FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the data show considerable inter-animal variation and were within the historical control range for this species.
Danish: Resultaterne viser imidlertid stor variation imellem dyrene og var indenfor grænserne for tidligere rapporteret variation for denne art.
English: Tell your doctor immediately if you notice any of the following side effects occur: cough and shortness of breath, including when laying flat, vomiting, confusion or passing less urine then normal.
Danish: Fortæl øjeblikkelig til Deres læge, hvis De oplever nogen af følgende bivirkninger: Hoste og åndenød, også hvis De ligger ned, opkastning, forvirring og mindre urinafgang end normalt.
English: The recommended dose for Zenapax in adult and paediatric patients is 1 mg/kg.
Danish: Den anbefalede dosis af Zenapax til voksne og pædiatriske patienter er 1 mg/kg.
English: Infectious episodes, including viral infections, fungal infections, bacteraemia and septicaemia, and pneumonia, were reported in 72% of the placebo-treated patients and in 68% of Zenapax-treated patients.
Danish: Infektiøse episoder, inklusive virusinfektioner, svampeinfektioner, bakteriæmi, septicæmi og pneumoni, rapporteredes hos 72% af de placebobehandlede patienter og hos 68% af de Zenapaxbehandlede patienter.
English: Pregnancy and breast-feeding You must not use this medicine if you are breast-feeding.
Danish: Graviditet og amning De må ikke anvende denne medicin, hvis De ammer.
English: However, the following adverse events occurred more frequently in paediatric patients: diarrhoea (41%), postoperative pain (38%), fever (33%), vomiting (33%), hypertension (28%), pruritus (21%) and infections of the upper respiratory tract (20%) and urinary tract (18%).
Danish: Følgende bivirkninger forekom imidlertid hyppigere hos pædiatriske patienter: Diarré (41%), postoperativ smerte (38%), feber (33%), opkastning (33%), hypertension (28%), pruritus (21%) og infektioner i de øvre luftveje (20%) og i urinvejene (18%).
English: The estimate terminal elimination half-life of daclizumab ranged from 270 to 919 hours (average 480 hours) in renal allograft patients and is equivalent to that reported for human IgG which ranged from 432 to 552 hours (average 480 hours).
Danish: De estimerede eliminationshalveringstid for daclizumab varierede fra 270 til 919 timer (gennemsnit 480 timer) hos patienter med allogen nyretransplantation og svarer til den der er rapporteret for humant IgG som varierede fra 432 til 552 timer (gennemsnit 480 timer).
English: The identified body weight influence on systemic clearance supports the dosing of Zenapax on a mg/kg basis and maintains drug exposure within 30% of the reference exposure for patient groups with wide range of demographic characteristics.
Danish: Den påviste indflydelse af legemsvægten på systemisk clearance støtter doseringen af Zenapax på en mg/kg basis og opretholder serumkoncentrationer indenfor 30% af referencekoncentrationen for patient grupper med vide demografiske karakteristika.
English: Care must be taken to assure sterility of prepared solution, since the drug product does not contain any antimicrobial preservative or bacteriostatic agents.
Danish: Pas på at bevare opløsningen steril da den ikke indeholder antimikrobielle konserveringsmidler eller bakteriostatiske stoffer.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: For hver frekvensinddeling er bivirkningerne ordnet i henhold til faldende alvorlighed.
English: Patients on immunosuppressive therapy following transplantation are at increased risk for developing lymphoproliferative disorders (LPDs) and opportunistic infections.
Danish: Patienter i immunosuppressiv behandling efter transplantation har øget risiko for at udvikle lymfoproliferative sygdomme og opportuniske infektioner.
English: No gross changes to circulating lymphocyte numbers or cell phenotypes were observed by fluorescence-activated cell sorter (FACS) analysis other than the expected transient decrease in Tac+ cells.
Danish: Der observeredes ingen større ændringer i antallet af cirkulerende lymfocytter eller cellefenotyper ved fluorescens-aktiveret celle sorteringsanalyse (FACS) udover det forventede forbigående fald i Tac+ celler.
English: Antibodies to daclizumab developed in approximately 9% of Zenapaxtreated patients in clinical studies but did not appear to affect efficacy, safety, serum daclizumab levels, or any other clinically relevant parameter examined.
Danish: I de kliniske undersøgelser udvikledes der antistoffer overfor daclizumab hos ca. 9% af de Zenapax-behandlede patienter, men antistofferne syntes ikke at påvirke effekt, sikkerhed, daclizumab serumniveauer eller andre af de undersøgte klinisk relevante parametre.
