natgillin/translations-raw huggingface dataset:
Bivirkninger i åndedrætssystemet forekom almindeligvis i kliniske undersøgelser med Caelyx og kan være relaterede til opportunistiske infektioner i AIDS- populationen.
Respiratory undesirable effects commonly occurred in clinical studies of Caelyx and may be related to opportunistic infections in the AIDS population.
Opportunistiske infektioner (OI' er) er iagttaget hos KS- patienter efter indgivelse af Caelyx og er hyppigt forekommende hos patienter med HIV- induceret immuninsufficiens.
Opportunistic infections (OI’ s) are observed in KS patients after administration with Caelyx, and are frequently observed in patients with HIV-induced immunodeficiency.
De hyppigst forekommende OI' er i kliniske undersøgelser var candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumoni og mycobakterium avium kompleks.
The most frequently observed OI’ s in clinical studies were candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumonia, and mycobacterium avium complex.
Bivirkninger observeret hos patienter med AIDS- KS i overensstemmelse med CIOMS III hyppigheds kategorier (Meget almindelig (> 1/ 10); Almindelig (> 1/ 100, < 1/ 10); Usædvanlig (> 1/ 1. 000, < 1/ 100)) var som følger:
Undesirable effects observed in patients with AIDS-KS according to CIOMS III frequency categories (Very common (> 1/ 10); Common (> 1/ 100 ,< 1/10); Uncommon (> 1/1 ,000, < 1/100)) were as follows:
Almindelige: oral moniliasis
Common: oral moniliasis
Blod - og lymfesystem:
Blood and lymphatic system disorders:
Meget almindelige: neutropeni, anæmi, leukopeni Almindelige: thrombocytopeni
Very common: neutropaenia, anaemia, leukopaenia Common: thrombocytopaenia
Almindelige: anoreksi
Common: anorexia
Almindelige: forvirring
Uncommon: confusion
Almindelige: svimmelhed Usædvanlige: paresthesi
Common: dizziness Uncommon: paresthesia
Almindelige: retinitis
Common: retinitis
18 Luftveje, thorax og mediastinum:
18 Common: vasodilatation
Almindelige: dyspnø
Common: dyspnoea
Meget almindelige: kvalme Almindelige: diarre, stomatitis, opkastning, sårdannelse i munden, abdominalsmerter, glossitis, forstoppelse, kvalme og opkastning
Very common: nausea Common: diarrhoea, stomatitis, vomiting, mouth ulceration, abdominal pain, glossitis, constipation, nausea and vomiting
Almindelige: alopeci, udslæt Usædvanlige: palmar- plantar erythrodysesthesi (PPE)
Common: alopecia, rash Uncommon: palmar-plantar erythrodysesthesia (PPE)
Almindelige: astheni, feber, infusionsassocierede akutte reaktioner
Common: asthenia, fever, infusion-associated acute reactions
Almindelige: vægttab
Common: weight loss.
Andre mindre hyppigt (< 5%) forekommende bivirkninger omfattede overfølsomhedsreaktioner inklusive anafylaktiske reaktioner.
Other less frequently (< 5%) observed undesirable effects included hypersensitivity reactions including anaphylactic reactions.
Klinisk betydende laboratorieabnormaliteter forekom hyppigt (≥ 5%) omfattende forøgelse af alkalisk fosfatase, AST og bilirubin, der mentes at være forbundet med den tilgrundliggende sygdom og ikke med Caelyx.
Clinically significant laboratory abnormalities frequently (≥ 5%) occurred including increases in alkaline phosphatase; AST and bilirubin which were believed to be related to the underlying disease and not Caelyx.
Reduktion af hæmoglobin og thrombocytter var mindre hyppigt rapporteret (< 5%).
Reduction in haemoglobin and platelets were less frequently (< 5%) reported.
Sepsis forbundet med leukopeni forekom sjældent (< 1%).
Sepsis related to leukopaenia was rarely (< 1%) observed.
Nogle af disse abnormaliteter kan have været forbundet med den tilgrundliggende HIV- infektion og ikke med Caelyx.
Some of these abnormalities may have been related to the underlying HIV infection and not Caelyx.
