FrancophonIA/ELRC3.0 huggingface dataset:
English: If an additional third or fourth course is administered, continue safety follow-up for at least 48 months after the last infusion (see section 4.4).
Danish: Hvis der gives yderligere 3. eller 4. behandlingsforløb, fortsættes sikkerhedsopfølgningen i mindst 48 måneder efter den sidste infusion (se pkt.
English: Contraception
Danish: Antikonception
English: Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to T and B lymphocytes.
Danish: Alemtuzumab virker via antistofafhængig cellulær cytolyse og komplementmedieret lyse efterfølgende celleoverfladebinding til T- og B-lymfocytter.
English: Several of the patient reported were below 50 years of age and had no history of hypertension, bleeding disorders or concomitant anticoagulants or platelet inhibitors.
Danish: Flere af de rapporterede tilfælde omfattede patienter under 50 år, som ikke havde hypertension, blødningssygdomme eller samtidig behandling med antikoagulantia eller antitrombotika i anamnesen.
English: Patients with Gadolinium enhancing lesions through Year 2
Danish: Patienter med gadolinium-opladende læsioner efter år 2
English: Reduced gestational weight gain relative to the vehicle controls was observed in pregnant mice dosed with 10 mg/kg/day.
Danish: Reduceret vægtforøgelse ved drægtighed i forhold til kontroldyrene blev observeret hos drægtige mus, der fik 10 mg/kg/dag.
English: Most patients treated with LEMTRADA in clinical trials in MS experienced mild to moderate IARs during and/or up to 24 hours after LEMTRADA 12 mg administration.
Danish: De fleste patienter, der blev behandlet med LEMTRADA i kliniske MS-studier, oplevede lette til moderate infusionsrelaterede reaktioner under og/eller op til 24 timer efter behandling med 12 mg LEMTRADA.
English: Symptomatic treatment can be initiated if needed - see SmPC.
Danish: Ved behov kan der gives symptomatisk behandling - se produktresuméet.
English: Pretreatment with antihistamines and/or antipyretics prior to LEMTRADA administration may also be considered.
Danish: Derudover kan præmedicinering med antihistaminer og/eller antipyretika før administration af LEMTRADA også overvejes.
English: Non-interventional post-authorisation safety study (PASS): In order to investigate the incidence of mortality in patients treated with Lemtrada compared to a relevant patient population, the MAH shall submit the results of a post-authorisation safety study
Danish: Ikke-interventionelt sikkerhedsstudie efter tilladelse til markedsføring (PASS): For at undersøge forekomsten af dødelighed hos patienter, der behandles med Lemtrada sammenlignet med en relevant patientpopulation, skal indehaveren af markedsføringstilladelsen indsende resultaterne af et sikkerhedsstudie udført efter udstedelse af markedsføringstilladelsen, der sammenligner Lemtrada med en relevant kontrol.
English: o Other autoimmune conditions
Danish: o Andre autoimmune tilstande
English: Nephrolithiasis, ketonuria, nephropathies including antiGBM disease
Danish: Nefrolitiasis, ketonuri, nefropatier herunder antiGBM sygdom
English: Contents of the pack and other information What LEMTRADA contains
Danish: Pakningsstørrelser og yderligere oplysninger LEMTRADA indeholder
English: SC IFNB-1a (N=187)
Danish: IFNβ-1a s.c. (N = 187)
English: Your doctor can also prescribe a medicine for cold sores (see section 2: What you need to know before you are administered LEMTRADA - Infections).
Danish: Din læge kan også ordinere medicin mod forkølelsessår (se punkt 2 - Infektioner).
English: Among patients who received one or two additional LEMTRADA treatment courses, improvements were seen in relapse rate, MRI activity and mean disability scores following a first or second LEMTRADA retreatment (Courses 3 and 4) when compared with outcomes in the preceding year.
Danish: Blandt patienter, der modtog et eller to yderligere LEMTRADA-behandlingsforløb, blev der set forbedringer i attak rate, MRI-aktivitet og gennemsnitlige funktionstabsresultater efter en første eller anden LEMTRADAbehandling (behandlingsforløb 3 og 4) i forhold til resultaterne i det foregående år.
