natgillin/translations-raw huggingface dataset:
Når resultatet af de første to undersøgelser ses samlet, var behandlingen virkningsløs hos 40% af de patienter, der blev behandlet med Simulect og en tostofsbehandling over en periode på seks måneder (145 ud af 363), sammenlignet med 56% af de patienter, der fik placebo (201 ud af 359).
Looking at the results of the first two studies taken together, 40% of the patients receiving Simulect in addition to dual therapy failed treatment over six months (145 out of 363), compared with 56% of the patients receiving placebo (201 out of 359).
I den tredje undersøgelse var behandlingen virkningsløs hos færre patienter, der blev behandlet med Simulect og en trestofsbehandling (26%), sammenlignet med de patienter, der fik placebo (40%).
In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%).
De mest almindelige bivirkninger hos voksne (som optræder hos mere end 20% af patienterne) var forstoppelse, urinvejsinfektioner (infektioner i urinledende strukturer), smerter, kvalme, perifert ødem (hævelse), hypertension (højt blodtryk), anæmi (nedsat antal røde blodlegemer), hovedpine, hyperkaliæmi (forhøjet indhold af kalium i blodet), hyperkolesterolæmi (forhøjet kolesteroltal), komplikation i forbindelse med operationssår, vægtforøgelse, forhøjet serumkreatinin (markør for nyreproblemer), hypofosfatæmi (lav fosfatkoncentration i blodet), diarré og infektioner i de øvre luftveje (forkølelse).
In adults, the most common side effects (seen in more than 20% of patients) were constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anaemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhoea and upper respiratory tract infection (colds).
Hos børn var de mest almindelige bivirkninger, som optræder hos mere end 20% af patienterne, urinvejsinfektioner, hypertrikose (øget behåring), rhinitis (stoppet eller løbende næse), pyreksi (feber), hypertension, infektioner i de øvre luftveje, virusinfektioner, blodforgiftning (blodinfektion) og forstoppelse.
In children, the side effects seen in more than 20% of patients were urinary tract infections, hypertrichosis (excess body hair), rhinitis (stuffy and runny nose), pyrexia (fever), hypertension, upper respiratory tract infection, viral infection, sepsis (blood infection) and constipation.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Simulect er større end risiciene til forebyggelse af akut organafstødning ved de novo allogen nyretransplantation hos voksne og pædiatriske patienter.
The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect’ s benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Simulect til Novartis Europharm Limited den 9. oktober 1998.
The European Commission granted a marketing authorisation valid throughout the European Union for Simulect to Novartis Europharm Limited on 9 October 1998.
Simulect 20 mg pulver og solvens til injektions - og infusionsvæske, opløsning
Simulect 20 mg powder and solvent for solution for injection or infusion
Hvert hætteglas indeholder 20 mg basiliximab *.
Each vial contains 20 mg basiliximab*.
* rekombinant muse/ menneske- kimerisk monoklonalt antistof, der er rettet mod interleukin- 2 receptor α- kæden (CD25 antigen), produceret i en muse myeloma cellelinie ved rekombinant DNA- teknologi.
* recombinant murine/ human chimeric monoclonal antibody directed against the interleukin-2 receptor α -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology.
Pulver og solvens til injektions - og infusionsvæske, opløsning
Powder and solvent for solution for injection or infusion
4. 2).
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).
Det skal anvendes samtidig med ciclosporin som mikroemulsion - og kortikosteroid- baseret immunsuppression hos patienter med panel reaktive antistoffer mindre end 80% eller i en tre- stofs vedligeholdelses immunosuppressiv behandling bestående af ciclosporin som mikroemulsion, kortikosteroider og enten azathioprin eller mycofenolatmofetil.
It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Simulect bør kun ordineres af læger, som har erfaring med immunosuppressiv terapi ved organtransplantation.
Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Simulect bør administreres sammen med ciclosporin som microemulsion - og kortikosteroid- baseret immunsuppression.
Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression.
Det kan administreres i en tre- stofs immunosuppressiv behandling baseret på ciclosporin som microemulsion og kortikosteroid samt azathioprin eller mycofenolmofetil.
It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple immunosuppressive regimen including azathioprine or mycophenolate mofetil.
Dosering Voksne Den totale standarddosering er 40 mg givet i 2 doser på 20 mg hver.
Posology Adults The standard total dose is 40 mg, given in two doses of 20 mg each.
4. 4).
The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).
2 Hos pædiatriske patienter, der vejer mindre end 35 kg er den anbefalede totale dosis 20 mg administreret i to doser på 10 mg hver.
