeholder et "polymethacrylat-triethylcitrat-kontrolleret udløsningssystem", bør suspenderes.
English: A European Commission decision on this opinion will be issued in due course.
Danish: Europa-Kommissionen traf en afgørelse den 20. april 2011.
English: Companies responses provided on: 25 January 2010, 4 May 2010 and 2 July 2010 Opinion date:
Danish: Efter revurderingen bekræftede udvalget disse anbefalinger den 18. november 2010.
English: INN + Strength
Danish: INN + styrke
English: Member State in EEA
Danish: Medlemsstat EU/EØS
English: Pharmaceutical form Route of administration
Danish: Lægemiddelform Administration
English: Product name
Danish: Særnavn
English: Marketing authorisaton holder
Danish: Indehaver af markedsføringstilladelsen
English: Meda Pharma Gmbh & Co. Kg
Danish: Meda Pharma Gmbh & Co.
English: Ratiopharm Gmbh Flupirtinmaleat Ratiopharm
Danish: Flupirtinmaleat Ratiopharm
English: Hormosan Pharma Gmbh
Danish: Aristo Pharma Gmbh
English: Farmacêuticos, S.A.
Danish: Meda Pharma - Produtos Farmacêuticos, S.A.
English: Human Medicines Evaluation Division
Danish: Bilag I Liste over nationalt godkendte lægemidler
English: Winthrop Arzneimittel Gmbh
Danish: Ratiopharm Gmbh
English: • An educational plan for patients which is aimed at risk minimisation and to support safe and effective use for the product.
Danish: • En undervisningsplan for patienter, for at minimere risici samt understøtte sikker og effektiv brug af produktet.
English: This plan shall consist of measures to provide adequate education on: l) Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure m) When to seek urgent attention from the health care provider
Danish: Denne plan skal indeholde forholdsregler til at sikre tilstrækkelig undervisning om: l) Vigtige tegn og symptomer på alvorlige bivirkninger i forbindelse med den intravitreale injektionsprocedure m) Hvornår der skal søges umiddelbar hjælp fra sundhedspersonalet
English: • An educational plan for physicians and health care providers which is aimed at risk minimisation and to support safe and effective use for the product.
Danish: • En undervisningsplan for læger og sundhedspersonale, for at minimere risici samt understøtte sikker og effektiv brug af produktet.
English: This plan shall consist of measures aiming to minimise adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) through adequate education about: a) The intravitreal procedure as it was performed in the pivotal clinical studies b) Sterile techniques to minimize risk of infection c) Use of antibiotics d) Use of povidone iodine e) Performing lid scrubs f) Use of anesthetic to ensure patient comfort g) Techniques for the intravitreal injection h) Management of intraocular pressure (IOP) i) Management of endophthalmitis j) Understanding the risk factors involved in developing endophthalmitis k) Reporting of serious adverse events
Danish: a) Den intravitreale procedure som blev udført i de kliniske studier b) Sterile teknikker for at minimere risikoen for infektion c) Brug af antibiotika d) Brug af povidone iod e) Udførsel af øjenlågsprocedure f) Brug af bedøvelse for at sikre patientens komfort g) Teknikker for den intravitreale injektion h) Monitorering af intraokulært tryk i) Behandling af endophthalmitis j) Forståelse af de risikofaktorer der er for udvikling af endophthalmitis k) Indberetning af alvorlige bivirkninger
English: ¾ The Member States must ensure that the education plans for physicians, health care providers, and patients contain the measures a) to m) as detailed below, and are suitable for the purpose of minimising adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) prior to marketing.
Danish: ¾ Indehaveren af markedsføringstilladelsen skal sikre at undervisningsplanen for læger, sundhedspersonale og patienter indeholder forholdsreglerne a) til m), som beskrevet nedenfor, og at den er tilstrækkelig til det formål, at minimere bivirkninger forbundet med den intravitreale injektionsprocedure (såsom endophthalmitis), før markedsføring:
English: EU/1/17/1176
Danish: EU/1/17/1176/001 Yargesa
English: 84 x 1 capsules (unit dose)
Danish: 84 x 1 kapsler (dosisenhed)
English: 100 mg Capsule, hard Oral use blister (PVC/ PCTFE/Alu)
Danish: Oral anvendelse blister (PVC/PCTFE/alu)
English: EMA Number
Danish: EMA-nummer
English: Similar results were seen after a year.
