Juvederm Volux 2x1ml

• Cross-linked hyaluronic acid gel: 25 mg per ml, of non-animal origin. The highest concentration in the Juvéderm® range.
• 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. In VOLUX™ the platform is taken to its maximum concentration to obtain a gel of high firmness, capable of supporting projected bony structures in the supraperiosteal plane while maintaining the low water uptake characteristic of VYCROSS®.

VOLUX™ is the structural extreme of the range: maximum HA concentration and an exclusively deep injection plane. It is not a dermal product and its package insert allows no superficial intradermal indication.

When to choose VOLUX™ over its neighbours: compared with VOLUMA® (20 mg/ml), when the aim is to define and project the mandibular border or the chin rather than to restore volume in the middle third: the indication of VOLUMA® is to restore facial volume, that of VOLUX™ is to restore and create volume, and its clinical development has been carried out in the chin and jawline. Compared with ULTRA 4 (24 mg/ml, HYLACROSS™), when the work is supraperiosteal and not intradermal. Both products share the 27G ½" needle and the 2 ml limit per area and session.

Injectable implant indicated for restoring and creating facial volume.

• Chin and chin projection
• Jawline and mandibular angle
• Definition of the facial contour in the deep plane

Scope of the clinical data: the manufacturer states that clinical trials with VOLUX™ have been carried out in the chin and jawline; there are no controlled clinical data for other anatomical regions.

Contraindicated areas: periorbital region (eyelid, tear trough area, crow's feet), glabellar region and lips. Intramuscular injection is not recommended. It is not indicated for breast augmentation or reconstruction.

• Injection plane: subcutaneous and supraperiosteal only. Technique and depth vary according to the area to be treated.
• Needles included: 4 units of 27G ½", sterilised by irradiation, for exclusive use with this product.
• Cannula accepted by the manufacturer: 25G × 38 mm cannula (ref. PRC-25038ISG-020S, STERiGLIDE / STERiJECT). The contraindications, method of use, precautions and warnings defined for the needle also apply to this cannula.
• Manufacturer's dose limit: do not inject more than 2 ml per treatment area in each session.
• 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 25 mg/ml formulation with 0.3 % lidocaine (Juvéderm® VOLUX™ XC) in loss of jawline definition: 69.9 % responders at month 6 and 61.3 % at month 12 (improvement ≥ 1 point on the Allergan jawline definition loss scale). Median total volume injected in initial treatment plus touch-up: 6.8 ml; maintenance: 3.0 ml.
• 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 27G 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.