Nazione: Bielorussia
Lingua: russo
Fonte: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Teoxane S.A., ШВЕЙЦАРИЯ
изделия медицинского назначения
Teoxane S.A.
2020-10-02
EN - INSTRUCTIONS FOR USE DESCRIPTION TEOSYAL RHA® 1 is a sterile, transparent, non-pyrogenic, viscoelastic gel of both crosslinked and non-crosslinked hyaluronic acid of non-animal origin and contains 0.3 % by mass of lidocaine hydrochloride, for its anaesthetic properties. Each box contains two pre-filled syringes of TEOSYAL RHA® 1. For each syringe, the box contains two sterile 30G1/2” needles and two traceability labels (one to be given to the patient, and one to be kept by the doctor in the patient medical record). The volume of each syringe is indicated on the cardboard box as well as on each syringe. COMPOSITION Hyaluronic acid 15 mg/mL Lidocaine hydrochloride 0.3% by mass Phosphate buffer pH 7.3 q.s. ad 1 mL INDICATIONS Therapeutic indications of TEOSYAL® products: Reconstructive surgery, filling of depressions due to scars, reconstruction of volumes lost by lipoatrophy in patient undergoing HIV treatment. Aesthetic indications of TEOSYAL® products: Modification of aged skin: restoration of volumes, filling of skin depression and wrinkles, restoration of skin hydration. TEOSYAL RHA® 1 is indicated for the even filling of fine superficial wrinkles (such as perioral rhytids, upper lip border and philtrum), skin cracks and lines, as well as for the correction of withered skin marked by signs of ageing on the face, neck and neckline. It is also indicated for skin folds (including circles under the eyes). Lidocaine hydrochloride is a local anaesthetic agent designed to reduce the sensation of pain. MODE OF ACTION Hyaluronic acid is a major constituent of the ground substance of the dermal extracellular matrix. A genuine molecular sponge, its helicoidal structure enables it to trap up to a thousand times its weight in water. It is widely distributed in cutaneous tissues and hydrates the skin, though its content diminishes with age. As the skin becomes thinner and fragile, initial skin fracture lines appear. For the correction of fine lines/wrinkles affecting a withered skin marked by signs of ageing (exc Leggi il documento completo