natgillin/translations-raw huggingface dataset:
Der er rapporteret tilfælde af dissektion af cerebral arterie, inklusive flere dissektioner, både inden for de første dage efter infusion med LEMTRADA eller senere inden for den første måned efter infusionen.
Cases of cervicocephalic arterial dissections, including multiple dissections, have been reported both within the first days after the LEMTRADA infusion or later on within the first month after the infusion.
Patienter med utilstrækkelig respons på tidligere behandling*
Treatment-naïve patients Patients with inadequate response to prior therapy*
Alemtuzumab er et rekombinant DNA-afledt humaniseret monoklonalt antistof rettet mod 21-28 kD celleoverfladeglykoprotein CD52.
Alemtuzumab, is a recombinant DNA-derived humanised monoclonal antibody directed against the 21-28 kD cell surface glycoprotein CD52.
Det anbefales, at patienten præmedicineres for at mindske virkningen af de infusionsrelaterede reaktioner (se pkt.
It is recommended that patients be premedicated to ameliorate the effects of infusion reactions (see section
Lægen vil også sikre sig, at du ikke lider af visse sygdomme eller lidelser, før din behandling med LEMTRADA sættes i gang.
Your doctor will also want to make sure that you do not have certain medical conditions or disorders before you start your treatment with LEMTRADA.
Det anbefales, at det fortyndede produkt anvendes øjeblikkeligt.
It is recommended that the diluted product be administered immediately.
Data for langtidseffekt
Long-term efficacy data
• lidelser, der involverer de røde og hvide blodlegemer (ikke almindelig - kan forekomme hos op til 1 ud af 100 personer), og som diagnosticeres ved hjælp af blodprøver.
• red and white blood cells disorders (uncommon - may affect up to 1 in 100 people): diagnosed from your blood tests.
Hvis der er mistanke om ITP, skal der øjeblikkeligt foretages en ny komplet blodtælling.
If ITP is suspected a complete blood count should be obtained immediately.
29% af patienter, der fik LEMTRADA, nåede CDI i Studie 2, mens kun 13% af patienterne, der fik subkutan IFNβ-1a, nåede dette endepunkt.
29% of patients treated with LEMTRADA reached CDI in Study 2, while only 13% of subcutaneous IFNB1a treated patiets reached this endpoint.
Blod- og lymfesystem Der er rapporteret alvorlige blødningsreaktioner hos ikke-MS-patienter.
Blood and lymphatic system disorders Severe bleeding reactions have been reported in non-MS patients.
Disse oplysninger findes også på Patientkortet og i den patientvejledning, du har fået af lægen.
You will also find this information in the Patient Alert Card and Patient Guide that you have been given by your doctor.
Epstein-Barr Virus-associerede lymfoproliferative sygdomme Epstein-Barr Virus-associerede lymfoproliferative sygdomme er observeret uden for firmasponsorerede studier.
Epstein-Barr Virus-associated lymphoproliferative disorders Epstein-Barr Virus-associated lymphoproliferative disorders have been observed outside company-sponsored studies.
De rapporterede tilfælde af trombocytopeni opstod inden for de første dage efter infusionen (i modsætning til ITP).
The reported thrombocytopenia occurred within the first days after the infusion (unlike ITP).
Neutrofilocytter, monocytter, eosinofilocytter, basofilocytter og natural killer celler er kun midlertidigt påvirkede af LEMTRADA.
Neutrophils, monocytes, eosinophils, basophils, and natural killer cells are only transiently affected by LEMTRADA.
Termer, der er markeret med en stjerne (*) i Tabel 1, omfatter bivirkninger, der er rapporteret som infusionsrelaterede reaktioner (IAR).
Terms marked with asterisk (*) in Table 1 include adverse reactions reported as Infusion Associated Reactions.
Generelt har en patient, der har haft en herpesinfektion én gang, en øget risiko for at udvikle en herpesinfektion igen.
In general, once a patient has had a herpes infection, they have an increased risk of developing another one.
MS er en autoimmun sygdom, der påvirker centralnervesystemet (hjernen og rygmarven).
MS is an autoimmune disease that affects the central nervous system (brain and spinal cord).
Flere af de patienter, der udviklede biopsidokumenteret AIH efter markedsføring, havde tidligere udviklet autoimmune thyreoidealidelser.
In the post-marketing setting several patients who developed biopsy proven AIH had previously developed autoimmune thyroid disorders.
