FrancophonIA/ELRC3.0 huggingface dataset:
English: These will include information on what to do before and after each injection, the differences between Zypadhera and other injectable medicines containing olanzapine, and the recommendations on how patients should be monitored.
Danish: Disse oplysninger omfatter bl.a. information om, hvad der skal gøres før og efter hver injektion, forskellene på Zypadhera og andre olanzapin-holdige lægemidler til injektion samt anbefalinger til, hvordan patienterne bør observeres.
English: Zypadhera has been studied in two main studies involving adults with schizophrenia.
Danish: Zypadhera er blevet undersøgt i to hovedundersøgelser af voksne med skizofreni.
English: The company that makes Zypadhera will provide an educational programme for doctors, nurses and pharmacists and a card for patients in all Member States, reminding them of how to use the medicine safely.
Danish: Virksomheden, der fremstiller Zypadhera, stiller et uddannelsesprogram til rådighed for læger, sygeplejersker og apotekspersonale og udarbejder et kort til patienter i alle medlemsstater, der indeholder oplysninger om, hvordan man bruger lægemidlet sikkert.
English: Zypadhera is given by deep injection into the buttock muscle by a doctor or nurse who has been trained in giving this type of injection.
Danish: Zypadhera gives som injektion dybt i ballemusklen af en læge eller en sygeplejerske, der er uddannet til at give denne type injektion.
English: All of the patients in this study had been stabilised with other treatments for schizophrenia and had been taking olanzapine by mouth for at least six weeks before the study began.
Danish: Alle patienter i undersøgelsen var først blevet stabiliseret med andre behandlinger for skizofreni og havde taget olanzapin i tabletform i mindst seks uger, inden undersøgelsen startede.
English: The most common side effects with Zypadhera (seen in more than 1 patient in 10) are weight gain, somnolence (sleepiness), orthostatic hypotension (sudden drop in blood pressure on standing up) and raised levels of prolactin (a hormone).
Danish: De hyppigste bivirkninger ved Zypadhera (som ses hos flere end 1 ud af 10 patienter) er vægtforøgelse, søvnighed, ortostatisk hypotension (pludseligt blodtryksfald, når patienten rejser sig) og forhøjet prolaktin (et hormon).
English: The main measures of effectiveness were the time taken for symptoms to get worse and the number of patients whose symptoms got worse over 24 weeks.
Danish: Behandlingens virkning blev hovedsagelig bedømt på den tid, det tog symptomerne at blive værre, samt det antal patienter, hvis symptomer blev værre i løbet af 24 uger.
English: In the study of the initial treatment of schizophrenia, Zypadhera was more effective than placebo.
Danish: I undersøgelsen af den indledende behandling af skizofreni var Zypadhera mere effektivt end placebo.
English: It is available as tablets, orodispersible tablets (tablets that dissolve in the mouth) and rapidly acting injections in Zyprexa, Zyprexa Velotab and other medicines.
Danish: Det fås som tabletter, smeltetabletter (dvs. tabletter, der opløses i munden) og hurtigtvirkende injektioner, blandt andet i lægemidlerne Zyprexa og Zyprexa Velotab.
English: Zypadhera must not be injected into a vein or under the skin.
Danish: Zypadhera må ikke injiceres i blodårerne eller under huden.
English: Patients who have symptoms of overdose should continue to be monitored until the symptoms have passed.
Danish: Patienter, der udviser tegn på overdosis, skal observeres, til symptomerne er helt væk.
English: The active substance in Zypadhera, olanzapine, is an antipsychotic medicine.
Danish: Det aktive stof i Zypadhera, olanzapin, er et antipsykotisk lægemiddel.
English: However, patients aged between 65 and 75 years or patients with kidney or liver problems may use Zypadhera if an effective and welltolerated dose of oral olanzapine has been found.
Danish: Patienter mellem 65 og 75 år eller patienter med nyre- eller leverproblemer kan dog godt bruge Zypadhera, hvis der er fundet en effektiv dosis olanzapin i tabletform, som patienten tåler godt.
English: Zypadhera must not be used in patients who are hypersensitive (allergic) to olanzapine or any of the other ingredients.
