FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should also be monitored for symptoms of liver injury (such as loss of appetite, nausea and vomiting, itching, tiredness and pain in the upper-right side of the belly) during treatment.
Danish: Patienten skal også overvåges for symptomer på leverskade under behandlingen (f.eks. appetitløshed, kvalme og opkastning, kløe, træthed og smerter i øvre højre side af maveregionen).
English: The first study included 1,445 patients with normal or moderately reduced kidney function, and measured the change in kidney size after 3 years of treatment.
Danish: Det første studie omfattede 1.445 patienter med normal eller moderat nedsat nyrefunktion og målte ændringen i nyrestørrelse efter 3 års behandling.
English: By blocking vasopressin receptors in the kidneys, Jinarc can slow down cyst formation.
Danish: Ved at blokere vasopressinreceptorerne i nyrerne kan Jinarc bremse cystedannelsen.
English: Subsequent supportive results confirmed that increase in kidney size over 5 years was slower with Jinarc.
Danish: Efterfølgende understøttende resultater bekræftede, at forøgelsen af nyrernes størrelse over 5 år skete langsommere ved brug af Jinarc.
English: Kidney size increases with disease severity due to swelling caused by cyst formation.
Danish: Nyrestørrelsen øges med sygdommens sværhedsgrad på grund af hævelse, der skyldes cystedannelse.
English: Why is Jinarc authorised in the EU?
Danish: Hvorfor blev Jinarc godkendt i EU?
English: Jinarc may increase blood levels of certain liver enzymes (a sign of possible liver problems).
Danish: Jinarc kan øge koncentrationen af visse leverenzymer i blodet (et tegn på mulige leverproblemer).
English: The active substance in Jinarc, tolvaptan, is a vasopressin-2-receptor antagonist: it blocks receptors (targets) in the kidneys for the hormone vasopressin.
Danish: Det aktive stof i Jinarc, tolvaptan, er en vasopressin-2-receptorantagonist, dvs. det blokerer de receptorer i nyrerne, som hormonet vasopressin binder til.
English: What is Jinarc and what is it used for?
Danish: Hvad er Jinarc, og hvad anvendes det til?
English: The company that markets Jinarc will provide patients and doctors expected to use the medicine with information on the risk of liver toxicity and on the importance of preventing pregnancy during treatment.
Danish: Den virksomhed, der markedsfører Jinarc, skal sikre, at patienter og læger, som forventes at anvende lægemidlet, informeres om risikoen for levertoksicitet og om vigtigheden af at undgå graviditet under behandlingen.
English: What are the risks associated with Jinarc?
Danish: Hvilke risici er der forbundet med Jinarc?
English: The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increase in urine production), nocturia (need to pass urine at night) and pollakiuria (increased need to pass urine during the day).
Danish: De hyppigste bivirkninger ved Jinarc (der kan forekomme hos mere end 2 ud af 10 patienter) er tørst, øget urinproduktion (polyuri), vandladningstrang om natten (nykturi) og øget vandladningstrang om dagen (pollakisuri).
English: Jinarc can be started in patients with normal to severely reduced kidney function and whose disease is progressing rapidly.
Danish: Jinarc kan anvendes hos patienter med normal til svært nedsat nyrefunktion, hvis sygdom udvikler sig hurtigt.
English: Jinarc is a medicine used to treat adults with autosomal dominant polycystic kidney disease.
Danish: Jinarc er et lægemiddel, der anvendes til behandling af voksne med autosomal dominant polycystisk nyresygdom.
English: In patients taking placebo, the total size of the kidneys increased by 19% whereas in those taking Jinarc the increase was 10%.
Danish: Hos patienter, der fik placebo, voksede nyrernes samlede størrelse med 19 %, mens forøgelsen hos patienter, der fik Jinarc, var 10 %.
English: This is an inherited condition in which numerous fluid-filled cysts develop in the kidneys, which eventually reduce kidney function and can cause the kidneys to fail.
Danish: Det er en arvelig sygdom, hvor der udvikles mange væskefyldte cyster i nyrerne, hvilket efterhånden nedsætter nyrefunktionen og kan bevirke, at nyrerne svigter.