Alle patienter:
All patients:
Hos 100 af 929 patienter (10, 8%) med massive tumorer blev infusionsrelaterede reaktioner beskrevet under behandling med Caelyx, karakteriseret ved følgende Costart termer: allergisk reaktion, anafylaktisk reaktion, astma, ansigtsødem, hypotension, vasodilatation, urticaria, rygsmerter, brystsmerter, kulderystelser, feber, hypertension, takycardi, dyspepsi, kvalme, svimmelhed, dyspnø, pharyngitis, udslæt, kløe, svedtendens, reaktion på injektionsstedet og lægemiddelinteraktion.
100 out of 929 patients (10.8%) with solid tumours were described as having an infusion-associated reaction during treatment with Caelyx as defined by the following Costart terms: allergic reaction, anaphylactoid reaction, asthma, face oedema, hypotension, vasodilatation, urticaria, back pain, chest pain, chills, fever, hypertension, tachycardia, dyspepsia, nausea, dizziness, dyspnoea, pharyngitis, rash, pruritus, sweating, injection site reaction and medicinal product interaction.
Vedvarende behandlingsophør blev sjældent rapporteret med 2%.
Permanent treatment discontinuation was infrequently reported at 2%.
En lignende hyppighed af infusionsreaktioner (12, 4%) og behandlingsophør (1, 5%) sås i brystcancer programmet.
A similar incidence of infusion reactions (12.4%) and treatment discontinuation (1.5%) was observed in the breast cancer program.
Hos patienter med multipelt myelom, der modtog Caelyx og bortezomib, har der været rapporteret infusionsassocierede reaktioner på 3%.
In patients with multiple myeloma receiving Caelyx plus bortezomib, infusion-associated reactions have been reported at a rate of 3%.
Hos patienter med AIDS- KS var infusionsrelaterede reaktioner karakteriserede ved rødme, kortåndethed, ansigtsødem, hovedpine, kulderysten, rygsmerter, sammensnørende fornemmelse over thorax og hals og/ eller hypotension og kan forventes med en hyppighed på 5% til 10%.
In patients with AIDS-KS, infusion-associated reactions, were characterised by flushing, shortness of breath, facial oedema, headache, chills, back pain, tightness in the chest and throat and/ or hypotension and can be expected at the rate of 5% to 10%.
Hos alle patienter forekom infusionsrelaterede reaktioner primært under den første infusion.
In all patients, infusion associated reactions occurred primarily during the first infusion.
I næsten alle patienter kan Caelyx- behandling genoptages, efter alle symptomer er ophørt, uden recidiv.
In nearly all patients, Caelyx treatment can be resumed after all symptoms have resolved without recurrence.
4. 2).
Infusion reactions rarely recur after the first treatment cycle with Caelyx (see section 4.2).
Myelosuppression associeret med anæmi, thrombocytopeni, leukopeni og sjældent febril neutropeni, har været rapporteret hos patienter behandlet med Caelyx.
Myelosuppression associated with anaemia, thrombocytopaenia, leukopaenia, and rarely febrile neutropaenia, has been reported in Caelyx -treated patients.
Stomatitis har været rapporteret hos patienter i behandling med kontinuerlige infusioner af konventionel doxorubicinhydrochlorid og var hyppigt rapporteret hos patienter i Caelyx- behandling.
Stomatitis has been reported in patients receiving continuous infusions of conventional doxorubicin hydrochloride and was frequently reported in patients receiving Caelyx.
Det influerede ikke på fuldførelsen af patienters behandling, og normalt er dosisændringer ikke nødvendige, med mindre stomatiten påvirker patientens evne til at spise.
It did not interfere with patients completing therapy and no dosage adjustments are generally required, unless stomatitis is affecting a patient’ s ability to eat.
4. 2).
In this case, the dose interval may be extended by 1 - 2 weeks or the dose reduced (see section 4.2).
En øget forekomst af hjerteinsufficiens er forbundet med doxorubicin- behandling ved kumulative livstidsdoser > 450 mg/ m2 eller ved lavere doser hos patienter med kardielle risikofaktorer.
19 An increased incidence of congestive heart failure is associated with doxorubicin therapy at cumulative lifetime doses > 450 mg/ m2 or at lower doses for patients with cardiac risk factors.
19 Endomyokardie- biopsier på ni ud af ti AIDS- KS patienter, som fik kumulative doser af Caelyx på mere end 460 mg/ m2, viste ingen tegn på antracyclin- induceret kardiomyopati.
