FrancophonIA/ELRC3.0 huggingface dataset:
English: - Just after an injection, your muscles may feel tense or very weak - as though you are having a relapse.
Danish: - Lige efter en injektion, vil dine muskler måske føles spændte eller meget svage - næsten som om du får et attak.
English: Interferons are natural substances made in your body to help protect you from infections and diseases.
Danish: Interferoner er naturlige stoffer, der dannes i kroppen, og som hjælper med til at beskytte dig mod infektioner og sygdomme.
English: This is rare.
Danish: Dette sker kun sjældent.
English: Do not use any more Avonex until you have spoken to a doctor.
Danish: Tag ikke mere Avonex, før du har talt med en læge.
English: The potential of additive effects from multiple medicinal products or other hepatotoxic agents (e.g. alcohol) has not been determined.
Danish: Muligheden for additive virkninger af lægemidler eller andre hepatotoksiske stoffer (f.eks. alkohol) er ikke blevet påvist.
English: This medicine is essentially ‘sodium-free'.
Danish: Denne medicin er i det væsentlige natriumfri.
English: The small rectangular window area will disappear.
Danish: Det lille firkantede vindues forsvinder.
English: Glycosylation of other proteins is known to affect their stability, activity, biodistribution, and half-life in blood.
Danish: Det er kendt, at glykosylering af andre proteiner kan påvirke disses stabilitet, aktivitet, biodistribution og halveringstid i blodet.
English: 2The frequency of occurrence is higher at the beginning of treatment.
Danish: 2Hyppigheden af forekomsten er højere ved behandlingens start.
English: AVONEX exerts its biological effects by binding to specific receptors on the surface of human cells.
Danish: AVONEX udøver biologisk aktivitet ved at binde sig til specifikke receptorer på overfladen af humane celler.
English: It was also shown that there was a one-third reduction in annual relapse rate.
Danish: Det blev også vist, at antallet af recidiver blev reduceret med en tredjedel pr. år.
English: This may allow you to sleep through the effects.
Danish: På denne måde kan du muligvis sove fra bivirkningerne.
English: Local Tolerance: Intramuscular irritation has not been evaluated in animals following repeated administration to the same injection site.
Danish: Lokal tolerance: intramuskulær irritation er ikke evalueret hos forsøgsdyr efter gentagne intramuskulære injektioner på samme injektionssted.
English: The interaction of AVONEX with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Danish: Interaktionen mellem AVONEX og kortikosteroider eller adrenocorticotropt hormon (ACTH) er ikke undersøgt systematisk.
English: You can get a larger print version of this leaflet by calling the local representatives.
Danish: Du kan få en version af denne indlægsseddel med større skrifttype ved at ringe til den lokale repræsentant.
English: No studies on the effects of AVONEX on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af virkningen af AVONEX på evnen til at føre motorkøretøj og betjene maskiner.
English: Avonex makes some people feel dizzy.
Danish: Avonex får nogle mennesker til at føle sig svimle.
English: - If you notice any irritation or skin problems after an injection, talk to your doctor.
Danish: - Hvis du bemærker irritation eller hudproblemer efter en injektion, bør du tale med din læge.
English: - Epilepsy or other seizure disorders not controlled by medication
Danish: - epilepsi eller andre lidelser med anfald, der ikke er kontrolleret med medicin
English: In order to obtain adequate efficacy, a dose of 30 micrograms once a week should be reached and maintained after the initial titration period.
Danish: For at opnå adækvat virkning bør en dosis på 30 mikrogram én gang ugentligt nås og opretholdes efter den indledende titreringsperiode.
English: In some cases these symptoms are associated with flu-like symptoms.
Danish: I nogle tilfælde associeres disse symptomer til influenza-lignende symptomer.
English: If you have a fever, drink plenty of water to keep you hydrated.
Danish: Hvis du har feber, skal du drikke meget vand, så du ikke bliver dehydreret.
English: It only happens when you inject and the effects soon pass.
Danish: Det sker kun under selve injektionen, og virkningerne går hurtigt over.
English: Transient episodes of hypertonia and/or severe muscular weakness that prevent voluntary movements may occur at any time during treatment.
Danish: Forbigående episoder med hypertoni og/eller svær muskelsvaghed, der besværliggør frivillige bevægelser, kan forekomme når som helst under behandlingen.
