FrancophonIA/ELRC3.0 huggingface dataset:
English: Pergoveris is injected under the skin once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels.
Danish: Pergoveris indsprøjtes under huden én gang dagligt, indtil patienten har dannet en egnet follikel.
English: Both active substances have already been authorised in the European Union (EU), follitropin alfa as GONAL-f and lutropin alfa as Luveris.
Danish: Follitropin alfa markedsføres under navnet GONAL-f, og lutropin alfa under navnet Luveris.
English: How does Pergoveris work?
Danish: Hvordan virker Pergoveris?
English: After five years, the marketing authorisation was renewed for a further five years.
Danish: Efter fem år blev markedsføringstilladelsen fornyet for yderligere fem år.
English: This summary was last updated in 10-2009.
Danish: Dette sammendrag blev sidst ajourført i 10-2009
English: It is intended for short-term use.
Danish: Det er beregnet til korttidsbehandling.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Danish: Hvert år gennemgår Det Europæiske Lægemiddelagentur alle nye oplysninger, der måtte foreligge, og ajourfører om nødvendigt dette sammendrag.
English: All the studies looked at the number of patients who had died after 28 days.
Danish: I alle undersøgelserne så man nærmere på antallet af patienter, som var døde efter 28 dage.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xigris to Eli Lilly Nederland B.V. on 22 August 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xigris til Eli Lilly Nederland B.V.
English: Xigris has been authorised under ‘Exceptional Circumstances'.
Danish: Xigris er blevet godkendt under ‘særlige omstændigheder'.
English: The recommended dose of Xigris is 24 micrograms per kilogram body weight per hour, given as a continuous infusion for 96 hours.
Danish: Den anbefalede dosis Xigris er 24 mikrogram pr. kg kropsvægt pr. time givet som en kontinuerlig infusion i 96 timer.
English: This means that it has not been possible to obtain complete information about Xigris.
Danish: Det betyder, at det ikke har været muligt at skaffe fuldstændige oplysninger om Xigris.
English: The toxins cause the patient's organs to fail, such as the heart, lungs and kidneys.
Danish: Toksinerne medfører, at patientens organer såsom hjerte, lunger og nyrer svigter.
English: It must not be used in patients below 18 years of age, in patients who have long-term liver disease, a brain tumour or pressure on the brain, in patients also receiving high-dose heparin (another medicine used to prevent blood clots) or in patients who currently have internal bleeding or are at risk of bleeding.
Danish: Det må ikke anvendes til patienter under 18 år, til patienter, som har langvarig leversygdom, en hjernetumor eller et tryk i hjernen, til patienter, som også får heparin i høje doser (et andet lægemiddel, der anvendes til at forebygge blodpropper) eller hos patienter, som har indre blødninger eller øget blødningsrisiko.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Xigris's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at fordelene ved Xigris opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
English: The full EPAR for Xigris is available here.
Danish: Den fuldstændige EPAR for Xigris findes her.
English: Other information about Xigris:
Danish: Andre oplysninger om Xigris:
English: Xigris drotrecogin alfa (activated) EPAR summary for the public
Danish: Xigris drotrecogin alfa (aktiveret) EPAR - sammendrag for offentligheden
English: The active substance in Xigris, drotrecogin alfa (activated), is very similar to a natural anticoagulant found in the body called activated protein C. Drotrecogin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce drotrecogin alfa.
Danish: Det aktive stof i Xigris, drotrecogin alfa (aktiveret), er meget lig det naturlige antikoagulerende stof i kroppen, som kaldes aktiveret protein C. Drotrecogin alfa fremstilles ved ‘rekombinant dna-teknologi': Det fremstilles af en celle, som har modtaget et gen (dna), der sætter den i stand til at producere eptacog alfa.
English: As with other anticoagulants, the most common side effect with Xigris is bleeding.
Danish: Som for andre antikoagulerende midler er den hyppigste bivirkning ved Xigris blødning.
English: • in the ENHANCE study, over 2,000 patients received Xigris;
Danish: • i ENHANCE-undersøgelsen fik godt 2 000 patienter Xigris
English: Excessive blood clotting is a problem during severe sepsis, because blood clots can block the blood supply to important parts of the body such as the kidneys and lungs.
Danish: Øget tendens til blodstørkning er et problem ved svær sepsis, idet blodpropperne kan blokere blodforsyningen til vigtige dele af kroppen såsom nyrer og lunger.
English: It contains the active substance drotrecogin alfa (activated).
