FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Vizimpro are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Vizimpro løbende overvåget.
English: If certain side effects develop the doctor may decide to reduce the dose or stop treatment.
Danish: Ved visse bivirkninger kan lægen beslutte at nedsætte dosis eller stoppe med behandlingen.
English: Vizimpro can only be obtained with a prescription and treatment must be started and supervised by a doctor with experience in using cancer medicines.
Danish: Vizimpro udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges af en læge med erfaring i brug af kræftlægemidler.
English: Side effects reported with Vizimpro are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Vizimpro vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Vizimpro, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Vizimpro, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency therefore decided that Vizimpro'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 Vizimpro opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Vizimpro is used on its own and only in patients with certain mutations (changes) in the gene for a protein called epidermal growth factor receptor (EGFR).
Danish: Vizimpro anvendes alene og hos patienter med visse mutationer (ændringer) i genet for et protein, der kaldes epidermal vækstfaktorreceptor.
English: Although Vizimpro caused more side effects than gefitinib, these were considered manageable.
Danish: Selv om Vizimpro forårsagede flere bivirkninger end gefitinib, blev de anset for at være håndterbare.
English: What measures are being taken to ensure the safe and effective use of Vizimpro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vizimpro?
English: An overview of Vizimpro and why it is authorised in the EU
Danish: En oversigt over Vizimpro, og hvorfor det er godkendt i EU
English: Vizimpro contains the active substance dacomitinib.
Danish: Vizimpro indeholder det aktive stof dacomitinib.
English: What is Vizimpro and what is it used for?
Danish: Hvad er Vizimpro, og hvad anvendes det til?
English: Vizimpro is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the disease is advanced or has spread.
Danish: Vizimpro er et kræftlægemiddel til behandling af voksne med ikke-småcellet lungekræft (NSCLC), når sygdommen er fremskreden eller har spredt sig.
English: The most common side effects with Vizimpro (which may affect more than 1 in 5 people) are diarrhoea, rash, stomatitis (inflammation of the lining of the mouth), nail disorder, dry skin, loss of appetite, conjunctivitis (redness and discomfort in the eye), weight and hair loss, itching, elevated levels of transaminases (a sign of liver problems) and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Vizimpro (som optræder hos mere end 1 ud af 5 patienter) er diarré, udslæt, stomatitis (betændelse i munden), negleproblemer, tør hud, appetitløshed, conjunctivitis (rødme og ubehag i øjet), vægttab og hårtab, kløe, høje niveauer af transaminaser (tegn på leverproblemer) og kvalme.
English: By blocking EGFR, dacomitinib helps to reduce the growth and spread of the cancer.
Danish: Ved at blokere EGFR bidrager dacomitinib til at nedsætte kræftens vækst og spredning.
English: What are the risks associated with Vizimpro?
Danish: Hvilke risici er der forbundet med Vizimpro?
English: The most frequent serious side effects are diarrhoea, interstitial lung disease (disorders causing scarring in the lungs), rash and loss of appetite.
Danish: De hyppigste alvorlige bivirkninger er diarré, interstitiel lungesygdom (sygdomme, der forårsager ardannelse i lungerne), udslet og appetitløshed.
English: Why is Vizimpro authorised in the EU?
Danish: Hvorfor blev Vizimpro godkendt i EU?
English: Vizimpro has been shown to be more effective than gefitinib (another medicine for non-small cell lung cancer) at prolonging the time patients lived without their disease getting worse.
Danish: Vizimpro har vist sig at være mere effektivt end gefitinib (et andet lægemiddel mod ikke-småcellet lungekræft) ved at forlænge den tid, patienterne overlevede uden forværring af deres sygdom.
English: Patients taking Vizimpro lived for an extra 6 months without their disease getting worse compared with those taking gefitinib.
Danish: Patienter, der fik Vizimpro, levede i yderligere 6 måneder uden forværring af sygdommen sammenlignet med dem, der fik gefitinib.
English: The active substance in Vizimpro, dacomitinib, belongs to a group of cancer medicine called tyrosine kinase inhibitor.