Endomyocardial biopsies on nine of ten AIDS-KS patients receiving cumulative doses of Caelyx greater than 460 mg/ m2 indicate no evidence of anthracycline-induced cardiomyopathy.
Den anbefalede Caelyx- dosis til AIDS- KS patienter er 20 mg/ m2 hver anden til tredje uge.
The recommended dose of Caelyx for AIDS-KS patients is 20 mg/ m2 every two-to-three weeks.
Den kumulative dosis, hvor kardio+toksicitet kunne give grund til betænkning hos disse AIDS- KS patienter (> 400 mg/ m2) ville kræve mere end 20 serier Caelyx- behandling over en 40 - 60 ugers periode.
The cumulative dose at which cardiotoxicity would become a concern for these AIDS-KS patients (> 400 mg/ m2) would require more than 20 courses of Caelyx therapy over 40 to 60 weeks.
Derudover blev der foretaget endomyokardiebiopsier hos 8 patienter med massive tumorer med kumulative antracyclin- doser på 509 mg/ m2 – 1. 680 mg/ m2.
In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/ m2 – 1,680 mg/ m2.
Omfanget af kardiotoksiciteten efter Billingham- skalaen var grad 0 - 1, 5.
The range of Billingham cardiotoxicity scores was grades 0 - 1.5.
I den pivotale fase III undersøgelse over for doxorubicin, opfyldte 58/ 509 (11, 4%) randomiserede patienter (10 behandlet med Caelyx i en dosis på 50 mg/ m2/ hver 4. uge mod 48 behandlet med doxorubicin i en dosis på 60 mg/ m2/ hver 3. uge) de protokoldefinerede kriterier for kardiel toksicitet under behandling og/ eller opfølgning.
In the pivotal phase III trial versus doxorubicin, 58/ 509 (11.4%) randomized subjects (10 treated with Caelyx at a dose of 50 mg/ m2/ every 4 weeks versus 48 treated with doxorubicin at a dose of 60 mg/ m2/ every 3 weeks) met the protocol-defined criteria for cardiac toxicity during treatment and/ or follow-up.
Hos patienter med massive tumorer, omfattende en undergruppe af patienter med bryst - og ovariecancer, behandlet med en dosis på 50 mg/ m2/ cyklus med livstidskumulative anthracyclin doser på op til 1. 532 mg/ m2, var hyppigheden af klinisk betydende kardielle funktionsfejl lav.
In patients with solid tumours, including a subset of patients with breast and ovarian cancers, treated at a dose of 50 mg/ m2/ cycle with lifetime cumulative anthracycline doses up to 1,532 mg/ m2, the incidence of clinically significant cardiac dysfunction was low.
Af de 418 patienter behandlet med Caelyx 50 mg/ m2/ cyklus, hvor baseline målinger af LVEF og mindst én opfølgende måling blev vurderet med MUGA scanning, havde 88 patienter en kumulativ antracyclindosis på > 400 mg/ m2, et eksponeringsniveau forbundet med en forøget kardiovaskulær toksicitet med konventionel doxorubicin.
Of the 418 patients treated with Caelyx 50 mg/ m2/ cycle, and having a baseline measurement of left ventricular ejection fraction (LVEF) and at least one follow-up measurement assessed by MUGA scan, 88 patients had a cumulative anthracycline dose of > 400 mg/ m2, an exposure level associated with an increased risk of cardiovascular toxicity with conventional doxorubicin.
Kun 13 af disse 88 patienter (15%) havde mindst én klinisk betydende forandring i deres LVEF, defineret som en LVEF- værdi mindre end 45% eller et fald på mindst 20 points fra baseline.
Only 13 of these 88 patients (15%) had at least one clinically significant change in their LVEF, defined as an LVEF value less than 45% or a decrease of at least 20 points from baseline.
Desuden stoppede kun 1 patient (kumulativ anthracyclin dosis på 944 mg/ m2) forsøgsbehandlingen på grund af kliniske symptomer på hjerteinsufficiens.
Furthermore, only 1 patient (cumulative anthracycline dose of 944 mg/ m2), discontinued study treatment because of clinical symptoms of congestive heart failure.
