Juvederm Volift 2x1ml

• Cross-linked hyaluronic acid gel: 17.5 mg per ml, of non-animal origin.
• 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 with high cross-linking efficiency. It produces a gel of homogeneous texture and lower water uptake at a moderate total HA concentration — in VOLIFT® this balance translates into a gel with supporting capacity in the deep dermis yet flexible in highly mobile areas such as the lower facial third.

VOLIFT® is the transition point of the VYCROSS® range between dermal filling and volumising: it works in the deep dermis and labial mucosa, not in the supraperiosteal plane, which corresponds to VOLUMA® and VOLUX™.

When to choose VOLIFT® over its neighbours: compared with VOLBELLA® (15 mg/ml), when the depression is deep rather than a fine line, and when structural support is required for facial contouring. Compared with VOLUMA® (20 mg/ml), when injecting into the deep dermis rather than the subcutaneous or supraperiosteal plane, and when the lip forms part of the treatment plan — the instructions for use of VOLUMA® contraindicate the lip, whereas those of VOLIFT® explicitly include it. Compared with ULTRA 3 and ULTRA 4 (24 mg/ml, HYLACROSS™), when documented duration and lower post-treatment water uptake are the priority.

Injectable implant indicated for:

• Deep cutaneous depressions associated with premature ageing (nasolabial fold, marionette lines)
• Facial contouring and volume restoration to correct structural defects of the face such as asymmetries, contour deformities or volume loss
• Lips, cheeks, chin and lower facial third

Injection plane: deep dermis or labial mucosa.

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

• Route of administration: intradermal injections and injections into the labial mucosa only.
• Needles included: 4 units of 30G ½", sterilised by irradiation, for exclusive use with this product.
• Cannulas accepted by the manufacturer: sterile Easyflow System-20 cannulas of 30G × 19 mm (ref. 94323), 30G × 25 mm (ref. 94324), 27G × 25 mm (ref. 94325), 27G × 38 mm (ref. 94326) and 25G × 38 mm (ref. 94327). The 25G cannula is not recommended for the lip indication. The choice of length is for the practitioner according to their technique.
• 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 17.5 mg/ml formulation with 0.3 % lidocaine (Juvéderm® VOLLURE™ XC, VYC-17.5L) in the nasolabial fold, with 123 subjects: 93.2 % responders at month 6 and 59.4 % at month 18 (improvement ≥ 1 point on the nasolabial fold severity scale). Usual total volume for optimal correction: 1.7 ml per treatment area; touch-ups require approximately one third of that volume.
• 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 30G 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.