natgillin/translations-raw huggingface dataset:
(≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100) og sjælden (≥
All adverse reactions are listed by System Organ Class and frequency: very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); and rare (≥1/10,000
Overvægtige patienter Den samlede bivirkningsprofil for sygeligt overvægtige patienter (BMI &gt; 40) tyder ikke på nogen relevant forskel i sikkerheden sammenlignet med patienter med et BMI på ≤ 40.
The overall adverse reaction profile for morbidly obese patients (BMI &gt; 40) does not suggest a meaningful difference in safety compared to patients with BMI ≤ 40.
Yderligere analyser tyder på, at det kirurgiske indgreb ikke påvirkede tendenserne i effektendemålene, og at effekten af IONSYS var ensartet på tværs af de undersøgt BMI'er ( &lt; 25 til &gt; 40 kg/m2 body mass index)
Additional analyses suggest that the surgical procedure type did not influence the trends in efficacy endpoints and the efficacy of IONSYS was similar across the range of body mass indices studied ( &lt; 25 to &gt; 40 kg/m2
Overvægtige patienter I den kontrollerede kliniske studiepopulation viste bivirkningsprofilen for patienter med et BMI på &gt;
Obese patients In the controlled clinical trial population, the adverse reaction profile in patients with BMI &gt; 40
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), meget sjælden ( &lt; 1/10.000) og 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 available data).
Den renale clearance for metformin er &gt; 400 ml/min, hvilket indikerer, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
Renal clearance of metformin is &gt; 400 mL/min indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Patienter (≥ 65 år) med type 2-diabetes mellitus vurderes at have større risiko for hypoglykæmi end patienter under 65 år.
Patients (≥65 years old) with type 2 diabetes mellitus are considered more susceptible to episodes of hypoglycaemia than patients &lt; 65 years old.
Metformin er kontraindiceret hos patienter med GFR &lt; 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
Metformin is contraindicated in patients with GFR &lt; 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Infektioner og parasitÃ¦re sygdomme infektioner i de Ã¸vre luftveje almindelig almindelig nasofaryngitis almindelig almindelig
Infections and infestations upper respiratory tract infections common common nasopharyngitis common common
Virkningen af og sikkerheden ved de anbefalede doser alogliptin og metformin hos en undergruppe af patienter på 65 år og derover med type 2-diabetes mellitus er blevet undersøgt, og data stemte overens med profilen for patienter under 65 år.
The efficacy and safety of the recommended doses of alogliptin and metformin in a subgroup of patients with type 2 diabetes mellitus and ≥65 years old were reviewed and found to be consistent with the profile obtained in patients &lt; 65 years old.
En enkelt dosis 50 mg alogliptin blev givet til 4 grupper af patienter med forskellige grader af nedsat nyrefunktion (CrCl beregnet ud fra Cockcroft-Gault-formlen): let (CrCl = &gt; 50 til ≤ 80 ml/min), moderat (CrCl = ≥ 30 til ≤ 50 ml/min), svært (CrCl = &lt; 30 ml/min) eller hæmodialysekrævende terminal nyresygdom.
A single dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = &gt; 50 to ≤80 mL/min), moderate (CrCl = ≥30 to ≤50 mL/min), severe (CrCl = &lt; 30 mL/min) and end-stage renal disease on haemodialysis.
Laktatacidose er en alvorlig bivirkning, som forekommer meget sjældent ( &lt; 1/10.000) og tilskrives metformin-komponenten i Vipdomet (se pkt.
Lactic acidosis is a serious adverse reaction, which may occur very rarely ( &lt; 1/10,000), and is attributed to the metformin component of Vipdomet (see section 4.4).
Andre bivirkninger såsom infektioner i de øvre luftveje, nasofaryngitis, hovedpine, gastroenteritis, mavesmerter, diarré, opkastning, gastritis, gastroøsofageal reflukssygdom, pruritus, udslæt og hypoglykæmi kan forekomme almindeligt (≥ 1/100 til &lt; 1/10) (se pkt.
