Revanesse Outline+ with Lidocaine (2 × 1.2 ml)

Revanesse

Aesthetic injectable

Cross-linked hyaluronic acid dermal filler for contouring and lips

Classified and supplied as a CE Marked medical device dermal filler based on cross Linked hyaluronic acid with lidocaine, rather than as a medicinal product.
Manufactured under medical device quality management systems by Prollenium Medical Technologies Inc. in Canada.
Intended for use exclusively by trained and licensed medical professionals in accordance with local regulations governing injectable aesthetic devices.
Biodegradable and hyaluronidase Reversible HA gel, allowing enzymatic adjustment or dissolution in case of adverse events or unsatisfactory results under medical supervision.

Classified and supplied as a CE Marked medical device dermal filler based on cross Linked hyaluronic acid with lidocaine, rather than as a medicinal product.
Manufactured under medical device quality management systems by Prollenium Medical Technologies Inc. in Canada.
Intended for use exclusively by trained and licensed medical professionals in accordance with local regulations governing injectable aesthetic devices.
Biodegradable and hyaluronidase Reversible HA gel, allowing enzymatic adjustment or dissolution in case of adverse events or unsatisfactory results under medical supervision.

Cross-linked hyaluronic acid dermal filler for contouring and lips

Description

Revanesse Outline+ with Lidocaine is a smooth, high-viscosity, cross-linked hyaluronic acid (HA) dermal filler developed by Prollenium for deep-tissue volumisation and contouring. Optimised with Thixofix cross-linking technology, the monophasic HA gel is designed to create volume in deep facial tissues and to sculpt areas such as cheeks, chin and jawline, while also being ideal for shaping and defining the vermillion border and lips. The formulation includes lidocaine to enhance treatment comfort and is supplied as a medical device intended for injection by trained medical professionals only. Each box contains two 1.2 ml prefilled syringes of Revanesse Outline+ with sterile needles.

Bnefits

High-viscosity HA gel designed to create volume in deep tissue areas for structural contouring and lift.
Smooth, cohesive monophasic gel optimised with Thixofix cross-linking technology for uniform injection and shape retention.
Contains lidocaine (0.3%) to reduce injection pain and improve patient comfort during treatment.
Effective for volumising and contouring cheeks, chin and jawline, as well as defining the vermillion border and enhancing the lips.
Higher HA concentration (25 mg/ml) compared with many standard fillers, supporting long-lasting volumising results.
Formulated to help minimise inflammatory responses such as pain and swelling, supporting shorter downtime.
Biodegradable hyaluronic acid that can be adjusted or reversed using hyaluronidase under medical supervision.

Indications

Restoration and addition of volume in deep facial tissue areas requiring contouring and shaping.
Volumisation and contouring of cheeks, chin and jawline.
Lip enhancement, including augmentation and definition of the vermillion border.
Treatment of medium to deep facial rhytides and folds by injection into the deep dermis to subcutaneous layers.
Correction of depressions and contour defects in indicated facial areas by HA gel implantation.

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, high viscosity, sterile, colourless, odourless and transparent.
HA concentration: 25 mg/ml in phosphate-buffered saline.
Lidocaine concentration: 3 mg/ml (0.3% w/w).
Optimised using Thixofix cross-linking technology to provide a smooth, cohesive, viscoelastic gel.
Intended for injection into deep dermis to subcutaneous tissue by qualified professionals.

Packaging

Box containing 2 prefilled disposable glass syringes x 1.2 ml Revanesse Outline+ gel (total 2.4 ml).
Up to 2 sterile needles (typically 27G–29G, single use) supplied in the box, depending on configuration.
Syringes packaged in sterile blister/tray within an outer carton bearing batch number, expiry date and product details.
Single-use syringes and needles; any unused product after a procedure must be discarded.

Usage

Revanesse Outline+ with Lidocaine is a medical device dermal filler for professional use only and must be injected by suitably trained and licensed medical practitioners.
Before treatment, obtain a complete medical history and assess suitability, including allergies to hyaluronic acid, lidocaine or amide local anaesthetics.
Cleanse and disinfect the treatment area using appropriate antiseptic measures and maintain aseptic technique throughout the procedure.
Remove the syringe end cap, securely attach the sterile needle provided (or another suitable sterile needle according to local protocols), and expel any air bubbles before injection.
Recommended injection depth is deep dermis to subcutaneous tissue, depending on indication and anatomical site (e.g. cheeks, chin, jawline, vermillion border, lips).
Use appropriate techniques such as linear threading, fanning or small bolus injections, injecting slowly and avoiding overcorrection.
Aspirate in accordance with the practitioner’s protocol where appropriate to reduce the risk of intravascular injection, especially in high-risk areas.
After injection, gently mould or massage the treated area if required to achieve even distribution, avoiding excessive pressure.
Advise the patient to avoid makeup on the treated areas for several hours, and to avoid extreme heat or cold, sunbeds, saunas, vigorous exercise and alcohol for 24–48 hours post-treatment or as per clinic protocol.
Inform the patient to report any signs of severe pain, blanching, discolouration, visual disturbance or other unexpected symptoms immediately.
Dispose of used syringes, needles and any remaining product 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 other 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, acne or other dermatologic disease at or near the intended injection sites.
Bleeding disorders or current significant anticoagulant/antiplatelet therapy unless carefully evaluated and deemed appropriate by the treating physician.
Autoimmune diseases or immunocompromised states, unless the treating clinician determines that treatment is safe and appropriate.
Pregnancy or breastfeeding, as safety has not been established for these populations.
Patients under the legal minimum age for aesthetic injectable procedures in the relevant jurisdiction.
Injection into blood vessels, intramuscular injection, or use in high-risk anatomical areas without appropriate expertise and precautions.

Adverse Effects

Common transient injection-site reactions including redness (erythema), swelling, tenderness, pain, itching, induration or bruising.
Formation of small lumps or nodules, unevenness or overcorrection at treated sites, which may resolve spontaneously or require clinical management.
Local infection, abscess or delayed inflammatory reactions if aseptic technique or aftercare are inadequate.
Allergic or hypersensitivity reactions to HA, lidocaine or other components, potentially including delayed-onset nodules or granuloma formation.
Vascular complications such as intravascular injection or compression, potentially causing blanching, severe pain, tissue ischaemia or necrosis, and in rare cases visual disturbances or blindness if ocular vessels are affected.
Temporary numbness, altered sensation or tingling related to lidocaine or mechanical effects of injection.
Post-inflammatory hyperpigmentation or scarring in susceptible individuals if significant inflammatory or ischaemic events occur.

Storage Conditions

Store between 2 °C and 25 °C as indicated in the instructions for use; do not freeze.
Keep syringes in their original blister/tray and outer carton to protect from light and contamination until ready for use.
Do not use after the expiry date printed on the packaging.
Do not use if the packaging, blister or syringe appears damaged, previously opened, or if the gel appears discoloured or contains visible particles.
Single-use only; once the syringe has been used, any remaining product must be discarded and not stored for future use.
Store out of reach of children and unauthorised persons.

Duration

Clinical effects typically last around 6\u201312 months, with some patients maintaining volumising and contouring results up to approximately 12 months or longer depending on treatment area, injection depth, metabolism and lifestyle; maintenance treatments can be scheduled according to clinical judgement and patient goals.

Onset

Volume and contouring effects are generally visible immediately after injection, with final results becoming apparent within approximately 1\u20132 weeks once initial swelling and redness have subsided.