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Restylane Kysse with Lidocaine (1 x 1.0 ml)

Restylane Kysse with Lidocaine (1 x 1.0 ml)

Restylane

Injectable Medical Device
  • CE Marked hyaluronic acid dermal filler for aesthetic lip augmentation and perioral line correction in applicable markets.
  • Manufactured using non Animal stabilized hyaluronic acid and BDDE crosslinking in accordance 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 Kysse with Lidocaine is a hyaluronic acid-based dermal filler specifically developed for lip augmentation and the correction of perioral lines. It uses non-animal, cross-linked hyaluronic acid formulated with Optimal Balance Technology (OBT) / XpresHAn-like properties to provide a soft yet supportive gel that integrates smoothly into the tissue. This allows for natural movement and expression while enhancing lip volume, shape and definition. The product contains 0.3% lidocaine to improve comfort during injection and is supplied as a sterile, single-use 1.0 ml pre-filled syringe for administration by qualified healthcare professionals.

Bnefits

  • Provides natural-looking lip volume and plumpness while preserving softness and flexibility.
  • Enhances lip shape, definition and border, helping to create a well-contoured lip profile.
  • Designed to maintain natural facial and lip movement, even in highly dynamic areas such as when speaking, smiling or kissing.
  • Soft, smooth gel integrates into the tissue for a natural feel and appearance rather than a firm or artificial look.
  • Formulated with non-animal, cross-linked hyaluronic acid using Optimal Balance Technology for an optimal balance of structure and flexibility.
  • Contains 0.3% lidocaine to reduce injection-related pain and improve patient comfort during treatment.
  • Can help soften perioral (smoker’s) lines and wrinkles around the mouth in addition to volumizing the lips.
  • Reversible via hyaluronidase if adjustment or dissolution is required.
  • Single-patient, sterile packaging with traceability labels supports safe clinical use and documentation.

Indications

  • Lip augmentation to increase lip volume and fullness in adults.
  • Enhancement of lip shape, contour and definition including cupid’s bow and vermilion border.
  • Correction and softening of perioral lines (smoker’s lines) and wrinkles around the mouth.
  • Improvement of lip symmetry and balance where appropriate in eligible patients.
  • 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), non-animal origin (typical concentration approximately 20 mg/mL).
  • Lidocaine hydrochloride 3 mg/mL (0.3% lidocaine) as a local anaesthetic to improve treatment comfort.
  • Phosphate buffered saline (approximate physiological pH).
  • Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether) used to stabilize the hyaluronic acid gel.
  • Sterile, clear, viscoelastic gel free from animal proteins.

Formulation

  • Sterile, transparent, cross-linked hyaluronic acid gel of non-animal origin with an approximate concentration of 20 mg/mL, containing 0.3% lidocaine hydrochloride in phosphate buffered saline, produced using Optimal Balance Technology to achieve a soft yet supportive gel structure suitable for lip augmentation and perioral line correction. Supplied in a single-use, pre-filled 1.0 ml glass syringe.

Packaging

  • 1 x 1.0 ml pre-filled glass syringe of Restylane Kysse with Lidocaine.
  • Syringe supplied sterile in an individual blister pack for single-patient use.
  • Typically supplied with one or more sterile disposable fine-gauge needles suitable for lip injection (for example, 30G 1/2" or similar, as specified on the packaging).
  • Luer-lock syringe with tamper-evident cap to maintain sterility prior to use.
  • Outer carton labelled with product name, volume, batch number, expiry date and regulatory marks.
  • Patient record / traceability labels affixed to syringe and/or carton for insertion into the patient’s medical record.

Usage

  • For professional use only: Restylane Kysse must be administered exclusively by appropriately trained and legally authorised healthcare professionals with experience in lip anatomy and dermal filler injection techniques.
  • Before use, inspect the outer carton, blister and syringe. Do not use if any packaging is damaged, if the product appears cloudy or contains particles, or if it is past the expiry date.
  • Take a full medical history, including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics and gram-positive bacterial proteins), bleeding disorders, autoimmune conditions, and previous aesthetic treatments or implants in the treatment area.
  • Clean and disinfect the lips and surrounding skin according to standard clinic protocols for injectable procedures.
  • Attach the supplied sterile needle (or another appropriate sterile needle or cannula within the recommended gauge range) securely to the luer-lock syringe using aseptic technique. Expel any air bubbles prior to injection.
  • Inject Restylane Kysse into the appropriate plane, generally the submucosal layer of the lip and/or superficial subcutaneous tissue around the mouth for perioral lines, in accordance with the official Instructions for Use.
  • Use small aliquots with appropriate techniques (e.g. serial puncture, linear threading, fanning) and inject slowly with gentle, steady pressure. Aspirate where appropriate to reduce the risk of intravascular injection.
  • Do not overcorrect; build the desired lip volume and contour gradually and symmetrically. Gently mould or massage the treated area if necessary to ensure even distribution, taking care not to compress the tissue excessively.
  • Avoid injecting into areas with active inflammation, infection, cold sores (herpes labialis) or other lesions. Stop injection immediately if the patient experiences intense pain, blanching or other signs suggesting vascular compromise, 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 excessive lip manipulation, kissing, smoking, alcohol, and extremes of temperature (saunas, sunbeds, very hot or cold drinks) for a short period according to clinic protocol.
  • Record the product name, batch number, injection sites, volumes used and any immediate reactions 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, lidocaine, other amide-type local anaesthetics, BDDE or any other component of the formulation, 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 infection, inflammation or lesions at or near the intended injection site, including herpes labialis (cold sores).
  • Injection into blood vessels (intravascular injection) or intramuscular injection is contraindicated; the product is intended for submucosal or superficial subcutaneous use only as directed in 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 a lack of sufficient safety data.
  • Use in patients below the minimum age specified in the product labelling and local regulations (typically adults over 21 years for lip augmentation).

Adverse Effects

  • Common, typically transient injection-site reactions such as swelling, redness (erythema), tenderness, pain, itching and bruising of the lips or surrounding tissue.
  • Localized lumps, bumps or nodules and temporary irregularities or asymmetry in lip contour.
  • Injection-site hematoma or ecchymosis, particularly in patients with a predisposition to bruising or on anticoagulant/antiplatelet therapy.
  • Temporary alterations in sensation such as numbness, tingling or tightness in the lips due to lidocaine and injection trauma.
  • Localized inflammatory reactions, including swelling and redness, which usually resolve spontaneously within days.
  • Infection at or near the injection site if strict aseptic technique is not maintained.
  • Rare delayed inflammatory reactions, granuloma formation or persistent nodules that may require additional medical management.
  • Rare but serious complications associated with inadvertent intravascular injection, such as vascular occlusion, ischemia, tissue necrosis or visual disturbances, which require urgent medical attention.
  • Post-inflammatory hyperpigmentation, scarring or other pigment and texture changes in the treated area, particularly in susceptible individuals.
  • Unsatisfactory cosmetic result or asymmetry that may require 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 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

Typical duration of effect is around 6 to 12 months for lip volume and perioral line correction, with many patients requiring maintenance or touch-up treatments after approximately 9 to 12 months depending on metabolism, lifestyle and injection technique.

Onset

Visible enhancement of lip volume and contour is usually immediate after injection, with the final aesthetic result becoming apparent once initial swelling and redness subside, typically within several days up to about 2 weeks.

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