FrancophonIA/ELRC3.0 huggingface dataset:
English: Investigations common uncommon not known lymphocyte count decreased, white blood cell count decreased, neutrophil count decreased, hematocrit decreased, blood potassium increased, blood urea nitrogen increased platelet count decreased weight decreased, weight increased, liver function tests abnormal
Danish: Undersøgelser almindelig ikke almindelig ikke kendt nedsat lymfocyttal, nedsat leukocyttal, nedsat neutrofiltal, nedsat hæmatokrit, forhøjet kalium i blodet, forhøjet blod urea nitrogen nedsat trombocyttal vægttab, vægtforøgelse, abnorme leverfunktionstests
English: General disorders and administration site conditions very common common uncommon not known flu-like symptoms, pyrexia2, chills2, sweating2
Danish: Almene symptomer og reaktioner på administrationsstedet meget almindelig almindelig ikke almindelig ikke kendt influenzalignende symptomer, pyreksi 2, kulderystelser2, svedudbrud2
English: Adults: The recommended dosage for the treatment of relapsing MS is 30 micrograms (0.5 ml solution), administered by intramuscular (IM) injection once a week (see section 6.6).
Danish: Voksne: Den anbefalede dosis til behandling af MS er 30 mikrogram (0,5 ml opløsning), indgivet ved intramuskulær (i.m.)
English: What AVONEX is
Danish: Hvad er Avonex
English: • Avonex is injected into a muscle, for example, the upper thigh muscle.
Danish: Avonex injiceres i en muskel, for eksempel øverst på låret.
English: Avonex Pen is used to inject Avonex.
Danish: Avonex Pen anvendes til injektion af Avonex.
English: Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with interferon beta-products.
Danish: Pulmonal arteriel hypertension er observeret på forskellige tidspunkter under behandlingen herunder op til flere år efter påbegyndelse af behandling med interferon beta-præparater.
English: Very common side effects (may affect more than 1 in 10 people) - Flu-like symptoms - headache, muscle aches, chills or a fever: see Flu-like symptoms - Headache.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 brugere) - influenzalignende symptomer - hovedpine, muskelsmerte, kulderystelser eller feber: se afsnittet
English: Musculoskeletal and connective tissue disorders common not known muscle cramp, neck pain, myalgia2, arthralgia, pain in extremity, back pain, muscle stiffness, musculoskeletal stiffness systemic lupus erythematosus, muscle weakness, arthritis
Danish: Knogler, led, muskler og bindevæv almindelig ikke kendt muskelkrampe, nakkesmerte, myalgi 2, artralgi, smerte i ekstremiteter, rygsmerte, muskelstivhed, muskel/knoglestivhed systemisk lupus erythematosus, muskelsvaghed, arthritis
English: Each Avostartclip should be used once and then discarded along with any remaining Avonex.
Danish: Hver Avostartclip må kun bruges én gang og skal kasseres med den resterende dosis Avonex.
English: How to use AVONEX PEN 4.
Danish: Sådan skal du bruge AVONEX PEN 4.
English: Pack size: Each single-use AVONEX PEN is packed in an individual carton, with one injection needle and a pen cover.
Danish: Pakningsstørrelse: Hver AVONEX PEN til éngangsbrug er pakket i en æske med én injektionskanyle og én penhætte.
English: Each AVOSTARTCLIP should be used once and then discarded along with any remaining AVONEX in the syringe.
Danish: Hver AVOSTARTCLIP må kun bruges én gang og skal kasseres sammen med den resterende dosis AVONEX i sprøjten.
English: Where to inject
Danish: Hvor du skal foretage injektionen
English: - Pulmonary arterial hypertension: A disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Danish: hvilket medfører højt blodtryk i de blodkar, der fører blodet fra hjertet til lungerne.
English: C. Using Avonex Pen
Danish: C. Brug af Avonex Pen
English: Store in the original package (sealed plastic tray) in order to protect from light.
