FrancophonIA/ELRC3.0 huggingface dataset:
English: For CLL patients with 17p deletion or TP53 mutation already on idelalisib therapy as first line, clinicians should carefully consider individual benefit-risk balance and decide whether to continue treatment.
Danish: For så vidt angår de CLL-patienter med 17p-deletion eller TP53-mutation, som allerede er i behandling med idelalisib som førstelinjevalg, bør lægerne omhyggeligt overveje benefit/risk-forholdet for den enkelte patient og beslutte, om behandlingen skal fortsætte.
English: Idelalisib is also indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
Danish: Idelalisib er også angivet som monoterapi til behandling af voksne patienter med follikulært lymfom (FL), som er refraktært til to tidligere behandlingsvalg.
English: The PRAC took into account the data submitted by the marketing authorisation holder (MAH).
Danish: PRAC har vurderet de data, som indehaveren af markedsføringstilladelsen har indsendt.
English: However, the committee recommended that idelalisib could be used for continuing treatment in those patients who had already initiated the medicine as first line treatment based on individual benefit-risk balance assessment and with the addition of new risk minimisation measures.
Danish: Udvalget anbefalede imidlertid, at behandlingen med idelalisib kan fortsættes hos de patienter, som allerede er begyndt at tage lægemidlet som førstelinjebehandling, efter en vurdering af benefit/risk-forholdet for den enkelte patient og med tilføjelse af nye risikominimerende foranstaltninger.
English: Therefore, the PRAC recommended that idelalisib should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal, or viral infection.
Danish: PRAC anbefalede derfor, at idelalisib-behandling ikke bør påbegyndes hos patienter med tegn på eksisterende systemisk bakterie-, svampe- eller virusinfektion.
English: Zydelig (Idelalisib) is a centrally authorised product and is currently indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Danish: Zydelig (idelalisib) er et centralt godkendt produkt og er angives aktuelt i kombination med rituximab til behandling af voksne patienter med kronisk lymfatisk leukæmi (CLL), som har fået mindst én tidligere behandling, eller som førstelinjebehandling ved tilstedeværelse af 17p-deletion eller TP53mutation hos patienter, der ikke er egnede til kemo-immunbehandling.
English: Idelalisib treatment should be discontinued in patients with evidence of infection or viraemia;
Danish: Behandling med idelalisib bør seponeres hos patienter med tegn på infektion eller viræmi
English: This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) 726/2004.
Danish: Anbefalingen er med forbehold for de endelige konklusioner i den igangværende procedure i henhold til artikel 20 i forordning (EF) nr.
English: The PRAC considered the very limited new safety data from three studies (GS-US-312-0123, GSUS-313-0124, GS-US-313-0125), now terminated, evaluating the addition of idelalisib to standard therapies in first line CLL and relapsed indolent non-Hodgkin lymphoma (iNHL)/small lymphocytic lymphoma (SLL).
Danish: PRAC har taget højde for de meget begrænsede nye sikkerhedsdata fra tre nu afsluttede undersøgelser (GS-US-312-0123, GS-US-313-0124 og GS-US-313-0125), som vurderede tilføjelsen af idelalisib til standardterapierne ved førstelinjebehandling af kronisk lymfatisk leukæmi (CLL) og recidiveret indolent non-Hodgkin-lymfom/småcellet lymfatisk lymfom (SLL).
English: The trials evaluated combinations with chemotherapy and immunotherapy which are currently not authorised for Zydelig (idelalisib), or authorised combination of Zydelig and immunotherapy but in a population with earlier disease characteristics than the currently approved indication.
Danish: Forsøgene undersøgte kombinationer af kemoterapi og immunterapi, der endnu ikke er godkendt for Zydelig (idelalisib), samt en godkendt kombination af Zydelig og immunoterapi, men i en population med tidlige sygdomskendetegn, som ikke er omfattet af den aktuelt godkendte indikation.
English: • The PRAC reviewed the very limited and preliminary data provided by the marketing authorisation holder on the interim results of study GS-US-312-0123, GS-US-313-0124, GS-US-313-0125 that suggested an increased risk of death and serious infection with idelalisib.