English: Instructions for use and handling
Danish: Instruktioner for brug og håndtering
English: Marketing Authorisation Holder Roche Registration Limited 6 Falcon Way
Danish: Roche Registration Limited 6 Falcon Way
English: Zenapax should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Danish: Zenapax må kun ordineres af læger som har erfaring med immunsuppresiv behandling efter organtransplantation.
English: Because Zenapax is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
Danish: Da Zenapax er et immunglobulin forventes der ingen metaboliske lægemiddelinteraktioner.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig eller De bemærker nogen former for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: Once the infusion is prepared it should be administered intravenously immediately.
Danish: Når infusionsopløsningen er tilberedt skal den straks indgives intravenøst.
English: A health care professional will give you a suitable dose (normally 1 mg/kg of body weight) in the form of an intravenous infusion over a 15- minute period.
Danish: En læge/sygeplejerske vil give en passende dosis (normalt 1 mg/kg legemsvægt) i form af en intravenøs infusion, der varer ca..15 minutter.
English: Daclizumab is excreted in cynomolgus monkey milk (see section 5.3).
Danish: Daclizumab udskilles i mælken hos cynomolgusaber (se pkt.5.3).
English: Zenapax has no influence on the ability to drive and use machines.
Danish: Zenapax har ingen indflydelse på evnen til at føre bil eller betjene maskiner.
English: Both trials showed a statistically significant superiority to placebo in reducing the rate of acute renal allograft rejection at six months post-transplant as confirmed by biopsy.
Danish: Begge undersøgelser viste en signifikant forbedring i forhold til placebo med hensyn til nedsættelse af hyppigheden af akut nyreafstødning seks måneder efter transplantationen, bekræftet ved biopsi.
English: While Zenapax is an immunosuppressive drug, to date no increase in LPDs or opportunistic infections have been observed in patients treated with Zenapax.
Danish: Selvom Zenapax er et immunosuppressivt stof er der indtil nu ikke observeret nogen stigning i lymfoproliferative sygdomme eller opportunistiske infektioner hos patienter behandlet med Zenapax.
English: From pooled data the difference in biopsy-proven acute rejection remained statistically different at one-year posttransplant (43% as compared with 28%).
Danish: Fra de sammenlagte data forblev forskellen i biopsibevist akut afstødning statistisk signifikant et år efter transplantationen (43% sammenlignet med 28%).
English: The beneficial effect of Zenapax prophylaxis upon the incidence of acute rejection after renal transplantation was not associated with adverse clinical sequelae, including the development of PostTransplant Lymphoproliferative Disease (PTLD), at 3 years posttransplant.
Danish: Den gavnlige effekt af profylaktisk behandling med Zenapax, ved forekomsten af akut afstødning efter nyretransplantation, var ikke forbundet med efterfølgende kliniske bivirkninger, herunder udvikling af post transplantation lymfoproliferativ sygdom (PTLD) 3 år efter transplantationen.
English: Pleural effusion Atelectasis
Danish: Pleural effusion Atelektase
English: Zenapax is used to prevent your body from rejecting transplanted kidneys.
Danish: Zenapax anvendes til at forhindre kroppen i at afstøde transplanterede nyrer.
English: However due to potential harmful effects for the newborn, breast-feeding is contraindicated during the treatment and up to 4 months following the last dose of Zenapax.
Danish: Men på grund af den potentielle negative effekt på den nyfødte, er amning kontraindiceret under behandlingen og i op til 4 måneder efter den sidste Zenapaxdosis.
English: Severe, acute (onset within 24 hours) hypersensitivity reactions on both initial and subsequent exposure to Zenapax have been reported rarely.
Danish: Alvorlige og akutte (begyndende inden for 24 timer) overfølsomhedsreaktioner efter administration af Zenapax, både initialt og senere hen i forløbet, er sjældent rapporteret.
English: Administration of Zenapax inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection.
Danish: Administration af Zenapax hæmmer IL-2-medieret aktivering af lymfocytter, en kritisk pathway i det cellulære immunrespons som er involveret i allotransplantat rejektion.
English: Daclizumab saturates the Tac receptor for approximately 90 days at the recommended dosage regimen for the majority of patients.
Danish: Daclizumab mætter Tac- receptoren i ca. 90 dage i den anbefalede dosering hos de fleste patienter.
English: Three year graft survival rates were significantly higher among those patients who did not experience acute rejection within the first year posttransplant (n=345) compared with those who experienced acute rejection during the first year (n=190) regardless of treatment.
