FrancophonIA/ELRC3.0 huggingface dataset:
English: • Ever since these impurities were first seen in some sartan medicines, regulatory authorities in the EU have been working to protect patients' health.
Danish: • Siden urenhederne første gang blev opdaget i nogle sartanlægemidler, har lægemiddelmyndighederne i EU arbejdet for at beskytte patienternes helbred.
English: Products containing either impurity above these limits or products containing both nitrosamines at whatever level will not be allowed in the EU.
Danish: Produkter, der indeholder en af urenhederne i en mængde over disse grænseværdier, og produkter, der indeholder begge nitrosaminer, uanset niveau, er ikke tilladt i EU.
English: The CHMP opinion was forwarded to the European Commission, which issued final legally binding decisions for the medicines concerned between 2 April and 17 April 2019 that are applicable in all EU Member States.
Danish: CHMP's udtalelse blev sendt til Europa-Kommissionen, der traf juridisk bindende afgørelser med gyldighed i alle EU's medlemsstater for de berørte lægemidler mellem den 2. april og den 17. april
English: Companies will have a transition period to make any necessary changes, during which strict temporary limits on levels of these impurities will apply.
Danish: Virksomhederne vil have en overgangsperiode til at gennemføre eventuelle nødvendige ændringer, og i denne periode vil der gælde midlertidige strenge grænseværdier for disse urenheder.
English: They work by blocking the action of angiotensin II, a hormone that constricts blood vessels and causes blood pressure to rise.
Danish: De virker ved at blokere virkningen af angiotensin II, der er et hormon, som indsnævrer blodkarrene og får blodtrykket til at stige.
English: For the vast majority of sartan medicines, impurities were either not found or were present at very low levels.
Danish: For størstedelen af sartanlægemidlernes vedkommende blev der enten ikke fundet urenheder, eller de blev fundet i meget små mængder.
English: Before June 2018, NDMA and NDEA were not among the impurities identified in sartan medicines and were therefore not detected by routine tests.
Danish: Før juni 2018 var NDMA og NDEA ikke blandt de urenheder, der var konstateret i sartanlægemidler, og de blev derfor ikke opdaget ved de rutinemæssige undersøgelser.
English: After the transition period, companies must exclude the presence of even lower levels of NDEA or NDMA in their products (< 0.03 parts per million).
Danish: Efter overgangsperioden skal virksomhederne sikre, at der er endnu lavere niveauer af NDEA eller NDMA i deres produkter (færre end 0,03 ppm).
English: • There is a very low risk that nitrosamine impurities at the levels previously found in some sartan medicines could cause cancer in humans.
Danish: • Der er en meget lille risiko for, at nitrosaminurenheder ved de niveauer, der tidligere er fundet i nogle sartanlægemidler, kan medføre kræft hos mennesker.
English: The transition period, which will last for 2 years, will allow companies to make the necessary changes to their manufacturing processes and to put in place testing regimes able to detect the smallest amounts of these impurities.
Danish: Overgangsperioden på 2 år vil sætte virksomhederne i stand til at foretage de nødvendige ændringer i deres fremstillingsprocesser og indføre undersøgelser, der kan opdage selv de mindste mængder af disse urenheder.
English: Dividing these by the maximum daily dose for each active substance gives the limit in parts per million (see Table 1).
Danish: Ved at dividere disse værdier med den maksimale daglige dosis for hvert aktive stof får man grænseværdien i ppm (parts per million; se tabel
English: On 20 September 2018, the review was extended to include medicines containing candesartan, irbesartan, losartan and olmesartan.
Danish: Den 20. september 2018 blev gennemgangen udvidet til at omfatte lægemidler, der indeholder candesartan, irbesartan, losartan og olmesartan.
English: EMA and national authorities will continue investigating the presence of nitrosamine impurities in medicines, including other impurities such as N-nitrosoethylisopropylamine (EIPNA), Nnitrosodiisopropylamine (DIPNA) and N-nitroso-N-methylamino butyric acid (NMBA).
