natgillin/translations-raw huggingface dataset:
Hvis behandling med sædvanlige laksantia har været utilstrækkelig, bør Relistor tilføjes for at inducere omgående afføring.
RELISTOR should be added to induce prompt bowel movements when response to usual laxative therapy has been insufficient.
Den anbefalede dosis methylnaltrexonbromid er 8 mg (0, 4 ml Relistor) (for patienter, der vejer 38- 61 kg) eller 12 mg (0, 6 ml Relistor) (for patienter, der vejer 62- 114 kg).
The recommended dose of methylnaltrexone bromide is 8 mg (0.4 ml RELISTOR) (for patients weighing 38-61 kg) or 12 mg (0.6 ml RELISTOR) (for patients weighing 62-114 kg).
Patienter, hvis vægt ligger uden for områderne, doseres med 0, 15 mg/ kg.
Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/ kg.
Injektionsvolumen for disse patienter beregnes som:
The injection volume for these patients should be calculated:
Dosis (ml) = patientens vægt (kg) x 0, 0075
Dose (ml) = patient weight (kg) x 0.0075
2 Nyrepatienter For patienter med svært nedsat nyrefunktion (kreatinin- clearance mindre end 30 ml/ min) skal dosen af methylnaltrexonbromid reduceres fra 12 mg til 8 mg (0, 4ml Relistor) for patienter, der vejer fra 62 til 114 kg, eller fra 0, 15 mg/ kg til 0, 075 mg/ kg for patienter, hvis vægt falder uden for området 62 til 114 kg (se pkt.
Renal patients In patients with severe renal impairment (creatinine clearance less than 30 ml/ min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 ml RELISTOR) for those weighing 62 to 114 kg, or from 0.15 mg/ kg to 0.075 mg/ kg for those whose weight falls outside the 62 to 114 kg range (see section 5.2).
4. 4).
There are no data available from patients with end-stage renal impairment on dialysis, and RELISTOR is not recommended in these patients (see section 4.4).
5. 2).
2 Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2).
4. 4).
There are no data available from patients with severe hepatic impairment (Child-Pugh Class C), and RELISTOR is not recommended in these patients (see section 4.4).
5. 2).
Paediatric patients There is no experience in children under the age of 18 (see section 5.2).
Methylnaltrexon bør derfor ikke anvendes i den pædiatriske aldersgruppe, før der foreligger yderligere dokumentation.
Therefore, methylnaltrexone should not be used in the paediatric age group until further data become available.
5. 2).
Elderly patients No dose adjustment is recommended based on age (see section 5.2).
Relistor gives som en subkutan injektion.
RELISTOR is given as a subcutaneous injection.
De tre områder på kroppen, der anbefales til injektion af Relistor, er lår, abdomen og overarme.
The three areas of the body recommended for injection of RELISTOR are upper legs, abdomen, and upper arms.
Relistor kan injiceres uden hensyn til fødeindtagelse.
RELISTOR can be injected without regard to food.
Relistor bør derfor ikke anvendes til behandling af patienter med obstipation, der ikke er forbundet med brug af opioider.
Therefore, RELISTOR should not be used for treatment of patients with constipation not related to opioid use.
Opstår svær eller persisterende diarré under behandlingen, skal patienterne rådes til ikke at fortsætte behandling med Relistor og kontakte deres læge.
If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with RELISTOR and consult their physician.
5. 2).
Methylnaltrexone bromide treatment has not been studied in clinical trials for longer than 4 months, and should therefore only be used for a limited period (see section 5.2).
3 Relistor bør kun anvendes til patienter, der får palliativ behandling.
RELISTOR should only be used in patients who are receiving palliative care.
Det bruges i tillæg til behandlingen med sædvanlige laksantia.
It is added to usual laxative treatment.
4. 2).
RELISTOR is not recommended in patients with severe hepatic impairment or with end-stage renal impairment requiring dialysis (see section 4.2).
Relistor bør derfor kun indgives til disse patienter med forsigtighed.
Therefore, RELISTOR should only be administered with caution in these patients.
Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. at det stort set er natriumfrit.
3 This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e., essentially sodium- free).
Methylnaltrexon påvirker ikke farmakokinetikken af lægemidler, der metaboliseres af cytokrom P450 (CYP) - isozymer.
Methylnaltrexone does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes.
Methylnaltrexon metaboliseres minimalt af CYP- isozymer.
Methylnaltrexone is minimally metabolised by CYP isozymes.
In vitro- undersøgelser af metabolismen viser, at methylnaltrexon ikke inhiberer aktiviteten af CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 og CYP3A4, hvorimod det svagt inhiberer metaboliseringen af et CYP2D6- modelsubstrat.
In vitro metabolism studies suggest that methylnaltrexone does not inhibit the activity of CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 or CYP3A4, while it is a weak inhibitor of the metabolism of a model CYP2D6 substrate.
I et klinisk lægemiddelinteraktionsforsøg med raske voksne mænd påvirkede en subkutan dosis methylnaltrexon på 0, 3 mg/ kg ikke signifikant metaboliseringen af dextromethorphan, der er et CYP2D6- substrat.
In a clinical drug interaction study in healthy adult male subjects, a subcutaneous dose of 0.3 mg/ kg of methylnaltrexone did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate.
Den potentielle interaktion mellem methylnaltrexon og andre lægemidler, der transporteres af den organiske kationstransporter (OCT), blev undersøgt hos 18 raske forsøgspersoner ved sammenligning af de farmakokinetiske profiler for en enkeltdosis methylnaltrexon før og efter flere 400 mg- doser cimetidin.
The organic cation transporter (OCT)-related drug-drug interaction potential between methylnaltrexone and an OCT inhibitor was studied in 18 healthy subjects by comparing the single- dose pharmacokinetic profiles of methylnaltrexone before and after multiple 400 mg doses of cimetidine.
Methylnaltrexons renale clearance blev reduceret efter flerdosisadministration af cimetidin (fra 31 l/ t til 18 l/ t).
The renal clearance of methylnaltrexone was reduced following multiple-dose administration of cimetidine (from 31 l/ h to 18 L/ h).
Det medførte imidlertid en mindre reduktion i den samlede clearance (fra 107 l/ t til 95 l/ t).
However, this resulted in a small reduction in total clearance (from 107 L/ h to 95 l/ h).
Der blev således ikke observeret nogen relevant ændring af methylnaltrexons AUC, foruden Cmax, før og efter flerdosisadministration af cimetidin.
Consequently, no meaningful change in AUC of methylnaltrexone, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine.
Der foreligger ikke tilstrækkelige data om brugen af methylnaltrexonbromid hos gravide kvinder.
Pregnancy There are no adequate data with the use of methylnaltrexone bromide in pregnant women.
Relistor bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
RELISTOR should not be used during pregnancy unless clearly necessary.
Det vides ikke, om methylnaltrexonbromid udskilles i human modermælk.
Lactation It is unknown whether methylnaltrexone bromide is excreted in human breast milk.
En beslutning om, hvorvidt amning skal forsættes/ stoppes eller behandling med Relistor skal fortsættes/ seponeres, skal træffes under hensyntagen til barnets fordel ved amning og kvindens fordel ved behandling med Relistor.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with RELISTOR should be made, taking into account the benefit of breast-feeding to the child and the benefit of RELISTOR therapy to the woman.
Sandsynligheden for, at methylnaltrexon påvirker sådanne aktiviteter, er dog lav, da det er en ren perifert begrænset opioidantagonist.
However, as a pure peripherally restricted opioid antagonist, the likelihood that methylnaltrexone will affect such activities is low.
4. 8).
Dizziness may occur, and this may have an effect on driving and use of machines (see section 4.8).
De mest almindelige bivirkninger relateret til lægemidler hos alle de patienter, der har fået methylnaltrexonbromid i alle faser af placebokontrollerede forsøg, var abdominalsmerter, kvalme, diarré og flatulens.
