Special precautions for disposal: For single use only.
It is recommended that after the non-permanent seals between the chambers have been opened, the contents should be used immediately, and should not be stored for subsequent infusion.
Do not connect bags in series in order to avoid air embolism due to possible residual gas contained in the primary bag.
Confirm the integrity of the bag and of the non-permanent seals. Use only if the bag is not damaged, if the non-permanent seals are intact (i.e., no content mixture of any of the three chambers), if the solution in the amino acids chamber and the solution in the glucose chamber are clear, colorless, or slightly yellow, practically free of visible particles, and if the lipid emulsion is a homogeneous liquid with a milky appearance.
Before opening the overpouch, check the color of the oxygen indicator. Compare it to the reference color printed next to the OK symbol and depicted in the printed area of the indicator label. Do not use the product if the color of the oxygen indicator does not correspond to the reference color printed next to the OK symbol.
To open: Remove the protective overpouch. Discard the overpouch and oxygen absorber/indicator sachet.
Mixing: Ensure that the product is at room temperature when breaking the non-permanent seals. Place the bag onto a flat clean surface. Do not use the bag if the contents are mixed due to accidental rupture of compartment seals during transport.
Activation of the 3CB (breaking two non-permanent seals): Start rolling the bag from the D-hanger side.
Apply pressure until peal seals open.
Then change direction by rolling the bag towards the D-hanger, continue until the seal is completely opened. Proceed the same way to complete the opening of the second peel seal.
Turn the bag over at least three times to mix the contents thoroughly. The appearance of the mixed solution should be a milky-white emulsion.
Remove the protective cap from the administration site and insert the IV administration set.
Activation of the 2CB (breaking the non-permanent seal between the Amino acid and Glucose chambers): To break only the amino acids/glucose peel seal, start rolling the bag from the D-hanger corner of the seal separating the amino acid and glucose chambers and apply pressure to open the seal separating the glucose and amino acid compartments.
Orient the bag such that the lipid emulsion compartment is nearest to the operator and roll the bag while protecting the lipid emulsion compartment in the palms of the hands.
With one hand, apply pressure by rolling the bag towards the tubes.
Then change direction by rolling the bag towards the D-hanger, pressing with the other hand, continuing until the seal separating the amino acids and glucose solutions is completely opened.
Turn the bag over at least three times to mix the content thoroughly. The appearance of the mixed solution should be clear, colorless or slightly yellow.
Remove the protective cap from the administration site and insert the IV administration set.
Additions: The capacity of the bag is sufficient to enable additions such as, electrolytes, trace elements, vitamins and water for injection. Any addition (including vitamins) may be made into the reconstituted mixture (after the non-permanent seals have been opened and after the contents of the two or three chambers have been mixed). Vitamins may also be added into the glucose chamber before the mixture is reconstituted (before opening the non-permanent seals and before mixing the solutions and the emulsion).
When making additions, the amount of electrolytes already present in the bag should be taken into account to meet the clinical needs of the patient. Maximum levels of electrolytes, and commercially available vitamins and trace elements formulations that can be added to Numeta activated 2CB and activated 3CB admixtures are described as follows. The composition of vitamins and trace elements preparations are illustrated in Dosage & Administration.
Numeta G13%E: See Table 21.
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Numeta G16%E: See Table 22.
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Composition of the commercial trace elements preparation used: See Table 17.
Click on icon to see table/diagram/image
Numeta G19%E: See Table 23.
Click on icon to see table/diagram/image
Composition of the commercial trace elements preparation used: See Table 24.
Click on icon to see table/diagram/image
Composition of the commercial vitamin preparation used: See Table 25.
Click on icon to see table/diagram/image
To perform an addition: Aseptic conditions must be observed.
Prepare the injection site of the bag.
Puncture the injection site and inject the additives using an injection needle or a reconstitution device.
Mix content of the bag and the additives.
Preparation of the infusion: Aseptic conditions must be observed.
Suspend the bag.
Remove the plastic protector from the administration outlet.
Firmly insert the infusion set spike into the administration outlet.
Administration of the infusion: For single use only.
Only administer the product after the non-permanent seals between the two or three chambers have been opened and the contents of the two or three chambers have been mixed.
Ensure that the final activated 3CB emulsion for infusion does not show any evidence of phase separation or the final 2CB solution for infusion does not show any evidence of particles.
After opening the bag, the content must be used immediately, and never stored for a subsequent infusion.
Do not connect any partially used bag.
Do not connect in series in order to avoid the possibility of air embolism due to possible residual gas contained in the primary bag.
Any unused product or waste material and all necessary disposable devices must be properly discarded and not used again.
Incompatibilities: Do not add other medicinal products or substances to one of the three components of the bag or to the reconstituted solution/emulsion without first confirming their compatibility and the stability of the resulting preparation (in particular, stability of the lipid emulsion or formation of precipitates), see Special precautions for disposal as previously mentioned.
As with any parenteral nutrition admixture, calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts may result in the formation of calcium phosphate precipitates.
Numeta must not be administered simultaneously with blood through the same infusion tubing, see Interactions.
Numeta contains calcium ions which pose additional risk of coagulation precipitated in citrate anticoagulated/preserved blood or components.
Numeta G13%E: As for other calcium-containing infusion solutions, concomitant treatment with ceftriaxone and Numeta G13%E is contraindicated in preterm newborn infants (see Contraindications, Precautions and Interactions).
Numeta G16%E: As for other calcium-containing infusion solutions, concomitant treatment with ceftriaxone and Numeta is contraindicated in term newborn infants (≤28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate's bloodstream, see Interactions.)
Numeta G16%E and Numeta G19%E: In patients of any age ceftriaxone must not be mixed or administered simultaneously with intravenous calcium-containing solutions, including Numeta, even via different infusion lines or at different infusion sites because of the risk of precipitation of ceftriaxone-calcium salt.