FrancophonIA/ELRC3.0 huggingface dataset:
English: It slows down the rate at which indinavir is broken down, helping to increase levels of indinavir in the blood.
Danish: Den mindsker den hastighed, hvormed indinavir nedbrydes, hvorved mængden af indinavir i blodet øges.
English: Crixivan is used in combination with other antiviral medicines and contains the active substance indinavir.
Danish: Crixivan anvendes i kombination med andre lægemidler mod virus og indeholder det aktive stof indinavir.
English: For more information about treatment with Crixivan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Crixivan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why is Crixivan been approved?
Danish: Hvorfor blev Crixivan godkendt?
English: What are the risks associated with Crixivan?
Danish: Hvilke risici er der forbundet med Crixivan?
English: In one study, 90% of those taking Crixivan in combination with zidovudine and lamivudine had viral loads below 500 copies/ml after 24 weeks of treatment, compared with 43% of those taking Crixivan alone and none (0%) of those taking zidovudine and lamivudine without Crixivan.
Danish: Undersøgelser har vist, at Crixivan sammen med andre antivirale lægemidler er effektivt til at mindske hiv-niveauet i blodet (virusindhold ) I en undersøgelse var virusindholdet hos 90 % af dem, der fik Crixivan i kombination med zidovudin og lamivudin, under 500 kopier/ml efter 24 uger sammenlignet med 43 % af dem, der kun fik Crixivan, og ingen af dem, der fik zidovudin og lamivudin uden Crixivan.
English: For the full list of side effects reported with Crixivan, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Crixivan fremgår af indlægssedlen.
English: For practical information about using Crixivan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Crixivan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Crixivan is an antiviral medicine for treating adults infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Crixivan er et antiviralt lægemiddel og anvendes til behandling af voksne, som er smittet med HIV-1 (humant immundefektvirus type 1).
English: How is Crixivan used?
Danish: Hvordan anvendes Crixivan?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Crixivan 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 Crixivan.
English: What benefits of Crixivan have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Crixivan?
English: How does Crixivan work?
Danish: Hvordan virker Crixivan?
English: The frequency of injections is adjusted again after 6 and 9 months depending on how well the medicine is working.
Danish: Hyppigheden af injektioner justeres igen efter 6 og 9 måneder afhængigt af, hvor godt lægemidlet virker.
English: At the start of treatment, Waylivra is given once a week.
Danish: Ved behandlingens start gives Waylivra én gang om ugen.
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Danish: Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet, som virksomheden er blevet bedt om at fremlægge.
English: Waylivra has been given ‘conditional authorisation'.
Danish: Waylivra har fået en "betinget godkendelse".
English: Patients must therefore be monitored closely and the frequency of injections adjusted if needed.
Danish: Patienterne skal derfor overvåges nøje, og hyppigheden af injektionerne skal om nødvendigt justeres.
English: Depending on the results, frequency of injections may be adjusted, or treatment paused or discontinued.
Danish: Afhængigt af resultaterne kan hyppigheden af injektionerne justeres, eller behandlingen kan afbrydes eller indstilles.
English: As for all medicines, data on the use of Waylivra are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Waylivra løbende overvåget.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3141249.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/eu3141249.
English: An overview of Waylivra and why it is authorised in the EU
Danish: En oversigt over Waylivra, og hvorfor det er godkendt i EU
English: Further information on Waylivra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/waylivra.
Danish: Yderligere information om Waylivra findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/waylivra.
English: Waylivra contains the active substance volanesorsen.
Danish: Waylivra indeholder det aktive stof volanesorsen.
English: Other information about Waylivra
Danish: Andre oplysninger om Waylivra
English: What measures are being taken to ensure the safe and effective use of Waylivra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Waylivra?
English: For more information about using Waylivra, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Waylivra, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: FCS is rare, and Waylivra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 February 2014.
Danish: FCS er sjælden, og Waylivra blev udpeget som "lægemiddel til sjældne sygdomme" den 19. februar 2014.
English: Side effects reported with Waylivra are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Waylivra vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Why is Waylivra authorised in the EU?
Danish: Hvorfor blev Waylivra godkendt i EU?
English: The active substance in Waylivra, volanesorsen, is an ‘antisense oligonucleotide,' a very short piece of synthetic RNA (a type of genetic material).
Danish: Det aktive stof i Waylivra, volanesorsen er et "antisense-oligonukleotid", et meget kort stykke syntetisk RNA (en type genetisk materiale).
English: What is Waylivra and what is it used for?
Danish: Hvad er Waylivra, og hvad anvendes det til?
English: The most common side effects with Waylivra are reduced platelet levels (which may affect 4 in 10 people) and reactions at the site of the injection such as pain, swelling, itching, or bruising (which may affect 8 in 10 people).
