FrancophonIA/ELRC3.0 huggingface dataset:
English: Capillary leak syndrome in preexisting monoclonal gammopathy*
Danish: Kapillær lækagesyndrom ved eksisterende monoklonal gammopati*
English: - If you have ever had seizures or if you are taking medicines to treat epilepsy (antiepileptics), you doctor will monitor your treatment carefully (see also “Other medicines and Extavia” and section 4, “Possible side effects”).
Danish: - Hvis du nogensinde har haft krampeanfald, eller hvis du tager medicin mod epilepsi (antiepileptika), vil din læge følge din behandling tæt (se også ”Brug af anden medicin sammen med Extavia” og afsnit 4 ”Bivirkninger”).
English: Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
Danish: Behandlingen bør ikke anvendes til patienter med recidiverende-remitterende dissemineret sklerose, som har haft færre end 2 relapser i de forudgående 2 år, eller til patienter med sekundær progressiv dissemineret sklerose, som ikke har haft aktiv sygdom i de forudgående to år.
English: In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres.
Danish: I de forskellige, kontrollerede kliniske forsøg udviklede mellem 23 % og 41 % af patienterne neutraliserende aktivitet mod interferon beta-1b i serum, bekræftet ved mindst 2 efterfølgende positive titreringer.
English: This might happen several weeks to several years after starting Extavia.
Danish: Dette kan ske flere uger til flere år efter, du er startet på behandlingen med Extavia.
English: - the liver does not work properly (hepatic injury [including hepatitis], hepatic failure), (rare).
Danish: - leveren virker ikke ordentligt (leverskade [inklusiv hepatitis], leversvigt), (sjælden).
English: - rash, redness of the skin in the face, joint pain, fever, weakness and others caused by the medicine (drug-induced lupus erythematosus), frequency unknown.
Danish: - udslæt, hudrødme i ansigtet, ledsmerter, feber, svaghed og andre tilstande forårsaget af medicinen (lægemiddelinduceret lupus erythematosus) (hyppighed ikke kendt).
English: To help you rotate the injection sites appropriately, we recommend that you keep a record of the date and location of your injection.
Danish: For at veksle passende mellem indsprøjtningsstederne anbefaler vi, at du noterer dato og sted for din indsprøjtning.
English: - sudden shortness of breath (bronchospasm), (rare).
Danish: - pludselig åndenød (bronkospasme), (sjælden).
English: If you forget to use Extavia
Danish: Hvis du har glemt at tage Extavia
English: Solvent - clear/colourless solution.
Danish: Solvens - klar, farveløs opløsning.
English: Swirl the syringevial assembly gently until the powder is completely dissolved.
Danish: Rotér det samlede sprøjtehætteglas forsigtigt indtil pulveret er opløst fuldstændigt.
English: In the following tables, the most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Danish: I nedenstående tabeller er de mest relevante MedDRA-termer anvendt til at beskrive en bestemt bivirkning, dens synonymer samt relaterede tilstande.
English: The following instructions and pictures explain how to prepare Extavia for injection and how to inject Extavia yourself.
Danish: Denne vejledning og billedet forklarer, hvordan Extavia klargøres til indsprøjtning, og hvordan du sprøjter dig selv.
English: - You will need blood tests to determine your blood cell count, blood chemistry and your liver enzymes.
Danish: - Du skal have foretaget blodprøver for at bestemme antallet af dine blodlegemer, din blodkemi og dine leverenzymer.
English: Therapy with Extavia was well accepted in the study of patients with a single clinical event as indicated by a high rate of trial completion (92.8% in the Extavia group).
Danish: Behandlingen med Extavia blev godt modtaget i studiet med patienter med en enkelt klinisk hændelse, hvilket underbygges af et højt antal patienter, som fuldførte studiet (92,8 % i Extaviagruppen).
English: Bronchospasm* Pulmonary arterial hypertension**
Danish: Bronkospasme* Pulmonal ateriel hypertension**
English: The PSUR cycle of Extavia is aligned with the cross-referred product, Betaferon, until otherwise specified.
