Juvederm Ultra 4 2x1ml

• Cross-linked hyaluronic acid gel: 24 mg per ml, of non-animal origin (obtained by bacterial fermentation).
• 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.
• Sterile, pyrogen-free physiological solution in a graduated single-use pre-filled syringe. Each syringe contains 1 ml of product.
• HYLACROSS™ technology: Allergan's designation for its monophasic, homogeneous HA gels at 24 mg/ml. ULTRA 4 shares the exact concentration with ULTRA 2, ULTRA 3 and ULTRA SMILE: the difference between the four variants lies in the degree of gel cross-linking, which in ULTRA 4 is the highest of the range and determines its indication in the deep dermis and its malar projection capacity.

ULTRA 4 is the volumising end of the HYLACROSS™ range and the only one of the four ULTRA gels whose official indication includes cheekbone augmentation.

When to choose ULTRA 4 over its neighbours: compared with ULTRA 3, when the depression is exclusively deep and malar projection is sought; ULTRA 3 retains the mid-dermis indication that ULTRA 4 does not have. Compared with VOLUMA (20 mg/ml, VYCROSS®), when working in the deep dermis by the intradermal route: VOLUMA is indicated only for subcutaneous and supraperiosteal injections or in the deep dermis, and its instructions for use expressly contraindicate the lip, whereas ULTRA 4 does include lip augmentation. Compared with VOLUX (25 mg/ml), when the objective is the cheekbone rather than the creation of jawline or chin volume.

Injectable implant indicated for filling deep cutaneous depressions by injection into the deep dermis, as well as for lip augmentation and cheekbone augmentation.

• Deep cutaneous depressions and marked folds
• Cheekbone augmentation
• Lip augmentation and 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 27G ½", sterilised by irradiation, for exclusive use with this product.
• 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.
• Massage the treated area after injection to ensure uniform distribution of the product.
• Duration of correction: Allergan's instructions for use do not publish a duration figure for the ULTRA range; the degree and duration of correction depend on the type of defect treated, the tissue stress at the implant site, the depth of the implant and the injection technique.
• 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.
• The composition of the product is compatible with the magnetic fields used in magnetic resonance imaging.

• 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.