natgillin/translations-raw huggingface dataset:
Da der ikke findes nogle data om Simulects kompatibilitet med andre lægemidler beregnet til intravenøs administration, må Simulect ikke blandes med andre lægemidler og skal altid indgives via en separat infusionsslange. 
Since no data are available on the compatibility of Simulect with other medicinal products intended for intravenous administration, Simulect should not be mixed with other medicinal products and should always be given through a separate infusion line.
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 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 tostofs- og tre-stofs-immunsuppressiv 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.
Trafik- og arbejdssikkerhed Der er intet, der tyder på, at Simulect påvirker din evne til at køre bil eller betjene maskiner. 
There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use machines.
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.
Farmakokinetikken for basiliximab blev vurderet hos 39 de novo nyretransplanterede børn. 
The pharmacokinetics of basiliximab were assessed in 39 paediatric de novo renal transplantation patients.
Simulects virkning og sikkerhed til forebyggelse af akut afstødning hos patienter, der er blevet transplanteret med solide organ-allografter bortset fra nyrer, er ikke blevet påvist. 
The efficacy and safety of Simulect for the prophylaxis of acute rejection in recipients of solid organ allografts other than renal have not been demonstrated.
Kassér den opblandede opløsning, hvis den ikke er brugt indenfor dette tidsinterval. 
Discard the reconstituted solution if not used within that time.
Sådan gives Simulect 
How Simulect is given
Opløst Simulect kan administreres som intravenøs bolus injektion eller som en intravenøs infusion over 20 til 30 minutter. 
Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20-30 minutes.
Simulect gives for at undgå, at din krop afstøder det nye organ gennem de første 46 uger efter transplantationen. 
Simulect is given to stop your body from rejecting the new organ during the first 4 to 6 weeks after the transplant operation, when rejection is most likely.
Kinetikken hos unge var identisk med den for voksne nyretransplanterede patienter. 
Disposition in adolescents was similar to that in adult renal transplantation patients.
I en poolet analyse af to fem-årige forlængede studier blev incidensen af LPD's og cancer fundet at være ens for basiliximab 7 % (21/295) og placebo 7 % (21/291) (se pkt. 
In a pooled analysis of two fiveyear 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).
Hvis borderlineafstødninger blev inkluderet i det primære effekt-endepunkt, var hyppigheden henholdsvis 26,0 % og 23,9 % uden statistisk signifikant forskel mellem basiliximab- og placebo-behandlede grupper (HR: 1,04; 90 % CI: [0,64; 1,68]). 
When borderline rejections were included in the primary efficacy endpoint, the rates were 26.0% and 23.9% respectively, with no statistically significant difference between the basiliximaband placebo-treated groups (HR: 1.04, 90% CI: [0.64; 1.68]).
Indeholder også kaliumdihydrogenphosphat; dinatriumphosphat, vandfri; natriumchlorid; saccharose; mannitol (E421); glycin. 
It also contains potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine.
Det anbefales at den farveløse, klare/opaliserende opløsning bruges straks efter fremstilling. 
It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately.
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.
Basiliximab er blevet testet i fire randomiserede dobbelt-blinde placebo-kontrollerede studier i nyretransplanterede recipienter som en induktionsagent i kombination med de følgende immunsuppressive 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).
Rekonstituering 
Reconstitution
Den anden dosis bør gives 4 dage efter transplantationen. 
The second dose should be given 4 days after transplantation.
Kliniske forsøg 
Clinical studies
Brug af basiliximab i en tre-stofs-terapi behandling, indeholdende azathioprin eller mycofenolatmofetil øgede ikke forekomsten af bivirkninger eller infektioner i basiliximab-gruppen sammenlignet med placebo gruppen (se pkt. 
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).
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 såsom hjertesvigt og myokardieinfarkt (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 such as cardiac failure and myocardial infarction (basiliximab 5%, placebo 4%).
Incidencen af akutte afstødningsepisoder var væsentligt lavere hos patienter behandlet med basiliximab og tre-stofslægemiddel immunsuppressiv behandling. 
The incidence of acute rejection episode was substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen.
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 første dosis gives umiddelbart før transplantationen og den anden dosis 4 dage efter operationen. 
The first dose is given just before the transplant operation, and the second dose 4 days after the operation.
Ud af 339 nyretransplanterede patienter behandlet med basiliximab og testet for anti-idiotype antistoffer udviklede fire patienter (1,2 %) anti-idiotyp antistof-respons. 
Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 (1.2%) developed an anti-idiotype antibody response.
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.
Basiliximab har potentielt skadelige immunsuppresive virkninger med hensyn til svangerskabsforløbet og for den ammede 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.
Kaliumdihydrogenphosphat Dinatriumphosphat, vandfri Natriumchlorid Saccharose 
Potassium dihydrogen phosphate Disodium phosphate, anhydrous Sodium chloride Sucrose
Du må ikke få Simulect - hvis du er overfølsom (allergisk) over for basiliximab eller et af de øvrige indholdsstoffer i 
You must not be given Simulect - if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect listed in section 6 under “What Simulect contains”.
