FrancophonIA/ELRC3.0 huggingface dataset:
English: Prophylaxis with an oral anti-herpes agent should be initiated starting on the first day of LEMTRADA treatment and continuing for a minimum of 1 month following each course of treatment.
Danish: Oral profylakse mod herpes skal igangsættes på LEMTRADA-behandlingens første dag, og fortsætte i mindst 1 måned efter hvert behandlingsforløb.
English: You should report to your doctor symptoms like shortness of breath, cough, wheezing, chest pain or tightness and coughing up blood, as these could be caused by pneumonitis.
Danish: Du skal fortælle det til lægen, hvis du får symptomer som åndenød, hoste, hvæsen, brystsmerter eller tæthed og hvis du hoster blod op, da disse kan være forårsaget af lungebetændelse.
English: Get help right away if you have any of the following symptoms of bleeding in the lung: trouble breathing, coughing up blood, chest pain, facial drooping, sudden severe headache, weakness on one side of the body, difficulty with speech or neck pain.
Danish: Du skal straks søge læge, hvis du får et eller flere af følgende symptomer på blødning i lungerne: vejrtrækningsbesvær, ophostning af blod, brystsmerter, hængende ansigtsmuskler, pludselig kraftig hovedpine, svaghedsfølelse i den ene side af kroppen, talebesvær eller nakkesmerter.
English: Patients with clinical symtoms suggesting development of a serious adverse event temporarily associated with the infusion (myocardial ischemia, haemorrhagic stroke, cervico-cephalic arterial dissection or pulmonary alveolar haemorrhage) should be closely monitored until complete resolution of the symptoms.
Danish: Patienter med kliniske symptomer, der tyder på udvikling af en alvorlig bivirkning, der er tidsmæssigt associeret med infusionen (myokardieiskæmi, hæmoragisk apopleksi, dissektion af cerebral arterie eller pulmonal alveolær blødning) skal monitoreres tæt, indtil symptomerne er helt forsvundet.
English: Remind the patient to remain vigilant for symptoms related to autoimmune conditions, and to seek medical help if they have any concerns.
Danish: Mind patienten om at være opmærksom på symptomer, der relaterer sig til autoimmune tilstande, og at søge lægehjælp, hvis der er noget, han/hun er bekymret for.
English: Autoimmune events reported in alemtuzumab-treated patients include neutropenia, haemolytic anaemia (including a fatal case), acquired haemophilia, anti-GBM disease, and thyroid disease.
Danish: Autoimmune tilfælde registreret hos alemtuzumab-behandlede patienter inkluderer neutropeni, hæmolytisk anæmi (herunder ét dødsfald), erhvervet hæmofili, anti-GBM-sygdomme og thyreoidea-sygdomme.
English: Patients treated with LEMTRADA are at a higher risk of developing herpes infection (e.g. a cold sore).
Danish: Patienter, der behandles med LEMTRADA, har højere risiko for at udvikle herpesinfektion (f.eks. forkølelsessår).
English: After this period of time, testing should be performed based on clinical findings suggestive of nephropathies.
Danish: Efter denne periode skal der udføres analyser baseret på kliniske fund, der kan tyde på nefropatier.
English: • inflammation of the mouth/gums/tongue
Danish: • betændelseslignende tilstand (inflammation) i mund, gummer eller tunge
English: Signs and symptoms of ITP are described in section 4.
Danish: Tegn og symptomer på ITP er beskrevet under punkt 4.
English: LEMTRADA Patient Guide.
Danish: LEMTRADA behandlingsforløb.
English: Premedication, general health, and pregnancy and contraception checks immediately before treatment Infusion instructions (before, during and after) to reduce risk for serious reactions temporally associated with the Lemtrada infusion Monitoring activities during treatment and for at least 48 months after last treatment A specific reference to the fact that the patient has been informed and understands the risks of serious autoimmune disorders, infections and malignancies, and the measures to minimize them The patient guide shall contain the following key messages: A description of the risks associated with the use of LEMTRADA namely: Immune Thrombocytopenic Purpura (ITP) Nephropathies, including anti-Glomerular Basement Membrane (anti-GBM) disease Thyroid disorders Serious infections Other secondary autoimmune or immune system diseases, including HLH, AIH, and acquired haemophilia A. Serious reactions temporally associated with LEMTRADA infusion, including myocardial ischemia, hemorrhagic stroke, cervico-cephalic arterial dissection and pulmonary alveolar haemorrhage .