Danish: For de patienter, som ikke oplevede akut afstødning indenfor det første år efter transplantationen (n=345), var graden af transplantatoverlevelse efter 3 år signifikant højere sammenlignet med de patienter, der oplevede akut afstødning inden for det første år (n=190) uanset behandling.
English: Do not use Zenapax after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Danish: Anvend ikke Zenapax efter udløbsdatoen, som er angivet på yderpakningen og på etiketten på hætteglasset efter forkortelsen EXP. Udløbsdatoen refererer til den sidste dag i den pågældende måned.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis infusionsvæsken ikke anvendes med det samme sker opbevaringen på brugerens ansvar.
English: No incompatibility between Zenapax and polyvinyl chloride bags or infusion sets has been observed.
Danish: Der er ikke set uforligelighed mellem Zenapax og polyvinylchloridposer eller infusionssæt.
English: At 1 year post-transplant 14 of 216 patients (6.5%) who received Zenapax and 4 of 207 (1.9%) patients who received placebo died of an infection, a difference of 4.6% (95% CI: 0.3%, 8.8%).
Danish: Ved det 1. år efter transplantationen var 14 af 216 patienter (6,5%), som fik Zenapax og 4 af 207 patienter (1,9%), som fik placebo døde af en infektion; en forskel på 4,6% (95% CI: 0,3%, 8,8%).
English: There is no pharmacokinetic interaction between Zenapax and mycophenolic acid, the active metabolite of mycophenolate mofetil (CellCept).
Danish: Der er ingen farmakokinetisk interaktion mellem Zenapax og mycophenolsyre, mycophenolatmofetils aktive metabolit (CellCept).
English: Daclizumab binds to an antigen found on the surface of specific white blood cells called T lymphocytes.
Danish: Daclizumab bindes til et antigen som ligger på overfladen af specielle hvide blodlegemer, T-lymfocytter.
English: A total of 16% (10 of 64 patients) of placebo-treated and 32% (28 of 88 patients) of Zenapax-treated patients had high fasting blood glucose values.
Danish: Ialt havde 16% (10 af 64 patienter) af placebo behandlede og 32% (28 af 88 patienter) af Zenapax behandlede patienter høje fastende blodsukker værdier.
English: One of 18 monkeys had an anaphylactic reaction to daclizumab.
Danish: En af 18 aber fik en anafylaktisk reaktion efter daclizumab.
English: Hyperglycaemia: No differences in abnormal haematologic or chemical laboratory test results were seen between placebo-treated and Zenapax-treated groups with the exception of fasting blood glucose.
Danish: Hyperglycæmi: Der observeredes ingen forskelle i abnorme hæmatologiske eller klinisk-kemiske laboratorieprøve resultater mellem placebo behandlede og Zenapax behandlede grupper med undtagelse af fastende blodsukker.
English: If diluted aseptically it may be stored for 24 hours when refrigerated between 2 °C - 8 °C or for 4 hours at 25 °C.
Danish: Hvis fortyndingen er sket aseptisk kan infusionsvæsken opbevares i 24 timer i køleskab ved 2 °C - 8 °C eller i 4 timer ved 25 °C.
English: A non-clinical reproduction toxicity study with daclizumab has shown an increased risk of early prenatal loss in cynomolgus monkeys compared to placebo.
Danish: Et præklinisk reproduktionstoxicitetsstudie med daclizumab har vist en øget risiko for tidlig prænatal død hos cynomolgusaber i forhold til placebo.
English: The recommended regimen of daclizumab will maintain serum concentrations sufficient to saturate IL-2R alpha receptors on activated T lymphocytes for more than 90 days post transplantation in the majority of patients.
Danish: Det anbefalede daclizumabregime vil opretholde serumkoncentrationer som hos de fleste patienter er tilstrækkelige til at mætte IL-2R alfareceptorer på aktiverede T-lymfocytter i mere end 90 dage efter transplantationen.
English: Incidence of malignancies: Three years after treatment, the incidence of malignancies was 7.8% in the placebo group compared with 6.4% in the Zenapax group.
Danish: Incidens af maligniteter: Tre år efter behandling var incidensen af maligniteter 7,8% i placebogruppen sammenlignet med 6,4% i Zenapaxgruppen.
English: Daclizumab binds with high specificity to the alpha or Tac subunit of the high affinity IL-2 receptor complex (expressed on activated T cells), and inhibits IL-2 binding and biological activity.
Danish: Daclizumab binder sig med høj specificitet til alfa- eller Tac subdelen af højaffinitets IL-2 receptorkomplekset (udtrykt på aktiverede T celler) og hæmmer IL-2 bindingen og den biologiske aktivitet.
