INFINI L+ LIDOCAINE PREMIUM FILLER (1x1ml)

INFINI L+ LIDOCAINE PREMIUM FILLER (1x1ml)

INFINI

Aesthetic dermatology
  • CE Marked injectable implant (medical device) within the INFINI PREMIUM FILLER range
  • Manufactured under ISO 13485 quality management system for medical devices
  • Manufacturing also aligned with ISO 22716 guidelines for good manufacturing practices of medical and cosmetic products
  • Hyaluronic acid of non Animal origin, pharmaceutical quality, not requiring skin testing
  • Produced in an Italian laboratory with documented quality and safety certifications for INFINI PREMIUM products
Cross-linked hyaluronic acid dermal filler with lidocaine for deep wrinkles and facial contouring

Description

INFINI L+ LIDOCAINE PREMIUM FILLER (1x1ml) is an ultra-smooth, cross-linked hyaluronic acid dermal filler with lidocaine, designed for restoring or increasing the volume of soft tissues and for the correction of deep wrinkles and skin grooves. With a high HA concentration of 24 mg/ml and a large molecular size of approximately 600 μm, it provides strong volumising capacity and structural support. The product is dedicated to facial contouring in areas such as the mandibular line, bridge of the nose, chin, nasolabial folds and marionette lines, while also being suitable for deep wrinkle correction and lip contouring/volume. The addition of lidocaine improves patient comfort during injection. It is intended strictly for medical use and injected into the dermal layer by qualified professionals.

Bnefits

  • High-concentration (24 mg/ml) cross-linked hyaluronic acid for effective volume restoration and contouring
  • Large molecular size (~600 μm) providing strong lifting and structural support for deep wrinkles and folds
  • Contains lidocaine to reduce injection pain and improve patient comfort during procedures
  • Ultra-smooth, highly cohesive gel for homogeneous distribution and natural-looking results
  • Specifically designed for correction of deep wrinkles and skin grooves such as nasolabial folds and marionette lines
  • Ideal for contouring the mandibular line, nose bridge and chin to enhance facial shape and profile
  • Suitable for lip contouring and volume enhancement where stronger structure is desired
  • Plasticity and volume rated 3/5, giving a balance between mouldability and stability
  • Durable effect, with results typically lasting around 8–9 months depending on individual factors
  • Produced in an Italian laboratory under strict quality and safety standards

Indications

  • Restoring or increasing the volume of soft tissues in the face
  • Correction of deep wrinkles and skin grooves
  • Correction of deep nasolabial folds
  • Treatment of marionette lines (puppet lines)
  • Contouring and definition of the mandibular (jaw) line
  • Improving the shape and projection of the chin
  • Non-surgical correction/improvement of nose shape (e.g., nasal dorsum contouring)
  • Contouring and increasing the volume of lips
  • General facial volumisation and structural support in indicated dermal planes

Composition

  • Cross-linked hyaluronic acid 24 mg/ml (non-animal origin)
  • Lidocaine (indicated as 3% / approx. 3 mg/ml to improve treatment comfort)
  • Physiological saline solution q.s.
  • Trace residual BDDE cross-linking agent below detectable levels as per Hy-BRID technology (per INFINI technical information)

Formulation

  • Sterile, single-phase, viscoelastic hydrogel of cross-linked hyaluronic acid with lidocaine
  • Transparent, non-pyrogenic gel with high viscoplasticity and tissue biocompatibility
  • Physiological pH and osmolarity with gradual resorption over time
  • Intended for dermal injection using hypodermic needles (TSK 25G or 27G) in the indicated areas

Packaging

  • 1 x 1 ml pre-filled, sterile syringe with Luer-lock connector
  • Individually blister-packed with two TSK needles (25G and 27G) dedicated to product implantation
  • Pack includes instructions for use (IFU) leaflet
  • Self-adhesive labels with batch numbers provided for medical records and traceability

Usage

  • For strict medical use only; injections must be performed by appropriately trained and qualified healthcare professionals experienced in dermal filler techniques.
  • Before treatment, take a full medical history, assess indications and contraindications, and obtain informed consent.
  • Cleanse and disinfect the treatment area thoroughly following aseptic protocols.
  • Attach the provided 25G or 27G TSK needle to the 1 ml pre-filled syringe, ensuring a secure Luer-lock connection and that any air bubbles are expelled.
  • Inject INFINI L+ LIDOCAINE into the dermal layer at the appropriate depth for the indication (typically mid to deep dermis, depending on area and technique).
  • Use suitable injection techniques such as linear threading, fanning, serial puncture or small bolus injections, tailored to each anatomical area (mandible line, nose, chin, nasolabial folds, marionette lines, lips).
  • Inject slowly, monitor tissue response and avoid overcorrection; gently mould or massage the area after injection if needed to achieve a smooth contour.
  • Continuously monitor the patient during the procedure for signs of discomfort or vascular compromise, and adhere to established protocols for the management of complications.
  • After treatment, provide post-procedure instructions: avoid applying makeup for several hours, avoid extreme temperatures (sauna, sunbeds, intense cold), vigorous exercise, alcohol and massaging the treated area for 24–48 hours unless directed otherwise.
  • Schedule follow-up to assess results and decide whether a touch-up session is required; do not re-inject the same area too soon without adequate assessment.

Contraindications

  • Hypersensitivity or allergy to hyaluronic acid, lidocaine, other local anaesthetics of the amide type, or any component of the product
  • Pregnancy or breastfeeding (as a precaution common to aesthetic injectable procedures)
  • Patients under 18 years of age
  • Active skin infections, inflammatory processes, or lesions at or near the intended injection site (e.g., herpes simplex, acne, dermatitis)
  • Known history of severe allergic reactions or anaphylaxis, unless adequate precautions and risk–benefit evaluation are undertaken
  • Autoimmune diseases or immunosuppression, unless the indication is carefully evaluated by a specialist
  • Bleeding disorders or current anticoagulant/antiplatelet therapy, unless evaluated and managed by the treating physician
  • Previous permanent fillers or incompatible implants in the area to be treated, where interaction or displacement may occur

Adverse Effects

  • Common, usually transient reactions at injection sites such as redness (erythema), swelling, tenderness, pain, itching, bruising or haematoma
  • Temporary irregularities or palpable lumps which usually resolve spontaneously or after gentle massage
  • Rare inflammatory reactions or hypersensitivity responses, including delayed-onset nodules or granulomas
  • Very rare but serious complications such as accidental intravascular injection leading to vascular occlusion, ischaemia or tissue necrosis, particularly in high-risk areas (e.g., nasolabial region, nose, glabella)
  • Infection at the injection site if aseptic technique is not strictly observed
  • Discomfort or altered sensation despite lidocaine, usually mild and transient

Storage Conditions

  • Store in the original blister and outer box, protected from light and moisture.
  • Maintain recommended storage temperature as per packaging (typically between 2°C and 25°C); do not freeze.
  • Do not expose the product to excessive heat or direct sunlight.
  • Keep out of the reach of children.
  • Single-use only: once the sterile blister is opened and the syringe used, any unused product must be discarded; do not resterilise or reuse.

Duration

The clinical effect typically lasts around 8\u20139 months, depending on the injection area, technique, patient age, lifestyle and individual metabolism of hyaluronic acid. The injection session itself usually takes approximately 20\u201340 minutes including consultation and preparation.

Onset

Volumising and contouring effects are visible immediately after injection, with final aesthetic outcome evident over the following days once transient swelling or erythema has resolved.

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