Regenovue Deep Plus with Lidocaine (1 x 1.1ml)

Regenovue

Aesthetic Injectable / Dermal Filler

Cross-linked hyaluronic acid dermal filler

CE Marked hyaluronic acid dermal filler (classification subject to local medical device regulations).
Manufactured under quality management systems consistent with ISO 13485 for medical devices.
Non Animal derived HA with low endotoxin and low residual BDDE levels in line with international safety standards for dermal fillers.

CE Marked hyaluronic acid dermal filler (classification subject to local medical device regulations).
Manufactured under quality management systems consistent with ISO 13485 for medical devices.
Non Animal derived HA with low endotoxin and low residual BDDE levels in line with international safety standards for dermal fillers.

Cross-linked hyaluronic acid dermal filler

Description

Regenovue Deep Plus with Lidocaine (1 x 1.1ml) is a highly cross-linked, non-animal hyaluronic acid dermal filler from NeoGenesis designed for the correction of medium to deep facial wrinkles and for facial contouring. The filler has a monophasic, homogenous gel structure with an HA concentration of 24 mg/ml and 3 mg/ml lidocaine to improve patient comfort during injection. Its 100% cross-linked structure between HA molecules provides excellent stability, cohesiveness and long-lasting results, typically 12–18 months. Regenovue Deep Plus with Lidocaine is suitable for treating nasolabial folds, marionette lines, medium to deep forehead lines, chin wrinkles and for defining and volumising lips, chin and cheeks.

Bnefits

High-performance cross-linked hyaluronic acid filler (24 mg/ml) providing long-lasting correction of medium to deep wrinkles and folds.
Contains 3 mg/ml lidocaine for improved patient comfort and reduced injection pain.
Monophasic, homogenous gel with fine, evenly dispersed particles for smooth injections and precise contouring.
100% cross-linked HA structure between molecules, resulting in enhanced gel stability and durability (approximately 12–18 months).
Non-animal, biocompatible HA with low endotoxin levels and low residual BDDE, supporting safety and tolerability.
Versatile indication profile: effective for nasolabial folds, marionette lines, forehead lines, chin wrinkles and lip, chin and cheek enhancement.
Provides natural-looking volume and elasticity while maintaining good tissue integration and low risk of lumpiness when correctly injected.

Indications

Correction of medium to deep wrinkles and folds, including nasolabial folds and marionette lines.
Treatment of medium to deep wrinkles on the forehead (worry lines, frown lines) and chin (mental crease).
Contour enhancement and volumisation of chin and cheeks.
Lip contouring and augmentation, including definition of the vermilion border and volume restoration.
Facial sculpting and reshaping of jawline and mid-face where a medium-high viscosity filler is indicated.

Composition

Cross-linked hyaluronic acid 24 mg/ml (non-animal origin).
Lidocaine hydrochloride 3 mg/ml (0.3%) as a local anaesthetic.
Physiological phosphate-buffered saline (PBS) solution at approximately neutral pH.
Very low endotoxin concentration (typically < 0.1 EU/g) and low residual BDDE after purification.

Formulation

Monophasic, highly cross-linked hyaluronic acid gel with homogeneous particle distribution.
Injectable, sterile, pyrogen-free gel supplied in a pre-filled 1.1 ml glass syringe with Luer-lock fitting.
Designed for injection into the lower dermis and superficial subcutaneous tissue for wrinkle correction and contouring.
Non-animal stabilised HA, gradually resorbed over time while maintaining structural support during its effective period.

Packaging

Each unit contains 1 pre-filled 1.1 ml syringe of Regenovue Deep Plus with Lidocaine.
Pack typically includes 2 sterile 27G needles for use with the syringe.
Syringe is supplied in a sterile blister tray within an outer carton bearing product name, batch number, expiry date, and manufacturer details.
For professional use only; labelling and packaging indicate use by trained healthcare or aesthetic practitioners.

Usage

For professional use only by appropriately trained medical or aesthetic practitioners familiar with facial anatomy and dermal filler injection techniques.
Take a full medical history, assess indications and contraindications, and obtain informed consent prior to treatment.
Clean and disinfect the treatment area thoroughly; apply topical or local anaesthesia if needed in addition to the lidocaine contained in the product.
Using aseptic technique, attach a suitable sterile needle (commonly 27G) or cannula to the Luer-lock syringe, ensuring a secure connection.
Inject slowly into the recommended plane (lower dermis or superficial subcutaneous layer) using appropriate techniques such as linear threading, serial puncture, fanning or depot injections, depending on the indication and area treated.
Treat nasolabial folds, marionette lines, forehead lines, chin and lips with small aliquots, avoiding overcorrection and intravascular injection.
After injection, gently mould and contour the filler to achieve a smooth, even result, taking care not to apply excessive pressure.
Advise the patient to avoid touching or massaging the treated areas (unless instructed), intense exercise, alcohol consumption, saunas, sunbeds and strong sun/heat exposure for at least 24 hours post-procedure.
Schedule follow-up appointments as required to assess results and consider touch-up treatments if necessary.
Dispose of all used needles and syringes immediately after use in approved sharps containers; do not reuse or resterilise.

Contraindications

Hypersensitivity or allergy to hyaluronic acid, lidocaine, amide-type local anaesthetics or any of the excipients.
History of severe anaphylactic reactions or multiple severe allergies without appropriate specialist assessment.
Presence of active skin infection, inflammation, herpetic lesions or dermatological disease at or near the intended injection site.
Pregnancy and breastfeeding (elective aesthetic filler treatments are generally not recommended).
Autoimmune diseases, uncontrolled systemic illness, immunosuppression or coagulation disorders unless carefully evaluated by a physician.
Concurrent use of strong anticoagulant or antiplatelet medication without assessing bleeding risk.
Previous permanent or semi-permanent fillers in the planned injection area where interaction may increase complication risk.
Intravascular injection is strictly contraindicated; do not inject into blood vessels or areas with high risk of vascular compromise.

Adverse Effects

Common transient reactions: redness, swelling, tenderness, pain, itching, bruising or firmness at injection sites.
Temporary lumps, nodules or asymmetry in the treated area, which may require massage, observation or correction.
Less frequent events: prolonged oedema, local inflammatory reactions, infection or granuloma formation.
Rare but serious complications related to inadvertent intravascular injection, including vascular occlusion, tissue ischaemia or necrosis, and ocular complications such as visual disturbance or blindness, requiring immediate emergency management.
Hypersensitivity or delayed inflammatory responses which may present as persistent redness, swelling, induration or discomfort; product use should be discontinued and medical evaluation sought.

Storage Conditions

Store in the original packaging at controlled room temperature (typically 2–25°C).
Keep away from direct sunlight, heat sources and freezing temperatures.
Do not use after the expiry date indicated on the packaging.
Do not use if the blister or syringe is damaged, the tamper-evident seal is broken, or the gel appears cloudy or contains visible particles.
Keep out of reach of children and unauthorised personnel.

Duration

Clinical effects typically last approximately 12\u201318 months, depending on treatment area, injection technique, patient metabolism and lifestyle.

Onset

Visible improvement is usually immediate after injection, with optimal results seen after initial post-injection swelling and redness subside over several days.