Revanesse Pure+ with Lidocaine (2 × 1.2 ml)
Revanesse
Aesthetic injectableNon-cross-linked hyaluronic acid skin booster / biorevitalisation
Certifications
- CE Marked as a hyaluronic acid gel indicated for treatment of facial rhytides and lipoatrophy by injection into the skin in applicable markets.
- Manufactured by Prollenium Medical Technologies Inc. in Canada under medical device quality management systems and regulatory oversight.
- Classified as a medical device dermal filler/skin booster rather than a medicinal product; for use only by trained medical professionals following local aesthetic device regulations.
- Non Cross Linked, biodegradable HA gel that can be adjusted or reversed using hyaluronidase in case of adverse events or unsatisfactory outcomes under medical supervision.
- CE Marked as a hyaluronic acid gel indicated for treatment of facial rhytides and lipoatrophy by injection into the skin in applicable markets.
- Manufactured by Prollenium Medical Technologies Inc. in Canada under medical device quality management systems and regulatory oversight.
- Classified as a medical device dermal filler/skin booster rather than a medicinal product; for use only by trained medical professionals following local aesthetic device regulations.
- Non Cross Linked, biodegradable HA gel that can be adjusted or reversed using hyaluronidase in case of adverse events or unsatisfactory outcomes under medical supervision.
Non-cross-linked hyaluronic acid skin booster / biorevitalisation
Description
Revanesse Pure+ with Lidocaine is a monophasic, non-animal, non-cross-linked hyaluronic acid (HA) gel skin booster developed by Prollenium Medical Technologies Inc. It contains 14 mg/ml of non-cross-linked HA with 0.3% lidocaine in a phosphate-buffered saline solution. As the only non-cross-linked HA gel in the Revanesse family, it is designed to nourish and hydrate the skin, replenish HA lost due to ageing, and restore elasticity for firmer, healthier-looking skin. Revanesse Pure+ is intended for bio-revitalisation and skin rehydration of the face, neck, hands and décolletage using superficial dermal or mesotherapy techniques. Each box contains two 1.2 ml prefilled syringes with up to two sterile needles (30G/32G) and is a medical device for professional use only.
Bnefits
- Non-cross-linked, highly pure HA gel specifically designed for skin hydration rather than volumetric filling.
- Replenishes hyaluronic acid lost due to ageing, helping restore skin firmness, elasticity and a healthier appearance.
- Provides bio-revitalisation and improves overall skin texture and tone, targeting emerging lines and fine wrinkles.
- Formulated with 0.3% lidocaine to enhance patient comfort and minimise pain during injection.
- Rapidly absorbed and distributed in the superficial dermis, allowing nourishment and moisturisation of the entire treated surface.
- Suitable for multiple areas including face, neck, hands and décolletage via mesotherapy-style techniques.
Indications
- Bio-revitalisation and rehydration of the skin of the face, neck, hands and décolletage.
- Treatment and softening of emerging lines and fine wrinkles (e.g. forehead, perioral lines).
- Improving overall skin texture, tone and elasticity for firm, healthy-looking skin.
- Superficial dermal HA replenishment in areas showing initial signs of ageing and dehydration.
Composition
- Non-cross-linked hyaluronic acid 14 mg/ml (non-animal, synthetic origin).
- Lidocaine 0.3% w/w (approximately 3 mg/ml) for local anaesthesia during injection.
- Phosphate-buffered saline (PBS) carrier solution.
- No cross-linking agent (non-cross-linked gel); part of the Revanesse range of HA products.
Formulation
- Monophasic, non-cross-linked, sterile hyaluronic acid gel for injectable use.
- HA concentration: 14 mg/ml.
- Lidocaine concentration: 0.3% w/w.
- Colourless, odourless, transparent and aqueous viscoelastic gel.
- Delivered in prefilled disposable glass syringes intended for superficial dermal/mesotherapy injection techniques.
Packaging
- Box containing 2 prefilled glass syringes x 1.2 ml Revanesse Pure+ with Lidocaine (total 2.4 ml).
- Includes up to 2 sterile needles (30G and/or 32G), single use.