English: LEMTRADA may cause different types of thyroid disorders, including: Over-active thyroid gland (hyperthyroidism) when the thyroid produces too much hormone Under-active thyroid gland (hypothyroidism) when the thyroid does not produce enough hormone.
Danish: LEMTRADA kan give anledning til forskellige typer af skjoldbruskkirtel-lidelser herunder: Over-aktiv skjoldbruskkirtel (hypertyreose), hvor skjoldbruskkirtlen producerer for meget hormon Under-aktiv skjoldbruskkirtel (hypotyreose), hvor skjoldbruskkirtlen ikke producerer tilstrækkeligt med hormon.
English: In studies in mice, alterations in lymphocyte counts were observed in pups exposed to alemtuzumab during gestation at doses of 3 mg/kg/day for 5 consecutive days (AUC 0.6 times the human exposure at the recommended dose of 12 mg/day).
Danish: I musestudier blev der observeret ændringer i lymfocyttal hos unger, der blev eksponeret for alemtuzumab i doser på 3 mg/kg/dag i 5 på hinanden følgende dage (AUC 0,6 gange human eksponering ved den anbefalede dosis på 12 mg/dag) in utero.
English: After this time, if you have symptoms of ITP, kidney or thyroid disorders, your doctor will perform more tests.
Danish: Hvis du efter denne periode har symptomer på ITP eller lidelser i nyrer eller skjoldbruskkirtel, vil din læge tage flere prøver.
English: Infections occurred in 71% of patients treated with LEMTRADA 12 mg as compared to 53% of patients treated with subcutaneous interferon beta-1a [IFNB 1a](44mcg 3-times weekly) in controlled clinical trials in MS up to 2 years in duration and were predominantly mild to moderate in severity.
Danish: Der opstod infektioner hos 71% af de patienter, der blev behandlet med LEMTRADA 12 mg, sammenlignet med hos 53% af de patienter, der blev behandlet med subkutan interferon beta-1a [IFNB 1a](44 mikrogram 3 gange om ugen) i kontrollerede kliniske MS-studier af op til 2 års varighed.
English: Serious reactions occurred in 3% of patients and included cases of headache, pyrexia, urticaria, tachycardia, atrial fibrillation, nausea, chest discomfort, and hypotension.
Danish: Der opstod alvorlige reaktioner hos 3% af patienterne og inkluderede tilfælde af hovedpine, feber, urticaria, takykardi, atrieflimren, kvalme, oppression og hypotension.
English: Serious varicella zoster virus infections, including primary varicella and varicella zoster re-activation, have occurred more often in patients treated with LEMTRADA 12 mg (0.4%) in clinical trials as compared to IFNB-1a (0%).
Danish: Der opstod oftere alvorlige varicella zoster virusinfektioner, herunder primær varicella og varicella zosterreaktivering, hos patienter, der blev behandlet med LEMTRADA 12 mg (0,4%) i forhold til IFNB-1a (0%) i kliniske studier.
English: • Vaccines
Danish: • Vacciner
English: Administration of 12 mg/day resulted in a mean Cmax of 3014 ng/ml on day 5 of the initial treatment course, and 2276 ng/ml on day 3 of the second treatment course.
Danish: Administration af 12 mg/dag medførte et gennemsnitligt Cmaks på 3.014 ng/ml på dag 5 i det første behandlingsforløb og på 2.276 ng/ml på dag 3 i det andet behandlingsforløb.
English: The most common adverse reactions with LEMTRADA (in ≥20% of patients) were rash, headache, pyrexia, and respiratory tract infections.
Danish: De hyppigst forekommende bivirkninger ved LEMTRADA (hos ≥ 20% af patienterne) var udslæt, hovedpine, feber og luftvejsinfektioner.
English: Treatment with intravenous alemtuzumab at doses up to 10 mg/kg/day, administered for 5 consecutive days (AUC of 7.1 times the human exposure at the recommended daily dose) had no effect on fertility and reproductive performance in male huCD52 transgenic mice.
