natgillin/translations-raw huggingface dataset:
Hvis CK niveauer er forhøjede ( &gt; 5xULN) bør behandlingen afbrydes (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
If CK levels are elevated ( &gt; 5xULN), treatment should be discontinued (see Section 4.4 Special warnings and special precautions for use).
En startdosis på 5 mg anbefales til patienter &gt; 70 år (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
A start dose of 5 mg is recommended in patients &gt; 70 years (see section 4.4 Special warnings and precautions for use).
Der er rapporteret om påvirkninger af skeletmuskulaturen, fx myalgi, myopati og sjældent rhabdomyolyse, hos individer behandlet med Crestor uafhængig af dosis, men specielt med doser &gt; 20
Skeletal muscle effects: Effects on skeletal muscle e.g. myalgia, myopathy and, rarely, rhabdomyolysis have been reported in Crestor-treated patients with all doses and in particular with doses &gt; 20 mg.
Poolet fase III data har vist, at Crestor er effektiv til behandling af størstedelen af patienter med type IIa og IIb hyperkolesterolæmi (gennemsnits baselinie LDL-C ca. 4,8 mmol/l) til anerkendte European
From pooled phase III data, Crestor has been shown to be effective at treating the majority of patients with type IIa and IIb hypercholesterolaemia (mean baseline LDL-C about 4.8 mmol/l) to recognised European Atherosclerosis Society (EAS; 1998) guideline targets; about 80% of patients treated with 10 mg reached the EAS targets for LDL-C levels ( &lt; 3 mmol/l).
Anbefalet startdosis er 5 mg hos patienter med moderat nedsat nyrefunktion (creatinin clearence &lt; 60 ml/min).
The recommended start dose is 5 mg in patients with moderate renal impairment (creatinine clearance
myopati og sjældent rhabdomyolyse, hos individer behandlet med Crestor uafhængig af dosis, men specielt med doser &gt; 20 mg.
Crestor-treated patients with all doses and in particular with doses &gt; 20 mg.
Skift i urinprotein fra “ingen” eller “spor” til “++” eller mere på et tidspunkt under behandling med 10 og 20 mg sås hos &lt; 1 % af patienterne og hos ca. 3 % af patienterne med 40
&lt; 1% of patients at some time during treatment with 10 and 20 mg, and in approximately 3% of patients treated with 40 mg. A minor increase in shift from none or trace to + was observed with the 20 mg dose.
fenofibrater, andre fibrater og lipid sænkende doser ( &gt; eller svarende til 1 g/dag) af niacin (nikotinsyre)
Gemfibrozil, fenofibrate, other fibrates and lipid lowering doses ( &gt; or equal to 1g/day) of niacin (nicotinic acid) increase the risk of myopathy when given concomitantly with HMG-CoA reductase inhibitors, probably because they can produce myopathy when given alone.
mmol/l).
&lt; 60 ml/min).
I tabellen nedenfor er alle medicinske vigtige bivirkninger, som er opstået i kliniske studier med en hyppighed større end placebo, anført efter organklasse og frekvens (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)).
In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo 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), rare (≥1/10,000 to &lt; 1/1,000)).
Sildenafil er en svag hæmmer af cytokrom P450-isoformer 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4 (IC50 &gt; 150 µM).
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 &gt; 150 µM).
Sikkerheden af sildenafil er ikke undersøgt i følgende patientundergrupper, og dets anvendelse er derfor kontraindiceret: Alvorlig leverinsufficiens, hypotension (blodtryk under 90/50 mmHg), nyligt overstået stroke eller hjerteinfakt og kendte arvelige degenerative sygdommer i retina som retinitis pigmentose (et mindretal af disse patienter har arvelige sygdomme i nethindens fosfodiesteraser).
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure &lt; 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
DATO FOR ÆNDRING AF TEKSTEN &lt; Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/. &gt;
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
I bivirkningsovervågningen efter markedsføring er der indsamlet bivirkninger i en periode på mere end 10 år.
Adverse reactions from post-marketing surveillance has been gathered covering an estimated period &gt; 10 years.
