CE Marked Class III sterile injectable hyaluronic acid medical device for intradermal/superficial subcutaneous use.
Manufactured using IBSA’s NAHYCO hybrid technology to produce stabilised hybrid cooperative complexes of high and low Molecular Weight hyaluronic acid without BDDE or similar chemical cross Linkers.
Produced under IBSA pharmaceutical and medical device quality systems compliant with applicable EU Medical Device Regulation and relevant ISO/EN standards.
CE Marked Class III sterile injectable hyaluronic acid medical device for intradermal/superficial subcutaneous use.
Manufactured using IBSA’s NAHYCO hybrid technology to produce stabilised hybrid cooperative complexes of high and low Molecular Weight hyaluronic acid without BDDE or similar chemical cross Linkers.
Produced under IBSA pharmaceutical and medical device quality systems compliant with applicable EU Medical Device Regulation and relevant ISO/EN standards.
Hyaluronic acid skin booster and bioremodeller
Description
Profhilo H+L (1 x 2 ml) is a CE-marked injectable hyaluronic acid medical device from IBSA Derma used as a skin booster and bioremodeller rather than a traditional volumising filler. Each pre-filled 2 ml syringe contains 64 mg of ultrapure hyaluronic acid (32 mg high-molecular-weight + 32 mg low-molecular-weight) in the form of stabilised hybrid cooperative complexes created with NAHYCO thermal technology and without BDDE or other chemical cross-linking agents. Injected into the superficial subcutaneous/deep dermal layer using specific techniques such as the Bio Aesthetic Points (BAP) protocol, Profhilo improves skin hydration, elasticity and firmness and reduces fine lines by stimulating fibroblasts to increase collagen and elastin production. The product diffuses widely through the tissue, delivering a subtle lifting and tightening effect and improving overall skin tone, texture and radiance on the face, neck, décolleté, hands and arms.
Bnefits
Contains 64 mg of pure hyaluronic acid in a 2 ml pre-filled syringe (32 mg high-molecular-weight HA + 32 mg low-molecular-weight HA), one of the highest HA concentrations in its class.
Uses patented NAHYCO hybrid technology to create stabilised hybrid cooperative complexes of HA without BDDE or other chemical cross-linkers, supporting excellent biocompatibility and safety.
Acts as a deep skin moisturiser and bioremodeller, focusing on skin quality (hydration, firmness, elasticity and texture) more than volumisation.
Improves skin tone and texture, boosts radiance and reduces the visible signs of ageing such as fine lines and mild skin laxity.
Restores skin firmness and elasticity by stimulating fibroblasts to increase collagen and elastin production.
Provides wide tissue diffusion from a limited number of injection points (e.g. BAP technique), improving comfort and reducing the number of injections needed.
Effective on multiple treatment areas including face, neck, décolleté, hands and arms for global skin quality improvement.
Can be combined with other aesthetic procedures such as dermal fillers, PRP and botulinum toxin as part of a comprehensive anti-ageing protocol when planned by a qualified clinician.
Tissue remodelling and improvement of skin laxity and firmness in areas such as the malar and sub-malar regions of the face (cheeks and jowls).
Improvement of skin hydration, tone, texture and radiance in photo- and chrono-aged skin.
Reduction of fine lines and early wrinkles on the face, neck and décolleté.
Enhancement of skin quality and elasticity on the hands and arms and other areas affected by mild to moderate laxity, according to the instructions for use and local regulations.
Support of dermal tissue repair processes in cases of superficial scarring (e.g. acne or minor traumatic scars), in line with the device’s intended use.
Composition
Hyaluronic acid sodium salt 3.2% – 64 mg per 2 ml (32 mg high-molecular-weight HA + 32 mg low-molecular-weight HA) as stable hybrid cooperative complexes.
Sodium chloride.
Sodium phosphate buffer.
Water for injections.
Formulation
Crystal-clear, sterile, apyrogenic injectable gel of hyaluronic acid sodium salt based on stabilised hybrid cooperative complexes (HCC) of high- and low-molecular-weight HA.
Total HA content: 64 mg in 2 ml (3.2% w/v), split equally between H-HA and L-HA (32 mg each).
Hybrid complexes produced by NAHYCO thermal technology without the use of BDDE or other chemical cross-linking reagents.
Designed for intradermal/superficial subcutaneous injection with high cohesivity and spreadability and minimal traditional filler-type volumising effect.
Single-use medical device supplied as a pre-filled 2 ml glass syringe for use by trained healthcare professionals only.
Packaging
Box containing:
• 1 x 2 ml pre-filled glass syringe of Profhilo H+L (3.2% – 32 mg H-HA + 32 mg L-HA/2 ml hyaluronic acid sodium salt).
• 2 x 29G x 1/2" sterile needles (e.g. 29G x 13 mm).
