FrancophonIA/ELRC3.0 huggingface dataset:
English: Retacrit must not be used prior to major bone surgery in patients who have a severe disease affecting their arteries or their blood vessels in the heart, neck or brain, including patients who have recently had a heart attack or stroke.
Danish: Retacrit må ikke anvendes forud for større kirurgiske indgreb hos patienter, som har en svær sygdom, der berører deres arterier eller deres blodårer i hjertet, halsen eller hjernen, herunder patienter, som for nylig har haft et hjerteanfald eller slagtilfælde.
English: • to treat anaemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions;
Danish: • til at behandle anæmi hos voksne, som får kemoterapi for visse kræftformer, og til at mindske af behovet for blodtransfusioner,
English: What is the risk associated with Retacrit?
Danish: Hvilken risiko er der forbundet med Retacrit?
English: For more information on biosimilar medicines, see the question-and-answer document here.
Danish: Der findes yderligere oplysninger om biosimilære lægemidler i dokumentet med spørgsmål og svar her.
English: For the full list of all side effects reported with Retacrit, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Retacrit fremgår af indlægssedlen.
English: The reference medicine for Retacrit is Eprex/Erypo, which contains epoetin alfa.
Danish: Referencelægemidlet for Retacrit er Eprex/Erypo, som indeholder epoetin alfa.
English: All of the patients in the second study had been receiving treatment with Eprex/Erypo for at least three months before they were either switched to Retacrit or remained on Eprex/Erypo for 12 weeks.
Danish: Alle patienterne i den anden undersøgelse var blevet behandlet med Eprex/Erypo i mindst tre måneder, inden de skiftede over til Retacrit eller fortsatte behandlingen med Eprex/Erypo i 12 uger.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Danish: Hos patienter i kemoterapi eller patienter med nyreproblemer kan der opstå anæmi, fordi de mangler erytropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på det naturligt dannede erytropoietin.
English: The company also presented the results of two studies looking at the effects of Retacrit injected under the skin: one involved 261 cancer patients receiving chemotherapy, and the other compared Retacrit with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Danish: Virksomheden forelagde desuden resultaterne af to undersøgelser af virkningen af Retacrit indgivet ved indsprøjtning under huden: den ene omfattede 261 kræftpatienter, der var i kemoterapi, og den anden sammenlignede Retacrit med Eprex/Erypo hos 462 patienter med anæmi på grund af nyreproblemer.
English: Retacrit can be injected under the skin by the patient or their carer if they have been trained appropriately.
Danish: Retacrit kan indsprøjtes under huden af patienten selv eller af omsorgsgiveren, hvis de er behørigt instrueret heri.
English: Retacrit, injected into a vein, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a technique for removing waste products from the blood).
Danish: Retacrit, indgivet i en vene, blev sammenlignet med referencelægemidlet i to hovedundersøgelser med 922 patienter, der havde anæmi efter langvarig nyresygdom, som nødvendiggjorde behandling med hæmodialyse (en teknik til at fjerne affaldsstoffer fra blodet).
English: The active substance in Retacrit, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Danish: Det aktive stof i Retacrit, epoetin zeta, er en kopi af det menneskelige erytropoietin og har nøjagtigt samme stimulerende virkning på dannelsen af røde blodlegemer som det naturlige hormon.
English: The CHMP concluded that, in accordance with EU requirements, Retacrit has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Danish: CHMP konkluderede, at det i overensstemmelse med EU-kravene er påvist, at Retacrits kvalitet, sikkerhed og virkning svarer til Eprex/Erypos.
English: Other information about Retacrit:
Danish: Andre oplysninger om Retacrit
English: For patients with kidney problems, Retacrit can be injected into a vein or under the skin.
Danish: Til patienter med nyreproblemer kan Retacrit gives ved indsprøjtning i en vene eller under huden.
English: Haemoglobin is the protein in red blood cells that carries oxygen around the body.
Danish: Hæmoglobin er det protein, der findes i de røde blodlegemer, som transporterer ilt rundt i kroppen.
English: Erythropoietin is produced by the kidneys.
Danish: Erytropoietin dannes i nyrerne.
English: Erythropoietin is also used before surgery to increase the number of red blood cells to help patients produce more blood for self-donation.
Danish: Erytropoietin kan desuden anvendes inden kirurgiske indgreb til at øge antallet af røde blodlegemer, så patienterne producerer mere blod, de kan donere til eget brug under indgrebet.
English: A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Danish: Et hormon kaldet erythropoietin stimulerer dannelsen af røde blodlegemer i rygmarven.
English: It must not be used in patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin, patients with hypertension (high blood pressure) that is not controlled, patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke, or patients who cannot receive medicines to prevent blood clots.
