FrancophonIA/ELRC3.0 huggingface dataset:
English: As with all therapeutic proteins, there is potential for immunogenicity.
Danish: Som ved alle terapeutisk proteiner er der potentiale for immunogenicitet.
English: In addition, these conditions may occur beyond 4 years, therefore, you must continue to look for signs and symptoms, even after you no longer need to do monthly blood and urine tests.
Danish: Desuden kan disse tilstande stadig opstå l mere end 4 år efter, og derfor skal du fortsat være opmærksom på tegn og symptomer, også selvom du ikke længere får taget blod- og urinprøver en gang om måneden.
English: Follow-up of patients
Danish: Opfølgning af patienter
English: There are certain signs and symptoms that you should look out for yourself.
Danish: Der er visse tegn og symptomer, som du selv skal være opmærksom på.
English: Confirmed disability improvement (CDI)
Danish: Bekræftet funktionstabs forbedring (CDI)
English: The antibody has an approximate molecular weight of 150 kD.
Danish: Antistoffet har en molekylvægt på cirka 150 kD.
English: • decreased/weak immune system
Danish: • nedsat/svagt immunsystem
English: In general, the infections can be treated with standard medicines.
Danish: Sædvanligvis kan disse infektioner behandles med standard-medicin.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSURer for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Patients had not received prior therapy for MS.
Danish: Patienterne havde ikke tidligere fået behandling for MS.
English: If you live in a region where tuberculosis infections are common, you may be at greater risk of infection with tuberculosis.
Danish: Hvis du bor i et område, hvor tuberkulose er almindelig, kan du have en øget risiko for at blive smittet med tuberkulose.
English: The difference was statistically significant (p=0.0002).
Danish: Forskellen er statistik signifikant (p = 0,0002).
English: If you develop one of these conditions your doctor will tell you, and take appropriate measures to treat it.
Danish: Hvis du udvikler en af disse tilstande, vil din læge fortælle dig det og tage de nødvendige foranstaltninger for at behandle dem.
English: LEMTRADA is used if your MS is highly active despite that you have been treated with at least one other medicine for MS or if your MS is rapidly evolving.
Danish: LEMTRADA anvendes, hvis din MS er meget aktiv, på trods af, at du er blevet behandlet med mindst ét andet lægemiddel mod MS, eller hvis din MS udvikler sig hurtigt.
English: In 79.5% of cases, ITP onset occurred within 4 years after first exposure.
Danish: I 79,5% af tilfældene opstod ITP indenfor 4 år efter første eksponering.
English: Talk to your doctor if you are thinking about trying to become pregnant.
Danish: Tal med lægen, hvis du planlægger at forsøge at blive gravid.
English: Adverse reactions are listed by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT).
Danish: Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) og Preferred Term (PT).
English: Summary of the safety profile in clinical studies
Danish: Oversigt over sikkerhedsprofilen i kliniske studier
English: These tests are done to see whether you may take LEMTRADA.
Danish: Disse prøver tages for at kontrollere, om du kan få LEMTRADA.
English: The symptoms you experience are determined by which part of your central nervous system is affected.
Danish: De symptomer, du oplever, varierer afhængigt af, hvilken del af centralnervesystemet der er påvirket.
English: • It is extremely important that your patient understands the commitment to having periodic testing performed (for 4 years after last infusion) even if they are asymptomatic and their MS disease is well controlled.
Danish: • Det er yderst vigtigt, at din patient forstår nødvendigheden af de regelmæssige prøver, der skal tages, (i 4 år efter den sidste infusion) også selv om, de er asymptomatiske, og deres MS-sygdom er velkontrolleret.
English: Read all of this leaflet carefully before you are administered this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: No characteristics at study entry identified patients who would later receive one or more additional courses.
Danish: Ingen karakteristika ved studieindgang identificerede patienter, der senere ville modtage et eller flere yderligere behandlingsforløb.
English: When you have medical treatment, even if it is not for your MS, show the Patient Alert Card to the doctor.
Danish: Når du går til lægen, også selv om det ikke er for din MS, skal du vise patientkortet til lægen.
English: From a microbiological point of view, it is recommended that the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt anbefales det, at produktet anvendes øjeblikkeligt.
