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Restylane Fynesse (1 x 1.0 ml)

Restylane Fynesse (1 x 1.0 ml)

Restylane

Injectable Medical Device
  • CE Marked hyaluronic acid dermal filler for aesthetic treatment of superficial wrinkles and fine lines in applicable markets.
  • Manufactured using non Animal stabilized hyaluronic acid and controlled crosslinking with BDDE in compliance with relevant quality and safety standards for sterile injectable medical devices.
  • Subject to regulatory post Market surveillance and adverse event reporting requirements in territories where it is marketed.
Hyaluronic Acid Dermal Filler

Description

Restylane Fynesse is a soft, superficial hyaluronic acid dermal filler from Galderma designed to smooth fine and superficial facial lines while maintaining a very natural look and feel. It uses non-animal, cross-linked hyaluronic acid at a concentration of 20 mg/mL formulated for injection into the superficial dermis. The thin, very fluid gel integrates smoothly into the tissue to treat early signs of aging such as crow’s feet, perioral (smoker’s) lines and fine cheek lines, and can also be used for subtle lip enhancement in suitable patients. The product is supplied as a 1.0 ml pre-filled syringe for single-patient use by qualified healthcare professionals.

Bnefits

  • Specifically designed to treat superficial and fine lines while preserving a natural appearance.
  • Soft, low-viscosity gel integrates smoothly into the tissue for subtle, refined correction.
  • Ideal for early and fine wrinkles such as crow’s feet, periorbital lines and perioral (smoker’s) lines.
  • Can be used for very gentle lip enhancement and refinement of lip borders in appropriate cases.
  • Non-animal, cross-linked hyaluronic acid with an established safety and biocompatibility profile.
  • Formulated for injection into the superficial dermis to target fine, shallow lines close to the skin surface.
  • Provides hydration and soft volumizing effect, improving skin texture and radiance.
  • Part of the Restylane portfolio, benefiting from extensive clinical experience in aesthetic medicine.

Indications

  • Correction of superficial or fine wrinkles and lines on the forehead.
  • Reduction of periorbital lines, including crow’s feet around the eyes.
  • Smoothing of fine superficial perioral lines (smoker’s lines) around the mouth.
  • Correction of other fine lines on the cheeks and midface suitable for a superficial dermal filler.
  • Subtle enhancement and refinement of the lips and lip contour when a soft, superficial filler is appropriate.
  • Use only by appropriately trained and legally authorised healthcare professionals, in accordance with the official Instructions for Use and local regulations.

Composition

  • Cross-linked sodium hyaluronate (hyaluronic acid) 20 mg/mL (non-animal origin).
  • Phosphate buffered saline, approximately pH 7, q.s. ad 1 mL.
  • Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether) used to stabilize the hyaluronic acid gel.
  • Sterile, transparent, biodegradable gel free of animal proteins.

Formulation

  • Sterile, transparent, cross-linked gel of non-animal stabilized hyaluronic acid at a concentration of 20 mg/mL in phosphate buffered saline (pH ~7), supplied in a single-use 1.0 ml pre-filled glass syringe for intradermal injection into the superficial dermis.

Packaging

  • 1 x 1.0 ml pre-filled glass syringe of Restylane Fynesse.
  • Syringe supplied sterile in an individual blister pack for single-patient use.
  • Typically supplied with a fine disposable needle (commonly 30G 1/2" or similar gauge/length as stated on the packaging) suitable for superficial dermal injection.
  • Luer-lock syringe with tamper-evident cap to maintain sterility before use.
  • Outer carton printed with product name, volume, batch number and expiry date.
  • Patient record and traceability labels provided on syringe/carton for placement in the patient’s medical records.

Usage

  • For professional use only: Restylane Fynesse must be administered exclusively by appropriately trained and legally authorised healthcare professionals experienced in dermal filler injection and facial anatomy.
  • Before use, inspect the outer carton, blister and syringe. Do not use if any packaging is damaged, if the solution appears cloudy or contains particles, or if the product is past its expiry date.
  • Take a complete medical history including allergies, bleeding disorders, autoimmune disease, previous fillers or implants, and current medications (especially anticoagulants and antiplatelet agents).
  • Prepare the treatment area using appropriate skin cleansing and antiseptic procedures according to local clinic protocols for injectable treatments.
  • Attach the supplied sterile needle (or another compatible sterile needle of the recommended gauge and length) securely to the luer-lock syringe using aseptic technique and expel air before injection.
  • Inject Restylane Fynesse into the superficial dermis using small aliquots and fine linear, serial puncture or micro-droplet techniques suitable for very superficial lines.
  • Inject slowly with minimal pressure and aspirate gently before injection where appropriate to reduce the risk of intravascular placement, even though injection is into the superficial dermis.
  • Do not overcorrect; build the desired effect gradually and massage gently if required to ensure even distribution and a smooth surface, avoiding excessive pressure.
  • Do not inject into areas with active skin disease, inflammation or infection. If the patient experiences unusual pain, blanching or signs of vascular compromise, stop immediately and manage 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 extreme heat or cold, sunbeds, saunas and strenuous exercise for a short period as per clinic protocol.
  • Record the product name, batch number, injection sites and volumes used in the patient’s medical record using the traceability labels provided.

Contraindications

  • History of severe allergies or anaphylactic reactions, or the presence of multiple severe allergies.
  • Known hypersensitivity to hyaluronic acid or to any of the excipients used in the formulation.
  • Bleeding disorders or current significant use of anticoagulant, thrombolytic or high-dose antiplatelet therapy where injection-related bleeding risk is considered unacceptable.
  • Active skin infection, inflammation or lesions (e.g. rashes, acne, herpes, dermatitis) at or near the proposed injection site.
  • Injection into blood vessels (intravascular injection) or intramuscular injection is contraindicated; product is intended for intradermal use only.
  • 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 defined by local regulations and product labelling (typically adults).

Adverse Effects

  • Common transient injection-site reactions, including redness (erythema), swelling, tenderness, pain, itching and bruising at the injection site.
  • Localized lumps, bumps or nodules, and minor irregularities in the treated area.
  • Injection-site hematoma or ecchymosis, particularly in patients with increased bleeding tendency or on anticoagulant/antiplatelet therapy.
  • Temporary alterations in sensation such as slight numbness, tingling or tightness in the treated area due to injection trauma.
  • Localized inflammatory reactions such as swelling and redness, which usually resolve spontaneously within days.
  • Infection at or near the injection site if aseptic procedure is not properly followed.
  • Rare delayed inflammatory reactions, granuloma formation or persistent nodules that may require medical management.
  • Rare but serious complications related to inadvertent intravascular injection (e.g. ischemia, tissue necrosis, visual disturbance) have been reported with hyaluronic acid fillers in general, and require urgent medical attention.
  • Post-inflammatory hyperpigmentation or other pigment changes, particularly in patients with darker skin types, and potential asymmetry or unsatisfactory cosmetic result requiring correction.

Storage Conditions

  • Store in the original outer carton to protect from light and maintain sterility until use.
  • Store at controlled room temperature, typically between 2°C and 25°C, as specified on the 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 before use.

Duration

Clinical results typically last up to approximately 12 months for superficial lines, with many patients requiring maintenance or touch-up treatments after about 6\u20139 months depending on area treated, technique and individual metabolism.

Onset

Visible softening of fine lines and superficial wrinkles is usually immediate after injection, with the final result evident once initial redness and swelling subside over several days to about 2 weeks.

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