English: It must not be used in patients with hypernatraemia (increased sodium levels in the blood) and in patients who are allergic to tolvaptan or medicines that are similar to tolvaptan, so-called benzazepines or their derivatives.
Danish: Jinarc må ikke anvendes hos patienter med forhøjede natriumniveauer i blodet (hypernatriæmi) eller hos patienter, som er allergiske over for tolvaptan eller lignende stoffer, såkaldte benzazepiner eller derivater heraf.
English: Jinarc can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in treating autosomal dominant polycystic kidney disease and with knowledge about the risks of treatment with Jinarc.
Danish: Jinarc udleveres kun efter recept, og behandlingen skal iværksættes og overvåges af en læge med erfaring i behandling af autosomal dominant polycystisk nyresygdom og med viden om risiciene ved behandling med Jinarc.
English: Jinarc must not be used in patients who are anuric (cannot pass urine or have difficulty in passing it), volume depleted (have reduced amounts of fluids in the body) and in patients who cannot perceive or respond to thirst.
Danish: Jinarc må ikke anvendes hos patienter, der ikke kan eller har svært ved at lade vandet (anuri), hos patienter med reduceret væskemængde i kroppen (volumendepletering) eller hos patienter, der ikke opfatter eller reagerer på tørst.
English: In autosomal dominant polycystic kidney disease, it is thought that kidney cells do not respond normally to vasopressin, leading to the formation of fluid-filled cysts.
Danish: Ved autosomal dominant polycystisk nyresygdom mener man, at nyrecellerne ikke reagerer normalt på vasopressin, hvorved der dannes væskefyldte cyster.
English: The Agency noted the unmet need for treatments for autosomal dominant polycystic kidney disease and considered that Jinarc is effective at slowing down cyst formation and the decline in kidney function in patients with the condition.
Danish: Agenturet fremhævede det uopfyldte behov for behandling af autosomal dominant polycystisk nyresygdom og vurderede, at Jinarc er effektivt til at bremse cystedannelsen og forringelsen af nyrefunktionen hos patienter med denne tilstand.
English: Jinarc must not be started in certain patients with increased blood levels of liver enzymes or with signs or symptoms of liver injury.
Danish: Jinarc må ikke anvendes hos visse patienter med forhøjede koncentrationer af leverenzymer i blodet eller med tegn eller symptomer på leverskade.
English: In 262 patients with severely reduced kidney function, the decline in kidney function was 17% less with Jinarc after 1 year of treatment compared with placebo.
Danish: Hos 262 patienter med svært nedsat nyrefunktion var forringelsen af nyrefunktionen 17 % mindre i Jinarc-gruppen end i placebo-gruppen efter 1 års behandling.
English: For the full list of side effects reported with Jinarc, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Jinarc fremgår af indlægssedlen.
English: While the most common side effects are manageable, the Agency identified liver toxicity as the most important risk with Jinarc, which was addressed by putting in place several measures (see below).
Danish: Mens de hyppigste bivirkninger kan håndteres, identificerede agenturet levertoksicitet som den væsentligste risiko ved Jinarc.
English: Results showed that in patients treated with Jinarc the decline in kidney function was 35% less than with placebo after 1 year of treatment.
Danish: Resultaterne viste, at forringelsen af nyrefunktionen var 35 % mindre hos patienter i Jinarc-gruppen end hos patienter i placebo-gruppen efter 1 års behandling.
English: How is Jinarc used?
Danish: Hvordan anvendes Jinarc?
English: What benefits of Jinarc have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Jinarc?
English: How does Jinarc work?
Danish: Hvordan virker Jinarc?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jinarc have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Jinarc.
English: Jinarc was shown to be effective at slowing down cyst formation when compared with placebo (a dummy treatment) in two main studies involving adults with autosomal dominant polycystic kidney disease who had rapidly progressing disease.
Danish: I to hovedstudier med voksne med autosomal dominant polycystisk nyresygdom, hvis sygdom udviklede sig hurtigt, er det påvist, at Jinarc er effektivt til at bremse cystedannelsen sammenholdt med placebo (ikke-aktivt stof).
English: The Reference Member State was Denmark and the Concerned Member States were: Czech Republic, Hungary, Poland, Slovakia, and United Kingdom.
Danish: Referencemedlemsstaten var Danmark og de berørte medlemsstater var: Den Tjekkiske Republik, Ungarn, Polen, Slovakiet og Det Forenede Kongerige.
