RESTYLANE VOLYME LIDOCAINE

RESTYLANE VOLYME LIDO is a gel:
- Sterile, biodegradable and transparent cross-linked hyaluronic acid of non-animal origin.
- Composed of lidocaine hydrochloride 3 mg/mL.
- Natural and long-lasting effect.
- Suitable for deep injection.

- GALDERMA
- NAME: RESTYLANE VOLYME LIDO
- COMPOSITION: Cross-linked hyaluronic acid 20 mg/mL, Lidocaine hydrochloride 3 mg/mL, Phosphate-buffered saline solution pH 7 q.s. up to 1 mL.
- PRESENTATION: 1 x 1 ml.
- INDICATIONS: Volumising filler with high lifting capacity, ideal for reconstructing lost volumes and shaping facial contours.
- NEEDLES: 2 x 27G×½”.
- INJECTION DEPTH: Supraperiosteal area or subcutaneous tissue.
- DURATION: Up to 12 months.
- USE: Strict medical use.

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

Cheeks, cheekbones, chin, jaw line and other facial volumes to be redefined.

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

- To minimise the risk of potential complications (such as perforation or compression of vessels, nerves or other vulnerable structures), this product should only be used by healthcare professionals with adequate training, experience and knowledge of the anatomy of the injection area and surrounding tissues.
- It is recommended that healthcare professionals discuss all potential risks of soft tissue injections with patients prior to treatment, ensuring that they are informed of the signs and symptoms of possible complications.
- The safety of the product during pregnancy, lactation or in patients under 18 years of age has not been established. Do not use in children.
- Injection procedures carry a risk of infection. Aseptic techniques and standard practices must be followed to prevent cross-infection.
- Do not use the product if the packaging is opened or damaged, or if the expiry date or batch number is not legible.
- Do not use the product if the contents of the syringe appear cloudy.
- Use with caution in patients undergoing immunosuppressive therapy.
- Use with caution in patients with a tendency to hypertrophic scar formation or other healing disorders.
- Avoid injecting in areas near permanent implants, as this may aggravate latent adverse events or interfere with the aesthetic result. Limited data are available on injection in areas where a non-permanent implant other than hyaluronic acid has been placed.
- Patients should avoid excessive sun exposure, UV lamps and extreme temperatures until the initial swelling and redness has resolved.
- If lasers, chemical peels or other procedures that stimulate an active dermal response are performed after treatment, there is a theoretical risk of provoking an inflammatory reaction at the implant site. The same applies if the product is injected before the skin has completely healed from such procedures.
- Post-inflammatory pigmentary changes may occur after dermal filler injections in people with dark skin (Fitzpatrick IV-VI).
- The product is packaged for single use. Do not re-sterilise.

RESTYLANE VOLYME 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 previous anaphylaxis or presence of multiple severe allergies.
- Do not use in patients with known hypersensitivity to lidocaine or amide-type local anaesthetics.
- Patients with porphyria.

RESTYLANE VOLYME LIDO adds volume to the tissues, restoring the skin contours of the face to the desired level.

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