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Juvederm Voluma

Juvederm Voluma

Juvederm

Dermal filler
  • CE Marked Class III medical device (CE mark number as per device labelling).
  • Manufactured by Allergan in the EU under applicable medical device regulations and quality systems.
  • Supplied in the UK under Medicines and Healthcare products Regulatory Agency (MHRA) oversight for medical devices.
  • Distributed by Medisave UK Ltd, an MHRA Registered wholesale dealer with WDA licence 18935.
  • Medisave UK Ltd quality management systems certified to ISO 9001 and ISO 14001 (organisation Level certifications, not product Specific).
Hyaluronic acid cheek, chin and facial volume filler

Description

Juvederm Voluma with Lidocaine is a cross-linked hyaluronic acid dermal filler specifically designed to restore and enhance facial volume, particularly in the cheeks, chin, jawline and temples. Supplied as two 1.0 ml pre-filled syringes with integrated lidocaine, it provides a smooth, long-lasting volumising effect with improved patient comfort during injection. The Vycross-based gel integrates into the tissues to lift and contour while maintaining a natural look and feel.

Bnefits

  • Restores lost facial volume in the cheeks, chin, jawline and temples for a lifted, contoured appearance.
  • Provides long-lasting results, typically up to about 18 months depending on area and patient factors.
  • Contains lidocaine (local anaesthetic) to increase comfort and reduce pain during treatment.
  • Smooth, cohesive hyaluronic acid gel designed for natural-looking results without a "puffy" effect.
  • Formulated using advanced cross-linking technology for durable yet supple volumisation.
  • Sterile, pyrogen-free, non-animal stabilised hyaluronic acid with a strong safety and clinical track record when used by trained professionals.

Indications

  • Injectable implant intended to restore volume of the face.
  • Deep (subcutaneous, upper-periosteal or deep dermal) injection for cheek augmentation to correct age-related volume deficit in the mid-face.
  • Augmentation and contouring of the chin region to improve chin profile.
  • Restoration and enhancement of volume in cheeks, cheekbones and jawline.
  • Treatment of age-related facial volume loss where structural support and contour are required, performed by appropriately trained healthcare professionals only.

Composition

  • Hyaluronic acid gel 20 mg/ml (cross-linked, non-animal origin).
  • Lidocaine (lignocaine) hydrochloride monohydrate 3 mg/ml (approximately 0.3% w/w).
  • Phosphate buffer solution, pH 7.2, q.s. to 1 ml.
  • Trace amounts (< 2 ppm) of cross-linking agent butanediol diglycidyl ether (BDDE).

Formulation

  • Sterile, pyrogen-free, physiological solution of cross-linked hyaluronic acid in a pre-filled, graduated, disposable glass syringe.
  • Non-animal stabilised hyaluronic acid produced by bacterial fermentation (Streptococcus species).
  • Smooth, cohesive Vycross-type HA gel designed for deep volumising and contouring of facial structures.
  • Includes integrated lidocaine to reduce injection discomfort.
  • Intended for subcutaneous, upper-periosteal or deep dermal injection by trained healthcare professionals.

Packaging

  • Box containing two (2) x 1 ml pre-filled syringes of Juvederm Voluma with Lidocaine.
  • Four (4) single-use sterile 27G 1/2" needles for use with the supplied syringes.
  • Instructions for use leaflet (Directions for Use).
  • Patient implant cards for traceability.
  • Traceability labels with batch/lot number for patient records.
  • Sterile, single-use packaging with tamper-evident blister; labelled with lot number and expiry date.