Der bør foretages kliniske undersøgelser og laboratorietest regelmæssigt indtil mindst 48 måneder efter den sidste infusion i behandlingsforløbet med LEMTRADA for at monitorere for eventuelle tidlige tegn på autoimmune sygdomme:
Clinical examination and laboratory tests should be conducted at periodic intervals until at least 48 months following the last treatment course of LEMTRADA in order to monitor for early signs of autoimmune diseases:
Som med andre immunmodulerende behandlinger skal der udvises forsigtighed ved indledning af LEMTRADA-behandling hos patienter med præeksisterende og/eller aktuelle maligniteter.
As with other immunomodulatory therapies, caution should be exercised in initiating LEMTRADA therapy in patients with pre-existing and/or an on-going malignancy.
Med henblik på at mindske infusionsreaktionerne vil lægen give dig anden medicin (se punkt 4 - infusionsreaktioner).
To try to reduce infusion reactions, your doctor will give you other medicine(s) (see section 4 - infusion reactions).
2 Patientvejledning: Med yderligere oplysninger om autoimmune reaktioner, infektioner og andre oplysninger.
For further information on autoimmune reactions, infections and other information.
Tabel 1: Bivirkninger i studie 1, 2, 3 og 4 observeret hos alle patienter, der blev behandlet med LEMTRADA 12 mg og overvågning efter markedsføringen
Table 1: Adverse reactions in study 1, 2, 3 and 4 observed in LEMTRADA 12 mg treated patients and post-marketing surveillance
• unormale tilstande, som kan konstateres ved undersøgelser: blod eller protein i urinen, langsom puls,
• abnormalities that can be found during examinations: blood or protein in urine, decreased heart rate,
• kaliumchlorid (E508)
• potassium chloride (E508)
Patienter med aktiv MS, defineret som mindst 2 attakker inden for de foregående 2 år.
Patients with active MS, defined as at least 2 relapses within the prior 2 years.
Du skal fortælle det til din læge hvis du lider af en alvorlig infektion, før du begynder LEMTRADA
Also, tell your doctor if you are suffering from a serious infection before the start of your LEMTRADA
Der er rapporteret symptomer inden for få måneder og op til 4 år efter behandlingsstart.
Symptoms have been reported to occur within a few months to four years following the initiation of treatment.
Registrering af klinisk signifikante ændringer i serumkreatinin fra baseline, uforklarlig hæmaturi og/eller proteinuri skal afstedkomme yderligere undersøgelser for nefropatier, herunder øjeblikkelig henvisning til en specialist.
The observation of clinically significant changes from baseline in serum creatinine, unexplained haematuria, and/or proteinuria, should prompt further evaluation for nephropathies including immediate referral to a specialist.
VZV-vaccination af antistof-negative patienter bør overvejes før behandling med LEMTRADA.
VZV vaccination of antibody-negative patients should be considered prior to treatment initiation with LEMTRADA.
Nedenstående tabel er baseret på de samlede sikkerhedsdata hos alle patienter behandlet med LEMTRADA 12 mg under alle tilgængelige opfølgninger i kliniske studier.
The table below is based on the pooled safety data on all LEMTRADA 12 mg-treated patients during all available follow up in clinical trials.
Undersøgelse for koagulopatier, inklusive aPTT, bør foretages hos alle patienter, der får disse symptomer.
A coagulopathy panel including aPTT must be obtained in all patients that present with such symptoms.
For at nedsætte risikoen for visse infektioner kan din læge beslutte at vaccinere dig mod skoldkopper og/eller give dig andre vaccinationer, som lægen mener, du har behov for (se punkt 2 - Vacciner).
To help reduce the risk of some infections your doctor may consider giving you vaccination against chickenpox and/or other vaccinations that they think are necessary for you (see section 2: What you need to know before you are administered LEMTRADA - Vaccines).
Der er registreret lidt eller intet CD52 på neutrofiler, plasmaceller og knoglemarvsstamceller.
There is little or no CD52 detected on neutrophils, plasma cells, or bone marrow stem cells.
Cirka 40% af patienterne havde totale lymfocyttal, der nåede den laveste normalgrænse (LLN) inden for 6 måneder efter hvert behandlingsforløb, og ca. 80% af patienterne havde totale lymfocyttal, der nåede LLN inden for 12 måneder efter hvert behandlingsforløb.
Approximately 40% of patients had total lymphocyte counts reaching the lower limit of normal (LLN) by 6 months after each treatment course, and approximately 80% of patients had total lymphocyte counts reaching the LLN by 12 months after each course.
I et understudie med 13 mandlige patienter i behandling med LEMTRADA (behandlet med enten 12 mg eller 24 mg) var der intet bevis for aspermi, azoospermi, konsistent nedsat sædtal, motilitetsforstyrrelser eller en stigning i spermmorfologiske abnormiteter.
