FrancophonIA/ELRC3.0 huggingface dataset:
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 250 IU/ml after reconstitution with 2 ml solvent.
Danish: ADYNOVI 500 IE/2 ml pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 500 IE human koagulationsfaktor VIII (rDNA) rurioctocog alfa pegol, svarende til en koncentration på 250 IE/ml efter rekonstitution med 2 ml solvens.
English: ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 200 IU/ml after reconstitution with 5 ml solvent.
Danish: ADYNOVI 1000 IE/5 ml pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 1000 IE human koagulationsfaktor VIII (rDNA) rurioctocog alfa pegol, svarende til en koncentration på 200 IE/ml efter rekonstitution med 5 ml solvens.
English: ADYNOVI 500 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Danish: ADYNOVI 500 IE/5 ml pulver til injektionsvæske rurioctocog alfa pegol IV
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 500 IU/ml after reconstitution with 2 ml solvent.
Danish: ADYNOVI 1000 IE/2 ml pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 1000 IE human koagulationsfaktor VIII (rDNA) rurioctocog alfa pegol, svarende til en koncentration på 500 IE/ml efter rekonstitution med 2 ml solvens.
English: ADYNOVI 1000 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Danish: ADYNOVI 1000 IE/2 ml pulver til injektionsvæske rurioctocog alfa pegol IV
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 50 IU/ml after reconstitution with 5 ml solvent.
Danish: ADYNOVI 250 IE/5 ml pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 250 IE human koagulationsfaktor VIII (rDNA) rurioctocog alfa pegol, svarende til en koncentration på 50 IE/ml efter rekonstitution med 5 ml solvens.
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Danish: ADYNOVI 1000 IE/2 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol
English: ADYNOVI 250 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Danish: ADYNOVI 250 IE/2 ml pulver til injektionsvæske rurioctocog alfa pegol IV
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Danish: ADYNOVI 500 IE/5 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Danish: ADYNOVI 250 IE/2 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol
English: Do not remove the blue cap from the BAXJECT II Hi-Flow device.
Danish: Lad det blå låg blive siddende på BAXJECT II Hi-Flow-udstyret.
English: ADYNOVI 1000 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Danish: ADYNOVI 1000 IE/5 ml pulver til injektionsvæske rurioctocog alfa pegol IV
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Danish: ADYNOVI 250 IE/5 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol
English: ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Danish: ADYNOVI 1000 IE/5 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol
English: ADYNOVI 250 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Danish: ADYNOVI 250 IE/5 ml pulver til injektionsvæske rurioctocog alfa pegol IV
English: The median dose per infusion to treat all bleeding episodes in the per-protocol population was 32.0 (Interquartile Range (IQR): 21.5) IU per kg.
Danish: Mediandosen pr. infusion til behandling af alle blødningsepisoder i per protokol-populationen var 32,0 (Interkvartilområde (IQR): 21,5) IE pr. kg. i alt blev 95,9 % af blødningsepisoderne kontrolleret med 1-2 infusioner, og 85,5 % blev kontrolleret med kun 1 infusion.
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Danish: ADYNOVI 250 IE/2 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol (pegyleret rekombinant human koagulationsfaktor VIII)
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Danish: ADYNOVI 500 IE/5 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol (pegyleret rekombinant human koagulationsfaktor VIII)
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Danish: ADYNOVI 1000 IE/2 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol (pegyleret rekombinant human koagulationsfaktor VIII)
English: ADYNOVI 500 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Danish: ADYNOVI 500 IE/2 ml pulver til injektionsvæske rurioctocog alfa pegol IV
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Danish: ADYNOVI 250 IE/5 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol (pegyleret rekombinant human koagulationsfaktor VIII)
English: ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Danish: ADYNOVI 1000 IE/5 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol (pegyleret rekombinant human koagulationsfaktor VIII)
English: Lot:
Danish: Batch:
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Danish: ADYNOVI 500 IE/2 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Danish: ADYNOVI 500 IE/2 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol (pegyleret rekombinant human koagulationsfaktor VIII)
English: ASSEMBLY LABEL (BAXJECT III SYSTEM)
Danish: MÆRKNING TIL SYSTEM (BAXJECT III-SYSTEM)
English: Posology
Danish: Udslæt
English: Do not refrigerate the solution after preparation.
