natgillin/translations-raw huggingface dataset:
Der blev ikke observeret samtidig stigning af ALAT ( &gt; 3 gange den øvre normalgrænse[ULN]) og bilirubin ( &gt; 2 gange den øvre normalgrænse).
No concurrent elevations of ALT ( &gt; 3 times the upper limit of normal [ULN]) and bilirubin ( &gt; 2 times the ULN) were observed.
Der er stort set ingen tilgængelige data vedrørende axitinib-behandling af patienter med en kreatin-clearance under 15 ml/min.
Virtually no data are available regarding axitinib treatment in patients with a creatinine clearance of &lt; 15 mL/min.
In vitro er den humane proteinbindingsgrad af axitinib &gt; 99% med overvejende binding til albumin og moderat binding til α1-syre-glykoprotein.
In vitro binding of axitinib to human plasma proteins is &gt; 99% with preferential binding to albumin and moderate binding to α1-acid glycoprotein.
En signifikant stigning i polyploidi ses in vitro ved koncentrationer &gt; 0,22 mikrog/ml, og en stigning i mikronuclære polykromatiske erytrocytter ses in vivo med No Observed Effect Level (NOEL) 69 gange forventet human eksponering.
A significant increase in polyploidy was observed in vitro at concentrations &gt; 0.22 µg/mL, and an elevation in micronucleated polychromatic erythrocytes was observed in vivo with No Observed Effect Level (NOEL) 69-fold the expected human exposure.
Patienter, som tåler en startdosis på 5 mg 2 gange daglig i 2 på hinanden følgende uger, uden bivirkninger &gt; Grad 2 (dvs. uden alvorlige bivirkninger i henhold til Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), kan få øget dosis til 7 mg 2 gange dagligt, med mindre patientens blodtryk er &gt; 150/90 mmHg, eller patienten behandles med antihypertensiva.
Patients who tolerate the axitinib starting dose of 5 mg twice daily with no adverse reactions &gt; Grade 2 (i.e. without severe adverse reactions according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) for two consecutive weeks may have their dose increased to 7 mg twice daily unless the patient's blood pressure is &gt; 150/90 mmHg or the patient is receiving antihypertensive treatment.
I et kontrolleret klinisk studie lå den mediane tid til udvikling af hypertension (systolisk blodtryk &gt; 150 mmHg eller diasystolisk blodtryk &gt; 100 mm Hg) inden for de første 4 måneder efter behandlingsstart med axitinib, og der er set blodtryksstigninger så tidligt som 4 dage efter behandlingsstart.
In a controlled clinical study, the median onset time for hypertension (systolic blood pressure &gt; 150 mmHg or diastolic blood pressure &gt; 100 mmHg) was within the first month of the start of axitinib treatment and blood pressure increases have been observed as early as 4 days after starting axitinib.
CYP1A2 og CYP2C19 bidrager mindre ( &lt; 10%) til metaboliseringen af axitinib.
CYP1A2 and CYP2C19 constitute minor ( &lt; 10%) pathways in axitinib metabolism.
Sikkerhed og virkning af Inlyta er ikke undersøgt hos børn og unge under 18 år.
The safety and efficacy of Inlyta in children and adolescents &lt; 18 years have not been established.
Pædiatrisk population Axitinib er ikke undersøgt hos patienter under 18 år.
Axitinib has not been studied in patients &lt; 18 years of age.
De hyppigste bivirkninger ( &gt; 20%), som ses ved behandling med axitinib er diarré, hypertension, træthed, nedsat appetit, kvalme, vægttab, dysfoni, palmo-plantar erytrodysæstesi (hånd- og fodsyndrom), blødning, hypotyreose, opkastning, proteinuri, hoste og obstipation.
The most common (≥ 20%) adverse reactions observed following treatment with axitinib were diarrhoea, hypertension, fatigue, decreased appetite, nausea, weight decreased, dysphonia, palmar-plantar erythrodysaesthesia (hand-foot) syndrome, haemorrhage, hypothyroidism, vomiting, proteinuria, cough, and constipation.
En risiko-ratio &gt; 1 indikerer større sandsynlighed for response i axitinib-armen; En risiko-ratio &lt; 1 indikerer større sandsynlighed for response i sorafenib-armen.
