Description
Jevelle is a sterile medical device that is injectable, apyrogenic, and reabsorbable. It contains reticulated hyaluronic acid from bacterial fermentation. Jevelle comes in the form of a clear, colorless, consistent gel, contained in pre – filled disposable syringes with Luer – lock connector.
Composition
Jevelle Orbites: Concentrated reticulated hyaluronic acid. Sterile saline solution: q.s.
Jevelle Général: High concentration reticulated hyaluronic acid. Sterile saline solution: q.s.
Jevelle Bouche: High concentration reticulated hyaluronic acid. Sterile saline solution: q.s.
Jevelle Contour: Extreme concentration reticulated hyaluronic acid. Sterile saline solution: q.s.
Jevelle Volume: Extreme concentration reticulated hyaluronic acid. Sterile saline solution: q.s.
Jevelle Revitalisant: Concentrated hyaluronic acid with low degree of concentration. Sterile saline solution: q.s.
Action Mechanism
Jevelle’s action consists of boosting the volume of the dermal – epidermal tissue, based on the natural capacity of the hydrophilic molecules of hyaluronic acid to bond with an amount of water many times greater than their own weight. This makes it possible to fill the intradermal spaces and integrate the intercellular matrix, firming up the tissue. The reticulation of hyaluronic acid inside the product makes the filling effect more stable and longer lasting.
Instructions For Use
Jevelle is intended to be a temporary filler to correct skin defects such as wrinkles or scars. It is also suitable for use on pathological conditions such as lipoatrophy linked to HIV infection and anti – retroviral treatments. Particularly, the following use is recommended:
Jevelle Orbites to correct lines and surface wrinkles, from fine to medium lines. Defects and particularly indicated areas:
laughter lines, bar code lip lines, wrinkles around the eyes, scarring from acne, chickenpox.
Jevelle Général to correct deep facial wrinkles and furrows. Defects and particularly indicated areas: nasolabial furrows,
marionette mouth wrinkles, temples, reshaping facial contours, lips.
Jevelle Bouche to correct deep facial wrinkles and furrows. Defects and particularly indicated areas: nasolabial furrows,
marionette mouth wrinkles, temples, reshaping facial contours, lips.
Jevelle Contour to correct very deep facial wrinkles and to restore volume to the face. Defects and particularly indicated areas:
cheekbones, malar area, sub – zygomatic hollows, sub – malar area, chin.
Jevelle Volume to correct very deep facial wrinkles and to restore volume to the face. Defects and particularly indicated areas:
cheekbones, malar area, sub – zygomatic hollows, sub – malar area, chin.
Jevelle Revitalisant to correct light hollows and skin blemishes. Defects and particularly indicated areas: photoageing and
chronoageing on the face, lifeless, dehydrated skin.
Contraindications
Jevelle must not be used: in injection form in the periorbital area (eyelids, dark circles); by injection into blood vessels; to increase breast tissue or for insertion into bones, tendons, ligaments or muscles. Jevelle must not be administered to patients with: pre – existing or ongoing autoimmune diseases, or which are being treated with immunotherapy drugs; verified tendency to develop keloids or hypertrophic scars, or pigmentation disorders; serious multiple allergies; infections and inflammatory processes in or near the area to be treated; coagulation problems; recognized hypersensitivity to hyaluronic acid. Jevelle must not be used by pregnant or breastfeeding women or on persons under the age of 18 years.
Warnings
Jevelle is only intended for subcutaneous or intradermal injection, and must not be injected by intravascular means. When injecting, there is a potential risk of inadvertent injection of the material into a blood vessel. In rare cases, this could lead to vascular occlusion, abscess, necrosis or embolism. To ensure that the needle is not inside a blood vessel during normal use of the medical device, gently aspirate with the syringe before proceeding