FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM Solution for injection.
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/257/004
English: • 6 pre-filled pen, each with 1 alcohol pad, in a blister.
Danish: • 6 fyldte pen med 1 alkoholserviet i en blisterpakning.
English: Common pyrexia, fatigue (including asthenia and malaise)
Danish: Almindelig pyreksi,træthed (herunder asteni og utilpashed) Usædvanlig brystsmerter, ødem, influenzalignende sygdom
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/257/005
English: PHARMACEUTICAL FORM AND CONTENTS 6 pre-filled syringes, each containing 40 mg adalimumab 6 alcohol pads
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 6 fyldte injektionssprøjter a 40 mg adalimumab 6 alkoholservietter
English: EU/1/03/257/007 EU/1/03/257/008 EU/1/03/257/009 EU/1/03/257/010
Danish: EU/1/03/257/008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/257/002
English: BEFORE YOU USE TRUDEXA
Danish: HVAD DE SKAL GØRE, FØR DE BEGYNDER AT ANVENDE TRUDEXA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/257/001
English: NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe Adalimumab
Danish: Trudexa, 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte Adalimumab
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/257/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/257/003
English: PHARMACEUTICAL FORM AND CONTENTS 2 pre-filled syringes, each containing 40 mg adalimumab 2 alcohol pads
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 2 fyldte injektionssprøjter a 40 mg adalimumab 2 alkoholservietter
English: NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe
Danish: Trudexa, 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: Frequency
Danish: Anafylaksi
English: PHARMACEUTICAL FORM AND CONTENTS 4 pre-filled syringes, each containing 40 mg adalimumab 4 alcohol pads
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 4 fyldte injektionssprøjter a 40 mg adalimumab 4 alkoholservietter
English: Evoltra clofarabine
Danish: Evoltra clofarabin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evoltra on 29 May 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Evoltra den 29. maj 2006.
English: Evoltra has been authorised under ‘exceptional circumstances'.
Danish: Evoltra er godkendt under "særlige omstændigheder".
English: It is given by infusion lasting two hours every day for five days.
Danish: Det gives ved en infusion af to timers varighed hver dag i fem dage.
English: The treatment should be repeated every two to six weeks.
Danish: Behandlingen bør gentages hver anden til sjette uge.
English: Other information about Evoltra
Danish: Andre oplysninger om Evoltra
English: In the main study, 20% of the patients went into remission (12 out of 61).
Danish: I hovedundersøgelsen gik 20 % af patienterne i remission (12 ud af 61).
English: A risk management plan has been developed to ensure that Evoltra is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Evoltra anvendes så sikkert som muligt.
English: This is a summary of the European public assessment report (EPAR) for Evoltra.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Evoltra.
English: The average age of the treated patients was 12 years.
Danish: De behandlede patienters gennemsnitsalder var 12 år.
English: Overall, the patients in the study survived for an average of 66 weeks.
Danish: Som helhed overlevede patienterne i undersøgelsen gennemsnitligt i 66 uger.
English: Breast-feeding should be stopped before, during and after treatment with Evoltra.
Danish: Amning bør stoppes inden, under og efter behandling med Evoltra.
English: Stem cells are cells that can develop into different types of cell.
Danish: Stamceller er celler, som kan udvikle sig til forskellige celletyper.
English: The recommended dose is 52 mg per square metre of body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede dosis er 52 mg pr. kvadratmeter legemsoverflade (beregnet på basis af patientens højde og vægt).
English: Because the number of patients with ALL is low, the disease is considered ‘rare', and Evoltra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 February 2002.
Danish: Da antallet af patienter med ALL er lavt, betragtes sygdommen som "sjælden", og Evoltra blev udpeget som "lægemiddel til sjældne sygdomme" den 5. februar 2002.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Danish: Europæiske Lægemiddelagentur alle nye oplysninger, der bliver tilgængelige, og ajourfører om nødvendigt dette sammendrag.
English: All of the patients had previously received at least two other types of treatment but were not eligible for any other treatment.
Danish: Alle patienterne havde tidligere fået mindst to andre former for behandling, men egnede sig ikke til nogen anden behandling.
English: Evoltra has been examined in one study of 61 patients below 21 years of age with ALL.
Danish: Evoltra blev undersøgt i en undersøgelse med 61 patienter under 21 år med ALL.
English: This is a complex procedure where the patient receives stem cells from a matched donor to help restore the bone marrow.
Danish: Dette er en kompleks procedure, hvor patienten modtager stamceller fra en matchende donor, hvilket skal medvirke til at genoprette knoglemarven.
English: The study did not compare Evoltra with any other treatments.
Danish: I undersøgelsen blev Evoltra ikke sammenlignet med andre behandlinger.