A risk ratio &gt; 1 indicated a higher likelihood of responding in the axitinib arm; a risk ratio &lt; 1 indicated a higher likelihood of responding in the sorafenib arm. g One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior therapy.
Ved rutinemæssige laboratorieundersøgelser sås stigninger i TSH til ≥10 µU/ml hos 32,2% af de axitinib-behandlede patienter, som havde TSH &lt; 5 µU/ml før behandlingsstart.
During routine laboratory assessments, in patients who had TSH &lt; 5 μU/mL before treatment, elevations of TSH to ≥ 10 μU/mL occurred in 32.2% of patients receiving axitinib.
I studier med axitinib givet som monoterapi (N = 850) så man hæmoptyse hos 3,9% af patienterne; hæmoptyse af grad ≥3 blev rapporteret hos 0,5 % af patienterne.
In monotherapy studies with axitinib (N = 850), haemoptysis was reported in 3.9% of patients; Grade &gt; 3 haemoptysis was reported in 0.5% of patients.
Patienter med serumkreatinin &gt; 1,5 gange den øvre normal grænse eller beregnet kreatininclearance &lt; 60 ml/min blev ekskluderet fra de kliniske studier.
In clinical studies with axitinib for the treatment of patients with RCC, patients with serum creatinine &gt; 1.5 times the ULN or calculated creatinine clearance &lt; 60 mL/min were excluded.
Blødningsrelaterede bivirkninger grad ≥3 blev set hos 3,1% af patienterne i behandling med axitinib (herunder hjerneblødning, gastrisk blødning, nedre gastrointestinal blødning og hæmoptyse).
Grade &gt; 3 haemorrhagic adverse reactions were reported in 3.1% of patients receiving axitinib (including cerebral haemorrhage, gastric haemorrhage, lower gastrointestinal haemorrhage and haemoptysis).
Meget almindelig: Knuder eller hævelse ( &lt; 2 cm) kan observeres på injektionsstedet, hvilket kan vare i 24 timer.
Very common: nodules or swelling ( &lt; 2 cm) can be observed in the injection site, which may last 24 hours.
Information til sundhedspersoner LÃ¦gemidler indeholdende testosteron er i EU godkendt til behandling af hypogonadisme hos mÃ¦nd.
Information to healthcare professionals Testosterone-containing medicines are licensed in the EU for the treatment of male hypogonadism.
For patienter med ClCr &lt; 60 ml/min bør alternative antibakterielle midler overvejes.
For patients with ClCr &lt; 60 mL/min, alternative antibacterials should be considered.
Eksponeringen for cobicistat og emtricitabin hos pædiatriske patienter i alderen 12 til &lt; 18 år var den samme som den eksponering, der opnås hos voksne.
Exposures of cobicistat and emtricitabine in paediatric patients aged 12 to &lt; 18 years were similar to exposures achieved in adults.
Hyppighed er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100) eller sjælden (≥ 1/10.000 til &lt; 1/1.000).
(≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100) or rare (≥ 1/10,000
Det anbefales, at Stribild ikke påbegyndes hos patienter med kreatininclearance &lt; 90 ml/min medmindre, efter en gennemgang af de tilgængelige behandlingsmuligheder, Stribild anses for at være den foretrukne behandling for den individuelle patient.
It is recommended that Stribild is not initiated in patients with creatinine clearance &lt; 90 mL/min unless, after review of the available treatment options, it is considered that Stribild is the preferred treatment for the individual patient.
Virologisk respons blev defineret som udetekterbart viral load ( &lt; 50 hiv 1-rna kopier/ml, snapshot-analyse).
Virologic response was defined as achieving an undetectable viral load ( &lt; 50 HIV-1 RNA copies/mL, snapshot analysis).
Forskellen i andelen af patienter, der havde &lt; 400 kopier/ml ved uge 48, skyldtes primært, at der var et højere antal af seponeringer i tenofovirdisoproxilgruppen.
The difference in the proportion of patients who maintained &lt; 400 copies/mL at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil treatment group.
