FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no known antidote for alemtuzumab over dosage.
Danish: Der er ingen kendt antidot for overdosering af alemtuzumab.
English: However, there may be benefits of breast milk (which can help protect a baby from infections), so talk to your doctor if you are planning to breast-feed your baby.
Danish: Brystmælk har dog en række fordele (blandt andet kan den beskytte barnet mod infektioner), så du skal tale med din læge, hvis du planlægger at amme dit barn.
English: During post-marketing use, rare, serious, sometimes fatal and unpredictable adverse events from various organ systems have been reported.
Danish: Efter markedsføring er der rapporteret om sjældne, alvorlige og i visse tilfælde dødelige samt uforudsigelige bivirkninger i flere forskellige organsystemer.
English: Please refer to the LEMTRADA Patient Guide for more information about these events.
Danish: Der henvises til LEMTRADA patientvejledningen for yderligere oplysninger om disse hændelser.
English: Active and latent tuberculosis, including a few cases of disseminated tuberculosis, have been reported in 0.3% of the patients treated with LEMTRADA, most often in endemic regions.
Danish: Der er rapporteret aktiv og latent tuberkulose, herunder få tilfælde af dissemineret tuberkulose, hos 0,3% af de patienter, der blev behandlet med LEMTRADA, oftest i endemiske områder.
English: Follow-up after treatment with LEMTRADA
Danish: Opfølgning efter behandling med LEMTRADA
English: CD52 is known to be present in human and rodent reproductive tissues.
Danish: Det vides, at CD52 er til stede i reproduktivt væv hos mennesker og gnavere.
English: Another side effect is an increased risk of infections (see below for information on how often patients experience infections).
Danish: En anden væsentlig bivirkning er en øget risiko for infektioner (se herunder for oplysninger om, hvor ofte patienterne rammes af infektioner).
English: A clear, colourless to slightly yellow concentrate with pH 7.0 - 7.4.
Danish: Et klart, farveløst eller lysegult koncentrat med en pH-værdi på 7,0-7,4.
English: If you become pregnant after treatment with LEMTRADA and experience a thyroid dirorder during pregnancy, extra caution is needed.
Danish: Hvis du bliver gravid efter behandling med LEMTRADA, og du får en skjoldbruskkirtel-lidelse under graviditeten, er ekstra opmærksomhed nødvendig.
English: A risk to the suckling newborn/infant cannot be excluded.
Danish: Det kan ikke udelukkes, at der kan være en risiko for ammede nyfødte/spædbørn.
English: The initial treatment you will receive will consist of one infusion per day for 5 days (course 1) and one infusion per day for 3 days one year later (course 2).
Danish: Den indledende behandling du får vil bestå af én infusion hver dag i 5 dage (behandlingsforløb 1) og én infusion hver dag i 3 dage et år senere (behandlingsforløb 2).
English: Table 3: Key Clinical and MRI Endpoints from Studies 1 and 2 Study 1
Danish: Tabel 3: Vigtige kliniske og MRI-endepunkter fra studie 1 og 2 Studie 1
English: Lymphocytes repopulate over time with B-cell recovery usually completed within 6 months.
Danish: Lymfocytter repopuleres over tid, og B-cellegendannelse er normalt afsluttet inden for 6 måneder.
English: treatment as your doctor should delay the treatment until the infection is resolved.
Danish: behandlingen, da din læge skal udsætte behandlingen, indtil infektionen er helbredt.
English: In clinical trials, there were 2 cases of anti-GBM disease.
Danish: I kliniske studier blev der observeret 2 tilfælde af anti-GBM-sygdom.
English: Several of the patients reported were below 40 years of age and had no risk factors for ischemic heart disease.
Danish: Flere af de rapporterede tilfælde omfattede patienter under 40 år, som ikke havde risikofaktorer for iskæmisk hjertesygdom.
English: It was noted that in some of the patients, blood pressure and /or heart rate was temporarily abnormal during the infusion.
Danish: Hos nogle af patienterne blev det bemærket, at blodtryk og/eller puls var midlertidigt anormal i løbet af infusionen.
English: It is not known if LEMTRADA affects your response to a vaccine.
Danish: Det vides ikke, om LEMTRADA påvirker den måde, hvorpå du reagerer på en vaccine.
English: • During infusion: o Perform continuous/frequent (at least every hour) monitoring of heart rate, blood pressure and overall clinical status of the patients Discontinue the infusion
Danish: • Under infusion: o Foretag løbende/hyppig (mindst én gang i timen) monitorering af puls, blodtryk og patientens overordnede kliniske status Afbryd infusionen:
English: LEMTRADA is not recommended for patients with inactive disease or those stable on current therapy.
