RESTYLANE LIDOCAINE

RESTYLANE LIDOCAINE is a gel:
- Sterile, transparent, biodegradable stabilised hyaluronic acid, not of animal origin.
- With the addition of lidocaine hydrochloride at 0.3%.
- Which guarantees biocompatibility and natural integration into tissues.

- GALDERMA
- NAME: RESTYLANE LIDOCAINE
- COMPOSITION: Hyaluronic acid, stabilised 20 mg/mL, Lidocaine hydrochloride 3 mg/mL, Buffered saline solution up to 1 mL.
- PRESENTATION: 1 x 1 ml.
- INDICATIONS: Indicated for facial tissue augmentation, correction of facial wrinkles, and lip augmentation and enhancement.
- NEEDLES: 2 x 29G TW.
- INJECTION DEPTH: Mid-dermis and submucosal layer of the lips. For areas of the face with reduced soft tissue support or limited skin coverage (e.g. periorbital region), injection into the subcutaneous adipose tissue or supraperiosteal area is recommended.
- DURATION: Up to 12 months.
- USE: Strict medical use.

- Syringes: 1 x 1 ml.
- Needles: 2 x 29G TW.
- Each box contains one 1 mL syringe of RESTYLANE LIDOCAINE, 2 sterile single-use 29G x ½” needles reserved exclusively for injection of RESTYLANE LIDOCAINE, instructions for use and labels to ensure traceability.

Face, in particular: nasolabial wrinkles, marionette lines, perioral wrinkles, facial furrows, volume and lip contour.

Hyaluronic acid, stabilised 20 mg/mL, Lidocaine hydrochloride 3 mg/mL, Buffered saline solution up to 1 mL.

- Healthcare professionals should discuss all potential risks of soft tissue injection with patients prior to treatment, making sure they know the signs and symptoms of possible complications.
- The product should only be used by healthcare professionals with appropriate training, experience and knowledge of the anatomy of the area to be treated, to reduce risks such as perforation or compression of vessels, nerves or other sensitive structures.
- Injectable procedures carry a risk of infection: aseptic techniques and standard practices must be followed to prevent cross-infection.
- Injection in areas close to permanent implants should be avoided, as it may aggravate latent adverse events or interfere with the aesthetic result. Data on use near non-permanent implants other than hyaluronic acid are limited.
- An injection that is too superficial, or in areas with reduced soft tissue support or thin skin (such as the periorbital region), may result in contour irregularities, palpable nodules or bluish discolourations.
- Injection into the lower periorbital region in patients with pre-existing dark circles or a tendency to oedema may cause marked discolouration and excessive swelling due to fluid accumulation.
- Possible post-inflammatory pigmentation changes in patients with dark skin (Fitzpatrick IV-VI).
- Injections may cause reactivation of latent or subclinical herpes.
- Use with caution in patients on immunosuppressive therapy.
- Patients with unrealistic expectations are not suitable candidates.
- Product packaged for single use. Do not resterilise.
- Do not use if the packaging is opened, damaged or if the expiry date/lot number is not legible.
- Avoid excessive exposure to sun, UV and extreme temperatures until initial swelling and redness have resolved.
- Subsequent treatments such as lasers, chemical peels or procedures that stimulate an active dermal response may cause inflammatory reactions at the implant site if performed before or after the filler is fully healed.
- Safety in pregnancy, breast-feeding or in patients under 18 years of age is not established.
- Individual variations and the area treated may influence the biodegradation of the product; in rare cases, residues may remain in the tissue.
- Consider the total dose of lidocaine administered when combined with dental blocks or topical lidocaine: high doses (>400 mg) may cause acute toxicity with effects on the CNS and cardiac conduction.
- Use lidocaine with caution in patients taking other local anaesthetics or structurally similar drugs (e.g. some antiarrhythmics), as the systemic toxic effects may add up.
- Use with caution in patients with epilepsy, cardiac conduction disorders, severe hepatic or renal impairment.
- Peribulbar injections of local anaesthetics present a low but possible risk of persistent ocular muscle dysfunction.

RESTYLANE LIDOCAINE is contraindicated in the following cases:
- Do not use in patients with a history of hypersensitivity to streptococcal proteins, as the product may contain traces of these substances.
- Do not use in patients with severe allergies, manifested by history of anaphylaxis or presence/history of multiple severe allergies.
- Do not use in patients with known hypersensitivity to lidocaine or amide-type local anaesthetics.

RESTYLANE LIDOCAINE is intended for correcting wrinkles and improving lip volume.

The contents of the syringe are sterilised by moist heat. Needles are sterilised by irradiation.