English: Tip: Place the pen down on the table before beginning step 2.
Danish: Tip: Læg sprøjten på bordet, inden du starter på trin nr. 2.
English: Pharmacotherapeutic Group: Interferons, ATC code: L03 AB07.
Danish: Farmakoterapeutisk klassifikation: interferoner, ATC-kode: L03 AB07
English: These effects have been seen in people using Avonex, but we do not know how likely they are to happen.
Danish: Disse bivirkninger er observeret hos mennesker, der anvendte Avonex; men vi ved ikke, hvor stor sandsynligheden er for, at de vil optræde.
English: No harmful effects on the breastfed newborn/infant are anticipated.
Danish: Der forventes ingen skadelig påvirkning af nyfødte/spædbørn, der ammes.
English: This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers.
Danish: Denne binding starter en kompleks kaskade af intracellulære reaktioner, der fører til ekspression af talrige interferon-inducerede genprodukter og markører.
English: • Patients diagnosed with relapsing multiple sclerosis (MS).
Danish: • patienter, som har diagnosen attakvis multipel sklerose (MS).
English: Speak to your doctor or pharmacist about a suitable dose.
Danish: Tal med din læge eller apotek om en egnet dosis.
English: Treatment with Avonex can help to prevent you from getting worse, although it will not cure MS.
Danish: Behandling med Avonex kan hjælpe med til at forebygge, at du får det værre, men vil ikke helbrede din MS.
English: These episodes are of limited duration, temporally related to the injections and may recur after subsequent injections.
Danish: Disse episoder er af begrænset varighed og tidsmæssigt relateret til injektionerne og kan vende tilbage efter efterfølgende injektioner.
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Danish: Risikoen for spontane aborter hos gravide kvinder eksponeret for interferon beta kan på nuværende tidspunkt ikke evalueres tilstrækkeligt på baggrund af de tilgængelige data, men indtil nu indikerer data ikke en øget risiko.
English: Leave it at room temperature for half an hour.
Danish: Lad den ligge ved stuetemperatur i en halv time.
English: Treatment should be discontinued if the patient develops chronic progressive MS.
Danish: Behandlingen bør seponeres, hvis patienten udvikler kronisk progressiv MS.
English: - Depression or problems affecting your moods
Danish: - en depression eller problemer, der påvirker dit humør
English: Avonex may affect other medicines or be affected by them.
Danish: Avonex kan påvirke den anden medicin eller blive påvirket af den.
English: Talk to your doctor to see if this is appropriate for you.
Danish: Tal med din læge om, hvorvidt dette ville være relevant for dig.
English: It should be clear and colourless.
Danish: Den bør være klar og farveløs.
English: However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed.
Danish: Dog er varigheden af eksponering i det første trimester usikker, da data blev indsamlet, mens brug af interferon beta under graviditet var kontraindiceret, og behandlingen sandsynligvis blev seponeret, når graviditeten blev konstateret og/eller bekræftet.
English: Patients should be clinically evaluated after two years of treatment and longer-term treatment should be decided on an individual basis by the treating physician.
Danish: Patienter bør evalueres klinisk efter to års behandling, og beslutning om fortsat behandling bør tages på individuel basis af den behandlende læge.
English: • Dispose of rubbish properly.
Danish: • Bortskaf affaldet korrekt.
English: Do not freeze.
Danish: MÅ IKKE NEDFRYSES.
English: Sometimes you will need to remind other medical staff that you are being treated with Avonex.
Danish: Sommetider vil det være nødvendigt, at du minder sundhedspersonalet om, at du bliver behandlet med Avonex.
English: Doctors may prescribe a 25 mm, 25 gauge needle to patients for whom such a needle is appropriate to administer an intramuscular injection.
Danish: Lægen kan ordinere en 25 mm, 25 gauge kanyle til patienter, hvor en sådan kanyle vil være passende for indgivelse af en intramuskulær injektion.
English: It may be possible for your doctor to prescribe you a shorter and thinner needle, depending on your body type.
Danish: Din læge kan ordinere en kortere og tyndere kanyle til dig, afhængigt af din legemstype.
English: Avonex is not to be used in children below the age of 12 years.
Danish: Avonex må ikke bruges til børn under 12 år.
English: However, the impact of early treatment with AVONEX is unknown even in this high-risk subgroup as the study was mainly designed to assess the time to the second event rather than the long-term evolution of the disease.
