FrancophonIA/ELRC3.0 huggingface dataset:
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Imraldi is used to treat.
Danish: Dette signalstof er en medvirkende årsag til betændelsestilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Imraldi.
English: Laboratory studies comparing Imraldi with Humira have shown that the active substance in Imraldi is highly similar to that in Humira in terms of structure, purity and biological activity.
Danish: Laboratorieundersøgelser, der sammenligner Imraldi med Humira, har vist, at det aktive stof i Imraldi i meget høj grad svarer til Humira hvad angår struktur, renhed og biologisk aktivitet.
English: The company that markets Imraldi must provide educational packs for doctors who prescribe the medicine.
Danish: Den virksomhed, som markedsfører Imraldi skal udlevere informationsmateriale til læger, der forventes at ordinere Imraldi.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Imraldi has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Imraldi og Humira i struktur, renhed og biologiske aktivitet svarer nøje til hinanden, og at de fordeles i kroppen på samme måde.
English: For more information about treatment with Imraldi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Imraldi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Eye specialists treating uveitis with Imraldi should also take advice from doctors who have experience of using the medicine.
Danish: Læger, der behandler uveitis, bør også rådføre sig med læger, der har erfaring i brug af Imraldi.
English: Imraldi is a medicine that acts on the immune system and is used to treat the following conditions:
Danish: er et lægemiddel, der virker på immunsystemet, og som anvendes til følgende sygdomme:
English: Therefore, the Agency's view was that, as for Humira, the benefit outweighs the identified risk, and it recommended that Imraldi be given marketing authorisation.
Danish: Agenturet var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Humira, og anbefalede, at Imraldi godkendes til anvendelse i EU.
English: For the full list of side effects and restrictions with Imraldi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Imraldi fremgår af indlægssedlen.
English: For practical information about using Imraldi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Imraldi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Imraldi used?
Danish: Hvordan anvendes Imraldi?
English: What benefits of Imraldi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Imraldi?
English: Studies have also shown that giving Imraldi produces similar levels of the active substance in the body to giving Humira.
Danish: Der er udført undersøgelser, der påviser, at behandling med Imraldi frembringer samme mængde aktivt stof i kroppen som behandling med Humira.
English: For information on the doses to be used for each condition and other information on the use of Imraldi, see the package leaflet.
Danish: Doseringsoplysningerne for de pågældende sygdomme samt andre oplysninger om anvendelsen af Imraldi fremgår af indlægssedlen.
English: Imraldi and other medicines of its class may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Danish: Imraldi og andre lægemidler i denne klasse kan påvirke immunsystemets evne til at bekæmpe infektioner og kræft.
English: Patients may be given other medicines during treatment with Imraldi, such as methotrexate or corticosteroids (other anti-inflammatory medicines).
Danish: f.eks. methotrexat eller kortikosteroider (andre antiinflammatoriske lægemidler).
English: How does Imraldi work?
Danish: Hvordan virker Imraldi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imraldi 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 Imraldi.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints)
Danish: • psoriasisarthritis (en sygdom, som fremkalder røde, afskallende pletter på huden og betændelse i leddene)
English: The full EPAR for Docetaxel Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Docetaxel Accord findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Accord on 22 May 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Docetaxel Accord den 22. maj 2012.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Accord.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Docetaxel Accord.
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 Docetaxel Accord.
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 Docetaxel Accord.
English: Docetaxel Accord is given as a one-hour infusion every three weeks.
Danish: Docetaxel Accord gives hver tredje uge ved en infusion, der varer en time.
English: Docetaxel Accord is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Danish: Docetaxel Accord må kun bruges, når neutrofiltallet (antallet af en type hvide blodlegemer) er normalt (mindst 1 500 celler/mm3).
English: This means that Docetaxel Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Danish: Det betyder, at Docetaxel Accord er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU) kaldet Taxotere.
English: For more information about treatment with Docetaxel Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Docetaxel Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For more information on generic medicines, see the question-and-answer document here.
Danish: De nærmere oplysninger om generiske lægemidler findes i dokumentet med spørgsmål og svar her.
English: The company provided data from published literature on docetaxel.
Danish: Virksomheden fremlagde oplysninger fra den publicerede litteratur om docetaxel.
English: The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated.
Danish: Dosis, behandlingsvarighed og kombination med andre lægemidler afhænger af den behandlede kræfttype.
English: Docetaxel Accord is used to treat the following types of cancer:
Danish: Docetaxel Accord anvendes til behandling af følgende kræfttyper:
English: An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Accord infusion.
