natgillin/translations-raw huggingface dataset:
Sammenlignet med placebo reducerede Humira 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 Humira-gruppen (ved uge 48) (p &lt; 0,001).
Humira 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 Humira group (at Week 48).
Humiras sikkerhed og virkning undersøgt i et randomiseret, dobbeltblindet, kontrolleret studie hos 90 pædiatriske patienter fra 2 til &lt; 18 år med aktiv JIA-associeret non-infektiøs anterior uveitis, som var refraktære overfor mindst 12 ugers behandling med methotrexat.
The safety and efficacy of Humira was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to &lt; 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
I Psoriasis-studie I oplevede 28% af de patienter, som opnåede PASI 75-respons, og som blev genrandomiseret til placebo i uge 33, “tab af tilstrækkeligt respons” (PASI-score efter uge 33 og ved eller før uge 52, som resulterede i et &lt; PASI 50-respons i forhold til baseline med en stigning på minimum 6 point i PASI-score i forhold til uge 33), sammenlignet med 5%, som fortsatte på Humira (p &lt; 0,001).
In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at Week 33 compared to 5% continuing on Humira, p &lt; 0.001, experienced “loss of adequate response” (PASI score after Week 33 and on or before Week 52 that resulted in a &lt; PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to Week 33).
Alle p-værdier er parvise sammenligninger af andelene for Humira vs. placebo * p &lt; 0,001 ** p &lt; 0,01
All p-values are pairwise comparisons of proportions for Humira versus placebo p &lt; 0.001 p &lt; 0.01
Humiras sikkerhed og virkning blev vurderet i et åben-label, multicenter studie med 32 børn (2 - &lt; 4 år gamle eller 4 år og derover med en vægt &lt; 15 kg) med moderat til alvorlig aktiv polyartikulær JIA.
The safety and efficacy of Humira was assessed in an open-label, multicentre study in 32 children (2 - &lt; 4 years old or aged 4 and above weighing &lt; 15 kg) with moderately to severely active polyarticular JIA.
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 ap-værdien for den parvise sammenligning af methotrexat-monoterapi og Humira/methotrexatkombinationsbehandling ved anvendelse af Mann-Whitney U test. bp-værdien for den parvise sammenligning af Humira monoterapi og Humira/methotrexatkombinationsbehandling ved anvendelse af Mann-Whitney U test cp-værdien for den parvise sammenligning af Humira monoterapi og methotrexat- monoterapi ved anvendelse af Mann-Whitney U test
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 Humira/methotrexate combination therapy using the Mann-Whitney U test. p-value is from the pairwise comparison of Humira monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Der foreligger ingen kliniske data om brugen af en Humira-induktionsdosis til børn &lt; 6 år(se pkt.
No clinical data are available on the use of a Humira loading dose in children &lt; 6 years of age (see section 5.2).
I RA-studie V var forbedringen i HAQ funktionsevneindeks og den fysiske komponent fra SF 36 større (p &lt; 0,001) for Humira/methotrexat-kombinationsterapi end for methotrexat-monoterapi og Humira-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 Humira/methotrexate combination therapy versus methotrexate monotherapy and Humira monotherapy at Week 52, which was maintained through Week 104.
Når Humira behandlingen påbegyndes, kan en induktionsdosis på 40 mg til patienter &lt; 30 kg eller 80 mg til patienter ≥ 30 kg administreres en uge før start af vedligeholdelsesdosis.
When Humira therapy is initiated, a loading dose of 40 mg for patients &lt; 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Humiras 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 manifestioner i ansigt, på kønsorganer eller hånd/fod), som ikke havde opnået tilstrækkelig kontrol med topikal behandling og helioterapi eller lysbehandling.
The efficacy of Humira 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 Physician's Global Assessment (PGA) ≥ 4 or &gt; 20% BSA involvement or &gt; 10% BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Humiras sikkerhed og virkning ved induktions- og vedligeholdelsesbehandling med doser afhængige af legemsvægt ( &lt; 40 kg eller ≥ 40 kg) er undersøgt i et multicenter, randomiseret, dobbeltblindet klinisk studie 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.
Humira 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.
Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i modificeret Totale Sharp Score ≤ 0,5) signifikant højere med Humira/methotrexat-kombinationsterapi (henholdsvis 63,8% og 61,2%) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4% og 33,5%, p &lt; 0,001) og Humira monoterapi (henholdsvis 50,7%, p &lt; 0,002 og 44,5%, p &lt; 0,001).
Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score  0.5) was significantly higher with Humira/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p &lt; 0.001) and Humira monotherapy (50.7%, p &lt; 0.002 and 44.5%, p &lt; 0.001 respectively).
***,** Statistisk signifikant på &lt; 0,001, &lt; 0,01 for alle sammenligning mellem Humira og placebo ved uge 2, 12 og a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
b 50 Week 2 Week 12 Week 24 ***,** Statistically significant at p &lt; 0.001, &lt; 0.01 for all comparisons between Humira and placebo at Weeks 2, 12 and 24 Assessments in Ankylosing Spondylitis Bath Ankylosing Spondylitis Disease Activity Index
På tværs af alle behandlingsgrupper var den gennemsnitlige baselinePASI-score 19,7, og baseline-PGA-score varierede sig fra “let” ( &lt; 1%) til “moderat” (48%), “alvorlig” (46%) og “meget alvorlig” (6%).
Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” ( &lt; 1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
Klinisk respons er fald fra baseline i Mayo score på &gt; 3 point og &gt; 30 % samt et fald i rektal blødning-subscore [RBS] på &gt; 1 eller en absolut RBS på 0 eller 1; *p &lt; 0,05 for Humira versus placebo ved parvis sammeligning af andelene **p &lt; 0,001 for Humira versus placebo ved parvis sammeligning af andelene a Af de patienter, der fik steroid ved baseline
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 Humira vs. placebo pairwise comparison of proportions **p &lt; 0.001 for Humira vs. placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studiet med Humira hos patienter med polyartikulær juvenile idiopatisk artrit, som var fra 2 til &lt; 4 år.
No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of Humira in patients with polyarticular juvenile idiopathic arthritis who were 2 to &lt; 4 years.
Steroid-fri remission i &gt; 90 dagea
Patients in steroid-free remission for &gt; =90 days
Hos patienter med polyartikulær juvenil idiopatisk arthritis, som var fra 2 til 4 år eller over 4 år og som vejede &lt; 15 kg, blev der påvist antistoffer mod adalimumab hos 7 % (1/15) af patienterne, og denne ene patient fik samtidig methotrexat.
In patients with polyarticular juvenile idiopathic arthritis who were 2 to &lt; 4 years old or aged 4 and above weighing &lt; 15 kg, anti-adalimumab antibodies were identified in 7% (1/15) of patients, and the one patient was receiving concomitant methotrexate.
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.
Uge 104 56,0% 49,3% 69,4% 0,002 &lt; 0,001 0,140
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
Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i modificeret Total Sharp Score ≤ 0,5) signifikant højere med Humira/methotrexat-kombinationsterapi (henholdsvis 63,8% og 61,2%) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4% og 33,5%, p &lt; 0,001) og Humira monoterapi (henholdsvis 50,7%, p &lt; 0,002 og 44,5%, p &lt; 0,001).
Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score  0.5) was significantly higher with Humira/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and
79 (73,1) a, b a p &lt; 0,001 Humira versus placebo b p &lt; 0,001 Humira versus methotrexat c p &lt; 0,01 Humira versus placebo d p &lt; 0,05 Humira versus methotrexat
PGA: Clear/minimal a, b p &lt; 0.001 Humira vs. placebo p &lt; 0.001 Humira vs. methotrexate p &lt; 0.01 Humira vs. placebo p &lt; 0.05 Humira vs. methotrexate
&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
506 (62,2)b a Procent af patienterne, som opnåede PASI 75-respons beregnet med justering for center variation b p &lt; 0,001, Humira versus Placebo
PGA: Clear/minimal a Percent of patients achieving PASI75 response was calculated as centreadjusted rate p &lt; 0.001, Humira vs. placebo
Nedenstående liste over bivirkninger er baseret på erfaring fra kliniske studier og erfaring efter markedsføring og er inddelt efter organklassesystem og hyppighed i tabel 3 nedenfor: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 3 below: 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); and not known (cannot be estimated from the available data).
≥90 dagea * p &lt; 0,001 for Humira vs. placebo parvise sammenligninger af andelene ** p &lt; 0,02 for Humira vs. placebo parvise sammenligninger af andelene a Af dem som fik kortikosteroider ved baseline
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for &gt; = 90 days * p &lt; 0.001 for Humira versus placebo pairwise comparisons of proportions ** p &lt; 0.02 for Humira versus placebo pairwise comparisons of proportions 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 g/ml for patients ≥ 40 kg (160/80 mg) and 10.6±6.1 g/ml for patients &lt; 40 kg (80/40 mg).