Danish: • PRAC har gennemgået de meget sparsomme og foreløbige data, som indehaveren af markedsføringstilladelsen har indsendt vedrørende de midlertidige resultater af forsøgene GSUS-312-0123, GS-US-313-0124 og GS-US-313-0125, der peger på en øget risiko for død og alvorlig infektion ved behandling med idelalisib.
English: The PRAC noted that in study -0123, idelalisib was administered in combination with bendamustine and rituximab (which is not an authorised combination) and CLL patients were previously untreated, which is not consistent with the current CLL indication.
Danish: Med hensyn til undersøgelse -0123 bemærker PRAC, at idelalisib blev administreret i kombination med bendamustin og rituximab (hvilket ikke er en godkendt kombination), og CLL-patienterne havde ikke tidligere været behandlet, hvilket ikke er i overensstemmelse med den nuværende CLL-indikation.
English: In view of the above, the Committee considers that the benefit-risk balance of Zydelig remains favourable subject to the agreed provisional amendments to the product information and other risk minimisation measures.
Danish: På grundlag af ovenstående konkluderede PRAC, at benefit/risk-forholdet for Zydelig fortsat er positivt under forudsætning af, at de foreslåede midlertidige ændringer indføres i produktinformationen, og at der træffes yderligere risikominimerende foranstaltninger.
English: Therefore, provisional measures are recommended but these are without prejudice of the outcome of the ongoing review under Article 20 procedure.
Danish: Derfor anbefales det at iværksætte foreløbige foranstaltninger, idet der dog tages forbehold for udfaldet af den igangværende gennemgangsprocedure i henhold til artikel 20, jf. ovenfor.
English: On 10 March 2016, the European Commission was informed that an increased risk of death and higher incidence of serious adverse events (SAE) among subjects receiving idelalisib compared to the control groups had been observed in three clinical trials by the Independent Safety Data Monitoring group.
Danish: Den 10. marts 2016 blev Europa-Kommissionen informeret om, at det uafhængige datasikkerhedsovervågningsudvalg i tre kliniske forsøg har observeret en øget risiko for død og en højere forekomst af alvorlige, uønskede hændelser (SAE'er) blandt idelalisib-behandlede patienter sammenholdt med kontrolgrupper.
English: As a temporary measure, the PRAC recommended that idelalisib should not be initiated as a first line treatment in CLL patients with 17p deletion or TP53 mutation.
Danish: Som midlertidig forholdsregel anbefalede PRAC, at idelalisib ikke bør anvendes som førstelinjebehandling hos CLL-patienter med 17p-deletion eller TP53-mutation.
English: • The PRAC noted that most of the serious adverse events reported in studies 0123, -0124 and -0125 were related to infections.
Danish: • PRAC bemærkede, at størstedelen af indberetningerne om alvorlige, uønskede bivirkninger i forsøgene -0123, -124 og -0125 er relateret til infektioner.
English: Although the potential impact of these new safety findings in the current authorised indications is presently unknown, the PRAC recommended provisional amendments of the indication of idelalisib and considered that as a precautionary measure, idelalisib should not be initiated as a first line treatment in CLL patients with 17p deletion or TP53 mutation.
Danish: Selvom den mulige indvirkning af disse nye sikkerhedsresultater på de aktuelt godkendte indikationer endnu ikke kendes, anbefalede PRAC en række midlertidige ændringer af indikationen for idelalisib, herunder at idelalisib-behandling af sikkerhedsmæssige årsager ikke bør påbegyndes som førstelinjebehandling hos CLL-patienter med 17p-deletion eller TP53-mutation.
English: The MAH suggested that in studies -0123, -0124 and -0125 lines of therapy (i.e. increased risk in earlier stages of disease) and concomitant medication (such as bendamustine) may have increased the risk of infection.