Danish: LEMTRADA anbefales ikke til patienter med inaktiv sygdom eller til patienter, som er stabile på den nuværende behandling.
English: It is not currently known if LEMTRADA confers a higher risk for developing thyroid malignancies, since thyroid autoimmunity may itself be a risk factor for thyroid malignancies.
Danish: På nuværende tidspunkt vides det ikke, om LEMTRADA udgør en højere risiko for udvikling af tyreoide maligniteter, da tyreoid autoimmunitet i sig selv kan udgøre en risikofaktor for tyreoide maligniteter.
English: LEMTRADA has not been administered for treatment of MS concomitantly with or following antineoplastic or immunosuppressive therapies.
Danish: LEMTRADA har ikke været administreret til behandling af MS samtidig med eller efter behandling med antineoplastiske eller immunsupprimerende lægemidler.
English: HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation.
Danish: HLH er et livstruende syndrom med patologisk immunaktivering, som er kendetegnet ved kliniske tegn og symptomer på ekstrem systemisk inflammation.
English: There is no relevant use of alemtuzumab in children aged from birth to less than 10 years for the treatment of multiple sclerosis.
Danish: Det er ikke relevant at anvende alemtuzumab til børn i alderen fra fødslen til under 10 år til behandling af multipel sclerose.
English: Your doctor will explain to you how LEMTRADA will be given.
Danish: Din læge vil forklare dig, hvordan LEMTRADA skal gives.
English: LEMTRADA has minor influence on the ability to drive and use machines.
Danish: LEMTRADA påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: It was often self-limiting and relatively mild, although severity and outcome was unknown in many cases.
Danish: Trombocytopenien var ofte selvbegrænsende og relativt let, om end sværhedsgraden og udfaldet i mange tilfælde var ukendt.
English: Reactions attributed to anaphylaxis have been reported rarely in contrast to infusion associated reactions.
Danish: Reaktioner, der henføres til anafylaksi, er kun sjældent blevet indberettet, i modsætning til infusionsrelaterede reaktioner.
English: Once you have received LEMTRADA, you will need to undergo regular tests to ensure that any potential side effects can be diagnosed and treated promptly.
Danish: Så snart du har fået LEMTRADA, skal du med regelmæssige mellemrum have taget prøver for at sikre, at eventuelle bivirkninger opdages og behandles korrekt.
English: Patients and physicians should be made aware of the potential later onset of autoimmune disorders after the 48 months monitoring period.
Danish: Patienter og læger skal være opmærksomme på potentiel senere opståen af autoimmune lidelser efter monitoreringsperioden på 48 måneder.
English: Other treatments to limit these reactions can also be given before the infusion or when you experience symptoms.
Danish: Der kan også gives anden behandling for at mindske reaktionerne enten før infusionen, eller når du får symptomer.
English: The rate of thyroid adverse reactions was highest in year three and declined thereafter.
Danish: Hyppigheden af thyreoideabivirkninger var højest i år 3 og aftog derefter.
English: In some patients there was increased blood pressure from baseline before the haemorrhage.
Danish: Hos nogle af patienterne sås forhøjet blodtryk fra baseline forud for blødningen.
English: It is not known if LEMTRADA will have an effect on fertility during this period.
Danish: Det vides ikke, om LEMTRADA påvirker frugtbarheden i denne periode.
English: In the majority of cases reactions occurred within 1-3 days of the infusion.
Danish: I størstedelen af tilfældene opstod reaktionerne inden for 1-3 dage efter infusionen.
English: 91.8% of the patients treated with LEMTRADA 12 mg in Studies 1 and 2 entered Study 4.
Danish: 91,8% af patienterne behandlet med LEMTRADA 12 mg i studie 1 og 2 indgik i studie 4.
English: Reactions may occur following any of the doses during the treatment course.
Danish: Reaktionerne kan opstå efter en hvilken som helst dosis i behandlingsforløbet.
English: Serum concentrations were low or undetectable within approximately 30 days following each treatment course.
Danish: Serumkoncentrationerne var lave eller ikke-detekterbare inden for ca. 30 dage efter hvert behandlingsforløb.
English: • tuberculosis
Danish: • tuberkulose
English: Study 3 (phase 2 study CAMMS223) evaluated the safety and efficacy of LEMTRADA in patients with RRMS over the course of 3 years.
Danish: Studie 3 (fase 2-studie CAMMS223) evaluerede LEMTRADAs sikkerhed og virkning hos patienter med RRMS i mere end 3 år.
