Dear Healthcare Professional Letter on reminder on importance of correct preparation and use of Periolimel N4E, Olimel N7E and Olimel N9E emulsion for infusion due to risks of medication errors
24.04.2015
Agmar d.o.o. is, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sending a letter to healthcare professionals to inform them on the risk of a medication error when preparing and using Periolimel N4E, Olimel N7E and Olimel N9E emulsion for infusion. This notice concerns all Olimel/periolimel emulsions for infusion authorised in the Republic of Croatia - Periolimel N4E, Olimel N5E, Olimel N7E, Olimel N9 and Olimel N9E. However, as of April 2015, only Periolimel N4E, Olimel N7E and Olimel N9E emulsion for infusion will be placed on the market.
Summary
The reported errors when using Periolimel/Olimel emulsion for infusion, due to incomplete or failed "activation” (mixing) of bag departments or due to other types of medication errors, like excessive infusion rate or wrong route of administration.
Instructions for preparation and use as described in the product information must be thoroughly followed in order to avoid an incomplete bag activation before use or occurrence of other medication errors.
All Olimel preparations may be used only via central vein. Only Periolimel N4E emulsion for infusion may, due to its osmolality (760 mosm/l), be used also via peripheral vein.
A poster - guide for use is attached to this letter, that serves as a reminder to healthcare professionals and depicts the correct way of using Periolimel/Olimel emulsion for infusion in order to avoid these medication errors.
Further information
Periolimel/Olimel emulsion for infusion for therapeutic groups indicated for parenteral nutrition for adults and children above 2 years when per oral or enteral nutrition is impossible, insufficient or contraindicated. These medicines are presented in bags with 3 compartments that need to be "activated” in order to mix the content of compartments before use.
the product information for Periolimel/Olimel emulsion for infusion contains detailed information on preparation, handling, dosing and method/route of administration as well as special warnings and caution measures for use.
The reported medication errors occurred during various phases before and during use of Olimel/Perolimel emulsion for infusion. These medication errors may lead to serious adverse reactions, like hyperglycaemia, overdosing or reactions at the infusion site associated with extravasation.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