Other reactions such as upper respiratory tract infections, nasopharyngitis, headache, gastroenteritis, abdominal pain, diarrhoea, vomiting, gastritis, gastroesophageal reflux disease, pruritus, rash, hypoglycaemia may occur commonly (≥ 1/100 to &lt; 1/10) (see section 4.4) which are attributed to Vipdomet.
En samlet analyse af data fra 12 studier viste, at den samlede forekomst af hypoglykæmi var den samme for patienter på 65 år og derover behandlet med 25 mg alogliptin (3,8 %) som for patienter under 65 år (3,6 %).
In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was similar in patients ≥65 years old treated with 25 mg alogliptin (3.8%) to that in patients &lt; 65 years old (3.6%).
Alogliptin er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-score &gt; 9), og det anbefales derfor ikke til disse patienter (se pkt.
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score &gt; 9) and is, therefore, not recommended for use in such patients (see sections 4.2, 4.3 and 5.2).
De signifikante fald i HbA1c observeret med 25 mg alogliptin og 30 mg pioglitazon og metformin var ensartede gennem behandlingsperioden på 52 uger sammenlignet med behandling med 45 mg pioglitazon og metformin (p &lt; 0,001 til alle tidspunkter).
The significant reductions in HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p &lt; 0.001 at all time points).
Vipdomet sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
The safety and efficacy of Vipdomet in children and adolescents &lt; 18 years old have not been established.
Signifikant flere af de patienter, der fik 12,5 mg alogliptin og 1.000 mg metforminhydrochlorid to gange dagligt (59,5 %), nåede i uge 26 behandlingsmålet for HbA1c på &lt; 7,0 % sammenlignet med dem, der fik 12,5 mg alogliptin givet alene to gange dagligt (20,2 %, p &lt; 0,001), og sammenlignet med dem, der fik 1.000 mg metforminhydrochlorid givet alene to gange dagligt (34,3 %, p &lt; 0,001).
Significantly more patients receiving 12.5 mg alogliptin and 1.000 mg metformin hydrochloride twice daily (59.5%) achieved target HbA1c levels of &lt; 7.0% compared to those receiving either 12.5 mg alogliptin twice daily alone (20.2%, p &lt; 0.001) or 1,000 mg metformin hydrochloride twice daily alone (34.3%, p &lt; 0.001) at Week 26.
Vipdomets farmakokinetik hos børn og unge under 18 år er ikke klarlagt.
The pharmacokinetics of Vipdomet in children and adolescents &lt; 18 years old has not been established.
Endvidere var den gennemsnitlige ændring i fasteplasmaglucose fra baseline til uge 52 for 25 mg alogliptin plus metformin signifikant større end for glipizid plus metformin (p &lt; 0,001).
Mean change from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin and metformin was significantly greater than that for glipizide and metformin (p &lt; 0.001).
Signifikant flere af de patienter, der fik 25 mg alogliptin og 30 mg pioglitazon og metformin (33,2 %), nåede behandlingsmålet i uge 52 (p &lt; 0,001) for HbA1c på ≤ 7,0 % i forhold til de patienter, der fik 45 mg pioglitazon og metformin (21,3 %).
Significantly more patients receiving 25 mg alogliptin plus 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p &lt; 0.001).
Den gennemsnitlige ændring i fasteplasmaglucose fra baseline til uge 52 ved administration af 25 mg alogliptin plus 30 mg pioglitazon plus metformin var desuden signifikant større end den gennemsnitlige ændring, der blev registreret ved administration af 45 mg pioglitazon plus metformin (p &lt; 0,001).
In addition, mean change from baseline in FPG at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p &lt; 0.001).
Signifikant flere patienter, der fik 25 mg alogliptin (44,4 %), nåede i uge 26 behandlingsmålet for HbA1c på ≤ 7,0 % sammenlignet med de placebobehandlede patienter (18,3 %) (p &lt; 0,001).
Significantly more patients receiving 25 mg alogliptin (44.4%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (18.3%) at Week 26 (p &lt; 0.001).
