FrancophonIA/ELRC3.0 huggingface dataset:
English: Single intravenous doses of 10 and 30 mg/kg produced moderate to severe dose related hypotension accompanied by a slight tachycardia.
Danish: Enkelte intravenøse doser på 10 og 30 mg/kg fremkaldte moderat til alvorlig dosisrelateret hypotension ledsaget af let takykardi.
English: • tumour lysis syndrome (a metabolic disorder, which may begin with pains in the side and blood in the urine)
Danish: • tumor lysis-syndrom (forstyrrelse i stofskiftet, der begynder med smerte i siden og blod i urinen).
English: Caution should be used in treating patients with ischaemic heart disease, angina and/or in patients receiving an antihypertensive medicinal product.
Danish: Der bør udvises forsigtighed ved behandling af patienter med iskæmisk hjertesygdom, angina og/eller patienter, som behandles med antihypertensiva.
English: Your doctor may give you other medicines or change your dose to help reduce any side effects
Danish: Din læge kan give dig anden medicin eller ændre din dosering for at hjælpe med at reducere evt. bivirkninger (se pkt.
English: MabCampath is not recommended in children below 17 years of age or in patients who have kidney or
Danish: MabCampath må ikke anvendes til børn under 17 år eller til patienter, som har nyre- eller
English: Acute infusion reactions usually occur during the first week of therapy and substantially decline thereafter.
Danish: Akutte reaktioner ved infusion forekommer sædvanligvis under den første behandlingsuge og falder derefter væsentligt.
English: Antibiotics and antivirals should be administered routinely to all patients throughout and following
Danish: Antibiotika og antivirale midler bør rutinemæssigt gives til alle patienter under hele behandlingen og
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Danish: Et monoklonal antistof er et antistof (en type protein), der er beregnet til at genkende og binde sig til en bestemt struktur (et såkaldt antigen), som findes i bestemte celler i kroppen.
English: The safety and efficacy of MabCampath in children aged less than 17 years of age have not been
Danish: MabCampaths sikkerhed og virkning hos børn under 17 år er ikke klarlagt.
English: MabCampath Fab binding was observed in lymphoid tissues and the mononuclear phagocyte system.
Danish: MabCampath Fab-binding blev observeret i lymfoide væv og det mononukleære fagocytsystem.
English: EBV-associated lymphoproliferative disorders, in some cases fatal, have been reported.
Danish: Der er indberettet EBV-relateret lymfoproliferativ sygdom, i nogle tilfælde fatal.
English: The secondary objectives included complete response (CR) and overall response (CR or partial response) rates using the 1996 NCIWG criteria, the duration of response, time to alternative treatment and safety of the two treatment arms.
Danish: De sekundære mål omfattede komplet respons (CR) og samlet respons (CR eller delvis respons), grader ved anvendelse af 1996 NCIWG kriterierne, respons-varighed, tid til alternativ behandling og sikkerhed i de to behandlingsgrene.
English: Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with sugar molecules) that is found on the surface of lymphocytes.
Danish: Alemtuzumab er designet, så det kan binde sig til et glykoprotein (et protein, der er dækket af sukkermolekyler), som findes på lymfocytters overflade.
English: These symptoms can be ameliorated or avoided if premedication and dose escalation are utilised (see section 4.4).
Danish: Disse symptomer kan mindskes eller undgås, hvis der anvendes præmedikation og dosisoptrapning (se pkt.
English: Diseases related to an overactive immune system where your immune system attacks your own body can lead to low red blood cells, low blood platelets and/or low white blood cells, and nerve disorders, and these can also be fatal.
Danish: Sygdomme relateret til et overaktivt immunsystem, hvor dit immunsystem angriber din egen krop, kan medføre et lavt antal røde blodlegemer, et lavt antal blodplader og/eller hvide blodlegemer og neurologiske sygdomme, og disse kan ligeledes være dødelige.
English: The cytogenetic profile of B-CLL has been increasingly recognized as providing important prognostic information and may predict response to certain therapies.
Danish: Den cytogenetiske profil af B-CLL vinder stigende anerkendelse som givende vigtige prognostiske informationer, og den kan forudsige respons på visse behandlinger.
English: The tables below report adverse reactions by MedDRA system organ classes (MedDRA SOCs).
Danish: Nedenstående tabeller rapporterer bivirkninger efter MedDRA-systemets organklasser (MedDRA SOCs).
English: Undesirable effects in first line patients
Danish: Bivirkninger hos 1. linje-patienter
English: Caution should be exercised in the handling and preparation of the MabCampath solution.