Danish: EMA og nationale myndigheder vil fortsat undersøge tilstedeværelsen af nitrosaminurenheder i lægemidler, herunder andre urenheder som f.eks. N-nitrosoethylisopropylamin (EIPNA), Nnitrosodiisopropylamin (DIPNA) og N-nitroso-N-methylamino-smørsyre (NMBA).
English: On 31 January 2019, EMA recommended that companies making sartan blood pressure medicines (also known as angiotensin II receptor blockers) review their manufacturing processes so that they do not produce nitrosamine impurities.
Danish: EMA anbefalede den 31. januar 2019, at de virksomheder, der fremstiller sartanholdige blodtrykslægemidler (såkaldte angiotensin II-receptor-blokkere), gennemgår deres fremstillingsprocesser, så der ikke dannes nitrosaminurenheder.
English: In addition, it is possible that impurities were present in some
Danish: Derudover er det muligt, at urenhederne var til stede i nogle sartaner,
English: While the goal is to have no quantifiable nitrosamine impurities in sartans, interim limits have been set for NDMA and NDEA in line with current international guidelines.2
Danish: Målet er, at der ikke skal være målbare niveauer af nitrosamin-urenheder i sartaner, men der er fastsat midlertidige grænseværdier for NDMA og NDEA i overensstemmelse med internationale retningslinjer.2
English: These sartan medicines have a specific ring structure (tetrazole) whose synthesis could potentially lead to the formation of nitrosamine impurities.
Danish: Disse sartanlægemidler har en specifik ringstruktur (tetrazol), hvis syntese kan medføre dannelse af nitrosaminurenheder.
English: • These impurities can form during the production of sartans that contain a tetrazole ring when certain reaction conditions are met or when contaminated materials are used.
Danish: • Disse urenheder kan dannes under fremstillingen af sartaner, der indeholder en tetrazolring, når visse reaktionsbetingelser er opfyldt, eller når der anvendes kontaminerede materialer.
English: The review concerns candesartan, irbesartan, losartan, olmesartan and valsartan, which belong to a class of medicines called sartans (also known as angiotensin-II-receptor antagonists).
Danish: Gennemgangen vedrører candesartan, irbesartan, losartan, olmesartan og valsartan, der hører til en gruppe lægemidler kaldet sartaner (såkaldte angiotensin II-receptor-blokkere).
English: It is now known that these impurities can form during the production of sartans that contain a specific ring structure known as a tetrazole ring under certain conditions and when certain solvents, reagents, and other raw materials are used.
Danish: Det vides nu, at disse urenheder kan dannes under visse betingelser ved fremstillingen af sartaner, der indeholder en specifik ringstruktur, som kaldes en tetrazolring, og når visse solvenser, reagenser og andre råmaterialer anvendes.
English: • For NDMA, the key step involves dimethylamine (DMA) which forms the impurity in the presence of nitrites, usually under acidic conditions.
Danish: • Hvad angår NDMA, involverer det centrale fremstillingstrin dimethylamin (DMA), der danner urenheden ved tilstedeværelse af nitriter, typisk under sure betingelser.
English: These recommendations follow EMA's review of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which are classified as probable human carcinogens (substances that could cause cancer) and have been detected in some sartan medicines.
Danish: Anbefalingerne kommer efter EMA's gennemgang af N-nitrosodimethylamin (NDMA) og Nnitrosodiethylamin (NDEA), der er klassificeret som sandsynlige karcinogener for mennesker (kræftfremkaldende stoffer), og som er konstateret i nogle sartanlægemidler.
English: Temporary limits for NDMA and NDEA impurities
Danish: Midlertidige grænseværdier for urenhederne NDMA og NDEA NDMA
English: It concluded that if 100,000 patients took valsartan from Zhejiang Huahai (where the highest levels of impurities were found) every day for 6 years at the highest dose, there could be 22 extra cases of cancer due to NDMA over the lifetimes of those 100,000 patients.
