RESTYLANE LYFT LIDOCAINE

RESTYLANE LYFT LIDO is a gel:
- Sterile hyaluronic acid generated by bacterial species of the genus Streptococcus, chemically cross-linked with BDDE, stabilised.
- For a structural and long-lasting volumising effect.
- It contains 0.3% lidocaine, which greatly improves comfort during injection.
- Deep shaping and support effect.

- GALDERMA
- NAME: RESTYLANE LYFT LIDO
- COMPOSITION: Concentration of 20 mg/mL, lidocaine 0.3%, buffered saline pH = 7.
- PRESENTATION: 1 x 1 ml.
- INDICATIONS: RESTYLANE LYFT LIDO is indicated for shaping facial contours, correcting folds and improving lip volume.
- NEEDLES: 2 x 29G½.
- INJECTION DEPTH: Deep layer of the dermis and/or in the superficial subcutaneous layer, or at the submucosal level of the lips. Deeper injections, into the subcutaneous fatty tissue or supraperiosteal layer, are appropriate for areas with adequate soft tissue support and coverage, such as the middle third of the face and the jaw line.
- DURATION: Up to 12 months.
- USE: Strict medical use.

- Syringes: 1 x 1 ml.
- Needles: 2 x 29G½.
- Each box contains one 1 mL syringe of RESTYLANE LYFT LIDO, 2 sterile disposable 29G x ½” needles reserved exclusively for injection of RESTYLANE LYFT LIDO, instructions for use and labels to ensure traceability.

Nose-labial furrows, cheeks, contour of the middle third of the face, lip contour and hands.

Concentration of 20 mg/mL, lidocaine 0.3%, buffered saline pH = 7.

- Restylane® Lyft with Lidocaine is packaged for single use. Do not resterilise. Do not use if package is opened or damaged.
- The safety of using a cannula for cheek augmentation and mid-third contour correction was only evaluated with three brands of blunt cannulae (DermaSculpt, Softfil, TSK Steriglide) of 25G-27G and length 1.5”-2”.
- Safety and efficacy beyond 1 year have not been studied.
- Like all transcutaneous procedures, it carries a risk of infection: follow standard aseptic techniques.
- The safety/efficacy for lip augmentation is not established.
- Safety in pregnancy, breast-feeding or in patients under 18 years of age is not established.
- Keloids may occur, although they were not observed in clinical studies of 709 patients (including subjects with phototypes IV-VI).
- The injection may cause hyperpigmentation.
- In a study of 150 patients with pigmented skin, the incidence of post-inflammatory hyperpigmentation was 6%.
- Use with caution in patients on immunosuppressive therapy.
- Possible bruising or bleeding at injection sites; use with caution if the patient has received thrombolytics, anticoagulants or antiplatelets in the previous 3 weeks.
- Syringes, needles and cannulas should be considered biological waste.
- Safety with concomitant treatments (epilation, UV, laser, mechanical/chemical peeling) is not established.
- Avoid excessive exposure to sun, UV rays and intense cold until the swelling/redness resolves.
- If laser/peeling or other active dermal procedures are performed after treatment, there is a risk of an inflammatory reaction at the implant site.
- Injection in patients with a history of herpes may lead to reactivation.
- The gel must be clear and colourless; do not use if turbid or separated.
- The product must not be mixed with other fillers before implantation.
- The product should only be used by trained and competent health professionals.

RESTYLANE LYFT LIDO is contraindicated in the following cases
- In patients with severe allergies, manifested by history of anaphylaxis or presence/history of multiple severe allergies.
- In patients with allergies to gram-positive bacterial proteins, as the product may contain traces of these.
- In patients with coagulation disorders.
- In patients with hypersensitivity to local anaesthetics of the amide type, such as lidocaine.

Correction of moderate to severe facial folds and wrinkles, such as: nasolabial folds.
Cheek augmentation and correction of age-related deficiencies in the contour of the middle third of the face in patients over 21 years of age.
Correction of volume deficit of the back of the hand in patients over 21 years of age.

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