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Juvéderm Volite (2 x 1 ml)

Juvéderm Volite (2 x 1 ml)

Juvederm

Derma fillers
  • CE Marked Class III medical device for the filling of superficial cutaneous depressions such as fine lines and improvement of skin quality (hydration and elasticity)
  • Manufactured under a medical device quality management system compliant with applicable EU/EEA and international regulatory standards for injectable HA implants
  • Part of the Allergan Juvéderm VYCROSS range, which has extensive clinical evaluation and post Market surveillance data in aesthetic indications
Hyaluronic acid skin-quality injectable / skin booster

Description

Juvéderm Volite (2 x 1 ml) is a cross-linked hyaluronic acid dermal filler with lidocaine, specifically developed as a skin-quality injectable rather than a volumising filler. Using VYCROSS technology and a 12 mg/mL HA concentration with 0.3% lidocaine, it is injected into the superficial to mid dermis to treat fine lines and superficial cutaneous depressions and to improve key skin-quality attributes such as hydration, elasticity and smoothness. Juvéderm Volite is suitable for use on the face, neck, décolletage and hands, delivering long-lasting improvements in skin texture and moisture with a single treatment course.

Bnefits

  • Improves overall skin quality, including hydration, elasticity, texture and smoothness
  • Designed specifically to treat superficial wrinkles and fine lines rather than add bulk volume
  • Provides deep, long-lasting dermal hydration with clinical data supporting skin-quality improvements for at least 6 months and hydration benefits up to 9 months in many patients
  • Uses VYCROSS cross-linking technology to optimise durability while maintaining a soft, natural feel
  • Contains 0.3% lidocaine to reduce injection discomfort and enhance patient comfort
  • Suitable for multiple areas including face, neck, décolletage and hands
  • Non-animal, biodegradable hyaluronic acid integrates smoothly with dermal tissue
  • CE-marked Class III medical device manufactured under stringent quality standards

Indications

  • Treatment, by filling, of superficial cutaneous depressions such as fine lines
  • Additional improvement of skin-quality attributes including hydration and elasticity
  • Skin-quality enhancement on the face, neck, décolletage and hands
  • Patients seeking smoother, more radiant and more elastic skin without significant volumising or contour change

Composition

  • Hyaluronic acid gel 12.0 mg/mL (cross-linked, non-animal origin)
  • Lidocaine hydrochloride 3.0 mg/mL (0.3% lidocaine) as a local anaesthetic
  • Phosphate buffer solution, pH 7.2, q.s. to 1 mL
  • Water for injection

Formulation

  • Sterile, pyrogen-free, viscoelastic, transparent and colourless cross-linked hyaluronic acid gel
  • HA concentration: 12 mg/mL with 0.3% lidocaine
  • Non-animal origin HA produced by bacterial fermentation
  • Part of the VYCROSS range (combination of low- and high-molecular-weight HA for efficient cross-linking)
  • Intended for injection into the superficial to mid dermis (intracutaneous) using needle or cannula
  • Supplied as prefilled, graduated, single-use glass syringes with luer-lock connection

Packaging

  • Outer carton containing 2 x 1 mL prefilled syringes of Juvéderm Volite with lidocaine
  • 4 sterile single-use 32G 1/2" needles supplied in the box for injection
  • Sterile blister trays housing each syringe and associated needles
  • Includes instructions for use (IFU) and detachable traceability labels for patient records and clinic documentation
  • CE-marked Class III medical device labelling with batch number, expiry date and manufacturer details

Usage

  • For professional use only by appropriately trained and licensed healthcare practitioners experienced in hyaluronic acid filler injection.
  • Obtain full medical history, assess treatment indications and rule out contraindications; obtain informed consent prior to treatment.
  • Cleanse and disinfect the treatment area (face, neck, décolletage or hands) according to local aseptic protocols; topical anaesthetic may be used in addition to the lidocaine contained in the product.
  • Inject Juvéderm Volite into the superficial to mid dermis using a series of microdroplet or linear injections with the supplied 32G 1/2" needle or an appropriate cannula, depending on area and technique.
  • Distribute small aliquots of product evenly over the treatment area to address fine lines and improve overall skin quality; avoid overcorrection.
  • Injection depth and pattern should follow the official instructions for use and the injector’s training, with care taken to avoid intravascular injection.
  • After injection, gently massage the treated area if needed to ensure even distribution and a smooth skin surface.
  • Typical clinical practice is a single treatment session using up to 2 mL total, with possible touch-up or repeat treatments approximately every 6–9 months based on patient response.
  • Advise patients to avoid makeup on the treated areas for several hours, and to avoid intense heat exposure, vigorous exercise and alcohol for 24 hours post-treatment; encourage regular use of sun protection.
  • Dispose of used syringes, needles and any remaining product immediately in approved sharps and clinical waste containers; do not resterilise or reuse.

Contraindications

  • Hypersensitivity to hyaluronic acid, lidocaine, amide-type local anaesthetics or any of the excipients in the formulation
  • Known hypersensitivity to Gram-positive bacterial proteins (source of HA production)
  • Patients with a history of severe allergy or anaphylactic reactions
  • Active inflammatory or infectious skin conditions (e.g. acne, herpes, dermatitis) at or near the intended injection sites
  • Patients with autoimmune diseases or undergoing immunosuppressive therapy, unless the risk–benefit has been carefully evaluated by a physician
  • Pregnancy and breastfeeding (use not recommended due to limited safety data)
  • Children and adolescents (product intended for adults)
  • Injection into blood vessels or in areas with compromised vascularity; intravascular injection is strictly contraindicated

Adverse Effects

  • Common transient injection-site reactions including redness, swelling, pain, tenderness, bruising, itching, firmness or lumps/bumps at the treatment area
  • Small haematomas or surface irregularities, usually resolving within days to weeks
  • Rare delayed inflammatory reactions, nodules or hypersensitivity responses which may require medical management
  • Very rare but serious complications from inadvertent intravascular injection, including vascular occlusion, tissue ischaemia or necrosis, and potential visual disturbances
  • As with any injection procedure, a small risk of infection exists if aseptic technique and aftercare instructions are not strictly followed

Storage Conditions

  • Store in the original packaging in a clean, dry place at controlled room temperature according to the manufacturer’s label (typically between 2 °C and 25 °C).
  • Protect from freezing and from excessive heat or direct sunlight.
  • Keep syringes in their sterile blister packs until immediately before use to maintain sterility.
  • Do not use after the expiry date printed on the outer carton and syringe label.
  • Discard any syringe if the packaging is damaged, the gel appears compromised, or sterility is suspected to be lost.

Duration

Clinical and post-marketing data indicate improvement in skin smoothness and quality for around 6 months with a single treatment, with hydration benefits in many patients lasting up to approximately 9 months. Maintenance treatments are typically performed every 6\u20139 months according to individual response and clinic protocol.

Onset

Initial improvements in hydration and skin radiance are often noticeable within days to a few weeks after injection, with optimal improvement in fine lines, texture and elasticity generally seen around 1 month post-treatment and maintained for several months.

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