Danish: Behandling med intravenøs alemtuzumab ved doser på op til 10 mg/kg/dag i 5 på hinanden følgende dage (AUC på 7,1 gange human eksponering ved den anbefalede daglige dosis) havde ingen effekt på fertilitet og reproduktionsevne hos hu-CD52-transgenetiske hanmus.
English: Liver inflammation can be diagnosed from the blood tests that you will be having regularly after LEMTRADA treatment.
Danish: Leverbetændelse kan diagnosticeres ved hjælp af de blodprøver, som du får taget med regelmæssige mellemrum efter behandlingen med LEMTRADA.
English: Cytokine release syndrome*, hypersensitivity including anaphylaxis*
Danish: Cytokinfrigive lsessyndrom*, hypersensitivit et, herunder anafylaksi*
English: Through all available follow-up, including patients who received additional treatment courses, the most common IARs included headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnoea, dysgeusia, chest discomfort, generalised rash, tachycardia, bradycardia, dyspepsia, dizziness, and pain.
Danish: Gennem al tilgængelig opfølgning, herunder patienter, der har modtaget yderligere behandlingsforløb, er de mest almindelige infusionsrelaterede reaktioner hovedpine, udslæt, feber, kvalme, urticaria, pruritus, søvnløshed, kuldegysninger, ansigtsrødme, træthed, dyspnø, dysgeusi, oppression, generaliseret udslæt, takykardi, bradykardi, dyspepsi, svimmelhed og smerter.
English: • decreased weight, weight increase, red blood cell decrease, blood glucose increase, increase in red blood cell size
Danish: • vægttab, vægtstigning, reduktion af røde blodlegemer, forhøjet blodsukker, forøgelse af de røde blodlegemers størrelse
English: Superficial fungal infections, especially oral and vaginal candidiasis, occurred more commonly in LEMTRADA -treated patients (12%) than in patients treated with IFNB-1a (3%) in controlled clinical trials in MS.
Danish: Superficielle svampeinfektioner, specielt oral og vaginal candidiasis, opstod oftere hos LEMTRADAbehandlede patienter (12%) end hos IFNB-1a-patienter (3%) i kontrollerede, kliniske MS-studier.
English: Infections that occurred more often in LEMTRADA -treated patients than IFNB 1a patients included nasopharyngitis, urinary tract infection, upper respiratory tract infection, sinusitis, oral herpes, influenza, and bronchitis.
Danish: Infektioner, der opstod oftere hos LEMTRADA-patienter end hos IFNB 1a-patienter, inkluderede nasofaryngitis, urinvejsinfektion, infektion i de øvre luftveje, sinuitis, oral herpes, influenza og bronkitis.
English: Any spillage or waste material should be disposed of in accordance with local requirements.
Danish: Spildt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: LEMTRADA is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:
Danish: LEMTRADA er indiceret som monoterapi til sygdomsmodificerende behandling af voksne med meget aktiv recidiverende-remitterende multipel sclerose (RRMS) hos følgende patientgrupper:
English: A positive Coombs test has been reported in an alemtuzumab-treated oncology patient.
Danish: Der er rapporteret en positiv Coombs-test hos en kræftpatient behandlet med alemtuzumab.
English: Cytopenias
Danish: Cytopenier
English: Cardiac disorders Tachycardia* Bradycardia*, palpitations*
Danish: Takykardi* Bradykardi*, palpitationer*
English: • kidney stones, excretion of ketone bodies in urine, kidney disease
Danish: • nyresten, udskillelse af ketonstoffer i urinen, nyrelidelse
English: Supportive analyses from Study 2 (CAMMS32400507) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (48% reduction, p=0.0121), and significantly fewer relapses that led to steroid treatment (56% reduction, p<0.0001) or to hospitalization (55% reduction, p=0.0045) compared to IFNB-1a.
Danish: Understøttende analyser fra Studie 2 (CAMMS32400507) viste, at LEMTRADA 12 mg/dag medførte signifikant færre LEMTRADA-behandlede patienter, der oplevede alvorlige attakker (48% reduktion, p = 0,0121), og signifikant færre attakker, der medførte steroidbehandling (56% reduktion, p < 0,0001) eller indlæggelse (55% reduktion, p = 0,0045) sammenlignet med IFNβ-1a.
