Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: This medicinal product is compatible with infusion sets composed of polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polybutadiene and polyurethane (PUR), and in-line filter membranes composed of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA).
Handling instructions: The vial should be visually inspected before use. If the solution is cloudy, discoloured, or contains large or coloured particulates, the vial should be discarded.
Spevigo is for single use only.
Aseptic technique must be used to prepare the solution for infusion. Draw and discard 15 mL from a 100 mL container of sodium chloride 9 mg/mL (0.9%) solution for injection and replace slowly with 15 mL spesolimab sterile concentrate (complete content from two vials of 450 mg/7.5 mL). Mix gently before use. The diluted spesolimab infusion solution should be used immediately.
Spevigo must not be mixed with other medicinal products. A pre-existing intravenous line may be used for administration of diluted spesolimab infusion solution, if the compatibility information previously mentioned is considered. The line must be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.