FrancophonIA/ELRC3.0 huggingface dataset:
English: Storage of radiopharmaceuticals will be in accordance with national regulations on radioactive materials.
Danish: Opbevaring af radioaktive stoffer sker i henhold til nationale regler om radioaktive materialer.
English: Diarrhoea Vomiting Nausea
Danish: Mave-tarm-kanalen Diarré opkastning kvalme
English: Xofigo 1100 kBq/mL solution for injection
Danish: Xofigo 1100 kBq/ml injektionsvæske, opløsning
English: Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see section 6.6) and after evaluation of the patient by a qualified physician.
Danish: Xofigo må kun administreres af personer med bemyndigelse til at håndtere radioaktive lægemidler på dertil godkendte afdelinger (se pkt.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om blindeskrift
English: Number (%) of deaths Median overall survival (months) (95% CI) Hazard ratiob (95% CI) p-valuea (2-sided)
Danish: Hazard ratiob (95 % CI) p-værdia (2-sidet)
English: Secondary malignant neoplasms
Danish: Sekundære maligne tumorer
English: Urinary bladder wall Uterus
Danish: Tyreoidea Urinblærens væg Livmoder Hele kroppen
English: Storage should be in accordance with national regulation on radioactive materials.
Danish: Opbevaring bør ske i henhold til nationale retningslinjer for radioaktive materialer.
English: Xofigo 1100 kBq/mL solution for injection radium Ra 223 dichloride
Danish: Xofigo 1100 kBq/ml injektionsvæske, opløsning radium Ra-223 dichlorid
English: Thrombocytopenia (all grades) occurred in 11.5% of patients treated with Xofigo and 5.6% of patients receiving placebo.
Danish: Trombocytopeni (alle grader) forekom hos 11,5 % af patienterne i behandling med Xofigo, og hos 5,6 % af patienterne, der fik placebo.
English: Each mL of solution contains 1100 kBq radium-223 dichloride, corresponding to 0.58 ng radium-223 at the reference date.
Danish: Hver ml opløsning indeholder 1100 kBq radium-223 dichlorid, svarende til 0,58 ng radium-223 ved referencedatoen.
English: Therefore, Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.3).
Danish: Xofigo er derfor kontraindiceret i kombination med abirateronacetat og prednison/prednisolon (se pkt.
English: SSE components
Danish: SSE-komponenter
English: Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date.
Danish: Hver ml opløsning indeholder 1100 kBq radium Ra 223 dichlorid (radium-223 dichlorid), svarende til 0,58 ng radium-223 på referencedatoen.
English: Neutropenia Pancytopenia Leukopenia
Danish: Neutropeni pancytopenileukop eni
English: Each vial contains 6 mL of solution (6600 kBq radium-223 dichloride at the reference date).
Danish: Hvert hætteglas indeholder 6 ml opløsning (6600 kBq radium-223 dichlorid ved referencedatoen).
English: Xofigo has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Xofigo påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Gamma emission (Gy/MBq)
Danish: Gammaemission (Gy/MBq)
English: Each vial contains 6 mL of solution (6.6 MBq radium-223 dichloride at the reference date).
Danish: Hvert hætteglas indeholder 6 ml opløsning (6,6 MBq radium-223 dichlorid ved referencedatoen).
English: Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.4).
Danish: Xofigo er kontraindiceret i kombination med abirateronacetat og prednison/prednisolon (se pkt.
English: Uncommon (may affect up to 1 in 100 people) - decrease in the number of lymphocytes, a type of white blood cells (lymphopenia) - weakened bones (osteoporosis)
Danish: - nedsat antal af lymfocytter, en speciel type hvide blodlegemer (lymfopeni) - knogleskørhed (osteoporose)
English: Gastrointestinal toxicity
Danish: Mave-tarm-toksicitet
English: - Xofigo contributes to your overall long-term cumulative radiation exposure.
Danish: - Xofigo bidrager til den samlede radioaktive stråling, du er udsat for over tid.
English: Grade 3 and 4 thrombocytopenia was observed in 6.3% of patients treated with Xofigo and in 2% of patients receiving placebo (see section 4.4).
Danish: Grad 3 og 4 trombocytopeni blev observeret hos 6,3 % af patienterne i behandling med Xofigo, og hos 2 % af patienterne i behandling med placebo (se pkt.
English: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established.
Danish: Sikkerheden og virkningen af kemoterapi sammen med Xofigo er ikke klarlagt.
English: Grade 3 and 4 thrombocytopenia was observed in 5.9% of patients treated with Xofigo and in 6.7% of patients receiving placebo (see section 4.4).
Danish: Grad 3 og 4 trombocytopeni sås hos 5,9% af de patienter, der blev behandlet med Xofigo og hos 6,7% af de patienter, der fik placebo (se pkt.
English: SSE = symptomatic skeletal event a Defined as occurrence of any of the following: external beam radiotherapy to relieve pain, or pathologic fracture, or spinal cord compression, or tumor-related orthopedic surgical intervention.
Danish: BASP = basisk fosfatase, CI = konfidensinterval, NE = kan ikke estimeres, PSA = prostataspecifikt antigen, SSE = symptomatiske skeletrelaterede hændelser a Defineret som forekomsten af følgende: Ekstern strålebehandling til smertelindring eller patologisk fraktur eller knoglemarvskompression eller tumorrelateret ortopædkirurgisk intervention b Kan ikke estimeres på grund af utilstrækkelige hændelser efter medianen c Defineret som ≥ 25 % forhøjelse, sammenlignet med baseline/nadir.
English: Bone fractures
Danish: Knoglefrakturer
English: The following information is intended for healthcare professionals only The complete SmPC of Xofigo is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Danish: Det har til formål at give sundhedspersonalet yderligere videnskabelige og praktiske oplysninger om administration og anvendelse af dette radioaktive lægemiddel.
English: Safety and efficacy of Xofigo in combination with cancer therapies other than LHRH analogues have not been established; an increased risk of mortality and fractures is possible.
Danish: Sikkerhed og virkning af Xofigo i kombination med andre cancerbehandlinger end LHRH-analoger er ikke klarlagt.
English: Xofigo contributes to your overall long-term cumulative radiation exposure.
Danish: Xofigo vil bidrage til den samlede radioaktive stråling, du er udsat for over tid.
English: - If your tumour has spread to the bone extensively, you may also be more likely to have decreases in your blood cells and platelets, so your doctor will give you Xofigo with caution.
Danish: - Hvis din kræft har spredt sig meget til knoglerne, kan du også have større risiko for at få et nedsat antal blodlegemer og blodplader.
English: Incidence
Danish: Forekomst
English: Due date
Danish: Data for tid
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Bayer AG
English: Q3 2020
Danish: 3. kvartal
English: - If you have any further questions, ask your doctor who will supervise the procedure.
Danish: Spørg den læge, der er ansvarlig for din behandling, hvis der er mere, du vil vide.
English: - If you take or have taken bisphosphonates or have received chemotherapy prior to treatment with Xofigo, please tell your doctor.
Danish: - Fortæl det til lægen, hvis du tager eller har taget bisfosfonater eller har fået kemoterapi inden behandlingen med Xofigo.
English: Xofigo must not be used after the expiry date which is stated on the vial and the lead pot.
Danish: Xofigo må ikke bruges efter den udløbsdato, der står på hætteglasset og blybeholderen efter EXP. Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.
English: Beta emission (Gy/MBq)
Danish: Betaemission (Gy/MBq)
English: The most serious adverse reactions were thrombocytopenia and neutropenia (see section 4.4 and ‘Description of selected adverse reactions' below).
Danish: 4.4 og 'Beskrivelse af udvalgte bivirkninger' nedenfor).
English: Time-to-event analysis (95% CI) [no. (%) of patients] [median no. of months] Hazard ratio < 1 favours Xofigo p-value
Danish: [median antal måneder] Hazard ratio < 1 favoriserer Xofigo
English: Renal impairment
Danish: Testikler Tymus
English: Hepatic impairment
Danish: Hjertevæg Nyrer
English: Hydrochloric acid, dilute
Danish: Vand til injektionsvæsker Natriumcitrat Natriumchlorid Saltsyre, fortyndet
English: Warnings and precautions
Danish: Generelle advarsler
English: Testes
Danish: Behandling
English: Bone marrow suppression
Danish: Knoglemarvssuppression
English: Whole body
Danish: Systemorganklasse
English: Q1 2020
Danish: 1. kvartal
English: The European Commission issued a decision on 22 October 2015.
Danish: Europa-Kommissionen traf en beslutning den 22. oktober 2015.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain).
Danish: Dette sker med henblik på udstedelse af en markedsføringstilladelse, der ud over denne stat er gyldig i andre medlemsstater (de "berørte medlemsstater", her Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Spanien).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 October 2015
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The active substance of Gutal is zinc oxide.
Danish: Det aktive stof i Gutal er zinkoxid.
English: Thus the CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Danish: CVMP konkluderede således, at de af Frankrig og Nederlandene udtrykte betænkeligheder ikke burde forhindre udstedelse af markedsføringstilladelse, og anbefalede, at der udstedes markedsføringstilladelse i de berørte medlemsstater.
English: The product is indicated for the prevention of post-weaning diarrhoea in piglets.
Danish: Produktet er beregnet til forebyggelse af fravænningsdiarré hos smågrise.
English: Huvepharma NV submitted a marketing authorisation application for Gutal to the United Kingdom via the decentralised procedure.
Danish: Huvepharma NV indgav en ansøgning om markedsføringstilladelse for Gutal til Det Forenede Kongerige via den decentrale procedure.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a risk to the environment has been identified due to accumulation of zinc, but that there is some uncertainty associated with the scale of this risk.
Danish: På grundlag af vurderingen af de aktuelt foreliggende data og de videnskabelige drøftelser i udvalget konkluderede CVMP, at der er fundet en risiko for miljøet på grund af ansamling af zink, men at der er nogen usikkerhed forbundet med størrelsen af denne risiko.
English: However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 30 September
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Det Forenede Kongeriges kompetente myndighed, Veterinary Medicines Directorate, indbragte den 30. september 2014 sagen for CVMP til voldgift.
English: Gutal is a generic veterinary medicinal product based on a reference product, ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff, which is authorised in the United Kingdom.
Danish: Gutal er et generisk veterinærlægemiddel, der er baseret på et referenceprodukt, ZincoTec, premix, 100 % zinkoxid, til medicineret foder, der er godkendt i Det Forenede Kongerige.
English: On 6 May 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Gutal 1000 g/kg premix for medicated feeding stuff for piglets.
Danish: Den 6. maj 2015 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelsen af lægemidlet Gutal, premix, 1000 g/kg, til medicineret foder til smågrise.
English: The CVMP also recommended that the product information for Gutal be amended.
Danish: CVMP anbefalede desuden, at produktoplysningerne for Gutal rettes.
English: Therefore, the Committee recommended several risk mitigation measures to be included in the product information, which are anticipated to reduce the accumulation of zinc in the environment.
Danish: Udvalget anbefalede derfor, at der indsættes flere andre risikoafhjælpende foranstaltninger i produktinformationen, hvilket forventes at reducere ansamling af zink i miljøet.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Gutal can be granted provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc in the environment, are added to the product information.
Danish: Agenturets udvalg for lægemidler til dyr (CVMP) konkluderede, at der kan udstedes markedsføringstilladelse for Gutal, forudsat at der i produktinformationen tilføjes de anbefalede risikoafhjælpende foranstaltninger, der forventes at reducere ansamling af zink i miljøet.
