FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Danish: En risiko for overførsel af Creutzfeld-Jacobs sygdom kan ikke udelukkes.
English: The procedure for self-administration by the patient should be reviewed periodically, especially if injection site reactions have occurred.
Danish: Patientens selv-injektionsprocedure bør gennemgås regelmæssigt, især hvis der er opstået reaktioner på injektionsstedet.
English: 1 - Choose a site for the injection (refer to the section “Choosing an injection site” and the diagrams at the end of this leaflet) and make a note of it in your medication record.
Danish: 1 - Vælg et område til indsprøjtningen (se afsnittet ”Valg af indsprøjtningssted” og diagrammer til sidst i denne indlægsseddel) og notér det i dit behandlingsskema.
English: This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end den medfølgende solvens, der er anført under pkt.
English: The solvent is a clear/colourless solution.
Danish: Solvensen er en klar/farveløs opløsning.
English: - If you have a heart disease, the flu-like symptoms which often occur at the start of treatment may prove stressful to you.
Danish: - Hvis du har en hjertesygdom, kan de influenzalignende symptomer, der forekommer i starten af behandlingen, være belastende for dig.
English: Redness, swelling, discolouration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8.0 million IU) Extavia treatment.
Danish: Rødme, hævelse, misfarvning, inflammation, smerte, overfølsomhed, nekrose og uspecifikke reaktioner var signifikant forbundet med Extaviadosen 250 mikrogram (8,0 millioner IE).
English: After reconstitution immediate use is recommended.
Danish: Efter rekonstitution anbefales øjeblikkelig anvendelse.
English: Interferon beta-1b has been given to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week without serious adverse events compromising vital functions.
Danish: Interferon beta-1b er blevet givet til voksne cancerpatienter i doser på op til 5.500 mikrogram (176 millioner IE) intravenøst 3 gange om ugen, uden at der opstod alvorlige bivirkninger på vitale funktioner.
English: The list also includes side effects which occurred commonly (may affect up to 1 in 10 people) but were significantly associated with the treatment:
Danish: Listen omfatter også almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer), som var tydeligt forbundet med behandlingen:
English: Common (1/100 to
Danish: Almindelig (1/100 til
English: Do not use Extavia - if you are allergic to natural or recombinant interferon beta, human albumin or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Extavia - hvis du er allergisk over for naturligt eller rekombinant interferon beta, humant albumin eller et af de øvrige indholdsstoffer i Extavia (angivet i afsnit 6).
English: Rotation schedule
Danish: Rotationsplan
English: These instructions also tell you how to prepare the Extavia solution for injection.
Danish: Disse anvisninger fortæller dig også, hvordan du klargør Extaviaopløsningen til indsprøjtning.
English: No harmful effects on the breastfed newborn/infant are anticipated.
Danish: Der forventes ingen skadelige påvirkninger hos det ammende nyfødte barn/spædbarn.
English: General disorders and administration site conditions Injection site reaction (various kinds)
Danish: Almene symptomer og reaktioner på administrationsstedet Reaktion ved injektionssted (forskellige typer)  * ° §
English: The following adverse event listings are based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from post-marketing surveillance (Table 2, frequencies - where known - based on pooled clinical trials (very common 1/10, common 1/100 to <1/10, uncommon 1/1,000 to <1/100, rare 1/10,000 to <1/1,000, very rare <1/10,000)) of Extavia use.
Danish: Nedenstående bivirkningstabeller er baseret på rapporter fra kliniske forsøg (Tabel 1, bivirkninger og unormale laboratorieprøveresultater) og fra overvågning efter markedsføring (Tabel 2, hyppighedhvor kendt - baseret på de samlede kliniske forsøg (meget almindelig 1/10, almindelig 1/100 til <1/10, ikke almindelig 1/1.000 til <1/100, sjælden 1/10.000 til <1/1.000 og meget sjælden <1/10.000)).
English: Experience with other interferons suggest a potential for impairment of male and female fertility.
Danish: Erfaringer med andre interferoner antyder, at begge køns fertilitet muligvis kan forringes.
English: Note: If the solution is discoloured or contains particles, discard it and start again with a new syringe and vial from your package.
