Description
Medical device for intra-dermal use consisting of a buffered physiological solution of hyaluronic acid (HA) with high molecular weight (H -HA) and low molecular weight (L-HA).
The high and low molecular weight HA used in the device is obtained by biofermentation and has not undergone chemical modification processes. This results in excellent tolerability.
The HA chains with different molecular weights present in PROFHILO, thanks to a specific and patented treatment of the solution (NAHYCO Hybrid Technology), interact with each other giving PROFHILO unique rheological characteristics that allow it to be administered , being equal of viscosity of the solution, higher concentrations of HA. The formulation based on HA with different molecular weights contained in PROFHILO is based on the Hydrolift Action system, an approach aimed at counteracting the physiological decrease in HA in the skin, restoring hydration, elasticity and elasticity. and tone, synergistically associating deep hydration with the mechanical action of lifting skin depression.
It is indicated for adults of both sexes for a corrective/filling action of natural and induced skin depressions. PROFHILO intervenes in the physiological process of reduction of skin hydration, alteration of the elastic and collagen fibers of the dermis, with loss of firmness and skin tone, as in cases of excessive dehydration, weight loss and aging, with relative loss of endogenous HA. The properties viscoelastic and hydrating HA, combined with the possibility of to maintain this HA at adequate levels in the skin tissues, allow the rehydration of the tissues themselves and allow the creation of optimal conditions to prevent and promote tissue remodeling with a consequent corrective effect on damage.
The intradermal administration of PROFHILO allows to restore the physiological quantity of of HA obtaining a benefit for the skin.

Mode instructions for use
It is recommended to carry out an initial cycle of two treatment sessions, with an interval of 30 days between each other, possibly followed by maintenance sessions every 2 months. However, it is suggested to evaluate the specific protocol for using the PROFHILO based on the patient's degree of aging.
Carefully unscrew the cap of the syringe, holding the "Luer Lock" closing collar firmly between your fingers. and paying particular attention to avoid contact with the opening. Insert the 29 G needle present inside the product package to the 'Luer Lock' type closure collar of the syringe, screwing it firmly, until you feel a slight pressure, in order to ensure a watertight seal and prevent the liquid from leaking during administration, holding the "Luer Lock" closure collar firmly between your fingers. Inject PROFHILO at room temperature and under strict aseptic conditions.

Injection techniques for the face
For the treatment of the malar and sub-malar area, we suggest identification of 5 points (Bio Aesthetic Point) for the intradermal administration of PROFHILO.

1) Zygomatic protuberance: make sure it is at least 2 cm away from the external canthus of the eye.
2) Wing of the nose: draw a line of conjunction between the wing of the nose and the tragus, then draw a perpendicular line starting from the pupillary midline. Then locate the injection point at the point of intersection of the two lines.
3) Tragus: make sure you are 1 cm anterior to the lower edge of the tragus.
4) Chin region: trace the midline of the chin. At a third of this line draw the perpendicular line. From the intersection point, move 1.5 cm towards the labial commissure to locate the injection point.
5) Mandibular angle: 1 cm above the mandibular angle.

Inject 0.2 ml of product with bolus technique at the dermis/subcutaneous level. Apply a light massage to the injection points. This injection technique allows you to focus the action of PROFHILO where the skin appears relaxed and with a loss of firmness and skin tone. The action is concentrated in a few anatomically receptive points of a defined volume of the compound, which will progressively spread. through the interstitial spaces, providing a lasting refreshment to the entire malar and sub-malar area.

Injection techniques for the neck
For the treatment of the neck area, we suggest the identification of 10 points (Bio Aesthetic Point) for the administration of PROFHILO.

1) Midline: halfway between the edge of the chin and the hyoid bone.
2) Halfway between the Adam's apple and the thyroid cartilage.
3) Halfway between the hyoid cartilage and the manubrium of the sternum.
4) Apex of the manubrium of the sternum.
5-6) Under the mandibular angle 0.5 cm from the medial edge of the SCM.
7-8 ) On the horizontal axis of point 2 at 0.5 cm from the medial edge of the SCM.
9-10) On the horizontal axis of point 3 at 0.5 cm from the medial edge of the SCM.

Inject 0.2 ml of product with a bolus technique at the level of the dermis. Apply a light massage to the injection points. This injection technique allows you to focus the action of PROFHILO where the skin appears relaxed and with a loss of firmness and skin tone. The action is concentrated in a few anatomically receptive points of a defined volume of the compound, which will progressively spread. through the interstitial spaces, providing a lasting refreshment to the entire neck area.

After the treatment
At the end of the treatment the doctor must fill in and deliver the implant to the patient card, which is found on the first page of the instructions for use contained in the package.

Components
Hyaluronic acid sodium salt [32 mg (H-HA) + 32 mg (L-HA)], sodium chloride 16,000 mg, sodium phosphate 0.410 mg, water for injections qs 2.0 ml.

Warnings
The contents of the syringe pre -filled is sterile. The syringe is packaged in a sealed blister. The external surface of the syringe is not sterile.
Do not use PROFHILO after the expiry date shown on the package.
Do not use PROFHILO if the packaging is sterile. opened or damaged because sterility could be compromised.
The injection point must be on healthy skin.
Do not use in pregnant or breastfeeding women.
Do not use in patients with autoimmune diseases.
Do not inject via the vascular route, in muscles, tendons or for breast augmentation.
Do not mix with other products.
Do not inject in areas where inflammatory processes are present.
Do not sterilize again. The device is intended for single use only.
Do not reuse to avoid any risk of contamination.
PROFHILO is indicated for adult patients. Keep out of reach of children.
Do not use PROFHILO in case of hypersensitivity. known or allergies to the components of the product.
The possible presence of an air bubble does not affect the characteristics of the product.
After the injection and in the following 3-5 days, advise the patient to avoid the treated part is exposed to UV rays, and it is recommended to protect the treated area with total protection sun creams.
Do not mix PROFHILO with disinfectants such as quaternary ammonium salts or chlorhexidine, as they can a precipitate may form.
To date, in vitro studies have been carried out to identify any incompatibilities and/or interactions between PROFHILO and platelet-rich plasma (PRP). The results obtained demonstrate that PRP does not modify the rheological behavior of sodium hyaluronate.
There are no known interactions between PROFHILO® and other medications/treatments. However, in case of therapies and/or taking drugs concomitantly with the treatment, consult your doctor for further information.
The extra-dermal infiltration of PROFHILO can cause side effects locally.
During the use of PROFHILO, symptoms such as pain, sensation of heat, itching, burning, redness, ecchymosis, edema, or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area. Normally they disappear after a short time.
The doctor must ensure that patients inform him of any side effects that may occur after treatment.
In the event of an accident, inform the Manufacturer or the relevant authority. competent person.
Follow the indicated dosage and in case of side effects related to an overdose, contact your doctor or the nearest hospital. close.
PROFHILO must not be used in conjunction with treatments such as laser resurfacing and medium-deep peeling.

Storage
Store at temperatures below 25 °C and away from heat sources. Do not freeze.
Once opened, PROFHILO must be used immediately and discarded after use.
The expiry date indicates the shelf life of the product. maximum of the medical device referring to the product with intact packaging and correctly stored.
Validity with intact packaging: 36 months.

Format
The package contains:
- 2 ml pre-filled syringe [32 mg (H-HA) + 32 mg (L-HA)] of hyaluronic acid sodium salt in 2 ml of buffered physiological sodium chloride solution;
- 2 29G needles.

Code 12708