Danish: Zypadhera må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for olanzapin eller andre af indholdsstofferne.
English: The first looked at the initial treatment of schizophrenia and the second looked at the maintenance of response to olanzapine treatment:
Danish: Den første undersøgelse fokuserede på den indledende behandling af skizofreni, og den anden fokuserede på opretholdelse af respons på behandling med olanzapin:
English: Zypadhera is a medicine that contains the active substance olanzapine.
Danish: Zypadhera er et lægemiddel, der indeholder det aktive stof olanzapin.
English: Other information about Zypadhera
Danish: Andre oplysninger om Zypadhera:
English: The Committee decided that Zypadhera's benefits are greater than its risks and recommended that Zypadhera be given marketing authorisation.
Danish: Udvalget fandt, at fordelene ved Zypadhera opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: In addition, it is not possible to stop treatment after giving a prolonged-release injection, which would not be suitable for patients experiencing side effects.
Danish: Det er desuden ikke muligt at afbryde behandlingen, når man først har givet en depotinjektion, og denne behandlingsform er derfor ikke egnet til patienter, der får bivirkninger.
English: For the full list of all side effects reported with Zypadhera, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Zypadhera fremgår af indlægssedlen.
English: The dose depends on the dose of olanzapine that the patient was previously taking by mouth.
Danish: Dosis afhænger af den dosis olanzapin, som patienten tog tidligere i tabletform.
English: The main measure of effectiveness was the change in symptoms measured on a standard scale for schizophrenia after eight weeks;
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen af patienternes symptomer, der blev målt på en standardskala for skizofreni efter otte uger.
English: The CHMP noted that Zypadhera is effective both in the initial treatment of schizophrenia and in maintaining a response to treatment in schizophrenia.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at Zypadhera er effektivt både ved indledende behandling af skizofreni og ved opretholdelse af respons på behandling af skizofreni.
English: In rare cases, patients receiving Zypadhera may experience symptoms of olanzapine overdose after injection if the medicine is accidentally injected into a vein.
Danish: I sjældne tilfælde kan patienter, der får Zypadhera, få symptomer på olanzapin-overdosis efter injektionen, hvis medicinen ved et uheld indsprøjtes i en blodåre.
English: Which measures are being taken to ensure the safe use of Zypadhera?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Zypadhera?
English: In the study looking at the maintenance of response to olanzapine treatment, Zypadhera was as effective as olanzapine taken by mouth: 10% of the patients receiving Zypadhera every two weeks had a worsening of symptoms, compared with 7% of those taking olanzapine by mouth.
Danish: I den undersøgelse, der fokuserede på opretholdelse af respons på behandling med olanzapin, var Zypadhera lige så effektivt som olanzapin i tabletform: 10 % af de patienter, der fik Zypadhera hver anden uge, oplevede, at symptomerne blev værre.
English: Because patients should be monitored by qualified staff for these symptoms for at least three hours after injection, they should receive Zypadhera at a centre with the appropriate facilities to deal with a potential overdose.
Danish: Patienterne skal være under opsyn af medicinsk personale i mindst tre timer efter injektionen, og de skal derfor behandles med Zypadhera på en klinik med tilstrækkelige faciliteter til at behandle en eventuel overdosis.
English: • the study of initial treatment compared the effects of three doses of Zypadhera with those of placebo (dummy injections) in 404 patients.
Danish: • - Undersøgelsen af den indledende behandling sammenlignede virkningen af tre doser Zypadhera med placebo (virkningsløse injektioner) hos 404 patienter.
English: A lower starting dose may be necessary in patients whose bodies may break olanzapine down slowly, such as those with moderate liver problems.
Danish: Det kan være nødvendigt med en lavere startdosis til patienter, hvis kroppe nedbryder olanzapin langsomt.
English: Zypadhera is used to maintain the improvement in symptoms in patients with schizophrenia who have already been stabilised on an initial course of olanzapine taken by mouth.
Danish: Zypadhera bruges til at fastholde forbedringen af symptomer hos patienter med skizofreni, der allerede er blevet stabiliseret med olanzapin i tabletform.
