FrancophonIA/ELRC3.0 huggingface dataset:
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Film coating Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Iron oxide yellow (E172)
Danish: Filmovertræk Lactosemonohydrat Hypromellose (E464) Titaniumdioxid (E171)
English: For post-MI or PAD patients with no history of stroke or TIA, the rate of study drug discontinuation because of adverse reactions was 6.8% for Zontivity and 6.9% for placebo.
Danish: Henholdsvis 6,8% af post-MI- og PAD-patienterne uden apopleksi eller TCI i anamnesen i Zontivitygruppen og 6,9% i placebogruppen seponerede studiemedicinen som følge af bivirkninger.
English: • antacids and pantoprazole (used to treat upset stomach)
Danish: • syreneutraliserende midler og pantoprazol (medicin til behandling af sur mave)
English: Severe renal impairment
Danish: Svært nedsat nyrefunktion
English: Zontivity 2 mg film-coated tablets
Danish: Zontivity 2 mg filmovertrukne tabletter
English: No dose adjustment is required in patients with mild hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion.
English: Zontivity 2 mg film-coated tablets vorapaxar
Danish: Zontivity 2 mg filmovertrukne tabletter vorapaxar
English: • Severe hepatic impairment.
Danish: • Svært nedsat leverfunktion.
English: No dose adjustment is required for patients with mild hepatic impairment.
Danish: Dosisjustering er ikke nødvendig for patienter med let nedsat leverfunktion.
English: In the TRA 2ºP-TIMI 50 trial, although CABG-related TIMI major bleeding was observed in patients taking vorapaxar (see section 4.8), patients who continued therapy with vorapaxar while undergoing CABG did not show an increased risk of major bleeding compared to placebo.
Danish: 4.8), udviste de patienter, som fortsatte i behandling med vorapaxar, mens de fik foretaget bypassoperation (CABG), ikke en øget risiko for større blødning i forhold til placebo.
English: Includes all CV Death, MI, Stroke and GUSTO severe events up to each timepoint as indicated in the table.
Danish: GUSTO på hvert tidspunkt som angivet i tabellen.
English: - a history of myocardial infarction (MI), co-administered with acetylsalicylic acid (ASA) and,
Danish: - myokardieinfarkt (MI) i anamnesen, administreret sammen med acetylsalicylsyre (ASA) og, hvor det er hensigtsmæssigt, clopidogrel eller - symptomatisk perifer arteriesygdom (PAD), administreret sammen med acetylsalicylsyre (ASA) eller, hvor det er hensigtsmæssigt, clopidogrel.
English: Because of the limited therapeutic experience and the increased inherent risk of bleeding in patients with severe hepatic impairment, Zontivity is contraindicated in such patients (see sections 4.3, 4.4, and 5.2).
Danish: Zontivity er kontraindiceret hos patienter med svært nedsat leverfunktion på grund af den begrænsede terapeutiske erfaring og den øgede iboende risiko for blødning hos sådanne patienter (se pkt.
English: (See section 4.4.)
Danish: 4.3 og 4.4).
English: Post-MI or PAD Patients with No History of Stroke or TIA
Danish: Post-MI- og PAD-patienter uden apopleksi eller TCI i anamnesen
English: Stroke
Danish: Virkning
English: TIMI Bleeding Category
Danish: TIMI-blødningskategori
English: Table 5: Multiple Occurrences of Net Clinical Outcome (CV Death/MI/Stroke/GUSTO Severe*) in Post-MI or PAD Patients with No History of Stroke or TIA
Danish: Tabel 5: Multiple forekomster af rene kliniske resultater (CV-død/MI/apopleksi/svær blødning iht.
English: Patients who experience a stroke, TIA, or ICH while on Zontivity should have therapy discontinued permanently (see sections 4.8 and 5.1).
Danish: Hos patienter, som får apopleksi, transitorisk cerebral iskæmi (TCI) eller intrakraniel blødning (ICH), mens de er i behandling med Zontivity, skal behandlingen seponeres permanent (se pkt.
English: In the cohort of post-MI or PAD patients with no history of stroke or TIA, the net clinical outcome analysis based on multiple occurrences of endpoints (CV Death/MI/Stroke/GUSTO Severe) is constant over time at each of the censoring times examined (12, 18, 24, 30, and 36 months) at cumulative 6-month intervals.
