TRIOMEL PERIPHERAL 4 g/l nitrogen 700 kcal/l with electrolytes, emulsion for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIOMEL PERIPHERAL 4 g/l nitrogen 700 kcal/l with electrolytes, emulsion for infusion, is presented in the form of a 3-compartment bag.
Each bag contains a glucose solution with calcium, a lipid emulsion and an amino acid solution with other electrolytes.
Baxter is a registered trademark of Baxter International, Inc. FCA-2014-002
04 June 2014
TRIOMEL – Reduction of maximum infusion rate for children aged 2 to 11 years
Dear Healthcare Professional,
Baxter Healthcare, in agreement with the MHRA, would like to inform you of the following:
Summary
• The maximum infusion rate of TRIOMEL has been reduced for children aged 2-11 years to match the recommendations in the 2005 European Society for Paediatric Gastroenterology, Hepatology & Nutrition / European Society for Parenteral and Enteral Nutrition (ESPGHAN/ESPEN) Guidelines1 for this age group.
• These guidelines recommend a maximum lipid infusion rate of 0.13 g/kg/hour for children aged 2-11 years.
• As a result, the maximum infusion rates for fluids, amino acids and glucose in the TRIOMEL range are being updated in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL). Please see dosing regimen table below for full information.
Further information
TRIOMEL are a range of products indicated for parenteral nutrition (PN) for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
These products provide a 3-in-1 total parenteral nutrition (TPN) solution that contains macronutrients (lipids, amino acids and glucose); certain TRIOMEL formulations also include electrolytes.
The product information for TRIOMEL previously recommended a maximum hourly infusion rate for lipids for children 2-11 years which was higher than that stated in the 2005 ESPGHAN/ESPEN Guidelines for this age group. An increased lipid infusion rate may increase the risk of adverse reactions (e.g., fat overload syndrome, septicaemia, or hypertriglyceridemia). No adverse reactions have been received by Baxter related to this issue since marketing.
In this age group, the limiting factor for the maximum infusion rate for each product is limited by the maximum infusion rate of the lipid. As a result, the maximum infusion rates for fluids, amino acids and glucose stated in the product information are also being revised.
Baxter is a registered trademark of Baxter International, Inc. FCA-2014-002
The revised dosing table is shown below.
Table: Revised maximum hourly infusion rate of TRIOMEL for children 2-11 years old
Constituent
Maximum Recom-mended infusion ratea
TRIOMEL PERIPHERAL 4 g/l nitrogen 700 kcal/l with electrolytes
TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes
TRIOMEL 7 g/l nitrogen 1140 kcal/l with electrolytes
TRIOMEL 7 g/l nitrogen 1140 kcal/l
TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes
TRIOMEL 9 g/l nitrogen 1070 kcal/l
Fluids (ml/kg/h)
4.3
3.3
3.3
3.3
3.3
3.3
Amino acids (g/kg/h)
0.20
0.11
0.11
0.15
0.15
0.19
0.19
Glucose (g/kg/h)
1.2
0.32
0.38
0.46
0.46
0.36
0.36
Lipids (g/kg/h)
0.13
0.13
0.13
0.13
0.13
0.13
0.13
Italics: limiting factor
a: Recommended values from 2005 ESPEN-ESPGHAN Guidelines
The Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) are being updated.
Call for reporting
Please report any suspected adverse reactions to any medicine to the MHRA through the Yellow Card Scheme online at www.mhra.gov.uk/yellowcard.
Alternatively, prepaid Yellow Cards for reporting are available:
- upon request by mail: "FREEPOST YELLOW CARD"
- at the back of the British National Formulary (BNF)
- by telephoning the Commission of Human Medicines (CHM) free phone line: 08007316789
- or by electronic download through the MHRA website (www.mhra.gov.uk/yellowcard)
Any suspected adverse reactions observed during use of TRIOMEL may also be reported to Baxter Healthcare Pharmacovigilance on telephone number 01635 206360, by fax to 01635 206281 or by email to vigilanceuk@baxter.com.
Should you have any questions or require additional information on the use of TRIOMEL, please do not hesitate to contact Surecall (Baxter Medical Information) on telephone number 01635 206345.
Yours faithfully, Dr Iain McNeil Medical Director Baxter Healthcare Ltd
[1] Koletzko, B., Goulet, O., Hunt, J., Krohn, K., Shamir, R., Parenteral Nutrition Guidelines Working Group, et al. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN), Journal of Pediatric Gastroenterology and Nutrition. 2005 Nov; 41 Suppl 2:S1-87.
