Juvederm Ultra 2 - 2 Syringes Of 0.55Ml

Fillers Juvéderm Ultra 2 CE medical device, sterile gel, pyrogen-free and physiological, made of non-animal derived cross-linked hyaluronic acid. The gel is sold in graduated syringes, pre-filled and for single use.
Injectable implant indicated for filling moderate skin sagging through injection into the mid-dermis and for lip contouring. The presence of Lidocaine aims to reduce patient discomfort during treatment.

Composition
Gel based on hyaluronic acid 24 mg;
Lidocaine hydrochloride 3 mg;
Phosphate buffer pH 7.2 qs.p. 1 g.
One syringe contains 0.55 mL of Juvéderm® ULTRA 2.

Sterilization
The contents of Juvéderm® ULTRA 2 syringes are sterilized by moist heat.
The 30G1/2"" needles 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 physicians who have received specific training related to this technique and have a good understanding of the physiology of this region.
- Do not inject into blood vessels (intravasculary).
- Do not exceed the corrective action.
- Juvéderm® ULTRA 2 must not be used:
in patients with uncontrolled epilepsy;
in patients prone to developing hypertrophic scars;
in patients with known hypersensitivity to hyaluronic acid;
in patients with known hypersensitivity to lidocaine or other amide-type local anesthetics;
in patients with porphyria;
during pregnancy or breastfeeding;
in children.
- Juvéderm® ULTRA 2 must not be used on areas with inflammatory and/or infectious skin problems (acne, herpes, etc.).
- Juvéderm® ULTRA 2 must not be used immediately in conjunction with laser treatment, deep chemical peeling, or dermabrasion. In case of superficial peeling, it is recommended not to inject if the inflammatory reaction is significant.

Precautions for use
- Juvéderm® ULTRA 2 is indicated solely for intradermal and lip mucosa injections.
- Usually, injection of medical devices carries a risk of infection.
- No clinical data are available regarding the efficacy and tolerability of injecting Juvéderm® ULTRA 2 in an area already treated with another filler product. It is recommended not to inject in an area with a permanent implant.
- No clinical data are available on the efficacy and tolerance of injecting Juvéderm® ULTRA 2 in patients with previous or active autoimmune disease. The physician must then decide on a case-by-case basis, considering the type of disease and associated treatment, and monitor these patients carefully. It is particularly recommended to propose a double preliminary test to these patients and avoid injections if the disease is progressive.
- No clinical data are available on the safety of injecting more than 20 mL of Juvéderm® ULTRA 2 with lidocaine per 60 kg of body weight per year.
- The combination of Juvéderm® ULTRA 2 with certain medications that reduce or inhibit liver metabolism (cimetidine, beta-blockers, etc.) is not recommended.
- Juvéderm® ULTRA 2 should be used with caution in patients with conduction problems.
- Advise the patient not to makeup within 12 hours after injection, to avoid prolonged exposure to sun, UV rays, temperatures below 0 °C, and to refrain from sauna or hammam during the two weeks following injection.
- If the needle is blocked, do not increase pressure on the plunger, pause the injection, and replace the needle.
- Athletes should be aware that this product contains an active substance that can give a positive result in doping tests.
- The surgeon must be aware and take into account that this product contains lidocaine.
- The composition makes the product compatible with magnetic resonance imaging fields.

Incompatibility
There is a known incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride.
It is therefore necessary to avoid contact of Juvéderm® ULTRA 2 with such products or with medical surgical instruments treated with these.
No known interactions with other local anesthetics.

Adverse effects
The patient should be informed about potential side effects related to the implantation of this device, which can occur immediately or after some time. These include (not exhaustive list):
- Inflammatory reactions (redness, swelling, erythema, etc.), sometimes with itching and pain on touch or both, that can appear after injection. Such reactions can last up to a week.
- Hematomas.
- Hardening or nodules at the injection site.
- Discoloration or decolorization of the injection area.
- Poor treatment efficacy or limited filling effect.
- Cases of necrosis in the glabellar region, abscesses, granulomas, and immediate or delayed hypersensitivity reactions have been reported in the literature after hyaluronic acid and/or lidocaine injections. It is therefore important to consider these potential risks.
- Persistence of inflammatory reactions beyond a week or appearance of other side effects should be promptly reported by the patient to their doctor, who will need to address these reactions with appropriate treatment.
- Any other undesirable side effect related to the injection of Juvéderm® ULTRA 2 should be reported to the distributor and/or manufacturer.

Dosage and method of use
- This device must be injected into the dermis or lip mucosa by a qualified medical professional in accordance with applicable local regulations. The technician's skill is crucial for successful treatment; therefore, the device should be used only by physicians trained specifically in injection techniques for filling.
- Juvéderm® ULTRA 2 must be used in its original packaging. Any modifications or use of this product beyond the specified conditions can compromise its sterility, homogeneity, and performance, which can no longer be guaranteed.
- Before starting treatment, inform the patient about the device's indications and contraindications, its incompatibilities, and potential side effects.
- Before injection, disinfect the treatment area thoroughly.
- Remove the needle cap. Then, firmly insert the needle supplied with the product onto the syringe tip, and gently tighten by turning clockwise.
Make an extra turn until it locks and turn until the needle cap is in the correct position.
Hold the syringe body in one hand and the needle cap in the other, then pull apart in opposite directions to separate.
Inject slowly.
Failure to follow these precautions could lead to needle expulsion or product loss at the luer lock.
- The amount of product to inject depends on the area to be corrected.
- After injection, it is important to massage the treated area to ensure uniform distribution of the product.

Warnings
Check the expiration date on the package.
Do not reuse. If this device is reused, sterility cannot be guaranteed.
Do not sterilize again.
For the needles (0123 Laboratorio TSK, Japan):
European representative: Emergo Europe
Molenstraat 15
2513 BH The Hague (NL).
Used needles should be disposed of in a designated container. Follow the same procedure for syringes. For disposal, refer to current regulations.
Do not attempt to straighten a bent needle: discard 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 30G1/2"" needles, for single use and designated for Juvéderm® ULTRA 2 injection, the instructions for use, and a series of labels to ensure traceability.

CE mark registration number
0459 (2007).

Code. 94127JR

922864350