JUVEDERM VOLBELLA

at Harley Street, London

Juvederm-Volbella-1ml

COMPOSITION
Hyaluronic acid gel 15 mg
Lidocaine hydrochloride 3 mg
Phosphate buffer pH 7.2 q.s. 1 mL

One syringe contains 1mL of Juvéderm®
VOLBELLA® with Lidocaine.

DESCRIPTION
Juvéderm® VOLBELLA® with Lidocaine is a sterile pyrogen-free physiological solution of cross- linked hyaluronic acid (HA) which is not of animal origin. The gel is presented in a graduated pre- filled disposable syringe. Each box contains two 1mL Juvéderm® VOLBELLA® with Lidocaine syringes, 4 single-use 30G1/2”
sterile needles to be used only for injecting Juvéderm® VOLBELLA® with Lidocaine, an instruction leaflet and a set of labels in order to ensure traceability.

STERILISATION
The contents of the Juvéderm® VOLBELLA® with Lidocaine syringes are sterilised by moist heat . The 30G1/2” needles are sterilised by radiation.

INDICATIONS
• Juvéderm® VOLBELLA® with Lidocaine is an injectable implant intended for the treatment of any fine lines and medium-sized skin depressions due to conditions such as premature ageing.
• Juvéderm® VOLBELLA® with Lidocaine can also be used for enhancement and pouting of the lips.
• Juvéderm® VOLBELLA® with Lidocaine is intended to be used via superficial or middermis injection or lips mucosa injection by an authorised medical practitioner.
• The presence of lidocaine is meant to reduce the patient’s pain during treatment.

CONTRA-INDICATIONS
• Do not inject Juvéderm® VOLBELLA® with Lidocaine into the eyelids. The application of Juvéderm® VOLBELLA® with Lidocaine in the bags under the eyes is reserved to specialists specifically trained in this technique and having a sound knowledge of the physiology for this particular area.
• Do not inject into the blood vessels (intravascular). Intravascular injection may lead to embolisation, occlusion of the vessels, ischaemia or infarction.
• Do not overcorrect.
• Juvéderm® VOLBELLA® with Lidocaine must not be used in :
-patients suffering from untreated epilepsy;
-patients who tend to develop hypertrophic
scarring;
-patients with known hypersensitivity to hyaluronic acid and/or to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria;
-patients with known hypersensitivity to lidocaine or to amide-type local anaesthetics;
-patients suffering from porphyria;
-women who are pregnant or breastfeeding;
-children.
• Juvéderm® VOLBELLA® with Lidocaine must not be used in areas presenting cutaneous inflammatory and/or infectious processes (acne, herpes, etc.).
• Juvéderm® VOLBELLA® with Lidocaine should not be used simultaneously with laser treatment, deep chemical peels or dermabrasion. For surface peels, it is recommended not to inject the product if the inflammatory reaction generated is significant.

PRECAUTIONS FOR USE
• Juvéderm® VOLBELLA® with Lidocaine is indicated only for injections for intra-dermal injections and injections in mucous membrane of the lips.
• Medical practitioners must take into account the fact that this product contains lidocaine.
• Juvéderm® VOLBELLA® with Lidocaine is not intended for use in breast augmentation/ reconstruction.
• As a matter of general principle, injection of a medical device is associated with a risk of infection. Standard precautions associated with injectable materials should be followed.
• There is no available clinical data about injection of Juvéderm® VOLBELLA® with Lidocaine into an area which has already been treated with a non–ALLERGAN dermal filler.
• It is recommended not to inject into a site which has been treated with a permanent implant.
• No clinical data is available regarding the efficiency and tolerance of Juvéderm® VOLBELLA® with Lidocaine injections in patients having a history of, or currently suffering from, autoimmune disease or autoimmune deficiency or being under immunosuppressive therapy. The medical practitioner shall therefore decide on the
indication on a case-by-case basis, according to the nature of the disease and its corresponding treatment, and shall also ensure the specific monitoring of these patients. In particular, it is recommended that these patients undergo a preliminary skin testing for hypersensitivity and to refrain from injecting the product if the disease is active.
• There is no available clinical data regarding the tolerance of the Juvéderm® VOLBELLA® with Lidocaine injection in patients presenting a history of severe and/or multiple allergies. The medical practitioner shall therefore decide on the indication on a case-by-case basis, according to the nature of the allergy, and shall also ensure the specific monitoring of these at-risk patients. In particular, the decision may be taken to propose skin
testing for hypersensitivity or suitable preventive treatment prior to any injection. In case of history of anaphylactic shock, it is recommended not to inject the product.
• Patients showing a history of streptococcal disease (recurrent sore throats, acute rheumatic fever) shall be subjected to skin testing for hypersensitivity before any injection is administered. In the event of acute rheumatic fever with heart complications, it is recommended not to inject the product.
• Patients on anti-coagulation medication or using substances that can prolong bleeding (warfarin, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, or other substances known to increase coagulation time such as
herbal supplements with garlic or ginkgo biloba, etc.) must be warned of the potential increased risks of bleeding and haematomas during injection.
• There is no data available regarding the safety of injecting greater amount than 20 mL of ALLERGAN dermal fillers per 60 kg (130 lbs) body mass per year.
• Due to presence of lidocaine, the combination of Juvéderm® VOLBELLA® with Lidocaine with certain drugs that reduce or inhibit hepatic metabolism (cimetidine, beta- blockers, etc.) is not recommended.
• Due to presence of lidocaine, Juvéderm® VOLBELLA® with Lidocaine should be used with caution in patients showing symptoms of cardiac conduction disorders.
• Please recommend that the patient not use any makeup during the 12 hours following the injection treatment and that any extended exposure to the sun, UV rays and temperatures below 0°C be avoided, as well as any sauna or hammam sessions during the two weeks following the injection treatment.
• The composition of this product is compatible with fields used for magnetic resonance imaging.