English: CB9 8PU United Kingdom
Danish: CB9 8PU Storbritannien
English: Baseline characteristics
Danish: Baseline karakteristika
English: Listeria infection can cause serious illness, including meningitis, but can be treated with appropriate medicines.
Danish: Listeriainfektion kan forårsage alvorlig sygdom, herunder meningitis, men kan behandles med passende medicin.
English: However, research suggests immunomodulatory effects through the depletion and repopulation of lymphocytes, including:
Danish: Forskning tyder dog på immunmodulerende effekter via depletion og repopulation af lymfocytter, herunder:
English: This medicinal product must not be diluted with other solvents.
Danish: Dette lægemiddel må ikke fortyndes med andre opløsningsmidler.
English: LEMTRADA does not cure MS, but it can reduce the number of MS relapses.
Danish: LEMTRADA helbreder ikke MS, men kan nedsætte antallet af attakker.
English: • LEMTRADA Training Module
Danish: • LEMTRADA træningsmodul
English: Safety profile in long-term follow-up
Danish: Sikkerhedsprofil i langsigtet opfølgning
English: If you have been diagnosed with cancer in the past, please inform your doctor about it.
Danish: Hvis du tidligere har fået diagnosen cancer, skal du informere din læge om det.
English: Missed doses should not be given on the same day as a scheduled dose.
Danish: Manglende doser bør ikke gives på samme dag som en planlagt dosis.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports (PSURSs)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: For these reasons, comparison of the incidence of antibodies to LEMTRADA with the incidence of antibodies to other products may be misleading.
Danish: Af disse årsager kan en sammenligning af forekomst af antistoffer mod LEMTRADA med forekomst af antistoffer mod andre produkter være misvisende.
English: These improvements were subsequently maintained, but no firm conclusions can be made with regards to the longer-term efficacy (e.g. 3 and 4 years after additional treatment courses) because many patients completed the study before reaching these time points.
Danish: Disse forbedringer blev efterfølgende opretholdt, men der kan ikke fastslås konkrete konklusioner med hensyn til den langsigtede effekt (fx 3 og 4 år efter yderligere behandlingsforløb), fordi mange patienter gennemførte studiet, inden de nåede disse tidspunkter.
English: Your doctor will monitor vital signs, including blood pressure, before and during the infusion.
Danish: Din læge vil overvåge dine livsvigtige funktioner, herunder blodtryk, før og under infusionen.
English: The study provides efficacy and safety through a median of 6 years from entry into Studies 1 and 2.
Danish: Studiet viser effekt og sikkerhed gennem en median på 6 år fra indgangen til studierne 1 og 2.
English: Before initiation of therapy, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection, according to local guidelines.
Danish: Inden behandlingen startes, skal alle patienter evalueres for både aktiv og inaktiv ("latent") tuberkuloseinfektion i henhold til lokale retningslinjer.
English: (additional test to diagnose kidney disorders)
Danish: (yderligere prøve for at diagnosticere nyrelidelser)
English: 1 Co-primary endpoints: ARR & CDW.
Danish: 1 Co-primære endepunkter: ARR og CDW.
English: Menorrhagia, menstruation irregular
Danish: Menorragi, uregelmæssig menstruation
English: CDI is a measure for sustained disability improvement.
Danish: CDI er et mål for forbedring i vedvarende funktionstab.
English: Fertility and reproduction
Danish: Fertilitet og reproduktion
English: The active substance is alemtuzumab.
Danish: Aktivt stof: alemtuzumab.
English: Each vial is intended for single use only.
Danish: Hvert hætteglas er kun beregnet til engangsbrug.
English: Results for Studies 1 and 2 are shown in Table 3.
Danish: Resultaterne for studie 1 og 2 er vist i tabel 3.
English: The incidence of antibodies is highly dependent on the sensitivity and specificity of the assay.
Danish: Forekomsten af antistoffer afhænger i høj grad af analysens følsomhed og specificitet.
English: LEMTRADA is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.
Danish: LEMTRADA er ikke beregnet til brug hos børn og unge under 18 år, da det ikke er blevet undersøgt hos MS-patienter under 18 år.