• 1 x Instructions for Use (IFU) leaflet.
• 2 x product traceability labels for medical records and patient documentation.
All components supplied in a sterile blister and outer carton.
Usage
Profhilo H+L is a Class III medical device and must only be administered by qualified physicians or appropriately trained healthcare professionals experienced in injectable aesthetic procedures and facial anatomy.
Before use, verify that the outer carton and sterile blister are intact and that the product is within its expiry date; do not use if packaging is damaged or if the gel appears cloudy or contains particulates.
Attach one of the supplied 29G x 1/2" needles securely to the syringe Luer-lock using aseptic technique. Carefully expel any air bubble and, if necessary, a small amount of product to prime the needle.
Inject Profhilo into the superficial subcutaneous/deep dermal layer using recommended techniques. For facial treatment, the Bio Aesthetic Points (BAP) technique is commonly used: typically 5 injection points per side of the face (10 points total) with 0.2 ml per point to deliver the full 2 ml syringe.
For other areas such as neck, décolleté, hands and arms, use adapted BAP or other recognised protocols in accordance with the IFU and appropriate training, always avoiding major vessels and high-risk anatomical structures.
Recommended initial treatment course is two sessions of 2 ml each, spaced approximately 4 weeks (one month) apart. Maintenance sessions may be performed according to clinical judgement, often every 6–9 months.
Do not inject intravascularly, intramuscularly, into tendons, mammary tissue, or into areas with active infection, inflammation or chronic skin disease. Do not mix Profhilo with other substances in the same syringe.
After injection, lightly massage the treated areas if required to aid even distribution of the gel; avoid aggressive manipulation.
Advise patients to avoid intense heat or cold, vigorous exercise, saunas, steam rooms, sunbeds and direct UV exposure for several days post-treatment and to use broad-spectrum high-SPF sunscreen on exposed treated areas.
Single-use only: any unused product remaining in the syringe after treatment must be discarded. Dispose of used syringes and needles immediately in approved sharps containers in accordance with local regulations.
Contraindications
Known hypersensitivity or allergy to hyaluronic acid or any excipient in the formulation (e.g. sodium chloride, sodium phosphate).
Presence of active skin infection, inflammation or disease (such as herpes simplex, dermatitis or bacterial infection) at or near the intended injection sites.
History of severe allergies or anaphylactic reactions to injectable biomaterials.
Pregnancy or breastfeeding, as adequate safety data are not available and treatment is generally not recommended.
Autoimmune diseases or patients receiving immunosuppressive therapy, unless the treating physician determines that potential benefits outweigh risks.
Uncontrolled coagulation disorders or concurrent use of anticoagulant/antiplatelet therapy that significantly increases bleeding or haematoma risk, without prior medical evaluation.
Do not inject into blood vessels, muscles, tendons, mammary tissue, or areas containing permanent fillers or implants where interactions and safety cannot be assured.
Not recommended immediately after medium/deep chemical peels, ablative laser resurfacing or other aggressive procedures in the same area until healing is complete.
Adverse Effects
Common, usually transient local reactions at injection sites, including redness (erythema), swelling/oedema, mild to moderate pain or tenderness, warmth, pruritus (itching) and small haematomas or bruising.
Transient palpable lumps or nodules at the injection points due to localised gel deposition and oedema, which typically resolve spontaneously within days to a few weeks.
Less common reactions may include prolonged swelling, induration, local inflammatory reactions or sensitivity, which should be assessed and managed by the treating clinician.
As with all injectable HA products, rare but serious complications can include infection, abscess formation, vascular occlusion and, in severe cases, local tissue necrosis if intravascular injection or significant vascular compression occurs.
Hypersensitivity or allergic-type reactions are rare but possible; clinicians should be prepared to recognise and promptly treat acute allergic reactions according to local emergency protocols.
Storage Conditions
Store the unopened syringe in its original blister and outer carton at controlled room temperature, generally between 2 °C and 25 °C as indicated on the packaging.
Protect from direct sunlight, excessive heat and moisture.
Do not freeze; freezing can damage the gel structure and compromise safety and efficacy.
Do not use after the expiry date printed on the carton and syringe label.
Once the blister is opened, use the syringe immediately and discard any unused product; do not resterilise or reuse.
Keep out of the reach and sight of children.
Duration
Standard protocol consists of an initial cycle of two treatment sessions of 2 ml each, performed approximately 4 weeks apart. Effects on hydration, texture and skin laxity typically last around 6\u20139 months and may persist up to about 12 months, after which maintenance treatments can be scheduled according to individual ageing, skin condition and clinician assessment.
Onset
Initial improvements in hydration and radiance may be visible within days to a few weeks after the first treatment. More pronounced improvements in firmness, elasticity and fine lines are usually evident 4\u20138 weeks from the start of treatment, particularly after completion of the second session.