Danish: Præmedicinering, generel helbredsstatus samt graviditets- og præventionskontrol umiddelbart inden behandling Infusionsvejledning (før, under og efter) med henblik på at reducere tidsmæssigt associerede alvorlige reaktioner ved LEMTRADA infusion Monitoreringer under behandlingen og i mindst 48 måneder efter den sidste behandling En specifik angivelse af, at patienten er blevet informeret og forstår risiciene ved alvorlige autoimmune lidelser, infektioner og maligniteter samt forholdsreglerne for at minimere dem Patientvejledningen skal indeholde følgende hovedpunkter: En beskrivelse af de risici, der er forbundet med brugen af LEMTRADA, dvs.: Immun trombocytopenisk purpura (ITP) Nefropati, herunder anti-glomerulær basalmembran-sygdom (anti-GBM-sygdom) Thyreoidea-lidelser Alvorlige infektioner Andre sekundære autoimmune sygdomme og sygdomme i immunsystemet, inklusive HLH, AIH og erhvervet hæmofili A. Alvorlige reaktioner tidsmæssigt associeret med LEMTRADA infusion, inklusive myokardieiskæmi, hæmoragisk apopleksi, dissektion af cerebral arterie og pulmonal alveolær blødning.
English: • autoimmune over-active or under-active thyroid gland, thyroid antibodies or goitre (swelling of the thyroid gland in the neck)
Danish: • autoimmun over-aktiv eller under-aktiv skjoldbruskkirtel, skjoldbruskkirtel antistoffer eller hævelse af skjoldbruskkirtlen i halsen (struma)
English: Contusion, infusion related reaction
Danish: Kontusion, infusionsrelate ret reaktion
English: Autoimmune hepatitis and hepatic injury
Danish: Autoimmun hepatitis og leverskade
English: • muscular and bone pain, chest discomfort
Danish: • muskel- og knoglesmerter, ubehag i brystet
English: • Thyroid disorders such as over-active or under-active thyroid gland
Danish: • Lidelser i skjoldbruskkirtlen såsom overaktiv eller underaktiv skjoldbruskkirtel
English: • increased sensation, sensory disturbance such as numbness, tingling and pain, tension headache
Danish: • øget følsomhed i huden, føleforstyrrelse som følelsesløshed, prikkende fornemmelse og smerte, spændingshovedpine
English: A reproductive toxicity study in pregnant mice exposed to intravenous doses of alemtuzumab up to 10 mg/kg/day (AUC 2.4 times the human exposure at the recommended dose of 12 mg/day) for 5 consecutive days during gestation resulted in significant increases in the number of dams with all conceptuses dead or resorbed, along with a concomitant reduction in the number of dams with viable foetuses.
Danish: Et studie af reproduktionstoksicitet hos drægtige mus eksponeret for intravenøse doser af alemtuzumab op til 10 mg/kg/dag (AUC 2,4 gange human eksponering ved den anbefalede dosis på 12 mg/dag) i 5 på hinanden følgende dage under drægtighedsperioden medførte en signifikant stigning i antallet af moderdyr, hvor alle fostre var døde eller resorberede, sammen med en ledsagende reduktion i antallet af moderdyr med levedygtige fostre.
English: Tell your doctor right away if you have symptoms of infection such as fever, or swollen glands.
Danish: Fortæl det straks til lægen, hvis du har symptomer på infektion som f.eks. feber eller hævede kirtler.
