PROPERTY
CE class III medical device.
Sterile, biodegradable and isotonic intradermal gel. It consists of a medium molecular weight hyaluronic acid (1.2-1.8 x 106 Dalton), produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. Each box contains one Jaluté syringe, two 30G ½" disposable sterile needles, intended for injection and a leaflet. There are two labels showing the batch number. One of these labels must be given to the patient to ensure traceability.
COMPOSITION
20 mg/ml sodium hyaluronate, sodium chloride, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dedecahydrate, water p.pthe One syringe contains 2.0 ml of non-pyrogenic gel, sterilized with moist heat.
INDICATIONS
Jaluté is indicated:
- in the physiological process of skin aging, whose effects include the thickening of the stratum corneum (roughness and less luminosity of the skin) and the alteration of the elastic fibers of the dermis ( wrinkles),
- in the process of repairing the dermal tissue, in cases of scarring following superficial skin trauma (e.g. scars from acne and chickenpox).
PRECAUTIONS FOR USE
Jaluté is indicated exclusively for intradermal injections. It is possible to pre-treat sensitive skin with creams or patches with local anesthetic action. Remember that anesthesia may cause local redness or hypersensitivity. There is no clinical data (efficacy, tolerance) on the injection of Jaluté into an area that has already been treated with another filler. It is necessary to inform patients not to apply cosmetic products for 12 hours after the injection and to avoid prolonged exposure to sunlight and UV rays, nor to frequent saunas or Turkish baths for a week after the injection. If the needle is blocked, do not increase the pressure on the plunger rod, but stop the injection and replace the needle. Do not inject into blood vessels. Do not inject Jaluté into bones, tendons, ligaments or muscles. Do not inject Jaluté into nevi (moles). After use, dispose of the syringe and remaining product. Do not use if the packaging is damaged.
METHODS OF USE
Inject Jaluté into disinfected, healthy and non-inflammatory skin. The technique used is fundamental to the success of the treatment. The medical device, therefore, must be used exclusively by doctors who have specific training in the injection technique. Before the injection, carefully disinfect the area to be treated. Use the 30G ½" needle supplied with the syringe and inject slowly using the appropriate injection technique. Assemble the syringe following the instructions below.
Inject Jaluté at room temperature and under strict aseptic conditions. Inject Jaluté intradermally with a linear or micro-wheal technique (picotage) at a medium-deep level.
The quantity injected depends on the wrinkle or depression to be corrected. After the injection the doctor can apply a light massage to evenly distribute the product. It is recommended to carry out an initial cycle of three treatment sessions, at intervals of one week from each other, possibly followed by monthly maintenance sessions.
WARNINGS
Before use, check the integrity of the syringe and the expiration date. Do not use needles or syringes other than those provided by the manufacturer. Do not reuse; quality and sterility are guaranteed only if the syringe has been sealed at the origin. Reusing the product carries the potential risk of infection for the patient or operator.
Do not resterilize. After use, dispose of the needle in a suitable container.
STORAGE
Store Jaluté at 2-25°C (36-37°F) in a dry place in the original box.
Protect from light, heat and frost and handle with care.
CE mark registration number 1014
