FrancophonIA/ELRC3.0 huggingface dataset:
English: • patients with a single demyelinating event with an active inflammatory process, 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, hvis alternative diagnoser er blevet udelukket, og hvis patienten vurderes at have en høj risiko for at udvikle klinisk definitiv multipel sklerose (se pkt.
English: Over 4 years, the reduction in the mean exacerbation rate was 22% in patients treated with Rebif 22 micrograms, and 29% in patients treated with Rebif 44 micrograms group compared with a group of patients treated with placebo for 2 years and then either Rebif 22 or Rebif 44 micrograms for 2 years.
Danish: Over 4 år blev den gennemsnitlige eksacerbationsrate reduceret 22% hos patienter, der blev behandlet med Rebif 22 mikrogram, og 29% hos patienter, der blev behandlet med Rebif 44 mikrogram, sammenlignet med en gruppe patienter, der blev behandlet med placebo i to år og derefter med enten Rebif 22 eller Rebif 44 mikrogram i to år.
English: Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Danish: Periodisk overvågning for tidlige tegn eller symptomer, f.eks. ødem, proteinuri og nedsat nyrefunktion anbefales, især hos patienter med en øget risiko for nyresygdom.
English: • Check (just after removing from the refrigerator) that the cartridge is not accidentally frozen in the pack or inside the device.
Danish: • Kontroller (umiddelbart efter, at du tager den ud af køleskabet), at cylinderampullen ikke ved et uheld er frosset til is i pakningen eller inde i apparatet.
English: If there are particles or other visible signs of deteriorations, do not use it and contact your doctor, nurse or pharmacist for assistance.
Danish: Hvis der er partikler eller andre synlige tegn på nedbrydning, må du ikke bruge den, og du skal kontakte din læge, sygeplejerske eller apotekspersonalet for hjælp.
English: Blood and the lymphatic system disorders Very common:
Danish: Blod og lymfesystem Meget almindelig:
English: B. Transparent window C. Plunger
Danish: B. Gennemsigtigt vindue C. Stempel
English: Intramuscular and subcutaneous administrations produce fully superimposable responses.
Danish: Intramuskulær og subkutan administration resulterer i fuldt sammenligneligt respons.
English: • Breathing difficulties
Danish: • Åndedrætsbesvær
English: •Talk to your doctor or pharmacist before taking Rebif if you have an allergy (hypersensitivity) to any other medicines.
Danish: • Kontakt lægen eller apotekspersonalet, før du tager Rebif, hvis du er allergisk (overfølsom) over for nogen som helst anden medicin.
English: Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Danish: Forøget frekvens af depression og selvmordstanker er kendt hos multipel sklerose-patienter og i forbindelse med anvendelse af interferoner.
English: Before the injection
Danish: Før injektionen
English: Frequency not known: Pulmonary arterial hypertension* (class label for interferon products, see below Pulmonary arterial hypertension)
Danish: Hyppighed ikke kendt: Pulmonal arteriel hypertension* (vedrørende klassebetegnelse for interferonlægemidler: se pulmonal arteriel hypertension nedenfor)
English: If the patient population was divided into 2 subgroups (those with and those without relapses in the 2-year period prior to study entry), there was no effect on disability in patients without relapses, but in patients with relapses, the proportion with progression in disability at the end of the study was reduced from 70% (placebo) to 57% (Rebif 22 micrograms and 44 micrograms combined).
Danish: Hvis man delte patientgruppen i to undergrupper (med og uden attakker i 2-års perioden før studiestart), fandt man ingen effekt på førligheden hos patienter uden attakker, men hos patienter med attakker blev andelen med forværret førlighed i slutningen af studiet reduceret fra 70% (placebo) til 57% (Rebif 22 mikrogram og 44 mikrogram kombineret).
English: • if you are allergic to natural or recombinant interferon beta or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for naturligt eller rekombinant interferon beta eller et af de øvrige indholdsstoffer i Rebif (angivet i punkt 6),
English: • Epileptic seizures
Danish: • Epileptiske anfald
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Rebif.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet ellersygeplejersken, før du bruger Rebif.
English: • Your doctor will tell you how to choose the correct dose.
Danish: • Din læge vil fortælle dig, hvordan du vælger den korrekte dosis.
English: The patients enrolled into the trial had at least two clinically silent lesions on the T2-weighted MRI scan, with a size of at least 3 mm, at least one of which is ovoid or periventricular or infratentorial.
