Juvéderm Volux 2 x 1 ml

Juvederm

Dermal filler

Hyaluronic acid jawline and chin contouring filler

CE Marked Class III medical device for aesthetic use within applicable European medical device regulations.
Manufactured under Allergan’s certified quality management systems and regulatory controls for hyaluronic acid dermal fillers.
Uses VYCROSS cross Linking technology for hyaluronic acid gels in the Juvéderm collection of fillers.
Distributed to practitioners through licensed and regulated pharmacy and medical device supply channels (such as Ageless Fillers and other authorised distributors).

CE Marked Class III medical device for aesthetic use within applicable European medical device regulations.
Manufactured under Allergan’s certified quality management systems and regulatory controls for hyaluronic acid dermal fillers.
Uses VYCROSS cross Linking technology for hyaluronic acid gels in the Juvéderm collection of fillers.
Distributed to practitioners through licensed and regulated pharmacy and medical device supply channels (such as Ageless Fillers and other authorised distributors).

Hyaluronic acid jawline and chin contouring filler

Description

Juvéderm Volux 2 x 1 ml is a high-density, cross-linked hyaluronic acid dermal filler specifically developed for sculpting and restoring volume in the lower face. With a 25 mg/ml hyaluronic acid concentration and integrated lidocaine, it is designed to define and enhance the jawline and chin, restore structural support, and improve facial contours while maximising patient comfort during injection. Supplied as two 1 ml pre-filled syringes, this CE-marked filler uses VYCROSS technology to provide strong lifting capacity, natural-looking results and long-lasting definition of the jawline and chin when administered by appropriately trained healthcare professionals.

Bnefits

Provides powerful volumisation and structural support to define and sculpt the jawline and chin.
Restores and creates facial volume in the lower third of the face, improving contour and profile.
High-density VYCROSS hyaluronic acid gel optimised for lifting capacity and shape retention.
Contains lidocaine to reduce pain and enhance patient comfort during treatment.
Produces natural-looking, harmonious results that move with facial expressions.
Long-lasting effect, typically up to 18–24 months depending on patient factors and treatment area.
Smooth, cohesive gel that allows precise placement and predictable outcomes in jawline and chin contouring.
Intended for subcutaneous and/or supraperiosteal injection by trained medical practitioners for safe, controlled sculpting.

Indications

Injectable implant intended to restore and create volume of the face.
Indicated for restoration and creation of facial volume in adults, particularly for redefining the jawline and increasing chin projection.
Used to enhance and contour facial structures in the lower third of the face (jawline and chin).
Intended for subcutaneous and/or supraperiosteal injection by suitably qualified and experienced healthcare professionals.
Suitable for patients with moderate to severe loss of jawline definition seeking improved contour and profile.

Composition

Hyaluronic acid gel 25 mg/ml (cross-linked, non-animal origin).
Lidocaine (lignocaine) hydrochloride monohydrate 3 mg/ml (approximately 0.3% w/w) as a local anaesthetic.
Phosphate buffer solution, pH 7.2, q.s. to 1 ml.
Trace amounts of cross-linking agent 1,4-butanediol diglycidyl ether (BDDE) as manufacturing residual.

Formulation

Sterile, biodegradable, pyrogen-free, viscoelastic, clear, colourless, homogeneous gel of cross-linked hyaluronic acid.
Non-animal stabilised hyaluronic acid produced by Streptococcus species bacteria.
High-density VYCROSS technology formulation designed for strong lifting and structural support in the jawline and chin.
Contains integrated lidocaine to improve tolerability during injection and reduce procedure-related pain.
Intended for subcutaneous and/or supraperiosteal injection in the lower face by trained healthcare professionals only.

Packaging

One box containing two (2) pre-filled 1 ml glass syringes of Juvéderm Volux with lidocaine.
Four (4) single-use sterile 27G 1/2" needles supplied for use with the syringes.
Instructions for use (IFU) leaflet with full indications, contraindications and directions for administration.
Patient implant cards and traceability labels showing batch/lot number for patient records and regulatory traceability.
Tamper-evident sterile blister and outer carton printed with product name, composition, lot number and expiry date.