I et klinisk studie af de hæmodynamiske virkninger efter én enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) ( &gt; 70% stenoser i mindst 1 koronararterie) faldt det gennemsnitlige hvilende systoliske og diastoliske blodtryk med henholdsvis 7% og 6% sammenlignet med baseline.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) ( &gt; 70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Da sildenafil-clearance er nedsat hos patienter med alvorlig nedsat nyrefunktion (kreatinclearance &lt; 30 ml/min), skal en 25 mg dosis overvejes.
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance &lt; 30 mL/min) a 25 mg dose should be considered.
Hos frivillige forsøgspersoner med svær nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min) reduceres sildenafilclearance resulterende i gennemsnitlige stigninger i AUC og Cmax på henholdsvis 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
In volunteers with severe renal impairment (creatinine clearance &lt; 30 mL/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
Informationen til sundhedspersonalet skal indeholde fÃ¸lgende:
The Information for healthcare professionals should contain the following key elements:
Patienter med venstre ventrikulær uddrivningsfraktion &lt; 45% eller venstre ventrikulær forkortningsfraktion &lt; 0,2% blev ikke undersøgt.
Patients with left ventricular ejection fraction &lt; 45 % or left ventricular shortening fraction &lt; 0.2 were not studied.
Den gennemsnitlige posturale ændring i systolisk og diastolisk blodtryk over tid var lille ( &lt; 10 mmHg) og vendte tilbage til baseline efter 2 timer.
The mean postural changes in systolic and diastolic blood pressure over time were small ( &lt; 10 mmHg) and returned towards baseline beyond 2 hours.
- hvis De for nylig har haft et slagtilfælde, eller et hjerteanfald, eller hvis De har svær leversygdom eller meget lavt blodtryk ( &lt; 90/50 mmHg).
- if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure ( &lt; 90/50 mmHg).
Nyligt overstået slagtilfælde eller myokardieinfarkt, Svær hypotension (blodtryk &lt; 90/50 mmHg) ved initiering.
Recent history of stroke or myocardial infarction, Severe hypotension (blood pressure &lt; 90/50 mmHg) at initiation.
I et klinisk studie af de hæmodynamiske virkninger efter en enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) ( &gt; 70% stenoser i mindst 1 koronararterie) faldt det gennemsnitlige systoliske og diastoliske blodtryk i hvile med hhv. 7% og 6% sammenlignet med baseline.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) ( &gt; 70 % stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7 % and 6 % respectively compared to baseline.
I dette studie var 63 af 234 (27%) af patienterne &lt; 7 år (sildenafil lavdosis=2, middeldosis=17, højdosis=28, placebo=16), og 171 af 234 (73%) af patienterne var &gt; 7 år (sildenafil lavdosis=40, middeldosis=37, højdosis=49, placebo=44 se nedenfor).
In this trial, 63 of 234 (27 %) patients were &lt; 7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73 %) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
Sildenafil er en svag hæmmer af cytokrom P450 (CYP)-isoformer 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4 (IC50 &gt; 150 µM).
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 &gt; 150 M).
Bivirkninger, der blev rapporteret hos &gt; 10% af 229 forsøgspersoner, der blev behandlet med sildenafil (alledosisgrupper, inklusive 9 patienter, som ikke fortsatte i det langvarige studie), var infektion i øvre luftveje (31%), hovedpine (26%), opkastning (22%), bronkitis (20%), pharyngitis (18%), pyreksi (17%), diarré (15%) samt influenza og epistaxis (12% hver).
Adverse reactions reported in &gt; 10% of 229 subjects treated with sildenafil (combined dose group, including 9 patients that did not continue into the long-term study) were upper respiratory infection (31%), headache (26%), vomiting (22%), bronchitis (20%), pharyngitis (18%), pyrexia (17%), diarrhoea (15%), and influenza, epistaxis (12% each).
Hos pædiatriske patienter i alderen 1-17 år er den anbefalede dosis til patienter ≤20 kg 10 mg 3 gange dagligt, og til patienter ≥20 kg er dosis 20 mg 3 gange dagligt.
For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤ 20 kg is 10 mg three times a day and for patients &gt; 20 kg is 20 mg three times a day.
