FrancophonIA/ELRC3.0 huggingface dataset:
English: California poppy is the common name for the above-ground parts of the plant Eschscholzia californica Cham.
Danish: Californisk guldvalmue er det danske navn for de overjordiske dele af planten Eschscholzia californica Cham.
English: Any applications for the licensing of medicines containing California poppy 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 californisk guldvalmue, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelse/informationer der indgår i HMPCs vurdering, findes i HMPC's vurderingsrapport.
English: Further information on the risks associated with California poppy 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 californisk guldvalmue, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på agenturets websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of California poppy 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 californisk guldvalmue, 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: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing California poppy.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder californisk guldvalmue.
English: Information on the use and licensing of California poppy medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse i EU's medlemsstater af lægemidler, der indeholder californisk guldvalmue, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater..
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of California poppy.
Danish: Dette er et sammendrag af Komiteen for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af californisk guldvalmue.
English: Herbal medicines containing California poppy are usually available in solid forms to be taken by mouth.
Danish: Plantelægemidler, der indeholder californisk guldvalmue, fås normalt i fast form til indtagelse gennem munden.
English: The HMPC conclusions on the use of California poppy medicines to relieve mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med californisk guldvalmue til at lindre milde stresssymptomer og gøre det lettere at falde i søvn, bygger på den "traditionelle anvendelse".
English: What is California poppy?
Danish: Hvad er californisk guldvalmue?
English: Detailed instruction on how to take California poppy medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler med californisk guldvalmue skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: California poppy preparations are obtained by powdering the dried above-ground parts of the plant.
Danish: Californisk guldvalmue forarbejdes ved pulverisering af de tørrede, overjordiske dele af planten.
English: The HMPC conclusions on the use of California poppy medicines are based on their long-standing use.
Danish: HMPC's konklusioner for anvendelsen af lægemidler med californisk guldvalmue bygger derfor på den mangeårige anvendelse.
English: Other information about California poppy medicines
Danish: Andre oplysninger om lægemidler, der indeholder californisk guldvalmue
English: The HMPC concluded that, on the basis of its long-standing use, California poppy can be used for the relief of mild symptoms of mental stress and to aid sleep.
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at californisk guldvalmue kan anvendes til at lindre milde stresssymptomer og gøre det lettere at falde i søvn.
English: This summary is not intended to provide practical advice on how to use medicines containing California poppy.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder californisk guldvalmue, anvendes.
English: What evidence supports the use of California poppy medicines?
Danish: Hvilken dokumentation underbygger anvendelsen af lægemidler med californisk guldvalmue?
English: California poppy
Danish: Californisk guldvalmue
English: For more information about treatment with California poppy 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 californisk guldvalmue, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What are the risks associated with California poppy medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder californisk guldvalmue?
English: How are California poppy medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder californisk guldvalmue, i EU?
English: For practical information about using California poppy 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 californisk guldvalmue, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: It should be taken consistently either with or without food.
Danish: Det tages enten med eller uden mad, dog altid på samme måde.
English: Further information on Epidyolex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/epidyolex.
Danish: Yderligere information om Epidyolex findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/epidyolex.
English: This risk can be managed with restrictions and regular liver monitoring and is considered acceptable given the seriousness of the conditions and the lack of treatments.
Danish: Denne risiko kan håndteres med begrænsninger og regelmæssig kontrol af leveren og anses for at være acceptabel i betragtning af sygdommenes alvorlige karakter og manglen på behandlinger.
English: Doses are measured and given by mouth with a suitable syringe supplied with the medicine.
Danish: Doserne afmåles og gives gennem munden med en egnet sprøjte, der leveres med lægemidlet.
English: Depending on the individual response and how well the medicine is tolerated, the doctor may increase the dose gradually up to a maximum of 10 mg/kg twice a day.
Danish: Afhængigt af den individuelle respons og af, hvor godt lægemidlet tolereres, kan lægen gradvist forhøje dosen op til højst 10 mg/kg to gange dagligt.
English: Further information on the orphan designations can be found on the European Medicines Agency's website: (Dravet syndrome: 15 October 2014; Lennox-Gastaut syndrome: 20 March 2017).
Danish: Yderligere oplysninger om lægemidler til sjældne sygdomme kan findes på Det Europæiske Lægemiddelagenturs websted under: (Dravet-syndrom: 15. oktober 2014, Lennox-Gastauts syndrom: 20. marts 2017).
