EN IT

NEAUVIA HYDRO DELUXE

NON-CROSS-LINKED HYALURONIC ACID

DESCRIPTION
NEAUVIA Hydro Deluxe is a non-crosslinked Hyaluronic Acid hydrogel enriched with Glycine, L-Proline and
Calcium Hydroxyapatite in phosphate buffer solution. The medical device is a sterile, non-pyrogenic, non-
crosslinked injectable hydrogel. The Hyaluronic Acid is a highly purified raw material of non-animal origin,
derived from bacterial fermentation, which is non-pathogenic for human. The hydrogel is transparent and
colourless and has a low viscosity. The device is supplied in 1.0 mL or 2.5 mL pre-filled disposable syringes
with a luer-lock connection. The package contains the device, instructions leaflet, needle, product
identification labels and implant card.
COMPOSITION
Sodium hyaluronate …………………………………..18 mg
Enriched* phosphate buffer solution …………qs ad 1 mL
* with Glycine, L-Proline and Calcium hydroxyapatite.

INTENDED USE
NEAUVIA Hydro Deluxe is an injectable medical device indicated for the temporary correction of the
sign of primary soft tissue senile atrophy of the face and neck with intradermal injection.
NEAUVIA Hydro Deluxe is intended for adults (over 27 years old) women (not pregnant or
breastfeeding) and men with primary senile atrophy soft tissues deficits of the face and neck.
INDICATIONS
NEAUVIA Hydro Deluxe is a biodegradable linear hyaluronic acid hydrogel resorbed over time,
intended to be injected into the dermis and epidermis to restore lost volume.
NEAUVIA Hydro Deluxe when injected in the dermis and epidermis, adds temporally volume to thinned
soft tissues of the face and neck. Pre-clinical and clinical studies demonstrated that NEAUVIA Hydro
Deluxe degradation average time is 2 weeks.
The volumetric increase of the treated injection site is always directly proportional to the quantity of
injected NEAUVIA Hydro Deluxe product.

CONTRAINDICATIONS
 Patients with secondary infectious, traumatic, viral and iatrogenic atrophy
 Infections and inflammations (acne, herpes, dermatitis, etc.) in situ or near the area of
treatment.
 Patients receiving treatment with anticoagulants.
 Patients undergoing radiation or ultrasound therapy in the area to treat.
 Patient with known hypersensitivity to hyaluronic acid.
 Patient who tend to develop hypertrophic scarring.
 Patient suffering from untreated epilepsy.
 Active autoimmune disorders affecting the skin.
 Varices in the area of the implant.
 Do not inject the product in pregnant or breastfeeding women.
 Do not inject in children or patients under 27 years of age.
 Do not inject in patients suffering from severe allergies.
 Do not inject in patients already treated with temporary or permanent fillers in the same area.
 Do not inject in the eyelids
 Do not inject into blood vessels.
 Do not overcorrect.
 Do not inject simultaneously or in sequentially advance with ablative laser sources, deep chemical
peels or dermabrasion.
 Do not inject the product in the mammary gland and internal genitals.