Hvis der opstår tegn eller symptomer på ekstravasation (f. eks. svien eller erythema) afsluttes infusionen straks og genstartes i en anden vene.
If any signs or symptoms of extravasation occur (e. g., stinging, erythema) terminate the infusion immediately and restart in another vein.
Genopblussen af hudreaktion forårsaget af tidligere stråleterapi er i sjældne tilfælde set ved Caelyx - behandling.
Recall of skin reaction due to prior radiotherapy has rarely occurred with Caelyx administration.
Efter markedsføring af Caelyx har alvorlige hudtilstande inklusive erythema multiforme, Stevens Johnson syndrom og toksisk epidermal nekrolyse været rapporteret i sjældne tilfælde.
Following the marketing of Caelyx, serious skin conditions including erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis have been reported very rarely.
Hos patienter, der blev behandlet med Caelyx, blev sjældne tilfælde af venøs thromboembolisme herunder thrombophlebitis, venøs thrombose og pulmonær embolisme set.
In patients treated with Caelyx, cases of venous thromboembolism, including thrombophlebitis, venous thrombosis and pulmonary embolism have been seen uncommonly.
Da patienter med cancer imidlertid har en øget risiko for thromboemboliske lidelser, kan en tilfældig sammenhæng ikke bestemmes.
However, because patients with cancer are at increased risk for thromboembolic disease, a causal relationship cannot be determined.
20 Akut overdosering med doxorubicinhydrochlorid forværrer de toksiske virkninger af mucositis, leukopeni og trombocytopeni.
20 Acute overdosing with doxorubicin hydrochloride worsens the toxic effects of mucositis, leukopaenia and thrombocytopaenia.
Behandling af akut overdosering af den udtalt knoglemarvssupprimerede patient omfatter hospitalsindlæggelse, antibiotika, trombocyt - og granulocyttransfusioner samt symptomatisk behandling af mucositis.
Treatment of acute overdose of the severely myelosuppressed patient consists of hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
Cytotoksiske stoffer (anthracycliner og relaterede substanser), ATC- kode:
Cytotoxic agents (anthracyclines and related substances), ATC code:
Det aktive indholdsstof i Caelyx er doxorubicin hydrochlorid, et cytotoksisk antracyclin- antibiotikum, der er udvundet af Streptomyces peucetius var. caesius.
The active ingredient of Caelyx is doxorubicin hydrochloride, a cytotoxic anthracycline antibiotic obtained from Streptomyces peucetius var. caesius.
Dette skyldes formentlig indføjelse af antracyclin mellem tilstødende basepar i DNA dobbelt helix, hvorved udfoldelsen af DNA forud for replikationen hæmmes.
This is probably the result of intercalation of the anthracycline between adjacent base pairs of the DNA double helix thus preventing their unwinding for replication.
En fase III randomiseret undersøgelse af Caelyx mod doxorubucin til patienter med metastaserende brystcancer blev gennemført med 509 patienter.
A phase III randomized study of Caelyx versus doxorubicin in patients with metastatic breast cancer was completed in 509 patients.
Det protokoldefinerede mål, at påvise at Caelyx ikke var ringere end doxorubicin, blev nået, hazard ratio (HR) for progressionsfri overlevelse (PFS) var 1, 00 (95% CI for HR=0, 82 - 1, 22).
The protocol-specified objective of demonstrating non-inferiority between Caelyx and doxorubicin was met, the hazard ratio (HR) for progression-free survival (PFS) was 1.00 (95% CI for HR=0.82 - 1.22).
Den primære analyse af kardiel toksicitet viste at risiko for udvikling af kardielle tilfælde som en funktion af den kumulative anthracyclin dosis var signifikant lavere med Caelyx end med doxorubicin (HR=3, 16, p < 0, 001).
The primary analysis of cardiac toxicity showed the risk of developing a cardiac event as a function of cumulative anthracycline dose was significantly lower with Caelyx than with doxorubicin (HR=3.16, p < 0.001).
Ved kumulative doser på over 450 mg/ m2 var der ingen kardielle tilfælde med Caelyx.
At cumulative doses greater than 450 mg/ m2 there were no cardiac events with Caelyx.
En fase III sammenlignende undersøgelse af Caelyx mod topotecan hos patienter med epithel - ovariecancer efter svigt af førstehånds, platinbaseret kemoterapi blev fuldført hos 474 patienter.