Danish: Opløsningen må ikke opbevares i køleskab efter klargøringen.
English: This means that it affects the activity of the immune system (the body's natural defences).
Danish: Det vil sige, at det påvirker aktiviteten af immunsystemet (kroppens naturlige forsvar).
English: Depending on the day, the patient may take one or more medicines or may not take any medicines.
Danish: Afhængig af dagen skal patienten måske tage et eller flere lægemidler eller måske slet ingen lægemidler.
English: Further information on Lenalidomide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Lenalidomide Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Lenalidomide Accord is taken in repeated 28-day cycles: the patient takes the medicine once a day on certain days over 28 days.
Danish: Lenalidomide Accord tages i gentagne cyklusser på 28 dage, hvor patienten tager lægemidlet én gang dagligt på bestemte dage over en periode på 28 dage.
English: The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen skal overvåges af læger med erfaring i anvendelse af kræftlægemidler.
English: • in combination with dexamethasone, in adults whose disease has been treated at least once in the past.
Danish: • i kombination med dexamethason hos voksne, hvis sygdom tidligere er blevet behandlet mindst en gang.
English: For more information about using Lenalidomide Accord, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Lenalidomide Accord, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: It will also supply cards for patients to ensure that they are informed about appropriate safety measures to be taken by each patient.
Danish: Virksomheden skal også sørge for patientkort for at sikre, at patienterne er informeret om de relevante sikkerhedsforanstaltninger, som den enkelte patient skal træffe.
English: Side effects reported with Lenalidomide Accord are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Lenalidomide Accord vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: The company has also set up a pregnancy prevention programme in each Member State and will collect information on the medicine's use outside its approved uses.
Danish: Virksomheden har desuden oprettet et graviditetsforebyggelsesprogram i alle medlemsstater og vil indsamle oplysninger om anvendelsen af lægemidlet til andre formål end den godkendte indikation.
English: Lenalidomide works in a number of different ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates specialised cells of the immune system to attack the abnormal cells.
Danish: Lenalidomid virker på forskellige måder: Det blokerer for udviklingen af unormale celler, forhindrer blodkarvækst i svulsterne og stimulerer desuden specialiserede celler i immunsystemet til at angribe de unormale celler.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Lenalidomide Accord has been shown to have comparable quality and to be bioequivalent to Revlimid.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Lenalidomide Accord er af sammenlignelig kvalitet og er bioækvivalent med Revlimid.
English: Lenalidomide Accord is available as capsules of various strengths to be taken by mouth.
Danish: Lenalidomide Accord fås som kapsler i forskellige styrker, der tages gennem munden.
English: • on its own, in adults who have had a stem cell transplant (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor) to stop the progression of the cancer;
Danish: • alene hos voksne, som har fået en stamcelletransplantation (en procedure, hvor alle celler fjernes fra patientens knoglemarv og erstattes med stamceller fra en donor) for at standse kræftens udvikling
English: As for all medicines, data on the use of Lenalidomide Accord are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Lenalidomide Accord løbende overvåget.
English: A lower dose should be used in patients who have moderate or more severe reduction in their kidney function.
Danish: Patienter med moderat eller svært nedsat nyrefunktion skal have en lavere dosis.
English: The dose should be reduced or treatment interrupted depending on whether the disease has worsened, the severity of any side effects and the levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that helps fight infection).
Danish: Dosis skal nedsættes, eller behandlingen bringes til ophør, hvis dette er nødvendigt, fordi sygdommen er blevet værre, eller på grund af alvorlige bivirkninger og blodets indhold af blodplader (de blodlegemer, der medvirker ved blodets størkning) og neutrofiler (en type hvide blodlegemer, der bekæmper infektioner).