Danish: Opbevares i den originale yderpakning (forseglet plastbakke) for at beskytte mod lys.
English: Pen in a three-day period, contact your doctor or pharmacist straight away for advice.
Danish: Avonex i en periode på tre dage, skal du omgående søge råd hos din læge eller apotek.
English: Avonex Pen - prepared for injection
Danish: Avonex Pen - klarggjort til injektion
English: • Peel off the foil from the base of the needle cover.
Danish: • Træk foliet af fra bunden af kanylehætten.
English: Laboratory abnormalities are associated with the use of interferons.
Danish: Afvigende laboratoriefund forekommer i forbindelse med behandling med interferoner.
English: They may happen any time after starting on Avonex.
Danish: Dette kan ske når som helst, efter at behandlingen med Avonex er påbegyndt.
English: Psychiatric disorders common not known depression (see section 4.4), insomnia suicide, psychosis, anxiety, confusion, emotional lability
Danish: 4.4), insomni selvmord, psykose, ængstelse, konfusion, emotionel labilitet
English: In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three-years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
Danish: I kliniske studier er dette defineret som to eller flere akutte attakker inden for de seneste 3 år uden tegn på fortsat progression mellem attakkerne.
English: What you need to know before you use AVONEX 3.
Danish: Det skal du vide, før du begynder at bruge AVONEX 3.
English: (may affect more than 1 in 10 people) - Flu-like symptoms - headache, muscle aches, chills or a fever: see Flu-like symptoms, below - Headache.
Danish: (kan forekomme hos flere end 1 ud af 10 brugere) - influenzalignende symptomer - hovedpine, muskelsmerte, kulderystelser eller feber: se afsnittet
English: The most commonly reported flu-like symptoms are myalgia, fever, chills, sweating, asthenia, headache and nausea.
Danish: De hyppigst rapporterede influenza-lignende symptomer er muskelsmerter, feber, kulderystelser, svedudbrud, asteni, hovedpine og kvalme.
English: This leaflet is changed from time to time.
Danish: Denne indlægsseddel ændres løbende.
English: What you need to know before you use AVONEX Do not use AVONEX
Danish: Det skal du vide, før du begynder at bruge AVONEX Brug ikke AVONEX
English: The best area is the upper, outer thigh muscle.
Danish: Det bedste område er den store, forreste lårmuskel.
English: • Hold Avonex Pen so that the cap is pointing up.
Danish: • Hold Avonex Pennen, så forseglingen peger opad.
English: If you have trouble handling the syringe, ask your doctor who may be able to help.
Danish: Hvis du har svært ved at håndtere sprøjten, så spørg din sygeplejerske eller læge til råds, de kan sikkert hjælpe dig.
English: Clear and colourless solution.
Danish: Klar og farveløs væske.
English: Solution for injection in pre-filled pen.
Danish: Opløsning til injektion i fyldt pen.
English: Patients with an EDSS of 1.0 to 3.5 at entry were included in the clinical trial.
Danish: - 3,5 ved studiestart blev inkluderede.
English: A pre-filled syringe of AVONEX is contained within a single-use, disposable, spring-powered pen injector called AVONEX PEN.
Danish: En fyldt sprøjte med AVONEX er indeholdt i en fjederdrevet injektionspen til éngangsbrug, som kaldes AVONEX PEN.
English: injection site pain, injection site erythema, injection site bruising, asthenia2, pain, fatigue2, malaise, night sweats injection site burning injection site reaction, injection site inflammation, injection site cellulitis1, injection site necrosis, injection site bleeding, chest pain
Danish: smerte ved injektionssted, erytem ved injektionssted, blå mærker ved injektionssted, asteni2, smerte, træthed2, ubehag, natlige svedudbrud brændende fornemmelse ved injektionssted reaktion ved injektionssted, inflammation ved injektionssted, cellulitis ved injektionssted1, nekrose ved injektionssted, blødning ved injektionssted, brystsmerte
English: Blood clots in the small blood vessels may occur during your treatment.
