FrancophonIA/ELRC3.0 huggingface dataset:
English: Simulect powder
Danish: Simulect pulver
English: These are patients in whom, following the initial administration of Simulect, the concomitant immunosuppression was discontinued prematurely due, for example, to abandoned transplantation or early loss of the graft.
Danish: Dette er patienter, der efter initial administration af Simulect har fået seponeret deres samtidige behandling med immunsupressiva i utide, f.eks. på grund af aflyst transplantation eller tidlig tab af graft.
English: Simulect belongs to a group of medicines called immunosuppressants.
Danish: Simulect tilhører den gruppe medicin, der kaldes immunsuppressiva.
English: Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
Danish: Da basiliximab er et immunglobulin, forventes ingen metaboliske lægemiddel-lægemiddel interaktioner.
English: Caution should be exercised when patients previously given Simulect are re-exposed to a subsequent course of therapy with this medicinal product.
Danish: Der bør udvises forsigtighed når patienter, der tidligere har fået Simulect, re-eksponeres for efterfølgende behandling med dette lægemiddel.
English: You should also tell your doctor if you are breast-feeding.
Danish: Du skal også fortælle din læge, hvis du ammer.
English: Complete and consistent blocking of the interleukin-2 receptor is maintained as long as serum basiliximab levels exceed 0.2 g/ml (usually up to 4-6 weeks after administration).
Danish: Fuldstændig og fortsat blokering af interleukin-2 receptoren opretholdes, så længe serum-basiliximab-niveauer overstiger 0,2 µg/ml (som regel op til 46 uger efter administration).
English: You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose of Simulect.
Danish: Du skal bruge passende prævention for at forhindre graviditet under behandlingen og op til 4 måneder efter du har modtaget den sidste dosis af Simulect.
English: However, based on the IgG1 nature of basiliximab, excretion into milk should be expected.
Danish: Baseret på basiliximabs IgG1-egenskaber, må udskillelsen i mælk forventes.
English: Shake the vial gently to dissolve the powder, avoiding foaming.
Danish: Ryst hætteglasset nænsomt for at opløse pulveret, undgå at det skummer.
English: Children and adolescents (aged 1 to 17 years)
Danish: Børn og unge (i alderen 1-17 år)
English: Listing of adverse reactions from post-marketing spontaneous reports
Danish: Liste over bivirkninger fra spontane post-marketingrapporter
English: You will only be given Simulect if you are receiving a new kidney.
Danish: Du vil kun få Simulect, hvis du skal have en ny nyre.
English: Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.
Danish: Spørg din læge, sundhedspersonalet eller apoteket til råds, før du tager nogen form for medicin, mens du er gravid eller ammer.
English: • Risk Management Plan (RMP) Not applicable.
Danish: Risikostyringsplan (RMP)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er det brugerens eget ansvar at overholde opbevaringstid og -betingelser før brug.
English: No clinically relevant influence of body weight or gender on distribution volume or clearance has been observed in adult patients.
Danish: Der er ikke observeret nogen klinisk relevant indflydelse af hverken vægt eller køn på fordelingsvolumen eller clearance hos voksne patienter.
English: Graft loss occurred in 6% of basiliximab-treated and 10% of placebo-treated patients by 6 months.
Danish: Graft-tab forekom hos 6 % af basiliximab-behandlede og 10 % af placebobehandlede patienter efter 6 måneder.
English: The overall incidence of infections was 75.9% in the basiliximab group and 75.6% in the placebo group and the incidence of serious infections was 26.1% and 24.8%, respectively.
Danish: Den overordnede incidens af infektioner var 75,9 % i basiliximab-gruppen og 75,6 % i placebogruppen, og incidensen af alvorlige infektioner var henholdsvis 26,1 % og 24,8 %.
English: In the 39-week study, the highest dose resulted in approximately 1,000 times the systemic exposure (AUC) observed in patients given the recommended clinical dose together with concomitant immunosuppressive therapy.
Danish: I 39- ugers undersøgelsen resulterede den højeste dosis i omkring 1.000 gange den systemiske udsættelse (AUC) som blev observeret hos patienter, som samtidig også fik anden immunsuppressiv behandling.
English: Paediatric population The efficacy and safety of basiliximab were evaluated in two paediatric studies.
Danish: Pædiatrisk population Basiliximabs virkning og sikkerhed blev evalueret i to pædiatriske studier.
English: Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2).