Danish: EMA konkluderede, at der ville forekomme 22 ekstra tilfælde af kræft pr. 100.000 patienter som følge af NDMA i løbet af patienternes livstid, hvis de tog den højeste dosis af valsartan fra Zhejiang Huahai hver dag i 6 år.
English: 1 The 6 and 4 years refer to the duration of time NDMA and NDEA are believed to have been present in valsartan from Zhejiang Huahai sartans because manufacturers had inadvertently used contaminated equipment or reagents in the manufacturing process.
Danish: De 6 og 4 år henviser til den tid, som NDMA og NDEA menes at være til stede i valsartan fra Zhejiang Huahai.
English: The limits are based on the maximum daily intake for each impurity derived from animal studies: 96.0 nanograms for NDMA and 26.5 nanograms for NDEA.
Danish: 96,0 nanogram for NDMA og 26,5 nanogram for NDEA.
English: How impurities came to be present in sartans
Danish: Årsagen til urenhederne i sartaner
English: 1 1 ml of solution contains 1.125 mg ibandronic acid, monosodium salt, monohydrate, corresponding to 1mg ibandronic acid.
Danish: 1 1 ml af opløsningen indeholder 1,125 mg ibandronsyre, mononatriunsalt, monohydrat svarende til 1 mg ibandronsyre
English: Ref. EMEA/CHMP/512295/2008
Danish: EMEA/CHMP/511858/2008
English: The procedure started on 21 June 2007.
Danish: Proceduren blev indledt den 21. juni 2007.
English: London, 24 September 2008 Doc.
Danish: London, den 24. september 2008 Ref. dok.
English: The Marketing Authorisation Holder provided supplementary information on 20 December 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte supplerende oplysninger den 20. december 2007.
English: A Decision was issued by the European Commission on 23 September 2008.
Danish: Europa-Kommissionen traf en afgørelse den 23. september 2008.
English: It is indicated in bladder cancer, advanced non-small cell lung cancer, advanced pancreatic cancer, breast cancer and ovarian cancer.
Danish: Det er indiceret til blærecancer, fremskreden ikke-småcellet lungecancer, fremskreden pancreascancer, brystcancer og ovariecancer.
English: Gemzar, 200 mg, 1000 mg, powder for solution for infusion, is a pyrimidine antagonist and is given in the management of solid tumours.
Danish: Gemzar 200 mg, 1000 mg pulver til infusionsvæske er et en pyrimidinantagonist og gives til behandling af solide tumorer.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Gemzar International Non-Proprietary Name (INN): gemcitabine
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN INDBRINGELSE I HENHOLD TIL ARTIKEL 30 Gemzar Internationalt fællesnavn (INN): gemcitabin
English: This medicinal product belongs to the list of products for SPC harmonisation.
Danish: Dette lægemiddel står på listen over lægemidler, for hvilke der skal udarbejdes et harmoniseret produktresumé.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Gemzar approved across EU Member States, mainly with respect to the approved indications, the posology, the contra-indications and the warnings.
Danish: Grundlaget for indbringelsen var, at der var afvigelser i produktresuméerne, herunder kvalitetsaspekter, for Gemzar, som er godkendt i alle EU-medlemsstaterne, hovedsageligt med henblik på de godkendte indikationer, doseringsanvisningen, kontraindikationerne og advarslerne.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Danish: Listen over de berørte lægemiddelnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II og det ændrede produktresumé, indlægsseddel og etikettering af bilag III.
English: On 8 June 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Gemzar.
Danish: Den 8. juni 2007 indbragte Europa-Kommissionen en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, for at harmonisere de nationalt godkendte produktresuméer, indlægsseddel og etikettering, herunder kvalitetsaspekter, for lægemidlet Gemzar.