Danish: Der skal udvises forsigtighed ved håndtering og tilberedning af opløsning med MabCampath.
English: Transient hypotension has occurred in patients receiving MabCampath.
Danish: Forbigående hypotension er forekommet hos patienter, der får MabCampath.
English: The MAH shall ensure that all doctors who prescribe MabCampath are provided with a healthcare professional information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der foreskriver MabCampath, modtager en informationspakke til sundhedspersonalet der indeholder følgende:
English: A trend towards improved PFS was observed in patients with 17p deletion, trisomy 12 and normal karyotype, which did not reach significance due to small sample size.
Danish: Der observeredes en tendens til forbedret PFS hos patienter med 17 q deletion, trisomi 12 og normal karyotype, som ikke nåede signifikans på grund af den lille
English: The frequency of infusion reactions was highest in the first week of therapy, and declined in the second or third week of treatment, in patients treated with MabCampath both as first line therapy and in previously treated patients.
Danish: Hyppigheden af infusionsreaktioner var højest i den første behandlingsuge og faldt i den anden eller tredje behandlingsuge hos patienter behandlet med MabCampath både som 1. linje-behandling og hos tidligere behandlede patienter.
English: Myocardial infarction and cardiac arrest have been observed in association with MabCampath infusion in this patient population.
Danish: Myokardieinfarkt og hjertestop er blevet observeret i forbindelse med infusion af MabCampath til denne patientpopulation.
English: It is not known if MabCampath can cause foetal harm when administered to a pregnant woman.
Danish: Det vides ikke, om MabCampath kan forårsage skade på fosteret, hvis det gives til en gravid kvinde.
English: Fatal Transfusion Associated Graft Versus Host Disease (TAGVHD) has also been reported.
Danish: Tilfælde med TAGVHD (Fatal Transfusion Associated Graft Versus Host Disease) er også indberettet.
English: Summary of first-line patient population and outcomes Independent review of response rate and duration MabCampath n=149
Danish: Resumé af 1. linje-patientpopulation og resultater Uafhængig oversigt over responsgrad og varighed MabCampath n=149
English: Blood and lymphatic system disorders: Severe bleeding reactions have been reported.
Danish: Sygdomme i blod- og lymfesystem: Der er indberettet alvorlige blødningsreaktioner.
English: There is no known specific antidote for MabCampath.
Danish: Der findes ingen kendt specifik antidot mod MabCampath.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC04.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC04.
English: Profound lymphocyte depletion, an expected pharmacological effect of MabCampath, inevitably occurs and may be prolonged.
Danish: Svær reduktion af lymfocyttallet, en forventet farmakologisk virkning af MabCampath, forekommer altid og kan være langvarig.
English: Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and the vial label.
Danish: Brug ikke MabCampath efter den udløbsdato (EXP), der står på pakningen og hætteglassets etiket.
English: Women who are pregnant or trying to become pregnant should not handle
Danish: Kvinder, der er gravide eller som prøver at blive gravide,
English: You should inform your doctor if you experience any unusual symptoms after a transfusion.
Danish: Informer din læge, hvis du kommer ud for ikke-almindelige symptomer efter en
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.
Danish: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Storbritannien Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland Bayer Schering Pharma AG, Müllerstraße 178, 13342 Berlin, Tyskland.
English: The antibody mediates the lysis of lymphocytes via complement fixation and antibody-dependent cell mediated cytotoxicity.
Danish: Antistoffet medierer lysen af lymfocytter via komplementfiksering og antistofafhængig cellemedieret cytotoksicitet.
English: • Recommendation to avoid vaccination with live vaccines for at least 12 months following MabCampath therapy
Danish: ● Anbefaling om at undlade vaccination med levende vacciner i mindst 12 måneder efter MabCampath-behandlingen
English: Although it has not been studied, it is recommended that patients should not receive live viral vaccines in, at least, the 12 months following MabCampath therapy.
Danish: Selv om det ikke er undersøgt, anbefales det, at patienterne ikke får levende virale vacciner i mindst 12 måneder efter behandling med MabCampath.
English: Transient grade 3 or 4 neutropenia occurs very commonly by weeks 5-8 following initiation of treatment.
Danish: Forbigående grad 3 eller 4 neutropeni forekommer meget almindeligt 5-8 uger efter påbegyndelse af behandlingen.
English: Solutions may be stored at 15C-30C or refrigerated.