Danish: Extavias PSUR-cyklus vil stemme overens med den, der gælder for krydsreference-lægemidlet Betaferon, indtil andet specificeres.
English: In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (89) of the patients treated immediately with Extavia.
Danish: I studiet med patienter med en enkelt klinisk hændelse, der tyder på dissemineret sklerose, sås neutraliserende aktivitet (målt hver 6. måned) hos 32 % (89) af patienterne behandlet med Extavia.
English: This may suggest a disease of the heart muscle (cardiomyopathy) which has been reported in patients using Extavia.
Danish: Dette kan være tegn på hjertemuskelsygdom (kardiomyopati), som er rapporteret hos patienter, der bruger Extavia.
English: While Extavia does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
Danish: Extavia har ikke nogen direkte kardiotoksicitet, men symptomer på det influenzalignende syndrom, som forbindes med beta-interferoner, kan vise sig at belaste patienter med tidligere alvorlige hjertesygdomme.
English: In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an auto-injector was used in the majority of patients.
Danish: I det pivotale studie med patienter med en enkelt klinisk hændelse, der tyder på dissemineret sklerose, anvendte størstedelen af patienterne en autoinjektor.
English: - severe loss of appetite leading to weight loss (anorexia), (rare).
Danish: - alvorlig mangel på appetit, der kan føre til vægttab (anoreksi), (sjælden).
English: This will give each injection site a chance to fully recover before receiving another injection.
Danish: Det giver hvert sted mulighed for at komme sig helt før en ny indsprøjtning.
English: • Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Danish: • Patienter med sekundær progressiv dissemineret sklerose med aktiv sygdom, vist ved relapser.
English: Very common side effects which have occurred in clinical trials with Extavia (may affect more than 1 in 10 people) and at a higher percentage than those observed with placebo.
Danish: Meget almindelige bivirkninger som er forekommet i kliniske forsøg med Extavia (kan forekomme hos flere end 1 ud af 10 personer), og som var hyppigere end hos personer, der fik placebo ("snydemedicin").
English: However, it is known that the biological response-modifying properties of interferon beta-1b are mediated through its interactions with specific cell receptors found on the surface of human cells.
Danish: Men det vides, at interferon beta-1bs biologiske responsmodificerende egenskaber formidles gennem interaktioner med specifikke cellereceptorer, der findes på overfladen af humane celler.
English: Latex-sensitive individuals
Danish: Personer med overfølsomhed overfor latex
English: Vascular disorders Vasodilatation
Danish: Vaskulære sygdomme Vasodilatation
English: During Extavia treatment you are likely to experience injection site reactions.
Danish: Under Extavia-behandlingen vil du sandsynligvis observere nogle reaktioner ved indsprøjtningsstedet.
English: After mixing Extavia, you should administer the injection immediately (if this medicine is not used immediately, see section 5 of the leaflet, “How to store Extavia”).
Danish: Efter at Extavia er opløst, skal du foretage indsprøjtningen omgående (hvis dette lægemiddel ikke bruges omgående, henvises der til afsnit 5 ”Opbevaring” på indlægssedlen).
English: 250 microgram (8.0 million IU) per ml after reconstitution.
Danish: 250 mikrogram (8,0 mio. IE)/ml efter rekonstitution.
English: Interferons are proteins produced by the body that help it fight against attacks on the immune system such as viral infections.
Danish: Interferoner er proteiner, der dannes af kroppen, og som hjælper immunsystemet med at bekæmpe fx luftvejsinfektioner.
English: Talk to your doctor, pharmacist or nurse for further information.
Danish: Bed din læge, apotekspersonalet eller sygeplejersken om yderligere information.
English: To minimise the risk of injection site necrosis patients should be advised to: use an aseptic injection technique, rotate the injection sites with each dose.
Danish: For at minimere risikoen for nekrose på injektionsstedet, bør patienten anbefales at: anvende en aseptisk injektionsteknik skifte injektionssted for hver dosis.
English: Storage after reconstitution
Danish: Opbevaring efter rekonstituering
English: Do not remove the vial adapter from its packaging.
Danish: Tag ikke adapteren til hætteglasset ud af pakningen.