Danish: I kohorten med post-MI- og PAD-patienter uden apopleksi eller TCI i anamnesen er det rene kliniske analyseresultat baseret på multiple forekomster af endepunkter (CV-død/MI/apopleksi/svær blødning iht.
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Næseblod Mave-tarm-kanalen
English: • bruising
Danish: • mavekatar
English: If you take more Zontivity than you are supposed to, talk to a doctor or go to hospital straight away.
Danish: Hvis du har taget for mange Zontivity tabletter Kontakt straks din læge eller tag på hospitalet, hvis du har taget for mange Zontivity tabletter.
English: • If you have any further questions, ask your doctor, pharmacist, or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: Wound haemorrhage
Danish: Nedsat nyrefunktion
English: • nose bleeds
Danish: • næseblod
English: • The other ingredients are: Tablet core: lactose monohydrate; cellulose microcrystalline (E460); croscarmellose sodium (E468); povidone (E1201); magnesium stearate (E572).
Danish: Tabletkerne: lactosemonohydrat; mikrokrystallinsk cellulose (E460); croscarmellosenatrium
English: This is because it is not known if Zontivity passes into your breast milk.
Danish: Fortæl det til din læge, hvis du ammer, da det er ukendt, om Zontivity udskilles i mælk.
English: TIMI Bleeding Category Major
Danish: TIMI-blødningskategori Større
English: The sooner it is taken after having unprotected sex the more effective it will be.
Danish: Jo hurtigere det tages efter ubeskyttet sex, desto mere effektivt vil det være.
English: Outcome of a procedure under Article 13 of Regulation (EC) 1234/2008
Danish: Resultatet af en procedure i henhold til artikel 13 i forordning (EF) nr. 1234/2008
English: What is Levonelle?
Danish: Hvad er Levonelle?
English: In most EU Member States Levonelle and associated names can be obtained without a prescription.
Danish: I de fleste EU-medlemsstater kan Levonelle og relaterede navne fås uden recept.
English: Levonelle has been authorised in the EU under a mutual recognition procedure based on an initial authorisation granted by the United Kingdom on 15 June 2004.
Danish: Levonelle er blevet godkendt i EU i kraft af en gensidig anerkendelsesprocedure, der er baseret på en indledende godkendelse udstedt af Storbritannien den 15. juni 2004.
English: No increased risk of side effects is expected from the higher dose.
Danish: Der forventes ingen øget risiko for bivirkninger som følge af den højere dosis.
English: Why was Levonelle reviewed?
Danish: Hvorfor blev Levonelle vurderet igen?
English: The company wanted this change to be recognised in Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain and Sweden.
Danish: Frankrig, Tyskland, Grækenland, Irland, Italien, Letland, Luxembourg, Nederlandene, Norge, Polen, Portugal, Spanien og Sverige.
English: On 1 October 2015, the UK referred the matter to the CHMP for arbitration.
Danish: Den 1. oktober 2015 indbragte Storbritannien sagen for CHMP med henblik på voldgift.
English: This could mean that the contraceptive effects of Levonelle are reduced.
Danish: Det kan betyde, at Levonelles svangerskabsforebyggende virkning er reduceret.
English: The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Levonelle on 01/08/2016.
Danish: Europa-Kommissionen traf en juridisk bindende afgørelse om at gennemføre CHMP's anbefalinger vedrørende Levonelle med gyldighed i hele EU 01/08/2016.
English: Although the review did not cover the 750 microgram Levonelle tablets, the CHMP recommended that similar changes should be considered for these medicines.
Danish: Selvom gennemgangen ikke vedrørte Levonelle 750 mikrogram-tabletterne, anbefalede CHMP, at lignende ændringer overvejes for disse lægemidler.
English: This review only covered the 1500 microgram tablets.
Danish: Denne gennemgang omfattede kun tabletter med 1 500 mikrogram.
English: It is available as a single tablet containing 1500 microgram levonorgestrel or as two tablets each containing 750 microgram levonorgestrel.
Danish: Det fås som én tablet med 1 500 mikrogram levonorgestrel eller som to tabletter med hver 750 mikrogram levonorgestrel.
English: On 26 May 2016, the European Medicines Agency completed a review for the emergency contraceptive Levonelle (levonorgestrel, 1500 microgram tablets) and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMA) afsluttede den 26. maj 2016 en gennemgang af nødpræventionsmidlet Levonelle (levonorgestrel, 1 500 mikrogram-tabletter) og relaterede navne.