Danish: Der bør desuden gives et antiinflammatorisk lægemiddel såsom dexamethason, begyndende dagen før infusionen med Docetaxel Accord.
English: • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
Danish: • kræft i hoved- og halsregionen, når sygdommen er lokalt fremskreden (kræft, der er vokset, men ikke har bredt sig).
English: Docetaxel Accord can be used on its own after other treatments have failed.
Danish: Docetaxel Accord kan anvendes som eneste behandling, når andre lægemidler har været uden virkning.
English: Other information about Docetaxel Accord
Danish: Andre oplysninger om Docetaxel Accord
English: What are the benefits and risks of Docetaxel Accord?
Danish: Hvilke fordele og risici er der forbundet med Docetaxel Accord?
English: Docetaxel Accord is a ‘generic medicine'.
Danish: Docetaxel Accord er et ‘generisk lægemiddel'.
English: It is available as a concentrate to be made up into a solution for infusion (drip into a vein).
Danish: Det leveres som et koncentrat, der efter fortynding indgives ved infusion (med drop i en vene).
English: Docetaxel Accord is used with prednisone or prednisolone (anti-inflammatory medicines);
Danish: Docetaxel Accord anvendes sammen med prednison eller prednisolon (antiinflammatoriske lægemidler).
English: Because Docetaxel Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Docetaxel Accord er et generisk lægemiddel, antages det at have de samme fordele og risici som referencelægemidlet.
English: The Committee recommended that Docetaxel Accord be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Docetaxel Accord.
English: No additional studies were needed as Docetaxel Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Danish: Der er ikke brug for yderligere undersøgelser, da Docetaxel Accord er et generisk lægemiddel, der gives ved infusion og indeholder samme aktive stof som referencelægemidlet Taxotere.
English: The active substance in Docetaxel Accord, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Danish: Det aktive stof i Docetaxel Accord, docetaxel, tilhører en gruppe lægemidler mod kræft, der kaldes taxaner.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Danish: Docetaxel påvirker også andre celler end kræftcellerne, således blodcellerne.
English: Docetaxel Accord is used with cisplatin and 5-fluorouracil.
Danish: Docetaxel Accord anvendes sammen med cisplatin og 5-fluoruracil.
English: The company also showed that the Docetaxel Accord solution for infusion has comparable quality to that of Taxotere.
Danish: Virksomheden påviste derudover, at infusionsopløsningen Docetaxel Accord har samme kvalitet som Taxotere.
English: Docetaxel Accord is a medicine that contains the active substance docetaxel.
Danish: Docetaxel Accord er et lægemiddel, der indeholder det aktive stof docetaxel.
English: It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;
Danish: Det kan også bruges sammen med cisplatin (et andet kræftmiddel) til patienter, der endnu ikke har fået nogen medicin mod deres kræftsygdom.
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Danish: CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Taxotere.
English: For full details, see the summary of product characteristics (also part of the EPAR).
Danish: De fuldstændige oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: Docetaxel Accord should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Danish: Behandling med Docetaxel Accord bør kun finde sted på en specialafdeling for kemoterapi (lægemidler mod kræft) under overvågning af en læge med speciale i kemoterapi.
English: Docetaxel Accord is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Danish: Docetaxel Accord anvendes sammen med cisplatin og 5-fluoruracil (andre lægemidler mod kræft).
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Accord has been shown to be comparable to Taxotere.
Danish: CHMP konkluderede, at Docetaxel Accord er påvist at svare til Taxotere i overensstemmelse med EUreglerne.
English: Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Danish: Docetaxel blokerer cellens evne til at nedbryde det indvendige celleskelet.
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Danish: Alt efter brystkræftens type og stadium kan det også bruges sammen med andre kræftmidler (doxorubicin, cyclophosphamid, trastuzumab eller capecitabin) til patienter, der endnu ikke har fået nogen medicin mod deres kræft, eller hos hvem andre midler har været uden virkning.
English: Why has Docetaxel Accord been approved?
Danish: Hvorfor blev Docetaxel Accord godkendt?
English: What is Docetaxel Accord?
Danish: Hvad er Docetaxel Accord?
English: How has Docetaxel Accord been studied?
Danish: Hvordan blev Docetaxel Accord undersøgt?
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Danish: • kirtelkræft i maven hos patienter, der endnu ikke har fået nogen medicin mod deres kræft.
English: What is Docetaxel Accord used for?
Danish: Hvad anvendes Docetaxel Accord til?
English: How is Docetaxel Accord used?
Danish: Hvordan anvendes Docetaxel Accord?
English: How does Docetaxel Accord work?