Danish: Imidlertid er virkningen af tidlig behandling med AVONEX uvis selv i denne høj-risiko undergruppe, da studiet hovedsageligt var designet til at bestemme tidspunktet for et nyt anfald frem for langtidsudviklingen af sygdommen.
English: Although the list of possible side effects can seem worrying, it's possible that you may not have any of them.
Danish: Selv om listen over mulige bivirkninger kan virke foruroligende, er det muligt, at du slet ikke vil få nogen af disse bivirkninger.
English: Do not use two injections to make up for a missed injection.
Danish: Du må ikke tage to injektioner som erstatning for den glemte injektion.
English: • After 10 seconds pull the pen straight out to remove the needle from the injection site.
Danish: • Efter 10 sekunder trækken pennen lige ud for at fjerne kanylen fra injektionsstedet.
English: Interferons are a family of naturally occurring proteins that are produced by eukaryotic cells in response to viral infection and other biological inducers.
Danish: Interferoner er en familie af naturligt forekommende proteiner, som produceres af eukaryote celler som reaktion på virusinfektioner og andre biologiske aktivatorer.
English: Interferons alpha and beta are classified as Type I interferons, and interferon gamma is a Type II interferon.
Danish: Interferonerne alfa og beta klassificeres som type I-interferoner, og interferon gamma er et type II-interferon.
English: • Check the safety lock is released.
Danish: • Kontrollér, at sikkerhedslåsen udløses.
English: (Notes information) Fold out
Danish: (Bemærk) Fold ud
English: Tip: If you twist the needle cover to remove it, you may accidentally remove the needle as well.
Danish: Tip: Hvis du drejer kanylens hætte for at tage den af, kan du utilsigtet komme til også at tage kanylen af.
English: • Continue to hold the pen on your skin and count slowly for a full
Danish: • Fortsæt med at holde pennen mod huden og tæl langsomt til
English: Interferons are cytokines that mediate antiviral, antiproliferative, and immunomodulatory activities.
Danish: Interferoner er cytokiner, der formidler antivirale, antiproliferative og immunmodulerende aktiviteter.
English: Your doctor or nurse will help you use the Avostartclip titration kit.
Danish: Din læge eller sygeplejerske vil hjælpe dig med at bruge Avostartclip titreringssættet.
English: • Press the blue activation button with your thumb to start the injection.
Danish: • Tryk med tommelfingeren på den blå aktiveringsknap for at starte injektionen.
English: Whether the mechanism of action of AVONEX in MS is mediated by the same pathway as the biological effects described above is not known because the pathophysiology of MS is not well established.
Danish: Hvorvidt virkningsmekanismen for AVONEX i MS sker via de samme kanaler som de biologiske virkninger, der er beskrevet herover, vides ikke, da patofysiologien for MS ikke er velbeskrevet.
English: After a single intramuscular dose of AVONEX, serum levels of these products remain elevated for at least four days and up to one week.
Danish: Efter en enkelt intramuskulær dosis af AVONEX forbliver serumniveauet af disse bestanddele forhøjet i mindst fire dage og op til én uge.
English: Some of these products have been measured in the serum and cellular fractions of blood collected from patients treated with AVONEX.
Danish: Nogle af disse forbindelser er blevet målt i serum og i cellulære fraktioner af blod fra patienter behandlet med AVONEX.
English: Do not use this medicine after the expiry date stated on the label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: Recent clinical studies with patients treated up to three years with AVONEX suggest that approximately 5% to 8% develop neutralising antibodies.
Danish: Data fra patienter, der har været i behandling med AVONEX i op til tre år, tyder på, at ca. 5% til 8% danner neutraliserende antistoffer.
English: Name and address of the manufacturers of the biological active substance Biogen Inc., 250 Binney Street, Cambridge, Massachusetts 02142, USA.
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof Biogen Inc., 250 Binney Street, Cambridge, Massachusetts 02142, USA.
English: • Firmly press until you hear a “click” to seal the needle.
Danish: • Tryk med fast hånd, indtil du hører et "klik", for at sætte kanylen fast.
English: You may even actually faint.
Danish: Muligvis vil du endda besvime.
English: Interferon beta is produced by various cell types including fibroblasts and macrophages.
