Revanesse Ultra+ with Lidocaine (2 × 1.2 ml)
Revanesse
Aesthetic injectableCross-linked hyaluronic acid dermal filler for deep wrinkles and facial contouring
Certifications
- Classified and marketed as a CE Marked, cross Linked hyaluronic acid dermal filler medical device with lidocaine, rather than as a licensed medicinal product.
- Manufactured by Prollenium Medical Technologies Inc. under medical device quality management systems and applicable regulatory standards for injectable HA fillers.
- Intended exclusively for use by trained healthcare professionals in accordance with local regulations governing aesthetic medical devices and injectable treatments.
- Biodegradable HA gel that can be adjusted or dissolved using hyaluronidase under medical supervision in case of adverse events or unsatisfactory aesthetic outcomes.
- Classified and marketed as a CE Marked, cross Linked hyaluronic acid dermal filler medical device with lidocaine, rather than as a licensed medicinal product.
- Manufactured by Prollenium Medical Technologies Inc. under medical device quality management systems and applicable regulatory standards for injectable HA fillers.
- Intended exclusively for use by trained healthcare professionals in accordance with local regulations governing aesthetic medical devices and injectable treatments.
- Biodegradable HA gel that can be adjusted or dissolved using hyaluronidase under medical supervision in case of adverse events or unsatisfactory aesthetic outcomes.
Cross-linked hyaluronic acid dermal filler for deep wrinkles and facial contouring
Description
Revanesse Ultra+ with Lidocaine is a biodegradable, cross-linked hyaluronic acid (HA) dermal filler formulated using Thixofix cross-linking technology. It contains a high-viscosity HA gel designed for mid- to deep-dermis injection to treat deep and more pronounced facial lines and wrinkles, such as nasolabial folds and oral commissures, and to restore or create facial volume and contour. The product is indicated for the correction of medium to deep facial rhytides and lipoatrophy and for volumising and shaping areas including the cheeks and other facial contours. Revanesse Ultra+ is supplied as a medical device for professional use only, in a pack containing two 1.2 ml prefilled syringes of HA gel with lidocaine.
Bnefits
- High-viscosity, cross-linked HA gel designed to treat deep and more pronounced facial lines and wrinkles.
- Provides volumising and contouring effects for areas such as cheeks and other facial contours, helping restore facial balance and symmetry.
- Formulated using Thixofix cross-linking technology for a smooth, cohesive gel with good shape retention and integration into tissues.
- Contains lidocaine to improve patient comfort by reducing pain during and immediately after injection.
- Biodegradable, non-animal hyaluronic acid filler that is gradually resorbed by the body over time.
- CE-marked dermal filler with a thicker, longer-lasting gel compared to many standard HA fillers, supporting extended duration of effect.
Indications
- Treatment of deep and more pronounced facial lines and wrinkles, including nasolabial folds and oral commissures, by injection into the mid- to deep dermis.
- Restoration and addition of facial volume to correct lipoatrophy and contour defects.
- Volumising and shaping of facial features such as cheeks and other regions requiring structural enhancement.
- General correction of medium to deep facial rhytides and folds in adult patients by qualified medical professionals.
Composition
- Cross-linked hyaluronic acid 25 mg/ml (non-animal, synthetic origin).
- Lidocaine 3 mg/ml (0.3% w/w) for local anaesthesia.
- Phosphate-buffered saline carrier solution.
- Cross-linking agent: Butanediol diglycidyl ether (BDDE).
Formulation
- Monophasic, cross-linked hyaluronic acid gel with high viscosity, sterile, colourless, transparent and injectable.
- Hyaluronic acid concentration: 25 mg/ml.
- Lidocaine concentration: 3 mg/ml (0.3% w/w).
- Biodegradable, non-animal HA dermal filler formulated using Thixofix cross-linking technology.
- Intended for injection into the mid- to deep dermis and/or subcutaneous tissue by trained medical professionals.
Packaging
- Box containing 2 prefilled disposable glass syringes x 1.2 ml Revanesse Ultra+ with Lidocaine (total 2.4 ml).
- Syringes supplied sterile in blister or tray packaging within an outer carton.
- Outer carton labelled with product name, HA and lidocaine concentrations, batch/lot number, expiry date and regulatory markings.