The most common drug-related adverse reactions in all patients exposed to methylnaltrexone bromide during all phases of placebo-controlled studies were abdominal pain, nausea, diarrhoea and flatulence.
Bivirkningerne er klassificeret som:
The adverse reactions are classified as:
Meget almindelig (≥1/ 10); almindelig (≥1/ 100 til < 1/ 10); ikke almindelig (≥1/ 1. 000 til < 1/ 100); sjælden (≥1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Very common (≥ 1/ 10); Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1,000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1,000); Very rare (< 1/ 10,000), unknown (cannot be estimated from the available data).
De alvorligste er anført først:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
Meget almindelige:
4 Gastrointestinal disorders Very common:
Abdominale smerter, kvalme, flatulens, diarré
Abdominal pain, nausea, flatulence, diarrhoea
Reaktioner på injektionsstedet (f. eks. brænden, svien, smerte, rødme, ødem)
Injection site reactions (e. g. stinging, burning, pain, redness, oedema)
Der er ikke rapporteret tilfælde af overdosering under de kliniske forsøg.
No case of overdose has been reported during clinical trials.
I et forsøg med raske forsøgspersoner blev der konstateret ortostatisk hypotension forbundet med en dosis på 0, 64 mg/ kg, der blev administreret som en intravenøs bolus.
A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/ kg administered as an intravenous bolus.
(ATC- kode) endnu ikke fastlagt.
Pharmacotherapeutic group: not yet assigned, ATC code: not yet assigned.
Virkningsmåde Methylnaltrexonbromid er en selektiv antagonist for opioidbinding til my- receptoren.
Mode of action Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor.
In vitro- forsøg har vist, at methylnaltrexon er en my- opioidreceptorantagonist (inhibitionskonstant [Ki] = 28 nM) med 8- fold mindre effekt på kappa- opioidreceptorer (Ki = 230 nM) og stærkt reduceret affinitet til delta- opioidreceptorer.
In vitro studies have shown methylnaltrexone to be a mu-opioid receptor antagonist (inhibition constant [Ki] = 28 nM), with 8-fold less potency for kappa opioid receptors (Ki = 230 nM) and much reduced affinity for delta opioid receptors.
Da methylnaltrexon er en kvaternær amin, er dets evne til at passere blod- hjerne- barrieren begrænset.
As a quaternary amine, the ability of methylnaltrexone to cross the blood-brain barrier is restricted.
Det gør det muligt for methylnaltrexon at fungere som en perifert virkende my- opioidantagonist i væv såsom mave - tarmkanalen uden at hæmme de opioid- medierede analgetiske effekter på det centrale nervesystem.
This allows methylnaltrexone to function as a peripherally acting mu-opioid antagonist in tissues such as the gastrointestinal tract, without impacting opioid-mediated analgesic effects on the central nervous system.
Klinisk virkning og sikkerhed Virkning og sikkerhed ved behandling med methylnaltrexonbromid af opioidinduceret obstipation hos patienter, der får palliativ pleje, blev påvist i to randomiserede, dobbeltblindede, placebo- kontrollerede forsøg.
Clinical efficacy and safety The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients receiving palliative care was demonstrated in two randomised, double-blind, placebo-controlled studies.
I disse forsøg var den gennemsnitlige alder 68 år (fra 21 til 100), hvoraf 51% var kvinder.
In these studies, the median age was 68 years (range 21-100); 51% were females.
Andre primære diagnoser omfattede terminal KOL/ emfysem, 5 kardiovaskulær sygdom/ hjerteinsufficiens, Alzheimers sygdom/ demens, HIV/ AIDS eller andre fremskredne sygdomme.
In both studies, patients had advanced terminal illness and limited life expectancy, with the majority having a primary diagnosis of incurable cancer; other primary diagnoses included end-stage COPD/ emphysema, cardiovascular disease/ heart failure, Alzheimer’ s disease/ dementia, HIV/ AIDS, or other advanced illnesses.
Før screening havde patienterne opioidinduceret obstipation defineret som enten < 3 afføringer i den foregående uge eller ingen afføring i > 2 dage).
