JUVÉDERM® ULTRA SMILE

Juvéderm® ULTRA SMILE is a physiological solution:
- Based on cross-linked hyaluronic acid (24 mg/ml) with 0.3% lidocaine.
- Sterile, pyrogen-free, based on cross-linked hyaluronic acid of non-animal origin.
- Soft, smooth and natural result.

- ALLERGAN
- NAME: JUVEDERM ULTRA SMILE
- COMPOSITION: Hyaluronic acid gel 24mg, Lidocaine hydrochloride 3mg, Phosphate buffer pH 7.2 q.s. 1mL.
- PRESENTATION: 2 x 0.55 ml.
- NEEDLES: 2 x 30G1/2”.
- INDICATIONS: Increases the volume of the lips and reshapes their contours. Corrects medium to deep nasolabial folds. Reshapes cheeks and chin.
- INJECTION DEPTH: Injections into the medium to deep dermis or mucous membrane of the lips.
- DURATION: Up to 12 months.
- USE: Strict medical use.

- Syringes: 2 x 0.55 ml.
- Needles: 2 x 30G1/2”.
- Each pack contains 2 pre-filled disposable syringes of Juvéderm® ULTRA SMILE 0.55 ml, 2 needles (30G1/2”) reserved exclusively for injecting Juvéderm® ULTRA SMILE, the package insert and labels for product traceability.

Face and lip contour.

Hyaluronic acid gel 24mg, Lidocaine hydrochloride 3mg, Phosphate buffer pH 7.2 q.s. 1mL.

- Juvéderm® ULTRA SMILE is indicated exclusively for intradermal injections and into the mucous membrane of the lips.
- Physicians should be aware that this product contains lidocaine.
- Juvéderm® ULTRA SMILE is not indicated for breast augmentation/reconstruction surgery.
- In general, injection of medical devices carries a risk of infection. The standard precautions associated with injectable materials must be observed.
- There are no clinical data available on the injection of Juvéderm® ULTRA SMILE into an area that has already been treated with a non-ALLERGAN filling product.
- It is recommended not to inject into an area that has been treated with a permanent implant.
- There are no clinical data available in terms of efficacy and tolerability regarding the injection of Juvéderm® ULTRA SMILE in patients with a history of, or currently suffering from, an autoimmune disease or deficiency, or who are on immunosuppressive therapy. The doctor must therefore decide on the indication on a case-by-case basis, depending on the type of disease and associated treatment, and must also ensure specific monitoring of these patients. In particular, it is recommended that these patients undergo a preliminary skin test for hypersensitivity and that the product not be injected if the disease is in an active phase.
- There are no clinical data available in terms of tolerability on the injection of Juvéderm® ULTRA SMILE in patients with a history of severe and/or multiple allergies. The doctor will therefore have to decide the indication on a case-by-case basis, depending on the type of allergy, and will also have to ensure specific monitoring of these patients at risk. In particular, it could be decided to propose a skin test for hypersensitivity or a suitable preventive treatment before each injection. In case of previous cases of anaphylactic shock, it is recommended not to inject the product.
- Patients with a history of streptococcal disease (recurrent sore throat, acute rheumatic fever) should have a skin test for hypersensitivity before administering any injection. In cases of acute rheumatic fever with cardiac complications, it is recommended not to inject the product.
- Patients undergoing anti-coagulant treatment or using substances that may prolong bleeding (warfarin, acetylsalicylic acid, non-steroidal anti-inflammatory drugs, or other substances known to increase the clotting time such as herbal supplements with garlic or ginkgo biloba, etc.) should be warned of the increased potential risk of bleeding and bruising during injection.
- There are no data available on the safety of injecting more than 20mL of ALLERGAN filling products per 60kg body mass per year.
- Because of the presence of lidocaine, the association of Juvéderm® ULTRA SMILE with certain medicines that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc.) is not recommended.
- Due to the presence of lidocaine, Juvéderm® ULTRA SMILE should be used with caution in patients showing symptoms of cardiac conduction disturbances.
- Please advise the patient not to wear make-up in the 12 hours following the injection and to avoid prolonged exposure to the sun, UV rays, temperatures below 0°C, and also the practice of sauna or hammam during the two weeks following the injection.
- The composition of this product is compatible with the fields used in MRI examinations.

Do not inject Juvéderm® ULTRA SMILE into the peri-orbital (eyelids, crow's feet) and glabellar (forehead) region. The application of Juvéderm® ULTRA SMILE for dark circles under the eyes is reserved for medical specialists specifically trained in this technique and with a good knowledge of the physiology of this particular region.
Do not inject into blood vessels (intravascular). Intravascular injection may cause embolisation, occlusion of blood vessels, ischaemia or infarction.
Do not overdo corrective action.
Juvéderm® ULTRA SMILE must not be used in:
- Patients with untreated epilepsy;
- Patients with a tendency to develop hypertrophic scars;
- Patients with a known hypersensitivity to hyaluronic acid and/or gram-positive bacterial proteins, hyaluronic acid being of Streptococcus bacterial origin;
- Patients with a known hypersensitivity to lidocaine or amide-type local anaesthetics;
- Patients with porphyria;
- During pregnancy or lactation;
- Children.
Juvéderm® ULTRA SMILE should not be used on areas with inflammatory and/or infectious skin processes (acne, herpes, etc.).
Juvéderm® ULTRA SMILE should not be used in immediate association with a laser treatment, deep chemical peeling or dermabrasion. In the case of superficial peeling, it is recommended not to inject if the inflammatory reaction generated is significant.

Juvéderm® ULTRA SMILE is an injectable implant indicated for filling medium and/or deep skin depressions by injection into the medium and/or deep dermis, as well as for defining the lip contour and increasing lip volume.

The contents of Juvéderm® ULTRA SMILE syringes are sterilised by moist heat. The 30G1/2” needles are sterilised by irradiation.

INCOMPATIBILITY
There is a known incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. Therefore, Juvéderm® ULTRA SMILE should never be placed in contact with such substances or with medical-surgical material that has been treated with such substances. There are no known interactions with other local anaesthetics.