Revanesse Contour+ with Lidocaine
Revanesse
Aesthetic injectableCross-linked hyaluronic acid dermal filler for facial contouring
Certifications
- Classified and supplied as a medical device dermal filler based on cross Linked hyaluronic acid with lidocaine; not authorised as a medicinal product.
- Manufactured by Prollenium Medical Technologies Inc. under medical device quality management systems and standards applicable to injectable HA fillers.
- Marketed in many regions with CE marking as a hyaluronic acid dermal filler medical device, subject to local regulatory approvals.
- Use restricted to trained medical professionals in accordance with local regulations governing injectable aesthetic devices and dermal fillers.
- Classified and supplied as a medical device dermal filler based on cross Linked hyaluronic acid with lidocaine; not authorised as a medicinal product.
- Manufactured by Prollenium Medical Technologies Inc. under medical device quality management systems and standards applicable to injectable HA fillers.
- Marketed in many regions with CE marking as a hyaluronic acid dermal filler medical device, subject to local regulatory approvals.
- Use restricted to trained medical professionals in accordance with local regulations governing injectable aesthetic devices and dermal fillers.
Cross-linked hyaluronic acid dermal filler for facial contouring
Description
Revanesse Contour+ with Lidocaine is an ultra–high viscosity, cross-linked hyaluronic acid (HA) dermal filler developed by Prollenium Medical Technologies Inc. Specifically formulated for facial contouring and shaping, it is designed for large-volume treatments such as mid-face volumisation, chin and jaw augmentation, temple filling and nose bridge correction. The gel contains 25 mg/ml of high-viscosity cross-linked HA in phosphate-buffered saline, cross-linked with BDDE, and includes 0.3% (3 mg/ml) lidocaine to enhance patient comfort during injection. Supplied as a medical device for professional use only, each box contains two 1.2 ml prefilled glass syringes and two sterile 27G needles.
Bnefits
- Ultra–high viscosity HA gel optimised for volumetric contouring and shaping of the face.
- High HA concentration (25 mg/ml) designed to provide substantial and durable volume.
- Contains 0.3% lidocaine to reduce pain and improve comfort during and immediately after injection.
- Indicated for large-volume treatment areas such as temples, cheeks, chin, jawline and nose bridge.
- Helps sculpt and contour facial features for a firm, lifted and more defined appearance.
- Thixofix cross-linking technology aims to deliver a smooth injection, high shape retention and long-lasting results.
- Implantation duration typically 12–18 months on average, depending on depth and treatment area.
- Non-animal, cross-linked HA gel with established safety profile when used by trained medical professionals.
Indications
- Restoration and addition of facial volume in large-volume areas by contouring and shaping.
- Treatment of medium to deep facial rhytides and lipoatrophy by injection into the deep dermis to subcutaneous tissue.
- Volumisation of the mid-face (cheeks and malar region).
- Chin and jawline augmentation and contouring.
- Nose bridge (dorsal) correction and contouring where appropriate and within the injector’s competence.
- Treatment of deep folds, lines and wrinkles, including nasolabial folds and glabellar lines (brow area), when indicated.
- Use in adult patients as a medical device dermal filler by appropriately trained medical professionals.
Composition
- Cross-linked hyaluronic acid (high viscosity) 25 mg/ml.
- Lidocaine 0.3% w/w (approximately 3 mg/ml) for local analgesia.
- Phosphate-buffered saline carrier solution.
- Cross-linking agent: Butanediol diglycidyl ether (BDDE).
- Non-animal, synthetic-origin hyaluronic acid gel, colourless, odourless, transparent and aqueous.
Formulation
- Monophasic, non-animal, cross-linked hyaluronic acid gel with ultra–high viscosity.
- Hyaluronic acid concentration: 25 mg/ml in phosphate-buffered saline.
- Lidocaine concentration: 0.3% w/w (3 mg/ml).
- Cross-linked using BDDE (Butanediol diglycidyl ether).
- Colourless, transparent, viscoelastic gel supplied sterile in prefilled syringes for single-patient use.
Packaging
- Box containing 2 prefilled disposable glass syringes x 1.2 ml each (total 2.4 ml).
- Each box includes 2 sterile 27G needles for injection.
- Syringes are supplied in sterile blister or tray packaging within an outer carton.
