natgillin/translations-raw huggingface dataset:
uge 8 og 52 vedligeholdt respons vedligeholdt remission vedligeholdt slimhindeheling klinisk remission er Mayo-score ≤ uden subscore &gt; 1; klinisk respons er fald fra baseline i Mayo-score på ≥ 3 point og ≥ 30 % samt et fald i rektal blødning-subscore [RBS] på ≥ 1 eller en absolut RBS på 0 eller 1; * p &lt; 0,05 for adalimumab versus placebo ved parvis sammenligning af andelene ** p &lt; 0,001 for adalimumab versus placebo ved parvis sammenligning af andelene a af de patienter, der fik steroid ved baseline
week 8 and 52 sustained response sustained remission sustained mucosal healing clinical remission is Mayo score ≤ 2 with no subscore &gt; 1; clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30 % plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p &lt; 0.05 for adalimumab vs. placebo pairwise comparison of proportions ** p &lt; 0.001 for adalimumab vs. placebo pairwise comparison of proportions a of those receiving corticosteroids at baseline
De gennemsnitlige dal-serumkoncentrationer (±SD) af adalimumab, som blev opnået ved uge 4, var 15,7±6,6 µg/ml for patienter ≥ 40 kg (160/80 mg) og 10,6±6,1 µg/ml for patienter &lt; 40 kg (80/40 mg).
The mean (± SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥ 40 kg (160 / 80 mg) and 10.6 ± 6.1 µg / ml for patients &lt; 40 kg (80 / 40 mg).
klinisk remission klinisk respons (CR-100) Patienter i steroid-fri remission i ≥90 dagea * p &lt; 0,001 for adalimumab vs. placebo parvise sammenligninger af andelene ** p &lt; 0,02 for adalimumab vs. placebo parvise sammenligninger af andelene a
clinical remission clinical response (CR-100) patients in steroid-free remission for &gt; = 90 daysa * p &lt; 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p &lt; 0.02 for adalimumab versus placebo pairwise comparisons of proportions a of those receiving corticosteroids at baseline
&lt; 40 kg • 40 mg i uge 0 og 20 mg i uge 2
&lt; 40 kg • 40 mg at week 0 and 20 mg at week 2
Sammenlignet med placebo reducerede adalimumab progressionshastigheden, hvormed de perifere led destrueres, målt ved ændring i mTSS fra baseline (gennemsnit + SD) 0,8 ± 2,5 i placebogruppen (ved uge 24) sammenlignet med 0,0 ±1,9 i adalimumab-gruppen (ved uge 48) (p &lt; 0,001).
Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p &lt; 0.001) in the adalimumab group (at week
N/A N/A *** p &lt; 0,001 for alle sammenligninger mellem adalimumab og placebo * p &lt; 0,05 for alle sammenligninger mellem adalimumab og placebo N/A ikke relevant
*** p &lt; 0.001 for all comparisons between adalimumab and placebo * p &lt; 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Adalimumabs virkning er undersøgt i et randomiseret, dobbeltblindet kontrolleret studie med 114 pædiatriske patienter fra 4 år med svær kronisk plaque-psoriasis (defineret ved PGA (physician global assessment) ≥ 4 eller &gt; 20 % BSA (body surface area)-involvering eller &gt; 10 % BSA-involvering med meget tykke læsioner eller PASI (psoriasis area and severity index) ≥ 20 eller ≥ 10 med klinisk relevante manifestationer i ansigt, på kønsorganer eller hånd/fod), som ikke havde opnået tilstrækkelig kontrol med topikal behandling og helioterapi eller lysbehandling.
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or &gt; 20 % BSA involvement or &gt; 10 % BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
I RA-studie V var forbedringen i HAQ funktionsevneindeks og den fysiske komponent fra SF 36 større (p &lt; 0,001) for adalimumab/methotrexat-kombinationsterapi end for methotrexat-monoterapi og adalimumab-monoterapi efter 52 uger.
In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p &lt; 0.001) for adalimumab / methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Adalimumabs sikkerhed og virkning ved induktions- og vedligeholdelsesbehandling med doser afhængige af legemsvægt ( &lt; 40 kg eller ≥ 40 kg) er undersøgt i et randomiseret, dobbeltblindet klinisk multicenterstudie med 192 pædiatriske patienter i alderen 6 til 17 (inklusive) år med moderat til svær Crohns sygdom (CD), defineret som Paediatric Crohn's Disease Activity Index (PCDAI) score &gt; 30.
Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight ( &lt; 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn's disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score &gt; 30.
Hos patienter med polyartikulær JIA, som var 2 til &lt; 4 år eller 4 år og derover med en vægt &lt; 15 kg, som blev doseret med adalimumab 24 mg/m2, var den gennemsnitlige dal-serumkoncentration af adalimumab ved steady state 6,0 ± 6,1 µg/ml (101 % CV) for adalimumab uden samtidig methotrexat og 7,9 ± 5,6 µg/ml (71,2 % CV) med samtidig methotrexat.
In patients with polyarticular JIA who were 2 to &lt; 4 years old or aged 4 and above weighing &lt; 15 kg dosed with adalimumab 24 mg / m2, the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg / ml (101 % CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg / ml (71.2 % CV) with concomitant methotrexate.
klinisk remission klinisk respons (CR-100) patienter i steroid-fri remission i ≥90 dagea
clinical remission clinical response (CR-100) patients in steroid-free remission for &gt; = 90 daysa week 56
10 kg til &lt; 30 kg ≥ 30 kg
10 kg to &lt; 30 kg ≥ 30 kg
uge 2 uge 12 uge 24 ***,** statistisk signifikant på p &lt; 0,001, &lt; 0,01 for alle sammenligninger mellem adalimumab og placebo ved uge 2, 12 og 24 a assessment in ankylosing spondylitis b Bath ankylosing spondylitis disease activity index
BASDAIb 50 week 2 week 12 week 24 ***,** statistically significant at p &lt; 0.001, &lt; 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24
15 kg til &lt; 30 kg ≥ 30 kg
15 kg to &lt; 30 kg ≥ 30 kg
&lt; 0,001c erosion score JSNd score a methotrexat b 95 % Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab.
d score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab c based on rank analysis d
Alle patienter fik åben induktionsbehandling med doser baseret på deres baseline-legemsvægt: henholdsvis 160 mg i uge 0 og 80 mg i uge 2 til patienter ≥ 40 kg og 80 mg henholdsvis 40 mg til patienter &lt; 40 kg.
All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects &lt; 40 kg.
p-værdia p-værdib p-værdic total sharp score erosion score 3,7 (2,7-4,7) 1,7 (1,0-2,4) JSN score a p-værdien for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexat- kombinationsbehandling ved anvendelse af Mann-Whitney U test. b p-værdien for den parvise sammenligning af adalimumab-monoterapi og adalimumab/methotrexat- kombinationsbehandling ved anvendelse af Mann-Whitney U test c p-værdien for den parvise sammenligning af adalimumab-monoterapi og methotrexat-monoterapi ved anvendelse af Mann-Whitney U test
adalimumab / M TX n=268 (95% confidence interval) p-valuea p-valueb p-valuec total Sharp score erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) &lt; 0.001 0.0082 &lt; 0.001 JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) &lt; 0.001 0.0037 0.151 a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Mediantiden til behandlingssvigt var 24,1 uge for patienter behandlet med placebo, mens mediantiden til behandlingssvigt hos patienter behandlet med adalimumab ikke var målbar, da mindre end halvdelen af disse patienter oplevede behandlingssvigt.
Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P &lt; 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
SPARCCh MRI sakroiliakaleddened,i SPARCC MRI rygsøjlend,j a assessments of SpondyloArthritis International Society b Bath ankylosing spondylitis disease activity index c ankylosing spondylitis disease activity score d gennemsnitlig ændring fra baseline e n=91 placebo og n=87 adalimumab f høj følsomhed C-reaktivt protein (mg/l) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo og adalimumab j n=82 placebo og n=85 adalimumab ***, **, * statistisk signifikant ved henholdsvis p &lt; 0,001, &lt; 0,01 og &lt; 0,05 for alle sammenligninger mellem adalimumab og placebo.
Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab ***,**,* statistically significant at p &lt; 0.001, &lt; 0.01, and &lt; 0.05, respectively, for all comparisons between adalimumab and placebo.