Nedenstående liste over bivirkninger er baseret på erfaring fra kliniske studier og erfaring efter markedsføring og er inddelt efter organklassesystem og hyppighed i tabel 6 nedenfor: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: 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); and not known (cannot be estimated from the available data).
Nedenstående liste over bivirkninger er baseret på erfaring fra kliniske studier og erfaring efter markedsføring og er inddelt efter organklassesystem og hyppighed i tabel 6 nedenfor: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: 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); and not known (cannot be estimated from the available data).
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 2, 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.
-11,5 -56,2a a p &lt; 0.001, Humira vs. placebo
Percent Change in Total Fingernail NAPSI (%) p &lt; 0.001, Humira vs. placebo
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.
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) 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.
* p &lt; 0,001 for Humira vs. placebo parvise sammenligninger af andelene ** p &lt; 0,02 for Humira vs. placebo parvise sammenligninger af andelene a Af dem som fik kortikosteroider ved baseline
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for &gt; =90 days * p &lt; 0.001 for Humira versus placebo pairwise comparisons of proportions ** p &lt; 0.02 for Humira versus placebo pairwise comparisons of proportions Of those receiving corticosteroids at baseline
1 Dormans et al.: Diuretic efficacy of high dose &lt; A &gt; pharmacokinetics and pharmacodynamics in health and disease - an update.
Diuretic efficacy of high dose furosemide pharmacokinetics and pharmacodynamics in health and diseasean update.
6MWD resultater hos patienter med en baseline 6MWD &lt; 350 meter.
6MWD Results in Patients with a Baseline 6MWD &lt; 350 meters.
Sikkerheden og virkning af Translarna hos børn &lt; 12 kg og i alderen 6 måneder til 2 år er endnu ikke klarlagt.
The safety and efficacy of Translarna in children &lt; 12kg and aged 6 months to 2 years have not yet been established.
Hvis du har svære nyreproblemer (eGDR &lt; 30 ml/min), eller hvis du får dialyse, fordi dine nyrer ikke fungerer (nyresygdom i slutstadiet), vil din læge fastlægge, om behandling med Translarna er egnet til dig.
If you have severe kidney problems (eGFR &lt; 30 ml/min) or if you are receiving dialisys because your kidneys do not work (end-stage renal disease) your doctor will established if treatment with Translarna is suitable for you.
Effekten af Translarna hos børn i alderen 2-5 år er blevet etableret ved ekstrapolering fra patienter &gt; 5 år.
The efficacy of Translarna in children aged 2 - 5 years has been established on extrapolation from patients aged &gt; 5years.
I urinen udgjorde uændret ataluren og acyl glucuronid metabolitten hhv. &lt; 1 % og 49 % af den administrerede dosis.
In the urine, unchanged ataluren and the acyl glucuronide metabolite account for &lt; 1% and 49%, respectively, of the administered dose.
Bivirkninger rapporteret hos &gt; 1 patient i 40 mg/kg/dag-gruppen med en forekomst, der var hyppigere end placebogruppens, er anført efter MedDRA systemorganklasse, foretrukket term og hyppighed.
Adverse reactions reported in &gt; 1 patient in the 40 mg/kg/day group at a frequency greater than that of the placebo group are presented by MedDRA System Organ Class, Preferred Term, and frequency.
(≥ 1/10) og almindelig (≥ 1/100 til &lt; 1/10).
Frequency groupings are defined to the following convention: very common (≥ 1/10) and common (≥ 1/100 to &lt; 1/10).
Bivirkninger rapporteret hos &gt; 1 ataluren-behandlede patienter med nmDMD ved en forekomst, som var hyppigere end placebo i de 2 placebokontrollerede studier (sammenlagt analyse)
Adverse reactions reported in &gt; 1 ataluren-treated patients with nmDMD at a frequency greater than placebo in the 2 placebo-controlled studies (pooled analysis)
Behandling bør ikke påbegyndes hos tidligere ubehandlede patienter med eGFR &lt; 30 ml/min (se pkt.
Treatment should not be initiated in previously untreated patients with eGFR &lt; 30 ml/min (see sections 4.2 and 5.2).
