Profhilo 1 x 2 ml

Profhilo

Injectable aesthetic medical device

Stabilised hyaluronic acid bioremodeling injectable (skin booster / dermal filler)

CE Marked Class III sterile injectable hyaluronic acid medical device (EU/EEA).
BDDE Free stabilised HA hybrid cooperative complexes produced with patented NAHYCO thermal technology.
Manufactured under IBSA pharmaceutical quality and medical device standards (including GMP and applicable ISO/EN standards for medical devices).

CE Marked Class III sterile injectable hyaluronic acid medical device (EU/EEA).
BDDE Free stabilised HA hybrid cooperative complexes produced with patented NAHYCO thermal technology.
Manufactured under IBSA pharmaceutical quality and medical device standards (including GMP and applicable ISO/EN standards for medical devices).

Stabilised hyaluronic acid bioremodeling injectable (skin booster / dermal filler)

Description

Profhilo 1 x 2 ml is an innovative, CE-marked injectable hyaluronic acid (HA) medical device from IBSA Derma designed for multi-level bioremodeling of skin. Each pre-filled 2 ml syringe contains 64 mg of ultrapure HA (32 mg high molecular weight + 32 mg low molecular weight) in the form of thermally stabilised hybrid cooperative complexes (HCC), produced with NAHYCO technology and without BDDE or other chemical cross-linking agents. Injected into the superficial subcutaneous layer using dedicated techniques (such as the BAP – Bio Aesthetic Points – protocol), Profhilo improves skin laxity, hydration, firmness and overall tissue quality on the face, neck, décolletage and other areas, acting more as a bio-stimulatory skin booster than a volumising filler.

Bnefits

Very high concentration of hyaluronic acid: 64 mg of HA in a 2 ml pre-filled syringe (32 mg H-HA + 32 mg L-HA), amongst the highest in its category.
BDDE-free stabilised hybrid cooperative complexes produced by NAHYCO thermal technology, reducing exposure to chemical cross-linking agents.
Bioremodeling action: stimulates fibroblasts, keratinocytes and adipocytes, improving skin quality, firmness and elasticity rather than simply filling lines.
Treats skin laxity and contour issues in the face, neck, décolletage and other body areas while providing intense, long-lasting hydration.
Homogeneous tissue diffusion and high flowability minimise risk of lumps and surface irregularities when injected correctly.
Can be used alone or in combination with other aesthetic treatments (e.g. fillers, toxins, energy-based devices) as part of a comprehensive rejuvenation plan.
Clinically studied safety and tolerability profile when administered by trained healthcare professionals following the IFU.
Convenient ready-to-use, sterile, pre-filled 2 ml syringe presentation with supplied needles and traceability labels.

Indications

Tissue remodelling and improvement in skin laxity of the face, neck and décolletage.
Contours redefinition and laxity remodelling of the malar-zygomatic and sub-malar areas of the face.
Improvement of skin quality (tone, elasticity, hydration and radiance) in areas showing signs of photo- and chrono-ageing.
Support of dermal tissue repair processes in superficial cutaneous scars (e.g. acne or varicella scars), according to the IFU.
May be used on other areas prone to laxity (such as hands, arms or body) in accordance with local regulatory guidance and practitioner training.

Composition

Hyaluronic acid sodium salt 3.2% – total 64 mg per 2 ml (32 mg high molecular weight HA + 32 mg low molecular weight HA) in buffered sodium chloride solution.
Sodium chloride.
Sodium phosphate (buffering agents).
Water for injections.

Formulation

Crystal-clear, sterile, apyrogenic injectable gel composed of stabilised hybrid cooperative complexes of high and low molecular weight hyaluronic acid.
Concentration: 3.2% HA sodium salt (32 mg H-HA + 32 mg L-HA in 2 ml).
Produced via patented NAHYCO thermal technology, without BDDE or other chemical cross-linkers.
Supplied as a single-use, pre-filled 2 ml glass syringe for intradermal/superficial subcutaneous injection.
Intended medical device for professional use only (physicians or appropriately trained and authorised healthcare professionals).

Packaging

1 x pre-filled 2 ml glass syringe of Profhilo (3.2% – 32 mg H-HA + 32 mg L-HA / 2 ml hyaluronic acid sodium salt).
2 x Terumo needles 29G x 13 mm (0.33 x 12–13 mm, depending on region).
1 x Instructions for Use leaflet (IFU).
1 x Patient Information Leaflet (PIL) and/or patient card (depending on market).
2 x product traceability labels for medical records.
Syringe packed in a sterile blister within an outer carton.