Infektioner og parasitÃ¦re sygdomme Almindelig cellulitis, influenza, bronkitis, sinuitis, rhinitis, gastroenteritis
Infections and infestations Common cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Hos frivillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min) reduceres sildenafils clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på hhv. 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
In volunteers with severe renal impairment (creatinine clearance &lt; 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100 % and 88 % respectively compared to age-matched volunteers with no renal impairment.
I et placebo-kontrolleret studie med Revatio til patienter i alderen 1-17 år med pulmonal arteriel hypertension blev i alt 174 patienter behandlet med enten lavdosis (10 mg til patienter &gt; 20 kg, ingen patienter ≤20 kg fik lavdosis), middeldosis (10 mg til patienter ≥8-20 kg, 20 mg til patienter ≥2045 kg, 40 mg til patienter &gt; 45 kg) eller højdosis (20 mg til patienter ≥8-20 kg, 40 mg til patienter ≥2045 kg, 80 mg til patienter &gt; 45 kg) Revatio og 60 blev behandlet med placebo.
In the placebo-controlled study of Revatio in patients 1 to 17 years of age with pulmonary arterial hypertension, a total of 174 patients were treated three times a day with either low (10 mg in patients &gt; 20 kg; no patients ≤ 20 kg received the low dose), medium (10 mg in patients ≥ 8-20 kg; 20 mg in patients ≥ 20-45 kg; 40 mg in patients &gt; 45 kg) or high dose (20 mg in patients ≥ 8-20 kg; 40 mg in patients ≥ 20-45 kg; 80 mg in patients &gt; 45 kg) regimens of Revatio and 60 were treated with placebo.
Infektioner og parasitÃ¦re sygdomme Almindelig cellulitis, influenza, bronkitis, sinuitis, rinitis, gastroenteritis
Infections and infestations Common cellulitis,influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
De hyppigste bivirkninger (med en frekvens ≥1%) hos Revatio-patienter (kombinerede doser) og med en frekvens på &gt; 1% i forhold til placebo-patienter var pyreksi, øvre luftvejsinfektioner (hver 11,5%), opkastning (10,9%), kraftigere erektion (herunder spontane erektioner hos drenge) (9,0%), kvalme, bronkitis (hver 4,6%), pharyngitis (4,0%), næseflåd (3,4%) samt pneumoni og rhinitis (hver 2,9%).
The most common adverse reactions that occurred (with a frequency ≥ 1 %) in Revatio patients (combined doses) and with a frequency &gt; 1 % over placebo patients were pyrexia, upper respiratory tract infection (each 11.5%), vomiting (10.9%), erection increased (including spontaneous penile erections in male subjects) (9.0%), nausea, bronchitis (each 4.6%), pharyngitis (4.0%), rhinorrhoea (3.4%), and pneumonia, rhinitis (each 2.9%).
Forsøgspersoner, der vejede ≤ 20 kg, blev inkluderet i middel- eller højdosisgruppen (1:1), mens forsøgspersoner, der vejede &gt; 20 kg, blev inkluderet i lav-, middel- eller højdosisgruppen (1:1:1).
Subjects who had been in the placebo group in the shortterm study were randomly reassigned to sildenafil treatment; subjects weighing ≤ 20 kg entered the medium or high dose groups (1:1), while subjects weighing &gt; 20 kg entered the low, medium or high dose groups (1:1:1).
For patienter med 6MWD &lt; 325 meter ved baseline blev der set en forbedret effekt med højere dosis (placebo-korrigeret stigning på 58 meter, 65 meter, 87 meter for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt).
For patients with a baseline 6MWD &lt; 325 m improved efficacy was observed with higher doses (placebo-corrected improvements of 58 metres, 65 metres and 87 metres for 20 mg, 40 mg and 80 mg doses TID, respectively).
Hos pædiatriske patienter i alderen 1-17 år er den anbefalede dosis til patienter ≤20 kg 10 mg (1 ml rekonstitueret suspension) 3 gange dagligt, og til patienter ≥20 kg er dosis 20 mg (2 ml rekonstitueret suspension eller 1 tablet) 3 gange dagligt.
