RESTYLANE REFYNE LIDOCAINE

RESTYLANE REFYNE LIDO is a gel:
- Sterile, biodegradable and transparent cross-linked hyaluronic acid of non-animal origin.
- With the addition of lidocaine hydrochloride 3 mg/mL.
- Natural and mobile result (XpresHAn technology), designed to maintain expressiveness and mimicry without rigidity.
- Soft, supple and flexible, suitable for gentle and progressive corrections for a harmonious result.
- Lifting effect and restoration of skin contours thanks to the ability of cross-linked hyaluronic acid to bind water and provide tissue support.

- GALDERMA
- NAME: RESTYLANE REFYNE LIDO
- COMPOSITION: Cross-linked hyaluronic acid 20 mg/mL, Lidocaine hydrochloride 3 mg/mL, pH 7 buffered saline solution up to 1 mL.
- PRESENTATION: 1 x 1 ml.
- INDICATIONS: Adds volume to the tissues, thus restoring the skin contours of the face to the desired level of correction.
- NEEDLES: 2 x 30G×½”.
- INJECTION DEPTH: Medium to deep dermis.
- DURATION: Up to 12 months.
- USE: Strict medical use.

- Syringes: 1 x 1 ml.
- Needles: 2 x 30G×½”.
- Each box contains one 1 mL syringe of RESTYLANE REFYNE LIDO, 2 sterile disposable 30G x ½” needles reserved exclusively for injection of RESTYLANE REFYNE LIDO, instructions for use and labels to ensure traceability.

Nasolabial folds, marionette lines and other fine lines and moderate wrinkles.

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

- To reduce the risk of possible complications (perforation or compression of vessels, nerves or other vulnerable structures), the product should only be used by adequately trained healthcare professionals who are familiar with the anatomy of the area to be treated.
- Healthcare professionals are encouraged to discuss all potential risks of soft tissue injections with patients prior to treatment.
- Safety during pregnancy, lactation or in patients under 18 years of age is not established. Do not use in children.
- Injections carry a risk of infection; follow aseptic techniques and standard procedures to prevent cross-infection.
- Do not use the product if the packaging is opened or damaged, or if the expiry date/batch is not legible.
- Do not use the product if the contents of the syringe appear cloudy.
- Use with caution in patients on immunosuppressive therapy.
- Use with caution in patients with a tendency to hypertrophic scar formation or other healing disorders.
- Injections in areas close to permanent implants should be avoided, as they may aggravate latent adverse events or alter the aesthetic result.
- Patients should avoid intense sun, UV lamps and extreme temperatures until swelling and redness have resolved.
- Treatments such as lasers, chemical peels or other procedures that stimulate the active dermal response after injection may cause inflammatory reactions at the site of the implant; the same applies if the filler is administered before the skin has completely healed from such procedures.
- Injections can cause reactivation of herpes.
- Post-inflammatory pigmentation changes may occur in subjects with dark skin (Fitzpatrick IV-VI).
- The product is packaged for single use. Do not resterilise.
- Lidocaine should be used with caution in patients taking other amide-type local anaesthetics or related drugs (e.g. some antiarrhythmics), as the systemic toxic effects may add up.
- Lidocaine should be used with caution in patients with epilepsy, cardiac conductivity disorders, severe hepatic impairment or severe renal failure.

RESTYLANE REFYNE LIDO 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 proteins.
- 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.
- Contraindicated in patients with porphyria.

For the correction of moderate to severe nasolabial grooves.

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