FrancophonIA/ELRC3.0 huggingface dataset:
English: If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of AVONEX is recommended.
Danish: Hvis TMA diagnosticeres, kræves der prompte behandling (idet udskiftning af plasma skal overvejes), og omgående seponering af AVONEX anbefales.
English: The formulation does not contain a preservative.
Danish: Opløsningen indeholder ingen konserveringsmidler.
English: 150 AVONEX-treated patients completed one year on study and 85 completed two years on study.
Danish: 150 AVONEX-behandlede patienter gennemførte behandlingen i ét år, og 85 patienter gennemførte behandlingen i to år.
English: Prepare alcohol wipes and sticking plasters (not supplied) if you need them.
Danish: Hav spritservietter og hæfteplaster klar (medfølger ikke), hvis du har brug for det.
English: The safety and efficacy of AVONEX in children below 12 years of age have not yet been established.
Danish: Sikkerhed og virkning af AVONEX hos børn under 12 år er endnu ikke klarlagt.
English: Press the plunger slowly until the syringe is empty.
Danish: Tryk langsomt stemplet ind, indtil sprøjten er tom.
English: The estimated risk of a second event was 50% in three years and 39% in two years in the placebo group and 35% (three years) and 21% (two years) in the AVONEX group.
Danish: Den anslåede risiko for et nyt anfald var 50% over tre år og 39% over to år i placebo-gruppen og 35% (tre år) og 21% (to år) i AVONEX-gruppen.
English: The clinical studies indicate that MS patients can receive AVONEX and corticosteroids or ACTH during relapses.
Danish: Kliniske afprøvninger indikerer, at patienter med MS kan behandles med AVONEX og kortikosteroider eller ACTH under anfald.
English: The active substance in Avonex is a protein called interferon beta-1a.
Danish: Det aktive stof i Avonex er et protein, der kaldes interferon beta-1a.
English: Leave the syringe to warm up
Danish: Lad sprøjten varme op
English: 1Injection site reactions including pain, inflammation and very rare cases of abscess or cellulitis that may require surgical intervention have been reported.
Danish: 1Der er rapporter om reaktioner ved injektionsstedet, inklusive smerte, inflammation og meget sjældne tilfælde af absces eller cellulitis, der kan kræve kirurgisk indgriben.
English: Tip: Continue to hold the pen firmly on the skin.
Danish: Tip: Fortsæt med at holde pennen fast mod huden.
English: These include MHC Class I, Mx protein, 2' / 5'-oligoadenylate synthetase, β2-microglobulin, and neopterin.
Danish: Disse forbindelser omfatter MHC klasse I, Mx protein, 2'/ 5'- oligoadenylat syntetase, β2-mikroglobulin og neopterin.
English: Chronic Toxicity: In a 26-week repeated dose toxicity study in rhesus monkeys by intramuscular route once per week, administered in combination with another immunomodulating agent, an anti CD40 ligand monoclonal antibody, no immune response toward interferon beta-1a and no signs of toxicity were demonstrated.
Danish: Kronisk toksicitet: I et 26-ugers gentagen dosis toksicitetsstudie i rhesusaber med intramuskulær administration én gang ugentlig, og givet i kombination med en anden immunmodulerende substans, et anti-CD40 ligand monoklonalt antistof, blev der ikke påvist noget immunrespons over for interferon-beta-1a, og der var ingen tegn på toksicitet.
English: • Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound.
Danish: • Brug ikke steder på huden, der har blå mærker, er ømme eller betændte, eller hvor der er et åbent sår.
English: Carcinogenesis: No carcinogenicity data for interferon beta-1a are available in animals or humans.
Danish: Karcinogenicitet: Der findes ingen karcinogenicitetsdata for interferon beta-1a, hverken for dyr eller mennesker.
English: The calculated bioavailability is greater without such adjustments.
Danish: Uden justeringer er den beregnede biotilgængelighed større.
English: Endocrine disorders not known hypothyroidism, hyperthyroidism
Danish: Det endokrine system ikke kendt hypothyroidisme, hyperthyroidisme
English: Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle.
Danish: Hold huden stram, eller klem på huden rundt om injektionsstedet, og træk kanylen ud.
English: Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Danish: Det er kendt, at depression og selvmordstanker optræder hyppigere hos patienter med MS og i forbindelse med anvendelse af interferon.
English: Patients may develop antibodies to AVONEX.
