natgillin/translations-raw huggingface dataset:
Når koncentrationen falder til under denne værdi, vender udtrykkelsen af CD25 antigenet tilbage til før- behandling- niveauet indenfor 1– 2 uger.
As concentrations fall below this level, expression of the CD25 antigen returns to pretherapy values within 1– 2 weeks.
Kliniske forsøg Basiliximabs forebyggende effekt mod organafstødning i de novo nyretransplantation er blevet påvist i dobbelt- blindede placebo- kontrollerede forsøg.
Clinical studies The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been demonstrated in double-blind placebo-controlled studies.
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.
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) og 12 (33% vs.
45%, p < 0.001) and 12 (33% vs.
48%, p < 0, 001) måneder efter transplantationen.
48%, p < 0.001) months after transplantation.
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%)).
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%)).
Incidencen af akutte afstødningsepisoder var væsentligt lavere hos patienter behandlet med basiliximab og tre- stofs - lægemiddel immunosuppressiv behandling.
The incidence of acute rejection episode was substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen.
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.
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%) eller mycofenolatmofetil (15% vs.
35%) or mycophenolate mofetil (15% vs.
27%).
27%).
Graft- tab forekom hos 6% af basiliximab- behandlede og 10% af placebo - behandlede patienter efter 6 måneder.
Graft loss occurred in 6% of basiliximab-treated and 10% of placebo-treated patients by 6 months.
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.
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.
Forlængelsesstudier viste også, at patienter, der oplever en akut afstødningsperiode i løbet af det første år efter transplantionen, oplevede flere graft- tab og dødsfald i løbet af den 5 års opfølgningsperiode end patienter, der ikke havde afstødning.
Extension studies also showed that patients who experienced an acute rejection episode during the first year after transplantation experienced more graft losses and deaths over the five-year follow-up period than patients who had no rejection.
Børn Basiliximab blev brugt sammen med ciclosporin som mikroemulsion og steroider i et ikke- kontrolleret studie i 41 pædiatriske de novo nyretransplanterede recipienter.
Paediatrics Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an uncontrolled study in 41 paediatric de novo renal transplant recipients.
Akut afstødning forekom i 14, 6% af patienterne 6 måneder efter transplantationen og i 24, 3% efter 12 måneder.
Acute rejection occurred in 14.6% of patients by 6 months post-transplantation, and in 24.3% by 12 months.
Den overordnede bivirkningsprofil var i overensstemmelse med den generelle kliniske erfaring med den pædiatriske nyretransplanterede population og med profilen i de kontrollerede transplantationsstudier på voksne.
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.
6 Ud af 339 nyretransplanterede patienter behandlet med basiliximab og testet for anti- idiotype antistoffer udviklede fire patienter (1, 2%) anti- idiotyp antistof- respons.
Immunogenicity Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 (1.2%) developed an anti-idiotype antibody response.
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.
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.
The available clinical data on the use of muromonab- CD3 in patients previously treated with basiliximab suggest that subsequent use of muromonab-CD3 or other murine anti-lymphocytic antibody preparations is not precluded.
Voksne Der er blevet udført enkelt- dosis og multi- dosis farmakokinetiske studier hos voksne nyretransplanterede patienter.
Adults Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients undergoing kidney transplantation.
Peak serum koncentrationen efter intravenøs infusion af 20 mg over 30 minutter var 7, 1±5, 1 mg/ l.
Peak serum concentration following intravenous infusion of 20 mg over 30 minutes is 7.1±5.1 mg/ l.
Der er en proportional stigning i Cmax og AUC fra 20 mg til 60 mg, som er det enkelt- dosis interval der blev testet.
There is a proportional increase in Cmax and AUC from 20 mg to 60 mg, the range of single-dose administrations tested.
Fordelingsvolumen ved steady state var 8, 6±4, 1 l.
The volume of distribution at steady state was 8.6±4.1 l.
In vitro undersøgelser med humant væv tyder på, at basiliximab kun binder til aktiverede lymfocytter og makrofager/ monocytter.
In vitro studies using human tissues indicate that basiliximab binds only to activated lymphocytes and macrophages/ monocytes.
Den terminale halveringstid var 7, 2±3, 2 dage.
The terminal half-life was 7.2±3.2 days.
Den totale clearance var 41±19 ml/ t.
Total body clearance was 41±19 ml/ h.
Børn Farmakokinetikken for basiliximab blev vurderet hos 39 de novo nyretransplanterede børn.
Paediatrics The pharmacokinetics of basiliximab were assessed in 39 paediatric de novo renal transplantation patients.
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.
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.
Fordelingsvolumen og clearance er reduceret med omkring 50% i forhold til voksne nyretransplanterede patienter.