Usage

  • For professional use only: inject only by healthcare professionals with appropriate training, experience and anatomical knowledge of the injection sites.
  • Intended injection depth: deep dermis, subcutaneous tissue or upper periosteum depending on area and technique; do not inject superficially.
  • Before use, disinfect the treatment area thoroughly and assemble the supplied needle using the luer-lock as per the IFU.
  • Prime the syringe by gently depressing the plunger until a small droplet appears at the needle tip before injection.
  • Inject slowly with minimal pressure and aspirate slightly before injection to help avoid intravascular administration.
  • Do not inject into periorbital region (eyelids, under-eye area, crow’s feet), glabellar region, or lips; and never inject intravascularly.
  • Do not inject into areas with active inflammation or infection (e.g. acne, herpes lesions).
  • Do not inject more than 2 ml per treatment area in a single session; total injected volume per year should remain within manufacturer guidance relative to body weight.
  • After injection, gently massage the treated area to ensure even distribution of the gel, unless contraindicated.
  • Advise patients to avoid makeup for at least 12 hours after treatment and to avoid extended exposure to sun, UV, extreme cold, sauna or steam rooms for around 2 weeks post-procedure.
  • Subsequent touch-up or repeat treatments may be performed after a minimum interval of 2 weeks, once any injection-related reactions have resolved.

Contraindications

  • Do not inject into the periorbital region (eyelids, under-eye area, crow’s feet), glabellar region or lips.
  • Do not inject intravascularly (into blood vessels); intravascular injection can cause embolisation, vessel occlusion, ischaemia, infarction or tissue necrosis.
  • Do not use in areas with active cutaneous inflammatory or infectious processes (e.g. acne, herpes, rashes).
  • Contraindicated in patients with untreated epilepsy.
  • Contraindicated in patients with a tendency to develop hypertrophic scars or keloids.
  • 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 porphyria.
  • Do not use in pregnant or breastfeeding women.
  • Do not use in children or minors.
  • Do not inject into areas previously treated with permanent implants or where there is a permanent filler present.
  • Use with caution or avoid in patients with a history of severe or multiple allergies, anaphylactic reactions, autoimmune disease or immunosuppression unless carefully assessed case-by-case.
  • Use with caution in patients on anticoagulants or medications/supplements that prolong bleeding time (e.g. warfarin, aspirin, NSAIDs, certain herbal supplements).
  • Use with caution in patients with cardiac conduction disorders or those taking drugs that reduce or inhibit hepatic metabolism of lidocaine (e.g. certain beta-blockers, cimetidine).

Adverse Effects

  • Common, usually transient injection-site reactions such as redness (erythema), swelling (oedema), tenderness or pain on pressure, itching and paraesthesia; typically resolve within about a week.
  • Local haematomas or bruising at injection sites.
  • Induration, firmness or palpable nodules at or near the injection site.
  • Discolouration or staining of the skin (including Tyndall effect/blueish hue) especially if injected too superficially or in thin skin.
  • Asymmetry, overcorrection or undercorrection of the treated area.
  • Rare but serious events associated with intravascular injection or tissue compression, including vascular occlusion, skin necrosis, and visual disturbances up to and including permanent visual impairment or blindness, stroke or other ischaemic events.
  • Hypersensitivity or allergic reactions (immediate or delayed), including possible granuloma formation or inflammatory nodules.
  • Infection or abscess formation at the injection site if aseptic technique is not strictly followed.
  • In extremely rare cases, systemic reactions related to lidocaine in susceptible individuals (e.g. signs of toxicity, cardiac conduction effects) if dosing limits or precautions are not respected.

Storage Conditions

  • Store between 2°C and 25°C (do not freeze).
  • Keep in the original blister and outer carton until use to protect from light and physical damage.
  • Handle as a fragile medical device; avoid excessive mechanical stress or heat.
  • Use before the expiry date printed on the packaging.
  • Single-use product: do not re-use syringes or needles; do not re-sterilise.
  • Dispose of used syringes and needles in appropriate sharps containers in accordance with local regulations.

Duration

Typically up to approximately 18 months of visible volume correction, depending on treatment area, injection technique and individual patient factors.

Onset

Immediate visible volumising and contouring effect after injection, with refinement of results over the following days as transient swelling resolves.

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