Restylane Vital Skinboosters Lido 1 ml

Restylane Vital Skinboosters Lido 1 ml

Restylane

Injectable Medical Device
  • CE Marked hyaluronic acid skin booster medical device 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 conformity with 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 evidence demonstrating improvements in skin elasticity, roughness and fine lines with courses of treatment.
Hyaluronic Acid Skin Booster

Description

Restylane Vital Skinboosters Lido 1 ml is a sterile, transparent injectable gel of stabilized, non-animal hyaluronic acid designed as a non-volumizing skin quality treatment. Using NASHA technology, it contains cross-linked hyaluronic acid at a dermal booster concentration together with 0.3% lidocaine hydrochloride to improve comfort during injection. Restylane Skinboosters are clinically proven to improve overall skin condition by gradually increasing elasticity, reducing surface roughness and softening fine lines and skin imperfections such as acne scars. Injected into the superficial to mid dermis, they provide deep hydration and improve texture and tone, making them a versatile solution for skin concerns on the face, neck, décolleté and backs of the hands. They are particularly suited for patients with younger skin who wish to address the first signs of ageing and progressively improve skin quality.

Bnefits

  • Clinically proven to improve overall skin condition, including elasticity and surface smoothness.
  • Reduces the appearance of fine lines and early signs of ageing.
  • Helps to gradually diminish skin imperfections such as acne scars.
  • Provides deep, long-lasting dermal hydration by replenishing hyaluronic acid in the skin.
  • Improves skin texture and tone, restoring a more radiant and healthy-looking complexion.
  • Versatile treatment suitable for face, neck, décolleté and backs of the hands.
  • Ideal for younger patients or those with early photoageing who want preventative and subtle rejuvenation.
  • Contains 0.3% lidocaine to reduce injection discomfort and improve patient tolerance.
  • Non-animal stabilized hyaluronic acid (NASHA) with well-established safety and biocompatibility.
  • Non-permanent and reversible; the gel is gradually metabolised by the body over time.

Indications

  • Improvement of overall skin quality by increasing dermal hydration, elasticity and smoothness.
  • Reduction of fine lines and superficial wrinkles associated with early photoageing.
  • Gradual improvement of skin imperfections such as shallow acne scars.
  • Skin quality enhancement and rejuvenation of the face.
  • Skin quality enhancement and rejuvenation of the neck and décolleté.
  • Rejuvenation and hydration of the backs of the hands.
  • Treatment of younger or moderately photoaged skin to act on the first signs of ageing.
  • Use as a skin booster rather than a volumising filler when subtle, diffuse improvement is desired.

Composition

  • Stabilized sodium hyaluronate (hyaluronic acid) of non-animal origin, NASHA technology (typical skinbooster concentration in the Vital range).
  • Lidocaine hydrochloride 3 mg/mL (0.3% lidocaine) as a local anaesthetic.
  • Phosphate buffered saline q.s. to 1.0 mL.
  • Physiological sodium chloride solution, approximately pH 7.
  • Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether) used to stabilise the hyaluronic acid gel.
  • Clear, viscoelastic, biodegradable gel free from animal proteins.

Formulation

  • Sterile, transparent, cross-linked hyaluronic acid gel containing stabilized, non-animal hyaluronic acid (NASHA technology) in a skinbooster concentration with 0.3% lidocaine hydrochloride in a physiological sodium chloride solution at approximately pH 7. The formulation is optimised for intradermal micro-depot injection into the superficial to mid dermis to improve skin hydration, elasticity and texture with minimal volumising effect.

Packaging

  • 1 x 1.0 ml pre-filled glass syringe of Restylane Vital Skinboosters Lido.
  • Syringe supplied sterile in an individual blister pack for single-patient use.
  • Pack typically includes fine-gauge sterile disposable needles suitable for intradermal injection (exact gauge and number 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 insertion into the patient’s medical records.

Usage

  • For professional use only: Restylane Vital Skinboosters Lido 1 ml 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 if the product is past its expiry date.
  • Obtain a comprehensive 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 fillers or skin treatments, and current medications (especially anticoagulants and antiplatelet agents).
  • Cleanse and disinfect the treatment area (face, neck, décolleté, hands) according to standard clinical protocols for injectable procedures.
  • Attach a suitable fine-gauge sterile needle (commonly 29–30G) or compatible microcannula securely to the luer-lock syringe using aseptic technique and expel any air 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 across the treatment area to create a uniform hydrating effect.
  • Inject slowly with gentle, controlled pressure and aspirate where appropriate to minimise the risk of inadvertent intravascular injection, even though the target layer is intradermal.
  • Avoid overcorrection; the goal is a subtle, diffuse improvement in skin quality rather than visible volume. Adjust total dose according to the size of the treatment area and the patient’s needs.
  • Gently massage or smooth the treated area, if required, to help distribute the gel and reduce palpable deposits, avoiding excessive pressure, especially in delicate regions.
  • Do not inject into areas with active skin disease, inflammation or infection. If severe pain, blanching, visual disturbance or other signs suggestive of vascular compromise occur, stop the injection immediately and initiate appropriate management according to current clinical guidelines.
  • Typical treatment protocols involve an initial course of approximately three sessions spaced about 2–4 weeks apart, followed by maintenance treatments every 4–6 months or according to clinical judgement and patient response.
  • After treatment, advise patients to avoid applying makeup to the treated area for several hours and to avoid extremes of temperature, sunbeds, saunas, vigorous exercise, alcohol and manipulation 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 presence of multiple severe allergies.
  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics, BDDE or any 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 (e.g. dermatitis, acne, bacterial infection, viral lesions such as herpes) at or near the intended injection sites.
  • 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 defined in the product labelling and local regulations (typically adults aged 18 years or older).

Adverse Effects

  • Common, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching and bruising.
  • Localized papules, small lumps or nodules at injection points, which typically resolve as the product integrates but may rarely persist and require further management.
  • Injection-site hematoma or ecchymosis, especially in patients with increased bleeding tendency or on anticoagulant/antiplatelet therapy.
  • Temporary alterations 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 within days to a few weeks.
  • Infection at or near the injection site if aseptic technique and post-treatment care are not strictly followed.
  • Rare delayed inflammatory reactions, granuloma formation or persistent nodules that may require 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, requiring urgent medical attention.
  • Post-inflammatory hyperpigmentation, scarring or other changes in pigmentation and skin texture, particularly in susceptible individuals.
  • Unsatisfactory aesthetic result or asymmetry that may necessitate additional or corrective treatments.

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 indicated 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 before use.

Duration

After a course of treatments, improvements in skin hydration, elasticity and texture typically last around 6 months, with duration influenced by individual factors such as metabolism, treatment area, technique and adherence to maintenance sessions.

Onset

Initial improvements in hydration and radiance are often noticeable shortly after treatment, with progressive enhancement of smoothness, elasticity and fine lines over the following weeks as the hyaluronic acid integrates into the dermis and binds water; full effect is usually evident after completion of the initial treatment series.

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