Logo
Restylane Volyme

Restylane Volyme

Restylane

Injectable Medical Device
  • CE Marked Class III hyaluronic acid dermal filler for facial volume augmentation and contouring in applicable European and international markets.
  • Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking in compliance with relevant quality and safety standards for sterile injectable medical devices.
  • Subject to regulatory post Market surveillance and adverse event (device vigilance) reporting requirements in territories where it is marketed.
  • Supported by clinical and post Marketing data demonstrating volumising efficacy, lifting effect and an acceptable safety profile when used as directed.
Hyaluronic Acid Dermal Filler \u2013 Facial Contouring & Volume Restoration

Description

Restylane Volyme with Lidocaine is a sterile, biodegradable, viscoelastic gel of non-animal, cross-linked hyaluronic acid with integrated 0.3% lidocaine hydrochloride, designed for facial volume restoration and contouring. Using Galderma’s Optimal Balance Technology / XpresHAn-type technology, it is intended for injection into the supraperiostic zone or subcutis to augment facial volume, particularly in the cheeks, chin and jawline. Restylane Volyme restores or enhances facial volume, recontours facial features and provides a lifting effect that reduces the appearance of moderate to deep facial wrinkles and folds. The highly concentrated hyaluronic acid helps maintain moisture balance and skin elasticity, giving a fresher, more defined and youthful appearance. The addition of lidocaine provides local anaesthesia for a more comfortable treatment.

Bnefits

  • Restores and enhances facial volume in key structural areas such as cheeks, chin and jawline.
  • Provides a lifting and contouring effect that helps re-shape and define facial features.
  • Reduces the appearance of moderate to deep facial wrinkles, folds and creases in the midface.
  • Supports the skin’s structure and improves facial fullness lost due to ageing.
  • Contains highly concentrated, cross-linked hyaluronic acid to maintain moisture balance and improve elasticity.
  • Delivers natural-looking results with smooth integration into surrounding tissues.
  • Long-lasting volumising and lifting effect, typically 6–12 months depending on patient and treatment factors.
  • Includes 0.3% lidocaine to reduce injection-related pain and enhance patient comfort.
  • Non-animal stabilized hyaluronic acid (NASHA-based technology) with an established safety and biocompatibility profile.
  • Reversible and non-permanent, as hyaluronic acid is gradually broken down by the body.

Indications

  • Injection into the supraperiostic zone or subcutis to augment the volume of the cheeks.
  • Restoration or enhancement of midface volume and contour (cheeks, cheekbones).
  • Non-surgical facial contouring of chin and jawline to improve facial profile and definition.
  • Non-surgical facelift effect by restoring volume and providing soft-tissue support.
  • Correction of age-related volume loss and sagging in the midface and lower face.
  • Softening of moderate to deep facial wrinkles and folds, including creases around the nose and mouth.
  • Skin rejuvenation and hydration in areas where deep volumising support is indicated, in accordance with the Instructions for Use.

Composition

  • Non-animal stabilized sodium hyaluronate (hyaluronic acid) 20 mg/mL.
  • Lidocaine hydrochloride 3 mg/mL (0.3% lidocaine) as a local anaesthetic.
  • Phosphate buffered saline, approximately pH 7, q.s. to 1.0 mL.
  • Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether) used to stabilise the hyaluronic acid gel.
  • Sterile, clear, viscoelastic, biodegradable gel free from animal proteins.

Formulation

  • Sterile, transparent, cross-linked hyaluronic acid gel at 20 mg/mL with 0.3% lidocaine hydrochloride in phosphate buffered saline (pH ~7), produced using Galderma’s Optimal Balance / XpresHAn-type technology to provide a soft, volumising filler optimised for supraperiostic and subcutaneous implantation in the cheeks and other facial volume-deficient areas.

Packaging

  • 1 x 1.0 ml pre-filled plastic or glass syringe of Restylane Volyme with Lidocaine.
  • Syringe supplied sterile in an individual blister pack for single-patient use.
  • 2 x 27G 1/2" ultra-thin wall disposable sterile needles included in the blister (as per current IFU; needle configuration can vary by market).
  • Luer-lock syringe with tamper-evident protective cap to maintain sterility until use.
  • Outer carton labelled with product name, volume, batch/lot number, expiry date, manufacturer details and regulatory markings.
  • Traceability / patient record labels supplied for placement into the patient’s medical records.