Danish: Patienterne, der indgik i studiet, havde mindst to klinisk stumme læsioner på den T2-vægtede MR-scanning med en størrelse på mindst 3 mm, og hvoraf mindst en er ovoid eller periventrikulær eller infratentoriel.
English: Possible symptoms resulting from these changes could include tiredness, reduced ability to fight infection, bruising or unexplained bleeding.
Danish: Symptomer på disse ændringer kan omfatte træthed, nedsat evne til at bekæmpe infektion, blå mærker eller uforklarlig blødning.
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, der kan påvirke dine nyrer (trombotisk trombocytopenisk purpura eller hæmolytisk uræmisk syndrom).
English: Mean CUA Lesions per Subject per Scan During the Double Blind Period Least Square Means (SE) * tiw - three times per week
Danish: Gennemsnitligt antal CUA-læsioner pr. person pr. scanning i løbet af den dobbeltblinde periode Mindste kvadraters gennemsnit (SE) * tiw - tre gange ugentligt
English: Very common (may affect more than 1 in 10 people): • Headache
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer): • Hovedpine
English: Injection site cellulitis* Frequency not known: Panniculitis (occurred in the injection site)
Danish: Cellulitis på injektionsstedet* Hyppighed ikke kendt: Panniculitis (opstod på injektionsstedet)
English: Frequency not known: Transient neurological symptoms (i.e. hypoesthesia, muscle spasm, paraesthesia, difficulty in walking, musculoskeletal stiffness) that may mimic multiple sclerosis exacerbations*
Danish: Hyppighed ikke kendt: Forbigående neurologiske symptomer (dvs. hypæstesi, muskelspasmer, paræstesi, gangproblemer, muskelstivhed), der kan ligne eksacerbation af multipel sklerose*
English: Rebif contains benzyl alcohol
Danish: Rebif indeholder benzylalkohol
English: • Inject the medicine by using a slow, steady push (push the plunger all the way in until the syringe is empty).
Danish: • Injicér lægemidlet ved at presse langsomt og jævnt på stemplet (pres stemplet helt i bund, til injektionssprøjten er tom).
English: Liver function tests may be disturbed (very common).
Danish: Resultater af leverfunktionsprøver kan blive unormale (meget almindelig).
English: The administration of interferons has been associated with anorexia, dizziness, anxiety, arrhythmias, vasodilation and palpitation, menorrhagia and metrorrhagia.
Danish: Administration af interferoner har været forbundet med anoreksi, svimmelhed, angst, arytmier, vasodilatation og palpitationer, menoragi og metroragi.
English: Treatment with Rebif should be stopped if icterus or other clinical symptoms of liver dysfunction appear.
Danish: Behandlingen med Rebif bør stoppes, hvis der forekommer gulsot eller andre kliniske symptomer på leverpåvirkning.
English: Rebif, like other interferons beta, has a potential for causing severe liver injury including acute hepatic failure (see section 4.8).
Danish: Rebif har ligesom andre beta interferoner potentialet til at fremkalde alvorlige leverskader inklusive akut hepatisk svigt (se pkt.
English: • Place RebiSmart at a right angle (90°) to the skin.
Danish: • Placer RebiSmart i en ret vinkel (90°) mod huden.
English: If you feel depressed or develop thoughts of suicide, report it immediately to your doctor.
Danish: Hvis du føler dig deprimeret eller får selvmordstanker, skal du straks kontakte din læge.
English: The majority of adverse reactions observed with interferon beta-1a are usually mild and reversible, and respond well to dose reductions.
Danish: Flertallet af bivirkninger, der er observeret med interferon beta-1a, er normalt lette og reversible og responderer godt på dosisreduktion.
English: Safety and efficacy with Rebif have not been demonstrated beyond 4 years of treatment.
Danish: Der er kun vist sikkerhed og virkning af Rebif i en behandlingsperiode på 4 år.
English: An increased formation of auto-antibodies may occur during treatment with interferon beta.
Danish: Der kan forekomme en øget dannelse af autoantistoffer ved behandling med interferon-beta.
English: • Flu-like symptoms, such as headache, fever, chills, muscle and joint pains, fatigue and nausea are very common (may affect more than 1 in 10 people).
Danish: • Influenzalignende symptomer, såsom hovedpine, feber, kulderystelser, smerter i muskler og led, træthed og kvalme er meget almindelige (kan forekomme hos flere end 1 ud af 10 personer).
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: Den begrænsede tilgængelige information om interferon beta-1as udskillelse i modermælk i tillæg med interferon betas kemiske/fysiologiske karakteristika antyder, at niveauerne af interferon beta-1a, der udskilles i human mælk, er ubetydelige.