Danish: Interferon beta produceres af forskellige celletyper, inklusive fibroblaster og makrofager.
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Danish: 5.3) kan der være en øget risiko for spontan abort.
English: The unused portion of Avonex must not be used.
Danish: Den ubrugte dosis Avonex må ikke anvendes.
English: Paediatric population: The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established.
Danish: Pædiatrisk population: Sikkerhed og virkning af AVONEX hos unge i alderen 12 til 16 år er ikke klarlagt.
English: Talk to your doctor if you have any of these conditions, or if they worsen whilst taking Avonex.
Danish: Kontakt din læge, hvis du har en eller flere af disse tilstande, eller hvis de bliver værre, mens du bruger Avonex.
English: A large amount of data (more than 1000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy.
Danish: En stor mængde data (mere end 1.000 graviditetsudfald) fra registre og erfaring efter markedsføring indikerer ingen øget risiko for større medfødte misdannelser efter eksponering for interferon beta inden undfangelse eller i graviditetens første trimester.
English: No teratogenic effects or effects on foetal development have been observed, but the available information on the effects of interferon beta-1a in the peri- and postnatal periods is limited.
Danish: Ingen teratogene virkninger eller virkninger på fosterudviklingen er observeret, men den tilgængelige information om virkningerne af interferon beta-1a i peri- og postnatal perioden er begrænset.
English: Tell your doctor you are using Avonex:
Danish: Fortæl din læge, at du bruger Avonex:
English: Your doctor will tell you how long you need to keep using Avonex.
Danish: Din læge vil fortælle dig, hvor længe du behøver at fortsætte med at bruge Avonex.
English: Avonex and allergic reactions.
Danish: Avonex og allergiske reaktioner.
English: AVONEX should be discontinued in patients who develop progressive MS.
Danish: AVONEX bør seponeres hos patienter, der udvikler progressiv MS.
English: Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during treatment with AVONEX.
Danish: Patienter med hjertesygdomme, såsom angina, kongestivt hjertesvigt eller arytmier, bør nøje observeres for forværring af deres kliniske tilstand under behandling med AVONEX.
English: The needle must go all the way in.
Danish: Kanylen skal trænge helt ind.
English: Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidneys.
Danish: Din læge kan ønske at kontrollere dit blodtryk, blod (blodpladetal) og funktionen af dine nyrer.
English: Do not lift the pen away from your skin.
Danish: Løft ikke sprøjten væk fra huden.
English: The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body.
Danish: Proteinet i Avonex består af nøjagtig samme stoffer som det interferon beta, der findes i menneskets krop.
English: If you have severe depression or thoughts about suicide, you must not use Avonex.
Danish: Hvis du lider af svær depression eller har selvmordstanker, må du ikke bruge Avonex.
English: AVONEX is indicated for the treatment of
Danish: AVONEX er indiceret til behandling af
English: The concentration is 30 micrograms per 0.5 ml.
Danish: Koncentrationen er 30 mikrogram per 0,5 ml.
English: Using the World Health Organisation (WHO) International Standard for Interferon, 30 micrograms of AVONEX contain 6 million IU of antiviral activity.
Danish: Ifølge Verdenssundhedsorganisationen WHO International Standard for interferon, indeholder 30 mikrogram AVONEX 6 millioner IE antiviral aktivitet.
English: Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Danish: Patienterne bør rådes til straks at rapportere ethvert tegn på depression og/eller selvmordstanker til den behandlende læge.
English: Air bubble(s) are normal.
Danish: Luftbobler er normale.
English: Talk to a doctor straight away if any of these apply to you.
Danish: Du skal straks kontakte en læge, hvis noget af dette gælder for dig.
English: The use of various assays to detect serum antibodies to interferons limits the ability to compare antigenicity among different products.
Danish: Anvendelsen af skiftende metoder til at måle serum-antistoffer mod interferoner begrænser muligheden for at sammenligne anti-geniciteten mellem de forskellige præparater.
English: If you have used the Avostartclip, the syringe (and the Avostartclip) must be thrown away afterwards.
Danish: Hvis du har brugt Avostartclip, skal sprøjten (og Avostartclip) smides ud bagefter.
English: Multiple sclerosis is linked to nerve (brain or spinal cord) damage.
Danish: Multipel sklerose forbindes med nervebeskadigelse (i hjerne eller rygsøjle).
