natgillin/translations-raw huggingface dataset:
Et volumen Zenapax indeholdende den nødvendige dosis sættes til 50 ml 0, 9% steril natriumchloridopløsning og indgives dle
The volume of Zenapax containing the appropriate dose is added to 50 ml of sterile 0.9% saline solution and is na
intravenøst i løbet af 15 minutter.
administered intravenously over a 15 minute period.
Den næste og hver af de følgende doser mi
The next and each i dic
indgives med intervaller på 14 dage indtil der er givet i alt 5 doser. ge
subsequent dose should be given at intervals of fourteen days, for a total of five doses.
Ældre Læ
Elderly Me
2 Der findes ingen data ved svær nedsat leverfunktion.
2 No data are available for patients with severe hepatic impairment.
6. 6
Instructions for the preparation of Zenapax infusions are described in section 6.6.
Zenapax er kontraindiceret til patienter med kendt overfølsomhed overfor daclizumab eller ethvert af
Zenapax is contraindicated in patients with known hypersensitivity to daclizumab or to any excipients of this product (see section 6.1).
6. 1).
ed Zenapax is contraindicated during lactation (see section 4.6).
4. 6).
4.4 Special warnings and precautions for use
ls 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
s ori There is no experience of the use of Zenapax in patients who are highly immunised.
t ti Der er ingen erfaringer med anvendelse af Zenapax til patienter som er højt immuniserede.
Severe, acute (onset within
Alvorlige og akutte (begyndende inden for 24 timer) overfølsomhedsreaktioner efter administration af Zenapax, både
uth 24 hours) hypersensitivity reactions on both initial and subsequent exposure to Zenapax have been reported rarely.
ris initialt og senere hen i forløbet, er sjældent rapporteret.
ra temperature increase, rash and pruritus.
Medicin til behandling af svære
Medications for the treatment of severe hypersensitivity reactions should therefore be available for immediate use.
to overfølsomhedsreaktioner skal derfor være til rådighed for øjeblikkelig brug. au Patienter i immunosuppressiv behandling efter transplantation har øget risiko for at udvikle lymfoproliferative sygdomme og opportuniske infektioner.
ge Patients on immunosuppressive therapy following transplantation are at increased risk for developing lymphoproliferative disorders (LPDs) and opportunistic infections.
Selvom Zenapax er et immunosuppressivt ere
While Zenapax is an lon immunosuppressive drug, to date no increase in LPDs or opportunistic infections have been observed in patients treated with Zenapax.
stof er der indtil nu ikke observeret nogen stigning i lymfoproliferative sygdomme eller opportunistiske infektioner hos patienter behandlet med Zenapax. ng
In transplant recipients there is no experience of exposure to second or subsequent treatment courses no
Der er ingen erfaringer med behandling nr.
using Zenapax.
2 eller efterfølgende behandlinger hos transplantatmodtagere. læ
In a single randomized controlled clinical trial in cardiac transplant recipients which compared t
I en enkel randomiseret kontrolleret klinisk undersøgelse hos hjertetransplanterede patienter, der sammenlignede Zenapax overfor placebo, begge anvendt i kombination med mycophenolat mofetil ke
Zenapax to placebo, each used in combination with mycophenolate mofetil (CellCept 1.5 g bid), uc
(CellCept 1, 5 g to gange daglig), cyclosporin og kortikosteroider var der flere infektionsrelaterede dødsfald hos patienter, der fik Zenapax.
cyclosporine, and corticosteroids, there were more infection related deaths among patients who received Zenapax.
Ved det 1. år efter transplantationen var 14 af 216 patienter (6, 5%), som fik Zenapax og 4 af 207 patienter (1, 9%), som fik placebo døde af en infektion; en forskel r ik
At 1 year post-transplant 14 of 216 patients (6.5%) who received Zenapax and 4 of rod
på 4, 6% (95% CI:
207 (1.9%) patients who received placebo died of an infection, a difference of 4.6% (95% CI:
Af disse 14 Zenapax patienter var der 4, der døde mere end 90 dage efter at have modtaget den sidste dosis Zenapax, hvilket gør det usandsynligt, at Zenapax havde te
Of these 14 Zenapax patients, 4 died more than 90 days after receiving their last dose of Zenapax, making it unlikely that Zenapax had a role in the infection related death.
indflydelse på de infektionsrelaterede dødsfald.
received Zenapax and in patients who received placebo, 18.5% and 17.9%, respectively.
