Examples of using Replagal in English and their translations into Hungarian
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Medicine
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Colloquial
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Financial
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Official/political
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Computer
Replagal has also been studied in 24 children aged between 6 and a half and 18 years of age.
Replagal has to be diluted in 9 mg/ ml(0.9%)
Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases.
Very limited clinical data on pregnancies exposed to Replagal(n=4) have shown no adverse effects on the mother
Do not use Replagal after the expiry date which is stated on the label after the letters EXP.
Pregnancy and breast feeding Very limited clinical data on pregnancies exposed to Replagal(n=4) have shown no adverse effects on the mother and newborn child.
Care must be taken to ensure the sterility of the prepared solution since Replagal does not contain any preservative
If treatment with Replagal makes your body produce antibodies this will not stop Replagal from working and the antibodies may disappear with time.
Some studies have looked at what happens to Replagal when given to children, and they suggested that Replagal could be used in children between 7 and 18 years of age at the same dose.
In addition, in the first study involving 25 patients, Replagal effected a significant reduction in cardiac mass after 12 to 18 months of maintenance therapy(p< 0.001).
Care must be taken to ensure the sterility of the prepared solutions since Replagal does not contain any preservative
Of adult patients treated with Replagal in clinical trials have experienced idiosyncratic infusion related reactions.
Idiosyncratic infusion related reactions 13.7% of patients treated with Replagal in clinical trials have experienced idiosyncratic infusion related reactions.
In subsequent studies, in male paediatric patients, a reduction in pain was observed after 9 and 12 months of Replagal therapy compared to pre-treatment baseline.
12 months of Replagal therapy compared to pre- treatment baseline.
Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g.
Replagal has been authorised under"Exceptional Circumstances",
The 6 month study with Replagal administered at 0.2 mg/ kg in this population, this dose regimen
Table 1 lists adverse drug reactions(ADRs) reported for the 153 patients treated with Replagal in clinical trials, including 21 patients with history
In male paediatric Fabry patients plasma Gb3 decreased 40-50% after 6 months of Replagal therapy and this reduction persisted after a total of 12 months of treatment.