Steqeyma Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
130 mg concentrate for solution for infusion: STEQEYMA should only be diluted with sodium chloride 9 mg/mL (0.9%) solution. STEQEYMA should not be administered concomitantly in the same intravenous line with other medicinal products.
Special precautions for disposal and other handling: The solution in the STEQEYMA pre-filled syringe/vial should not be shaken. The solution should be visually inspected for particulate matter or discolouration prior to administration. The solution is clear to slightly opalescent, colourless to pale yellow. The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
45 mg and 90 mg solution for injection: May contain a few small translucent or white particles of protein. This appearance is not unusual for proteinaceous solutions. Before administration, STEQEYMA should be allowed to reach room temperature (approximately half an hour). Detailed instructions for use are provided in the package leaflet.
STEQEYMA does not contain preservatives; therefore any unused medicinal product remaining in the syringe should not be used. STEQEYMA is supplied as a sterile, single use pre-filled syringe. The syringe must never be re-used. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
130 mg concentrate for solution for infusion: Dilution: STEQEYMA concentrate for solution for infusion must be diluted and prepared by a healthcare professional using aseptic technique.
1. Calculate the dose and the number of STEQEYMA vials needed based on patient weight (see Table 9 under Dosage & Administration). Each 26 mL vial of STEQEYMA contains 130 mg of ustekinumab. Only use complete vials of STEQEYMA.
2. Withdraw and discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of STEQEYMA to be added. (Discard 26 mL sodium chloride for each vial of STEQEYMA needed, for 2 vials - discard 52 mL, for 3 vials - discard 78 mL, for 4 vials - discard 104 mL.)
3. Withdraw 26 mL of STEQEYMA from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Gently mix.
4. Visually inspect the diluted solution before administration. Do not use if visibly opaque particles, discolouration or foreign particles are observed.
5. Administer the diluted solution over a period of at least one hour. Once diluted, the infusion should be completed within forty-eight hours of the dilution in the infusion bag.
6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
7. Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements.