Restylane Skinboosters Vital with Lidocaine (1 x 1.0 ml)

Restylane

Injectable Medical Device

Hyaluronic Acid Skin Booster

CE Marked hyaluronic acid skin booster for improvement of skin quality and hydration in applicable European and international markets.
Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking in compliance with relevant quality and safety standards for sterile injectable medical devices (Class III).
Subject to regulatory post Market surveillance and adverse event (device vigilance) reporting requirements in territories where it is marketed.
Supported by clinical studies demonstrating improvements in skin hydration, elasticity, smoothness and reduction of fine lines following treatment courses.

CE Marked hyaluronic acid skin booster for improvement of skin quality and hydration in applicable European and international markets.
Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking in compliance with relevant quality and safety standards for sterile injectable medical devices (Class III).
Subject to regulatory post Market surveillance and adverse event (device vigilance) reporting requirements in territories where it is marketed.
Supported by clinical studies demonstrating improvements in skin hydration, elasticity, smoothness and reduction of fine lines following treatment courses.

Hyaluronic Acid Skin Booster

Description

Restylane Skinboosters Vital with Lidocaine is a sterile, transparent, biodegradable injectable gel of stabilized, non-animal hyaluronic acid (NASHA technology) at a concentration of 20 mg/mL with 0.3% lidocaine hydrochloride. It is specifically designed as a skin quality treatment rather than a volumising filler, boosting hydration levels deep within the dermis to improve skin smoothness, elasticity and firmness. Once injected into the superficial to mid dermis, it forms small reservoirs of moisture that gradually release water, restoring a natural glow and improving texture in areas such as the face, neck, décolleté and backs of the hands. The added lidocaine provides local anaesthesia to enhance patient comfort during injections.

Bnefits

Deeply hydrates the skin from within by replenishing dermal hyaluronic acid levels.
Improves skin smoothness, elasticity and firmness without significantly changing facial volume or shape.
Reduces the appearance of fine lines and superficial wrinkles, especially in photo-damaged or mature skin.
Enhances overall skin texture and tone, contributing to a more radiant, healthy-looking complexion.
Suitable for multiple treatment areas including face, neck, décolleté and backs of the hands.
Uses stabilized, non-animal hyaluronic acid (NASHA) with an established safety and biocompatibility profile.
Contains 0.3% lidocaine to reduce injection-related pain and improve patient comfort.
Provides gradual, natural-looking improvements that can be built up over a course of treatments.
Non-permanent and reversible, with the gel gradually broken down by the body over time.

Indications

Improvement of overall skin quality by increasing dermal hydration, elasticity and firmness.
Reduction of fine lines and superficial wrinkles in areas with signs of photoaging or dryness.
Skin quality enhancement and deep hydration of the face (including cheeks and lower face).
Skin quality enhancement and deep hydration of the neck and décolleté.
Skin quality enhancement and deep hydration of the backs of the hands.
Treatment of dull, rough or uneven-looking skin to restore a more luminous and refreshed appearance.
Use in adults for whom a skin quality booster (rather than a volumising dermal filler) is clinically appropriate.

Composition

Hyaluronic acid, stabilized (non-animal origin), 20 mg/mL.
Lidocaine hydrochloride, 3 mg/mL (0.3% lidocaine) as a local anaesthetic.
Phosphate buffered saline q.s. to 1 mL.
Physiological sodium chloride solution, pH approximately 7.
Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether) used to stabilize the hyaluronic acid gel.
Clear, transparent, viscoelastic, biodegradable gel free from animal proteins.

Formulation

Sterile, transparent, cross-linked hyaluronic acid gel at 20 mg/mL with 0.3% lidocaine hydrochloride in a physiological sodium chloride solution at pH ~7, produced using NASHA (Non-Animal Stabilized Hyaluronic Acid) technology. The formulation is non-volumising and optimized for intradermal implantation into the superficial to mid dermis to improve skin hydration and quality rather than provide structural lifting.

Packaging

1 x 1.0 ml pre-filled glass syringe of Restylane Skinboosters Vital with Lidocaine.
Syringe supplied sterile in an individual blister pack for single-patient use.
Pack typically includes fine-gauge sterile disposable needles (e.g. 30G) suitable for intradermal injection; exact configuration may vary by market.
Luer-lock syringe with tamper-evident protective cap to maintain sterility until use.
Outer carton printed with product name, volume, batch/lot number, expiry date, manufacturer details and regulatory markings.
Traceability / patient record labels supplied for inclusion in the patient’s medical record.

