RESTYLANE DEFYNE

RESTYLANE DEFYNE is a gel:
- Sterile, biodegradable, transparent, based on cross-linked non-animal hyaluronic acid, enriched with lidocaine hydrochloride.
- With volumising and lifting capacity.
- 69.8% of the subjects maintained a clinically significant improvement at 48 weeks after treatment.

- GALDERMA
- NAME: RESTYLANE DEFYNE
- COMPOSITION: Cross-linked hyaluronic acid 20 mg/mL, Lidocaine hydrochloride 3 mg/mL, Phosphate-buffered saline solution pH 7 qs to 1 mL.
- PRESENTATION: 1 x 1 ml.
- INDICATIONS: Increases tissue volume, restoring facial skin contours to the desired effect.
- NEEDLES: 2 x 27Gx½”.
- INJECTION DEPTH: Medium-deep dermis.
- DURATION: Up to 12 months.
- USE: Strict medical use.

- Syringes: 1 x 1 ml.
- Needles: 2 x 27G x ½”.
- Each box contains one 1mL syringe of RESTYLANE DEFYNE, 2 sterile disposable needles x 27G x ½” reserved exclusively for injecting RESTYLANE DEFYNE, instructions for use and labels to ensure traceability.

Severe facial wrinkles and folds such as nasolabial folds and marionette lines.

Cross-linked hyaluronic acid 20 mg/mL, Lidocaine hydrochloride 3 mg/mL, Phosphate-buffered saline solution pH 7 qs to 1 mL.

- The product should only be used by qualified healthcare professionals who are experienced in the injection technique and knowledge of the anatomy of the treated area.
- Practitioners should discuss all potential risks of soft tissue injections with patients and make sure they understand any signs of complications.
- Not indicated in patients with unrealistic expectations.
- Safety not established in pregnancy, lactation or in patients <18 years. Do not use in children.
- Injection procedures carry a risk of infection: strictly follow aseptic techniques.
- Do not use if the packaging is opened, damaged, if the expiry date or batch number is not legible, or if the contents of the syringe appear cloudy.
- Use with caution in patients on immunosuppressive therapy or with a tendency to hypertrophic scars or other healing disorders.
- Avoid injecting too superficially or in areas with little skin support, such as around the eyes, to prevent irregularities or dyschromia.
- Avoid excessive exposure to sun, UV lamps or extreme temperatures until resolution of initial reddening or oedema.
- Caution if laser treatments, chemical peels or other active procedures are performed after injection; theoretical risk of inflammatory reaction.
- Possible reactivation of latent or subclinical herpes infections.
- Possible pigmentary changes post-injection, especially in dark skins (Fitzpatrick IV-VI).
- Consider the total volume of lidocaine administered if local anaesthesia or dental blocks are used simultaneously; high doses (>400 mg) may cause acute toxicity.
- Use caution in patients with epilepsy, cardiac conduction problems, severe liver failure or severe renal failure.

RESTYLANE DEFYNE is contraindicated in the following cases:
- Do not use in patients with hypersensitivity to streptococcal proteins, as the product may contain traces of these proteins.
- Do not use in patients with severe allergies, anaphylaxis or multiple severe allergies.
- Do not use in patients with known hypersensitivity to lidocaine or amide-type local anaesthetics.
- Do not use in patients with porphyria.

RESTYLANE DEFYNE is intended to increase tissue volume, restoring facial skin contours to the desired effect. Lidocaine is added to reduce pain during treatment.

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