English: In alignment with the effect on relapse rate, supportive analyses from Study 1 (CAMMS323) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (61% reduction, p=0.0056) and signficantly fewer relapses that led to steroid treatment (58%
Danish: På linje med effekten på attakhyppighed viste understøttende analyser fra Studie 1 (CAMMS323), at LEMTRADA 12 mg/dag medførte signifikant færre LEMTRADA-behandlede patienter, der oplevede alvorlige attakker (61% reduktion, p = 0,0056), og signifikant færre attakker, der medførte steroidbehandling (58% reduktion, p < 0,0001) sammenlignet med IFNβ-1a.
English: Duration of extension
Danish: Varighed af opfølgning
English: If you develop one or more of the following symptoms report this to your doctor: nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellow skin or eyes, dark urine, or bleeding or bruising more easily than normal.
Danish: Hvis du får et eller flere af følgende symptomer, skal du fortælle det til lægen: kvalme, opkastning, mavesmerter, træthed, manglende appetit, gulfarvning af huden og det hvide i øjnene, mørkfarvet urin eller øget tendens til blødning eller til at få blå mærker.
English: Educate patients on the signs and symptoms of acquired haemophilia A and to seek immediate medical attention, if any of these symptoms are observed.
Danish: Patienterne skal oplyses om tegn og symptomer på erhvervet hæmofili A og instrueres i at søge øjeblikkelig lægehjælp, hvis et eller flere af disse symptomer opstår.
English: There is no LEMTRADA treatment between the two courses.
Danish: Mellem de to forløb får du ingen behandling med LEMTRADA.
English: Animal data have shown effects on fertility in humanised mice (see section 5.3), however a potential impact on human fertility during the period of exposure is unknown based on the available data.
Danish: 5.3), men baseret på de tilgængelige data er det ukendt, om der er en potentiel påvirkning af human fertilitet i eksponeringsperioden.
English: • If the patient shows clinical symptoms suggesting development of a serious adverse event associated with the infusion (myocardial ischemia, hemorrhagic stroke, cervico-cephalic arterial dissection or pulmonary alveolar haemorrhage
Danish: • Hvis patienten udviser kliniske symptomer, der tyder på en alvorlig bivirkning, der er associeret med infusionen (myokardieiskæmi, hæmoragisk apopleksi, dissektion af cerebral arterie eller pulmonal alveolær blødning
English: In clinical trials, infusion associated reactions (IARs) were defined as any adverse event occurring during or within 24 hours of LEMTRADA infusion.
Danish: I kliniske studier blev IAR'er defineret som enhver bivirkning, der opstår under eller inden for 24 timer efter infusion af LEMTRADA.
English: • Second treatment course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after the first treatment course.
Danish: • 2. behandlingsforløb: 12 mg/dag på 3 fortløbende dage (samlet dosis 36 mg) 12 måneder efter det første behandlingsforløb.
English: The mechanism by which LEMTRADA exerts its therapeutic effects in MS is not fully elucidated.
Danish: Det er ikke fuldt belyst, via hvilke mekanismer LEMTRADA udøver dets terapeutiske effekter.
English: Annualised Relapse rate (ARR) (95% CI)
Danish: Årlig attakhyppighed (ARR) (95% CI)
English: LEMTRADA contains sodium and potassium
Danish: LEMTRADA indeholder natrium og kalium
English: therapy (≥1 drug used)
Danish: MS-behandling (≥ 1
English: Some patients, if they have symptoms or signs of MS disease after the initial two courses, may receive one or two additional treatment courses consisting of one infusion per day for 3 days .
Danish: Nogle patienter kan få et eller to yderligere behandlingsforløb bestående af én infusion hver dag i 3 dage, hvis de har symptomer eller tegn på MS-sygdom efter de første to behandlingsforløb.
English: Uncommonly, patients developed a bleeding disorder caused by antibodies that work against factor VIII (a protein needed for normal clotting of blood), called acquired hemophilia A. This condition must be diagnosed and treated immediately.
Danish: Ualmindeligvis har patienter udviklet en blødningssygdom, som hedder erhvervet hæmofili A, der skyldes, at antistoffer modarbejder faktor-VIII (et protein der er nødvendigt for at blodet kan størkne).