Usage

  • For professional use only: Restylane Volyme with Lidocaine must be administered exclusively by appropriately trained and legally authorised healthcare professionals experienced in facial anatomy and deep dermal/subcutaneous injection techniques.
  • Before use, visually inspect the outer carton, blister and syringe. Do not use if any component is damaged, sterility is in doubt, the gel appears cloudy or contains visible particles, or the product is past its expiry date.
  • Obtain a comprehensive medical history including allergies (particularly to hyaluronic acid, lidocaine or other amide-type local anaesthetics and gram-positive bacterial proteins), bleeding disorders, autoimmune disease, previous fillers or implants, and current medications (especially anticoagulant and antiplatelet agents).
  • Cleanse and disinfect the treatment area (e.g. midface, cheeks, chin, jawline) according to clinic protocols for injectable procedures.
  • Attach a supplied 27G 1/2" ultra-thin wall needle (or recommended alternative) securely to the luer-lock syringe using aseptic technique and expel any air prior to injection.
  • Restylane Volyme is intended for injection into the supraperiostic zone or subcutis. Use appropriate techniques such as linear threading, fanning or depot injections at the correct depth, depending on the anatomical area and desired contour.
  • Inject slowly with controlled pressure and aspirate carefully before injecting to reduce the risk of inadvertent intravascular injection. Never inject into blood vessels.
  • Begin with small volumes and avoid overcorrection. Gradually build the desired contour and lift, assessing symmetry and facial balance throughout the procedure.
  • Gently mould or sculpt the treated areas after injection, if needed, to optimise contour and integration, taking care not to apply excessive pressure.
  • Do not inject into areas with active inflammation, infection or skin disease. If the patient experiences intense pain, blanching, visual disturbance or other signs of possible vascular compromise, stop the injection immediately and institute appropriate emergency management.
  • Following treatment, advise the patient to avoid makeup on the treated area for several hours and to avoid extreme temperatures, saunas, sunbeds, vigorous exercise, alcohol and manipulation or massage of the treated areas for a short period, in line with clinic protocol.
  • Record the product name, batch/lot number, treatment areas, depth and technique, total volume used and any immediate reactions in the patient’s medical record using the supplied traceability labels.

Contraindications

  • History of severe allergies or anaphylactic reactions, or the presence of multiple severe allergies.
  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics, BDDE or any other excipients including gram-positive bacterial proteins.
  • Bleeding disorders or current significant use of anticoagulant, thrombolytic or high-dose antiplatelet therapy where injection-related bleeding risk is considered unacceptable.
  • Active skin or mucosal disease, inflammation, infection or lesions at or near the intended injection sites (e.g. dermatitis, acne, bacterial infection, viral lesions such as herpes).
  • Intravascular injection is strictly contraindicated; the product must never be injected into blood vessels.
  • Intramuscular injection is contraindicated; the product is intended only for injection into the supraperiostic zone or subcutis in accordance with the Instructions for Use.
  • Patients with a known tendency to hypertrophic scarring or keloid formation should generally not be treated with dermal fillers.
  • Use during pregnancy or breastfeeding is not recommended due to insufficient safety data.
  • Use in patients below the minimum age specified in the product labelling and local regulations (typically adults aged 18 years or older, and over 21 years for some indications in certain jurisdictions).

Adverse Effects

  • Common, usually transient injection-site reactions including redness (erythema), swelling, tenderness, pain, itching and bruising.
  • Localized lumps, bumps or nodules at the injection site or along the injection track, which often resolve spontaneously but may require massage or further treatment.
  • Injection-site hematoma or ecchymosis, particularly in patients with a tendency to bruise or on anticoagulant/antiplatelet therapy.
  • Temporary changes in sensation such as numbness, tingling or tightness in the treated area due to the injection procedure and lidocaine.
  • Localized inflammatory reactions, including swelling and redness, which may appear immediately or be delayed and typically resolve within days to a few weeks.
  • Infection at or near the injection site if aseptic technique and aftercare recommendations are not strictly followed.
  • Delayed inflammatory reactions, granuloma formation or persistent nodules that may require medical treatment and, in some cases, hyaluronidase.
  • Rare but serious complications associated with inadvertent intravascular injection, including vascular occlusion, ischemia, tissue necrosis or visual disturbance/vision loss, which require urgent medical attention.
  • Post-inflammatory hyperpigmentation, scarring or other changes in skin pigmentation and texture, particularly in susceptible individuals.
  • Unsatisfactory cosmetic result, asymmetry or over/undercorrection that may necessitate additional treatment, adjustment or product dissolution with hyaluronidase.

Storage Conditions

  • Store in the original outer carton to protect from light and maintain sterility until use.
  • Store at a controlled temperature between 2°C and 25°C as specified in the Instructions for Use.
  • Do not freeze; avoid exposure to excessive heat and direct sunlight.
  • Do not use after the expiry date printed on the syringe and outer carton.
  • Do not use if the sterile blister or syringe packaging has been opened or damaged prior to use.

Duration

Clinical experience and product information indicate that results typically last between 6 and 12 months, with many patients experiencing stable volumising and contouring effects for around 9 months depending on treatment area, injection technique, metabolism and lifestyle. Touch-up or maintenance treatments can be performed as needed.

Onset

Restylane Volyme provides immediate visible volume restoration and contouring upon injection, with the final aesthetic result becoming more apparent as initial swelling and redness subside over several days to a few weeks.

Browse more Injectable Medical Device

Top Treatments

Top Cities in the UK