English: For further details, speak with your doctor
Danish: For yderligere information tal med din læge.
English: Do not stop your Avonex treatment without speaking to your neurologist.
Danish: Stop ikke behandlingen med Avonex uden at tale med din neurolog.
English: Tip: The needle cover will come off automatically during step 3, below.
Danish: Tip: Kanylehætten fjernes automatisk i trin 3 herunder.
English: In some cases, these reactions have occurred in the presence of other medicinal products that have been associated with hepatic injury.
Danish: I nogle tilfælde forekom disse reaktioner, hvor der blev anvendt andre lægemidler, der er blevet associeret med leverbeskadigelse.
English: Patient-time is the sum of individual units of time that the patient in the study has been exposed to AVONEX before experiencing the adverse reaction.
Danish: Patient-tid er summen af individuelle tidsenheder, hvor patienten i studiet er blevet eksponeret for AVONEX, inden patienten oplevede bivirkningen.
English: Your doctor, nurse or pharmacist should provide you with instructions on how to dispose of your used Avonex Pen, for example into a sharps bin.
Danish: Din læge, sygeplejerske eller apoteket bør instruere dig i, hvordan du bortskaffer din brugte Avonex Pen, f.eks. i en beholder til skarpe genstande.
English: Your doctor may find changes in your blood and the function of your kidneys.
Danish: Din læge kan finde ændringer i dit blod eller i funktionen af dine nyrer.
English: Tip: Take care not to press the blue activation button too early.
Danish: Tip: Pas på ikke at trykke for tidligt på den blå aktiveringsknap.
English: Name and address of the manufacturers responsible for batch release Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Denmark.
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Biogen Denmark Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Danmark.
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Danish: 4.8 og 5.1 men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: What AVONEX is used for Avonex is used to treat Multiple Sclerosis (MS).
Danish: Hvad bruges AVONEX til Avonex bruges til behandling af multipel sklerose (MS).
English: You will be provided with an Avostartclip titration kit.
Danish: Du vil få udleveret et Avostartclip titreringssæt.
English: At very high doses, anovulatory and abortifacient effects in test animals were observed.
Danish: Ved meget høje doser observeredes der anovulatoriske og abortfremkaldende virkninger hos forsøgsdyrene.
English: Tell your doctor if you are using, have recently used or might use any other medicines, especially those used to treat epilepsy or depression.
Danish: Fortæl lægen, hvis du bruger anden medicin eller har gjort det for nylig, især medicin til behandling af epilepsi eller depression.
English: This makes the injection more comfortable than using straight from the refrigerator.
Danish: Det gør injektionen mere behagelig, end hvis den kom direkte ud af køleskabet.
English: This is what causes the symptoms of MS. Avonex seems to work by stopping your body's defence system from attacking the myelin.
Danish: Avonex synes at virke ved at det forhindrer kroppens forsvarssystem i at angribe myelinet.
English: Three major forms of interferons have been distinguished: alpha, beta, and gamma.
Danish: Der skelnes mellem tre hovedgrupper af interferoner: alfa, beta og gamma.
English: Tip: Do not press the blue activation button at the same time.
Danish: Tip: Tryk ikke på den blå aktiveringsknap på samme tid.
English: In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file.
Danish: For at forbedre sporbarheden af dette lægemiddel skal lægen eller apotekspersonalet registrere handelsnavn og batchnummer på det produkt, du har fået, i din patientjournal.
English: Neutralising antibodies are associated with a reduction in the in vivo biological effects of AVONEX and may potentially be associated with a reduction of clinical efficacy.
Danish: Neutraliserende antistoffer er forbundet med en reduktion af de biologiske virkninger af AVONEX in vivo, og kan medføre en reduktion af klinisk effekt.
English: Natural interferon beta and AVONEX (interferon beta-1a) are glycosylated and have a single N-linked complex carbohydrate moiety.
Danish: Naturlig interferon beta og AVONEX (interferon beta-1a) er glykosylerede og har en enkelt N-bundet kompleks kulhydratfraktion.
English: With one hand, stretch the skin around the injection site.
Danish: Med den ene hånd strækkes huden rundt om injektionsstedet.
English: Avonex works best when you use it: - at the same time - once a week - on a regular basis
Danish: Avonex virker bedst, når du tager det: - på samme tidspunkt - én gang om ugen - regelmæssigt