Den overordnede anvendelse af polyklonal antilymfocyt antistofterapi (OKT3, ATG, ATGAM) var ens hos patienter, som fik Zenapax og hos patienter, som fik placebo, henholdsvis 18, 5 og 17, 9%.
However, of the 40 patients who received both Zenapax and antilymphocyte therapy, 8 (20.0%) died whereas of the na
antilymfocytterapi, var der 8 der døde (20, 0%) mens hos de 37 patienter, der fik både placebo og antilymfocytterapi, var der 2 der døde (5, 4%).
37 patients who received both placebo and antilymphocyte therapy, 2 (5.4%) died.
Samtidig anvendelse af Zenapax med en anden antilymfocyt antistofterapi i forbindelse med en intensiv immunosuppression med cyclosporin, mi
Concomitant use of Zenapax with another antilymphocyte antibody therapy in the context of intensive immunosuppression with cyclosporine, mycophenolate mofetil and corticosteroids may be a factor leading to fatal i dic
mycophenolat mofetil og kortikosteroider kan være en faktor, der fører til fatal infektion. ge
infection.
4. 5 Interaktion med andre lægemidler og andre former for interaktion Læ
4.5 Interaction with other medicinal products and other forms of interaction Me
Følgende transplantationslægemidler er anvendt i kliniske undersøgelser sammen med Zenapax uden interaktioner: ciclosporin, mycophenolatmofetil, ganciclovir, aciclovir, tacrolimus, azathioprin, antithymocyt immunglobulin, muromonab- CD3 (OKT3) og kortikosteroider.
The following transplant medications have been administered in clinical trials with Zenapax without any interactions: cyclosporine, mycophenolate mofetil, gancyclovir, acyclovir, tacrolimus, azathioprine, antithymocyte immune globulin, muromonab-CD3 (OKT3), and corticosteroids.
3 Der er begrænsede data på brugen af daclizumab til gravide kvinder.
3 There are limited data from the use of daclizumab in pregnant women.
Et forsøg med cynomolgusaber har ikke vist teratogen effekt, men viste en øgning i tidlig prænatal død, som er indenfor grænserne af tidligere rapporteret hyppighed for spontane aborter for arten (se pkt. 5. 3).
A study in cynomolgus monkeys has not shown teratogenic effects but did show an increase of early prenatal loss which remains in the historical spontaneous abortion rate (see section 5.3).
a lg i 4 måneder efter, den sidste dosis af Zenapax er administreret.
Women of childbearing potential must use an effective contraceptive method during Zenapax therapy and continue its use for an additional 4 months following the last dose of Zenapax.
ls Daclizumab udskilles i mælken hos cynomolgusaber (se pkt. 5. 3).
ed Lactation Daclizumab is excreted in cynomolgus monkey milk (see section 5.3).
Det vides ikke om Zenapax udskilles i human mælk.
s excreted in human milk.
Men på grund af den potentielle negative effekt på den nyfødte, er amning
However due to potential harmful effects for the newborn, breast-feeding is
t ti kontraindiceret under behandlingen og i op til 4 måneder efter den sidste Zenapaxdosis.
ori contraindicated during the treatment and up to 4 months following the last dose of Zenapax.
ere 4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Zenapax har ingen indflydelse på evnen til at føre bil eller betjene maskiner.
uth Zenapax has no influence on the ability to drive and use machines.
ris 4. 8 Bivirkninger
ra 4.8 Undesirable effects
to Zenapax’ s sikkerhedsprofil blev undersøgt overfor placebo hos patienter som samtidigt fik au immunosuppressiv behandling indeholdende ciclosporin og kortikosteroider alene, med tillæg af azathioprin eller med tillæg af mycophenolatmofetil.
The safety profile of Zenapax was studied in comparison to placebo in patients who concomitantly ge received immunosuppressive regimens containing cyclosporine and corticosteroids alone, with the addition of azathioprine or with the addition of mycophenolate mofetil.
Data fra de fire undersøgelser (O14392, O14393, O14874 og O15301) viste, at incidensen og arten af bivirkninger var sammenlignelige hos både ere
The data from the four studies lon (O14392, O14393, O14874 and O15301) showed that the incidence and types of adverse events were similar in both placebo-treated and Zenapax-treated patients.
39, 9% af de behandlede patienter i Zenapaxgruppen.