6 måneder 6,7 % 52,4 % 8,2 % 22,1 % 9,5 % 39,1 % 12 måned NA
ACR 20 week 52 62.6 % 54.4 % 72.8 % 0.013 &lt; 0.001 0.043 week 104 56.0 % 49.3 % 69.4 % 0.002 &lt; 0.001 0.140 ACR 50 week 52 45.9 % 41.2 % 61.6 % &lt; 0.001 &lt; 0.001 0.317 week 104 42.8 % 36.9 % 59.0 % &lt; 0.001 &lt; 0.001 0.162 ACR 70 week 52 27.2 % 25.9 % 45.5 % &lt; 0.001 &lt; 0.001 0.656 week 104 28.4 % 28.1 % 46.6 % &lt; 0.001 &lt; 0.001 0.864
Liraglutid bindes i udstrakt grad til plasmaproteiner ( &gt; 98%).
Liraglutide is extensively bound to plasma proteins ( &gt; 98%).
Eksponeringen var signifikant lavere (44%) hos patienter med svært nedsat leverfunktion (Child Pughscore &gt; 9).
Exposure was significantly lower (44%) in patients with severe hepatic impairment (Child Pugh score &gt; 9).
Hyppighederne er defineret som følger: 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), meget sjælden ( &lt; 1/10.000), 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); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).
Ældre patienter ( &gt; 65 år) Dosisjustering, baseret på alder, er ikke nødvendig (se pkt.
Elderly patients ( &gt; 65 years old) No dose adjustment is required based on age (see section 5.2).
Patienter &gt; 70 år kan få flere gastrointestinale bivirkninger ved behandling med liraglutid.
Patients &gt; 70 years may experience more gastrointestinal effects when treated with liraglutide.
Eksponeringen for liraglutid var reduceret med 33%, 14%, 27% og 26% hos patienter med henholdsvis let (kreatinin-clearance (CrCl) 50-80 ml/min), moderat (CrCl 30-50 ml/min) og svært (CrCl &lt; 30 ml/min) nedsat nyrefunktion samt dialysekrævende terminal nyreinsufficiens.
Liraglutide exposure was lowered by 33%, 14%, 27% and 26% in patients with mild (creatinine clearance, CrCl 50-80 ml/min), moderate (CrCl 30-50 ml/min), and severe (CrCl &lt; 30 ml/min) renal impairment and in end-stage renal disease requiring dialysis, respectively.
Der er rapporteret om få tilfælde af akut pankreatitis ( &lt; 0,2%) under de langvarige, kontrollerede kliniske fase 3-studier med Victoza.
Few cases of acute pancreatitis ( &lt; 0.2%) have been reported during long-term, controlled phase 3 clinical trials with Victoza.
Patienter, behandlet med liraglutid, oplevede en signifikant reduktion i kropsvægt sammenlignet med patienter, behandlet med sitagliptin (-2,9 kg og -3,4 kg versus -1,0 kg, p &lt; 0,0001).
Patients treated with liraglutide had a significant decrease in body weight compared to that of patients treated with sitagliptin (-2.9 kg and -3.4 kg vs -1.0 kg, p &lt; 0.0001).
HR: 0,87 95% CI [0,78; 0,97] p &lt; 0,001 for non-inferioritet p=0,005 for superioritet
HR: 0.87 95% CI [0.78; 0.97]
&gt; 5,5 og &lt; 6,7 mmol/l ( &gt; 100 og &lt; 120 mg/dl)
&gt; 5.5 and &lt; 6.7 mmol/l ( &gt; 100 and &lt; 120 mg/dl) 0-2 IUa ≥6.7 mmol/l (≥120 mg/dl)
Reduktionerne i HbA1c og fordelen af liraglutid i forhold til sitagliptin, observeret efter 26 ugers behandling (1,2 mg og 1,8 mg), blev opretholdt efter 52 ugers behandling (-1,29% og -1,51% versus -0,88%, p &lt; 0,0001).
The reductions in HbA1c and superiority vs sitagliptin observed after 26 weeks of liraglutide treatment (1.2 mg and 1.8 mg) were sustained after 52 weeks of treatment (-1.29% and -1.51% vs -0.88%, p &lt; 0.0001).
I et 104 ugers klinisk studie opnåede 57% af de patienter med type 2-diabetes, der blev behandlet med insulin degludec i kombination med metfomin, et target HbA1c på &lt; 7%, og de resterende patienter fortsatte i et 26 ugers åbent studie og blev randomiseret til at tilføje liraglutid eller en enkelt dosis insulin aspart (i forbindelse med hovedmåltidet).