English: Most patients who respond to treatment do so after one or two treatment cycles.
Danish: De fleste patienter, som responderer på behandlingen, gør dette efter et eller to behandlingsforløb.
English: What measures are being taken to ensure the safe and effective use of Evoltra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Evoltra?
English: It belongs to the group of cancer medicines called ‘antimetabolites'.
Danish: Det hører til den gruppe af lægemidler mod kræft, der kaldes "antimetabolitter".
English: For more information about treatment with Evoltra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Evoltra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is used when the disease has not responded to or has come back (relapsed) after at least two other treatments, and when no other treatment is expected to work.
Danish: Det anvendes, når behandlingen ikke har virket på sygdommen, eller når sygdommen er vendt tilbage (recidiv) efter mindst to andre behandlinger, og når ingen anden behandling forventes at virke.
English: The company that makes Evoltra will set up a registry to monitor the medicine's side effects.
Danish: Virksomheden, der markedsfører Evoltra, vil oprette et register med henblik på at overvåge lægemidlets bivirkninger.
English: This stops the cells making new DNA and RNA, and slows down the growth of tumour cells.
Danish: Dette forhindrer cellerne i at danne nyt dna og rna og forhaler væksten af tumorceller.
English: Evoltra must not be given to patients with severe kidney or liver disease.
Danish: Evoltra må ikke gives til patienter med svære nyre- eller leversygdomme.
English: Patients with ALL who have not responded to or who have relapsed after receiving at least two treatments have a very poor chance of survival.
Danish: Patienter med ALL, som ikke har responderet, eller som har haft recidiv efter at have modtaget mindst to behandlinger, har en meget beskeden chance for at overleve.
English: What is the risk associated with Evoltra?
Danish: Hvilken risiko er der forbundet med Evoltra?
English: Evoltra is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), which is a cancer of the lymphocytes (a type of white blood cell).
Danish: Evoltra anvendes til behandling af børn og voksne op til 21 år, som har akut lymfoblastisk leukæmi (ALL), der er kræft i lymfocytterne (en type hvide blodlegemer).
English: After treatment with Evoltra, 10 patients were able to go on to have a stem cell transplant.
Danish: Efter behandlingen med Evoltra kunne 10 patienter gå videre til at få en stamcelletransplantation.
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 Evoltra.
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, hvordan Evoltra skal anvendes.
English: The full EPAR for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Evoltra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common side effects with Evoltra (seen in more than 1 patient in 10) were febrile neutropenia (low white blood cell counts with fever), anxiety, headache, flushing (reddening of the face), vomiting, diarrhoea, nausea (feeling sick), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), pruritus (itching), pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces, such as the lining of the mouth) and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Evoltra (som optræder hos flere end 1 ud af 10 patienter) var febril neutropeni (lavt leukocyttal med feber), angst, hovedpine, rødme, opkastninger, diarre, kvalme, smertefuld rødme på hænder og fødder, kløe, feber, betændelse i slimhinder (såsom i munden) og træthed.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evoltra, 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 Evoltra, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The Committee decided that Evoltra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede, at fordelene ved Evoltra opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: What information is still awaited for Evoltra?
Danish: Hvilke oplysninger afventes der stadig for Evoltra?
English: The summary of opinion of the Committee for Orphan Medicinal Products for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare Disease Designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Evoltra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare Disease Designations.
English: Clofarabine is an ‘analogue' of adenine, which is part of the fundamental genetic material of cells (DNA and RNA).
Danish: Clofarabin er en "analog" til adenin, som er en del af cellernes genetiske grundmateriale (dna og rna).
English: This means that clofarabine takes the place of adenine in the body, and interferes with the enzymes involved in making genetic material, called ‘DNA polymerase' and ‘RNA reductase'.
Danish: Det vil sige, at clofarabin overtager adenins plads i kroppen og påvirker de enzymer, der medvirker til at skabe det genetiske materiale kaldet "dna-polymerase" og "rna-reductase".
English: This means that, because the disease is rare, it has not been possible to obtain complete information about Evoltra.
Danish: Dette betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om Evoltra, da sygdommen er sjælden.
English: Evoltra is a cancer medicine that contains the active substance clofarabine.
Danish: Evoltra er et lægemiddel mod kræft, der indeholder det aktive stof clofarabin.
English: Evoltra treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias.
Danish: Behandling med Evoltra skal overvåges af en læge med erfaring i behandling af patienter med akut leukæmi.
English: The main measure of effectiveness was the number of patients who went into ‘remission' (clearance of leukaemia from the bone marrow and complete or partial recovery of blood cell counts to normal levels).
