FrancophonIA/ELRC3.0 huggingface dataset:
English: 20 October 2009
Danish: 20. oktober 2009
English: The patients were treated for at least 24 weeks.
Danish: Patienterne blev behandlet i mindst 24 uger.
English: It was to be available as capsules to be taken by mouth.
Danish: Det var meningen, at det skulle kunne fås som kapsler, der tages gennem munden.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Luveniq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Luveniq findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is Luveniq?
Danish: Hvad er Luveniq?
English: The effects of Luveniq were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Luveniq blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It is called ‘non-infectious' when it is caused by the body's own immune system (the body's natural defences) attacking the uvea.
Danish: Den kaldes "ikke-smitsom", når den skyldes kroppens eget immunsystem (kroppens naturlige forsvar), som angriber uvea.
English: It targets T-cells, a type of white blood cell in the immune system that is particularly active in inflammation.
Danish: Det er målrettet mod T-cellerne, som er en type hvide blodlegemer i immunsystemet, der er særligt aktive ved betændelse.
English: Withdrawal of the marketing authorisation application for Luveniq (voclosporin)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Luveniq (voclosporin)
English: It belongs to the class of calcineurin inhibitors.
Danish: Det tilhører gruppen af calcineurinhæmmere.
English: Luveniq also caused side effects which are known to occur with this type of immunosuppressive medicine, including hypertension (high blood pressure).
Danish: Luveniq havde desuden bivirkninger, som er kendt for at forekomme med denne type immunosuppressive lægemiddel, herunder hypertension (højt blodtryk).
English: Luveniq is a medicine that contains the active substance voclosporin.
Danish: Luveniq er et lægemiddel, der indeholder det aktive stof voclosporin.
English: What was Luveniq expected to be used for?
Danish: Hvad forventedes Luveniq anvendt til?
English: It was expected to decrease the inflammation seen in uveitis by blocking an enzyme called calcineurin which is involved in activating Tcells.
Danish: Det forventedes at mindske den betændelse, der opstår ved uveitis, ved at blokere et enzym kaldet calcineurin, som er med til at aktivere T-cellerne.
English: The main measure of effectiveness was how the inflammation of the eye improved after 16 weeks and 24 weeks of treatment, measured by looking at the change in the amount of vitreous haze (clouding of the vitreous humour, the clear gel between the lens and the retina of the eyeball).
Danish: Det primære effektmål var, hvordan øjenbetændelsen blev bedre efter 16 ugers og 24 ugers behandling, målt ved at se på ændringen af uklarheden i glaslegemet (den klare gele mellem linsen og nethinden i øjeæblet).
English: Luveniq is an immunosuppressive agent, which means that it reduces the activity of the immune system.
Danish: Luveniq er et immunosuppressivt middel, hvilket betyder, at det nedsætter immunsystemets aktivitet.
English: The application was supported by one main study involving 218 patients with non-infectious uveitis which compared Luveniq with placebo.
Danish: Til støtte for ansøgningen blev der fremlagt en hovedundersøgelse, som omfattede 218 patienter med ikke-smitsom uveitis, og hvor Luveniq blev sammenlignet med placebo.
English: How is Luveniq expected to work?
Danish: Hvordan forventes Luveniq at virke?
English: The company informed the CHMP that there are no consequences for patients included in ongoing clinical trials.
Danish: Virksomheden har informeret CHMP om, at der ikke er nogen konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Luveniq.
English: Luveniq was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 14 September 2007 for the treatment of chronic non-infectious uveitis.
Danish: Luveniq blev udpeget som lægemiddel til sjældne sygdomme den 14. september 2007 til behandling af kronisk ikke-smitsom uveitis.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had previously given a negative opinion in June 2011 recommending that the marketing authorisation be refused for Luveniq for the treatment of chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP tidligere afgivet en negativ udtalelse i juni 2011 og anbefalet afslag på udstedelse af markedsføringstilladelse for Luveniq til behandling af kronisk aktiv ikke-smitsom uveitis, som omfatter øjets mellemliggende eller bagerste dele.
English: Therefore, the CHMP was of the opinion that the benefits of Luveniq had not been shown to outweigh its risks and recommended that it be refused marketing authorisation.
Danish: Derfor var CHMP af den opfattelse, at der ikke er dokumentation for, at fordelene ved Luveniq opvejer risiciene, og CHMP anbefalede at give afslag på ansøgningen om markedsføringstilladelse for Luveniq.
English: At the time of the negative opinion, the CHMP was not convinced that the benefits of Luveniq had been shown to outweigh the risks as a treatment for chronic non-infectious uveitis.
Danish: På tidspunktet for den negative udtalelse var CHMP ikke overbevist om, at det var dokumenteret, at fordelene ved Luveniq opvejer risiciene til behandling af kronisk ikke-smitsom uveitis.