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer)
English: Therefore, women of childbearing potential have to use effective contraception when receiving a course of treatment with LEMTRADA and up to 4 months after each course of treatment.
Danish: Kvinder i den fertile alder skal derfor bruge effektiv antikonception under et behandlingsforløb med LEMTRADA og i op til 4 måneder efter hvert behandlingsforløb.
English: After this period of time, testing should be performed based on clinical findings suggestive of ITP.
Danish: Efter denne periode skal prøven tages, hvis der er kliniske fund, som tyder på ITP.
English: This medicine contains less than 1 mmol sodium (23 mg) per infusion, i.e. it is essentially ‘sodium- free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per infusion, dvs. det i det væsentlige er ‘natriumfrit'.
English: • water for injections
Danish: • vand til injektionsvæske
English: • trembling, loss of sensation, burning or prickling sensation
Danish: • rysten, følelsesløshed, sviende eller prikkende følelse
English: This medicine contains less than 1 mmol potassium (39 mg) per infusion, i.e. it is essentially ‘potassiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol kalium (39 mg) per infusion, dvs. det i det væsentlige er ‘kaliumfrit'.
English: If an additional course is administered, safety-follow up should be continued until at least 48 months after the last infusion.
Danish: Hvis der gives yderligere behandlingsforløb, fortsættes sikkerhedsopfølgningen i mindst 48 måneder efter den sidste infusion.
English: In a controlled clinical trial in MS patients recently treated with beta interferon and glatiramer acetate were required to discontinue treatment 28 days before initiating treatment with LEMTRADA.
Danish: Der er ikke udført formelle lægemiddelinteraktionsstudier med LEMTRADA i den anbefalede dosis hos patienter med MS. I et kontrolleret klinisk studie med MS skulle patienter, der for nylig var behandlet med beta interferon og glatirameracetat, være ophørt med behandlingen 28 dage før start af behandling med LEMTRADA.
English: • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Danish: • Patienter med hurtigt udviklende svær recidiverende-remitterende multipel sclerose defineret ved 2 eller flere invaliderende attakker på ét år og med 1 eller flere gadolinium-opladende læsioner ved MR-hjernescanning eller en signifikant stigning i T2-læsionsbyrden sammenlignet med en tidligere nylig MR-scanning.
English: • listeriosis/listeria meningitis
Danish: • listeriose (infektion med bakterien Listeria monocytogenes)/listeria meningitis
English: Each vial contains 12 mg alemtuzumab in 1.2 ml.
Danish: Hvert hætteglas indeholder 12 mg alemtuzumab i 1,2 ml.
English: Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).
Danish: Hvert hætteglas indeholder 12 mg alemtuzumab i 1,2 ml (10 mg/ml).
English: You should report to your doctor if you have symptoms such as stomach pain or discomfort, fever, nausea or vomiting.
Danish: Du bør fortælle det til din læge, hvis du har symptomer som mavesmerter eller ubehag, feber, kvalme eller opkastning.
English: Placental transfer and potential pharmacologic activity of LEMTRADA were observed in mice during gestation and following delivery.
Danish: Placentapassage og potentiel farmakologisk virkning af LEMTRADA blev registreret hos mus under drægtighed og efter fødslen.
English: Symptoms of acute acalculous cholecystitis include abdominal pain, abdominal tenderness, fever, nausea, and vomiting.
Danish: Symptomer på akut acalculøs cholecystitis omfatter mavesmerter, ømhed i maven, feber, kvalme og opkastning.
English: Cervical dysplasia, amenorrhoea
Danish: Cervikal dysplasi, amenorre
English: Autoimmune thyroiditis including thyroiditis subacute, goitre, anti-thyroid antibody positive
Danish: Autoimmun tyreoiditis herunder subakut tyreoiditis, struma, antityreoidantistofpositiv
English: Renal or hepatic impairment LEMTRADA has not been studied in patients with renal or hepatic impairment.
Danish: Nedsat nyre- eller leverfunktion Behandling med LEMTRADA er ikke undersøgt hos patienter med nedsat nyre- eller leverfunktion.