Danish: Det aktive stof i Vizimpro, dacomitinib, tilhører lægemiddelgruppen "tyrosinkinasehæmmere".
English: For the full list of side effects and restrictions of Vizimpro, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved og begrænsninger for Vizimpro fremgår af indlægssedlen.
English: Vizimpro was shown to significantly improve the length of time patients lived without their disease getting worse.
Danish: Det er påvist, at Vizimpro markant forbedrer den tid, patienterne levede uden sygdomsprogression.
English: How is Vizimpro used?
Danish: Hvordan anvendes Vizimpro?
English: What benefits of Vizimpro have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Vizimpro?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vizimpro 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 Vizimpro.
English: How does Vizimpro work?
Danish: Hvordan virker Vizimpro?
English: involving 452 patients with EGFR mutations, patients given Vizimpro lived on average for around 15 months without their disease getting worse, compared with 9 months for those given gefitinib.
Danish: I et hovedstudie, som omfattede 452 patienter, levede de patienter, der fik Vizimpro, i gennemsnit ca.
English: The company submitted the results of two main studies.
Danish: Virksomheden fremlagde resultaterne af to hovedundersøgelser.
English: EMA/177547/2013 EMEA/H/C/002429
Danish: Den 21. marts 2013 EMA/275106/2013 EMEA/H/C/002429
English: What is Kynamro?
Danish: Hvad er Kynamro?
English: The company that applied for authorisation is Genzyme Europe B.V.
Danish: Den virksomhed, der har indgivet ansøgningen, er Genzyme Europe B.V.
English: This was considered an important limitation because Kynamro is intended for long-term treatment.
Danish: Dette blev anset for en vigtig begrænsning, fordi Kynamro er beregnet til langtidsbehandling.
English: The effects of Kynamro were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Kynamro blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Therefore, the CHMP refusal was confirmed after re-examination.
Danish: Derfor blev CHMP's afslag fastholdt efter den fornyede overvejelse.
English: Refusal of the marketing authorisation for Kynamro (mipomersen)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Kynamro (mipomersen)
English: Kynamro is a medicine that contains the active substance mipomersen.
Danish: Kynamro er et lægemiddel, der indeholder det aktive stof mipomersen.
English: The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned.
Danish: Virksomheden har til CHMP oplyst, at de patienter, der får lægemidlet i kliniske undersøgelser, vil fortsætte dermed som planlagt.
English: During the re-examination in March 2013, the CHMP's concerns remained unresolved and were not fully addressed by measures proposed by the company.
Danish: Ved den fornyede overvejelse i marts 2013 var CHMP's betænkeligheder fortsat ikke afklarede og blev ikke fuldt ud afhjulpet af de foranstaltninger, virksomheden foreslog.
English: What was Kynamro expected to be used for?
Danish: Hvad forventedes Kynamro anvendt til?
English: The CHMP was also concerned by the potential longterm consequences of liver test results showing a build-up of fat in the liver and increased enzyme levels, and was not convinced that the company had proposed sufficient measures to prevent the risk of irreversible liver damage.
Danish: CHMP var ligeledes betænkelig ved de mulige langsigtede konsekvenser af resultaterne af leverprøver, der viste fedtophobning i leveren og forhøjede enzymtal, og udvalget var ikke overbevist om, at virksomheden havde foreslået fyldestgørende foranstaltninger til at forebygge uoprettelig leverskade.
English: The active substance in Kynamro, mipomersen, is an ‘antisense oligonucleotide', a very short fragment of DNA designed to block the production of a protein called apolipoprotein B, by attaching to the genetic material of cells responsible for producing it. Apolipoprotein B is the main component of ‘low density lipoprotein' (LDL) cholesterol, commonly known as ‘bad cholesterol', and of two closely related types of cholesterol called ‘intermediate density lipoprotein' (IDL) and ‘very low density lipoprotein' (VLDL) cholesterol.
