NEURAMIS® VOLUME with Lidocaine

Neuramis

Dermal filler

Cross-linked hyaluronic acid dermal filler

CE Marked hyaluronic acid dermal filler under European medical device legislation for injectable implants.
Manufactured in a facility operating under ISO 13485 Certified quality management system for medical devices.
Complies with applicable biocompatibility and safety testing standards for injectable hyaluronic acid fillers as documented by the manufacturer.
Post Market surveillance and regulatory approvals reported in multiple regions including the EU, UK, and various Asian markets, subject to local regulatory status.

CE Marked hyaluronic acid dermal filler under European medical device legislation for injectable implants.
Manufactured in a facility operating under ISO 13485 Certified quality management system for medical devices.
Complies with applicable biocompatibility and safety testing standards for injectable hyaluronic acid fillers as documented by the manufacturer.
Post Market surveillance and regulatory approvals reported in multiple regions including the EU, UK, and various Asian markets, subject to local regulatory status.

Cross-linked hyaluronic acid dermal filler

Description

NEURAMIS® VOLUME with Lidocaine is a high-density, cross-linked hyaluronic acid dermal filler containing 20 mg/ml HA and 0.3% lidocaine. It is designed for deep injection to restore facial volume, enhance contours, and correct moderate to severe wrinkles in areas such as the cheeks, chin, jawline, and facial folds. Manufactured by Medytox Inc. using proprietary SHAPE™ cross-linking and purification technology, it is supplied as a sterile, prefilled 1 ml syringe intended for use by trained medical professionals.

Bnefits

High-density, cross-linked hyaluronic acid gel provides strong volumizing and lifting capacity in cheeks, chin, jawline, and other contouring areas.
Designed for correction of moderate to severe wrinkles and deep folds (e.g., nasolabial folds, marionette lines) and for structural facial contouring.
Contains 0.3% lidocaine to improve patient comfort by reducing pain during and shortly after injection.
Long-lasting aesthetic results, typically around 6–9 months and in some cases up to approximately 12 months depending on treatment area, technique, and patient factors.
Manufactured using Medytox SHAPE™ two-step cross-linking and enhanced purification technology for gel stability, longevity, and low residual BDDE and impurities.
CE-marked hyaluronic acid dermal filler produced in an ISO 13485-certified medical device facility.
Provides immediate visible volume restoration with natural-looking integration into surrounding tissues as post-treatment swelling settles.
Supplied with ultra-thin wall 27G needles to facilitate smooth, precise injection and extrusion.

Indications

Restoration of facial volume loss in areas such as cheeks, chin, jawline, and mid-face.
Correction of moderate to severe facial wrinkles and folds including nasolabial folds and marionette lines.
Cheek and chin augmentation, including enhancement of facial contours and profile balancing.
Facial contouring and sculpting of areas requiring deeper structural support (e.g., jawline definition).
Treatment of deep furrows and depressions in the dermis where a high-viscosity filler is appropriate, as assessed by a qualified practitioner.

Composition

Cross-linked hyaluronic acid 20 mg/ml (non-animal origin, produced via microbial fermentation).
Lidocaine 0.3% (3 mg/ml) as a local anaesthetic.
Residual protein content typically ≤ 0.1%.
Endotoxin level typically < 0.04 IU/mg.
Physiological buffer solution and stabilizing excipients as specified in the manufacturer’s instructions for use.

Formulation

Sterile, pyrogen-free, viscoelastic cross-linked hyaluronic acid gel with lidocaine for injection.
Single-use, prefilled 1 ml syringe intended for deep dermal or subcutaneous injection by trained medical professionals.
High-viscosity, highly cross-linked HA gel providing structural support and volume restoration in deeper facial planes.

Packaging

Box containing 1 x 1 ml prefilled syringe of NEURAMIS® VOLUME with Lidocaine.
Typically supplied with 1–2 disposable 27G x 1/2" (13 mm) ultra-thin wall needles (UTW), depending on regional pack configuration.
Each pack includes package insert / instructions for use and traceability labels for patient records.
Single-use only; do not resterilize or reuse the syringe or needles.

Usage

Product is intended strictly for use by appropriately trained and licensed medical professionals experienced in dermal filler injections.
Before treatment, perform a full medical history, examination, and indication assessment, and obtain informed consent.
Clean and disinfect the treatment area thoroughly using appropriate antiseptic technique.
Attach a sterile 27G needle supplied or recommended for use with this product, ensuring the needle is securely fitted to the prefilled syringe.
Inject into the appropriate anatomical plane (typically deep dermis or subcutaneous layer) using suitable techniques such as linear threading, small aliquots, or layering, while aspirating according to local practice and training to minimize intravascular injection risk.
Administer slowly and avoid overcorrection; massage gently if required to achieve a smooth, even distribution, unless local guidelines advise otherwise.
After injection, apply light pressure or cooling as needed to reduce swelling or bruising, and reassess symmetry and aesthetic outcome.
Provide patients with post-treatment care instructions, including avoiding extreme temperatures, vigorous exercise, and manipulation of the treated area for a specified period, and advising when to seek medical attention for adverse effects.
Do not inject into blood vessels, areas of active inflammation or infection, or in proximity to compromised vascular territories.
Refer to the official instructions for use (IFU) and local clinical guidelines for detailed injection techniques, indications, and precautions.

Contraindications

Hypersensitivity or known allergy to hyaluronic acid, lidocaine, or amide-type local anaesthetics, or to any excipients in the formulation.
History of severe anaphylactic reactions or multiple severe allergies to injectable products.
Presence of active skin infection, inflammation, dermatitis, or herpetic lesions at or near the intended injection site.
Autoimmune or connective tissue diseases, uncontrolled systemic illness, or significant coagulation disorders where dermal fillers are contraindicated according to the treating physician’s judgment.
Pregnancy or breastfeeding, due to lack of adequate safety data in these populations.
History of hypertrophic scarring or keloid formation where fillers are clinically contraindicated.
Previous permanent or semi-permanent fillers in the intended treatment area, unless the treating clinician judges it safe after careful risk assessment.

Adverse Effects

Common, usually transient reactions at the injection site such as redness (erythema), swelling, bruising, tenderness, pain, itching, or mild firmness/lumps.
Temporary asymmetry, palpable nodules, or irregularities in contour that may require massage, observation, or clinical management.
Less common reactions including prolonged swelling, inflammatory responses, or hypersensitivity reactions.
Rare but serious complications associated with dermal fillers such as infection, abscess formation, granuloma, tissue necrosis, or vascular occlusion (including visual disturbance or blindness if filler is inadvertently injected into or compresses vessels).
Local anaesthetic-related adverse reactions in sensitive individuals (e.g., dizziness, headache, or systemic lidocaine effects in cases of overdose or inadvertent intravascular administration).
Delayed inflammatory or immune-mediated reactions, which require prompt evaluation and management by an experienced clinician.

Storage Conditions

Store between 2°C and 25°C as indicated by the manufacturer.
Do not freeze or heat the product; avoid temperature extremes during transport and storage.
Protect from direct sunlight and keep in the original packaging until use.
Do not use if the packaging, syringe, or sterility barrier is damaged, or if the product is past its expiry date.
Do not apply pressure, heavy weight, or mechanical shock to the syringe or packaging.

Duration

Clinical and real-world data suggest results typically last about 6\u20139 months, with some reports of effect persistence up to approximately 12 months depending on injection site, volume used, and individual metabolic factors.

Onset

Initial volumizing and wrinkle-filling effects are generally visible immediately after injection, with final results stabilizing over several days to a few weeks as swelling resolves and the gel integrates with surrounding tissues.