English: During post-marketing use, HLH (including fatal cases) has been reported in patients treated with LEMTRADA.
Danish: Efter markedsføringen er der rapporteret HLH (inklusive tilfælde med dødelig udgang) hos patienter, der er blevet behandlet med LEMTRADA.
English: Thyroid function tests, such as thyroid stimulating hormone levels, should be obtained prior to initiation of treatment and every 3 months thereafter until 48 months following the last infusion.
Danish: Thyreoidea-funktionsprøver, f.eks. niveauet af thyreoideastimulerende hormon, skal tages før behandlingsstart og hver 3. måned derefter indtil 48 måneder efter sidste infusion.
English: These can be diagnosed from the blood tests that you will be having regularly after LEMTRADA treatment.
Danish: Disse lidelser kan diagnosticeres ved hjælp af de blodprøver, som du får taget med regelmæssige mellemrum efter behandlingen med LEMTRADA.
English: Epstein-Barr virus (EBV) reactivation, including severe EBV hepatitis cases, has been reported in LEMTRADA-treated patients.
Danish: Der er rapporteret om reaktivering af Epstein-Barr-Virus (EBV), inklusive alvorlige tilfælde af EBVhepatitis, hos patienter, der blev behandlet med LEMTRADA.
English: • Patients should be premedicated with corticosteroids immediately prior to LEMTRADA infusion for the first 3 days on any treatment course.
Danish: • Patienten skal præmedicineres med kortikosteroid umiddelbart inden LEMTRADA-infusionen i de første 3 dage af alle behandlingsforløb.
English: Erythema*, ecchymosis, alopecia, hyperhidrosis, acne, skin lesion, dermatitis
Danish: Erytem*, ekkymose, alopeci, hyperhidrose, acne, hudlæsion, dermatitis
English: Symptoms of ITP could include (but are not limited to) easy bruising, petechiae, spontaneous mucocutaneous bleeding (e.g., epistaxis, haemoptysis), heavier than normal or irregular menstrual bleeding.
Danish: Symptomer på ITP omfatter (men er ikke begrænset til) tendens til at få blå mærker, petekkier, spontane blødninger fra slimhinder (f.eks. epistaxis, hæmoptyse), voldsommere eller uregelmæssig menstruation.
English: • A test of thyroid function, such as thyroid stimulating hormone level (prior to treatment initiation and every 3 months thereafter).
Danish: • Thyreoidea-funktionsprøver, f.eks. niveauet af thyreoideastimulerende hormon (før behandlingsstart og derefter hver 3. måned).
English: Very Common Common
Danish: Organklasse Meget almindelig
English: Patients who are relapse free at Year 2 (95% CI)
Danish: Patienter uden attaker ved år 2 (95% CI)
English: If you experience multiple symptoms such as fever, swollen glands, bruising, or skin rash, contact your doctor immediately.
Danish: Hvis du får flere forskellige symptomer som f.eks. feber, hævede lymfekirtler, blå mærker eller hududslæt, skal du straks kontakte lægen.
English: Clinical manifestations of nephropathy may include elevation in serum creatinine, haematuria, and/or proteinuria.
Danish: Kliniske manifestationer af nefropati kan omfatte forhøjet serumkreatinin, hæmaturi og/eller proteinuri.
English: LEMTRADA may increase your chance of getting inflammation of the gallbladder.
Danish: LEMTRADA kan øge din risiko for at få betændelse i galdeblæren.
English: Weight decreased, weight increased, red blood cell count decreased, bacterial test positive, blood glucose increased, mean cell volume increase
Danish: Vægttab, vægtforøgelse, reduceret antal røde blodlegemer, positiv bakterietest, forhøjet blodglukose, forøget gennemsnitlig cellevolumen
English: Abdominal pain, vomiting, diarrhoea dyspepsia*, stomatitis
Danish: Abdominalsm erter, opkastning, diarré, dyspepsi*, stomatitis
English: Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy.