Danish: De hyppigste bivirkninger ved Waylivra er reducerede blodpladetal (som kan forekomme hos 4 ud af 10 personer) og reaktioner på injektionsstedet som f.eks. smerte, hævelse, kløe eller blå mærker (som kan forekomme hos 8 ud af 10 personer).
English: All patients in the study were on a low fat diet in addition to receiving Waylivra or placebo.
Danish: Alle patienter, der deltog i studiet, blev sat på fedtfattig kost sideløbende med, at de fik Waylivra eller placebo.
English: After 3 months, patients given Waylivra had an average 77% reduction in the level of triglycerides compared with an average 18% reduction in patients given placebo (a dummy treatment).
Danish: Efter 3 måneder oplevede de patienter, der fik Waylivra, en gennemsnitlig reduktion på 77 % af triglyceridindholdet sammenlignet med en gennemsnitlig reduktion på 18 % hos de patienter, der fik placebo (en uvirksom behandling).
English: After 3 months, patients who have had a sufficient reduction in the level of triglycerides can continue to receive the medicine once every 2 weeks.
Danish: Efter 3 måneder kan patienter, hos hvem triglyceridindholdet i blodet er tilstrækkeligt reduceret, fortsat modtage lægemidlet én gang hver anden uge.
English: The main risk with this medicine is thrombocytopenia which, when severe, can lead to bleeding.
Danish: Den største risiko ved dette lægemiddel er trombocytopeni, der i svære tilfælde kan føre til blødning.
English: Waylivra must not be used in patients who have long-term or unexplained thrombocytopenia (low blood platelet levels).
Danish: Waylivra må ikke anvendes til patienter med længerevarende eller uforklarlig trombocytopeni (lave blodpladetal).
English: Waylivra can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in treating FCS.
Danish: Waylivra udleveres kun efter recept, og behandlingen bør overvåges af en læge med erfaring i behandling af FCS.
English: What information is still awaited for Waylivra?
Danish: Hvilke oplysninger afventes der stadig for Waylivra?
English: It has been designed to block the production of a protein that slows down the breakdown of fats called apolipoprotein C-III.
Danish: Det er udformet således, at det blokerer for produktionen af et protein kaldet apolipoprotein C-III, der bremser nedbrydningen af fedt.
English: What are the risks associated with Waylivra?
Danish: Hvilke risici er der forbundet med Waylivra?
English: By blocking the production of this protein, the medicine reduces the level of triglycerides in the blood and, as a result, fat accumulation in the body, which is expected to reduce the risk of pancreatitis.
Danish: Ved at blokere for produktionen af dette protein reducerer lægemidlet triglyceridindholdet i blodet og dermed fedtophobningen i kroppen, hvilket forventes at mindske risikoen for bugspytkirtelbetændelse.
English: Waylivra is available as a solution for injection under the skin, which patients or their carers can inject themselves once they have been trained.
Danish: Waylivra fås som en opløsning til injektion under huden, som patienterne selv eller deres plejere kan indsprøjte efter forudgående oplæring.
English: It is only given to patients in whom other medicines to reduce triglycerides have not worked and who are at high risk of developing pancreatitis.
Danish: Det gives kun til patienter, hos hvem andre lægemidler til reduktion af triglyceridindholdet i blodet ikke har virket, og som har en høj risiko for at udvikle bugspytkirtelbetændelse.
English: Excess fat builds up in various parts of the body and leads to symptoms including abdominal pain (belly ache), deposits of fat under the skin and pancreatitis (inflammation of the pancreas).
Danish: Overskydende fedt ophobes i forskellige dele af kroppen og giver symptomer såsom mavesmerter, fedtdepoter under huden og bugspytkirtelbetændelse.
English: The European Medicines Agency decided that, for patients at high risk of pancreatitis and for whom other medicines and a low-fat diet have not worked well enough, Waylivra's benefits are greater than its risks and that it can be authorised for use in the EU.
Danish: Hvad angår patienter med høj risiko for bugspytkirtelbetændelse, for hvem andre lægemidler og fedtfattig kost ikke har fungeret godt nok, konkluderede Det Europæiske Lægemiddelagentur, at fordelene ved Waylivra opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Because Waylivra can reduce blood levels of platelets (components that help the blood to clot), patients' blood platelet levels should be checked regularly, in addition to regular checks of triglycerides to see how well the medicine is working.
Danish: Da Waylivra kan reducere antallet af blodplader (komponenter, der hjælper blodet med at størkne), bør patienternes blodpladetal kontrolleres regelmæssigt, ud over de regelmæssige triglyceridkontroller, for at se, hvor godt lægemidlet virker.
English: Since Waylivra has been given conditional authorisation, the company that markets Waylivra will provide results of a study based on a registry of patients to investigate how blood checks and adjustments to frequency of injections are carried out in practice and how well they work to prevent thrombocytopenia and bleeding.
