Примери за използване на Sapropterin на Английски и техните преводи на Български
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The active substance is sapropterin dihydrochloride.
Dihydrochloride(equivalent to 77 mg of sapropterin).
The active substance in Kuvan, sapropterin dihydrochloride, is a synthetic copy of BH4.
Kuvan is a medicine that contains the active substance sapropterin dihydrochloride.
It is not known whether sapropterin or its metabolites are excreted in human breast milk.
Emesis is considered to be related to the pH of the solution containing sapropterin.
The rate and extent of absorption of sapropterin is influenced by food.
Sapropterin dihydrochloride is primarily metabolised in the liver to dihydrobiopterin and biopterin.
The powder is filled in unit dose sachets containing 500 mg sapropterin dihydrochloride.
It is not known whether sapropterin or its metabolites are excreted in human breast milk.
In the studies of patients with BH4 deficiency, patients showed an improvement in blood phenylalanine levels andother markers of the disease when they were taking sapropterin dihydrochloride.
Caution is advised when sapropterin is used in patients with predisposition to convulsions.
In a further clinical trial,approximately 30% of the 27 children aged below 4 years who received treatment with sapropterin dihydrochloride(10 or 20 mg/kg/day) experienced adverse reactions.
Treatment with sapropterin may decrease blood phenylalanine levels below the desired therapeutic level.
Do not take Kuvan If you are allergic(hypersensitive) to sapropterin or any of the other ingredients of Kuvan.
However, sapropterin has not been shown to be genotoxic in the in vitro test with human lymphocytes as well as in in vivo micronucleus mouse tests.
Following intravenous administration in rats, sapropterin dihydrochloride is mainly excreted in the urine.
Sapropterin is a synthetic version of the naturally occurring 6R-BH4, which is a cofactor of the hydroxylases for phenylalanine, tyrosine and tryptophan.
Each sachet contains 500 mg of sapropterin dihydrochloride(equivalent to 384 mg of sapropterin).
Sapropterin was found to be weakly mutagenic in bacterial cells and an increase in chromosome aberrations was detected in Chinese hamster lung and ovary cells.
In preclinical studies, no effects of sapropterin on male and female fertility were observed.
Since sapropterin dihydrochloride is a synthetic version of the naturally occurring 6R-BH4, it can be reasonably anticipated to undergo the same metabolism, including 6R-BH4 regeneration.
There was a significant difference in dietary phenylalanine tolerance in the sapropterin treatment group as compared to the placebo group.
Patients previously treated with sapropterin were required to discontinue treatment at least 14 days prior to first dose of Palynziq.
Limited studies have been conducted in patients under 4 years of age with BH4 deficiency using another formulation of the same active substance(sapropterin) or an un-registered preparation of BH4.
Kuvan contains the active substance sapropterin which is a synthetic copy of a body's own substance called tetrahydrobiopterin(BH4).
Sapropterin should be used with caution in patients who are receiving concomitant levodopa, as combined treatment with sapropterin may cause increased excitability and irritability.
Headache and dizziness have been reported after the administration of sapropterin dihydrochloride above the recommended maximum dose of 20 mg/ kg/ day.
The absorption of sapropterin is higher after a high-fat, high-calorie meal as compared to fasting, resulting, in average, in 40-85% higher maximum blood concentrations achieved 4 to 5 hours after administration.
The mean± SD decrease from baseline in blood phenylalanine levels at the end of the 6 week study period was 235.9± 257.0 μ mol/ l for the sapropterin treated group(n=47) as compared to an increase of 2.9± 239.5 μ mol/ l for the placebo group(n=41)(p< 0.001).