Danish: Det indeholder det aktive stof drotrecogin alfa (aktiveret).
English: Fewer patients treated with Xigris had died at 28 days than patients treated with placebo.
Danish: Blandt patienter behandlet med Xigris forekom der færre dødsfald inden for 28 dage end blandt patienter behandlet med placebo.
English: In the body, drotrecogin alfa limits how much thrombin (one of the factors involved in blood clotting) is produced, and also reduces the inflammation caused by the infection.
Danish: I organismen begrænser drotrecogin alfa dannelsen af thrombin (en af de faktorer, der medvirker ved blodets størkning) og mindsker desuden den betændelse, der forårsages af infektionen.
English: Xigris should not be used in people who may be hypersensitive (allergic) to drotrecogin alfa (activated), any of the other ingredients or bovine thrombin (a cow protein).
Danish: Xigris må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for drotrecogin alfa (aktiveret), andre af indholdsstofferne eller over for bovint thrombin (et okseprotein).
English: For the full list of restrictions, see the Package Leaflet.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: By using Xigris during sepsis, the risk of blood clots forming and damaging the organs is reduced.
Danish: Ved at anvende Xigris under sepsis begrænses risikoen for blodpropdannelse og beskadigelse af organerne.
English: Xigris has been studied in three studies in severe sepsis:
Danish: Xigris blev undersøgt i tre undersøgelser af svær sepsis:
English: Xigris is an anticoagulant, which means that it stops the blood coagulating (clotting).
Danish: Xigris er et antikoagulerende middel, hvilket betyder, at det forhindrer blodet i at koagulere (størkne).
English: The effect of Xigris was more marked when it was given within 24 hours of the start of organ failure, and in patients who had more than one organ failing.
Danish: Effekten af Xigris var mere markant, når det blev givet inden for 24 timer efter organsvigtets indtræden, og hos patienter med mere end et organsvigt.
English: Sepsis is a condition when bacteria get into the bloodstream and produce harmful substances (toxins).
Danish: Sepsis er en tilstand, hvor der trænger bakterier ind i blodbanen, som danner skadelige stoffer (toksiner).
English: What information is still awaited for Xigris?
Danish: Hvilke oplysninger afventes der stadig for Xigris?
English: The company that makes Xigris will conduct an additional study looking at the safety and effectiveness of Xigris in patients with severe sepsis.
Danish: Virksomheden, som fremstiller Xigris, skal gennemføre en yderligere undersøgelse af sikkerheden ved og effekten af Xigris hos patienter med svær sepsis.
English: For the full list of all side effects reported with Xigris, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Xigris fremgår af indlægssedlen.
English: Why has Xigris been approved?
Danish: Hvorfor blev Xigris godkendt?
English: Xigris should be started within 48 hours, and preferably within 24 hours, after the start of organ failure.
Danish: Behandling med Xigris skal indledes inden for 48 timer og helst inden for 24 timer efter organsvigtets indtræden.
English: Xigris is used in adult patients with severe sepsis.
Danish: Xigris anvendes til voksne med svær sepsis.
English: Xigris should be used mainly when it can be started within 24 hours of the organ failure.
Danish: Xigris bør hovedsagelig anvendes, når behandlingen kan påbegyndes inden for 24 timer efter organsvigtets indtræden.
English: Xigris is a powder that is made up into a solution for infusion (drip into a vein).
Danish: Xigris er et pulver, der blandes til en opløsning til infusion (drop i en vene).
English: What is the risk associated with Xigris?
Danish: Hvilken risiko er der forbundet med Xigris?
English: Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis.
Danish: Xigris bør gives af erfarne læger på sundhedscentre, der besidder kvalifikationerne til at behandle patienter med svær sepsis.
English: What is Xigris?
Danish: Hvad er Xigris?
English: Giving Xigris using an infusion pump is the recommended way to ensure that infusion rates are well controlled.
Danish: Til indgivelse af Xigris tilrådes det at anvende en infusionspumpe for at sikre god kontrol med infusionshastigheden.
English: Xigris is used when the patient has two or more organs failing, in addition to best standard care such as antibiotics, medicines to support the organs and treatment in a specialised unit.
Danish: Xigris anvendes som supplement til bedste standardbehandling dvs. antibiotika, lægemidler, der støtter organfunktionen og indlæggelse på specialafdeling, når to eller flere af patientens organer svigter.