Danish: Patienter med kendt koagulopati eller patienter, der behandles med antitrombotiske eller antikoagulerende lægemidler.
English: In the majority of cases time to onset was within 1-3 days of the LEMTRADA infusion.
Danish: I størstedelen af tilfældene var tiden til indtræden 1-3 dage efter infusion med LEMTRADA.
English: Autoimmune disease
Danish: Autoimmun sygdom
English: • Urinalysis with microscopy (prior to treatment initiation and at monthly intervals thereafter)
Danish: • Urinmikroskopi (forud for behandlingsstart og derefter hver måned).
English: In female mice dosed with intravenous alemtuzumab up to 10 mg/kg/day (AUC of 4.7 times the human exposure at the recommended daily dose) for 5 consecutive days prior to cohabitation with wild-type male mice, the average number of corpora lutea and implantation sites per mouse were significantly reduced as compared to vehicle treated animals.
Danish: Hos hunmus doseret med intravenøs alemtuzumab op til 10 mg/kg/dag (AUC 4,7 gange den human eksponering ved den anbefalede daglige dosis) i 5 på hinanden følgende dage før indsættelse til vild-type hanmus, blev det gennemsnitlige antal corpus luteum og implantationsområder pr. mus signifikant reduceret sammenlignet med vehikelbehandlede dyr.
English: Most events were mild to moderate in severity.
Danish: De fleste tilfælde var lette eller moderate.
English: • stiffness, arms or legs discomfort
Danish: • stivhed, ubehag i arme eller ben
English: Thyroid disease poses special risks in women who are pregnant (see section 4.6).
Danish: Thyreoidea-lidelse er specielt risikabelt for gravide kvinder (se pkt.
English: Human IgG is known to cross the placental barrier; alemtuzumab may cross the placental barrier as well and thus potentially pose a risk to the foetus.
Danish: Alemtuzumab passerer muligvis også placentabarrieren og kan dermed udgøre en risiko for fostret.
English: Referral to a haematologist for management should be considered.
Danish: Det bør overvejes at konsultere en hæmatolog for behandling.
English: To reduce this risk, you should avoid eating uncooked or undercooked meats, soft cheeses and unpasteurized dairy products two weeks before treatment, during the treatment and for at least one month after LEMTRADA treatment.
Danish: For at mindske risikoen for dette bør patienter, der får LEMTRADA, ikke spise råt eller delvist råt kød, bløde oste og upasteuriserede mælkeprodukter to uger før behandling, under behandlingen og i mindst en måned efter LEMTRADAbehandlingen.
English: As for any immune modulating medicinal product, before initiating a course of LEMTRADA treatment, patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV.
Danish: Som det er tilfældet med alle immunmodulerende lægemidler, skal patienter, der ikke har haft skoldkopper, eller som ikke er vaccineret mod VZV-virus (varicella-zoster-virus), testes for antistoffer mod VZV, inden igangsættelse af behandling med LEMTRADA.
English: Cytomegalovirus infections (CMV) including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Danish: Der er indberettet tilfælde af cytomegalovirus (CMV)-infektioner, herunder tilfælde af CMV-reaktivering, hos patienter behandlet med LEMTRADA.
English: Missed LEMTRADA doses
Danish: Hvis en dosis LEMTRADA bliver glemt
English: Basedow's disease, hyperthyrodisim, hypothyroidism
Danish: Basedows sygdom, hypertyreoidism e, hypotyreoidisme
English: Nephropathies, including anti-glomerular basement membrane (anti-GBM) disease, have been observed in 6 (0.4%) patients in clinical trials in MS through a median of 6.1 years (maximum 12 years) of follow-up and generally occurred within 39 months following the last administration of LEMTRADA.
Danish: Nefropatier, herunder anti-glomerulær basalmembran-sygdom (anti-GBM-sygdom) blev observeret hos 6 patienter (0,4%) i kliniske studier med MS igennem en median af 6,1 års opfølgning (maksimum 12 år) og opstod generelt inden for 39 måneder efter den sidste behandling med LEMTRADA.
