The composition may be subject to variations, so we advise you to always check the list on the purchased product.
Composition:
- 1 syringe of 1 ml
- 22 mg/ml of cross-linked HA with PEG
- Glycine and L-Proline
CONTRAINDICATIONS:
- Autoimmune skin diseases.
- Infections and inflammations (herpes, dermatitis, etc.) in situ or near the treatment area.
- Varicose veins in the area of administration.
- Patients undergoing treatment with anticoagulants.
- Patients undergoing radiotherapy or ultrasound in the area of administration.
- Patients with a known hypersensitivity to Hyaluronic Acid.
- Patients with a tendency to develop hypertrophic scars.
- Patients suffering from untreated epilepsy.
- Do not inject in pregnant or Milk feeding women.
- Do not inject in Children or young people under the age of 18.
- Do not inject in patients suffering from severe Allegy.
- Do not inject in patients already treated with temporary or permanent fillers in the same area.
- Do not inject into blood vessels.
- Do not use simultaneously with laser treatment, deep chemical peeling or dermabrasion.
- Do not inject into mammary glands or internal genitalia
PRECAUTIONS FOR USE:
Neauvia Intensive Rheology must be administered under suitable conditions, in an appropriate Environment.
Current rules of asepsis for injections must be strictly observed.
To ensure the efficiency of the treatment, the doctor must be qualified in the injection techniques of the filling agents.
WARNINGS:
- Do not use the product after the expiry date.
- Do not use the product if the packaging is damaged or if it has not been stored correctly.
- Do not use the product if it does not appear to be in normal condition (see "Description and composition").
- Packaging is disposable and CANNOT BE RESTORED.
- Once the packaging has been opened, the material must be used immediately: leftover product must be discarded.
- Do not use the same syringe for different patients.
- Do not use the same needle for corrections in different anatomical regions.
- Do not mix Neauvia Intensive Rheology with other substances.
- Do not bring Neauvia Intense Rheology into contact with quaternary ammonium salts such as benzalkonium chloride.
- Do not inject any type of drug into the gel.
- Neauvia Intense Rheology is for single use only; re-use may result in loss of sterility and consequences for the patient's health.
ANESTHESIA:
In order to reduce any possible allergic reaction, Neauvia Intense Rheology does not contain any anaesthetic.
- Assess the need for a local anaesthetic. In this case, it is preferable to use the local (truncal) nerve block technique.
- In patients with a history of known allergies, assess the appropriateness of anaesthesia.
REACTIONS TO THE TREATMENT AND POSSIBLE SIDE EFFECTS The doctor must inform the patient of the potential side effects associated with the administration of the product, which may occur immediately or some time after the injection. Studies have shown certain undesirable effects following the injection of Hyaluronic Acid.
These include but are not limited to:
- Inflammatory reactions (redness, oedema, erythema, etc.) which may be accompanied by itching or pain on pressure or both;
- Ecchymosis / haematomas;
- Induration or nodules at the injection site;
- Spotting or discoloured Skin around the injection site;
- Product intolerance reactions;
- Increased surface sensitivity;
- Infection;
- Unsatisfactory filling effect;
- Granuloma;
- Dislocation of material;
- Numbness;
- Blistering;
- Necrosis;
- Wounds and lumps;
- Allegy reactions.
If any of the above or other side effects last for more than a week, the implant should be checked by the doctor, who should use appropriate treatment.
The resolution of any implant-related adverse event is closely related to the speed of intervention.
The manufacturer and/or distributor must be informed of any adverse side effects associated with the injection of the product.
STORAGE:
- Store at a temperature between +4°C and +27°C
- Do not expose to direct sunlight.
- Do not freeze or heat.
The manufacturer declines all responsibility for direct, indirect or consequential damage caused by an error in use or abnormal use of the Neauvia Intense Rheology medical device by its use in a manner other than that described in this leaflet.
The user is responsible for verifying the suitability of the product for the intended use and therefore assumes all risk and liability in this regard.
DISPOSAL
In order to avoid biological hazards, syringes and needles must be handled and disposed of in accordance with the procedures of the healthcare establishment and the regulations in force. Neauvia Intensive Rheology should only be used by trained practitioners with good anatomical knowledge of the site to be treated
These class III medical devices are regulated health products which, under these regulations, bear the CE mark. Manufacturer : MATEX LAB SPA, via Carlo Urbani 2ang. via Enrico Fermi, Brindisi, Italy. Please read the instructions for use carefully. The use of these products requires the intervention of a health professional.