Danish: Patienter kan udvikle antistoffer over for AVONEX.
English: Avonex and allergic reactions
Danish: Avonex og allergiske reaktioner
English: Limited information available on the transfer of interferon beta-1a into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1a excreted in human milk are negligible.
Danish: Begrænset tilgængelig information om udskillelse af interferon beta-1a i modermælk, kombineret med interferon betas kemiske/fysiologiske egenskaber, tyder på, at niveauet af interferon beta-1a, som udskilles i human mælk, er ubetydeligt.
English: Flu-like symptoms tend to be most prominent at the initiation of therapy and decrease in frequency with continued treatment.
Danish: Influenza-lignende symptomer har en tendens til at være mest fremtrædende i starten af en behandling og falder i hyppighed ved fortsat behandling.
English: A double-blind randomised dose comparison study of 802 relapsing MS patients (AVONEX 30 micrograms n=402, AVONEX 60 micrograms n=400) has shown no statistically significant differences or trends between the 30 micrograms and the 60 micrograms doses of AVONEX in clinical and general MRI parameters.
Danish: Et dobbeltblindt randomiseret dosis-sammenligningsstudie med 802 patienter med recidiverende MS (AVONEX 30 mikrogram n=402, AVONEX 60 mikrogram n=400) har vist, at der ikke er signifikante forskelle eller trends mellem 30 mikrogram og 60 mikrogram doseringerne af AVONEX på kliniske og generelle MRI parametre.
English: These are the side effects that people reported when Avonex was being tested.
Danish: Disse bivirkninger er bivirkninger, som folk har indberettet, mens Avonex blev afprøvet.
English: Patients should be monitored for signs of hepatic injury and caution exercised when interferons are used concomitantly with other medicinal products associated with hepatic injury.
Danish: Patienter bør monitoreres for tegn på leverskade, og der bør udvises forsigtighed, når interferoner anvendes samtidig med andre lægemidler, der associeres med leverskade.
English: Warnings and precautions Talk to your doctor before using Avonex if you have or have had in the past:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du bruger Avonex, hvis du har eller tidligere har haft:
English: The antibodies of some of those patients reduce the activity of interferon beta-1a in vitro (neutralising antibodies).
Danish: Hos nogle af disse patienter kan antistofferne reducere aktiviteten af interferon beta-1a in vitro (neutraliserende antistoffer).
English: Hold the syringe so that the white cap is facing up.
Danish: Hold sprøjten, så den hvide hætte vender opad.
English: Similar reproductive dose-related effects have also been observed with other forms of alpha and beta interferons.
Danish: Lignende dosisafhængige virkninger på reproduktionen er også observeret med andre former af alfa og beta interferoner.
English: Side effects seen in clinical trials
Danish: Bivirkninger, der er set i kliniske forsøg
English: You can't pass it on to anyone else.
Danish: Du kan ikke smitte andre.
English: Do not twist it.
Danish: Den må ikke drejes.
English: For example, if you are prescribed other medicines, or if you have a blood test, Avonex may affect the other medicines or the test result.
Danish: Det gælder for eksempel, hvis du skal have ordineret anden medicin, eller hvis du skal have taget en blodprøve, da Avonex kan påvirke den anden medicin eller blodprøveresultatet.
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with AVONEX should be considered.
Danish: Hurtig behandling af nefrotisk syndrom er påkrævet, og seponering af AVONEX bør overvejes.
English: Adverse reactions identified from studies (clinical trials and observational studies, with a period of follow-up ranging from two years to six years) and other adverse reactions identified through spontaneous reporting from the market, with unknown frequency, are provided in the table below.
Danish: Tabellen nedenfor viser bivirkninger observeret i studier (kliniske forsøg og observationsstudier med en opfølgningsperiode, varende fra to til seks år) og andre bivirkninger observeret ved spontan indberetning fra markedet, med ukendt hyppighed.
English: Following intramuscular administration of AVONEX, serum antiviral activity levels peak between 5 and 15 hours post-dose and decline with a half-life of approximately 10 hours.
Danish: Efter intramuskulær injektion af AVONEX når det antivirale aktivitetsniveau i serum maksimum mellem fem og femten timer efter injektionen, og det aftager med en halveringstid på ca. ti timer.
English: • Use your other hand, and with one quick motion pull up the injector shield (grooved area) over the needle until the needle is fully covered.