English: Figure 1: Time to 6 Month Confirmed Disability Worsening in Study 2
Danish: Figur 1: Tid til 6-måneders bekræftet funktionstabs forværring i Studie 2
English: Follow-up month
Danish: Opfølgningsmåned
English: Conclusions cannot be made with available data on the effect of race and gender on the pharmacokinetics of alemtuzumab.
Danish: Der kan ikke træffes nogen konklusioner ud fra de tilgængelige data vedrørende effekten af race eller køn på alemtuzumabs farmakokinetik.
English: LEMTRADA should be administered during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: LEMTRADA bør kun ordineres under graviditet, hvis de potentielle fordele berettiger den potentielle risiko for fostret.
English: Urine test
Danish: Urinprøve
English: Nevertheless, please note that in case of missed dose, this should not be given on the same day as a scheduled dose.
Danish: Bemærk dog, at i tilfælde af en glemt dosis bør denne ikke gives samme dag som en planlagt dosis.
English: LEMTRADA must be diluted before infusion.
Danish: LEMTRADA skal fortyndes før infusion.
English: The safety and efficacy of LEMTRADA in children with MS aged 0 to 18 years have not yet been established.
Danish: LEMTRADAs sikkerhed og virkning hos børn i alderen 0 til 18 år med MS er endnu ikke klarlagt.
English: The pharmacokinetics of alemtuzumab in RRMS has not been studied in patients aged 55 years and older.
Danish: Farmakokinetikken af alemtuzumab i RRMS er ikke blevet undersøgt hos patienter i alderen 55 år og derover.
English: Study design
Danish: Studiedesign
English: • In case of a severe adverse event
Danish: • I tilfælde af en alvorlig bivirkning
English: All of these serious side effects can start many years after you have received LEMTRADA.
Danish: Alle disse alvorlige bivirkninger kan dukke op mange år efter, du har fået LEMTRADA.
English: Tell your doctor right away if you have any of these signs of infection
Danish: Fortæl det straks til din læge, hvis du mærker nogle af disse tegn på infektion
English: Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem Belgium
Danish: Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem Belgien
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: Recommended laboratory tests for monitoring patients
Danish: Anbefalede laboratorietest til monitorering af patienter
English: Clinical studies did not include any patients aged over 61 years old.
Danish: Kliniske studier med LEMTRADA omfattede ikke patienter over 61 år.
English: The following information is intended for healthcare professionals only: Information on risk minimisation - autoimmune conditions
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Oplysninger om risikominimering - autoimmune tilstande
English: Complete blood count results (see above under ITP) should be used to monitor for cytopenias, including neutropenia.
Danish: Resultaterne fra komplette blodtællinger (se ovenfor under ITP) skal bruges til at undersøge for cytopenier, inklusive neutropeni.
English: In most cases these are mild but some serious reactions are possible.
Danish: I de fleste tilfælde er disse lette, men visse alvorlige reaktioner kan forekomme.
English: The damage done to your nerves during this inflammation may be reversible, but as your disease progresses the damage may accumulate and become permanent.
Danish: Den beskadigelse af nerverne, der sker på grund af inflammationen, kan bedres, men efterhånden som sygdommen skrider frem, kan skaderne akkumulere og blive permanente.
English: • abnormally heavy, prolonged or irregular menstruation
Danish: • unormalt kraftig, langvarig eller uregelmæssig menstruation
English: Patients who participated in CAMMS223, CAMMS323, or CAMMS32400507 (see baseline characteristics above)
Danish: Patienter, der deltog i CAMMS223, CAMMS323 eller CAMMS32400507 (se baseline karakteristika ovenfor)
English: • infection due to a virus known as Epstein-Barr virus
Danish: • infektion der skyldes en virus ved navn Epstein-Barr-Virus
English: Pack size: carton with 1 vial.
Danish: Pakningsstørrelse: karton med 1 hætteglas.
English: The number of normal sperm was significantly reduced (<10%) relative to controls and the percent abnormal sperm (detached heads or no heads) were significantly increased (up to 3%).
Danish: Antallet af normale sædceller var signifikant reduceret (< 10%) i forhold til kontroller, og den procentvise andel af unormale sædceller (adskilte hoveder eller ingen hoveder) var signifikant forøget (op til 3%).
English: The reduction in the level of circulating B and T cells by LEMTRADA and subsequent repopulation, may reduce the potential for relapse, which ultimately delays disease progression.
