FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from clinical trials in MS has shown that adherence to the blood monitoring requirements and education relative to signs and symptoms of ITP has led to early detection and treatment of ITP with most cases responding to first-line medical therapy.
Danish: Data fra kliniske MS-studier har vist, at overholdelse af krav til blodprøvemonitorering og oplæring i tegn og symptomer på ITP har medført tidlig diagnosticering og behandling af ITP, hvor de fleste tilfælde reagerede positivt på medicinsk første-linje-behandling.
English: Uncontrolled, rater-blinded extension study
Danish: Ukontrolleret, rater-blindet forlængelsesstudie
English: 3 years‡
Danish: 3 år‡
English: Patients treated with LEMTRADA have had infections due to a virus called Epstein-Barr virus (EBV), including cases with severe liver inflammation.
Danish: Patienter, som behandles med LEMTRADA, har fået infektioner, der skyldes en virus ved navn EpsteinBarr-Virus (EBV), herunder alvorlige tilfælde af leverbetændelse.
English: Details about the signs and symptoms, testing, and actions you need to take are described in sections 2 and 4autoimmune conditions.
Danish: Du finder detaljerede oplysninger om tegn og symptomer, prøver og ting, du skal gøre, under punkt 2 og 4 - autoimmune tilstande.
English: In patients continuing from controlled clinical studies and who did not receive any additional LEMTRADA after the initial 2 treatment courses, the rate (events per person-year) of most adverse reactions was comparable to or reduced in years 3-6 as compared to years 1 and 2.
Danish: Hos patienter, der fortsatte fra kontrollerede kliniske studier, og som ikke modtog yderligere LEMTRADA efter de 2 initiale behandlingsforløb, var hyppigheden (hændelser pr. personår) af de fleste bivirkninger sammenlignelig med eller reduceret i år 3-6 sammenlignet med år 1 og 2.
English: In each year of Study 4, patients from both studies continued to show a low risk of forming new T2 (27.4% to 33.2%) or gadolinium-enhancing lesions (9.4% to 13.5%), and the median annual percent change in brain parenchymal fraction ranged from 0.19% to -0.09%.
Danish: Hvert år i studie 4 fortsatte patienter fra begge studier med at vise lav risiko for at danne nye T2 (27,4% til 33,2%) eller gadolinium-opladende læsioner (9,4% til 13,5%) og den gennemsnitlige årlige procentvise ændring i hjerneparenkymfraktionen varierede fra 0,19% til 0,09%.
English: • The vial contents should be inspected for particulate matter and discolouration prior to administration.
Danish: • Indholdet af hætteglasset skal undersøges for partikler og misfarvning før administration.
English: Clinical endpoints
Danish: Kliniske endepunkter
English: • kidney disorders, (rare - may affect up to 1 in 1,000 people): may show as blood in the urine (your urine may be red or tea-coloured), or as swelling in your legs or feet.
Danish: • nyrelidelser (sjælden - kan forekomme hos op til 1 ud af 1.000 personer): kan vise sig som blod i urinen (urinen er rød eller te-farvet) eller som hævede ben eller fødder.
English: Alemtuzumab binds to CD52, a cell surface antigen present at high levels on T (CD3+) and B (CD19+) lymphocytes, and at lower levels on natural killer cells, monocytes, and macrophages.
Danish: Alemtuzumab binder til CD52, som er et celleoverfladeantigen, der findes i høje niveauer på T- (CD3+) og B- (CD19+) lymfocytter og i lavere niveauer på natural killer(NK-) celler, monocytter og makrofager.
English: Having an untreated thyroid disorder could harm your unborn baby, or harm your baby after birth.
Danish: En ubehandlet skjoldbruskkirtel-lidelse kan skade fostret eller skade barnet efter fødslen.
English: Hypotension*, hypertension*
Danish: Ansigtsrødme* Hypotension*, hypertension*
English: Screening for tuberculosis will be arranged by your doctor.