2 Children and adolescents (1– 17 years) In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each.
Hos pædiatriske patienter, der vejer 35 kg eller mere er den anbefalede dosis voksendosis, det vil sige en total dosis på 40 mg administreret i to doser på 20 mg hver.
In paediatric patients weighing 35 kg or more, the recommended dose is the adult dose, i. e. a total dose of 40 mg, given in two doses of 20 mg each.
Ældre (≥65 år) Der er begrænsede data tilgængelige vedrørende anvendelsen af Simulect til ældre, men der er intet, der tyder på, at ældre patienter kræver en anden dosering end yngre voksne patienter.
Elderly (≥ 65 years) There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Administrationsmåde Opløst Simulect kan administreres som intravenøs bolus injektion eller som en intravenøs infusion over 20 til 30 minutter.
Method of administration Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20– 30 minutes.
6. 6.
For information on reconstitution, see section 6.6.
4. 6).
Pregnancy and lactation (see section 4.6).
Immunosuppressive regimer, der inkluderer lægemiddelkombinationer, øger modtageligheden over for infektioner inklusive opportunistiske infektioner, dødbringende infektioner og blodforgiftning; risikoen øges ved total immunosuppressiv belastning.
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.
Overfølsomhed Der er blevet observeret alvorlige, akutte (indenfor 24 timer) overfølsomhedsreaktioner både ved initial anvendelse af Simulect og gentagen anvendelse ved et efterfølgende behandlingsforløb.
Hypersensitivity 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.
Disse inkluderede anafylaksilignende reaktioner så som urticaria, pruitus, nysen, hypotension, takykardi, dyspnø, bronkospasme, lungeødem og respirationsinsuffiens.
These included anaphylactoid-type reactions such as urticaria, pruritus, sneezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema and respiratory failure.
Det er sjældent, at sådanne reaktioner er blevet rapporteret hos patienter i behandling med Simulect (< 1/ 1. 000 patienter).
There have been rare reports of such reactions in patients receiving Simulect (< 1/ 1,000 patients).
Der bør udvises forsigtighed når patienter, der tidligere har fået Simulect, re - eksponeres for efterfølgende behandling med dette lægemiddel.
Caution should be exercised when patients previously given Simulect are re-exposed to a subsequent course of therapy with this medicinal product.
Dette er patienter, der efter initial administration af Simulect har fået seponeret deres samtidige behandling med immunosopressiva i utide, f. eks. på grund af aflyst transplantation eller tidlig tab af graft.
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.
Akutte overfølsomhedsreaktioner blev observeret hos nogle af disse patienter ved re- administration af Simulect ved efterfølgende transplantation.
Acute hypersensitivity reactions were observed on re-administration of Simulect for a subsequent transplantation in some of these patients.
Transplantationspatienter, der er i immunosuppressive 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,
In a pooled analysis of two
4. 8).
3 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).
Da basiliximab er et immunglobulin, forventes ingen metaboliske lægemiddel- lægemiddel interaktioner.
Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
Disse ledsagende præparater inkluderer systemisk antivirale, antibakterielle og antimykotiske præparater, analgetika, antihypertensive lægemidler, så som beta- blokkere eller calcium- kanal- blokkere og diuretika.
These concomitant medications include systemic antiviral, antibacterial and antimycotic medications, analgesics, antihypertensive medications such as beta-blocking agents or calcium channel blockers, and diuretics.
Humant antimuse- antistof (HAMA) respons er uden prædiktiv værdi for klinisk tolerabilitet baseret på en klinisk undersøgelse af 172 patienter behandlet med basiliximab.
Human antimurine antibody (HAMA) responses were reported in a clinical trial of 172 patients treated with basiliximab, without predictive value for clinical tolerability.
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.
The incidence was 2/ 138 in patients not exposed to muromonab-CD3 (OKT3) and 4/ 34 in patients who received muromonab-CD3 concomitantly.
Brug af basiliximab udelukker ikke efterfølgende behandling med muse- antilymfocyt antistof præparationer.
The use of basiliximab does not preclude subsequent treatment with murine antilymphocyte antibody preparations.
I de oprindelige fase III studier, havde 14% af patienterne i basiliximab- gruppen og 27% af patienterne i placebo gruppen i de 3 første måneder efter transplantationen, en akut afstødning som blev behandlet med antistofterapi (OKT 3 eller antithymocytglobulin/ antilymphocytglobulin (ATG/ ALG)), uden nogen øget forekomst af bivirkninger eller infektioner i basiliximab- gruppen sammenlignet med placebogruppen.