Danish: Reduktion i niveauet af cirkulerende B- og T-celler via LEMTRADA og efterfølgende repopulation kan reducere potentialet for attakker, hvilket i sidste ende forsinker sygdomsudviklingen.
English: Besides LEMTRADA, there are other treatments (including those for MS, or to treat other conditions) which could affect your immune system and so could affect your ability to fight infections.
Danish: Ud over LEMTRADA er der andre behandlinger (herunder til behandling af MS eller andre tilstande), der kan påvirke dit immunsystem og dermed din evne til at bekæmpe infektioner.
English: It can also lead to damage of your lungs, which can result in coughing up blood.
Danish: Det kan også føre til lungeskader, der kan resultere i, at du hoster blod op.
English: Initial treatment of 2 courses:
Danish: 2 indledende behandlingsforløb:
English: During your treatment course and for 4 months afterwards, you may have LEMTRADA in your body.
Danish: Under selve behandlingen og i 4 måneder derefter kan du have LEMTRADA i kroppen.
English: These additional treatment courses may be adminisitered twelve months or more after the prior treatments.
Danish: Disse yderligere behandlingsforløb kan administreres tolv måneder eller længere efter de tidligere behandlinger.
English: To allow for the full effect of the VZV vaccination to occur, treatment with LEMTRADA should be postponed for 6 weeks following vaccination.
Danish: For at opnå den fulde effekt af VZV-vaccinen bør man udskyde behandlingen med LEMTRADA i 6 uger efter vaccination.
English: HR: 0.58 p-value: 0.0084
Danish: HR: 0,58 p-værdi: 0,0084
English: It is unknown whether alemtuzumab is excreted in human milk.
Danish: Der vides ikke, om alemtuzumab udskilles i human mælk.
English: Change from Baseline in EDSS at Year 23 (95% CI)
Danish: Ændring fra baseline i EDSS ved år 23 (95% CI)
English: 4.5/3.8 years
Danish: 4,5/3,8 år
English: Both cases were serious, were identified early through clinical and laboratory monitoring, and had a positive outcome after treatment.
Danish: Begge tilfælde var alvorlige, de blev identificeret tidligt via klinisk monitorering og laboratoriekontrol, og begge tilfælde reagerede positivt på behandling.
English: Show the Patient Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Danish: Vis Patientkortet og denne indlægsseddel til alle læger, der behandler dig, ikke kun til din neurolog.
English: There is a limited amount of data from the use of alemtuzumab in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af alemtuzumab til gravide kvinder.
English: This analysis includes data from Phase 3 studies only (CAMMS324 and CAMMS323) due to differences in the MRI acquisition algorithms between the Phase 2 and Phase 3 studies.
Danish: Denne analyse indbefatter udelukkende data fra fase 3-studier (CAMMS324 og CAMMS323) på grund af forskelle i algoritmerne for MR-optagelserne mellem fase 2- og fase 3-studierne.
English: CD3+ and CD4+ lymphocyte counts rise more slowly towards normal, but generally do not return to baseline by 12months post-treatment.
Danish: CD3+- og CD4+-lymfocyttal stiger langsommere mod normalen, men er generelt ikke vendt tilbage til baseline ved 12-måneders postbehandling.
English: Patients with other concomitant autoimmune diseases (besides MS).
Danish: Patienter med andre samtidige autoimmune sygdomme (ud over MS).
English: ‡ Study primary endpoint was scored at 3 years.
Danish: ‡ Studiets primære endepunkt blev nået efter 3 år.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (including any vaccinations or herbal medecines).
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig (herunder også eventuelle vaccinationer eller naturlægemidler).
English: There are no adequate clinical safety data on the effect of LEMTRADA on fertility.
Danish: Der er ikke tilstrækkelige kliniske sikkerhedsdata om LEMTRADAs effekt på fertilitet.
English: Doses higher than the recommended dose may result in more serious or longer lasting infusion reactions (see section 4) or a stronger effect on the immune system.
Danish: Doser, der er højere end den anbefalede dosis, kan resultere i alvorligere eller længerevarende infusionsreaktioner (se punkt 4) eller en kraftigere indvirkning på immunsystemet.