For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤ 20 kg is 10 mg (1 ml of reconstituted suspension) three times a day and for patients &gt; 20 kg is 20 mg (2 ml of reconstituted suspension) three times a day.
Kaplan-Meier-estimat af overlevelse efter 3 år for patienter &gt; 20 kg ved baseline var hhv. 94%, 93% og 85% for lav-, middel- og højdosis-grupperne.
Kaplan-Meier estimates of survival at 3 years in patients &gt; 20 kg in weight at baseline were 94 %, 93 % and 85 % in the low, medium and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94 % and 93 % for subjects in the medium and high dose groups respectively (see sections 4.4 and 4.8).
I alt 106 ud af 234 (45%) forsøgspersoner kunne evalueres ved CPET, hvilket omfattede børn ≥7 år, som udviklingsmæssigt var i stand til at udføre testen.
A total of 106 out of 234 (45 %) subjects were evaluable for CPET, which comprised those children ≥ 7 years old and developmentally able to perform the test. Children &lt; 7 years (sildenafil combined dose = 47; placebo = 16) were evaluable only for the secondary endpoints.
(p &lt; 0,0001) for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt.
(p &lt; 0.0001) for sildenafil 20 mg, 40 mg and
Placebo-korrigeret stigning i 6MWD var 45 meter (p &lt; 0,0001), 46 meter (p &lt; 0,0001) og 50 meter (p &lt; 0,0001) for hhv. sildenafil 20 mg, 40 mg og 80 mg. Der var ingen signifikant forskel i effekten mellem sildenafildoserne.
Placebo corrected increases in 6MWD were 45 metres (p &lt; 0.0001), 46 metres (p &lt; 0.0001) and 50 metres (p &lt; 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID, respectively.
Hos patienter med en gangdistance på &lt; 325 m var behandlingseffekten 2,3 m til placebos fordel.
For patients with a baseline walking distance ≥ 325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance &lt; 325 metres, the treatment effect was 2.3 metres in favour of placebo.
Den sædvanlige dosis til børn og unge i alderen 1-17 år er 10 mg 3 gange dagligt ved legemsvægt 20 kg eller derunder og 20 mg 3 gange dagligt ved legemsvægt over 20 kg. Revatio kan tages sammen med eller uden mad.
For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents &gt; 20 kg, taken with or without food.
Bivirkninger, der forekommer hos &gt; 1% af Revatio-behandlede patienter, og som er hyppigere ( &gt; 1% forskel) for Revatio i pivotal-studiet eller i det Revatiokombinerede datasæt for begge placebokontrollerede studier med pulmonal arteriel hypertension i oralt administrerede doser på 20 mg, 40 mg eller 80 mg 3 gange dagligt, er anført i skemaet nedenfor.
Adverse reactions which occurred in &gt; 1 % of Revatio-treated patients and were more frequent ( &gt; 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at oral doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common ( 1/10), common ( 1/100 to &lt; 1/10), uncommon ( 1/1000 to ≤ 1/100) and not known (cannot be estimated from the available data).
Bivirkninger, der forekommer hos &gt; 1% af Revatio-behandlede patienter, og som er hyppigere ( &gt; 1% forskel) for Revatio i pivotal-studiet eller i det Revatiokombinerede datasæt for begge placebokontrollerede studier med pulmonal arteriel hypertension i doser på 20 mg, 40 mg eller 80 mg 3 gange dagligt, er anført i skemaet nedenfor.
Adverse reactions which occurred in &gt; 1 % of Revatio-treated patients and were more frequent ( &gt; 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common ( 1/10), common ( 1/100 to &lt; 1/10), uncommon ( 1/1000 to &lt; 1/100) and not known (cannot be estimated from the available data).
Bivirkningerne er angivet efter klasse og frekvens (meget almindelig (1/10), almindelig (1/100 til &lt; 1/10), ikke almindelig (1/1000 til &lt; 1/100), ikke kendt (kan ikke bestemmes ud fra tilgængelige data)).
