FrancophonIA/ELRC3.0 huggingface dataset:
English: If therapy is withheld for more than 7 days, MabCampath should be reinstituted with gradual dose escalation.
Danish: Hvis behandlingen seponeres i mere end 7 dage bør MabCampath genoptages med gradvis dosisøgning.
English: • are allergic to alemtuzumab or to proteins of a similar origin or to any of the other ingredients of MabCampath (see section 6 “Further Information”).
Danish: • hvis du er overfølsom (allergisk) over for alemtuzumab eller over for proteiner af lignende oprindelse eller ethvert af de øvrige indholdsstoffer i MabCampath (se pkt.
English: Concomitant medicinal products
Danish: Anden samtidig lægemiddelbehandling
English: It is recommended that MabCampath should be interrupted in patients whose platelet count falls to < 25,000/l or whose absolute neutrophil count (ANC) drops to < 250/l.
Danish: Det anbefales, at MabCampath seponeres hos patienter, hvis trombocyttal falder til < 25.000/µl eller hvis det absolutte neutrofiletal (ANC) falder til < 250/µl.
English: Store in the original packaging in order to protect from light.
Danish: Opbevares i den originale emballage for at beskytte mod lys.
English: Also, you should not be vaccinated with live viral vaccines during treatment and for at least 12 months after you have finished your treatment.
Danish: Du bør heller ikke under behandlingen og i mindst 12 måneder efter afslutningen af din behandling blive vaccineret med vacciner med levende virus.
English: During the first week, 3 mg of MabCampath is given on Day 1, then 10 mg on Day 2 and then 30 mg on Day 3, depending on tolerability.
Danish: Under den første behandlingsuge gives 3 mg MabCampath på dag 1, derefter 10 mg på dag 2, og 30 mg på dag 3, afhængig af tolerans.
English: It is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate.
Danish: Det anvendes til patienter, hvor kombinationsbehandling med fludarabin (en anden medicin, der anvendes ved leukæmi) ikke er
English: However, if acute moderate to severe adverse reactions such as hypotension, rigors, fever, shortness of breath, chills, rashes and bronchospasm (some of which may be due to cytokine release) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated before further dose escalation is attempted (see section 4.4).
Danish: Hvis der imidlertid opstår akutte, moderate til alvorlige bivirkninger som f.eks. hypotension, kulderystelser, feber, kortåndethed, kuldegysninger, hududslæt og bronkospasme (hvor nogle af reaktionerne kan skyldes cytokinfrigivelse) ved et doseringsniveau på enten 3 mg eller 10 mg, bør disse doser gentages daglig, indtil de tåles godt, før yderligere dosisoptrapning forsøges (se pkt.
English: ≥ 50% decrease from baseline in patients initiating therapy with a baseline ANC ≤ 250/μl and/or a
Danish: ≥ 50% fald fra baseline hos patienter, hvor behandling startes med baseline-ANC ≤ 250/l og/eller baseline-trombocyttal ≤ 25.000/l.
English: MabCampath is used to treat patients with chronic lymphocytic leukaemia (CLL), a cancer of the lymphocytes (a type of white blood cell).
Danish: MabCampath anvendes til behandling af patienter med kronisk lymfatisk leukæmi (CLL), som er kræft i lymfocytterne (en type hvide blodceller).
English: B-CLL pts who had failed to respond or relapsed following treatment with conventional chemotherapy
Danish: B-CLL-patienter, som ikke havde responderet på eller som havde fået recidiv efter behandling med konventionel kemoterapi
English: In data available from first line patients treated with MabCampath, loss of CD52 expression was not observed around the time of disease progression or death.
Danish: I tilgængelige data fra 1. linje-patienter behandlet med MabCampath, observeredes intet tab af CD52-ekspression omkring tidspunktet for
English: Pregnancy MabCampath must not be administered to patients who are pregnant, therefore if you:
Danish: MabCampath må ikke gives til patienter, som er gravide, og derfor skal du, hvis du:
English: The antibody is produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium.
Danish: Antistoffet fremstilles i en cellekultursuspension fra pattedyr (kinesisk hamsterovarie) i et næringssubstrat.
English: Because of the potential for Transfusion Associated Graft Versus Host Disease (TAGVHD) it is recommended that patients who have been treated with MabCampath receive irradiated blood
Danish: På grund af muligheden for TAGVHD (Transfusion Associated Graft Versus Host Disease), bør patienter, der er blevet behandlet med MabCampath, modtage bestrålede blodprodukter.