Danish: Virkningen blev hovedsageligt bedømt på antallet af patienter, der gik i "remission" (leukæmien forsvandt fra knoglemarven, og antallet af blodlegemer blev bragt helt eller delvist tilbage til det normale niveau).
English: Why has Evoltra been approved?
Danish: Hvorfor blev Evoltra godkendt?
English: The CHMP concluded that Evoltra treatment may provide a way of obtaining remission, and of facilitating a stem cell transplant.
Danish: CHMP konkluderede, at behandling med Evoltra kan medvirke til at opnå remission, og at det kan give mulighed for en stamcelletransplantation.
English: For the full list of all side effects reported with Evoltra, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Evoltra fremgår af indlægssedlen.
English: How has Evoltra been studied?
Danish: Hvordan blev Evoltra undersøgt?
English: What benefit has Evoltra shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Evoltra?
English: What is Evoltra used for?
Danish: Hvad anvendes Evoltra til?
English: How is Evoltra used?
Danish: Hvordan anvendes Evoltra?
English: How does Evoltra work?
Danish: Hvordan virker Evoltra?
English: 100 mg Powder for Oral Suspension
Danish: 100 mg Pulver til oral suspension
English: Sachet (PE/alu/PET)
Danish: Brev(PE/alu/PET)
English: Content (concentration)
Danish: Administration Emballage Indhold (Koncentration)
English: 30 sachets + 2 syringes + 1 mixing cup
Danish: 30 breve + 2 sprøjter + 1blandekop
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelfor
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Danish: Styrke Lægemiddelform Administration Emballage Paknings-størrelse
English: 1 vial
Danish: (Særnavn) Navn
English: Wash your hands before opening the pack.
Danish: Vask hænder, før du åbner pakningen.
English: Phone: +46 8 697 20 00
Danish: Telefon: +46 8 697 20 00
English: This would be checked by your doctor.
Danish: Din læge vil kontrollere dette.
English: The following side effects may occur with this medicine.
Danish: Følgende bivirkninger kan forekomme med denne medicin.
English: Do not use external heat.
Danish: Brug ikke en ydre varmekilde.
English: The benefit of treatment with ALPROLIX in these situations should be weighed against the risk of these complications.
Danish: Fordelen ved behandling med ALPROLIX i disse situationer bør vejes op imod risikoen for disse komplikationer.
English: Patients were less than 12 years of age (15 were <6 years of age and 15 were 6 to <12 years of age).
Danish: Patienterne var under 12 år (15 var <6 år, og 15 var 6 til <12 år).
English: Administration (Intravenous Injection):
Danish: Administration (intravenøs injektion):
English: The rate of administration should be determined by the patient's comfort level and should not exceed 10 mL/min.
Danish: Administrationshastigheden bør fastlægges ud fra patientens komfortniveau, og den bør ikke overstige 10 ml/min.
English: Your doctor may change your recommended injection rate to make it more comfortable for you.
Danish: Din læge kan ændre den anbefalede injektionshastighed for at gøre det mere behageligt for dig.
English: The haemostatic response was rated as excellent or good in 100% of major surgeries.
Danish: Det hæmostatiske respons blev klassificeret som fremragende eller godt i 100 % af de større operationer.
English: t½α (h)2 t½β (h)2
Danish: t½α (t)2 t½β (t)2
English: How often you need an injection will depend on how well ALPROLIX is working for you.
Danish: Hvor ofte, du behøver en injektion, afhænger af, hvor godt ALPROLIX virker på dig.
English: Take your dose as soon as you remember and then resume your normal dosing schedule.
Danish: Tag din dosis, så snart du kommer i tanker om det, og vend derefter tilbage til dit normale doseringsprogram.
English: You or somebody else may administer ALPROLIX after receiving adequate training.
Danish: Du eller en anden kan administrere ALPROLIX, når I har fået tilstrækkelig træning.
English: Elderly population There is limited experience in patients ≥ 65 years.
Danish: Der er begrænset erfaring hos patienter ≥65 år.
English: For long term prophylaxis against bleeding, the recommended starting regimens are either:
Danish: Til langtidsprofylakse mod blødning er det anbefalede startprogram enten:
English: The procedure below describes the preparation and administration of ALPROLIX.
Danish: Proceduren nedenfor beskriver klargøring og administration af ALPROLIX.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke straks anvendes er opbevaringstiderne under anvendelse og opbevaringsforholdene før anvendelse brugerens ansvar.
English: QR code to be included + http://www.alprolix-instructions.com
Danish: QR-kode, som skal inkluderes + http://www.alprolix-instructions.com
English: Check the name and strength of the package, to make sure it contains the correct medicine.
Danish: Kontroller navn og styrke på pakningen, så du er sikker på, at den indeholder den korrekte medicin.
English: In case of self-administration or administration by a caregiver appropriate training is needed.
