Restylane Classic Restylane L with Lidocaine 1 ml (D16)
Restylane
Injectable Medical DeviceHyaluronic Acid Dermal Filler
Certifications
- CE Marked medical device, produced according to regulatory standards for dermal fillers.
- Non Animal origin, cross Linked HA gel (BDDE) with established safety and biocompatibility record.
- CE Marked medical device, produced according to regulatory standards for dermal fillers.
- Non Animal origin, cross Linked HA gel (BDDE) with established safety and biocompatibility record.
Hyaluronic Acid Dermal Filler
Description
Restylane Classic / Restylane-L with Lidocaine is a sterile, transparent, stabilized hyaluronic acid (HA) gel filler for aesthetic facial tissue augmentation. It uses cross-linked, non-animal origin HA (20 mg/mL) plus lidocaine (0.3%) in phosphate-buffered saline, supplied in a 1 ml pre-filled syringe for injection. The addition of lidocaine reduces discomfort during the injection procedure. It is intended for correction of moderate facial wrinkles and folds and for lip enhancement or volume restoration in suitable facial areas. The gel is biodegradable and gradually resorbs over time.
Bnefits
- Smooths moderate facial wrinkles and folds (e.g. nasolabial folds, marionette lines).
- Enhances and restores lip volume and shape.
- Provides balanced, natural-looking volumization thanks to intermediate gel particle size and crosslinked HA properties.
- Contains lidocaine to minimize injection pain and increase patient comfort.
- Non-animal based HA, free from animal proteins — allergen pretesting usually not required.
- Single-use, sterile syringe ensures hygiene and traceability with patient record labels.
Indications
- Correction of moderate to severe facial wrinkles and folds (e.g. nasolabial folds, marionette lines) via mid-to-deep dermal implantation.
- Lip augmentation / lip volume enhancement via submucosal implantation of the lip in patients eligible per local regulations (commonly age 21+).
- Facial tissue augmentation and volume restoration in areas suitable for a mid-dermal HA filler, when performed by appropriately trained medical professionals.
Composition
- Stabilized hyaluronic acid (non-animal origin), 20 mg/mL.
- Lidocaine hydrochloride 3 mg/mL (0.3% lidocaine).
- Phosphate buffered saline (pH ~7) qs ad 1 mL.
- Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether) used to stabilize HA gel.
Formulation
- Sterile, transparent cross-linked HA gel with 20 mg/mL HA concentration, containing 0.3% lidocaine hydrochloride, suspended in phosphate buffered saline, supplied in a single-use pre-filled glass syringe.
Packaging
- 1 × 1.0 mL pre-filled glass syringe of Restylane-L / Restylane Classic with Lidocaine.
- Sterile, single-use syringe with patient traceability labels for medical records.
- Typically supplied with disposable 29G thin-walled needles (sometimes 27–30G depending on market) or compatible cannula as per local practice.
- Individually blister-packed syringe to ensure sterility and protection until use.
Usage
- For professional use only — to be administered by a trained, licensed healthcare professional experienced in dermal filler injection.
- Inspect packaging and expiry date before use; do not use if packaging is damaged or sterility compromised.
- Prepare the skin thoroughly (cleanse, disinfect) per clinic protocol prior to injection. (common practice in aesthetic medicine)
- Use aseptic technique; attach appropriate thin-walled needle or blunt cannula according to local practice; avoid intravascular injection — aspirate before injecting.
- Inject into mid-to-deep dermis for wrinkle correction, or submucosal lip layer for lip enhancement; avoid intramuscular injection.
- Use small aliquots and incremental injection to avoid overcorrection; gently massage if needed to ensure even distribution and natural contour. (standard guidance derived from IFU practices)
- Record batch number, injection sites, volume used and patient-specific data in medical records using the patient label provided.
- Advise patient on post-procedure care: avoid extreme cold/heat, intense exercise, excessive facial movements or makeup for several hours; monitor for signs of complications. (standard post-treatment care)
Contraindications
- History of severe allergies (e.g. anaphylaxis) or multiple severe allergies.
- Allergy to lidocaine or other amide-type local anaesthetics.
- Allergy to gram-positive bacterial proteins (used in HA production).
- Bleeding disorders, use of anticoagulants/antiplatelet therapy or other conditions increasing bleeding risk.
- Active skin infection or inflammation at or near injection site (e.g. cysts, acne, rashes, herpes simplex).
- Injection into anatomical spaces other than dermis (for wrinkles) or lip submucosa (for lip augmentation).
- Use in patients under legal adult age (usually under 21 for lip augmentation depending on jurisdiction).
- Pregnancy or breastfeeding — safety not established (local practice/precaution). (common clinical precaution)
Adverse Effects
- Injection-site reactions: redness, swelling, pain, tenderness, bruising, itching, erythema.
- Transient lumps, bumps, nodules, or small irregularities under the skin or lip surface.
- Hematoma or ecchymosis at injection site, particularly in patients on anticoagulants or with bleeding tendency.
- Temporary numbness or altered sensation due to lidocaine or injection trauma.
- Infection if aseptic technique not maintained.
- Rare but serious events: vascular occlusion, ischemia, necrosis, or visual disturbance if filler is inadvertently injected into or compresses a blood vessel.
- Delayed inflammatory reactions, possible hypersensitivity, granuloma formation, or post-inflammatory hyperpigmentation particularly in patients with darker skin types. (documented in broader HA filler literature)
Storage Conditions
- Store in original sealed blister/ carton until use to maintain sterility.
- Avoid exposure to extreme temperatures, direct sunlight, and freezing; store at controlled room temperature per manufacturer instructions. (standard practice for injectable medical devices)
- Do not use after the expiry date printed on the packaging.
Duration
Results typically last between 6 to 12 months depending on treatment area, injection technique, and individual metabolism.
Onset
Visible volume restoration and smoothing are generally immediate after injection; final aesthetic result becomes evident as swelling subsides over several days.