Serious adverse events were reported by 44.4% of the patients in the placebo-treated group and 39.9% of the patients in the Zenapax-treated group. no
Bivirkninger, som optræder med en frekvens på ≥ 2% hos patienter i hver gruppe gennem de første 3 læ
Adverse events occurring with a frequency of ≥ 2% in patients in either group during the first 3 months post-transplant are listed below. t uc
For hver organklasse, er bivirkningerne rapporteret under den relevante hyppighed, ved brug af følgende frekvenskategorier: meget almindelig (≥ 1/ 10); almindelig (≥1/ 100 to < 1/ 10); usædvanlig (≥1/ 1. 000 til 1 < 1/ 100); sjælden (≥1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000, ukendt frekvens r ik
Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to rod
(kan ikke estimeres ud fra tilgængelige data).
< 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
For hver frekvensinddeling er bivirkningerne ordnet i henhold til faldende alvorlighed. te
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. lp
Zenapax (%)
Zenapax (%)
Placebo (%)
Placebo (%)
n=293
n=293
Infektiøse og parasitære sygdomme mi
Infections and infestations
Pharyngitis Rhinitis
Pharyngitis Rhinitis
Stofskiftesygdomme og ernæringsbetingede ge
Metabolism and dic
Diabetes mellitus Ophobning af væske
Diabetes mellitus
3, 3 3, 3
3.3
4, 8 5, 8
4.8
sygdomme
nutrition disorders
Dehydrering
Fluid overload Dehydration
3, 0
3.3 3.0
3, 1
5.8 3.1
Psykiske lidelser Læ
Psychiatric disorders Me
13, 7
13.7
Depression Ængstelse
Depression Anxiety
Rysten Hovedpine Svimmelhed Paræstesi
Tremor Headache Dizziness Paraesthesia
Øjensygdomme Hjertesygdomme
Eye disorders Cardiac disorders Vascular disorders
Almindelig Almindelig
Common Common Very common Common
Sløret syn Takykardi
2.7 6.5 32.1 8.6 7.4
2, 7 6, 5
4.4 6.8 27.7 10.2 10.6
4, 4 6, 8
4
4 Organklasse
System organ class
Zenapax (%) n=336
Zenapax (%) n=336
Placebo (%) n=293
Placebo (%) n=293
Meget almindelig
Lymphocele Thrombosis
32, 1
7.4 5.4
27, 7
6.5 4.4
Hypotension Blødning Lymfocele Trombose
Respiratory, thoracic and mediastinal disorders
Pleural effusion Atelektase
Dyspnoea Pulmonary oedema Pleural effusion Atelectasis Hypoxia
2, 1 3, 3
11.9 6.3 2.1 3.3 2.7
1, 4 3, 8
15.4 4.4 1.4 3.8 3.1
t ti
ed
Hypoxi Tilstopning af luftvejene
Respiratory tract congestion Rales
2, 7 3, 3
3.3 3.3
3, 1 3, 8
3.8 1.4
ere
s
Rallen Hoste Abnorme vejrtrækningslyde
Cough Breath sounds abnormal
3, 3 5, 1 2, 7
5.1 2.7
1, 4 4, 8 1, 7
4.8 1.7
ris Gastrointestinale sygdomme
ori Gastrointestinal disorders
Forstoppelse Diarré Opkastning
Constipation Diarrhoea
34, 8 15, 2 14, 9
34.8 15.2
37, 9 16, 4 14, 3
37.9 16.4
to
uth
Kvalme Dyspepsi (inkl. halsbrand) au
Vomiting Nausea Dyspepsia (incl. pyrosis)
27, 4 15, 1
14.9 27.4 15.1
25, 9 14, 7
14.3 25.9 14.7
5, 7 2, 4 9, 8
Common
4, 4 0, 7 13, 0
Abdominal distension
3, 8
4.4
2, 1
ra
0, 7
Gastritis Abdominal pain Abdominal pain upper (epigastric pain) Haemorrhoids Flatulence
Flatulens
2.4 9.8 5.4
Almindelig
0.7 13.0 3.8
Udslæt læ
ge lon
3, 3
2.1 3.9
4, 4
0.7 4.1
ke
Common
Acne Kløe Nattesved
Rash Acne Pruritus Night sweats no
8, 9 3, 9 2, 1
3.3 8.9 3.9 2.1
7, 2 5, 8 2, 0
4.4 7.2 5.8 2.0
Forøget svedproduktion Hirsutisme
Hyperhidrosis Hirsutism
2, 1 4, 8
2.1 4.8
1, 7 2, 0
1.7 2.0
Sygdomme i
Musculoskeletal, connective tissue and
Meget r ik
Very common Common
Muskulo- skeletale smerter
Musculoskeletal pain Back pain
almindelig
12.3 6.5
bindevæv
12.5 8.2
Almindelig te
t
Rygsmerter Muskelkramper
bone disorders uc
dle
rod
Artralgi Myalgi
Muscle spasms Arthralgia Myalgia
2, 7 2, 1
2.4 2.7 2.1
2, 7 1, 0
1.4 2.7 1.0
Almene lidelser og reaktioner på indgivelsesstedet mi
General disorders and administration site conditions
Meget almindelig
Very common Common lp
Ødem Perifere ødemer Svækket sårheling (uden infektion)
Oedema Oedema peripheral Impaired healing (without infection) Chest pain
15, 8 28, 0 12, 2
15.8 28.0 12.2 8.6
18, 4 30, 0 10, 2
18.4 30.0 10.2 8.9
ge
na
Almindelig
Pain Fatigue
Brystsmerter Smerter
7.1 7.4
8, 6 7, 1
8.2 9.6
8, 9 8, 2
dic
Træthed Reaktioner på injektionsstedet Pyreksi
Application site reaction Pyrexia Asthenia
7, 4 4, 8 5, 4
4.8 5.4 3.3
9, 6 5, 1 10, 2
5.1 10.2 2.7
Asteni Kulderystelser
Chills
3, 3 3, 0
3.0
2, 7 5, 1
5.1
Sygdomme i nyre og urinveje
Renal and urinary disorders Me
Nyresvigt Renal tubulær nekrose Hydronephros Nyrelidelser (skader) Urinvejsblødning Urinretention Urinvejssygdomme
Renal failure Renal tubular necrosis Hydronephrosis
3, 6 7, 4 2, 1 4, 5 2, 1 2, 1 2, 7
3.6 7.4 2.1
3, 3 6, 8 4, 4 7, 8 3, 4 3, 1 2, 4
3.3 6.8 4.4
5 Organklasse
Renal disorder (damage) Haemorrhage urinary tract Urinary retention Urinary tract disorder Oliguria Dysuria
Zenapax (%) n=336
4.5 2.1 2.1 2.7 9.5 6.0
Placebo (%) n=293
7.8 3.4 3.1 2.4 10.6 12.3
Post- traumatisk smerte
Post-traumatic pain
Incidens af maligniteter:
Incidence of malignancies:
Tre år efter behandling var incidensen af maligniteter 7, 8% i placebogruppen
Three years after treatment, the incidence of malignancies was 7.8% in the placebo group compared with 6.4% in the Zenapax group.
a lg sammenlignet med 6, 4% i Zenapaxgruppen.
Addition of Zenapax did not increase the
Tillæg af Zenapax øgede ikke antallet af post - transplantations lymfomer, som forekom med en frekvens på 1, 5% i placebogruppen og 0, 7% i Zenapax gruppen.
5 number of post-transplant lymphomas, which occurred with a frequency of 1.5% in the placebo- treated group and 0.7% in the Zenapax-treated group.
ls Hyperglycæmi:
Hyperglycaemia:
t ti laboratorieprøve resultater mellem placebo behandlede og Zenapax behandlede grupper med undtagelse af fastende blodsukker.
No differences in abnormal haematologic or chemical laboratory test results were seen between placebo-treated and Zenapax-treated groups with the exception of fasting blood glucose.
Fastende blodsukker blev målt hos et mindre antal placebo - og Zenapax behandlede patienter.
Fasting blood glucose was measured in a small number of placebo- and Zenapax-treated patients.
Ialt havde 16% (10 af 64 patienter) af placebo behandlede og 32% (28
A total of 16% (10 of 64 patients) of placebo-treated and 32% (28 of 88 patients) of Zenapax-treated patients had high fasting blood glucose values.
ris Dødsfald, der forekom i de første 6 måneder efter transplantationen, rapporteredes hos 3, 4% i
ed Deaths occurring during the first 6 months post-transplant were reported in 3.4% of the placebo- and in 0.6% of the Zenapax-treated groups.
Infektionstyperne var de samme i Zenapax - og placebogruppen.
s 1.5% in the Zenapax-treated groups.
I sjældne tilfælde er overfølsomhedsreaktioner efter administration af Zenapax blevet rapporteret (se læ
ori Infectious episodes, including viral infections, fungal infections, bacteraemia and septicaemia, and pneumonia, were reported in 72% of the placebo-treated patients and in 68% of Zenapax-treated
4. 4).
uth patients.