Danish: OBS: Hvis opløsningen er misfarvet eller indeholder partikler, skal du kassere den og starte forfra med en ny sprøjte og et nyt hætteglas fra din æske.
English: Secondary Progressive Multiple Sclerosis (European Study)
Danish: Sekundær progressiv dissemineret sklerose (Europæisk studie)
English: The available data for the additional three years are consistent with sustained treatment efficacy of Extavia over the whole time period.
Danish: Ifølge tilgængelige data for de følgende tre år har Extavia en vedvarende behandlingseffekt i hele perioden.
English: Depression and suicidal ideation are known to occur with increased frequency in the multiple sclerosis population and in association with interferon use.
Danish: Det er kendt, at depression og selvmordstanker kan opstå med øget frekvens hos patienter med dissemineret sklerose og i forbindelse med brug af interferon.
English: These blood tests will be in addition to the tests which are normally done to monitor your MS.
Danish: Blodprøverne vil være en tilføjelse til andre prøver, der normalt tages for at følge din disseminerede sklerose.
English: On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites altogether), left and right: upper, middle and lower part of each area.
Danish: I vores eksempel er hvert område igen opdelt i seks steder, nemlig venstre og højre: øverste, mellemste og nederste del af hvert område, hvilket giver i alt 48 indsprøjtningssteder.
English: Interferon alpha, interferon beta, and interferon gamma have overlapping yet distinct biological activities.
Danish: Interferon alfa, interferon beta og interferon gamma har overlappende og alligevel forskellige biologiske virkninger.
English: Therefore, the tip cap may contain natural rubber latex, which should not be handled by persons sensitive to this substance.
Danish: Beskyttelseshætten kan derfor indeholde naturgummi-latex og bør ikke håndteres af personer, som er overfølsomme over for denne substans.
English: The Extavia powder is provided in a 3-millilitre vial.
Danish: Extaviapulveret leveres i et 3 mililiter hætteglas.
English: If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with his/her physician before continuing injections with Extavia.
Danish: Hvis patienten oplever bristning af huden, som kan være forbundet med opsvulmen eller drænage af væske fra injektionsstedet, bør patienten rådgives til at søge læge, før injektionerne med Extavia fortsættes.
English: Secondary Progressive Multiple Sclerosis (North American Study)
Danish: Sekundær progressiv dissemineret sklerose (Nordamerikansk studie)
English: Patients treated with Extavia should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Danish: Patienter, der behandles med Extavia, skal rådes til straks at meddele symptomer på depression og/eller selvmordstanker til deres læge.
English: To increase tolerability of Extavia in the study of patients with a first clinical event, a dose titration was applied and nonsteroidal anti-inflammatory medicinal products were administered at start of therapy.
Danish: For at øge tolerabiliteten for Extavia i studiet med patienter med en første klinisk hændelse blev der anvendt dosistitrering, og der blev givet ikkesteroide antiinflammatoriske lægemidler i starten af behandlingen.
English: ► If you have more than one sore injection sites (multiple lesions) you must stop using Extavia until your skin has healed.
Danish: ► Hvis du har mere end et ømt indsprøjtningssted (flere sår), skal du holde op med at tage Extavia, indtil din hud er helet.
English: - Extavia contains human albumin and therefore carries a potential risk for transmission of viral diseases.
Danish: - Extavia indeholder humant albumin og kan derfor medføre risiko for at overføre virussygdomme.
English: List 2:
Danish: Liste 2:
English: Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Extavia (see section 4.2).
Danish: Generelt anbefales dosistitrering ved behandlingsstart for at øge tolerabiliteten over for Extavia (se pkt.
English: The placebo-controlled phase lasted for 2 years or until the patient developed clinically definite multiple scleroiss (CDMS), whichever came first.
Danish: Den placebokontrollerede fase varede i 2 år, eller indtil patienten udviklede klinisk definitiv dissemineret sklerose, afhængig af hvilken hændelse, der indtraf først.
English: Cases of cardiomyopathy have been reported.
Danish: Der er rapporteret om tilfælde af kardiomyopati.
English: There have been no formal clinical trials undertaken in children or adolescents.
Danish: Der er ikke udført formelle kliniske forsøg med børn og teenagere.