Danish: Din læge sørger for screening for tuberkulose.
English: • Other medicinal products should not be added to the LEMTRADA infusion solution or simultaneously infused though the same intravenous line.
Danish: • Der må ikke tilsættes andre lægemidler til LEMTRADA-infusionsvæske, ligesom sådanne ikke må infunderes via den samme intravenøse slange.
English: Patients with new T1 hypointense lesions through Year 2
Danish: Patienter med nye T1-hypointense læsioner efter år 2
English: Observed autoimmune thyroid disorders included hyperthyroidism or hypothyroidism.
Danish: Observerede autoimmune thyreoidea-lidelser omfatter hypertyreose eller hypotyreose.
English: Before initiation of therapy, evaluation of immune serostatus could be considered according to local guidelines.
Danish: Før iværksættelse af behandlingen kan det overvejes at vurdere patientens serostatus i henhold til lokale retningslinjer.
English: If you develop a thyroid disorder, in most cases you will need to be treated for the rest of your life with medicines to control your thyroid disorder, and in some cases your thyroid gland may have to be removed.
Danish: Hvis du udvikler en skjoldbruskkirtel-lidelse, vil det i de fleste tilfælde være nødvendigt, at du får livslang behandling med medicin, der kan kontrollere lidelsen, og i visse tilfælde kan det være nødvendigt at fjerne skjoldbruskkirtlen.
English: Patients should be advised to report symptoms of pneumonitis, which may include shortness of breath, cough, wheezing, chest pain or tightness and hemoptysis.
Danish: Patienter bør rådes til at rapportere symptomer på pneumoni, som kan omfatte åndenød, hoste, hvæsen, brystsmerter eller tæthed og hæmoptyse.
English: • LEMTRADA Health Care Professional Guide
Danish: • LEMTRADA vejledning til sundhedspersonale
English: The patients should be educated on the potential for delayed onset of infusion associated reactions and instructed to report symptoms and seek appropriate medical care.
Danish: Patienterne skal oplyses om muligheden for forsinket indtræden afinfusionsrelaterede reaktioner og instrueres i at indberette symptomer og søge lægehjælp.
English: Terms marked with two asterisks (**) in Table 1 include adverse reactions observed in the post marketing setting which have occurred in the majority of cases with time to onset within 1-3 days of LEMTRADA infusion, following any of the doses during the treatment course.
Danish: Termer, der er markeret med to stjerner (**) i Tabel 1, omfatter bivirkninger, der er observeret efter markedsføring og som i størstedelen af tilfældene er opstået inden for 1-3 dage efter infusion af enhver dosis af LEMTRADA i løbet af behandlingsforløbet.
English: Alemtuzumab is an IgG1 kappa antibody with human variable framework and constant regions, and complementary-determining regions from a murine (rat) monoclonal antibody.
Danish: Alemtuzumab er et IgG1-kappa-antistof med human variabel struktur og konstante regioner samt komplementær-determinerende regioner fra et rottemonoklonalt antistof.
English: The percentage of patients with new or enlarging T2 lesions declined from 50.8% the year prior to Course 3 to 35.9% one year after, and new gadolinium-enhancing lesions from 32.2% to 11.9%.
Danish: Procentdelen af patienter med nye eller forstørrende T2-læsioner faldt fra 50,8% året før behandlingsforløb 3 til 35,9% et år efter og nye gadoliniumopladende læsioner fra 32,2% til 11,9%.
English: The cumulative annualised rate of infections was 0.99 through a median of 6.1 years (maximum 12 years) of follow-up from the first LEMTRADA exposure, as compared to 1.27 in controlled clinical trials.
Danish: Den kumulative årlige infektionshyppighed var 0,99 gennem en median på 6,1 år (maksimum 12 år) af opfølgningen fra den første LEMTRADA-eksponering sammenlignet med 1,27 i kontrollerede kliniske studier.