Pædiatriske patienter:
The type of infections reported was similar in both the Zenapax- and the placebo-treated groups.
Sikkerhedsprofilen for anvendelse af Zenapax til pædiatriske patienter er vist at ke
Cytomegalovirus infection was reported in 16% of the patients in the placebo group and in 13% of the patients in the Zenapax group.
være sammenlignelig med sikkerhedsprofilen for voksne patienter.
ra In rare cases severe hypersensitivity reactions following administration of Zenapax have been reported (see section 4.4). ge Paediatric patients:
Diarré (41%), postoperativ smerte (38%), feber (33%), r ik
The safety profile for the use of Zenapax in paediatric patients was shown to be lon comparable to that in adult patients.
opkastning (33%), hypertension (28%), pruritus (21%) og infektioner i de øvre luftveje (20%) og i urinvejene (18%). te
However, the following adverse events occurred more frequently in paediatric patients: diarrhoea (41%), postoperative pain (38%), fever (33%), vomiting (33%), hypertension (28%), pruritus (21%) and infections of the upper respiratory tract (20%) and urinary tract (18%). no
4. 9 Overdosering dle
4.9 Overdose t
Der er ikke fundet nogen maksimal tolererbar Zenapax dosis hos patienter og den kunne ikke bestemmes på dyr.
A maximum tolerated dose has not been determined in patients and could not be achieved in animals uc
En dosis på 1, 5 mg/ kg blev givet til knoglemarvstranplanterede patienter uden der forekom uønskede hændelser.
that received Zenapax.
I en enkeltdosis toksikologisk undersøgelse på mus var der ingen tegn mi
A dose of 1.5 mg/ kg has been administered to bone marrow transplant recipients without any associated adverse events.
på toksicitet efter intravenøs indgift af 125 mg/ kg. ge
In a single dose toxicity study a dose of 125 mg/ kg rod
FARMAKOLOGISKE EGENSKABER Læ
PHARMACOLOGICAL PROPERTIES lp
5. 1 Farmakodynamiske egenskaber
5.1 Pharmacodynamic properties na
Farmakoterapeutisk klassifikation: selektive immunsupprimerende midler, ATC code:
Pharmacotherapeutic group: selective immunosuppressive agents ATC code:
Klinisk farmakologi Zenapax indeholder daclizumab, et rekombinant humaniseret IgG 1 anti- Tac antistof, og virker som en interleukin (IL- 2) receptor antagonist.
Clinical Pharmacology Zenapax contains daclizumab, a recombinant, humanized IgG1 anti-Tac antibody, and functions as an Me
6 subdelen af højaffinitets IL- 2 receptorkomplekset (udtrykt på aktiverede T celler) og hæmmer IL- 2 bindingen og den biologiske aktivitet.
Daclizumab binds with high specificity to the alpha or Tac subunit of the high affinity IL-2 receptor complex (expressed on activated T cells), and inhibits IL-2 binding and biological activity.
Administration af Zenapax hæmmer IL- 2- medieret aktivering af lymfocytter, en kritisk pathway i det cellulære immunrespons som er involveret i allotransplantat rejektion.
Administration of Zenapax inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection.
90 dage i den anbefalede dosering hos de fleste patienter.
Daclizumab saturates the Tac receptor for approximately 90 days at the recommended dosage regimen for the majority of patients.
9% af de Zenapax- behandlede patienter, men antistofferne syntes ikke at påvirke effekt, sikkerhed, daclizumab serumniveauer eller andre af de undersøgte klinisk relevante parametre.
Antibodies to daclizumab developed in approximately 9% of Zenapax- treated patients in clinical studies but did not appear to affect efficacy, safety, serum daclizumab levels, or any other clinically relevant parameter examined.
a lg Der observeredes ingen større ændringer i antallet af cirkulerende lymfocytter eller cellefenotyper ved fluorescens- aktiveret celle sorteringsanalyse (FACS) udover det forventede forbigående fald i Tac+ celler.
6 No gross changes to circulating lymphocyte numbers or cell phenotypes were observed by fluorescence-activated cell sorter (FACS) analysis other than the expected transient decrease in Tac+ cells.
ls Kombinationsbehandling hos renal allotransplanterede
Combination Therapy in Renal Allograft Recipients
t ti I fase III undersøgelserne blev Zenapax givet sammen med et standard immunsuppressivt regime
In Phase III trials Zenapax was added to a standard immunosuppressive regimen of cyclosporine (5 mg/ kg) and steroids (prednisone or methylprednisolone), with or without addition of azathioprine (4 mg/ kg).
ere bestående af ciclosporin (5 mg/ kg) og steroider (prednison eller metylprenisolon) med eller uden tillæg af azathioprin (4 mg/ kg).