English: During its June 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Danish: På mødet i juni 2008 var CHMP, på baggrund af de samlede fremlagte oplysninger og den faglige drøftelse i udvalget, af den opfattelse, at forslaget til harmonisering af produktresuméet, indlægssedlen og etiketteringen, herunder kvalitetsaspekterne, var acceptabelt, og at disse følgelig burde ændres.
English: The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Gemzar.
Danish: CHMP afgav en positiv udtalelse den 26. juni 2008, hvori udvalget anbefalede harmonisering af produktresuméet, indlægssedlen og etiketteringen, herunder kvalitetsaspekter, for Gemzar.
English: 33 mg/g Granules
Danish: Viread 33 mg/g Granulat
English: Oral use bottle (HDPE) 1 x 60 g granules
Danish: 1 x 60 g granulat
English: This is a summary of the European public assessment report (EPAR) for Karvezide.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Karvezide.
English: The European Commission granted a marketing authorisation valid throughout the EU for Karvezide on 16 October 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Karvezide den 16. oktober 1998.
English: The full EPAR for Karvezide can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Karvezide findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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 Karvezide.
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 Karvezide.
English: Other information about Karvezide
Danish: Andre oplysninger om Karvezide:
English: For more information about treatment with Karvezide, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Karvezide, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Karvezide's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Karvezide opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: What is the risk associated with Karvezide?
Danish: Hvilken risiko er der forbundet med Karvezide?
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Karvezide.
Danish: De undersøgelser, der blev foretaget med Karvea/Aprovel i kombination med hydrochlorothiazid som enkelttabletter, blev brugt til at understøtte brugen af Karvezide.
English: The most common side effects with Karvezide (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles).
Danish: De mest almindelige bivirkninger ved Karvezide (der ses hos mellem 1 og 10 patienter ud af 100) er svimmelhed, kvalme eller opkastning, uregelmæssig vandladning, træthed, forhøjet indhold af urinkvælstof (BUN, et spaltningsprodukt af protein), kreatinin (et spaltningsprodukt fra musklerne) og kreatinkinase (et enzym i musklerne).
English: Karvezide irbesartan / hydrochlorothiazide
Danish: Irbesartan/hydrochlorothiazid
English: Why has Karvezide been approved?
Danish: Hvorfor blev Karvezide godkendt?
English: Karvezide was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Danish: Karvezide var mere effektivt end placebo (en virkningsløs behandling) og hydrochlorothiazid alene til at reducere det diastoliske blodtryk.
English: The dose of Karvezide to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Danish: Dosen af Karvezide afhænger af den dosis irbesartan eller hydrochlorothiazid, som patienten tog tidligere.
English: Karvezide in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Danish: Karvezide i kombination med lægemidler, der indeholder aliskiren (som anvendes til behandling af essentiel hypertension), må ikke anvendes til patienter med diabetes eller moderat eller alvorlig nyresygdom.
English: Karvezide must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Danish: Karvezide må ikke anvendes til personer, som er overfølsomme (allergiske) over for irbesartan, hydrochlorothiazid, sulfonamider eller andre af indholdsstofferne.
English: Care must be taken when using Karvezide with other medicines that have an effect on blood potassium levels.
Danish: Der skal udvises forsigtighed, når Karvezide anvendes sammen med andre lægemidler, som kan påvirke indholdet af kalium i blodet.
English: What is Karvezide?
Danish: Hvad er Karvezide?
English: Karvezide is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Danish: Karvezide anvendes til voksne med essentiel hypertension (forhøjet blodtryk), som ikke kan kontrolleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
English: For the full list of all side effects reported with Karvezide, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Karvezide fremgår af indlægssedlen.
English: Karvezide must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Danish: Karvezide må heller ikke gives til patienter, som har svære lever-, nyre- eller galdeproblemer, for lavt indhold af kalium i blodet eller for højt indhold af calcium i blodet.