English: As for all medicines, data on the use of Epidyolex are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Epidyolex løbende overvåget.
English: The recommended starting dose is 2.5 mg per kilogram body weight given twice a day.
Danish: Den anbefalede startdosis er 2,5 mg pr. kg legemsvægt to gange dagligt.
English: Regarding safety, treatment with Epidyolex is associated with an increased risk of liver problems.
Danish: Med hensyn til sikkerheden er behandling med Epidyolex forbundet med en øget risiko for leverproblemer.
English: The most common reason for stopping treatment was increased blood levels of liver enzymes (a sign of liver problems).
Danish: Den hyppigste årsag til at stoppe behandlingen var forhøjet indhold af leverenzymer i blodet (et tegn på leverproblemer).
English: Symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Danish: Symptomerne omfatter forskellige typer anfald, unormal elektrisk aktivitet i hjernen, indlæringsvanskeligheder og adfærdsproblemer.
English: After one week, the dose should be increased to a maintenance dose of 5 mg/kg twice a day.
Danish: Efter en uge bør dosis øges til en vedligeholdelsesdosis på 5 mg/kg to gange dagligt.
English: Epidyolex can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of epilepsy.
Danish: Epidyolex fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af epilepsi.
English: The European Medicines Agency therefore decided that Epidyolex's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Epidyolex opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common side effects with Epidyolex (which may affect more than 1 in 10 people) are somnolence (sleepiness), decreased appetite, diarrhoea, fever, tiredness and vomiting.
Danish: De hyppigste bivirkninger ved Epidyolex (som kan forekomme hos mere end 1 ud af 10 personer) er søvnighed (somnolens), nedsat appetit, diarré, træthed og opkast.
English: Epidyolex is available as a liquid containing 100 mg cannabidiol per ml.
Danish: Epidyolex fås som en væske, der indeholder 100 mg cannabidiol pr. ml.
English: Side effects reported with Epidyolex are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Epidyolex vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Cannabidiol is also thought to act on adenosine, a chemical messenger in the brain that plays an important role in suppressing seizures.
Danish: Cannabidiol menes også at virke på adenosin, et kemisk signalstof i hjernen, som spiller en vigtig rolle mht. at forhindre anfald.
English: What measures are being taken to ensure the safe and effective use of Epidyolex?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Epidyolex?
English: They showed that Epidyolex lowered the number of seizures after 14 weeks in patients who were also taking clobazam.
Danish: De viste, at Epidyolex reducerede antallet af anfald efter 14 uger hos patienter, der også fik clobazam.
English: These conditions are rare, and Epidyolex was designated an ‘orphan medicine' (a medicine used in rare diseases).
Danish: Disse sygdomme er sjældne, og Epidyolex blev udpeget som "lægemiddel til sjældne sygdomme".
English: Other information about Epidyolex
Danish: Andre oplysninger om Epidyolex
English: Four studies involving 715 patients with Lennox-Gastaut or Dravet syndrome looked at the effect of Epidyolex when added to treatment with other epilepsy medicines.
Danish: Fire studier med 715 patienter med Lennox-Gastauts syndrom eller Dravet-syndrom så på virkningen af Epidyolex, når det tilføjes til behandling med andre epilepsilægemidler.
English: For more information about using Epidyolex, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Epidyolex, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Epidyolex must not be used in patients whose blood levels of liver enzymes are more than three times the normal limit and who also have levels of bilirubin (another marker of liver problems) more than twice the normal limit.
Danish: Epidyolex må ikke anvendes til patienter, hvis indhold af leverenzymer i blodet ligger over tre gange det normale, og som også har over to gange den normale mængde bilirubin (en anden markør for leverproblemer).
English: Epidyolex contains the active substance cannabidiol.
Danish: Epidyolex indeholder det aktive stof cannabidiol.
English: An overview of Epidyolex and why it is authorised in the EU
Danish: En oversigt over Epidyolex, og hvorfor det er godkendt i EU
English: As this is important for the transmission of electrical signals in some nerve cells, and seizures are caused by excessive electrical activity in the brain, altering the movement of calcium is expected to reduce or prevent the
Danish: Da dette er vigtigt for transmissionen af elektriske signaler i visse nerveceller, og da anfald skyldes overdreven elektrisk aktivitet i hjernen,
English: Although the way it works is not clearly understood, the active substance in Epidyolex, cannabidiol, is thought to act on targets that play a role in the movement of calcium in the cells.