In a sub-study in 13 male LEMTRADA-treated patients (treated with either 12 mg or 24 mg), there was no evidence of aspermia, azoospermia, consistently depressed sperm count, motility disorders or an increase in sperm morphological abnormalities.
LEMTRADA kan øge risikoen for akut acalculøs cholecystitis.
LEMTRADA may increase the risk of acute acalculous cholecystitis.
1,5/1,3 år
1.5/1.3 years
Cholecystitis, herunder acalculøs cholecystitis og akut acalculøs cholecystitis
Cholecystitis including acalculous cholecystitis and acute acalculous cholecystitis
Det vides ikke, om LEMTRADA kan overføres til barnet via mælk, med det er en risiko.
It is unknown if LEMTRADA can be transferred to a baby through breast milk, but there is a possibility that it could be.
Patienter, der behandles med LEMTRADA, skal have udleveret et patientkort og en patientvejledning og oplyses om risiciene ved LEMTRADA (se også indlægssedlen).
Patients treated with LEMTRADA must be given the Patient Alert Card and Patient Guide and be informed about the risks of LEMTRADA (see also package leaflet).
Screening af patienter med høj risiko for HBV- og/eller HCV-infektion, bør overvejes før igangsættelse af LEMTRADA-behandling, og der skal udvises forsigtighed ved ordinering af LEMTRADA til patienter, der er diagnosticeret som bærere af HBV og/eller HCV, da der er risiko for, at disse patienter får irreversible leverskader i forbindelse med en potentiel virusreaktivering forårsaget af deres aktuelle tilstand.
Screening patients at high risk of HBV and/or HCV infection before initiation of LEMTRADA should be considered and caution should be exercised in prescribing LEMTRADA to patients identified as carriers of HBV and/or HCV as these patients may be at risk of irreversible liver damage relative to a potential virus reactivation as a consequence of their pre-existing status.
Karcinogenese og mutagenese Der er ingen studier, der evaluerer alemtuzumabs karcinogene og mutagene potentiale.
There have been no studies to assess the carcinogenic or mutagenic potential of alemtuzumab.
Fordelene ved overført immunitet via brystmælk kan dog for ammede nyfødte/spædbørn, opveje risiciene ved potentiel udsættelse for alemtuzumab.
However, benefits of conferred immunity through breast-milk may outweigh the risks of potential exposure to alemtuzumab for the suckling newborn/infant.
Sikkerhed og virkning af alemtuzumab ved MS blev evalueret i 3 randomiserede, rater-blindede, aktivkomparator kliniske studier og et ukontrolleret, rater-blindet forlængelsesstudie med RRMS-patienter.
The safety and efficacy of alemtuzumab in MS were evaluated in 3 randomised, rater-blinded, activecomparator clinical trials and 1 uncontrolled, rater-blinded extension study in patients with RRMS.
Tal med lægen, før du får LEMTRADA.
Talk to your doctor before LEMTRADA is given.
Søvnløshed*, angst, depression
Insomnia*, anxiety, depression
Det skal du vide, før du får LEMTRADA Du må ikke få LEMTRADA:
What you need to know before you are administered LEMTRADA Do not use LEMTRADA:
En længere observationstid (hospitalsindlæggelse) bør overvejes efter behov.
Extended observation time (hospitalization) should be considered, as appropriate.
Studie 4 var et fase 3, multicenter, åben-label, rater-blindet, effekt og sikkerheds forlænget studie for patienter med RRMS, der deltog i studie 1, 2 eller 3 (tidligere fase 3 og 2 studier) for at vurdere langtids effekt og sikkerhed af LEMTRADA.
Study 4, was a Phase 3, multicenter, open-label, rater-blinded, efficacy and safety extension study for patients with RRMS who participated in Study 1, 2, or 3 (prior phase 3 and 2 studies) to assess long-term efficacy and safety of LEMTRADA.
Efter at have gennemgået et behandlingsforløb med LEMTRADA kan du have en øget risiko for at udvikle andre autoimmune tilstande eller alvorlige infektioner.
After having a course of treatment with LEMTRADA you may be at greater risk of developing other autoimmune conditions, or experiencing serious infections.
De fleste patienter i kontrollerede kliniske studier fik antihistaminer og/eller antipyretika før mindst én LEMTRADA-infusion.
Most patients in controlled clinical trials received antihistamines and/or antipyretics before at least one LEMTRADA infusion.