In a 104-week clinical trial, 57% of patients with type 2 diabetes treated with insulin degludec in combination with metformin achieved a target HbA1c &lt; 7% and the remaining patients continued in a
Signifikant flere patienter opnåede HbA1c under 7% med liraglutid sammenlignet med lixisenatid (74,2% versus 45,5%, p &lt; 0,0001), lige så vel som HbA1c target under eller lig med 6,5% (54,6% versus 26,2%, p &lt; 0,0001).
(74.2% vs 45.5%, p &lt; 0.0001), as well as the HbA1c target below or equal 6.5% (54.6% vs 26.2%, p &lt; 0.0001).
I et åbent studie, der sammenligner virkningen og sikkerheden af liraglutid (1,2 mg og 1,8 mg) og sitagliptin (en DPP-4 inhibitor, 100 mg) hos patienter, der er utilstrækkeligt kontrolleret med metformin (middel HbA1c 8,5%), var liraglutid ved begge doser statistisk bedre end sitagliptin til at reducere HbA1c efter 26 ugers behandling (-1,24%, -1,50% versus -0,90%, p &lt; 0,0001).
In an open label trial comparing the efficacy and safety of liraglutide (1.2 mg and 1.8 mg) and sitagliptin (a DPP-4 inhibitor, 100 mg) in patients inadequately controlled on metformin therapy (mean HbA1c 8.5%), liraglutide at both doses was statistically superior to sitagliptin treatment in reducing HbA1c after 26 weeks (-1.24%, -1.50% vs -0.90%, p &lt; 0.0001).
Placebo *Superioritet (p &lt; 0,01) versus aktiv komparator; **Superioritet (p &lt; 0,0001) versus aktiv komparator; ***Superioritet (p &lt; 0,001) versus aktiv komparator; †Non-inferioritet (p &lt; 0,0001) versus aktiv komparator 1alle patienter; 2tidligere monoterapi med orale antidiabetika; 3patienter tidligere behandlet med kost 5Victoza tillægsbehandling til SGLT2i blev undersøgt for alle godkendte doseringer af SGLT2i 4doseringen af insulin glargin var åben, og blev foretaget i henhold til Vejledning for titrering af insulin glargin.
1all patients; 2previous OAD monotherapy; 3previous diet treated patients 5Victoza add-on to SGLT2i was investigated at all approved doses of SGLT2i 4the dosing of insulin glargine was open-labelled and was applied according to Guideline for titration of insulin glargine.
I et åbent studie, der sammenligner virkningen og sikkerheden af 1,8 mg liraglutid med 20 mikrogram lixisenatid hos 404 patienter, der er utilstrækkeligt kontrollerede med meformin (middel-HbA1c 8,4%), var liraglutid bedre end lixisenatid til at reducere HbA1c efter 26 ugers behandling (-1,83% versus1,21%, p &lt; 0,0001).
In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg with lixisenatide 20 mcg in 404 patients inadequately controlled on metformin therapy (mean HbA1c 8.4%), liraglutide was superior to lixisenatide in reducing HbA1c after 26 weeks of treatment (-1.83% vs -1.21%, p &lt; 0.0001).
Farmakokinetiske data på ældre ( &gt; 65 år) er begrænsede, men svarer til farmakokinetikken hos yngre voksne.
Pharmacokinetic data in elderly ( &gt; 65 years) are limited but consistent with pharmacokinetics in younger adults.
Infektioner kan fÃ¥ et mere alvorligt forlÃ¸b og kan derfor krÃ¦ve tidlig og intensiv behandling.
Infections may be more severe in nature and may, therefore, require early and vigorous treatment.
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); meget sjælden ( &lt; 1 /10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
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); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
leukopeni (leukocyter &gt; 2 G/L)
leucopenia (leucocytes &gt; 2 G/L)
Leflunomid 20 mg/dag var signifikant bedre end placebo til at reducere arthritis symptomerne hos patienter med arthritis psoriatica: PsARC respons (Psoriatic Arthritis treatment Response Criteria) var 59% i leflunomidgruppen og 29,7 % i placebogruppen ved 6 måneder (p &lt; 0,0001).
Leflunomide 20 mg/day was significantly superior to placebo in reducing the symptoms of arthritis in patients with psoriatic arthritis: the PsARC (Psoriatic Arthritis treatment Response Criteria) responders were 59% in the leflunomide group and 29.7% in the placebo group by 6 months (p &lt; 0.0001).