English: On 13 October 2011, Lux Biosciences GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Luveniq, for the treatment of chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye.
Danish: Den 13. oktober 2011 meddelte Lux Biosciences GmbH officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Luveniq til behandling af kronisk aktiv ikke-smitsom uveitis (betændelse i øjets årehinde), som omfatter øjets mellemliggende eller bagerste dele.
English: Only one main study supported the application and the results did not show in a robust way that Luveniq was more effective than placebo at reducing eye inflammation, while no difference was seen in the patients' eyesight compared with placebo.
Danish: Resultaterne gav ikke pålidelig dokumentation for, at Luveniq var mere effektivt end placebo til at mindske øjenbetændelse, og der blev ikke konstateret nogen forskel på patientens syn sammenlignet med placebo.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Luveniq eller i programmer for anvendelse af Luveniq med særlig udleveringstilladelse?
English: Luveniq was expected to be used to treat chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye. Uveitis is inflammation of the uvea (the middle layer of the eye) which can lead to loss of vision.
Danish: Luveniq forventedes anvendt til behandling af kronisk aktiv ikke-smitsom uveitis (betændelse i øjets årehinde), som omfatter øjets mellemliggende eller bagerste dele.
English: EU Number
Danish: EMA-nummer
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasilamlo on 14 April 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rasilamlo den 14. april 2011.
English: The patient should take one tablet once a day with a light meal, preferably at the same time each day.
Danish: Patienten skal tage én tablet en gang dagligt sammen med et let måltid, helst samme tid hver dag.
English: The full EPAR for Rasilamlo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rasilamlo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Rasilamlo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rasilamlo.
English: A risk management plan has been developed to ensure that Rasilamlo is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Rasilamlo anvendes så sikkert som muligt.
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter.
Danish: Det blokerer særlige kanaler på celleoverfladen kaldet calciumkanaler, hvorigennem calciumionerne normalt kommer ind.
English: It should not be taken together with fruit juice or drinks containing plant extracts such as herbal teas.
Danish: Den må ikke tages sammen med frugtsaft eller drikkevarer, som indeholder planteekstrakter, såsom urtete.
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 Rasilamlo.
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 Rasilamlo.
English: Other information about Rasilamlo
Danish: Andre oplysninger om Rasilamlo
English: Rasilamlo aliskiren / amlodipine
Danish: Rasilamlo aliskiren/amlodipin
English: What measures are being taken to ensure the safe and effective use of Rasilamlo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rasilamlo?
English: For more information about treatment with Rasilamlo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rasilamlo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The main measure of effectiveness was the change in the average diastolic blood pressure (blood pressure measured between two heartbeats) measured when the patients were seated.
Danish: Virkningen blev hovedsagelig målt på ændringen i det gennemsnitlige diastoliske blodtryk (blodtryk målt mellem to hjerteslag) målt hos patienter i siddende stilling.
English: Rasilamlo is for use in adults only; it must not be used in children aged less than 2 years and is not recommended for older children.
Danish: Det må ikke anvendes til børn under 2 år, og det anbefales ikke til ældre børn
English: In three main studies involving 2,212 patients Rasilamlo was compared with aliskiren or amlodipine taken alone for eight or six weeks.
Danish: I tre hovedundersøgelser, der omfattede 2 212 patienter, blev Rasilamlo sammenlignet med aliskiren eller amlodipin anvendt alene i otte eller seks uger.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasilamlo, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Rasilamlo, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The CHMP decided that Rasilamlo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Rasilamlo opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Rasilamlo.
English: The most common side effects with Rasilamlo are hypotension (low blood pressure) and peripheral oedema (swelling, especially of the ankles and feet).
Danish: De hyppigste bivirkninger ved Rasilamlo er hypotension (lavt blodtryk) og perifert ødem (opsvulmen af især ankler og fødder).
English: What is the risk associated with Rasilamlo?
Danish: Hvilken risiko er der forbundet med Rasilamlo?
English: It must also not be used in women who are more than three months pregnant or in patients taking medicines containing ciclosporin, itraconazole or other medicines known as ‘potent Pglycoprotein inhibitors' (such as quinidine).
Danish: Det må heller ikke anvendes hos kvinder, der er gravide i mere end tredje måned, eller hos patienter, der tager medicin indeholdende ciclosporin, itraconazol eller andre lægemidler af typen “potente P-glykoproteinhæmmere” (såsom kinidin).
English: The dose may be adjusted based on the side effects the patient experienced with their previous treatment with aliskiren or amlodipine and also on how the patient responds to treatment with Rasilamlo.