Danish: Det aktive stof i Kynamro, mipomersen, er et "antisense-oligonukleotid", dvs. et meget kort stykke DNA, der skal blokere produktionen af proteinet apolipoprotein B ved at bindes til det genetiske materiale i de celler, der producerer det. Apolipoprotein B er hovedkomponenten i LDL-kolesterol ("low density lipoprotein"-kolesterol), der også kaldes "skadeligt kolesterol", og i de to nært beslægtede typer kolesterol IDL ("intermediate density lipoprotein"-kolesterol) og VLDL ("very low density lipoprotein"-kolesterol).
English: Patients applying for compassionate use programmes will continue to be evaluated and will receive the medicine if eligible.
Danish: Patienter, der søger om at deltage i programmer med særlig udleveringstilladelse, vil fortsat blive vurderet og vil få lægemidlet, hvis de er egnede.
English: On 13 December 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Kynamro, intended for the treatment of patients with certain forms of familial hypercholesterolaemia.
Danish: Den 13. december 2012 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Kynamro, der er bestemt til behandling af visse former for familiær hyperkolesterolæmi.
English: Moreover, the Committee was concerned that more cardiovascular events (problems with the heart and blood vessels) were reported in patients taking Kynamro than in patients taking placebo.
Danish: Desuden var der i udvalget betænkelighed ved, at der blev indberettet flere kardiovaskulære hændelser (problemer med hjerte og blodkar) hos patienter, der fik Kynamro, end hos patienter, der fik placebo.
English: How is Kynamro expected to work?
Danish: Hvordan forventes Kynamro at virke?
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 21 March 2013.
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 21. marts 2013 afslaget på ansøgningen om markedsføringstilladelse.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Kynamro did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CHMP fandt således på daværende tidspunkt, at fordelene ved Kynamro ikke opvejede risiciene, og anbefalede afslag på ansøgning om markedsføringstilladelse.
English: It was expected to be used together with other cholesterol-lowering medicines and a low-fat diet.
Danish: Det forventedes anvendt sammen med andre kolesterolsænkende lægemidler og fedtfattig diæt.
English: By blocking the production of apolipoprotein B, Kynamro was expected to reduce the levels of these types of lipoproteins in the blood of patients.
Danish: Kynamro blokerer produktionen af apolipoprotein B og forventes derfor at mindske indholdet af disse typer lipoprotein i patienternes blod.
English: One involved 51 patients with homozygous familial hypercholesterolaemia and the other involved 58 patients with severe heterozygous familial hypercholesterolaemia.
Danish: Den ene omfattede 51 patienter med homozygot familiær hyperkolesterolæmi, og den anden omfattede 58 patienter med svær heterozygot familiær hyperkolesterolæmi.
English: The studies compared the effects of Kynamro with placebo when added onto treatment with other cholesterol-lowering medicines and a low-fat diet, for a treatment period of 26 weeks.
Danish: I undersøgelserne sammenlignedes virkningerne af Kynamro med placebo, når det blev anvendt som tillægsbehandling til andre kolesterolsænkende lægemidler og fedtfattig diæt i en behandlingsperiode på 26 uger.
English: It was to be available as a solution for injection under the skin.
Danish: Det var meningen, at det skulle kunne fås som injektionsvæske, opløsning, til indsprøjtning under huden.
English: Patients with homozygous familial hypercholesterolaemia have high blood levels of these types of cholesterol, which increases the risk of coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle).
Danish: Patienter med homozygot familiær hyperkolesterolæmi har for højt indhold i blodet af disse typer kolesterol, hvilket øger risikoen for koronar hjertesygdom (hjertesygdom forårsaget af tilstopning af de blodkar, der forsyner hjertemusklen).
English: In December 2012, the CHMP was concerned that a high proportion of patients stopped taking the medicine within two years, even in the restricted group of patients with homozygous familial hypercholesterolaemia, mainly due to side effects.
Danish: I december 2012 var der i CHMP betænkelighed ved, at en stor del af patienterne hovedsageligt på grund af bivirkninger holdt op med at tage lægemidlet inden to år, selv i den begrænsede patientgruppe med homozygot familiær hyperkolesterolæmi.