English: Patients may have allergic or hypersensitivity reactions to MabCampath and to murine or chimeric
Danish: Patienterne kan få allergiske reaktioner eller hypersensitivitetsreaktioner på MabCampath og på murine antistoffer eller kimære-monoklonale antistoffer.
English: Nervous system disorders: Intracranial haemorrhage has occurred with fatal outcome, in patients with
Danish: Sygdomme i nervesystemet: Der er set intrakraniel blødning med dødelig udgang hos patienter med
English: In the randomized controlled trial in first line patients (Study 4), patients in the MabCampath arm were tested weekly for CMV using a PCR (polymerase chain reaction) assay from initiation through completion of therapy, and every 2 weeks for the first 2 months following therapy.
Danish: I det randomiserede kontrollerede forsøg med 1. linje-patienter (Undersøgelse 4), blev patienter i MabCampath-grenen testet ugentligt for CMV ved hjælp af en PCR (polymerasekædereaktion) analyse fra indledning til afslutning af behandlingen, og hver 2. uge i de første to måneder efter behandlingen.
English: The MabCampath solution must be prepared according to the instructions provided in section 6.6.
Danish: MabCampath-opløsningen bør tilberedes i henhold til vejledningen i pkt.
English: Patients should be premedicated with oral or intravenous steroids, an appropriate antihistamine and analgesic 30-60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated thereafter (see section 4.4).
Danish: Patienterne bør præmedicineres med orale eller intravenøse steroider, et passende antihistaminikum og analgetikum 30-60 minutter forud for hver infusion med MabCampath ved dosisoptrapning og på klinisk indikation derefter (se pkt.
English: Clear Type I glass ampoule, containing 3 ml of concentrate.
Danish: Klar glas, Type 1-ampul, som indeholder 3 ml koncentrat
English: Assessment and ongoing monitoring of cardiac function (e.g. echocardiography, heart rate and body weight) should be considered in patients previously treated with potentially cardiotoxic agents.
Danish: Vurdering og løbende overvågning af hjertefunktion (f.eks. ekkokardiografi, hjerterytme og kropsvægt) bør overvejes hos patienter, der tidligere er blevet behandlet med potentielt kardiotoksiske
English: MabCampath is administered into one of your veins via a drip (see also ‘information intended for
Danish: MabCampath administreres ind i en af dine vener via et drop (se også 'oplysninger tiltænkt læger og sundhedspersonale').
English: More than 80% of previously treated patients may be expected to experience adverse reactions; the most commonly reported reactions usually occur during
Danish: Mere end 80% af de tidligere behandlede patienter kan forvente at få bivirkninger; de bivirkninger, der er indberettet mest almindeligt, forekommer sædvanligvis i den første behandlingsuge.
English: You should inform your doctor if you are taking or have recently taken any other medicines, even
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Lymphocyte depletion was rapidly reversible after cessation of dosing.
Danish: Reduktionen af lymfocyttallet blev hurtigt reversibel efter behandlingsophør.
English: No studies have been conducted which specifically address the effect of age on MabCampath disposition and toxicity.
Danish: Der er ikke foretaget undersøgelser, som specifik er rettet mod at vise relation mellem fordeling på alder og toksicitet af MabCampath.
English: HOW TO STORE MABCAMPATH
Danish: SÅDAN SKAL DU BRUGE MABCAMPATH
English: Treatment may be reinstituted following resolution of the haematological toxicity (see section 4.2).
Danish: Behandling kan genoptages, når den hæmatologiske toksiske reaktion er gået i ro (se pkt.
English: Steroids may be discontinued as appropriate, once dose escalation has been achieved.
Danish: Steroider kan seponeres efter behov, så snart dosisøgningen er gennemført.
English: Alemtuzumab was generated by the insertion of six complementarity-determining regions from an IgG2a rat monoclonal antibody into a
Danish: Alemtuzumab blev dannet ved at indsætte seks komplementaritets-bestemmende områder fra et IgG2a rotte monoklonalt antistof i et humant IgG1
English: During the first week of treatment, MabCampath should be administered in escalating doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3 assuming that each dose is well tolerated.
Danish: I løbet af den første uges behandling bør MabCampath gives i stigende dosering: 3 mg den 1. dag, 10 mg den 2. dag og 30 mg den 3. dag under forudsætning af, at hver enkelt dosis tåles godt.
English: Hypokalaemia Diabetes mellitus aggravated
Danish: Forværret diabetes mellitus
English: It is not known whether MabCampath is excreted in human milk.
Danish: Det vides ikke, om MabCampath udskilles i modermælken.
English: Dermatitis allergic Pruritus
Danish: Allergisk dermatit
English: Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52).