Adverse reactions which occurred in &gt; 1 % of Revatio-treated patients and were more frequent ( &gt; 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension,, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common ( 1/10), common ( 1/100 to &lt; 1/10), uncommon ( 1/1000 to &lt; 1/100) and not known (cannot be estimated from the available data).
Hyppighed inddeles på følgende måde: 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, herunder enkeltstående indberetninger), ikke kendt (kan ikke beregnes af 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 including isolated reports), not known (cannot be estimated from the available data).
Ved doser ≥ 500 mg pr. dosis eller &lt; 3 g dagligt er sikkerhedsforanstaltninger nødvendige på grund af øget risiko for blødning, ulceration og gastrointestinal perforation.
At doses ≥ 500 mg per dose or &lt; 3 g per day, precautions are required due to increased risk of haemorrhage, ulcerations and gastro-intestinal perforation.
InfektiÃ¸se og parasitÃ¦re sygdomme
Infections and Infestations
Hyppighederne er defineret som følgende: Meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10).
The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10).
Hyppighederne er defineret som følgende: 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).
The frequency terms listed are defined as follows: 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 data available).
Hos 44 patienter &gt; 65 år med skizofreni gav dosering med 5-20 mg/dag ingen udsving i bivirkningsprofilen.
In 44 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
I prækliniske studier udviste olanzapin affinitet (Ki &lt; 100 nM) til serotonin 5-HT2A/2C, 5-HT3, 5-HT6, dopamin D1, D2, D3, D4, D5, kolinerge muskarine receptorer m1-m5, α1-adrenerge og histamin H1-receptorer.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki &lt; 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors.
Akutte symptomer såsom perspiration, søvnløshed, rysten, angst, kvalme eller opkastning er rapporteret sjældent (≥ 0,01 % og &lt; 0,1 %) når olanzapin stoppes pludseligt.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ≥ 0.01% and &lt; 0.1%) when olanzapine is stopped abruptly.
Observerede normalniveauer ved faste ved baseline ( &lt; 1,016 mmol/l, som steg til (≥ 1,467 mmol/l) og ændringer i triglycerider ved faste fra grænser ved baseline (≥ 1,016 mmol/l- &lt; 1,467 mmol/l) op til (≥ 1,467 mmol/l).
Observed for fasting normal levels at baseline ( &lt; 1.016 mmol/l) which increased to high (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l- &lt; 1.467 mmol/l) to high (≥ 1.467 mmol/l).
Hos patienter med nedsat nyrefunktion (kreatinin clearance &lt; 10 ml/min) versus raske forsøgspersoner fandtes ingen signifikant forskel i den gennemsnitlige eliminationshalveringstid (37,7 versus 32,4 timer) eller clearance (21,2 versus 25,0 l/time).
In renally impaired patients (creatinine clearance &lt; 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/hr).
Observeret for fastende normalt niveau ved baseline ( &lt; 1,69 mmol/l), der blev øget til højt niveau ( 2,26 mmol/l).
Observed for fasting normal levels at baseline ( &lt; 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
Ændringer i de totale kolesterolniveauer ved faste fra normale ved baseline ( &lt; 4,39 mmol/l) op til (≥ 5,17 mmol/l) blev observeret almindeligt.
Changes in total fasting cholesterol levels from normal at baseline ( &lt; 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Ændring i fastende triglyceridniveau fra let forhøjet niveau ved baseline ( 1,69- &lt; 2,26 mmol/l) til højt niveau ( 2,26 mmol/l) var meget almindeligt.
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l- &lt; 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
QTc-forlængelse blev defineret som Fridericia korrigeret QT (QTcF) 500 millisekunder (msek) på et hvilket som helst tidspunkt post-baseline hos patienter med baseline QTcF &lt; 500 msek.
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF &lt; 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
Observeret for fastende normalt niveau ved baseline ( &lt; 5,56 mmol/l), der blev øget til højt niveau ( 7 mmol/l).
Observed for fasting normal levels at baseline ( &lt; 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
Observeret for fastende normalt niveau ved baseline ( &lt; 5,17 mmol/l), der blev øget til højt niveau ( 6,2 mmol/l).
Observed for fasting normal levels at baseline ( &lt; 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).