Prior to screening, patients had opioid-induced constipation defined as either< 3 bowel movements in the preceding week or no bowel movement for > 2 days.
I forsøg 301 blev en enkelt, dobbeltblindet, subkutan dosis methylnaltrexonbromid på 0, 15 mg/ kg eller 0, 3 mg/ kg sammenlignet med placebo.
Study 301 compared methylnaltrexone bromide given as a single, double-blind, subcutaneous dose of 0.15 mg/ kg, or 0.3 mg/ kg versus placebo.
Den dobbeltblindede dosis blev efterfulgt af en ublindet, 4- ugers doseringsperiode, hvor methylnaltrexonbromid kunne anvendes efter behov, men ikke oftere end én dosis i løbet af 24 timer.
The double-blind dose was followed by an open-label, 4-week dosing period, where methylnaltrexone bromide could be used as needed, no more frequently than 1 dose in a 24-hour period.
I løbet af begge forsøgsperioder opretholdt patienterne deres sædvanlige laksativ- regimen.
Throughout both study periods, patients maintained their usual laxative regimen.
I alt 154 patienter (methylnaltrexonbromid 0, 15 mg/ kg, n=47, methylnaltrexonbromid 0, 3 mg/ kg, n=55, placebo, n=52) blev behandlet i den dobbeltblindede periode.
A total of 154 patients (methylnaltrexone bromide 0.15 mg/ kg, n=47, methylnaltrexone bromide 0.3 mg/ kg, n=55, placebo, n=52) were treated in the double-blind period.
Det primære effektmål var andelen af patienter med afføring uden brug af laksativ nødmedicin inden for 4 timer efter den dobbeltblindede dosis forsøgsmedicin.
The primary endpoint was the proportion of patients with a rescue-free laxation within 4 hours of the double-blind dose of study medicinal product.
De patienter, der blev behandlet med methylnaltrexonbromid, havde en signifikant højere afføringsfrekvens inden for 4 timer efter den dobbeltblindede dosis (62% for 0, 15 mg/ kg og 58% for 0, 3 mg/ kg) end de patienter, der blev behandlet med placebo (14%); p < 0, 0001 for hver dosis i forhold til placebo.
Methylnaltrexone bromide-treated patients had a significantly higher rate of laxation within 4 hours of the double-blind dose (62% for 0.15 mg/ kg and 58% for 0.3 mg/ kg) than placebo-treated patients (14%); p < 0.0001 for each dose versus placebo.
I forsøg 302 blev dobbeltblindede, subkutane doser af methylnaltrexonbromid, der blev givet hver anden dag i 2 uger, sammenlignet med placebo.
During the first week (days 1, 3, 5, 7), patients received either
I løbet af den første uge (dag 1, 3, 5, 7) fik patienterne enten 0, 15 mg/ kg methylnaltrexonbromid eller placebo.
5 methylnaltrexone bromide 0.15 mg/ kg or placebo.
I den anden uge kunne patientens tildelte dosis forøges til 0, 30 mg/ kg, hvis patienten havde 2 eller færre afføringer uden nødmedicin op til dag 8.
In the second week, a patient’ s assigned dose could be increased to 0.30 mg/ kg if the patient had 2 or fewer rescue-free laxations up to day 8.
Patienternes tildelte dosis kunne til hver en tid reduceres baseret på tolerabilitet.
At any time, the patient’ s assigned dose could be reduced based on tolerability.
Der var 2 primære effektmål: andelen af patienter med afføring uden brug af nødmedicin inden for 4 timer efter den første dosis forsøgsmedicin og andelen af patienter med afføring uden brug af nødmedicin inden for 4 timer efter mindst 2 af de første 4 doser forsøgsmedicin.
There were 2 primary endpoints: proportion of patients with a rescue-free laxation within 4 hours of the first dose of study medicinal product and proportion of patients with a rescue-free laxation within 4 hours after at least 2 of the first 4 doses of medicinal product.
