FrancophonIA/ELRC3.0 huggingface dataset:
English: Some of the IARs (e.g. dizziness) could temporarily impact the patient's ability to drive or use machines and caution should be exercised until these are resolved.
Danish: Visse af disse infusionsrelaterede reaktioner (f.eks. svimmelhed) kan midlertidigt påvirke patientens evne til at føre motorkøretøj og betjene maskiner, og der skal derfor udvises forsigtighed, indtil de forsvinder.
English: LEMTRADA adjusts your immune system to limit its attacks on your nervous system.
Danish: LEMTRADA virker ved at påvirke immunsystemet, så det begrænser angrebene på nervesystemet.
English: • fever and/or chills
Danish: • feber og/eller kulderystelser
English: Blood test
Danish: Blodprøve
English: LEMTRADA is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate) that comes in a glass vial with stopper.
Danish: LEMTRADA er et klart, farveløst til let gulligt koncentrat til infusionsvæske, opløsning (sterilt koncentrat), som leveres i et hætteglas af glas med prop.
English: If ITP onset is confirmed, appropriate medical intervention should be promptly initiated, including immediate referral to a specialist.
Danish: Hvis der registreres ITP, skal relevant medicinsk behandling igangsættes straks, herunder øjeblikkelig henvisning til en specialist.
English: In clinical trials, patients were pre-treated with 1,000 mg methylprednisolone for the first 3 days of each LEMTRADA treatment course.
Danish: I kliniske studier blev patienter præmedicineret med 1.000 mg methylprednisolon de første 3 dage i begge behandlingsforløb med LEMTRADA.
English: Resources for the management of anaphylaxis or serious reactions (see below) should be available.
Danish: Der skal være udstyr til rådighed til håndtering af anafylaktiske reaktioner eller andre alvorlige reaktioner (se nedenstående).
English: IARs may occur in patients despite pretreatment.
Danish: IAR kan opstå trods præmedicinering.
English: • exaggerated immune response
Danish: • overdrevet immunreaktion (allergisk reaktion)
English: Patients were treated with LEMTRADA 12 mg/day (N=108) or 24 mg/day (N=108) administered once per day for 5 days at month 0 and for 3 days at month 12 or subcutaneous IFNB-1a 44 µg (N=107) administered 3 times per week for 3 years.
Danish: Patienterne blev behandlet med LEMTRADA 12 mg/dag (N = 108) eller 24 mg/dag (N = 108), givet én gang dagligt i 5 dage i måned 0 og i 3 dage ved -mMåned 12, eller med IFNβ-1a 44 µg s.c. (N = 107) administreret 3 gange om ugen i 3 år.
English: • Decrease in white blood cell numbers (lymphocytes, leukocytes, neutrophils)
Danish: • Nedsat antal hvide blodlegemer (lymfocytter, leukocytter, neutrofile granulocytter)
English: Before treatment, patients must be informed about the risks and benefits, and the need to commit to follow-up from treatment initiation until at least 48 months after the last infusion of the second LEMTRADA treatment course.
Danish: Før behandlingen skal patienterne informeres om risici og fordele ved behandlingen og nødvendigheden af at forpligte sig til opfølgning fra behandlingsstart i mindst 48 måneder efter den sidste infusion i det 2.
English: Proteinuria, haematuria
Danish: Proteinuri, hæmaturi
English: • Use aseptic techniques to withdraw 1.2 ml of LEMTRADA from the vial and inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Danish: • Brug aseptisk teknik til at trække 1,2 ml LEMTRADA fra hætteglasset og injicere det i 100 ml 9 mg/ml (0,9%) natriumchlorid-infusionsvæske eller (5%) glucose-infusionsvæske.
English: Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Polysorbate 80 (E433) Sodium chloride
Danish: Kaliumchlorid E508) Kaliumdihydrogenphosphat (E340) Polysorbat 80 (E433) Natriumchlorid
English: Educational programme Prior to launch in each Member State the MAH shall agree an educational programme for HCPs and patients with the National Competent Authority.
