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Jubbonti

Jubbonti Patient Counseling Information

denosumab

Manufacturer:

Novartis Pharmaceutical Manufacturing GmbH

Distributor:

Zuellig Pharma

Marketer:

Sandoz
Full Prescribing Info
Patient Counseling Information
Instructions for Use: These "Instructions for Use" contain information on how to inject Jubbonti.
If your doctor decides that you or your caregiver may be able to give your injections of Jubbonti at home, ensure that your doctor or nurse shows you or your caregiver how to prepare and inject with the Jubbonti pre-filled syringe before you use it for the first time.
Be sure that you read and understand these Instructions for Use before injecting with the Jubbonti pre-filled syringe. Talk to your doctor if you have any questions.
Important information you need to know before injecting Jubbonti: Jubbonti is for subcutaneous injection only (inject directly into fatty layer under the skin).
Do not use the pre-filled syringe if any of the safety seals on the outer carton or the seal of the plastic tray is broken.
Do not shake the pre-filled syringe at any time.
Do not use if the pre-filled syringe has been dropped onto a hard surface or dropped after removing the needle cap.
The pre-filled syringe has a safety guard that activates to cover the needle after the injection is finished. The safety guard helps to prevent needle stick injuries to anyone who handles the pre-filled syringe after injection.
Be careful not to touch the safety guard wings before use. Touching them may cause the safety guard to activate too early.
Do not attempt to re-use or disassemble the pre-filled syringe.
Do not pull back on the plunger.
Store Jubbonti: Store in a refrigerator between 2°C and 8°C.
Do not freeze.
If needed, you may store the pre-filled syringe at room temperature up to 25°C for up to 30 days.
Throw away the pre-filled syringe that has been stored at room temperature after 30 days.
Keep the pre-filled syringe in the original carton until ready to use in order to protect from light.
Prepare to inject Jubbonti: Step 1. Bring to room temperature: Take the carton containing the pre-filled syringe out of the refrigerator and leave it unopened for about 15 to 30 minutes so that it reaches room temperature.
Step 2. Gather supplies: Ensure that you have the following (not included in the carton): Alcohol wipe, Cotton ball or gauze pad, Sharps disposal container, Adhesive plaster.
Step 3. Unpack: Open the plastic tray by peeling away the cover. Remove the pre-filled syringe by holding it in the middle.
Do not remove the needle cap until you are ready to inject.
Step 4. Perform safety checks: Look through the viewing window of the pre-filled syringe. The liquid inside should be a clear, colourless to slightly yellowish or slightly brownish solution. You may see air bubbles in the liquid, which is normal. Do not attempt to remove the air.
Do not use the pre-filled syringe if liquid is cloudy or contains visible particles.
Do not use the pre-filled syringe if it appears to be damaged or if it has leaked.
Do not use the pre-filled syringe after the expiry date (EXP), which is printed on the pre-filled syringe label and carton.
In all of these cases, contact your doctor, nurse or pharmacist.
Step 5. Choose injection site: You should inject into the front of the thighs or the lower stomach area but not the area 5 cm around the belly button.
Do not inject into skin that is tender, bruised, red, scaly, hard or into areas with scars or stretch marks.
If your caregiver, doctor or nurse is giving you the injection, they may also inject into the upper arm.
Inject with Jubbonti: Step 6. Clean injection site: Wash your hands with soap and water.
Clean the chosen injection site with an alcohol wipe. Leave it to dry before injecting.
Do not touch or blow on the cleaned area before injecting.
Step 7. Remove needle cap: Firmly pull straight to remove the needle cap from the pre-filled syringe. You may see a drop of liquid at the end of the needle. This is normal.
Do not put the needle cap back on. Throw away the needle cap.
Step 8. Insert needle: Gently pinch the skin at the injection site and hold the pinch throughout the injection. With the other hand insert the needle into the skin at an angle of approximately 45 degrees.
Do not press the plunger while inserting the needle.
Step 9. Start injection: Continue to pinch the skin. Slowly press the plunger as far as it will go. This will ensure that a full dose is injected.
Step 10. Complete injection: Confirm that the plunger head is between the safety guard wings. This will ensure that the safety guard has been activated and will cover the needle after the injection is finished.
Step 11. Release plunger: Keeping the pre-filled syringe at the injection site, slowly release the plunger until the needle is covered by the safety guard. Remove the pre-filled syringe from the injection site and release the pinch.
There may be a small amount of blood at the injection site. You can press a cotton ball or gauze pad over the injection site until any bleeding stops. Do not rub the injection site. If needed, cover the injection site with a small adhesive plaster.
After the injection: Step 12. Dispose of the pre-filled syringe: Put the pre-filled syringe in a sharps disposal container immediately after use. Do not throw away the pre-filled syringe into household waste.
Talk to your doctor or pharmacist about proper disposal of the sharps disposal container. There may be local regulations for disposal.
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