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Juvéderm Volift Range

Juvéderm Volift Range

Juvederm

Aesthetics
  • CE Marked Class III medical device (hyaluronic acid dermal filler with lidocaine)
  • Manufactured in compliance with applicable EU Medical Device Directive / UK MDR transitional requirements
  • Produced under an ISO 13485–compliant quality management system (manufacturer level)
Hyaluronic acid dermal filler for smile lines and midface volume restoration

Description

Juvéderm Volift with Lidocaine is a hyaluronic acid–based dermal filler using VYCROSS technology, designed to correct deep wrinkles and folds such as nasolabial folds and mentolabial folds, restore facial volume, and contour the lips and lower face. The cross-linked HA gel contains lidocaine to improve treatment comfort and provides natural-looking, long-lasting results when injected by trained healthcare professionals into the deep dermis or lip mucosa.

Bnefits

  • Smooths deep wrinkles and folds, especially nasolabial and mentolabial folds
  • Restores lost facial volume and improves facial contours
  • Can be used for lip augmentation and definition
  • VYCROSS technology enables effective, long-lasting results with a relatively low HA concentration
  • Contains lidocaine for increased injection comfort and reduced treatment pain
  • Provides results that can last up to approximately 12–15 months, depending on area treated and individual factors
  • Biocompatible, biodegradable hyaluronic acid gel

Indications

  • Correction of deep skin depressions such as nasolabial folds
  • Treatment of mentolabial folds and oral commissure lines
  • Restoration of facial volume and contouring of the mid and lower face
  • Lip contouring and volume enhancement
  • Correction of contour deformities related to soft-tissue volume loss

Composition

  • Hyaluronic acid 17.5 mg/ml (cross-linked, of non-animal origin)
  • Lidocaine hydrochloride 3 mg/ml
  • Phosphate buffer (pH approximately 7.2)
  • Trace amounts (<2 ppm) of cross-linking agent BDDE (butanediol diglycidyl ether)

Formulation

  • Sterile, pyrogen-free, physiological, cross-linked hyaluronic acid gel with lidocaine
  • Single-use pre-filled syringes for injection into the deep dermis or lip mucosa
  • Latex-free components

Packaging

  • Box containing 2 x 1.0 ml pre-filled glass syringes of Juvéderm Volift with Lidocaine
  • 4 x single-use sterile 30G 1/2" needles (or equivalent, depending on market)
  • Package insert with directions for use and patient information
  • Patient implant cards (in some markets) for recording batch/lot details

Usage

  • For professional use only; must be administered by an appropriately trained and qualified healthcare professional experienced in dermal filler injection techniques.
  • Intended injection planes are the deep dermis or lip mucosa, depending on the indication and treatment area.
  • Use the supplied sterile 30G 1/2" needle or other suitable sterile needle/cannula according to the official instructions for use.
  • Disinfect the treatment area according to standard aseptic technique before injection.
  • Inject slowly using appropriate techniques (e.g. linear threading, serial puncture, fan or cross-hatching) while avoiding intravascular injection.
  • Do not inject into blood vessels, the periorbital region (eyelids, under-eye area, crow’s feet) or the glabellar region.
  • Do not use in areas previously treated with permanent fillers or implants.
  • Gently massage the treated area after injection to ensure even distribution if clinically appropriate.
  • Discard any unused product; each syringe is for single patient, single session use only.

Contraindications

  • Hypersensitivity or allergy to hyaluronic acid
  • Known hypersensitivity to lidocaine or other amide-type local anaesthetics
  • Known allergy to gram-positive bacterial proteins (HA is produced by Streptococcus species)
  • Pregnancy or breastfeeding
  • Patients under 18 years of age
  • Untreated epilepsy
  • History of or tendency to develop hypertrophic scars or keloids (relative contraindication; use only after risk–benefit assessment)
  • Porphyria or other rare genetic disorders involving porphyrin metabolism
  • Active skin inflammation, infection or lesions (e.g. acne, herpes) at or near the intended injection sites
  • Autoimmune diseases or immune deficiency, or patients on immunosuppressive therapy, unless the treating physician considers treatment appropriate after individual assessment
  • Known severe or multiple allergies or history of anaphylactic reactions
  • Previous permanent filler or implant in the planned treatment area

Adverse Effects

  • Transient injection-site reactions such as redness (erythema), swelling, pain, tenderness, warmth, itching or bruising
  • Lumps or nodules at the injection site
  • Firmness or induration in the treated area
  • Temporary discoloration or hyperpigmentation at the injection site
  • Rare inflammatory reactions including granuloma formation
  • Infection at the injection site if aseptic technique is not properly followed
  • Hypersensitivity reactions, including immediate or delayed allergic reactions
  • Very rare but serious vascular complications (e.g. intravascular injection leading to ischemia, tissue necrosis or visual disturbance/vision loss) if product is inadvertently injected into a blood vessel

Storage Conditions

  • Store between 2°C and 25°C.
  • Do not freeze.
  • Keep the syringes in the original packaging and protect from light.
  • Do not use if the blister or packaging is damaged or if the product is past the expiry date.

Duration

Clinical effects are typically maintained for up to about 12\u201315 months, depending on the treatment area, injection technique and individual patient factors.

Onset

Immediate visible improvement after injection, with optimal results apparent once initial swelling or redness has resolved, usually within about 1 week.

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