Usage

For use only by appropriately trained and qualified healthcare professionals with experience in dermal filler injection and detailed knowledge of facial anatomy.
Indicated injection depth is subcutaneous and/or supraperiosteal in the jawline and chin region; avoid superficial intradermal injections with this product.
Inspect packaging and syringe before use; do not use if package is damaged, previously opened or past its expiry date.
Disinfect the treatment area thoroughly and maintain strict aseptic technique throughout the procedure.
Attach the supplied sterile needle using the Luer-lock system and prime the syringe by expelling a small droplet of gel before injection.
Inject slowly with minimal pressure and in small aliquots; where appropriate, aspirate gently before injection to help reduce the risk of intravascular injection.
Administer in the subcutaneous or supraperiosteal planes along the jawline and chin, building volume gradually to achieve symmetrical and natural contours.
Do not inject into blood vessels, into or near areas with active skin disease, infection or inflammation (e.g. acne, herpes, dermatitis), or into regions which have been previously treated with permanent fillers.
After injection, gently massage the treated area if required to ensure even distribution of the gel and optimal contour (unless local anatomy or technique dictates otherwise).
Advise patients to avoid makeup on the treated area for at least 12 hours and to avoid extreme temperatures (intense sun/UV exposure, saunas, steam rooms, very cold environments) for approximately 2 weeks post-treatment.
Consider a follow-up visit to assess outcomes and, if needed, perform touch-up treatment no sooner than 2 weeks after the initial procedure, once any transient injection-related reactions have resolved.

Contraindications

Do not inject Juvéderm Volux in the periorbital area (eyelids, under-eye area, crow’s feet) or glabellar region.
Not indicated for use in the lips with this specific product; Volux is designed for jawline and chin contouring.
Do not inject intravascularly; intravascular injection can cause embolisation, vessel occlusion, ischaemia, infarction, tissue necrosis or serious vascular complications.
Contraindicated in patients with known hypersensitivity to hyaluronic acid or to gram-positive bacterial proteins.
Contraindicated in patients with known hypersensitivity to lidocaine or other amide-type local anaesthetics.
Contraindicated in patients with a history of severe or multiple allergies or anaphylactic reactions unless a careful risk–benefit assessment is performed.
Contraindicated in patients with porphyria.
Contraindicated in patients suffering from untreated epilepsy according to IFU guidance for this filler class.
Do not use in pregnant or breastfeeding women, as safety has not been established.
Do not use in children or adolescents; adults only.
Do not inject into areas presenting active inflammation, infection or skin disease (e.g. acne, herpes, rashes or dermatitis).
Avoid injecting into scar tissue with poor vascularisation or into sites previously treated with permanent fillers or implants.
Use with caution in patients taking anticoagulants, antiplatelet agents, NSAIDs or supplements that may increase bruising or bleeding.
Use with caution in patients with autoimmune disease or immunosuppression, and only after individual risk–benefit evaluation.

Adverse Effects

Common, usually transient injection-site reactions including redness (erythema), swelling (oedema), tenderness or pain, bruising, induration, itching or warmth; typically resolve within a week.
Local haematoma or bruising at injection sites.
Induration, firmness, palpable nodules or small lumps at or near the injection site.
Asymmetry, overcorrection or undercorrection of the treated area requiring possible adjustment or additional treatment.
Skin discolouration or Tyndall effect (bluish discolouration) if the product is injected too superficially.
Infection or abscess formation at the injection site if aseptic technique is not strictly followed or if injected into infected tissue.
Hypersensitivity or allergic reactions (immediate or delayed), including erythema, oedema, induration or granuloma formation.
Rare but serious complications associated with inadvertent intravascular injection, including vascular occlusion, tissue ischaemia, necrosis, and visual disturbances up to and including permanent vision loss or stroke.
Very rare systemic adverse effects related to lidocaine in susceptible patients, including signs of local anaesthetic toxicity or cardiac conduction disturbances if recommended dose limits and precautions are not observed.

Storage Conditions

Store between 2°C and 25°C.
Do not freeze.
Keep syringes in the original blister and outer carton to protect from light and physical damage until use.
Do not use if the packaging is damaged, previously opened, or if the product is past the expiry date printed on the pack.
This is a sterile single-use medical device; do not re-sterilise or reuse syringes or needles.
Dispose of used syringes and needles in approved sharps containers in accordance with local regulations.

Duration

Clinical and practitioner experience suggests that results typically last up to approximately 18\u201324 months in the jawline and chin, depending on individual patient characteristics, injection technique and treatment volume.

Onset

Immediate visible volumising and contouring effect after injection, with final appearance refined over the subsequent days as swelling and other injection-related reactions subside.