Danish: Opløsningen kan opbevares ved 15°C30°C eller opbevares i køleskab.
English: It is not known if MabCampath can affect human reproductive capacity (see section 5.3).
Danish: Det vides ikke, om MabCampath kan påvirke den menneskelige forplantningsevne (se pkt.
English: Do not use MabCampath if you notice any signs of particulate matter or discolouration prior to
Danish: Brug ikke MabCampath, hvis der er tegn på partikulært materiale eller misfarvning inden
English: If you experience early side effects the initial smaller doses may be repeated until the effects go away or reduce.
Danish: Hvis du kommer ud for tidlige bivirkninger, kan du vende tilbage til de mindre doser i begyndelsen, indtil bivirkningerne forsvinder eller mindskes.
English: Transient grade 3 or 4 thrombocytopenia occurs very commonly during the first 2 weeks of therapy and then begins to improve in most patients.
Danish: Forbigående grad 3 eller 4 trombocytopeni forekommer meget almindeligt under de første 2 ugers behandling og begynder derpå at bedres hos de fleste patienter.
English: Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands
Danish: Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Holland
English: MabCampath pharmacokinetics followed a 2-compartment model and displayed non-linear elimination kinetics.
Danish: Farmakokinetikken for MabCampath fulgte en 2kompartmentmodel og udviste non-lineær eliminationskinetik.
English: In this study, asymptomatic positive PCR only for CMV was reported in 77/147 (52.4%) of MabCampath-treated patients; symptomatic CMV infection was reported less commonly in 23/147 MabCampath treated patients (16%).
Danish: I denne undersøgelse rapporterede asymptomatisk positive PCR alene for CMV hos 77/147 (52.4%) af MabCampath-behandlede patienter; symptomatisk CMV-infektion blev rapporteret mindre hyppigt hos 23/147 MabCampath-behandlede patienter (16%).
English: When you first receive MabCampath, you may experience side effects soon after the first infusions (see section 4 “Possible side effects”).
Danish: Når du første gang får MabCampath, kan du måske komme ud for bivirkninger hurtigt efter de første infusioner (se pkt.
English: Within each frequency grouping, undesirable effects observed during treatment or within 30 days following the completion of treatment with MabCampath are presented in order of decreasing
Danish: Inden for hver frekvensgruppering præsenteres bivirkninger observeret under behandlingen eller inden for 30 dage efter gennemført behandling med MabCampath efter faldende grad.
English: Severe anaphylactic and other hypersensitivity reactions, including anaphylactic shock and angioedema, have been reported following MabCampath administration.
Danish: Alvorlige anafylaktiske og andre hypersensivitetsreaktioner, herunder anafylaktisk chok og angioødem, er indberettet efter MabCampath-behandling.
English: • have other side effects, most often blood disorders from taking MabCampath.
Danish: • får andre bivirkninger, som for det meste er blodsygdomme, af at tage MabCampath.
English: In first line patients, treated with either MabCampath or chlorambucil, there were 21 patients with the 17p deletion, 54 patients with 11q deletion, 34 patients with trisomy 12, 51 patients with normal karyotype and 67 patients with sole 13q deletion.
Danish: Hos 1. linje-patienter behandlet med enten MabCampath eller chlorambucil var der 21 patienter med 17 q deletion, 54 patienter med 11 q deletion, 34 patienter med trisomi 12, 51 patienter med normal karyotype og 67
English: Tell your doctor immediately if you experience any of these side effects.
Danish: Fortæl det straks til din læge, hvis du oplever nogen af disse
English: Clear type I glass vial, closed with a rubber stopper, containing 1 ml of concentrate.
Danish: Klar glas, Type 1-hætteglas, lukket med gummiprop, som indeholder 1 ml koncentrat
English: The safety and efficacy of MabCampath were evaluated in a Phase 3, open-label, randomized comparative trial of first line (previously untreated) Rai stage I-IV B-CLL patients requiring therapy (Study 4).
Danish: Sikkerhed og effektivitet for MabCampath blev evalueret i et Fase 3, open-label, randomiseret komparativt forsøg med 1. linje-patienter (tidligere ubehandlede) behandlingskrævende Rai-stadie IIV B-CLL patienter (Undersøgelse 4).
English: MabCampath was shown to be superior to chlorambucil as measured by the primary endpoint progression free survival (PFS) (see Figure 1).
Danish: MabCampath viste sig at være chlorambucil overlegent målt ved det primære endepunkt progressionsfri overlevelse (PFS) (se Figur 1).