English: Extavia is available in pack sizes of:
Danish: Extavia findes i pakninger med:
English: Drug-induced lupus erythematosus
Danish: Lægemiddelinducer et lupus erythematosus
English: The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Danish: Administration af cytokiner til patienter, der lider af monoklonal gammopati, er blevet forbundet med udvikling af systemisk kapillær lækage-syndrom med choklignende symptomer og dødelig udgang.
English: There is no evidence of Extavia having an effect on the duration of relapses.
Danish: Det er ikke påvist, at Extavia påvirker varigheden af relapserne.
English: ► If you have only one sore injection site (lesion) and the tissue damage (necrosis) is not too extensive you may continue using Extavia.
Danish: ► Hvis du kun har ét ømt indsprøjtningssted (sår) og bristningen af hud og ødelæggelsen af væv (nekrose) ikke er alt for udbredt, kan du fortsætte brugen af Extavia.
English: Rare (1/10,000 to
Danish: Sjælden (1/10.000 til
English: ** Class label for interferon products, see below “Pulmonary arterial hypertension”.
Danish: ** Klasserelateret bivirkning for interferonlægemidler: se pulmonal ateriel hypertension nedenfor.
English: In retrospective meta-analyses including the data of both studies, a statistically significant overall treatment effect was found (p=0.0076; 8.0 million IU Extavia versus all placebo patients).
Danish: I retrospektive metaanalyser, som omfattede data fra begge studier, blev der påvist en statistisk signifikant samlet behandlingseffekt (p=0,0076; 8,0 millioner IE Extavia sammenlignet med alle placebopatienter).
English: Patients with single lesions may continue on Extavia provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis whilst on Extavia.
Danish: Patienter med enkelte læsioner kan fortsætte på Extavia, hvis nekrosen ikke er alt for omfattende, da nogle patienter har oplevet heling af nekrose på injektionsstedet, mens de stadig anvendte Extavia.
English: To reconstitute and inject your medicine you will need to use an ExtaviPro 30G application kit (supplied separately to your medicine), which contains the following components and instructions on how to use them:
Danish: Til opløsning og indsprøjtning af din medicin skal du bruge et ExtaviPro 30G applikationskit (som leveres særskilt), som indeholder følgende dele samt instruktion i, hvordan det skal bruges:
English: No investigations on fertility have been conducted (see section 5.3).
Danish: Der er ikke foretaget undersøgelser vedrørende fertilitet (se pkt.
English: A risk of transmission of Creutzfeld-Jacob disease (CJD) cannot be ruled out.
Danish: Risiko for overførsel af Creutzfeld-Jacobs sygdom kan ikke udelukkes.
English: If you stop using Extavia
Danish: Hvis du holder op med at tage Extavia
English: Talk to your doctor before using Extavia:
Danish: Kontakt lægen, før du tager Extavia:
English: Do not use this medicine if you notice it contains particles or is discoloured.
Danish: Brug ikke lægemidlet, hvis du bemærker, at det indeholder partikler, eller hvis det er misfarvet.
English: These symptoms may be reduced by taking paracetamol or non-steroidal antiinflammatory medicines such as ibuprofen.
Danish: Disse symptomer kan reduceres ved at tage paracetamol eller ibuprofen (ikke-steroide antiinflammatoriske lægemidler).
English: ► Very common (may affect more than 1 in 10 people): - painful joints (arthralgia).
Danish: ► Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer): - ledsmerter (artralgi)
English: List 1:
Danish: Liste 1:
English: Follow the sequence described in the schedule at the end of the Annex (see Part II “Rotating injection sites”) and you will come back to your first injection site area after 8 injections (16 days).
Danish: Følg den rækkefølge, der er beskrevet i skemaet til sidst i bilaget (se DEL II Vælg forskellige injektionssteder), så du kommer tilbage til det første sted efter 8 indsprøjtninger (16 dage).
English: Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Extavia during clinical trials.
Danish: Asymptomatiske stigninger i serumtransaminaser, der i de fleste tilfælde var milde og forbigående, forekom under kliniske studier hyppigt hos patienter, der blev behandlet med Extavia.
English: In addition, the following side effects have been identified during post-marketing experience.
Danish: Herudover er følgende bivirkninger set efter markedsføringen.
English: Giving many times the dose of Extavia recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
Danish: Indsprøjtning af Extavia i doser, der er mange gange større end den anbefalede dosis til behandling af dissemineret sklerose, har ikke ført til livstruende situationer.