English: • the study of maintenance treatment compared the effects of four doses of Zypadhera with those of olanzapine taken by mouth in 1,065 patients.
Danish: • - Undersøgelsen af vedligeholdelsesbehandlingen sammenlignede virkningen af fire doser Zypadhera med olanzapin i tabletform hos 1 065 patienter.
English: Symptom scores were around 100 points at the start of the study, but had fallen by around 25 points in the patients receiving Zypadhera after eight weeks, compared with around 9 points in the patients receiving placebo.
Danish: Symptomscorerne lå på omkring 100 point i starten af undersøgelsen, men efter otte uger var de faldet med omkring 25 point hos de patienter, der fik Zypadhera.
English: The effectiveness of Zypadhera was greater than placebo from the second week of treatment onwards.
Danish: Effekten af Zypadhera var større end placebo fra den anden behandlingsuge og frem.
English: The olanzapine in Zypadhera is presented as a ‘pamoate' salt, which makes the olanzapine less soluble.
Danish: Olanzapinet i Zypadhera har form af en såkaldt "pamoat"salt, der gør, at olanzapinet opløses langsommere.
English: What is the risk associated with Zypadhera?
Danish: Hvilke risici er der forbundet med Zypadhera?
English: Why has Zypadhera been approved?
Danish: Hvorfor blev Zypadhera godkendt?
English: What is Zypadhera?
Danish: Hvad er Zypadhera?
English: It is available as a powder and solvent that are made up into a prolonged-release suspension for injection.
Danish: Det fås som et pulver og en opløsningsvæske, der blandes og gives som depotinjektion.
English: How has Zypadhera been studied?
Danish: Hvordan er Zypadhera blevet undersøgt?
English: Patients should be monitored closely for signs of relapse (a return of symptoms) during the first one to two months of treatment, and the dose adjusted if necessary.
Danish: I en til to måneder efter behandlingsstart skal patienterne observeres nøje for at se, om der er tegn på tilbagefald (symptomerne vender tilbage).
English: What is Zypadhera used for?
Danish: Hvad anvendes Zypadhera til?
English: How is Zypadhera used?
Danish: Hvordan anvendes Zypadhera?
English: What benefit has Zypadhera shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zypadhera?
English: How does Zypadhera work?
Danish: Hvordan virker Zypadhera?
English: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).Avoid the use of abbreviations].
Danish: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE
English: On the basis of the scientific conclusions for {name of active substance(s)} the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing {name of active substance(s)} is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for {navn på det/de aktive stof(fer)} er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder {navn på det/de aktive stof(fer)}, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {name of active substance(s)}, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for {navn på det/de aktive stof(fer)} er CHMP nået frem til følgende videnskabelige konklusioner:
English: OF THE MARKETING AUTHORISATION(S)
Danish: FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: The European Commission issued a decision on 16 September 2011.
Danish: Europa-Kommissionen traf en afgørelse den 16. september 2011.
English: Outcome of a procedure under Article 36 of Directive 2001/83/EC as amended
Danish: Resultat af en indbringelsesprocedure i henhold til artikel 36 i direktiv 2001/83/EF med senere ændringer
English: What is Goserelin?
Danish: Hvad er Goserelin?
English: Why was Goserelin reviewed?
Danish: Hvorfor blev Goserelin vurderet igen?
English: It is a copy of the natural hormone (luteinizing hormone-releasing hormone) that regulates many processes in the body.
Danish: Det er en kopi af det naturlige hormon (luteiniserende hormonfrigivende hormon), som regulerer mange processer i kroppen.
English: Goserelin is used to treat patients with advanced prostate cancer.
Danish: Goserelin anvendes til behandling af patienter med fremskreden prostatakræft.
English: In prostate cancer it works by depriving prostate cancer cells of the male hormone testosterone on which they depend to grow and spread.
Danish: Ved prostatakræft virker det ved at unddrage prostatacancerceller det mandlige hormon testosteron, som de er afhængige af for at vokse og brede sig.
English: The marketing authorisation should therefore be suspended in all member states until the companies provide new studies showing therapeutic equivalence and being GCP compliant.
