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Restylane Refyne

Restylane Refyne

Restylane

Injectable Medical Device
  • CE Marked hyaluronic acid dermal filler for the correction of moderate to severe facial wrinkles and folds in applicable European and international markets.
  • Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking in conformity with relevant quality and safety standards for sterile injectable medical devices (Class III).
  • FDA Approved in the United States for injection into the mid To Deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over 21 years of age.
  • Subject to regulatory post Market surveillance and adverse event (device vigilance) reporting obligations in territories where it is marketed.
Hyaluronic Acid Dermal Filler \u2013 Flexible Filler for Expression Lines

Description

Restylane Refyne with Lidocaine is a sterile, transparent, biodegradable injectable gel of non-animal stabilized hyaluronic acid (NASHA technology) at 20 mg/mL with 0.3% lidocaine hydrochloride. Designed with a soft, flexible gel texture, it is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and marionette lines, while maintaining natural facial expression and movement. The filler provides effective lifting and smoothing of dynamic expression lines with good tissue integration and skin tolerance. It can also be used in suitable patients for minor nonsurgical nose contour refinement. The product is supplied as a 1.0 ml pre-filled glass syringe for single-patient professional use.

Bnefits

  • Smooth, soft gel with excellent lifting effect and good tissue distribution, ideal for dynamic expression lines.
  • Effectively treats moderate to deep wrinkles and folds, including nasolabial folds, marionette lines and forehead lines.
  • Designed with flexible properties so the treated areas move naturally with facial expressions, giving natural-looking results.
  • Non-animal stabilized hyaluronic acid provides long-lasting but reversible correction and sustained hydration of the skin.
  • Contains 0.3% lidocaine to reduce injection pain and improve patient comfort during treatment.
  • Lower proportion of free hyaluronic acid compared to some fillers, which may reduce the risk of post-treatment swelling.
  • Can be used for subtle nonsurgical refinement of nasal contours in suitable patients, harmonising the nose with the rest of the face.
  • Immediate visible results after treatment with a typical duration of 6–12 months depending on area, technique and individual factors.
  • Backed by FDA approval (for nasolabial folds) and extensive clinical experience in aesthetic medicine.

Indications

  • Injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds such as nasolabial folds (laugh lines) in adults over 21 years of age.
  • Treatment of marionette lines and oral commissures, helping to correct the appearance of a persistent frown or downturned mouth corners.
  • Softening of expression lines including selected forehead wrinkles where a flexible gel is appropriate.
  • Refinement and definition of the vermilion border and perioral lines in suitable cases.
  • Minor nonsurgical correction and contour harmonisation of the nose (rhinomodeling) in appropriately selected patients and in accordance with local regulations.
  • General correction of medium-deep to deep dynamic facial wrinkles in areas where maintaining natural facial movement is important.

Composition

  • Non-animal stabilized sodium hyaluronate (hyaluronic acid) 20 mg/mL.
  • Lidocaine hydrochloride 3 mg/mL (0.3% lidocaine).
  • 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.
  • Sterile, clear, 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 phosphate buffered saline (pH ~7), produced using proprietary Galderma technology (often referred to as XpresHAn / OBT-type technology) to deliver a soft, flexible gel suitable for dynamic expression lines. Supplied as a single-use, pre-filled 1.0 ml glass syringe intended for mid-to-deep dermal injection by qualified healthcare professionals.

Packaging

  • 1 x 1.0 ml pre-filled glass syringe of Restylane Refyne with Lidocaine.
  • Syringe supplied sterile in an individual blister pack for single-patient use.
  • 2 x 30G 1/2" ultra-thin-wall disposable sterile needles supplied in the pack (configuration may vary by market).
  • Luer-lock syringe with tamper-evident protective cap to maintain sterility prior to use.
  • Outer carton printed with product name, volume, batch/lot number, expiry date, manufacturer and regulatory markings.
  • Patient record and traceability labels provided for placement in the patient’s medical records.

Usage

  • For professional use only: Restylane Refyne with Lidocaine must be administered exclusively by appropriately trained and legally authorised healthcare professionals experienced in facial anatomy and dermal filler injections.
  • Before use, inspect the outer carton, blister and syringe; do not use if packaging is damaged, sterility is compromised, the gel appears cloudy or contains particulates, or the product is past the 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, prior fillers or implants, and current medications (particularly anticoagulants and antiplatelet agents).
  • Prepare the treatment area by cleansing and disinfecting the skin according to standard protocols for injectable procedures.
  • Attach one of the supplied 30G 1/2" sterile needles (or another recommended needle/cannula) securely to the luer-lock syringe using aseptic technique and expel any air prior to injection.
  • Restylane Refyne is generally injected into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds. Use appropriate injection techniques (e.g. linear threading, serial puncture, fanning or cross-hatching) depending on the area treated.
  • Inject slowly with controlled pressure and aspirate carefully before injecting where appropriate to reduce the risk of intravascular placement; always avoid injection into blood vessels.
  • Use small aliquots and avoid overcorrection; aim for gradual, conservative correction and, if necessary, schedule a follow-up session for refinement.
  • Gently mould or massage the treated area if required to ensure even distribution and smooth contour, taking care not to exert excessive pressure.
  • Do not treat areas with active skin disease, inflammation or infection (e.g. rashes, acne, herpes). If intense pain, blanching, visual disturbance or other signs of vascular compromise occur, stop the injection immediately and institute appropriate management according to current clinical guidelines.
  • After treatment, advise patients to avoid makeup on the treated area for several hours and to avoid exposure to extreme heat or cold, intense exercise, alcohol consumption and manipulation or massage of the treated area for a short period as per clinic protocol.
  • Record product name, batch/lot number, injection sites and 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 the 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 or mucosal disease, inflammation, infection or lesions (such as acne, rashes, hives, cysts or herpes) at or near the intended injection site.
  • Intravascular injection is strictly contraindicated; the product must not be injected into blood vessels.
  • Intramuscular injection is contraindicated; the product is intended for intradermal implantation (mid-to-deep dermis) only, in accordance with 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 lack of sufficient safety data.
  • Use in patients under the minimum age specified in the product labelling and local regulations (typically adults over 21 years for FDA-approved indications and over 18 years in some other regions).

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, especially in patients prone to bruising or using anticoagulant/antiplatelet medications.
  • Temporary alterations in sensation including numbness, tingling or tightness in the treated area, partly due to lidocaine and injection trauma.
  • Localized inflammatory reactions such as swelling and redness, which may occur immediately or be delayed and usually resolve within days to a few weeks.
  • Infection at or near the injection site if aseptic technique is not strictly followed.
  • Delayed inflammatory reactions, granulomatous responses or persistent nodules, which may require additional medical management and, in some cases, hyaluronidase treatment.
  • 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 skin pigmentation and texture, particularly in susceptible individuals.
  • Unsatisfactory cosmetic result or asymmetry that may necessitate correction, additional treatment or dissolution of the filler with hyaluronidase.

Storage Conditions

  • Store in the original outer carton to protect from light and maintain sterility until use.
  • Store at a controlled temperature between 2°C and 25°C, as specified on the product packaging.
  • 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 results are typically visible immediately and usually last from about 6 to 12 months, depending on the area treated, injection technique, dose and individual patient factors such as metabolism and lifestyle.

Onset

Smoothing of wrinkles and improvement in facial contours are usually visible immediately after injection, with the final aesthetic result becoming apparent once initial swelling and redness have resolved, typically within several days up to about 2 weeks.

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