Scapho Caution For Usage

Instructions for Use and Handling: Instruction for Use of Scapho 150 mg powder for solution for injection: The following information is intended for medical or healthcare professionals only.
Store the vial of 150 mg powder for solution for injection in the refrigerator between 2°C to 8°C.
Each pack contains a single-use vial containing 150 mg of secukinumab for reconstitution with sterile water for injection (SWFI). Do not use the vial after the expiry date shown on the outer box or vial. If it has expired, return the entire pack to the pharmacy.
The preparation of the solution for subcutaneous injection shall be done without interruption ensuring that aseptic technique is used. The preparation time from piercing the stopper until end of reconstitution on average takes 20 minutes and should not exceed 90 minutes.
To prepare the drug for administration, please adhere to the following instructions: Instructions for reconstitution: 1. Bring the vial of the drug product to room temperature and ensure sterile water for injection (SWFI) is at room temperature.
2. Withdraw slightly more than 1.0 mL sterile water for injection (SWFI) 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 lyophilized cake of drug powder through the center of the rubber stopper and reconstitute the cake by slowly injecting 1.0 mL of SWFI into the vial. The stream of SWFI should be directed onto the lyophilized cake.
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 color may vary from colorless to slightly yellow. Do not use if the lyophilized powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Prepare the required number of vials (1 vial for the 75 mg dose, 1 vial for the 150 mg dose, 2 vials for the 300 mg dose).
After preparation, the solution for subcutaneous injection can be used immediately or can be stored at 2°C to 8°C for up to 24 hours. Do not freeze. After storage at 2°C to 8°C, the solution should be allowed to come to room temperature for approximately 20 minutes before administration. The solution should be administered within 1 hour after removal from the 2°C to 8°C storage.
Instructions for administration: 1. Tilt the vial to an angle of approximately 45 degrees and position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. DO NOT invert the vial.
2. For the 150 mg and 300 mg doses, carefully withdraw slightly more than 1.0 mL of the solution for subcutaneous injection from the vial into a 1 mL graduated disposable syringe using a suitable needle (e.g. 21G x 2"). This needle will only be used for withdrawing the drug product into the disposable syringe. Prepare the required number of syringes (1 syringe for the 150 mg dose, 2 syringes for the 300 mg dose). For a child receiving the 75 mg dose, carefully withdraw slightly more than 0.5 mL of the solution for subcutaneous injection and discard the rest immediately.
3. With the needle pointing upward, gently tap the syringe to move any air bubbles to the top.
4. Replace the attached needle with a 27G x ½" needle.
5. Expel the air bubbles. For the 150 mg dose, advance the plunger to the 1.0 mL mark. For the 75 mg dose, advance the plunger to the 0.5 mL mark.
6. Clean the injection site with an alcohol swab.
7. Inject the drug solution subcutaneously into the front of thighs, lower abdomen (but not the area 2 inches (5 centimeters) around the navel (belly button) or outer upper arms. Choose a different site each time an injection is administered. Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.
8. Any remaining solution in the vial must not be used and should be discarded in accordance with local requirements. Vials are for single use only. Dispose of the used syringe in a sharps container (closable, puncture resistant container). For the safety and health of the patient and others, needles and used syringes must never be re-used.
Instructions for use of Scapho 150 mg SensoReady solution for injection in pre-filled pen: Store the boxed Scapho SensoReady pen in a refrigerator between 2°C and 8°C.
Do not freeze the Scapho SensoReady pen.
Do not shake the Scapho SensoReady pen.
Do not use the Scapho SensoReady pen if it has been dropped with the cap removed.
Do not remove the cap until the patient is ready to inject.
For a more comfortable injection, take the Scapho SensoReady pen out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature.
What does the patient need for the injection: Included in the carton: A new and unused Scapho SensoReady pen. 1 pen is needed for a 150 mg dose and 2 pens are needed for a 300 mg dose.
Not included in the carton: Alcohol swab, Cotton ball or gauze, Sharps disposal container.
Before the injection: 1. Important safety checks before injecting: The liquid should be clear. Its color may vary from colorless to slightly yellow.
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown. The healthcare professional may see a small air bubble, which is normal.
Do not use the Scapho SensoReady pen if the expiration date has passed.
Do not use if the safety seal has been broken.
Contact the pharmacist if the Scapho SensoReady pen fails any of these checks.
2a. Choose the patient's injection site: The recommended site is the front of the thighs. May also use the lower abdomen, but not the area 2 inches around the navel (belly button).
Choose a different site each time the patient is given an injection.
Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.
2b. Caregivers and Healthcare Professionals Only: If a caregiver or healthcare professional is giving the patient the injection, may also inject into the outer upper arm.
3. Cleaning the injection site: Wash the hands with hot soapy water.
Using a circular motion, clean the injection site with the alcohol swab. Leave it to dry before injecting.
Do not touch the cleaned area again before injecting.
The patient's injection: 4. Removing the cap: Only remove the cap when ready to use the Scapho SensoReady pen.
Twist off the cap in the direction of the arrows.
Once removed, throw away the cap. Do not try to re-attach the cap.
Use the Scapho SensoReady pen within 5 minutes of removing the cap.
5. Holding the Scapho SensoReady pen: Hold the Scapho SensoReady pen at 90 degrees to the cleaned injection site.
During the injection the patient will hear 2 loud clicks.
The 1st click indicated that the injection has started. Several seconds later a 2nd click will indicate that the injection is almost finished.
The patient must keep holding the Scapho SensoReady pen firmly against the skin until the patient sees a green indicator fill the window and stop moving.
6. Starting the injection: Press the Scapho SensoReady pen firmly against the skin to start the injection.
The 1st click indicates the injection has started.
Keep holding the Scapho SensoReady pen firmly against the skin.
The green indicator shows the progress of the injection.
7. Completing the injection: Listen for the 2^nd click. This indicates the injection is almost complete.
Check the green indicator fills the window and has stopped moving.
The Scapho SensoReady pen can now be removed.
After the injection: 8. Check the green indicator fills the window: This means the medicine has been delivered. Contact the doctor if the green indicator is not visible.
There may be a small amount of blood at the injection site. The healthcare professional can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. The healthcare professional may cover the injection site with a small adhesive bandage, if needed.
9. Disposing of the Scapho SensoReady pen: Dispose of the used Scapho SensoReady pen in a sharps disposal container (i.e. a puncture-resistant closable container, or similar).
Never try to reuse the Scapho SensoReady pen.
Incompatibilities: Powder for solution for injection: Scapho should not be mixed with any medication or diluents other than sterile water for injection.
Solution for injection in pre-filled pen: These medicinal products must not be mixed with other medicinal products.