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Revlimid, and do not need to be repeated for Lenalidomide Accord.
Danish: Der er allerede foretaget studier af benefit/risk-forholdet for det aktive stof ved de godkendte anvendelser med referencelægemidlet, Revlimid, og det er ikke nødvendigt at gentage disse med Lenalidomide Accord.
English: This means that Lenalidomide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Revlimid.
Danish: Det betyder, at Lenalidomide Accord indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU, og som hedder Revlimid.
English: An overview of Lenalidomide Accord and why it is authorised in the EU
Danish: En oversigt over Lenalidomide Accord, og hvorfor det er godkendt i EU
English: As for every medicine, the company provided studies on the quality of Lenalidomide Accord.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Lenalidomide Accord.
English: The boxes containing Lenalidomide Accord capsules also bear a warning stating that lenalidomide can be harmful to the unborn child.
Danish: Æskerne med Lenalidomide Accord-kapsler skal derudover være påført en advarsel om, at lenalidomid kan være skadeligt for det ufødte barn.
English: Because Lenalidomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Lenalidomide Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Lenalidomide Accord (lenalidomide)
Danish: Lenalidomide Accord (lenalidomid)
English: The company that markets Lenalidomide Accord will provide a letter and educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely.
Danish: Virksomheden, der fremstiller Lenalidomide Accord, skal udarbejde et brev og informationsmateriale til sundhedspersoner og brochurer til patienter, hvori det forklares, at lægemidlet kan være skadeligt for det ufødte barn, og som udførligt fortæller om de foranstaltninger, der skal træffes, for at lægemidlet kan anvendes sikkert.
English: What measures are being taken to ensure the safe and effective use of Lenalidomide Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lenalidomide Accord?
English: Lenalidomide Accord contains the active substance lenalidomide and is a ‘generic medicine'.
Danish: Lenalidomide Accord indeholder det aktive stof lenalidomid og er et "generisk lægemiddel".
English: Lenalidomide Accord is a medicine used for the treatment of multiple myeloma, a cancer of a type of white blood cells called plasma cells.
Danish: Lenalidomide Accord er et lægemiddel, der anvendes til behandling af myelomatose (kræft i en type hvide blodlegemer, der hedder plasmaceller).
English: Other information about Lenalidomide Accord
Danish: Andre oplysninger om Lenalidomide Accord
English: The dose depends on the situation in which Lenalidomide Accord is used.
Danish: Dosen afhænger af den tilstand, som Lenalidomide Accord anvendes til at behandle.
English: What are the benefits and risks of Lenalidomide Accord?
Danish: Hvilke fordele og risici er der forbundet med Lenalidomide Accord?
English: The active substance in Lenalidomide Accord, lenalidomide, is an immunomodulating agent.
Danish: Det aktive stof i Lenalidomide Accord, lenalidomid, er et immunmodulerende middel.
English: Therefore, the Agency's view was that, as for Revlimid, the benefit of Lenalidomide Accord outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Lenalidomide Accord opvejer de identificerede risici som for Revlimid, og at det kan godkendes til anvendelse i EU.
English: What is Lenalidomide Accord and what is it used for?
Danish: Hvad er Lenalidomide Accord, og hvad anvendes det til?
English: • in combination with melphalan (a cancer medicine) and prednisone (an anti-inflammatory medicine) for the treatment of adults with previously untreated multiple myeloma, who cannot have a stem cell transplant;
Danish: • i kombination med melphalan (et kræftlægemiddel) og prednison (et antiinflammatorisk lægemiddel) til behandling af voksne med myelomatose, som ikke tidligere er blevet behandlet, og som ikke kan få stamcelletransplantation
English: Why is Lenalidomide Accord authorised in the EU?
Danish: Hvorfor blev Lenalidomide Accord godkendt i EU?