Danish: Da Waylivra har fået en betinget godkendelse, vil virksomheden, der markedsfører Waylivra, fremlægge resultaterne af et studie, der er baseret på et patientregister, med henblik på at undersøge, hvordan blodtest og justeringer af hyppigheden af injektioner foretages i praksis, og hvor effektive de er i henseende til at forebygge trombocytopeni og blødning.
English: Waylivra is a medicine used to treat familial chylomicronaemia syndrome (FCS), a genetic condition that gives rise to high levels of fats called triglycerides in the blood.
Danish: Waylivra er et lægemiddel til behandling af familiært chylomicronæmisyndrom (FCS), en genetisk tilstand, der medfører forhøjet indhold af en type fedtstof i blodet kaldet triglycerid.
English: For the full list of side effects and restrictions with Waylivra, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Waylivra fremgår af indlægssedlen.
English: The company that markets Waylivra will provide educational materials for patients and healthcare professionals with information on the risk of thrombocytopenia and bleeding with treatment and the importance of regularly checking platelet levels in patients.
Danish: Virksomheden, der markedsfører Waylivra, vil udlevere oplysningsmateriale til patienter og sundhedspersonale med information om risikoen for trombocytopeni og blødning som følge af behandlingen og vigtigheden af regelmæssigt at kontrollere patienternes blodpladetal.
English: How is Waylivra used?
Danish: Hvordan anvendes Waylivra?
English: Waylivra effectively reduces triglyceride levels and is expected to reduce the risk of pancreatitis in patients with FCS.
Danish: Waylivra reducerer triglyceridindholdet i blodet og forventes at mindske risikoen for bugspytkirtelbetændelse hos patienter med FCS.
English: Waylivra, along with a low fat diet, is used to reduce triglyceride blood levels in patients with FCS that has been confirmed by genetic testing.
Danish: Waylivra anvendes sammen med fedtfattig kost til at reducere triglyceridindholdet i blodet hos patienter med FCS, som er blevet konstateret ved en gentest.
English: How does Waylivra work?
Danish: Hvordan virker Waylivra?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Waylivra have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Waylivra.
English: What benefits of Waylivra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Waylivra?
English: Waylivra was effective in reducing triglycerides in the blood in a study of 67 patients with FCS.
Danish: Af et studie, der omfattede 67 patienter med FCS, fremgik det, at Waylivra var effektivt til at reducere triglyceridindholdet i blodet.
English: Close surveillance with regard to immunological reactions is especially important in such situations.
Danish: Nøje overvågning med hensyn til immunologiske reaktioner er særlig vigtig i sådanne situationer.
English: Date of first authorisation: 28 July 2006 Date of latest renewal: 15 July 2016
Danish: Dato for første markedsføringstilladelse: 28. juli 2006 Dato for seneste fornyelse: 15. juli 2016
English: • Information about the currently registered indications and population, including that the product is not indicated in the paediatric population.
Danish: • Information om de aktuelt registrerede indikationer og population, herunder at produktet ikke er indiceret til den pædiatriske population.
English: Antithrombin contains two functionally important domains.
Danish: Antithrombin indeholder to funktionsmæssigt vigtige domæner.
English: The experience from repeated treatment with this medicine is very limited.
Danish: Erfaring fra gentagen behandling med dette lægemiddel er meget begrænset.
English: This post-marketing surveillance will run up until such time as 40 patients are enrolled.
Danish: Denne post-marketingsovervågning vil ske indtil 40 patienter er rekrutteret.
English: Antibody status should be monitored and reported.
Danish: Antistofstatus skal overvåges og rapporteres.
English: Available data do not suggest harmful effects to the mother or infant.
Danish: De tilgængelige data antyder ikke skadelige virkninger for moder eller barn.
English: This medicine should therefore not be used if you are less than18 years.
Danish: Dette lægemiddel må derfor ikke bruges, hvis De er under 18 år gammel.
English: Please discuss possibility of stopping the treatment with your doctor.
Danish: De bedes venligst drøfte muligheden af at ophøre med behandlingen med Deres læge.
English: The Physician educational material shall contain the following key elements:
Danish: Undervisningsmaterialet til læger skal indeholde følgende elementer:
English: It is one of the most important natural inhibitors of blood coagulation.
Danish: Det er en af de vigtigste, naturlige blodkoagulationshæmmere.
English: Therefore, it is important that your antithrombin blood level be maintained at sufficient levels in these situations.
Danish: Det er derfor vigtigt, at niveauet for antithrombin i blodet kan opretholdes på et tilstrækkeligt niveau i disse situationer.