A phase III comparative study of Caelyx versus topotecan in patients with epithelial ovarian cancer following the failure of first-line, platinum based chemotherapy was completed in 474 patients.
Der var en stigning i total overlevelse (OS) for Caelyx- behandlede patienter i forhold til topotecan - behandlede patienter indiceret ved en hazard ratio (HR) på 1, 216 (95% CI; 1, 000; 1, 478), p=0, 050.
There was a benefit in overall survival (OS) for Caelyx-treated patients over topotecan-treated patients as indicated by a hazard ratio (HR) of 1.216 (95% CI; 1.000, 1.478), p=0.050.
Overlevelsen ved 1, 2 og 3 år var henholdsvis 56, 3%, 34, 7% og 20, 2% for Caelyx sammenlignet med henholdsvis 54, 0%, 23, 6% og 13, 2% for topetecan.
The survival rates at 1, 2 and 3 years were 56.3%, 34.7% and 20.2% respectively on Caelyx, compared to 54.0%, 23.6% and 13.2% on topotecan.
For undergruppen af patienter med platinsensitiv sygdom var forskellen større:
For the sub-group of patients with platinum-sensitive disease the difference was greater:
HR på 1, 432 (95% CI; 1, 066; 1, 923), p=0, 017.
HR of 1.432 (95% CI; 1.066, 1.923), p=0.017.
Overlevelsen ved 1, 2 og 3 år var henholdsvis 74, 1%, 51, 2% og 28, 4% for Caelyx sammenlignet med henholdsvis 66, 2%, 31, 0% og 17, 5% for topotecan.
The survival rates at 1, 2 and 3 years were 74.1%, 51.2% and 28.4% respectively on Caelyx, compared to 66.2%, 31.0% and 17.5% on topotecan.
Behandlingerne var sammenlignelige i undergruppen af patienter med platinrefraktær sygdom:
The treatments were similar in the sub-group of patients with platinum refractory disease:
HR på 1, 069 (95% CI; 0, 823; 1, 387), p=0, 618.
HR of 1.069 (95% CI; 0.823, 1.387), p=0.618.
Overlevelsen ved 1, 2 og 3 år var henholdsvis 41, 5%, 21, 1% og 13, 8% for Caelyx sammenlignet med henholdsvis 43, 2%, 17, 2% og 9, 5% for topotecan.
The survival rates at 1, 2 and 3 years were 41.5%, 21.1% and 13.8% respectively on Caelyx, compared to 43.2%, 17.2% and 9.5% on topotecan.
I en randomiseret fase III open- label multicenter- undersøgelse med parallelgruppe, der blev udført hos 646 patienter, blev sikkerhed og effekt af kombinationsbehandling med Caelyx og bortezomib sammenlignet med bortezomib monoterapi hos patienter med multipelt myelom.
A phase III randomized, parallel-group, open-label, multicentre study comparing the safety and efficacy of Caelyx plus bortezomib combination therapy with bortezomib monotherapy in patients with multiple myeloma who have received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy, was conducted in 646 patients.
Patienterne havde fået mindst 1 tidligere behandling, og der sås ingen fremskridt, imens de modtog antracyklin- baseret behandling.
There was a significant improvement in the primary endpoint of time to progression (TTP) for patients treated with combination therapy of Caelyx plus bortezomib compared to patients treated with bortezomib monotherapy as indicated by a risk reduction (RR) of 35% (95% CI; 21-47%), p < 0.0001, based on 407 TTP events.
Der var en signifikant forbedring i det primære endpoint i tid til progression (TTP) for patienter, der blev behandlet med Caelyx og bortezomib kombinationsbehandling sammenlignet med patienter, der blev behandlet med bortezomib monoterapi.
A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
Dette er indikeret ved en risikonedsættelse (RR) på 35% (95% Cl; 21- 47%), p < 0, 0001, baseret på 407 TTP tilfælde.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%), p < 0.0001.
En foreløbig protokol- defineret
The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the Caelyx plus
Median TTP var 6, 5 måneder for patienterne, der fik bortezomib monoterapi sammenlignet med 9, 3 måneder for de patienter, der fik Caelyx plus bortezomib kombinationsbehandling.
21 bortezomib combination therapy patients.