Usage

Profhilo must only be administered by doctors or suitably trained and authorised healthcare professionals familiar with injectable HA medical devices and facial anatomy.
Before use, verify that the packaging and blister are intact and that the product is within its expiry date; do not use if packaging is damaged or opened.
Attach one of the supplied sterile needles securely to the syringe luer-lock, taking care not to touch the needle tip or syringe opening; expel any air bubble if necessary.
Inject Profhilo using strict aseptic technique, at room temperature, into the superficial subcutaneous / deep dermal layer as recommended in the IFU.
For global treatment of the malar and sub-malar facial areas, the manufacturer recommends the BAP (Bio Aesthetic Points) technique: typically 5 injection points per side of the face with 0.2 ml per bolus in the superficial subcutaneous plane, for a total of 2 ml per session.
Standard face protocol: 2 treatment sessions of 2 ml each, usually 4 weeks (1 month) apart; additional maintenance sessions can be performed according to clinical judgement, typically every 6–9 months depending on patient response.
Similar BAP-based schemes or adapted injection patterns can be used for the neck and other areas, following official Profhilo training, current IFU and local regulatory guidance.
Do not inject intravascularly, intramuscularly, into tendons, in or near mammary tissue, or into areas with active inflammation, infection or compromised skin.
After injection, lightly massage the treated areas if required to assist even distribution; avoid aggressive manipulation of the product.
Advise patients to avoid intense heat or cold exposure, vigorous exercise, saunas/steam rooms and sunbeds, and to minimise UV exposure for several days after treatment; recommend use of high-SPF sunscreen on exposed treated areas.
Single use only: once opened and used, any residual product must be discarded appropriately; do not resterilise and do not reuse on another patient.

Contraindications

Hypersensitivity or allergy to hyaluronic acid or any of the excipients (sodium chloride, sodium phosphate, water for injections).
Presence of active skin disease, inflammation or infection (e.g. herpes, dermatitis, bacterial or fungal infection) at or near the intended injection sites.
Known severe allergies or history of anaphylactic reactions to injectable biomaterials.
Pregnancy and breastfeeding (use is generally not recommended due to lack of sufficient clinical data).
Autoimmune diseases or patients under immunosuppressive therapy, unless the treating physician judges that potential benefits outweigh risks.
Coagulation disorders or concurrent anticoagulant/antiplatelet therapy that significantly increases the risk of bleeding or haematoma, unless carefully evaluated by the treating physician.
Previous permanent fillers or other implants in the planned injection area where interactions are uncertain.
Do not inject into blood vessels, muscles, tendons, mammary tissue, or deeply into areas with significant structural compromise.

Adverse Effects

Common, usually transient injection-site reactions such as redness (erythema), swelling, mild to moderate pain or tenderness, warmth, itching and small haematomas (bruising).
Transient palpable lumps or nodules at injection points due to product placement or local oedema, generally resolving spontaneously over days to weeks.
Less commonly, local inflammatory reactions or prolonged swelling which may require medical evaluation and management.
Rare but serious complications, as with all injectable HA products, may include infection, abscess, vascular compromise or, very rarely, tissue necrosis if injected intravascularly or if significant vascular compression occurs.
Hypersensitivity or allergic-type reactions are rare but possible; practitioners should be prepared to manage acute reactions in accordance with standard medical practice.

Storage Conditions

Store at 0–25 °C, away from direct heat sources and sunlight.
Do not freeze; freezing can alter the gel structure and compromise safety and efficacy.
Keep the syringe in its original packaging until use to protect from light and contamination.
Do not use after the expiry date printed on the carton and syringe label.
Once the sterile blister is opened, use the syringe immediately; any unused product must be discarded.
Keep out of the reach and sight of children.
Do not resterilise; the device is intended for single use only.

Duration

Typical treatment protocol comprises 2 sessions of 2 ml each, spaced 4 weeks apart. Clinical improvements in skin quality and laxity often persist for around 6 months or longer, with many practitioners recommending maintenance treatments approximately every 6\u20139 months depending on individual response and ageing profile.

Onset

Initial improvements in hydration and skin radiance may be observed within days to a few weeks after the first session, with more pronounced bioremodeling effects (improved firmness, elasticity and laxity) typically evident 4\u20138 weeks after the first injection, especially after completion of the second session.