Juvederm Volbella 2x1ml

• Cross-linked hyaluronic acid gel: 15 mg per ml, of non-animal origin. It is the lowest concentration in the Juvéderm® range together with SKINVIVE™ (12 mg/ml).
• Lidocaine hydrochloride: 3 mg per ml (0.3 %), included to reduce patient pain during treatment.
• Phosphate buffer pH 7.2 q.s. to 1 ml.
• Cross-linking agent: butanediol diglycidyl ether (BDDE) in trace amounts (< 2 ppm).
• VYCROSS® technology: a combination of high- and low-molecular-weight hyaluronic acid. The greater cross-linking efficiency makes it possible to maintain gel performance at a lower total HA concentration, with a homogeneous texture and lower water uptake — which in VOLBELLA® translates into a fluid gel, suitable for superficial planes and for areas of thin skin.

VOLBELLA® is the lowest-concentration VYCROSS® gel intended for filling (SKINVIVE™, at 12 mg/ml, is not a volumiser but a skin quality treatment). It is the only product in the range with an infraorbital indication documented in its package insert.

When to choose VOLBELLA® over its neighbours: compared with SKINVIVE™, when there is a depression to be filled (a marked fine line, tear trough, lip volume) and not merely a deficit in skin quality. Compared with VOLIFT® (17.5 mg/ml), when working in the superficial or mid dermis rather than the deep dermis, and when a 32G needle is required. Compared with ULTRA 2 and ULTRA SMILE (24 mg/ml, HYLACROSS™), when a more subtle result and a more fluid integration in thin skin are sought, or when the area is the infraorbital region — contraindicated or restricted throughout the ULTRA range.

Injectable implant indicated for:

• Fine lines and medium-sized cutaneous depressions associated with premature ageing
• Lip augmentation and projection, and correction of structural lip defects such as asymmetries, contour deformities or volume loss
• Infraorbital cutaneous depressions (tear trough)

Injection planes by area: superficial or mid dermis and labial mucosa for lines and lips; submuscular / preperiosteal plane for treatment of the infraorbital region.

Contraindicated areas: do not inject into the eyelids. It is not indicated for breast augmentation or reconstruction.

Specific warning for the infraorbital region: no clinical data are available on infraorbital treatment in patients with a pre-existing tendency to infraorbital oedema. The practitioner must assess the patient's medical history and infraorbital anatomy and physiology before indicating treatment, and must warn of the possible increased risk of prolonged oedema.

• Needles included: 4 units of 32G ½", sterilised by irradiation, for exclusive use with this product.
• Alternatives accepted by the manufacturer: sterile 30G ½" needle, or sterile 30G cannula — Easyflow System-20 of 30G × 19 mm (ref. 94323 / HPC30019ACSH) and 30G × 25 mm (ref. 94324 / HPC30025ACSH). If a cannula is used in the infraorbital region, use the introducer needle to create the entry point below the orbital rim.
• Infraorbital region with a needle: insert the needle below the orbital rim, perpendicular to the skin surface, and inject into the submuscular / preperiosteal plane.
• Aspiration beforehand: after inserting the needle and before injecting, it is recommended to withdraw the plunger slightly to verify that the needle is not intravascular.
• Immediate blanching: stop the injection and massage the area until normal colour returns.
• Inject slowly and with the minimum pressure necessary. If the needle becomes blocked, do not increase pressure on the plunger: stop the injection and replace the needle.
• Manufacturer's annual limit: no safety data are available for the injection of more than 20 ml of Allergan dermal fillers per 60 kg of body weight per year.
• Interval between sessions: wait for side effects to resolve, with a minimum interval of 2 weeks between two injections.
• Do not overcorrect: injecting an excessive volume may cause tissue necrosis and oedema.
• Documented duration: in the pivotal study registered with the FDA for this same 15 mg/ml formulation with 0.3 % lidocaine (Juvéderm® VOLBELLA® XC) — lip augmentation: 80.3 % responders at month 3 and 61.8 % at 12 months (n = 168); infraorbital region: 83.3 % responders at month 3 and 73.4 % at 12 months (n = 105).
• Aftercare: no make-up for the following 12 hours; avoid prolonged exposure to the sun and to UV rays, temperatures below 0 °C, sauna and hammam for the following two weeks.

• Storage: between 2 °C and 25 °C. Fragile product. Do not use after the expiry date stated on the label.
• Do not use the syringe if the contents show signs of separation or a cloudy appearance.
• Single-use product. Do not reuse or re-sterilise: sterility cannot be guaranteed after reuse.
• Sterilisation: syringe contents by moist heat; needles by irradiation.
• The pack includes: 2 pre-filled syringes of 1.0 ml, 4 sterile needles of 32G ½", instruction leaflet and a set of traceability labels.
• Used needles must be disposed of in appropriate containers; never straighten a bent needle.

Contraindications: untreated epilepsy; tendency to hypertrophic scarring; known hypersensitivity to hyaluronic acid or to Gram-positive bacterial proteins (the HA is obtained from bacteria of the genus Streptococcus); hypersensitivity to lidocaine or to amide-type local anaesthetics; porphyria; pregnancy and breastfeeding; minors. Do not inject into areas with inflammatory or infectious skin processes (acne, herpes). Do not inject intravascularly. Do not overcorrect.

Incompatibilities: hyaluronic acid is incompatible with quaternary ammonium salts such as benzalkonium chloride; avoid all contact with these substances or with instruments treated with them. No interactions with other local anaesthetics are known.

Precautions and individual assessment: there are no clinical data on efficacy and tolerance in patients with autoimmune disease, immunodeficiency or immunosuppressive therapy, nor in patients with a history of severe or multiple allergies — the indication is assessed case by case and a prior skin test is recommended; in case of a history of anaphylactic shock, it is recommended not to inject. Patients with a history of streptococcal disease (recurrent pharyngitis, acute rheumatic fever) should undergo a prior skin test. Warn patients on anticoagulant or antiplatelet therapy of the increased risk of bleeding and bruising. Because of the presence of lidocaine, combination with drugs that reduce or inhibit hepatic metabolism (cimetidine, beta blockers) is not recommended, and caution is advised in patients with cardiac conduction disorders.

Do not use simultaneously with laser, deep chemical peels or dermabrasion. With superficial peels, do not inject if the inflammatory reaction generated is significant.

Vascular risk: serious adverse events have been reported in association with intravascular injection of facial dermal fillers — temporary or permanent visual impairment, blindness, cerebral ischaemia or haemorrhage with stroke, skin necrosis and injury to underlying structures. Stop the injection immediately in the event of any visual change, sign of stroke, skin pallor or unusual pain.

Always consult the instructions for use enclosed in the packaging before application.