Danish: Under din behandling kan der opstå blodpropper i de små blodårer.
English: If you feel dizzy, do not drive.
Danish: Kør ikke, hvis du føler dig svimmel.
English: Store in the original package (sealed plastic tray) in order to protect from light (see section 6.5).
Danish: Opbevares i den originale yderpakning (forseglet plastbakke) for at beskytte mod lys (se pkt.
English: Package leaflet: Information for the user AVONEX 30 micrograms/0.5 ml solution for Injection
Danish: Indlægsseddel: Information til brugeren AVONEX 30 mikrogram /0,5 ml injektionsvæske, opløsning
English: Sodium acetate trihydrate Acetic acid, glacial Arginine hydrochloride Polysorbate 20
Danish: Natriumacetat trihydrat Eddikesyre, krystalliseret Argininhydrochlorid Polysorbat 20
English: The recommended weekly dose One injection using Avonex Pen, once a week.
Danish: Den anbefalede ugentlige dosis Én injektion med Avonex Pen, én gang om ugen.
English: Gastrointestinal disorders common vomiting, diarrhoea, nausea2
Danish: Mave-tarm-kanalen almindelig opkastning, diaré, kvalme2
English: Cessation of therapy with AVONEX should be considered (see also sections 4.3 and 4.8).
Danish: Ophør af behandling med AVONEX bør overvejes (se også pkt.
English: 3A syncope episode may occur after AVONEX injection, it is normally a single episode that usually appears at the beginning of the treatment and does not recur with subsequent injections.
Danish: Normalt er det en enkeltstående episode, der sædvanligvis forekommer ved behandlingens start og ikke optræder igen ved efterfølgende injektioner.
English: Check the pack contains one Avonex Pen, one needle and one pen cover.
Danish: Kontrollér at pakken indeholder én Avonex Pen, én kanyle og én penhætte.
English: Do not use if it is out-of-date.
Danish: Må ikke anvendes, hvis udløbsdatoen er overskredet.
English: - Feeling faint: Your first injection of Avonex may be given by your doctor.
Danish: - En følelse af at være lige ved at besvime: din læge vil muligvis give dig din første Avonexinjektion.
English: Fertility and developmental studies in rhesus monkeys have been carried out with a related form of interferon beta-1a.
Danish: Der er udført fertilitets- og udviklingsstudier hos rhesusaber med et interferon, der er beslægtet med interferon beta-1a.
English: How to inject AVONEX PEN Avonex Pen (single use)
Danish: Sådan injicerer du med AVONEX PEN Avonex Pen (éngangsbrug)
English: Avonex Pen contains a pre-filled syringe of Avonex.
Danish: Avonex Pen indeholder en fyldt sprøjte med Avonex.
English: - If you are having a blood test. Avonex may interfere with the results.
Danish: Avonex kan påvirke blodprøveresultaterne.
English: Each single pack contains 1 Avonex pen, injection needle and pen cover.
Danish: Hver pakke indeholder 1 Avonex pen, injektionskanyle og penhætte.
English: Store the Avonex pen in the original box to protect from light.
Danish: Opbevar Avonex pen i den originale æske for at beskytte den mod lys.
English: Tip: Make sure the injection needle is firmly attached to the syringe.
Danish: Tip: Sørg for, at injektionskanylen er sat helt fast i sprøjten, da den ellers kan lække.
English: C. Giving the injection
Danish: C. Injektion
English: Contents of the pack and other information What AVONEX PEN contains
Danish: Pakningsstørrelser og yderligere oplysninger AVONEX PEN indeholder:
English: Dispose of the rubbish properly
Danish: Korrekt bortskaffelse af affaldet
English: Store the Avonex pen in the original package to protect from light.
Danish: Opbevar Avonex pen i den originale pakning for at beskytte den mod lys.
English: Remove the syringe cap
Danish: Tag sprøjtehætten af
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OUTER
English: Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with AVONEX administration.