Danish: • Med den anden hånd trækkes injektorafskærmningen (det rillede område) med en hurtig bevægelse op over kanylen, indtil kanylen er helt dækket.
English: If you miss an injection
Danish: Hvis du har glemt at tage en injektion
English: This might happen several weeks to several years after starting Avonex.
Danish: Dette kan ske flere uger til flere år efter start af behandling med Avonex.
English: 4 pre-filled pens.
Danish: 4 fyldte penne.
English: • Look through the oval display window.
Danish: • Se gennem det ovale medicinvisningsvindue.
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products.
Danish: Der er indberettet tilfælde af pulmonal arteriel hypertension (PAH) for lægemidler indeholdende interferon beta.
English: Check the blister tray contains one pre-filled syringe and one injection needle (see picture “Contents of the plastic tray”).
Danish: Kontrollér, at plastbakken indeholder én fyldt sprøjte og én injektionskanyle (se diagrammet “Plastbakkens indhold”).
English: Very common (≥1/10 patient-years);
Danish: Meget almindelig (≥1/10 patient-år);
English: Subcutaneous administration cannot be substituted for intramuscular administration.
Danish: Subkutan indgift kan ikke substituere intramuskulær indgift.
English: • Hold the body of the pen at a right angle to the injection site with one hand.
Danish: • Hold pennen med den ene hånd i en ret vinkel på injektionsstedet.
English: This assay is limited in that it is sensitive for interferon but lacks specificity for interferon beta.
Danish: Denne analyse begrænses af, at den er følsom for interferon, men mangler specificitet for interferon beta.
English: (Notes information)
Danish: (Bemærk)
English: *Class label for interferon beta products (see section 4.4).
Danish: *Klasseetiket til interferon-beta-præparater (se pkt.
English: Side effects seen in clinical trials.
Danish: Bivirkninger, der er set i kliniske forsøg.
English: Rare side effects (may affect up to 1 in 1,000 people) - Difficulty breathing.
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 brugere) - åndedrætsbesvær.
English: - Thoughts about committing suicide.
Danish: - selvmordstanker.
English: Avonex Pen - after injection (prepared for disposal)
Danish: Avonex Pen - efter injektion (klar til bortskaffelse)
English: (may affect up to 1 in 1,000 people) - Difficulty breathing.
Danish: ( kan forekomme hos op til 1 ud af 1.000 brugere) - åndedrætsbesvær.
English: A small rectangular area will be visible next to the oval display window.
Danish: Et lille firkantet vindue er synligt ved siden af det ovale medicinvisningsvindue.
English: Call a doctor immediately as they may be signs of a possible liver problem.
Danish: Søg omgående læge, da disse symptomer kan være tegn på et muligt leverproblem.
English: Vascular disorders common not known flushing vasodilatation
Danish: Vaskulære sygdomme almindelig ikke kendt hedeture vasodilatation
English: Limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
Danish: Begrænsede publicerede data antyder, at sikkerhedsprofilen hos unge fra 12 til 16 år, der får AVONEX 30 mikrogram i.m.
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Danish: Det har været rapporteret, at interferoner kan reducere aktiviteten af de leverenzymer, der er afhængige af cytokrom - P450 hos mennesker og dyr.
English: Caution should be exercised when AVONEX is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. some classes of antiepileptics and antidepressants.
Danish: Der bør udvises forsigtighed, når AVONEX gives i kombination med lægemidler, der har et snævert terapeutisk index og hvis clearance overvejende er afhængig af cytokrom P-450 systemet, f. eks. visse klasser af antiepileptika og antidepressiva.
English: Tip: Do not use external heat sources such as hot water to warm the syringe.
Danish: Tip: Brug ikke eksterne varmekilder såsom varmt vand til at opvarme sprøjten.
English: In the study, the cumulative percentage of patients who developed disability progression (by Kaplan-Meier life table analysis) by the end of two years was 35% for placebo-treated patients and 22% for AVONEX-treated patients.
Danish: I undersøgelsen var den kumulative del af patienter, som udviklede progression af invaliditeten (målt med “Kaplan-Meier life table” analyse) ved slutningen af de to år 35% for patienter i placebo-gruppen og 22% for patienter i AVONEX-gruppen.
English: Please check every time you get your prescription refilled to see if the leaflet has been updated.
Danish: Hver gang du får en ny pakke medicin, bør du undersøge, om indlægssedlen er blevet opdateret.