Danish: Indehaveren af markedsføringstilladelsen mener, at der i undersøgelserne -0123, -0124 og -0125 (dvs. øget risiko i de tidlige sygdomsstadier) kan være en øget risiko for infektion ved samtidig behandling med forsøgslægemidlet og anden medicin (f.eks. bendamustin).
English: Notwithstanding this fact, the PRAC considered that the limited data available justified the recommendation of temporary measures to ensure that healthcare professionals and patients are aware of the risks and of the measures to mitigate those.
Danish: Ikke desto mindre vurderede PRAC, at de begrænsede tilgængelige data berettigede anbefalingen om midlertidige foranstaltninger, så det kan sikres, at patienter og sundhedspersoner er opmærksomme på disse risici og på, hvad de skal gøre for at opveje dem. PRAC foreslog derfor risikominimerende foranstaltninger, herunder ændringer i produktinformationen og en meddelelse til sundhedspersoner.
English: It shall thus be set up in advance of placing the product on the market.
Danish: Registeret skal således oprettes, inden produktet bringes på markedet.
English: The registry's protocol shall be submitted to the national competent authorities within 2 months of Commission Decision.
Danish: Protokollen for registeret skal forelægges de nationale kompetente myndigheder senest 2 måneder efter Kommissionens afgørelse.
English: This RMP shall follow the EU RMP template and shall include the measures to assess the effectiveness of the risk minimisation.
Danish: Denne RMP skal følge EU-skabelonen for RMP og omfatte foranstaltninger til vurdering af risikominimeringens effektivitet.
English: Marketing authorisation holders shall conduct a registry, in order to monitor the pattern of use of aprotinin.
Danish: Indehaverne af markedsføringstilladelserne skal føre et register til overvågning af anvendelsesmønstret for aprotinin.
English: Updates on the registry will be submitted to national competent authorities with periodic safety update reports (PSURs).
Danish: Ajourføringer af registret skal indsendes til de nationale kompetente myndigheder sammen med de periodiske sikkerhedsopdateringsrapporter (PSUR'er).
English: The MAH shall take due account of the draft protocol and comments received during assessment.
Danish: Indehaveren af markedsføringstilladelsen skal tage behørigt hensyn til protokoludkastet og de kommentarer, der modtages under vurderingen.
English: The registry shall record utilisation information on patients at cardiac surgery centres exposed to aprotinin in participating countries.
Danish: I registret skal indføres oplysninger om anvendelsen til patienter, der eksponeres for aprotinin på hjertekirurgiske afdelinger i de deltagende lande.
English: A restricted distribution of aprotinin with the above mentioned registry, with aprotinin available only to centres that perform cardiac surgery on cardio-pulmonary bypass and that commit to participate in the registry.
Danish: Udleveringen af aprotinin, med henvisning til ovennævnte register, vil blive begrænset til centre, der udfører hjertekirurgi eller kardiopulmonal bypass, og som forpligter sig til at deltage i registret.
English: National Competent Authorities shall ensure that the following conditions are fulfilled by the MAHs of aprotinin containing medicinal products:
Danish: De nationale kompetente myndigheder skal sikre, at indehaverne af markedsføringstilladelserne for lægemidler indeholdende aprotinin opfylder følgende betingelser:
English: Marketing authorisation holders of aprotinin containing medicinal products shall submit to the national competent authorities, further to the issuing of the Commission Decision and prior to relaunch of the medicinal product to the European market, an update of the risk management plan (RMP) referring to the agreed products' safety concerns as described in the assessment report of the referral procedure and their risk minimisation which includes a direct healthcare professional communication.
Danish: Opdateringen af denne RMP skal dække de vedtagne sikkerhedsmæssige betænkeligheder ved produkterne, der er beskrevet i vurderingsrapporten til indbringelsesproceduren, og den hertil svarende risikominimering, herunder en DHPC-meddelelse (direkte meddelelse til fagfolk i sundhedssektoren).
English: This summary was last updated in February 2016.
Danish: Dette sammendrag blev sidst ajourført i februar 2016.
English: Letifend is a vaccine.
Danish: Letifend er en vaccine.
English: Only non-infected animals should be vaccinated.
