Eksempler på brug af Methylnaltrexone bromide på Engelsk og deres oversættelser til Dansk
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One mL of solution contains 20 mg methylnaltrexone bromide.
Methylnaltrexone bromide is excreted via the milk of lactating rats.
Each vial of 0.6 mL contains 12 mg methylnaltrexone bromide.
Mode of action Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor.
Animal studies have shown excretion of methylnaltrexone bromide in breast milk.
Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids.
Lactation It is unknown whether methylnaltrexone bromide is excreted in human breast milk.
Relistor is a medicine that contains the active substance methylnaltrexone bromide.
The active substance in Relistor, methylnaltrexone bromide, is a mu-opioid receptor antagonist.
Use of methylnaltrexone bromide in patients with colostomy, peritoneal catheter, active diverticular disease or fecal impaction has not been studied.
Pregnancy There are no adequate data with the use of methylnaltrexone bromide in pregnant women.
The effects of methylnaltrexone bromide in pregnant women are not known, and so the use of RELISTOR during pregnancy is not recommended.
Women using RELISTOR should not breast-feed,since it is not known if methylnaltrexone bromide passes into human breast milk.
Use of methylnaltrexone bromide in patients with known or suspected mechanical gastrointestinal obstruction or acute surgical abdomen is contraindicated.
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.
The efficacy and safety of methylnaltrexone bromide were also demonstrated in open-label treatment administered from Day 2 through Week 4 in Study 301, and in two open-label extension studies(301EXT and 302EXT) in which methylnaltrexone bromide was given as needed for up to 4 months only 8 patients up to this point.
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. .
The usual dose is 8 mg methylnaltrexone bromide(0.4 ml RELISTOR) for patients weighing 38-61 kg or 12 mg(0.6 ml RELISTOR) for patients weighing 62-114 kg.
Data from clinical trials suggest treatment with methylnaltrexone bromide can result in the rapid onset(within 30 to 60 minutes on average) of a bowel movement.
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.
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.