English: However, chemical and physical stability has been demonstrated for 3 hours after reconstitution and 8 hours after dilution at a temperature not above 25°C.
Danish: Kemisk og fysisk stabilitet er dog blevet påvist 3 timer efter rekonstitution og 8 timer efter fortynding ved en temperatur, der ikke overstiger 25 °C.
English: Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Danish: Patienterne skal overvåges nøje og observeres omhyggeligt for eventuelle symptomer i hele infusionsperioden.
English: Frequencies are defined as: common (≥ 1/100 to < 1/10) and uncommon (≥1/1,000 to <1/100).
Danish: Hyppigheden defineres som følger: Almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥1/1.000 t <1/100).
English: A marketing authorization variation will be submitted to seek to expand the indication and dosing of pregnant women.
Danish: En variationsansøgning af markedsføringstilladelsen vil blive indsendt med henblik på at udvide indikationen og doseringen af gravide kvinder.
English: The expiry date refers to the last date of that month.
Danish: Udløbsdatoen (Exp) er den sidste dag i den nævnte måned.
English: • bleeding (at site of infusion or after surgery)
Danish: • blødning (på infusionsstedet eller efter operationen)
English: Compatibility with PVC infusion lines with in-line filters has been established.
Danish: Kompatibilitet med PVC-infusionsslanger med in-line filtre er påvist.
English: Patients treated with this medicine should be monitored for possible clinical immunological reactions.
Danish: Patienter under behandling med dette lægemiddel bør overvåges for mulige klinisk-immunologiske reaktioner.
English: No information on the use of ATryn in patients less than 18 years is available.
Danish: Der findes ingen oplysninger om brugen af ATryn til patienter under 18 år.
English: To test whether you developed an allergic reaction, blood may be collected and tested before and some time after you have been treated with ATryn.
Danish: For at undersøge om De har udviklet en allergisk reaktion, kan der blive taget blodprøver både før og efter, De er blevet behandlet med ATryn.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for
English: The educational material for healthcare professionals is aimed at increasing the awareness about the potential efficacy issues resulting from off-label use of Atryn.
Danish: Undervisningsmaterialet til sundhedsprofessionelle har til formål at øge bevidstheden om potentielle problemer med effekt, der resultere fra off-label brug af ATryn.
English: What you need to know before you use ATryn
Danish: Det skal du vide, før du begynder at bruge ATryn
English: Response may vary in individual patients, achieving different levels of in vivo recovery and different half-lives.
Danish: Patienter kan respondere forskelligt, således at der opnås forskellige niveauer af in vivo aktivitet og forskellige halveringstider.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme
English: The results of completed study GTC AT HD 012-04 and in particular the results of investigations in pregnant women treated during the peri-partum period have been submitted.
Danish: Resultaterne af det gennemførte studie GTC AT HD 012-04 og specielt resultaterne fra undersøgelser af gravide kvinder behandlet i peripartum perioden er blevet indsendt.
English: LFB-BIOTECHNOLOGIES, 3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France MedImmune Pharma BV Lagelandseweg 78 6545 CG Nijmegen, The Netherlands.
Danish: LFB-BIOTECHNOLOGIES, 3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, Frankrig MedImmune Pharma BV Lagelandseweg 78 6545 CG Nijmegen, Holland
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering)er nået.
English: • Clearance: 0.665 ± 0.0493 l/h (Mean ± SE)
Danish: ● Clearance: 0,665 ± 0,0493 l/time (gennemsnit ± SE)
English: Adverse reactions are presented below by system organ class and absolute frequency.
Danish: Bivirkningerne angives herunder efter systemorganklasse og absolut hyppighed.
English: The inhibitor-coagulation enzyme complexes are removed by the reticulo-endothelial system.
Danish: Koagulationshæmmer enzymkomplekserne fjernes af det retikulo-endoteliale system.
English: • Information regarding the resulting efficacy issues associated with off-label use of ATryn, especially
Danish: • Information om problemerne med effekt, som resulterer fra off-label brug af ATryn, særligt til den
English: Therefore, an additional check of the AT activity level should be done after the surgery.
Danish: Der skal derfor udføres en ekstra kontrol af AT-aktivitetsniveauet efter operationen.
English: A risk to the suckling child cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: This may be in the vessels of your legs (deep vein thrombosis) or in other vessels of your body (thromboembolism).
Danish: Dette kan ske i karrene i Deres ben (dyb venetrombose) eller i andre kar i kroppen (tromboembolisme).
English: ATryn is not indicated for use in pregnant women.
Danish: ATryn er ikke indiceret til brug i gravide kvinder.
English: Population pharmacokinetic parameters for ATryn derived from the same study revealed (mean ± SD):
Danish: Populations farmakokinetiske parametre for ATryn afledt fra samme forsøg viste (gennemsnit ± SD):