English: In most cases, these are mild but serious infections can occur.
Danish: I de fleste tilfælde er disse lette, men alvorlige infektioner kan forekomme.
English: • Pre-infusion evaluations: o Obtain a baseline ECG and vital signs, including heart rate and blood pressure measurement.
Danish: • Undersøgelser før infusion: o Foretag baseline-EKG og mål vitale tegn, inklusive måling af puls og blodtryk.
English: In addition, you will be monitored during the infusion and for 2 hours after the infusion has been completed.
Danish: Desuden vil du blive overvåget under infusionen og i 2 timer efter afslutningen af infusionen.
English: It is associated with high mortality rates if not recognized early and treated.
Danish: Det er associeret med høj dødelighed, hvis det ikke opdages tidligt og behandles.
English: Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of infusion associated reactions, but would tend to be more severe or potentially life-threatening.
Danish: Kliniske manifestationer af anafylaksi kan synes at svare til de kliniske manifestationer af infusionsrelaterede reaktioner, men vil normalt være alvorligere eller potentielt livstruende.
English: Treatment consists of discontinuation of the medicinal product and supportive therapy.
Danish: Behandling består af seponering af lægemidlet og understøttende behandling.
English: Most patients were treated conservatively with antibiotics and recovered without surgical intervention, whereas others underwent cholecystectomy.
Danish: De fleste patienter blev behandlet konservativt med antibiotika og kom sig uden kirurgisk indgreb, mens andre gennemgik cholecystektomi.
English: o Kidney disease (such as anti-GBM disease)
Danish: o Nyrelidelse (som f.eks. anti-GBM-sygdom)
English: Additional follow-up provided data through a median of 4.8 years (maximum 6.7).
Danish: Yderligere opfølgning gav data gennem en median på 4,8 år (maks.
English: Time to onset of symptoms ranged from less than 24 hours to 2 months after LEMTRADA infusion.
Danish: Tid til indtræden af symptomer varierede fra mindre end 24 timer til 2 måneder efter infusion af LEMTRADA.
English: E339, disodium edetate, E508, E340, E433, sodium chloride, water for injections
Danish: E339, dinatriumedetat, E508, E340, E433, natriumchlorid, vand til injektionsvæske
English: Lymphopenia, leukopenia, including neutropenia
Danish: Lymfopeni, leukopeni inklusive neutropeni
English: Information from use of alemtuzumab prior to the marketing authorisation of LEMTRADA outside of company-sponsored studies
Danish: Information fra brug af alemtuzumab uden for firmasponsorerede studier før udstedelse af markedsføringstilladelse til LEMTRADA
English: The frequency of PML in BCLL patients treated with alemtuzumab is no greater than the background frequency.
Danish: Hyppigheden af PML hos B-CLLpatienter behandlet med alemtuzumab er ikke højere end baggrundshyppigheden.
English: • You should monitor their test results and remain vigilant for symptoms of adverse events.
Danish: • Du skal overvåge analyseresultaterne og være på vagt over for symptomer på bivirkninger.
English: Reported cases of temporally associated events were not related to anti-GBM disease (Goodpasteurs syndrome).
Danish: De rapporterede tilfælde af midlertidigt associerede bivirkninger var ikke relateret til anti-GBM-sygdom (Goodpastures syndrom).
English: Read the summary of product characteristics (available at the EMA website mentioned above) for more information.
Danish: Læs produktresuméet (findes på EMAs hjemmeside, anført herover) for yderligere oplysninger.
English: Most cases occurred within the first month after treatment with LEMTRADA.
Danish: De fleste tilfælde forekom inden for den første måned efter behandling med LEMTRADA.
English: Doses of LEMTRADA greater than those tested in clinical studies may increase the intensity and/or duration of infusion-associated adverse reactions or its immune effects.
Danish: Højere LEMTRADA-doser end dem, som er testet i kliniske studier, kan øge intensiteten og/eller varigheden af infusionsrelaterede bivirkninger eller dets immuneffekter.
English: LEMTRADA depletes circulating T and B lymphocytes after each treatment course with the lowest observed values occurring 1 month after a course of treatment (the earliest post-treatment time point in phase 3 studies).
Danish: LEMTRADA depleterer cirkulerende T- og B-lymfocytter efter hvert behandlingsforløb med de lavest observerede værdier 1 måned efter et behandlingsforløb (det tidligste postbehandlingstidspunkt i fase-3studier).
English: Time to onset of CDI was defined as a decrease of at least one point on the EDSS from a baseline EDSS score ≥ 2 that was sustained for at least 6 months.