Danish: Alemtuzumab er et genetisk fremstillet, humaniseret IgG1 kappa monoklonalt antistof specifikt for et 21-28 kD lymfocyt-celleoverfladeglykoprotein (CD52).
English: Respiratory disorder
Danish: Respiratorisk lidelse
English: MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampath should be prepared for intravenous infusion using aseptic techniques and that the diluted solution for infusion should be administered within 8 hours after preparation and protected from light.
Danish: Det anbefales derfor, at MabCampath tilberedes til intravenøs infusion ved anvendelse af aseptisk teknik og at den fortyndede infusionsopløsning indgives indenfor 8 timer efter tilberedning og beskyttet mod lys.
English: MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.
Danish: MabCampath er indiceret til behandling af patienter med kronisk lymfatisk B-celleleukæmi (B-CLL) for hvem fludarabin-kombinationskemoterapi ikke er hensigtsmæssig.
English: Urinary tract infection Sinusitis
Danish: Urinvejsinfektion Sinusitis
English: The most frequent serious adverse reactions are cytopenias, infusion reactions, and
Danish: De hyppigste alvorlige bivirkninger er cytopenier, infusionsreaktioner og immunsuppression/infektioner.
English: A slight cumulative effect on the degree of lymphocyte depletion was seen in repeated dose studies compared to single dose studies.
Danish: Lymfocytopeni var den mest almindelige behandlingsrelaterede virkning hos denne art. En let kumulativ virkning på graden af reduktion af lymfocyttallet blev set i studier med gentagne doser sammenlignet med enkeltdosistudier.
English: The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen skal fortsætte med at indsende årlige periodiske sikkerhedsopdateringsrapporter (PSURs), hvis ikke andet specificeres af CHMP.
English: Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days up to a maximum of
Danish: Derefter er den anbefalede dosis 30 mg dagligt indgivet 3 gange om ugen, hver anden dag op til maksimalt 12
English: Pharmacokinetics were characterised in MabCampath-naive patients with B-cell chronic lymphocytic leukaemia (B-CLL) who had failed previous therapy with purine analogues.
Danish: Farmakokinetikken blev beskrevet hos MabCampath-naive patienter med B-celle kronisk lymfatisk leukæmi (B-CLL), hvor tidligere behandling med purinanaloger havde slået fejl.
English: MabCampath should be permanently discontinued if autoimmune anaemia or autoimmune thrombocytopenia appears.
Danish: MabCampath bør seponeres permanent, hvis der forekommer autoimmun anæmi eller autoimmun trombocytopeni.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: • pain when urinating, decreases in urine flow, increased frequency in urination, blood in urine, incontinence
Danish: • smerter ved vandladning, nedsat urindannelse, øget vandladningstrang, blod i urinen, inkontinens
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: • Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
English: In patients receiving MabCampath as first line therapy, the recovery of CD4+ counts to ≥200 cells/µl occurred by 6 months post-treatment, however, at 2 months post-treatment the median was 183 cells/l.
Danish: Hos patienter, der får MabCampath som 1. linje-behandling, blev der opnået restitution af CD4+ tal til ≥200 celler/µL på 6 måneder efter behandling, 2 måneder efter behandlingen var medianen dog 183 celler/µl.
English: • heart disorders (heart stopping, heart attack, heart congestion, irregular heart rate) • blood disorders (abnormal clotting, decreased protein, low potassium levels)
Danish: • hjertelidelser (hjertestop, hjerteanfald, hjertekongestion, uregelmæssig hjerterytme) • blodsygdomme (abnorm størkning af blodet, mindsket æggehvidestof, lavt kaliumindhold)
English: Genzyme Europe B.V., Tel: +31 35 699 1200
Danish: Nederland Genzyme Europe BV, Tel: +31 35 699 1200
English: Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52) expressed primarily on the surface of normal and malignant peripheral blood B and T cell lymphocytes.
Danish: Alemtuzumab er et genetisk fremstillet humaniseret IgG1 kappa-monoklonalt antistof specifikt for et 21-28 kD lymfocyt-celleoverfladeglykoprotein (CD 52) udskilt primært på overfladen af normale eller maligne perifere blod B- og T-celle lymfocytter.
English: If a severe haematological toxicity develops, MabCampath treatment should be interrupted until the event resolves.
Danish: Hvis der udvikles en alvorlig hæmatologisk toksisk reaktion, bør behandlingen med MabCampath seponeres, indtil tilfældet går i ro.
English: Human IgG is known to cross the placental barrier; MabCampath may cross the placental barrier as well and thus potentially cause foetal B and T cell lymphocyte depletion.