Danish: Det må desuden ikke anvendes til patienter, der har fået aplastisk anæmi (nedsat eller ophørt produktion af røde blodlegemer) efter behandling med en hvilken som helst form for erytropoietin, patienter med for højt blodtryk, der ikke er velreguleret, patienter, der skal have foretaget kirurgiske indgreb, og som har svære hjerte-karproblemer, herunder nyligt hjerteanfald eller slagtilfælde, patienter, der ikke må få blodfortyndende medicin.
English: • to increase the amount of blood that patients with moderate anaemia can self-donate before surgery, so that their own blood can be given back to them during or after surgery;
Danish: • til at øge den mængde blod, som kan tages fra patienter med let anæmi før et kirurgisk indgreb, således at de kan donere blod til eget brug under eller efter indgrebet,
English: In the study of patients already being treated with an epoetin, haemoglobin levels were maintained at around 11.4 g/dl when the patients were receiving Retacrit and when they were receiving Eprex/Erypo.
Danish: I undersøgelsen af patienter, der allerede var i behandling med epoetin, blev hæmoglobinniveauet fastholdt på ca. 11,4 g/dl ved behandling med Retacrit og ved behandling med Eprex/Erypo.
English: Retacrit was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts.
Danish: Retacrit var lige så effektivt som Eprex/Erypo til at øge og opretholde antallet af røde blodlegemer.
English: For patients receiving chemotherapy, it must be injected under the skin, and for patients about to undergo surgery, it must be injected into a vein.
Danish: Til patienter i kemoterapi gives det som indsprøjtning under huden, og hos patienter, der skal have foretaget et kirurgisk indgreb, gives det som indsprøjtning i en vene.
English: Why has Retacrit been approved?
Danish: Hvorfor blev Retacrit godkendt?
English: • to reduce the need for blood transfusions in patients with moderate anaemia about to undergo major bone surgery (such as a hip or knee replacement).
Danish: • til at nedsætte behovet for blodtransfusioner hos patienter med moderat anæmi, som skal gennemgå en større knogleoperation (så som udskiftning af en hofte eller et knæ)
English: In the correction study, haemoglobin levels were around 11.6 g/dl during the last four weeks of the study, having risen from around 8.0 g/dl before treatment.
Danish: I undersøgelsen af stoffets evne til at øge antallet af røde blodlegemer var hæmoglobinniveauet cirka 11,6 g/dl gennem de sidste fire uger af undersøgelsen i forhold til cirka 8,0 g/dl inden behandlingens start.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Danish: • til at behandle anæmi (lavt antal røde blodlegemer), som giver symptomer hos patienter med ‘kronisk nyreinsufficiens' (langvarig, fremadskridende nedsættelse af nyrefunktionen) eller andre nyreproblemer,
English: Retacrit can also lead to skin rash and influenza (flu)-like symptoms.
Danish: Retacrit kan desuden give hududslæt og influenza- eller forkølelseslignende symptomer.
English: In both studies, the main measures of effectiveness were the levels of haemoglobin during treatment, as well as the dose of epoetin received.
Danish: Behandlingens virkning blev i begge undersøgelser hovedsagelig bedømt på blodets indhold af hæmoglobin i løbet af behandlingen og på den modtagne dosis epoetin.
English: What is Retacrit?
Danish: Hvad er Retacrit?
English: What benefit has Retacrit shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Retacrit?
English: The second study compared the effects of Retacrit with those of Eprex/Erypo in maintaining red blood cell counts in 313 patients.
Danish: I den anden undersøgelse sammenlignedes Retacrits og Eprex'/Erypos evne til at fastholde antallet af røde blodlegemer hos 313 patienter.
English: Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Eprex/Erypo.
English: The first study compared the effects of Retacrit with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks.
Danish: I den første undersøgelse blev Retacrits og Eprex'/Erypos evne til at øge antallet af røde blodlegemer sammenlignet hos 609 patienter over 24 uger.
English: How has Retacrit been studied?
Danish: Hvordan blev Retacrit undersøgt?
English: Retacrit is a solution for injection.
Danish: Retacrit er en injektionsvæske, opløsning.
English: What is Retacrit used for?
Danish: Hvad anvendes Retacrit til?
English: How is Retacrit used?
Danish: Hvordan anvendes Retacrit?
English: As with other medicines containing an epoetin, the most common side effect with Retacrit is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden stabbing migraine-like headache and confusion.
Danish: Den mest almindelige bivirkning ved Retacrit er øget blodtryk, hvilket også gælder for andre lægemidler, der indeholder epoetin.
English: Retacrit was studied to show that it is comparable with the reference medicine, Eprex/Erypo, in experimental models and in humans.
Danish: Forsøgsmodeller og undersøgelser hos mennesker har vist, at Retacrit er sammenligneligt med referencelægemidlet Eprex/Erypo.
English: How does Retacrit work?
Danish: Hvordan virker Retacrit?
