Restylane Defyne

Restylane

Injectable Medical Device

Hyaluronic Acid Dermal Filler

CE Marked hyaluronic acid dermal filler for aesthetic use in accordance with applicable European medical device regulations.
Manufactured using non Animal stabilized hyaluronic acid technology with established safety and biocompatibility.
Subject to post Market surveillance and safety reporting requirements, including national adverse event reporting schemes such as the MHRA Yellow Card system in the UK.

CE Marked hyaluronic acid dermal filler for aesthetic use in accordance with applicable European medical device regulations.
Manufactured using non Animal stabilized hyaluronic acid technology with established safety and biocompatibility.
Subject to post Market surveillance and safety reporting requirements, including national adverse event reporting schemes such as the MHRA Yellow Card system in the UK.

Hyaluronic Acid Dermal Filler

Description

Restylane Defyne with Lidocaine is a sterile, transparent, cross-linked hyaluronic acid dermal filler designed as a deep dynamic filler to smooth deep facial wrinkles and folds while maintaining natural facial expression. Using Galderma’s Balancing (OBT) technology, it has a flexible gel structure that supports natural movement in dynamic areas such as nasolabial folds and marionette lines. The formulation contains 20 mg/mL of non-animal stabilized hyaluronic acid with 0.3% lidocaine hydrochloride in phosphate buffered saline, supplied in a 1.0 ml pre-filled glass syringe for injection by trained healthcare professionals.

Bnefits

Targets deep dynamic wrinkles such as nasolabial folds and marionette lines for a smoother, more youthful appearance.
Designed to maintain natural facial expressions and flexibility in dynamic areas, supporting natural movement when smiling, frowning, or talking.
Restores moderate facial volume loss and provides lifting and tightening effect in areas with reduced soft tissue support.
Contains 0.3% lidocaine to reduce injection pain and improve patient comfort during treatment.
Cross-linked, non-animal hyaluronic acid (20 mg/mL) provides durable yet reversible results.
BT (Balancing) / OBT technology gives a smoother gel texture for even distribution and a soft, natural look and feel.
Single-use, sterile syringe with traceability labels to support safe medical use and documentation.
Recognised Restylane portfolio product backed by clinical experience and long-term use in aesthetic medicine.

Indications

Injection into the mid-to-deep dermis for correction of moderate to severe, deep facial wrinkles and folds, such as nasolabial folds (laugh lines) in adults over 21 years of age.
Correction of marionette lines and deep lines around the mouth.
Moderate volume restoration and contouring in areas of the lower and mid face where a deep, dynamic filler is appropriate, including smile lines and selected cheek or chin areas as per official labelling and local regulations.
Treatment is to be performed only by suitably trained and legally authorised healthcare professionals.

Composition

Stabilized sodium hyaluronate (hyaluronic acid), 20 mg/mL.
Lidocaine hydrochloride, 3 mg/mL (0.3% lidocaine).
Phosphate buffered saline at approximately pH 7.
Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether) used to stabilize the hyaluronic acid gel.

Formulation

Sterile, transparent, biodegradable gel of non-animal stabilized, cross-linked hyaluronic acid at 20 mg/mL with 0.3% lidocaine hydrochloride in phosphate buffered saline, supplied ready to use in a single-use, pre-filled 1.0 ml glass syringe for injection into the mid-to-deep dermis or appropriate deeper planes according to tissue support.

Packaging

1 x 1.0 ml pre-filled glass syringe of Restylane Defyne with Lidocaine.
Supplied with 2 x 27G 1/2" disposable sterile needles (or other needle sizes specified on the pack depending on market).
Syringe fitted with luer-lock fitting and tamper-evident cap.
Individual blister pack to maintain sterility until use.
Outer carton including product name, batch number, expiry date, and regulatory markings.
Patient record and traceability labels attached to the syringe and carton for insertion into medical records.

Usage

For professional use only: administer only by appropriately trained and legally authorised healthcare professionals experienced in dermal filler injections and facial anatomy.
Before use, inspect the outer carton, blister and syringe. Do not use if packaging is damaged, compromised, or if the product is past its expiry date.
Obtain a full medical history, including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics), bleeding tendencies, autoimmune conditions and previous filler or implant treatments.
Prepare the treatment area using appropriate skin cleansing and antiseptic measures according to clinic protocol.
Attach the supplied sterile 27G 1/2" needle (or compatible needle/cannula within the recommended gauge range) securely to the luer-lock of the syringe using aseptic technique.
Restylane Defyne should generally be injected into the mid-to-deep dermis for correction of deep facial wrinkles and folds, or into deeper planes such as subcutaneous or supraperiosteal layers in areas with limited soft tissue support, following the official Instructions for Use.
Inject slowly with minimal pressure, aspirating before each injection to reduce the risk of intravascular placement. Use small aliquots and incremental placement to avoid overcorrection.
Gently massage the treated area if needed to ensure even distribution and smooth contour, taking care not to exert excessive pressure.
Do not inject into blood vessels, muscles, or areas with active inflammation or infection. Stop injection immediately if blanching, unusual pain or signs of vascular compromise occur and follow current clinical guidelines for management.
After treatment, advise the patient to avoid makeup on the treated area for several hours, and to avoid extreme temperatures, intense exercise, alcohol and manipulation of the treated area for a short period as per clinic protocol.
Record the product batch number, injection sites, injected volumes and any immediate reactions in the patient’s medical record using the traceability labels supplied.

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, or any of the excipients, including gram-positive bacterial proteins.
Active skin disease, inflammation, infection or lesions (such as acne, rashes, or herpes simplex) at or near the proposed injection site.
Bleeding disorders, or current use of anticoagulants, thrombolytics or high-dose antiplatelet therapy where injection-related bleeding risk is unacceptable.
Injection into blood vessels or into anatomical structures other than those specified in the Instructions for Use (e.g. intramuscular injection is contraindicated).
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 as safety has not been established.
Use in patients under the minimum age specified by local regulations and the product’s approved labelling (commonly adults over 21 years for some indications).

Adverse Effects

Common, usually transient injection-site reactions such as redness, swelling, pain, tenderness, itching, bruising and erythema.
Localized lumps, bumps, nodules or irregularities at or near the injection site.
Injection-site hematoma or ecchymosis, especially in patients with increased bleeding tendency or on anticoagulant/antiplatelet therapy.
Temporary changes in sensation such as numbness, tingling or altered sensitivity, partly related to lidocaine or injection trauma.
Localized inflammatory reactions including redness, swelling or discomfort that may occur immediately or be delayed.
Infection at or near the injection site if aseptic technique is not strictly followed.
Rare but serious complications including vascular occlusion, ischemia, tissue necrosis or visual disturbance if filler is inadvertently injected into or compresses a blood vessel.
Hypersensitivity or allergic reactions, including very rare cases of severe or anaphylactic responses.
Granuloma formation, persistent nodules or delayed inflammatory reactions, which may require additional medical management.
Post-inflammatory hyperpigmentation or other changes in skin pigmentation, particularly in patients with darker skin types.

Storage Conditions

Store in the original carton to protect from light and maintain sterility until use.
Store at a controlled room temperature between 2°C and 25°C, as indicated on the packaging.
Do not freeze and avoid excessive heat or 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 is damaged or opened prior to use.

Duration

Clinical effect generally lasts about 6 to 12 months, with many patients experiencing typical durability of approximately 6 to 9 months depending on treatment area, injection technique and individual metabolism.

Onset

Visible smoothing and volume correction are usually immediate after injection, with final results evident once initial swelling and redness subside over several days up to approximately 2 weeks.