English: In MS your immune system mistakenly attacks the protective layer (myelin) around the nerve fibres, causing inflammation.
Danish: Ved MS angriber immunsystemet fejlagtigt det beskyttende lag (myelin), som omgiver nervefibrene, hvilket giver anledning til, at der opstår en betændelseslignende tilstand (inflammation).
English: irregular or abnormal heart beat, high blood pressure, impaired kidney function, white blood cells in urine
Danish: uregelmæssig eller unormal puls, højt blodtryk, nedsat nyrefunktion, hvide blodlegemer i urinen
English: Ask your doctor if you have any questions.
Danish: Spørg din læge, hvis der er noget, du er i tvivl om.
English: Median % Change in Brain Parenchymal Fraction
Danish: Median %-ændring i hjerneparenkymfraktion
English: After this period of time testing should be performed based on clinical findings suggestive of thyroid dysfunction or in case of pregnancy.
Danish: Efter denne periode skal der udføres analyser på basis af kliniske fund, der kan tyde på dysfunktion af thyreoidea eller i tilfælde af graviditet.
English: 2 Patient Guide:
Danish: 1 Patientkort:
English: • Complete baseline tests and screening as decribed in SmPC section 4.
Danish: • Udfør baseline-test og screening som beskrevet i produktresuméet pkt.
English: In clinical trials, 74% of patients with positive anti-thyroid peroxidase (anti-TPO) antibodies at baseline developed a thyroid event compared with 38% of patients with a baseline negative status.
Danish: I kliniske studier udviklede 74% af patienterne med positive anti-thyroidperoxidase (anti-TPO) antistoffer ved baseline en thyreoidea-relateret lidelse sammenlignet med 38% af patienterne med en negativ baseline status.
English: Infusion instructions to reduce serious reactions temporally associated with LEMTRADA infusion
Danish: Infusionsvejledning med henblik på at reducere alvorlige reaktioner tidsmæssigt associeret med infusion af LEMTRADA
English: Autoimmunity
Danish: Autoimmunitet
English: For intravenous administration, withdraw 1.2 ml of LEMTRADA from the vial into a syringe using aseptic technique.
Danish: Til intravenøs anvendelse skal der suges 1,2 ml LEMTRADA fra hætteglasset til en kanyle via en aseptisk teknik.
English: Acute acalculous cholecystitis is a condition that may be associated with high morbidity and mortality rates if not diagnosed early and treated.
Danish: Akut acalculøs cholecystitis er en tilstand, der kan være forbundet med høj morbiditet og mortalitet, hvis den ikke diagnosticeres tidligt og behandles.
English: If untreated it can cause kidney failure requiring dialysis or transplantation, and may lead to death.
Danish: Hvis sådanne lidelser ikke behandles, kan de føre til nyresvigt, der kræver dialyse eller transplantation, og være dødelige.
English: Cervical human papilloma virus (HPV) infection, including cervical dysplasia and anogenital warts, has also been reported in patients treated with LEMTRADA 12 mg (2%).
Danish: HPV-virusinfektion (human papilloma virus), herunder cervikal dysplasi og anogenitale vorter, blev også rapporteret hos patienter, der blev behandlet med LEMTRADA 12 mg (2%).
English: Anti-GBM disease may lead to renal failure requiring dialysis and/or transplantation if not treated rapidly and can be life-threatening if left untreated.
Danish: Anti-GBM-sygdom kan føre til dialysekrævende og/eller transplantationskrævende nyresvigt, hvis det ikke behandles hurtigt, og kan være livstruende, hvis det ikke behandles.
English: 2.0/1.6 years
Danish: 2/1,6 år
English: Commonly, patients have developed a bleeding disorder caused by a low level of blood platelets, called immune thrombocytopenic purpura (ITP).
Danish: Almindeligvis har patienter udviklet en blødningsforstyrrelse, der skyldes et lavt antal blodplader, og som kaldes primær immun-trombocytopeni (ITP).