English: The main measure of effectiveness was the reduction in the patients' LDL cholesterol levels.
Danish: Behandlingens virkning blev hovedsagelig bedømt på reduktionen i patienternes LDL-kolesteroltal.
English: It was initially expected to be used to treat two closely related forms of the disease called ‘severe heterozygous' and ‘homozygous' familial hypercholesterolaemia.
Danish: Kynamro forventedes oprindeligt anvendt til behandling af de to nært beslægtede former af sygdommen "svær heterozygot" og "homozygot" familiær hyperkolesterolæmi.
English: This prevented the CHMP from concluding that Kynamro's intended cardiovascular benefit, in terms of reducing cholesterol levels, outweighed its potential cardiovascular risk.
Danish: Derfor kunne CHMP ikke konkludere, at den tilsigtede hjerte-kar-fordel ved Kynamro i form af nedsættelse af kolesterolniveauet opvejede den mulige hjerte-kar-risiko ved Kynamro.
English: During the assessment of Kynamro, the indication was restricted to the most severely affected patients with homozygous and compound heterozygous familial hypercholesterolaemia only.
Danish: Under vurderingen af Kynamro blev indikationen indskrænket til de sværest berørte patienter med homozygot og sammensat heterozygot familiær hyperkolesterolæmi.
English: Kynamro was expected to be used to treat patients with an inherited disease causing high blood cholesterol levels, called familial hypercholesterolaemia.
Danish: Kynamro forventedes anvendt til behandling af patienter med den arvelige sygdom familiær hyperkolesterolæmi, der medfører for højt kolesterolindhold i blodet.
English: Packaging Content Package size
Danish: Emballage Indhold Pakningsstør relse
English: Withdrawal period
Danish: Tilbageholdelse stid
English: Date of first authorisation: 29 November 2010 Date of latest renewal: 19 June 2015
Danish: Dato for første tilladelse: 29. november 2010 Dato for seneste fornyelse: 19. juni 2015
English: - if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Danish: • hvis du nogensinde har haft tuberkulose eller, hvis du har været i kontakt med en, som har eller har haft tuberkulose.
English: 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: 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: - if you are due to have a specific blood test (calcium level).
Danish: • hvis du skal have taget en særlig blodprøve (calciumniveau).
English: 3°years
Danish: 3 år
English: Leflunomide is indicated for the treatment of adult patients with:
Danish: Leflunomid er indiceret ved behandling af voksne patienter med:
English: The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
Danish: Den terapeutisk effekt sætter sædvanligvis ind efter 4-6 uger og kan forbedres yderligere i op til 4-6 måneder.
English: There have been reports of chronic overdose in patients taking Leflunomide ratiopharm at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Danish: Der har været rapporter om kronisk overdosering hos patienter, som har taget Leflunomide ratiopharm i daglige doser op til 5 gange den anbefalede daglige dosis og rapporter om akut overdosering hos voksne og børn.
English: marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility
Danish: marginalt (reversibelt) fald i spermkoncentration, totalt spermtal og hurtig progressiv spermmotilitet.
English: The efficacy of Leflunomide ratiopharm in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Danish: Effekten af Leflunomide ratiopharm i behandlingen af reumatoid artrit er vist i 4 kontrollerede forsøg (1 i fase II og 3 i fase III).
English: Leflunomide ratiopharm can make you feel dizzy which may impair your ability to concentrate and react.
Danish: Leflunomide ratiopharm kan gøre dig svimmel, hvilket kan hæmme din evne til at koncentrere dig og reagere.
English: Leflunomide ratiopharm is not recommended for use in children and adolescents below 18 years of age.
Danish: Børn og teenagere Leflunomide ratiopharm anbefales ikke til børn og unge under 18 år.
English: If you take more Leflunomide ratiopharm than you should, contact your doctor or get other medical advice.
Danish: Hvis du tager mere Leflunomide ratiopharm end du skal, skal du kontakte din læge eller få anden medicinsk rådgivning.
