CE medical device, sterile, apyrogenic and physiologic cross-linked hyaluronic acid gel of nonanimal origin. The gel is sold in graduated, pre-filled, disposable syringes.
Injectable implant indicated for filling deep skin sagging by injection into the deep dermis and for lip and cheekbone volume augmentation. The presence of lidocaine is intended to reduce the patient’s pain sensation during treatment.
27G1/2″ needles are sterilized by irradiation.Contraindications
– Do not inject Juvéderm® ULTRA 4 into the periorbital (eyelid, dark circles area, crow’s feet) and glabellar region.
– Do not inject into blood vessels (intravascular).
– Do not overdo the corrective action.
– Juvéderm® ULTRA 4 should not be used:
On patients with a tendency to develop hypertrophic scars;
On patients with known hypersensitivity to hyaluronic acid;
On patients with known hypersensitivity to lidocaine or amide-type local anesthetics;
On patients with porphyria;
During pregnancy or lactation;
– Juvéderm® ULTRA 4 should not be used on areas with inflammatory and/or infectious skin problems (acne, herpes, etc.).
– Juvéderm® ULTRA 4 should not be used in immediate association with a laser treatment, deep chemical peel or dermabrasion. In case of superficial peeling, it is recommended not to inject if the inflammatory reaction caused is important.Precautions for use.
– Juvéderm® ULTRA 4 is indicated exclusively for injections intradermally and into the mucosa of the lips.
– In general, injection of medical devices carries a risk of infection.
– There are no clinical data available in terms of efficacy and tolerance on the injection of Juvéderm® ULTRA 4 into an area already treated with another filler product. It is recommended not to inject into an area treated with a permanent implant.
– There are no available clinical data in terms of efficacy and tolerance on Juvéderm® ULTRA 4 injection in patients with prior or active autoimmune disease. The physician will then need to decide the indication on a case-by-case basis, depending on the type of disease and associated treatment, and will need to ensure special surveillance of these patients. In particular, it is recommended that these patients be offered double pre-testing and not given injections if the disease is evolving.
– There are no clinical data available in terms of tolerance on Juvéderm® ULTRA 4 injection on patients with a history of multiple severe allergies or anaphylactic shock. Therefore, the physician will have to decide the indication on a case-by-case basis, depending on the type of allergy, and will have to ensure special surveillance of these at-risk patients. In particular, it may be decided to offer these patients double testing or suitable preventive treatment before any injection.
– Patients with a history of streptococcal disease (recurrent pharyngitis, acute rheumatic fever) should undergo a double test before any injection. In cases of acute rheumatic fever with cardiac localization, no injection is recommended.
– Patients on anti-coagulant treatment (anti-coagulants, aspirin, nonsteroidal anti-inflammatory drugs) should be warned of the increased potential risk of bruising and bleeding during injection.
– No data are available on the safety of injecting a volume greater than 20 mL of Juvéderm® ULTRA 4 with lidocaine per 60 kg of body mass per year.
– The association of Juvéderm® ULTRA 4 with certain medications for decreasing or inhibiting hepatic metabolism (cimetidine, beta blocker, etc.) is not recommended.
– Juvéderm® ULTRA 4 should be used with caution on patients with cardiac conduction problems.
– Advise the patient not to wear makeup in the 12 hours following the injection, avoid prolonged exposure to the sun, UV rays, temperatures below 0 °C, and sauna or hammam practice during the two weeks following the injection.
– If the needle is clogged, do not increase pressure on the piston, stop injection and replace the needle.
– Athletes should be aware that this product contains an active ingredient that can induce a positive reaction in tests practiced during doping control.
– The surgeon should be aware and keep in mind that this product contains lidocaine.
– The composition of the device makes the product compatible with fields used for magnetic resonance imaging.Incompatibility
There is a known incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. It will therefore be necessary to prevent Juvéderm® ULTRA 4 from coming into contact with such products or medical-surgical instrumentation treated with this type of product. There are no known interactions with other local anesthetics.Undesirable effects
The patient should be informed of the existence of potential side effects related to the implantation of this device that may appear immediately or after a period of time. Among them, the following are noted (non-exhaustive list):
– Inflammatory reactions (redness, edema, erythema, etc), sometimes associated with itching and pain to the touch or both, which may occur after injection. Such reactions may persist for up to a week.
– Hardening or nodules at the site of injection.
– Staining or discoloration of the injection zone.
– Poor treatment efficacy or poor filling effect.
– Cases of necrosis in the glabellar region, abscesses, granulomas, and immediate or delayed hypersensitivity have been described in the literature after injections of hyaluronic acid and/or lidocaine. It is therefore necessary to take such potential risks into account.
– The persistence of inflammatory reactions beyond a week or the appearance of other side effects should be promptly reported by the patient to his or her physician, who should arrange for the elimination of such reactions through appropriate treatment.
– Any other undesirable side effects related to Juvéderm® ULTRA 4 injection should be reported to the distributor and/or manufacturer.Posology and mode of use.
– This device must be injected into the dermis or mucosa of the lips by a licensed physician according to applicable local regulations. The technical skill of the physician is essential to the success of the treatment, so the device should be used by physicians who have received specific training related to the injection technique for filling.
– Juvéderm® ULTRA 4 should be used in its original packaging provided. Any modification or use of this product other than the conditions of use defined in this manual may harm its sterility, homogeneity and performance, which can therefore no longer be guaranteed.
– Before embarking on treatment, it is recommended that the patient be informed of the indications and contraindications of the device itself, its incompatibilities, and undesirable effects that may occur.
– Before injection, proceed to thoroughly disinfect the area to be treated.
– Remove the needle cap. Then, firmly inserting the needle supplied with the product onto the end of the syringe, gently screw in by turning clockwise. Make an additional turn until it locks and rotate until the needle cap is in the correct position. Then holding the syringe body in one hand and the needle cap in the other, pull in opposite directions to separate them. Inject slowly. Failure to follow these precautions may result in the risk of needle leakage and/or loss of product at the luer lock level.
– The amount of product to be injected will depend on the type of area to be corrected.
– After injection, it is important to massage the treated area to ensure even distribution of the product.Warnings
Check the expiration date on the package.
Do not reuse. If this device is reused, the sterility of the product cannot be guaranteed.
Do not sterilize a second time.
For needles ( 0123 TSK Laboratory, Japan):
Representative for Europe: Emergo Europe
2513 BH The Hague (NL).
Used needles should be disposed of in an appropriate container. Proceed in the same way for syringes. Refer to current guidelines for their elimination.
Do not try to straighten a curved needle: throw it away and replace it.Storage
Store at a temperature between 2 °C and 25 °C.Format
Each package contains 2 1 mL syringes of Juvéderm® ULTRA 4, 4 sterile 27G1/2″ needles, disposable and reserved for injection of Juvéderm® ULTRA 4, instructions for use and a set of labels to ensure traceability.CE Mark Registration Number
0459 (2007).Code. 94553JR