Fraizeron Caution For Usage

Incompatibilities: Powder for solution for injection: Fraizeron 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.
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 adhere to the following instructions: Instructions for reconstitution of Fraizeron 150 mg powder for solution for injection: 1. 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.
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 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.
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.
9. 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: 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 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.
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 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.
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, needles and used syringes must never be re-used.
Instructions for Use of Fraizeron 300 mg UNOREADY solution for injection in pre-filled pen: Fraizeron UNOREADY pen 300 mg
Solution for injection in a pre-filled pen
Single-use pen for subcutaneous injection
Secukinumab
Patient Instructions for Use: Read ALL the way through these instructions before injecting.
These instructions are to help inject correctly using the Fraizeron UNOREADY pen.
It is important not to try to inject until patient have been trained by a doctor, nurse or pharmacist.
Fraizeron UNOREADY pen 300 mg: Do not use the Fraizeron UNOREADY pen if the seal on the outer carton is broken.
Keep the Fraizeron UNOREADY pen in the sealed outer carton until ready to use to protect it from light.
Do not freeze the Fraizeron UNOREADY pen.
Do not shake the Fraizeron UNOREADY pen.
Do not use the Fraizeron UNOREADY pen if it has been dropped with the cap removed.
The needle is covered by the needle guard and the needle will not be seen. Do not touch or push the needle guard because you could get a needle stick.
Do not remove the cap until ready to inject.
What are needed for injection: Included in the carton: A new, unused Fraizeron UNOREADY pen.
Not included in the carton: Alcohol swab, Cotton ball or gauze, Sharps disposal container.
See “Disposing Fraizeron UNOREADY pen” in the following text.
Before injection: For a more comfortable injection, take the Fraizeron UNOREADY pen out of the refrigerator 30 to 45 minutes before injecting to allow it to reach room temperature.
1. Important safety checks before injection: For the “viewing window”: The liquid should be clear. Its color may vary from colorless to slightly yellow.
Do not use if the liquid contains visible particles, is cloudy or is distinctly brown. Air bubbles may be seen, which is normal.
For the “Expiration date”: Look at the expiration date (EXP) on the Fraizeron pen. Do not use the pen if the expiration date has passed.
Check that the pen contains the correct medicine and dosage. Contact a pharmacist if the pen fails any of these checks.
2a. Choose the injection site: The recommended site is the front of the thighs. The lower abdomen may also be used, but not the area 2 inches (5 cm) around the navel (belly button).
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.
2b. Caregivers and healthcare professionals only: If a caregiver or healthcare professional is giving the injection, they may also inject into the outer upper arm.
3. Cleaning the injection site: Wash hands with soap and hot 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.
4. Removing the cap: Only remove the cap when ready to use the pen.
Pull the cap straight off.
Once removed, throw away the cap. Do not try to re attach the cap as the needle might bend.
Use the pen within 5 minutes of removing the cap.
5. Holding Fraizeron UNOREADY pen: Hold the pen at 90 degrees to the cleaned injection site.
READ THE FOLLOWING BEFORE INJECTING.
During the injection 2 clicks will be heard.
The 1st click indicates that the injection has started. Several seconds later a 2nd click will indicate that the injection is almost finished.
Keep holding the pen firmly against the skin until a green indicator with a grey tip fill the window is seen and stop moving.
6. Starting the injection: Press the pen firmly against the skin to start the injection.
The 1st click indicates the injection has started.
Keep holding the pen firmly against the skin.
The green indicator with the grey tip shows the progress of the injection.
7. Completing the injection: Listen for the 2nd click. This indicates the injection is almost complete.
Check the green indicator with the grey tip has filled the window and has stopped moving.
The pen can now be removed.
After injection: 8. Check the green indicator fill the window: This means the medicine has been delivered. Contact a doctor or pharmacist if the green indicator is not visible.
There may be a small amount of blood at the injection site. Press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. Cover the injection site with a small adhesive bandage, if needed.
9. Disposing Fraizeron UNOREADY pen: Dispose of the used pen in a sharps disposal container (i.e. a puncture-resistant closable container, or similar). Never try to reuse the pen.
Instructions for use of Fraizeron 150 MG SENSOREADY solution for injection in pre-filled pen: Fraizeron SensoReady pen 150 mg
Solution for injection in a pre-filled pen
Secukinumab
Patient Instructions for Use: Read ALL the way through these instructions before injecting.
These instructions are to help inject correctly using the Fraizeron SensoReady pen.
It is important not to try to inject until patient have been trained by a doctor, nurse or pharmacist.
Do not freeze the Fraizeron SensoReady pen.
Do not shake the Fraizeron SensoReady pen.
Do not use the Fraizeron SensoReady pen if it has been dropped with the cap removed.
For a more comfortable injection, take the Fraizeron SensoReady pen out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature.
Do not remove the cap until ready to inject.
What are needed for injection: Included in the carton: A new and unused Fraizeron 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 injection: 1. Important safety checks before injection: 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. Small air bubble may be seen, which is normal.
Do not use Fraizeron SensoReady pen if the expiration date has passed. Do not use if the safety seal has been broken.
Contact a pharmacist if the Fraizeron SensoReady pen fails any of these checks.
2a. Choose the injection site: The recommended site is the front of the thighs. The lower abdomen may also be used, but not the area 2 inches around the navel (belly button).
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.
2b. Caregivers and Healthcare Professionals Only: If a caregiver or healthcare professional is giving the injection, they may also inject into the outer upper arm.
3. Cleaning the injection site: Wash 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.
4. Removing the cap: Only remove the cap when you ready to use the Fraizeron SensoReady pen.
Twist off the cap.
Once removed, throw away the cap. Do not try to re-attach the cap.
Use the Fraizeron SensoReady pen within 5 minutes of removing the cap.
5. Holding Fraizeron SensoReady pen: Hold the Fraizeron SensoReady pen at 90 degrees to the cleaned injection site.
READ THE FOLLOWING BEFORE INJECTING.
During the injection 2 loud clicks will be heard.
The 1st click indicates that the injection has started. Several seconds later a 2nd click will indicate that the injection is almost finished.
Keep holding the Fraizeron SensoReady pen firmly against the skin until a green indicator fill the window is seen and stop moving.
6. Starting the injection: Press the Fraizeron SensoReady pen firmly against the skin to start the injection.
The 1st click indicates the injection has started.
Keep holding the Fraizeron SensoReady pen firmly against the skin.
The green indicator shows the progress of the injection.
7. Completing the injection: Listen for the 2nd click. This indicates the injection is almost complete.
Check the green indicator fills the window and has stopped moving.
The Fraizeron SensoReady pen can now be removed.
After injection: 8. Check the green indicator fills the window: This means the medicine has been delivered. Contact a doctor if the green indicator is not visible.
There may be a small amount of blood at the injection site. Press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. Cover the injection site with a small adhesive bandage, if needed.
9. Disposing Fraizeron SensoReady pen: Dispose of the used Fraizeron SensoReady pen in a sharps disposal container (i.e. a puncture-resistant closable container, or similar).
Never try to reuse Fraizeron SensoReady pen.