Examples of using Refacto in English and their translations into Italian
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Medicine
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Colloquial
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Official
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Financial
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Ecclesiastic
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Ecclesiastic
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Computer
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Programming
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Official/political
In a study in which the potency of ReFacto AF, ReFacto and FVIII activity in patient plasma were
The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for K-value, AUCt and AUC∞(area under the plasma concentration curve from time zero to infinity), respectively.
demonstrating bioequivalence of ReFacto AF to ReFacto.
The need for an increased dose relative to that used for adults and older children should be anticipated when treating younger children(less than 6 years of age) with ReFacto AF.
one chamber contains the ReFacto AF lyophilised powder and the other chamber contains the solvent sodium chloride 9 mg/ml(0.9%) solution.
The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for recovery, AUCt and AUC∞(area under the plasma concentration curve from time zero to infinity), respectively.
instructions on when to change to using the ReFacto AF laboratory standard.
all of the solvent is transferred to the top chamber containing the ReFacto AF powder.
in the syringe connector and the ReFacto AF pre-filled syringe to the remaining open port on the opposite end.
to break the perforation of the cap and expose the grey rubber tip cap of the ReFacto AF pre-filled syringe.
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.
stage clotting essay and the need for patients to take an adequate supply of their ReFacto AF for anticipated treatment while traveling.
the CHMP considers that the benefit-risk balance of ReFacto AF remains positive,
Additional messages regarding the transition plan for replacement of ReFacto with ReFacto AF in the Member States.
The potential risks for medication errors in using different assays or laboratory standard for patient monitoring Information that the chromogenic substrate assay is strongly recommended to be used by laboratories when monitoring patients receiving ReFacto AF and that typically one stage clotting assay results are 20-50% lower than the chromogenic substrate assay results.
The educational programme for laboratories should inform about the following key elements:• The main differences between ReFacto AF and ReFacto• Specific instructions regarding the proper monitoring of ReFacto AF.• The potential risks for medication errors in using different assays
which was lower than that obtained in PTPs treated with ReFacto at Week 0 with a mean recovery of 2.4± 0.4 IU/dl per IU/kg range 1.1 to 3.8 IU/dl per IU/kg.
To prepare for the gradual replacement of ReFacto with ReFacto AF on the market, the company that makes the medicine will provide educational packs for healthcare workers who will prescribe or use ReFacto AF, for all associations of haemophilia patients in the European Union(EU), for patients receiving ReFacto AF and for laboratories that will monitor patients receiving ReFacto AF.
in which the drug potency of ReFacto AF and a full-length recombinant factor VIII( FLrFVIII) comparator, and the FVIII activity measured in patient plasma samples were all determined using the same one-stage clotting assay at a central laboratory, ReFacto AF was shown to be pharmacokinetically equivalent to FLrFVIII in 30 previously treated patients(≥ 12 years) using the standard bioequivalence approach.
which was lower than that obtained in PTPs treated with ReFacto at Week 0 with a mean K-value of 2.4± 0.4 IU/ dl per IU/ kg range 1.1 to 3.8 IU/ dl per IU/ kg.