Danish: Tid til indtruffet CDI blev defineret som en reduktion på mindst et point på EDSS fra en baseline EDSSscore ≥ 2, der blev fastholdt i mindst 6 måneder.
English: Serum concentrations increased with each consecutive dose within a treatment course, with the highest observed concentrations occurring following the last infusion of a treatment course.
Danish: Serumkoncentrationen blev forøget for hver dosis i et behandlingsforløb, hvor de højeste observerede koncentrationer opstod efter den sidste infusion i et behandlingsforløb.
English: Human Immunodeficiency Virus (HIV) infection.
Danish: HIV (humant immundefektvirus) -infektion.
English: Patients with severe active infection until complete resolution.
Danish: Patienter med alvorlig aktiv infektion indtil fuld remission.
English: What you need to know before you are administered LEMTRADA 3.
Danish: Det skal du vide, før du får LEMTRADA 3.
English: Data reflect the percentage of patients whose test results were considered positive for antibodies to alemtuzumab using an enzyme-linked immunosorbent assay (ELISA) and confirmed by a competitive binding assay.
Danish: Data afspejler den procentdel af patienter, hvis testresultater blev betragtet som værende positive for antistoffer mod alemtuzumab vha. en enzymkoblet immunadsorptionsanalyse (ELISA) og bekræftet ved kompetitiv bindingsteknik.
English: • It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination.
Danish: • Det anbefales, at produktet anvendes umiddelbart efter fortynding på grund af den mulige risiko for mikrobiel forurening.
English: The bag should be inverted gently to mix the solution.
Danish: Posen skal vendes forsigtigt for at blande opløsningen.
English: The ability to generate an immune response to any vaccine following LEMTRADA treatment has not been studied.
Danish: Evnen til at udvikle immunrespons på en vaccine efter behandling med LEMTRADA er ikke undersøgt.
English: To assist in the education of patients regarding potential side-effects and instructions on what to do in case of certain side-effects, the following risk minimisation materials are available:
Danish: Som en hjælp til oplysning af patienter om mulige bivirkninger og vejledning i, hvad der skal gøres i tilfælde af visse bivirkninger, findes følgende materialer vedr.
English: It is recommended that HPV screening be completed annually for female patients.
Danish: Det anbefales, at kvindelige patienter screenes for HPV en gang om året.
English: Therefore, it is recommended that all female patients have an annual screening performed, such as a cervical smear.
Danish: Derfor anbefales det, at alle kvindelige patienter screenes hvert år, f.eks. i form af et skrab (smear) fra livmoderhalsen.
English: Listeriosis/Listeria meningitis has been reported in LEMTRADA treated patients, generally within one month of LEMTRADA infusion.
Danish: Der er rapporteret Listeriose/Listeria meningitis hos patienter, der blev behandlet med LEMTRADA, generelt inden for en måned efter LEMTRADA-infusion.
English: Therefore, regardless of pretreatment anti-TPO antibody status patients may develop a thyroid adverse reaction and must have all tests periodically performed as described above.
Danish: Derfor kan en patient, uanset anti-TPOantistofstatus før behandlingen, udvikle en thyreoidea-relateret bivirkning og skal derfor periodisk have foretaget alle de ovenfor beskrevne analyser.
English: Patients who develop early manifestations of pathologic immune activation should be evaluated immediately, and a diagnosis of HLH should be considered.
Danish: Patienter, der udvikler tidlige symptomer på patologisk immunaktivering, bør omgående evalueres og en diagnose med HLH bør tages i betragtning.
English: It is recommended that your doctor prescribes a medicine to reduce the chance of developing a herpes infection, which should be taken on the days that you receive LEMTRADA treatment, and for one month following the treatment.
Danish: Det anbefales, at lægen ordinerer medicin med henblik på at nedsætte risikoen for at udvikle en herpesinfektion; du skal tage medicinen på de dage, hvor du får LEMTRADA, og i en måned efter behandlingen.
English: If you are using such a medicine, your doctor may ask you to stop this medicine before starting treatment with LEMTRADA.
Danish: Hvis du bruger en sådan medicin, kan lægen bede dig om at holde op med det, før du starter behandlingen med LEMTRADA.
English: Summary of tests you will have for autoimmune conditions: Test
Danish: Oversigt over prøver for autoimmune tilstande: Prøve
English: If severe infusion reactions occur, the intravenous infusion should be discontinued immediately.
Danish: I tilfælde af alvorlige infusionsreaktioner skal infusionen straks afbrydes.
English: Without treatment of hypothyroidism during pregnancy, there is an increased risk for miscarriage and foetal effects such as mental retardation and dwarfism.
