Ultiva Caution For Usage

Instructions for use/handling: Ultiva should be prepared for intravenous use by adding, as appropriate 1 mL of diluent to give a reconstituted solution with a concentration of 1 mg/mL remifentanil. The reconstituted solution is clear, colourless, and practically free from particulate material. After reconstitution, visually inspect the product (where the container permits) for particulate material, discolouration or damage of container. Discard any solution where such defects are observed. Reconstituted product is for single use only. Any unused material should be discarded.
Ultiva should not be administered by manually-controlled infusion without further dilution to 20 to 250 µg/mL (50 µg/mL is recommended dilution for adults and 20-25 µg/mL in paediatric patients aged 1 year and over).
The dilution is dependent upon the technical capability of the infusion device and the anticipated requirements of the patient.
One of the following IV fluids listed as follows should be used for dilution: Water for Injections; Glucose 5% solution for injection; Glucose 5% and Sodium Chloride 0.9% solution for injection; Sodium Chloride 0.9% solution for injection; Sodium Chloride 0.45% solution for injection.
After dilution, visually inspect the product to ensure it is clear, colourless, practically free from particulate matter and the container is undamaged.
Discard any solution where such defects are observed.
Ultiva has been shown to be compatible with the following intravenous fluids when administered into running IV catheter of: Lactated Ringer's solution for injection; Lactated Ringer's and Glucose 5% solution for injection.
Ultiva has been shown to be compatible with propofol when administered into running IV catheter.
The following tables give guidelines for infusion rates of Ultiva for manually-controlled infusion: (See Tables 7, 8, 9, 10 and 11.)

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Incompatibilities: Ultiva should only be reconstituted and diluted with those infusion solutions recommended (see Instructions for use/handling).
It should not be reconstitute, diluted, or mixed with Lactated Ringer's Injection or Lactated Ringer's and 5% Dextrose Injection.
Ultiva should not be mixed with propofol in the same infusion bag prior to administration.
Administration of Ultiva into the same intravenous line with blood/serum/plasma is not recommended. Non-specific esterases in blood products may lead to the hydrolysis of remifentanil to its inactive metabolite.
Ultiva should not be mixed with other therapeutic agents prior to administration.