English: For mixing the solution, do not shake, gently invert the bag in order to avoid foaming.
Danish: Opløsningen blandes ved at vende posen forsigtigt op og ned for at undgå skumning.
English: In Phase III trials Zenapax was added to a standard immunosuppressive regimen of cyclosporine (5 mg/kg) and steroids (prednisone or methylprednisolone), with or without addition of azathioprine (4 mg/kg).
Danish: I fase III undersøgelserne blev Zenapax givet sammen med et standard immunsuppressivt regime bestående af ciclosporin (5 mg/kg) og steroider (prednison eller metylprenisolon) med eller uden tillæg af azathioprin (4 mg/kg).
English: Fasting blood glucose was measured in a small number of placebo- and Zenapax-treated patients.
Danish: Fastende blodsukker blev målt hos et mindre antal placebo- og Zenapax behandlede patienter.
English: One vial of 5 ml contains 25 mg of daclizumab* (5 mg/ml).
Danish: 1 hætteglas á 5 ml indeholder 25 mg daclizumab* (5 mg/ml).
English: A maximum tolerated dose has not been determined in patients and could not be achieved in animals that received Zenapax.
Danish: Der er ikke fundet nogen maksimal tolererbar Zenapax dosis hos patienter og den kunne ikke bestemmes på dyr.
English: Overall, use of polyclonal antilymphocyte antibody therapy (OKT3, ATG, ATGAM) was similar in patients who received Zenapax and in patients who received placebo, 18.5% and 17.9%, respectively.
Danish: Den overordnede anvendelse af polyklonal antilymfocyt antistofterapi (OKT3, ATG, ATGAM) var ens hos patienter, som fik Zenapax og hos patienter, som fik placebo, henholdsvis 18,5 og 17,9%.
English: Peak serum concentrations (peak + SD) rose between the first dose (16 + 12 µg/ml) and the fifth dose (21 + 14 µg/ml).
Danish: Peak serum koncentrationer (peak ± SD) øgedes mellem den første dose (16 ± 12 µg/ml) og den femte dose (21 ± 14 µg/ml).
English: Appreciable daclizumab serum levels were maintained except in 2 out of 18 monkeys that developed anti-daclizumab antibodies.
Danish: Der opretholdtes acceptable daclizumabkoncentrationer hos alle 18 aber bortset fra 2 som udviklede anti-daclizumabantistoffer.
English: Addition of Zenapax did not increase the number of post-transplant lymphomas, which occurred with a frequency of 1.5% in the placebotreated group and 0.7% in the Zenapax-treated group.
Danish: Tillæg af Zenapax øgede ikke antallet af posttransplantations lymfomer, som forekom med en frekvens på 1,5% i placebogruppen og 0,7% i Zenapax gruppen.
English: Very common Insomnia Depression
Danish: Insomni Depression
English: Daclizumab was well tolerated after single bolus intravenous or subcutaneous doses ranging from 50 to 125 mg/kg in mice, rats, and rabbits and after 28 days administration of 15 mg/kg to monkeys.
Danish: Daclizumab tolereredes godt af mus, rotte og kanine efter enkelt-bolusdoser, intravenøst eller subkutant, i doser fra 50 til 125 mg/kg og efter 28 dages administration af 15 mg/kg til aber.
English: Cytomegalovirus infection was reported in 16% of the patients in the placebo group and in 13% of the patients in the Zenapax group.
Danish: Cytomegalovirus infektion rapporteredes hos 16% af patienterne i placebogruppen og hos 13% af patienterne i Zenapax gruppen.
English: You will receive 4 subsequent doses which are spaced 14 days apart from each other.
Danish: De vil få yderligere 4 doser med 14 dages mellemrum.
English: What Zenapax contains
Danish: Hvad Zenapax indeholder
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: Very common Hypertension(incl.
Danish: Hypertension (inkl.
English: Concomitant use of Zenapax with another antilymphocyte antibody therapy in the context of intensive immunosuppression with cyclosporine, mycophenolate mofetil and corticosteroids may be a factor leading to fatal infection.
Danish: Samtidig anvendelse af Zenapax med en anden antilymfocyt antistofterapi i forbindelse med en intensiv immunosuppression med cyclosporin, mycophenolat mofetil og kortikosteroider kan være en faktor, der fører til fatal infektion.
English: In total you should receive 5 doses of Zenapax for a complete treatment course.
Danish: I alt får De 5 doser svarende til en komplet behandling.
English: There is no evidence to indicate that Zenapax has an effect on your ability to drive a car or operate machinery.