English: What is Gutal 1000 g/kg premix for medicated feeding stuff for piglets?
Danish: Hvad er Gutal, premix, 1000 g/kg, til medicineret foder til smågrise?
English: Why was Gutal 1000 g/kg premix for medicated feeding stuff for piglets reviewed?
Danish: Hvorfor blev Gutal, premix, 1000 g/kg, til medicineret foder til smågrise, gennemgået på ny?
English: The grounds for the referral were concerns raised by France and The Netherlands that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement in all pig farms.
Danish: Begrundelsen for indbringelsen var betænkelighed rejst af Frankrig og Nederlandene om, at markedsføringstilladelsen for Gutal kan udgøre en potentiel alvorlig risiko for miljøet, og at de
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sancuso on 20 April 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sancuso den 20. april 2012.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but given in a different way.
Danish: Det vil sige, at det svarer til et “referencelægemiddel”, der indeholder samme aktive stof, men indgives på en anden måde.
English: The full EPAR for Sancuso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Sancuso 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 Sancuso.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sancuso.
English: The transdermal patch should not be cut into pieces.
Danish: Depotplasteret må ikke klippes i stykker.
English: Each patch releases 3.1 mg of granisetron over 24 hours.
Danish: Hvert plaster afgiver 3,1 mg granisetron i løbet af 24 timer.
English: Other information about Sancuso
Danish: Andre oplysninger om Sancuso
English: Because Sancuso is a hybrid generic, the applicant presented comparative data on the reference medicine in addition to results from its own studies.
Danish: Da Sancuso er et hybridt generisk lægemiddel, fremlagde ansøgeren sammenlignende oplysninger om referencelægemidlet foruden resultaterne af sine egne undersøgelser.
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Danish: Når 5HT bindes til disse receptorer medfører det normalt kvalme og opkastning.
English: EPAR summary for the public granisetron
Danish: EPAR - sammendrag for offentligheden granisetron
English: For more information about treatment with Sancuso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sancuso, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sancuso.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Sancuso.
English: The most common side effect with Sancuso (seen in between 1 and 10 patients in 100) is constipation.
Danish: Den almindeligste bivirkning af Sancuso (ses hos mellem 1 og 10 patienter ud af 100) er forstoppelse.
English: Sancuso transdermal patch showed similar effects to granisetron given by mouth in the prevention of vomiting and nausea after chemotherapy: 60.2% of patients receiving the Sancuso transdermal patch (171 out of 284 patients) had their nausea and vomiting under control, compared with 64.8% of patients taking granisetron by mouth (193 out of 298 patients).
Danish: Sancuso depotplaster havde samme forebyggende virkning som granisetron indgivet gennem munden mod opkastninger og kvalme efter kemoterapi: 60,2% af de patienter, der fik Sancuso depotplaster (171 ud af 284 patienter), fik bragt deres kvalme og opkastninger under kontrol, sammenlignet med 64,8% af de patienter, der indtog granisetron gennem munden (193 ud af 298 patienter).
English: It is available as a transdermal patch (a patch that delivers a medicine across the skin).
Danish: Det leveres som depotplaster (et plaster, der afgiver et lægemiddel gennem huden).
English: One transdermal patch is applied 24 to 48 hours before chemotherapy.
Danish: Der påsættes ét depotplaster 24-28 timer før kemoterapi.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Danish: Det betyder, at det forhindrer stoffet 5-hydroxytryptamin (5HT, der også kaldes serotonin) i at bindes til 5HT3receptorerne i maven.
English: The active substance in Sancuso, granisetron, is a ‘5HT3 antagonist'.
Danish: Det aktive stof i Sancuso, granisetron, er en “5-5HT3-receptorantagonist”.
English: Sancuso is a ‘hybrid generic medicine'.