English: See LEMTRADA Health Care Professional Guide for more information, or read the summary of product characteristics available at the EMA website mentioned above.
Danish: Der henvises til LEMTRADA vejledning til sundhedspersonale for yderligere oplysninger, eller læs produktresuméet, der findes på EMAs hjemmeside, anført herover.
English: Neutropenia Cases of severe (including fatal) neutropenia have been reported within 2 months of LEMTRADA infusion.
Danish: Der er rapporteret tilfælde af svær (inklusive tilfælde med dødelig udgang) neutropeni inden for 2 måneder efter infusion med LEMTRADA.
English: Some patients have had serious or life-threatening reactions after LEMTRADA infusion, including bleeding in the lung, heart attack, stroke or tears in blood vessels supplying the brain.
Danish: Nogle patienter har fået alvorlige eller livstruende reaktioner efter infusion med LEMTRADA, herunder blødning i lungerne, hjertetilfælde, slagtilfælde eller rifter i de blodkar, der forsyner hjernen med blod.
English: The vast majority (approximately 80%) of patients who presented with a thyroid event after treatment were anti-TPO antibody negative at baseline.
Danish: Langt den overvejende del (ca. 80%) af de patienter, der oplevede en thyreoidea-relateret lidelse efter behandlingen, var anti-TPO-antistofnegative ved baseline.
English: Treatment with LEMTRADA may increase the risk of excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis), which can be fatal if not diagnosed and treated early.
Danish: Behandling med LEMTRADA kan øge risikoen for overaktivering af de hvide blodlegemer i forbindelse med inflammation (hæmofagocytisk lymfohistiocytose), hvilket kan være dødeligt, hvis det ikke konstateres og behandles tidligt.
English: Your doctor will perform blood tests before you start treatment with LEMTRADA.
Danish: Din læge vil tage blodprøver, før din behandling med LEMTRADA sættes i gang.
English: The safety of immunisation with live viral vaccines following a course of LEMTRADA treatment has not been formally studied in controlled clinical trials in MS and should not be administered to MS patients who have recently received a course of LEMTRADA.
Danish: Sikkerheden ved immunisering med levende virale vacciner efter et behandlingsforløb med LEMTRADA er ikke undersøgt formelt i kontrollerede kliniske MS-studier, og levende virale vacciner bør ikke ordineres til MS-patienter, der for nyligt har gennemgået et behandlingsforløb med LEMTRADA.
English: Patients treated with LEMTRADA must be given the Package Leaflet, the Patient Alert Card and the Patient Guide.
Danish: Patienter, der behandles med LEMTRADA, skal have udleveret indlægssedlen, patientkortet og patientvejledningen.
English: Many patients experience side effects at the time of the infusion or within 24 hours after the infusion with LEMTRADA, and some of these, for example dizziness, could make it unsafe to drive or use machines.
Danish: Mange patienter oplever bivirkninger i forbindelse med infusion eller inden for 24 timer efter infusion af LEMTRADA, og nogle af disse kan gøre det usikkert at køre bil og betjene maskiner, for eksempel svimmelhed.
English: Tuberculosis has been reported for patients treated with LEMTRADA and IFNB-1a in controlled clinical trials.
Danish: Der er rapporteret tuberkulose hos patienter, der blev behandlet med LEMTRADA og IFNB-1a i kontrollerede kliniske studier.
English: Thyroid disorders could be harmful to the baby (see section 2 Warnings and precautions - autoimmune conditions).
Danish: Skjoldbruskkirtel-lidelser kan være skadelige for barnet (se punkt 2 - autoimmune tilstande).
English: Serious endocrine events occurred in 4.4% of patients, with Basedow's disease (also known as Graves' disease), hyperthyroidism, hypothyroidism, autoimmune thyroiditis, and goitre occurring in more than 1 patient.