Danish: Der er ingen holdepunkter for at antage, at Zenapax påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: Zenapax contains daclizumab, a recombinant, humanized IgG1 anti-Tac antibody, and functions as an interleukin 2 (IL-2) receptor antagonist.
Danish: Zenapax indeholder daclizumab, et rekombinant humaniseret IgG 1 anti-Tac antistof, og virker som en interleukin (IL-2) receptor antagonist.
English: Diabetes mellitus Fluid overload
Danish: Diabetes mellitus Ophobning af væske
English: Clear to slightly opalescent, colourless to slightly yellowish liquid.
Danish: Klar til let opaliserende, farveløs til svagt gullig væske.
English: A study in cynomolgus monkeys has not shown teratogenic effects but did show an increase of early prenatal loss which remains in the historical spontaneous abortion rate (see section 5.3).
Danish: Et forsøg med cynomolgusaber har ikke vist teratogen effekt, men viste en øgning i tidlig prænatal død, som er indenfor grænserne af tidligere rapporteret hyppighed for spontane aborter for arten (se pkt.5.3).
English: The following transplant medications have been administered in clinical trials with Zenapax without any interactions: cyclosporine, mycophenolate mofetil, gancyclovir, acyclovir, tacrolimus, azathioprine, antithymocyte immune globulin, muromonab-CD3 (OKT3), and corticosteroids.
Danish: Følgende transplantationslægemidler er anvendt i kliniske undersøgelser sammen med Zenapax uden interaktioner: ciclosporin, mycophenolatmofetil, ganciclovir, aciclovir, tacrolimus, azathioprin, antithymocyt immunglobulin, muromonab-CD3 (OKT3) og kortikosteroider.
English: ● CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF
English: A dose of 1.5 mg/kg has been administered to bone marrow transplant recipients without any associated adverse events.
Danish: En dosis på 1,5 mg/kg blev givet til knoglemarvstranplanterede patienter uden der forekom uønskede hændelser.
English: Paediatric Patients: Pharmacokinetic and pharmacodynamic properties were evaluated in 61 paediatric patients treated with 1 mg/kg IV dose of Zenapax every 14 days for a total of 5 doses.
Danish: Pædiatriske patienter: Farmakokinetiske og farmakodynamiske egenskaber blev vurderet på 61 pædiatriske patienter behandlet med en dosis Zenapax på 1 mg/kg i.v.
English: - difficulty breathing - constipation; diarrhoea; vomiting; nausea; or heartburn - pain in joints and muscles - excess fluid in the body (oedema); swelling of the arms and legs (peripheral oedema) - problems with wound healing
Danish: - vejrtrækningsproblemer - forstoppelse; diarré; opkastning; kvalme; eller halsbrand - smerter i led og muskler - overskud af væske i kroppen (ødem); opsvulmede arme og ben (perifere ødemer); - problemer med sårheling
English: Your doctor should advise you about using contraception before treatment with Zenapax is started, during treatment with Zenapax, and for an additional 4 months following the last dose of Zenapax.
Danish: Deres læge bør informere Dem om at bruge prævention, før behandlingen med Zenapax starter, under behandlingen med Zenapax og i yderligere 4 måneder efter den sidste dosis af Zenapax.
English: Some side effects are more likely to occur in children than in adults, these include diarrhoea, pain following surgery, fever, vomiting, high blood pressure, itchy skin, infections of the nose and throat and infections in the urine.
Danish: Nogle bivirkninger forekommer oftere hos børn end hos voksne, og det drejer sig om diarré, smerter efter operation, feber, opkastning, forhøjet blodtryk, kløende hud, infektioner i næse og svælg og infektioner i urinen.
English: The three year graft survival was not significantly different between placebo and daclizumab in the triple immunosuppressant trial (83% Vs. 84%) or the double immunosuppressant trial (78% Vs. 82%).
Danish: Tre års transplantatoverlevelse var ikke signifikant forskellig mellem placebo og daclizumab i det tredobbelte immunosuppressive forsøg (83% vs. 84%) eller i det dobbelte immunosuppressive forsøg (78% vs. 82%).
English: The safety profile of Zenapax was studied in comparison to placebo in patients who concomitantly received immunosuppressive regimens containing cyclosporine and corticosteroids alone, with the addition of azathioprine or with the addition of mycophenolate mofetil.
Danish: Zenapax's sikkerhedsprofil blev undersøgt overfor placebo hos patienter som samtidigt fik immunosuppressiv behandling indeholdende ciclosporin og kortikosteroider alene, med tillæg af azathioprin eller med tillæg af mycophenolatmofetil.