Danish: MabCampath kan eventuelt også passere gennem placenta og dermed potentielt forårsage depletering af føtale B- og T-lymfocytter.
English: • high blood pressure, fast or slow heart rate, feeling your heart racing, blood vessel spasm • becoming red in the face, bruising of the skin
Danish: • højt blodtryk, hurtig eller langsom hjerterytme, følelse af at hjertet farer af sted, kramper i blodkarrene
English: A trend toward improved ORR was observed in patients with 17p deletion treated with MabCampath (64% v 20%; p=0.0805).
Danish: Der observeredes en tendens til forbedret ORR hos patienter med 17p deletion behandlet med MabCampath (64% v 20%; p=0,0805).
English: Safety data in first-line B-CLL patients are based on adverse reactions that occurred on study in 147 patients enrolled in a randomized, controlled study of MabCampath as a single agent administered at a dose of 30 mg intravenously three times weekly for up to 12 weeks, inclusive of dose escalation period.
Danish: Sikkerhedsdata hos førstegangs B-CLL patienter er baseret på bivirkninger, der forekom under forsøget hos 147 patienter, der deltog i en randomiseret, kontrolleret undersøgelse af MabCampath som enkeltstående behandling administreret i en dosis på 30 mg intravenøst tre gange om ugen i op til 12 uger, inklusive dosisoptrapningsperioden.
English: You may experience an allergic or hypersensitivity reaction to MabCampath solution, especially against the protein contained in it, while the infusion is given to you.
Danish: Mens du modtager infusionen, kan du komme ud for en allergisk reaktion eller overfølsomhedsreaktion over for MabCampath-opløsningen, især over for de proteiner, den indeholder.
English: Additional reactions include nausea, urticaria, vomiting, fatigue, dyspnoea, headache, pruritus, diarrhoea and bronchospasm.
Danish: Yderligere reaktioner omfatter kvalme, urtikaria, opkastning, træthed, dyspnø, hovedpine, pruritus, diarré og bronchospasme.
English: ORR was superior in patients with any 11q deletion (87% v 29%; p<0.0001) or sole deletion 13q (91% v 62%; p=0.0087) treated with MabCampath compared to chlorambucil.
Danish: ORR var højere hos patienter med nogen 11q deletion (87% v 29%; p<0,0001) eller kun 13 q deletion (91% v 62%; p=0,0087) behandlet med MabCampath sammenlignet med chlorambucil.
English: Cytomegalovirus infection
Danish: Cytomegalovirus infektion Bakterieinfektion
English: Acute adverse reactions, which may occur during initial dose escalation and some of which may be due to the release of cytokines, include hypotension, chills/rigors, fever, shortness of breath and rashes.
Danish: Akutte bivirkninger, som kan opstå i løbet af den initiale dosisoptrapning, og hvor nogle af dem kan skyldes cytokinfrigivelse, omfatter hypotension, kulderystelser, feber, åndenød og hududslæt.
English: Cardiac disorders: Congestive heart failure, cardiomyopathy, and decreased ejection fraction have been reported in patients previously treated with potentially cardiotoxic agents.
Danish: Hjertesygdomme: Kongestiv hjerteinsufficiens, kardiomyopati og nedsat ejektionsfraktion er indberettet hos patienter, der tidligere er behandlet med potentielt kardiotoksiske midler.
English: In the event of serious infection or severe haematological toxicity MabCampath should be interrupted until the event resolves.
Danish: I tilfælde af alvorlig infektion eller alvorlig hæmatologisk toksisk påvirkning bør MabCampath seponeres, indtil tilfældet går i ro.
English: Gastrointestinal haemorrhage Ulcerative stomatitis Stomatitis
Danish: Gastrointestinal blødning Gastroenteritis Ulcerøs stomatitis
English: Chest pain Influenza-like symptoms
Danish: Influenza-lignende symptomer
English: B-CLL (plus a PLL) pts who had failed to respond or relapsed following treatment with fludarabine
Danish: B-CLL (plus en med prolymfocytleukæmi (PLL)) patienter, som ikke havde responderet på eller som havde fået recidiv efter behandling med fludarabin
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65
Danish: Boehringer Ingelheim Pharma GmbH & Co.
English: In particular, you should not be given MabCampath within 3 weeks of taking any other anti-cancer
Danish: Især bør du ikke tage MabCampath, hvis du indenfor de seneste 3 uger har taget et andet stof til
English: However, it is recommended that MabCampath should not be given within 3 weeks of
Danish: Det anbefales imidlertid, at MabCampath ikke bør gives inden for 3 uger efter andre kemoterapeutika.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter hvor alvorlige de er.
