Profhilo

What it is

Profhilo® is a CE-marked medical device for intradermal use from IBSA Farmaceutici Italia. The pre-filled syringe contains 2 ml of buffered physiological solution with 32 mg high molecular weight (H-HA) and 32 mg low molecular weight (L-HA) sodium hyaluronate (3.2%). The hyaluronic acid is of microbial origin and is produced by biofermentation without chemical modification.

Indication

According to the manufacturer's instructions for use, Profhilo® is intended for treatment of the malar-zygomatic and submalar areas of the face, for contour redefinition and laxity remodelling.

Mode of action

The manufacturer describes that Profhilo® acts through a corrective/filling effect on natural and induced depressions in the skin, and that the viscoelastic and hydrating properties of hyaluronic acid rehydrate the skin. A defined volume is injected at a few points and diffuses progressively through the interstitial spaces of the malar and submalar area.

How supplied

• Format: 1 × 2 ml pre-filled syringe, sterile, single use.
• Needles: 2 × 29G ½″ (0.33 × 12 mm) included.
• Storage: 0–25 °C, away from heat sources. Do not freeze.

Contraindications and precautions

Do not use concurrently with laser resurfacing or medium-deep skin peeling. Do not inject intravenously, into muscles or tendons, for breast augmentation or into inflamed areas. Do not mix with other products or with disinfectants such as quaternary ammonium salts or chlorhexidine. Full warnings and possible side effects are listed in the instructions for use.

Documentation

Norwegian instructions for use (IFU) are attached. Manufacturer: IBSA Farmaceutici Italia srl, Lodi, Italy. CE 0373. Prescription only; intradermal injection must only be performed by healthcare professionals.

CE-marked medical device. For professional use only.

Composition: sodium hyaluronate 3.2% – 32 mg high molecular weight (H-HA) and 32 mg low molecular weight (L-HA) per 2 ml – in buffered physiological solution with sodium chloride, sodium phosphate and water for injection.

According to the manufacturer's instructions for use: 5 injection points (Bio Aesthetic Points) per side of the face – zygomatic protrusion (at least 2 cm from the outer corner of the eye), nasal base, tragus (at least 1 cm anterior to the inferior margin of the tragus), chin and mandibular angle (1 cm above the angle). 0.2 ml per point using a bolus technique into the dermal/subcutaneous layer, followed by gentle massage around the injection site. Maximum 2 ml per treatment session.

Inject at room temperature under strictly aseptic conditions. The course of treatment is assessed according to the patient – see the instructions for use.

After treatment: The patient should avoid UV exposure and use SPF 50 sunscreen on the treated area for 3–5 days.

Do not combine with laser resurfacing or medium-deep skin peeling.