English: • in the PROWESS study, Xigris was compared with placebo (dummy treatment) in 1,690 patients;
Danish: • i PROWESS-undersøgelsen blev Xigris sammenlignet med placebo (en virkningsløs behandling)
English: • in the ADDRESS study, Xigris was compared with placebo in almost 3,000 patients who were at a lower risk of death than in the first two studies.
Danish: • i ADDRESS-undersøgelsen blev Xigris sammenlignet med placebo hos næsten 3 000 patienter,
English: What is Xigris used for?
Danish: Hvad anvendes Xigris til?
English: How has Xigris been studied?
Danish: Hvordan blev Xigris undersøgt?
English: How is Xigris used?
Danish: Hvordan anvendes Xigris?
English: What benefit has Xigris shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Xigris?
English: How does Xigris work?
Danish: Hvordan virker Xigris?
English: No significant differences were also observed in any of the secondary endpoints.
Danish: Der blev desuden ikke iagttaget signifikante forskelle i nogen af de sekundære endepunkter.
English: Whereas
Danish: Eftersom
English: The European Commission requested the Agency to give its opinion on whether the marketing authorisation for these products should be maintained, varied, suspended or withdrawn.
Danish: Europa-Kommissionen anmodede agenturet om at udtale sig om, hvorvidt markedsføringstilladelserne for disse produkter burde opretholdes, ændres, suspenderes eller inddrages.
English: Risk minimisation measures
Danish: Foranstaltninger til risikominimering
English: The results of the SIGNIFY study were published4 while this review was ongoing and are discussed below.
Danish: Resultaterne af SIGNIFY-undersøgelsen blev offentliggjort4 mens denne gennemgang foregik og vil blive omhandlet i det følgende.
English: As the absolute risk is based on 69 events, the possibilities for further analysis to identify the contributing risk factors are limited.
Danish: Da den absolutte risiko er baseret på 69 hændelser, er der kun begrænset mulighed for yderligere analyse til identifikation af de medvirkende risikofaktorer.
English: The Product Information for Corlentor and Procoralan was revised to include the following:
Danish: Produktinformationen for Corlentor og Procoralan blev revideret, så den indeholder følgende:
English: • Reinforcement of the recommendation not to exceed the authorised posology.
Danish: • Skærpelse af anbefalingen om ikke at overskride den godkendte dosering.
English: The individual components of the endpoint were not significantly increased.
Danish: Endepunktets enkelte komponenter var ikke signifikant forhøjet.
English: Grounds for the recommendation
Danish: Begrundelse for anbefalingen
English: Ivabradine was also associated with a significantly higher risk of bradycardia.
Danish: Ivabradin var desuden forbundet med væsentligt højere risiko for bradykardi.
English: After three to four weeks of treatment, the dose may be increased to 7.5 mg twice daily depending on the therapeutic response.
Danish: Efter tre til fire ugers behandling kan dosis øges til 7,5 mg to gange dagligt afhængigt af den terapeutiske respons.
English: The frequency of atrium fibrillation (AF) was higher than currently described in the product information.
Danish: Hyppigheden af atrieflimren var større end beskrevet i den nuværende produktinformation.
English: This highlights the need to comply with the currently authorized posology.
Danish: Dette understreger nødvendigheden af at overholde den gældende godkendte dosering.
English: 2 - Detailed explanation of the scientific differences from PRAC recommendation
Danish: - Detaljeret redegørelse for de videnskabelige afvigelser fra PRAC's anbefaling
English: Additional clarifications were also introduced in the DHPC.
Danish: Der blev desuden indført yderligere præciseringer i brevet til sundhedspersoner (DHPC).
English: The beneficial effect of symptomatic improvement of angina is considered of clinical relevance.
Danish: Den gavnlige virkning af symptomatisk bedring af angina anses for klinisk relevant.
English: Other factors could not be directly related to a higher CV risk.
Danish: Andre faktorer kunne ikke direkte sættes i forbindelse med højere kardiovaskulær risiko.
English: Scientific discussion
Danish: Videnskabelig drøftelse
English: Overall conclusion
Danish: Samlet konklusion
English: The MAH is requested to submit within the agreed timelines, the final study protocol of the drug utilisation study.
Danish: Indehaveren af markedsføringstilladelsen anmodes om inden for de aftalte frister at indsende den endelige protokol for undersøgelsen af lægemiddelanvendelse.
English: None of the factors identified in the SIGNIFY study had an impact on the beneficial effect of ivabradine observed in the SHIFT study.