Danish: Der blev observeret lignende resultater efter et år.
English: This summary was last updated in 10-2008.
Danish: Dette sammendrag blev sidst ajourført i 10-2008.
English: The marketing authorisation was renewed on 9 October 2003 and on 9 October 2008.
Danish: Markedsføringstilladelsen blev fornyet den 9. oktober 2003 og den 9. oktober 2008.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Simulect to Novartis Europharm Limited on 9 October 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Simulect til Novartis Europharm Limited den 9. oktober 1998.
English: Other information about Simulect:
Danish: Andre oplysninger om Simulect:
English: Simulect is given as two injections.
Danish: Simulect indgives som to injektioner.
English: Simulect was more effective than placebo.
Danish: Simulect var mere effektiv end placebo.
English: It should be given under qualified medical supervision.
Danish: Det skal indgives under lægelig overvågning.
English: The Committee recommended that Simulect be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Simulect.
English: Simulect has been assessed in three main studies involving a total of 1,067 adults who were having a kidney transplant.
Danish: Simulect er blevet vurderet i tre hovedundersøgelser, som omfattede i alt 1.067 voksne, der fik en nyretransplantation.
English: The full EPAR for Simulect can be found here.
Danish: Den fuldstændige EPAR for Simulect findes her.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SIMULECT EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) SIMULECT EPAR - sammendrag for offentligheden
English: This reduces the number of activated T-lymphocytes, lowering the risk of the transplant being rejected.
Danish: Dette reducerer antallet af aktiverede T-lymfocytter, hvilket reducerer risikoen for afstødning af transplantatet.
English: The studies in children and adolescents showed that the lower dose of Simulect was appropriate for children, and that adolescents could use the adult dose.
Danish: Undersøgelserne af børn og unge viste, at den lave dosis af Simulect var hensigtsmæssig til børn, og at unge kunne bruge voksendosen.
English: It contains the active substance basiliximab.
Danish: Det indeholder det aktive stof basiliximab.
English: The first injection should be given a maximum of two hours before transplantation surgery, and the second four days after the transplant, unless the patient has had a severe hypersensitivity (allergic) reaction or has complications after the operation, such as loss of the new kidney.
Danish: Den første injektion skal gives højst to timer før transplantationsoperationen, og den anden skal gives fire dage efter transplantationen, medmindre patienten har haft en alvorlig overfølsomhedsreaktion (allergisk reaktion) eller har komplikationer efter operationen såsom tab af den nye nyre.
English: Two additional studies looked at how Simulect is handled in the body when it is given to children aged over one year or to adolescents.
Danish: To yderligere undersøgelser undersøgte, hvordan Simulect virker i kroppen, når det gives til børn i alderen et år og opefter eller til unge.
English: Simulect should not be used in people who may be hypersensitive to basiliximab or any of the other ingredients.
Danish: Simulect må ikke anvendes til personer, som kan være overfølsomme over for basiliximab eller et eller flere af de øvrige indholdsstoffer.
English: Simulect should not be given unless it is absolutely certain that the patient will receive the transplant and other medicines to prevent rejection.
Danish: Simulect bør kun gives, hvis det er helt sikkert, at patienten vil modtage transplantationen og andre lægemidler til forebyggelse af afstødning.
English: In adults and children weighing more than 35 kg, the recommended total dose is 40 mg, given as two 20 mg doses.
Danish: Hos voksne og børn, der vejer mere end 35 kg, er den anbefalede samlede dosis 40 mg, der gives som to doser på 20 mg.
English: The main measure of effectiveness was the number of treatment failures (death, loss of the new kidney or signs of rejection) over the first year after the transplant.
Danish: Det primære effektmål var antallet af patienter med manglende terapeutisk effekt (død, tab af ny nyre eller tegn på afstødning) i løbet af det første år efter transplantationen.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect's benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Simulect er større end risiciene til forebyggelse af akut organafstødning ved de novo allogen nyretransplantation hos voksne og pædiatriske patienter.
English: What is the risk associated with Simulect?
Danish: Hvilken risiko er der forbundet med Simulect?
