Juvederm ULTRA  3 is a sterile pyrogen-free physiological solution of cross-linked hyaluronic acid which is not of animal origin. Moreover, the gel is presented in a graduated, pre-filled, disposable syringe. Also, each box contains two 1 mL Juvéderm® ULTRA 3 syringes, 4 single-use 27G1/2” sterile needles to be used only for injecting Juvéderm® ULTRA 3. Besides, there is an instruction leaflet and a set of labels in order to ensure traceability.

STERILISATION

The contents of the Juvéderm® ULTRA 3 syringes is sterilised by moist heat. The 27G1/2” needles are sterilised by radiation.

INDICATIONS

•  Firstly, Juvéderm® ULTRA 3 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.

• Secondly, the presence of lidocaine is meant to reduce the patient’s pain during treatment. CONTRA-INDICATIONS

• Also, do not inject Juvéderm® ULTRA  3 in the periorbital area (eyelids, crow’s feet) and glabellar region (forehead). The application of Juvéderm® ULTRA  3 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.

• Further, 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 3 must not be used in areas presenting cutaneous inflammatory and/or infectious processes (acne, herpes, etc.).

• Lastly, Juvéderm® ULTRA 3 should not be used simultaneously with laser treatment, deep chemical peels or dermabrasion. For surface peels, it is recommended not to inject the product if the inflammatory reaction generated is significant.

Juvéderm® ULTRA 3 must not be used in Patients :

-suffering from untreated epilepsy;

– who tend to develop hypertrophic scarring;

– with known hypersensitivity to hyaluronic acid and/or to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria;

– with known hypersensitivity to lidocaine or to amide-type local anaesthetics;

– suffering from porphyria;

– women who are pregnant or breastfeeding;

– Children.

• Hyaluronic Acid gel 24 mg
• Lidocaine hydrochloride 3 mg
• Phosphate buffer pH 7.2 q.s. 1 ml