Description
Injectable implant indicated for filling medium skin sagging through injection into the mid-dermis and for lip contouring. The presence of Lidocaine aims to reduce the patient’s pain sensation during treatment.
Composition
Gel based on hyaluronic acid 24 mg;
Lidocaine hydrochloride 3 mg;
phosphate buffer pH 7.2 q.s.p. 1 g.
One syringe contains 0.55 mL of Juvéderm® ULTRA 2.
Sterilization
The contents of the Juvéderm® ULTRA 2 syringes are sterilized by moist heat.
The needles 30G1/2″” are sterilized by irradiation.
Contraindications
– Do not inject Juvéderm® ULTRA 2 into the eyelid.
The use of Juvéderm® ULTRA 2 in the under-eye 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 (intravasculature).
– Do not exceed the corrective action.
– Juvéderm® ULTRA 2 should not be used:
on patients suffering from uncontrolled epilepsy through treatment;
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 breastfeeding;
on children.
– Juvéderm® ULTRA 2 should not be used on areas with inflammatory and/or infectious skin problems (acne, herpes, etc.).
– Juvéderm® ULTRA 2 should not be used in immediate association with laser treatment, deep chemical peeling, or dermabrasion. In the case of superficial peeling, it is recommended not to inject if the inflammatory reaction caused is significant.
Precautions for Use
– Juvéderm® ULTRA 2 is indicated exclusively for intradermal injections and in the mucosa of the lips.
– In general, the injection of medical devices carries a risk of infection.
– There are no clinical data available in terms of effectiveness and tolerance for the injection of Juvéderm® ULTRA 2 in 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 clinical data available in terms of effectiveness and tolerance for the injection of Juvéderm® ULTRA 2 in patients with pre-existing or active autoimmune disease. The doctor will therefore need to decide the indication case by case, depending on the type of disease and associated treatment, and must ensure particular monitoring of these patients. In particular, it is recommended to propose a double preliminary test to these patients and not to inject them if the disease is progressive.
– There are no clinical data available in terms of tolerance for the injection of Juvéderm® ULTRA 2 in patients with a history of multiple severe allergies or anaphylactic shock. The doctor will therefore need to decide the indication case by case, depending on the type of allergy, and must ensure particular monitoring of these at-risk patients. In particular, it may be decided to propose a double test or a suitable preventive treatment before any injection.
– Patients with a history of streptococcal disease (recurrent pharyngitis, acute rheumatic fever) must undergo a double test before any injection. In cases of acute rheumatic fever with cardiac localization, it is recommended not to perform injections.
– Patients undergoing anticoagulant treatment (anticoagulants, aspirin, non-steroidal anti-inflammatory drugs) should be warned of the increased potential risk of bruising and bleeding during injection.
– There are no data available regarding the safety of injecting a volume greater than 20 mL of Juvéderm® ULTRA 2 with lidocaine for 60 kg of body weight per year.
– The association of Juvéderm® ULTRA 2 with certain medicines to decrease or inhibit liver metabolism (cimetidine, beta-blockers, etc.) is not recommended.
– Juvéderm® ULTRA 2 must be used with caution in patients with cardiac conduction problems.
– Recommend the patient not to wear makeup in the 12 hours following the injection, to avoid prolonged exposure to the sun, UV rays, temperatures below 0 °C, and the practice of saunas or hammams during the two weeks following the injection.
– If the needle is blocked, do not increase pressure on the piston, stop the injection, and replace the needle.
– Athletes should be aware that this product contains an active ingredient that may induce a positive reaction in tests conducted during anti-doping checks.
– The surgeon should be aware 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.
Incompatibilities
There is a known incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride.
It will therefore be necessary to avoid allowing Juvéderm® ULTRA 2 to come into contact with such products or with medical-surgical instruments treated with this type of product.
There are no known interactions with other local anesthetics.
Side Effects
The patient must 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, the following are reported (list not exhaustive):
– Inflammatory reactions (redness, edema, erythema, etc.), sometimes associated with itching and tenderness or both, that may manifest after the injection. Such reactions may persist for a week.
– Bruising.
– Hardening or lumps at the injection site.
– Discoloration or depigmentation of the injection area.
– Poor treatment effectiveness or poor filling effect.
– Cases of necrosis in the glabellar region, abscesses, granulomas, and immediate or delayed hypersensitivity have been described in the literature following injections of hyaluronic acid and/or lidocaine. It is therefore necessary to consider such potential risks.
– The persistence of inflammatory reactions beyond one week or the onset of other side effects must be promptly reported by the patient to their doctor, who must provide for the elimination of such reactions through appropriate treatment.
– Any other unwanted side effect related to the injection of Juvéderm® ULTRA 2 must be reported to the distributor and/or the manufacturer.
Dosing and Usage
– This device must be injected into the dermis or the mucosa of the lips by a qualified physician according to the applicable local regulations. The technical skill of the physician is essential for the success of the treatment; therefore, the device must be used by physicians who have received specific training related to the injection technique for filling.
– Juvéderm® ULTRA 2 must be used in its original packaging provided. Any modification or use of this product different from the usage conditions defined in this manual may damage its sterility, its homogeneity, and its performance, which thus can no longer be guaranteed.
– Before starting treatment, it is recommended to inform the patient of the indications and contraindications of the device itself, its incompatibilities, and the potential side effects that may occur.
– Before injection, proceed to thoroughly disinfect the area to be treated.
– Remove the needle cap. Then, firmly inserting the needle provided with the product onto the end of the syringe, carefully twist in a clockwise direction.
Make an additional 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, pulling in opposite directions to separate them.
Inject slowly.
Failure to adhere to these precautions may involve the risk of needle escape and/or product loss 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 an even distribution of the product.
Warnings
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 the needles (0123 TSK Laboratory, Japan):
Representative for Europe: Emergo Europe
Molenstraat 15
2513 BH The Hague (NL).
Used needles should be disposed of in a designated container. Proceed in the same way for syringes. For their disposal, refer to the prevailing regulations.
Do not attempt to straighten a bent needle: dispose of it and replace it.
Storage
Store at a temperature between 2°C and 25°C.
Format
Each package contains 2 syringes of 0.55 mL of Juvéderm® ULTRA 2, 2 sterile needles 30G1/2″”, single-use and reserved for the injection of Juvéderm® ULTRA 2, the instructions for use and a series of labels to ensure traceability.
CE mark registration number
0459 (2007).
Code 94127JR
Product Code
* The application of the product is reserved exclusively for professional healthcare operators with appropriate qualifications.