English: Treatment day
Danish: Behandlingsdag
English: No acute toxicity studies have been performed.
Danish: Der er ikke foretaget studier af akut toksicitet.
English: For subcutaneous use after reconstitution with 1.2 ml of solvent.
Danish: Til subkutan brug efter rekonstitution med 1,2 ml solvens.
English: Extavia contains sodium
Danish: Extavia indeholder natrium
English: - disease of the heart muscle (cardiomyopathy), (rare).
Danish: - hjertemuskelsygdom (kardiomyopati), (sjælden).
English: ► Tell your doctor immediately: - if you get some or all of these symptoms: foamy urine, fatigue, swelling, particularly and the ankles and eyelids, and weight gain, as they may be signs of a possible kidney problem.
Danish: ► Kontakt straks din læge: hvis du får nogen eller alle af de følgende symptomer: skummende urin, træthed, hævelser, især i ankler og øjenlåg, og vægtøgning, da disse kan være tegn på mulige nyreproblemer.
English: In the absence of clinical evidence for liver damage, and after normalisation of liver enzymes, a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
Danish: Hvis der ikke er klinisk påvist leverbeskadigelse, og når leverenzymerne er normaliseret, kan det overvejes at genoptage behandlingen med en passende kontrol af leverfunktionerne.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially 'sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. ml, dvs. det er i det væsentlige natriumfrit.
English: Further subgroup analyses indicated a high risk for progression to CDMS within 2 years in monofocal patients with at least 9 T2lesions (55% risk for placebo, 26% for Extavia) or Gd-enhancement (63% versus 33%).
Danish: Yderligere analyser af undergrupper viste en høj risiko for progression til CDMS inden for 2 år hos monofokale patienter med mindst 9 T2-læsioner (55 % risiko for placebo, 26 % for Extavia) eller Gd-forstærkning (63 % mod 33 %).
English: Limited information available on the transfer of interferon beta-1b into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are negligible.
Danish: Den begrænsede information om interferon beta-1b udskillelse i human mælk sammenholdt med de kemiske/fysiologiske egenskaber ved interferon beta antyder, at niveauer af interferon beta-1b, der udskilles i human mælk, er ubetydelige.
English: If more than 3 hours pass, discard the medicine and prepare a new injection.
Danish: Hvis der går mere end 3 timer, skal du kassere opløsningen og klargøre en ny.
English: The most serious events often occurred in patients exposed to other medicinal products or substances known to be associated with hepatotoxicity or in the presence of co-morbid medical conditions (e.g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Danish: De alvorligste tilfælde forekom ofte hos patienter, i behandling med andre lægemidler eller stoffer, der er kendt for at være forbundet med levertoksicitet eller ved andre samtidige medicinske tilstande (f.eks. metastaserende malignitet, alvorlig infektion og sepsis eller alkoholmisbrug).
English: • Vial adapters for use when reconstituting your medicine
Danish: • Adapter til hætteglas, som du skal bruge ved opløsningen af din medicin
English: Thrombocytopenia Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome#
Danish: Trombocytopeni Trombotisk mikroangiopati, herunder trombotisk trombocytopenisk purpura/hæmolytisk uræmisk syndrom#
English: Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated.
Danish: Regelmæssige thyroideafunktionsprøver anbefales til patienter med thyroideaforstyrrelser i anamnesen eller efter klinisk indikation.
English: Caution should be exercised when Extavia 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. anti-epileptics.
Danish: Der bør udvises forsigtighed, når Extavia anvendes samtidig med medikamenter, der har et smalt terapeutisk indeks, og som hovedsageligt er afhængige af cytokrom P450-systemet til clearance.
English: Aspartate aminotransferase increased (SGOT >5 times baseline)
Danish: Øget aspartataminotransferase (ASAT >5 gange baseline)   * °
English: Side effects derived only during post marketing:
Danish: Bivirkninger, der kun er set efter markedsføringen:
English: RR-MS, SP-MS and single clinical event suggestive of MS In all multiple sclerosis studies Extavia was effective in reducing disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
Danish: RR-DS, SP-DS og en enkelt klinisk hændelse, der tyder på DS I alle studier af dissemineret sklerose viste Extavia sig effektivt at reducere sygdomsaktivitet (akut inflammation i centralnervesystemet og permanente vævsændringer), målt ved brug af magnetisk resonans scanning (MRI).
