Restylane Lidocaine 1 mL

Restylane

Injectable Medical Device

Hyaluronic Acid Dermal Filler

CE Marked hyaluronic acid dermal filler for aesthetic facial tissue augmentation in applicable markets under European medical device regulations.
Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking in compliance with quality and safety standards for Class III sterile injectable medical devices.
Subject to regulatory post Market surveillance and adverse event (device vigilance) reporting requirements in countries where it is marketed.
For some markets and indications (e.g. mid To Deep dermal implantation for nasolabial folds and submucosal implantation for lip augmentation), Restylane with lidocaine is FDA Approved.

CE Marked hyaluronic acid dermal filler for aesthetic facial tissue augmentation in applicable markets under European medical device regulations.
Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking in compliance with quality and safety standards for Class III sterile injectable medical devices.
Subject to regulatory post Market surveillance and adverse event (device vigilance) reporting requirements in countries where it is marketed.
For some markets and indications (e.g. mid To Deep dermal implantation for nasolabial folds and submucosal implantation for lip augmentation), Restylane with lidocaine is FDA Approved.

Hyaluronic Acid Dermal Filler

Description

Restylane Lidocaine 1 mL (often referred to as Restylane with Lidocaine or Restylane Classic/L) is a sterile, transparent, biodegradable injectable gel of non-animal stabilized hyaluronic acid (NASHA technology) at a concentration of 20 mg/mL with 0.3% lidocaine hydrochloride. It is designed for facial tissue augmentation to correct moderate facial wrinkles and folds such as nasolabial folds, glabellar and forehead lines, and for lip augmentation in adults. The integrated lidocaine improves patient comfort during injection. The gel is injected into the mid-to-deep dermis of the facial skin or into the submucosal layer of the lip by trained healthcare professionals.

Bnefits

Reduces and fills moderate facial wrinkles and lines, including nasolabial folds, marionette lines and glabellar/frown lines.
Adds volume and fullness to targeted areas of the face, helping restore more youthful contours.
Suitable for lip augmentation and lip contour enhancement in adults over 21 years of age.
NASHA (Non-Animal Stabilized Hyaluronic Acid) technology provides a cohesive, stable gel with predictable lifting capacity and longevity.
Contains 0.3% lidocaine to reduce injection pain and improve patient comfort during treatment.
Non-animal origin hyaluronic acid minimizes risk of immunogenic reactions associated with animal-derived products.
Biodegradable and reversible: the gel is gradually resorbed over time and can be dissolved with hyaluronidase if necessary.
Immediate visible effect with natural-looking correction when injected appropriately.
CE-marked and (for specific indications/markets) FDA approved, with extensive clinical experience in aesthetic practice.

Indications

Facial tissue augmentation for aesthetic purposes in adults, performed by appropriately trained healthcare professionals.
Correction of moderate to severe facial wrinkles and folds such as nasolabial folds (lines between nose and mouth).
Treatment of glabellar lines and frown lines between the eyebrows, and forehead lines where suitable.
Softening of marionette lines and downturned corners of the mouth (bitter lines).
Lip augmentation and improvement of lip contour via submucosal injection in adults over 21 years of age.
Volume restoration in selected areas such as cheeks, chin, jawline and other midface regions with adequate soft tissue support, when consistent with the Instructions for Use.
General facial contouring and refinement where a mid-to-deep dermal hyaluronic acid filler is appropriate.

Composition

Stabilized sodium hyaluronate (hyaluronic acid) 20 mg/mL, non-animal origin (NASHA technology).
Lidocaine hydrochloride 3 mg/mL (0.3% lidocaine) as an integrated local anaesthetic.
Phosphate buffered saline, approximately pH 7, q.s. to 1.0 mL.
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 (20 mg/mL) of non-animal origin with 0.3% lidocaine hydrochloride in phosphate buffered saline at physiological pH, produced with NASHA technology and supplied ready-to-use in a single-use 1.0 mL pre-filled glass syringe for injection into the mid-to-deep dermis or submucosal layer of the lip.