DOSAGE AND INSTRUCTIONS FOR USE

PRECAUTIONS FOR USE :The product is intended to be used observing aseptic technique and standard
practice in compliance with local legislation. The product is only intended to be used by physicians in
accordance with local legislation, trained in the appropriate injection techniques on Hyaluronic acid
based fillers.
Depending on the severity of the clinical treated sign, the necessary dose required for treatment is defined
by the physician. It is however recommended to not exceed 22.5 ml per session. Regular sessions and touch-
ups may be necessary. It is advised to not exceed 4 sessions per year at 2 or 3-months intervals. Despite
being below the toxicity threshold, the maximum recommended annual dose of NEAUVIA Hydro Deluxe is
90 ml for a 60 kg patient.
PREPARING FOR TREATMENT:
 Recommended needle size: 30 G (it is possible to use the 30 G Mesorelle needle)
 Collect data on the patient’s medical history (current infections, current medication, ongoing dental
treatment, surgical procedures, allergies, etc.);
 Note down the REF (type of product) and batch number of the product used in the patient’s medical
records, in order to ensure traceability.
 Inform the patient about the indications, contraindications and possible adverse reactions of the
product.
 Obtain the patient’s signature on the informed consent form.
ANAESTHESIA: In order to reduce any possible allergic reaction, the product does not contain any
anaesthetic.
 Evaluate whether it is appropriate to use local anaesthesia. In this case, it is advisable to use the local
nerve block technique (troncular technique).
 In patients with known allergies, evaluate whether it is appropriate to use the anaesthetic.
TREATMENT PROCEDURE:
 Before injecting the product, disinfect thoroughly the area to be treated with iodopovidone or
chlorhexidine disinfectant.
 Unscrew the syringe protection cap.
 Screw the needle firmly onto the luer-lock connection of the syringe.
 Push the plunger gently in order to expel any residual air from the product.
 If the needle is clogged, do not increase pressure on the plunger; replace the needle instead.
 Inject the product slowly using the retrograde sliding injection technique or multi injection point
technique. While realizing that every professional will use his or her preferred technique, when using the
product it is advisable to perform the implantation in accordance with the injection technique
recommended by the Manufacturer.
 During injection, the product can be shaped with by the physician using the contralateral hand.
 At the end of the procedure massage the treated area gently for an improved distribution of the product.
POST-TREATMENT ADVICE
 An anti-inflammatory drug may be administered to the patient to reduce oedema (which is a
physiological response to any filler implant).
 Ice can be applied to the treated area, although not in direct contact with the skin, to reduce the
inflammatory effects typically associated with an injection.
 Ecchymosis/haematoma can be treated with appropriate creams or gels.
 During the 24 hours following the treatment, do not apply pressure or cosmetics to the treated area.
 Surgical or dental interventions are to be avoided for two weeks starting from the day of the injection. If
the patient must undergo these procedures, it is ALWAYS essential to inform the physician concerned of
 the location of the implant.
 Similarly, beauty treatments (laser, peeling, etc.) in the treated area are to be avoided for 3 weeks
starting from the day of the implantation.
 Avoid direct exposure to sunlight and UVA-B radiation (e.g. tanning lamps) for two weeks starting from
the day of the treatment.
WARNINGS
 Do not use the product after the expiry date.
 Do not use the product if the package is not intact or damaged or has not been stored correctly.
 Do not use the product if it does not appear to be in normal condition (as described in Description and
Composition).
 Once the package has been opened, the product must be used immediately. Leftover product
must be disposed of.
 Do not inject product from the same syringe in different patients.
 Do not use the same needle for corrections in different anatomic districts.
 Do not mix the product with other substances.
 Do not allow the product to come into contact with quaternary ammonium salts such as
benzalkonium chloride.
 Do not add any type of drug into the hydrogel.
 The product is for single use; its re-use may result in loss of sterility and serious
consequences for the patient’s health.
 The safety and effectiveness of NEAUVIA products for the treatment of tear trough, the perioral lines,
the glabella and the crow’s feet have not been established in controlled clinical trials. Caution should be
exercised in treating this part of the body. In order to avoid important complications, it is mandatory an
excellent knowledge of the anatomy, the injection must be performed by a skill injector.
REACTIONS TO TREATMENT AND POSSIBLE UNDESIRABLE EFFECTS
The physician must inform the patient of the potential undesirable effects associated with the use
of the product, which can occur immediately or a certain period of time after the treatment. Some
adverse reactions following the injection of hyaluronic acid have been reported in the literature. These
include, but are not limited to:
 Inflammatory reactions (redness, oedema, erythema, etc.) possibly associated to itching or pain to
pressure or both;
 Ecchymosis/Haematomas;
 Staining or discolouration around the injected area;
 Intolerance reactions;
 Hypersensitivity of the treated area;
 Infection;
 Poor filling effect;
 Displacement of the material;
 Numbness;
 Lumps;
 Papules and nodules in the injected area;
 Temporary or permanent vision impairment or blindness;
 Allergic reactions.
Report any adverse event (cited above or other) immediately to the physician if it lasts for more than 7 days.
The implant must be checked and treated appropriately.
The resolution of any adverse event related to the implant is strictly dependent on the timeliness of
intervention.
The Manufacturer and/or the Distributor of the product must be notified of any undesirable effect associated
with the treatment with NEAUVIA Hydro Deluxe; moreover, any serious incident that has occurred in
relation to the device shall be reported to manufacturer and the competent authority of the Member
State in which the user and/or patient is established.
STORAGE
 Store at a temperature between 4° C and 27° C.
 Do not expose to sunlight.
 Do not freeze and do not heat.
The Manufacturer declines all liability for direct, indirect or consequential damage caused by the
incorrect use or abnormal use of the medical device NEAUVIA Hydro Deluxe or by its use in any way other
than that described in this package leaflet. The qualified physician is responsible for verifying the
product’s suitability for the intended use, and thus takes all responsibilities and risks in this regard.

DISPOSAL
In order to avoid biological risks, handle and dispose of syringes and needles according to the
health facility’s procedures and the relevant local regulations.

The product must be used solely by physicians.

The SSCP is available in the European database on medical devices (Eudamed), linked to the Basic
UDI-DI (805373608M0H0D325W): https://ec.europa.eu/tools/eudamed

LFT03 Rev.02

Last revision date: 2022-11