På grund af protokolovertrædelser afbrød to patienter med historiske K103N-substitutioner studiet tidligt med hiv 1-rna &lt; 50 kopier/ml.
Due to protocol violation, two patients with historical K103N substitutions discontinued early with HIV-1 RNA &lt; 50 copies/mL.
Der anbefales klinisk overvågning for patienter med ClCr &lt; 90 ml/min.
Clinical monitoring is recommended for patients with ClCr &lt; 90 mL/min.
Ved uge 48 havde seks unge i tenofovirdisoproxilgruppen og én ung i placebogruppen signifikant BMD-tab i columna lumbalis (defineret som &gt; 4 % tab).
At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as &gt; 4% loss).
Patienterne skulle være stabilt supprimerede i mindst seks måneder, før de indgik i studiet, de måtte ikke have nogen aktuel eller tidligere resistens over for de antiretrovirale indholdsstoffer Stribild, og de skulle have hiv 1-rna &lt; 50 kopier/ml ved screening.
Patients had to be stably suppressed for at least six months prior to study entry, have no current or past history of resistance to the antiretroviral components of Stribild, and have HIV-1 RNA &lt; 50 copies/mL at screening.
Eksponeringen for elvitegravir og tenofovir hos pædiatriske patienter i alderen 12 til &lt; 18 år, som fik Stribild i GS-US-236-0112, steg med hhv. 30 % og 37 % i forhold til historiske kontrolværdier hos voksne.
Exposures of elvitegravir and tenofovir in paediatric patients aged 12 to &lt; 18 years who received Stribild in GS-US-236-0112 were increased by 30% and 37% respectively, when compared with historical adult controls.
Alle 48 patienter, som fik mindst én dosis Stribild, var fortsat supprimerede (hiv 1-rna &lt; 50 kopier/ml) til og med uge 48.
All 48 patients who received at least one dose of Stribild remained suppressed (HIV-1 RNA &lt; 50 copies/mL) through Week 48.
Det anbefales, at Stribild seponeres hos patienter med kreatininclearance, der falder til &lt; 70 ml/min under behandling, medmindre den potentielle fordel ved denne kombination af antiretrovirale stoffer for den individuelle patient anses for at opveje den potentielle risiko ved at fortsætte behandlingen.
It is recommended that Stribild is discontinued in patients with creatinine clearance that falls to &lt; 70 mL/min while on treatment unless it is considered that the potential benefit of this combination of antiretroviral agents for the individual patient outweighs the possible risks of continuing with therapy.
Elvitegravirs eller cobicistats farmakokinetik hos pædiatriske personer &lt; 12 år er ikke fuldstændig klarlagt.
The pharmacokinetics of elvitegravir or cobicistat in paediatric subjects &lt; 12 years of age have not been fully established.
Stribild opfyldte kriterierne for non-inferioritet ved at opnå hiv 1-rna &lt; 50 kopier/ml, sammenlignet med efavirenz/emtricitabin/tenofovirdisoproxil, og sammenlignet med atazanavir/ritonavir + emtricitabin/tenofovirdisoproxil.
Stribild met the non-inferiority criteria in achieving HIV-1 RNA &lt; 50 copies/mL when compared to efavirenz/emtricitabine/tenofovir disoproxil and when compared to atazanavir/ritonavir + emtricitabine/tenofovir disoproxil.
Stribild bør seponeres hos patienter med bekræftet kreatininclearance, der falder til &lt; 50 ml/min (da de påkrævede justeringer af dosisintervallet ikke er mulige med denne fastdosis-kombinationstablet) eller med fald i serumphosphat til &lt; 0,32 mmol/l (1,0 mg/dl) (se pkt.
Stribild should be discontinued in patients with confirmed creatinine clearance that falls to &lt; 50 mL/min (since the required dose interval adjustments are not possible using this fixed dose combination tablet) or with decreases in serum phosphate to &lt; 0.32 mmol/L (1.0 mg/dL) (see sections 4.2 and 5.2).
Når manglende data blev ekskluderet havde 91 % af patienterne i den gruppe, der blev behandlet med tenofovirdisoproxil, og 94 % af patienterne i den gruppe, der fik behandling med stavudin eller zidovudin, hiv 1-RNA-koncentrationer &lt; 400 kopier/ml ved uge 48.