Packaging

1 x 1.0 mL pre-filled glass syringe of Restylane Lidocaine (Classic/L).
Supplied in a sterile blister pack for single-patient use.
Typically includes 2 disposable sterile needles (commonly 29G 1/2" thin-wall or 30G 13 mm, depending on market configuration).
Luer-lock syringe with tamper-evident protective cap to maintain sterility before use.
Outer carton printed with product name, volume, batch/lot number, expiry date, manufacturer and regulatory markings.
Patient record and traceability labels attached to the syringe/carton for placement in patient medical records.

Usage

For professional use only: Restylane Lidocaine must be administered exclusively by appropriately trained and legally authorised healthcare professionals such as physicians experienced in dermal filler injections and facial anatomy.
Before use, inspect the outer carton, blister and syringe. Do not use if the packaging is damaged, the contents appear cloudy or contain particles, or if the product is past its expiry date.
Obtain a complete medical history, including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics and gram-positive bacterial proteins), bleeding disorders, autoimmune disease, and previous aesthetic procedures or implants.
Cleanse and disinfect the treatment area with appropriate antiseptic according to clinical protocol for injectable procedures.
Attach a suitable sterile needle (e.g. 29G 1/2" thin wall or equivalent) securely to the luer-lock syringe using aseptic technique and expel air prior to injection.
For wrinkle and fold correction (e.g. nasolabial folds), inject into the mid-to-deep dermis using appropriate techniques such as linear threading, serial puncture or cross-hatching, ensuring slow injection and gentle, steady plunger pressure.
For lip augmentation, inject into the submucosal layer while avoiding intramuscular or intravascular injection; aspirate gently before injecting to help reduce risk of intravascular placement.
Inject small aliquots and avoid overcorrection; aim for approximately 100% of desired correction recognizing that minor post-treatment swelling will occur.
Gently mould or massage the treated area, if needed, to ensure even distribution and a smooth contour, taking care not to exert excessive pressure.
Do not inject into areas with active skin disease, inflammation or infection. If the patient experiences intense pain, blanching, visual changes or other signs of vascular compromise, stop injection immediately and initiate appropriate management according to current clinical guidelines.
After treatment, advise the patient to avoid touching or applying makeup to the treated area for several hours and to avoid extremes of temperature, sunbeds, saunas, strenuous exercise and alcohol for a short period as per clinic protocol.
Record product name, batch number, injection sites, volumes used and any immediate reactions in the patient’s medical record using the supplied traceability labels.

Contraindications

Severe allergies manifested by a history of anaphylaxis or 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 or mucosal disease, inflammation, infection or lesions (e.g. acne, dermatitis, herpes) at or near the intended injection site.
Intravascular injection is strictly contraindicated; product must not be injected into blood vessels.
Intramuscular injection is contraindicated; product is intended for dermal or submucosal implantation as directed by the Instructions for Use.
Patients with a known tendency to hypertrophic scarring or keloid formation should generally not be treated with dermal fillers.
Use during pregnancy or breastfeeding is not recommended due to insufficient safety data.
Use in patients below the minimum age specified in local regulations and the product’s approved labelling (typically adults over 21 years for lip augmentation indications).

Adverse Effects

Common, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching and bruising.
Localized lumps, bumps, nodules or palpable irregularities at or near the injection site.
Injection-site hematoma or ecchymosis, particularly in patients with increased bleeding tendencies or those on anticoagulant/antiplatelet therapy.
Temporary alterations in sensation such as numbness, tingling or tightness in the treated area, partly due to lidocaine and injection trauma.
Localized inflammatory reactions including swelling and redness, which may occur immediately or be delayed and usually resolve spontaneously within days.
Infection at or near the injection site if strict aseptic technique is not maintained.
Rare delayed inflammatory reactions, granulomas or persistent nodules that may require further medical treatment.
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 cosmetic outcome or asymmetry potentially requiring correction, adjustment or product removal with hyaluronidase.

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 excessive heat and direct sunlight.
Do not use after the expiry date printed on the syringe and carton.
Do not use if the sterile blister or syringe packaging has been opened or damaged before use.

Duration

Results typically last about 6 to 9 months, with many patients maintaining visible correction up to 12 months in less mobile areas depending on injection site, technique, and individual metabolism.

Onset

Visible correction of wrinkles and volume enhancement is usually immediate after injection, with the final aesthetic outcome apparent once initial swelling and redness subside over several days up to about 2 weeks.