Danish: Ingen af de faktorer, der blev påvist i SIGNIFY-undersøgelsen, havde betydning for den gavnlige virkning af ivabradin, der blev iagttaget i SHIFT-undersøgelsen.
English: The potential impact of the SIGNIFY results in the heart failure indication was considered, but the two populations are substantially different in terms of underlying cardiac function and presence or absence of clinical heart failure.
Danish: Den potentielle betydning af resultaterne fra SIGNIFY for indikationen hjerteinsufficiens blev taget i betragtning, men de to populationer afviger væsentligt med hensyn til underliggende kardial funktion og tilstedeværelse eller fravær af klinisk hjerteinsufficiens.
English: Treatment should be discontinued if the symptoms of angina do not improve within 3 months.
Danish: Behandlingen bør seponeres, hvis der ikke er bedring i anginasymptomerne i løbet af 3 måneder.
English: In addition, the higher dose of 10 mg could clarify the higher incidence of bradycardia during the SIGNIFY study in comparison to other large studies with ivabradine, BEAUTIFUL and SHIFT.
Danish: Den højere dosis på 10 mg kan desuden tænkes at forklare den højere forekomst af bradykardi i SIGNIFY-undersøgelsen end i de andre store undersøgelser med ivabradin, BEAUTIFUL og SHIFT.
English: Applying such a cut-off based on data from the BEAUTIFUL study is a reasonable measure to exclude patients who are likely to be at higher risk.
Danish: Anvendelse af denne afskæringsværdi på grundlag af data fra BEAUTIFUL-undersøgelsen er en rimelig måde at ekskludere patienter med formodet højere risiko på.
English: The safety profile was dominated by adverse reactions already described for the product, notably all forms of bradycardia (17.9% ivabradine vs 2.1% placebo) and phosphenes (5.3% ivabradine vs 0.5% placebo).
Danish: Sikkerhedsprofilen var domineret af produktets allerede beskrevne bivirkninger, navnlig alle former for bradykardi (17,9 % for ivabradin mod 2,1 % for placebo) og fosfen (5,3 % for ivabradin mod 0,5 % for placebo).
English: The CHMP considered it necessary to introduce a statement in section 4.8 of the Summary of Product Characteristics reflecting the incidence of atrial fibrillation in the SIGNIFY study.
Danish: CHMP fandt det nødvendigt, at der i punkt 4.8 af produktresuméet indsættes en erklæring, som afspejler forekomsten af atrieflimren i SIGNIFY-undersøgelsen.
English: Also a lower dose and different titration method was used in the SHIFT study when compared to the SIGNIFY study.
Danish: Desuden blev der anvendt lavere dosis og en anden titreringsmetode i SHIFT-undersøgelsen end i SIGNIFY-undersøgelsen.
English: Given the importance of ensuring that patient are not exposed to higher than recommended dose of ivabradine, the currently existing warning on concomitant intake of grapefruit juice should be strengthened to avoid a potential pharmacokinetic interaction.
Danish: Da det er vigtigt at sikre, at patienten ikke eksponeres for højere dosis af ivabradin end anbefalet, bør den eksisterende advarsel om sideløbende indtagelse af grapefrugtjuice skærpes for at undgå potentiel farmakokinetisk interaktion.
English: There was no significant difference in the incidence of the primary endpoint between the ivabradine group and the placebo group (6.8% and 6.4%, respectively; HR=1.08, 95% CI [0.96 -1.20]; p=0.2).
Danish: Der var ingen signifikant forskel i forekomsten af det primære endepunkt mellem ivabradingruppen og placebogruppen (hhv. 6,8 % og 6,4 %, HR=1,08, 95 % SI [0,96; 1,20]; p=0,2).
English: If atrial fibrillation develops during treatment, the benefits and risks of continued treatment with ivabradine should be carefully reconsidered.
Danish: Ved opståen af atrieflimren under behandlingen bør fordelene og risiciene ved fortsat behandling med ivabradin nøje overvejes,
English: On 30 April 2014, the EMA received from the MAH a communication on the preliminary results of the SIGNIFY3 study.
Danish: Den 30. april 2014 blev EMA af markedsføringstilladelsesindehaveren underrettet om de foreløbige resultater af SIGNIFY-undersøgelsen3.
English: Therefore it is considered that overall, the results of the SIGNIFY study do not impact on the heart failure indication.
Danish: Overordnet findes resultaterne af SIGNIFY-undersøgelsen derfor ikke at have betydning for indikationen hjerteinsufficiens.
English: Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions and grounds for recommendation.