Danish: Alvorlige endokrine tilfælde opstod hos 4,4% af patienterne, hvor Basedows sygdom (også kaldet Graves' sygdom), hypertyreose, hypotyreose, autoimmun thyroiditis, og struma blev observeret hos mere end 1 patient.
English: Uncommonly, patients have experienced autoimmune conditions involving red blood cells or white blood cells.
Danish: I nogle ualmindelige tilfælde har patienter oplevet autoimmune tilstande, der involverer de røde eller hvide blodlegemer.
English: Patients should be informed about the risk of autoimmune hepatitis, hepatic injury and related symptoms.
Danish: Patienten skal oplyses om risikoen for autoimmun hepatitis, leverskade og relaterede symptomer.
English: In controlled clinical studies, 0.2% of LEMTRADA-treated MS patients developed acute acalculous cholecystitis, compared to 0% of patients treated with INFB-1a.
Danish: I kontrollerede kliniske studier udviklede 0,2% af LEMTRADA-behandlede MS-patienter akut acalculøs cholecystitis sammenlignet med 0% af patienterne, der blev behandlet med INFB-1a.
English: Continue to test the patient every month for autoimmune conditions, until 4 years after last infusion.
Danish: Fortsæt med at tage prøver for autoimmune tilstande hver måned indtil 4 år efter sidste infusion.
English: • Infusion reactions
Danish: • Infusionsreaktioner
English: The European Medicines Agency has deferred the obligation to submit the results of studies with LEMTRADA in one or more subsets of the paediatric population in RRMS (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med LEMTRADA i en eller flere undergrupper af den pædiatriske population ved RRMS (se pkt.
English: Aspartate aminotransferase increased, alanine aminotransferase increase
Danish: Forhøjet aspartataminot ransferase, forhøjet alaninaminotra nsferase
English: Pneumonitis has been reported in patients who received LEMTRADA infusions.
Danish: Pneumoni er blevet rapporteret hos patienter, der fik LEMTRADA infusioner.
English: The diluted solution should be administered by intravenous infusion over a period of approximately 4 hours.
Danish: Den fortyndede opløsning skal administreres via intravenøs infusion over ca. 4 timer.
English: The therapy is recommended as an initial treatment of 2 courses with up to 2 additional treatment courses if needed (see posology) with safety follow-up of patients from initiation of the first treatment course and for at least 48 months after the last infusion of the second treatment course.
Danish: Behandlingen anbefales som en indledende behandling af 2 forløb med op til 2 yderligere behandlingsforløb efter behov (se dosering) med sikkerhedsopfølgning af patienten fra 1. behandlingsforløbs start og i mindst 48 måneder efter den sidste infusion i 2. behandlingsforløb.
English: There is no evidence that LEMTRADA has an impact on male fertility.
Danish: Der er ingen tegn på, at LEMTRADA påvirker fertiliteten hos mænd.
English: Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på yderpakningen og hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: o Platelet count should be obtained immediately after infusion on Days 3 and 5 of the first infusion course, as well as immediately after infusion on Day 3 of any subsequent course.
Danish: o Trombocyttallet skal måles umiddelbart efter infusionen på dag 3 og 5 i det første infusionsforløb samt umiddelbart efter infusionen på dag 3 i alle efterfølgende behandlingsforløb.
English: • Post-infusion: o Observation for infusion reactions is recommended for a minimum of 2 hours after LEMTRADA infusion.
Danish: • Efter infusion: o Det anbefales at observere for infusionsreaktioner i minimum 2 timer efter LEMTRADA infusion.
English: Resources for the management of cytokine release syndrome, hypersensitivity and/or anaphylactic reactions should be available.
Danish: Der skal være udstyr til rådighed til håndtering af cytokinfrigivelsessyndrom, overfølsomhedsreaktioner og/eller anafylaktiske reaktioner.
English: Patients who were accidentally given too much LEMTRADA in one infusion have experienced serious reactions, such as headache, rash, low blood pressure or increased heart rate.