Danish: Markedsføringstilladelsen bør derfor suspenderes i alle medlemsstater, indtil virksomhederne fremsender nye undersøgelser, der påviser den terapeutiske ækvivalens og er i overensstemmelse med kravene til god klinisk praksis.
English: Based on the evaluation of the studies that were submitted in support of the marketing authorisation application and the scientific discussion within the Committee, the CHMP concluded that therapeutic equivalence has not been demonstrated and as such the benefit risk balance for these hybrid products was considered negative.
Danish: Baseret på vurderingen af de undersøgelser, der blev fremsendt som støtte for ansøgningen om markedsføringstilladelse og den videnskabelige drøftelse i udvalget, konkluderede CHMP, at terapeutisk ækvivalens ikke er blevet påvist, og som sådan blev risk/benefit-forholdet for disse hybride lægemidler anset for at være negativt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that these medicines have not be shown to be equivalent to the reference medicine (Zoladex) and therefore the marketing authorisation should be suspended until therapeutic equivalence has been demonstrated.
Danish: EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at det ikke er blevet påvist, at disse lægemidler svarer til referencelægemidlet (Zoladex), og derfor bør markedsføringstilladelsen suspenderes, indtil terapeutisk ækvivalens er blevet påvist.
English: The German medicines regulatory agency considered that a suspension of the marketing authorisation of the already authorised medicines was necessary as therapeutic equivalence with the reference medicinal product could not be guaranteed.
Danish: Den tyske lægemiddelkontrolmyndighed var af den opfattelse, at en suspendering af markedsføringstilladelsen af de allerede godkendte lægemidler var nødvendig, eftersom terapeutisk ækvivalens med referencelægemidlet ikke kunne garanteres.
English: Goserelin is marketed as a hybrid of Zoladex under the names Novimp, Goserelin Cell Pharma, Novosis Goserelin and associated names.
Danish: Goserelin markedsføres som en hybrid af Zoladex under navnene Novimp, Goserelin Cell Pharma, Novosis Goserelin og relaterede navne.
English: whether the marketing authorisations for Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names should be maintained, varied, suspended or withdrawn across the EU.
Danish: Cell Pharm, Novimp og relaterede navne burde opretholdes, varieres, suspenderes eller tilbagekaldes i hele EU.
English: Following an inspection, the German medicines regulatory agency found that the clinical studies performed as part of the marketing authorisation applications for some goserelin containing medicines were not conducted in accordance with Good Clinical Practice (GCP) and questioned whether their results could be relied on.
Danish: Efter en inspektion fandt den tyske lægemiddelkontrolmyndighed, at de kliniske undersøgelser, som udførtes som en del af ansøgningen om markedsføringstilladelse for visse lægemidler indeholdende goserelin, ikke var blevet udført i overensstemmelse med god klinisk praksis, og den satte spørgsmålstegn ved, om deres resultater var pålidelige.
English: The European Medicines Agency has completed a review of the clinical studies that were submitted as part of the marketing authorisation application of the hybrid (a type of generic) medicinal products Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant).
Danish: Det Europæiske Lægemiddelagentur har gennemført en vurdering af de kliniske undersøgelser, der blev fremsendt som en del af ansøgningen om markedsføringstilladelse for de hybride (en form for generiske) lægemidler Novosis Goserelin, Goserelin Cell Pharm, Novimp og relaterede navne (goserelin, 3,6 mg implantat).
English: On 16 March 2011, the German agency referred the matter to the CHMP so that the Committee could give its opinion on
Danish: Den 16. marts 2011 indbragte den tyske lægemiddelkontrolmyndighed sagen for CHMP, for at udvalget kunne afgive sin udtalelse om, hvorvidt markedsføringstilladelserne for Novosis Goserelin, Goserelin
English: The physician information should contain the following key messages:
Danish: Informationen til lægen bør indeholde følgende nøglebeskeder:
English: • The need to evaluate patients for both active and inactive tuberculosis prior to starting the treatment, including use of appropriate screening tests,
Danish: • Nødvendigheden af at undersøge patienter for både aktiv og inaktiv tuberkulose før behandlingsstart, inklusive brug af hensigtsmæssige screeningstests,
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Cimzia are provided with a physician information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal før lancering sikre, at alle læger, som forventes at ordinere/anvende Cimzia, er forsynet med en informationspakke til læger, som indeholder følgende:
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, som er beskrevet nedenfor, er implementeret:
English: • The role and use of patient alert card.