English: • Patients with relapsing remitting multiple sclerosis and two or more relapses within the last two years.
Danish: • Patienter med recidiverende-remitterende dissemineret sklerose, som har haft to eller flere relapser inden for de seneste to år.
English: ► Stop using Extavia and tell your doctor immediately if any of these happens to you.
Danish: ► Stop brugen af Extavia og kontakt straks din læge, hvis du oplever et eller flere af disse symptomer.
English: ► Tell your doctor immediately and stop using Extavia: if you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
Danish: ► Kontakt straks din læge og hold op med at tage Extavia: - Hvis du får symptomer som kløe over hele kroppen, opsvulmning af dit ansigt og/eller din tunge eller pludselig åndenød.
English: When you use the solution, warm it up by holding the syringe or vial in your hands before injecting to avoid pain.
Danish: Varm opløsningen op i dine hænder inden du bruger den for at undgå smerte.
English: Withdrawal of Extavia should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundice.
Danish: Det bør overvejes at stoppe behandlingen med Extavia, hvis koncentrationerne stiger signifikant, eller hvis der er kliniske symptomer på f.eks. gulsot.
English: Single clinical event indicating a high risk of developing multiple sclerosis: Extavia has been shown to delay progression to definite multiple sclerosis.
Danish: Enkelt klinisk hændelse, der antyder, at man er i højrisikogruppen for at udvikle dissemineret sklerose: Extavia har vist sig at forsinke sygdommen i at udvikle sig til definitiv dissemineret sklerose.
English: There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years.
Danish: Der foreligger opfølgninger fra kontrollerede kliniske forsøg af patienter med recidiverende-remitterende dissemineret sklerose i op til 5 år og af patienter med sekundær progressiv dissemineret sklerose i op til 3 år.
English: PART II: ROTATING INJECTION SITES
Danish: DEL II: VÆLG FORSKELLIGE INDSPRØJTNINGSSTEDER
English: The best places for injections are where the skin is loose and soft, and away from joints, nerves and bones, for example the abdomen, arm, thigh or buttocks.
Danish: De steder, der er bedst egnet til indsprøjtning, er der, hvor huden er løs og blød og ikke i nærheden af led, nerver og knogler, fx mave, arm, lår eller balder.
English: Do not use this medicine after the expiry date which is stated on the pack.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There is evidence that the patients included in this study had overall less active disease than in the other study in secondary progressive multiple sclerosis.
Danish: Noget tyder på, at sygdommen generelt var mindre aktiv hos de patienter, som deltog i dette studie, end hos patienter i det andet studie af sekundær progressiv dissemineret sklerose.
English: Other medicines and Extavia Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: In two years, the risk was 85% in the placebo group and 69% in the Extavia group (Hazard Ratio = 0.57, 95% confidence interval (0.46, 0.71), p<0.00001).
Danish: Over 2 år var risikon 85 % i placebogruppen og 69 % i Extaviagruppen (Hazard Ratio = 0,57, 95 % konfidensinterval (0,46, 0,71), p<0,00001).
English: Side effects reported on the marketed product (frequencies - where known - based on clinical trials):
Danish: Bivirkninger indberettet efter præparatet er markedsført (hvor hyppighederne er kendt, er de baseret på kliniske forsøg):
English: Hyperthyroidism, Thyroid disorders
Danish: Hypertyroidisme, thyroideaforstyrrelse r
English: Dispose of the vial and the remaining unused portion of the solution into the disposal unit.
Danish: Smid hætteglas og den ubrugte del af opløsningen i affaldsbeholderen.
English: If reactions are severe, Extavia should be discontinued and appropriate medical intervention instituted.
Danish: Hvis reaktionerne er svære, bør Extavia-behandlingen seponeres, og passende medicinsk behandling indledes.