De patienter, der blev behandlet med methylnaltrexonbromid, havde en højere afføringsfrekvens inden for 4 timer efter den første dosis (48%) end de patienter, der blev behandlet med placebo (16%); p < 0, 0001.
Methylnaltrexone bromide-treated patients had a higher rate of laxation within 4 hours of the first dose (48%) than placebo-treated patients (16%); p < 0.0001.
De patienter, der blev behandlet med methylnaltrexonbromid, havde også signifikant højere afføringsfrekvens inden for 4 timer efter mindst 2 ud af de første 4 doser (52%) end de patienter, der blev behandlet med placebo (9%); p < 0, 0001.
Methylnaltrexone bromide-treated patients also had significantly higher rates of laxation within 4 hours after at least 2 of the first 4 doses (52%) than did placebo-treated patients (9%); p < 0.0001.
En eventuel effekt af race kunne ikke analyseres, da forsøgspopulationen var overvejende kaukasisk (88%).
The effect on race could not be analysed because the study population was predominantly Caucasian (88%)
Holdbarheden af responset blev påvist i forsøg 302, hvor responsraten for afføring var konsistent fra første til sidste dosis i den 2 uger lange dobbeltblindede periode.
Durability of response was demonstrated in Study 302, in which the laxation response rate was consistent from dose 1 through dose 7 over the course of the 2-week, double-blind period
Relistor blev givet med 3, 2 dages mellemrum (det mediane doseringsinterval i perioden 1 – 39 dage).
RELISTOR was administered every 3.2 days (median dosing interval, with a range of 1-39 days).
I disse forsøg var der ingen signifikant sammenhæng mellem baseline- opioiddosis og afføringsrespons hos patienter, der blev behandlet med methylnaltrexonbromid.
There was no significant relationship between baseline opioid dose and laxation response in methylnaltrexone bromide-treated patients in these studies.
Endvidere var den gennemsnitlige daglige opioiddosis ikke væsentligt forskellig i forhold til baseline for hverken patienter behandlet med methylnaltrexonbromid eller patienter behandlet med placebo.
In addition, median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebo-treated patients.
6 Effekt på hjertets repolarisering I et dobbeltblindet, randomiseret, parallelgruppe- EKG- forsøg med subkutane enkeltdoser af methylnaltrexonbromid (0, 15, 0, 30 og 0, 50 mg/ kg) indgivet hos 207 raske forsøgspersoner blev der ikke påvist QT/ QTc- forlængelse eller effekt på sekundære EKG- parametre eller formen og strukturen af bølgeformen sammenlignet med placebo og en positiv kontrol (400 mg oralt administreret moxifloxacin).
Effect on cardiac repolarisation In a double-blind, randomised, parallel-group ECG study of single, subcutaneous doses of methylnaltrexone bromide (0.15, 0.30 and 0.50 mg/ kg), in 207 healthy volunteers, no signal of QT/ QTc prolongation or any evidence of an effect on secondary ECG parameters or waveform morphology was detected as compared to placebo and a positive control (orally administered 400 mg moxifloxacin).
0, 5 time efter subkutan administration.
Absorption Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (Cmax) achieved at approximately 0.5 hours following subcutaneous administration.
Cmax og arealet under plasmakoncentrations- tids- kurven (AUC) forøges ved dosisforøgelse fra 0, 15 mg/ kg til 0, 5 mg/ kg proportionelt med dosis.
The Cmax and area under the plasma concentration-time curve (AUC) increase with dose increase from 0.15 mg/ kg to 0.5 mg/ kg in a dose- proportional manner.
Den absolutte biotilgængelighed af en subkutan dosis på 0, 30 mg/ kg sammenlignet med en intravenøs dosis på 0, 30 mg/ kg er 82%.
Absolute bioavailability of a 0.30 mg/ kg subcutaneous dose versus a 0.30 mg/ kg intravenous dose is 82%.
Distribution Methylnaltrexon gennemgår moderat vævsdistribution.
Distribution Methylnaltrexone undergoes moderate tissue distribution.
1, 1 l/ kg.
