Juvederm Ultra 3 Injectable implant indicated for filling medium and deep skin sagging by injection. The presence of lidocaine is intended to reduce the patient’s pain sensation during treatment.
CE medical device, sterile, pyrogen-forming and physiological gel of cross-linked hyaluronic acid of non-animal origin. The gel is sold in graduated syringes, previously filled and disposable.
Injectable implant indicated for filling medium and deep skin sagging by injection into the middle and / or deep dermis, as well as for increasing the volume and contour of the lips.
The presence of lidocaine is intended to reduce the patient’s pain sensation during treatment.
Gel based on hyaluronic acid 24 mg;
lidocaine hydrochloride 3 mg; phosphate buffer pH 7,2 q.s.p. 1 mL.
One syringe contains 1 mL of Juvéderm® ULTRA 3.
The contents of the Juvéderm® ULTRA 3 syringes are sterilized by wet heat.
The 27G1/2″ needles are sterilized by irradiation.
– Do not inject Juvéderm® ULTRA 3 into the periorbital (eyelid, crow’s feet) and glabellar (forehead) region. The use of Juvéderm® ULTRA 3 in the dark circles area is reserved for doctors who have received specific training related to this technique and possess a good knowledge of the physiology of this region.
– Do not inject into blood vessels (intravascular).
– Do not exceed in corrective action.
– Juvéderm® ULTRA 3 should not be used:
-on patients suffering from uncontrolled epilepsy through treatment;
on patients with a tendency to develop hypertrophic scars;
on patients who have a known hypersensitivity to hyaluronic acid;
on patients who have a known hypersensitivity to lidocaine or local anesthetics of the amide type;
on patients suffering from porphyria;
during pregnancy or lactation;
– Juvéderm® ULTRA 3 should not be used on areas that have inflammatory and/or infectious skin problems (acne, herpes, etc.).
– Juvéderm® ULTRA 3 should not be used in immediate combination with laser treatment, deep chemical peeling or dermabrasion. In case of superficial peeling, it is recommended not to inject if the provoked inflammatory reaction is important.
Precautions for use
– Juvéderm® ULTRA 3 is indicated exclusively for injections of the intradermal type and into the mucous membrane of the lips.
– In general, the 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 3 in an area already treated with another filling product. It is recommended not to inject into a treated area with a permanent implant.
– There are no clinical data available in terms of efficacy and tolerance on the injection of Juvéderm® ULTRA 3 in patients with previous or active autoimmune disease. The doctor will then have to decide on the indication on a case-by-case basis, depending on the type of disease and the associated treatment and will have to ensure special surveillance of these patients. In particular, it is recommended to offer these patients a double preliminary test and not to give them injections if the disease is evolutionary.
– There are no clinical data available in terms of tolerance on The injection of Juvéderm® ULTRA 3 in patients with a history of multiple severe allergies or anaphylactic shock. The doctor will then have to decide on the indication on a case-by-case basis, depending on the type of allergy and will have to ensure a particular surveillance of these patients at risk. In particular, it may be decided to offer these patients a double test or a 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 case of acute rheumatic fever with cardiac localization, it is recommended not to make injections.
– Patients undergoing anti-coagulant treatment (anti-coagulants, aspirin, nonsteroidal anti-inflammatories) should be advised of the increased potential risk of hematomas and bleeding during the injection.
– No data are available on the safety of injection of more than 20 mL of Juvéderm® ULTRA 3 with lidocaine per 60 kg of body mass per year.
– The combination of Juvéderm® ULTRA 3 with certain medicinal products for the decrease or inhibition of hepatic metabolism (cimetidine, beta-blocker, etc.) is not recommended.
– Juvéderm® ULTRA 3 should be used with caution on patients with cardiac conduction problems.
– Recommend the patient not to wear make-up during the 12 hours following the injection, to avoid prolonged exposure to the sun, UV rays, temperatures below 0 ° C and the practice of sauna or hammam during the two weeks following the injection.
– If the needle is clogged, do not increase the pressure on the piston, stop the injection and replace the needle.
– Athletes should be aware that this product contains an active ingredient that can induce a positive reaction in tests carried out during anti-doping control.
– Your doctor should be aware of and take into account that this product contains lidocaine.
– The composition of the device makes the product compatible with the fields used for magnetic resonance imaging.
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 3 from coming into contact with these products or with medical surgical equipment treated with this type of product. There are no known interactions with other local anesthetics.
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 certain period of time. Among these, they are reported (non-exhaustive list):
– Inflammatory reactions (redness, edema, erythema, etc.), sometimes associated with itching and pain to the touch or both, which may occur after the injection. Such reactions may persist for a week.
– Hardening or nodules at the place where the injection was given.
– Staining or discoloration of the injection area.
– Poor effectiveness of treatment 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 these potential risks into account.
– The persistence of inflammatory reactions beyond the week or the appearance of other side effects should be promptly reported by the patient to his doctor, who should eliminate these reactions through appropriate treatment.
– Any other side effects related to the injection of Juvéderm® ULTRA 3 should be reported to the distributor and/or manufacturer.
Dosage and method of use
– This device should be injected into the dermis or mucous membrane of the lips by a qualified doctor according to the applicable local regulations. The technical skill of the doctor is essential for the success of the treatment, therefore the device should be used by doctors who have received specific training related to the injection technique for filling.
With this product, the “nappage” technique can also be used.
– Juvéderm® ULTRA 3 must 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, its homogeneity and its performance, which can therefore no longer be guaranteed.
– Before embarking on treatment, it is recommended to inform the patient of the indications and contraindications of the device itself, its incompatibilities and the side effects that may occur.
– Before the injection, proceed to thoroughly disinfect the area to be treated.
– Remove the needle cap by pulling it.
Then, firmly inserting the needle supplied with the product on the end of the syringe, gently screw by turning clockwise. Make an extra turn until it locks and rotate until the needle cap is in the correct position.
Then hold the body of the syringe in one hand and the needle cap in the other, pull in the opposite directions to separate them.
Failure to comply with these precautions may result in the risk of needle leakage and/or product loss at the level of the luer lock.
– The amount of product to be injected will depend on the type of area to be corrected.
– After the injection, it is important to massage the treated area so as to ensure a uniform distribution of the product.
Check the expiration date on the package.
Do not reuse. In case of reuse of this device, 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 must be disposed of in a special container. Proceed in the same way for syringes. For their elimination, please refer to the directives in force.
Do not try to straighten a curved needle: throw it away and replace it.
Store at a temperature between 2°C and 25°C.
Each pack contains 2 syringes of 1 mL of Juvéderm® ULTRA 3, 4 sterile needles 27G1/2″, disposable and reserved for the injection of Juvéderm® ULTRA 3, instructions for use and a series of labels to ensure traceability.
CE Mark Registration Number