English: Each pack of MabCampath contains 3 vials.
Danish: Hver pakning med MabCampath indeholder 3 hætteglas.
English: Safety data in previously treated B-CLL patients are based on 149 patients enrolled in single-arm studies of MabCampath (Studies 1, 2, and 3).
Danish: Sikkerhedsdata hos tidligere behandlede B-CLL patienter er baseret på 149 patienter, der deltog i enkeltgrenede undersøgelser af MabCampath (Forsøg 1, 2 og 3).
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Danish: Yderligere information om denne medicin er tilgængelig på Det europæiske Lægemiddelagenturs
English: Alemtuzumab causes the lysis of lymphocytes by binding to CD52, a highly expressed, nonmodulating antigen which is present on the surface of essentially all B and T cell lymphocytes as well as monocytes, thymocytes and macrophages.
Danish: Alemtuzumab fremkalder lyse af lymfocytter ved at binde sig til CD52, stærkt udtrykt, ikkemodulerende antigen, som befinder sig på overfladen af i det væsentlige alle B- og T-celle-lymfocytter samt monocytter, thymocytter og makrofager.
English: If treatment is needed, breast-feeding should be discontinued during treatment and for at least 4 weeks following MabCampath therapy.
Danish: Hvis behandling er nødvendig bør amning bør ophøre under behandling og i mindst 4 uger efter behandling med MabCampath.
English: Because of the potential for a fatal reaction to transfusion of any blood products following treatment with MabCampath, it is recommended that you speak to your doctor regarding the irradiation of blood products prior to receiving the transfusion.
Danish: På grund af risikoen for en fatal reaktion ved transfusion af et hvilket som helst blodprodukt efter behandling med MabCampath, bør du tale med din læge om bestråling af blodprodukter, inden du får transfusionen.
English: Care should be taken to ensure the sterility of the prepared solution particularly as it contains no antimicrobial preservatives.
Danish: Man skal sørge for at sikre den tilberedte opløsnings sterilitet, specielt da den ikke indeholder antimikrobielle konserveringsmidler.
English: Ongoing clinical assessment should be performed for symptomatic CMV infection during MabCampath treatment and for at least 2 months
Danish: Der bør foretages løbende klinisk vurdering for symptomatisk CMV-infektion under behandling med MabCampath i mindst 2 måneder
English: As such, half-life was 8 hours (range: 2-32 hours) after the first 30 mg dose and was 6 days (range: 1-14 days) after the last 30 mg dose.
Danish: Som sådan var halveringstiden 8 timer (område: 2-32 timer) efter den første dosis på 30 mg og den var 6 dage (område: 1-14 dage) efter den sidste dosis på 30 mg. Steady state-koncentrationer opnåedes efter ca. 6 ugers dosering.
English: The recommended anti-infective prophylaxis treatment appears to be effective in reducing the risk of PCP and herpes infections (see section 4.4).
Danish: Den anbefalede antiinfektiøse profylaktiske behandling synes at være effektiv til at mindske risikoen for PCP og
English: • have been treated in the past with chemotherapies or general medications that have a high risk of causing heart damage, your doctor may wish to monitor your cardiac function (ECG, heart rate, body weight) while receiving MabCampath.
Danish: • tidligere er blevet behandlet med kemoterapi eller almindelige lægemidler, som har en stor risiko for at forårsage hjerteskader, kan din læge vælge at overvåge din hjertefunktion (EKG,
English: Pneumocystis jiroveci infection
Danish: Pneumocystis jiroveci infektion
English: Severe anaphylactic and other hypersensitivity reactions
Danish: Alvorlige anafylaktiske og andre overfølsomhedsreaktioner
English: In the MabCampath arm 36/77 (46.8%) of patients with asymptomatic PCR positive CMV received antiviral therapy and 47/77 (61%) of these patients had MabCampath therapy interrupted.
Danish: I MabCampath-grenen fik 36/77 (46,8%) af patienterne med asymptomatisk PCR positiv CMV antiviral behandling, og 47/77 (61%) af disse patienter fik seponeret MabCampath-behandlingen.
English: No studies of the effects of MabCampath on the ability to drive and use machines have been performed.
Danish: Der er ikke gennemført undersøgelser af MabCampaths virkninger på evnen til at køre bil eller betjene maskiner.
English: Pneumonia Herpes simplex
Danish: Herpes simplex
English: In the studies in first line and previously treated patients no substantial differences in safety and efficacy related to age were observed; however the
Danish: I undersøgelserne af 1. linje-patienter og tidligere behandlede patienter observeredes ingen væsentlige forskelle i sikkerhed og effektivitet relateret til alder. Databasernes størrelse er dog begrænset.