Danish: Simulect er indiceret til forebyggelse af akut organafstødning ved de novo allogen nyretransplantation hos voksne og pædiatriske patienter (1-17 år) (se pkt.
English: Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Danish: Simulect bør kun ordineres af læger, som har erfaring med immunsuppressiv terapi ved organtransplantation.
English: Safety data in paediatric patients have been obtained from one open-label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Danish: Sikkerhedsdata hos pædiatriske patienter blev opnået fra et åbent farmakokinetisk og farmakodynamisk studie hos nyretransplanterede recipienter (41 patienter).
English: In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without Simulect.
Danish: I kliniske studier var forekomsten af opportunistiske infektioner ens hos patienter, der anvendte immunsuppressive regimer med og uden Simulect.
English: Do not use after the expiry date stated on the pack.
Danish: Brug ikke Simulect efter udløbsdatoen, der fremgår af pakningen.
English: Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC02.
Danish: Farmakoterapeutisk klassifikation: Interleukinhæmmere, ATC-kode: L04AC02.
English: The relationship between serum concentration and receptor saturation was assessed in 13 patients and was similar to that characterised in adult renal transplantation patients.
Danish: Forholdet mellem serum koncentrationen og receptor mætningen blev vurderet hos 13 patienter og var i overensstemmelse med hvad der er karakteritisk hos voksne nyretransplanterede patienter.
English: There is a proportional increase in Cmax and AUC from 20 mg to 60 mg, the range of single-dose administrations tested.
Danish: Der er en proportional stigning i Cmax og AUC fra 20 mg til 60 mg, som er det enkelt-dosis interval der blev testet.
English: Overall the adverse event profile was consistent with general clinical experience in the paediatric renal transplantation population and with the profile in the controlled adult transplantation studies.
Danish: Den overordnede bivirkningsprofil var i overensstemmelse med den generelle kliniske erfaring hos den pædiatriske nyretransplanterede population og med profilen i de kontrollerede transplantationsstudier på voksne.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D stregkode, som indeholder en entydig identifikator.
English: Usual dose for adults The usual dose for adults is 20 mg in each infusion or injection.
Danish: Sædvanlig dosis til voksne Den sædvanlige dosis til voksne er 20 mg ved hver infusion eller injektion.
English: What Simulect contains - The active substance is basiliximab.
Danish: Simulect indeholder - Aktivt stof: basiliximab.
English: In vitro studies using human tissues indicate that basiliximab binds only to activated lymphocytes and macrophages/monocytes.
Danish: In vitro undersøgelser med humant væv tyder på, at basiliximab kun binder til aktiverede lymfocytter og makrofager/monocytter.
English: The incidence rates of adverse events and the pattern of adverse events were comparable between the two treatment groups and to be expected for the treatment regimens and the underlying diseases.
Danish: Hyppigheden af bivirkninger og bivirkningsmønsteret var sammenlignelig i de to behandlingsgrupper og som forventet ud fra behandlingsregimerne og de underliggende sygdomme.
English: Disposition parameters were not influenced to a clinically relevant extent by age (1-11 years), body weight (9-37 kg) or body surface area (0.44-1.20 m
Danish: De farmakokinetiske parametre blev ikke påvirket i en klinisk relevant grad af alder (1-11 år), legemsvægt (9-37 kg) eller legemsoverfladeareal (0,44-1,20 m2) i denne aldersgruppe.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: In several small clinical trials in heart transplant recipients, serious cardiac adverse events such as cardiac arrest (2.2%), atrial flutter (1.9%) and palpitations (1.4%) have been reported more frequently with Simulect than with other induction agents.
Danish: I flere små kliniske studier hos hjertetransplanterede patienter er alvorlige hjerte-relaterede bivirkninger såsom hjertestop (2,2 %), atrieflagren (1,9 %) og palpitationer (1,4 %) blevet rapporteret oftere med Simulect end med andre inducerende lægemidler.
English: Solvent for Simulect Water for injections
Danish: Solvens til Simulect Vand til injektionsvæsker
English: Transplant patients receiving immunosuppressive regimens involving combinations with or without basiliximab are at increased risk of developing lymphoproliferative disorders (LPDs) (such as lymphoma) and opportunistic infections (such as cytomegalovirus [CMV], BK virus).
Danish: Transplantationspatienter, der er i immunsuppressive behandlingsregimer, som omfatter kombinationer med eller uden basiliximab, har øget risiko for at udvikle lymfeproliferative anormaliteter (LPD's) (såsom lymfoma) og opportunistiske infektioner (såsom cytomegalovirus [CMV], BK-virus).