6.1 eller en tidligere alvorlig overfølsomhedsreaktion, herunder anafylaktisk reaktion, anafylaktisk shock og angioødem, eller over for en dipeptidyl-peptidase-4 (DPP-4)-hæmmer (se pkt.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8) - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) - Diabetic pre-coma - Severe renal failure (GFR &lt; 30 mL/min) - Acute conditions with the potential to alter renal function such as: - dehydration - severe infection - shock - Acute or chronic disease which may cause tissue hypoxia (see section 4.4) such as: - cardiac or respiratory failure - recent myocardial infarction - shock - Hepatic impairment (see section 4.4) - Acute alcohol intoxication, alcoholism (see sections 4.4 and 4.5)
Tilgængelig på: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp &amp; mid=WC 0b01ac058004d5c1
Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp &amp; mid =WC0b01ac058004d5c1
Navnlig bør ACE-hæmmere og ARB ikke anvendes sideløbende hos patienter med diabetisk nefropati, og de eksisterende kontraindikationer bekræftes for anvendelse af aliskiren sammen med enten en ARB eller en ACE-hæmmer hos patienter med diabetes mellitus eller moderat til svær nyreinsufficiens (GFR &lt; 60 ml/min/1,73 m2).
In particular, ACE-inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy, and existing contraindications on the use of aliskiren with either an ARB or an ACE inhibitor in patients with diabetes mellitus or moderate to severe renal impairment (GFR &lt; 60 ml/min/1.73 m2) are confirmed.
• De gennemgåede supplerende data bekræftede den eksisterende kontraindikation af samtidig brug af ACE-hæmmere eller ARB sammen med aliskiren-holdige produkter hos patienter med diabetes mellitus eller nyreinsufficiens (GFR &lt; 60 ml/min/1,73 m2), som bygger på data fra ALTITUDEundersøgelsen.
• The existing contraindication on the concomitant use of ACE-inhibitors or ARBs with aliskirencontaining products in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2), which is based on the ALTITUDE study data, was confirmed in the light of the additional data reviewed.
BCVA blev enten forbedret eller vedligeholdt ( &lt; 5 forringelse i forhold til bogstaver) i 88,4% af øjnene ved uge 78.
BCVA was either improved or maintained ( &lt; 5 letters deterioration) in 88.4% of the eyes at week 78.
Kriterier for opblussen af sygdommen var defineret som en forværring på ≥ 30% i forhold til baseline af ≥ 3 ud af 6 pædiatrisk ACR-hovedkriterier, ≥ 2 aktive led og en forbedring på &gt; 30% i ikke mere end 1 af de 6 kriterier.
Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of &gt; 30% in no more than 1 of the 6 criteria.
Klinisk remission (defineret som Mayo-score &lt; 2 med ingen subscore &gt; 1) blev vurderet ved uge 8.
Clinical remission (defined as Mayo score ≤ 2 with no subscore &gt; 1) was assessed at week 8.
c Ankylosing Spondylitis Disease Activity Score d Delvis opblussen afs sygdom defineret som ASDAS ≥ 1,3 men &lt; 2,1 ved 2 på hinanden følgende besøg.
c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but &lt; 2.1 at 2 consecutive visits.
Blandt de patienter, som havde et respons ved uge 8, var 47% i respons, 29% var i remission, 41% havde slimhindeheling og 20% var i steroid-fri remission i &gt; 90 dage ved uge 52.
Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
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).
En større del af patienterne på adalimumab havde ingen opblussen af sygdommen i den dobbeltblindede periode ved sammenligning med dem på placebo (70,4% versus 47,1%, p &lt; 0,001) (Figur 1).
A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p &lt; 0.001) (Figure 1).
Inflammationen kan fÃ¸re til nedsat syn og/eller âfluerâ i Ã¸jet (svÃ¦rm af uklarheder i Ã¸jet, som bevÃ¦ger sig i synsfeltet).
This inflammation leads to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Klinisk remission Klinisk respons (CR-100) Patienter i steroid-fri remission i ≥90 dagea Uge 56
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for &gt; =90 daysa Week 56
***,** Statistisk signifikant med p &lt; 0,001, &lt; 0,01 for alle sammenligninger mellem adalimumab og placebo ved uge 2, 12 og 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
***,** Statistically significant at p &lt; 0.001, &lt; 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Adalimumab viste en behandlingsfordel hos patienter med neglepsoriasis med forskellig omfang af hudinvolvering (BSA≥10% (60% af patienterne) og BSA &lt; 10% og ≥5% (40% af patienterne)).
Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA≥10% (60% of patients) and BSA &lt; 10% and ≥5% (40% of patients)).
Når Hulio-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 Hulio 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.
Klinisk respons er fald fra baseline i Mayo score på &gt; 3 point og &gt; 30% samt et fald i rektal blødningsubscore [RBS] på &gt; 1 eller en absolut RBS på 0 eller 1; * p &lt; 0,05 for adalimumab vs. placebo ved parvis sammenligning af andelene **p &lt; 0,001 for adalimumab vs. placebo ved parvis sammenligning af andelene a Af de patienter, der fik kortikosteroid 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 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
Der foreligger ingen kliniske data om brugen af en Hulio-induktionsdosis til børn &lt; 6 år (se pkt.
No clinical data are available on the use of a Hulio loading dose in children &lt; 6 years of age (see section 5.2).
* P &lt; 0,05, ***P &lt; 0,001, adalimumab versus placebo a Blandt alle randomiserede patienter.
* P &lt; 0.05, ***P &lt; 0.001, adalimumab versus placebo a Among all randomised patients.
I Psoriasis-studie I oplevede 28% af de patienter, som opnåede PASI 75-respons, og som blev genrandomiseret til placebo ved 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 adalimumab (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 adalimumab, 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).
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 adalimumab/methotrexat-kombinationsterapi (henholdsvis 63,8% og 61,2%) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4% og 33,5%, p &lt; 0,001) og adalimumab-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 adalimumab /methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p &lt; 0.001) and adalimumab monotherapy (50.7%, p &lt; 0.002 and 44.5%, p &lt; 0.001 respectively).
Trin 7 - Begynd injektionen Trin 8 Tryk ned mod huden i 10 sekunder, og indtil du hører 2 klik
Step 7 - Begin injection Step 8 - Hold down for 2nd “CLICK” &amp; 10 seconds
* p &lt; 0,001 for adalimumab versus placebo parvise sammenligninger af andelene ** p &lt; 0,02 for adalimumab versus placebo parvise sammenligninger af andelene a Af dem, som fik kortikosteroider ved baseline
* 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
Ved uge 52 opnåede 42,9% af patienterne, som fik adalimumab/methotrexat-kombinationsterapi, klinisk remission (DAS28(CRP) &lt; 2,6) sammenlignet med 20,6% af patienterne, som fik methotrexatmonoterapi og 23,4% af patienterne, som fik adalimumab-monoterapi.
At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) &lt; 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
506 (62,2)b a Procent af patienterne, som opnåede PASI 75-respons beregnet med justering for center variation b p &lt; 0,001, adalimumab versus placebo
506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate b p &lt; 0.001, adalimumab vs. placebo
På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 19,7, og baseline-PGA-score varierede fra “mild” ( &lt; 1%) til moderat (48%) til “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%).
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 48).
Adalimumabs sikkerhed og virkning er 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 over for mindst 12 ugers behandling med methotrexat.
The safety and efficacy of adalimumab 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.
Patienter, som opnåede vedvarende remission i mindst 12 uger (N=305) (ASDAS &lt; 1,3 ved uge 16, 20, 24, og 28) i den åbne periode, blev herefter randomiseret til at modtage enten fortsat behandling med adalimumab 40 mg hver anden uge (N=152) eller placebo (N=153) i yderligere 40 uger i den dobbeltblindede, placebokontrollerede periode (total studievarighed 68 uger).
(N=305) (ASDAS &lt; 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
*** 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
Trin 10 - Bortskaffelse af pen &amp; hætte Den brugte pen og hætte lægges i en særlig kanyleboks.
Step 10 - Dispose pen &amp; cap Dispose of the used pen and cap in an approved sharps disposal container.
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).
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 ved uge 52.
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.
Hos patienter med polyartikulær JIA, som var 2- &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'-steady state-serumadalimumab 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.