The Medicines and Healthcare products Regulatory Agency (MHRA) have agreed a letter about the important of protecting parenteral nutrition products from light if they are to be used in neonates and in children below 2 years.
The letter is a Direct Healthcare Professional Communication arising from an EU assessment of risk with the parenteral nutrition products containing amino acids and/or lipids with or without admixture of vitamins and/or trace element registered as medicines. The review identified a risk of toxic degradations of ingredients that may lead to severe clinical outcomes in premature neonates when the products have been exposed to light.
The letter was agreed by the MHRA and sent by the marketing authorisation holders of parenteral nutrition products containing amino acids and/or lipids, indicated for use in neonates and in children below 2 years. As a result of the EU procedure, the product information (Summary of Product Characteristics, Package Leaflet and Labelling) for the concerned products is being updated accordingly.
The relevant section of the report is on page 3.