Danish: Hvordan virker Docetaxel Accord?
English: Before starting reconstitution you will need the following:
Danish: Inden du starter rekonstitutionen, får du brug for følgende:
English: The educational programme is aimed to minimize the risk of dose dispensing errors.
Danish: Uddannelsesprogrammet har til formål at minimere risikoen for doseringsfejl.
English: Tel.: +44(0)1256 894 959
Danish: Tlf.: +44(0)1256 894 959
English: Subjects were in a non-bleeding state.
Danish: Personerne var i en ikke-blødende tilstand.
English: Annually within the annual reassessment
Danish: Årligt i forbindelse med den årlige revurdering
English: It is a glycoprotein.
Danish: Det er et glykoprotein.
English: You must contact your doctor immediately if you have any of the following early symptoms:
Danish: Du skal straks kontakte lægen, hvis du får nogen af følgende tidlige symptomer:
English: Your doctor will also check if the bleeding is adequately controlled.
Danish: Lægen vil også kontrollere, om blødningen er tilstrækkeligt kontrolleret.
English: <There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til andre websteder om sjældne sygdomme og om, hvordan de behandles.
English: OTHER Baxalta Logo
Danish: ANDET Baxalta logo
English: Extensive cutaneous purpura do not necessarily require treatment.
Danish: Ekstensiv kutan purpura kræver ikke nødvendigvis behandling.
English: The manufacturing process is free of human serum and human protein products and does not contain any additional animal derived materials.
Danish: Fremstillingsprocessen er fri for human serum og humane proteinprodukter, og indeholder ingen yderligere materialer, som stammer fra dyr.
English: Those with pre-existing cardiovascular disease and the elderly are at particular risk.
Danish: Personer med forudeksisterende kardiovaskulære sygdomme og ældre personer har en særlig risiko.
English: OBIZUR is indicated in adults.
Danish: OBIZUR er indiceret til voksne.
English: ATC code: B02BD14
Danish: ATC-kode: B02BD14
English: The following information is intended for healthcare professionals only: INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION Preparation
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: INSTRUKTIONER VEDRØRENDE FORBEREDELSE OG ADMINISTRATION Forberedelse
English: One pack of OBIZUR contains 1, 5 or 10 each of the following
Danish: En pakke med OBIZUR indeholder 1, 5 eller 10 af hver af følgende
English: It requires clinical supervision of the bleeding status of the patient.
Danish: Det kræver klinisk tilsyn af patientens blødningsstatus.
English: Frequency and Duration of Subsequent Dosing
Danish: Hyppighed og varighed af den efterfølgende dosering
English: Of these 11 subjects, eight had eventual successful treatment (73%).
Danish: Ud af disse 11 deltagere havde 8 endelig succesfuld behandling (73 %).
English: You should contact your doctor if you missed a dose and do not know how to compensate for this.
Danish: Du skal kontakte lægen, hvis du har glemt en dosis, og ikke ved, hvordan du skal kompensere for dette.
English: You should be aware of the early signs of allergic reactions (see section 4 for signs and symptoms).
Danish: Du bør være opmærksom på de tidlige tegn på allergiske reaktioner (se tegn og symptomer under punkt 4).
English: The product contains trace amounts of hamster proteins.
Danish: Produktet indeholder spormængder af hamsterproteiner.
English: The maximum blood FVIII activity must not exceed 200%.
Danish: Den maksimale faktor VIII blodaktivitet må ikke overstige 200 %.
English: • An on-line video to further elaborate on the required calculation and administration of the drug
Danish: • En video, der er tilgængelig online, til yderligere specificering af den påkrævede beregning og administration af lægemidlet
English: Talk to your doctor if you are on a controlled sodium diet.
Danish: Tal med lægen, hvis du er på en natriumkontrolleret diæt.
English: The length of treatment depends on clinical judgement.
Danish: Behandlingens varighed afhænger af den kliniske vurdering.
English: A positive response was observed in 95% (19/20) of subjects evaluated at 8 hours and 100% (18/18) at 16 hours.
Danish: Et positivt respons sås hos 95 % (19/20) af deltagerne vurderet efter 8 timer og 100 % (18/18) efter 16 timer.
English: A total of 24/28 (86%) had successful control (resolution) of the initial bleeding episode.
Danish: I alt 24/28 (86 %) havde succesfuld kontrol (behandling) af den indledende blødningsepisode.
English: Common side effects (may affect up to 1 in 10 people) - Development of antibodies against the medicine
Danish: Almindelige bivirkninger (kan ses hos op til 1 ud af 10 patienter) - Udvikling af antistoffer mod medicinen
English: The product is for in-patient administration only.