English: Levonelle contains levonorgestrel, which works mainly by preventing or delaying ovulation.
Danish: Levonelle indeholder levonorgestrel, der hovedsageligt virker ved at forhindre eller forsinke ægløsning.
English: Based on data on interactions with these medicines, which all increase the activity of the liver enzyme CYP3A4, as well as data on combined hormonal contraceptives, the CHMP concluded that interactions between these medicines and Levonelle may prevent Levonelle from working effectively and could lead to contraceptive failure.
Danish: På grundlag af data vedrørende interaktioner med disse lægemidler, der alle øger aktiviteten af leverenzymet CYP3A4, samt data for kombinerede hormonelle præventionsmidler, konkluderede CHMP, at interaktionerne mellem disse lægemidler og Levonelle kan forhindre Levonelle i at virke effektivt og føre til præventionssvigt.
English: Levonelle is an emergency contraceptive used to prevent unintended pregnancy when taken within 72 hours (3 days) of unprotected intercourse or failure of a contraceptive method.
Danish: Levonelle er et nødpræventionsmiddel, der bruges til at forebygge uønsket graviditet, og det skal tages inden for 72 timer (3 døgn) efter ubeskyttet samleje eller præventionssvigt.
English: On 17 September 2014, the company for Levonelle applied for a change to the marketing authorisation to include the HIV medicine efavirenz as an interacting medicine in the product information.
Danish: Den 17. september 2014 ansøgte virksomheden, der markedsfører Levonelle, om en ændring af markedsføringstilladelsen, så den omfatter hiv-medicinen efavirenz som et interagerende lægemiddel i produktinformationen.
English: However, when this is not an option, the CHMP considered that doubling the dose of Levonelle from 1500 to 3000 microgram is recommended to compensate for the reduction in blood levonorgestrel levels.
Danish: Når dette ikke er muligt, mener CHMP dog, at en fordobling af dosen fra 1 500 mikrogram til 3 000 mikrogram bør anbefales for at kompensere for reduktionen af levonorgestrel-koncentrationen i blodet.
English: Although the Member States agreed that efavirenz interacts with levonorgestrel and that this information should be included in the product information, the Member States were unable to reach an agreement on how this interaction should be managed and whether specific recommendations such as dose adjustment were required for women taking Levonelle while on efavirenz or other medicines which also reduce levonorgestrel levels.
Danish: Selvom medlemsstaterne var enige om, at efavirenz interagerer med levonorgestrel, og at denne oplysning bør fremgå af produktinformationen, kunne de ikke blive enige om, hvordan denne interaktion bør håndteres, og om det er nødvendigt med specifikke anbefalinger, f.eks. justering af dosen, for kvinder, der tager Levonelle samtidigt med efavirenz eller andre lægemidler, der også reducerer koncentrationen af levonorgestrel.
English: However, Levonelle should only be used with these medicines when a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) is not an option.
Danish: Levonelle bør imidlertid kun bruges sammen med disse lægemidler, når et ikke-hormonelt nødpræventionsmiddel (f.eks. et kobberindlæg) ikke er en mulighed.
English: The company that markets these medicines is Gedeon Richter Plc.
Danish: Det er virksomheden Gedeon Richter Plc., der markedsfører disse lægemidler.
English: The grounds for the referral were concerns from Italy that there are insufficient clinical data to support doubling the dose of Levonelle in cases where the woman is also taking a medicine that interacts with Levonelle.
Danish: Begrundelserne for indbringelsen er betænkeligheder fra Italien, der mener, at der er utilstrækkelige kliniske data til at understøtte en fordobling af Levonelle-dosen i de tilfælde, hvor kvinden samtidig tager et lægemiddel, der interagerer med Levonelle.
English: In addition there were concerns that, since Levonelle is available without prescription in many EU Member States, any new advice issued could lead to medication errors as there may not always be a consultation with a healthcare professional prior to taking the medicine.
Danish: Der var også betænkeligheder ved følgende: Da Levonelle fås i håndkøb i mange EU-medlemsstater, vil udstedelsen af en ny vejledning ikke nødvendigvis forhindre medicineringsfejl, da kvinderne ikke altid rådfører sig med en sundhedsperson, inden de tager medicinen.
English: The CHMP recommended that women who use liver enzyme inducers should instead use a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) which is not affected by liver enzyme inducing medicines.
