Promoitalia Nucleofill Eyes (Soft Plus) 1 x 2 ml
Promoitalia
Injectable skin boosterPeriocular polynucleotide biostimulator
Certifications
- 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).
