Examples of using Refacto in English and their translations into Dutch
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Programming
Previously known as ReFacto.
In a clinical study with ReFacto in PTPs, 1 inhibitor was observed in 113 patients.
The table lists adverse reactions reported in the clinical trials with ReFacto or ReFacto AF.
In PUPs, pharmacokinetic parameters of ReFacto were evaluated using the chromogenic assay.
previously untreated patients(PUPs) treated with ReFacto developed inhibitors.
People also translate
Pharmacokinetic parameter estimates for ReFacto in previously treated patients with haemophilia A PK parameter.
batch number of the product received, using the peel-off labels provided on the vial.• Additional messages regarding the transition plan for replacement of ReFacto with ReFacto AF in the Member States.
The main differences between ReFacto AF and ReFacto.
The studies showed that ReFacto AF was as safe and effective as ReFacto in preventing and treating bleeding episodes in patients with haemophilia A.
Frequency of Occurrence per Patient with ReFacto or ReFacto AF System organ class.
In a study in which the potency of ReFacto AF, ReFacto and FVIII activity in patient plasma were measured using the chromogenic substrate assay, ReFacto AF was shown to be bioequivalent to ReFacto.
Additional messages regarding the transition plan for replacement of ReFacto with ReFacto AF in the Member States.
The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%,
Following these changes, the company carried out a study to show that ReFacto and ReFacto AF were treated by the body in the same way.
The manufacturing process for ReFacto has been modified to eliminate any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name has been changed to ReFacto AF.
Adverse reactions based on experience from clinical trials with ReFacto or ReFacto AF are presented in the table below by system organ class.
Pharmacokinetic properties of ReFacto, derived from a cross-over study of ReFacto and a plasma- derived FVIII concentrate,
As part of the pivotal trial with ReFacto in PUPs, ITI data from 25 patients were reviewed see Section 4.8.
Paediatric patients Safety and efficacy studies with ReFacto have been performed both in previously treated children and adolescents(n=31,
These packs will include information on the differences between ReFacto and ReFacto AF, how to use ReFacto AF safely, how to report side effects, information on similar medicines available outside the EU, and a reminder that patients should carry enough ReFacto AF with them if they are travelling.