Fraizeron Caution For Usage

Instructions for use and handling: Instruction for Use of Fraizeron 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 of Fraizeron in the refrigerator between 2°C to 8°C.
The single-use vial contains 150 mg of Fraizeron 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 Fraizeron 150 mg powder for solution for injection please adhere to the following instructions: Instructions for Reconstitution of Fraizeron 150 mg powder for solution for injection: Bring the vial of Fraizeron 150 mg powder for solution for injection to room temperature and ensure sterile water for injection (SWFI) is at room temperature.
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.
Remove the plastic cap from the vial.
Insert the syringe needle into the vial containing the lyophilized cake of Fraizeron 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.
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.
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.
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.
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 of Fraizeron solution: 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.
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 Fraizeron 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.
With the needle pointing upward, gently tap the syringe to move any air bubbles to the top.
Replace the attached needle with a 27G x ½" needle.
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.
Clean the injection site with an alcohol swab.
Inject the Fraizeron 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.
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, needles and used syringes must never be re-used.
Incompatibilities: Powder for solution for injection: Fraizeron should not be mixed with any medication or diluents other than sterile water for injection.