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)
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
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.