English: Immunosuppressive regimens involving combinations of medications increase the susceptibility to infection, including opportunistic infections, fatal infections and sepsis; the risk increased with total immunosuppressive load.
Danish: Immunsuppressive regimer, der inkluderer lægemiddelkombinationer, øger modtageligheden over for infektioner inklusive opportunistiske infektioner, dødbringende infektioner og blodforgiftning; risikoen øges ved total immunsuppressiv belastning.
English: FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK
Danish: KARTON TIL 1 HÆTTEGLAS OG 1 AMPUL SOM SAMLET PAKNING
English: In a pooled analysis of two five-year open-label extension studies (586 patients total) the combined graft and patient survival rates were not statistically different for the basiliximab and placebo groups.
Danish: I en poolet analyse af to fem-årige åbne forlængede studier (586 patienter i alt) var den kombinerede graft- og patientoverlevelsesrate ikke signifikant forskellige for basiliximab og placebo grupperne.
English: If a severe hypersensitivity reaction occurs, therapy with Simulect must be permanently discontinued and no further dose be administered.
Danish: Hvis der opstår en alvorlig overfølsomhedsreaktion, skal Simulect seponeres permanent og der skal ikke administreres nogle yderligere doser.
English: The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been demonstrated in double-blind placebo-controlled studies.
Danish: Basiliximabs forebyggende effekt mod organafstødning i de novo nyretransplantation er blevet påvist i dobbelt-blindede placebo-kontrollerede forsøg.
English: In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and multiple doses of up to 150 mg over 24 days with no acute undesirable effects.
Danish: Basiliximab er blevet givet til mennesker i kliniske forsøg med op til 60 mg som enkelt dosis og med op til 150 mg som multidosis i 24 dage uden nogle akutte bivirkninger.
English: There was no significant difference between basiliximab and placebo-treated patients in graft survival after 6 and 12 months (at 12 months 32 graft losses on basiliximab (9%) and 37 graft losses on placebo (10%)).
Danish: Der var ingen signifikant forskel mellem patienter behandlet med basiliximab og placebo med hensyn til graft overlevelse efter 6 og 12 måneder (efter 12 måneder var der 32 graft tab på basiliximab (9 %) og 37 graft tab hos placebo (10 %)).
English: Acute hypersensitivity reactions were observed on re-administration of Simulect for a subsequent transplantation in some of these patients.
Danish: Akutte overfølsomhedsreaktioner blev observeret hos nogle af disse patienter ved re-administration af Simulect ved efterfølgende transplantation.
English: White powder
Danish: Hvidt pulver
English: The primary objective of the study was to demonstrate superiority of this combination versus treatment with ciclosporin for microemulsion, mycophenolate mofetil and steroids in the prevention of acute rejections.
Danish: Det primære formål med studiet var at påvise superioritet ved denne kombination versus behandling med ciclosporin som mikroemulsion, mycophenolatmofetil og steroider til forebyggelse af akut afstødning.
English: In a pooled analysis of two five-year extension studies, no differences were found in the incidence of malignancies and LPDs between immunosuppressive regimens with or without combination of basiliximab (see section 4.8).
Danish: I en poolet analyse af to fem-årige forlængede studier blev der ikke fundet nogen forskel i incidensen af maligniteter og LPD's mellem immunsuppressive behandlingsregimer med eller uden kombination af basiliximab (se pkt.
English: The incidence of CMV infections was similar in both groups (14.6% vs. 17.3%), following either dual or triple therapy regimen (see section 4.4).
Danish: Hyppigheden af CMVinfektioner var ens i begge grupper (14,6 % vs. 17,3 %) efter henholdsvis to-stofs- eller tre-stofs-terapi behandling (se pkt.
English: Incidence of adverse events: In the above four placebo-controlled trials, the pattern of adverse events in 590 patients treated with the recommended dose of basiliximab was comparable to that observed in 595 patients treated with placebo.
Danish: Hyppigheden af bivirkninger: I de ovennævnte fire placebo-kontrollerede forsøg, var bivirkningsmønstret hos 590 patienter behandlet med den rekommanderede dosis af basiliximab sammenligneligt med det, som blev observeret hos 595 patienter behandlet med placebo.
English: Simulect is contraindicated in pregnancy and lactation (see section 4.3).
Danish: Simulect er kontraindiceret under graviditet og amning (se pkt.
English: The overall incidence of treatment-related adverse events among all patients in the individual studies was not significantly different between the basiliximab (7.1% - 40%) and the placebo (7.6% - 39%) treatment groups.