- Single-use syringes; any remaining product after a procedure must be discarded in accordance with sharps and clinical waste regulations.
Usage
- Revanesse Ultra+ with Lidocaine is a medical device dermal filler intended only for injection by suitably trained and licensed medical professionals.
- Before treatment, obtain a complete medical history, assess the patient’s suitability and indications, and secure informed consent.
- Clean and disinfect the treatment area using appropriate antiseptic solutions and maintain strict aseptic technique throughout the procedure.
- Attach a suitable sterile needle (commonly 27G) to the prefilled syringe, ensuring it is firmly secured; expel any air bubbles and carefully prime the syringe.
- Inject into the mid- to deep dermis (and where appropriate superficial subcutaneous tissue) using techniques such as linear threading, serial puncture or small bolus injections, depending on the treatment area and practitioner’s judgement.
- Typical treatment areas include deep facial lines (e.g. nasolabial folds, oral commissures) and regions requiring added volume and contour, such as cheeks and other facial contours.
- Inject slowly and avoid overcorrection; aspirate in line with clinic protocol where appropriate to help reduce the risk of intravascular injection.
- After injection, gently mould or massage the treated area if necessary to achieve uniform distribution, taking care not to apply excessive pressure.
- Provide post-treatment guidance: patients should generally avoid strenuous exercise, alcohol, makeup on the treated area, and exposure to extreme heat or cold (e.g. saunas, sunbeds) for a period recommended by the practitioner (often 24–48 hours).
- Advise patients to report immediately any signs of severe or increasing pain, blanching, discolouration, visual disturbance, unusual swelling or other unexpected symptoms that may suggest complications.
- Dispose of used syringes, needles and any remaining filler as clinical sharps waste; never reuse syringes or needles.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or any component of the product.
- History of severe allergic reactions or anaphylaxis to injectable fillers or local anaesthetics.
- Presence of active skin infections, inflammatory lesions, herpes, or other dermatological diseases at or near the intended injection sites.
- Bleeding disorders or current significant anticoagulant or antiplatelet therapy, unless carefully evaluated and deemed appropriate by the treating physician.
- Autoimmune disease or immunocompromised status, unless the clinician considers treatment safe based on individual assessment.
- Pregnancy or breastfeeding, as safety has not been established for these groups.
- Patients under the minimum legal age for aesthetic injectable treatments in the relevant jurisdiction.
- Intravenous or intra-arterial injection, or injection into highly vascular or high-risk anatomical areas without appropriate expertise and precautions.
Adverse Effects
- Common transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching, bruising or mild discomfort.
- Formation of small lumps, nodules, asymmetry or irregularities at the treated area, which may resolve spontaneously or require clinical management.
- Local infection or abscess if aseptic technique is not strictly followed or if post-procedure care is inadequate.
- Allergic or hypersensitivity reactions to HA, lidocaine or other components, including rare delayed inflammatory responses or granuloma formation.
- Vascular complications if filler is inadvertently injected intravascularly or causes vessel compression, potentially resulting in blanching, severe pain, tissue ischaemia or necrosis and, in rare cases, visual disturbance or blindness if ocular vessels are affected.
- Temporary numbness, altered sensation or tingling associated with lidocaine or mechanical effects of injection.
- Post-inflammatory hyperpigmentation or, rarely, scarring in predisposed individuals if significant inflammation or complications occur.
Storage Conditions
- Store at a controlled room temperature as specified on the packaging (commonly between 2 °C and 25 °C); do not freeze.
- Keep syringes in their original sterile blister or tray and outer carton to protect from light and physical damage until use.
- Do not use the product after the expiry date printed on the packaging.
- Do not use if the sterile packaging is damaged, opened or compromised, or if the gel appears discoloured or contains visible particles.
- Single-use device: once a syringe has been used for treatment, any remaining product must be discarded and must not be reused.
- Store out of reach of children and unauthorised persons.
Duration
Clinical effects typically last around 6 to 12 months on average, depending on injection depth, treatment area, patient metabolism, lifestyle and the volume of product injected; maintenance or repeat treatments can be scheduled as needed based on clinical assessment.
Onset
Volumising and wrinkle-correction effects are visible immediately after injection, with final results more clearly apparent after several days once initial swelling and redness have resolved.
