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Special precautions for disposal and other handling: No special requirements for disposal.
Parenteral nutrition products should be visually inspected for damage, discolouration and emulsion instability before use.
Do not use bags which are damaged. Overwrap, primary bag and the peel seams between the chambers should be intact. Only use if the amino acid and glucose solutions are clear and colourless up to straw-coloured and the lipid emulsion is homogenous with milky white appearance. Do not use if the solutions contain particulate matter.
After mixing the three chambers, do not use if the emulsion shows discolouration or signs of phase separation (oil drops, oil layer). Stop the infusion immediately in case of discolouration of the emulsion or signs of phase separation.
Before opening the overwrap, check the colour of the oxygen indicator. Do not use if the oxygen indicator turned pink. Use only if the oxygen indicator is yellow.
Preparation of the mixed emulsion: Strict adherence to aseptic handling principles must be complied with.
To open: Tear overwrap starting from the tear notches. Remove the bag from its protective overwrap. Discard overwrap, oxygen indicator and oxygen absorber.
Visually inspect the primary bag for leaks. Leaky bags must be discarded, since the sterility cannot be guaranteed.
To open and mix the chambers sequentially, roll the bag with both hands, starting first by opening the peel seam that separates the top chamber (glucose) and the bottom chamber (amino acids). Then continue applying pressure so that the peel seam separating the middle chamber (lipids) and the bottom chamber opens.
Addition of additives: After removing the aluminium seal, one can add compatible additives via the medication port.
OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion can be mixed with the following additives up to the specified upper concentration limits or maximum amount of additives after supplementation as follows. The resulting admixtures are stable for 7 days between +2°C to +8°C plus 2 days at 25°C.
Electrolytes: Take account of the electrolytes already present in the bag; stability has been demonstrated up to a total quantity of 200 mmol/L of sodium + potassium (sum), 9.6 mmol/L of magnesium and 6.4 mmol/L of calcium in the ternary mixture.
Phosphate: Omegaflex Peri: Stability has been demonstrated up to a maximum concentration of 20 mmol/L for inorganic phosphate.
Omegaflex Special: Stability has been demonstrated up to a maximum concentration of 20 mmol/L for inorganic phosphate or up to a maximum concentration of 30 mmol/L organic phosphate, respectively (however not both simultaneously).
Alanyl-glutamine: Up to 24 g/L.
Trace elements and vitamins: Stability has been demonstrated with commercially available multi-trace elements and multi-vitamins (e.g. Tracutil, Cernevit) up to the standard dosage recommended by the respective manufacturer of the micronutrient.
Detailed information about the previously mentioned additives and the corresponding shelf life of such admixtures can be provided on demand by the manufacturer.
Mix the contents of the bag thoroughly and visually inspect the mixture. There should be no signs of emulsion phase separation.
The mixture is a milky white homogenous oil-in-water emulsion.
Preparation for infusion: The emulsion should always be brought to room temperature prior to infusion.
Remove the aluminium foil from the infusion port and attach the infusion set. Use a non-vented infusion set or close the air vent when using a vented set. Hang the bag on an infusion stand and carry out infusion using the standard technique.
For single use only. Container and unused residues must be discarded after use.
Do not reconnect partially used containers.
If filters are used, they must be lipid-permeable (pore size ≥1.2 μm).
Incompatibilities: This medicinal product must not be mixed with other medicinal products for which compatibility has not been documented. See Special precautions for disposal and other handling as previously mentioned.
OMEGAFLEX Peri Emulsion for Infusion/OMEGAFLEX Special Emulsion for Infusion should not be given simultaneously with blood (see Precautions and Interactions).