Danish: Hyppigheden af behandlingsrelaterede bivirkninger blandt alle patienter i de individuelle studier var ikke signifikant forskellig for basiliximab (7,1 % - 40 %) og placebo (7,6 % - 39 %) behandlingsgrupperne.
English: No toxicity was observed when rhesus monkeys received intravenous doses of either up to 5 mg/kg basiliximab twice weekly for 4 weeks followed by an 8-week withdrawal period or 24 mg/kg basiliximab weekly for 39 weeks followed by a 13-week withdrawal period.
Danish: Der blev ikke observeret toksicitet hos rhesus aber, som fik intravenøse doser af basiliximab på enten op til 5 mg/kg to gange om ugen gennem 4 uger efterfulgt af en 8 ugers seponeringsperiode eller 24 mg/kg basiliximab ugentligt i 39 uger efterfulgt af en 13 ugers seponeringsperiode.
English: Simulect can be given to older patients, but the information available is limited.
Danish: Ældre patienter (patienter på 65 år eller derover) Simulect kan gives til ældre patienter, men den tilgængelige information er begrænset.
English: Incidence of infectious episodes: The overall incidence and profile of viral, bacterial and fungal infections among patients treated with basiliximab or placebo in combination with dual and triple immunosuppressive therapy was comparable between the groups.
Danish: Hyppigheden af infektiøse episoder: Den overordnede incidens og profil af virus-, bakterie- og svampe-infektioner blandt patienter, der blev behandlet med basiliximab eller placebo i kombination med to-stofs- og tre-stofs immunsuppressiv behandling var sammenlignelig mellem grupperne.
English: If you are unsure about anything, ask your doctor, nurse or pharmacist.
Danish: Hvis du er usikker på noget, bør du spørge din læge, sygeplejerske eller apoteket.
English: Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients undergoing kidney transplantation.
Danish: Der er blevet udført enkelt-dosis og multi-dosis farmakokinetiske studier hos voksne nyretransplanterede patienter.
English: Use in heart transplantation
Danish: Hjertetransplantation
English: The primary efficacy endpoint, time to first biopsy-proven acute rejection (BPAR) episode or treatment failure defined as graft loss, death or presumptive rejection within the first 6 months post transplantation, occurred in 16.7% of basiliximab-treated patients and 21.7% of placebo-treated patients.
Danish: Det primære effekt-endepunkt, tid indtil første biopsi-verificerede tilfælde af akut afstødning (BPAR) eller behandlingssvigt defineret som graft-tab, død eller formodet afstødning inden for de første 6 måneder efter transplantationen, forekom hos 16,7 % af de basiliximab-behandlede patienter og hos 21,7 % af de placebo-behandlede patienter.
English: In addition to ciclosporin for microemulsion, steroids, azathioprine and mycophenolate mofetil, other concomitant medications routinely administered in organ transplantation have been administered in clinical trials without any incremental adverse reactions.
Danish: Udover ciclosporin som mikroemulsion, steroider, azathioprin og mycofenolatmofetil er anden ledsagende medicin, som rutinemæssigt administreres i forbindelse med organtransplantation, blevet administeret i kliniske forsøg uden nogen stigning i bivirkningsfrekvensen.
English: Incidence of malignant neoplasms: The overall incidence of malignancies among all patients in the individual studies was similar between the basiliximab and the comparator treatment groups.
Danish: Hyppigheden af maligne neoplasmer: Den samlede hyppighed af magliniteter blandt samtlige patienter i de individuelle studier var ens for basiliximab og comparator behandlingsgrupperne.
English: You must not breast-feed after being given Simulect or up to 4 months after the second dose.
Danish: Du må ikke amme efter at have fået Simulect eller op til 4 måneder efter du har fået anden dosis.
English: The incidence was 2/138 in patients not exposed to muromonab-CD3 (OKT3) and 4/34 in patients who received muromonab-CD3 concomitantly.
Danish: Incidensen var 2/138 hos patienter, der ikke blev behandlet med muromonab-CD3 (OKT3) og 4/34 hos patienter, der modtog samtidig behandling med muromonab-CD3.
English: The rates of BPAR were 9.4% in the basiliximab group and 17.4% in the placebo group (HR: 0.50, 90% CI: [0.25; 0.99]).
Danish: Hyppigheden af BPAR var 9,4 % i basiliximab-gruppen og 17,4 % i placebo-gruppen (HR: 0,50; 90 % CI: [0,25; 0,99]).