English: • in combination with dexamethasone (an anti-inflammatory medicine), for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant;
Danish: • i kombination med dexamethason (et antiinflammatorisk lægemiddel) til behandling af voksne med myelomatose, som ikke tidligere er blevet behandlet (nydiagnosticeret), og som ikke kan få stamcelletransplantation
English: Lenalidomide Accord is used:
Danish: Lenalidomide Accord anvendes:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Accord have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Lenalidomide Accord.
English: How has Lenalidomide Accord been studied?
Danish: Hvordan blev Lenalidomide Accord undersøgt?
English: How is Lenalidomide Accord used?
Danish: Hvordan anvendes Lenalidomide Accord?
English: How does Lenalidomide Accord work?
Danish: Hvordan virker Lenalidomide Accord?
English: Apply usual aseptic procedures.
Danish: Anvend sædvanlige aseptiske procedurer.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/03/2012.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 08/03/2012.
English: The level of efficacy for other species may differ from that observed in cattle.
Danish: Virkningen hos andre dyrearter kan variere fra den, der er observeret hos kvæg.
English: Primary vaccination:
Danish: Primær vaccination:
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af markedsføringstilladelsen skal informere Europa-Kommisionen om planerne for markedsføring af det lægemiddel, der er godkendt under denne procedure.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Danish: Hjælpestofferne (inklusive adjuvanter) som er anført under punkt 6.1 i SPC'et er tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRL-værdier ikke er påkrævet.
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Danish: Ethvert revaccinationsprogram skal aftales med den ansvarlige myndighed eller den ansvarlige dyrlæge, der skal tage den lokale epidemiologiske situation med i betragtning.
English: 2nd injection: 3 weeks after 1st injection.
Danish: Anden injektion: 3 uger efter 1. injektion.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 3 months of age.
Danish: Indgiv én dosis på 2 ml i henhold til følgende vaccinationsprogram: Første injektion: fra 3 måneders alderen.
English: a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) At behandling af dyr med veterinærlægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Danish: * (Cyklusværdi (Ct) ≥ 36 bestemt med en valideret RT-PCR-metode, som ikke indikerede tilstedeværelse af viralt genom).
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against bluetongue virus (BTV).
Danish: Anvend derfor kun vaccinen til denne kategori af dyr i henhold til en benefit/risk-vurdering foretaget af den ansvarlige dyrlæge og/eller de nationale myndigheder, der er ansvarlige for den foreliggende vaccinationspolitik for Bluetongue virus (BTV).
English: No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
Danish: Der foreligger ingen oplysninger om brugen af vaccinen til seropositive dyr herunder dyr med maternelle antistoffer.
English: Aluminium hydroxide, saponin and thiomersal.
Danish: Aluminiumhydroxid, saponin og thiomersal.
English: Local reactions may increase slightly following the second dose in this case lasting up to 15 days.
Danish: Lokale reaktioner kan forekomme hyppigere efter den anden dosis, i dette tilfælde kan de vare op til 15 dage.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Danish: Anvendelse af dette veterinærlægemiddel er kun tilladt under de særlige omstændigheder, der er fastsat af EU-lovgivning vedr.
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Danish: * Relativ styrke bestemt ved en styrketest i mus, som blev sammenlignet med en referencevaccine, der blev påvist at være effektiv hos kvæg.
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Danish: Sikkerhed og virkning af vaccinen er endnu ikke fastlagt hos avlshanner.
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Danish: Ved anvendelse til andre husdyr eller vilde dyrearter tilhørende drøvtyggere, som skønnes at være i risikogruppe for infektion, skal vaccinationen gennemføres med forsigtighed og det tilrådes at afprøve vaccinen på et lille antal dyr før vaccination af hele populationen.
English: Date of latest renewal: 13/12/2016
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 13/12/2016
English: Active substance:
Danish: Aktive stoffer:
English: Lactation: Can be used during lactation.
Danish: Laktation: Kan anvendes under laktation.
English: High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer rubber stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
Danish: Hætteglas af høj densitet polyethylen (HDPE) med 20, 100 eller 240 ml med chlorobutylelastomer prop og aluminiumshætte indeholdende 10, 50 eller 120 doser vaccine.