Danish: • Patient-informationskortets rolle og anvendelse.
English: • The risk of acute injection-related reactions and delayed serious systemic hypersensitivity reactions, the need for instructing patients on techniques for administration, and guidance for Health Care Professionals on how to report administration errors,
Danish: • Risikoen for akutte injektionsrelaterede reaktioner og forsinkede systemiske allergiske reaktioner, nødvendigheden af at instruere patienter i administrationsteknik og vejledning af sundhedspersonale i, hvordan administrationsfejl rapporteres,
English: • The contraindication of Cimzia in patients with history of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure being worsened by Cimzia,
Danish: • Kontraindikation af Cimzia hos patienter med moderat til alvorligt hjertesvigt (NYHA funktionsklasse III/IV) og potentiel risiko for at kongestiv hjertesvigt forværres af Cimzia,
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Cimzia,
Danish: • Risikoen for alvorlige infektioner, inklusive opportunistiske bakterielle-, virale- eller svampeinfektioner hos patienter behandlet med Cimzia,
English: • Patient Alert Card
Danish: • Patient-informationskort
English: The mutual recognition procedure (UK/V/0373/001/MR) started on 29 July 2010.
Danish: Den gensidige anerkendelsesprocedure (UK/V/0373/001/MR) blev indledt den 29. juli 2010.
English: The final opinion was converted into a Decision by the European Commission on 24 August 2011.
Danish: Den endelige udtalelse blev den 24. august 2011 omarbejdet til en beslutning af EuropaKommissionen.
English: The referral procedure started on 9 February 2011.
Danish: Henvisningsproceduren blev indledt den 9. februar 2011.
English: The marketing authorisation holder, Dechra Ltd, submitted an application for Clavudale 50 mg via a mutual recognition procedure in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Spain and Sweden on the basis of the marketing authorisation granted by the United Kingdom.
Danish: Indehaveren af markedsføringstilladelsen, Dechra Ltd, indgav en ansøgning for Clavudale, 50 mg, via en gensidig anerkendelsesprocedure i Østrig, Belgien, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Luxembourg, Nederlandene, Norge, Polen, Portugal, Slovakiet, Spanien og Sverige på grundlag af den markedsføringstilladelse, der var udstedt af Det Forenede Kongerige.
English: On 28 January 2011, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by two of the Concerned Member States, the Netherlands and Sweden, that the safety and efficacy of the product had not been sufficiently demonstrated.
Danish: Den 28. januar 2011 indbragte Det Forenede Kongerige som referencemedlemsstat sagen for Det Europæiske Lægemiddelagentur i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF på grund af betænkeligheder rejst af to af de berørte medlemsstater, Nederlandene og Sverige, der fandt, at produktets sikkerhed og virkning ikke var tilfredsstillende godtgjort.
English: There was disagreement between the Reference Member State and these Concerned Member States on the demonstration of bioequivalence in the cat target species.
Danish: Der var uenighed mellem referencemedlemsstaten og disse berørte medlemsstater vedrørende påvisningen af bioækvivalens i måldyrearten katte.
English: International non-proprietary name (inn): amoxicillin, clavulanic acid
Danish: Internationalt fællesnavn (INN): amoxicillin, clavulansyre
English: The list of product names concerned is given in Annex I. The scientific conclusions for the granting of the marketing authorisation are provided in Annex II.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De faglige konklusioner, der ligger til grund for udstedelsen af markedsføringstilladelsen, fremgår af bilag II.
English: The Committee appointed Dr Karolina Törneke as rapporteur and Ms Helen Jukes as co-rapporteur.
Danish: Som rapportør og medrapportør udpegedes henholdsvis dr. Karolina Törneke og Helen Jukes.