English: These concomitant medications include systemic antiviral, antibacterial and antimycotic medications, analgesics, antihypertensive medications such as beta-blocking agents or calcium channel blockers, and diuretics.
Danish: Disse ledsagende præparater inkluderer systemisk antivirale, antibakterielle og antimykotiske præparater, analgetika, antihypertensive lægemidler, så som beta-blokkere eller calcium-kanal-blokkere og diuretika.
English: The available clinical data on the use of muromonabCD3 in patients previously treated with basiliximab suggest that subsequent use of muromonab-CD3 or other murine anti-lymphocytic antibody preparations is not precluded.
Danish: De tilgængelige kliniske data vedrørende brug af muromonab-CD3 hos patienter, der forud er behandlet med basiliximab tyder på, at efterfølgende brug af muromonab-CD3 eller andre murine anti-lymfocyt antistof præparationer ikke er udelukket.
English: Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to Simulect and on re-exposure to a subsequent course of therapy.
Danish: Der er blevet observeret alvorlige, akutte (inden for 24 timer) overfølsomhedsreaktioner både ved initial anvendelse af Simulect og gentagen anvendelse ved et efterfølgende behandlingsforløb.
English: set, Abbott - Infusion set, Codan - Infusomat, Braun - Infusionsgerät R 87 plus, Ohmeda - Lifecare 5000Plumset Microdrip, Abbott - Vented basic set, Baxter - Flashball device, Baxter - Vented primary administration set, Imed
Danish: Infusionssæt - Luer Lock, H. Noolens - Steril udledningssæt i.v., Abbott - Infusionssæt, Codan - Infusomat, Braun - Infusionsgerät R 87 plus, Ohmeda - Lifecare 5000Plumset Microdrip, Abbott - Basis udledningssæt, Baxter - Flashball device, Baxter - Udledningssæt til primær administration , Imed
English: Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an uncontrolled study in 41 paediatric de novo renal transplant recipients.
Danish: Basiliximab blev brugt sammen med ciclosporin som mikroemulsion og steroider i et ikke-kontrolleret studie i 41 pædiatriske de novo nyretransplanterede recipienter.
English: No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgous monkeys following injections of up to 5 mg/kg basiliximab administered twice weekly during the organogenesis period.
Danish: Der blev ikke observeret nogen maternal toksicitet, embryotoksicitet eller teratogenicitet hos cynomolgusaber efter injektioner med basiliximab i op til 5 mg/kg indgivet to gange om ugen gennem organogeneseperioden.
English: What Simulect is and what it is used for What do you need to know before you are given Simulect How Simulect is given
Danish: Virkning og anvendelse Det skal du vide, før du får Simulect Sådan gives Simulect
English: Basiliximab specifically binds with high affinity (KD-value 0.1 nM) to the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor (IL2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the cellular immune response involved in allograft rejection.
Danish: Basiliximab binder specifikt med høj affinitet (KD-værdi 0,1 nM) til CD25 antigenet på aktiverede T-lymfocytter, som udtrykker højaffinitets interleukin-2 receptoren (IL-2R) og forhindrer derved interleukin-2-binding, som er et kritisk signal til T-celle formering i det cellulære immunrespons involveret i allograft-afstødning.
English: In infants and children (age 1-11 years, n=25), the steady-state distribution volume was 4.82.1 l, half-life was 9.54.5 days and clearance was 176 ml/h.
Danish: Hos spædbørn og børn (1-11 år, n=25), var steady state fordelingsvolumen 4,82,1 l, halveringstiden var 9,54,5 dage og clearance var 176 ml/t.
English: The use of basiliximab does not preclude subsequent treatment with murine antilymphocyte antibody preparations.
Danish: Brug af basiliximab udelukker ikke efterfølgende behandling med muse-antilymfocyt antistof præparationer.
English: Cytokine release syndrome.
Danish: 4.4), cytokin-release-syndrom.
English: In adolescents (age 12-16 years, n=14), the steady-state distribution volume was 7.85.1 l, half-life was 9.13.9 days and clearance was 3119 ml/h.
Danish: Hos unge (12-16 år, n=14), var steady state fordelingsvolumen 7,85,1 l, halveringstiden var 9,13,9 dage og clearance var 3119 ml/t.
English: Other medicines and Simulect
Danish: Brug af anden medicin sammen med Simulect
English: What do you need to know before you are given Simulect
Danish: Det skal du vide, før du får Simulect