English: Check the expiry date on the Avonex Pen label.
Danish: Kontrollér udløbsdatoen på Avonex Pen-etiketten.
English: Transient neurological symptoms that may mimic MS exacerbations may occur following injections.
Danish: Forbigående neurologiske symptomer, der kan ligne attakker, kan optræde efter injektioner.
English: Infections and infestations not known injection site abscess1
Danish: Infektioner og parasitære sygdomme ikke kendt absces ved injektionssted1
English: Find a clean, hard surface to lay out the items needed for your injection.
Danish: Find en ren, hård bordplade, hvor de enkelte dele, du skal bruge til injektionen, kan lægges frem.
English: Effects of the injection
Danish: Virkninger fra injektionen
English: Talk to your doctor before using Avonex if you have or have had in the past:
Danish: Kontakt lægen, før du bruger Avonex, hvis du har eller tidligere har haft:
English: A reduction of the risk of experiencing a second event was noted in the AVONEX treatment group.
Danish: Man observerede en reduktion af risikoen for at få et nyt attak i den gruppe, der blev behandlet med AVONEX.
English: Avonex Pens are provided in packs of four or twelve for one or three months of injections.
Danish: Avonex Pen leveres i pakker på fire eller tolv til injektioner i én eller tre måneder.
English: The pharmacokinetic profile of AVONEX has been investigated indirectly with an assay that measures interferon antiviral activity.
Danish: AVONEX'farmakokinetiske profil er blevet undersøgt indirekte med en analyse, der måler interferons antivirale aktivitet .
English: - Serious kidney or liver problems - A low number of white blood cells or platelets, which can cause an increased risk of infection, bleeding or anaemia - Heart problems, which can cause symptoms such as chest pain (angina), particularly after any activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmias).
Danish: - alvorlige nyre- eller leverproblemer - et lavt antal hvide blodlegemer eller blodplader, der kan medføre en øget risiko for infektion, blødning eller anæmi - hjerteproblemer, der kan medføre symptomer såsom brystsmerte (angina), især efter enhver form for fysisk aktivitet; hævede ankler, kortåndethed (kongestivt hjertesvigt); eller uregelmæssige hjerteslag (arytmi).
English: If you have decided to start treatment with Avonex, your doctor may provide you with an Avostartclip titration kit.
Danish: Hvis du har besluttet at begynde behandlingen med Avonex, vil din læge måske give dig et Avostartclip titreringssæt.
English: Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is:
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen:
English: • Firmly press the body of the pen down onto the skin to release the safety lock.
Danish: • Tryk pennen med fast hånd mod huden for at udløse sikkerhedslåsen.
English: 1 Clean the injection site
Danish: 1 Rengør injektionsstedet
English: Keep a note of where you have injected each week.
Danish: Skriv ned, hvor du har foretaget injektionen hver uge.
English: Take paracetamol or ibuprofen half an hour before your Avonex injection and continue taking it for up to a day.
Danish: Tag paracetamol eller ibuprofen en halv time inden din Avonex-injektion, og fortsæt i op til én dag.
English: 12 pre-filled pens.
Danish: 12 fyldte penne.
English: If you get any symptoms of depression: - Feeling unusually sad, anxious or worthless.
Danish: Hvis du får symptomer på depression: - hvis du føler dig ualmindelig trist, angst eller har ringe selvagtelse.
English: At very high doses, anovulatory and abortifacient effects in test animals were observed (see section 5.3).
Danish: Ved meget høje doser observeredes der anovulatoriske og abortfremkaldende virkninger hos forsøgsdyrene (se pkt.
English: Titrating AVONEX at the initiation of therapy has demonstrated a reduction in the severity and incidence of flu-like symptoms.
Danish: Titrering ved behandlingsstart af AVONEX har vist at reducere sværhedsgraden og forekomsten af influenzalignende symptomer.
English: • Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1).
Danish: • patienter, som har haft ét attak med en aktiv inflammatorisk proces, som behøver intravenøs steroid behandling, hvis anden differentialdiagnose er udelukket, og patienten vurderes at være i høj risiko for at udvikle klinisk sikker multipel sklerose (se pkt.
English: Furthermore, for the time-being there is no well established definition of a high risk patient although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least three months after the initial scan.
Danish: Der findes endnu ikke nogen veletableret definition af høj-risiko patienter, men en konservativ holdning vil være at anvende mindst ni T2 hyperintense læsioner på den første MRI efterfulgt af mindst én ny T2 eller én ny Gd-forstærket læsion på den efterfølgende MRI foretaget minimum tre måneder efter den første.