Danish: Dosen kan tilpasses i forhold til de bivirkninger, patienten oplevede ved den tidligere behandling med aliskiren eller amlodipin, samt i forhold til hvordan patienten reagerer på behandling med Rasilamlo.
English: Rasilamlo was more effective at controlling essential hypertension than placebo, aliskiren or amlodipine used alone.
Danish: Rasilamlo var mere effektivt til at kontrollere essentiel hypertension end placebo, aliskiren eller amlodipin anvendt alene.
English: The strength of the tablet the patient takes depends on the doses of aliskiren or amlodipine that they received previously.
Danish: Styrken af den tablet, patienten tager, afhænger af de doser aliskiren eller amlodipin, som patienten har taget tidligere.
English: It must not be used in patients with a history of angioedema (swelling beneath the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, severe hypotension, shock, narrowing of the aortic heart valve or in patients with heart failure after a heart attack.
Danish: Det må ikke anvendes hos patienter, der tidligere har haft angioødem (hævelser under huden) med aliskiren, arveligt angioødem eller angioødem uden nogen indlysende årsag, alvorlig hypotension, chok, forsnævring af aortahjerteklappen eller hos patienter med hjerteinsufficiens efter et hjerteanfald.
English: It is available as tablets (150 mg aliskiren and 5 mg amlodipine; 150 mg aliskiren and 10 mg amlodipine; 300 mg aliskiren and 5 mg amlodipine; 300 mg aliskiren and 10 mg amlodipine).
Danish: Det fås som tabletter (150 mg aliskiren og 5 mg amlodipin, 150 mg aliskiren og 10 mg amlodipin, 300 mg aliskiren og 5 mg amlodipin samt 300 mg aliskiren og 10 mg amlodipin).
English: Rasilamlo is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.
Danish: Rasilamlo anvendes til behandling af voksne med essentiel hypertension (højt blodtryk), hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af aliskiren eller amlodipin alene.
English: Why has Rasilamlo been approved?
Danish: Hvorfor blev Rasilamlo godkendt?
English: Rasilamlo is a medicine that contains the active substances aliskiren and amlodipine.
Danish: Rasilamlo er et lægemiddel, der indeholder de aktive stoffer aliskiren og amlodipin.
English: Rasilamlo must not be used in people who are hypersensitive (allergic) to aliskiren, amlodipine, to any of the other ingredients of the medicine or other substances derived from dihydropyridine (a group that includes amlodipine).
Danish: Rasilamlo må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for aliskiren, amlodipin eller andre af indholdsstofferne eller andre stoffer afledt af dihydropyridin (en gruppe, der omfatter amlodipin).
English: For the full list of all side effects reported with Rasilamlo, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rasilamlo fremgår af indlægssedlen.
English: Rasilamlo can be used with other antihypertensive medicines, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Danish: Rasilamlo kan anvendes sammen med andre lægemidler mod hypertension, bortset fra “angiotensinkonverterende enzymhæmmer” (ACE-hæmmere) eller “angiotensinreceptorantagonister” (ARB) hos patienter med sukkersyge eller moderat til svært nedsat nyrefunktion.
English: Rasilamlo in combination with an ACE inhibitor or an ARB must not be used in patients with diabetes, or moderate or severe kidney impairment.
Danish: Rasilamlo kombineret med en ACE-hæmmer eller en ARB må ikke anvendes hos patienter med sukkersyge eller moderat til svær nyresygdom.
English: What is Rasilamlo?
Danish: Hvad er Rasilamlo?
English: In the first study, patients taking Rasilamlo 300/10 mg and 300/5 mg had a fall in their sitting diastolic blood pressure of 13.1 mmHg and 10.5 mmHg, respectively, compared with a fall of 5.8 mmHg in patients taking aliskiren 300 mg.
Danish: I den første undersøgelse oplevede patienter, der tog Rasilamlo 300/10 mg og 300/5 mg, et fald i deres diastoliske blodtryk i siddende stilling på henholdsvis 13,1 mmHg og 10,5 mmHg sammenlignet med et fald på 5,8 mmHg hos patienter, der tog aliskiren 300 mg.
English: Rasilamlo contains two active substances, aliskiren and amlodipine.
Danish: Rasilamlo indeholder de to aktive stoffer aliskiren og amlodipin.
English: The third study showed a fall in blood pressure of 8.5 mmHg with Rasilamlo 150/5 mg compared with 8.0 mmHg and 4.8 mmHg with amlodipine 10 mg and 5 mg, respectively.
Danish: Den tredje undersøgelse viste et fald i blodtrykket på 8,5 mmHg med Rasilamlo 150/5 mg sammenlignet med 8,0 mmHg og 4,8 mmHg med amlodipin på henholdsvis 10 mg og 5 mg.