English: Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Danish: Dosis bør ved behandlingsstart være 62,5 mikrogram (0,25 ml) subkutant hver anden dag, som langsomt øges til en dosis på 250 mikrogram (1,0 ml) hver anden dag (se Tabel A).
English: The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.
Danish: Bindingen af interferon beta-1b til disse receptorer starter en produktion af forskellige genetiske produkter, som menes at formidle interferon beta-1bs biologiske virkning.
English: Pulmonary arterial hypertension
Danish: Pulmonal ateriel hypertension
English: It is best to use your thumb rather than your nail, as your nail could break.
Danish: Undgå at bruge neglene, da de kan brække.
English: Within the study period of two years, CDMS occurred in 45% of the placebo group compared to 28% of the Extavia group (Kaplan-Meier estimates).
Danish: I studieperioden på to år forekom CDMS hos 45 % af placebogruppen sammenlignet med 28 % af Extaviagruppen (Kaplan-Meier-bedømmelser).
English: In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Danish: Ud over de laboratorietests, som normalt er nødvendige til monitorering af patienter med dissemineret sklerose, anbefales fuldstændig blodtælling og differentialtælling af hvide blodceller og blodpladetal samt blodkemi, herunder leverfunktionstests (f.eks. aspartat aminotransferase serum glutaminoksalsyre transaminase (SGOT), alanin aminotransferase serum glutamat pyruvat transaminase (SGPT) og gamma-glutamyltransferase) før behandlingen indledes med regelmæssige intervaller efter Extavia-behandlingen og med mellemrum derefter, hvis der ikke foreligger nogen kliniske symptomer.
English: The 30-gauge needles provided with the application kit for the administration of this medicine can be used either for manual injection OR with an ExtaviPro 30G auto-injector.
Danish: Kanyle nr. 30 som leveres med behandlingspakken til indsprøjtning af dette lægemiddel kan bruges enten til manuel indsprøjtning eller sammen med ExtaviPro 30G autoinjektor.
English: Attach it to the vial by pushing down until the vial adapter penetrates and locks around the top of the vial.
Danish: Fastgør adapteren til hætteglasset ved at trykke nedad, indtil adapteren bryder igennem og låser omkring toppen af hætteglasset.
English: If you suffer from severe depression and/or suicidal thoughts, you will not be treated with Extavia (see also “Do not use Extavia”).
Danish: Hvis du lider af alvorlig depression og/eller selvmordstanker, vil du ikke blive behandlet med Extavia (se også ”Brug ikke Extavia”).
English: Blood and lymphatic system disorders Lymphocyte count decreased (<1500/mm³)
Danish: Blod og lymfesystem Reduceret lymfocyttælling (<1500/mm
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 med en enkelt demyeliniserende hændelse med en aktiv inflammatorisk proces, der er alvorlig nok til at berettige til intravenøs behandling med kortikosteroider, hvis alternative diagnoser er blevet udelukket, og hvis patienten bedømmes til at være i højrisikogruppen for at udvikle klinisk definitiv dissemineret sklerose (se pkt.
English: The reconstituted solution is to be injected subcutaneously every other day.
Danish: Den rekonstituerede injektionsvæske skal injiceres subkutant hver anden dag.
English: If the patient fails to respond, for example a steady progression in Expanded Disability Status Scale (EDSS) for 6 months occurs or treatment with at least 3 courses of adrenocorticotropic hormone (ACTH) or corticosteroids during a one-year period is required despite Extavia therapy, treatment with Extavia should be stopped.
Danish: Extaviabehandlingen seponeres, hvis patienten ikke reagerer på behandlingen, f.eks. hvis der sker en stadig progression af Expanded Disability Status Scale (EDSS) i 6 måneder, eller der inden for 1 år har været behov for mindst 3 supplerende behandlinger med adrenokortikotropt hormon (ACTH) eller kortikosteroider til trods for behandling med Extavia.
English: What Extavia is
Danish: Hvad er Extavia?
English: • 30-gauge needles for injecting your medicine
Danish: • Kanyler nr. 30 til indsprøjtning af din medicin