Danish: I tilfælde af selvadministration eller administration af en omsorgsperson er det nødvendigt med en passende træning.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Danish: Pædiatrisk population De angivne advarsler og forsigtighedsregler gælder for både voksne og børn.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Danish: I sådanne tilfælde anbefales det at kontakte et specialiseret hæmofilicenter.
English: ALPROLIX can be used for all age groups.
Danish: ALPROLIX kan anvendes til alle aldersgrupper.
English: See sections 5.1 and 5.2.
Danish: 5.1 og 5.2.
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Danish: Fra en mikrobiologisk betragtning bør præparatet anvendes umiddelbart efter rekonstitution.
English: MedDRA System Organ Class
Danish: MedDRA-systemorganklasse
English: If the product is not used within 6 hours, it must be discarded.
Danish: Hvis præparatet ikke anvendes inden for 6 timer, skal det bortskaffes.
English: Always use this medicine exactly as your doctor has told you (see section 7).
Danish: Brug altid lægemidlet nøjagtigt efter lægens anvisning (se punkt 7).
English: Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Tabel 2, som vises nedenfor, er opdelt i henhold til MedDRA-systemorganklasser (SOC og foretrukken term).
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Danish: Det er af speciel vigtighed ved skift af laboratorium og/eller reagens anvendt til analysen.
English: The median time on Study II+III was 2.88 years and median number of exposure days was 166.
Danish: Mediantiden i studie II+III var 2,88 år, og median antal eksponeringsdage var 166.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Danish: Det skal bemærkes, at ABR for forskellige faktorkoncentrater og i forskellige kliniske studier ikke kan sammenlignes.
English: If you stop using ALPROLIX you may no longer be protected against bleeding or a current bleed may not stop.
Danish: Hvis du holder op med at bruge ALPROLIX, kan det være, at du ikke længere er beskyttet mod blødning, eller at en aktuel blødning ikke stopper.
English: NA 4.81
Danish: IR 4,81
English: The effects of higher than recommended doses of ALPROLIX have not been characterised.
Danish: Virkningen af en højere end anbefalet dosering af ALPROLIX er ikke blevet karakteriseret.
English: Your doctor will decide the dose of ALPROLIX (in International Units or “IU”) you will receive.
Danish: Din læge vil bestemme den dosis ALPROLIX (i internationale enheder [IE]/International Units [”IU”]), du skal have.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Danish: Derfor skal patienter, der oplever allergiske reaktioner, evalueres for tilstedeværelse af en inhibitor.
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Danish: Hvis nogle af disse symptomer opstår, skal du straks stoppe injektionen og kontakte lægen.
English: If you are on a controlled sodium diet, see section 2.
Danish: Hvis du er på natrium- eller saltfattig diæt, se punkt 2.
English: 1 See section 4.2; NA: Not available
Danish: 4.2, IR: Ikke relevant
English: Frequency, type and severity of adverse reactions in children are expected to be similar as in adults.
Danish: Hyppigheden, typen og sværhedsgraden af bivirkninger hos børn forventes at være de samme som for voksne.
English: ALPROLIX is used to replace the missing or deficient factor IX.
Danish: ALPROLIX anvendes til at erstatte manglende eller defekt faktor IX.
English: The Fc fusion protein in ALPROLIX increases the length of time that the medicine works.
Danish: Fc-fusionsproteinet i ALPROLIX forlænger den periode, lægemidlet virker.
English: • There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ALPROLIX.
Danish: • Der er en lille risiko for, at du kan opleve en anafylaktisk reaktion (en alvorlig, pludselig allergisk reaktion) over for ALPROLIX.
English: ALPROLIX has no influence on the ability to drive and use machines.
Danish: ALPROLIX påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: Do not use this medicine if it has been stored at room temperature for longer than 6 months.
Danish: Brug ikke lægemidlet, hvis det er blevet opbevaret ved stuetemperatur i mere end 6 måneder.
English: The specific activity of ALPROLIX is 55-84 IU/mg protein.
Danish: Den specifikke aktivitet af ALPROLIX er 55-84 IU/mg protein.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Danish: Den mængde, som skal administreres, og administrationshyppigheden skal altid tilpasses den kliniske virkning i hvert enkelt tilfælde.
English: Chemical and physical stability has been demonstrated for 6 hours when stored at room temperature (up to 30°C).
Danish: Der er blevet påvist kemisk og fysisk stabilitet i 6 timer ved opbevaring ved stuetemperatur (op til 30 °C).
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Dosering baseret på legemsvægt kan kræve justering hos undervægtige og overvægtige patienter.
English: In case of anaphylactic shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af anafylaktisk shock skal standardbehandling af shock iværksættes.