Danish: Det anbefales at give et analgetikum med antipyretisk virkning inden injektion og gennem de næste 24 timer efter hver injektion for at reducere de influenzalignende symptomer associeret med AVONEX.
English: (may affect up to 1 in 10 people) - Loss of appetite - Feeling weak and tired - Difficulty sleeping - Depression - Flushing - Runny nose
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 brugere) - appetitløshed - følelse af svaghed og træthed - søvnbesvær - depression - hedeture - løbende næse - diaré (løs afføring)
English: Titration: To help patients reduce the incidence and severity of flu-like symptoms (see section 4.8), titration can be performed at the initiation of treatment.
Danish: Titrering: Det er muligt at titrere ved behandlingsstart, hvilket kan reducere forekomsten og sværhedsgraden af influenzalignende symptomer (se sektion 4.8).
English: - If you are allergic to interferon beta or any of the other ingredients of this medicine (listed in section 6) - If you have severe depression or think about committing suicide.
Danish: − Hvis du er allergisk over for interferon beta eller et af de øvrige indholdsstoffer i Avonex (angivet i punkt 6)
English: If the solution for injection contains particulate matter or if it is any colour other than clear colourless, the pre-filled pen must not be used.
Danish: Hvis injektionsvæsken indeholder partikler, eller hvis den ikke er klar og farveløs, må den fyldte pen ikke anvendes.
English: Sodium acetate trihydrate, acetic acid glacial, arginine hydrochloride, polysorbate 20, water for injections.
Danish: Natriumacetat trihydrat, krystalliseret eddikesyre, argininhydrochlorid, polysorbat 20, vand til injektionsvæsker.
English: - The pre-filled syringe is broken.
Danish: Forseglingen på hætten er brudt.
English: Contents of the pack and other information How to inject AVONEX
Danish: Pakningsstørrelser og yderligere oplysninger Sådan injicerer du AVONEX
English: Impairment of Fertility: Fertility and developmental studies in rhesus monkeys have been carried out with a related form of interferon beta-1a.
Danish: Nedsat fertilitet: Hos rhesusaber er der foretaget undersøgelser over fertilitet og fosterudvikling med et interferon, der er beslægtet med interferon beta-1a.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER
English: Your doctor may provide you with an Avostartclip titration kit which enables you to gradually increase your dose at the start of treatment to help limit flu-like symptoms.
Danish: Din læge vil muligvis gradvis øge din dosis, når du starter behandlingen for at reducere forekomsten af influenzalignende symptomer.
English: If clinically needed, the use of Avonex may be considered during pregnancy.
Danish: AVONEX kan anvendes under graviditeten, hvis det er klinisk nødvendigt.
English: - The solution is coloured or you can see particles floating in it. - The tamper evident cap has been broken.
Danish: Opløsningen er farvet, eller du kan se partikler flyde rundt i væsken.
English: AVONEX 30 micrograms/0.5 ml solution for injection Interferon beta-1a
Danish: AVONEX 30 mikrogram/0,5 ml injektionsvæske, opløsning Interferon beta-1a
English: Alternate needle:
Danish: Alternativ kanyle:
English: Caution should be used and close monitoring considered when administering AVONEX to patients with severe renal and hepatic failure and to patients with severe myelosuppression.
Danish: Der bør udvises forsigtighed ved brug af AVONEX til patienter med stærkt nedsat nyre- og leverfunktion, og til patienter med stærkt nedsat knoglemarvsfunktion.
English: Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta.
Danish: Hændelserne blev indberettet på forskellige tidspunkter under behandlingen og kan opstå efter flere års behandling med interferon beta.
English: If any of the effects trouble you, talk to your doctor.
Danish: Hvis du har problemer med en eller flere af disse bivirkninger, skal du tale med din læge.
English: You should inject using only one Avonex Pen, once a week.
Danish: Du må kun injicere med en Avonex Pen, én gang om ugen.
English: Open needle to expose the connection port. Keep the cover on.