English: The Mutual Recognition Procedure started on 25 May 2005.
Danish: Den gensidige anerkendelsesprocedure indledtes den 25. maj 2005.
English: Pharmcom OY submitted applications for mutual recognition of Cardoreg 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Danish: Pharmcom OY indgav ansøgninger om gensidig anerkendelse af Cardoreg 4 mg depottabletter og tilknyttede navne på grundlag af den markedsføringstilladelse, Danmark udstedte den 30. september 2002.
English: Cardoreg 4 mg prolonged release tablets and associated names (doxazosin) is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Danish: Cardoreg 4 mg depottabletter og tilknyttede navne (doxazosin) er et alfa-1-receptor-blokerende stof, som anvendes til behandling af patienter med essentiel hypertension og til symptomatisk behandling af benign prostatahyperplasi.
English: The scope of the referral was to agree whether Cardoreg 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Danish: Formålet med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for Cardoreg 4 mg depottabletter afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom svimmelhed og hypotension, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995 og hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP's retningslinjer, navnlig når det gælder virkningen af fødevarer.
English: The Marketing Authorisation Holder provided written explanations on 08 April 2006.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 8. avril 2006.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Cardoreg 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Cardoreg 4 mg depottabletter og tilknyttede navne Internationalt fællesnavn ( INN): Doxazosin
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Cardoreg 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: I lyset af de samlede data, der var blevet fremlagt, og den faglige debat i udvalget var CHMP på sit møde i juni 2006 af den opfattelse, at benefit-risk forholdet er gunstigt for Cardoreg 4 mg depottabletter og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: 4 December 2015
Danish: Den 4. December 2015
English: These medicines should only be used in adults and should not be taken for longer than 10 days.
Danish: Disse lægemidler bør kun anvendes til voksne og bør ikke anvendes længere end 10 dage.
English: EMA/HMPC/333915/2015 Corr.1
Danish: EMA/HMPC/333915/2015
English: However, the amount of pyrrolizidine alkaloids has to be specified in each comfrey root medicine and patients should not be exposed to more than 0.35 microgram of pyrrolizidine alkaloids per day.
Danish: Mængden af pyrrolizidinalkaloider skal imidlertid specificeres for hvert lægemiddel med kulsukkerrod, og patienterne bør højst udsættes for 0,35 mikrogram pyrrolizidinalkaloider dagligt.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: ikke foreligger tilstrækkelig dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og at der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (heraf mindst 15 år i EU).
English: No significant risk is expected when comfrey root medicines are used on the skin for short periods.
Danish: Der forventes ingen nævneværdig risiko, når lægemidler med kulsukkerrod anvendes på huden i korte perioder.
English: Comfrey root EMA/HMPC/333915/2015
Danish: Kulsukkerrod EMA/HMPC/333915/2015
English: The HMPC also noted 4 clinical studies carried out with a different comfrey preparation (not covered by this summary).
Danish: HMPC bemærkede desuden, at der er udført fire kliniske undersøgelser med en anden drogetilberedning af kulsukkerrod (ikke omfattet af denne sammenfatning).
English: Information on the use and licensing of comfrey root medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse lægemidlermed kulsukkerrod, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater..
English: Any applications for the licensing of medicines containing comfrey root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder kulsukkerrod, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: What is comfrey root?
Danish: Hvad er kulsukkerrod?
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing comfrey root.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder kulsukkerrod.
English: Further information on the HMPC assessment of comfrey root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder kulsukkerrod, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på det europæiske lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with comfrey root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder kulsukkerrod, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of comfrey root.
Danish: Dette er et sammendrag af Komiteen Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af kulsukkerrod.
English: However, since the exact composition of the herbal preparation used in these studies is not known, these data were not taken into account and the HMPC conclusions on the use of comfrey root medicines are based on their long-standing use.
Danish: Da man ikke kender den nøjagtige sammensætning af drogetilberedningerne anvendt i disse undersøgelser, blev de ikke taget i betragtningI sin vurdering tog HMPC derfor hensyn til den meget langvarige anvendelse af kulsukkerrod til ovenstående formål.
English: Comfrey root contains substances known as pyrrolizidine alkaloids, which have toxic effects on the liver when taken by mouth.