English: Leflunomide ratiopharm may be taken with or without food.
Danish: Du kan tage Leflunomide ratiopharm med eller uden mad.
English: Leflunomide ratiopharm can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Danish: Leflunomide ratiopharm kan lejlighedsvis forårsage problemer med dit blod, din lever og lunger eller nerverne i dine arme eller ben.
English: Your doctor will also check your blood pressure regularly as Leflunomide ratiopharm can cause an increase in blood pressure.
Danish: Din læge vil også kontrollere dit blodtryk jævnligt, da Leflunomide ratiopharm kan medføre en stigning i blodtrykket.
English: Film-coating Lecithin (soybeans) Poly(vinyl alcohol) Talc
Danish: Filmovertræk Lecithin (sojabønner) Poly(vinylalkohol) Talcum
English: Leflunomide ratiopharm with food, drink and alcohol
Danish: Brug af Leflunomide ratiopharm sammen med mad, drikke og alkohol
English: In rats and dogs, Heinz bodies and/or Howell-Jolly bodies were found.
Danish: Hos rotter og hunde er set Heinzlegemer og/eller Howell-Jones legemer.
English: Leflunomide ratiopharm is for oral use.
Danish: Leflunomide ratiopharm er til oral anvendelse.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemidddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing
Danish: Læger og patienter skal gøres opmærksomme på, at at der findes en ad hoc-informationsservice, som rådgiver i forbindelse med laboratorieanalyser af plasma-leflunomid.
English: To minimise any possible risk, men wishing to father a child should consider discontinuing use of leflunomide and taking colestyramine 8 g 3 times daily for 11 days or 50 g of activated powdered charcoal 4 times daily for 11 days.
Danish: For at mindske den potentielle risiko, bør mænd, som ønsker at blive fædre, overveje at stoppe behandlingen med leflunomid og tage kolestyramin 8 g 3 gange daglig i 11 dage eller 50 g aktivt kul 4 gange daglig i 11 dage.
English: Most patients improved after discontinuation of leflunomide.
Danish: De fleste patienter kom i bedring efter seponering af leflunomid.
English: LDH increased
Danish: øget LDH
English: If you are pregnant or become pregnant while taking Leflunomide ratiopharm, the risk of having a baby with serious birth defects is increased.
Danish: Hvis du er gravid eller bliver gravid, mens du tager Leflunomide ratiopharm, er der en øget risiko for at få et barn med alvorlige medfødte misdannelser.
English: leucopenia (leucocytes >2 G/L)
Danish: leukopeni (leukocytter > 2 G/l)
English: The Marketing Authorisation Holder (MAH) shall ensure that any changes to the safety profile of the reference medicinal product requiring changes to the Risk Management Plan or Product Information are immediately implemented for Leflunomide ratiopharm.
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle ændringer af sikkerhedsprofilen for referencelægemidlet, som kræver ændringer i risikostyringsprogrammet eller produktinformationen øjeblikkeligt implementeres for Leflunomide ratiopharm.
English: However, in study US301 no significant differences were observed between leflunomide and methotrexate in the primary efficacy parameters.
Danish: I forsøg US301 sås ingen signifikante forskelle mellem leflunomid og methotrexate, hvad angår de primære effektparametre.
English: It may also cause some serious allergic reactions (including Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), or increase the chance of a severe infection.
Danish: Det kan også forårsage alvorlige allergiske reaktioner (herunder lægemiddelreaktion med eosinofili og systemiske symptomer [DRESS]), eller øge risikoen for en alvorlig infektion.
English: CPK increased
Danish: øget CPK
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Leflunomide ratiopharm are provided with a physician educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger, som forventes at ordinere/anvende Leflunomide ratiopharm forsynes med en undervisningspakke for læger indeholdende følgende:
English: Reliable contraception during treatment with leflunomide should also be guaranteed.
Danish: Sikker kontraception under behandling med leflunomid skal også garanteres.
English: Tablet 30 tablets 100 tablets
Danish: Tablet 30 tabletter 100 tabletter