Derfor er det nødvendigt regelmæssigt at tage blod- og urinprøver indtil 4 år efter den sidste infusion.
Therefore, regular blood and urine tests are needed until 4 years after your last infusion.
Akut acalculøs cholecystitis
Acute acalculous cholecystitis
Hæmoptyse kan også være indikativ for anti-GBM-sygdom (se nedenfor), og der skal udføres en relevant differentialdiagnostisk undersøgelse.
Haemoptysis may also be indicative of anti-GBM disease (see below), and an appropriate differential diagnosis has to be undertaken.
Omkring halvdelen (51,2%) af patienterne, der oprindeligt blev behandlet med LEMTRADA 12 mg/dag i studie 1 eller 2, som indgik i studie 4, modtog kun de første 2 behandlingsforløb af LEMTRADA og ingen anden sygdomsmodificerende behandling gennem 6 års opfølgning.
Approximately half (51.2%) of patients initially treated with LEMTRADA 12 mg/day in Study 1 or 2 who enrolled in Study 4, received only the initial 2 courses of LEMTRADA and no other disease modifying treatment throughout 6 years of follow-up.
Behandlingen kan resultere i dannelse af autoantistoffer og øge risikoen for autoimmunmedierede lidelser, som kan være alvorlige og livstruende.
Treatment may result in the formation of autoantibodies and increase the risk of autoimmune mediated conditions which may be serious and life threatening.
Det anbefales at anvende produktet umiddelbart efter fortynding på grund af den mulige risiko for mikrobiel forurening.
It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination.
Hvis en cytopeni bekræftes, skal relevant medicinsk behandling igangsættes straks, herunder henvisning til en specialist.
If a cytopenia is confirmed, appropriate medical intervention should be promptly initiated, including referral to a specialist.
• fornemmelse af at snurre rundt eller miste balancen, migræne
• sensation of spinning or loss of balance, migraine
For disse patienter faldt ARR fra 0,79 i året før behandlingsforløb 3 til 0,18 et år efter, og den gennemsnitlige EDSS score fra 2,89 til 2,69.
For these patients, the ARR declined from 0.79 in the year prior to Course 3 to 0.18 one year after, and the mean EDSS score from 2.89 to 2.69.
Positive prøver blev yderligere undersøgt for beviser på in vitro inhibering vha. flowcytometriteknik.
Positive samples were further evaluated for evidence of in vitro inhibition using a flow cytometry assay.
* Defineret som patienter med mindst 1 attak under behandling med betainterferon eller glatirameracetat efter at have været i behandling med lægemidlet i mindst 6 måneder.
4 years * Defined as patients having experienced at least 1 relapse during treatment with beta interferon or glatiramer acetate after having been on therapy with medicinal product for at least 6 months.
Behandling med LEMTRADA kan øge risikoen for autoimmune tilstande.
Treatment with LEMTRADA may increase the risk for autoimmune conditions.
Hvis der er mistanke om akut acalsuløs cholecystitis, skal det omgående vurderes og behandles.
If acute acalculous cholecystitis is suspected, evaluate and treat promptly.
Klinisk signifikant trombocytopeni skal følges, indtil det er forsvundet.
Clinically significant thrombocytopenia needs to be followed until resolution.
Tidlig diagnosticering og behandling af nefropatier kan nedsætte risikoen for alvorlig sygdom.
Early detection and treatment of nephropathies may decrease the risk of poor outcomes.
I kontrollerede kliniske studier fik to MS-patienter utilsigtet op til 60 mg LEMTRADA (dvs. totaldosis for første behandlingsforløb) i én infusion, og de oplevede alvorlige reaktioner (hovedpine, udslæt og enten hypotension eller sinustakykardi).
In controlled clinical trials two MS patients accidentally received up to 60 mg LEMTRADA (i.e. total dose for initial treatment course) in a single infusion and experienced serious reactions (headache, rash, and either hypotension or sinus tachycardia).
• LEMTRADA-infusionsvæske administreres via intravenøs administration over cirka 4 timer.
• Administer LEMTRADA infusion solution via intravenous administration over approximately 4 hours.
Du kan finde yderligere nyttige oplysninger om disse autoimmune tilstande (og de prøver, der skal til for at afsløre dem) i LEMTRADA patientvejledningen.
More helpful information about these autoimmune conditions (and the testing for them) can be found in the
Inden for hver hyppighedsgruppe er bivirkningerne angivet efter faldende alvorlighedsgrad.
Within each frequency grouping, adverse reactions have been presented in order of decreasing seriousness.
Der skal tages forholdsregler til at sikre sterilitet af den klargjorte opløsning.
