The composition may be subject to variations, so we advise you to always check the list on the purchased product.
Composition:
Cross-linked sodium hyaluronate 23 mg/ml.
With 0.3% lidocaine hydrochloride
Phosphate buffer pH 6.8-7.3 q.s.p.,
Sodium chloride.
The device should not be used in:
- patients with a tendency to develop hypertrophic or keloid scars and pigmentation disorders.
- patients with a history of autoimmune diseases or who are undergoing immunity treatment.
- Patients with a known hypersensitivity to Hyaluronic Acid.
- Patients in whom permanent fillers have already been injected into the area to be treated.
- Pregnant or Milk feeding women.
- Patients under 18 years of age.
Patients taking anticoagulants or anti-platelet agents (e.g. acetylsalicylic acid) should not be treated with the device without consulting their doctor. The device must not be used in areas with skin reactions or inflammatory and/or infectious processes (e.g. acne, herpes, etc.). The device must not be used in association with laser treatment, chemical peeling, dermabrasion or mesotherapy.
Precautions for use:
The use of this device is reserved for doctors who have received specific training in the injection technique for filling wrinkles. Sensitive skin may be pre-treated with a cream or local anaesthetic patch. Dispose of the syringe, remaining product and needle in a special container after use.
Undesirable effects:
Physicians should inform patients of adverse reactions and/or incompatibilities potentially associated with the implantation of this device, which may occur immediately or at a later date. The following reactions and adverse reactions have been observed with the device or similar products:
abscesses, angioedema, bacterial infections, bulging/bumping, bleeding, bruising, burning, discolouration (depigmentation), discomfort oedema, erythema, hypertonicity, granulomas, haematoma, herpes reactivation, hypersensitivity, implant site mass, visible implant, induration, inflammation, irritation, itching, livid lesions after accidental arterial embolisation, malar oedema, migration, necrosis due to vascular damage, nodules (inflammatory and non-inflammatory), numbness, pain, paresthesia, puncture marks, redness, retinal artery occlusion, skin scarring, scleromyxedema (generalised), telangiectatic swelling, tenderness, vasculitis, vascular spasm, vasovagal reaction during injection, loss of vision due to retinal artery occlusion.
In very rare cases, injections of other soft tissue fillers into the glabellar region and nasal wings have resulted in retinal artery occlusion. Reactivation of the herpes virus may occur in rare cases following direct needle injury to neural axons or tissue manipulation and inflammatory reaction following injection of a filler. Dissection of the sub-epidermal plane when using a fan-shaped injection needle may increase the incidence of local adverse reactions. Too superficial placement of the filler or uneven distribution of the injected product may lead to the appearance of visible nodules and piles in the skin. It is therefore important to be aware of these possible complications. Patients should inform their doctor as soon as possible of any inflammatory reaction lasting more than a week or of any other side effect. Any other adverse reactions associated with the injection of the device should be reported to the distributor and/or manufacturer.
Check the integrity of the syringe and the expiry date before use. Do not use a syringe with an open or displaced protective cap inside the protective packaging. Only use syringes or needles supplied by the manufacturer. Do not handle/twist the needle. Do not reuse; quality and sterility can only be guaranteed for a syringe in its original packaging. Reuse of the device entails a risk of infection for patients or users. If the 27G and W needle is obstructed, do not increase the pressure on the plunger rod, but interrupt the injection and replace the needle. There are no clinical data (efficiency, Tolérance) available concerning the injection of the device into a bone already treated with another filling product. Do not inject into blood vessels, bones, tendons, ligaments, nerves or muscles. Do not inject into the periorbital area (including the lacrimal fold, upper periorbital rim and eyelids), the glabella or the wings of the nose. Do not inject into nevi. Do not overcorrect. Patients should be advised not to apply make-up for 12 hours after injection and to avoid prolonged exposure to the Sun and UV rays as well as the use of saunas or Turkish baths for one week after injection. To avoid any risk of mobility of the product, patients should be advised not to massage the treatment site in the days following the injection. There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds such as benzalkonium chloride solutions. The device must therefore never be placed in contact with these substances or with medical or surgical instruments which have been in contact with these substances.
The device must be stored between 2 and 25°C / 36 and 77°F in a dry place in the original packaging, protected from light, heat and freezing. Handle with care.
The list of ingredients may be subject to variations, so we advise you always to check the list on the product purchased.
