Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Cyramza® (ramucirumab): Beredning och koncentrationsintervall

Förbered enligt anvisningarna nedan med aseptisk teknik och steril natriumkloridlösning (0,9%) som spädningsmedel för en slutlig volym på 250 ml i koncentrationsområdet 0,4 till 4,0 mg/ml.

Preparation

Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.1

Each vial of ramucirumab is intended for single use only.1

  1. Inspect the contents of the vials for particulate matter and discoloration prior to dilution. The color should be clear to slightly opalescent and colorless to slightly yellow without visible particles. If particulate matter or discolorations are identified, discard the vial.

  2. Calculate the dose and the required volume of ramucirumab needed to prepare the infusion solution. Vials contain either 100 mg or 500 mg as a 10 mg/ml solution of ramucirumab. Only use sodium chloride 9 mg/ml (0.9%) solution for injection as a diluent. 

  3. Dilute ramucirumab as required to achieve a final volume of 250 mL. Only use sterile sodium chloride (0.9%) solution for injection as a diluent. 

    1. In case of prefilled intravenous (IV) infusion container usage: based on the calculated volume of ramucirumab, remove the corresponding volume of sterile sodium chloride (0.9%) solution for injection from the prefilled 250-mL IV container. Aseptically transfer the calculated volume of ramucirumab to the IV container. The final total volume in the container should be 250 mL.

    2. In case of empty IV infusion container usage: aseptically transfer the calculated volume of ramucirumab into an empty IV container. Add a sufficient quantity of sterile sodium chloride (0.9%) solution for injection to the container to make the total volume 250 mL.

  4. The container should be gently inverted to ensure adequate mixing. 

    1. Do not freeze or shake the infusion solution.

    2. Do not dilute with other solutions or co-infuse with other electrolytes or medication.

  5. Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is identified, discard the infusion solution.

  6. Discard any unused portion of ramucirumab left in a vial, as the product contains no preservatives.1,2

Additional information on final volume and concentration range

Lilly does not have specific data to support diluting ramucirumab to concentrations below 0.4 mg/mL (ie, 10 mL of the 100 mg/10mL vial diluted with sodium chloride [0.9%] solution for injection to a final volume of 250 mL).

The concentration of ramucirumab in the prepared dose must be within 0.4 to 4.0 mg/mL. Larger containers (ie, 500 ml) of sodium chloride (0.9%) solution for injection may be used if adjusted to the target dose volume of 250 mL and the concentration of ramucirumab in the prepared dose is within 0.4 to 4.0 mg/mL.1

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Datum fӧr senaste ӧversyn August 09, 2019


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