- Label information includes product name, HA concentration, lidocaine content, batch/lot number and expiry date.
- Intended for single use per syringe; any unused product must be discarded after treatment.
Usage
- Revanesse Contour+ is a medical device dermal filler intended only for trained and qualified medical professionals; do not use for self-injection.
- Prior to treatment, perform a full medical history, facial assessment and discussion of indications, expectations and potential risks; obtain informed consent.
- Clean and disinfect the treatment area according to standard aseptic technique.
- Attach the supplied sterile 27G needle securely to the syringe, ensuring removal of air bubbles and correct priming.
- Recommended injection depth: deep dermis to subcutaneous tissue, depending on area and indication.
- Typical treatment areas include temples, cheeks, chin, jawline, nose bridge and deep folds/lines; injection technique may include linear threading, bolus or fanning, adapted to anatomy and training.
- Inject slowly and carefully, aspirating in accordance with the practitioner’s protocol to minimise risk of intravascular injection; avoid overcorrection.
- Massage the treated area gently if needed to achieve an even distribution, taking care not to apply excessive pressure.
- Implantation life is generally 12–18 months (often quoted 6–12 months in some literature), depending on injection depth, area, patient metabolism and lifestyle.
- After the procedure, advise patients to avoid makeup, intense heat or cold exposure, sunbeds, saunas, vigorous exercise and alcohol for a period recommended by the practitioner.
- Instruct patients to report any signs of unusual pain, blanching, discolouration, visual disturbance, severe swelling or other concerning symptoms immediately.
- Dispose of used syringes and needles in accordance with sharps and clinical waste regulations; do not reuse any part of the kit.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or any component of the formulation.
- History of severe allergies or anaphylactic reactions to injectable products or local anaesthetics.
- Patients with known hypersensitivity to gram-positive bacterial proteins (trace amounts may be present).
- Presence of active skin infections, inflammatory lesions, acne or other skin disease at or near the intended injection sites.
- Patients with a history of hypertrophic scarring or keloid formation.
- Autoimmune diseases or patients under immunotherapy, unless thoroughly evaluated and deemed appropriate by the treating physician.
- Pregnant or breastfeeding women, as safety has not been established in these populations.
- Patients under 18 years of age.
- Do not inject into blood vessels; intravascular injection can cause embolism, ischaemia or tissue necrosis.
- Do not use in or near the periorbital eye contour (eyelids, eye circle) or for intramuscular injection.
- Avoid use in conjunction with laser, intense pulsed light, chemical peels or dermabrasion at the same session or in close temporal proximity at the same site without appropriate clinical judgement.
Adverse Effects
- Common, usually transient injection-site reactions such as redness (erythema), swelling, bruising, tenderness, pain, itching or mild discomfort.
- Formation of palpable or visible lumps, nodules or irregularities at the injection site, which may resolve spontaneously or require clinical management.
- Local inflammation or infection if aseptic technique is not strictly followed.
- Hypersensitivity or allergic reactions to hyaluronic acid, lidocaine or trace bacterial proteins, potentially including delayed-type reactions.
- Vascular occlusion if the filler is inadvertently injected intra-arterially or compresses a vessel, potentially leading to blanching, pain, tissue ischaemia or necrosis and, in very rare cases, visual disturbances or blindness if ocular vessels are affected.
- Post-inflammatory hyperpigmentation or scarring in predisposed individuals or if complications occur.
- Rare granulomatous reactions or long-lasting induration at the injection site.
- Temporary numbness or altered sensation related to lidocaine or injection trauma.
Storage Conditions
- Store in accordance with the instructions on the carton, typically at controlled room temperature (commonly between 2°C and 25°C); do not freeze.
- Keep the syringes in their original packaging to protect from light and physical damage until use.
- Do not use after the expiry date printed on the packaging.
- Do not use if the blister or outer packaging is damaged, the sterility is compromised or the gel appears discoloured or contains visible particulates.
- Single-use only; any remaining product in a syringe after a procedure must be discarded and must not be reused.
- Store out of reach of children and unauthorised individuals.
Duration
Implantation life typically averages between 12 and 18 months depending on injection depth, treatment area, patient-specific factors and technique; some sources reference 6\u201312 months as a minimum expected duration.
Onset
Volumising and contouring effects are usually visible immediately after injection, with final results evident once initial swelling and redness subside over several days.