Danish: Pak kanylen ud, så sammenkoblingsporten blottes.
English: If you inject more than you should
Danish: Hvis du har taget mere end én injektion
English: 1 What AVONEX is and what it is used for What AVONEX is
Danish: Virkning og anvendelse Hvad er AVONEX
English: Avonex can be used during breast-feeding.
Danish: AVONEX kan anvendes under amning.
English: Once removed from the refrigerator, AVONEX in a pre-filled syringe should be allowed to warm to room temperature (15°C - 30°C) for about 30 minutes.
Danish: Når AVONEX i den fyldte sprøjte er taget ud af køleskabet - lad den opvarme til stuetemperatur (15 °C - 30 °C) i cirka 30 minutter.
English: Should refrigeration be unavailable, AVONEX PEN can be stored at room temperature (between 15°C and 30°C) for up to one week.
Danish: Er der ikke noget køleskab til rådighed, kan AVONEX PEN opbevares ved stuetemperatur (mellem 15 °C og 30 °C) i op til én uge.
English: Tip: The best area is the upper, outer thigh.
Danish: Tip: Det bedste område er den store muskel foran på låret.
English: Contents of the pack and other information What AVONEX contains
Danish: Pakningsstørrelser og yderligere oplysninger AVONEX indeholder:
English: Each individual pack contains one Avonex Pen, one needle and one pen cover.
Danish: Hver pakke indeholder én Avonex Pen, én kanyle og én penhætte.
English: Box of four pre-filled syringes of 0.5 ml of solution.
Danish: Pakning med fire fyldte sprøjter af 0,5 ml injektionsvæske.
English: If the solution is cloudy, coloured or contains any floating particles, do not use the pre-filled syringe.
Danish: Hvis opløsningen er grumset, farvet eller indeholder flydende småpartikler, må den fyldte sprøjte ikke bruges.
English: The other ingredients are: Sodium acetate, trihydrate; acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections.
Danish: Øvrige indholdsstoffer: Natriumacetat trihydrat, krystalliseret eddikesyre, argininhydrochlorid, polysorbat 20, vand til injektionsvæsker.
English: Press the needle onto the syringe.
Danish: Sæt kanylen fast på sprøjten.
English: - Diarrhoea (loose stools) - Feeling or being sick (nausea or vomiting) - Numbness or tingling of skin - Rash, bruising of the skin - Increased sweating, night sweats - Pain in your muscles, joints, arms, legs or neck - Muscle cramps, stiffness in the joints and muscles - Pain, bruising and redness at the injection site - Changes to blood tests.
Danish: - kvalme eller opkastning - følelsesløshed eller prikkende fornemmelse i huden - udslæt, blå mærker på huden - øget svedafsondring, natlige svedudbrud - smerte i muskler, led, arme, ben eller nakke/hals - muskelkramper, stivhed i led og muskler - smerte, blå mærker og rødme ved injektionsstedet - ændringer i blodprøveværdier.
English: AVONEX is provided as ready to use solution for injection in a pre-filled syringe.
Danish: AVONEX leveres som brugsklar injektionsvæske i en fyldt sprøjte.
English: 1 Remove the tamper-evident cap Make sure the cap is intact and has not been opened.
Danish: B. Klargøring af Avonex Pen 1 Tag forseglingen af Kontrollér, at forseglingen er intakt og ikke har været åbnet.
English: Each pre-filled syringe of AVONEX contains a single dose only.
Danish: Hver fyldt sprøjte indeholder kun én enkelt dosis AVONEX.
English: The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX).
Danish: Sidst i denne indlægsseddel findes en instruktion i, hvordan du selv foretager injektionen (se pkt.
English: Store the AVONEX PEN in the inner carton in order to protect from light (see section 6.5).
Danish: Opbevar AVONEX PEN i den indre æske for at beskytte den mod lys (se pkt.
English: Continue injecting on this new day every week.