INCOMPATIBILITIES
Hyaluronic acid is known to be incompatible with quaternary ammonium salts such as benzalkonium chloride. Juvéderm® VOLBELLA® with Lidocaine should therefore never be placed in contact with these substances or
with medical-surgical instrumentation which has been treated with this type of substance. There is no known interaction with other local anaesthetics.

UNDESIRABLE EFFECTS
The patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed. These include, but are not limited to:
• Inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching, and/or pain on pressure and/ or paraesthesia, occurring after the injection. These reactions may last for a week. In particular, it has to be noted that injection in the mucous membrane may cause more oedema and bruising due to the specific
physiology of these tissues. Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended.
• Haematomas.
• Induration or nodules at the injection site.
• Staining or discolouration of the injection site might be observed, especially when HA dermal filler is injected too superficially and/or in thin skin (Tyndall effect).
• Poor effect or weak filling effect.
• Rare but serious adverse events associated with intravascular injection of dermal fillers in the face and tissue compression have been reported and include temporary or permanent vision impairment, blindness, cerebral ischaemia or cerebral haemorrhage, leading to stroke, skin necrosis and damage to underlying structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in the vision, signs of stroke, blanching of the skin or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate medical practitioner specialist should an intravascular injection occur. Abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have also been reported. It is therefore advisable to take these potential risks into account.
• Patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible. The medical practitioner should use an appropriate treatment.
• Any other undesirable side effects associated with injection of Juvéderm® VOLBELLA® with Lidocaine must be reported to the distributor and/or to the manufacturer.

METHOD OF USE – POSOLOGY
• This product is designed to be injected into the dermis or the mucous membrane of the lips by an authorised medical practitioner in accordance with local applicable regulation. In order to minimise the risks of potential complications and as precision is essential to a successful treatment, the product should be only used by medical practitioners who have appropriate training and experience in injection techniques for filling skin depression, face contouring and volume restoration. They have to be knowledgeable about the anatomy at and around the site of injection.
• Use of the supplied 30G 1/2” needle is recommended. However, depending on the medical practitioner’s preferred injection technique, it is possible to use a 30G sterile cannula (please refer to the list hereunder). Choice of cannula length is determined by the user according to his/her injection technique.

Material Number Description
94323/
HP30019ACSH
Easyflow System-20*
cannula 30G x 19mm.
94324/
HP30025ACSH
Easyflow System-20*
cannula 30G x 25mm.

