Somatuline Caution For Usage

Incompatibilities: Not applicable.
Instructions for Use and Handling: The Somatuline Autogel 120 mg prolonged-release solution for injection in a pre-filled syringe is a ready-for use supersaturated lanreotide solution that forms a whitish, translucent autogel.
For immediate and single use following first opening.
It is important that the injection of the product is performed exactly according to the instruction in the package leaflet.
Do not use if the laminated pouch is damaged or opened.
Any unused product or waste material should be disposed of in accordance with local requirements.
The following instructions explain how to inject Somatuline Autogel.
Somatuline Autogel is supplied in a ready to use pre-filled syringe fitted with an automatic safety system. The needle will retract automatically following the full administration of the product, to prevent needle stick injury.
1. Remove Somatuline Autogel from the refrigerator 30 minutes prior to administration. Injection of cold medication may be painful. Keep laminated pouch sealed until just prior to injection.
2. Attention: Before opening the pouch, check that it is intact and that the medication has not expired.
Do not use the pre-filled syringe: If the patient drops or damages the pre-filled syringe or if the pre-filled syringe or pouch appears damaged in any way; If the product has expired; the expiry date is printed on the outer carton and the pouch.
If any of the previously mentioned apply, contact the doctor or pharmacist.
3. Wash hands with soap.
4. Tear-open the pouch along the dotted line and take out the pre-filled syringe. The content of the pre-filled syringe is a semi-solid phase having a gel-like appearance, with viscous characteristics and a colour varying from white to pale yellow. The supersaturated solution can also contain micro bubbles that can clear up during injection. These differences are normal and do not interfere with the quality of the product.
After opening the protective laminated pouch, the product should be administered immediately.
5. Select an injection site: 5a. If a healthcare professional (HCP) or someone else like a trained family member or friend is doing the injection: use the superior external (upper, outer) quadrant of the buttock (for injection by healthcare professional (HCP) or someone else like a trained family member or friend).
5b. If self-injection will be done by the patient: use the upper outer part of the thigh (if the patient will self-inject).
Alternate the injection site between the right and left side each time the patient receives an injection of Somatuline Autogel. Avoid areas with moles, scar tissues, reddened skin, or skin that feels bumpy.
6. Clean the injection.
7. Before injecting, remove the pre-filled syringe from its tray. Discard the tray.
8. Remove the needle cap by pulling off and discarding it.
9. Flatten injection area using the thumb and index finger of the hand not holding the pre-filled syringe to stretch the skin. Do not pinch the skin. Use a strong, straight dart-like motion to quickly insert the needle perpendicular to the skin (90 degree angle), all the way into the skin. It is very important that the patient inserts the needle completely. The patient should not see any needle once it is fully inserted.
Do not aspirate (do not draw back).
10. Release inject site that has been flattened by the hand. Push plunger with steady very firm pressure. The medication is thicker and harder to push than the patient might expect. Typically, 20 seconds are needed. Inject the full dose and give a final push to make sure that the patient cannot depress it any further.
Note: Maintain pressure on the plunger with the thumb to avoid activation of the automatic safety system.
11. Without releasing the pressure on the plunger, withdraw the needle from the injection site.
12. Then release pressure on the plunger. The needle will automatically retract into the needle guard where it will be locked permanently.
13. Apply gentle pressure to the injection site with a dry cotton ball or sterile gauze to prevent any bleeding. Do not rub or massage the injection site after administration.
14. Dispose of the used syringe as instructed by the doctor or healthcare provider. Do not dispose of the device in the general household rubbish.