Description
Juvéderm Volumawith Lidocaine 2 X 1 ml
CE medical device, sterile, apyrogenic and physiologic cross-linked hyaluronic acid gel of nonanimal origin. The gel is sold in pre-filled disposable syringes. Injectable implant indicated for facial volume restoration. The presence of Lidocaine is intended to reduce pain during the injection procedure.
Format
Each box contains 2 syringes of Juvéderm® VOLUMA™ with Lidocaine, 4 sterile 27G1/2″ disposable needles reserved for injection of Juvéderm® VOLUMA™ with Lidocaine, instructions for use, and a set of labels to ensure traceability.
Composition
Hyaluronic acid 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 contents of Juvéderm® VOLUMA™with Lidocaine syringes are moist heat sterilized.
The 27G1/2″” needles are sterilized by irradiation.
Contraindications
Do not inject Juvéderm® VOLUMA™ with Lidocaine into the periorbital (eyelid, sub-ocular region, crow’s feet) and glabellar region, nor into the lips.
– Do not inject Juvéderm® VOLUMA™ with Lidocaine into blood vessels (intravascular).
– Do not overdo the 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 with a known hypersensitivity to hyaluronic acid;
In patients with known hypersensitivity to lidocaine or amide-type local anesthetics;
In patients with porphyria;
During pregnancy or lactation;
In children.
– Juvéderm® VOLUMA™ with Lidocaine should not be used on skin regions that have inflammatory and/or infectious type conditions (acne, herpes…).
– b® VOLUMA™ with Lidocaine 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® VOLUMA™ with Lidocaine is not indicated for injections other than subcutaneously, supraperiosteally, or into 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, injection of medical devices carries a risk of infection.
– There are no available clinical data in terms of efficacy and tolerability regarding the injection of Juvéderm® VOLUMA™ with Lidocaine into an area that has already been 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 tolerability regarding the injection of Juvéderm® VOLUMA™ with Lidocaine in patients with prior or active autoimmune diseases. Therefore, the physician will 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. Specific monitoring of these patients will have to be ensured. In particular, it is recommended that these patients be tested twice beforehand and that injections should not be given if the disease is evolving.
– There are no clinical data available in terms of tolerability on the injection of Juvéderm® VOLUMA™ with Lidocaine in patients with a history of multiple severe allergies and/or anaphylactic shock. Therefore, the physician will need to decide the indication on a case-by-case basis, depending on the type of allergy, and should ensure special surveillance of these at-risk patients. In particular, it is recommended that these patients undergo double testing or suitable preventive treatment before any injection.
– Patients who present no history of streptococcal disease (relapsing pharyngitis, acute rheumatic fever) should be double tested before each injection. Injection treatment is not recommended in cases of acute rheumatic fever with cardiac involvement (endocarditis).
– Patients on anti-coagulant treatment (anti-coagulants, aspirin or, nonsteroidal anti-inflammatory drugs) should be warned of the increased potential risk of bruising and bleeding during 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 greater than 20 mL of Juvéderm® VOLUMA™ with Lidocaine per 60 kg of body mass per year.
– The association of Juvéderm® VOLUMA™with Lidocaine with certain medications that may cause reduction or inhibition of hepatic metabolism (cimetidine, beta blocker…) 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 in the 12 hours following the injection and to avoid prolonged exposure to the sun, UV light, temperatures below 0 °C, and also the practice of sauna or hammam during the two weeks following the injection.
– Advise the patient to avoid massaging the implantation area and/or applying pressure to it for several days after the injection.
– If the needle is clogged, do not increase pressure on the piston; stop injection and replace the needle.
– Athletes should be made aware that this product contains an active ingredient that can induce a positive reaction to doping tests.
– The physician should be made aware and take into account that this product contains lidocaine.
– The composition of the device makes the product compatible with the performance of MRI examinations.
Incompatibility
There is a known incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. It is therefore advisable never to put Juvéderm® VOLUMA™with Lidocaine in contact with such products or with medical-surgical material treated with this type of product.
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), which may be associated with itching and pain on pressure. They may occur after injection and persist for up to a week.
– Hematoma.
– Hardening or nodules at the injection site.
– Staining or discoloration of the injected area.
– Poor efficacy or reduced filling/restoration effect in 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 take such potential risks into account.
– The persistence of inflammatory reactions beyond a week or the appearance of other undesirable effects should be promptly reported by the patient to his or her physician, who should arrange for appropriate treatment to be implemented for its resolution.
– Any other side effects related to the injection of Juvéderm® VOLUMA™ with Lidocaine should be reported to the distributor and/or manufacturer.
Posology and mode of use:
– This device manufactured by Allergan is intended to be injected slowly into the deep dermis or supra-periosteal area or subcutaneous area by a licensed physician according to applicable local regulations.
– Juvéderm® VOLUMA™ with Lidocaine should be used in its original packaging provided. Any modification or use of this product other than the conditions of use defined in this sheet may harm its sterility, homogeneity and performance, which can therefore no longer be guaranteed.
– Because its technicality is essential to successful treatment, this device must be used by physicians who have received specific training in volume restoration injection techniques. A good knowledge of the anatomy and physiology of the area to be treated is necessary.
– Before embarking on treatment, the patient should be informed of the device’s indications, contraindications, incompatibilities, and potential side effects.
– Before injection, carry out rigorous preliminary disinfection of the area to be treated.
– Local or locoregional anesthesia can be used if necessary. In this case, the instructions for the use of such products must be followed.
– Remove the needle cap by pulling it off. 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. Holding the syringe body 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 a 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 If this device is reused, the sterility of the product cannot be guaranteed.
Do not resterilize.
For needles ( 0123, TSK Laboratory, Japan):
Representative for Europe: Emergo Europe
Molenstraat 15
2513 BH The Hague (NL)
Used needles should be disposed of inside a designated container. Proceed in the same way for syringes. Refer to current guidelines for their proper disposal.
Do not try to straighten a curved needle: throw it away and replace it.
Conservation
Store at a temperature between 2 °C and 25 °C.
CE Mark Registration Number
0459 (2009).
* The application of the product is reserved only for professional health workers with appropriate qualifications.