• Contra-Indications, Method of use, Precautions for use and Warnings defined for the needle in this leaflet apply also to the cannula referenced above if used with this product.
• Juvéderm® VOLBELLA® with Lidocaine is to be used as supplied. Modification or use of the product outside the Directions For Use may adversely impact the sterility, homogeneity and performance of the product and it can
therefore no longer be assured.
• Prior to treatment , medical practitioners shall inform their patients about the product’s indications, contra-indications, incompatibilities and potential undesirable effects/risks associated with dermal fillers injection and ensure that patients are aware of signs and symptoms of potential complications.
• The area to be treated should be disinfected thoroughly prior to the injection.
• Remove tip cap by pulling it straight off the syringe as shown in fig. 1. Then firmly push the needle provided in the box (fig. 2) into the syringe, screwing it gently clockwise. Twist once more until it is fully locked and has the
needle cap in the position shown in fig. 3. If the needle cap is positioned as shown in fig. 4, it is incorrectly attached. Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other, as shown in fig. 5, and pulling the two hands in opposite directions. Prior to injecting, depress the plunger rod until the product flows out of the needle. Inject slowly and apply the least amount of pressure necessary. If the needle is blocked, do not increase the pressure on the plunger rod. Instead, stop the injection and replace the needle. Failure to comply with these precautions could cause a disengagement of the needle and/ or product leakage at luer-lock level and/or increase the risk of vascular compromise.
• After needle insertion and before injection, it is recommended to withdraw slightly the plunger to aspirate and verify the needle is not intravascular.
• If immediate blanching occurs at any time during the injection, the injection should be stopped and appropriate action taken such as massaging the area until its return to a normal colour.
• The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant in the tissue and the injection technique. The amount injected will depend
on the areas which are to be corrected based on the experience of the medical practitioner.
• Do not overcorrect as injection of an excessive volume can be at the origin of some side effects such as tissue necrosis and oedema.
• A touch up (for achieving optimal correction) and/or a repeat (for maintaining optimal correction) treatment with Juvéderm® VOLBELLA® with Lidocaine might be required.
• It is recommended to wait until side effects are resolved (with a minimal interval of 2 weeks) between two injections.
• It is important to massage the area treated after the injection in order to ensure that the substance has been uniformly distributed.

WARNINGS
• Check the expiry date on the product label.
• In the event that the content of the syringe shows signs of separation and/or appears cloudy, do not use the syringe.
• Do not re-use. Sterility of this device cannot be guaranteed if the device is re-used.
• Do not re-sterilise.
• For the needles ( 0123) :
- Used needles must be thrown away in the appropriate containers. Do the same for the syringes. Please consult the current applicable directives to ensure their correct elimination.
- Never try to straighten a bent needle; throw it away and replace it. Juvéderm® VOLBELLA® with Lidocaine gel
must be used prior to the expiration date printed on the package.

STORAGE CONDITIONS
•Store between 2°C and 25°C.
•Fragile.
•Shelf life: 2 years
Juvéderm® VOLBELLA® with Lidocaine contains trace amounts (<2ppm) of the cross linking agent butanediol diglycidyl ether (BDDE).



 
RSA_footer-id_Rupesh_Shah_Aesthetics_Botox_Clinic_Harley_Street_W1G_9PG_Ski
London Clinic
12 Harley St, London, W1G 9PG


Contact us to arrange a consultation:
Tel: 
0207 193 9717
Mob: 07956 576666
Email: rupesh@rupeshshahaesthetics.co.uk
HARLEY STREET LONDON CLINIC LOCATION


Luton Clinic
255 Birdsfoot Lane, Luton, LU3 2HX


Contact us to arrange a consultation:
Email: rupesh@rupeshshahaesthetics.co.uk
Tel: 01582 591616
Mob: 07956 576666
FOLLOW US: OPENING HOURS: TREATMENTS:

Monday: 9am - 9pm
Tuesday: 9am - 9pm
Wednesday: 9am - 9pm
Thursday: 9am - 9pm
Friday: 9am - 9pm
Saturday: 9am - 6pm
Sunday: 9am - 6pm

Rupesh Shah Aesthetics, Harley Street, London is a Save Face Accredited clinic.
We have been independently assessed against a robust set of standards in order to be certified as Save Face Accredited. Read more about our accreditation here.
B
LOG
Save Face

020 7193 9717
BOOK RUPESH
PRICE LIST
RUPESH SHAH
AESTHETICS
12 Harley Street, London, W1G 9PG
Mon - Fri 9am-9pm
Sat - Sun 9am-6pm

Rupesh Shah Aesthetics, Harley Street, London is a Save Face Accredited clinic.

We have been independently assessed against a robust set of standards in order to be certified as Save Face Accredited.
Read more about our accreditation here

Save Face
*Before & After photos are not guarantees that your results will be the same or even similar: each individual patient's results will vary.
Website design by SiteBuilder Bespoke