English: Simulect should only be prescribed and given by a doctor who has experience in the use of immunosuppressive treatment following an organ transplant.
Danish: Simulect må udelukkende ordineres og indgives af læger, som har erfaring med immunosuppressiv behandling efter organtransplantation.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Danish: Et monoklonalt antistof er et antistof (en proteintype), som er blevet udviklet til at genkende og binde sig til en specifik struktur (kaldet et antigen), som findes på visse af kroppens celler.
English: Simulect is used in adults and children aged over one year, to prevent the body from rejecting a newly transplanted kidney.
Danish: Simulect anvendes til voksne og børn i alderen et år og opefter for at forhindre kroppen i at afstøde en nytransplanteret nyre.
English: Looking at the results of the first two studies taken together, 40% of the patients receiving Simulect in addition to dual therapy failed treatment over six months (145 out of 363), compared with 56% of the patients receiving placebo (201 out of 359).
Danish: Når resultatet af de første to undersøgelser ses samlet, var behandlingen virkningsløs hos 40 % af de patienter, der blev behandlet med Simulect og en tostofsbehandling over en periode på seks måneder (145 ud af 363), sammenlignet med 56 % af de patienter, der fik placebo (201 ud af 359).
English: Basiliximab has been designed to target an antigen called CD25, which is present on the surface of T-lymphocytes (a type of white blood cell that is involved in the rejection of organ transplants).
Danish: Basiliximab er udviklet til at binde sig til antigenet CD25, som findes på overfladen af T-lymfocytter (en type hvide blodlegemer, der er involveret i afstødningen af organtransplantater).
English: Simulect is used in combination with other medicines used to prevent organ rejection, such as ciclosporin, corticosteroids, azathioprine and mycophenolate mofetil.
Danish: Simulect anvendes i kombination med andre lægemidler, der bruges til at forhindre organafstødning, f.eks. ciclosporin, kortikosteroider, azathioprin og mycophenolat mofetil. Lægemidlet udleveres kun efter recept.
English: All three studies compared the effectiveness of Simulect with that of placebo (a dummy treatment).
Danish: I alle tre undersøgelser blev effektiviteten af Simulect sammenlignet med effektiviteten af placebo (en virkningsløs behandling).
English: The active substance in Simulect, basiliximab, is a monoclonal antibody.
Danish: Det aktive stof i Simulect, basiliximab, er et monoklonalt antistof.
English: Why has Simulect been approved?
Danish: Hvorfor blev Simulect godkendt?
English: Simulect must not be used during pregnancy or breast-feeding.
Danish: Simulect må ikke bruges til gravide eller ammende kvinder.
English: In adults, the most common side effects (seen in more than 20% of patients) were constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anaemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhoea and upper respiratory tract infection (colds).
Danish: De mest almindelige bivirkninger hos voksne (som optræder hos mere end 20 % af patienterne) var forstoppelse, urinvejsinfektioner (infektioner i urinledende strukturer), smerter, kvalme, perifert ødem (hævelse), hypertension (højt blodtryk), anæmi (nedsat antal røde blodlegemer), hovedpine, hyperkaliæmi (forhøjet indhold af kalium i blodet), hyperkolesterolæmi (forhøjet kolesteroltal), komplikation i forbindelse med operationssår, vægtforøgelse, forhøjet serumkreatinin (markør for nyreproblemer), hypofosfatæmi (lav fosfatkoncentration i blodet), diarré og infektioner i de øvre luftveje (forkølelse).
English: Simulect is a powder and solvent that are made up into a solution for injection or infusion (drip into a vein).
Danish: Simulect er et pulver og et opløsende middel, der blandes til en væske til injektion eller infusion (drop i en vene).
English: By binding to CD25, basiliximab blocks the activity of interleukin-2, reducing the rate at which the lymphocytes multiply.
Danish: Gennem bindingen til CD25 blokerer basiliximab aktiviteten for interleukin-2 og reducerer dermed den hastighed, hvormed lymfocytterne formerer sig.
English: CD25 is a receptor for the messenger interleukin-2, which stimulates the T-lymphocytes to divide.
Danish: CD25 er receptor for signalmolekylet interleukin-2, som får T-lymfocytterne til at dele sig.