English: The Reference Member State was Germany and the Concerned Member States were Finland and the United Kingdom.
Danish: Referencemedlemsstaten var Tyskland og de berørte medlemsstater var Finland og Det Forende Kongerige.
English: A positive opinion was adopted by majority on 1 June 2006.
Danish: Der blev vedtaget en positiv udtalelse med flertal den 1. juni 2006.
English: The Mutual Recognition Procedure started on 24 March 2005.
Danish: Den gensidige anerkendelsesprocedure indledtes den 24. marts 2005.
English: The final opinion was converted into a Decision by the European Commission on 21 August 2006.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 21. august 2006.
English: The arbitration procedure started on 15 September 2005 with the adoption of a list of questions.
Danish: Voldgiftsproceduren indledtes den 15. september 2005 med vedtagelsen af liste med spørgsmål.
English: The Rapporteur was Dr. Broich and Co-Rapporteurs were Dr. Hudson and Dr. Kuitunen.
Danish: Rapportør var dr. Broich og medrapportører var dr. Hudson og dr. Kuitunen.
English: The United Kingdom referred the reasons for disagreement to the EMEA on 16 August 2005.
Danish: Det Forenede Kongerige fremsendte begrundelserne for uenighederne til EMEA den 16. august 2005.
English: London, 21 August 2006 EMEA/CHMP/212746/2006
Danish: London, den 21.08.06 EMEA/CHMP/212746/2006
English: The Marketing Authorisation Holder provided written explanations on 28 November 2005.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 28. november 2005.
English: The posology in neonates where higher doses were proposed for neonates aged 15-27 days (80 mg/kg) while the standard dose is 20-50mg/kg in the UK for neonates 0-28 days.
Danish: Dosisanbefalingen til nyfødte omfatter nemlig højere doser til nyfødte mellem 15-27 dage (80 mg/kg), mens standarddoseringen i Det Forenede Kongerige er 20-50mg/kg til nyfødte mellem 0-28 dage.
English: This refers to the dosing recommendation for the newborn and this was considered to be of serious public health concern.
Danish: Disse forskelle vedrører den anbefalede dosis og blev anset for at udgøre et alvorligt problem for folkesundheden.
English: It is indicated for the treatment of the following infections when caused by micro-organisms that are susceptible to ceftriaxone and if parenteral treatment is necessary:
Danish: Det er indiceret til behandling af følgende infektioner, som skyldes mikroorganismer, der er følsomme over for ceftriaxon og som kræver parenteral behandling:
English: Ceftriaxone is indicated for perioperative prophylaxis in patients with a certain risk of severe postoperative infections.
Danish: • Pneumonier Ceftriaxon er indiceret til perioperativ profylakse hos patienter med en vis risiko for alvorlig postoperativ infektion.
English: Depending on the mode of surgery and the expected spectrum of pathogens ceftriaxone should be combined with an appropriate antimicrobial agent with additional anaerobic coverage.
Danish: Afhængigt af operationens art og det forventede patogenspektrum, bør ceftriaxon kombineres med et andet passende antibiotikum med yderligere anaerob dækning.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Ceftriaxone Tyrol Pharma and associated names International Non-Proprietary Name (INN): Ceftriaxone
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Ceftriaxon Tyrol Pharma og tilknyttede navne Internationalt fællesnavn (INN): Ceftriaxon
English: Significant difference has been identified with regard to the proposed SPC compared to the SPC of the reference product in the UK.
Danish: Der er påpeget væsentlige forskelle mellem det foreslåede produktresumé og produktresuméet for referenceproduktet i Det Forenede Kongerige.
English: Ceftriaxone Tyrol Pharma and associated names, 1g and 2 g powder for solution for injection/infusion, is an antibiotic, being a third generation cephalosporin.
Danish: Ceftriaxon Tyrol Pharma og tilknyttede navne 1 og 2 g pulver til injektionsvæske eller infusionsvæske, opløsning, er et antibiotikum, et cephalosporin af tredje generation.
English: Sandoz GmbH submitted applications for mutual recognition of Ceftriaxone Tyrol Pharma and associated names, 1g and 2g, solution for injection/infusion on the basis of the marketing authorisation granted by Germany on 13 August 2002.
Danish: Sandoz GmbH har indgivet ansøgning om gensidig anerkendelse af Ceftriaxon Tyrol Pharma og tilknyttede navne 1g og 2g opløsning til injektionsvæske eller infusionsvæske, opløsning, på grundlag af en markedsføringstilladelse udstedt af Tyskland den 13. august 2002.
English: During their May 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ceftriaxone Tyrol Pharma and associated names, that the objections raised by United Kingdom should
Danish: I lyset af de samlede data, der var blevet fremlagt, og den faglige debat i udvalget var CHMP på sit møde i maj 2006 af den opfattelse, at benefit-risk forholdet er gunstigt for Ceftriaxon Tyrol Pharma og
English: not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: tilknyttede navne, at de af Det Forenede Kongerige rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rixubis on 19 December 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rixubis den 19 december 2014.