English: Karvezide is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Karvezide er et lægemiddel, der indeholder de to aktive stoffer irbesartan og hydrochlorothiazid.
English: Karvezide may be added to some other treatments for hypertension.
Danish: Karvezide kan bruges som tillægsbehandling til visse andre behandlinger mod hypertension.
English: Karvezide contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Karvezide indeholder to aktive stoffer, irbesartan og hydrochlorothiazid.
English: What is Karvezide used for?
Danish: Hvad anvendes Karvezide til?
English: How has Karvezide been studied?
Danish: Hvordan blev Karvezide undersøgt?
English: What benefit has Karvezide shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Karvezide?
English: How is Karvezide used?
Danish: Hvordan anvendes Karvezide?
English: How does Karvezide work?
Danish: Hvordan virker Karvezide?
English: The European Commission issued a decision on 2 June 2009.
Danish: Europa-Kommissionen traf en afgørelse den 2. juni 2009.
English: The company wanted the authorisation to be recognised in Austria, Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia (the concerned Member States).
Danish: Virksomheden ønskede, at markedsføringstilladelsen blev anerkendt i Østrig, Bulgarien, Den Tjekkiske Republik, Ungarn, Polen, Rumænien og Slovakiet (de berørte medlemsstater).
English: London, 4 June 2009 Doc.
Danish: London, den 4. juni 2009 Dok.
English: What is Betavert N?
Danish: Hvad er Betavert N?
English: Medicines are bioequivalent when they produce the same levels of active substance in the body.
Danish: Lægemidler er bioækvivalente, når de producerer det samme indhold af aktivt stof i kroppen.
English: Questions and answers on the referral for Betavert N tablets containing betahistine dihydrochloride (8 or 16 mg)
Danish: Spørgsmål og svar vedrørende indbringelsen af sagen om Betavert N tabletter indeholdende betahistin dihydrochlorid (8 eller 16 mg)
English: However, the member states were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 30 October 2008.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og den tyske lægemiddelmyndighed henviste sagen til CHMP til voldgift den 30. oktober 2008.
English: Betavert N is a ‘generic medicine'.
Danish: Betavert N er et “generisk lægemiddel”.
English: Why was Betavert N reviewed?
Danish: Hvorfor blev Betavert N revurderet?
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Betavert N. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Betavert N outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the European Union.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har gennemført en voldgiftsprocedure som følge af uenighed blandt medlemsstater i Den Europæiske Union om godkendelsen af lægemidlet Betavert N. Agenturets Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Betavert N opvejer risiciene, og at den udstedte markedsføringstilladelse i Tyskland kan anerkendes i de andre medlemsstater i Den Europæiske Union.
English: Patients with Menière's disease have vertigo (a spinning sensation), often associated with feeling sick or vomiting, tinnitus (ringing in the ear) and hearing loss.
Danish: Patienter med Menières sygdom oplever svimmelhed, der ofte ledsages af kvalme eller opkast, samt tinnitus (ringen i ørerne) og høretab.
English: Betavert N is used to treat patients with Menière's disease.
Danish: Betavert N anvendes til behandling af patienter med Menières sygdom.
English: The active substance in Betavert N, betahistine, is an analogue of histamine, a naturally-occurring substance in the body that is involved in many processes.
Danish: Det aktive stof i Betavert N, betahistin, svarer til histamin, som er et naturligt forekommende stof i kroppen, der er involveret i mange processer.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Betavert N and Betaserc 8 had been demonstrated.
Danish: På grundlag af vurderingen af de aktuelt foreliggende data og den faglige drøftelse i udvalget var CHMP af den opfattelse, at der var påvist bioækvivalens mellem Betavert N og Betaserc 8.
English: In Menière's disease, betahistine is thought to attach to some receptors to which histamine normally attaches.
Danish: Ved Menières sygdom menes betahistin at binde sig til nogle receptorer, som histamin normalt binder sig til.