JUVÉDERM® VOLBELLA® with Lidocaine

Juvéderm® VOLBELLA® with Lidocaine is an injectable implant intended for the treatment of any fine lines and medium-sized skin depressions due to conditions such as premature aging. The presence of lidocaine is meant to reduce the patient’s pain during treatment.

Juvéderm® VOLBELLA® with Lidocaine is an injectable implant intended to treat any fine lines, medium-sized, or infraorbital (area under the eyes or tear trough area) skin depressions due to conditions such as premature aging. It can also be used for enhancement and pouting of the lips. Juvéderm® VOLBELLA® with Lidocaine is intended to be used via superficial or mid-dermis injection or lips mucosa injection by an authorized healthcare professional. For the treatment of the infraorbital skin depressions (also known as tear trough area), it is recommended to inject in the submuscular/pre-periosteal plane. The presence of lidocaine is meant to reduce the patient’s pain during treatment.

Juvéderm® VOLBELLA® with Lidocaine is a sterile, pyrogen-free physiological solution of cross-linked hyaluronic acid (HA) which is not of animal origin. The gel is presented in a graduated pre-filled disposable syringe. Each box contains two 1mL Juvéderm® VOLBELLA® with Lidocaine syringes, 4 single-use 32G1/2” sterile needles to be used only for injecting Juvéderm® VOLBELLA® with Lidocaine, an instruction leaflet, and a set of labels in order to ensure traceability.

Contraindications:

• Do not inject Juvéderm® VOLBELLA® with Lidocaine into the eyelids. The application of Juvéderm® VOLBELLA® with Lidocaine in the infraorbital area is reserved for appropriately qualified healthcare professionals specifically trained in the appropriate injection technique and with a sound knowledge of the anatomy and physiology for 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® VOLBELLA® with Lidocaine must not be used in:
  • Patients suffering from untreated epilepsy;
  • Patients who tend to develop hypertrophic scarring;
  • Patients with known hypersensitivity to hyaluronic acid and/or to gram-positive bacterial proteins as hyaluronic acid is produced by Streptococcus-type bacteria;
  • Patients with known hypersensitivity to lidocaine or to amide-type local anesthetics;
  • Women who are pregnant or breastfeeding;
  • Patients suffering from porphyria;
  • Children.
• Juvéderm® VOLBELLA® with Lidocaine must not be used in areas presenting cutaneous inflammatory and/or infectious processes (acne, herpes, etc.).
• Juvéderm® VOLBELLA® with Lidocaine 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.

After-care:

• You should not use any makeup for at least 12 hours following the injection treatment.
• You should avoid extended exposure to the sun, ultraviolet (UV) rays, and temperatures below 0°C, as well as any sauna or hammam sessions, during the two weeks following the injection treatment.