Endvidere er der rapporteret en 3 til 8 gange stigning i ataluren-metabolit hos patienter med svært nedsat nyrefunktion (eGFR &lt; 30 ml/min).
In addition, a 3 to 8 fold increase in ataluren metabolite has been reported in patients with severe renal impairment (eGFR &lt; 30 ml/min).
En stigning i ataluren-eksponering og ataluren-metabolit er rapporteret hos patienter med svært nedsat nyrefunktion (eGFR &lt; 30 ml/min).
An increase in ataluren exposure and in ataluren metabolite has been reported in patients with severe renal impairment (eGFR &lt; 30 ml/min).
Patienter med svært nedsat nyrefunktion (eGFR &lt; 30 ml/min) eller nyresygdom i slutstadiet bør kun behandles med ataluren, hvis den forventede kliniske gavn opvejer den potentielle risiko (se pkt.
Patients with severe renal impairment (eGFR &lt; 30 ml/min) or end-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk (see sections 4.2 and 4.4).
Hos patienter med en baseline 6MWD &lt; 350 meter, blev middelændringen, der blev observeret 6MWD fra baseline til uge 48, 68 meter bedre i ataluren 40 mg/kg/dag armen end i placebo-armen (p=0,0053).
In patients with a baseline 6MWD &lt; 350 meters, the mean change in observed 6MWD from baseline to Week 48 was 68 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm (p=0.0053).
Behandling af patienter med svært nedsat nyrefunktion (eGFR &lt; 30 ml/min) nyresygdom i slutstadiet anbefales ikke (se pkt.
Treatment of patients with severe renal impairment (eGFR &lt; 30 ml/min) or end-stage renal disease is not recommended (see sections 4.4 and 5.2).
Ældre patienter ( &gt; 65 år)
Elderly patients ( &gt; 65 years)
Stik ind, tryk på knappen &amp; vent
Insert, Push Button, &amp; Wait
Den kliniske erfaring med patienter &gt; 75 år er meget begrænset (se pkt.
The clinical experience in patients &gt; 75 years is very limited (see section 5.2).
Hyppighederne hos patienterne er defineret som: meget almindelig ≥ 1/10, almindelig ≥ 1/100 til &lt; 1/10, ikke almindelig ≥ 1/1.000 til &lt; 1/100 og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Patient 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 and not known (cannot be estimated from the available data).
Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
This leaflet was last revised in &lt; {MM/YYYY} &gt;
Hold lodret &amp; drej til tallet 2
Hold Upright &amp; Twist to 2
Når Eperzan blev anvendt som monoterapi, var incidensen af symptomatisk hypoglykæmi ( &lt; 3,9 mmol/l) af samme størrelsesorden for Eperzan 30 mg (2 %), Eperzan 50 mg (1 %) og placebo (3 %).
When Eperzan was used as monotherapy, the incidence of symptomatic hypoglycaemia ( &lt; 3.9 mmol/l) was similar for Eperzan 30 mg (2%), Eperzan 50 mg (1%) and placebo (3%).
Den modeljusterede gennemsnitlige reduktion i HbA1c i forhold til baseline med Eperzan var -0,80 (N = 125), -0,83 (N = 98) og -1,08 (N = 19) hos patienter med henholdsvis let (eGFR 50 - 89 ml/min/1,73m2), moderat (eGFR 30 - 59 ml/min/1,73m2) og svært (eGFR &lt; 30 ml/min/1,73m2 nedsat nyrefunktion (se tabel 9).
The model-adjusted mean decrease in HbA1c from baseline with Eperzan was -0.80 (n = 125), -0.83 (n = 98), and -1.08 (n = 19) in patients with mild (eGFR 60 to 89 ml/min/1.73m2), moderate (eGFR 30 to 59 ml/min/1.73m2), and severe (eGFR &lt; 30 ml/min/1.73m2) renal impairment, respectively (see Table 9).
Erfaringen med patienter med svært nedsat nyrefunktion ( &lt; 30 ml/min/1,73 m2) eller i dialysebehandling er meget begrænset, og derfor anbefales Eperzan ikke til disse patienter (se pkt.
Experience in patients with severe renal impairment ( &lt; 30 ml/min/1.73m2) or on dialysis is very limited and therefore Eperzan is not recommended in this population (see sections 4.4, 4.8, 5.1, 5.2).