The following are key features and instructions for using BELOTERO® Intense with Lidocaine:

• Hyaluronic acid concentration: 25.5 mg/ml.
• Lidocaine concentration: 3 mg/ml for pain reduction during treatment.
• The product is suitable for deep dermal injections.
• It is recommended that trained professionals administer the treatment with knowledge of anatomy and injection techniques.
• The gel should be injected slowly and evenly into the treatment area, and post-injection, the area should be gently massaged for uniform distribution.
• Injection sites include areas such as cheeks, nasolabial folds, chin, and lips.

BELOTERO® Intense with Lidocaine is used for the treatment of deep wrinkles and folds, as well as for volume restoration in soft tissues. It is designed to provide long-lasting volume enhancement in areas such as the contours of the face and lip volume. Additionally, it can be used to correct atrophic scars and restore lost volume, giving a fuller, more youthful appearance.

Indications:

• Treatment of deep facial wrinkles, such as nasolabial folds.
• Volume restoration for areas like the cheeks, chin, and lips.
• Correction of atrophic facial scars.

Contraindications:

• Known hypersensitivity to hyaluronic acid or lidocaine.
• Not suitable for pregnant or breastfeeding women.
• Individuals under 18 years old.
• Active skin infections or inflammatory conditions in the treatment area.
• Should not be used in areas treated with permanent dermal fillers or in the glabellar region.

Side Effects:

• Injection site reactions such as redness, swelling, bruising, and itching.
• Rare side effects include nodule formation, skin discoloration, granulomas, abscesses, or necrosis.
• Some patients may experience localized pain or increased sensitivity at the injection site.

The BELOTERO® Intense with Lidocaine gel is a sterile and transparent filler composed of cross-linked sodium hyaluronate (25.5 mg/ml). This highly viscoelastic formulation ensures smooth integration into the skin, creating a natural, smooth appearance. The addition of lidocaine (3 mg/ml) provides pain relief during the injection, improving patient comfort. It is packaged in a 1 ml pre-filled syringe, which is sterilized by moist heat and comes with two sterile needles for precision and safety.

Ingredients:

• Sodium hyaluronate (25.5 mg/ml): Hydrates the skin, restores volume, and improves elasticity.
• Lidocaine (3 mg/ml): A local anesthetic that reduces pain during the procedure.
• Phosphate buffer: To stabilize the pH of the gel, ensuring skin compatibility.

Packaging:

• 1 ml pre-filled glass syringe with two sterile needles.
• The syringe is single-use and sterile.
• CE-marked, ensuring compliance with European medical device standards.

BELOTERO® Intense with Lidocaine should be injected by a licensed healthcare professional with expertise in dermal filler injections. The injection should be carried out slowly to allow the gel to be distributed evenly.

Method of Use:

1. Prepare the treatment area: Cleanse the skin and disinfect the area to be treated.
2. Needle assembly: Attach the sterile needle provided to the pre-filled syringe.
3. Injection: Inject the gel slowly into the deep dermis, avoiding overcorrection.
4. Massage the treated area gently to ensure even distribution.
5. Post-treatment care: Advise the patient to avoid makeup for 12 hours, and refrain from saunas, hot tubs, and direct sun exposure for 2 weeks after treatment.
6. Follow-up: Schedule regular follow-up appointments to maintain the results, which typically last between 6-12 months.

It is essential for practitioners to avoid direct injection into blood vessels and use correct aseptic techniques to reduce the risk of infections or complications.