Maa: Valko-Venäjä
Kieli: venäjä
Lähde: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
ALLERGAN, ФРАНЦИЯ
изделия медицинского назначения
ALLERGAN
2022-11-21
27 73 70 68 73912RX10 Revision 2022-06-30 ALLERGAN Route de Promery Zone Artisanale de Pré-Mairy Pringy 74370 Annecy - FRANCE Tel : +33 (0) 4 50 27 27 03 2 x 0.55 mL EN - Only for professional use FR - Réservé à un usage professionnel RU - Только для профессионального использования UK - Лише для професійного використання COMPOSITION Hyaluronic Acid gel 24 mg Lidocaine hydrochloride 3 mg Phosphate buffer pH 7.2 q.s. 1 mL One syringe contains 0.55 mL of _JUVÉDERM® ULTRA SMILE_. DESCRIPTION _JUVÉDERM® _ _ULTRA _ _SMILE_ is a sterile pyrogen-free physiological solution of cross-linked hyaluronic acid which is not of animal origin. The gel is presented in a graduated, pre-filled, disposable syringe. Each box contains two 0.55 mL _JUVÉDERM® _ _ULTRA _ _SMILE_ syringes, 2 single-use 30G1/2” sterile needles to be used only for injecting _ JUVÉDERM® _ _ULTRA SMILE_, an instruction leaflet and a set of labels in order to ensure traceability. STERILISATION The contents of the _ JUVÉDERM® ULTRA SMILE_ syringes is sterilised by moist heat. The 30G1/2” needles are sterilised by radiation. INDICATIONS • _ JUVÉDERM® ULTRA SMILE_ is an injectable implant used for filling mid and/or deep depressions of the skin via mid and/ or deep dermis injection, as well as for lip definition and enhancement. • The presence of lidocaine is meant to reduce the patient’s pain during treatment. CONTRA-INDICATIONS • Do not inject _ JUVÉDERM® ULTRA SMILE_ in the periorbital area (eyelids, crow’s feet) and glabellar region (forehead). The application of _ JUVÉDERM® ULTRA SMILE_ in the under- eye area is to be performed only by specialists specifically trained in this technique who have a sound knowledge of the physiology of this particular area. • Do not inject into the blood vessels (intravascular). Intravascular injection may lead to embolization, occlusion of the vessels, ischemia or infarction. • Do not overcorrect. • _ JUVÉDERM® ULTRA Lue koko asiakirja