- Syringes supplied in sterile blister/tray packaging with tamper-evident seals.
- Outer carton labelled with product name, HA concentration (14 mg/ml), lidocaine content (0.3%), batch/lot number and expiry date.
- Medical device, single-use syringes and needles; any remaining gel after treatment must be discarded.
Usage
- Revanesse Pure+ with Lidocaine is a medical device intended only for use by trained and qualified medical professionals experienced in aesthetic injections.
- Before treatment, perform a full medical history and skin assessment, and obtain informed consent; evaluate for allergies to hyaluronic acid, lidocaine or other components.
- Clean and disinfect the treatment area using appropriate antiseptic preparations; maintain aseptic technique throughout the procedure.
- Attach a sterile 30G or 32G needle to the prefilled syringe according to the manufacturer’s instructions and expel any air bubbles prior to injection.
- Recommended injection depth is superficial dermis, using mesotherapy-style microinjections, nappage or small bolus techniques spread evenly across the treatment area.
- Typical treatment areas include face, neck, hands and décolletage, focusing on emerging lines, fine wrinkles and areas of visible dehydration.
- Inject small amounts per point, avoiding overcorrection; distribute product homogeneously to achieve even hydration and bio-revitalisation.
- Massage gently if needed to ensure uniform distribution, without exerting excessive pressure.
- Advise patients to avoid makeup, intense heat or cold, tanning beds, saunas, vigorous exercise and alcohol for a period recommended by the practitioner (often 24–48 hours) after treatment.
- Multiple sessions may be scheduled based on clinical judgement (e.g. initial course followed by maintenance at intervals determined by patient needs and response).
- Dispose of used syringes, needles and any remaining gel as clinical sharps waste; do not 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 formulation.
- History of severe allergic reactions or anaphylaxis to injectable products.
- Active skin infection, inflammation, herpes lesions or other dermatological disease at or near the intended injection sites.
- Bleeding disorders or current use of significant anticoagulant/antiplatelet therapy unless carefully evaluated and deemed appropriate by the treating physician.
- Autoimmune diseases or immunocompromised states, unless considered safe by the treating clinician.
- Pregnant or breastfeeding women, as safety has not been established.
- Patients under the minimum legal age for aesthetic injections in the relevant jurisdiction.
- Do not inject intravascularly; avoid use in areas with compromised vascular supply or high vascular risk without appropriate training and precautions.
Adverse Effects
- Common, usually transient injection-site reactions such as redness, swelling, bruising, tenderness, itching, local warmth or mild pain.
- Small lumps, papules or irregularities at injection points, generally resolving as the product integrates; persistent nodules require clinical evaluation.
- Local infection or abscess formation if aseptic procedures are not strictly followed.
- Allergic or hypersensitivity reactions to HA, lidocaine or other components, including delayed inflammatory responses in rare cases.
- Very rare vascular complications (if inadvertently injected into or compressing a vessel), potentially causing blanching, pain, tissue ischaemia or necrosis.
- Temporary numbness or altered sensation due to lidocaine or injection trauma.
- Post-inflammatory pigmentation changes or, rarely, scarring in susceptible individuals if significant inflammation or complications occur.
Storage Conditions
- Store in accordance with the information on the carton, typically at controlled room temperature (commonly between 2 °C and 25 °C); do not freeze.
- Keep the syringes in their original blister/tray and outer carton 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 sterile blister/tray or outer packaging is damaged or opened, or if the gel appears discoloured or contains visible particles.
- Single-use only; once a syringe has been used, any remaining product must be discarded and must not be stored or reused.
- Store out of reach of children and unauthorised individuals.
Duration
Hydration and bio-revitalisation effects typically last around 6\u20139 months, with some literature citing a remanence of approximately 9\u201312 months depending on treatment protocol, injection depth, treated area, metabolism and lifestyle; repeat or maintenance sessions are scheduled according to clinical assessment.
Onset
Improved hydration and skin glow are generally visible shortly after treatment, with further improvements in texture, elasticity and fine lines becoming more noticeable over the following days to weeks as the HA integrates and attracts water.