Danish: Det vides ikke nøjagtigt, hvordan Epidyolex virker, men det aktive stof, cannabidiol, menes at påvirke mål, der har indflydelse på calciums bevægelse rundt i cellerne.
English: Why is Epidyolex authorised in the EU?
Danish: Hvorfor er Epidyolex godkendt i EU?
English: What is Epidyolex and what is it used for?
Danish: Hvad er Epidyolex, og hvad anvendes det til?
English: The main studies showed that Epidyolex is effective at lowering the number of seizures in patients with Lennox-Gastaut and Dravet syndromes who are taking clobazam.
Danish: Hovedstudierne viste, at Epidyolex er effektivt til at mindske antallet af anfald hos patienter med Lennox-Gastauts syndrom og Dravet-syndrom, som får clobazam.
English: In the first two studies, patients with Lennox-Gastaut syndrome taking Epidyolex in combination with clobazam had a reduction of up to 64% in the number of drop seizures (brief loss of muscle tone and reduced consciousness, causing abrupt falls), compared with a reduction of up to 31% for patients given placebo (a dummy treatment) with clobazam.
Danish: I de første to studier oplevede de patienter med Lennox-Gastauts syndrom, der fik Epidyolex i kombination med clobazam, en reduktion på op til 64 % i antallet af atoniske anfald (kort tab af muskeltonus og nedsat bevidsthed, der forårsager et pludseligt fald) sammenlignet med en reduktion på op til 31 % for de patienter, der fik placebo (en uvirksom behandling) sammen med clobazam.
English: In the two other studies in patients with Dravet syndrome, the reduction in the number of convulsive seizures (major fits with loss of consciousness) was up to 61% for patients taking Epidyolex and clobazam, and up to 38% for patients on placebo and clobazam.
Danish: I de to andre studier hos patienter med Dravet-syndrom blev antallet af anfald (store anfald med bevidsthedstab) reduceret med op til 61 % for patienter, der fik Epidyolex og clobazam, og med op til 38 % for patienter, der fik placebo og clobazam.
English: What are the risks associated with Epidyolex?
Danish: Hvilke risici er der forbundet med Epidyolex?
English: For the full list of side effects of Epidyolex, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Epidyolex fremgår af indlægssedlen.
English: Epidyolex is a medicine used in addition to clobazam, another epilepsy medicine, to treat patients from the age of two years who have Lennox-Gastaut syndrome or Dravet syndrome, rare types of epilepsy that begin in childhood and can continue into adulthood.
Danish: Epidyolex er et lægemiddel, der anvendes sammen med clobazam (et andet epilepsilægemiddel) til behandling af patienter fra toårsalderen, der har Lennox-Gastauts syndrom eller Dravet-syndrom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Epidyolex have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Epidyolex.
English: How is Epidyolex used?
Danish: Hvordan anvendes Epidyolex?
English: How does Epidyolex work?
Danish: Hvordan virker Epidyolex?
English: What benefits of Epidyolex have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Epidyolex?
English: seizures in patients with Lennox-Gastaut syndrome or Dravet syndrome.
Danish: forventes ændringen af calciummets bevægelse at reducere eller forhindre anfald hos patienter med Lennox-Gastauts syndrom eller Dravet-syndrom.
English: 180 (6 x 30) tablets (multipack)
Danish: 180 (6 x 30) filmovertrukne tabletter
English: bottle (HDPE) (without outer carton)
Danish: Oral anvendelse HDPE-tabletbeholder (uden ydre karton)
English: 90 sachets (with dosing spoon)
Danish: 90 breve (med måleske)
English: Strength Pharmaceutical Form
Danish: Oral anvendelse HDPE-tabletbeholder 30 filmovertrukne tabletter
English: This summary was last updated in 10/2017.
Danish: Dette sammendrag blev sidst ajourført i 10/2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ninlaro on 21/11/2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ninlaro 21.11.2016.
English: This is a summary of the European public assessment report (EPAR) for Ninlaro.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ninlaro.
English: This means that it blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed.
Danish: Det betyder, at det blokerer proteasomet, som er cellernes system til at nedbryde proteiner, der ikke længere er brug for.
English: When the proteins in the cancer cells are not broken down, including the proteins that control cell growth, the cancer cells are damaged and they eventually die.
Danish: Når proteinerne i kræftcellerne ikke bliver nedbrudt, herunder de proteiner, der styrer cellernes vækst, bliver kræftcellerne beskadiget og ender med at dø.
