Juvéderm Volite (2 x 1 ml)

Juvederm

Derma fillers

Hyaluronic acid skin-quality injectable / skin booster

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

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.