Danish: Uddannelsesprogram Inden markedsføring i hver medlemsstat skal indehaveren af markedsføringstilladelsen indgå aftale med de relevante nationale myndigheder om et uddannelsesprogram for sundhedspersoner og patienter.
English: • An oral anti-herpes agent should be administered to all patients during and for 1 month following treatment.
Danish: • Der skal gives oral profylakse mod herpes til alle patienter under behandlingen og i 1 måned derefter.
English: Patients with active MS, defined as at least 2 relapses within the prior 2 years and 1 or more contrastenhancing lesions
Danish: Patienter med aktiv MS, defineret som mindst 2 attakker inden for de foregående 2 år og 1 eller flere kontrastforstærkende læsioner
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL/VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET/HÆTTEGLAS
English: HLH is characterized by fever, hepatomegaly and cytopenias.
Danish: HLH er karakteriseret ved feber, hepatomegali og cytopenier.
English: Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology.
Danish: Alemtuzumab er et monoklonalt antistof, der produceres ved rekombinant DNA-teknolog i en pattedyrscelle (ovarie fra kinesisk hamster) suspensionskultur i et dyrkningsmedium.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har vist reproduktionstoksicitet (se pkt.
English: Serious events of ITP have been observed in 12 (1%) patients treated in controlled clinical trials in MS (corresponding to an annualised rate 4.7 events/1000 patient years).
Danish: Der er observeret alvorlige tilfælde af ITP hos 12 patienter (1%), der blev behandlet i kontrollerede kliniske MS-studier (svarende til 4,7 hændelser på årsbasis/1000 patientår).
English: Very commonly, patients have experienced an autoimmune disorder of the thyroid gland affecting its ability to make or control hormones that are important for your metabolism.
Danish: Mange patienter har oplevet en autoimmun lidelse i skjoldbruskkirtlen, der påvirker dennes evne til at producere eller kontrollere hormoner, der er vigtige for stofskiftet.
English: • Autoimmune conditions
Danish: • Autoimmune tilstande
English: While not observed in clinical trials, alveolar haemorrhage manifested as haemoptysis may occur with anti-GBM disease.
Danish: Selvom det ikke er observeret i kliniske studier, kan der opstå alveolær blødning, der viser sig som hæmoptyse, i forbindelse med anti-GBM-sygdom.
English: In mothers with Graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing foetus and can cause transient neonatal Graves' disease.
Danish: Hos mødre med Basedows sygdom kan maternelle TSH (thyreoideastimulerende hormon)-receptor-antistoffer overføres til fostret og medføre forbigående neonatal Basedows sygdom.
English: The alpha half-life approximated 4-5 days and was comparable between courses leading to low or undetectable serum concentrations within approximately 30 days following each treatment course.
Danish: Den initiale (α) halveringstid var ca. 4-5 dage, var sammenlignelig mellem de 2 forløb og medførte lave eller ikke-detekterbare serumkoncentrationer inden for ca. 30 dage efter hvert behandlingsforløb.
English: Thyroid disease (see section 4.4 Thyroid Disorders) poses special risks in women who are pregnant.
Danish: 4.4 Lidelser i thyreoidea) er specielt risikabelt for gravide kvinder.
English: • Other serious reactions occurring shortly after LEMTRADA infusion
Danish: • Andre alvorlige bivirkninger, der er opstået kort tid efter infusion med LEMTRADA
English: In case of serious reactions, the infusion may be slowed down or even stopped.
Danish: I tilfælde af alvorlige reaktioner kan man nedsætte infusionshastigheden eller helt stoppe infusionen.
English: • First treatment course: 12 mg/day on 5 consecutive days (60 mg total dose)
Danish: • 1. behandlingsforløb: 12 mg/dag på 5 fortløbende dage (samlet dosis 60 mg)
English: Additionally, the observed incidence of antibody (including inhibitory antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medicines, and underlying disease.