When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations &lt; 400 copies/mL at week 48.
Stribild bør ikke påbegyndes hos patienter med kreatininclearance &lt; 70 ml/min.
Stribild should not be initiated in patients with creatinine clearance &lt; 70 mL/min.
Ved uge 48 havde 44 ud af 50 (88 %) pædiatriske patienter behandlet med Stribild opnået hiv 1 rna &lt; 50 kopier/ml, og 4 havde opnået hiv 1 rna ≥ 50 kopier/ml; 1 patient havde fået seponeret studielægemidlet, og 1 patient havde ingen virologiske data ved uge 48.
At Week 48, 44 of 50 (88%) adolescent patients treated with Stribild achieved HIV-1 RNA &lt; 50 copies/mL and 4 achieved HIV-1 RNA ≥50 copies/mL; 1 patient discontinued study drug, and 1 had no virologic data at Week 48.
Stribilds sikkerhed og virkning hos børn under 12 år, eller som vejer &lt; 35 kg, er ikke klarlagt (se pkt.
The safety and efficacy of Stribild in children under the age of 12 years or weighing &lt; 35 kg have not been established (see section 5.2).
Én af de forsøgsdeltagere, der fik behandling med tenofovirdisoproxil, men ingen af de forsøgsdeltagere, der fik behandling med stavudin eller zidovudin, oplevede signifikant ( &gt; 4 %) BMD-tab i spinalis lumbalis ved uge 48.
One tenofovir disoproxil treated subject and no stavudine or zidovudine treated subjects experienced significant ( &gt; 4%) lumbar spine BMD loss at week 48.
Tyve procent havde hiv 1-rna i plasma &gt; 100.000 kopier/ml ved baseline.
Twenty percent had baseline plasma HIV-1 RNA &gt; 100,000 copies/mL.
Hvis serumphosphat er &lt; 0,48 mmol/l (1,5 mg/dl) eller kreatininclearance falder til &lt; 70 ml/min, skal vurderingen af nyrefunktionen gentages inden for en uge, herunder måling af glucose- og kaliumkoncentration i blodet samt uringlucose (se pkt.
If serum phosphate is &lt; 0.48 mmol/L (1.5 mg/dL) or creatinine clearance is decreased to &lt; 70 mL/min, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8).
I en samlet analyse af antiretroviral-naive patienter, der fik Stribild i fase 3-studie GS-US-236-0102 og GS-US-236-0103 til og med uge 144, blev der foretaget genotypebestemmelse af plasma-hiv 1-isolater fra alle patienter med bekræftet virologisk svigt, eller som havde hiv 1-rna &gt; 400 kopier/ml på tidspunktet for virologisk svigt, ved uge 48, ved uge 96, ved uge 144 eller på tidspunktet for tidlig seponering af studiemedicinen.
In a pooled analysis of antiretroviral-naïve patients receiving Stribild in Phase 3 studies GS-US-236-0102 and GS-US-236-0103 through Week 144, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed virologic failure or who had HIV-1 RNA &gt; 400 copies/mL at virologic failure, at Week 48, at Week 96, at Week 144 or at the time of early study drug discontinuation.
Ved uge 48 havde 83 % af patienterne i den gruppe, der blev behandlet med tenofovirdisoproxil, og 92 % af patienterne i den gruppe, der blev behandlet med stavudin eller zidovudin, hiv 1-rna-koncentrationer &lt; 400 kopier/ml.
At week 48, 83% of patients in the tenofovir disoproxil treatment group and 92% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations &lt; 400 copies/mL.
I studie GS-US-104-0352 blev 97 behandlingserfarne patienter i alderen 2 til &lt; 12 år, der havde stabil virologisk suppression med stavudin- eller zidovudinholdige regimer, randomiseret til enten at erstatte stavudin eller zidovudin med tenofovirdisoproxil (n = 48) eller til at fortsætte med deres oprindelige regime (n = 49) i 48 uger.
In study GS-US-104-0352, 97 treatment experienced patients 2 to &lt; 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
I et klinisk studie af hiv 1-inficerede behandlingsnaive patienter i alderen 12 til &lt; 18 år (n = 50) blev der observeret små fald i de gennemsnitlige BMD Z-scorer efter behandling med Stribild (se pkt.