Distribution volume and clearance are reduced by about 50% compared to adult renal transplantation patients.
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.
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 m2) in this age group.
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.
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.
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.
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.
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 immunosuppressiv behandling.
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.
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.
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.
7 Pulver Kaliumdihydrogenphosphat Dinatriumphosphat, vandfri Natriumchlorid Saccharose Mannitol (E421) Glycin
7 6.2 Incompatibilities
6. 6).
Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature (see section 6.6).
Simulect pulver 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.
Simulect powder 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.
Solvens Farveløs glasampul, type I glas, indeholdende 5 ml vand til injektionsvæske.
Solvent Colourless glass ampoule, type I glass, containing 5 ml water for injections.
Rekonstituering For at tilberede den opblandede opløsning tilsættes 5 ml vand til injektionsvæsker aseptisk fra den medfølgende ampul til hætteglasset, der indeholder Simulect pulver.
Reconstitution To prepare the solution for infusion or injection, add 5 ml of water for injections from the accompanying ampoule aseptically to the vial containing the Simulect powder.
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.
Kemisk og fysisk stabilitet er påvist efter opblanding i 24 timer ved 2°C - 8°C eller ved almindelig stuetemperatur i 4 timer.
After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature.
Hvis det ikke anvendes straks, er det brugerens eget ansvar at overholde opbevaringstid og - betingelser under brug.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Den færdigfremstillede opløsning er isotonisk og kan gives som en bolusinjektion eller fortyndet til et volumen på 50 ml eller mere med normal saltvandsopløsning eller glucose 50 mg/ ml (5%) til infusion.
The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ ml (5%) for infusion.
8 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.
09/ 10/ 1998 Dato for fornyelse:
09/ 10/ 1998 Date of renewal:
Simulect 10 mg pulver og solvens til injektions - og infusionsvæske, opløsning
Simulect 10 mg powder and solvent for solution for injection or infusion
Det kan administreres i en tre- stofs immunsuppressiv 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 Børn og unge (1- 17 år) Hos pædiatriske patienter, der vejer mindre end 35 kg er den anbefalede totale dosis 20 mg administreret i to doser på 10 mg hver.
Posology 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.
Den anden dosis kan tilbageholdes, hvis der enten opstår en alvorlig overfølsomhedsreaktion over for Simulect eller post- operative komplikationer, så som graf- tab.
10 hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).
10 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 næste 20 mg skal gives 4 dage efter transplantationen.
The second 20 mg dose should be given 4 days after transplantation.
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, CMV).
Transplant patients receiving immunosuppressive regimens involving combinations with or without basiliximab are at increased risk of developing lymphoproliferative disorders (LPDs) (such as
11 kombination af basiliximab (se pkt.
11 lymphoma) and opportunistic infections (such as cytomegalovirus, CMV).
4. 8).
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).
Basiliximab er blevet testet i fire randomiserede dobbelt- blinde placebo- kontrollerede studier i nyretransplanterede recipienter som en induktionsagent i kombination med de følgende immunosuppressive regimer: ciclosporin som mikroemulsion og kortikosteroider i to studier (346 og 380 patienter), ciclosporin som mikroemulsion, azathioprin og kortikosteroider i ét studie
Safety data in paediatric patients have been obtained from one open-label
Sikkerhedsdata hos pædiatriske patienter blev opnået fra et åbent farmakokinetisk og farmakodynamisk studie hos nyretransplanterede recipienter (41 patienter).
12 pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Hyppigheden af birvirkninger:
Incidence of adverse events:
5. 3.
13 5.
I en klinisk afprøvning med
Immunogenicity Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 (1.2%) developed an anti-idiotype antibody response.
14 172 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.
Pulver Kaliumdihydrogenphosphat
Solvent Water for injections
15 Dinatriumphosphat, vandfri Natriumchlorid Saccharose Mannitol (E421) Glycin
15 6.2 Incompatibilities
Simulect pulver 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.
Simulect powder 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.
Rekonstituering For at tilberede injektions - eller infusionsopløsningen, træk 2, 5 ml vand til injektionsvæsker aseptisk fra den medfølgende 5 ml ampul og tilføj aseptisk disse 2, 5 ml vand til injektionsvæsker til hætteglasset, der indeholder Simulect pulver.
Reconstitution To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml of water for injections aseptically to the vial containing the Simulect powder.
Det anbefales at anvende den farveløse, klare/ opaliserende opløsning straks efter fremstilling.
It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately.
Den færdigfremstillede opløsning er isotonisk og kan gives som en bolusinjektion eller fortyndet til et volumen på 25 ml eller mere med normal saltvandopløsning eller glucose 50 mg/ ml (5%) til infusion.
The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ ml (5%) for infusion.
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
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.