In the original phase III studies during the first 3 months post-transplantation, 14% of patients in the basiliximab group and 27% of patients in the placebo group had an acute rejection episode treated with antibody therapy (OKT 3 or antithymocyte globulin/ antilymphocyte globulin (ATG/ ALG)), with no increase in adverse events or infections in the basiliximab group as compared to placebo.
Tre kliniske forsøg har undersøgt brugen af basiliximab i forbindelse med en tre- stofs- terapi behandling, som omfattede enten azathioprin eller mycofenolatmofetil.
Three clinical trials have investigated basiliximab use in combination with a triple therapy regimen which included either azathioprine or mycophenolate mofetil.
Den totale clearance af basiliximab i kroppen blev reduceret i gennemsnit med 22%, når azathioprin blev tilføjet en behandling bestående af ciclosporin som microemulsion og kortikosteroider.
The total body clearance of basiliximab was reduced by an average 22% when azathioprine was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
Den totale clearance af basiliximab i kroppen blev i gennemsnit reduceret med 51%, når mycofenolatmofetil blev tilføjet til en behandling indeholdende ciclosporin som microemulsion og kortikosteroider.
The total body clearance of basiliximab was reduced by an average 51% when mycophenolate mofetil was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
4. 8).
The use of basiliximab in a triple therapy regimen including azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab group as compared to placebo (see section 4.8).
4. 3).
Simulect is contraindicated in pregnancy and lactation (see section 4.3).
Basiliximab har potentielle skadelige immunosuppresive virkninger med hensyn til svangerskabsforløbet og for den ammende nyfødte, som får basiliximab via modermælken.
Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate exposed to basiliximab in breast milk.
Kvinder i den fødedygtige alder skal anvende effektiv antikonception under og indtil 16 uger efter behandlingen.
Women of childbearing potential must use effective contraception during and up to 16 weeks after treatment.
Der foreligger ingen data på dyr eller mennesker vedrørende udskillelse af basiliximab i modermælken.
There is no animal or human data available concerning excretion of basiliximab into breast milk.
Baseret på basiliximabs IgG1- egenskaber, må udskillelsen i modermælken forventes.
However, based on the IgG1 nature of basiliximab, excretion into milk should be expected.
4 immunosuppressive regimer: ciclosporin som mikroemulsion og kortikosteroider i to studier (346 og 380 patienter), ciclosporin som mikroemulsion, azathioprin og kortikosteroider i ét studie (340 patienter), og ciclosporin som mikroemulsion, mycophenolatmofetil og kortikosteroider i et andet studie (123 patienter).
Basiliximab has been tested in four randomised, double-blind, placebo-controlled studies in renal transplant recipients as an induction agent in combination with the following immunosuppressive regimens: ciclosporin for microemulsion and corticosteroids in two studies (346 and 380 patients), ciclosporin for microemulsion, azathioprine and corticosteroids in one study (340 patients), and ciclosporin for microemulsion, mycophenolate mofetil and corticosteroids in another study (123 patients).
Hyppigheden af birvirkninger:
4 Incidence of adverse events:
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.
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.
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.
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.
Voksne patienter De mest almindelige rapporterede bivirkninger efter to- stofs - eller tre- stofs- terapi, hos begge behandlingsgrupper (basiliximab vs. placebo) var forstoppelse, urinvejsinfektion, smerte, kvalme, perifert ødem, hypertension, anæmi, hovedpine, hyperkalæmi, hyperkolesterolæmi, postoperative sårkomplikationer, vægtøgning, stigning i blod kreatinin, hypophosphatæmi, diarré og øvre luftvejsinfektion.
Adult patients The most commonly reported (> 20%) events following dual or triple therapy in both treatment groups (basiliximab vs. placebo) were constipation, urinary tract infection, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postoperative wound complication, weight increase, increase in blood creatinine, hypophosphataemia, diarrhoea and upper respiratory tract infection.
Pædiatriske patienter De mest almindelige rapporterede (> 20%) bivirkninger efter to- stofs- terapi i begge (< 35 kg vs. ≥35 kg) vægtgrupper var urinvejsinfektion, hypertrikose, rhinitis, pyreksi, hypertension, øvre luftvejsinfektion, viral infektion, sepsis og forstoppelse.
Paediatric patients The most commonly reported (> 20%) events following dual therapy in both (< 35 kg vs. ≥ 35 kg weight) cohorts were urinary tract infection, hypertrichosis, rhinitis, pyrexia, hypertension, upper respiratory tract infection, viral infection, sepsis and constipation.