In a clinical study of HIV-1-infected, treatment-naïve patients aged 12 to &lt; 18 years (N=50), small decreases in mean BMD Z-scores were observed following treatment with Stribild (see section 4.8).
Virologisk supprimerede hiv 1-inficerede patienter I studie GS-US-236-0115 og studie GS-US-236-0121 skulle patienterne være i gang med enten deres første eller andet antiretrovirale behandlingsregime uden tidligere virologisk svigt, de måtte ikke tidligere have oplevet resistens mod de antiretrovirale indholdsstoffer i Stribild, og de skulle være supprimerede med PI+RTV eller en NNRTI i kombination med FTC/tenofovirdisoproxil (hiv 1-rna &lt; 50 kopier/ml) i mindst seks måneder før screening.
In Study GS-US-236-0115 and Study GS-US-236-0121, patients had to be on either their first or second antiretroviral regimen with no history of virologic failure, have no current or past history of resistance to the antiretroviral components of Stribild and must have been suppressed on a PI+RTV or an NNRTI in combination with FTC/tenofovir disoproxil (HIV-1 RNA &lt; 50 copies/mL) for at least six months prior to screening.
Stribild er også indiceret til behandling af infektion hos unge i alderen 12 til &lt; 18 år, som vejer ≥ 35 kg, og som er inficerede med hiv 1 uden kendte mutationer forbundet med resistens over for nogle af de tre antiretrovirale stoffer i Stribild, og som har oplevet toksiciteter, der udelukker brug af andre regimer, som ikke indeholder tenofovirdisoproxil (se pkt.
Stribild is also indicated for the treatment of HIV-1 infection in adolescents aged 12 to &lt; 18 years weighing ≥ 35 kg who are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil (see sections 4.2, 4.4 and 5.1).
Vurderingen af bivirkninger relateret til tenofovirdisoproxil er baseret på to randomiserede studier (studie GS-US-104-0321 og GS-US-104-0352) med 184 hiv 1-inficerede pædiatriske patienter (i alderen 2 til &lt; 18 år), der fik behandling med tenofovirdisoproxil (n = 93) eller placebo/aktiv komparator (n = 91) i kombination med andre antiretrovirale midler i 48 uger (se pkt.
Assessment of adverse reactions related to tenofovir disoproxil is based on two randomised trials (studies GS-US-104-0321 and GS-US-104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to &lt; 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
I studie GS-US-104-0321 fik 87 hiv 1-inficerede behandlingserfarne patienter i alderen 12 til &lt; 18 år behandling med tenofovirdisoproxil (n = 45) eller placebo (n = 42) i kombination med et optimeret baggrundsregime (OBR) i 48 uger.
In study GS-US-104-0321, 87 HIV-1-infected treatment experienced patients 12 to &lt; 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Hos hiv 1-inficerede unge (i alderen 12 til &lt; 18 år) blev der set lavere BMD Z-scorer hos de forsøgsdeltagere, der fik tenofovirdisoproxil, end hos de forsøgsdeltagere, der fik placebo.
In HIV-1 infected adolescents (aged 12 to &lt; 18 years), the BMD Z-scores observed in subjects who received tenofovir disoproxil were lower than those observed in subjects who received placebo.
Hvis serumphosphat bekræftes at være &lt; 0,96 mmol/l (3,0 mg/dl) hos en pædiatrisk patient, der får Stribild, skal vurderingen af nyrefunktionen gentages inden for en uge, herunder måling af glucose- og kaliumkoncentration i blodet samt uringlucose (se pkt.
If serum phosphate is confirmed to be &lt; 0.96 mmol/L (3.0 mg/dL) in any paediatric patient receiving Stribild, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Der er rapporteret om bivirkninger på nyrerne, der er overensstemmende med proksimal nyre tubulopati, hos hiv 1-inficerede pædiatriske patienter i alderen 2 til &lt; 12 år i et klinisk studie af tenofovirdisoproxil (GS-US-104-0352) (se pkt.
Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV-1 infected paediatric patients aged 2 to &lt; 12 years in a clinical study of tenofovir disoproxil (GS-US-104-0352) (see sections 4.8 and 5.1).
Hiv 1-rna &lt; 50 kopier/ml
Virologic success HIV-1 RNA &lt; 50 copies/mL Treatment difference
Sikkerheden af Stribild blev evalueret hos 50 hiv 1-inficerede, behandlingsnaive pædiatriske patienter i alderen 12 til &lt; 18 år igennem 48 uger i et klinisk studie med åben behandling (GS-US-236-0112, se pkt.
The safety of Stribild in 50 HIV-1-infected, treatment-naïve paediatric patients aged 12 to &lt; 18 years was evaluated through 48 weeks in an open-label clinical study (GS-US-236-0112, see section 5.1).
Gennemsnitlig plasma hiv 1-rna ved baseline (interval) log10 kopier/ml Procentdel af personer med viral load &gt; 100.000 kopier/ml
Mean baseline plasma HIV-1 RNA (range) log10 copies/mL Percentage of subjects with viral load &gt; 100,000 copies/mL Mean baseline CD4+ cell count (range), x 106 cells/L
At nyrefunktionen bør evalueres igen i løbet af en uge, hvis serumphosphat bekræftes at være &lt; 3,0 mg/dl (0,96 mmol/l) hos en ung patient, der får Stribild.
That if serum phosphate is confirmed to be &lt; 3.0 mg/dl (0.96 mmol/l) in any adolescent patient receiving Stribild, renal function should be re-evaluated within one week.
Hyppigheden defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til &lt; 1/10); ikke almindelig (≥ 1/1.000 til &lt; 1/100); sjælden (≥ 1/10.000 til &lt; 1/1.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); not known (cannot be estimated from available post-marketing data).
Hvis marvcellulariteten er &gt; 10%, kan en genoptagelse af behandlingen med SPRYCEL overvejes.
If marrow cellularity is &gt; 10%, resumption of treatment with SPRYCEL may be considered.
De fleste resistente patienter (72%) havde fået &gt; 600 mg imatinib.
Most resistant patients (72%) had received &gt; 600 mg imatinib.
Cytogenetisk respons inden for 12 måneder cCCyRa p &lt; 0,007*
Cytogenetic response within 12 months cCCyRa p &lt; 0.007*
Da dasatinib og dets metabolitter har en nyre-clearance &lt; 4%, forventes total-clearance ikke at falde hos patienter med nyreinsufficiens.
Since the renal clearance of dasatinib and its metabolites is &lt; 4%, a decrease in total body clearance is not expected in patients with renal insufficiency.
17 patienter havde 2 separate bivirkninger, 6 havde 3 bivirkninger, 18 havde 4-8 bivirkninger og 5 havde &gt; 8 hændelser med pleuraeffusion.
Seventeen patients had 2 separate adverse reactions, 6 had 3 adverse reactions, 18 had 4 to 8 adverse reactions and 5 had &gt; 8 episodes of pleural effusions.
Kongestivt hjertesvigt/hjerteinsufficiens og lungeødem blev rapporteret hos &lt; 2% af patienterne.
Congestive heart failure/cardiac dysfunction and pulmonary oedema were reported in &lt; 2% of patients.
CTC-grader: neutropeni (grad 3 ≥ 0,5- &lt; 1,0 × 109/l, grad 4 &lt; 0,5 × 109/l); trombocytopeni (grad 3 ≥ 25- &lt; 50 × 109/l, grad 4 &lt; 25 × 109/l); anæmi (hæmoglobin grad 3 ≥ 65- &lt; 80 g/l, grad 4 &lt; 65 g/l).
CTC grades: neutropaenia (Grade 3 ≥ 0.5- &lt; 1.0 × 109/l, Grade 4 &lt; 0.5 × 109/l); thrombocytopaenia (Grade 3 ≥ 25 - &lt; 50 × 109/l, Grade 4 &lt; 25 × 109/l); anaemia (haemoglobin Grade 3 ≥ 65 - &lt; 80 g/l, Grade 4 &lt; 65 g/l).
12 måneder p &lt; 0,00003*
12 months p &lt; 0.00003*