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LAPIENA Sub Q 1ml x 1 Syringe

LAPIENA Sub Q 1ml x 1 Syringe

Lapiena

Dermal filler
  • CE Marked medical device (CE 2265) for LAPIENA Cross Linked Hyaluronic Acid Dermal Filler with Lidocaine.
  • Class III medical device classification in EU/EEA markets for cross Linked hyaluronic acid dermal fillers with lidocaine.
  • Manufactured under an ISO 13485 Compliant quality management system for medical devices.
  • Hyaluronic acid raw material is pharmaceutical grade and supported by FDA Drug Master File (DMF) and EDQM certifications, as declared in Lapiena materials.
  • Needles supplied with the product are sterilised with ethylene oxide and carry CE 0068 certification.
  • Gel sterilised by moist heat, with a stated shelf life of 3 years from the date of manufacture.
Cross-linked hyaluronic acid dermal filler with lidocaine for deep volume restoration and facial contouring

Description

LAPIENA Sub-Q is a CE-marked, cross-linked hyaluronic acid dermal filler with 0.3% lidocaine, developed using advanced HCCL™ (High Cohesive Cross-Linking) technology. It is the thickest formulation in the Lapiena range and is specifically designed for restoring facial shape, lifting soft tissues and reconstructing volume loss. With a concentration of 20 mg/ml HA and 0.3% lidocaine, the monophasic gel features a reinforced 3D matrix that provides high cohesivity, elasticity and plasticity for deep structural contouring. Supplied as a sterile, single-use 1.1 ml pre-filled syringe with needles, LAPIENA Sub-Q is intended for deep dermal and periosteal injections by trained medical professionals, delivering immediate, natural-looking and long-lasting correction of deep wrinkles, folds and facial volume deficits.

Bnefits

  • Thickest formulation in the Lapiena range, engineered for deep volume restoration and structural contouring.
  • Designed to restore facial shape and reconstruct volume loss in cheeks, nose, jawline, chin and forehead.
  • Advanced HCCL™ technology with reduced pendant BDDE and a low-temperature, extended cross-linking process for improved safety and gel stability.
  • Reinforced 3D gel matrix offering high cohesivity and elasticity, facilitating precise shaping and long-lasting volumising effects.
  • Contains 0.3% lidocaine to reduce pain during injection and improve patient comfort.
  • High, consistent monophasic gel structure that integrates smoothly with tissues and maintains shape under dynamic facial movement.
  • CE-certified Class III medical device with clinical data supporting safety and efficacy for nasolabial fold correction.
  • Can be used alone for deep structural work or in combination with Lapiena Classic and Deep as part of layered, full-face treatment protocols.
  • Provides immediate visible results with little or no downtime for most patients.
  • Long-lasting correction compared with non-cross-linked HA products, with effects typically persisting for many months depending on treatment area and individual metabolism.

Indications

  • Lifting facial soft tissues and restoring facial volume in adults over 21 years of age.
  • Reconstruction of severe mimic lines and deep facial folds.
  • Correction of deep facial wrinkles and folds, including deep nasolabial folds and pronounced marionette lines.
  • Cheek augmentation and volumisation of mid-face contours.
  • Nose augmentation, including nose bridge and nose tip contouring (non-surgical rhinoplasty by experienced injectors).
  • Jawline augmentation and contouring to improve definition of the lower face.
  • Chin augmentation and reshaping to correct retrusion or asymmetry.
  • Forehead augmentation and contour refinement.
  • General deep volumising where strong structural support and shape maintenance are required.
  • Part of combination protocols with Lapiena Classic and Deep to address different dermal depths and correction needs across the face.

Composition

  • Cross-linked hyaluronic acid 20 mg/ml (sodium hyaluronate cross-linked using 1,4-butanediol diglycidyl ether).
  • Lidocaine hydrochloride 3 mg/ml (0.3%).
  • Phosphate buffer saline solution with excipients, pH approximately 7, q.s. to full volume.
  • Cross-linked hyaluronic acid synthesised from sodium hyaluronate and 1,4-butanediol diglycidyl ether as the cross-linking agent.

Formulation

  • Sterile, pyrogen-free, physiological gel of cross-linked hyaluronic acid with 0.3% lidocaine.
  • Colourless, odourless, highly viscous water-based monophasic gel.
  • Designed for injection into the deep dermis and periosteum (deep layer of the skin) using a needle angle of approximately 30–45 degrees, according to the manufacturer’s injection guide.
  • Pre-filled single-use syringe containing 1.1 ml of gel for deep dermal and structural contouring applications.

Packaging

  • 1 x 1.1 ml pre-filled syringe of LAPIENA Sub-Q gel.
  • 1 x 25G needle (sterile, single use).
  • 1 x 27G needle (sterile, single use).
  • Sterile blister pack containing the syringe and needles.
  • Outer carton with product labelling, CE mark (CE 2265), batch number, manufacturing date, expiry date and instructions for use.