Danish: CHMP anbefalede, at kvinder, der bruger leverenzym-fremmere, i stedet bør anvende et ikke-hormonelt præventionsmiddel (f.eks. et kobberindlæg), som ikke påvirkes af leverenzymfremmende medicin.
English: Feedback was sought from patients and relevant healthcare professionals to ensure that women could identify when to use a double dose versus a single dose based on the information provided.
Danish: Der efterspurgtes feedback fra kvinder i målgruppen og fra relevante sundhedspersoner for at sikre, at kvinderne forstår ud fra de anførte oplysninger, hvornår de skal tage en dobbelt dosis i stedet for en enkelt dosis.
English: The CHMP noted that the reductions in blood levels of levonorgestrel seen with efavirenz were similar to those seen with other medicines (so-called liver enzyme inducers) that interact with levonorgestrel (including certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort).
Danish: CHMP bemærkede, at de reduktioner i koncentrationen af levonorgestrel i blodet, der er observeret ved samtidig administration af efavirenz, svarer til dem, der ses med andre lægemidler (såkaldte leverenzym-fremmere), som interagerer med levonorgestrel (herunder visse lægemidler mod tuberkulose og epilepsi samt naturlægemidler indeholdende prikbladet perikon).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that when Levonelle is taken together with certain interacting medicines (including the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort) the dose of Levonelle should be doubled.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) har anbefalet, at dosen af Levonelle fordobles, når lægemidlet tages sammen med visse interagerende lægemidler (herunder hiv-medicinen efavirenz og ritonavir, visse lægemidler mod tuberkulose og epilepsi samt naturlægemidler indeholdende prikbladet perikon).
English: around 50% in women taking efavirenz, which is known to increase the activity of a particular liver enzyme (CYP3A4) which is involved in the breakdown of levonorgestrel.
Danish: Ansøgningen var baseret på en undersøgelse, der viste, at koncentrationen af levonorgestrel i blodet blev reduceret med ca. 50 % hos kvinder, som tog efavirenz, et middel, der øger aktiviteten af et bestemt leverenzym (CYP3A4), som er involveret i nedbrydningen af levonorgestrel.
English: In order to ensure the correct use of Levonelle, the CHMP also recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
Danish: For at sikre korrekt brug af Levonelle anbefalede CHMP også, at det af yderpakningen og indlægssedlen fremgår, hvornår man skal tage en dobbelt dosis.
English: In order to ensure the correct use of Levonelle, the CHMP recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
Danish: For at sikre korrekt brug af Levonelle anbefalede CHMP, at det af yderpakningen og indlægssedlen fremgår, hvornår man skal tage en dobbelt dosis.
English: It was to be available as capsules.
Danish: Det var hensigten, at det skulle leveres som kapsler.
English: The company that applied for authorisation is Teva Pharma GmbH.
Danish: Den virksomhed, der har indgivet ansøgningen, er Teva Pharma GmbH.
English: EMA/311892/2014 EMEA/H/C/002546
Danish: Den 23. maj 2014 EMA/405477/2014 EMEA/H/C/002546
English: What is Nerventra?
Danish: Hvad er Nerventra?
English: Nerventra is a medicine that contains the active substance laquinimod.
Danish: Nerventra er et lægemiddel, der indeholder det aktive stof laquinimod.
English: The CHMP opinion has no consequences on these trials.
Danish: CHMP's udtalelse har ingen konsekvenser for disse undersøgelser.
English: If you are taking part in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Nerventra og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: The effects of Nerventra were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Nerventra blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: In addition, the Committee was not convinced about the effectiveness of the company's proposed measures to prevent pregnancies in women who would take the medicine.
Danish: Desuden var udvalget ikke overbevist om effektiviteten af de foranstaltninger, virksomheden påtænkte for at undgå graviditet hos kvinder, der tager lægemidlet.
English: Refusal of the marketing authorisation for Nerventra (laquinimod)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Nerventra (laquinimod)
English: There was also a possible risk (again from animal studies) of effects on the unborn baby when the medicine is taken by pregnant women.
Danish: Der var desuden en mulig risiko (igen ud fra dyreundersøgelserne) for påvirkning af det ufødte barn, når lægemidlet bruges af gravide kvinder.
English: The exact way Nerventra works is not known, but it is believed to have a modulator effect on the immune system (the body's defences).