English: How LEMTRADA works
Danish: Sådan virker LEMTRADA
English: The incidence of thyroid events was higher in patients with a medical history of thyroid disorders both in the LEMTRADA and interferon beta 1a (IFNB1a) treatment groups.
Danish: Forekomsten var højere hos patienter med tidligere tilfælde af thyreoidea-lidelser, både i LEMTRADA-gruppen og i interferon beta 1a (IFNB-1a)gruppen.
English: Serious and sometimes fatal autoimmune phenomena including autoimmune haemolytic anaemia, autoimmune thrombocytopenia, aplastic anaemia, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyradiculoneuropathy have been reported in alemtuzumab-treated non-MS patients.
Danish: Alvorlige og til tider dødelige autoimmune fænomener, herunder autoimmun hæmolytisk anæmi, autoimmun trombocytopeni, aplastisk anæmi, Guillain-Barrés syndrom og kronisk inflammatorisk demyeliniserende polyradikuloneuropati, er blevet registreret hos alemtuzumab-behandlede ikke-MS-patienter.
English: Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Thyroid endocrine disorders including autoimmune thyroid disorders have been observed in 36.8% of patients treated with LEMTRADA 12 mg in clinical trials in MS with a median of 6.1 years (maximum 12 years) of follow- up from the first LEMTRADA exposure.
Danish: Endokrine lidelser, herunder autoimmune lidelser i thyreoidea er observeret hos 36,8% af de patienter, der blev behandlet med LEMTRADA 12 mg i kliniske MS-studier med en median af 6,1 års opfølgning (maksimum 12 år) fra den første behandling med LEMTRADA.
English: Neoplasms benign, malignant and unspecified (incl.
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper)
English: Oral prophylaxis for herpes infection should be administered to all patients starting on the first day of each treatment course and continuing for a minimum of 1 month following treatment with LEMTRADA (see also under ‘Infections' in section 4.4).
Danish: Alle patienter skal behandles med oral profylakse mod herpesinfektion, begyndende på den første dag i begge behandlingsforløb, og behandlingen bør fortsætte i mindst 1 måned efter LEMTRADA-behandling (se også 'Infektioner' i pkt.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Straße 65
Danish: Boehringer Ingelheim Pharma GmbH & Co.
English: • swelling of arms and/or legs
Danish: • hævede arme og/eller ben
English: The most important adverse reactions are autoimmunity (ITP, thyroid disorders, nephropathies, cytopenias), IARs, and infections.
Danish: De vigtigste bivirkninger er autoimmunitet (ITP, sygdomme i thyreoidea, nefropatier, cytopenier), infusionsrelaterede reaktioner og infektioner.
English: Most patients experience IARs which occur during or within 24 hours after treatment with LEMTRADA.
Danish: De fleste patienter oplever infusionsrelaterede reaktioner, som opstår under eller inden for 24 timer efter behandling med LEMTRADA.
English: Suspected autoimmune cytopenias such as neutropenia, haemolytic anaemia and pancytopenia have been infrequently reported in clinical trials in MS.
Danish: Formodede autoimmune cytopenier, f.eks. neutropeni, hæmolytisk anæmi og pancytopeni, rapporteredes af og til i kliniske MS-studier.
English: 2 Herpes zoster infections include PTs: Herpes zoster, Herpes zoster cutaneous disseminated, Ophthalmic herpes zoster, Herpes ophthalmic, Herpes zoster infection neurological, Herpes zoster meningitis.
Danish: 2 Herpes zoster-infektioner omfatter: Herpes zoster, herpes zoster kutan spredt, oftalmisk herpes zoster, oftalmisk herpes, neurologisk herpes zoster infektion, herpes zoster meningitis.
English: A fatal event of transfusion associated graft versus host disease has been reported in an alemtuzumab-treated oncology patient.
Danish: Der er rapporteret et dødeligt tilfælde af transfusionsassocieret graft versus host-sygdom hos en kræftpatient behandlet med alemtuzumab.
English: The treatment consists of stopping LEMTRADA administration and treating the symptoms.
Danish: Behandlingen består i at afbryde infusionen med LEMTRADA og afhjælpe symptomerne.