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Recently, the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) has endorsed the European Medicine's Agency PRAC (Pharmacovigilance Risk Assessment Committee) recommendation to suspend the marketing authorisations of hydroxyethyl starch solutions for infusion across the European Union.
Such chemical modifications can occur during bioprocesses and storage conditions of the commercial HSA solutions, resulting in heterogeneous solutions for infusion.
A usual dose between 100 and 400 mg daily is recommended orally (capsule) and parenterally (injections, solutions for infusion) to patients (4).
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Nevertheless, it is recommended that an injection of adrenaline is ready and available in case it is needed to treat a severe anaphylactic reaction, and also that the antivenom from the vial is administered diluted in a 100 ml bag of intravenous solution for infusion over 30 minutes.
Patients were randomly assigned to receive a daily iv infusion over 60 minutes either verum [n = 40, moxifloxacin 400 mL/250 mL solution for infusion (Avalox®, Bayer Vital GmbH)] or placebo [n = 40, riboflavin as a colorant, 20 mL/250 mL NaCl 0.9%] for five days starting within 36h after stroke onset.
Trastuzumab IV needs to be reconstituted into solution for infusion, with the dose calculated on the basis of patient bodyweight.
All bottles containing solution for infusion (active and placebo) were identical and had a nontransparent plastic cover, while tubes for infusion were manufactured in colored plastic material.
15, 16, 30– 32 The lacosamide solution for infusion is also approved as an alternative for patients when oral administration is temporarily not feasible.
Biosimilar trastuzumab (440 mg powder for concentrate for solution for infusion) from Probiomed S.A. de C.V. (Mexico City, Mexico) and Herceptin (440 mg powder for concentrate for solution for infusion) from F. Hoffmann, La Roche Ltd. (Basel, Switzerland), were used for the comparability study.
A study of risk areas for managing IV drugs concluded that approximately 1/3 of the high risk errors were knowledge-based errors: hygiene; infusion time; incompatibilities; visual inspection; prescribing information; shelf life; labeling; and solution for infusion [ 11].
Two brands of trastuzumab (440 mg powder for concentrate for solution for infusion) were employed: biosimilar Trastuzumab-Probiomed (Probiomed S.A. de C.V., Mexico) and Herceptin (F. Hoffmann-La Roche Ltd., Basel, Switzerland).
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