Danish: Patienter, der ved et uheld fik for meget LEMTRADA i én infusion, oplevede alvorlige bivirkninger som f.eks. hovedpine, udslæt, lavt blodtryk eller hurtigere puls.
English: Infections with a virus called cytomegalovirus have been reported in patients treated with LEMTRADA.
Danish: Infektioner med en virus, der kaldes cytomegalovirus, er indberettet hos patienter, der blev behandlet med LEMTRADA.
English: Administer within 8 hours after dilution.
Danish: Anvendes senest 8 timer efter fortynding.
English: Initiation of treatment with LEMTRADA should be delayed in patients with severe active infection until resolution.
Danish: Behandlingsstart med LEMTRADA bør udsættes hos patienter med alvorlig aktiv infektion indtil infektionen er helbredt.
English: • Review the LEMTRADA Patient Guide and Package Leaflet with your patient.
Danish: • Gennemgå LEMTRADA patientvejledningen og indlægssedlen sammen med patienten.
English: Up to two additional treatment courses, as needed, may be considered (see section 5.1):
Danish: Op til to yderligere behandlingsforløb kan overvejes efter behov (se pkt.
English: Disability1 (Confirmed Disability Worsening [CDW] 2
Danish: Funktionstab1 (Bekræftet funktionstabs forværring [CDW]2 Patienter med 6 måneder
English: o Perform laboratory tests (complete blood count with differential, serum transaminases, serum creatinine, test of thyroid function and urinanalysis with microscopy).
Danish: Foretag laboratorietests (komplet blodtælling med differentialtælling, serumtransaminaser, serumkreatinin, kontrol af thyreoideafunktion og urinmikroskopi).
English: Rarely, patients have experienced autoimmune related problems with their kidneys, such as antiglomerular basement membrane disease (anti-GBM disease).
Danish: I sjældne tilfælde har patienter oplevet autoimmunrelaterede problemer med nyrerne, som f.eks. anti-glomerulær basalmembransygdom (anti-GBM sygdom).
English: Information about some specific conditions that have been seen in MS patients who have been treated with LEMTRADA is provided below.
Danish: I det følgende finder du oplysninger om visse specifikke tilstande, som er set hos MS-patienter, der har været behandlet med LEMTRADA.
English: An additional 12 serious events of ITP has been observed through a median of 6.1 years (maximum 12 years) of follow-up (cumulative annualised rate of 2.8 events/1000 patient years).
Danish: Yderligere 12 alvorlige hændelser af ITP er blevet observeret igennem en median af 6,1 års opfølgning (maksimum 12 år) (samlet 2,8 hændelser på årsbasis/1000 patientår).
English: • Together with your patient you need to plan and manage their periodic monitoring.
Danish: • Du skal planlægge denne periodiske overvågning sammen med patienten.
English: Patients with a history of angina pectoris or myocardial infarction.
Danish: Patienter med angina pectoris eller myokardieinfarkt i anamnesen.
English: These are the side effects that you may experience:
Danish: Du kan få følgende bivirkninger:
English: LEMTRADA 12 mg/day led to significantly lower EDSS scores (improved compared to baseline) through 2 years of follow up, compared with IFNB-1a (p<0.0001).
Danish: LEMTRADA12 mg/dag medførte signifikant lavere EDSSscorer (forbedring sammenlignet med baseline) 2 år efter opfølgning sammenlignet med IFNβ-1a (p <
English: Similar improvements in ARR, mean EDSS score, and T2 and gadolinium-enhancing lesions were seen after Course 4 when compared with the prior year.
Danish: Lignende forbedringer i ARR, gennemsnitlig EDSS score og T2 og gadolinium-opladende læsioner blev set efter behandlingsforløb 4 sammenlignet med det foregående år.
English: Other serious reactions temporally associated with LEMTRADA infusion
Danish: Andre alvorlige reaktioner tidsmæssigt associeret med infusion af LEMTRADA