Danish: Sancuso er et “hybridt generisk lægemiddel”.
English: The patch can remain on the skin for up to seven days depending on the duration of the chemotherapy, and it is removed a minimum of 24 hours after completing chemotherapy.
Danish: Plasteret kan blive siddende på huden i op til syv dage afhængigt af kemoterapiens varighed, og man skal vente med at fjerne det til mindst 24 timer efter at kemoterapien er afsluttet.
English: Sancuso must not be used in people who are hypersensitive (allergic) to granisetron, other 5HT3 antagonists or any of the other ingredients.
Danish: Sancuso bør ikke anvendes hos personer, der er overfølsomme (allergiske) over for granisetron, andre 5HT3-receptorantagonister eller andre af indholdsstofferne.
English: Therefore, the CHMP decided that Sancuso's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP afgjorde derfor, at fordelene ved Sancuso overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse for Sancuso.
English: Sancuso is a medicine that contains the active substance granisetron.
Danish: Sancuso er et lægemiddel, der indeholder det aktive stof granisetron.
English: These patients were receiving chemotherapy which was a moderate or strong trigger of nausea and vomiting, lasting for several days.
Danish: Patienterne var i kemoterapi, som medførte moderat eller stærk kvalme og opkastning i flere dage.
English: The CHMP considered however that Sancuso would be of benefit for patients with difficulty swallowing, who might otherwise need to be given daily intravenous injections.
Danish: CHMP fandt alligevel, at Sancuso vil være til fordel for patienter, der har vanskeligt ved at synke og derfor ellers må have intravenøse indsprøjtninger hver dag.
English: It is used to prevent nausea and vomiting caused by types of chemotherapy (medicines used to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Danish: Det anvendes til at forebygge kvalme og opkastning forårsaget af forskellige former for kemoterapi (lægemidler mod kræft), der giver moderat eller kraftig kvalme og opkastninger.
English: The main measure of effectiveness was the number of patients who had their nausea and vomiting under control.
Danish: Behandlingens virkning blev hovedsagelig bedømt på det antal patienter, der fik bragt deres kvalme eller opkastninger under kontrol.
English: By blocking these receptors, Sancuso prevents the nausea and vomiting that often happen after certain types of chemotherapy.
Danish: Sancuso blokerer disse receptorer og forhindrer derved kvalme og opkastning, der ofte optræder efter visse typer kemoterapi.
English: The majority of adverse reactions were mild or moderate in severity.
Danish: Størstedelen af bivirkningerne var lette til moderate.
English: The study compared one Sancuso transdermal patch worn over seven days with granisetron taken by mouth once a day for the duration of the chemotherapy.
Danish: I undersøgelsen sammenlignedes Sancuso depotplaster, der blev båret i syv dage, med granisetron, der blev indtaget gennem munden en gang dagligt i kemoterapibehandlingens varighed.
English: What is the risk associated with Sancuso?
Danish: Hvilken risiko er der forbundet med Sancuso?
English: Why has Sancuso been approved?
Danish: Hvorfor blev Sancuso godkendt?
English: For the full list of all side effects reported with Sancuso, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Sancuso fremgår af indlægssedlen.
English: The patch is applied to dry, clean, healthy skin on the outer part of the upper arm or if this is not possible, it may be applied to the abdomen.
Danish: Plasteret sættes på tør, ren, sund hud på ydersiden af overarmen.
English: Sancuso is only used in adults who would have difficulty swallowing medicines and when the chemotherapy lasts from three to five days.
Danish: Sancuso anvendes kun til voksne, som har vanskeligt ved at synke medicin og får kemoterapi af 3 til 5 dages varighed Lægemidlet udleveres kun efter recept.
English: Sancuso is an ‘anti-emetic', a medicine that prevents nausea (feeling sick) and vomiting.
Danish: Sancuso er et “antiemetikum”, dvs. et lægemiddel mod kvalme og opkastninger.