English: The safety profile was considered acceptable and was outweighed by the beneficial effects.
Danish: Sikkerhedsprofilen blev fundet acceptabel i betragtning af de gavnlige virkninger.
English: The full EPAR and risk management plan summary for Rixubis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Rixubis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Rixubis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rixubis.
English: It can be used in patients of all ages, and for short-term or long-term use.
Danish: Det kan bruges hos alle patienter uanset alder og til korttids- eller langtidsbrug.
English: A risk management plan has been developed to ensure that Rixubis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Rixubis anvendes så sikkert som muligt.
English: The evaluation of these studies also indicated that Rixubis was distributed in the body similarly to another approved factor IX product.
Danish: Vurderingen af disse undersøgelser viste desuden, at Rixubis fordeles i kroppen på samme måde som et andet godkendt faktor IX-produkt.
English: Patients or their carers may be able to administer Rixubis themselves at home once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsgiver kan selv give Rixubis i hjemmet efter at have fået passende instruktion.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rixubis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Rixubis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: In the first study, involving 73 patients aged 12 to 59 years, 249 bleeding episodes were treated with Rixubis.
Danish: I den første undersøgelse, hvor der deltog 73 patienter i alderen 12-59 år, blev der behandlet 249 blødningsepisoder med Rixubis.
English: What measures are being taken to ensure the safe and effective use of Rixubis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rixubis?
English: The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs.
Danish: De hyppigste bivirkninger ved Rixubis (som kan forekomme hos op til 1 ud af 10 personer) er smagsforstyrrelser (dysgeusi) og smerter i lemmerne.
English: The effect of treatment in stopping bleeding episodes was rated excellent in 41% of cases and good in a further 55%.
Danish: Behandlingens evne til at standse blødningsepisoderne blev bedømt som meget god i 41 % af tilfældene, og god i 55 %.
English: With respect to prevention of bleeding, the average bleeding rate during treatment was 4.26 bleeds a year, compared with an average of about 17 per year before enrolment.
Danish: Vedrørende forebyggelse af blødning var den gennemsnitlige forekomst af blødninger under behandlingen 4,26 blødninger årligt, sammenholdt med et gennemsnit på ca. 17 årligt før undersøgelsen.
English: What is Rixubis and what is it used for?
Danish: Hvad er Rixubis, og hvad anvendes det til?
English: Why is Rixubis approved?
Danish: Hvorfor blev Rixubis godkendt?
English: Other information about Rixubis
Danish: Andre oplysninger om Rixubis:
English: Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations.
Danish: I sjældne tilfælde kan der forekomme overfølsomhedsreaktioner (allergi) med hævelse af vævet under huden (angioødem), brænden og stikken på injektionsstedet, kulderystelser, rødmen, kløende udslæt, hovedpine, nældefeber, for lavt blodtryk (hypotension), træthed eller rastløshed, kvalme eller opkastning, hurtig hjerterytme (takykardi), trykken for brystet, hiven efter vejret eller snurrende fornemmelser.
English: Effectiveness in stopping bleeding was measured on a standard scale in which ‘excellent' meant complete relief of pain and no signs of bleeding after a single dose of the medicine, and ‘good' meant relief of pain and signs of improvement with a single dose, although further doses might be needed for complete resolution.
Danish: Evnen til at standse blødning blev målt på en standardskala, hvor “meget godt” betød fuldstændig lindring af smerter og ingen tegn på blødning efter en enkelt dosis af lægemidlet, og “god” betød, at en enkelt dosis lindrede smerterne og medførte tegn på bedring, selv om det kunne være nødvendigt med flere doser til at få symptomerne til at svinde helt.
English: It is not intended to provide practical advice on how to use Rixubis.
Danish: Det er ikke en praktisk vejledning i, hvordan Rixubis bør anvendes.
English: Rixubis contains the active substance nonacog gamma.
Danish: Rixubis indeholder det aktive stof nonacog gamma.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rixubis, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Rixubis, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Rixubis must not be used in patients who are hypersensitive (allergic) to nonacog gamma or any of its other ingredients, or who are known to be allergic to hamster protein.
Danish: Rixubis må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nonacog gamma eller andre af indholdsstofferne eller vides at være allergiske over for hamsterproteiner.
English: The active substance in Rixubis, nonacog gamma, is a version of human factor IX and helps the blood to clot in the same way.
Danish: Det aktive stof i Rixubis, nonacog gamma, er en variant af den menneskelige faktor IX og hjælper blodet med at størkne på samme måde.
English: This lack causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Danish: Denne mangel medfører, at det er vanskeligt for blodet at størkne, så der opstår blødning i led, muskler eller indre organer.