Usage

  • LAPIENA Sub-Q should only be administered by licensed and appropriately trained healthcare professionals experienced in dermal filler injections.
  • Before treatment, assess the patient’s medical history, indications and expectations and screen for contraindications including hypersensitivity to HA or lidocaine, pregnancy, lactation, active skin disease and bleeding disorders.
  • Store the syringe as directed and allow it to reach room temperature for approximately 30 minutes before injection.
  • Inspect packaging and syringe; do not use if the blister, syringe or sterility barrier is damaged, opened or past the expiry date.
  • Thoroughly disinfect the treatment area and maintain strict aseptic technique throughout the procedure.
  • Attach one of the supplied sterile needles (25G or 27G) securely to the syringe and expel a small drop of gel to remove air before injection.
  • Inject slowly into the deep dermis or onto periosteum at approximately 30–45 degrees, using appropriate techniques such as linear threading, depot injections or serial puncture; adjust volume to the depth and extent of the defect.
  • Avoid intravascular injection at all times; if blanching or sudden pain occurs, stop the injection immediately and gently massage the area until normal skin colour returns.
  • After injection, gently massage the treated area to ensure even distribution and integration of the filler without applying excessive pressure.
  • Do not over-correct at the first session; perform additional correction immediately or after a few weeks if required based on clinical assessment.
  • Do not mix LAPIENA Sub-Q with other products in the same syringe and do not inject into areas with permanent implants.
  • Patients should avoid aspirin, NSAIDs and high doses of vitamin C for one week prior to treatment where possible, and avoid makeup for at least 12 hours after injection.
  • Advise patients to avoid strong sun/UV exposure, extreme cold or heat, saunas and vigorous exercise for about 2 weeks after treatment.
  • Dispose of used needles and syringes as clinical sharps; the product is single-use and must not be resterilised or reused.

Contraindications

  • Use in individuals under 21 years of age.
  • Pregnant or breastfeeding women.
  • Known hypersensitivity to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or any component of the formulation.
  • Patients prone to hypertrophic scarring or keloid formation.
  • Injection into the periorbital area (under-eye dark circles and eyelids).
  • Intravascular injection; LAPIENA must never be injected into blood vessels.
  • Injection into areas with active inflammatory or infectious skin disease (e.g., local infection, active herpes, dermatitis).
  • Use in conjunction with laser therapy, deep chemical peels or dermabrasion on the same area until the skin has fully healed.
  • Injection into or directly over areas with implants or other foreign bodies in the treatment zone.
  • Patients with bleeding disorders or those who have received thrombolytics, anticoagulants or platelet aggregation inhibitors within the previous two weeks, unless managed under appropriate clinical guidance.
  • Caution or avoidance in patients with epilepsy, cardiac conduction disorders, severe hepatic impairment or severe renal dysfunction due to lidocaine content and potential systemic toxicity.
  • Use in patients with a known severe allergy to local anaesthetics of the amide type.

Adverse Effects

  • Common transient inflammatory reactions at the injection site such as redness, swelling, pain, tenderness or warmth, which may persist for up to approximately 2 weeks.
  • Formation of nodules, papules or localised induration (lumps) at the injection site.
  • Haematoma or bruising in the treated area.
  • Discolouration or pigmentation changes at the injection site.
  • Unsatisfactory or insufficient filling effect, temporary asymmetry, or overcorrection/undercorrection of wrinkles or volume.
  • Local infection at the injection site, including possible abscess formation in rare cases.
  • Granuloma formation or foreign-body reactions, as reported in the hyaluronic acid filler literature.
  • Immediate or delayed hypersensitivity reactions, including swelling, erythema or pruritus; patients should seek medical attention if reactions persist beyond one week or are severe.
  • Serious but rare complications described for HA fillers, such as glabella necrosis, skin necrosis due to vascular occlusion, and visual disturbances or blindness following inadvertent intravascular injection.
  • Potential systemic lidocaine-related adverse effects in the event of high systemic exposure, including central nervous system symptoms (e.g., dizziness, tinnitus, seizures) and cardiac conduction disturbances.

Storage Conditions

  • Store at 1–30 °C as indicated in the user manual.
  • Protect from direct sunlight and do not freeze.
  • Keep the product in its original packaging until use to maintain sterility and protect from light and moisture.
  • Keep dry and avoid excessive heat or major temperature fluctuations.
  • Do not use after the expiry date or if the packaging, blister or syringe appears damaged or compromised.
  • Keep out of reach of children and unauthorised persons.

Duration

Described by the manufacturer and distributors as long-lasting; clinical evaluation of the Lapiena range demonstrates effective correction of nasolabial folds over at least 24 weeks, and in practice results with deep structural fillers like LAPIENA Sub-Q typically persist for many months, depending on treatment area, injection technique, product volume and individual patient metabolism.

Onset

Immediate visible correction is seen during and directly after injection, with the final aesthetic result stabilising over the following days as any procedure-related swelling and redness subside.

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