English: Temperature change sensation
Danish: Følelse af temperaturændring
English: Grade 3 or 4 infusion reactions are uncommon after the first week
Danish: Grad 3- eller 4-reaktioner ved infusion er ikkealmindeligt forekommende efter den første behandlingsuge.
English: Approximately 97% of first-line patients experienced adverse reactions; the most commonly reported reactions in first line patients usually occurred in the first week of therapy.
Danish: Cirka 97% af 1. linje-patienterne oplevede bivirkninger; og de hyppigst rapporterede reaktioner hos førstegangsbehandlede patienter forekom i reglen i den første uge af behandlingen.
English: • The risk of infusion reactions o Need for premedication o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
Danish: ● Risiko for infusionsreaktioner o Behov for præmedicinering o At behandling for hypersensitivitetsreaktioner, herunder forholdsregler for genoplivning, skal være tilgængelig under administration o At risikoen for infusionsreaktioner er højest i behandlingens første uge o At såfremt reaktionen er moderat eller alvorlig, bør dosering fortsætte på samme niveau (dvs. ingen dosisoptrapning), indtil hver dosis tolereres godt.
English: It is highly recommended that anti-infective prophylaxis (e.g. trimethoprim/sulfamethoxazole 1 tablet twice daily, 3 times weekly, or other prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and an effective oral anti-herpes agent, such as famciclovir, 250 mg twice daily) should be initiated while on therapy and for a minimum of 2 months following completion of treatment with MabCampath or until the CD4+ count has recovered to 200 cells/l or greater, whichever is the later.
Danish: Det anbefales stærkt at initiere antiinfektiøs profylakse (f.eks. trimetoprim/sulfametoksazol 1 tablet 2 gange dagligt, 3 gange ugentligt eller anden profylakse mod Pneumocystis jiroveci pneumoni (PCP) og et effektivt peroralt antiherpesmiddel som f.eks. famciclovir 250 mg 2 gange dagligt), under behandlingen og i minimum 2 måneder efter afslutning af behandlingen med MabCampath eller indtil CD4+-tallet er steget til 200 celler/µl eller mere, afhængig af hvad der indtræffer senest.
English: In previously treated patients receiving MabCampath, the median time to reach a level of 200 cells/l is 2 months following last infusion with MabCampath but may take more than 12 months to approximate pretreatment levels.
Danish: Hos tidligere behandlede patienter, der fik MabCampath, er mediantiden for at nå et niveau på 200 celler/µl er 2 måneder efter den sidste infusion med MabCampath, men det kan tage mere end 12 måneder at nærme sig niveauet fra før behandlingen.
English: Of the first-line patients (n=282) in whom baseline cytogenetic (FISH) data were available in Study 4, chromosomal aberrations were detected in 82%, while normal karyotype was detected in 18%.
Danish: Ud af de 1. linje-patienter (n=282), hos hvem der var cytogene (FISH) data til rådighed ved udgangspunktet i undersøgelse 4, blev der detekteret kromosomale afvigelser hos 82%, mens normal karyotype blev detekteret hos 18%.
English: MabCampath was administered as a 2 hour intravenous infusion, at the recommended dosing schedule, starting at 3 mg and increasing to 30 mg, 3 times weekly, for up to 12 weeks.
Danish: MabCampath blev indgivet som en 2-timers intravenøs infusion efter anbefalet doseringsskema, startende med 3 mg og stigende til 30 mg 3 gange ugentlig i op til 12 uger.
English: Animal reproduction studies have not been conducted with MabCampath.
Danish: Der er ikke udført dyre-reproduktionsundersøgelser med MabCampath.
English: Reconstituted solution: MabCampath contains no antimicrobial preservative.
Danish: Fortyndet opløsning: MabCampath indeholder intet antimikrobielt konserveringsmiddel.
English: Undesirable effects observed during post-marketing surveillance
Danish: Bivirkninger indberettet efter markedsføringen
English: Staphylococcal bacteraemia Tuberculosis Bronchopneumonia Herpes ophthalmicus Beta haemolytic streptococcal infection Candidiasis Genital candidiasis Urinary tract infection Cystitis
Danish: Bronkopneumoni Herpes ophthalmicus Beta-hæmolytisk streptococinfektion Candidiasis Genital candidiasis Urinvejsinfektion Cystitis