Danish: Derudover kan den observerede incidens for antistof- (herunder hæmmende antistof) positivitet i en analyse være påvirket af flere faktorer, herunder analysemetode, prøvehåndtering, tidspunkt for prøveindsamling, anden samtidig lægemiddelbehandling samt underliggende sygdom.
English: Patients typically present with spontaneous subcutaneous haematomas and extensive bruising although haematuria, epistaxis, gastrointestinal or other types of bleeding may occur.
Danish: Patienterne får typisk spontane subkutane hæmatomer og omfattende blå mærker, om end der kan forekomme hæmaturi, epistaxis og gastrointestinale eller andre typer af blødning.
English: Reactions have occurred following any of the doses and also after course number 2.
Danish: Reaktionerne er forekommet efter flere forskellige doser og også efter andet behandlingsforløb.
English: • sodium chloride
Danish: • natriumchlorid
English: There were no external, soft tissue, or skeletal malformations or variations observed at doses up to 10 mg/kg/day.
Danish: Der blev ikke observeret eksterne misdannelser, misdannelser i bløddele eller skeletmisdannelser ved doser på til 10 mg/kg/dag.
English: • Infections: airway infections such as colds and sinus infections, urinary tract infections, herpes infections
Danish: • Infektioner: infektioner i luftvejene som f.eks. forkølelse og bihulebetændelse, urinvejsinfektioner, herpes infektioner
English: • excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis)
Danish: • overaktivering af hvide blodlegemer i forbindelse med inflammation (hæmofagocytisk lymfohistiocytose)
English: If you notice any of these signs or symptoms for bleeding or kidney disorders, call your doctor immediately to report the symptoms.
Danish: Hvis du bemærker nogle af disse tegn eller symptomer på blødningsforstyrrelser eller nyrelidelser, skal du straks kontakte lægen for at fortælle om symptomerne.
English: Uncommon Rare
Danish: Almindelig Ikke almindelig
English: How LEMTRADA will be administered 4.
Danish: Sådan får du LEMTRADA 4.
English: Haemoptysis may also be indicative of ITP or acquired haemophilia A (see above), and an appropriate differential diagnosis has to be undertaken.
Danish: Hæmoptyse kan også være indikativ for ITP eller erhvervet hæmofili A (se ovenfor), og der skal udføres en relevant differentialdiagnostisk undersøgelse.
English: Patients treated with LEMTRADA are at a higher risk of getting a serious infection (see section 4infections).
Danish: Patienter, der bliver behandlet med LEMTRADA, har en højere risiko for at få en alvorlig infektion (se punkt 4 - infektioner).
English: Patients should be advised to seek immediate medical attention if any of these symptoms occur and be informed on the potential for delayed onset.
Danish: Patienten skal rådes til straks at søge læge, hvis et eller flere af disse symptomer opstår og skal oplyses om muligheden for forsinket indtræden.
English: LEMTRADA is supplied in a clear, 2 ml glass vial, with a butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Danish: LEMTRADA leveres i et klart, 2 ml hætteglas med en butylgummiprop og aluminiumshætte med et aftageligt plastiklåg.
English: Patients treated with LEMTRADA are also at a higher risk of developing listeria infection (a bacterial infection caused by ingestion of contaminated foods).
Danish: Patienter, der behandles med LEMTRADA, har ligeledes en højere risiko for at udvikle listeriainfektion (en bakteriel infektion forårsaget af indtagelse af forurenede fødevarer).
English: Specialists and equipment required for the timely diagnosis and management of adverse reactions, especially myocardial ischaemia and myocardial infarction, cerebrovascular adverse reactions, autoimmune conditions, and infections, should be available.
Danish: Specialister og udstyr, der er påkrævet til rettidig diagnosticering og håndtering af bivirkninger, især myokardieiskæmi og myokardieinfarkt, cerebrovaskulære bivirkninger, autoimmune tilstande og infektioner, skal være til rådighed.
English: • Complete blood count with differential, serum transaminases and serum creatinine levels (prior to treatment initiation and at monthly intervals thereafter).
Danish: • Komplet blodtælling med differentialtælling, serumtransaminaser og serumkreatinin (før behandlingsstart og derefter hver måned).
English: SC IFNB-1a (N=202)
Danish: IFNβ-1a s.c. (N = 202)
English: Through 2 treatment courses, there was no association of the presence of anti-alemtuzumab or inhibitory anti-alemtuzumab antibodies with a reduction in efficacy, change in pharmacodynamics, or the occurrence of adverse reactions, including infusion associated reactions.
Danish: Gennem 2 behandlingsforløb var der ingen sammenhæng mellem tilstedeværelse af anti-alemtuzumab eller hæmmende anti-alemtuzumab-antistoffer og reduktion i effektivitet, ændring i farmakodynamiske egenskaber eller forekomst af bivirkninger, herunder IAR'er.
English: Through 6 years from initial LEMTRADA treatment, patients continuing in follow-up showed rates of MS relapse, brain lesion formation on MRI, and brain volume loss consistent with LEMTRADA's treatment effects during Studies 1 and 2 as well as predominantly stable or improved disability scores.
Danish: Gennem 6 års indledende LEMTRADA-behandling viste patienterne, der fortsatte i opfølgningen, antal MSattakker, hjerne læsionsdannelse på MRI og hjernevolumentab, som var i overensstemmelse med LEMTRADAs behandlingseffekter i studie 1 og 2, samt overvejende stabile eller forbedrede invaliditets scorer.
English: Forty-six patients received a third course of LEMTRADA treatment at 12 mg/day or 24 mg/day for 3 days at month 24.
Danish: 46 patienter fik et tredje behandlingsforløb med LEMTRADA på 12 mg/dag eller 24/mg dag i 3 dage ved -mMåned 24.
English: A total of 1,486 patients treated with LEMTRADA (12 mg or 24 mg) constituted the safety population in a pooled analysis of MS clinical studies with a median follow-up of 6.1 years (maximum 12 years), resulting in 8,635 patient-years of safety follow-up.
Danish: I alt 1486 patienter behandlet med LEMTRADA (12 mg eller 24 mg) udgjorde sikkerhedspopulationen i en samlet analyse af kliniske MS studier med en median opfølgning på 6,1 år (maksimalt 12 år), hvilket gav 8635 patientår med sikkerhedsopfølgning.
English: • autoimmune disorder characterized by bleeding (acquired haemophilia A)
Danish: • autoimmun lidelse kendetegnet ved blødning (erhvervet hæmofili A)
English: Most cases occurred within two months of alemtuzumab dosing.
Danish: De fleste tilfælde skete inden for to måneder efter administration af alemtuzumab.
English: Congestive heart failure, cardiomyopathy, and decreased ejection fraction have been reported in alemtuzumab-treated non-MS patients previously treated with potentially cardiotoxic agents.
Danish: Hjertesvigt, kardiomyopati og nedsat ejektionsfraktion er rapporteret hos alemtuzumab-behandlede ikke-MSpatienter, der tidligere er behandlet med potentielt kardiotoksiske stoffer.
English: Inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Danish: Injicer koncentratet i 100 ml 9 mg/ml (0,9%) natriumchlorid-infusionsvæske eller (5%) glucoseinfusionsvæske.
English: LEMTRADA contains the active substance alemtuzumab, which is used to treat a form of multiple sclerosis (MS) in adults, called relapsing remitting multiple sclerosis (RRMS).
Danish: LEMTRADA indeholder det aktive stof alemtuzumab, der anvendes til behandling af den type af multipel sclerose (MS) hos voksne, der kaldes recidiverende-remitterende multipel sclerose (RRMS).
English: The recommended dose of alemtuzumab is 12 mg/day administered by intravenous infusion for 2 initial treatment courses, with up to 2 additional treatment courses if needed.
