Promoitalia Nucleofill Eyes (Soft Plus) 1 x 2 ml

Promoitalia

Injectable skin booster

Periocular polynucleotide biostimulator

CE marked Class III medical device for injectable use in the EU/EEA
Complies with applicable European medical device regulations for polynucleotide Based skin biostimulators

CE marked Class III medical device for injectable use in the EU/EEA
Complies with applicable European medical device regulations for polynucleotide Based skin biostimulators

Periocular polynucleotide biostimulator

Description

Nucleofill Eyes (Soft Plus) by Promoitalia is a sterile, sodium DNA-based polynucleotide gel specifically formulated for the delicate periocular area. It acts as a biostimulatory skin booster to improve under-eye bags, dark circles, fine lines and wrinkles by deeply hydrating tissues, stimulating cellular regeneration and enhancing skin elasticity. The product is supplied as a 2 ml pre-filled syringe intended for professional, in-clinic injection by trained medical practitioners only.

Bnefits

Biorestructuring of the periocular (under-eye) area
Reduces eye bags, puffiness and under-eye swelling
Improves dark circles and overall brightness around the eyes
Smooths fine lines and superficial periocular wrinkles
Enhances skin firmness, elasticity and turgor
Provides deep, long-lasting hydration via polynucleotide-mediated water binding
Supports tissue regeneration and dermal remodelling
Suitable as a subtler alternative or complement to tear trough fillers
Can be used as a pre- and post-surgical adjunct for blepharoplasty and laser procedures
Low risk of oedema due to low molecular weight polynucleotides

Indications

Treatment of under-eye bags and mild periocular puffiness
Improvement of dark circles in the periocular area
Correction of fine lines and superficial wrinkles around the eyes (crow’s feet, lower eyelid lines)
Bio-restructuring and revitalisation of thin, lax periocular skin
Adjunctive treatment before and after periocular surgery (e.g. blepharoplasty, surgical eye lift) or laser procedures as directed by a clinician
Early periocular ageing with loss of elasticity and skin dullness
Patients unsuitable for traditional tear-trough hyaluronic acid fillers where a biostimulatory approach is preferred

Composition

Polymerised polynucleotides (PDRN) 7.5 mg/ml (0.75%)
Physiological saline solution (Aqua, Sodium Chloride)
Sterile, apyrogenic excipients suitable for injectable polynucleotide gel

Formulation

Sterile, apyrogenic, viscoelastic polynucleotide gel for periocular injection
Polynucleotide gel 15 mg in 2 ml syringe (7.5 mg/ml), based on highly purified, naturally derived polynucleotides
Polynucleotide molecular weight approximately 50–100 kDa
pH between 6.8 and 7.2
Viscosity approximately 28–35 Pa·s
Delivered in a pre-filled glass syringe with Luer-Lok connection for single-patient use

Packaging

Box containing 1 x 2 ml pre-filled sterile glass syringe of Nucleofill Soft Plus Eyes
2 x sterile, single-use 30G x 13 mm needles
Plastic syringe support to aid handling during injection
Package leaflet (instructions for use)
Traceability labels with batch number for patient record and patient copy
Sterile blister and outer carton packaging

Usage

For professional use only and must be administered by a suitably qualified and trained medical practitioner experienced in injectable aesthetic procedures.
Perform a full medical history, including allergy and immunologic status, and clinical assessment of the periocular area before treatment to confirm suitability.
Disinfect the treatment area thoroughly and maintain strict aseptic technique during the entire procedure.
Inject Nucleofill Eyes into the periocular area using a micro-deposit (micro-bolus) technique, typically around 0.05 ml per injection point, with injection points spaced approximately 0.5 cm apart, following the official Nucleofill Soft Plus protocol.
Use the supplied or recommended 30G x 13 mm needle, ensuring careful aspiration and slow injection to minimise risk of intravascular injection and tissue trauma.
Typical initial protocol: 2 treatment sessions spaced 2–4 weeks apart; in more severe cases, up to 4 sessions may be performed at 2–4 week intervals, according to clinical judgment.
For maintenance of results, repeat treatment approximately every 3 months or as advised by the treating clinician based on the patient’s response and level of skin ageing.
Avoid massage or manipulation of the treated area unless specifically recommended by the manufacturer’s protocol or treating practitioner.
After treatment, advise patients to avoid make-up, saunas, intense heat, and strenuous exercise for the period recommended by the clinic protocol, and to report any unexpected or severe adverse reactions immediately.
Do not inject into blood vessels, inflamed or infected skin, or into areas with significant fat pad herniation; strictly follow all precautions and contraindications listed in the official instructions for use.

Contraindications

Known hypersensitivity or allergy to polynucleotides, sodium DNA, or any component of the formulation
Significant fat pad herniation or overgrowth of adipose tissue in the lower eyelid region (pronounced fat bags)
Marked chronic oedema or pronounced swelling of the lower eyelids
Active skin infections, inflammatory skin disease or lesions in the treatment area (including herpes simplex in the periocular region)
Severe circulatory disorders or uncontrolled cardiovascular disease, as per clinician judgment
Uncontrolled diabetes mellitus
Epilepsy or severe systemic neurological disorders, where injections may pose additional risk as assessed by the treating physician
History of severe allergies or anaphylactic reactions
Autoimmune disease or immunosuppression, unless the treating physician determines the benefit outweighs the risk
Pregnancy and breastfeeding
Age under 18 years
Any other contraindication listed in the official instructions for use or determined by the treating medical professional

Adverse Effects

Transient redness (erythema), swelling and tenderness at the injection sites
Mild to moderate bruising (ecchymosis) around the treated periocular area
Temporary oedema or puffiness at injection points, typically resolving within 1–2 days
Itching, discomfort, or a feeling of tightness in the treated area
Small palpable bumps or nodules at injection sites that usually resolve spontaneously as the product integrates into the tissue
Rarely, infection at the injection site if aseptic technique is not strictly followed
Very rare hypersensitivity or allergic reactions; patients should seek immediate medical attention if signs of severe allergic reaction occur

Storage Conditions

Store between 2°C and 25°C.
Do not freeze the product.
Keep away from direct sunlight, heat sources and moisture.
Store in a dry environment in the original blister and outer carton until use to maintain sterility.
Do not use after the expiry date printed on the packaging or if the sterile blister or syringe appears damaged.

Duration

A standard treatment course typically consists of 2\u20134 sessions spaced 2\u20134 weeks apart, followed by maintenance sessions approximately every 3\u20136 months, depending on the patient\u2019s skin condition and clinical assessment.

Onset

Mild improvements in hydration and skin quality may be visible after the first session, with more pronounced and optimal results usually observed after completion of the initial course (around 4\u20136 weeks from the start of treatment).