Cosentyx Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling under Cautions for Usage as follows.
Special precautions for disposal and other handling: Vial: The single-use vial contains 150 mg secukinumab for reconstitution with sterile water for injections. The resulting solution should be clear and colourless to slightly yellow. Do not use if the lyophilised powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Reconstitution: Cosentyx 150 mg powder for solution for injection must be prepared by a healthcare professional. The preparation of the solution for subcutaneous injection must be done without interruption and ensuring that aseptic technique is used. The preparation time from piercing the stopper until end of reconstitution takes 20 minutes on average and should not exceed 90 minutes.
1. Bring the vial of powder to room temperature and ensure that the sterile water for injections is at room temperature.
2. Withdraw slightly more than 1.0 ml sterile water for injections into a 1 ml graduated disposable syringe and adjust to 1.0 ml.
3. Remove the plastic cap from the vial.
4. Insert the syringe needle into the vial containing the powder through the centre of the rubber stopper and reconstitute the powder by slowly injecting 1.0 ml of sterile water for injections into the vial. The stream of sterile water for injections should be directed onto the powder.
5. Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 1 minute. Do not shake or invert the vial.
6. Keep the vial standing at room temperature for a minimum of 10 minutes to allow for dissolution. Note that foaming of the solution may occur.
7. Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 1 minute. Do not shake or invert the vial.
8. Allow the vial to stand undisturbed at room temperature for approximately 5 minutes. The resulting solution should be clear. Its colour may vary from colourless to slightly yellow. Do not use if the lyophilised powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or is distinctly brown.
9. Prepare the required number of vials (2 vials for the 300 mg dose).
Use in the paediatric population: For paediatric patients receiving the 75 mg dose from the single-use vial containing 150 mg secukinumab for reconstitution with sterile water for injections, slightly more than 0.5 ml of the reconstituted solution for subcutaneous injection have to be withdrawn and the rest of the solution must be discarded immediately. Detailed instructions for use are provided in the package leaflet.
Pre-filled pen: Cosentyx solution for injection in pre-filled pen 150 mg/ml: Cosentyx solution for injection in pre-filled pen 150 mg/ml is supplied in a single-use pre-filled pen for individual use. The pen should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.
Cosentyx solution for injection in pre-filled pen 300 mg/2 ml: Cosentyx solution for injection in pre-filled pen 300 mg/2 ml is supplied in a single-use pre-filled pen for individual use. The pen should be taken out of the refrigerator 30-45 minutes before injecting to allow it to reach room temperature.
Prior to use, a visual inspection of the pre-filled pen is recommended. The liquid should be clear. Its colour may vary from colourless to slightly yellow. A small air bubble may be seen, which is normal. Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Detailed instructions for use are provided in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.