Informationsfolderen til lÃ¦ger skal indeholde fÃ¸lgende nÃ¸gleinformation:
The Physician Leaflet should contain the following key messages:
Infektioner og parasitÃ¦re sygdomme SjÃ¦lden:
Infections and infestations Rare:
Ikke almindelig: anæmi, let trombocytopeni (trombocytter &lt; 100 G/L) Sjælden:
Uncommon: anaemia, mild thrombocytopenia (platelets &lt; 100 G/L) Rare:
pancytopeni (formentlig via en antiproliferativ mekanisme) leukopeni (leukocytter &lt; 2 G/L), eosinofili Meget sjælden: agranulocytose
pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes &lt; 2 G/L), eosinophilia
Efter 16 ugers behandling var forskellen i responsraterne statistisk signifikant til methotrexats fordel til børnegigt ”definition of improvement (DOI)” ≥30 % (p=0,02 %).
In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: &lt; 20 kg, 20-40 kg, and &gt; 40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥30% (p=0.02).
Patienter med lav legemsvægt ( &lt; 65 kg), asiatiske og kvindelige patienter har en større risiko for forhøjelser af leverenzymer.
Patients with low body weight ( &lt; 65 kg), Asian and female patients have a higher risk of elevations of liver enzymes.
Følgende hyppighedskategorier er defineret vha. følgende konvention: 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), meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequency categories are defined using the following convention: 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), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Patienter med FVC &lt; 50 % af forventet ved baseline eller carbonmonooxid diffusionskapacitet (DLCO, korrigeret for hæmoglobin) &lt; 30 % af forventet ved baseline, blev ekskluderet fra studierne.
Patients with FVC baseline &lt; 50% predicted or carbon monoxide diffusing capacity (DLCO, corrected for haemoglobin) &lt; 30% predicted at baseline were excluded from the trials.
Nintedanib elimineres primært ved udskillelse via galde/fæces ( &gt; 90 %).
Nintedanib is predominantly eliminated via biliary/faecal excretion ( &gt; 90%).
Hvis de målte aminotransferaseniveauer (ASAT eller ALAT) er &gt; 3 x ULN, anbefales dosisreduktion eller afbrydelse af behandlingen med Ofev, og patienten skal monitorers nøje.
If transaminase (AST or ALT) elevations &gt; 3x ULN are measured, dose reduction or interruption of the therapy with Ofev is recommended and the patient should be monitored closely.
Nintedanibs sikkerhed, virkning og farmakokinetik er ikke undersøgt hos patienter med svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min).
The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment ( &lt; 30 ml/min creatinine clearance).
Hvis behandlingen afbrydes på grund af forhøjet aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) til &gt; 3 x øvre grænse for normalværdien (ULN), kan behandlingen med Ofev påbegyndes igen ved en reduceret dosis (100 mg to gange dagligt), når aminotransferase-værdierne er vendt tilbage til baseline.
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations &gt; 3x upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with Ofev may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily) (see sections 4.4 and 4.8).
Ved analyser af aldersundergrupper blev der observeret en stigning i den mediane samlede overlevelse for alle grupper ( &lt; 65 år, ≥ 65 år og ≥ 75 år).
On analyses of age subgroups, an increase in median overall survival was observed for all groups ( &lt; 65 years, ≥ 65 years and ≥ 75 years).
Hyppighederne 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), meget sjælden ( &lt; 1/10.000), 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); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).
• AML med &gt; 30 % knoglemarvsblaster i henhold til klassifikationen fra WHO.
• AML with &gt; 30% marrow blasts according to the WHO classification.
Hvis knoglemarvscellulariteten er &gt; 50 %, bør der ikke foretages dosisjusteringer.
If the bone marrow cellularity is &gt; 50 %, no dose adjustments should be made.
Efter intravenøs og subkutan administration af 14C-azacitidin, blev hhv. 85 og 50 % af den administrerede radioaktivitet genfundet i urin, mens &lt; 1 %
Following intravenous and subcutaneous administration of 14C-azacitidine, 85 and 50 % of the administered radioactivity was recovered in urine respectively,
To-års overlevelsesraterne var 50,8 % hos patienter, der fik azacitidin kontra 26,2 % for patienter, der fik CCR (p &lt; 0,0001).
The two-year survival rates were 50.8 % in patients receiving azacitidine versus 26.2 % in patients receiving CCR (p &lt; 0.0001).