Danish: Hvis hypotyreose ikke behandles under graviditet, er der en øget risiko for abort og fosterskader, f.eks. mental retardering og dværgvækst.
English: SANOFI BULGARIA EOOD
Danish: SANOFI BULGARIA EOOD Тел.
English: Concomitant use of LEMTRADA with any of these therapies could increase the risk of immunosuppression.
Danish: Brug af LEMTRADA samtidig med nogen af disse behandlinger kan øge risikoen for immunsuppression.
English: • feelings of anxiety, depression
Danish: • angstfølelse, depression
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 8 hours at 2°C - 8°C, under protection from light.
Danish: Hvis det ikke anvendes øjeblikkeligt, er opbevaringstider og -forhold før brug brugerens ansvar og bør ikke være længere end 8 timer ved 2 °C - 8 °C, beskyttet mod lys.
English: Patients receiving LEMTRADA should be instructed to report symptoms of infections to a physician.
Danish: Patienter, der får LEMTRADA skal instrueres i at rapportere symptomer på infektioner til en læge.
English: High titer anti-alemtuzumab antibodies observed in some patients were associated with incomplete lymphocyte depletion following a third or fourth treatment course, but there was no clear impact of anti-alemtuzumab antibodies on the clinical efficacy or safety profile of LEMTRADA.
Danish: Højtiter anti-alemtuzumab antistoffer observeret hos nogle patienter var forbundet med ufuldstændig lymfocytudtømning efter et tredje eller fjerde behandlingsforløb, men der var ingen klar påvirkning af anti-alemtuzumab antistoffer på den kliniske effekt eller sikkerhedsprofil af LEMTRADA.
English: • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or
Danish: • Patienter med højaktiv sygdom trods et fuldstændigt og tilstrækkeligt behandlingsforløb med mindst én sygdomsmodificerende behandling (DMT) eller
English: Treatment- naïve patients
Danish: Behandlingsnaive patienter
English: If you are a carrier of hepatitis B or hepatitis C infection (these affect the liver), extra caution is needed before you receive LEMTRADA treatment as it is unknown if treatment could lead to activation of the hepatitis infection which could subsequently damage your liver.
Danish: Hvis du er bærer af en hepatitis B- eller hepatitis C-infektion (disse påvirker leveren), er det nødvendigt at udvise særlig forsigtighed, før du får LEMTRADA, da det ikke vides, om behandlingen kan føre til aktivering af hepatitisinfektionen, hvilket i så fald kan skade leveren.
English: No data are available on the association of LEMTRADA with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) reactivation as patients with evidence of active or chronic infections were excluded from clinical trials.
Danish: Der findes ingen data om en mulig forbindelse mellem LEMTRADA og reaktivering af Hepatitis B-virus (HBV) eller Hepatitis C-virus (HCV), da patienter med dokumenterede aktive eller kroniske infektioner blev ekskluderet fra de kliniske studier.
English: To try to reduce infusion reactions, your doctor will give you medicine (corticosteroids) before each of the first 3 infusions of a LEMTRADA course.
Danish: Med henblik på at mindske infusionsreaktionerne vil lægen give dig medicin (kortikosteroider) før hver af de første 3 infusioner i et behandlingsforløb med LEMTRADA.
English: This includes any possible side-effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: If it is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 8 hours at 2oC to 8oC, under protection from light.
Danish: Hvis det ikke anvendes øjeblikkeligt, er opbevaringstider og -forhold før anvendelse brugerens ansvar og bør ikke være længere end 8 timer ved 2 oC til 8 oC, beskyttet mod lys.
English: Severe anaphylaxis and other hypersensitivity reactions, including anaphylactic shock and angioedema have also been reported.
Danish: Alvorlige anafylaktiske reaktioner og andre overfølsomhedsreaktioner, herunder anafylaktisk chok og angioødem er også rapporteret.
English: Package leaflet: Information for the patient LEMTRADA 12 mg concentrate for solution for infusion alemtuzumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten LEMTRADA 12 mg koncentrat til infusionsvæske, opløsning alemtuzumab Dette lægemiddel er underlagt supplerende overvågning.
English: Information on preparing to administer LEMTRADA and patient monitoring
Danish: Oplysninger om klargøring forud for administration af LEMTRADA og om patientovervågning
English: SC IFNB-1a
Danish: Alemtuzumab SC IFNB-1a
English: Some patients have developed liver inflammation after receiving LEMTRADA.
Danish: Nogle patienter har udviklet leverbetændelse efter, de har fået LEMTRADA.