English: Read carefully the package leaflet of Rebif 22 micrograms/0.5 mL or Rebif 44 micrograms/0.5 mL before you start your fifth week treatment.
Danish: Læs indlægssedlen til Rebif 22 mikrogram/0,5 ml eller Rebif 44 mikrogram/0,5 ml omhyggeligt, inden du starter din 5.uges behandling.
English: Patients were randomised in a double-blind manner to either Rebif 44 micrograms given three times per week, Rebif 44 micrograms once weekly, or placebo.
Danish: Patienterne blev randomiseret dobbeltblindt til enten Rebif 44 mikrogram givet tre gange ugentligt, Rebif 44 mikrogram en gang ugentligt eller placebo.
English: Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during initiation of therapy with interferon beta-1a.
Danish: Patienter med hjertesygdomme såsom angina, kongestionshjertesvigt eller arrhytmia skal følges tæt, hvis deres kliniske tilstand bliver forværret ved behandling med interferon beta-1a.
English: If the patient has multiple lesions, Rebif should be discontinued until healing has occurred.
Danish: Hvis patienten har adskillige læsioner, skal Rebif-behandlingen ophøre, indtil der har fundet opheling sted.
English: What you need to know before you use Rebif
Danish: Det skal du vide, før du begynder at bruge Rebif
English: Time to peak concentrations following a single subcutaneous injection were 24 to 48 hours for neopterin, beta-2-microglobulin and 2'5'OAS, 12 hours for MX1 and 24 hours for OAS1 and OAS2 gene expression.
Danish: Tiden til maksimunkoncentration efter en enkelt subkutan injektion var 24 til 48 timer for neopterin, beta-2-mikroglobulin og 2'5'OAS, 12 timer for MX1 og 24 timer for OAS1- og OAS2-genekspression.
English: These symptoms are usually mild, are more common at the start of the treatment and decrease with continued use.
Danish: Disse symptomer er sædvanligvis milde, er mest almindelige i starten af behandlingen og aftager ved fortsat brug.
English: These changes in the thyroid activity are almost always not felt by the patient as symptoms; however your doctor may recommend testing as appropriate.
Danish: Du vil næsten aldrig mærke disse ændringer i skjoldbruskkirtlens aktivitet, men din læge kan anbefale, at der bliver taget prøver, hvis det er relevant.
English: • Press the injection button.
Danish: • Tryk på injektionsknappen.
English: Rebif is a highly purified soluble protein that is similar to the natural interferon beta that is produced in the human body.
Danish: Rebif er et højt oprenset opløst protein, der ligner det naturlige interferon beta, der produceres i den menneskelige krop.
English: For multidose use.
Danish: Til flergangsbrug.
English: In a 3-year study in patients with secondary progressive multiple sclerosis (EDSS 3-6.5) with evidence of clinical progression in the preceding two years and who had not experienced relapses in the preceding 8 weeks, Rebif had no significant effect on progression of disability, but relapse rate was reduced by approximately 30%.
Danish: I et 3-årigt studie hos patienter med sekundær progressiv MS (EDSS 3-6,5) med bekræftet klinisk progression i de forudgående to år, og som ikke havde oplevet attakker i de forudgående 8 uger, havde Rebif ingen signifikant effekt på forværring af førlighed, men antallet af attakker blev reduceret med ca. 30%.
English: During week three and four: 0.25 mL, which corresponds to the dose of 22 micrograms
Danish: I løbet af uge tre og fire: 0,25 ml, der svarer til en dosis på 22 mikrogram
English: If you miss a dose, continue to inject from the day of the next scheduled dose.
Danish: Hvis du glemmer en injektion, skal du blot tage injektionen den næste fastsatte dag.
English: Injection site inflammation, injection site reaction, influenza-like symptoms
Danish: Inflammation ved injektionsstedet, reaktion ved injektionsstedet, influenzalignende symptomer
English: During week one and two: 0.1 mL, which corresponds to the dose of 8.8 micrograms
Danish: I løbet af uge et og to: 0,1 ml, der svarer til en dosis på 8,8 mikrogram
English: In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1).
Danish: I kliniske studier var dette karakteriseret ved to eller flere akutte attakker i de foregående to år (se pkt.
English: • Resting your wrist on the skin near the site, stick the needle at a right angle straight into the skin with a quick, firm motion.
Danish: • Hvil håndleddet mod huden i nærheden af injektionsstedet og stik kanylen lodret ind i huden med en hurtig og bestemt bevægelse.
