Juvederm Voluma Syringes 2 X 1Ml

Fillers Juvéderm Voluma

With Lidocaine 2 X 1 ml

CE medical device, sterile gel, pyrogen-free and physiological cross-linked hyaluronic acid of non-animal origin. The gel is sold in pre-filled single-use syringes. Injectable implant indicated for restoring facial volumes. The presence of Lidocaine aims to reduce pain during the injection procedure.

Format
Each box contains 2 syringes of Juvéderm® VOLUMA™ with Lidocaine, 4 sterile 27G1/2” single-use needles, reserved for the injection of Juvéderm® VOLUMA™ with Lidocaine, the instructions for use, and a set of labels to ensure traceability.

Composition
Hyaluronic acid-based gel 20 mg;
lidocaine hydrochloride 3 mg;
phosphate buffer pH 7.2 q.s.p. 1 mL.
One syringe contains 1 mL of Juvéderm® VOLUMA™ with Lidocaine.

Sterilization
The content of the Juvéderm® VOLUMA™ with Lidocaine syringes is sterilized by moist heat.
The 27G1/2"" needles are sterilized by irradiation.

Contraindications
Do not inject Juvéderm® VOLUMA™ with Lidocaine in the periorbital region (eyelid, subocular region, crow's feet) and glabellar area, nor in the lips.
- Do not inject Juvéderm® VOLUMA™ with Lidocaine into blood vessels (intravenous).
- Do not exceed in corrective action.
- Juvéderm® VOLUMA™ with Lidocaine should not be used:
in patients with untreated epilepsy;
in patients with a tendency to develop hypertrophic scars;
in patients who present a known hypersensitivity to hyaluronic acid;
in patients who present a known hypersensitivity to lidocaine or to amide-type local anesthetics;
in patients with porphyria;
during pregnancy or breastfeeding;
in children.
- Juvéderm® VOLUMA™ with Lidocaine should not be used on skin areas with inflammatory and/or infectious disorders (acne, herpes...).
- Juvéderm® VOLUMA™ with Lidocaine 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® VOLUMA™ with Lidocaine is not indicated for injections other than subcutaneous, supraperiosteal, or in the hypodermis. The technique and depth of injection vary depending on the area to be treated.
- Juvéderm® VOLUMA™ with Lidocaine is not recommended for intramuscular injections.
- In general, the injection of medical devices carries a risk of infection.
- No clinical data are available regarding effectiveness and tolerability concerning the injection of Juvéderm® VOLUMA™ with Lidocaine in an area that has already been treated with another filler product. It is recommended not to inject in an area treated with a permanent implant.
- No clinical data are available regarding effectiveness and tolerability concerning the injection of Juvéderm® VOLUMA™ with Lidocaine in patients with pre-existing autoimmune diseases or in an active phase. The physician should therefore decide the indication on a case-by-case basis, depending on the type of disease and associated treatment, and should ensure specific monitoring of these patients. In particular, it is recommended to subject these patients to a double pre-test and not to perform injections if the disease is progressive.
- There are no clinical data available regarding tolerability concerning the injection of Juvéderm® VOLUMA™ with Lidocaine in patients with a history of multiple severe allergies and/or anaphylactic shock. The physician should therefore decide the indication on a case-by-case basis, depending on the type of allergy, and should ensure specific monitoring of these at-risk patients. In particular, it is recommended to subject these patients to a double test or appropriate preventive treatment before any injection.
- Patients with a history of streptococcal disease (recurrent pharyngitis, acute rheumatic fever) should undergo a double test before each injection. Injectable treatment is not recommended in cases of acute rheumatic fever with cardiac involvement (endocarditis).
- Patients undergoing anticoagulant treatment (anticoagulants, aspirin, or non-steroidal anti-inflammatory drugs) should be warned of the increased potential risk of bruising and bleeding during the injection.
- Do not inject more than 2 mL per treatment area during each session.
- No data are available regarding the safety of injecting a volume exceeding 20 mL of Juvéderm® VOLUMA™ with Lidocaine per 60 kg of body weight per year.
- The combination of Juvéderm® VOLUMA™ with Lidocaine with certain medications that may cause a reduction or inhibition of hepatic metabolism (cimetidine, beta-blockers...) is not recommended.
- Juvéderm® VOLUMA™ with Lidocaine should be used with caution in patients with cardiac conduction disorders.
- Advise the patient not to wear makeup for the 12 hours following the injection and to avoid prolonged exposure to the sun, UV rays, temperatures below 0 °C, as well as sauna or hammam practices during the two weeks following the injection.
- Advise the patient to avoid massaging the implantation area and/or applying pressure for a few days after the injection.
- If the needle is blocked, do not increase the pressure on the plunger; stop the injection and replace the needle.
- Athletes should be made aware that this product contains an active ingredient that may induce a positive reaction in anti-doping tests.
- The doctor should be made aware and take into account that this product contains lidocaine.
- The composition of the device makes the product compatible with magnetic resonance imaging tests.

Incompatibility
There is a known incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. It is therefore advisable not to put Juvéderm® VOLUMA™ with Lidocaine in contact with such products, nor with medical-surgical material treated with this type of product.

Adverse effects
The patient must be informed of the potential adverse 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 (non-exhaustive list):
- Inflammatory reactions (redness, edema, erythema, etc.), which may be associated with itching and pain upon pressure. They may occur after the injection and persist for a week.
- Bruises.
- Hardening or nodules at the injection site.
- Discoloration or fading of the injected area.
- Poor effectiveness or reduced filling/restoration effect of the treated area.
- 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 consider these potential risks.
- Persistence of inflammatory reactions beyond a week or the appearance of other adverse effects should be promptly reported by the patient to their doctor, who must ensure appropriate treatment for resolution.
- Any other adverse effect related to the injection of Juvéderm® VOLUMA™ with Lidocaine must be reported to the distributor and/or the manufacturer.

Dosage and method of use:
- This device produced by Allergan is intended to be injected slowly into the deep dermis or the supraperiosteal area or into the subcutaneous tissue by a qualified physician according to applicable local regulations.

- Juvéderm® VOLUMA™ with Lidocaine must be used in its original packaging provided. Any modification or use of this product different from the defined usage conditions in this leaflet may harm its sterility, homogeneity, and performance, which can therefore no longer be guaranteed.
- Being its technicality essential for the success of the treatment, this device must be used by doctors who have received specific training in injection techniques for volume restoration. A good understanding of the anatomy and physiology of the area to be treated is required.
- Before starting treatment, the patient must be informed of the indications of the device, its contraindications, incompatibilities, and potential adverse effects.
- Prior to injection, a rigorous preliminary disinfection of the area to be treated should be performed.
- It is possible, if necessary, to use local or locoregional anesthesia. In this case, the instructions for the use of such products must be followed.
- Remove the cap of the needle by pulling it. Then, firmly inserting the needle provided with the product onto the end of the syringe, gently screw it in by rotating clockwise. Make an additional turn until it locks and rotate until the needle cap is in the correct position. Holding the body of the syringe in one hand and the 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 detachment 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 that the product is well distributed evenly.

Warnings
Check the expiration date on the labeling.
Do not reuse In case of reuse of this device, the sterility of the product cannot be guaranteed.
Do not re-sterilize.
For the needles (0123, TSK Laboratory, Japan):
Representative for Europe: Emergo Europe
Molenstraat 15
2513 BH The Hague (NL)
Used needles must be disposed of in a designated container. The same procedure applies to syringes. For their proper disposal, refer to the applicable 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.

CE trademark registration number

* The application of the product is reserved exclusively for qualified healthcare professionals.

0459 (2009).