English: Ninlaro has been given ‘conditional approval'.
Danish: Ninlaro har fået en "betinget godkendelse".
English: The recommended dose is 4 mg taken once a week (on the same day of the week) for 3 consecutive weeks, followed by a week with no Ninlaro treatment.
Danish: Den anbefalede dosis er 4 mg, der tages én gang om ugen (på den samme ugedag) i tre uger i træk, efterfulgt af en uge uden Ninlaro-behandling.
English: However, there is uncertainty regarding the size of the improvement because further analysis of the data showed a reduced effect.
Danish: Der hersker imidlertid en vis usikkerhed med hensyn til omfanget af forbedringen, idet en efterfølgende analyse af dataene viste en reduceret virkning.
English: Ninlaro is available as capsules (2.3, 3 and 4 mg) to be taken at least one hour before or two hours after food.
Danish: Ninlaro fås som kapsler (2,3 mg, 3 mg og 4 mg), der skal tages mindst én time før eller to timer efter et måltid.
English: Other information about Ninlaro
Danish: Andre oplysninger om Ninlaro
English: This 4-week treatment cycle should be continued until the disease gets worse or side effects become unacceptable.
Danish: Denne fireugers behandlingscyklus gentages, indtil sygdommen forværres eller bivirkningerne bliver uacceptable.
English: The dose may be reduced also in patients with moderately or severely reduced liver function and patients with severely reduced kidney function.
Danish: Dosis kan også nedsættes hos patienter med moderat eller svært nedsat leverfunktion og hos patienter med svært nedsat nyrefunktion.
English: It is given together with two other medicines, lenalidomide and dexamethasone, to patients who have received at least one prior treatment.
Danish: Det anvendes sammen med to andre lægemidler (lenalidomid og dexamethason) hos patienter, der har gennemgået mindst én tidligere behandling.
English: The European Medicines Agency therefore decided that Ninlaro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Ninlaro opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Ninlaro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ninlaro?
English: The full EPAR for Ninlaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ninlaro findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Similar side effects were seen when lenalidomide and dexamethasone were used without Ninlaro.
Danish: Lignende bivirkninger sås, når lenalidomid og dexamethason blev anvendt uden Ninlaro.
English: Because the number of patients with multiple myeloma is low, the disease is considered ‘rare', and Ninlaro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 September
Danish: Da antallet af patienter med myelomatose er lavt, betragtes sygdommen som "sjælden", og Ninlaro blev udpeget som "lægemiddel til sjældne sygdomme" den 27. september 2011.
English: Ninlaro has been investigated in one main study involving 722 adults with multiple myeloma whose disease had not got better or had come back after previous treatment.
Danish: Ninlaro er blevet undersøgt i én hovedundersøgelse, der omfattede 722 voksne med myelomatose, hvis tilstand ikke havde vist tegn på bedring, eller hvis sygdom var vendt tilbage efter tidligere behandlinger.
English: The most common side effects with Ninlaro taken together with lenalidomide and dexamethasone (seen in more than 1 in 5 people) were diarrhoea, constipation, thrombocytopenia (low blood platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell), peripheral neuropathy (nerve damage in the hands and feet causing tingling or numbness), nausea (feeling sick), peripheral oedema (swelling, especially of the ankles and feet), vomiting and nose and throat infection.
Danish: De hyppigste bivirkninger ved Ninlaro, når det tages sammen med lenalidomid og dexamethason (som optræder hos mere end 1 ud af 5 patienter), var diarré, forstoppelse, trombocytopeni (lavt antal blodplader), neutropeni (lavt indhold af neutrofiler), perifer neuropati (nerveskader i hænder og fødder, som medfører en prikkende fornemmelse eller følelsesløshed), kvalme, perifert ødem (hævelse, især af anklerne og fødderne), opkastning og næse- og halsinfektion.
English: The active substance in Ninlaro, ixazomib, is a proteasome inhibitor.
Danish: Det aktive stof i Ninlaro, ixazomib, er en proteasomhæmmer.
English: Why is Ninlaro approved?
Danish: Hvorfor blev Ninlaro godkendt?
English: What is Ninlaro and what is it used for?
Danish: Hvad er Ninlaro, og hvad anvendes det til?
English: Ninlaro contains the active substance ixazomib.
Danish: Ninlaro indeholder det aktive stof ixazomib.