Italian Medicines Agency Agenzia Italiana del Farmaco

Direct communication with healthcare professionals on Lipidem - Direct communication with healthcare professionals on Lipidem

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Direct communication with healthcare professionals on Lipidem

Lipidem® / Lipoplus® emulsion for infusion (10 x 500 ml, 10 x 250 ml, glass bottles; PZN 04237727; 04237733) – Important information on subvisual agglomerates, use of an infusion filter for fat emulsions
In stability studies, agglomerates of droplet-like structures were detected in individual batches of the finished medicinal product. These structures are composed of components of the emulsion and can form during the shelf life.

Therefore, the emulsion for infusion must be administered with an infusion filter for fat emulsions with a pore size of 1.2 µm (Intrapur® Lipid – 1.2 µm infusion filter for fat emulsions and mixed solutions, B. Braun Melsungen AG, or equivalent filter).

If it cannot be guaranteed that an appropriate filter is used, Lipidem® / Lipoplus® emulsion should not be used for more than 12 months, which means one year less than labelled on the packaging.

Direct communication with healthcare professionals available in "related documents".


Published on: 29 August 2025

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