English: Absolute neutrophil count decreased (<1500/mm³)
Danish: Reduceret absolut neutrofiltælling (<1500/mm
English: Furthermore, there was a prolongation of the relapse-free interval.
Danish: Ydermere gik der længere tid mellem relapserne.
English: There is no evidence of an effect of Extavia on the duration of relapses or on symptoms in between relapses, and no significant effect was seen on the progression of the disease in relapsing-remitting multiple sclerosis.
Danish: Extavias virkning på varigheden af relapserne eller på symptomerne mellem relapserne er ikke blevet påvist, og der blev ikke observeret nogen signifikant virkning på udviklingen af recidiverende-remitterende dissemineret sklerose.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført 2D-stregkode, som indeholder en entydig identifikator.
English: By following this sequence, you will give each area a chance to recover before receiving another injection.
Danish: Hvis du følger denne rækkefølge, får hvert område mulighed for at komme sig, før der igen indsprøjtes.
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Extavia should be considered.
Danish: Hurtig behandling af nefrotisk syndrom er påkrævet, og det skal overvejes at seponere Extavia.
English: Injection site reactions usually become less frequent over time.
Danish: Reaktioner ved indsprøjtningsstedet aftager sædvanligvis med tiden.
English: Additional caution should be exercised with any co-medication which has an effect on the haematopoetic system.
Danish: Der bør udvises yderligere forsigtighed ved enhver samtidig brug af medicin, som har en virkning på det hæmatopoetiske system.
English: - If you have severe kidney problems, your doctor may monitor your kidney function during treatment.
Danish: - Hvis du har alvorlige nyreproblemer, kan din læge vælge at måle din nyrefunktion under behandlingen.
English: The dose should be increased at every fourth injection in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml).
Danish: Dosen bør øges ved hver fjerde indsprøjtning i fire trin (0,25 ml, 0,5 ml, 0,75 ml, 1,0 ml).
English: You will also need a disposal unit for used syringes and needles.
Danish: Desuden skal du bruge en affaldsbeholder til brugte sprøjter og kanyler.
English: Serious hypersensitivity reactions (severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Danish: Der kan forekomme alvorlige overfølsomhedsreaktioner (svære, akutte reaktioner som bronkospasmer, anafylakse og urticaria).
English: If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Extavia is recommended.
Danish: Hvis TMA diagnosticeres, er øjeblikkelig behandling nødvendig (udskiftning af plasma skal overvejes), og omgående seponering af Extavia anbefales.
English: The recommended dose is every other day (once every two days), 1.0 ml of the prepared Extavia solution (see Annex “Self-injection procedure” in the second part of this leaflet) injected under the skin (subcutaneously).
Danish: Den anbefalede dosis er: hver anden dag (én gang hver anden dag) indsprøjtes 1,0 ml af den klargjorte Extavia-injektionsvæske (se bilag ”Fremgangsmåde, når du selv skal indsprøjte lægemidlet” i anden del af denne indlægsseddel) under huden (subkutant).
English: The medicinal product should be discarded before use if it contains particulate matter or is discoloured.
Danish: Lægemidlet skal kasseres før brug, hvis det indeholder partikler eller er misfarvet.
English: Within this period, the development of neutralising activity was associated with a significant increase in newly active lesions and T2 lesion volume on magnetic resonance imaging.
Danish: I denne periode var udviklingen af neutraliserende aktivitet forbundet med en signifikant øgning i nye aktive læsioner og T2-læsionsbyrden set ved magnetisk resonansscanninger (MRI).
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Danish: YDERKARTON TIL MULTIPAKNING (MED BLUE BOX)
English: Due to the lack of clinical experience in multiple sclerosis patients, the use of Extavia together with immunomodulators other than corticosteroids or ACTH is not recommended.
Danish: Grundet manglende klinisk erfaring med patienter med dissemineret sklerose bør Extavia ikke anvendes sammen med andre immunomodulatorer end kortikosteroider eller ACTH.
English: Blood triglycerides increased
Danish: Forhøjede triglycerider i blodet
English: Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
Danish: Dissemineret sklerose (DS) er en kronisk sygdom, der rammer centralnervesystemet (CNS), især hjernens og rygmarvens funktion.
