Numeta

(glucose solution, lipid emulsion, amino acids, electrolytes)

The first and only licensed ready-to-use three-chamber bag parenteral nutrition (PN) solution specifically designed for neonatal and paediatric patients.  

Prescribing Information
Numeta bags

When oral or enteral nutrition is not possible, insufficient or contraindicated, Numeta provides neonatal and paediatric patients specifically formulated nutritional support that could help reduce growth deficits and improve long-term growth outcomes.1-4  Numeta PN bags are the first and only ready-to-use three-chamber bag (3CB) solutions for preterm neonates (Numeta G13%E Preterm), term infants and children up to 2 years (Numeta G16%E ), and children older than 2 years through adolescence (Numeta G19%E ).1-3  They are designed to give the flexibility of administering PN with or without lipids and the ability to add micronutrients and compatible additives as needed.1-3  Numeta may help reduce the risk of compounding errors, bloodstream infections, and medication errors that are seen with compounded PN.4-5  

 

Parenteral Nutrition is a complicated, yet critical, therapy for many preterm infants and paediatric patients

Poor nutrition in preterm infants and critically ill children is associated with higher mortality and can be detrimental for long-term growth.6, 7 For patients who cannot receive adequate nutrition orally or enterally, PN can be lifesaving.7 Because of its complexity, PN is classified as a “high-alert” medication with an increased risk of causing significant patient harm if provided incorrectly.8   

Current international guidelines recommend the use of standardised PN solutions in the majority of paediatric and newborn patients that require PN therapy.9 Standardised PN solutions help align nutritional intakes with guideline recommendations, helping to improve weight gain and avoid nutritional deficits.9 Commercial production of standard PN bags can assure better pharmaceutical control and better aseptic manufacturing conditions than the average hospital pharmacy.9 In an observational study to assess accuracy in compounding intravenous (IV) admixtures, commercially produced ready-to-use PN achieved an error rate of <1%.10

Error rate by type of compounded products10

graphic 1
Adapted from Flynn EA et al. Am J Health Syst Pharm. 1997 Apr 15;54(8):904-12.

Innovative nutritional therapy that meets the majority of needs

Graphics

Heart and a hand

Supportive

Aligns with ESPGHAN/ESPEN/ESPR/CSPEN guidelines and supports growth and development in neonatal and paediatric patients.9

Lock

Secure

Commercially prepared, helping to lower the risk of medication errors and infections associated with custom compounding.9

Timer

Ready

Available for immediate nutritional support, with stability to store at room temperature for 18 months (Numeta G13%E Preterm/G16%E) and 24 months (Numeta G19%E).1-3

Numeta supports improved growth outcomes12

A retrospective study found that Numeta G13%E Preterm was associated with improved nutrient intakes and postnatal growth in very low-birthweight (VLBW) infants.12 The use of Numeta G13%E Preterm as a concentrated PN regime for VLBW infants showed improved weight and length gain during the first weeks of life with a persistent difference at 36 weeks post-menstrual age compared to infants given a pharmacy-prepared PN.12 A separate study in VLBW infants showed that Numeta G13%E Preterm was associated with improved protein intake and found a higher and faster likelihood of achieving protein targets.13

Graf with Numeta and before Numeta
Adapted from Späth C, et al. JPEN J Parenter Enteral Nutr. 2020;44:327-336.
Changes in weight standard deviation scores (SDS) on postnatal days 1 to 28 in infants who received either original (dark blue) or concentrated
parenteral nutrition (light blue), relative to birth weight as baseline (Original PN group: n=71 to 74 at different time points due to infant death;
Concentrated PN group: n=44). Values are expressed as 95% confidence intervals for mean of change.
  *P-value < 0,01
**P-value < 0,00112

Numeta may help reduce hospital resource use and cost

According to a cost-consequences analysis, the increased use of ready-to-use 3CBs is associated with a decrease in adverse events and reduction in hospital labour, which can provide substantial resource and cost savings to the institution.5 These resources can be used to optimise hospital care in other areas. Across seven countries, there was an average of 3.4% savings to hospital budgets.5

Numeta provides a unique composition for delivering optimal nutrition

   

Women in hospital with PN bags

Benefits of all-in-one PN bags

Paediatric PN is typically made up of approximately 50 components, presenting ample opportunity for compounding errors and contamination.14 At the bedside, providing lipids via Y-line introduces the risk of infusing at the rate intended for the aqueous PN solution.15

Using an industrially produced, all-in-one PN solution, like Numeta, ensures the patient receives guideline-recommended nutrition, including essential and semi-essential amino acids and essential fatty acids.16,17 If there is clinical reason to withhold lipids or use a different lipid emulsion, Numeta provides the flexibility to infuse only the aqueous solution.

Clinoleic bag

ClinOleic composite lipid emulsion (80% olive oil / 20% soybean oil)

The ESPGHAN/ESPEN/ESPR/CSPEN guidelines on Paediatric PN recommend intravenous lipid emulsions should be an integral part of PN.18 Specifically, composite lipids, with or without fish oil, should be used rather than pure soybean oil lipids since composite lipids provide more balanced nutrition.18  Numeta contains ClinOleic, an olive-based lipid emulsion formulated to meet the high energy needs of neonatal and pediatric patients. ClinOleic has been shown to be well-tolerated and may preserve immune function.19,20,24 Unlike lipid emulsions that contain fish oil, ClinOleic does not contain eicosapentaenoic acid (EPA), which has been linked to reduced arachidonic acid (ARA) levels.21  

Mom and baby

Extensive compatibility data improves safety and flexibility

Baxter has conducted extensive compatibility testing for each Numeta formulation. The testing includes vitamins, trace elements, electrolytes, macronutrients, and additives, and was conducted both with and without the lipid chamber activated.

Numeta portfolio of solutions

Small baby on mother

Numeta G13%E Preterm

Numeta G13%E Preterm is indicated for parenteral nutrition in preterm newborn infants when oral or enteral nutrition is not possible, insufficient or contraindicated.1

Girl and baby

Numeta G16%E

Numeta G16%E is indicated for parenteral nutrition in term newborn infants and children up to 2 years when oral or enteral nutrition is not possible, insufficient or contraindicated.2

Boy playing

Numeta G19%E

Numeta G19%E is indicated for parenteral nutrition in children older than 2 years and adolescents 16-18 years old when oral or enteral nutrition is not possible, insufficient or contraindicated.3

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ADVERSE EVENT REPORTING

Adverse Events and any drug or medical device product quality complaints (including suspected defective medicines or medical device adverse incidents) should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse Events should also be reported to Baxter Healthcare Ltd, by email ([email protected]) or by phone (+44 (0)1635 206360). Drug or medical device product quality complaints relating to Baxter products can be reported directly to Baxter Healthcare Ltd by email ([email protected]) or by phone (+44 (0)1604 704603).

 

Numeta Prescribing Information