English: Infusion-associated Reactions (IARs)
Danish: Infusionsrelaterede reaktioner (IAR'er)
English: • vision problems, conjunctivitis, eye disease associated with thyroid disease
Danish: • synsproblemer, øjenbetændelse med røde øjne og tåreflåd, øjensygdom forbundet med sygdom i skjoldbruskkirtlen
English: LEMTRADA 12 mg sterile concentrate alemtuzumab
Danish: LEMTRADA 12 mg koncentrat, sterilt alemtuzumab i.v.
English: Atrial fibrillation*
Danish: Atrieflimren*
English: Study design/demographics for Studies 1, 2, 3 and 4 are shown in Table 2 Table 2: Study Design and Baseline Characteristics for Studies 1, 2, 3 and 4 Study 1
Danish: Tabel 2: Studiedesign og baseline-karakteristika for studie 1,2, 3 og 4 Studie 1
English: Dissection of the cervicocephalic arteries
Danish: Dissektion af cerebral arterie
English: The MAH shall ensure that, following agreement with the National Competent Authorities in each Member State where LEMTRADA is marketed, at launch and after launch, all physicians who intend to prescribe LEMTRADA are provided with an updated physician educational pack containing the following elements: The Summary of Product Characteristics HCP guide Prescriber checklist Patient guide Patient alert card The HCP guide shall contain the following key messages: 1.
Danish: Indehaveren af markedsføringstilladelsen skal ved markedsføringen og efter markedsføringen sikre, at alle læger, som har til hensigt at ordinere LEMTRADA, efter aftale med de relevante nationale myndigheder i hver medlemsstat, hvor LEMTRADA markedsføres, får tilsendt en opdateret uddannelsespakke til læger med følgende indhold: Produktresuméet Vejledning til sundhedspersonale Tjekliste til den ordinerende læge Patientvejledning Patientkort Vejledningen til sundhedspersoner skal indeholde følgende hovedpunkter: LEMTRADA-behandling skal 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.
English: Reported autoimmune conditions, include thyroid disorders, immune thrombocytopenic purpura (ITP), nephropathies (e.g. anti-glomerular basement membrane disease), autoimmune hepatitis (AIH), and acquired haemophilia A. In the post-marketing setting, patients developing multiple autoimmune disorders after LEMTRADA treatment have been observed.
Danish: Rapporterede autoimmune lidelser omfatter thyreoidealidelser, immuntrombocytopenisk purpura (ITP), nefropatier (f.eks. anti-glomerulær basalmembran (anti-GBM)sygdom), autoimmun hepatitis (AIH) og erhvervet hæmofili A. Efter markedsføring er der rapporteret om patienter, der har udviklet flere autoimmune lidelser efter LEMTRADA-behandling.
English: Haemophagocytic lymphohistiocytosis (HLH)
Danish: Hæmofagocytisk lymfohistiocytose (HLH)
English: Sensory disturbance, hyperaesthesia, tension headache
Danish: Sensoriske forstyrrelser, hyperæstesi, spændingshov edpine
English: Do not use if particulate matter is present or the concentrate is discoloured.
Danish: Lægemidlet må ikke anvendes, hvis der er partikler i koncentratet, eller hvis det er misfarvet.
English: Patients with a history of arterial dissection of the cervicocephalic arteries.
Danish: Patienter med dissektion af cerebral arterie i anamnesen.
English: • Haemophagocytic lymphohistiocytosis
Danish: • Hæmofagocytisk lymfohistiocytose
English: Contact details of the prescriber of LEMTRADA
Danish: Kontaktdata for den læge, der ordinerer LEMTRADA
English: In RRMS patients experience relapses followed by periods of recovery.
Danish: Patienter, der lider af RRMS, oplever attakker, der efterfølges af symptomfri perioder.
English: Serious and sometimes fatal IARs including bronchospasm, hypoxia, syncope, pulmonary infiltrates, acute respiratory distress syndrome , respiratory arrest, myocardial infarction, arrhythmias, acute cardiac insufficiency, and cardiac arrest have been observed in non-MS patients treated with alemtuzumab at higher and more frequent doses than used in MS.