Danish: Kun ikke-inficerede dyr bør vaccineres.
English: Protection starts four weeks after vaccination and lasts one year.
Danish: Beskyttelsen begynder fire uger efter vaccinationen og varer i et år.
English: The European Commission granted a marketing authorisation valid throughout the EU for Letifend on 20.04.2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for Letifend med gyldighed i hele Den Europæiske Union den 20. april 2016.
English: The full EPAR for Letifend can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Letifend findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Letifend.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Letifend.
English: In the future, if the animals are exposed to the parasite, the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for parasitten, vil immunsystemet reagere hurtigere.
English: This will help to protect against the disease.
Danish: Dette medvirker til at beskytte dyrene mod sygdommen.
English: What is Letifend and what is it used for?
Danish: Hvad er Letifend, og hvad anvendes det til?
English: The most common side effect with Letifend (which may affect more than 1 in 10 animals) is scratching at the injection site which resolves within four hours.
Danish: Den hyppigste bivirkning ved Letifend (som kan forekomme hos op til 1 ud af 10 dyr) er kløe på injektionsstedet, der aftager i løbet af fire timer.
English: In a field study in France and Spain 275 dogs were vaccinated with Letifend and 274 dogs received placebo (a dummy vaccination).
Danish: I en feltundersøgelse foretaget i Frankrig og Spanien blev 275 hunde vaccineret med Letifend, og 274 hunde fik placebo (ikke-aktiv vaccination).
English: Over a two year period there were 8 confirmed cases of leishmaniasis in the vaccinated group compared with 19 cases in the placebo group, showing that Letifend was effective in reducing the occurrence of the disease.
Danish: Over en periode på to år var der 8 bekræftede tilfælde af leishmaniasis i den vaccinerede gruppe, mens der var 19 tilfælde i placebo-gruppen, hvilket viser, at Letifend var effektivt til at reducere forekomsten af sygdommen.
English: The parasite is widespread in countries bordering the Mediterranean Sea and is transmitted by the bites of sand flies.
Danish: Parasitten er udbredt i landene omkring Middelhavet og overføres ved bid fra sandfluer.
English: Dogs that have been infected may show no signs of infection, but some have active disease with symptoms such as fever, hair and weight loss, and skin sores.
Danish: Nogle inficerede hunde viser ikke tegn på infektion, mens andre har aktiv sygdom med symptomer som f.eks. feber, hårtab, vægttab og hudsår.
English: It is not intended to provide practical advice on how to use Letifend.
Danish: Det er ikke en praktisk vejledning i, hvordan Letifend bør anvendes.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Letifend's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Letifend opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Why is Letifend approved?
Danish: Hvorfor blev Letifend godkendt?
English: The vaccine is given to dogs from 6 months of age as a single injection under the skin.
Danish: Vaccinen gives til hunde i alderen 6 måneder og derover som en enkelt injektion under huden.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" kroppens naturlige forsvar, immunsystemet, hvordan det skal forsvare kroppen mod en sygdom.
English: Infected dogs can help spread the disease to humans.
Danish: Inficerede hunde kan sprede smitten til mennesker.
English: Letifend contains the active substance protein Q, which is made of different fragments of proteins from Leishmania infantum.
Danish: Letifend indeholder det aktive stof protein Q, der er fremstillet af forskellige fragmenter af proteiner fra Leishmania infantum.
English: What are the risks associated with Letifend?
Danish: Hvilke risici er der forbundet med Letifend?
English: Other information about Letifend?
Danish: Andre oplysninger om Letifend
English: Letifend canine leishmaniasis vaccine (recombinant protein)
Danish: Letifend leishmaniasis-vaccine til hunde (rekombinant protein)
English: When Letifend is given to dogs the immune system recognises the Leishmania protein as ‘foreign' and makes defences against it.
Danish: Når Letifend gives til hunde, opfatter deres immunsystem Leishmania-proteinet som "fremmed" og producerer antistoffer mod det.
English: The dogs were exposed to natural infection with Leishmania infantum.
Danish: Hundene blev eksponeret for naturlig infektion med Leishmania infantum.