Hyppigheden af maligne neoplasmer:
Incidence of malignant neoplasms:
Den samlede hyppighed af magliniteter blandt samtlige patienter i de individuelle studier var ens for basiliximab og comparator behandlingsgrupperne.
The overall incidence of malignancies among all patients in the individual studies was similar between the basiliximab and the comparator treatment groups.
I alt forekom lymfom/ lymfoproliferative sygdomme hos 0, 1% (1/ 701) af patienterne i basiliximab gruppen sammenlignet med 0, 3% (2/ 595) af patienterne, der modtog placebo, både i kombination med to - stofs - og tre- stofs- immunosuppressiv behandling.
Overall, lymphoma/ lymphoproliferative disease occurred in 0.1% (1/ 701) of patients in the basiliximab group compared with 0.3% (2/ 595) of patients receiving placebo, both in combination with dual and triple immunosuppressive therapy.
Der blev rapporteret andre magliniteter hos 1, 0% (7/ 701) af patienterne i basiliximab gruppen sammenlignet med 1, 2% (7/ 595) af placebo patienterne.
Other malignancies were reported among 1.0% (7/ 701) of patients in the basiliximab group compared with 1.2% (7/ 595) of placebo patients.
4. 4).
In a pooled analysis of two five- year extension studies, the incidence of LPDs and cancer was found to be equal with basiliximab 7% (21/ 295) and placebo 7% (21/ 291) (see section 4.4).
Hyppigheden af infektiøse episoder:
Incidence of infectious episodes:
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 immunosuppressiv behandling var sammenlignelig mellem grupperne.
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.
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%.
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.
Hyppigheden af CMV - infektioner var ens i begge grupper (14, 6% vs.
The incidence of CMV infections was similar in both groups (14.6% vs.
4. 4).
17.3%), following either dual or triple therapy regimen (see section 4.4).
Hyppigheden og årsagen til dødsfald var ens når man fulgte to- stofs - eller tre- stofsterapi i basiliximab (2, 9%) og placebo gruppen (2, 6%) med infektion som den mest almindelige dødsårsag i begge terapi behandlingsgrupper (basiliximab = 1, 3%, placebo = 1, 4%).
The incidence and causes of deaths following dual or triple therapy were similar in basiliximab (2.9%) and placebo groups (2.6%), with the most common cause of deaths in both treatment groups being infections (basiliximab = 1.3%, placebo = 1.4%).
I en poolet analyse af to fem- årige forlængede studier forblev incidensen og årsagen til død tilsvarende i begge behandlingsgrupper (basiliximab 15%, placebo 11%), hvor den primære dødsårsag var hjerte- relaterede sygdomme (basiliximab 5%, placebo 4%).
In a pooled analysis of two five-year extension studies the incidence and cause of death remained similar in both treatment groups, (basiliximab 15%, placebo 11%), the primary cause of death being cardiac-related disorders (basiliximab 5%, placebo 4%).
4. 4), og cytokin release syndrom er blevet rapporteret ved post- marketing erfaringer med Simulect.
Post-marketing adverse reactions Hypersensitivity/ anaphylactoid reactions such as rash, urticaria, sneezing, wheezing, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome (see section 4.4), and cytokine release syndrome have been reported during post-marketing experience with Simulect.
Hyppigheden er ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The frequency is not known (cannot be estimated from the available data).
Basiliximab er blevet givet til mennesker i kliniske forsøg med op til 60 mg som enkelt dosis og med
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.
5 op til 150 mg som multidosis i 24 dage uden nogle akutte bivirkninger.
For information on preclinical toxicology see section 5.3.
5. 3.
5 5.
Interleukinhæmmere, ATC- kode:
Interleukin inhibitors, ATC code:
Virkningsmekanisme Basiliximab er et muse/ menneske- kimerisk monoklonalt antistof (IgG1κ), der er rettet mod interleukin - 2 receptor α- kæden (CD25 antigen), som udtrykkes på overfladen af T- lymfocytter som svar på antigen- påvirkningen.
Mechanism of action Basiliximab is a murine/ human chimeric monoclonal antibody (IgG1 κ) that is directed against the interleukin-2 receptor α -chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge.
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.
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 (IL- 2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the cellular immune response involved in allograft rejection.
Fuldstændig og fortsat blokering af interleukin- 2 receptoren opretholdes, så længe serum- basiliximab- niveauer overstiger 0, 2 µg/ ml (som regel op til 4 – 6 uger efter administration).
Complete and consistent blocking of the interleukin-2 receptor is maintained as long as serum basiliximab levels exceed 0.2 μ g/ ml (usually up to 4– 6 weeks after administration).