The steady-state volume of distribution (Vss) is approximately 1.1 l/ kg.
Methylnaltrexon er minimalt bundet til humane plasmaproteiner (11, 0% til 15, 3%) som bestemt ved ligevægtsdialyse.
Methylnaltrexone is minimally bound to human plasma proteins (11.0% to 15.3%) as determined by equilibrium dialysis.
Metabolisme Methylnaltrexon metaboliseres i beskedent omfang i mennesker bedømt på basis af den mængde af methylnaltrexonmetabolitter, der genfindes i ekskreter.
6 Metabolism Methylnaltrexone is metabolised to a modest extent in humans based on the amount of methylnaltrexone metabolites recovered from excreta.
Omdannelse til methyl- 6- naltrexol- isomerer og methylnaltrexonsulfat synes at være den primære metaboliseringsvej.
Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism.
8%.
Each of the methyl-6- naltrexol isomers has somewhat less antagonist activity than parent compound, and a low exposure in plasma of approximately 8% of the drug-related materials.
25% af de lægemiddel- relaterede stoffer.
Methylnaltrexone sulphate is an inactive metabolite and present in plasma at a level of approximately 25% of drug related materials.
N- demethylering af methylnaltrexon til naltrexon er ikke signifikant og udgør 0, 06% af den administrerede dosis.
N- demethylation of methylnaltrexone to produce naltrexone is not significant, accounting for 0.06% of the administered dose.
Udskillelse Methylnaltrexon udskilles primært som det uændrede, aktive stof.
Excretion Methylnaltrexone is eliminated primarily as the unchanged active substance.
8 timer.
The terminal disposition half-life (t1/ 2) is approximately 8 hours.
Leverinsufficiens Virkningen af mild og moderat nedsat leverfunktion på den systemiske eksponering af methylnaltrexon er blevet undersøgt særskilt hos 8 forsøgspersoner med en Child- Pugh- score, klasse A eller B, sammenlignet med raske personer.
Hepatic insufficiency The effect of mild and moderate hepatic impairment on the systemic exposure to methylnaltrexone has been studied in 8 subjects each, with Child-Pugh Class A and B, compared to healthy subjects.
Resultaterne viste ingen væsentlig virkning af nedsat leverfunktion på methylnaltrexons AUC eller Cmax.
Results showed no meaningful effect of hepatic impairment on the AUC or Cmax of methylnaltrexone.
Virkningen af svært nedsat leverfunktion på methylnaltrexons farmakokinetik er ikke blevet undersøgt.
The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone has not been studied.
Nyreinsufficiens I et forsøg med frivillige forsøgspersoner med forskellige grader af nedsat nyrefunktion, som fik en enkeltdosis methylnaltrexonbromid på 0, 30 mg/ kg, havde nedsat nyrefunktion en markant effekt på renal udskillelse af methylnaltrexon.
Renal insufficiency In a study of volunteers with varying degrees of renal impairment receiving a single dose of 0.30 mg/ kg methylnaltrexone bromide, renal impairment had a marked effect on the renal excretion of methylnaltrexone.
Methylnaltrexons renale clearance faldt proportionalt med, hvor meget nyrefunktionen var nedsat.
The renal clearance of methylnaltrexone decreased with increasing severity of renal impairment.
Dette medførte dog kun en 2- fold forøgelse af den samlede methylnaltrexoneksponering (AUC).
Severe renal impairment decreased the renal clearance of methylnaltrexone by 8- to 9-fold; however, this resulted in only a 2-fold increase in total methylnaltrexone exposure (AUC).
4. 2).
Paediatric patients No studies have been performed in the paediatric population (see section 4.2).
Her fandtes, at alder havde lille effekt på eksponeringen af methylnaltrexon.
Elderly patients In a study comparing single and multiple-dose pharmacokinetic profiles of intravenous methylnaltrexone at a dose of 24 mg between healthy, young (18 to 45 years of age n=10) and elderly (65 years of age and over n=10) subjects, the effect of age on exposure to methylnaltrexone was found to be minor.