Juvéderm Volbella with Lidocaine (2 x 1 ml)

Juvederm

DERMA FILLERS

Hyaluronic acid dermal filler for lips and fine lines

CE Marked sterile injectable hyaluronic acid gel for use as a dermal filler in applicable markets.
Manufactured under ISO 13485–compliant quality management systems for medical devices.
Complies with relevant EU/UK medical device regulations for hyaluronic acid dermal fillers.

CE Marked sterile injectable hyaluronic acid gel for use as a dermal filler in applicable markets.
Manufactured under ISO 13485–compliant quality management systems for medical devices.
Complies with relevant EU/UK medical device regulations for hyaluronic acid dermal fillers.

Hyaluronic acid dermal filler for lips and fine lines

Description

Juvéderm Volbella with Lidocaine (2 x 1 ml) is a Vycross-based, cross-linked hyaluronic acid dermal filler formulated for subtle lip enhancement and correction of fine lines and superficial wrinkles. Supplied as two 1 ml prefilled syringes with ultra-fine needles, the soft, smooth gel restores natural-looking lip volume, redefines the contours of the mouth and treats fine folds around the buccal area associated with ageing. The product contains 15 mg/ml non-animal hyaluronic acid with 0.3% lidocaine in a physiologic phosphate buffer, providing immediate, natural results and improved comfort during injection. In many markets it is also indicated for the treatment of infraorbital hollows (tear troughs) and other delicate facial areas when injected by suitably trained professionals.

Bnefits

Soft, smooth gel designed for subtle, natural-looking enhancement rather than excessive bulk.
Restores gentle lip volume and improves definition of the vermilion border and Cupid’s bow.
Redefines the contours of the mouth and smooths fine perioral lines and superficial wrinkles.
Helps reduce fine folds around the buccal area associated with ageing.
Can be used in appropriate hands for infraorbital hollowing (tear troughs) and other delicate facial areas.
Contains 15 mg/ml cross-linked hyaluronic acid for durable hydration and volume.
Includes 0.3% lidocaine to enhance patient comfort and reduce injection pain.
Vycross technology provides a smooth, moldable gel that integrates well into tissue with reduced post-treatment swelling.
Biocompatible, biodegradable hyaluronic acid of non-animal origin, gradually resorbed over time.
Effects commonly last up to about 12 months, depending on indication, technique and individual factors.

Indications

Restoration and enhancement of lip volume.
Redefinition of the contours of the mouth and lip border.
Treatment of fine lines and superficial wrinkles around the mouth (perioral rhytids).
Correction of fine folds around the buccal area due to ageing.
Subtle correction of fine to medium-sized skin depressions in the lower face.
Improvement of infraorbital hollowing (tear troughs) in appropriately selected adults, where locally approved and when performed by experienced practitioners.

Composition

Cross-linked hyaluronic acid gel 15 mg/ml (non-animal origin).
Lidocaine (lignocaine) hydrochloride monohydrate 3 mg/ml (0.3% w/w).
Phosphate buffer pH 7.2 q.s. to 1 ml.

Formulation

Sterile, pyrogen-free, physiological gel of cross-linked hyaluronic acid of non-animal origin.
Viscoelastic, clear, colourless, homogeneous gel implant.
Hyaluronic acid concentration 15 mg/ml with 0.3% lidocaine in a physiologic buffer.
Manufactured using Vycross technology (combination of low- and high-molecular-weight HA) to optimise smoothness and longevity.
Presented in prefilled, graduated, single-use disposable syringes.

Packaging

Box containing two 1 ml prefilled syringes of Juvéderm Volbella with Lidocaine.
Four single-use sterile 32G 1/2" needles supplied for injection (needle specification may vary slightly by market, but typically 30G or 32G 1/2").
Instruction leaflet (Directions for Use) included in each box.
Traceability labels for patient and practitioner records.
Syringes and needles packaged in a sterile blister within an outer carton.

Usage

For professional use only; must be administered by a trained and licensed healthcare professional experienced in dermal filler injections.
Evaluate the patient’s medical history, aesthetic goals and treatment indications; obtain informed consent prior to use.
Cleanse and disinfect the treatment area thoroughly, adhering to strict aseptic technique.
Attach one of the supplied sterile needles (e.g., 32G 1/2") or an appropriate cannula to the syringe and expel air before injection.
Inject slowly into the appropriate tissue plane according to indication: typically superficial to mid-dermis or lip mucosa for fine lines and lips, and deeper (e.g., submuscular or pre-periosteal) for tear troughs in line with training and local guidelines.
Use suitable injection techniques such as serial puncture, linear retrograde threading, fanning or cross-hatching, depositing small aliquots with low injection pressure.
Avoid intravascular injection; aspirate where appropriate and exercise extreme caution in high-risk anatomical areas.
Do not overcorrect; build volume gradually and reassess symmetry, contour and facial balance throughout the procedure.
After injection, gently massage the treated area to ensure even distribution and reduce the risk of palpable lumps.
Dispose of any unused product, needles and syringes as clinical sharps waste after a single treatment session; do not resterilise or reuse.

Contraindications

Known hypersensitivity to hyaluronic acid, lidocaine, or any of the excipients.
History of severe allergies or anaphylaxis, or presence of multiple severe allergies.
Known allergy or intolerance to local anaesthetics of the amide type (such as lidocaine).
Active infection, inflammation, herpes labialis or other skin or mucosal disease at or near the intended injection site.
Bleeding disorders or concurrent anticoagulant or antiplatelet therapy where injections may increase bleeding risk, unless the treating physician judges benefits to outweigh risks.
History of hypertrophic scarring or keloid formation in the proposed treatment area.
Autoimmune diseases or immunosuppressive therapy where dermal filler use may pose additional risks, unless carefully evaluated by the physician.
Use during pregnancy or breastfeeding, due to insufficient safety data.

Adverse Effects

Common local reactions at the injection site, such as redness, swelling, tenderness, pain, itching, bruising or discolouration, typically resolving within a few days.
Temporary lumps, papules, nodules or irregularities that often improve with gentle massage and as the gel integrates into tissue.
Haematoma or prolonged bruising, particularly in the highly vascular lip and periocular regions.
Transient firmness or induration in the treated area.
Rare inflammatory reactions, including persistent nodules or granuloma formation.
Rare hypersensitivity or allergic reactions to hyaluronic acid, lidocaine or other components.
Very rare but serious complications related to inadvertent intravascular injection, including vascular occlusion, tissue necrosis or visual disturbance (including potential blindness) in high-risk areas.
Risk of local infection, abscess or biofilm formation if aseptic technique is not strictly followed.
Possible reactivation of herpes labialis in predisposed individuals when treating the lip area.

Storage Conditions

Store in the original unopened packaging in a clean, dry place.
Maintain recommended storage temperature, typically between 2°C and 25°C, as indicated on the outer carton.
Do not freeze.
Protect from direct sunlight and excessive heat.
Do not use if the blister pack, syringe or needles are damaged or previously opened.
Do not use after the expiry date printed on the carton and syringe labels.

Duration

Clinical effects generally appear immediately after injection and can last up to approximately 12 months following an initial treatment course, with maintenance or touch-up sessions scheduled according to individual response and practitioner assessment.

Onset

Visible improvement in lip volume, contours and fine lines is typically immediate after injection, with final results becoming more evident as transient swelling and redness subside over the ensuing days.