English: The treatment with Extavia should be initiated under the supervision of a physician experienced in the treatment of the disease.
Danish: Behandling med Extavia skal påbegyndes under opsyn af en læge med erfaring i behandling af sygdommen.
English: During the post-marketing period very rare reports have been received of temporary worsening of cardiac status at the start of Extavia therapy in patients with pre-existing significant cardiac disease.
Danish: I perioden efter markedsføringen er der modtaget meget sjældne rapporter om forbigående forværret hjertetilstand ved behandlingsstart med Extavia hos patienter med tidligere hjertesygdom.
English: What Extavia is used for Extavia is for use in patients ► who have experienced for the first time symptoms which indicate a high risk of developing multiple sclerosis.
Danish: Extavia skal bruges til patienter ► som har oplevet symptomer for første gang, som tyder på en høj risiko for at udvikle dissemineret sklerose.
English: Cases of pancreatitis were observed with Extavia use, often associated with hypertriglyceridaemia.
Danish: Tilfælde af pankreatitis blev observeret ved brug af Extavia, ofte i forbindelse med hypertriglyceridæmi.
English: See section 2 “Warnings and precautions” and follow the instructions under “Rotating injection sites” in the Annex at the back of this leaflet.
Danish: Se afsnit 2 ”Advarsler og forsigtighedsregler”, og følg anvisningerne under ”Vælg forskellige indsprøjtningssteder” i bilaget bagerst i denne vejledning.
English: Hepatic injury (including hepatitis), Hepatic failure*
Danish: Leverskade (inklusive hepatitis), Leversvigt*
English: The risk for progression to CDMS within two years in patients with monofocal onset was 47% for placebo and 24% for Extavia, without gadolinium (Gd-) enhancement 41% and 20%, with less than 9 T2 lesions 39% and 18%.
Danish: Risikoen for progression til CDMS over 2 år hos patienter med monofokal debut var 47 % for placebo og 24 % for Extavia, uden gadolinium(Gd-)forstærkning 41 % og 20 %, med færre end 9 T2-læsioner 39 % og 18 %.
English: At the beginning of treatment side effects are common but in general they decrease with further treatment.
Danish: I starten af behandlingen er bivirkninger almindelige, men generelt aftager de i takt med yderligere behandling.
English: If excessive foaming is present - which can happen if the vial is shaken or swirled too vigorously - let the vial sit undisturbed until the foam settles.
Danish: Hvis der er meget skum - hvilket kan forekomme, hvis hætteglasset rystes eller roteres for voldsomt - skal du lade hætteglasset stå, til skummet er væk.
English: In both trials there was a reduction (30%) in frequency of clinical relapses in patients with secondary progressive multiple sclerosis patients receiving Extavia.
Danish: I begge studier var der en reduktion (30 %) i hyppigheden af kliniske relapser hos patienter med sekundær progressiv dissemineret sklerose.
English: - Be consistent - use this medicine as described in section 3 of the leaflet, “How to use Extavia”.
Danish: - Vær konsekvent - anvend dette lægemiddel som beskrevet underafsnit 3: ”Sådan skal du tage
English: Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activity.
Danish: Interferon beta-1b har vist sig at besidde både antivirale og immunregulerende egenskaber.
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 din nyrefunktion.
English: Your doses will then be increased gradually to the full dose of 1.0 ml (250 microgram).
Danish: Doserne øges herefter gradvist til den fulde dosis på 1,0 ml (250 mikrogram).
English: However, limited published data suggest that the safety profile in adolescents from 12 to 17 years of age receiving Extavia 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Danish: Begrænsede offentliggjorte data antyder dog, at sikkerhedsprofilen hos unge i 12-17-års-alderen, som behandles med 8 millioner IE Extavia subkutant hver anden dag, svarer til sikkerhedsprofilen hos voksne.
English: In the second trial of Extavia in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
Danish: I det andet studie med Extavia til patienter med sekundær progressiv dissemineret sklerose blev der ikke observeret forsinkelse til invaliditetsprogression.
English: By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days).
Danish: Hvis du følger denne plan, kommer du tilbage til det første sted (fx højre side af maven) efter 8 indsprøjtninger (16 dage).