English: Letifend is available as a freeze-dried powder (lyophilisate) and solvent that are made up into a solution for injection, and can only be obtained with a prescription.
Danish: Letifend fås som frysetørret pulver (lyofilisat) og solvens, der klargøres til en suspension til injektion.
English: Letifend is a veterinary vaccine used in dogs to protect them against leishmaniasis due to the parasite Leishmania infantum.
Danish: Letifend er et veterinærlægemiddel, der anvendes til hunde for at beskytte dem mod leishmaniasis forårsaget af parasitten Leishmania infantum.
English: A ‘booster' injection should be given every year to maintain the vaccine's effect.
Danish: Vaccinationen bør gentages hvert år med injektion af en enkelt "boosterdosis" for at opretholde
English: Before vaccination, dogs should be tested for Leishmania infection.
Danish: Før vaccinationen skal hundene testes for Leishmania-infektion.
English: What benefits of Letifend have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Letifend?
English: How is Letifend used?
Danish: Hvordan anvendes Letifend?
English: For more information about treatment with Letifend, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Letifend, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Letifend, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Letifend, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Letifend work?
Danish: Hvordan virker Letifend?
English: vaccinated dogs since the vaccine does not prevent Leishmania infection.
Danish: Der bør træffes foranstaltninger for at reducere vaccinerede hundes eksponering for sandfluer, da vaccinen ikke forhindrer Leishmania-infektion.
English: Frequencies are defined as 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) and not known (cannot be estimated from available data).
Danish: Hyppigheder er defineret som 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) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER (E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: 84 tablets
Danish: 84 tabletter
English: Patients in amenorrhea at week 13
Danish: Patienter med amenorré i uge 13
English: Patients with controlled bleedingb,c, d
Danish: Patienter med kontrolleret blødningb,c,d
English: Study 3a
Danish: Studie 3a
English: The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre-menopausal women of this age group (mean of 40 years).
Danish: Den observerede frekvens svarer til kontrolgrupper og den almindelige forekomst, der er rapporteret i litteraturen for symptomatiske præmenopausale kvinder i denne aldersgruppe (gennemsnitsalder på 40 år).
English: Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Danish: Før lægemiddelproduktet lanceres i hvert medlemsland, skal indehaveren af markedsføringstilladelsen aftale informationsmaterialets indhold og format med medlemsstatens kompetente myndighed.
English: PHARMACEUTICAL FORM AND CONTENTS 28 tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 28 tabletter
English: EU/1/18/1309/001 28 tablets EU/1/18/1309/002 84 tablets EU/1/18/1309/003 30 tablets EU/1/18/1309/004 28 tablets EU/1/18/1309/005 84 tablets
Danish: EU/1/18/1309/001 28 tabletter EU/1/18/1309/002 84 tabletter EU/1/18/1309/003 30 tabletter EU/1/18/1309/004 28 tabletter EU/1/18/1309/005 84 tabletter
English: 17, rue de Pontoise F-95520 Osny France
Danish: 17, rue de Pontoise F-95520 Osny Frankrig
English: Ulipristal Acetate Gedeon Richter should not be taken by children under 18 years of age since safety and efficacy of ulipristal acetate has not been established in this age group.
Danish: Ulipristal Acetate Gedeon Richter bør ikke anvendes til børn under 18 år, da ulipristalacetats sikkerhed og virkning ikke er klarlagt for denne aldersgruppe.
English: Treatment whilst pregnant might affect your pregnancy (it is not known if Ulipristal Acetate Gedeon Richter might harm your baby or whether can cause miscarriage).
Danish: Behandling under graviditet kan påvirke graviditeten (det vides ikke, om Ulipristal Acetate Gedeon Richter kan skade barnet, eller om det kan forårsage abort).
English: Ulipristal Acetate Gedeon Richter is used in adult women (over 18 years of age) before they reach the menopause.
Danish: Ulipristal Acetate Gedeon Richter anvendes til voksne kvinder (over 18 år), før de kommer i overgangsalderen.