Simulect må ikke administreres medmindre man har absolut vished om, at patienten vil modtage graft og ledsagende immunsuppression. 
Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Hvis du bemærker pludselige tegn på allergi såsom udslæt, kløe eller nældefeber, opsvulmen af ansigt, læber, tunge eller andre dele af kroppen, hurtig hjerterytme (puls), svimmelhed, stakåndethed, nysen, pibende eller besværet vejrtrækning, svært nedsat vandladning eller feber og symptomer på influenza, skal du omgående fortælle det til din læge eller sygeplejerske. 
If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, sneezing, wheezing or trouble breathing, severely decreased urine output, or fever and flu-like symptoms, tell your doctor or nurse immediately.
1 hætteglas med 20 mg pulver 1 ampul med 5 ml solvens 
1 vial with 20 mg powder 1 ampoule with 5 ml solvent
Resultaterne fra to pivotale 12-måneders multicenter forsøg (722 patienter sammenlagt), der sammenligner basiliximab med placebo, viste, at basiliximab anvendt samtidig med ciclosporin som mikroemulsion og kortikosteroider reducerer incidensen af akutte afstødninger både indenfor 6 (31 % vs. 45 %, p<0,001) og 12 (33 % vs. 48 %, p<0,001) måneder efter transplantationen. 
Results from two pivotal 12-month multicentre studies (722 patients in total) comparing basiliximab with placebo show that basiliximab, used concomitantly with ciclosporin for microemulsion and corticosteroids, significantly reduces the incidence of acute rejection episodes both within 6 (31% vs. 45%, p<0.001) and 12 (33% vs. 48%, p<0.001) months after transplantation.
natriumchlorid, saccharose, mannitol (E421), glycin. 
sodium chloride; sucrose; mannitol (E421); glycine.
Sædvanlig dosis til børn og unge (i alderen 1-17 år) - Til børn og unge som vejer mindre end 35 kg, er dosis af Simulect ved hver infusion eller injektion 10 mg. - Til børn og unge som vejer 35 kg eller mere, er dosis af Simulect ved hver infusion eller injektion 20 mg. 
Usual dose for children and adolescents (aged 1 to 17 years) - For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg. - For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg.
* rekombinant muse/menneske-kimerisk monoklonalt antistof, der er rettet mod interleukin-2 receptor -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 -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology.
Sædvanlig dosis til børn og unge (i alderen 1-17 år) - Til børn og unge der vejer 35 kg eller mere, er dosis af Simulect ved hver infusion eller injektion 20 mg. - Til børn og unge der vejer mindre end 35 kg, er dosis af Simulect ved hver infusion eller injektion 10 mg. 
Usual dose for children and adolescents (aged 1 to 17 years) - For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg. - For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg.
For information om præklinisk toksikologi, se pkt. 
For information on preclinical toxicology see section 5.3.
Et 12-måneders, randomiseret, placebo-kontrolleret, dobbeltblindet, multicenterstudie undersøgte basiliximab i kombination med ciclosporin som mikroemulsion, mycophenolatmofetil og steroider i pædiatriske nyretransplantationspatienter. 
A 12-month, randomised, placebo-controlled, double-blind, multicentre study investigated basiliximab in combination with ciclosporin for microemulsion, mycophenolate mofetil and steroids in paediatric renal allograft recipients.
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 immunsuppressiv 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.
Opblandet Simulect administreres som en intravenøs infusion over 20 til 30 minutter eller som en bolusinjektion. 
Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus injection.
1 hætteglas med 10 mg pulver 1 ampul med 5 ml solvens 
1 vial with 10 mg powder 1 ampoule with 5 ml solvent
Fortæl det altid til lægen, sundhedspersonalet eller apotekspersonalet, hvis du bruger anden medicin eller har brugt det for nylig. 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Hos børn var de hyppigst rapporterede bivirkninger forstoppelse, rigelig hårvækst, løbende eller stoppet næse, feber, højt blodtryk og forskellige slags infektioner. 
In children, the most commonly reported side effects were constipation, excessive growth of normal hair, runny or blocked nose, fever, high blood pressure, and various kinds of infections.
Simulect 10 mg må ikke gives, medmindre man er fuldstændig sikker på, at patienten vil modtage transplantatet og ledsagende immunsuppression. 
Simulect 10 mg must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
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.
Kumulative doser 20 mg op til 60 mg blev undersøgt. 
Cumulative doses ranged from 20 mg up to 60 mg.
Graviditet og amning (se pkt. 
Pregnancy and lactation (see section 4.6).
I en klinisk afprøvning med 172 patienter behandlet med basiliximab var incidencen af humant antimuse-antistof (HAMA) for nyretransplanterede patienter 2/138 hos patienter, der ikke blev behandlet med muromonab-CD3 og 4/34 hos patienter, der samtidig blev behandlet med muromonab-CD3. 