English: In the studies, side effects were similar in patients taking Simulect and those receiving placebo, in combination with other medicines.
Danish: I undersøgelserne havde de patienter, der blev behandlet med Simulect, de samme bivirkninger som de patienter, der fik placebo, når det blev indgivet sammen med andre lægemidler.
English: In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%).
Danish: I den tredje undersøgelse var behandlingen virkningsløs hos færre patienter, der blev behandlet med Simulect og en trestofsbehandling (26 %), sammenlignet med de patienter, der fik placebo (40 %).
English: For the full list of all side effects reported with Simulect, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Simulect fremgår af indlægssedlen.
English: In children, the side effects seen in more than 20% of patients were urinary tract infections, hypertrichosis (excess body hair), rhinitis (stuffy and runny nose), pyrexia (fever), hypertension, upper respiratory tract infection, viral infection, sepsis (blood infection) and constipation.
Danish: Hos børn var de mest almindelige bivirkninger, som optræder hos mere end 20 % af patienterne, urinvejsinfektioner, hypertrikose (øget behåring), rhinitis (stoppet eller løbende næse), pyreksi (feber), hypertension, infektioner i de øvre luftveje, virusinfektioner, blodforgiftning (blodinfektion) og forstoppelse.
English: In the first two studies, most of the 722 patients were also taking ciclosporin and corticosteroids (‘dual therapy'), with some patients also taking azathioprine or mycophenolate mofetil.
Danish: I de første to undersøgelser blev de fleste af de 722 patienter også behandlet med ciclosporin og kortikosteroider ("tostofsbehandling"), og nogle patienter blev også behandlet med azathioprin eller mycophenolat mofetil. I den tredje undersøgelse blev alle 345 voksne patienter behandlet med ciclosporin, steroider og azathioprin ("trestofsbehandling").
English: What benefit has Simulect shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Simulect?
English: What is Simulect?
Danish: Hvad er Simulect?
English: How has Simulect been studied?
Danish: Hvordan blev Simulect undersøgt?
English: What is Simulect used for?
Danish: Hvad anvendes Simulect til?
English: How is Simulect used?
Danish: Hvordan anvendes Simulect?
English: In children weighing less than 35 kg, it is 20 mg, given as two 10 mg doses.
Danish: Hos børn, der vejer mindre end 35 kg, er den anbefalede dosis 20 mg, der gives som to doser på 10 mg. Simulect indgives i en åre som en bolusinjektion (dosen gives på én gang) eller som en infusion i løbet af 20 til 30 minutter.
English: How does Simulect work?
Danish: Hvordan virker Simulect?
English: This is usually reached within three to five months.
Danish: Dette opnås sædvanligvis inden for tre til fem måneder.
English: It is available as tablets (500 mg).
Danish: Det leveres som tabletter (500 mg).
English: This is a summary of the European public assessment report (EPAR) for Lysodren.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lysodren.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lysodren on 28 April 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Lysodren den 28. april 2004.
English: It may also alter the breakdown of these hormones.
Danish: Det kan desuden ændre nedbrydningen af disse hormoner.
English: Treatment should continue as long as there is a benefit.
Danish: Behandlingen fortsættes, så længe det er til fordel for patienten.
English: Levels above 20 mg/l may cause severe side effects without increasing the medicine's effectiveness.
Danish: Koncentrationer på over 20 mg/l kan forårsage alvorlige bivirkninger uden at forøge lægemidlets virkning.
English: If there is no improvement in symptoms after three months of treatment at the optimal dose, treatment should be stopped.
Danish: Hvis symptomerne ikke er aftaget efter tre måneders behandling med optimal dosis, bør behandlingen ophøre.
English: Treatment with Lysodren should be started and followed by a specialist who has suitable experience.
Danish: Behandling med Lysodren bør startes og overvåges af en speciallæge med passende erfaring.
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 Lysodren.
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 Lysodren.
English: There was insufficient evidence to support its use as an add-on to other anticancer medicines.
Danish: Der var ikke tilstrækkelig dokumentation for, at det kan anvendes som tillægsbehandling til anden kræftmedicin.
English: Other information about Lysodren
Danish: Andre oplysninger om Lysodren
English: Lysodren mitotane
Danish: Lysodren mitotan