Disse resultater udgjorde den protokoldefinerede endelige analyse, selvom de ikke er færdigudviklede.
These results, though not mature, constituted the protocol defined final analysis.
Disse lineære MPEG- grupper udgår fra overfladen af liposomerne og danner derved en beskyttende kappe, der reducerer interaktioner mellem den tolagede lipidmembran og plasmakomponenterne.
These linear MPEG groups extend from the liposome surface creating a protective coating that reduces interactions between the lipid bilayer membrane and the plasma components.
Beviser på penetrering af pegylerede liposomer fra blodkar og deres indgang og ophobning i tumorer er set i mus med C- 26 kolon carcinoma- tumorer og i transgeniske mus med KS- lignende læsioner.
Evidence of penetration of pegylated liposomes from blood vessels and their entry and accumulation in tumours has been seen in mice with C-26 colon carcinoma tumours and in transgenic mice with KS-like lesions.
De pegylerede liposomer har også en lav- permeabel lipidmatrix og et internt vandigt buffersystem, der sammen holder doxorubicinhydrochlorid indkapslet under liposomets tilstedeværelse i blodbanen.
The pegylated liposomes also have a low permeability lipid matrix and internal aqueous buffer system that combine to keep doxorubicin hydrochloride encapsulated during liposome residence time in circulation.
De farmakokinetiske forhold i plasma for Caelyx hos mennesker adskiller sig væsentligt fra de farmakokinetiske forhold, der i litteraturen er rapporteret for standard doxorubicin hydrochlorid - præparationer.
The plasma pharmacokinetics of Caelyx in humans differ significantly from those reported in the literature for standard doxorubicin hydrochloride preparations.
Ved lavere doser (10 mg/ m2 - 20 mg/ m2) udviser Caelyx lineær farmakokinetik.
At lower doses (10 mg/ m2 – 20 mg/ m2) Caelyx displayed linear pharmacokinetics.
Over dosisintervallet 10 mg/ m2 - 60 mg/ m2 udviser Caelyx non- lineær farmakokinetik.
Over the dose range of 10 mg/ m2 – 60 mg/ m2 Caelyx displayed non-linear pharmacokinetics.
Standard doxorubicinhydrochlorid udviser udbredt vævsdistribution (distributionsvolumen 700 til 1. 100 liter/ m2) og en hurtig eliminationsclearance (24 til 73 liter/ time/ m2).
700 to 1,100 l/ m2) and a rapid elimination clearance (24 to 73 l/ h/ m2).
I modsætning hertil indicerer den farmakokinetiske profil for Caelyx, at Caelyx fortrinsvis er begrænset til blodbanen, og at eliminationen af doxorubicin fra blodet er afhængig af liposomet som "bærestof".
In contrast, the pharmacokinetic profile of Caelyx indicates that Caelyx is confined mostly to the vascular fluid volume and that the clearance of doxorubicin from the blood is dependent upon the liposomal carrier.
Ved ækvivalente doser er plasmakoncentrationen og AUC- værdierne for Caelyx, der primært repræsenterer pegyleret liposomal doxorubicinhydrochlorid (indeholdende 90% til 95% af det målte doxorubicin), betydeligt højere end de tilsvarende værdier for standard doxorubicin hydrochlorid - præparationer.
At equivalent doses, the plasma concentration and AUC values of Caelyx which represent mostly pegylated liposomal doxorubicin hydrochloride (containing 90% to 95% of the measured doxorubicin) are significantly higher than those achieved with standard doxorubicin hydrochloride preparations.
Populations- farmakokinetik Farmakokinetikken af Caelyx blev vurderet i 120 patienter fra 10 forskellige kliniske undersøgelser ved brug af fremgangsmåden for populations- farmakokinetik.
Population pharmacokinetics The pharmacokinetics of Caelyx was evaluated in 120 patients from 10 different clinical trials using the population pharmacokinetic approach.
Farmakokinetikken af Caelyx over dosisintervallet 10 mg/ m2 til 60 mg/ m2 blev bedst beskrevet ved en to- kompartment non- lineær model med nulte ordens input og Michaelis- Menten elimination.
The pharmacokinetics of Caelyx over the dose range of 10 mg/ m2 to 60 mg/ m2 was best described by a two compartment non-linear model with zero order input and Michaelis-Menten elimination.