English: In the second study the falls in blood pressure were 11.0 mmHg and 9.0 mmHg with Rasilamlo 300/10 mg and 150/10mg, respectively, compared with 7.2mmHg with amlodipine 10 mg.
Danish: I den anden undersøgelse var faldet i blodtrykket på henholdsvis 11,0 mmHg og 9,0 mmHg med Rasilamlo 300/10 mg og 150/10 mg sammenlignet med 7,2 mmHg med amlodipin 10 mg.
English: How has Rasilamlo been studied?
Danish: Hvordan blev Rasilamlo undersøgt?
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Danish: Det blokerer virkningen af det humane enzym renin, der i kroppen medvirker ved dannelsen af stoffet angiotensin I. Angiotensin I omdannes til hormonet angiotensin II, som er en kraftig vasokonstriktor (et stof, der forsnævrer blodkarrene).
English: What benefit has Rasilamlo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rasilamlo?
English: What is Rasilamlo used for?
Danish: Hvad anvendes Rasilamlo til?
English: How is Rasilamlo used?
Danish: Hvordan anvendes Rasilamlo?
English: How does Rasilamlo work?
Danish: Hvordan virker Rasilamlo?
English: (Best response rates)
Danish: (Bedste respons)
English: Similar findings were found based on a 18-months landmark analysis.
Danish: Lignende resultater fandtes baseret på analysen efter 18 måneder.
English: For CML, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment.
Danish: Ved CML kan din læge foreskrive højere eller lavere dosis afhængigt af, hvordan du reagerer på behandlingen.
English: Very common Weight increased Common
Danish: Meget almindelig Vægtstigning Almindelig
English: Traces of the dissolved tablets may be left behind in the glass.
Danish: Der kan være spor af de opløste tabletter tilbage i glasset.
English: Date of first authorization: 01 July 2013 Date of latest renewal: 19th April 2018
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 1. juli 2013 Dato for seneste fornyelse: 19. april 2018
English: A major response (0-35%) combines both complete and partial responses.
Danish: Et større respons (0-35 %) omfatter både fuldstændig og delvis respons.
English: Therefore, the use of imatinib in combination requires special precaution.
Danish: Brug af Imatinib i denne kombination kræver derfor særlig forsigtighed.
English: Chronic phase, newly diagnosed
Danish: Kronisk fase, nydiagnosticeret
English: Imatinib Accord may do the same to some other medicines.
Danish: Imatinib Accord kan gøre det samme ved andre lægemidler.
English: A total of 1,106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
Danish: I alt randomiseredes 1.106 patienter, 553 til hver arm. Baselinekarakteristika var velafbalancerede mellem de to arme.
English: This is because Imatinib Accord could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Imatinib Accord kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: A complete haematological response was achieved in 95% of patients.
Danish: Fuldstændigt hæmatologisk respons opnåedes hos 95 % af patienterne.
English: Your doctor has prescribed Imatinib Accord because you suffer from a serious condition.
Danish: Din læge har udskrevet Imatinib Accord, fordi du lider af en alvorlig sygdom.
English: Median age was 51 years (range 18-70 years), with 21.9% of patients ≥ 60 years of age.
Danish: Gennemsnitsalderen var 51 år (variationsbredde 18-70 år), med 21,9 % patienter ≥60 år.
English: Frequency categories are defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvenskategorier er defineret ved brug af følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Other side effects may include
Danish: Andre bivirkninger kan omfatte
English: They may increase or decrease the effect of Imatinib Accord, either leading to increased side effects or making Imatinib Accord less effective.
Danish: De kan enten øge eller nedsætte virkningen af Imatinib Accord, hvilket kan resultere i enten flere bivirkninger, eller de kan gøre Imatinib Accord mindre virksomt.
English: The amount of Imatinib Accord given will depend on your child's condition, body weight and height.
Danish: Antallet af Imatinib Accord-tabletter afhænger af barnets tilstand, kropsvægt og højde.
English: After 42 months of follow-up, 11 patients experienced a confirmed loss (within 4 weeks) of their cytogenetic response.
Danish: Efter 42 måneders opfølgning fik 11 patienter bekræftet tab (inden for 4 uger) af cytogenetiske respons (indenfor 4 uger).
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 mol/l, respectively.
Danish: Ki værdier i humane levermikrosomer var henholdsvis 27; 7,5 og 7,9 mol/l.
English: Some children and adolescents taking Imatinib Accord may have slower than normal growth.
Danish: Nogle børn og unge, der får Imatinib Accord, kan vokse langsommere end normalt.
English: Imatinib Accord can help you to fight this condition.
Danish: Imatinib Accord kan hjælpe dig med at bekæmpe denne tilstand.
English: - Imatinib Accord is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Danish: - Imatinib Accord anbefales ikke under graviditeten, medmindre det er strengt nødvendigt, da det kan skade din baby.