Danish: Efter gennemgang af PRAC's anbefaling tilsluttede CHMP sig anbefalingens overordnede videnskabelige konklusioner og begrundelse.
English: Several pre-specified subgroup analyses were performed and the only significant interaction identified was in the incidence of the primary composite endpoint in the angina Canadian Cardiovascular Society (CCS) class ≥ II patients.
Danish: Der blev udført flere præspecificerede undergruppeanalyser, og den eneste konstaterede signifikante interaktion var i forekomsten af det primære sammensatte endepunkt hos patienter med angina af CCS (Canadian Cardiovascular Society) klasse ≥ II.
English: Nevertheless information monitoring of patients for AF needs to be reinforced.
Danish: Alligevel bør overvågningen af patienterne for atrieflimren styrkes.
English: • Concomitant use of grapefruit juice is now not recommended due to the potential for a pharmacokinetic interaction resulting in increased exposure to ivabradine.
Danish: • Samtidig indtagelse af grapefrugtjuice frarådes nu pga. potentialet for farmakokinetisk interaktion, der medfører øget eksponering for ivabradin.
English: • The PRAC also noted a small but significant increase of the combined risk of cardiovascular death and non-fatal myocardial infarction in a subgroup of symptomatic angina patients in the SIGNIFY study.
Danish: • PRAC bemærkede desuden en lille, men signifikant stigning i den kombinerede risiko for kardiovaskulær død og ikke-fatalt myokardieinfarkt hos en undergruppe af patienter med symptomatisk angina i SIGNIFY-undersøgelsen.
English: In February 2012, ivabradine was approved for the treatment of heart failure in the European Union based on the results of the SHIFT2 study.
Danish: Ivabradin blev i februar 2012 godkendt i EU til behandling af hjerteinsufficiens på grundlag af SHIFT-undersøgelsen2.
English: • The PRAC reviewed all data presented by the MAH on the safety and efficacy of ivabradine, including the results of the SIGNIFY study, as well as the views expressed by the cardiovascular scientific advisory group.
Danish: • PRAC gennemgik alle oplysninger fra markedsføringstilladelsesindehaveren om sikkerheden og virkningen af ivabradin, herunder resultaterne af SIGNIFY-undersøgelsen, samt udtalelsen fra den videnskabelige rådgivende gruppe vedrørende kardiovaskulære sygdomme,
English: This is further supported by some of the data indicating that a heart rate <50 bpm is associated with a trend toward a higher CV risk.
Danish: Dette støttes yderligere af nogle af dataene, der viser, at der ved hjertefrekvens <50 slag pr. min. er tendens til større kardiovaskulær risiko.
English: This study used doses of ivabradine higher than the currently recommended in the product information (starting dose in SIGNIFY: 7.5 mg twice daily [5 mg twice daily if age>75 years], that could be increased up to 10 mg twice daily).
Danish: I undersøgelsen anvendtes højere doser af ivabradin end de doser, der aktuelt anbefales i produktinformationen (startdosis i SIGNIFY: 7,5 mg to gange dagligt (for patienter over 75 år: 5 mg to gange dagligt), hvilket kunne øges til 10 mg to gange dagligt).
English: • The PRAC concluded that there are clinically relevant benefits to the symptomatic treatment of angina pectoris with ivabradine.
Danish: • PRAC konkluderede, at der er klinisk relevante fordele ved symptomatisk behandling af angina pectoris med ivabradin,
English: The PRAC is of the opinion that the higher than approved dose used in the SIGNIFY study does not fully explain these findings.
Danish: Det er PRAC's opfattelse, at de doser, der blev anvendt i SIGNIFY-undersøgelsen, ikke fuldt ud forklarer disse resultater,
English: Atrial fibrillation (AF) occurred in 5.3% of patients on ivabradine vs. 3.8% of patients on placebo.
Danish: Atrieflimren forekom hos 5,3 % af patienterne på ivabradin mod 3,8 % for patienterne på placebo.
English: • The PRAC considered Procoralan and Corlentor (ivabradine) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission.
Danish: • PRAC behandlede den procedure, som var indledt af Europa-Kommissionen i henhold til artikel 20 i forordning (EF) nr. 726/2004 for Procoralan og Corlentor (ivabradin),
English: • Warnings added on measurement of heart rate, lack of benefit on clinical outcomes, and atrial fibrillation.
Danish: • Der tilføjes advarsler om måling af hjertefrekvens, manglende gavnlig virkning på klinisk udfald og atrieflimren.