16 en separat infusionsslange.
16 7.
Novartis Pharma AG Lichtstrasse 35 CH- 4056 Basel Schweiz
Novartis Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland
Simulect 20 mg pulver og solvens til injektions - og infusionsvæske, opløsning basiliximab
Simulect 20 mg powder and solvent for solution for injection or infusion basiliximab
1 hætteglas med 20 mg pulver til injektions - og infusionsvæske, opløsning 1 ampul med 5 ml solvens
One vial with 20 mg powder for solution for injection/ infusion One ampoule of 5 ml solvent
Udløbsdato Anvendes straks efter rekonstituering (kemisk og fysisk stabilt ved 2°C - 8°C i 24 timer eller ved almindelig stuetemperatur i 4 timer).
EXP Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours).
Simulect 20 mg pulver til injektions - / infusionsvæske, opløsning basiliximab Intravenøs anvendelse
Simulect 20 mg powder for solution for injection/ infusion basiliximab Intravenous use
Simulect 10 mg pulver og solvens til injektions - og infusionsvæske, opløsning basiliximab
Simulect 10 mg powder and solvent for solution for injection or infusion basiliximab
1 hætteglas med 10 mg pulver til injektions - og infusionsvæske, opløsning 1 ampul med 5 ml solvens
One vial with 10 mg powder for solution for injection/ infusion One ampoule of 5 ml solvent
Simulect 10 mg pulver til injektions - / infusionsvæske, opløsning basiliximab Intravenøs anvendelse
Simulect 10 mg powder for solution for injection/ infusion basiliximab Intravenous use
Simulect 20 mg pulver og solvens til injektions - og infusionsvæske, opløsning Basiliximab
Simulect 20 mg powder and solvent for solution for injection or infusion Basiliximab
Virkning og anvendelse 2.
What Simulect is and what it is used for 2.
Det skal du vide, før du får Simulect 3.
Before you are given Simulect 3.
Sådan gives Simulect til dig 4.
How Simulect is given to you 4.
Opbevaring 6.
How to store Simulect 6.
VIRKNING OG ANVENDELSE
WHAT SIMULECT IS AND WHAT IT IS USED FOR
Simulect tilhører den gruppe medicin, der kaldes immunosuppressiva.
Simulect belongs to a group of medicines called immunosuppressants.
Immunosuppressiva reducerer kroppens respons på alt som synes ” fremmed ” – inklusive transplanterede organer.
Immunosuppressants reduce the body’ s response to anything that it sees as “ foreign” – which includes transplanted organs.
Kroppens immunforsvar ser et transplanteret organ som et fremmedlegeme og vil forsøge at afstøde det.
The body’ s immune system thinks a transplanted organ is a foreign body and will try to reject it.
Det er på dette tidspunkt, at en afstødning er mest sandsynlig.
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.
Følg nøje din læges anvisninger.
Follow your doctor’ s instructions carefully.
Du må ikke få Simulect
You must not be given Simulect
- hvis du er overfølsom (allergisk) over for basiliximab eller et af de øvrige indholdsstoffer i
- if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect
6 under ” Simulect indeholder ”.
listed in section 6 under “ What Simulect contains”.
- hvis du tidligere har fået transplanteret et organ, som svigtede efter kun kort tid eller,
- if you have previously received a transplant that failed after only a short time or,
- hvis du tidligere har været på operationsbordet med henblik på en transplantation, der alligevel
- if you have previously been in the operating theatre for a transplantation that in the end was not
ikke blev gennemført.
performed.
Dette gælder også medicin, som ikke er købt på recept.
31 Using other medicines Please tell your doctor, nurse or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
31 Ældre patienter (patienter på 65 år eller derover) Simulect kan gives til ældre patienter, men den tilgængelige information er begrænset.
Older patients (aged 65 years and over) Simulect can be given to older patients, but the information available is limited.
Børn og unge (i alderen 1– 17 år) Simulect kan gives til børn og unge.
Children and adolescents (aged 1 to 17 years) Simulect can be given to children and adolescents.
Graviditet og amning Det er meget vigtigt, at du fortæller din læge forud for transplantationen, hvis du er gravid eller overvejer, om du kan være gravid.
Pregnancy and breast-feeding It is very important to tell your doctor before your transplant if you are pregnant or you think that you may be pregnant.
Spørg din læge, sygeplejerske eller apoteket til råds, før du tager nogen form for medicin, mens du er gravid eller ammer.
Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.
Trafik - og arbejdssikkerhed Der er intet, der tyder på, at Simulect påvirker din evne til at køre bil eller betjene maskiner.
Driving and using machines There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use machines.
Simulect gives to gange på hospitalet.
You will only be given Simulect if you are receiving a new kidney.