English: It may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Danish: Det kan forårsage toksiske og anafylaktoide reaktioner hos spædbørn og børn op til 3 år.
English: The presence of antibodies has been shown to attenuate the pharmacodynamic response to interferon beta-1a (beta-2 microglobulin and neopterin).
Danish: Forekomsten af antistoffer har vist sig at svække det farmakodynamiske respons på interferon beta-1a (beta-2 mikroglobulin og neopterin).
English: This lower dose is recommended for patients who cannot tolerate the higher dose.
Danish: Denne lavere dosis anbefales til patienter, som ikke kan tåle den høje dosis.
English: The safety guard automatically surrounds the needle and locks into place to protect you from the needle.
Danish: Sikkerhedshætten dækker automatisk kanylen og låses på plads for at beskytte dig mod kanylen.
English: • Insert the needle into the skin as you have been told by your doctor.
Danish: • Stik kanylen ind i huden, som anvist af din læge.
English: Biological response markers (e.g., 2',5'-OAS activity, neopterin and beta 2-microglobulin) are induced by interferon beta-1a following subcutaneous doses administered to healthy volunteer subjects.
Danish: Biologiske responsmarkører (f.eks. 2',5'-OAS-aktivitet, neopterin og beta-2-mikroglobulin) induceres efter subkutane doser af interferon beta-1a administreret til raske frivillige forsøgspersoner.
English: If a second clinical demyelinating event occurred confirming definite multiple sclerosis, patients switched to the recommended posology of Rebif 44 micrograms three times per week in an open label manner, while maintaining blinding as to initial randomisation.
Danish: Hvis der forekom en anden klinisk demyeliniserende hændelse, der bekræftede definitiv multipel sklerose, skiftede patienterne til den anbefalede dosering med Rebif 44 mikrogram tre gange ugentligt som ”open-label”, mens blindingen fra den indledende randomisering blev bibeholdt.
English: These reactions are rare (may affect up to 1 in 1,000 people).
Danish: Disse reaktioner er sjældne (kan forekomme hos op til 1 ud af 1.000 personer).
English: Rebif has not yet been investigated in patients with primary progressive multiple sclerosis and should not be used in these patients.
Danish: Rebif er endnu ikke undersøgt hos patienter med primær progressiv multipel sklerose og bør ikke anvendes til disse patienter.
English: Patients treated with Rebif should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Danish: Patienter, der behandles med Rebif, skal rådgives til øjeblikkeligt at oplyse deres læge omkring enhver form for symptom på depression og/eller selvmordstanker.
English: No information is available on the effects of the interferon beta-1a on male fertility.
Danish: Der er ingen tilgængelige informationer om virkningen af interferon beta-1a på den mandlige fertilitet.
English: • Current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Danish: • Aktuel alvorlig depression og/eller selvmordstanker (se pkt.
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 Rebif administration.
Danish: Før hver injektion og yderligere 24 timer efter hver injektion anbefales det at tage et smertestillende middel med antipyretisk effekt for at mindske de influenzalignende symptomer, der forbindes med behandling med Rebif.
English: • Inform your doctor immediately if you experience any of the following possible symptoms of a liver problem: jaundice (yellowing of the skin or of the whites of the eyes), widespread itching, loss of appetite accompanied by nausea and vomiting and easy bruising of the skin.
Danish: • Kontakt straks din læge, hvis du får nogle af følgende bivirkninger, der kan være symptomer på et leverproblem: gulsot (gulfavning af huden eller det hvide i øjnene), udbredt kløe, appetitløshed ledsaget af kvalme og opkastning og tendens til blå mærker.
English: If you forget to use Rebif
Danish: Hvis du har glemt at bruge Rebif
English: • The first injection(s) must be performed under the supervision of an appropriately qualified healthcare professional.
Danish: • Den/de første injektion(er) skal foretages under vejledning af en kvalificeret sundhedsperson.
English: For administration of Rebif with RebiDose, the instructions provided in the package leaflet should be followed.
Danish: Administration af Rebif med RebiDose skal ske i henhold til indlægssedlens anvisninger.
English: Marketing Authorisation Holder Merck Europe B.V.
Danish: Indehaver af markedsføringstilladelsen Merck Europe B.V.
English: Neutropenia, lymphopenia, leukopenia, thrombocytopenia, anaemia
Danish: Neutropeni, lymfopeni, leukopeni, trombocytopeni, anæmi
English: • Short instructions on how to use Rebif cartridges with each device are given below.
