Numeta G13%E/Numeta G16%E/Numeta G19%E Description

This medicinal product is presented in the form of a three chamber bag. Each bag contains a sterile nonpyrogenic combination of a glucose solution, a paediatric amino acids solution, with electrolytes, and a lipid emulsion, as described as follows.
Numeta G13%E: See Table 1.

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Numeta G16%E: See Table 2.

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Numeta G19%E: See Table 3.

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If lipid administration is undesirable, the design of the bag allows the possibility to activate only the peel seal between the amino acids/electrolytes and glucose chambers, leaving the peel seal between the amino acids and lipid chambers intact. The content of the bag can subsequently be infused with or without lipids. The composition of the drug product after mixing of the two [amino acids and glucose, 2 chamber bag, 240 mL solution (Numeta G13%E only), 376 mL solution (Numeta G16%E only), 775 mL solution (Numeta G19%E only)] or three [amino acids, glucose and lipid, 3 chamber bag, 300 mL emulsion (Numeta G13%E only), 500 mL emulsion (Numeta G16%E only), 1000 mL emulsion (Numeta G19%E only)] chambers are provided in the following tables.
Numeta G13%E: See Table 4.

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Numeta G16%E: See Table 5.

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Numeta G19%E: See Table 6.

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For the full list of excipients, see as follows.
The reconstituted solution/emulsion provides the following: Numeta G13%E: See Table 7.

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Numeta G16%E: See Table 8.

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Numeta G19%E: See Table 9.

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Excipients/Inactive Ingredients: See Table 10.

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