Danish: Fortsæt med at tage din Avonex-injektion på denne ”nye” dag hver uge.
English: If you have depression, your doctor may still prescribe Avonex for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods.
Danish: Det er imidlertid vigtigt, at du fortæller det til din læge, hvis du har haft en depression, eller hvis du har haft lignende problemer, der påvirker dit humør.
English: If you miss your usual weekly dose, inject a dose as soon as you can. Then leave a week before using Avonex again.
Danish: Hvis du glemmer at tage din sædvanlige ugentlige dosis, skal du injicere en dosis, så snart du kan.
English: AVONEX 30 micrograms/0.5 ml solution for injection.
Danish: AVONEX 30 mikrogram /0,5 ml injektionsvæske, opløsning.
English: In this leaflet…
Danish: I denne indlægsseddel.
English: Each single-use, disposable, pre-filled pen contains a single dose of AVONEX.
Danish: Hver fyldt engangspen indeholder en enkelt dosis AVONEX.
English: There are more details on how to inject Avonex at the end of this leaflet.
Danish: Sidst i denne indlægsseddel findes der yderligere oplysninger om, hvordan Avonex injiceres.
English: Box of twelve pre-filled syringes of 0.5 ml of solution.
Danish: Pakning med tolv fyldte sprøjter med 0,5 ml injektionsvæske.
English: - Feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness,
Danish: - En fornemmelse af at man har dårlig balanceevne eller svimmelhed, gangproblemer,
English: The Avostartclip attaches to the syringe and enables you to gradually increase your dose of Avonex when you first start treatment.
Danish: Avostartclip sættes på sprøjten og gør det muligt gradvis at øge dosis, når du starter behandling med Avonex, for at reducere de influenzalignende symptomer som visse personer oplever, når de begynder at bruge Avonex.
English: A separate needle to give the injection is also included in the tray.
Danish: I bakken medfølger endvidere en separat kanyle til selve injektionen.
English: If the solution for injection contains particulate matter or if it is any colour other than clear colourless, the pre-filled syringe must not be used.
Danish: Injektionsvæsken inspiceres, og hvis den indeholder partikler, eller hvis den ikke er klar og farveløs, må den fyldte sprøjte ikke anvendes.
English: 2 Fit the needle
Danish: 2 Påsætning af kanyle
English: Common side effects (may affect up to 1 in 10 people) - Loss of appetite - Feeling weak and tired - Difficulty sleeping - Depression - Flushing - Runny nose - Diarrhoea (loose stools) - Feeling or being sick (nausea or vomiting) - Numbness or tingling of skin - Rash, bruising of the skin - Increased sweating, night sweats - Pain in your muscles, joints, arms, legs or neck - Muscle cramps, stiffness in the joints and muscles - Pain, bruising and redness at the injection site - Changes to blood tests.
Danish: - søvnbesvær - depression - hedeture - løbende næse - diaré (løs afføring) - kvalme eller opkastning - følelsesløshed eller prikkende fornemmelse i huden - udslæt, blå mærker på huden - øget svedafsondring, natlige svedudbrud - smerte i muskler, led, arme, ben eller nakke/hals - muskelkramper, stivhed i led og muskler - smerte, blå mærker og rødme ved injektionsstedet - ændringer i blodprøveværdier.
English: Hepatobiliary disorders not known hepatic failure (see section 4.4), hepatitis, autoimmune hepatitis
Danish: 4.4), hepatitis, autoimmun hepatitis
English: • Gently, turn the needle clockwise until it is firmly attached, otherwise the needle may leak.
Danish: • Drej forsigtigt kanylen med uret, indtil den sidder fast, så samlingen ikke lækker.
English: What you need to know before you use AVONEX
Danish: Det skal du vide, før du begynder at bruge AVONEX
English: Check the liquid in the syringe
Danish: B. Klargøring af injektionsvæsken Kontrollér væsken i sprøjten
English: 3 Extend the injector shield
Danish: 3 Træk injektorafskærmningen ud.