English: The syringe will not empty.
Danish: Sprøjten tømmes ikke.
English: • Attach the needle by pressing it onto the glass pen tip.
Danish: • Sæt kanylen på ved at trykke den på glasspidsen.
English: Flu-like symptoms associated with AVONEX therapy may prove stressful to patients with underlying cardiac conditions.
Danish: Influenza-lignende symptomer, der kan forekomme under en behandling med AVONEX, kan være belastende for patienter med underliggende hjerteproblemer.
English: Your pack of Avonex already includes a needle for injection.
Danish: Din pakke med Avonex indeholder allerede en kanyle til injektion.
English: Common (≥1/100 to <1/10 patient-years);
Danish: Almindelig (≥1/100 til < 1/10 patient-år);
English: Take paracetamol or ibuprofen half an hour before your Avonex Pen injection and continue taking it for up to a day.
Danish: Tag paracetamol eller ibuprofen en halv time inden din Avonex Pen-injektion, og fortsæt med at tage det i op til ét døgn.
English: Each syringe is packed in a sealed plastic tray.
Danish: Hver enkelt sprøjte er emballeret i en forseglet plastbakke.
English: Try to use Avonex at the same time on the same day each week.
Danish: Prøv så vidt muligt at tage Avonex på samme tidspunkt på samme ugedag hver uge.
English: You should have had training in how to use your Avonex Pen.
Danish: Du bør have fået undervisning i, hvordan du bruger Avonex Pen.
English: How to inject AVONEX You should have had training in how to inject Avonex
Danish: Sådan injicerer du AVONEX Du bør have fået undervisning i, hvordan du injicerer Avonex.
English: Store in a refrigerator (between 2°C and 8°C).
Danish: Opbevares i køleskab (mellem 2°C og 8°C).
English: - Blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uremic syndrome).
Danish: - Blodpropper i de små blodårer kan påvirke dine nyrer (trombotisk trombocytopenisk purpura eller hæmolytisk uræmisk syndrom).
English: The injection site should be varied each week.
Danish: Injektionsstedet bør skifte ugentligt.
English: After you have finished each injection, put the needle and syringe into a special container (such as a sharps bin), not in ordinary rubbish.
Danish: Når du er færdig med injektionen, anbringes kanyle, og sprøjte i en særlig beholder (beregnet til skarpe genstande); ikke sammen med almindeligt affald.
English: Inside the back cover there's a fold-out chart with everything you need to make injections with your Avonex Pen.
Danish: På indersiden af det bageste omslag finder du et folde-ud skema med alt, du behøver for at injicere med Avonex Pen.
English: AVONEX PEN is available in pack sizes of four or twelve.
Danish: AVONEX PEN fås i pakningsstørrelser på fire eller tolv.
English: Do not use Avonex pen if you notice:
Danish: Brug ikke Avonex pen, hvis du bemærker, at:
English: These notes are a reminder.
Danish: Disse anvisninger er en hjælp til at huske hvordan.
English: If you use alcohol wipes, hold one on the injection site.
Danish: Hvis du bruger spritservietter, hold da en spritserviet på injektionsstedet.
English: Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Danish: Patienter, der viser symptomer på depression, bør overvåges nøje under behandlingen og behandles efter vanlig praksis.
English: Central nervous system-related adverse reactions may have a minor influence on the ability to drive and use machines in susceptible patients (see section 4.8).
Danish: Bivirkninger relateret til centralnervesystemet kan hos modtagelige patienter i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: If you have used more than one injection of Avonex in a three-day period, contact your doctor or pharmacist straight away for advice.
Danish: Hvis du har taget mere end én Avonex Pen inden for en periode på tre dage, skal du omgående søge kontakte din læge eller apotek.
English: The intramuscular injection site should be varied each week (see section 5.3).
Danish: Stedet for intramuskulær injektion bør skifte ugentligt (se pkt.
English: Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness.
Danish: Symptomer kan omfatte flere blå mærker, blødning, feber, ekstrem svaghed, hovedpine, svimmelhed eller uklarhed.
English: The right hand pages have the information you will need to use Avonex Pen properly.
Danish: Siderne til højre indeholder de oplysninger, der er nødvendige for at kunne bruge Avonex Pen korrekt.