Danish: Kulsukkerrod indeholder stoffer af typen pyrrolizidinalkaloider, som er giftige for leveren ved indtagelse gennem munden.
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelser/informationer, der indgår i HMPCsvurdering findes i HMPC's vurderingsrapport.
English: Comfrey root is the common name for the root of the plant Symphytum officinale L. This summary covers Comfrey root medicines containing a specific herbal preparation, which is obtained by ethanol extraction (a technique used to extract compounds from plant material by dissolving them in alcohol).
Danish: Kulsukkerrod er det danske navn for roden af planten Symphytum officinale L. Dette sammendrag omfatter lægemidler indeholdende en særlig drogetilberedning af kulsukkerrod, der fås ved at fremstille et udtræk af plantematerialet med alkohol (ethanolekstraktion).
English: Detailed instructions on how to take comfrey root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler indeholdende kulsukkerrod skal anvendes, og hvem der kan anvende dem, findes i indlægssedlen i pakningen.
English: This summary is not intended to provide practical advice on how to use medicines containing comfrey root.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder kulsukkerrod, anvendes.
English: In its assessment, the HMPC considered the well documented use of comfrey root for the relief of symptoms of minor sprains and bruises.
Danish: I sin vurdering tog HMPC hensyn til den veldokumenterede anvendelse af kulsukkerrod til lindring af symptomerne på lettere forstuvninger og knubs.
English: Herbal medicines containing this comfrey root preparation are available in semi-solid forms (such as creams or ointments) to be applied to the skin.
Danish: Plantelægemidler med en sådan drogetilberedning af kulsukkerrod fås i halvfast form til påføring på huden (som creme eller salve).
English: How are comfrey root medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder kulsukkerrod, i EU?
English: Comfrey root
Danish: Kulsukkerrod
English: For more information about treatment with comfrey root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder kulsukkerrod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: These studies suggested a reduction in swelling and pain in patients using this herbal preparation for sprains and bruises.
Danish: Disse undersøgelser tydede på, at den pågældende drogetilberedning mindsker hævelse og smerte ved forstuvninger og knubs.
English: For practical information about using comfrey root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med kulsukkerrod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Other information about comfrey root medicines
Danish: Andre oplysninger om lægemidler, der indeholder kulsukkerrod
English: What are the risks associated with comfrey root medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder kulsukkerrod?
English: What evidence supports the use of comfrey root medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af kulsukkerrod?
English: The HMPC conclusions on the use of comfrey root medicines for the relief of symptoms of minor sprains and bruises are based on their ‘traditional use' in these conditions.
Danish: HMPC's konklusioner vedr brugen af lægemidler med kulsukkerrod er baseret på lægemidlernes ”traditionelle anvendelse” til lindring af lettere forstuvninger og knubs..
English: The HMPC concluded that, on the basis of its long-standing use, these comfrey root medicines can be used for the relief of symptoms of minor sprains and bruises.
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at ekstrakt af kulsukkerrod kan anvendes til at lindre symptomerne ved lettere forstuvninger og knubs.
English: Date of first authorisation: 28 July 2009 Date of latest renewal: 16 May 2014
Danish: Dato for første tilladelse: 28. juli 2009 Dato for seneste fornyelse: 16. maj 2014
English: The patient population included 41.8% women.
Danish: Patientpopulationen inkluderede 41,8 % kvinder.
English: • Fever, signs of infection or extreme tiredness.
Danish: • feber, tegn på infektion eller ekstrem træthed.
English: • The active substance is clopidogrel.
Danish: • Det aktive stof er clopidogrel.
English: Push the tablet out.
Danish: Tryk tabletten ud
English: Put the tablet in your mouth and swallow with water or another liquid.
Danish: Put tabletten i munden og synk den med vand eller anden væske
English: You have been prescribed Clopidogrel Teva to help prevent blood clots and reduce the risk of these severe events because:
Danish: Du har fået recept på Clopidogrel Teva til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi:
English: • Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg.
Danish: • Voksne og ældre Clopidogrel bør gives som en enkelt daglig dosis på 75 mg.
English: These may be due to rare decrease of some blood cells
Danish: Dette kan ske på grund af et fald i visse blodlegemer