Danish: • Herunder gives en kort anvisning i, hvordan Rebif cylinderampuller anvendes med hvert apparat.
English: • Your doctor will tell you how to choose the correct dose of 44 micrograms.
Danish: • Din læge vil fortælle dig, hvordan du vælger den korrekte dosis på 44 mikrogram.
English: The safety and efficacy of Rebif has been evaluated in patients with relapsing-remitting multiple sclerosis at doses ranging from 11 to 44 micrograms (3-12 million IU), administered subcutaneously three times per week.
Danish: Sikkerheden og virkningen af Rebif er blevet evalueret hos patienter med recidiverende-remitterende multipel sklerose ved dosering fra 11 til 44 mikrogram (3-12 millioner IE), administreret subkutant 3 gange ugentligt.
English: After a single dose, intracellular and serum activity of 2'5'OAS synthetase and serum concentrations of beta-2 microglobulin and neopterin increase within 24 hours, and start to decline within 2 days.
Danish: Efter en enkelt dosis stiger den intracellulære aktivitet og serumaktiviteten af 2-5A synthetase og serumkoncentrationen af beta-2-mikroglobulin og neopterin inden for 24 timer og begynder at aftage inden for 2 dage.
English: • Your doctor will tell you how to choose the correct dose of 22 micrograms.
Danish: • Din læge vil fortælle dig, hvordan du vælger den korrekte dosis på 22 mikrogram.
English: • When you do this please read carefully and follow the “RebiDose Instructions for Use” provided separately in the booklet.
Danish: • Når du gør dette bør du omhyggeligt læse og følge "RebiDose brugsvejledning", som er beskrevet særskilt i hæftet.
English: Titration dose for Rebif 44 micrograms three times per week (tiw)
Danish: Titreringsdosis for Rebif 44 mikrogram tre gange ugentligt (tiw)
English: OTHER Merck Europe B.V.
Danish: ANDET Merck Europe B.V.
English: Metabolism Interferon beta-1a is mainly metabolised and excreted by the liver and the kidneys.
Danish: Metabolisme Interferon beta-1a metaboliseres og udskilles hovedsageligt gennem lever og nyrer.
English: If you use more Rebif than you should In case of overdose, contact your doctor immediately.
Danish: Hvis du har brugt for meget Rebif I tilfælde af overdosis skal du omgående kontakte din læge.
English: (LOWER FLAP) 6 pre-filled pens RebiDose
Danish: (Nederste lag) 6 fyldte penne RebiDose
English: Please read also the instructions in the manual provided with your device.
Danish: Læs også anvisningerne i brugsvejledningen, der fulgte med dit apparat.
English: • Disorders of the retina (back of the eye) such as inflammation or blood clots with consequent vision disorders (vision disturbances, loss of vision)
Danish: • Sygdomme i nethinden (bagsiden af øjet) såsom betændelse eller blodpropper med deraf følgende øjenlidelser (synsforstyrrelser, synstab)
English: In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
Danish: I kliniske forsøg med Rebif var en asymptomatisk forhøjelse af hepatisk aminotransferase (især alanin-aminotransferase (ALAT)) almindelig, og 1-3% af patienterne fik forhøjelser af hepatisk aminotransferase fem gange over den øvre normalgrænse.
English: If tests are normal at baseline, routine testing is not needed but should be performed if clinical findings of thyroid dysfunction appear (see section 4.8).
Danish: Hvis thyreoideafunktionen er normal ved behandlingens start, er det ikke nødvendigt med rutinemæssig kontrol, men den bør kontrolleres, hvis der forekommer kliniske tegn på thyreoideapåvirkning (se pkt.
English: Rebif is used for the treatment of multiple sclerosis.
Danish: Rebif anvendes til behandling af multipel sklerose.
English: Rebif is available in three strengths: 8.8 micrograms, 22 micrograms and 44 micrograms.
Danish: Rebif findes i tre styrker: 8,8 mikrogram, 22 mikrogram og 44 mikrogram.
English: 8.8 micrograms tiw
Danish: 8,8 mikrogram tiw
English: If there is liquid left, not all of the medicine has been injected and you should consult your doctor or nurse for assistance.
Danish: Hvis der stadig er væske tilbage, har du ikke fået al medicin injiceret, og du bør kontakte din læge eller sygeplejerske.
English: No interaction studies have been performed with interferon beta-1a in humans.
Danish: Der er ikke udført interaktionsstudier med interferon beta-1a hos mennesker.
English: (LOWER FLAP)
Danish: (Nederste lag)