Danish: Det vides ikke nøjagtigt, hvordan Nerventra virker, men det menes at have modulerende virkning på kroppens naturlige forsvar (immunsystemet).
English: On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis.
Danish: Den 23. januar 2014 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Nerventra til behandling af multipel sklerose.
English: What was Nerventra expected to be used for?
Danish: Hvad forventedes Nerventra anvendt til?
English: How is Nerventra expected to work?
Danish: Hvordan forventes Nerventra at virke?
English: During the re-examination, the CHMP considered advice from an expert group in neurology.
Danish: Under den fornyede overvejelse tog CHMP hensyn til rådgivningen fra en ekspertgruppe i nervesygdomme.
English: The company informed the CHMP that there are a number of ongoing and planned clinical trials with Nerventra in patients with multiple sclerosis.
Danish: Virksomheden har til CHMP oplyst, at der på nuværende tidspunkt er en række igangværende og planlagte kliniske undersøgelser med Nerventra hos patienter med multipel sklerose.
English: The CHMP noted that the risk could not be excluded with current data and that animal studies suggest that some of the harmful effects may be delayed and only seen later on in the child's life.
Danish: CHMP bemærkede, at denne risiko ikke kunne udelukkes ud fra de foreliggende oplysninger, og at dyreundersøgelserne tyder på, at nogle af de skadelige virkninger optræder forsinket og først opdages senere i barnets liv.
English: The expert group advised that the risks seen in animal studies could have been acceptable if a clear benefit was seen in clinical studies, although a strict pregnancy prevention scheme would have been required.
Danish: Ekspertgruppen udtalte, at risiciene i dyreundersøgelserne kunne have været accepteret, hvis de kliniske undersøgelser havde vist en klar fordel, men at det ville have krævet streng forebyggelse af graviditet.
English: Refusal of the marketing authorisation for Nerventra (laquinimod) EMA/311892/2014
Danish: Afslag på ansøgningen om markedsføringstilladelse for Nerventra (laquinimod) EMA/405477/2014
English: Nerventra was expected to be used to treat multiple sclerosis (MS), a disease in which the immune system malfunctions, causing inflammation that destroys the protective sheath around the nerves in the brain and spinal cord.
Danish: Nerventra forventedes anvendt til behandling af voksne med multipel sklerose, en sygdom, hvor immunsystemet fungerer dårligt og medfører inflammation, der ødelægger den beskyttende skede omkring nerverne i hjernen og rygmarven.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Danish: CHMP gennemgik begrundelsen for anmodningen og foretog en fornyet overvejelse af den oprindelige udtalelse, men bekræftede den 22. maj 2014 afslaget på ansøgningen om markedsføringstilladelse.
English: Nerventra was to be used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Danish: Nerventra skulle anvendes ved den form af sygdommen, hvor der er gentagne tilbagefald af symptomerne (recidiv) efterfulgt af perioder med bedring (remission).
English: control the inflammation and the damage to nerves, thus helping to reduce symptoms and the worsening of disability in patients with MS.
Danish: Ved at modulere immunsystemet forventes det at begrænse inflammation og beskadigelse af nerverne og derved mindske symptomer og forværring af invaliditet hos patienter med multipel sklerose.
English: The company also provided results of two main studies in patients with relapsing-remitting MS. One of the studies involving 1,106 patients compared Nerventra with placebo (a dummy treatment), while the second study in 1,331 patients compared Nerventra with placebo and another medicine used to treat MS, interferon-beta 1a.
Danish: Den anden omfattede 1 331 patienter og sammenlignede Nerventra med placebo og et andet lægemiddel mod multipel sklerose, interferon-beta 1a.
English: Both studies lasted two years and the main measure of effectiveness was based on the reduction in the number of relapses per patient per year (what is known as the ‘annualised relapse rate').
Danish: Virkningen blev hovedsagelig bedømt på faldet i antallet af tilbagefald pr. patient pr. år (den årlige tilbagefaldsrate).
English: Therefore the Committee concluded that the benefits of Nerventra at the dose studied were not sufficient to outweigh the potential risks in patients with relapsing remitting MS and maintained its recommendation that the medicine be refused marketing authorisation.
Danish: Udvalget konkluderede derfor, at fordelene ved Nerventra ved den undersøgte dosis ikke var tilstrækkelige til at opveje de mulige risici for patienter med recidiverende/remitterende multipel sklerose.