Danish: Der er registreret alvorlige, til tider dødelige infusionsrelaterede reaktioner, herunder bronkospasme, hypoxi, synkope, lungeinfiltrater, akut respiratorisk distress syndrom, respirationsstop, myokardieinfarkt, arytmi, akut hjerteinsufficiens og hjertestop hos ikke-MS-patienter behandlet med alemtuzumab ved højere og hyppigere doser end de, der anvendes ved MS.
English: 1 Patient Alert Card: For the patient to present to other healthcare providers to alert them to the use of LEMTRADA in this patient.
Danish: Til patienten til at vise til andet sundhedspersonale for at gøre opmærksom på, at denne patient er i behandling med LEMTRADA.
English: • potassium dihydrogen phosphate (E340)
Danish: • kaliumdihydrogenfosfat (E340)
English: Myocardial ischaemia and myocardial infarction
Danish: Myokardieiskæmi og myokardieinfarkt
English: The vial contents should be inspected for particulate matter and discoloration prior to administration.
Danish: Indholdet af hætteglasset skal inspiceres for synlige partikler og misfarvning før anvendelse.
English: Pulmonary alveolar haemorrhage
Danish: Pulmonal alveolær blødning
English: Patients in clinical trials in MS had serum samples collected 1, 3, and 12 months after each treatment course for determination of antialemtuzumab antibodies.Approximately 85% of patients receiving LEMTRADA tested positive for antialemtuzumab antibodies during the study, with ≥90% of these patients testing positive also for antibodies that inhibited alemtuzumab binding in vitro.
Danish: Cirka 85% af de patienter, der fik LEMTRADA, blev testet positive for anti-alemtuzumab-antistoffer i løbet af studiet, og ≥90% af disse patienter blev også testet positive for antistoffer, der hæmmede alemtuzumab-binding in vitro.
English: Patients should be informed about the signs and symptoms and on the time to onset of the events.
Danish: Patienten skal oplyses om tegn og symptomer på bivirkninger og om, hvornår de kan indtræde.
English: Patients should be pre-treated with corticosteroids immediately prior to LEMTRADA administration on each of the first 3 days of any treatment course.
Danish: Patienten bør præmedicineres med kortikosteroider umiddelbart inden behandling med LEMTRADA de første 3 dage i begge behandlingsforløb.
English: In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.
Danish: I kliniske studier fik patienterne 200 mg aciclovir to gange om dagen eller behandling ækvivalent hermed.
English: % receiving ≥2 prior MS
Danish: Andel, der tidligere har fået ≥ 2 MSbehandlinger
English: Varicella zoster virus antibody testing/vaccination
Danish: Test af/vaccination mod varicel-zoster-virusantistoffer
English: Women of childbearing potential should use effective contraceptive measures during treatment and for 4 months following a course of LEMTRADA treatment (see section 4.6).
Danish: Kvinder i den fertile alder skal anvende sikker antikonception under behandlingen og i 4 måneder efter et behandlingsforløb med LEMTRADA (se pkt.
English: You should also continue looking for signs and symptoms of side effects beyond four years as detailed in your patient guide, and you should continue carrying the Patient Alert Card with you.
Danish: efter de fire år er forløbet, sådan som det er beskrevet i patientvejledningen, og du skal fortsætte med at have patientkortet på dig.
English: Headache*
Danish: kuldegysninger*
English: Patients should be informed about symptoms of HLH and time to onset.
Danish: Patienterne skal informeres om symptomerne på HLH og om, hvornår de kan indtræde.
English: If you are given more LEMTRADA than you should receive
Danish: Hvis du får for meget LEMTRADA
English: LEMTRADA contains potassium and sodium
Danish: LEMTRADA indeholder kalium og natrium
English: Dyspnoea*, cough, epistaxis, hiccups, oropharyngeal pain, asthma
Danish: Dyspnø*, hoste, epistaxis, hikke, orofaryngeal smerte, astma,