Care should be taken to ensure the sterility of the prepared solution.
En patient udviklede ITP, der ikke blev diagnosticeret før implementering af krav om månedlige blodprøver.
One patient developed ITP that went unrecognised prior to implementation of monthly blood monitoring requirements and died from intracerebral haemorrhage.
• rifter i blodkar (karotider eller vertebrale arterier), der forsyner hjernen med blod
• tears in carotid or vertebral arteries (blood vessels supplying the brain)
Det anbefales, at patienten har fået de lokalt krævede vacciner mindst 6 uger før behandling med LEMTRADA.
It is recommended that patients have completed local immunisation requirements at least 6 weeks prior to treatment with LEMTRADA.
De fleste tilfælde blev behandlet med konventionel medicinsk behandling, men nogle patienter havde brug for kirurgisk indgreb.
Most thyroid events were managed with conventional medical therapy however some patients required surgical intervention.
- Ændringer i antal, proportioner og egenskaber for visse lymfocytundergrupper efter behandling - Øget repræsentation af regulatoriske T-celleundergrupper - Øget repræsentation af memory T- og B-lymfocytter - Forbigående effekter på komponenter med naturlig immunitet (dvs. neutrofiler, makrofager, NK-celler)
- Alterations in the number, proportions, and properties of some lymphocyte subsets post-treatment - Increased representation of regulatory T cell subsets - Increased representation of memory T- and B-lymphocytes - Transient effects on components of innate immunity (i.e., neutrophils, macrophages, NK cells)
• blødning i lungerne
• bleeding in lungs
Patienterne havde EDSS 0-3,0, mindst 2 MS-attakker i løbet af de forudgående 2 år og ≥ 1 gadolinium-opladende læsion ved studiestart.
Patients had an EDSS from 0-3.0, at least 2 clinical episodes of MS in the prior 2 years, and ≥1 gadolinium-enhancing lesion at study entry.
46,6% af patienterne, der oprindeligt blev behandlet med LEMTRADA 12 mg/dag i studie 1 eller 2, modtog yderligere behandlingsforløb efter dokumenteret bevis for MS-sygdomsaktivitet (attak og/eller MRI) og den behandlende læges beslutning om at genbehandle.
46.6% of the patients initially treated with LEMTRADA 12 mg/day in Study 1 or 2 received additional courses upon documented evidence of MS disease activity (relapse and/or MRI) and the treating physician's decision to retreat.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON/PAKNING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/PACK
LEMTRADA-behandling bør udelukkende initieres og superviseres af en neurolog med erfaring i behandling af patienter med multipel sclerose (MS) på et hospital med adgang til en intensivafdeling.
LEMTRADA treatment should only be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis (MS) in a hospital with ready access to intensive care.
Patienter, der udvikler autoimmunitet, bør undersøges for andre autoimmunmedierede lidelser (se pkt.
Patients who develop autoimmunity should be assessed for other autoimmune mediated conditions (see section 4.3).
Rate ratio (95% CI) Risikoreduktion
Rate ratio (95% CI) Risk reduction
Amning Alemtuzumab blev detekteret i mælken og i diende unger fra mus.
Alemtuzumab was detected in the milk and offspring of lactating female mice.
Kognitiv, fysisk og seksuel udvikling af unger, der blev eksponeret for alemtuzumab under diegivning blev ikke påvirket ved alemtuzumab-doser på op til 10 mg/kg/dag.
Cognitive, physical, and sexual development of pups exposed to alemtuzumab during lactation were not affected at doses up to 10 mg/kg/day alemtuzumab.
• Efter hver infusion skal patienten holdes under opsyn i 2 timer for infusionsassocierede reaktioner.
After each infusion, the patient should be observed for 2 hours for infusion associated reactions.
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.
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.
Ukontrolleret, rater-blindet forlængelsesstudie
Uncontrolled, rater-blinded extension study
3 år‡
3 years‡
Patienter, som behandles med LEMTRADA, har fået infektioner, der skyldes en virus ved navn EpsteinBarr-Virus (EBV), herunder alvorlige tilfælde af leverbetændelse.
Patients treated with LEMTRADA have had infections due to a virus called Epstein-Barr virus (EBV), including cases with severe liver inflammation.
Du finder detaljerede oplysninger om tegn og symptomer, prøver og ting, du skal gøre, under punkt 2 og 4 - autoimmune tilstande.
Details about the signs and symptoms, testing, and actions you need to take are described in sections 2 and 4autoimmune conditions.
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.
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.
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%.
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%.