English: It is very important that you are properly treated for a thyroid disorder, especially if you become pregnant after using LEMTRADA.
Danish: Det er meget vigtigt, at du får den rette behandling for en skjoldbruskkirtel-lidelse, især hvis du bliver gravid efter behandlingen med LEMTRADA.
English: Infections were generally of typical duration and resolved following conventional medical treatment.
Danish: Infektionerne var typisk af normal varighed og blev afhjulpet via konventionel medicinsk behandling.
English: This must be diagnosed and treated early, as otherwise the effects can be serious or even fatal.
Danish: ITP skal diagnosticeres og behandles så hurtigt som muligt, da tilstanden ellers kan blive alvorlig eller ligefrem dødelig.
English: If you cannot reach your doctor, you must seek immediate medical attention.
Danish: Hvis du ikke kan få fat på din egen læge, skal du straks søge anden lægehjælp.
English: The autoimmune conditions can occur many years after treatment with LEMTRADA.
Danish: De autoimmune tilstande kan opstå mange år efter behandlingen med LEMTRADA.
English: These tests must continue until 4 years after your last infusion and are described in section 4 most important side-effects.
Danish: Disse prøver skal fortsætte indtil 4 år efter den sidste infusion og er beskrevet under punkt 4 - de vigtigste bivirkninger.
English: It is not known whether alemtuzumab can cause foetal harm when administered to pregnant women or whether it can affect reproductive capacity.
Danish: Det vides ikke, om alemtuzumab kan medføre fosterskader, når det ordineres til gravide kvinder, eller om det kan påvirke reproduktionsevnen.
English: Alemtuzumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes.
Danish: Alemtuzumab er et protein, hvor den forventede metaboliseringsvej er nedbrydning til små peptider og individuelle aminosyrer via vidt udbredte proteolytiske enzymer.
English: • If non-compliant, patients may need further counseling to highlight the risks of missing scheduled monitoring tests.
Danish: • Patienter, der har problemer med at overholde disse aftaler, kan behøve yderligere rådgivning for at understrege de risici, der er forbundet med ikke at møde op til planlagte prøvetagninger.
English: • polysorbate 80 (E433)
Danish: • polysorbat 80 (E433)
English: Frequencies are defined according to the following convention: 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); not known (cannot be estimated from the available data).
Danish: Hyppigheder er defineret i henhold til følgende inddeling: 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), meget sjælden (<
English: A “Frequently asked questions” section The prescriber checklist shall contain the following key messages: Lists of tests to be conducted for the initial screening of the patient Vaccination course to be completed 6 weeks before treatment
Danish: Et afsnit med "ofte stillede spørgsmål" Tjeklisten til den ordinerende læge skal indeholde følgende hovedpunkter: Liste over test, der skal udføres i forbindelse med den indledende screening af patienten Vaccinationsforløb, der skal være afsluttet 6 uger inden behandling
English: The type of adverse reactions including seriousness and severity observed in LEMTRADA treatment groups through all available follow-up including patients who received additional treatment courses were similar to those in the active-controlled studies.
Danish: Typen af bivirkninger, herunder alvorlighed og sværhedsgrad, der blev observeret hos LEMTRADAbehandlingsgrupper gennem al tilgængelig opfølgning, herunder patienter, der modtog yderligere behandlingsforløb, lignede dem i de aktivt kontrollerede studier.
English: As with other immunomodulating therapies, potential combined effects on the patient's immune system should be taken into account when considering administration of LEMTRADA.
Danish: Som med andre immunmodulerende behandlinger skal der tages højde for potentielle kombinerede virkninger på patientens immunsystem, når administration af LEMTRADA overvejes.
English: In order to reduce the chance of getting an infection, your doctor will check if other medicines you are taking might be affecting your immune system.
Danish: Med henblik på at reducere risikoen for at få en infektion vil lægen undersøge, om du tager andre lægemidler, der kan påvirke immunsystemet.
English: Patients who developed anti-alemtuzumab antibodies did so by 15 months from initial exposure.
Danish: Patienter, der udviklede antialemtuzumab-antistoffer, gjorde dette inden for 15 måneder efter den første eksponering.
English: Mean EDSS score at baseline
Danish: Gennemsnitlig EDSS-score ved baseline