Danish: Produktet er udelukkende til administration hos indlagte patienter.
English: Severe symptoms, including difficulty in breathing and (near) fainting, require emergency treatment.
Danish: Svære symptomer, herunder vejrtrækningsbesvær og (næsten) besvimelse, kræver akut behandling.
English: If any of these symptoms occur, the injection should be stopped.
Danish: Hvis nogen af disse symptomer opstår, skal injektionen stoppes.
English: The procedures below are provided as general guidelines for the preparation and reconstitution of OBIZUR.
Danish: Procedurerne nedenfor angives som generelle retningslinjer for forberedelse og rekonstitution af OBIZUR.
English: Frequencies have been evaluated according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighed er vurderet i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til < 1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If severe and sudden allergic reactions occur, the injection must be stopped immediately.
Danish: Hvis der opstår svære og pludselige allergiske reaktioner, skal injektionen straks stoppes.
English: • Large sterile syringe to contain the final volume of reconstituted product
Danish: • Stor steril sprøjte, som skal indeholde den endelige mængde rekonstitueret lægemiddel
English: Name and batch number
Danish: Navn og batchnummer
English: Use aseptic technique during the reconstitution procedure.
Danish: Brug aseptisk teknik under rekonstitutionsproceduren.
English: The osmolality of the formulation buffer ranges between 59 and 65 10% mOsm/kg H2O.
Danish: Osmolariteten af formuleringsbufferen varierer mellem 59 og 65 10 % mOsm/kg H2O.
English: The specific activity of OBIZUR is approximately 10,000 U/mg protein.
Danish: Den specifikke aktivitet af OBIZUR er ca. 10.000 E/mg protein.
English: Your doctor will calculate your dose of OBIZUR (in units or U) depending on your condition and body weight.
Danish: Lægen vil beregne din dosis af OBIZUR (i enheder eller E), som afhænger af din tilstand og kropsvægt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2015
Danish: Dato for første markedsføringstilladelse: 11. november 2015
English: The effects of higher than recommended doses of OBIZUR have not been characterised.
Danish: Virkningen af doser, der er højere end de anbefalede doser af OBIZUR, er ikke blevet karakteriseret.
English: In addition to response to treatment, the overall treatment success was determined by the investigator based on his/her ability to discontinue or reduce the dose and/or dosing frequency of OBIZUR.
Danish: Ud over responset på behandlingen blev den samlede behandlingssucces bestemt af investigator baseret på hans/hendes evne til at stoppe eller reducere dosis og/eller doseringshyppighed af OBIZUR.
English: The dose and frequency of administration should be based on results of Factor VIII activity (to be maintained within recommended limits) and on the clinical response achieved.
Danish: Dosis og hyppighed af administrationen bør baseres på resultat af faktor VIII aktivitet (som skal fastholdes inden for de anbefalede grænser) og på det opnåede kliniske respons.
English: If venous catheterisation is required, the risk of catheter-related complications such as catheter site thrombosis should be considered.
Danish: Hvis det er nødvendigt at anvende venekateter, bør risikoen for kateter-relaterede komplikationer såsom trombose på kateterstedet tages i betragtning.
English: Your doctor will measure your Factor VIII activity regularly to decide the subsequent dose and frequency of OBIZUR.
Danish: Lægen vil måle din faktor VIII aktivitet regelmæssigt for at fastlægge den efterfølgende dosis og hyppighed af OBIZUR.
English: The required initial dose of OBIZUR for a patient is calculated using the following formula:
Danish: Den nødvendige startdosis af OBIZUR for en patient beregnes ud fra følgende formel:
English: Therefore, OBIZUR should be used during pregnancy and lactation only if clearly indicated.
Danish: OBIZUR bør kun bruges under graviditet og amning, hvis det er klart indiceret.
English: Development of inhibitory antibodies
Danish: Udvikling af inhibitoriske antistoffer
English: If you use more OBIZUR than recommended, tell your doctor as soon as possible.
Danish: Hvis du har brugt mere end den anbefalede dosis OBIZUR, skal du fortælle det til lægen hurtigst muligt.
English: Activated Factor VIII acts as a co-factor for activated Factor IX, accelerating the conversion of Factor X to activated Factor X, which ultimately converts prothrombin into thrombin.
Danish: Aktiveret faktor VIII fungerer som en kombinationsfaktor for aktiveret faktor IX, hvilket accelererer omdannelsen af faktor X til aktiveret faktor X, hvilket i sidste ende omdanner protrombin til trombin.