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Intraline M4 Plus with Lidocaine

Intraline M4 Plus with Lidocaine

Intraline

Dermal Filler
  • CE Marked Class III medical device hyaluronic acid dermal filler
  • Manufactured according to applicable medical device quality and safety standards (e.g., ISO Compliant production for injectable HA fillers)
Hyaluronic Acid Dermal Filler

Description

Intraline M4 Plus with Lidocaine is a CE-marked, monophasic, cross-linked hyaluronic acid dermal filler from Intraline’s M-Series. With a high HA concentration of 24 mg/ml and 3 mg/ml lidocaine, it is designed for deep-set wrinkles, volume restoration and facial contouring in the cheeks, chin and jawline. Its large gel particle size and high viscosity make it particularly suitable for non-surgical rhinoplasty and high-definition lip enhancement, with injection in the lower subcutaneous plane.

Bnefits

  • Monophasic, homogenised gel for smooth injection and natural integration
  • High HA concentration (24 mg/ml) for strong lifting and volumising capacity
  • Contains 3 mg/ml lidocaine to improve patient comfort during treatment
  • Large gel particle size and high viscosity provide excellent projection for contouring
  • Indicated for deep-set wrinkles and folds as well as facial contouring
  • Suitable for non-surgical rhinoplasty and high-definition lip augmentation
  • Long-lasting aesthetic effect, typically around 9–18 months depending on area and patient factors
  • CE-certified dermal filler manufactured to medical device quality standards

Indications

  • Deep-set facial wrinkles and folds (e.g., nasolabial folds, marionette lines)
  • Facial contouring of cheeks, chin and jawline
  • Non-surgical rhinoplasty (liquid nose reshaping)
  • High-definition lip augmentation and shaping
  • Volume restoration in deep dermal and subcutaneous facial areas

Composition

  • ingredient: Cross-linked sodium hyaluronate (Hyaluronic Acid)
  • concentration: 24 mg/ml

Formulation

  • Monophasic, cross-linked hyaluronic acid gel
  • Sterile, clear, viscoelastic injectable gel
  • Non-animal origin HA produced by bacterial fermentation

Packaging

  • 1 x 1.1 ml prefilled glass syringe
  • 1 x 25G sterile needle
  • 1 x 27G sterile needle
  • Sterile blister pack with package insert and traceability labels

Usage

  • For professional use only by suitably trained and qualified healthcare practitioners.
  • Inspect packaging and syringe for integrity and expiry date before use; do not use if damaged or expired.
  • Clean and disinfect the treatment area thoroughly before injection.
  • Attach the supplied 25G or 27G needle securely to the prefilled syringe under aseptic conditions.
  • Recommended level of injection: lower subcutaneous (lower Sub-Q) in the indicated facial areas.
  • Inject slowly using appropriate techniques (e.g., linear threading, fanning, or serial puncture) to achieve the desired contour and correction.
  • Massage the treated area gently after injection to ensure even distribution and smooth contours, if clinically appropriate.
  • Do not overcorrect; respect recommended maximum volumes per treatment area based on professional judgment.
  • Dispose of any unused product, syringe and needles as clinical waste according to local regulations.
  • Advise patients to avoid makeup on the treated area for at least 12 hours and to avoid exposure to extreme heat or cold, saunas, and strenuous exercise for a short period after treatment.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, lidocaine, amide-type local anaesthetics, or any component of the product.
  • Presence of active skin infection, inflammation or lesions (e.g., acne, herpes, dermatitis) at or near the intended injection site.
  • History of severe anaphylactic reactions or multiple severe allergies without appropriate specialist evaluation.
  • Autoimmune disease or immunodeficiency unless the patient has been carefully evaluated and cleared by a physician.
  • Pregnant or breastfeeding women.
  • Patients under 18 years of age.
  • Injection into blood vessels, into or near permanent implants, or into areas previously treated with certain energy-based devices at the same session.

Adverse Effects

  • Transient redness (erythema), swelling and tenderness at the injection site.
  • Bruising or haematoma formation.
  • Pain or discomfort during or after injection despite lidocaine content.
  • Itching or local irritation.
  • Palpable lumps or nodules in the treated area.
  • Asymmetry or irregular contour if placed unevenly.
  • Rare but serious complications such as vascular occlusion, tissue necrosis, infection, or visual disturbance in case of intravascular injection.
  • Hypersensitivity reactions, including delayed inflammatory responses or granuloma formation (rare).

Storage Conditions

  • Store between 2°C and 25°C.
  • Do not freeze.
  • Keep away from direct sunlight and excessive heat.
  • Store in the original packaging until use to maintain sterility.
  • Keep out of reach of children.

Duration

Single treatment session with results typically maintained for approximately 9\u201318 months depending on treatment area, injection technique and individual patient factors; repeat treatments may be performed as needed.

Onset

Immediate visible correction and contouring after injection, with optimal results once any initial swelling subsides over several days.

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