From pooled data the
Fra de sammenlagte data forblev forskellen i biopsibevist akut afstødning statistisk signifikant et år efter
s difference in biopsy-proven acute rejection remained statistically different at one-year posttransplant
to transplantationen (43% sammenlignet med 28%).
ori (43% as compared with 28%).
For de patienter, som ikke oplevede akut afstødning au indenfor det første år efter transplantationen (n=345), var graden af transplantatoverlevelse efter 3 år signifikant højere sammenlignet med de patienter, der oplevede akut afstødning inden for det første år (n=190) uanset behandling.
The
placebo og daclizumab i det tredobbelte immunosuppressive forsøg (83% vs.
uth three year graft survival was not significantly different between placebo and daclizumab in the triple immunosuppressant trial (83% Vs.
96%; p=0, 017) ng
ra double immunosuppressant trial (88% Vs.
men ikke i det tredobbelte immunosuppressive forsøg (94% vs.
96%; p = 0.017), but not in the triple immunosuppressant trial (94% Vs.
92%).
92%).
Den gavnlige effekt af profylaktisk behandling med Zenapax, ved forekomsten af akut afstødning efter nyretransplantation, var ikke forbundet med efterfølgende kliniske bivirkninger, herunder udvikling af post transplantation lymfoproliferativ sygdom (PTLD) 3 år efter transplantationen. r ik
ge Renal function evaluated by serum creatinine and GFR was similar in both groups at three years posttransplant. lon The beneficial effect of Zenapax prophylaxis upon the incidence of acute rejection after renal transplantation was not associated with adverse clinical sequelae, including the development of Post- Transplant Lymphoproliferative Disease (PTLD), at 3 years posttransplant. no
5. 2 Farmakokinetiske egenskaber te
5.2 Pharmacokinetic properties t
I kliniske undersøgelser med nyretransplanterede patienter som blev behandlet med 1 mg/ kg Zenapax hver anden uge, i alt 5 doser, steg gennemsnit peak- serumkoncentrationen (middel ± SD) fra den dle
In clinical trials involving renal allograft patients-treated with 1 mg/ kg of Zenapax every 14 days for a uc
første dosis (21 ± 14 µg/ ml) til den femte dosis (32 ± 22 µg/ ml).
total of 5 doses, average peak serum concentrations (mean ± standard deviation) rose between the first dose (21 ± 14 µg/ ml) and fifth doses (32 ± 22 µg/ ml).
Den gennemsnitlige trough serumkoncentration ± SD før femte dosis var 7. 6 ± 4. 0 µg/ ml.
The mean ± standard deviation trough serum rod
nødvendigt for at mætte IL- 2 receptoren og koncentrationer på 5 til 10 µg/ ml er nødvendige for at hæmme IL- 2 medieret biologisk aktivitet.
concentration prior to fifth dose was 7.6 ± 4.0 µg/ ml.
Det anbefalede daclizumabregime vil opretholde serumkoncentrationer som hos de fleste patienter er tilstrækkelige til at mætte IL- 2R alfareceptorer på ge
Serum levels of 0.5 to 0.9 µg/ ml are needed to saturate the IL-2 receptor and levels of 5-10 µg/ ml are needed to inhibit IL-2 mediated biologic activity.
aktiverede T- lymfocytter i mere end 90 dage efter transplantationen.
The recommended regimen of daclizumab will maintain serum concentrations sufficient to saturate IL-2R alpha receptors on activated T lymphocytes for more than 90 days post transplantation lp
Læ
This first three months, is the most critical period post-transplantation. na
Dette tilskrives humaniseringen af proteinet.
This is attributable to the humanisation of the protein. i dic
Populationsfarmakokinetisk analyse viste at systemisk clearance af daclizumab påvirkedes af legemsvægt, alder, køn, proteinuri og race.
Me
7 Den påviste indflydelse af legemsvægten på systemisk clearance støtter doseringen af Zenapax på en mg/ kg basis og opretholder serumkoncentrationer indenfor 30% af referencekoncentrationen for patient grupper med vide demografiske karakteristika.
The identified body weight influence on systemic clearance supports the dosing of Zenapax on a mg/ kg basis and maintains drug exposure within 30% of the reference exposure for patient groups with wide range of demographic characteristics.