English: *If the delay between dosing is  7 days, initiate therapy at MabCampath 3 mg and escalate to 10 mg
Danish: *Hvis behandlingen har været seponeret i ≥ 7 dage, startes MabCampathbehandlingen med 3 mg med optrapning til 10 mg og derefter 30 mg, alt efter
English: Although no formal drug interaction studies have been performed with MabCampath, there are no known clinically significant interactions of MabCampath with other medicinal products.
Danish: Der er ingen kendte klinisk betydende interaktioner af MabCampath med andre lægemidler.
English: In addition, testing indicating the presence of antibodies that may destroy red blood cells (Coombs test) has been reported.
Danish: Endvidere er der indberetninger om tests, som viser tilstedeværelse af antistoffer, der kan ødelægge de
English: Males and females of childbearing capacity should use effective contraceptive measures during treatment and for 6 months following MabCampath therapy (see section 5.3).
Danish: Mænd og kvinder i den fertile alder bør anvende effektive antikonceptionsmetoder under behandlingen og i 6 måneder efter behandling med MabCampath (se pkt.
English: • fever, shivering/chills, sweating, nausea (feeling sick), vomiting, low blood pressure, low white/red blood cell levels, infections including pneumonia and blood poisoning, irritation and/or blistering of the mouth region, low blood platelet levels, tiredness, rash, itching, red raised lesions on the skin, shortness of breath, headache, diarrhoea and loss of appetite.
Danish: • feber, kulderystelser, svedeture, kvalme (utilpashed), opkastning, lavt blodtryk, lavt antal hvide/røde blodlegemer, infektioner, herunder lungebetændelse og blodforgiftning, irritation og/eller blærer i munden, lavt antal blodplader, træthed, hududslæt, kløe, røde, hævede områder på huden, kortåndethed, hovedpine, diaré og appetitløshed.
English: - Hypersensitivity to alemtuzumab, to murine proteins or to any of the excipients.
Danish: - Overfølsomhed over for alemtuzumab, museproteiner eller hjælpestofferne
English: B. CONDITIONS OF THE MARKETING AUTHORISATION
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: Complete remissions were also superior in patients with sole 13q deletion treated with MabCampath (27% v 0%; p=0.0009).
Danish: Komplette remissioner var også højere hos patienter med kun 13q deletion behandlet med MabCampath (27% v 0%; p=0,0009).
English: • inflammation, irritation and/or tightness of the lungs, throat and/or sinuses, too little oxygen reaching the body organs, coughing, coughing up of blood
Danish: • betændelse, irritation og/eller stramhed i lungerne, svælget og/eller bihuler, for ringe iltforsyning til kroppens organer, hoste, ophostning af blod.
English: The required amount of the vial contents should be added to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Danish: Den nødvendige mængde af hætteglassets indhold bør tilsættes til 100 ml 9 mg/ml (0,9%) natriumklorid opløsning til infusion eller 5% glukoseopløsning til infusion.
English: MabCampath will be given at 30 mg three times per calendar week on alternate days, for up to 12 weeks.
Danish: MabCampath gives med 30 mg 3 gange om ugen på skiftende dage
English: The required amount of the ampoule contents should be added, via a sterile, low-protein binding, non-fibre 5 μm filter, to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Danish: Den nødvendige mængde af ampullens indhold bør via et sterilt, fiberfrit, 5 μm filter med lav proteinbinding tilsættes til 100 ml 9 mg/ml (0,9%) natriumkloridopløsning til infusion eller 5% glukoseopløsning til infusion.
English: Renal function abnormal
Danish: Abnorm nyrefunktion
English: Infections and infestations: Serious and sometimes fatal viral (e.g. adenovirus, parainfluenza, hepatitis B, progressive multifocal leukoencephalopathy (PML)), bacterial (including tuberculosis and atypical mycobacterioses, nocardiosis), protozoan (e.g. toxoplasma gondii), and fungal (e.g. rhinocerebral mucormycosis) infections, including those due to reactivation of latent infections have occurred during post-marketing surveillance.
Danish: Infektiøse og parasitære sygdomme: Alvorlige og sommetider fatale virale infektioner (f.eks. adenovirus, parainfluenza, hepatitis B, progressiv multifokal leukoencephalopati (PML)), bakterielle infektioner (herunder tuberkulose og atypiske mykobakterier, nokardiose) protozo- (f.eks. toxoplasma gondii) og svampeinfektioner (f.eks. rinocerebral mucormycose), herunder de der skyldes reaktivering af latente infektioner, er forekommet under post-marketing overvågning.