Danish: Den anbefalede dosis alemtuzumab er 12 mg/dag som intravenøs infusion i 2 indledende behandlingsforløb med op til 2 yderligere behandlingsforløb efter behov.
English: Study name
Danish: Studiets navn
English: • thyroid disorders (very common - may affect more than 1 in 10 people): may show as excessive sweating; unexplained weight-loss or gain; eye swelling; nervousness; fast heartbeat; feeling cold; worsening tiredness; or newly occurring constipation.
Danish: • lidelser i skjoldbruskkirtlen (meget almindelig - kan forekomme hos flere end 1 ud af 10 personer): kan vise sig som overdreven svedtendens; uforklarligt vægttab eller vægtstigning; hævede øjne; nervøsitet; hurtig puls; kuldefølelse; øget træthed; nyopstået forstoppelse.
English: Patients with new or enlarging T2 lesions through Year 2
Danish: Patienter med nye eller forstørrede T2læsioner efter år 2
English: In addition, infections which can result in abnormalities of the cervix (the neck of the womb) are possible.
Danish: Desuden er infektioner, der kan føre til forandringer i livmoderhalsen (cervix), en risiko.
English: During post-marketing use, additional cases of acute acalculous cholecystitis have been reported in LEMTRADA-treated patients.
Danish: Ved brug efter markedsføring er der rapporteret yderligere tilfælde af akut acalculøs cholecystitis hos patienter behandlet med LEMTRADA.
English: • ITP (bleeding disorders), (common - may affect up to 1 in 10 people): may show as small scattered red, pink or purple spots on your skin; easy bruising; bleeding from a cut that is harder to stop; heavier, longer or more frequent menstrual periods than normal; bleeding between menstrual periods; bleeding from your gums or nose that is new or takes longer than usual to stop; or coughing up blood.
Danish: • ITP (blødningsforstyrrelse) (almindelig - kan forekomme hos op til 1 ud af 10 personer): kan vise sig som små, spredte, røde, lyserøde eller violette prikker eller pletter på huden; at du lettere får blå mærker; blødning fra et sår, som er svær at stoppe; kraftigere, længere eller hyppigere menstruationer end normalt; blødning i perioden mellem menstruationerne, blødende gummer eller næseblødning, der er nyopstået, eller som det tager længere end normalt at få stoppet; eller at du hoster blod op.
English: 1 Herpes virus infections include PTs: Oral herpes, Herpes simplex, Genital herpes, Herpes virus infection, Genital herpes simplex, Herpes dermatitis, Ophthalmic herpes simplex, Herpes simplex serology positive.
Danish: 1 Herpes virusinfektioner omfatter: Oral herpes, herpes simplex, genital herpes, herpesvirusinfektion, genital herpes simplex, herpes dermatitis, oftalmisk herpes simplex, positiv herpes simplex-serologi.
English: • Increase in white blood cells counts such as neutrophils, eosinophils (different types of white blood cells) anaemia, decrease in percentage of red blood cells, easy or excessive bruising or bleeding,
Danish: • forøgelse af antallet af hvide blodlegemer, såsom neutrofilocytter, eosinofilocytter (forskellige typer hvide blodlegemer), bleghed og træthed på grund af blodmangel, fald i procent af røde blodlegemer, få eller mange blå mærker eller let eller megen blødning, hævelse af lymfeknuder
English: To reduce the risk of infection, patients receiving LEMTRADA should avoid ingestion of uncooked or undercooked meats, soft cheeses and unpasteurized dairy products two weeks prior to, during, and for at least one month after LEMTRADA infusion.
Danish: For at mindske risikoen for infektion bør patienter, der får LEMTRADA, ikke indtage råt eller delvist råt kød, bløde oste og upasteuriserede mælkeprodukter to uger før, under og i mindst en måned efter LEMTRADA-infusion.
English: Cases of autoimmune hepatitis (including fatal cases and cases requiring liver transplantation) and hepatic injury related to infections have been reported in patients treated with LEMTRADA (see section 4.3).
