The composition may be subject to variations, so we advise you to always check the list on the purchased product.
Composition:
Hyaluronic Acid Gel 15 mg
Lidocaine hydrochloride 3 mg
Phosphate buffer pH 7.2 q.s.p. 1 mL
One syringe contains 1mL of Juvéderm® VOLBELLATM with Lidocaine
CONTRAINDICATIONS
- Do not inject Juvéderm® VOLBELLATM with Lidocaine into the eyelid. The use of Juvéderm® VOLBELLATM with Lidocaine in the eye rim is reserved for practitioners specifically trained in this technique and with a good knowledge of the physiology of this region.
- Do not inject into blood vessels (intravascular). Intravascular injections can lead to embolisms, vascular occlusions, ischaemia or infarction.
- Do not overcorrect.
Juvéderm® VOLBELLATM with Lidocaine must not be used in :
- patients suffering from epilepsy not controlled by treatment ;
- patients with a tendency to develop hypertrophic scars;
- patients with a known hypersensitivity to hyaluronic acid and/or gram-positive bacterial Proteins, as hyaluronic acid is obtained from bacteria such as Streptococcus ;
- patients with a known hypersensitivity to lidocaine or amide-type local anaesthetics;
- patients suffering from porphyria;
- pregnant or Milk feeding women;
- children.
- Juvéderm® VOLBELLATM with Lidocaine must not be used on areas with inflammatory and/or infectious skin problems (acne, herpes, etc.).
- Juvéderm® VOLBELLATM with Lidocaine must 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 provoked is significant.
PRECAUTIONS FOR USE
- Juvéderm® VOLBELLATM with Lidocaine is not indicated for injections other than intra-dermal and into the mucosa of the Lips.
- The practitioner's attention is drawn to the fact that this product contains lidocaine and that he must take this into account.
- Juvéderm® VOLBELLATM with Lidocaine is not intended for breast augmentation/reconstruction.
- In general, the injection of medical devices carries a risk of infection. The usual precautions for an injectable product must be observed.
- There are no clinical data available on the injection of Juvéderm® VOLBELLATM with Lidocaine into an area that has already been treated with a filler not manufactured by ALLERGAN.
- It is recommended not to inject into a site treated with a permanent implant.
- There are no clinical data available in terms of efficiency and tolerance for the injection of Juvéderm® VOLBELLATM with Lidocaine in patients with a history of autoimmune disease or a deficiency of the immune system or who are undergoing immunosuppressive treatment. The practitioner will therefore have to decide on the indication on a case-by-case basis, depending on the nature of the disease and the associated treatment, and will have to ensure special monitoring of these patients. In particular, it is recommended that a hypersensitivity skin test be performed on these patients beforehand, and that they not be injected if the disease is progressive.
- No clinical data are available on the tolerability of injections of Juvéderm® VOLBELLATM with Lidocaine in patients with a history of severe and/or multiple allergies. The practitioner will therefore have to decide on the indication on a case-by-case basis, depending on the nature of the allergy, and will have to ensure special monitoring of these at-risk patients. In particular, it may be decided to carry out a hypersensitivity skin test or appropriate preventive treatment prior to any injection. In the event of a history of anaphylactic shock, it is recommended that the product not be injected.
- Patients with a history of streptococcal disease (recurrent angina, rheumatic fever) should undergo a hypersensitivity skin test prior to any injection. In the case of rheumatic fever involving the heart, it is recommended not to inject.
- Patients undergoing anti-coagulant treatment or using substances that may prolong bleeding (warfarin, acetylsalicylic acid, non-steroidal anti-inflammatory drugs, or other substances known to increase clotting time such as herbal Supplements containing garlic or ginkgo biloba, etc.) should be warned of the potential increased risk of bleeding and haematomas when injected.
- There are no data on the safety of injecting more than 20 mL of ALLERGAN fillers per 60kg of body weight per year.
- As this product contains lidocaine, the combination of Juvéderm® VOLBELLATM with Lidocaine with certain drugs that reduce or inhibit hepatic Metabolism (cimetidine, beta-blockers, etc.) is not recommended.
- As this product contains lidocaine, Juvéderm® VOLBELLATM with Lidocaine should be used with caution in patients with cardiac conduction disorders.
- Patients should be advised not to wear make-up for 12 hours after the injection and to avoid prolonged exposure to the Sun, UV rays, temperatures below 0°C, as well as saunas and steam baths for a fortnight after the injection.
- 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. Juvéderm® VOLBELLATM with Lidocaine should therefore never be placed in Contact with such products, or with medical and surgical equipment treated with this type of product.
There is no known interaction with other local anaesthetics.
UNDESIRABLE EFFECTS
The patient must be informed that there are potential side effects associated with the implantation of this device, which may occur immediately or may be delayed. These include (but are not limited to)
- Inflammatory reactions (redness, oedema, erythema...) which may be associated with itching, pain on pressure or tingling may occur after injection. These reactions may persist for up to a week. In particular, it should be noted that injection into the mucous membranes is likely to cause more oedema and haematomas due to the particular physiology of these tissues. The practitioner may therefore recommend a preventive anti-inflammatory treatment.
- Haematomas.
- Induration or nodules at the injection site.
- Colouring or discolouration of the injection area may be observed, particularly when the filler is injected too superficially into thin Skin (Tyndall effect).
- Poor efficiency or filling effect.
- Rare but serious adverse events associated with intravascular injection of facial fillers and tissue compression have been reported. These include temporary or permanent blurring of vision, blindness, cerebral ischaemia or haemorrhage leading to stroke, necrosis of the Skin and damage to underlying structures. Stop the injection immediately if a patient experiences any of the following symptoms, changes in vision, signs of stroke, blanching of the skin or unusual pain during or shortly after injection. Such patients should receive prompt medical attention and, if possible, assessment by a specialist physician if an intravascular injection occurs. Cases of abscess, granuloma and immediate or delayed hypersensitivity have also been reported following injection of Hyaluronic Acid and/or lidocaine. These potential risks should therefore also be taken into account.
- The persistence of inflammatory reactions beyond one week or the appearance of any other side effect must be reported by the patient to the practitioner as soon as possible, who will have to remedy the situation with appropriate treatment.
- Any other undesirable side effects related to the injection of Juvéderm® VOLBELLATM with Lidocaine should be reported to the distributor and/or manufacturer.
WARNINGS
- Check the expiry date on the label.
- If the contents of the syringe show signs of phasing and/or appear cloudy, do not use the syringe.
- Do not reuse. If this device is reused, the sterility of the product cannot be guaranteed.
- Do not resterilise.
- For needles ( 0123 TSK Laboratory, Japan):
European Representative :
Emergo Europe
Molenstraat 15
2513 BH The Hague (NL)
- Used needles should be disposed of in a special collector. Proceed in the same way for syringes. Refer to the directives in force for their disposal.
- Never attempt to straighten a bent needle, but discard and replace it.
STORAGE CONDITIONS
- Store between 2°C and 25°C.
- Fragile.