Usage

For professional use only: Restylane Skinboosters Vital with Lidocaine must be administered exclusively by appropriately trained and legally authorised healthcare professionals experienced in dermal injection techniques and anatomy of the treatment area.
Before use, inspect the outer carton, blister and syringe; do not use if packaging is damaged, sterility may be compromised, the gel appears cloudy or contains visible particles, or the product is past its expiry date.
Obtain a complete medical history including allergies (particularly to hyaluronic acid, lidocaine or other amide-type local anaesthetics and gram-positive bacterial proteins), bleeding disorders, autoimmune disease, previous aesthetic treatments and current medications (notably anticoagulants and antiplatelet agents).
Cleanse and disinfect the treatment area (face, neck, décolleté, hands, etc.) in accordance with clinic protocols for injectable procedures.
Attach a suitable sterile needle (commonly 29–30G) or compatible microcannula to the luer-lock syringe using aseptic technique and expel any air from the system before beginning injections.
Inject small aliquots into the superficial to mid dermis using micro-depot, serial puncture, linear threading or nappage techniques, distributing the product evenly throughout the treatment area to create a uniform hydrating effect.
Inject slowly with minimal pressure and aspirate where appropriate to reduce the risk of inadvertent intravascular injection, even though the target layer is intradermal.
Avoid overcorrection; spread the total dose according to the size of the treatment area and the patient’s clinical needs. Multiple treatment sessions are usually scheduled as part of a protocol.
Gently massage or smooth the treated area if necessary to ensure even distribution and to reduce palpable deposits, avoiding excessive pressure.
Do not treat areas with active skin disease, inflammation or infection (e.g. dermatitis, acne, rashes, bacterial or viral lesions). If severe pain, blanching, visual disturbance or other signs of vascular compromise occur, stop the injection immediately and initiate appropriate management.
A typical treatment program consists of an initial series of about 3 treatment sessions spaced approximately 2–4 weeks apart, followed by maintenance treatments usually every 4–6 months, adjusted to patient response and local guidelines.
After treatment, advise patients to avoid makeup on the treated area for several hours and to avoid extremes of temperature, sunbeds, saunas, strenuous exercise, alcohol and manipulation or massage of the treated area for a short period as per clinic protocol.
Record the product name, batch/lot number, treatment areas, injection technique and volumes used, and any immediate reactions in the patient’s medical record using the supplied traceability labels.

Contraindications

History of severe allergies or anaphylactic reactions, or the presence of multiple severe allergies.
Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics, BDDE or any of the excipients including gram-positive bacterial proteins.
Bleeding disorders or current significant use of anticoagulant, thrombolytic or high-dose antiplatelet therapy where injection-related bleeding risk is considered unacceptable.
Active skin disease, inflammation, infection or lesions at or near the intended injection sites (e.g. dermatitis, acne, bacterial infection, viral lesions such as herpes).
Intravascular injection is strictly contraindicated; the product must never be injected into blood vessels.
Intramuscular injection is contraindicated; the product is intended only for intradermal use in the superficial to mid dermis.
Patients with a known tendency to hypertrophic scarring or keloid formation should generally not be treated with dermal fillers or skin boosters.
Use during pregnancy or breastfeeding is not recommended due to insufficient safety data.
Use in patients below the minimum age specified in the product labelling and local regulations (typically adults aged 18 years or older).

Adverse Effects

Common, usually transient injection-site reactions including redness (erythema), swelling, tenderness, pain, itching and bruising.
Localized small papules, lumps or nodules at injection sites, which usually resolve as the product integrates into the dermis but may occasionally persist and require medical management.
Injection-site hematoma or ecchymosis, especially in patients with a tendency to bruise or on anticoagulant/antiplatelet therapy.
Temporary changes in sensation such as numbness, tingling or tightness in the treated area due to lidocaine and injection trauma.
Localized inflammatory reactions including swelling, redness and warmth, which may appear immediately or be delayed and usually resolve spontaneously within days to a few weeks.
Infection at or near the injection site if aseptic technique is not strictly followed.
Rare delayed inflammatory reactions, granuloma formation or persistent nodules that may require additional medical treatment and, in some cases, hyaluronidase.
Rare but serious complications associated with inadvertent intravascular injection, including vascular occlusion, ischemia, tissue necrosis or visual disturbance/vision loss, which require urgent medical attention.
Post-inflammatory hyperpigmentation, scarring or other changes in skin pigmentation and texture, particularly in susceptible individuals.
Unsatisfactory aesthetic result or asymmetry that may necessitate additional treatments or corrective procedures.

Storage Conditions

Store in the original outer carton to protect from light and maintain sterility until use.
Store at a controlled temperature, typically between 2°C and 25°C, as specified on the product packaging and Instructions for Use.
Do not freeze; avoid exposure to excessive heat and direct sunlight.
Do not use after the expiry date printed on the syringe and outer carton.
Do not use if the sterile blister or syringe packaging has been opened or damaged prior to use.

Duration

Clinical studies and practical experience indicate that improvements in skin hydration, elasticity and smoothness can last for several months following a treatment course, with many patients maintaining visible benefits for around 6 to 12 months when initial sessions are followed by regular maintenance treatments approximately every 4 to 6 months.

Onset

Improvement in hydration and radiance is often noticeable shortly after treatment, with progressive enhancement of skin smoothness, elasticity and fine lines over the following weeks as the hyaluronic acid integrates into the dermis and binds water; full results are typically seen after completion of the initial treatment series.