Danish: Der er rapporteret om autoimmun hepatitis (inklusive tilfælde med dødelig udgang og tilfælde, som krævede levertransplantation) og leverskade, der er relateret til infektioner hos patienter, der er blevet behandlet med LEMTRADA (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with alemtuzumab in children from birth to less than 10 years in treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med alemtuzumab hos børn fra fødslen til under 10 år til behandling af multipel sclerose (se pkt.
English: Serious and sometimes fatal viral, bacterial, protozoan, and fungal infections, including those due to reactivation of latent infections, have been reported in non-MS patients treated with alemtuzumab at higher and more frequent doses than used in MS. Progressive multifocal leukoencephalopathy (PML) has been reported in patients with B-CLL with or without treatment with alemtuzumab.
Danish: Alvorlige og til tider dødelige virale, bakterielle, protozo- og svampeinfektioner, herunder dem, der skyldes reaktivering af latente infektioner, er rapporteret hos ikke-MS-patienter behandlet med alemtuzumab ved højere og hyppigere doser end ved MS. Progressiv multifokal leukoencefalopati (PML) er rapporteret hos patienter med B-CLL med eller uden behandling med alemtuzumab.
English: The pharmacokinetics of alemtuzumab were evaluated in a total of 216 patients with RRMS who received intravenous infusions of either 12 mg/day or 24 mg/day on 5 consecutive days, followed by 3 consecutive days 12 months following the initial treatment course.
Danish: Alemtuzumabs farmakokinetiske egenskaber blev evalueret hos i alt 216 patienter med RRMS, der fik intravenøse infusion af enten 12 mg/dag eller 24 mg/dag i 5 på hinanden følgende dage og derefter i 3 på hinanden følgende dage 12 måneder efter det første behandlingsforløb.
English: • pain in the back, the neck, or in arms or legs, muscle pain, muscle spasms, joint pain, painful mouth or throat
Danish: • smerter i ryg, nakke eller i arme eller ben, muskelsmerter, muskelkramper, ledsmerter, smerter i mund eller hals
English: Therefore, breast-feeding should be discontinued during each course of treatment with LEMTRADA and for 4 months following the last infusion of each treatment course.
Danish: Derfor bør amning afbrydes under alle behandlingsforløb med LEMTRADA og i 4 måneder efter den sidste infusion i hvert behandlingsforløb.
English: Monitoring for side effects and regular testing must continue for 4 years after the last infusion.
Danish: Overvågning af bivirkninger og regelmæssige blod- og urinprøver skal fortsætte i 4 år efter den sidste infusion.
English: Immune Thrombocytopenic Purpura (ITP)
Danish: Immun trombocytopenisk purpura (ITP)
English: Observation for infusion reactions is recommended during and for at least 2 hours after LEMTRADA infusion.
Danish: Det anbefales at observere for infusionsreaktioner under og i mindst 2 timer efter infusion.
English: Non-interventional post-authorisation safety study (PASS): In order to assess compliance with the therapeutic indication and effectiveness of measures to minimise the risk of cardiovascular and cerebrovascular adverse events in close temporal association with Lemtrada infusion and immune-mediated adverse reactions, the MAH shall submit the results of a drug utilisation study.
Danish: Ikke-interventionelt ssikkerhedsstudie efter tilladelse til markedsføring (PASS): For at vurdere komplians med den terapeutiske indikation og effektiviteten af foranstaltninger, der skal minimere risikoen for kardiovaskulære og cerebrovaskulære bivirkninger i tæt tidsmæssig sammenhæng med Lemtrada infusion og immummedierede bivirkninger, skal indehaveren af markedsføringstilladelsen indsende resultaterne af et compliancestudie.
English: Most patients treated with LEMTRADA will experience side-effects at the time of the infusion or within 24 hours after the infusion.
Danish: De fleste af de patienter, der bliver behandlet med LEMTRADA, vil få bivirkninger på tidspunktet for infusionen eller op til 24 timer efter infusionen.