In a clinical trial with 172 patients receiving basiliximab, the incidence of human antimurine antibody (HAMA) in renal transplantation patients treated with basiliximab was 2/138 in patients not exposed to muromonab-CD3 and 4/34 in patients who received muromonab-CD3 concomitantly.
Basiliximab er et muse/menneske-kimerisk monoklonalt antistof (IgG1), der er rettet mod interleukin2 receptor -kæden (CD25 antigen), som udtrykkes på overfladen af T-lymfocytter som svar på antigen-påvirkningen. 
Basiliximab is a murine/human chimeric monoclonal antibody (IgG1) that is directed against the interleukin-2 receptor -chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge.
Hvis borderline-afstødninger blev inkluderet, var hyppigheden henholdsvis 20,8 % og 19,6 % (HR: 1,01; 90 % CI: [0,59; 1,72]). 
When borderline rejections were included, the rates were 20.8% and 19.6% respectively (HR: 1.01, 90% CI: [0.59; 1.72]).
Da der ikke er nogle tilgængelige data på forligeligheden mellem Simulect og andre intravenøse lægemidler, skal Simulect ikke blandes med andre præparater og altid indgives via en separat infusionslange. 
Since no data are available on the compatibility of Simulect with other intravenous substances, Simulect should not be mixed with other medications/substances and should always be given through a separate infusion line.
Farveløs glasampul, type I glas, indeholdende 5 ml vand til injektionsvæske. 
Colourless glass ampoule, type I glass, containing 5 ml water for injections.
Voksne Den totale standarddosering er 40 mg, givet i 2 doser af 20 mg. 
Adults The standard total dose is 40 mg, given in two doses of 20 mg each.
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. 
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.
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.
Hos pædiatriske patienter, der vejer mindre end 35 kg er den anbefalede totale dosis 20 mg administreret i to doser på 10 mg hver. 
In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each.
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.
Det leveres pakket sammen med en farveløs glasampul med 5 ml sterilt vand til injektionsvæsker. 
It is supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections.
Ampullen indeholder 5 ml vand til injektionsvæsker. 
The solvent ampoule contains 5 ml water for injections.
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.
- Øvrige indholdsstoffer: kaliumdihydrogenphosphat, vandfri dinatriumhydrogenphosphat, 
- The other ingredients are potassium dihydrogen phosphate; disodium phosphate, anhydrous;
Den anden dosis på 20 mg skal gives 4 dage efter transplantation. 
The second 20 mg dose should be given 4 days after transplantation.
Det gives enten langsomt via en kanyle i din vene som en infusion over 20 til 30 minutter eller som en intravenøs injektion ved brug af en sprøjte. 
Simulect is given twice, in hospital, either slowly through a needle in your vein as an infusion lasting 20-30 minutes or as an intravenous injection using a syringe.
Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (jf. bilag I: Produktresumé; pkt. 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Resultater fra to multicenter dobbelt-blinde studier sammenlignende basiliximab med placebo (463 patienter sammenlagt) viser, at basiliximab mindsker forekomsten af akutte afstødningsepisoder indenfor 6 måneder efter transplantationen signifikant, når det administreres sammen med ciclosporin som mikroemulsion, korikosteroider og enten azathiopin (21 % vs. 35 %) eller mycofenolatmofetil (15 % vs. 27 %). 
Results from two multicentre double-blind studies comparing basiliximab with placebo (463 patients in total) show that basiliximab significantly reduces the incidence of acute rejection episodes within 6 months after transplantation when used concomitantly with ciclosporin for microemulsion, corticosteroids, and either azathioprine (21% vs. 35%) or mycophenolate mofetil (15% vs. 27%).
Den anden dosis skal ikke gives, hvis alvorlige overfølsomhedsreaktioner eller transplantattab opstår. 
The second dose should not be given if severe hypersensitivity reactions to Simulect or graft loss occur.
Hos voksne var de hyppigst rapporterede bivirkninger forstoppelse, kvalme, diarré, vægtøgning, hovedpine, smerte, opsvulmen af hænder, ankler eller fødder, højt blodtryk, blodmangel, ændringer i blodbilledet (for eksempel kalium, kolesterol, phosphat, kreatinin), komplikationer med operationssåret og forskellige slags infektioner. 
In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.
Anvendes straks efter rekonstituering (kemisk og fysisk stabilt ved 2 °C - 8 °C i 24 timer eller ved almindelig stuetemperatur i 4 timer). 
Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours).
Farveløst type I hætteglas, grå fluor-resina-dækket butyl gummiprop, holdt på plads med et ombøjet aluminiumsbånd, blå polypropylen aftagelig låg, indeholdende 20 mg basiliximab som pulver til injektions- og infusionsvæske, opløsning. 
Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion.
Farveløst type I hætteglas, grå fluor-resina-dækket butyl gummiprop, holdt på plads med et ombøjet aluminiumsbånd, blå polypropylen aftagelig låg, indeholdende 10 mg basiliximab som pulver til injektions- og infusionsvæske, opløsning. 
Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 10 mg basiliximab as powder for solution for injection or infusion.